compression - Collegio Italiano di Flebologia
Transcription
compression - Collegio Italiano di Flebologia
COMPRESSION CONSENSUS DOCUMENT based on SCIENTIFIC EVIDENCE AND CLINICAL EXPERIENCES COMPRESSION impa.indd 1 20-05-2009 14:33:32 COMPRESSION impa.indd 2 20-05-2009 14:33:32 COMPRESSION CONSENSUS DOCUMENT BASED ON SCIENTIFIC EVIDENCE AND CLINICAL EXPERIENCES Editor Fabrizio Mariani International Board Claudio Allegra, Hans Bernbach, Werner Blättler, Vladimir Blazek, Albert Claude Benhamou, Jean Patrick Benigni, Monika Gniadecka, Horst Gerlach, Sergio Mancini, Michel Perrin, Hugo Partsch Task Force 2009 Teresa Lucia Aloi, Carlo Astara, Pier Antonio Bacci, Valerio Bianchi, Giuseppe Botta, Matteo Bucalossi, Giuseppe Castagna, Edoardo Colombo, Vincenzo Coscia, Stefano De Franciscis, Francesco Ferrara, Christian Gardon-Mollard, Vincenzo Gasbarro, Bertrand Lun, Marcello Izzo, Alberto Macciò, Vincenzo Mattaliano, Sergio Mancini, Stefano Mancini, Giovanni Mosti, Massimo Pisacreta With the collaboration of: Math for Tech-Vasaetech Centre Ferrara University EDIZIONI MINERVA MEDICA TORINO 2009 COMPRESSION impa.indd 3 20-05-2009 14:33:32 In collaboration with Le fotocopie per uso personale del lettore possono essere effettuate nei limiti del 15% di ciascun volume/fascicolo di periodico dietro pagamento alla SIAE del compenso previsto dall’art. 68, commi 4 e 5, della legge 22 aprile 1941 n. 633. Le riproduzioni effettuate per finalità di carattere professionale, economico o commerciale o comunque per uso diverso da quello personale possono essere effettuate a seguito di specifica autorizzazione rilasciata da AIDRO, Corso di Porta Romana n. 108, Milano 20122, e-mail [email protected] e sito web www.aidro.org ISBN-10: 88-7711-636-6 ISBN-13: 978-88-7711-650-5 © 2009 – EDIZIONI MINERVA MEDICA S.p.A. – Corso Bramante 83/85 – 10126 Torino Sito Internet: www.minervamedica.it / e-mail: [email protected] All rights reserved. No part of this publication may by reproduced, stored in a retrieval system, or transmitted in any form or by any means. COMPRESSION impa.indd 4 20-05-2009 14:33:32 Authors Editor Fabrizio Mariani (Italy) International Board Claudio Allegra (Italy) Hans Bernbach (Switzerland) Werner Blättler (Switzerland) Vladimir Blazek (Germany) Albert Claude Benhamou (France) Jean Patrick Benigni (France) Monika Gniadecka (Denmark) Horst Gerlach (Germany) Sergio Mancini (Italy) Michel Perrin (France) Hugo Partsch (Austria) Task Force 2009 Teresa Lucia Aloi, Pavia (Italy) Carlo Astara, Cagliari (Italy) Pier Antonio Bacci, Arezzo (Italy) Valerio Bianchi, Florence (Italy) Giuseppe Botta, Siena (Italy) Matteo Bucalossi, Siena (Italy) Giuseppe Castagna, Cagliari (Italy) Edoardo Colombo, Como (Italy) Vincenzo Coscia, Ferrara (Italy) Stefano De Franciscis, Catanzaro (Italy) Francesco Ferrara, Naples (Italy) Christian Gardon-Mollard, Chamalieres (France) Vincenzo Gasbarro, Ferrara (Italy) Marcello Izzo, Nola (Italy) Bertrand Lun, St. Etienne (France) Alberto Macciò, Savona (Italy) Sergio Mancini, Siena (Italy) Stefano Mancini, Siena (Italy) Vincenzo Mattaliano, Florence (Italy) Giovanni Mosti, Lucca (Italy) Battistino Paggi, Novara (Italy) Massimo Pisacreta, Milan (Italy) CTG - Scientific Committee Teresa Lucia Aloi, Pavia (Italy) Guido Arpaia, Milano (Italy) Carlo Astara, Cagliari (Italy) Biagio Innocenzo Bonfiglio, Messina (Italy) Giuseppe Castagna, Cagliari (Italy) Vincenzo Coscia, Ferrara (Italy) Egidio De Gaudenzi, Domodossola (Italy) Panfilo Di Gregorio, Pescara (Italy) Rossella Di Stefano, Pisa (Italy) Ciro Falasconi, Napoli (Italy) Massimo Fonti, Ancona (Italy) Vincenzo Gasbarro, Ferrara (Italy) Massimo Gatti, Firenze (Italy) Saverio Giliberti, Bari (Italy) Egidio Imbalzano, Reggio Calabria (Italy) Alberto Macciò, Savona (Italy) Stefano Mancini, Siena (Italy) Ettore Manconi, Cagliari (Italy) Vincenzo Mattaliano, Firenze (Italy) Giovanni Mosti, Lucca (Italy) Marco Romanelli, Pisa (Italy) Angelo Santoliquido, Roma (Italy) The Compression Therapy study Group - CTG www.terapiacompressiva.it COMPRESSION impa.indd 5 20-05-2009 14:33:32 COMPRESSION impa.indd 6 20-05-2009 14:33:32 Preface Compression is one of the most ancient treatments employed by man and its role has been defined over the centuries by a wealth of experience and a large number of studies. Compression therapy is of fundamental importance in the treatment of lymphatic and venous diseases, which affect more than a quarter of the population, and it has also become essential in the prophylaxis of venous thromboembolism; if performed well in the classes of patients at risk, it may be life-saving. The “Compression Therapy study Group” – CTG was founded in Italy in 2003. It is engaged in scientific research and to promote the “culture” of compression therapy in phlebolymphology in Italy. There is no legislation in Italy defining the quality of compression methods such as medical compression stockings and bandages whereas in other European countries production standards have been in force for many years; compliance with these is essential if medical stockings are to be reimbursed by the national health services, which serves as public recognition of the efficacy of such devices, if made using materials and methods that comply with legislation. The second Consensus on compression therapy in phlebolymphology issued by the CTG was necessary in order to update the previous one of 2006 and to link the daily clinical and scientific experience of many experts with evidencebased medicine, as summarised in the Guidelines of the major scientific associations and in the documents of the International Compression Club (ICC). The purpose of this is to provide the briefest possible and at the same time most complete picture of compression materials and methods in phlebolymphology and recommend the procedures required in the various clinical conditions. Fabrizio Mariani Scientific Director of the CTG COMPRESSION impa.indd 7 20-05-2009 14:33:32 COMPRESSION impa.indd 8 20-05-2009 14:33:32 Contents Preface . ............................................................................................................................................................................................................................... VII Contents . ............................................................................................................................................................................................................................ IX The history of compression therapy ........................................................................................................................................... 1 But when did elastic stockings appear? ......................................................................................................................................................... 3 The birth of modern textile fibres ..................................................................................................................................................................... 4 Compression therapy: actions and methods .................................................................................................................. 6 Actions .................................................................................................................................................................................................................................... 6 The bandage ..................................................................................................................................................................................................................... 8 Characteristics of bandages . ................................................................................................................................................................................... 9 Poorly extensible or short-stretch bandages (extensibility ≤70% of the initial length) .............................................. 10 Medium- and long-stretch bandages . ......................................................................................................................................................... 10 Classification of elastic compression bandages ...................................................................................................................................... 12 Bandaging techniques ............................................................................................................................................................................................. 14 Bandaging with regular turns ......................................................................................................................................................................... 14 Figure of eight bandaging .................................................................................................................................................................................. 15 Figure of eight bandaging fixed at the ankle ......................................................................................................................................... 15 Spontaneously unrolled bandage ................................................................................................................................................................... 15 Multilayer bandaging ........................................................................................................................................................................................... 15 Technique of applying the bandage, defined as “short elastic” according to Sigg ........................................................... 16 Eccentric compression ............................................................................................................................................................................................ 12 Recommendations ..................................................................................................................................................................................................... 18 The elastic stocking . ......................................................................................................................................................................................... 19 Definitions. ................................................................................................................................................................................................................... 19 The characteristics of the medical compression stocking (MCS) ............................................................................................... 19 Quality marks ............................................................................................................................................................................................................ 21 Intermittent pneumatic compression .................................................................................................................................... 22 Techniques of measuring compression in vivo . ...................................................................................................... 23 Compression therapy and ceap classification ........................................................................................................... 25 COMPRESSION impa.indd 9 20-05-2009 14:33:32 X COMPRESSION CEAP “0” ........................................................................................................................................................................................................................ 25 CEAP “1” ........................................................................................................................................................................................................................ 26 CEAP “2” ......................................................................................................................................................................................................................... 26 CEAP “3” ........................................................................................................................................................................................................................ 27 Oedema in the economic class syndrome (prolonged sitting position syndrome) ............................................................ 28 Occupational phlebopathy-oedema due to a prolonged standing position for occupational reasons ................. 28 Oedema due to a defect of muscle pump function ............................................................................................................................. 28 Post-traumatic oedema . ....................................................................................................................................................................................... 29 Oedema in angiodysplasia ................................................................................................................................................................................. 29 CEAP “4-6” ................................................................................................................................................................................................................... 29 Compression and CEAP 6 ................................................................................................................................................................................. 29 Compression therapy: guide to the treatment of venous ulcers ................................................................................................... 30 Recommendations ..................................................................................................................................................................................................... 31 Compression therapy and deep venous thrombosis ........................................................................................ 33 Recommendations ..................................................................................................................................................................................................... 33 Compression therapy and pregnancy ..................................................................................................................................... 34 Recommendations ..................................................................................................................................................................................................... 36 Compression therapy and peripheral arterial disease ................................................................................... 37 What are the clinical indications depending on the C.E.A.P. classification? ................................................................... 38 Conclusions .................................................................................................................................................................................................................. 39 Recommendations ..................................................................................................................................................................................................... 39 Compression therapy and vein surgery ............................................................................................................................... 40 Recommendations ..................................................................................................................................................................................................... 40 Compression therapy and sclerotherapy ........................................................................................................................... 42 Recommendations ..................................................................................................................................................................................................... 42 Compression therapy and lymphoedema ......................................................................................................................... 44 Recommendations ..................................................................................................................................................................................................... 46 Compression therapy and prophylaxis of venous thromboembolism ................................... 47 Risk factor stratification ........................................................................................................................................................................................ 47 Effects of compression therapy in the prophylaxis of VTE ...................................................................................................... 49 The antithromboembolism stocking ............................................................................................................................................................. 49 Bandaging .................................................................................................................................................................................................................... 50 Intermittent pneumatic compression . ......................................................................................................................................................... 51 Compression therapy in the prophylaxis of VTE in patients at risk. .................................................................................. 51 General surgery . ........................................................................................................................................................................................................ 51 Oncological surgery . ............................................................................................................................................................................................... 53 COMPRESSION impa.indd 10 20-05-2009 14:33:32 Contents XI Cardiac surgery ......................................................................................................................................................................................................... 53 Vascular surgery ........................................................................................................................................................................................................ 54 Gynaecological surgery . ........................................................................................................................................................................................ 55 Urological surgery .................................................................................................................................................................................................... 56 Laparoscopic surgery .............................................................................................................................................................................................. 56 Orthopaedic surgery ............................................................................................................................................................................................... 57 Knee arthroscopy .................................................................................................................................................................................................. 57 Elective THA surgery ....................................................................................................................................................................................... 57 Elective TKA surgery ........................................................................................................................................................................................ 57 Surgery for hip fracture ................................................................................................................................................................................... 57 Elective surgery of the spine ........................................................................................................................................................................ 58 Neurosurgery ............................................................................................................................................................................................................... 58 Trauma ........................................................................................................................................................................................................................... 58 Burns . .............................................................................................................................................................................................................................. 59 Pregnancy and puerperium ............................................................................................................................................................................... 59 General medicine ..................................................................................................................................................................................................... 61 Myocardial infarction ...................................................................................................................................................................................... 61 Ischaemic and haemorrhagic stroke ........................................................................................................................................................ 61 Cancer patients . ................................................................................................................................................................................................... 62 Patients in intensive therapy ........................................................................................................................................................................ 62 Management of compression therapy in the prophylaxis of VTE in surgery ..................................................................... 62 Conclusions .................................................................................................................................................................................................................... 62 Recommendations ..................................................................................................................................................................................................... 64 Contraindications to compression therapy ................................................................................................................... 65 General recommendations on compression therapy. ...................................................................................... 66 Bandages ........................................................................................................................................................................................................................ 66 Medical compression stockings . ....................................................................................................................................................................... 66 Intermittent pneumatic compression . ......................................................................................................................................................... 68 References ........................................................................................................................................................................................................................ 69 COMPRESSION impa.indd 11 20-05-2009 14:33:32 COMPRESSION impa.indd 12 20-05-2009 14:33:32 1 The history of compression therapy The history of containment and compression is lost in the mists of time until the first evidence is found in the Neolithic period (5000-2500 BC) with the discoveries in the Tassili caves in the Sahara, where paintings on the rocks show warriors with bandaged legs in a sort of ritual dance. We find further evidence among the Scythian warriors with their bandage leggings and the Egyptians (17th dynasty, 1650-1552 BC), as reported in the Edwin Smith papyrus (155 BC), where the earliest descriptions of curettage of skin ulcers are found; in the Ebers papyrus (XVIII dynasty, 1400 BC) where the use of haemostatic bandages is mentioned in the eighth section dedicated to the heart and blood vessels; in biblical evidence in the Old Testament (prophetic books, Isaiah, I: 6; 8th century BC “…they are not bound up nor dressed…”); in the descriptions of Hippocrates (450-350 BC); in the Indian medical text “Sushruta Samhita” (200 BC) in which the use of linen bandages, among others, is mentioned, and finally, among the Greeks, Hebrews and Romans. There are further references in the early Christian period in Celsus (in his “De Medicina”, 25 AD), in Galen (130-200 AD) with his bandages of wool and linen and with the description of an adherent bandage intended to prevent blood from flowing back and downwards and compresses soaked in wine, the first examples of positive eccentric compression, and in Oribasius (324 AD) with his treatise on the surgery of ulcers and what is probably the first description of stripping. After that time, reports of compression therapy disappear and re-emerge, though only sporadically, with the Persian philosopher and physician Avicenna (980-1037) and with Guglielmo of Saliceto (1210-1276) who was among the first to isolate wounds from the air (the modern concept of occlusive dressings). Compression was subsequently treated by Henry de Mondeville (1320), Guy de Chauliac (1363) and Giovanni Michele Savonarola (1384-1468) in his treatise on venous diseases; he taught at Padua and was the grandfather of the theologian Girolamo who was burned at the stake; he was summoned in 1440 to the d’Este court in Ferrara, where he became physician to Niccolò III; Paracelsus (1493-1541), physician and alchemist who publicly burned the writings of Galen and Avicenna, famously saying “Thus every bad thing goes up in smoke”; Ambroise Parè (1510-1590 COMPRESSION impa.indd 1 AD), Henry II of France’s personal surgeon, who described bandaging with a layer of lead. A historical moment in Italian phlebology is thus reached: prior to the description in the famous work De Venarum Ostiolis by Girolamo Fabrizio of Acquapendente (1537-1619) the venous valves had been described by Giambattista Canano (1515-1579), who was already a lecturer in anatomy at Ferrara while still a student and who was famous for his description of muscles (Muscolorum Humani Corporis Picturata Dissectio, 1541). He subsequently told Andrea Vesalius (1514-1564), whose brother Francesco was with Canano at Ferrara, of his discovery of venous valves in the azygos vein system. In reality, Canano had already observed venous valves in the horse in 1536 and he then described them in the azygos veins in humans. In the autumn of 1542 Vesalius showed Canano the plates of his work De Humani Corporis Fabrica (first edition 1543, second edition 1555) designed by Kalkar, a famous apprentice of Titian’s, and Canano halted publication of his treatise on myology. Canano in fact destroyed the copies of the book that were already printed but fortunately a few examples distributed to friends and relatives survived. In the same years, around the time of the discovery of the venous valves, another famous anatomist of the period (Charles Estienne or Carolus Stephanus, 1504-1564), a contemporary of Vesalius and a pupil of the same master as Vesalius’s (Jacques Dubois known as Sylvius, 14781555), published his important anatomical work, De Dissectione Partium Corporis Humani (1545), in which he described the valves of the hepatic veins. This monumental work was started in 1530 but was only published in 1545 and Albrecht von Haller in 1751 called l’Estienne “primus valvularum auctor”. Girolamo Fabrizio of Acquapendente (1537-1619, a successor to Savonarola as a teacher in Padua described both venous valves (De Venarum Ostiolis) and laced calf leather stockings (De Chirurgicis Operationibus). Guy de Chauliac (1300-1386), a surgeon in Montpellier, in his “Chirurgia Magna” marked a historical moment for compression as this work was referred to for the next four centuries. Michele Savonarola is regarded as the founder of conservative treatment of varicose veins; in his “Pratica”, he specifies that the bandage had to be applied from the 20-05-2009 14:33:33 2 COMPRESSION foot to the top of the limb, an idea also supported by Parè. In 1628, based on the observations of Fabrizio of Acquapendente (De Venarum ostiolis), William Harvey (1578-1657) described the circulation of the blood and indicated the relationship between venous stasis and compression therapy. Richard Wiseman (1622-1676), Charles II of England’s sergeant surgeon, described puerperal venous thrombosis in his “Several chirurgical treatises” which he treated with bandaging from the foot to the knee; he recommended the use of a laced stocking made of dog skin, and was probably the first to use the term “varicose ulcer”. In the same years, the Parisian surgeon Pierre Dionis (1643-1718) described the use of elastic laces and flannel bandages, while Johann Christian Anton Theden (1714-1797), surgeon general to the court of Frederick II of Prussia, in the first part of his work, which appeared in 1771 (“Neue Bemerkungen und Erfahrungen zur Bereicherung der Wundarzneykunst und Arzneygelahrtheit” or “The great benefit of wrapping the extremities in bandages”), illustrated bandaging techniques with the detail of including the fingers or toes, stitching the turns or wearing a sock to avoid displacement of the bandage. In the same period, two other publications appeared in England: the first by Else J on compression of ulcers with lead plates (a method developed by Battiscomb, an apothecary who jealously kept this technique secret from everyone), and the second by Rowley in his monograph on ambulatory treatment of leg ulcers. The importance of compression in healing leg ulcers was confirmed in a detailed manner by Bell B in 1778 by using tight bandages with the aim of approximating the ulcer margins to promote healing. Compression with India rubber was described by Wye in 1781 and soon afterwards there were reports on the use of inflatable India rubber leggings (aerie pulse leggins) for ulcers or even compression packs impregnated with turpentine wax and covered with bandages of different types (leather, cardboard, cork, celluloid). Thomas Baynton represents a further stage in the history of compression therapy with his “New method of treating old ulcers” of 1797, which, based on Bell’s observations, described a tight bandage (Baynton bandage) with plasters of pitch resin cut in strips and positioned on the limb like tiles, which was able to exert strong pressure to approximate the margins of the ulcer. Other authors such as Velpeau (1826) and Boyer (1831) confirmed Baynton’s method while Sir Everard Home (1801) described the role of elastic compression in reducing ulcer recurrence; finally, Sir Astley Cooper (1824) affirmed that “elastic compression is able to restore valvular continence”. Different historical testimonies prove the widespread use in London hospitals towards the end of the 18th century of COMPRESSION impa.indd 2 elastic containment for treating leg ulcers, while its prophylactic therapeutic use appeared later in the 19th century, especially because of the importance attributed to ulcerative pathology of the legs as a cause of absence from work. In 1730, counsellor Eller TJ in Berlin complained of the fact that very large numbers of persons affected by ulcers of the limbs applied to the Charité hospital, where more than 20% of those admitted around 1850 were suffering from ulcers of the lower limbs. In those years, the often criticised poor skill of healthcare workers together with superstition (the ulcer was regarded as a sort of common cloaca through which the negative humours were removed) caused a disproportionate increase in the carriers of this disease as well as of hospital crowding. At the same time, severe criticism was directed even at the university because of poor medical education in this important area of human pathology. Finally, outpatient treatment with bandages that could be removed and applied by the patient himself was introduced by Martin of Boston (1870), who suggested a rubber bandage, an example of a highly extensile bandage, in direct contact with the skin and covered by a second bandage. Victor von Bruns criticised the use of rubber for strong compression and the risk of skin maceration, while his son Paul, a surgeon in Tübingen, described it as “the best method set up until now”. Paul Unna, a dermatologist in Hamburg (1885), marked another historic point with his rigid zinc oxide bandage (Unna’s paste boot), like the “Klebrobinde” from Teufel of Stuttgart at the end of the 19th century, the first industrial example of adhesive bandages. In 1929 in association with Beiersdorf, N. Brann produced “Novoplast” bandages, with adhesive on both sides. Numerous other types of bandages were manufactured between the end of the 1880s and the early 1900s. Heinrich Fischer (1910), based on Unna’s observations, was the first to show the fundamental ideas of graduated decreasing pressure and the dual concept of compression and mobilisation in the treatment of venous thrombosis. Prophylaxis of venous thromboembolism was recommended as early as 1900 by Hagapoff at the international medical conference in Paris, while Kappis practised it systematically from 1923 in Würzburg University surgical clinic with excellent results. Post-sclerotherapy compression appeared late because there was a common conviction that sclerosis should be followed by rest due to the risk of embolism and so there was a “fear of bandaging”. Paul Linser (1871-1963) introduced sclerotherapy in Germany, employing outpatient treatment, unlike his pupil Karl Linser (1895-1976) who admitted all patients who were undermedical-lsing sclerotherapy. Another great supporter of outpatient treatment was Gabor Nobl (1864-1938) at the Vienna polyclinic: 20-05-2009 14:33:33 The history of compression therapy “systematic use of elastic compression is the best treatment for varicose nodules and ulcers”. Compression therapy with bandages in surgical treatment came later, long after the use of this therapy for leg ulcers and essentially after the discovery and advent of surgical anaesthesia (William Morton, dentist in Boston, gave the first real demonstration of surgical anaesthesia with nitrous oxide at Massachusetts General Hospital in 1846). Karl Sigg (1912-1986), a supporter of compression therapy in sclerotherapy with his famous method, together with the Dutch Van der Molen (Van der Molen’s “tuyautage” [piping]) and the French Robert Stemmer then established the scientific basis of compression therapy. Karl Sigg was also the inventor of the graduated compression elastic stocking produced by the Ganzoni Sigvaris® company from 1958-1960. The elastic bandage appeared in very remote periods, certainly long before the elastic stocking, and was used for the most varied reasons (ritual, ornamental and protective) especially because of its haemostatic effect (“Morelli’s haemostatic laces”, 1674) and for the treatment of aneurysms (Moro, 1760 and Guattani, 1772). The Startin bandage for treating varices (1851) is the precursor of Van der Molen’s “tuyautage”, together with a more recent one by Helferich (1937), who described a method with rubber laces for the treatment of oedema of the lower limbs in which rubber laces were positioned on the leg at regular intervals. Examples of this, today known as “eccentric positive compression”, were used in numerous schools beyond the Alps; thus, one type of garter, to which a compression patch of various materials was attached, was the “Hoeftmann compression ball”, or Wolfram’s rigid plates for compressing the femoral artery and thus reducing venous stasis. History always conceals something that is then presented in a new guise today; for instance, the first devices that were precursors of modern sequential pressure therapy were invented by Hofmeister, who in 1902 presented his metal cylinder filled with mercury for the treatment of oedema of the upper limb; Hurtel in 1917 created the first pneumatic chamber and Hammesfahr in 1929 the first intermittent pneumatic chamber. But when did elastic stockings appear? A precursor of elastic stockings were gaiters (a sort of stockings without feet and with anterior or lateral laces), already described by Fabrizio of Acquapendente (15371619) and used for various reasons. They were made of dog skin, string, rubber etc., but they were rapidly abandoned because they produced oedema of the foot and ankle. Between the end of the 18th and the start of the 19th centuries, they were replaced by true stockings (elastic leggings), which also included the foot. COMPRESSION impa.indd 3 3 Murphy created an elastic “leg corset”, Heermann a made-to-measure shoe which continued into a gaiter, and Stephan described a patented gaiter for varicose veins. The first true elastic stockings (which replaced unsuccessful attempts in natural or India rubber, which were difficult to put on and poorly tolerated) appeared in the 19th century, after the discovery of rubber vulcanisation by Charles Goodyear in 1839. In 1846, only seven years after Goodyear vulcanisation, Brockedon W and Thomas Hancock in England registered the first patent for fine and quadrangular rubber thread, which rapidly conquered the textile industry. The elastic stocking was born on the 26th of October 1848 when William Brown of Middlesex registered patent no. 12294 concerning the elastic stocking in India rubber manufactured on hand looms. Shortly afterwards, in 1851, Jonathan Sparks introduced threads made of silk and cotton (patent no. 13787, 1851). In 1861, thanks to William Saville we have the first example of surgical elastic stockings manufactured on hand looms and also to measure. Almost at the same time, the Ganzoni elastic materials factory was founded in Winterthur in Switzerland in 1864 (today Ganzoni Sigvaris®), which then became the world leader in the production of medical elastic stockings. In 1866 criticism of elastic stockings also began, little different from that of today: Billroth complained of the excessively high costs of rubber stockings and also of the fact that they were difficult to wash. Industrialisation thus commenced (especially in Middlesex and Nottingham and later in Louvain in Belgium thanks to Anne Catherine Laury) and compression therapy reached its peak with the founding by the engineer Julius Römpler of the first factory manufacturing rubber elastic bandages in Germany in 1861. In 1871 Römpler introduced elastic weaving, moving the factory to Zeulenroda (a small town in Thuringia where there was great availability of labour). In 1930 the little town of Zeulenroda had about 30 industries, thus rapidly becoming established as the world centre for stockings for varicose veins. However, rubber elastic stockings continued to be poorly regarded by doctors and patients because they were thick and poorly transpiring, so that in 1907 N. Brann (of the Novoplast bandages) wrote “...the elastic stockings are badly constructed and have failed in their aim …”. But matters improved, first with the “Viktoria“ company and its “smooth knit“, then in 1904 when Oskar Huppelsberg produced the first seamless stockings known as “Ohrs-Ohrsana”, and finally in 1920 when a new very fine rubber thread with a round cross section was produced, which was used to manufacture double-elastic, circular knit and seamless stockings (“lastic flor” stockings with a patent held by Römpler J, subsequently produced at Apoda due to Böttgen W). Elastic stockings with fibres other than rubber appeared for 20-05-2009 14:33:33 4 COMPRESSION the first time in 1917 and towards the end of the 1920s they were produced by the Thalysia company, while modern elastic stockings with synthetic elastomers appeared in the second half of the twentieth century. The birth of modern textile fibres The American “Viscose Company“ created the name Rayon® in 1924 to replace “artificial silk”, which had aroused such anger among producers of natural silk. This name was comfortable because it was easy to use, sounded nice and recalled the brightness of the fabric. With time, new textile fibres were produced, derived from water, carbon and hydrocarbons, which can today be grouped into two main categories: cellulose or natural fibres (animal, vegetable or mineral) and chemical fibres (artificial or synthetic). Natural fibres Chemical fibres Animal: silk, wool, etc. Vegetable: cotton, linen, hemp, coconut, bamboo etc. Mineral: asbestos wool Artificial: viscose, cellulose acetate, cupro, etc. Synthetic: acrylic, polyester, polypropylene ( nylon, spandex, etc.), glass, etc. The synthetic polymers (containing at least 85% polyurethanes by mass) appeared on the market in both monofilament and multifilament form (Lycra®, now a registered trademark of Invista, or Dorlastan® from Bayer, etc.); in general, the latter are used in stockings and the former in bandages (DuPont patented Lycra® in 1959 and Nylon® or polyamide in 1938). These extremely fine and light threads (1500-3000 times finer than a hair; 1 g = 10 metres of yarn) are always used in various combinations with other fibres such as cotton, nylon and silk and have gradually provided us with ever finer elastic hose with greater wearability. 1938 was the year of the first revolution in stocking production because Nylon® was invented and patented (1935) by Wallace H Carothers at the factory founded by the French chemist Eleuthère Irènèe DuPont of Nemours, who had emigrated to the state of Delaware in the USA. In those years, the advertising described it as “…the first synthetic fibre as tough as steel and as delicate as a cobweb…”. In 1939 sales began in a few shops in Wilmington (the headquarters of DuPont of Nemours) and from there they extended throughout America and the world. DuPont presented the Nylon® stocking in 1939 at the international exhibition in Boston and in 1940 64 million pairs of Nylon® stockings were sold. While this was happening, the chemist Otto Bayer (1902-1982) in COMPRESSION impa.indd 4 Europe started his studies of polyurethane and in 1939 Paul Schlack obtained the first elastic polymer capable of sustaining great stretching. The second revolution arrived in the 1960s, again under the DuPont name, first with the patenting (1959) and then with the marketing of Lycra®, which would become the fibre of the 20th century. In 1951, Brenschede W obtained the fibre known as “Vulkollan“ and from 1962-64 production (Bayer-Germany and USA) of “compression stockings” began, under the trademark Dorlastan® which was patented by Bayer. Between the end of the 1970s and the start of the 1980s, Lycra® (the elastomer synthetic fibres were called Elastam or Spandex in the USA and Canada) became the new and indisputable leader in the stocking industry. The modern chemical textile industry in little over 50 years has made such giant steps that in 1990 it has produced 20 million tons of chemical fibres globally, much more than wool, cotton, linen and silk. Numerous other fibres have followed in the last few decades, employed not only in the textile industry but also in other sectors. LACTRON: this is a biodegradable synthetic fibre based on polylactic acid and obtained ecologically from maize by fermentation of its amide. It is thus a synthetic fibre of an ecological, biodegradable nature, not derived from petroleum but from a plant and completely degradable to carbonic anhydride and water. It has physical properties almost identical to those of nylon and polyester. It is used by Kanebo® for diverse uses such as civil engineering, the paper industry, sutures, gauze, clothing (corn fibre). CALAFINE QD: this is a polyester, which has the advantage of being able to be dyed at atmospheric pressure and not under pressure like other types of polyester. Toyobo® produces Calafine QD® (Quick Dry) which also has the merit of great ease of maintenance (wash and wear). NOMEX: a vast range of “engineering fibres” developed by DuPont, particularly resistant to heat and much used in electrical insulation. In the form of fabrics particularly resistant to wear and tearing, used in fire-fighters’ clothing. “Delta K” NOMEX contains KEVLAR fibres, a filtering agent for atmospheric pollution. Fig. 1 – Classical polyester fibre. 20-05-2009 14:33:33 The history of compression therapy Fig. 2 – PTT fibre. DYNEEMA: this is a flexible and particularly tough polyethylene because of its special physical and mechani- COMPRESSION impa.indd 5 5 cal characteristics, much used in industry (naval, electrical insulation, bullet-proof jackets, skis, canoes, sails, etc.). Corterra fibres or PTT (polycondensation of PTA or purified terephthalic acid) (Fig. 2): this is a special polyester obtained by chemical (Shell) or biochemical (DuPont) polycondensation. It is a fibre with characteristics better than those of nylon and polyester, capable of undermedical-lsing great deformation and returning readily to its original form; it dries rapidly and is used in clothing, the automobile sector, furnishings, etc. About 10% of the current stocking market consists of elastic stockings, with support and therapeutic stockings each accounting for about 5%, and non-elastic (fashion) stockings accounting for the other 90%. 20-05-2009 14:33:33 6 Compression therapy: actions and methods It is not easy to give an exact definition of compression therapy, but it can be understood as: pressure exerted on a limb by materials of varying elasticity in order to prevent and treat disease of the venolymphatic system (Diagnostic and therapeutic guidelines for diseases of the veins and lymphatics of the Italian College of Phlebology CIF, revisions 2003-2004). The terms containment and compression are often used incorrectly as synonyms but in reality they indicate different concepts: –– Containment: passive action (static) of a rigid compression system (nonelastic or with hardly any elasticity), which is more or less inextensible and opposes systolic muscle dilatation, developing a raised working pressure (reinforcement effect on the venous pump); the leg is contained at rest but not compressed. –– Compression: active action exercised at rest on a limb by the more or less elastic characteristics of the system with the development of high resting pressures; the leg is compressed even at rest. ACTIONS The mechanisms of action and the clinical consequences of compression therapy in phlebolymphology have been described in a large number of scientific studies and can be summarised in brief as: a) action on the superficial and deep venous system; b) action on the blood volume; c) action on the tissues; d) action on the microvascular tissue compartment; e) action on the venous thrombus. Compression exerted on the lower limbs causes a reduction in the calibre of the veins, consequent better coaptation of healthy valve cusps and a reduction of pathological reflux (incompetent perforators) of up to 30-40% (Fischer H. 1976; Stemmer R. et al. 1976; Emter M. et al. 1991, Sarin S. et al. 1992, Mariani F. et al. 1991). Compression both by bandages and by elastic stockings reduces in a very obvious way the cross section of the calf muscle veins; on the other hand, the reduction in the calibre of the popliteal vein is variable, as is that of the common femoral vein, whereas the volume of the superficial varicose veins always appears reduced. COMPRESSION impa.indd 6 Many authors, using radionuclides, have also shown an increase in lymphatic drainage in the course of compression therapy. The bandage reduces the blood volume of the lower limb by about 45% in lying position and 62% in the standing position, with a significant increase in right ventricular filling. The local blood pool measured by Partsch H et al. with labelled red blood cells diminishes by 30% after application of a compression bandage of about 40 mmHg to the entire lower limb. During walking, these effects, added to the reinforced squeezing of the venous pump (foot and calf ) cause an increase in the rate of venous (up to 5-fold) and lymphatic flow with a reduction in backflow and therefore of stasis (Partsch H 1979). Some studies also demonstrate that to obtain optimal efficacy of compression therapy it must be combined with mobilisation and normal plantar support (Brizzio EO et al. 1994). Radioisotope studies have shown that the external pressure exerted by the bandage increases tissue pressure, promoting the reabsorption of fluids back into the veins in accordance with Starling’s law, thus producing a reduction of oedema, together with the mechanisms referred to above. Curri SB et al. (1989) have demonstrated that compression therapy with an elastic stocking produces a reduction of veno-capillary ectasia, interstitial oedema and reactive thickening of the arteriolar basal membrane in patients affected by Widmer stage II venous insufficiency. Allegra C et al. (1995) in a microlymphographic study have shown a reduction in endolymphatic and tissue pressure after 4 weeks of treatment with a bandage worn constantly. Compression promotes detachment of leucocytes from the endothelium and prevents them from adhering further (AbuOwn A et al. 1994). Capillary filtration is also reduced and reabsorption is promoted due to the greater tissue pressure. The therapeutic elastic stocking is also able to reduce oxidative stress in healthy subjects obliged to stand for prolonged periods at work (Flore R et al. 2007). The results of all the studies conducted show unanimously that compression causes a reduction of venous capacity, which will automatically diminish venous output and speed up venous return with an increase in the flow rate, which must be regarded as the main cause of the effects of compression therapy in the prophylaxis of VTE. 20-05-2009 14:33:33 Compression therapy: actions and methods The compression bandage increases the adhesion of any thrombus to the vein wall provided this does not extend beyond the upper border of the bandage (Fischer H, Bassi G, Stemmer R); recent studies by Partsch H et al. (1997, 2000, 2004), Gerlach HE and Blättler W (2002, 2003) show that in patients with DVT (provided they are able to walk) there is a lower incidence of embolic episodes if they are treated with bandaging, heparin and mobilisation compared to heparin therapy alone. Compression therapy has an effective action on various coagulation factors: a few studies suggest a reinforcement of fibrinolysis of the vein wall with the use of pneumatic compression (Altenkamper H 1983; Comerota AJ et al. 1997) and also with an elastic bandage. Pneumatic compression also produces an increase in capillary perfusion and tissue oxygenation, with an increase in the release of nitric oxide. The treatment acts also by reducing blood viscosity, with suppression of procoagulant activity, but the effect of this in the prophylaxis of DVT appears to lead back to the increase in the venous flow rate demonstrated by many authors. Besides the reinforcement of venous emptying by means of the containment action on the muscle mass during walking and exercise, with muscle volume increasing during the contraction phase, it must today be regarded as one of the most effective mechanisms, just as the dual concept of compression and mobilisation is regarded as indispensable for obtaining significant effects from the clinical aspect (Bassi G and Stemmer R 1983). Recently (International Angiology 2008) a group of experts (ICC-International Compression Club) review published literature concerning the use of compression treat- 7 ments in the management of venous and lymphatic diseases and establish where reliable evidence exists to justify the use of medical compression and where further research is required to address areas of uncertainty. The authors searched medical literature databases and reviewed their own collections of papers, monographs and books for papers providing information about the effects of compression and randomized clinical trials of compression devices. Papers were classified in accordance with the recommendations of the GRADE group (Guyatt G et al., CHEST 2006) to categorize their scientific reliability. Further classification was made according to the particular clinical problem that was addressed in the papers. The review included papers on compression stockings, bandages and intermittent pneumatic compression devices (Table 1). Low levels of compression 10-30 mmHg applied by stockings are effective in the management of telangiectases after sclerotherapy, varicose veins in pregnancy, the prevention of edema and deep vein thrombosis (DVT). High levels of compression produced by bandaging and strong compression stockings (30-40 mmHg) are effective at healing leg ulcers and preventing progression of post-thrombotic syndrome as well as in the management of lymphedema. In some areas no reliable evidence was available to permit recommendations of level of compression or duration of treatment. These included: management of varicose veins to prevent progression, following surgical treatment or sclerotherapy for varicose veins, and the level of compression required to treat acute DVT. This review shows that whilst good evidence for the use of compression is available in some clinical indications, there is much still to be discovered. Table I – Evidence Based Medicine and Compression Therapy. Modified from: Partsch H., Flour M., Coleridge Smith P., Benigni J.P., Cornu-Thénard A., Delis K., Gniadecka M., Mariani F., Mosti G., Neumann H.A.M., Rabe E., Schuren J., Uhl J.F. Indications for compression therapy in venous and lymphatic disease. Consensus based on experimental data and scientific evidence. Under the auspice of the IUP. Int. Angiol. 2008;27,3,193-219. INDICATIONS VCI C0s C1s C1 after sclero C2 a,s C2s pregnancy C3 pregnancy C3 therapy C4b C5 C6 After procedures VTE Prevention Therapy SPT Prevention Therapy LYMPHEDEMA Therapy COMPRESSION impa.indd 7 10-20 mmHg 1B 1B 1B 1B ? MCS 20-30 mmHg 1B 2B 1B 2B ? 1B 2B 1A 30-40 mmHg Bandage CP ? 1B 1A 1A 1B ? ? 1A 1B 2B 1B 1B 1A 2B ? ? ? 1A 1B 1B 1B 20-05-2009 14:33:33 8 The bandage The most important properties of bandages and elastic supports are represented by their elasticity and extensibility or stretch. Elasticity defines the ability of the material to return to its original length when the stretching force ceases. The force required to obtain specific stretching indicates the power: this parameter is a determinant in defining the pressure exerted by the bandage at a fixed extension. Inextensible or short-stretch (<70%) bandages produce high “working pressures” during ambulation because of the containment effect on the contraction of the muscles of the leg, whereas the “resting pressure” is reduced compared with the working pressure. In contrast, elastic bandages classified as medium- (between 70 and 140%) or longstretch (>140%) compared with their initial dimensions are characterised by the fact that there is a gap between the resting and working pressures that they exert which is inversely proportional to their elasticity. They therefore maintain continuous pressure on the superficial venous system, relatively independent of muscle activity, as do stockings made of long-stretch elastic fibres. Depending on their extensibility, they thus have different actions during the static phase and movement, bearing in mind that compression therapy must be combined with mobilisation of the patient to achieve maximum efficacy: –– inextensible short-stretch bandages (<70%), like Unna’s zinc oxide boot or medicated adhesive bandages, produce high working pressures and lower pressures at rest, which can be maintained constantly over 24 hours; they reinforce the action of the calf muscle pump, have a greater action on the deep venous system and are tolerated at rest; –– bandages that stretch over 70% and elastic stockings instead produce lower working pressures and usually have to be removed at bedtime because they are not well tolerated. The pressure exerted by a bandage depends essentially on the tension T at which it is applied, the number of layers n and the radius of the limb R. The relation between these quantities is expressed by Laplace’s law P = Tn/R, which is modified to P = Tnt/Rw, where t is the thickness of the material employed and w is the width of the bandage. COMPRESSION impa.indd 8 The tension is produced by the force applied to the bandage when it is stretched but the ability of the bandage to maintain a specific tension and thus the pressure exerted is derived from its elastomeric properties (hysteresis – stretching and retraction curves), which in turn are dependent on the type of thread and the methods employed in making the fabric. As mentioned above, the ability of a bandage to stretch if subjected to a pulling force is called its extensibility, which describes the stretching ability of the elastic material, which in any case behaves differently in response to traction depending on its hysteresis properties: the applied pressure increases in proportion to the tension up to a maximum, beyond which the phenomenon of overstretching occurs, that is, the pressure stabilises. When the bandage is applied, numerous factors determine its compression efficacy over time: wear of the material, walking with repeated and continuous stretching and retraction, any reduction of the oedema, and the physical characteristics of the material utilised. It is believed that the pressure falls by about 40% just a few hours after application and these effects are greater the more short-stretch the bandage, while highly elastic materials reduce such effects to the minimum. The patient’s position also contributes to the change in pressure; it is increased when the patient is standing as compared with lying down. The bandage must be applied keeping the tension of the bandage constant and overlapping the turns regularly so as to provide uniform pressure, since the pressure increases proportionally at each overlap in accordance with Laplace’s law. Different techniques can be used (regular turns, figure of eight, figure of eight fixed at the ankle, spontaneous unrolling etc.) and they should be used depending on the case, always following a few fixed rules: –– the bandage must extend as far as the base of the toes; –– it must be done from the inside to the outside of the limb, maintaining regularity and uniformity (the bandage must be unrolled at constant tension, overlapping the turns by about 50% of their width), thus avoiding areas of excessive pressure and local constriction. It should be recalled that in practice the pressure exerted by the bandage and its efficacy when using that particular material depend closely on the tension to which the bandage is subjected, the number of overlapping turns 20-05-2009 14:33:33 The bandage and the technique employed: the figure of eight bandage remains in place longer without changing and compresses about 30-40% more compared with regular turns; the spontaneously unrolled bandage compresses mainly the calf and is therefore indicated for venous disorders in the posterior part of the leg; the figure of eight bandage fixed at the ankle compresses mainly the medial inside regions of the leg and is therefore indicated for venous disorders in that region, such as ulcers and hypodermitis (Partsch H, Rabe E, Stemmer R 2000, Mariani F 2005). The use of so-called eccentric compression with cotton or rubber pads is based on the physical principle that every change in the radius of the compressed surface produces a change in the pressure exerted that is inversely proportional to the radius. Its practical usefulness is therefore the possibility of varying the pressure according to the regions to be compressed, for example, greater pressures are usually required in the region of the venous ulcer where the effects of venous reflux are greater, or the creation of a radius that can be compressed is required where the surface is flat (for example areas of indurated hypodermitis) or even concave (retromalleolar fossae). This technique is also found useful in levelling the radii that are to be compressed or protected (such as the tibial crest, the Achilles tendon etc.) in all legs that have an irregular circumference. The pressure exerted beneath the pad, when nonelastic bandages are used, has special characteristics: the resting pressures come very close to the working pressures so that a local compression effect is obtained similar to that of elastic bandages. An interesting innovation in the bandage area is represented by the multilayer system kits (four layer bandages, Profore® Smith & Nephew – Rosidal sys® Lohmann & Rauscher, or bi layer bandage Coban 2® 3M) which consist of application of four or two superimposed bandages of different elasticity; the systems allow a high pressure (between 40 and 60 mmHg) to be maintained for more days with optimal tolerability at rest and is indicated especially in the reduction of “difficult” oedema, such as indurated and lymphatic oedema, and in the treatment of venous ulcers. The elastic material provides constant pressure and the non-elastic material provides high working pressures during walking. The practical problems of bandage application and therefore of their efficacy are substantially represented by the skill of the healthcare professional and the choice of suitable material. Manufacturers have sought to solve some of these problems by providing visual guides to the bandage (lines, circles, rectangles), which are modified according to the tension exerted and which should therefore help the healthcare professional to apply appropriate and uniform pressures to the limb. The development of manufacturing technologies may help to reduce the COMPRESSION impa.indd 9 9 variability in inter- and intra-bandage tension; one of the most promising possibilities is fabrication of a vari-stretch elastomer (Proguide®, Smith & Nephew) which is able to exert relatively constant pressure independent of limited variations in extension. Characteristics of bandages The art of bandage requires a more or less prolonged apprenticeship and trained staff, the bandage is closely dependent by the operators. Another aspect to consider is the more or less limited duration of containment/compression therapy carried out with bandaging, because the bandage loses about 40% of its original pressure after 120 min (Damstra RJ 2008). The principal reasons of this loose of pressure are: the volume reduction of the bandaged limb and the deterioration of the bandaging components (Benigni JP et al. 2007). Elasticity and hysteresis. Elasticity is the property of a material to recover its original size and/or shape after the removal of a deforming force. In order to evaluate this property, it is subjected to a series of cycles of traction (application of the deforming force) and retraction (cancellation of the deforming force) with the aid of a dynamometer which records a load diagram of force/stretching and the graph of these stresses over time. This is expressed as the percentage change between the sample at the start and the sample after it has undermedical-lsne the hysteresis cycle. In general the hysteresis cyclef (Fig. 3) defines the visco-elastic properties of a material. The term extensibility is used as a synonym of elasticity: the meanings are completely different. Thus, extensibility indicates the degree of stretching of a bandage under the action of a certain tractional force, whereas elasticity is the capacity of that particular bandage to resume its original dimensions after the tractional force has ceased. Another parameter that characterises compression materials is their stiffness (or slope), defined as the increase in pressure per increase of one centimetre in the circumference of the lower limb, expressed Fig. 3 – Hysteresis (short-stretch band). 20-05-2009 14:33:34 10 COMPRESSION in hectopascals or mmHg (CEN - European Committee for Standardisation). The working pressures are intermittent elevated pressures that coincide with muscle contractions, while the resting pressures are usually lower. Based on these concepts, bandages used for bandaging a limb are classified as rigid or non-elastic (extremely low modulus of elasticity) or elastic: short-stretch (<70% of the original length), medium-stretch (70-140%) and long-stretch (>140%) according to the type of elastomer utilised; the elastic stocking is an example of long stretch Poorly extensible or short-stretch bandages (extensibility ≤70% of the initial length) These are pure containment bandages where the action is exerted especially during muscle contraction during ambulation and not during muscle relaxation; they are bandages that produce a working pressure greater than the resting pressure and are well tolerated at rest. They exert effective pressure on deep regions and are able rapidly to reduce oedematogenic conditions of various origin. Although this type of bandage is included among the short-stretch bandages (bandages with elasticity ≤70%) it is clear that in the strict sense of the term, a bandage with a very low Young’s modulus of elasticity (close to zero) is rigid or inextensible so that a distinction should be made clinically between non-elastic or so-called rigid bandages (≤30%) and short-stretch ones (>30%≤70%). An example of a rigid or inextensible bandage still frequently utilised today is the zinc oxide bandage conceived by the dermatologist Paul Gerson Unna in 1885; there are also elastic versions of this today. Other types of inextensible bandages are usually made of cotton (or more rarely of linen, flannel etc.) with a variable polyamide percentage between 20-40%, for instance Ideal bandages (Lohmann & Rauscher), still used today in our operating theatres. Some authors (Marmasse G) consider that the optimal percentage elasticity of short-stretch bandages is 30-40%, which is the optimal level for obtaining increased working pressure on the one hand and will also act on deep regions, and on the other hand, does not at the same time involve the disadvantages of a completely rigid bandage, such as the marked difficulty of application and of keeping it in place over time. The fundamental problem of bandaging with this type of bandage is its execution and therefore its stability especially during ambulation; in fact, this bandaging is difficult in practice because it readily produces regions of greater and less compression with a loss of the uniformity and reduction of the pressure, or the bandage slips downwards or shifts, creating oedematous areas in a few criti- COMPRESSION impa.indd 10 cal regions such as the dorsum of the foot. It is certainly easier to bandage a limb with a medium- or long-stretch bandage (which will be poorly tolerated at rest by the patient) than with a rigid bandage (which is most tolerated by the patient). The inextensible bandage is used today basically in ulcer disease, lipodermatosclerosis, erysipeloid dermatitis with or without lymphangitis, severe oedematogenic conditions and the acute phase of DVT of the lower limb prior to an elastic stocking. Medium- and long-stretch bandages A distinction is classically made between one-way or two-way stretch bandages according to the direction of stretch (length or length + width) and between: –– medium-stretch bandages ( >70 ≤140 % of the initial length); –– long-stretch bandages (>140% of the initial length). They are made with natural or synthetic elastic threads of various types such as caoutchouc or natural rubber, polyamide (Nylon®) and elastane (Lycra®) in combination with materials such as cotton. Natural rubber: in nature, rubber is present as a colloidal suspension in the latex obtained from some plants (Hevea brasiliensis or rubber tree, originally from Amazonia but cultivated today in Malaysia, Indonesia, Sri Lanka etc.) and raw rubber is extracted from the latex of these plants. The vast majority of rubbers today are petroleum derivatives (synthetic rubbers), whereas natural rubbers were used predominantly up to the middle of the 20th century. According to international agreements (Geneva Agreement of 20 March 1987) natural rubber is today defined as a non-vulcanised elastomer in liquid or solid form derived from Hevea brasiliensis or from other similar plants (Tarassaco russo, Parthenium argentatum etc.). The physical and chemical properties of interest to us are the thermal dependency of the mechanical elastic characteristics (thermal instability) in that products made of natural rubber become fragile and rigid in winter (between 0-10°C) and often become sticky in summer (elastic and supple above 20°C). The rubber is not affected by weak acids and bases, and it dissolves in petroleum, benzene and carbon disulphide; it is insoluble in water and is oxidised slowly by atmospheric oxygen. Polyamide or Nylon®: these are thermoplastic polymers, and those used most often in the textile industry are polyamides 6 and 6.6 (PA 6 and PA 6.6) even if the market today offers a wide choice up to Grilamid, an extremely stable and tough polyamide 12 (of which there are different versions) with a density similar to that of water, which is used in various sectors including the area of sports. 20-05-2009 14:33:34 The bandage The main characteristics of this polymer are its high resistance to traction, to solvents and to basic products, while their main limitation is their marked sensitivity to moisture and UV rays. A particular polyamide used in the elastic stocking industry is microfibre. Elastam, Elastane, Spandex (commercial names Lycra® Invista or Dorlastan® Bayer): these are synthetic polymers containing at least 85% polyurethane by mass; they are on the market in both monofilament and multifilament form, with the latter employed usually in the stocking sector while the former are used in bandages. Lycra® can be imagined as a segmented polymer structure in which elastic segments are linked to rigid segments which keep distension in check, thus avoiding breakage. These elastic threads can be stretched 7-fold and then return to their original size; in the 1960s, this represented the second revolution in the elastic textile industry (elastic stockings with high wearability) after that of Nylon® in the 1930s, both produced by Du Pont (Du Pont patented Lycra® in 1959 and Nylon® or polyamide in 1938. These extremely fine and light threads (1500-3000 times finer than a hair; 1 g = 10 metres of thread) are always used in various combinations with other fibres such as cotton, nylon and silk and have provided us with very sheer elastic stockings of great wearability. Elastic bandages sometimes contain a certain amount of viscose (Rayon® Viscose), derived from cellulose, together with cotton and various types of elastic polymers. As noted above, elastic bandages are classified as short-, medium- and long-stretch. This classification of elastic bandages by the French school is probably the most widespread worldwide. However, in this connection a few considerations and precise definitions are needed: 1. the tension with which elastic bandaging is carried out indicates the force dissipated on stretching the bandage when it is wrapped around a limb; 2. the pressure exerted by the elastic bandage on the tissues depends on the structural characteristics of the bandage (Young’s modulus, hysteresis), the tension to which the bandage is subjected, the number of layers applied and the curvature of the limb (which differs in the various regions of the leg); 3. the ability of the bandage to maintain a certain tension over time and, secondly, the pressure on the tissues depend on its elastic properties (type of elastomer used in manufacture of the bandage); 4. the ability of an elastic bandage to stretch under traction is defined as extensibility, whereas the ability of a bandage to return to the original length on cessation of stretching is defined as elasticity; 5. locking represents the bandage’s point of maximum stretch; 6. the locking point should be at 70% of extension for COMPRESSION impa.indd 11 11 short-stretch bandages, while this locking point should exceed 140% of the original length in the case of longstretch bandages. For bandages belonging to the same categories, for instance short-stretch, but containing different elastomers, this locking can occur with the use of different forces (different hysteresis curves). In other words, if the force used to produce that particular extension, that is, the power = work over time, is not expressed, the definitions short-, medium- or long-stretch lose their significance because they only express the physical characteristics of the material employed. The concept of power is the basis of that of tension, since the latter is a parameter that is directly correlated with the force employed to produce that particular stretch; 7. the pressure exerted with a particular material and potency in application also depends on the bandaging technique and the overlapping of the turns: figure of eight bandaging, for instance, provides more compression than bandaging with regular turns; the pressure also depends on the structure of the bandage, stretch being equal: bandages with different fabric structures exert different pressures, and heavier bandages with the same maximum stretch compress more than others under the same application conditions. For example, the Dauerbinde® K bandage from Lohmann & Rauscher (stretch 180%), which is heavier, compresses more than the F (stretch 180%), which is light. The industry is examining new elastomers closely (vari-stretch) that are able to produce constant pressures so that variations within certain ranges of bandage extension can be eliminated so as to reduce intra-bandaging (same operator) and inter-bandaging (different operators) variability. Adhesive and cohesive bandages These are usually short- to medium-stretch bandages which are able to stick to the skin and to themselves (adhesive bandages) or only to themselves (cohesive bandages) by means of acrylic adhesive or zinc oxide glue. Cohesive bandages are manufactured by atomisation of the surface of both sides of the bandage with latex or acrylic microspheres diluted in water, which evaporates on heating to 50°C in suitable furnaces. The latex suspension is fixed and covers the entire surface of the bandage and is able to adhere only to itself. The acrylic or zinc oxide glues are highly hypoallergenic and these bandages can be used relatively readily in direct contact with the skin. In this connection, the following precise definitions are required: 1. adhesive bandages can be manufactured with the presence of elastomers (natural rubber etc.) or be made completely of cotton with a defined elastic weave (or 20-05-2009 14:33:34 12 COMPRESSION the elasticity is not associated with elastomers but with the particular weft of the weave); 2. a few bandages with zinc glue are made of cotton and Rayon® and have soft and tough edges so as to reduce the lacing effect at difficult points; 3. some adhesive elastic bandages are made of pure cotton without elastomers and with a particular weft, producing elasticity in the bandage which is defined as “variable memory”. These bandages, which often require shaving when they are placed in contact with the skin, have the adhesive arranged in strips with a protective film which is removed when they are used. If they are stretch to up to 50% of their length (submaximal tension), they behave like normal elastic bandages and can regain their original length but if this exceeds 50% they lose their elastic capacity (maximum tension) and are transformed into rigid bandages. These bandages are used mainly in orthopaedics, sports medicine and physiotherapy; 4. adhesive elastic bandages, like elastic bandages, can be one-way stretch (stretch in the longitudinal direction) or two-way stretch (stretching in both longitudinal and transverse directions); 5. cohesive bandages are a further example of short- and medium-stretch bandages and are described as strong, medium, light or soft to indicate their compressive power; 6. in general it is preferable to use a skin protector (polyurethane foam film with high porosity) beneath the adhesive bandage even if this technique may reduce the stability of the bandage (slipping). The use of elastic tubing beneath the bandage produces greater stability of the bandage itself with the addition of the pressure exerted by the tubing, which is about 10 mmHg at the ankle. The types of bandaging with adhesive and cohesive bandages provide permanent bandages (fixed bandages that the patient must not remove) which are more stable over time and provide medium to high pressures on the tissues. This type of bandage is indicated when a fixed bandage has to be applied, which the patient must not remove for a long period and must leave on both day and night (venous ulcers, oedema, post-operative or post-sclerotherapy etc.). Working and resting pressure of bandages Working pressures (muscle contraction) and resting pressures (muscle relaxation or rest) have been mentioned several times with reference to bandage type. It was explained above that the non-elastic or rigid type of bandage in the strict sense is the zinc oxide bandage in its nonelastic form or the Ideal type of bandage, and that a rigid COMPRESSION impa.indd 12 bandage in general must have a Young’s modulus of elasticity close to zero, whereas we can have different types of elastic bandages depending on the elastomer employed. Non-elastic (rigid) bandages create peak pressures, and conversely, elastic bandages, especially long-stretch ones, absorb the volumetric changes of muscle contraction in the limb and do not demonstrate peak pressure variations but more constant pressures with minimal pressure changes during walking. The more a bandage, when applied, is able to give peak pressures (working pressures), the more the action is transmitted deeply (deep venous system). To further simplify this concept, we can say that passing gradually from the rigid bandage to the elastic stocking the net difference between the resting and working pressures is reduced more and more in favour of lower but more constant pressures. Within certain limits, we can transform a long-stretch into a medium-stretch bandage and a medium- to a short-stretch bandage by doubling the number of turns of the bandage; the overlapping of the turns causes not only an increase in the pressure exerted but also a shift of the system towards rigidity (Von Gregory’s force-stretch diagrams). This stratagem allows a greater variety of bandaging with fewer types of bandages. Finally, a sort of general rule can be formulated “the more severe the venous disease, the more the bandaging must be short-stretch or completely non-elastic in combination with movement, and in this way the best result will be obtained in correcting stasis”. Classification of elastic compression bandages There are national standards that classify bandages; the most important ones are German and English (Table II). The German standard (RAL-GZ 387) classifies bandaging materials into: –– material for protection, absorption and fixation (orthopaedic wool, light cohesive bandages, foam) and material for eccentric compression; –– non-elastic bandages (rigid zinc oxide bandages, CircAid®); –– short-stretch bandages (40-70%); –– medium-stretch bandages (70-140%); –– long-stretch bandages (>140%). Instead, the English standard (BS 7505:1995) divides bandages into: –– fixation bandages (orthopaedic wool, foam, light cohesive bandages); –– short stretch bandages (zinc oxide bandages, shortstretch elastic bandages); –– long stretch bandages (long-stretch elastic bandages (3A - 3B - 3C - 3D). 20-05-2009 14:33:34 The bandage As regards the long-stretch elastic bandages, the German and English standards divide the bandages into four classes of different elastic strength and therefore different resting pressure. This pressure is calculated at a known ankle circumference (23 cm) with the bandaging overlapping 50%; it should be noted that the pressures relating to the different classes differ considerably in the two classifications. Table II – Classifications of bandages. RAL-GZ 387 Germany standard pressure mmHg BS 7505 England standard pressure mmHg Class 1 18,4-21,2 3A up to 20 Class 2 25,1-32,1 3B 21-30 Class 3 36,4-46,5 3C 31-40 Class 4 >59 3D 41-60 Moreover, these classifications, as mentioned above, consider the parameter of extensibility, which has no clinical relevance if other more important characteristics are not described at the same time; these are: 1. Elasticity understood as the ability of the bandage to regain its original form after extension; this is due to the addition of elastic threads in the longitudinal direction of the bandage; the force employed to stretch the bandage (deformation energy) indicates the elastic power or tension. The ability of the bandage to maintain tension and therefore the pressure it exerts depends on its elastomer properties (which depend in turn on the thread and the method used to construct the fabric); 2. Rigidity can be defined as the ability of the bandage to oppose muscle expansion when it contracts. It depends on the elastic recoil of the material used in its construction. The more compact the weft (and with a lower presence of elastic fibres) the shorter the stretch of the bandage and the more its rigidity increases. Today, as mentioned above, the rigidity of a bandage can be measured with simple, economical and reproducible methods and can be expressed with various indices, the most studied of which is the “static stiffness index” (SSI), which is the difference between the pressure exerted in vivo by the bandage on the surface of the leg (point B1) standing and lying, and if this pressure difference is greater than 10, the bandaging is of the rigid type (Partsch H. 2005). Stiffness (CEN 1996-1998) signifies the increase in the pressure of the bandage (given by the resistance offered by the bandage) with a 1 cm increase in the circumference of the limb; 3. Extensibility is defined as the ability of the bandage to elongate when subjected to stretching; this is measured COMPRESSION impa.indd 13 13 by the lengthening of the bandage when a force of 10 N is applied per cm of height and is expressed as a percentage of the length at rest. Once a given extension has been reached, the physical structure of the bandage prevents further stretching; this condition is called “locking”. According to Stemmer’s classification, shortstretch bandages should lock once a maximum of 70% of extension has been reached (preferably between 30 and 40%) while long-stretch bandages should lock beyond 140%. However, extensibility cannot be translated into a clinical indication if the degree of elasticity and rigidity of the bandage is not indicated at the same time. In fact, there are bandages that can achieve similar extension when forces of very different intensity are applied. We therefore regard it as more appropriate to employ the terms “elastic” and “non-elastic” to indicate bandages with a highly elastic component (medium- and longstretch) and bandages with a reduced elastic component (short- and medium-stretch). As can be observed in the medium-stretch group of bandages (between 70% and 140%) we find bandages with a reduced elastic component which should therefore be considered in the non-elastic group, and bandages with a strong elastic component which to all intents and purposes can be placed in the elastic bandage categories. The elastic bandage can therefore be classified as: –– elastic bandage constructed with predominantly elastic fibres in various combinations of weave, which when extended exert pressure (at rest), which is proportional to its elastic power (force utilised to extend it); –– non-elastic bandage constructed with predominantly non-elastic fibres in various combinations of weave, which, by opposing muscle contraction during walking, cause an increase in (working) pressure, which is proportional to its rigidity and indirectly proportional to its extensibility. Because of the invariability of the physical qualities and because they are only partly subject to Laplace’s law, a separate classification is warranted for the non-elastic inextensible bandage made with materials (e.g. zinc oxide bandages), which do not extend when subjected to stretching (inextensibility) and do not have any tendency to regain their original shape after being subjected to traction (nonelasticity). The differential between working pressure and resting pressure (which is present especially if the bandage is pulled) is very high. The resting pressure can be weak or absent in the case of application without traction or high if the bandage is applied exerting more or less firm traction; in the former case, this type of bandage is optimally tolerated even in conditions of supine rest. 20-05-2009 14:33:34 14 COMPRESSION In view of what has been stated, the bandage can be classified in the following way: –– Fixation bandages (cotton, foam, crepe, etc.); –– Elastic bandages; –– Rigid and inextensible (Zn oxide - Circ Aid®). The elastic bandages in turn can be divided into: –– bandages with elastic fibres: •• medium-stretch; •• long-stretch both with light/medium/strong/extra strong elasticity; –– bandages with a low elastic component: •• medium-stretch; •• short-stretch classified on the basis of their stiffness (more or less high). A new classification of the bandages is named P-LA-CE (Pressure-Layers-Components-Elastic Properties) and was proposed by a group of experts of the ICC (Partsch H et al. 2008). The non-elastic bandage exerts greater resting and working pressures compared with elastic bandages and a greater haemodynamic effect in terms of the reduction of venous reflux, venous volume, venous calibre and venous hypertension. In all of the venous diseases in the active phase, characterised by severe haemodynamic damage, the non-elastic bandage should be preferred to the elastic bandage and applied in a manner that develops high resting and working pressures; since this has a marked effect on the reduction of the oedema, it is removed more often than recommended (1 week) in the initial treatment period, as the pressure exerted falls dramatically with the reduction of the oedema. The elastic bandage or elastic stocking is reserved for cases with mild haemodynamic damage or following remission of the acute symptoms in order to maintain the results and prevent recurrence. Bandaging techniques Elastic compression bandaging can be carried out with different materials and different techniques, depending on the disease, particular needs and the shape of the limb or the site of the limb to be bandaged. The basic physical characteristics that a bandage must have are graduation and uniformity. Elastic compression bandaging can be carried out using: –– non-elastic and short-stretch bandages; –– medium- and long-stretch bandages. This is a fundamental distinction from the clinical aspect, as, depending on which group of bandages is used, COMPRESSION impa.indd 14 the bandage can be kept in place for several days (with bandages of the first group) or the bandage has to be removed in the evening and replaced the following morning (bandages of the second group) because they are not tolerated at rest. As a general rule, the bandages of the first group are used in more elderly patients, in more severe venous insufficiency complicated by trophic disorders, and in forms associated with obliterative peripheral arterial disease (mild or moderate). In each case, these are bandages that are not easy to handle and they can be used only by professionals with a degree of experience. Conversely, the bandages of the second type are used for less severe venous disease, to reduce oedema and for compression of the superficial venous circulation. As regards application of the bandage, this can be done using different techniques, each with different indications. The bandage should be unrolled keeping the hand close to the surface of the skin so as to avoid pulling it upwards or downwards and to avoid differences in tension, which can cause areas of non-uniform pressure within the same region. The patient’s position, seated or lying, does not influence the placement of the bandage apart from the greater or less comfort of application. The heel can be kept covered or uncovered according to whether it is desired to allow the patient to walk correctly (maintenance of proprioceptive sensation on contact with the ground during a step), or it may be necessary to reduce oedema involving the retromalleolar fossae. In the case of bandaging as far as the thigh, the knee joint must be kept free, except in special cases. The most common techniques, of which numerous “personal” versions are possible, are: –– Bandaging with regular turns; –– Figure of eight bandaging; –– Figure of eight bandaging fixed at the ankle; –– Spontaneously unrolled bandage. Described separately: –– Multilayer bandaging. Bandaging with regular turns (Fig. 4) All of the techniques share the rule of unrolling the bandage from inside to outside, that is, in the medialto-lateral direction. In practice, proceed anticlockwise for bandaging the right limb and clockwise for the left limb. Bandaging is started at the base of the toes and after 2-3 turns around the foot, it moves to the ankle and proceeds proximally ensuring that the turns overlap by 50%, that is, the bandage is extended covering half of the turn underneath. When it has reached below the knee, the turn is finished and if there are a few leftover centimetres of band- 20-05-2009 14:33:34 The bandage Fig. 4 – Hysteresis (short stretch bandage). age, these are extended in a distal direction without exerting much traction. Figure of eight bandaging (Fig. 5) This is a version of the above: it starts at the base of the toes in regular turns and proceeds proximally, crossing the turns of the bandage from the dorsum of the foot or from the ankle to below the knee in a figure of eight; the maximum pressure is obtained at the crossing points of the turns; this type of bandage is more compressive than the preceding one because it provides greater overlapping of the turns of the bandage, and it is more stable over time. When placing this bandage, it is important to ensure that the crossing points of the bandage do not correspond to the tibial crest as they could cause skin injury. 15 Fig. 6 – Figure of eight bandaging fixed at the ankle. Spontaneously unrolled bandage (Fig. 7) This bandage is indicated especially for diseases of the calf as it exerts its maximum compression posteriorly; starting at the base of the toes, a few turns are made and the bandage moves to the lower border of the belly of the calf muscle; at this point, it is rolled around the calf to below the knee, then making a so-called fixation turn, that is, a complete turn of the bandage below the knee. It is then brought downwards again in regular turns so as to cover the leg completely to above the ankle. Fig. 7 – Spontaneously unrolled bandage. Fig. 5 – Figure of eight bandaging. Figure of eight bandaging fixed at the ankle (Fig. 6) In this case, starting at the ankle, one turn of the bandage is placed and it is continued distally on the foot, which is covered as far as the base of the toes. It is then continued proximally again, back to the ankle; at this point, a figure of eight turn is made and it is continued upwards with regular turns. It is indicated especially in the treatment of venous ulcers exerting strong pressure just above the ankle around the medial malleolus, where at least 5-6 turns of the bandage overlap in this case. COMPRESSION impa.indd 15 Multilayer bandaging This is a system produced by Smith & Nephew (Profore®), comprising a kit of 4 bandages, produced for different ankle circumferences (18-25 cm and over 25 cm), which are applied in a precise sequence, each one with a different technique: –– the first layer consists of a bandage of synthetic wadding (orthopaedic wool), which is applied in regular turns overlapping 50% and covering the heel also; –– the second layer consists of a non-stretch cotton crepe bandage which fixes the first layer, and is applied in regular turns with overlapping of 50%; –– the third layer consists of a light long-stretch bandage, which is placed using the figure of eight technique, 20-05-2009 14:33:34 16 COMPRESSION stretching the bandage about 50% and following a central yellow line which acts as a guide; –– the fourth and last layer consists of a cohesive bandage, which is applied with regular turns with extension of 50% and overlapping of 50%, which will produce final compression at the ankle of 40-50 mmHg This bandage, with its characteristics of optimal comfort and especially its exceptional ability to reduce marked oedema, is particularly indicated in venous disease complicated by large ulcers, areas of hypodermitis resistant to other treatments and significant oedema and lymphoedema. Multilayer bandages with different features are: Rosidal sys® (Lohmann & Rauscher) and Coban 2® (3 M). “Handcrafted” multilayer bandages can be made, provided that quality bandages are used and the general bandaging rules are taken into account. The long-stretch bandage must be placed above the rigid one if obtaining adequate pressures is desired. The cohesive bandage is used to keep the bandage obtained thus in place better, increase the pressure and provide uniformity to the compression system. Technique of applying the bandage, defined as “short elastic” according to Sigg (Fig. 8) The bandaging of an entire limb must be carried out with 3 short elastic bandages plus an underlayer of ETA foam for the thigh. The short elastic bandages have a length of 5 m under tension and come in different widths: 8 cm for the foot, 10 cm for the leg, and 10 or 12 cm for the thigh. It is applied immediately after performing sclerosis of any vein with the exception of telangiectasia, where use of a therapeutic elastic stocking is permitted. It is worn whenever the patient is standing in conjunction with frequent walking, it is removed completely at night and reapplied before rising from bed, even if this is for a short time: –– the foot is bandaged starting with an initial turn behind the base of the toes (these are bandaged only if they are the site of oedema or ulcer). The tension must be able to utilise all the elastic capacity of the fabric so that after it is applied, it unrolls on its own if it is not stopped; the pressure is correct when the fingers take on a cyanotic hue which disappears after a dozen footsteps. The foot is at a right angle relative to the leg and this is at 90° to the thigh. This bandage wraps the foot and ankle until it reaches the start of the calf, in more overlapping turns until all of the bandage has been used. In this way, every part of the foot is covered, in particular, with the bandage passing 4-8 times around the ankle as otherwise this site would be compressed insufficiently. –– from here the leg is bandaged as far as the popliteal fossa with a second 10 cm bandage, unrolling it in direct contact with the leg, thus creating the direction of the bandage, and it is possible at each turn to pull it with force. In this way, the edges of the bandage are subject to identical tension and furrows are not created; the leg is covered following its anatomical shape, with each part covered 4-5 times with figure of eight turns. Particularly large legs require the use of a 12 cm bandage. Fig. 8 – Sigg bandage. COMPRESSION impa.indd 16 20-05-2009 14:33:35 The bandage –– the thigh must be bandaged differently because of its tapering shape. An ETA foam (foam rubber) bandage 12 or 15 cm wide is used, which adheres very well to the skin though it is not adhesive. This is used to prevent the thigh bandage from slipping; it must be 3-4 mm thick as it tears if it is thinner. The foam rubber is attached to the skin and ensures that the overlying 10 or 12 cm short elastic bandage remains in place even if the shape of the thigh is very tapered. The bandage starts immediately below the knee and continues to the groin. The knee is enclosed by the bandage and can move freely due to the foam rubber bandage without destabilising the efficacy of the compression in this area. An adhesive bandage is required rarely, and is intended only for phlebitic conditions necessitating further compression even in bed at night. In this case, this bandage is cut at each turn and it is often medical-lsod practice to place a protective “skin sparing” layer of foam because of the frequent reactions with the adhesive. This bandage is usually employed to keep hard-core pads in place following sclerosis of the saphenofemoral junction, cutting it after a half turn. If the patient has been well instructed, he himself will be able to apply it better than anyone else because he will feel the compression force on his leg so that he will soon be able to bandage like a healthcare professional. However, this bandage is inspected at every consultation to avoid oedema, which is frequent at the foot, where the patient is told to apply it with low tension. Any oedema present is revealed and demonstrated to the patient, teaching him how to detect pitting so that he will be better able to calibrate the tension of the bandage, and he is asked to reapply it several times a day when it loosens and slips, which allows compressive grooves to form and thus oedema to develop in the distal segment. If applied well, the bandage is so adherent that it becomes troublesome and painful after 2-4 hours at night so it should be removed at bedtime and reapplied in the morning. If this is not possible, the bandage is applied a little more loosely, enabling it to be worn at night also, until the patient is able to reapply it correctly himself after a few days. Eccentric compression By modifying the radius of curvature of the part of the limb to which it is applied, in the sense of an increase (negative eccentric compression), or a reduction (positive eccentric compression), the aim is to reduce in the first case or increase in the second the compression exerted by any concentric compression (stocking or bandage). Negative eccentric compression is generally used over the dorsum of the foot, the Achilles tendon, the tibial COMPRESSION impa.indd 17 17 crest and tendons. It can be achieved with strips of foam up to 4 mm thick or with cotton wool rolls (instep) and prevents irritation of the skin and pain in subcutaneous structures. The aim of positive eccentric compression is to provide a focal increase in compression; this can use various materials: 1. Gauze is used because of its breathable and anti-exudative capacity on areas of epidermis and eczema. Because of its low deformability, gauze is used by choice when making circular compact pads 2-3 cm in diameter, which are placed over varicosities or reticular veins and held in place for a day with hypoallergenic adhesive plaster. 2. Another material is cotton wool in the form of pads with a core: •• soft, spherical pads 1 cm in diameter; •• semirigid, cylindrical pads 1/5 cm in diameter (dental), to be applied like a bridge between two gauze pads; •• rigid, the cotton wool covers a sheet of compacted aluminium, rolled into various shapes, used for selective compression of escape points; they are held in place for 7 days with half a turn of adhesive bandage; –– for perforating veins, hemispherical pads 2 cm thick and circular in shape can be used over the muscle perforators (calf muscle), or half-moon over the retrotibial perforators; –– cylindrical for the saphenofemoral junction, 4-5 cm in length but of various thickness: •• thin, 2 cm, for the internal and external saphenous in thin thighs; •• medium, 3 cm, for the internal saphenous and Hunter and Dodd perforators; •• thick, 4 cm, for the internal saphenous of large thighs. The purpose of these pads is to reduce the radius of curvature of the thigh and therefore make the compression more intensive, according to Laplace’s law. 3. Another important device for eccentric compression consists of rubber or latex foam pads of various shapes. The physical characteristics of natural rubber described above make such wedges capable of increasing even the resting pressure. In fact, with the increase in limb volume that characterises muscle contraction, the rubber, which cannot expand, is squeezed between the skin and the rigid bandage and exerts a constant, elastic and soft pressure on the veins but increases the compression force less than rigid pads. When the muscle relaxes, on the other hand, its re-expansion fills the potential space between bandage and skin, preventing blood stasis, in practice restoring force to the compres- 20-05-2009 14:33:35 18 COMPRESSION sion of the bandage, which would otherwise be practically non-existent in this phase. This results in a direct pumping effect on blood reflux. Such devices are used widely in the treatment of all stages of CVI, including venous ulcer, with the precaution of avoiding the rubber coming in direct contact with affected skin, such as eczema, hypodermitis or white atrophy. Recommendations –– The bandaging should extend to the base of the toes, it should be carried out from the inside to the outside of the limb and maintain the characteristics of regularity and uniformity: the bandage should be applied at constant tension, overlapping the turns by about 50% of their width, thus avoiding areas of excess pressure and local constriction. –– Figure of eight bandaging fixed at the ankle compresses the medial regions of the leg mainly and is therefore indicated for venous disorders in that region such as ulcers and hypodermitis. –– The pressure exerted by the bandage and its efficacy, according to the material utilised, depend closely on the tension to which the bandage is subjected, on the number of overlapping turns and on the technique employed. –– Multilayer bandaging is indicated particularly in venous disorders complicated by large ulcers, areas of hypodermitis resistant to other treatments, and significant oedema and lymphoedema, including indurated oedema. –– The static stiffness index (SSI) is the most important clinical index to choose the type of compression bandage. –– Eccentric compression should be used when the radius to be compressed needs to be controlled, to protect some areas from excessive pressure, to obtain effective compression where the curvature of the skin surface does not allow it or to increase the pressure where necessary. –– Figure of eight bandaging remains in place longer without altering and provides about 30-40% more compression compared to one with regular turns. COMPRESSION impa.indd 18 –– The spontaneously unrolled bandage compresses the calf mainly and is therefore indicated for venous disorders in the posterior region of the leg. 20-05-2009 14:33:35 19 The elastic stocking Definitions boembolism stocking is a therapeutic elastic stocking tolerated at rest which guarantees a pressure of 18 mmHg at the ankle (tolerance limits ± 3 mmHg); the pressure profile along the lower limb must be graduated: in B1 80-100% of the pressure at the ankle (B), in C between 60-80% and in F or G between 40-70% (CEN 1998, draft prEN 12719). Therapeutic or medical compression stocking (MCS) (Fig. 9). The therapeutic or medical compression stocking (MCS) is a stocking made with materials and methods according to the standards defined by the legislation in force (currently the German RAL-GZ 387, French NFG 30-102B IFTH and English BS7505), which guarantees a defined and graduated pressure along the limb between certain parameters, specified according to compression classes and available in different models and sizes. The compression and compliance with the specified manufacturing methods must be certified constantly by independent national institutes. In clinical trials and in world scientific literature the therapeutic elastic stocking has demonstrated a certain efficacy in the prevention and treatment of phlebolymphological disorders: it is a medical device in all its effects. Elastic support stocking (Fig. 10). An elastic stocking that does not meet the standards, in whole or even in part, but which can guarantee pressure in mmHg at the ankle and/or other points of the lower limb, maintaining a certain reduction in pressure from below to above is defined as an elastic support stocking. Elastic stocking. All other types of stockings made with elastic fibres, which state pressures in den (deniers) or do not guarantee defined and graduated pressures are defined simply as elastic stockings. Antithromboembolism stocking. The antithrom- The MCS must meet the manufacturing and quality criteria defined by the German standard RAL-GZ 387 (Reichs Ausschuß für Lieferbedingungen, 23 April 1925; Medical Compression Hosiery Quality Assurance, last revision September 2000), French NFG 30-102B (IFTH) or English BS7505 adopted by European producers: –– manufacture with circular looms (or linear for some types of made-to-measure stockings); –– production with materials of a quality and methods defined in the standard; –– graduated and uniform compression from below to above; –– declaration of the compression class in mmHg at the ankle and along all the lower limb; –– extensibility of the knit in both directions to facilitate joint movement; –– aerated fabric to allow evaporation and cutaneous transpiration; Fig. 9 – Medical compression stocking (MCS). Fig. 10 – Support elastic stocking. COMPRESSION impa.indd 19 The characteristics of the medical compression stocking (MCS) 20-05-2009 14:33:36 20 COMPRESSION –– knitted heel to allow anatomical position of the ankle and therefore the required compression in the specific region of the leg; –– perfect adaptability to the shape of the lower limb; –– guarantee of the duration of compression for a period of at least 4-6 months, depending on the type of threads used in manufacturing the stocking; –– production and product expiry dates on the packaging together with all the details needed for certifying traceability and the quality of the medical device; –– inspection of the products with tests conducted constantly by independent authorised institutes. The standards differ essentially only in the difference in the compression range in the various therapeutic classes, even if an attempt is being made to achieve uniformity in Europe with compliance with the compression classes specified by the CEN, which the RAL-GZ producers have already adopted (Table III). The stocking consists essentially of a transverse weft thread which produces the compression. The weft thread is made of natural rubber or elastane, a synonym of Spandex (Lycra®, Dorlastan®, Linel®), which is usually double wrapped (guipage phase) with threads such as cotton, polyamide (Nylon®) or microfibre polyamide so as to fix the weft thread itself at a predetermined tension and produce the physical and aesthetic characteristics of the stocking. The knit through which the weft thread passes consists of elastic yarns, of lower strength compared with the weft, usually woven with the method known as crossed and locked knit. In Italy there is still no standard in force, although the UNI [Italian Standardisation Organisation] adopted the experimental European standard (CEN/TC205 prEN12718-19) in January 2002, whereas in other European countries, therapeutic elastic supports are subject to strict quality controls by the appointed organs (Forschungsinstitut Hohenstein in Germany, ITF in France, EMPA in Switzerland, TNO in the Netherlands, Segar Design in Great Britain) and are partially reimbursable by the national health systems. MCSs have different stiffness values depending on the compression class and within the different classes according to the materials used for their manufacture (Wegen- Franken K et al. 2006). The stiffness is a factor in the compression characteristics of the stocking and also in the duration of the compression. In brief, it can be stated that a stocking with weft threads of natural rubber compresses more and with higher working pressures than elastane within the same therapeutic class, and it also maintains this pressure better (the pressure falls at the end of the day by about 7-8% compared with the morning, whereas the decrease is about 15% for elastane). The efficacy of “support” stockings, defined with the incorrect term “preventive” (up to 18 mmHg), which do not have the weft thread but are produced only with a knit fabric (usually of Nylon® fibre), is controversial, like that of support stockings that state the pressure in “deniers” (den). The denier is a unit of measurement of the weight of synthetic threads and its specific value is 1 denier = weight in grams of 9 Km of thread. The producers of MCS propose different compression classes to be prescribed according to the severity of the phlebolymphological disease, together with the socalled “antithromboembolism” stocking (18 mmHg at the ankle, 8 at the thigh), which is distinguished from the other models because it should be worn at rest to prevent thromboembolic episodes. The use of the antithromboembolism stocking can be extended to post-thrombophlebitic patients to provide prophylactic compression at rest to prevent recurrence and to patients who have had varicose vein surgery in the days following the operation, in combination with an elastic support to be worn during daytime activity. A relatively recent use of elastic stockings as a replacement for the medicated adhesive bandage (non-stretch or short-stretch) is the one described by Mariani F et al. (Phlebologie 2008) in the treatment of venous ulcers of small-medium dimensions; once the large oedema has reduced (if it is present), wearing a kit of stockings (Ulcer X® Sigvaris®) constantly over a suitable medicated dressing is indicated. MCS is useful in prevention and in maintaining the results obtained; the adhesive bandage (rigid or shortstretch) should be used in the “active” treatment of oedema and complications. The elastic bandage is certainly the most suitable for reducing soft reversible oedema in the absence of trophic skin changes, but has the disadvan- Table III – Compression classes at the ankle point B (mmHg). European standards. Class RAL-GZ 387 AFNOR G 30.12 BS 6612:1985 1a 18-21 10-15 14-17 2a 23-32 15-20 18-24 3a 34-46 20-36 25-35 4a >49 >36 COMPRESSION impa.indd 20 20-05-2009 14:33:36 The elastic stocking tage of having to be removed daily with all the subsequent technically difficulties of reapplying it. The choice of medium- and long-stretch bandages is determined greatly by whether the patient has ready access to staff skilled in bandaging techniques. Prescription of a therapeutic elastic stocking is of great importance, both because of the choice of compression classes and because of the size and type of support. In general, the practical rules are as follows: –– the compression class should be suitable for the disease (see table at the end of this document); –– the choice of stocking model (below-knee, thigh length, tights or single-leg tights) must take into account the clinical needs (extent of the disease and site of any therapeutic intervention) and patient compliance, bearing in mind that the effects of the compression will be exercised substantially on the leg; –– the circumferences of the limb should be taken accurately, bearing in mind that an elastic support of the wrong size will exert pressures different from those desired and not graduated, thus impugning the efficacy and tolerability of the compression therapy; there should therefore be no hesitation to prescribe a custom-made stocking if the dimensions of the limb do not correspond to the available sizes; these are available today with the same methods of manufacture as standard stockings. Quality marks The marks attached to the products have various meanings and values. There are obligatory marks; in Europe, the only mark of this type is the mark, which indicates that the product meets the safety requirements laid down by specific community directives. The mark is found on many categories of products and is also present on medical stocking packaging; it is a kind of passport that allows the medical-lsods to circulate freely within the European Community. However, it has a limitation, which is due to the lack of an external body to certify it, in other words, it is self-certification by the producer, supported by technical documentation, which states that the product complies with the requirements. It is therefore a basic guarantee, a safety mark, but it does COMPRESSION impa.indd 21 21 not assure the actual qualities of the specific product. In some cases, the SQS mark, which refers to a specific mark. Then certifying body, is combined with the there are voluntary marks, accredited by governments or by a third organ recognised by the national government. In this case, it is the producers who voluntarily ask external certification bodies to inspect their product and declare that it complies with specific requirements. The best known is ISO 9002. The international ISO 9000 standards define the quality standards associated with industrial production processes. This type of certification guarantees the production system but is not a guarantee of greater product quality. As regards medical stockings, the most widespread mark is the RAL-GZ 387 mark (Fig. 11), which is issued by independent certifying bodies (Hohenstein in Germany); these guarantee the quality of the threads utilised in addition to compliance of the declared pressure values with the standard. This is necessary if the medical stocking is to be reimbursed by the national health systems of these countries. The standards also specify that medical stockings must carry the Öko-Tex standard 100 mark or an equivalent (class II product in contact with the skin), which certifies that the fabric does not contain substances that are harmful or irritant to the skin. In Italy there are no precise standards in force, so that when choosing a medical device such as a therapeutic elastic stocking (according to the Universal Medical Device Nomenclature System, UMDNS, medical stockings are identified with the number 13-789) it is important to confirm the presence of one of the cited quality marks (RAL-GZ 387, IFTH, BS7505), to protect the medical prescription and the patients. Fig. 11 – RAL-GZ mark. 20-05-2009 14:33:36 22 Intermittent pneumatic compression Pneumatic compression (IPC) systems differ in the number and superimposition of the segments constituting the boot and armlet and in the determination of the inflation sequences. A distinction is made between equipment that exerts intermittent compression, first produced in the 1950s, consisting of a sleeve with a single chamber that inflates and deflates alternately; peristaltic (presence of more aligned chambers that deliver compression one at a time); sequential (the chambers are multiple, overlapping each other, inflated sequentially and deflated at the same time); plantar pneumatic (PPC). There is no definitive proof in the literature of the superiority of one or the other system but it is considered that the action exerted should be as physiological as possible. According to this criterion, the best compression therapy appears to be the sequential one as the squeezing of the fluid takes place in the physiological distal-proximal direction without causing reflux as the chambers are inflated sequentially one after the other, remaining inflated until they all decompress simultaneously; moreover, the cycle times are rapid (about 30 sec) so they allow a greater number of cycles in the same period of time (about 60 in 30 minutes with 20 effective minutes of treatment). However, it is advisable not to exceed pressures of 40-60 mmHg and to intersperse the sessions with application of a bandage when significant oedema has to be reduced, changing then to an elastic support of COMPRESSION impa.indd 22 a suitable compression class in the maintenance phase. A sequential compression device (SCD Response® TycoKendall) has been introduced recently in clinical use for VTE prophylaxis; this allows personalised intermittent compression cycles, obtained by an automatic analysis of venous refilling of the plethysmographic type. The pressure exerted by the three-chamber and six-compartment boot is 45 mmHg at the ankle, 40 mmHg at the calf and 30 at thigh level. Pneumatic compression has a grade 1A recommendation level (grading of Guyatt G et al., CHEST 2006) in the prophylaxis of venous thromboembolism and 1B in the treatment of lymphoedema and the venous postthrombotic syndrome. The contraindications are represented essentially by cardiac failure, which can be markedly exacerbated in a short time because of the rapid major movement of the blood mass towards the right heart and the extrinsic compressions on veins. Obstructive arterial disease does not appear to be an absolute contraindication to the treatment, since there are articles in the literature which even demonstrate an improvement of peripheral perfusion after low pressure PC: the emptying of the veins induces a reduction in the flow resistance (reduction in the arteryvein gradient), the increased shear stress produces vasodilator biological effects and the reduction in the oedema improves capillary flow (Labropulos N et al. 2002). 20-05-2009 14:33:36 23 Techniques of measuring compression in vivo Measurement in vivo of the pressure exerted by the different compression methods has always been a subject of great interest for all who study compression therapy in phlebolymphology. It can be performed with various systems, which have developed from those of the past, such as Van Der Molen’s tonometer (1955), the Sigg Tester (1964) or that of Haid (1970), to today’s devices, which are accurate, reliable and repeatable (Table IV). Measurement of the pressures defined as interface pressure with numerous sensors and devices can provide a whole range of information that is extremely useful for the study of the compression effects of various materials, such as the resting and working pressures, stiffness (static stiffness index by Partsch H), and the pressure exerted according to the stocking, bandage or bandaging technique utilised, so that compression methods can be classified according to their actual clinical activity. It can also be highly useful for learning bandaging technique, measuring in real time the pressure exerted at various points in the limb. Many modern measurement systems are available and none has been shown to be superior to the others. However, it is advisable that they should meet a few basic principles if they are to provide reliable and repeatable results: –– the system should provide measurement continuously during rest and movement; –– calibration of the sensors in contact with the compressed surface should be simple and repeatable at each measurement; –– the sensor should have a maximum thickness of 0.5 mm (Ferguson-Pell model) and be flexible but not distensible and be readily adaptable to different surfaces; –– the sensor should be insensitive to variations in temperature and humidity; –– the response to variations in pressure should be linear; –– the optimal sensitivity is <0.1 sec, <0.1 mmHg; –– the sensor should be durable and made of materials that can remain in contact with the skin even for long periods without causing irritation. The points for measuring pressures on the lower limb should be standardised according to the following anatomically regions: –– B, at the smallest circumference of the ankle; –– B1, at the circumference where the Achilles tendon meets the inferior tip of the calf muscle (about 10-15 cm proximal to the medial malleolus); –– C, at the greatest circumference of the calf; –– D, just below the tibial tuberosity; –– F, halfway up the thigh, between the midpoint of the inguinal crease and the tibial tuberosity; –– G, at the maximum circumference of the thigh, about 5 cm below the inguinal crease. Point B, as a reference for the manufacturers of elastic stockings, is the point of main choice in the measurements because there is usually no irregularity of the radius and it is a reliable index of the pressure exerted, together Table IV – Devices for measuring interface pressure. Pneumatic, pneumatic electric or piezoelectric systems Kikuhime (Meditrade-Denmark) MST MKIII Salzmann (Salzmann Medico-Switzerland) Juzo Tester (Elcat-Germany) Oxford Pressure Monitor Talley Pressure Evaluator (Talley Ltd.-UK) PicoPress (Microlab, Italy) SIGaT Tester (Blazek device-Ganzoni Sigvaris-Switzerland) Piezoelectric systems MCDM-I (Mammendorfer Inst. Physik, Munich-Germany) Strain gauge systems, resistive Diastron (Diastron Ltd.-UK) Fontanometer (Gaeltec Ltd.-Scotland) Fscan, Iscan (Tekscan-USA) FSR, FSA (Vista Medical-Canada) MCDM (Mammendorfer Inst. Physik, Munich-Germany) Rincoe SFS (Rincoe and Associates-USA) COMPRESSION impa.indd 23 20-05-2009 14:33:36 24 COMPRESSION with points C and D. Partsch H et al. (2006) also propose point B1 as a reference parameter for the measurements since the maximum increase in circumference during movement and passage from the supine to the erect position occurs in this area. The interface pressure can be recorded with the patient lying and standing, during plantar and dorsiflexion, during tip-toeing movement or walking (for example the treadmill test). Recording of these data with digital equipment (computers) is recommended, as is recording COMPRESSION impa.indd 24 of pressor profiles, which should be produced from multiple simultaneous measurements at different points on the lower limb. Recording of the pressor data should include at least the resting pressure lying and standing, the systolic and diastolic working pressure, the circumference where the pressure is measured and the measurement points, the times of application of compression and recording, and the ambient temperature. Calibration of the sensor should be accurate and the measurement method should be standardised. 20-05-2009 14:33:36 25 Compression therapy and ceap classification CEAP “0” Equivalent to the stage at which there are no visible or palpable clinical signs of venous disease. This stage comprises all the conditions where there are symptoms compatible with functional or early venous insufficiency (Bassi G). These are often borderline conditions that are difficult to classify and are more often identified by the symptoms than by a precise clinical sign. The most important of these conditions is hypotonic phlebopathy, a term attributed to Andreozzi GM and his school. In practical terms, this consists of typical varicose symptoms without varicose veins: a feeling of heaviness in the upright position (68%), a feeling of discomfort or actual paraesthesias in the upright position (12%), restless legs (8%), and mild evening oedema (9%) which recedes fully with bed rest. As mentioned above, there is no evidence of varicose veins; the most important measurable signs are relative insufficiency of the venous muscle pump and an increase in the distensibility of the vein wall as assessed with plethysmography, LRR (light reflex reography) and duplex ultrasound. In essence, in hypotonic phlebopathy there is hypotonia of the vein wall which translates into a reduction in the tonic reaction of the wall to a pressure load and thus to reduced efficiency of the normal orthodynamic decrease (vasomotor venous reflex). This varied group of so-called constitutional disorders also includes the panniculopathies and so-called occupational venule hypertension, which are associated only with prolonged standing and which probably, in the majority of cases, belong with hypotonic phlebopathy. Is elastic compression indicated in these forms? When the pathophysiology of the disorder is considered, elastic compression therapy certainly appears rational but studies published hitherto have not provided definitive results. Since these are functional, or more accurately, microcirculatory disorders, the use of so-called therapeutic compression cannot be proposed readily. Usually, in clinical practice, support stockings are chosen, which are also incorrectly called preventive; we use the former term as no preventive action on the development of the venous insufficiency has been demonstrated but only on the onset of the symptoms. These are light stockings very similar to COMPRESSION impa.indd 25 ordinary ones and relatively low in cost. The compression is graduated in mmHg: 10-14 mmHg and 15-18 mmHg. They guarantee compression, however limited, only at ankle level which decreases rapidly as the limb circumference increases (Laplace’s law) and is therefore insufficient to counterbalance the altered interstitial pressures. A further limitation is the availability of standard sizes only, similar to those of fashion stockings, which adapt because of their elasticity but which do not conform precisely to the different dimensions of the patients. The main indications for using these stockings are: –– “tired” legs due to working for many hours while standing without an opportunity for adequate mobilisation; –– moderate oedema which is found in the premenstrual period or in the evening; –– “restless legs” syndrome; –– alternating for a few hours a day with treatment stockings, especially when the aesthetic appearance is particularly affected; –– placed over MCS to improve their appearance and increase their efficacy, even if only minimally. Since the majority of the above-listed indications are not always of purely phlebopathic origin, we can say that these stockings are symptomatic, that is, they allow an improvement or disappearance of some disorders so they have been shown to have an action on the symptom but do not have a preventive effect on the development of the phlebopathy. According to Vayssairat M et al. (2000) compression with stockings of 10-15 mmHg (1st class of compression - French standard) at the ankle produces a significant improvement of quality of life (reduction in subjective symptoms) and a reduction of the orthostatic oedema; the study by Benigni JP and Vin F (2003) confirmed the efficacy of support stockings with compression of 10-15 mmHg on the typical symptoms of the early phases of venous insufficiency. Accordingly, we would agree with some Italian authors (Arpaia G, Mariani F) and with the CIF guidelines (Italian College of Phlebology 2003-2004) according to which the use of compression less than 18 mmHg has not been fully codified. It is probably reserved for patients without varicose veins who have a family history of varicose veins and/or whose work involves pro- 20-05-2009 14:33:36 26 COMPRESSION longed standing. However, even for these indications, it is necessary, according to the literature, to prescribe compression at the ankle of at least 10-12 mmHg, always with stocking of optimal manufacturing quality (CIF 2004 guidelines, grade B recommendation). CEAP “1” In this stage, apart from the symptoms of chronic venous insufficiency, there are telangiectasias and reticular varicose veins. The telangiectasias are small distal veins (maximum calibre about 1 mm) located in the superficial dermis, which can appear in isolation, that is, without obvious varicose veins, or in association with definite varicose veins. These are very common alterations, especially in women, generally asymptomatic but possible accompanied by localised or diffuse pain in the involved region they usually have a branching appearance, or else have the form of a star, spider, reticulum, etc. Reticular varicose veins are small-calibre veins that usually spread out in a reticular pattern but which can give rise to complex branching; they have a blue or greenish tinge and occur predominantly in women. They are usually superficial (between the skin and subcutaneous tissue), they are fed by incompetent perforating veins, they increase in number because they multiply at escape points, and they are nearly always bilateral (Bassi G). They are often associated with telangiectatic branching. It is well known that the treatment of these two forms of varicose veins is sclerotherapy. Elastic compression is certainly indicated as the presence of clinically apparent ectatic veins necessitates an increase in the levels of compression (Choucair M et al. 1998) in order to halt progression of these varicose veins, though it should be accepted that compression is not able to produce regression of these veins in any way. However, it should be stated that telangiectasias, with a calibre less than 1 mm, are not easily compressed by either resting or working pressure; on the other hand, reticular varicose veins are compressible only if they are surrounded by elastic subcutaneous tissue, whereas this is not easy if they are surrounded by indurated oedema (Partsch H et al. 2004). The elastic stockings recommended in this situation are usually MCS 1st class (from 18 to 21 mmHg at the ankle, German standard), which ensure adequate compression of the superficial veins; since the reticular veins are present particularly in the thigh, tights are usually prescribed. For stage C1, 140 denier or even 70 denier stockings are frequently prescribed; as mentioned above, these do not exert an effective compressive action, but they are certainly better accepted by the patients, usually women who are still young, who do not tolerate the idea of wear- COMPRESSION impa.indd 26 ing stockings with greater compression which are often unpopular from the aesthetic aspect; it is the duty of the specialist to explain the need to use a stocking with correct compression, choosing a design of attractive appearance where possible. In the study by Benigni JP and Vin F (2003) referred to above, patients with C1-C3, S, Ep As 1-5 were subdivided into two groups; the first group wore so-called support stockings and the second wore MCS 1st class. On follow-up after 15 and 30 days, the second group had an appreciable improvement in pain, heaviness and paraesthesias. The conclusion, though based only on the clinical result, was that compression of at least 18 mmHg at the ankle with a MCS 1st class is clearly superior to support stockings. The purpose of the elastic compression in this study was to minimise the symptoms of VCI in the form of heaviness, evening oedema or, as will be stated by others, to consolidate the results of sclerotherapy. In any case, according to the CIF guidelines (Italian College of Phlebology 2003-2004), it is not possible, based on the results in the literature, to recommend chronic use of elastic compression for these manifestations of VCI (grade C recommendation). It can be concluded that treatment of stages C0-C1 is practically identical. CEAP “2” This is the stage of large varicose veins. The truncal varicose veins develop in the territory of the long saphenous vein, short saphenous vein or both; it is important always to assess the saphenofemoral and saphenopopliteal junctions; the location of the varicose veins is usually along the course of the long saphenous vein with a variable extension from the saphenofemoral junction as far as the medial malleolus. Varicose veins of the main collateral branches of the long saphenous and short saphenous veins are also frequent. Elastic compression is a fundamental element in the treatment of these varicose veins. We shall therefore consider the type of elastic compression that should be prescribed in stage C2. The aim of the treatment is to oppose further dilatation of the superficial veins and thus slow down the extension of the varicose process. Elective treatment of superficial venous insufficiency is active in type (surgery and sclerotherapy); for instance, the incompetent “cross” (saphenofemoral junction) is the most important reflux point, and eliminating this is fundamental for the success of treatment; this is a site that is difficult to compress because of the inguinal crease; in any case, adequate compression of the dilated saphenous vein as far as the thigh will be fundamental. In asymptomatic (C2 A) varicose veins, compression therapy is usually recommended to prevent complications, while 20-05-2009 14:33:37 Compression therapy and ceap classification with symptomatic varicose veins (C2 S) the aim of compression is to reduce the symptoms, that is, to improve the quality of life of these patients. When the varicosities are not extensive and there is no significant oedema, 1st class (German standard) compression can be prescribed. With particularly extensive varicose veins, insufficiency of large trunks and major collaterals, often accompanied by oedema, 2nd class is prescribed. However, it should be borne in mind that from the haemodynamic aspect, the legging is sufficient for obtaining the necessary treatment effects. The problem of the type of compression to use and the pressure that should be applied correlates with the pressure level that must be counterbalanced not only in the leg but also in the thigh; this obviously determines the type of elastic stocking that should be used. In fact, this choice will correlate with the involved region (superficial, deep, perforating) and level (ankle, middle third of the leg, entire leg, thigh). Depending on the classical conception (Stemmer R, Bassi G et al.), early or post-thrombotic venous insufficiency requires firmer compression, the greater the venous hypertension and, on the clinical level, the greater the tendency to oedema; in general, the MCS should provide the greatest possible level of compression if there is deep reflux, if the saphenous veins are dilated, and if the medial perforators of the leg and thigh are incompetent; in obese patients who frequently have particular adiposity of the lower limbs, which aggravates the venous insufficiency, the compression should be greater compared with a patient with a normal or reduced subcutaneous fat layer. On the other hand, excessive compression, apart from absolute contraindications, can have repercussions on the microcirculation, which does not tolerate major pressure variations (Allegra C). Returning to the so-called essential varicose veins, we know that the ideal treatment is surgery and/ or sclerotherapy; the role of compression is to maintain the results obtained with the other techniques and to prevent or minimise the microcirculatory compromise that is always associated with venous hypertension. From what has been said, stage C2 usually requires 2nd compression class; a change to 1st class should be linked to precise clinical and instrumental assessment and patient compliance. In conclusion: elastic compression is recommended with a level of compression at the ankle greater than 18 mmHg (CIF 2004 guidelines, grade B recommendation). CEAP “3” The oedema in the C3 classification is defined as a perceptible increase in the volume of fluid in the subcutaneous tissue identified by the formation of an imprint COMPRESSION impa.indd 27 27 on pressure; it is usually apparent in the perimalleolar region but can extend to the foot and leg. It is the result of complex interactions involving the capillary wall and the hydrostatic and oncotic pressure gradients between the blood vessels and the surrounding tissue. This situation is produced by various causes of both vascular and extravascular origin so there are numerous classifications in the literature. Venous oedema is regarded as a symptom which is now generally accepted and supported as an indication for elastic compression, both from the scientific aspect and especially from the practical aspect, as confirmed frequently both subjectively and objectively. The effect of compression therapy consists basically of a reduction in the volume of the limb with a consequent improvement of the patient’s symptoms and quality of life (QoL), which, as is well known, represents a factor of great importance in the assessment of any medical treatment. Oedema is a very common complication of chronic venous insufficiency from the early stages until it characterises the clinical picture of the post-thrombotic syndrome. According to what is suggested by Starling’s equation, external application of compression produces an increase in local tissue pressure, reducing the loss of capillary fluid and in this way promoting the reabsorption of the fluid into the veins and lymphatics. Compression speeds the blood flow at the microcirculatory level and promotes the detachment of leukocytes from the endothelium, preventing their further adhesion. Capillary filtration is greatly reduced and reabsorption is promoted due to the greater tissue pressure. It also has an action on the mediators that take part in the local inflammatory response, in this way causing the immediate relief of symptoms that is obtained with adequate elastic compression therapy. As regards the effect of elastic compression on lymphoedema, its efficacy should be explained by the action of reducing the lymphatic fluid in the tissues rather than by an improvement of lymph transport. According to Földi M, venous oedema is always so greatly linked to coinvolvement of the lymphatic system that the term venolymphatic oedema is used more and more often. This concept is important in that, regardless of the different causes that may produce it, the pathophysiological damage is the same, and in consequence, the therapeutic approach should be uniform and directed at the disappearance or at least reduction of the fluid at interstitial level. Apart from the more well-known causes of venolymphatic oedema of the lower limbs, we can consider various situations that do not have a direct vascular cause but that undoubtedly involve the vascular system indirectly. Consequently, it may be considered useful to classify as C3 various conditions that cause oedema of the lower limbs, ranging from the post-thrombotic syndrome to angiodysplasia, from chronic venous insufficiency to post-trau- 20-05-2009 14:33:37 28 COMPRESSION matic oedema, and also include causes that are sometimes overlooked, such as the oedema described in the so-called economic class syndrome; the oedema present in occupational phlebopathy characterised by prolonged standing for many hours during the day, often combined with high environmental temperatures; the oedema present in all situations of altered plantar loading because of congenital or acquired deformities of the plantar surface; oedema due to defects of the muscle pump. Oedema in the economic class syndrome (prolonged sitting position syndrome) The oedema that occurs in this situation is quite frequent and not necessarily linked with deep vein thrombosis. In fact, it would be better to speak of “jet flight leg” to indicate oedema of the lower limbs due to low pressure at high altitude. Acute postural venous stasis can be manifested on the occasion of long journeys by car or coach in patients who already have venous disease or have predisposing risk factors such as age, obesity, and popliteal cysts compressing the venous axis. A prolonged sitting position in close spaces with compression of the popliteal and femoral vein plays a fundamental part in the genesis of the venous stasis; further promoting environmental factors, especially associated with pressurised airplane cabins, can cause a reduction in fibrinolytic activity and significant activation of the coagulation cascade. Elastic support stockings or MCS 1st class are usually sufficient in the absence of concomitant venous disease. Occupational phlebopathy-oedema due to a prolonged standing position for occupational reasons Among the various risk factors for venous disease, prolonged standing is a fairly frequent condition, especially in certain occupational categories. Nowadays, if the prolongation of working life due to postponement of retirement age, the prolongation of the average lifespan and consequent ageing of the working population are taken into account, it is considered that such occupational pathology will be found more and more. Early retirement, the costs of diagnostic investigations and the costs associated with medical and surgical treatment represent high economic commitments because of the high incidence of disease and temporary inability to work. In order to have a crucial influence on the improvement in the quality of life in the workplace and to reduce the social costs, tight prevention is important to eliminate occupational and general risk factors, with early diagnosis and targeted treatment including the elastic compression type. In this regard, it should be recalled that in the context of the CEAP classification, assessment is made using a suitable invalidity score, which is subdivided into 4 classes: 0 asymptomatic, 1 symptomatic COMPRESSION impa.indd 28 but can lead a normal life without compression, 2 able to work eight hours a day only with compression, 3 unable to work even with compression. Elastic support stockings or MCS 1st class, in the absence of venous insufficiency, are adequate for preventing evening oedema. Oedema due to a defect of muscle pump function In changing from a horizontal to a vertical position, the main centrifugal factor that comes into action is the force of gravity, against which the human body opposes walking to facilitate the return of blood to the heart. In the dynamics of walking, the movement makes the structures close to the veins act on the veins, behaving like true pumps. These are called pushing and aspiration pumps. The components of the pumps are subdivided into venous, primary and secondary. The venous components are those in direct anatomical contact with the structure that compresses, the primary are represented by muscle, tendon and joint structures, and the secondary by bone structures. The pumps are located at different points and are activated by both walking and respiration. The walking pumps are the plantar, the peroneal hallux muscle, the tibiotalar articular pump, the calf muscles, the popliteal articular pump and the quadriceps muscle. The abdominal pump is activated by respiration. The plantar pump consists of various components (venous muscular, tendon, aponeurotic, osteo-articular). The venous plantar pump consists of a superficial plantar system and a deep one, the superficial and deep plantar veins. The alterations of function of the plantar pump are due to anatomical structural alterations of the plantar veins, static alterations of the plantar support and dynamic alterations that produce a limping gait, and alterations of the functional ejectors of the plantar pump. Alterations of the abdominal pump are produced by extrinsic pathological compression at crural level, at the level of the left iliac vein and at the level of the caval ring. From all of this, it is clear that it is essential to maintain the integrity of the complex system of pumps in order to guarantee correct venous return to the heart and exclude the insidious complication of peripheral venous stasis. Compression therapy, as demonstrated by Brizzio EO et al. (1994), has better effects if combined with correct plantar support. An immobile sitting position, for example in a motorcycle sidecar, aggravates physiological venous stasis with the development of soft bilateral oedema originating distally and involving all of the leg in the course of the day. Compression therefore has a preventive function on the development of the oedema. MCS of 1st - 2nd class are usually employed, depending on the severity of the condition and the patient’s tolerance, recalling that in such patients the assistance of mobilisation cannot be counted on. 20-05-2009 14:33:37 Compression therapy and ceap classification Post-traumatic oedema Post-traumatic oedema is included among the indications for elastic compression therapy since phlebographic investigations have demonstrated co-involvement of the venous and lymphatic areas. These investigations confirmed that persistent oedema after fractures generally follows a previous unobserved venous thrombosis. Lymphographic investigations have demonstrated that even minor trauma such as tibiotarsal sprains can cause lymphatic stasis and consequent oedema. It should also be recalled that for therapeutic purposes, plaster casts or semimobile splints are often used, which cause further venous stasis combined with poor mobilisation. The compression to use in these cases is 1st-2nd class, once the oedema has been reduced with bandages. Oedema in angiodysplasia Oedema in angiodysplasia involving the vein side requires obligatory use of elastic compression, especially if arteriovenous fistulas with venous dysplasia and lymphangiodysplasia are considered. Elastic compression slows the development of the disease, preventing trophic disorders and improving lymphatic function. The compression classes to use, depending on the type and nature of the disorder, are 2nd-3rd-4th. Concluding this brief examination of venolymphatic oedema, it is evident that elastic compression is indicated for various different conditions; the literature in this regard is somewhat meagre; referring to the study by Partsch H (VASA 2004), we can say that stage C3 can in general be treated with 1st-2nd compression classes, preceded by medium-stretch bandages, for the reduction of soft, non-reversible oedema during rest or indurated oedema. In this regard, it is well known that the medium-stretch bandage is the most effective in reducing soft oedema, especially when there are no trophic lesions of the skin; the main disadvantage is the need for daily removal and reapplication, which requires the presence of staff who are experienced in bandaging. Elastic compression therapy of oedema differs according to whether it is reversible or irreversible. In the irreversible form of oedema, as in advanced forms of varicosis or angiodysplasia, use of a shortstretch bandage and MCS 2nd or 3rd class is indicated. CEAP “4-6” Compression and CEAP 4 and 5 Review of the literature shows that there is no study of the efficacy of bandaging in class 4a; there is only a grade C recommendation based on expert agreement. In class 4b there is one study of MCS of 3rd class compression vs. non-compression and one of non-elastic COMPRESSION impa.indd 29 29 compression, which show a reduction in the area of lipodermatosclerosis and in ulcer recurrence (grade 1B evidence). In class 5 (healed ulcers) the MCS with at least 30 mmHg at the ankle is essential for maintaining the result and preventing recurrence (grade 1B evidence). The greater the degree of compression, the lower the incidence of recurrence so that the maximum elastic compression that the patient can tolerate should be prescribed. It is necessary to stress that there are no studies comparing elastic stockings with elastic or non-elastic bandages for the condition of acute lipodermatosclerosis for which the latter appears superior to a stocking alone. Compression and CEAP 6 Compression is better than no compression: –– High compression is better than light compression (great attention should be paid to arterial and mixed ulcers with significant arterial compromise; the W.I. must be >0.8; trained staff can also apply the bandage with a W.I. between 0.55 and 0.8); –– Multilayer systems are preferable to single-layer systems as they are able to exert greater pressure, confer greater rigidity on the bandage, and absorb exudate better with the protective layers (cotton or polyurethane foam); –– The efficacy of the bandage in patients with venous stasis ulcers has been conclusively demonstrated with a grade 1a level of evidence; –– There is no agreement on the efficacy of different types of compression; the lack of randomised controlled studies requires a pragmatic approach and the recommendations in this field are based on the opinion of experts. In short, the type of compression in CEAP class 6 remains controversial: the German school prefers the nonelastic bandage whereas the English school prefers the elastic bandage. There are also studies comparing the two types of bandage which demonstrate substantially similar efficacy of the two bandages or superiority of the elastic bandage. These studies have some methodological defects: –– the ulcers considered are very small (often <10 cm2); –– the pathogenesis and severity of the venous insufficiency are not indicated; –– known risk factors for healing are not indicated, such as the size and age of the ulcers and the patient’s mobility; –– the pressure with which the bandage is applied is not known nor whether the selected staff was equally skilled in applying the two types of bandage, if the bandaging technique for the different bandage types was equally 20-05-2009 14:33:37 30 COMPRESSION known and therefore whether the compression was always applied in an optimal manner. Other common and universally accepted recommendations are that the bandage should guarantee maintenance of effective pressure over time (at least 1 week), guarantee similar pressure in all patients (reproducibility), be easy to apply and lack side effects as far as possible. Reusability should be considered in relation to economy of treatment; in this case, maintenance of bandage quality after repeated washing should be guaranteed. The MCS 2nd class in natural rubber can be used successfully in the treatment of venous ulcers of limited size based on the most recent randomised studies (Mariani F et al. 2008), with an improvement to grade 1A recommendation level (grading of Guyatt G et al. CHEST 2006). The cited study shows the efficacy of stockings for ulcers up to 8 cm in diameter, provided a kit composed by an understocking with at least 18 mmHg compression at the ankle to wear day and night over the dressing of the ulcer, and a MCS of 2nd class to put over during the day (Ulcer X® - Sigvaris®). Compression therapy: guide to the treatment of venous ulcers Despite the fact that compression therapy has always been used successfully in the healing of venous ulcers, the optimal procedure for carrying out this treatment is still not available today. Compression plays a central role in the treatment of venous ulcers. The factors to consider prior to applying it are: accurate diagnosis (the pathogenesis of the ulcer is a determining factor in the choice of treatment), the presence of contraindications (obstructive arterial disease, severe cardiac failure etc.) and any complications (infection, hypodermitis etc.); the patient’s ability to walk; the anatomical shape of the limb (for reasons explained above); the condition of the skin (fragile skin or areas of white atrophy can be damaged by excessive pressure). The majority of controlled randomised studies show that compression on its own facilitates the healing of venous ulcers (grade 1A recommendation, according to the grading of Guyatt G et al., CHEST 2006), but defining the best compression and the relative cost effectiveness is more complex. Firm compression (35-45 mmHg at the ankle) seems to be more effective than less intense compression (15-25 mmHg at the ankle) and multilayer bandages have proven more effective than single- or two-layer bandages. No differences have been found between stockings, the Unna boot and high-compression multilayer elastic and nonelastic bandages. Based on these data, the use of highintensity multilayer elastic and non-elastic compression is recommended for the treatment of venous ulcers; in COMPRESSION impa.indd 30 non-ambulant patients or when the ankle is immobilised, the use of multilayer elastic bandages is recommended since the non-elastic bandages do not succeed in exerting adequate levels of compression if the calf muscle pump is weak or absent. Intermittent pneumatic compression can be added if ulcer healing does not proceed normally even though there is inadequate evidence in the literature in this regard. The available data show that the most effective treatment is also the most expensive; the studies by Franks PJ and Posnett J (2003) show moreover that the cost effectiveness of firm multilayer compression is better than that of conventional therapy. Despite the fact that the initial cost of the first option is four times greater compared with the second, the weekly cost is lower due to the lower frequency of bandage replacement and even if the efficacy of the treatment were the same, the cost effectiveness would still be in favour of the first method. In addition, the mean time for healing is considerably lower with the application of highly compressive multilayer bandages. The use of MCS can be extended to patients with a venous ulcer of limited size in the active phase, according to studies by Horakova H et al. (1994) and Mariani F et al. (2008) (grade 1A recommendation). On this basis, various so-called “advanced” compression systems are available to the physician (Ulcer-Kit®, Tubulcus®, Tubi-press®, Mediven® ulcer kit); these should be assessed from both the clinical aspect (pressures exerted, tolerability and time for healing the venous ulcers) and as regards their cost effectiveness, comparing use of the bandage with use of MCS. In brief, the therapeutic compression protocol involves the following: in the acute phase of the venous ulcer, following any debridement of the base, a non-elastic bandage is used, applied with the figure of eight technique or figure of eight fixed at the ankle, possibly with eccentric compression in the region of the ulcer, to be replaced on average every four days in the initial treatment period and every seven days subsequently. We reserve four-layer bandages (Profore® Smith & Nephew, Coban 2® 3M or Rosidal sys® Lohmann & Rauscher) for patients who have indurated or combined lymphatic oedema and venous ulcers resistant to conventional therapy, or to cases where there is early deep venous insufficiency or that are secondary to DVT and in patients who are poorly ambulant. In the majority of venous ulcers, a simple nonadherent dressing offers sufficient protection beneath the bandage; the dressing is chosen based on the characteristics of the ulcer and the skin surrounding it, taking other factors into consideration also, such as the presence of exudate and symptoms. The use of a antiembolism stocking plus MCS 2nd class or “advanced” compression system is limited to ulcers of medium size and in the final phases of the 20-05-2009 14:33:37 Compression therapy and ceap classification skin repair process. In these cases we use the new Ulcer-X® Sigvaris® system, an understocking of about 18 mmHg at the ankle worn constantly over the dressing, and a MCS 2nd class (23-32 mmHg at the ankle) during the day for some reasons: firstly, the QoL of life is improved in patients, secondly, because the stocking can be worn by the patient after healing with a reduction in the costs compared to purchasing specific compression systems for the active ulcer period. Superimposing elastic stockings with different elasticity results in effective compression (4050 mmHg at the ankle) with working pressures that are higher compared with a single stocking and very effective to heal venous ulcers. The efficacy of the treatment should be monitored constantly. The relationship between the degree of improvement of the ulcer after four weeks and healing has been studied; if the lesion improves clinically and diminishes perceptibly, it is advisable to continue with the initial treatment, whereas if this does not occur or the patient’s health status alters, clinical diagnostic reassessment is needed, possibly taking a sample for bacterial culture and/or biopsy. Use of additional treatments (medical and surgical, skin grafts etc.) is advisable for patients who show only slight improvements in the first 3-4 weeks of treatment or who do not heal, after the causes of the delay in the healing process have been investigated. In our view, use of active treatment, such as surgery, in combination with compression therapy, should be considered early even before healing of the ulcer is obtained, since removal of the causes of the venous insufficiency, whenever possi- 31 ble, has the double effect of hastening re-epithelialisation and reducing the incidence of recurrence. Recurrence of venous ulcers is frequent in both the short and long term, ranging from 20 to 75%. One of the most effective treatments is the MCS, provided it exerts compression of at least 35-45 mmHg at the ankle. Among the elastic supports, we prefer to prescribe a natural rubber stocking in these cases (the below-knee stocking is nearly always sufficient) because of the elastomeric characteristics of the fibres, which guarantee high pressure throughout the day, unlike other fibres which demonstrate a slow drop in pressure after a few hours of use. The efficacy of the treatment depends closely on the prescription (type and size of stocking) and regular renewal of the stockings. The patient’s compliance with compression therapy is another factor that determines the result. Instructions on the importance and use of compression carried out or prescribed must be detailed, including all the instructions needed for optimal maintenance of the elastic stocking (method of washing, duration etc.). Sometimes, despite this, the patient does not succeed in wearing and tolerating the support; this is the case especially in elderly and obese patients and those affected by osteoarthritic disease. In these cases it may be useful to prescribe devices that facilitate application of the stocking (for example the Medi Butler® or Easy Slide®) and a support of a lower compression class than required, which can be worn with less strain, then putting a similar one over it, which will slide more easily over the first, thus achieving optimal pressure. Recommendations –– A custom-made therapeutic elastic stocking should always be prescribed when the limb circumference is outside the standard measurements. –– In the majority of cases, the below-knee model is sufficient to obtain a therapeutic result. –– Wearing two MCS of 1st class is recommended to improve compliance when obtaining high pressures is desirable in patients with limited ability to wear therapeutic elastic stockings of a higher class (for example 2n -3rd class). –– CEAP 0: compression at the ankle with a support stocking of at least 10-12 mmHg, and always of optimal manufacturing quality. –– CEAP 1: the treatment of stages C0-C1 is practically identical; in some cases, a support stocking or MCS 1st class can be recommended. –– CEAP 2: MCS 1st class is recommended, and 2nd class in the case of very extensive or recurrent varicose veins. COMPRESSION impa.indd 31 –– CEAP 3: MCS 2nd-3rd classes are recommended except in oedema due to standing or prolonged sitting (for example, long journeys) in the absence of concomitant venous disease, where 1A or 1st class is usually sufficient; in angiodysplasia, depending on the type and severity, 2nd- 3rd- 4th classes are recommended. –– CEAP 4: in the case of superficial venous insufficiency use of a MCS 2nd class is recommended whereas in the case of deep venous insufficiency use of a 2nd -3rd classes are indicated, preferably made with a natural rubber weft thread. In the case of acute hypodermitis: non-elastic bandage worn constantly, to be renewed at least every 6-7 days. –– CEAP 5: in the case of superficial venous insufficiency MCS 2nd class; in the case of deep venous insufficiency MCS 3rd class, preferably made of natural rubber, for the reasons explained above. However, it should be recalled that the greater the 20-05-2009 14:33:37 32 COMPRESSION degree of compression by the stocking, the lower the incidence of recurrence, so the highest possible compression class relative to the patient’s compliance should be prescribed. –– CEAP 6: in the initial phases of the treatment of venous ulcers, especially in the presence of oedema or concomitant hypodermitis, use of multilayer bandaging is recommended; in the subsequent phases, this can be replaced by non-elastic or short-stretch bandages, or where feasible, by MCS class 2nd . In the case of deep venous insufficiency with a postthrombotic ulcer, use of constant non-elastic multilayer bandaging of high stiffness is appropriate. The MCS 2nd class with an understocking (antithromboembolism or another type, provided it exerts graduated compression of at least 18 mmHg) to be applied over the dressing is advised for all venous ulcers up to a diameter of 8 cm, including in the case of oedema (provided it does not exceed the dimensions of the prescribed size) or local complications, combined with topical medications to COMPRESSION impa.indd 32 absorb any exudate or adapted to the skin conditions surrounding the ulcer, according to Wound Bed Preparation and TIME principles. –– Prevention of venous ulcer recurrence: 1. Maintenance phase: MCS, preferably made of natural rubber (2nd-3rd class). 2. Acute phase of the pre-ulcer pathology (hypodermitis etc.): –– Short-stretch bandages (<100%); –– “Heavy” bandages (more compressive with the same extensibility); –– Bandaging techniques that provide for overlapping of 3-4 turns of the bandage (figure of eight, figure of eight fixed at the ankle…); –– Multilayer bandaging; –– Eccentric compression. 3. Eccentric compression is not recommended in the case of areas of white atrophy because of the possible progress of such “ischaemic” areas towards ulceration if they are subjected to excessively firm compression. 20-05-2009 14:33:37 33 Compression therapy and deep venous thrombosis The use of compression therapy in the course of deep vein thrombosis (DVT) and for the prevention of the post-thrombotic syndrome (PTS) is now routine. Application of an elastic stocking of a high compression class (3rd class - compression of 34/46 mmHg at the ankle) 2-3 weeks after the acute event reduces the incidence of PTS by 57% (Brandjes DPM et al. 1997), a result confirmed by a randomised trial that involved a total of 180 patients followed up for 5 years after the acute event who used support stockings with compression of 30-40 mmHg at the ankle (Prandoni P et al. 2004). The role of compression in the early phases of DVT is still controversial. Partsch H et al. have demonstrated that application of bandages combined with early ambulation in patients with both proximal and distal DVT, treated with overlapping heparin therapy and oral anticoagulants, is safe and does not cause an increase in the frequency of pulmonary embolism during the treatment period. The type of compression chosen, i.e. bandaging, would appear to be more indicated especially in the initial phases. Oedema of the lower limb, often present acutely at diagnosis and which usually resolves in the first days of pharmacological therapy, involves a need to adapt the elastic containment to the new limb measurements in order to maintain the desired level of compression. However, bandages, which adapt more to this need, must be applied by skilled staff in order to avoid excessive or insufficient compression or, worse, incorrect application with a “lacing effect”. Domiciliary treatment of DVT and early hospital discharge make monitoring of correct bandaging difficult, as this would have to be entrusted to the patient himself or to his relatives. Partsch H and colleagues subsequently demonstrated that application of a MCS 2nd class adapted progressively to the changes in volume of the limb, Recommendations –– Compression therapy in the course of DVT with a rigid or short-stretch bandage is always indicated in the oedema reduction phase and a MCS 2nd-3rd class in the maintenance phase. –– The antiembolism stocking is indicated in the acute phase of DVT in patients confined to bed af- COMPRESSION impa.indd 33 if necessary, and fixed bandaging, which is also replaced if it becomes insufficient, have almost equal efficacy in producing resolution of the oedema and pain in a limb affected by DVT; above all, they have a marked influence on thrombosis evolution, understood as a reduction in the length of the thrombus as measured by ultrasound, which was obtained in 69% of those treated with bandaging and 89% of those treated with an elastic stocking (Partsch H et al. 2000). However, early application of compression, regardless of quality (bandage or stocking) is able to reduce significantly the signs and symptoms of PTS compared to pharmacological treatment combined with bed rest (Partsch H et al. 2004). Recent evidence has shown a greater incidence of recurrent thrombosis in patients in whom complete recanalisation of the involved veins was not achieved (Prandoni P et al. 2002) and when D-dimer was still elevated when oral anticoagulant therapy was suspended. In the absence of elastic compression, complete recanalisation would be obtained with conventional pharmacological therapy in 20 to 30% of cases after 4 months, about 50% at 6-12 months, and 75% at 24 months (Caprini JA et al. 1995). Measurement of the residual thickness of the thrombus is obtained after compression at the inguinal crease and popliteal fossa; a residual thickness ≥ 2 mm is regarded as an index of normalisation (Prandoni P et al. 1993). Early application of elastic compression (MCS 2nd class in the COM.PRE study, Arpaia G et al. 2007), from the time of diagnosis of DVT, encourages faster and more complete recanalisation of the thrombus and therefore a lesser risk of recurrent thrombosis and late sequelae such as PTS (Partsch H et al. 2000; Blättler W et al. 2003; Arpaia G et al. 2003; Partsch H et al. 2004; Arpaia G et al. 2005; Arpaia G et al. 2007). ter reduction of the oedema. It can be used at night during the maintenance phase and combined with a MCS of a suitable class during daytime activity. –– The MCS below-knee stocking of a high compression class (2nd-3rd class), applied early after the acute event, encourages recanalisation and significantly reduces the incidence of PTS. 20-05-2009 14:33:37 34 Compression therapy and pregnancy Review of the international literature on the subject has shown that graduated elastic compression in gynaecology and obstetrics is still not widespread, mainly because of the fact that the available studies are still too limited in size to attain to solid scientific evidence or have structural gaps (sampling and choice of statistical validation parameters) which preclude a correct assessment of their real efficacy in preventing DVT and PE in the obstetric/ gynaecologic area. The Guidelines of the Italian College of Phlebology – CIF (Acta Flebologica 2003, International Angiology, revised 2004) are also of this opinion. Elastic compression in obstetrics, up to recently recognised and codified only in the case of acute DVT occurring during pregnancy, is now becoming part of clinical practice for pregnant women with major oedema of the lower limbs. For the prevention of VTE in gynaecology, some consensus statements have been drawn up involving specialists in both the gynaecology and cardiovascular fields. The majority of these publications were in the Englishspeaking area, like these: –– Expert Consensus Document on management of cardiovascular diseases during pregnancy. Eur Heart J 2003 24; 176; –– Venous thromboembolism during pregnancy. NEJM 1996 335 (2); 108; –– Barbour LA, Pickard J. Controversies in thromboembolic disease during pregnancy: a critical review. Obstetrics and Gynecology 1995; 86:621; –– Quinones JN, James DN, Stamilio DM, Cleary KL, Macones GA. Thromboprophylaxis after cesarean delivery: a decision analysis. Obstet Gynecol. 2005 Oct;106(4):733-40; –– American College of Obstetricians and Gynecologists (ACOG). Thromboembolism in pregnancy. Int J Gynaecol Obstet. 2001;75:203-212; –– Shannon M. Bates and Jeffrey S. Ginsberg. How we manage venous thromboembolism during pregnancy. Blood, 15 November 2002, 100 (10); 3470; –– Aburahma AF, Boland JP. Management of deep vein thrombosis of the lower extremity in pregnancy: a challenging dilemma. Am Surg, 1999; 65:164-167; are marked for the prevention of VTE solely on a phar- COMPRESSION impa.indd 34 macological basis, using unfractionated heparin, low molecular weight heparin or warfarin. Since warfarin passes the placental membrane, it is not recommended in the first trimester of pregnancy because of its embryotoxicity and in the third trimester because of the risk of bleeding during delivery. Unfractionated heparin (UFH) or low molecular weight heparin (LMWH), which does not pass the placental membrane, has been shown to be the drug of first choice in the management of pregnant women at thromboembolic risk. In these articles and in the guidelines derived from them, there is no mention of elastic compression as an anti-thrombosis measure. The Maternal and Neonatal Haemostasis Working Party of the Haemostasis and Thrombosis Task Force, through the British Society for Haematology (J Clin Pathol 1993; 46: 489-96), has published guidelines for the prevention and management of thrombosis associated with pregnancy, which do not mention elastic stockings as a preventive measure for thrombosis in pregnancy. In the Consensus Conference on the prevention of DVT, issued by the Medical Academy of Malaysia in 1999, elastic stockings are indicated as an anti-thrombotic device only for women with a previous episode of VTE or women who are carriers of congenital thrombophilia (it is not stated whether this is only homozygote or also heterozygote) in whom pharmacological anti-thrombotic treatment with warfarin or LMWH is contraindicated. This preventive treatment, moreover, is suggested only in the post-partum period and for a period of 6-12 weeks. For a pregnant woman, whether a patient at risk of thrombosis or with a previous episode of VTE, pharmacological prophylaxis only with warfarin or LMWH is indicated. Furthermore, the Consensus Conference on Thrombophilia and Pregnancy, published in 2003 by the Collège National des Gynécologues et Obstétriciens Français in association with the Groupe d’Études en Hémostase et Thrombose does not indicate elastic containment to prevent thrombotic disease in the guidelines drawn up at the end of the Consensus. The committee that was in charge of the work of the 20-05-2009 14:33:37 Compression therapy and pregnancy Maternal Medicine Symposium in Glasmedical-lsw in 2005 was of the same opinion, suggesting that elastic containment should be worn only by women who have been delivered and who are carriers of congenital thrombophilia (here, too, it is not specified whether homozygote or heterozygote); however, the duration of this antithrombotic prophylaxis is not stated. All the protocols examined, instead, state that a MCS 2nd class needs to be worn for at least two years after a thrombotic episode occurring during pregnancy, in agreement with the universally accepted guidelines on DVT recurrence. One publication suggests the use of elastic stockings for preventive purposes only in pregnant patients with a previous episode of VTE. These recommendations are graded as 2C and are included in one of the most important studies on the prevention of thrombotic disease, organised by the American College of Chest Physicians at its 2004 conference (Seventh ACCP Conference - Chest 2004 126; 627) Recently (February 2007) the Green-Top Guidelines of the Royal College of Obstetrics and Gynaecology (RCOG) published a revision of the guidelines proposed in the previous edition of January 2004. In this revision, compression by means of elastic stockings is suggested as a measure for preventing VTE in patients with constant oedema of the lower limbs. The compression class indicated as most effective in preventing VTE is the 2nd class therapeutic elastic stocking. This revision signals the first important recognition of elastic compression therapy as an effective measure against venous thromboembolism in pregnancy. Caesarean delivery is stated by most study groups to be a condition that predisposes more to the risk of thrombotic disease. In two studies, the first published in the Department of Health, Report on Confidential Enquiries into Maternal Deaths in the United Kingdom (1991-1993) and the second published by the Australasian Obstetric Medicine Working Group in MJA (2001 175; 258), elastic compression therapy is indicated as a prophylactic measure for VTE in women operated of caesarean section. However, this recommendation is still codified in both cases as an expert opinion. In the recent Cochrane Review (2005) on the prevention of VTE in pregnancy and the puerperium eight trials were reviewed which examined a total of 649 women. None of these studies included graduated elastic compression stockings as prophylaxis; the studies considered the use of heparin (non-fractionated and LMWH) and aspirin. From the research that has been conducted, it is apparent that the use of elastic stockings during pregnancy and COMPRESSION impa.indd 35 35 the post-partum period, as a preventive measure against venous thrombosis, is regarded as an ineffective procedure. Among the few dissenting voices, a few study groups have shown that elastic compression during the months of gestation confers a definite haemodynamic benefit: Br J Obstet Gynaecol (1999 106(6):563); Rev Med Liege (1999 54(5):424). The conclusions arrived at by these authors demonstrate that elastic compression produces significant changes in venous return from the legs in pregnant and puerperal women and that therefore elastic containment during pregnancy can diminish the incidence of thrombotic episodes. In the SISET (Italian Society for Studies on Haemostasis and Thrombosis) guidelines for obstetrics and gynaecology (J Hematol 2002 87; suppl. 12) the use of elastic compression for primary prevention is suggested for women at low to moderate risk (identified according to the criteria of the Royal College of Obstetrics and Gynaecology); in the same article, elastic compression is also stated to be useful in primary prevention for women who are thrombophilia carriers. A study published by a Swiss group in Swiss Medical Weekly 2001 (131 (45-46): 659-62) demonstrated that MCS 1st or 2nd class during pregnancy does not prevent the appearance of varicose veins but diminishes the incidence of reflux in the long saphenous vein and saphenofemoral junction and also improves the patients’ symptoms. On the beneficial effects of elastic compression, we have also found a review by the Cochrane group published in the Cochrane Database Syst Rev 2000 (2: CD001066), which showed how external pneumatic pressure (IPC) is able to reduce ankle swelling during pregnancy. Some authors have demonstrated that elastic compression in pregnancy significantly increases the afterload and vascular resistance, thereby preventing compartmentalisation of the blood at the level of the lower limbs (Am J Obstet Gynec 1996 (174 (6): 1734-40). Compared with the paucity of randomised studies on the use of elastic compression in pregnancy, more study groups have shown that among pregnant women, the highest risk period for DVT and pulmonary embolism is the post-partum period; a recent study published by the Mayo Clinic (Ann Int Med 2005, 143 (10): 697-706) stresses that any prophylactic strategy should be directed particularly at the post-partum period. In agreement with what has been stated here and also in a study published in Pathophysiol Haemost Thromb 2002, 35(5-6): 322-4 it was shown that the risk of DVT is 5 times greater in pregnant women than in non-pregnant women of the same age and that DVT is more frequent post-partum than ante-partum. 20-05-2009 14:33:38 36 The efficacy of elastic compression, when the oxidative stress in workers who stand for long periods during their working shift is considered, was published in Occup Environ Med. (2004; 61(6):548-50). This study showed how compression can reduce the production of free oxygen radicals, which are responsible for the onset and exacerbation of venous insufficiency and probably for other chronic degenerative diseases. Recommendations –– Pregnancy, because of the physiological changes in coagulation and haemodynamics, is to all intents and purposes a risk factor for thrombosis. –– Pregnancy places the woman in CEAP clinical class 1, even if asymptomatic from the venous aspect. The elastic stocking may be a support stocking, provide compression of 18 mmHg at the ankle, or a MCS 1st class and should be worn throughout the gestation period. –– Women who already have varicose veins should wear MCS throughout pregnancy of a class appropriate for the severity of the disease. COMPRESSION impa.indd 36 –– Natural delivery requires antithrombotic prophylaxis with antithromboembolism stockings. –– Caesarean delivery adds a further thrombosis risk factor to the pre-existing situation and these women should therefore be given the usual antithrombotic prophylaxis for surgical procedures: antithromboembolism stockings and possibly pharmacological antithrombotic therapy. –– When assessing the thrombotic risk of a pregnant woman, this should also include multiparity, age over 40 years and excessive weight gain. 20-05-2009 14:33:38 37 Compression therapy and peripheral arterial disease Elastic compression is universally recognised because of its efficacy in the treatment of numerous venous disorders of the lower limbs. A large proportion of the patients who can benefit from compression treatment are elderly and consequently affected by numerous other conditions. Among the most frequent is obliterative arterial disease of the lower limbs (PAD), which may be associated with diabetes. Elastic compression is often contraindicated in cases of PAD, since external compression may conflict with arterial insufficiency and cause tissue damage that may even lead to necrosis. It is therefore necessary to clarify the criteria for and limits to the use of elastic compression in patients with arterial disease. Elastic compression, carried out by means of bandages or stockings, acts especially at the surface of the lower limb; the pressure applied diminishes from the superficial to the deep level. It is in the surface that the most important pathological alterations occur in patients with diabetes or arterial disease. In arterial insufficiency, the trophic disorders start at the level of the skin. In the early phases of the arterial disease, a reduction in the hairs, atrophy of the hair roots and a slowing of epidermal turnover are noted. In the second phase, an alteration of the colour of the skin can be observed, caused by an alteration of oxidative exchange and a reduction of the superficial temperature. The last stage is that of gangrene, which is present when the trophic changes are no longer reversible. The damage to the deep structures is manifested first with disorders of the neurological type (paraesthesia and anaesthesia). The muscular structures are the last to be involved; in fact, deep rest pain of the muscle type appears late. The pain associated with intermittent claudication, of muscle origin, is a dynamic phenomenon, which appears in the early stages of obliterative arterial disease. It is intermittent and reversible, and is an expression of the increased need for oxygen during muscular exercise. Elastic compression acts especially on the most superficial part of the tissues; consequently, the target organ (epidermis and dermis) is the same as that of peripheral arterial disease, which may be associated with diabetes. Theoretically, elastic compression and arterial disease are therefore incompatible. The effects of elastic compression are also manifested deeply especially during the dynamic phase represented by walking. Compression has positive effects on venous return, on the one hand (reduction of stasis, COMPRESSION impa.indd 37 diminution of interstitial pressure, improvement of exchange, speeding of blood flow rate in the veins, etc.), but on the other hand, pressure is exerted on the tissues that opposes arterial pressure. The precapillary arterial pressure is reduced in a patient with arterial disease. The precapillary pressure falls in the case of microangiopathy and the pressure exerted by the elastic compression can be greater than that of the capillary unit; this can cause an ischaemic state in the arteriopathic patient. This phenomenon occurs especially when the patient is lying down. Conversely, during walking and/or in the standing position, the hydrostatic pressure aids the peripheral arterial pressure. The rhythmical muscle contraction of walking alters the effect of the elastic compression, which becomes intermittent. These two elements contribute in a broadly proven manner to an improvement of peripheral perfusion even in the arteriopathic patient. Active elastic compression must be distinguished from passive compression. Compression exerts a resting pressure, especially on superficial structures. Consequently, it interferes with the superficial arterial perfusion of arteriopathic patients. Conversely, correctly applied containment exerts reduced resting pressures. Its maximum effect takes place during walking and interferes less with perfusion at rest, instead improving perfusion during physical activity. It can therefore be stated that elastic compression is tolerated only by the arteriopathic patient who walks and maintains his physical activity, whereas containment is more suitable for arterial disease in general, including non-ambulant patients. There are numerous indications for elastic compression in arteriopathic and/or diabetic patients (Table V) and they do not differ much from those of the general population. Unfortunately, few studies have been dedicated to the effects of elastic compression in patients with arterial disease, in view of the fact that elastic compression is not commonly regarded as indicated in these cases. In fact, experience is episodic and fragmentary and the studies present only partial results. Nevertheless, it should be stated that elastic compression is not contraindicated in the arteriopathic patient. In fact, the term arteriopathy is a broad and varied term that refers to a very wide range of pathological conditions. Furthermore, the textile structure of the means of elastic compression is varied and its characteristics can be more or less compatible with arteriopathy. Elastic compression of the 20-05-2009 14:33:38 38 COMPRESSION Table V – Indications for compression therapy in arterial disease. Mixed ulcers of the lower limbs Essential varicose veins Secondary varicose veins Lymphovenous oedema Prevention of vte Distal femoral bypass post-operative period Table VI – Factors that influence tolerance of compression therapy in arterial disease. Ankle-brachial index <0.55 Peripheral neuropathy Diabetes Trophic changes in the skin Deformities of the lower limb Ambulation Cardiac disease lower limbs should be utilised when useful and necessary in the patient with arterial disease, observing the rules of “good use of elastic compression”, and taking into account the factors associated with arteriopathy, which often interact, exacerbating the consequences (Table VI). These factors are: 1. Perfusion index: the ankle/brachial perfusion index is an important element but may be a source of error. It can be regarded as a guide but is not absolute. An ankle/brachial index <0.55 needs to be regarded as the risk limit but an index over 1.2 should also be regarded with suspicion because it may indicate incompressibility of the arteries, as occurs in diabetic patients; 2. Neuropathy: the presence of any neuropathy needs to be assessed clinically as this can alter the patient’s superficial sensation and expose him to trophic lesions induced by the compression; 3. Diabetes: the diabetic patient should be assessed with the greatest care. He is particularly susceptible to skin infections and the consequences of neuropathy. Finally, it must not be formedical-lstten that the rigidity of the arterial wall that is typical of the arteriopathic patient can alter the ankle/brachial index, as mentioned above; 4. Skin dystrophy: any increase in skin fragility must be sought, since this may constitute a contraindication to elastic compression therapy even when the indices of distal perfusion are satisfactory; 5. Bony irregularities: the tibial and malleolar bony and tendon prominences, when they are very pronounced, can expose the skin to excessive compression because of their small radii of curvature (Laplace’s law). In this case, skin ulcers can develop; 6. Ambulation: the negative effects of elastic compression are more significant in patients who move little or who are confined to bed. Elastic compression is much more effective in patients who move actively. The indication for elastic compression in patients with arterial COMPRESSION impa.indd 38 disease must take their ability to move and walk into account; 7. Cardiopathy: heart disease, always in association with peripheral arteriopathy, can produce oedema of the lower limb. These criteria should be assessed before prescribing compression. If these criteria are heeded, positive and beneficial results are obtained. There will be an increase of capillary pressure and skin oxygenation and a reduction of the oedema. The reduction of the oedema will promote arterial flow and diminish tissue pressure. From the clinical point of view, the patient will tolerate the compression better and the tolerance will be increased when he is standing and walking What are the clinical indications depending on the C.E.A.P. classification? C2 patients affected by moderate peripheral arterial disease (stage IIA), which may be associated with diabetes, do not have any contraindication to daytime elastic compression, which can be applied with MCS 2nd class. Tolerance of compression is good in these patients. C3 patients at the same stage of arteriopathy can benefit from compression with medium-stretch bandages to reduce oedema and can then wear MCS 2nd class for maintenance. In C4-5-6 patients with the same level of PAD, it is preferable to employ passive containment achieved with short-stretch bandages or ideally with a rigid bandage that ensures more tolerable resting pressure. In extreme cases such as mixed ulcers, healing is difficult when the PAD is high-grade. In these cases, arterial revascularisation is necessary where possible, performing PTA or femoro-distal bypass. Elastic compression by means of a Fischer bandage can be applied after the procedure. The purpose of the revascularisation is not only to improve the peripheral perfusion index but also and above all to improve the efficacy of vasoactive and antibiotic treatments, whose action is indispensable for healing these particular ulcers. Antithromboembolism stockings can be combined with administration of subcutaneous heparin in patients with arteriopathy (stage IIA) in order to prevent the risk of perioperative thrombosis and pulmonary embolism. In the case of severe arteriopathy (stage IIB, III, IV), the use of elastic compression is dangerous. It is contraindicated except in exceptional situations. Nevertheless, the results can be positive in patients at stage III in the presence of postural peripheral oedema associated with stasis, on condition that the patients are willing to walk despite the pains caused by wearing rigid bandages that exert low pressure at rest. Good results are also obtained with intermittent pneumatic pressure devices (IPC). During the postoperative period following a lower limb revas- 20-05-2009 14:33:38 Compression therapy and peripheral arterial disease cularisation procedure, elastic compression may be particularly indicated. In fact, patients operated with these procedures often develop lymphovenous oedema in the postoperative period secondary to the increase in arterial flow in a territory where autonomic regulation is compromised. Moreover, the oedema can be caused by deep vein thrombosis or by extrinsic venous compression secondary to the surgery. In these cases, it is important to apply passive containment at first, especially if the oedema is significant or there is a DVT. MCS 2nd class can be applied subsequently for 2-3 weeks until the patient is walking better. In all cases, elastic compression should be utilised with great caution in arterial disease and patient selection must be strict. It is essential to confirm the flow indices at the ankle. When the ankle/brachial index is <0.55, Doppler ultrasound should be performed and possibly arteriography to see whether surgical revascularisation is necessary. If this is not necessary, the patient’s condition should be reviewed frequently both to assess his tolerance of the compression and to monitor the condition of the skin. This monitoring should be even closer in the case of arthropathy associated with diabetes and it is particularly important to check the state of the skin; to avoid excessive friction from the stockings or bandages on the tibial prominences, foam or cotton protection should be used. These often complex precautions make it very difficult or even impossible for the patient to put on the stockings. In these cases, there should be no hesitation in abandoning elastic compression in favour of fixed bandages applied by highly skilled healthcare professionals. Once the bandage has been applied, it should be checked after 24 hours at the most to monitor the condition of the skin. Patients with arterial disease for whom elastic compression is recommended should be well informed about the need to rapidly remove the compression stocking or unbandage Recommendations –– The recognised limit beyond which compression in the arteriopathic patient becomes dangerous is a peripheral perfusion index, or W.I. (Winsor), <0.55; it is advisable to record the index with a stress test and confirm the compressibility of the arteries with Doppler ultrasound. An index above 1.2 should also be investigated. –– C2-3 patients with mild PAD (stage IIA), which may be associated with diabetes, do not have a contraindication to daytime elastic compression which can be applied with MCS 2nd class, often preceded in C3 by bandages to reduce the oedema. –– In C4-5-6 patients with mild PAD (stage IIA), it is COMPRESSION impa.indd 39 39 the limb in the case of peripheral pain, especially in the toes, at the ankle or in the heel. In addition to these instructions, it is important to remind the patient that the stocking should be worn only during the day. During use of the bandages, the most frequent complication is skin necrosis, which is very slow to heal and is at risk of becoming infected. In many cases, the loss of substance caused by bandages left in place for too long has been followed by amputation. Peripheral ischaemia of the toes and forefoot may be found. This begins with cyanosis of the toes, pain and functional loss of power of the toes and ankle. The ischaemia is due to excessive compression by the bandage at rest. This should not occur when the healthcare professional is skilled. The lesions can regress after immediate removal of the bandage. We are not aware of incidents with regard to the use of antithromboembolism stockings. In the patient with arterial disease, monitoring must always be very careful, which is easy in the case of a hospitalised patient under frequent medical surveillance. Conclusions There are no absolute contraindications to the use of elastic compression in the arteriopathic patient. Careful patient selection is necessary. The history should enquire about previous disease, investigation of the patient’s suitability, knowledge of his disease and understanding of compression systems and their risks, and finally assess the possibility of motor activity. Clinical examination must identify disorders of sensation and/or fragility of the skin and any anatomical deformities of the lower limb. The type of compression must be adapted to the patient’s clinical condition and, depending on the case, should employ compression with bandages or MCS. Compression may improve the arterial circulation in certain conditions (i.e. the use of ICP). preferable to use passive containment with shortstretch bandages or better, with a fixed adhesive bandage which will ensure a resting pressure as low as possible. –– Antithromboembolism stockings can be combined with administration of subcutaneous heparin in patients with arterial disease (stage IIA), with the aim of reducing as far as possible the risk of perioperative thrombosis and embolism. –– In the case of severe arteriopathy (stage IIB, III, IV), the use of elastic compression is dangerous: it is contraindicated except in exceptional situations. –– Intermittent pneumatic compression can be utilised to improve peripheral arterial perfusion in the initial stages of arteriopathy. 20-05-2009 14:33:38 40 Compression therapy and vein surgery The rationale for compression carried out with various methods in conjunction with venous surgery is prevention of thromboembolic episodes in patients at risk (this topic is discussed below), prevention of superficial venous thrombosis and reduction of the side effects of surgery such as pain and haematomas. Prolonged use of compression can also have a positive effect on the later appearance of varicose recurrences. There is insufficient evidence in the literature for advising one type of compression compared with another; the choice of compression depends on personal preferences and economic considerations (Bond R et al. 1999). There are no significant differences between 1, 2 or 6 weeks of compression for controlling postoperative complications; a minimum period of 1 week is therefore advised (Rodrigus I et al. 1991; Raraty MGT et al. 1999). Compression with a MCS 2nd class worn for 12 months after the surgical procedure has been shown to be effective in reducing the incidence of recurrent varicose veins (Travers JP, Makin GS 1994). The elastic compression rationale varies depending on whether the varicose disease is treated with traditional methods (stripping) or with endovascular or CHIVA techniques. In the first two types of treatment, use of eccentric compression is very widespread, at least for the first 24-48 hours, whereas concentric compression with a stocking is utilised after CHIVA surgery. The most widespread therapeutic approach, at least in our country, appears to be short- to medium-stretch compression bandaging in the immediate postoperative period in order to obtain the most effective pressure possible to control haematomas, and for the patient to wear a therapeutic elastic stocking subsequently for a period that varies greatly from surgeon to surgeon, bearing in main that the patient’s compliance with compression therapy is often very poor once he/she has recovered from the procedure. A study by Bisacci R et al. (2005) in 112 centres in Italy – 26792 procedures/year – showed that compression in the preoperative period is regarded as: –– indispensable by 49.1% (55 centres), but only 53 use it systematically; –– not indispensable by 50.89% (57 centres), but 15 use it systematically which means that it is used systematically in 60.71% (68 centres). In the immediate post-operative period 17.43% utilise COMPRESSION impa.indd 40 elastic stockings of various types with a predominance of MCS 2nd class, 82.57% use bandaging with a predominance of adhesive bandages (29.98%) and two-way stretch elastic (28.53%). The preferred compression after discharge is the elastic stocking (53.68%), 2nd class (21.36%) or 1st class (21.05%) single-leg tights; the bandage is kept in 46.32% of cases, with adhesive bandages predominating. Compression therapy after venous surgery is indispensable, as shown by the data cited above on the treatment of CVI, and should be routine in all centres. Compression can be carried out with different methods, but it must be effective, at least 20 mmHg at the ankle and in keeping with the underlying venous pathology (CEAP class), and must have the characteristics of graduated pressure and uniformity: the MCS or, when necessary for VTE prevention, superimposition of two elastic stockings (antithromboembolism round the clock and MCS 1st or 2nd class during the day) is preferable if staff are not available who are sufficiently skilled in bandaging practice. The use of stockings (Sigvaris® postoperative stocking) with greater compression in the thigh compared with traditional ones (about 20 mmHg) is probably preferable if graduated pressure is guaranteed and can replace the traditional bandage in the immediate postoperative period, especially in patients with objective anatomical difficulties (for instance a thigh of disproportionate dimensions) for keeping an effective bandage in place. In a recent study, Biswas S et al. (EJVES 2007) assessed some outcomes (resumption of work, duration of pain and quantity of analgesics utilised, postoperative complications and patient satisfaction) after traditional surgery (saphenofemoral ligation and stripping). All of the treated patients had been bandaged for the first 3 days and had subsequently worn an antithromboembolic stocking for a period varying between 1 and 3 weeks. The results were not significantly different if compression was carried out for one or for three weeks. The choice of antithromboembolic stocking, which should not be prescribed for therapeutic purposes after a stripping procedure, seems debatable. This serious methodological error does not allow conclusions to be drawn on the clinical level and therefore we still have no studies today conducted with methodological strictness that would allow accurate assessments of the value of elastic compression after surgery, whatever its kind. 20-05-2009 14:33:38 Compression therapy and vein surgery 41 Recommendations –– Compression after venous surgery is indispensable. –– Compression with MCS 2nd class worn for at least 12 months after the surgical procedure reduces the incidence of recurrent varicose veins. –– There is insufficient evidence for advising one type of compression compared to another: the choice of COMPRESSION impa.indd 41 compression method depends on personal preferences and on economic considerations. –– Compression can be carried out with different methods but it must be effective, at least 20 mmHg at the ankle, and in keeping with the underlying venous pathology (CEAP class), and have the characteristics of graduated pressure and uniformity. 20-05-2009 14:33:38 42 Compression therapy and sclerotherapy Compression therapy is the cornerstone of sclerotherapy. It involves the use of bandages during treatment in order to obtain a reaction to the sclerosis therapy that is confined to the vein walls and use of elastic stockings following convalescence with the aim of ensuring adequate compression to consolidate the venous fibrosis. There is broad agreement on important principles in the various methods of state of the art sclerotherapy, such as immediate ambulation, avoidance of air bubbles, haemostatic lacing, wheals in telangiectasias, etc. The comparison of elastic compression in the eternal diatribe between the maximalists and minimalists, remains open, i.e. those who maintain the need for it and those who do not regard it as useful. European phlebology at the end of the century has seen the experience of the former become popular especially in Switzerland, the United Kingdom and Germany, under the influence of Sigg K (removable short-stretch bandage for 3 weeks) and Fegan G (fixed bandage under a removable stocking for 6 weeks); the second has become widespread especially in France, Italy and Spain, under the influence of Tournay R (adhesive bandage over visibly bulky varicosities or stocking, still routine for local complications of intravaricose haematoma, phlebitic reaction) and Bassi G (adhesive bandage). This variety of views found justification since the maximalists aimed at global treatment, including the saphenous ostia, whereas the others often employed sclerosis to treat collateral and reticular veins exclusively or often following previous surgery on the saphenous trunks. However, the debate regarding reticular varicose veins and telangiectasias remained open. To improve the results of sclerosis of varicosities and perforating veins, their diameter and the degree of reflux must be reduced with constant pressure during activity and rest so as to prevent them from refilling with blood coming from the incompetent points and from below. Medium-stretch bandages combined with targeted compression and stockings therefore exert a more suitable action because of their physical characteristics. The problem is that this type of compression is not usually tolerated in bed (even if, according to Cornu-Thénard A, the pressure does not exceed 30 mmHg, it can be maintained during rest) and must therefore be removed at night. Since it is necessary to exert constant pressure over the 24 hours on sclerosed COMPRESSION impa.indd 42 varices, rigid or short-stretch bandages worn constantly are often employed, especially in the treatment of largecalibre varicose veins, combined with eccentric compression in order to increase the local pressure and pressure at rest on the treated vein segments, then changing to an elastic support appropriate to the pathology once the venous thrombus has consolidated following the action of the sclerosing agent. The indications for compression therapy in combination with sclerotherapy vary according to the pathophysiology, the calibre of the varicosities and their anatomical position. It should always be carried out in the case of: –– veins of large dimensions (over 2 mm), especially in the lower leg; –– haemodynamically significant incompetent perforators; –– varicosities at risk of haemorrhage; –– peri-ulcer varicosities or those in areas of skin dystrophy; –– varicose veins of the foot; –– post-thrombotic varicose veins; –– periphlebitic complications; –– lack of experience in sclerosing therapy. The critical areas in the lower limbs, which do not allow optimal compression, are the inguinal region and the thigh (especially if obese); various stratagems can be used (bandages applied in a figure of eight, with vein rolls etc.) but even with their aid, the anatomical shape often prevents effective pressure from being exerted. The retromalleolar fossae and the popliteal fossa present different difficulties due to their concavity; it is necessary to make them convex by using suitable padding so that correct bandaging can be applied, which is useful, for instance, with sclerosis at the saphenopopliteal junction. The foot represents another difficult area, for the opposite reason: the very pronounced convexities alternate with just as obvious concavities and furthermore, the plantar contact with the ground during walking causes firm pressures through the periplantar veins on those of the foot surface. “Canyon” varicose veins in sclerotic hypodermitis and indurated oedema, even though located in readily accessible regions, are not greatly influenced by compression therapy, and neither are telangiectasias and reticular veins. In these cases, it is useful only in controlling the CVI and 20-05-2009 14:33:38 Compression therapy and sclerotherapy limiting inflammatory dermal complications due to overdosage of the sclerosing liquid. The duration and methods of compression vary according to the specialists and sclerotherapy techniques, as shown by Partsch H et al. in 1997. Some studies show equal efficacy in the therapeutic outcome of bandages maintained for a few hours to six weeks, as a significant fall in the pressure exerted by the bandages 6-8 hours following application has been shown. Compression combined with mobilisation of the patient is, however, fully justified after sclerosis of varicose veins, especially if they are large in size and located in the lower leg. This cannot be standardised but must be assessed from case to case. In general, a rigid bandage with the aid of “eccentric” compression is applied after sclerotherapy of medium to large varicose veins, and this is replaced after about a week by a MCS 1st or 2nd class. The recent Sigvaris® postoperative stocking (23-32 mmHg at the ankle), devised to exert greater compression of the thigh (about 20 mmHg) compared with classical therapeutic elastic stockings, which maintained sufficient graduation of the pressure exerted along the lower limb, can be an effective means when 43 used in sclerosis of the saphenous vein and varicose veins at the thigh. Compression therapy in brief controls extension of the thrombus resulting from the endothelial lesion produced by the sclerosing agent, approximates the vein walls and limits periphlebitic reactions, thus improving the final result. However, we are unable to define the appropriate level of pressure that should be exerted or to standardise the type of compression (CIF guidelines 2004). The use of elastic stockings after sclerotherapy of reticular varices and telangiectasias is controversial since the pressures necessary to exert an effective action on small veins are too high (about 80 mmHg); it is advisable to prescribe support of a compression class suitable for the degree of venous insufficiency that is present. A recent study by Kern P, Ramelet AA, Wutschert R, Hayoz D (J.Vasc.Surg. 2007) shows the necessity of a MCS 2nd class (Sigvaris® 702) worn for three weeks to improve the results of sclerotherapy carried out with liquid drug in 100 cases with C1, Ep, As1, Pn. The table below (Table VII) gives suggestions for application of compression during sclerotherapy. Table VII – Compression therapy during sclerotherapy. (*) Varicose veins Concentric compression Duration Eccentric compression GSV Collateral varicose veins Non-elastic or short-stretch bandages. MCS(*) at least 2nd class or Sigvaris® postoperative 7-21 days Obligatory, better if in non-compressible material Fixed or removable 4-7 days SSV Collateral varicose veins Non-elastic or short-stretch bandages. MCS(*) at least 2nd class 7-21 days Optional, Obligatory for large varicosities Fixed or removable 4-7 days Non-saphenous varicose veins Non-elastic or short-stretch bandages. MCS at least 1st class 7-21 days Optional, not necessary for veins with a diameter <2 mm - Duration It is possible to use two superimposed elastic stockings, removing one of them at night. Recommendations –– Compression therapy is indicated after sclerotherapy of every type of varicose veins, utilising at least a MCS 1st class for C1 cases and 2nd class for C2 cases. –– Bandaging is indicated after sclerotherapy of vari- COMPRESSION impa.indd 43 cose veins, using elastic or short-stretch bandages and eccentric compression for the larger varicosities until organisation of the intravenous thrombus (710 days), and in the subsequent period, a MCS 1st or 2nd class is indicated. 20-05-2009 14:33:38 44 Compression therapy and lymphoedema In lymphoedema and in cases of lymphatic insufficiency in general, compression therapy in the broadest sense of the term represents a universally recognised cornerstone in the nonsurgical approach to this type of disease. Compression therapy in the area of lymphology can be subdivided into at least 4 subsections: 1. manual lymphatic drainage; 2. mechanical lymphatic drainage; 3. bandaging; 4. elastic compression devices (supports and stockings). In international protocols such as the Consensus Document of the International Society of Lymphology (revised, I.S.L. International Congress – Salvador Bahia, Brazil - September 2005) and the Guidelines – EBM of the Italian Society of Lymphangiology (Guidelines: S.I.L. Lymphology. 2004 Dec; 37(4):182-4), which inspire the present work and with which it conforms, the above subdivision of compression therapy is not mentioned but, on the contrary, given the complementarity and necessity of the elements that comprise it, it is considered as a single therapeutic entity under the name of “Combined Physical Therapy - CPT”. “This method generally consists of a programme of treatment in two phases: the first phase involves treatment of the skin, manual lymphatic drainage, a series of gymnastic exercises and elastic compression normally applied with multilayer bandages. The second phase, which is started as soon as phase 1 is finished, with the aim of maintaining and optimising the results obtained in phase 1, consists of (…) elastic compression by means of a support (stocking or sleeve) with a low degree of elasticity, (…) repeated sessions of manual lymphatic drainage according to the individual case”. “Essential conditions for the success of the combined physical therapy are the availability of medical staff (clinical lymphologists), nurses and physiotherapists appropriately trained in this therapeutic method. If not applied appropriately, elastic compression may be useless or even harmful. For longterm treatment, it is essential that supports are prescribed for elastic compression”. “Failure of CPT is confirmed only in the case of failure of intensive nonsurgical treatment conducted in an institution specialised in the treatment of peripheral lymphoedema under the direction of an expert clinical lymphologist”. From Italian Society Of Lymphangiology “Guidelines – Ebm On The Diagnosis And Treatment Of Lymphoedema COMPRESSION impa.indd 44 The elastic compression bandage used most often in the area of lymphology is the multilayer bandage, which is also used in the acute phases of the disease and in erysipeloid lymphangitis and which owes its efficacy to the combination of the characteristics and qualities of various materials. From the physical aspect, the material utilised should have “short-stretch” characteristics, which allow low resting pressures and high working pressures to be obtained (greater patient compliance and greater efficacy over time). It should be applied only by expert staff; in the German school (Vodder-Foeldi) the patients themselves are taught the rudiments of the technique so that they are able to apply it “on demand”. The description of the physical foundations, the materials and bandaging methods has already been illustrated exhaustively in other sections of this treatise; therefore, as regards lymphatic disease specifically, two peculiarities that characterise this type of functional elastic vascular bandage can be noted, distinguishing it from the others: in the first place, the pressures and tensions applied by the healthcare professional for elastic compression supports in the course of lymphoedema should be markedly higher compared with the bandages used in venous and/ or arterial disease; secondly, given the extreme variability and dissimilarity that can be encountered in limbs affected by chronic lymphatic stasis, it is often difficult to describe accurate standardisation in applying the bandage, which is usually performed with flexible techniques that can be easily adapted to the individual case. For this purpose, special thicknesses (in latex or cotton) are often employed, which make it possible to level anatomically the treated surfaces. In the acute phases of the disease (e.g. lymphangitis) or in elephantiasic limbs, the bandage often represents the only therapeutic device for effective maintenance, as elastic compression with stockings and supports cannot be employed. For elastic compression supports (e.g. sleeves, stockings, etc.) it is pointed out that the pressure parameters utilised in lymphostasis are higher on average compared with diseases in which the venous component predominates, as was mentioned above for elastic functional bandages. In fact, use of greater compression classes is advised in 20-05-2009 14:33:39 Compression therapy and lymphoedema lymphoedema, such as 3rd class (34-46 mmHg) and 4th class (>49 mmHg). Use of custom-made elastic supports is often required where the limb does not fit the standard parameters on the market. Intermittent pneumatic compression IPC (often simplistically called “pressotherapy”) is subdivided into two categories depending on whether the equipment is able to exert uniform pressure and/or peristaltic sequential pressure. For this type of method, more than for the others, the synergy of the treatments is indispensable. Carrying out mechanical lymphatic drainage not combined with other therapeutic devices (manual lymphatic drainage, tailored bandages and supports) or carried out incorrectly (e.g. pressures too high) could also cause a worsening of the clinical condition; conversely, well-considered and synergistic use allows better results and greater therapeutic “flexibility”. Usually, the combined programme, which includes mechanical therapy, consists of 3 phases: manual treatment of the proximal lymph node regions of the limb to prepare them and prevent them from becoming blocked or, ideally, complete manual lymphatic drainage; mechanical compression therapy at suitable pressures depending on the clinical stage of the disease (better if peristaltic/sequential); application of an elastic support (stocking, sleeve) or multilayer bandaging appropriately tailored. Mechanical lymphatic drainage can also be carried out at home in selected cases with the aid of suitable dedicated equipment. There are also other types of mechanical devices that are useful in the treatment of lymphatic insufficiency. However, specific elements and dedicated probes succeed in imitating effects more proximal to those obtained with manual lymphatic drainage rather than acting in a manner similar to equipment with uniform or peristaltic pressures. Manual lymphatic drainage is carried out following the classical methods of the German (Vodder-Foeldi) and Belgian (Leduc) schools. Depending on the case, different techniques of manual lymphatic drainage can be combined. The manual manoeuvres should not be performed excessively vimedical-lsrously in order to avoid possible damage to lymphatic and lymph node structures. The techniques of manual lymphatic drainage are quite complex; their execution requires expert staff trained in the subject (universities or accredited centres). Finally, it is necessary to note again that both lymphatic drainage and elastic compression devices represent complementary elements in a single therapeutic programme and it is only their synergy that can guarantee a satisfactory and lasting result. It can therefore be stated that strict therapeutic coordination of a team specialising in lymphoangiology should always be employed with appropriate and measured use of the resources of CPT. COMPRESSION impa.indd 45 45 Gasbarro V et al. (2008) proposed the following therapeutical approach to lymphedema at the CEAP stages: C1: pre-clinical stage (no clinical signs) INTENSIVE THERAPY PHASE 2 sessions x week (2 times for a MLD month/year) Compression multilayer bandage after MLD session 2 sessions x week (2 times for a month/year) MAINTENANCE PHASE Compression: MCS 1st class at home 2 times x week ( 20-40 IPC mmHg.) Vascular gimnastic C2: oedema disappears at rest IPC INTENSIVE THERAPY PHASE 3 sessions x week (2 times for a month/year) Compression multilayer bandage after MLD session 3 sessions x week (2 times for a IPC month/year) MAINTENANCE PHASE Compression: MCS 2nd class IPC at home daily ( 30-60 mmHg.) Vascular gimnastic C3: stable oedema INTENSIVE THERAPY PHASE 3 sessions x week (3 times for a MLD month/year) Compression multilayer bandage after MLD session 3 sessions x week (3 times for a IPC month/year) MAINTENANCE PHASE Compression: MCS 3rd class IPC at home daily ( 30-60 mmHg.) Vascular gimnastic C4: fibrotic oedema INTENSIVE THERAPY PHASE 3 sessions x week (4 times for a MLD month/year) Compression multilayer bandage after MLD session 3 sessions x week (4 times for a IPC month/year) MAINTENANCE PHASE Compression: MCS 4th class IPC at home daily ( 40-80 mmHg.) Vascular gimnastic C5: elephantiasic lymphedema INTENSIVE THERAPY PHASE Compression multilayer bandage MAINTENANCE PHASE Compression: MCS 4th class Vascular gimnastic MLD 20-05-2009 14:33:39 46 COMPRESSION Recommendations –– Compression therapy represents a cornerstone in the treatment of diseases of the peripheral lymphatic system; this consists of various elements: manual lymphatic drainage, mechanical lymphatic drainage (IPC), functional elastic bandages and elastic compression devices which, to obtain the best clinical results, should be appropriately combined to give what is defined internationally as “Combined Physical Therapy - CPT”. –– In lymphostatic disorders, the initial treatment is variable in duration depending on the individual case, and this is followed by maintenance therapy; in both, the approaches can usefully be combined with the various “compression” approaches cited above. –– For long-term treatment it is essential to prescribe supports for elastic compression (including custom- COMPRESSION impa.indd 46 made) and it is also possible to combine use of suitable home mechanical lymphatic drainage devices (better if peristaltic/sequential in more sectors) in selected cases with intensive periodic cycles in specialised institutions,. –– Essential conditions for the success of combined physical therapy (CPT) and therefore of compression therapy are the availability of medical staff (clinical lymphologists), nurses and physiotherapists adequately trained and skilled in these therapeutic methods. –– Therapeutic failure is confirmed only in the case of failure of intensive nonsurgical treatment conducted in an institution specialised in the treatment of peripheral lymphoedema under the direction of an expert clinical lymphologist. 20-05-2009 14:33:39 47 Compression therapy and prophylaxis of venous thromboembolism Risk factor stratification Knowledge of the specific risk factors in groups of patients or in individual patients is the basis of appropriate use of prophylaxis (Tables VIII-IX). The clinical risk factors are as follows: age over 40 years, prolonged immobility, stroke or paralysis, previous VTE, neoplasia and related treatments; major surgery (especially operations on the abdomen, pelvis and lower limbs); trauma (especially fractures of the pelvis, hip or leg); obesity; varicose veins; cardiac failure; indwelling central venous catheters; inflammatory bowel disease; nephrotic syndrome; pregnancy or use of oestrogens, with a greater risk from replacement therapy at menopause compared with the contraceptive pill. It has been demonstrated by Wells PS et al. (1997) that even if the clinical diagnosis of DVT of the lower limbs is itself unreliable, assessment of the clinical probability in the patient with suspected DVT is recommended after risk stratification for each patient according to standardised criteria (Table X), in order to classify him to one of the three categories of risk that have a different probability of actually having a DVT. Attribution to one of these categories allows different diagnostic paths to be adopted depending on the degree of clinical probability. These risk factors are present, often in combination, in Table VIII – Absolute risk of VTE in hospitalised patients (in the absence of prophylaxis). Patient group Medical diseases General surgery Major gynaecological surgery Major urological surgery Neurosurgery Stroke Hip or knee arthroplasty, hip fracture Major trauma Acute spinal cord trauma Intensive care COMPRESSION impa.indd 47 VTE prevalence % 10-20 15-40 15-40 15-40 15-40 20-50 40-60 40-80 60-80 10-80 a high percentage of hospitalised patients. For operated patients, the incidence of DVT depends on the listed preexisting factors and on factors connected with the surgery, such as the site, technique and duration of the operation, type of anaesthetic, presence of infection and time of postoperative immobilisation. General anaesthesia induces marked vasodilatation and a major reduction in the rate of venous outflow, which justifies the widespread Table IX – Risk factors. General risk factors –– –– –– –– –– –– –– –– –– –– –– Age >40 Immobility >3 d Obesity (BMI Body Mass Index ≥ 30 Kg/m2) Family history of VTE Previous VTE Varicose Veins of The Lower Limbs Thrombophilia Contraceptive pill Hormone replacement therapy Sepsis or shock Journeys >8 hours Specific risk factors –– Anaesthesia •• General/spinal/epidural anaesthesia –– Surgical procedure •• Minor lasting >45 min. •• Major or pelvic •• Laparoscopy –– Gynaecology-obstetrics •• Pregnancy •• Caesarean section –– Orthopaedics •• Contusions, sprains •• Fracture of tibia, fibula •• Femoral fracture •• Hip fracture •• Hip, knee replacement –– Medical diseases •• Stroke •• Pneumonia •• Nephrotic syndrome •• Cardiac failure •• Antiphospholipid syndrome •• Behcet’s disease •• Myeloproliferative diseases •• Paraproteinaemia •• Paroxysmal nocturnal haemoglobinuria •• Inflammatory bowel disease •• Leg paresis or amputation –– Neoplastic diseases –– Indwelling venous catheters 20-05-2009 14:33:39 48 COMPRESSION Table X – Assessment of the clinical probability of a diagnosis of DVT (pretest). Clinical characteristics Score Malignant disease (on treatment currently or in the previous 6 months) 1 Paralysis, paresis or recent immobilisation of a lower limb 1 Recent confinement to bed >3days or major surgery (within 4 weeks) 1 Localised tenderness along the course of the deep venous system 1 Oedema of all of the lower limb 1 Swelling of the calf >3 cm more than the contralateral calf 1 Increased pitting in a symptomatic limb 1 Superficial collateral venous circulation 1 Alternative diagnosis (probably at least as great as DVT) -2 Total score FINAL ASSESSMENT: High probability Medium probability Low probability score ≥3 score 1-2 score 0/neg. opinion that this in itself presents a risk of VTE greater than that of other types of anaesthesia. The role of congenital and acquired thrombophilic abnormalities (hypercoagulation states) in increasing the risk of VTE associated with clinical risk factors (especially hospitalisation and surgery) has yet to be clarified. The thrombophilic abnormalities include: resistance to activated protein C (factor V Leiden) present in 3-7% of the general Caucasian population; the G20210A prothrombin mutation present in 2-5% of the general population; antiphospholipid antibodies (anticardiolipin antibody and lupus anticoagulant); deficiency or dysfunction of antithrombin, protein C, protein S or heparin cofactor II; dysfibrinogenaemia; a reduction in the levels of plasminogen and plasminogen activators; thrombocytopenia induced by heparin; hyperhomocysteinaemia, frequently associated with a mutation of methylene tetrahydrofolate reductase (MTHFR) present in 8-10% of healthy controls; myeloproliferative conditions such as polycythaemia vera and primary thrombocytosis. The clinical penetrance of these thrombophilic conditions and the frequency with which carriers incur thrombotic events, is variable, being greatest (60-70%) for antithrombin III deficiency and decreasing for the other conditions, down to 8-10% of carriers of the factor V Leiden mutation. In many patients, multiple risk factors may be present Table XI – Levels of risk of thromboembolism in operated patients with prophylaxis. Modified from: “Prevention of Venous Thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines” (8th Edition - CHEST 2008) Approximate risk of DVT without thromboprophylaxis Levels of risk Suggested Thromboprophylaxis options Low risk Minor surgery* in patients without other risk factors**. Medical patients who are fully mobile. <10% Moderate risk Minor surgery* in patients with other risk factors; major surgery*** in patients without other risk factor. Medical patients, bed rest or sick. 10-40% LMWH (at recommended doses), LDUH bid or tid, fondaparinux, ATS o IPC High risk Major surgery*** in patients with other risk factor. Hip or knee arthroplasty, hip fracture surgery. Major trauma, SCI 40-80% LMWH (at recommended doses), fondaparinux, oral vitamin K antagonist ATS/IPC + LMWH No specific thromboprophylaxis. Early and “aggressive” ambulation, ATS VTE risk plus bleeding risk ATS - IPC Abbreviations: ATS antithromboembolism stocking; IPC intermittent pneumatic compression; LDUH low dose unfractionated heparin; LMWH low molecular weight heparin; DVT deep vein thrombosis; VTE venous thromboembolism. * Minor surgery: all operations lasting less than 45 minutes with the exception of abdominal surgery ** Additional risk factors: age, weight, varicose veins, previous DVT, neoplasm, thrombophilia, infectious diseases * ** Major surgery: all operations lasting longer than 45 minutes or abdominal surgery COMPRESSION impa.indd 48 20-05-2009 14:33:39 Compression therapy and prophylaxis of venous thromboembolism and the risks are cumulative. For instance, elderly patients with hip fractures who undergone major orthopaedic surgery and remain immobile in bed after the operation are the most exposed to fatal PE. Modules for assessing the risk of DVT have been proposed but these are used rarely in the medical and surgical departments of our country, thus preventing clear risk stratification in patients and consistent and coherent VTE prevention. Knowledge of the clinical context in which the risk is present has been defined by epidemiological studies and is equally important in the correct application of the recommendations on prophylaxis (Table XI). For instance, patients at greater risk of VTE are those who undergone major orthopaedic surgery of the lower limbs and those who sustain major trauma or spinal cord injury. Effects of compression therapy in the prophylaxis of VTE The antithromboembolism stocking The first studies of the efficacy of the antithromboembolism stocking (ATS) in preventing episodes of VTE were published by Sigel B et al. in 1973 and 1975. These defined the optimal pressure at the ankle as 18 mmHg and the pressure exerted on the thigh as 8 mmHg in the supine patient. These values have been confirmed as optimal in the prophylaxis of VTE by numerous subsequent studies and nowadays represent the reference pressure for all ATS products. The main mechanism of action for the prophylactic efficacy lies in the increase in the rate of venous flow at rest: Partsch H et al. in 1983 and 1985 demonstrated a significant increase in the venous flow rate with ATS compared with control groups, using isotope phlebography to measure the average times for Tc microspheres to pass from the femoroiliac tract and from the vena cava. A study by Mariani F et al. (2006) shows that a below-knee ATS (Kit Embol-stop sanaGens®) produces a significant increase in the rate of popliteal and femoral vein flow at rest and that this rate is further increased by activation of the muscle pump by dorsiflexion of the foot and by respiratory exercises. The ATS is today produced with computerised circular looms using hypoallergenic polyamide (Nylon®) and elastane (Lycra®) threads in different proportions depending on the manufacturing company (for example, 74% polyamide and 26% elastane by sanaGens®; 82% polyamide and 18% elastane by Ganzoni Sigvaris®, 85% polyamide and 15% elastane in the T.E.D.® stockings, Tyco Healthcare Kendall®), has a knitted mesh structure without seams and is white in colour with an opening on the foot for inspection. The ATS can be washed and COMPRESSION impa.indd 49 49 sterilised at 95°C about 40 times. The contraindications are represented by oedema, hypodermitis, dermatitis in the acute stage, infective and exudative dermatosis, ulcers in the florid phase, obstructive arterial disease of the lower limbs with a peripheral perfusion index (W.I.) <0.55, uncompensated cardiac failure and lower limb dimensions that do not match the available sizes. The CEN standard on ATS (European Committee for Standardisation, draft prEN 12719 “Medical Thrombosis Prophylaxis Stockings”, 1998), which corresponds in broad outline to the standard for therapeutic elastic stockings (CEN prEN 12718, WG2-CEN TC 205, RAL-GZ 387, French standard NFG 30-102 B), also specifies that: –– there is a single compression class; –– the pressure exerted at the ankle is between 13 and 18 mmHg, with a margin of variation of ± 3 mmHg, in order to have a prophylactic action and so that it can be worn both day and night without compromising peripheral arterial perfusion; –– the graduated pressure profile must be as follows: 100% in B, 80-100% in B1, 60-80% in C, 40-70% in F and G. The margin of variation of the exerted pressure of ± 3 mmHg appears excessive objectively and moreover, ATS produced by different manufacturers do not always comply with the specified pressure levels, as demonstrated by a study by Thomas S (1992) of 10 different brands of ATS, where it was found in some that the tolerance limit even exceeded 20%, with pressures at the ankle between 8 and 27 mmHg, and by a more recent study by MacLellan DG (2002) of 4 different brands, which found that only one met the specified standards. Future regulation will therefore have to reduce the tolerance limits on the one hand and on the other hand control of production of so important a therapeutic device should be very strict, as in the case of therapeutic elastic stockings. Monitoring by the physician or paramedical staff is therefore fundamental, both at the stage of measuring the limb circumference and then prescribing the corresponding size (a determining factor in the efficacy of the prophylaxis) and in the choice of ATS brand that will provide the necessary guarantees of quality. Scientific publications on the action of ATS in the prevention of VTE are numerous. The conclusions that can be reached from an analysis of the literature are as follows: –– the ATS should be worn by patients at risk in the periand postoperative period throughout the 24 hours and for at least four weeks or longer in the case of postoperative complications that prolong the recovery period, during prolonged confinement to bed and whenever prescribed and instructed by the physician; 20-05-2009 14:33:39 50 COMPRESSION –– use of ATS significantly reduces the incidence of VTE after low and medium risk surgery (grade B recommendation, Guidelines for the diagnosis and therapy of diseases of the veins and lymphatic vessels - Italian College of Phlebology CIF); –– the combination of ATS and heparin is more effect than ATS alone in patients at medium and high risk (grade B recommendation, Guidelines for the diagnosis and therapy of diseases of the veins and lymphatic vessels Italian College of Phlebology CIF); –– the efficacy of the ATS depends closely on the quality and size prescribed on the basis of the measured circumference of the patient’s limb; –– significant differences in efficacy have not been found between different models so that except in particular cases, use of the below-knee model is sufficient; –– the ATS is sterilisable (about 40 times) and can be reused by more hospitalised patients; –– the ATS exerts compression sufficient for VTE prophylaxis only in patients confined to bed and should therefore by combined with a therapeutic elastic stocking during mobilisation of the patient according to the following procedures: a) A MCS 1st compression class should be worn over the ATS during daily activity and ambulation (not at rest!) by patients with a low and moderate risk of VTE in the case of CVI of a mild degree (CEAP classes 0-1); b) A MCS 2nd compression class should be worn over the ATS during daily activity and ambulation (not at rest!) by patients with a high and very high risk of VTE and in the presence of chronic and/or lymphatic venous insufficiency of the lower limbs of a medium to high degree (CEAP classes 2-5); c) At the physician’s discretion, treatment with MCS 1st-2nd class can be prolonged for treatment of the CVI of the lower limbs even after suspension of the antithromboembolism stocking. Antithromboembolism stockings reduce the incidence of DVT and increase the protection ensured by LDUH and LMWH. Patients with malignant disease and other highrisk general surgery conditions have been assessed in sufficient numbers to allow secure conclusions regarding the efficacy of the ATS in these clinical situations. In some of the randomised studies, the high-risk patients were excluded specifically. Other clinical studies are necessary to assess the efficacy of ATS in these patients. Another limitation lies in the fact that some patients cannot wear the ATS effectively because of the dimensions or unusual shape of their limbs. Combining ATS and other prophylactic agents, it appears that greater protection against VTE is obtained COMPRESSION impa.indd 50 compared with one or the other method applied singly. The ATS combats venous stasis and increases venous return during abdominal insufflation for laparoscopic procedures. In a recent non-controlled study, a 2% risk of DVT was demonstrated with duplex ultrasound in patients undergone laparoscopic cholecystectomy or minilaparotomy when LMWH, intraoperative IPC and ATS were combined, which was significantly diminished compared with controls. A meta-analysis of the studies published between 1966 and June 1992 identified 35 randomised trials among 122 articles, only 12 of which were considered suitable for analysis. In 11 of these, the prophylaxis concerned medium-risk surgery (abdominal, gynaecologic, neurosurgery); only one included high-risk orthopaedic surgery: use of the stockings resulted in a significant reduction of the risks. The Consensus Conference, issued by the International Union of Phlebology in San Diego in August 2003 and published in Vasa in 2004 under the title “Evidence based compression therapy”, concludes that from an analysis of the data in the literature, ATS are effective in reducing the risk of VTE in hospitalised patients with a recommendation level of A-B. The main publication referred to is that of Amarigiri SV and Lees TA (2003) which analyses the results of 9 randomised controlled studies of the efficacy of ATS alone and in combination with other methods versus placebo. However, the data should be assessed with caution since patients at high risk were specifically excluded in some of the randomised studies. Other clinical studies are necessary to assess the efficacy of antithromboembolism stockings in these patients. Combining the stockings with other prophylactic agents, it appears that greater protection against VTE is obtained compared with one or the other method applied singly: there is favourable evidence in randomised controlled studies for the combination of ATS and PC combined with low-dose unfractionated heparin (LDUH) or low molecular weight heparin (LMWH). The ATS is intended for patients who are confined to bed and does not exert effective pressure when the patient is sitting or standing or during movement; it must therefore be combined with or replaced by a therapeutic stocking of a suitable class at the time of mobilisation if there are risk factors in addition to the surgical operation such as thrombophilic conditions or varicose veins of the lower limbs (Struckmann JR et al. 1986, Cooke EA et al. 1996, Partsch H et al. 2000). Bandaging There are no significant data in the literature on the preventive efficacy of bandaging of the lower limbs in the prevention of VTE, despite the frequency with which it 20-05-2009 14:33:39 Compression therapy and prophylaxis of venous thromboembolism is used. The effects of bandaging on the venous and microvascular tissue system and in the treatment of superficial (SVT) and deep (DVT) venous thrombosis are well known, but we have insufficient data on VTE prevention in patients at risk. Moreover, application of the bandages is closely operator-dependent and up to now there are no reliable and reproducible clinical methods for measuring the exerted pressure in every patient and its uniformity and graduation in the bandaged limb; to this is added the deterioration of the applied material (greater than that of the ATS) and the drop in pressures exerted a few hours after application (Raj TB et al. 1980; Partsch H et al. 2000). Bandaging may therefore be indicated in the prevention of VTE only if carried out by highly skilled staff. Intermittent pneumatic compression Pneumatic compression (IPC) is one of the preventive methods used most often in the USA. It produces a significant increase in the rate and volume of venous flow in all segments; in particular it is significantly higher compared with simple elevation of the lower limbs in the patient who is confined to bed (Lurie F et al. 2003). It also causes an increase in tissue tcPO2, stimulates microcirculatory vasomotor activity and fibrinolytic activity, though to a lesser degree compared with pharmacological therapy. IPC is utilised in the prevention of DVT in patients at risk in conjunction with surgery or prolonged confinement to bed. The significant reduction in the incidence of thromboembolic phenomena has been well demonstrated by numerous studies, among them those of Hull RD et al. (1990) and Pidala MJ et al. (1992). Only a few compared IPC with the ATS; the results did not demonstrate highly significant differences although slight superiority of the IPC was recorded in operated patients. The combination of IPC and heparin improves the results compared with use of the two methods singly. Ramos R et al. (1996) in 2551 patients undermedical-lsing cardiac surgery demonstrated a reduction in the incidence of pulmonary embolism of 62% between patients treated with heparin alone and those who also had IPC (reduction in incidence from 4% to 1.5%). Thrombosis prophylaxis in surgery is usually carried out with the following parameters even though there are no definitive data in the literature in this regard: –– minimum pressure of 35 mmHg, maximum 60 mmHg; –– chamber inflation time between 10 and 35 sec, more often between 10 and 12 sec; –– deflation time of about 60 sec. The treatment is carried out from the time of entering the operating theatre until active mobilisation of the COMPRESSION impa.indd 51 51 patient and is repeated for at least two weeks in patients who are confined to bed. Apart from the actual contraindications to compression therapy, patients who require surgery on the lower limbs cannot use IPC on the operated limb, although the boot can be applied on the non-operated limb or only as far as the knee, with the therapeutic action remaining practically unchanged. The principle of action of plantar pneumatic compression (PPC) is based on the action of a pneumatic plantar pad that produces intermittent pressures that can empty the plantar venous plexuses. The pad acts only on the sole of the foot and the pressures are of the order of 100-160 mmHg; the duration of the cycle is very short, corresponding to the contact time of the sole of the foot with the ground during walking, and is from 0.4 to a maximum of 2 seconds, with an overall time between insufflation and deflation of about 20 seconds. Although the method is rarely used on its own, it has demonstrated efficacy in increasing the rate of venous flow, reducing venous oedema and in the prophylaxis of VTE but the studies that have been conducted are too small to allow significant conclusions to be drawn. Compression therapy in the prophylaxis of VTE in patients at risk General surgery The incidence of DVT in general surgery in the absence of prophylaxis varies between 15 and 30%, with a rate of fatal PE between 0.2 and 0.9%. The actual risk of VTE occurring is still not defined today because comparative studies with patients without prophylaxis are fortunately no longer conducted. The additional major risk factors, apart from the different surgical procedures, are represented by: 1. previous episode of VTE, obesity, varicose veins, use of oestrogens, cancer; 2. advanced age (>60 years); 3. type of anaesthesia (< risk for spinal/epidural anaesthesia); 4. poor possibility for postoperative mobilisation, dehydration, need for transfusion. Antithromboembolism stockings (ATS) reduce the incidence of DVT and increase the definite protection provided by heparin but the available data are too few because it is not possible to fully assess the effect on proximal DVT and on PE. Patients with malignant disease and other high-risk general surgery conditions have not been 20-05-2009 14:33:39 52 COMPRESSION assessed in sufficient numbers to allow secure conclusions regarding the efficacy of ATS in these clinical situations. In some of the randomised studies, high-risk patients were specifically excluded. Other clinical studies are necessary to assess the efficacy of ATS in these patients. Better protection against VTE is obtained by combining ATS with other prophylactic agents compared with one or the other method applied singly. It has been shown that the ATS interferes with venous stasis and increases venous return during abdominal insufflation for laparoscopic procedures. Pneumatic compression (IPC) is an effective preventive method which should be regarded as first choice together with ATS when there is a risk of severe haemorrhagic complications. Various studies have demonstrated that IPC is effective in reducing DVT in general surgery patients with malignant disease. In studies in which IPC was compared with LDUH, both agents produced similar reductions in the incidence of DVT. Plantar pneumatic compression (PPC), utilising the foot vein pump, produces haemodynamic effects on the emptying of the lower limbs similar to those of IPC and like it appears to stimulate fibrinolytic activity. However, as far as we know there are no studies of these methods in general surgery patients. A suitable prevention strategy in general surgery should take into account the risk of VTE and the efficacy of various agents in reducing the risk as well as the ensuing costs and the possible complications of each method. In low-risk patients undergoing minor or relatively short surgical procedures, aged <40 years and without other risk factors, specific prophylaxis is not necessary apart from early ambulation. Some large-scale studies document a risk close to zero for the development of clinically manifested VTE after minor surgery in low-risk patients. In patients at medium risk aged >40 years or undergoing major surgery but without other clinical risk factors, LDUH administered once a day (5000 IU every 12 hours) or LMWH (≤3,400 IU every 24 hours) or ATS used correctly could be sufficient. IPC is a reasonable alternative, even if it involves management problems and the cost of the equipment, and it should be provided to each patient at least throughout the hospitalisation period and be combined with an elastic stocking on mobilisation. For patients >60 years of age undergoing major surgery who have other risk factors, various effective methods are available for prophylaxis. LDUH administered every 8 or 12 hours and LMWH at doses above 3500 IU every 24 hours is effective. The addition of ATS or IPC to one of these methods ensures further protection and is always obligatory in patients at risk of haemorrhage, at least until COMPRESSION impa.indd 52 this risk is reduced and pharmacological prophylaxis can also be used at the same time. The “International Consensus Conference on Compression Therapy”, issued by the French Society of Phlebology (2003), recommends the use of ATS in the prevention of VTE in medium-risk general surgery patients (grade A). In general surgery patients with multiple risk factors, combination of the most effective pharmacological methods with IPC or ATS offers excellent protection. Higher daily doses of LMWH (>3,400 IU), such as those often used in orthopaedic surgery, would likewise be indicated. The problem of the duration of prophylaxis after the hospitalisation period has not yet been solved; some studies show that prolonged prophylaxis with LMWH for 3 weeks after discharge from hospital seems not to reduce significantly the incidence of DVT. The question of the duration of thrombosis prophylaxis in general surgery should be reassessed at this point in view of the currently ever shorter duration of hospitalisation. A study by White RH et al. (2003), conducted on 1,653,275 procedures of various types, shows that, as regards abdominal surgery, the incidence of DVT after discharge from hospital is from 0.9% for splenectomy to 0.1% for appendicectomy or laparoscopic cholecystectomy, versus an overall incidence of 1.6% and 0.2% for the procedures, whereas in the case of abdominal surgery because of cancer, the values range from 1.7% for surgery of the colon to 0.9% for rectal surgery, versus 2.6% and 1.5% overall. The size of the problem is thus not negligible: about 50% of cases of VTE are found after discharge, and review of the duration of prophylaxis strategies is needed. The problem of extending prophylaxis after discharge following major abdominal surgery was addressed in the “Enoxacan 2” study in 2002. Patients were randomised after treatment with enoxaparin for one week to receive enoxaparin or placebo for a further 21 days. A statistically significant reduction in DVT on phlebography was observed, from 12% in the placebo group to 4.8% in those treated with LMWH. Finally, it can be stated that, based on the available evidence and in the absence of an optimal prophylaxis regimen, VTE prophylaxis should be started before the surgical operation and continued for at least 4 weeks at least in cancer patients. ATS are useful and may increase the efficacy of pharmacological prophylaxis in these patients and together with IPC they are an alternative in patients with active haemorrhage or at high risk of haemorrhage. The majority of patients who have day surgery fall into the low, moderate and high risk categories, with the first two predominating so, since they benefit from early mobilisation, prevention of thromboembolic episodes with physical methods (ATS, IPC, PPC) should be employed frequently and systematically according to risk stratification, given the efficacy, ease of use and low cost (the ATS 20-05-2009 14:33:39 Compression therapy and prophylaxis of venous thromboembolism appears to meet these criteria the best). In patients at high risk of bleeding, and also if they have a medium and high risk of venous thromboembolism, early ambulation combined with use of ATS or IPC is recommended (grade A recommendation according to the instructions in the majority of current guidelines: ACCP 2001-2004-2008, SIAPAV-SIDV-SISET-GIUV 2000, SISET 2002, CIF 2001-2003-2004). Oncological surgery There are numerous controversies in the area of oncological surgery. Some studies demonstrate the efficacy of compression therapy in combination with pharmacological therapy in the prevention of VTE; others deny the efficacy of pharmacological therapy in favour of compression therapy alone in the prevention of thromboembolic events in these categories of patients, and other still support the use of compression therapy only in patients in whom anticoagulant therapy is absolutely contraindicated. The clinical evidence suggests the need for further and more precise identification of the thrombotic risk in oncology. New staging is needed that involves thromboembolic risk categories adapted to the type and staging of the patient’s malignancy. At present, it is appropriate to regard the cancer patient undergoing surgical procedures as at least moderate or high risk and to integrate this with the specific surgical risk. Cardiac surgery Patients undergoing cardiac surgery in the form of CABG (coronary artery by-pass graft) or valve replacement, have a very low incidence of symptomatic DVT (0.7%). However, the incidence of asymptomatic thromboembolic events in cardiac surgery patients is surprisingly higher. The low incidence of symptomatic VTE after CABG is somewhat understandable. Dyspnoea with possible desaturation is often attributed to the precarious physical condition, episodes of atelectasis and/or pre-existing left ventricular dysfunction. Undoubtedly, in the majority of patients who suffer “sudden death” within the first thirty days after the cardiac surgery, the death is due to PE in the absence of premonitory clinical symptoms or signs. The clinical diagnosis of DVT in these patients is difficult as the oedema in the lower limbs is attributable to the surgical trauma of saphenectomy to provide the aortocoronary bypass grafts; the muscle cramps reported by the patients are often due to the perioperative immobility. Rarely, DVT is suspected in the contralateral lower limb from the saphenectomy. In a randomised clinical trial conducted in 330 patients who underwent CABG, DVT was diagnosed with diagnostic ultrasound COMPRESSION impa.indd 53 53 methods in 20% of cases (67 patients). In 56 of these patients (84 %) the thrombosis was distal and located at calf level, whereas the thrombosis was proximal in 11 patients (16 %). Only one patient developed a proximal symptomatic DVT. These data show that the majority of patients develop an asymptomatic and distally located DVT after cardiac surgery with a ratio of 5 to 1. Moreover, the symptomatic DVT found in 1% of operated patients can be manifested directly as a fatal PE. In the United States, about 500,000 CABG operations are performed; approximately 100,000 patients develop a DVT, 84,000 of which are isolated in the calf and 16,000 at a proximal level. Only 10,000 patients develop symptoms and clinical instrumental diagnosis is definitive. Between asymptomatic and symptomatic patients, the incidence of mortality due to thromboembolic complications is about 1% and 2-4% respectively. Thus, about 1100-1300 patients die postoperatively of PE each year in the United States. These deaths are incorrectly attributed to episodes of arrhythmia or myocardial reinfarction. The most greatly feared complication of pulmonary embolism should also be recalled, namely, chronic disability due to pulmonary hypertension secondary to thromboembolic phenomena. PE and DVT constitute the fifth most common cause (about 6.3%) of readmission within the first thirty days postoperatively. It has been seen that of 5451 patients with DVT confirmed with ultrasound methods, only 42 % had received prophylaxis within the last thirty days prior to the diagnosis of the thrombotic event. This indicates the importance of early diagnosis of DVT for the purpose of rapid treatment and accurate stratification of the cardiovascular risk. Clinical diagnosis of DVT is not specific or sensitive. In view of the unreliability of the clinical signs of DVT, use of instrumental diagnostic methods such as non-invasive Doppler ultrasound is necessary to investigate the iliacfemoral, subpopliteal and superficial venous circulation. Thromboembolic disease and its consequences have significant weight both in general terms of public health and in social costs due, for example, to the post-thrombotic venous syndrome. Correct prophylaxis of patients who have undergone cardiac surgery should involve a reduction in health costs as well as a lower incidence of postthrombotic complications. Various strategies can be utilised to prevent VTE episodes after CABG or valve surgery. Both mechanical and pharmacological prophylaxis can be employed, or a combination of the two. Prophylaxis of the mechanical type is provided by devices such as the ATS and IPC. The antithromboembolism stockings increase the rate of venous flow and prevent venous stasis in the lower limbs. They are inexpensive medical devices that are easy to use and free from serious complications. Venous stasis can also be 20-05-2009 14:33:40 54 COMPRESSION prevented by means of inflatable boots that induce intermittent pneumatic compression of both lower limbs. By insufflation of air into cuffs in a centripetal direction, ICP prevents peripheral venous stasis and causes stimulation of local and systemic endogenous fibrinolysis, and is indicated particularly in patients transferred to the intensive therapy unit. What is the practical approach for preventing PE after CABG or valve surgery? Both mechanical devices, ATS and IPC, can be used immediately in the postoperative period. The ATS reduces the frequency of venous thrombosis and should therefore be regarded as prophylaxis par excellence against PE except for patients suffering from critical peripheral vascular disease. There is level 1 evidence of the real efficacy of ATS but protection against fatal PE events has not been adequately confirmed by sufficiently large studies. This limitation also applies to IPC. IPC is very useful in intensive care units where the patient’s compliance can be monitored promptly. Pharmacological prophylaxis should be regarded as a routine method of prevention after CABG. In fact, in current clinical practice, VTE thromboprophylaxis consists of the use of mechanical means (ATS, IPC) and early mobilisation, with pharmacological prophylaxis only in case of clinical suspicion of thromboembolic risk. Acetylsalicylic acid and clopidogrel are prescribed routinely after percutaneous angioplasty with coronary stenting, while the majority of patients who underwent CABG take low-dose aspirin for secondary prevention of cardiovascular disease. Even though a meta-analysis has shown that aspirin on its own is not effective for thromboembolic prophylaxis if compared with other pharmacological therapies, conversely there are trials which have demonstrated the prophylactic benefit of using it after general and orthopaedic surgery. After cardiac surgery, because of the existence of probable “resistance” to simultaneous use of both drugs (aspirin and clopidrogel), there is a need for them to be adjusted therapeutically or for an alternative treatment. Oral anticoagulant therapy (warfarin) in the immediately postoperative period is recommended only in well selected cases (mechanical valves, presence of large left ventricular thrombus), where the benefits largely exceed any haemorrhagic risks following cardiac surgery. A preliminary multicentre study is underway to determine the efficacy of LMWH used in the immediate postoperative period as a bridge to warfarin therapy in patients undermedical-lsing mechanical valve replacement. Vascular surgery The majority of surgical patients should receive perioperative prophylaxis according to the published recommendations and guidelines. It has been broadly demonstrated that intraoperative anticoagulant therapy with COMPRESSION impa.indd 54 intravenous heparin sodium provides adequate protection against thromboembolic events. Systematic use of intraoperative heparin sodium during elective aortic reconstruction, besides reducing the risk of arterial thrombosis in the prosthetic graft and especially of myocardial infarction in the postoperative period, also has a prophylactic effect on VTE, resulting in a lower perioperative risk of DVT when compared with other major intra-abdominal general surgical procedures. Thromboprophylaxis of vascular surgery patients, despite all this, is still controversial for the simple reason that the incidence of DVT in the lower limbs in the postoperative period is regarded as low. A few studies have demonstrated a high incidence of postoperative DVT (equal to 32 %) in patients undergoing vascular procedures of the aortic and/or peripheral type without adequate prophylaxis. The limitation of these studies is the small population cohort examined so that the results obtained preclude any generalised recommendation. In fact, the results show that there is an urgent need for further randomised clinical trials to determine the correct therapeutic strategy for preventive purposes. Patients who underwent vascular surgery are at high risk of developing episodes of VTE. In vascular surgery, the potential risk factors are advanced age, critical ischaemia of the lower limbs, excessive duration of the surgical procedure and damage to the vein wall. The incidence of DVT after aortoiliac or aortofemoral surgery is similar to that observed with other abdominal or pelvic surgical procedures. Naturally, these studies excluded patients with a previous history of DVT and/ or PE or who underwent non-elective surgery or carotid vascular or varicose surgery. For thromboembolism risk stratification in vascular patients, therefore, any disability on walking due to disabling claudication with a walking distance of 50 metres or less is fundamental, in addition to age, sex, the presence of varicose veins, any history of thrombophilia, use of antiplatelet or anticoagulant therapy. Libertiny G and Hands L in a study conducted in patients with disabling peripheral vascular disease documented a preoperative DVT in 19.6% of the enrolled patients. The preoperative propensity of patients with critical peripheral ischaemia to develop DVT is due to high levels of homocysteinaemia and a generalised state of hypercoagulability as well as the prolonged immobilisation resulting from the vascular disability. It is now certain that immobilisation involves a greater incidence of DVT and this is why early revascularisation is recommended in the case of critical ischaemia, not only for limb salvage but also to reduce the risk of VTE to a minimum, while improving the claudication and ambulatory disability in the broad sense. Even though the ideal prophylactic regime still remains elusive, it is certain that patients given phar- 20-05-2009 14:33:40 Compression therapy and prophylaxis of venous thromboembolism macological prophylaxis with LDUH or LMWH and possibly with mechanical prophylaxis have a lower risk of developing thromboembolic events. Patients who underwent major vascular surgery procedures and who have additional risk factors should receive adequate antithrombosis prophylaxis with LDUH or LMWH. Even though the optimal time for starting anticoagulant prophylaxis has not yet been well established, the majority of surgeons prefer to give the first dose after the surgical procedure. As regards patients having infrainguinal vascular surgery (femoro-popliteal, femoro-tibial, femoro-femoral, iliaco-femoral, axillo-femoral bypass, reoperation because of bypass thrombosis and grafting for popliteal aneurysm), in view of the low incidence of DVT (2.8%) in the postoperative period, anticoagulant prophylaxis is not recommended unless strictly required for specific indications regardless of the risk of VTE. On the other hand, it is recommended for patients undergoing major amputation. The incidence of DVT following revascularisation procedures is in fact 9.1%, compared with 14.3% in the case of ablative procedures such as above-knee amputation. LMWH can play an effective role. However, there is so far no definite evidence regarding the antithromboembolism therapeutic strategy for patients undergoing endovascular treatment of abdominal aortic aneurysms. Vascular surgery of the superficial and deep venous system should, in contrast, always be preceded and followed by compression therapy. The incidence of symptomatic VTE after superficial venous surgery is difficult to assess for the reasons described above for arterial surgery but in general it can be stated that prophylaxis should be carried out according to the criteria defined in general surgery, bearing in mind that varicose veins are a known additional risk factor. Optimising the prophylaxis of patients at higher risk should involve the use of unfractionated heparin -LDUH- or low molecular weight heparin -LMWH- with ever broader recourse to the use of graduated compression elastic stockings. Gynaecological surgery VTE is an important and potentially avoidable complication after gynaecological surgery. The overall incidence of DVT is similar or slightly lower than that associated with general surgery. Using labelled fibrinogen as a diagnostic test, the reported frequency of postoperative DVT in 19 studies involving 2,268 patients who underwent gynaecological surgery without prophylaxis was between 4 and 38%, with a mean of 16%. Fatal PE was reported in 0.4% of a cumulative sample involving >1,000 unprotected patients. The factors that appear to increase the thromboembolic risk most after gynaecological surgery are similar to those for general surgery such as COMPRESSION impa.indd 55 55 advanced age, previous DVT/PE, malignant disease and abdominal surgery (as opposed to vaginal). In particular, patients with gynaecological malignancy have a substantially increased risk of DVT as many of these patients are elderly; in some there may be compression of major veins by a pelvic mass; they are exposed to injury of the venous intima during the operation, especially when dissection of the pelvic lymph nodes is performed; the operations are often long; postoperative mobility is often compromised and chemotherapy is itself thrombogenic. As in other surgical patients, even if the thrombus generally begins to form during or shortly after the operation, a marked percentage of symptomatic events occurs after discharge from hospital (1.1% after discharge compared with 2.3% in total, according to the study by White RH cited above). When the incidence of fatal PE in prospective studies of 7,000 gynaecological surgery patients is added up, a 75% reduction in risk is obtained with the use of thromboprophylaxis (from 0.4 to 0.1%). However, rational prophylaxis is always based on knowledge of the risk factors: gynaecological surgery, compared to other types, has a few peculiarities that make the risk of VTE relevant: in the first place, hormonal contraception or hormone replacement therapy, which increases the risk about fourfold, and the operations are performed in particular anatomical regions for diseases that involve important venous drainage regions. The risk stratification proposals can be summarised according to the International Consensus Statement (Tab.XII) which is the one most widely utilised. In it a distinction is made between vaginal and abdominal surgery, oestrogen therapy in young women is regarded as an additional risk factor and a high risk is found in the case of malignant disease or previous DVT. Studies on patients undergoing gynaecological surgery for benign disease have shown that antithromboembolism stockings ensure greater protection against DVT compared with the absence of prophylaxis. Randomised studies assessed IPC in patients undergoing gynaecological surgery. The use of IPC on its own during the surgery and in the first 24 hours after the operation was not effective, whereas continuing the prophylaxis with IPC for at least five days after the operation was highly effective compared with controls and ensures protection similar to that of LDUH. The risk classification and recommendations for prophylaxis described in tables IX-XI are applicable in gynaecological surgery. The risk of VTE in conjunction with laparoscopy has not yet been well defined and therefore it is recommended that prophylaxis be carried out after assessment of the patient’s individual risk; when risk factors are present, the choice can be made indifferently between LDUH, LMWH, ATS or IPC. 20-05-2009 14:33:40 56 COMPRESSION Table XII – Risk of VTE in gynaecological surgery. Modified from: International Consensus Statement (1997). Risk Surgery* Age Risk factors Low risk Minor Major <60 years <40 years None None Medium risk Minor Minor Major Major >60 years <60 years <40 years 40-60 years None Oestrogen therapy, cancer, previous VTE Oestrogen therapy None Major Major Any type <60 years >60 years Any age Cancer, previous VTE None Thrombophilic state High risk *Minor surgery: vaginal access <45 min; mayor surgery: vagina access >45 min, abdominal access. In brief, the following can be recommended: –– low risk: no pharmacological treatment, early mobilisation and possibly elastic compression with ATS (especially in patients with difficulty in mobilisation, for instance, elderly patients); –– medium risk: LDUH 5000 IU every 12 hours (the first injection 2 hours before the surgery) or LMWH 2000 to 3500 IU anti-Xa, depending on the product, once a day (the first dose 2-4 hours before the surgery) and IPC/ATS; –– high risk: LDUH 5000 IU three times a day (the first injection 2 hours before the surgery) or LMWH 3800 to 5000 IU anti-Xa, depending on the product, once a day (the first dose 10-12 hours before the surgery) and IPC/ATS. In patients operated because of malignant disease, prophylaxis with LMWH and elastic compression is recommended for at least one month, and continued during any radiotherapy. Urological surgery Thromboembolic events are regarded as the most important non-surgical complication of major urological surgery. A percentage ranging from 1 to 5% of patients undergoing major urological surgery has a DVT and a fatal PE is found occasionally (risk less than or equal to 1/500). The factors that increase the risk of DVT in these patients are open surgery (compared with transurethral), malignant disease, more advanced age, general anaesthesia (compared with regional) and the duration of the operation. Only a few randomised studies with adequate methodological criteria have been published in the past decade: Belcaro G and Nicolaides A (1994) demonstrated that LDUH and IPC are effective prophylactic measures in reducing the incidence of VTE (about 50%), confirming the studies by Coe NP et al. in 1978 and Salzman EW et al. in 1980; Soderdahl DW et al. (1997) and Donat R et COMPRESSION impa.indd 56 al. (2002) demonstrated the activity of antithromboembolism stockings and IPC without finding significant differences between one method and the other. The use of ATS or IPC is effective in urological surgery as in general abdominal and pelvic surgery, and likewise, combining mechanical prophylaxis with pharmacological will provide greater protection compared with one or the other method on its own. The risks of VTE are low in patients undergoing transurethral prostatectomy and there may be a greater risk of haemorrhage with the use of perioperative LDUH or LMWH. Early postoperative mobilisation and the use of ATS is probably the only intervention justified in these and other patients undergoing low-risk urological surgery. Routine prophylaxis is recommended for more extensive open surgery, such as radical prostatectomy, cystectomy or nephrectomy, especially in the presence of malignant disease. Until we have further data, the treatment of patients at high risk should be based, as in general surgery, on the use of LDUH, ATS, IPC, LMWH and a combination of mechanical and pharmacological methods. Urological patients undergoing major open surgery should be given pharmacological treatment with LDUH every 8/12 hours; an acceptable alternative is the use of ATS or IPC or LMWH. In patients with multiple risk factors, combined use of ATS and/or IPC with LDUH or LMWH is recommended, bearing in mind the fact that in those at high risk of haemorrhage, mechanical prophylaxis should be regarded as obligatory, at least until the risk of haemorrhage is reduced. Laparoscopic surgery Laparoscopic techniques are associated with moderate activation of coagulation and fibrinolysis, and the use of pneumoperitoneum and the patient’s intraoperative position increase venous stasis. The low availability of clinical, epidemiological and prospective studies does not allow definitive conclusions to be drawn on the incidence of VTE and better prophylaxis but the Society of Ameri- 20-05-2009 14:33:40 Compression therapy and prophylaxis of venous thromboembolism can Gastrointestinal Endoscopic Surgery recommends the same prophylaxis as that followed for surgical procedures while the European Association for Endoscopic Surgery recommends the use of intraoperative IPC or ATS throughout the procedure. In patients undergoing laparoscopic surgery with additional risk factors, prophylaxis using a method chosen from LDUH, LMWH or ATS/IPC is recommended. Orthopaedic surgery Based on the results of phlebography performed on control patients or patients randomised to receive placebo, the total prevalence of DVT in the absence of prophylaxis 7-14 days after total hip arthroplasty (THA), total knee arthroplasty (TKA) and hip fracture surgery is 4060%. The incidence of PE is less definable (3-28% in the first two weeks), even if it has been greatly reduced since routine use of prophylaxis became widespread (1.5-10% in the first three postoperative months). The incidence of proximal DVT is about 25%, 15-20% and 30% in surgery for THA, TKA and hip fracture respectively. Although the operated leg is involved most commonly, the other leg is affected in about 20% of THA patients and about 14% of TKA patients. New DVT and PE after discharge from hospital are equally common. Phlebographic studies indicate that without prophylaxis after discharge, 10-20% of patients have a new episode of DVT within 4-5 weeks of discharge from hospital and about 6% have pulmonary scintigraphy with an intermediate or high probability of PE Knee arthroscopy Diagnostic arthroscopy and arthroscopic surgery of the knee are today among the most frequent orthopaedic surgical procedures and are performed on young patients; nevertheless, we have few data on the risk of VTE. In the absence of prophylaxis, the incidence of DVT varies between 2 and 18%, with a higher risk for therapeutic arthroscopy. The duration of intraoperative torsion, together with the complexity of the surgery and possible need for firm compression with a tourniquet to obtain a bloodless surgical field, are risk factors that must be taken into account in the overall assessment of the risk of VTE. In cases where venous stasis is prolonged, use of ATS during the operative and convalescent period is advisable until complete mobilisation, even if there are so far no randomised studies on the prophylactic efficacy of ATS or IPC. Elective THA surgery Various non-pharmacological methods of prophylaxis have been studied in TKA patients, among them ATS, IPC and early ambulation. All of these methods offer a COMPRESSION impa.indd 57 57 certain benefit, ensuring reductions in the risk of DVT from 20 to 70%, but with little effect on the levels of proximal DVT. Some studies suggest that PPC may be moderately effective in diminishing overall DVT. Nevertheless, since the available data on the use of PPC are limited and the figures for proximal DVT incidence seem to be higher compared with those found with current prophylaxis using anticoagulants, this method cannot be recommended for primary prophylaxis. Elective TKA surgery From the aspect of onset of VTE, knee arthroplasty differs from THA in various important ways. Without prophylaxis, the overall incidence of DVT is greater with TKA compared with THA. Prophylactic measures employed successfully in THA have significantly lower efficacy in TKA patients. The results of some studies indicate that IPC is effective prophylaxis in TKA patients. This technique is most effective if it is applied during the operation or immediately afterwards and if the pneumatic boots are worn continually at least until the patient has resumed full ambulation. Use of IPC is limited by poor patient compliance and patient intolerance, significant costs and the impossibility of continuing the prophylaxis following discharge from hospital. IPC can be useful as a complementary hospital treatment in addition to prophylaxis regimes based on anticoagulants and ATS. For patients with other risk factors for postoperative VTE, obligatory combined prophylaxis should be considered: IPC and LMWH and use of ATS on suspension of the IPC. Surgery for hip fracture The incidence of extensive or proximal DVT after a hip fracture (HFS) is 50% and 27% respectively without prophylaxis, based on prospective studies in which phlebography was performed routinely. These figures are similar to those obtained in patients having hip and knee arthroplasty. Fatal PE is more common in patients with a hip fracture than after elective arthroplasty and ranges from 1.4 to 7.5% within three months of the event. In an autopsy study of 581 patients who died after a hip fracture from 1953 to 1992, PE was the fourth cause of death in order of frequency, representing 14% of all deaths. The factors that further increase the incidence of VTE in patients with a hip fracture include age, trauma, delays in admission to hospital or in performing surgery and the use of general anaesthesia (compared with regional procedures). The site of the fracture (subcapital or intertrochanteric) does not appear to be important. The risk of death following a hip fracture is reduced significantly in patients who are given pharmacological prophylaxis. These data bear out the recommendation that routine 20-05-2009 14:33:40 58 COMPRESSION VTE prophylaxis should be guaranteed in all patients in whom surgery for hip fracture is performed. In a clinical study, the incidence of VTE was significantly reduced in a group that had postoperative PC compared with placebo. Moreover, studies comparing PC with other prophylaxis regimes have not been conducted. The evidence we have is insufficient to allow recommendation of the use of ATS or IPC in hip fracture, even if these methods have been shown to reduce the incidence of DVT. Elective surgery of the spine The incidence of thromboembolic complications after elective surgery of the spine is not known. The majority of available studies are retrospective, of limited size and defective methodologically. Symptomatic VTE and fatal PE are sometimes observed in these patients despite the use of aggressive mobilisation and prophylaxis with IPC and/or ATS. Duplex ultrasound identified DVT in 3% of 554 patients in 6 prospective studies all of which used mechanical prophylaxis routinely. It is not known whether or not mechanical prophylaxis has a protective effect on the incidence of DVT in this group of patients as none of the studies was controlled. In one clinical study, symptomatic thromboembolic events were not found in any of the 110 patients who had been randomised to receive prophylaxis with ATS only, ATS + IPC or ATS + warfarin. Since there are few data regarding thromboprophylaxis after surgery on the spine, specific recommendations cannot be made. However, it appears reasonable to use ATS alone, LDUH alone or both in combination in patients with further risk factors; intraoperative and postoperative IPC may also be effective. Certainly, in patients undergoing surgery of the spine with other thromboembolism risk factors, prophylaxis with at least one of the above methods is suggested. Neurosurgery Patients who undergoing elective neurosurgery have a high risk of postoperative DVT and PE. Randomised studies that include a broad range of neurosurgical patients showed that 22% of these patients had signs of DVT on the labelled fibrinogen test and 5% had a proximal DVT. The risk factors that appear to increase the incidence of DVT in neurosurgical patients include intracranial surgery (as compared with spinal), malignant disease (compared with benign), the duration of the operation and advanced age. Patients with brain tumours are at particularly high risk of VTE (31% in patients operated because of glioma), both during the operation and in the subsequent follow-up. Physical methods of prophylaxis are frequently recom- COMPRESSION impa.indd 58 mended in neurosurgery, both because intracranial or spinal haemorrhage can occur with the use of pharmacological prophylaxis and also because they have demonstrated marked preventive efficacy. IPC and ATS appear to be very effective in preventing DVT in these patients, with a mean reduction in risk of 68% compared with controls (incidence from 21 to 7% in randomised studies). One study conducted in 2,643 neurosurgical patients who had prophylaxis with ATS and IPC found DVT in 6% of cases. Turpie AGG et al. found a similar incidence of DVT in patients with ATS compared with those with combined AST and IPC (both methods were more effective than no prophylaxis). The two major studies on prophylaxis in neurosurgical patients compared use of ATS alone with combined ATS and LMWH started after the operation. Both studies employed phlebography routinely for screening, and both demonstrated a significant reduction in the risk with combined prophylaxis compared with ATS alone. In the study conducted by Nurmohamed MT et al. the incidence of DVT and proximal DVT in patients with ATS was 26% and 12%, whereas patients with ATS + LMWH demonstrated rates of 19% and 7% respectively. In a double-blind study conducted by Agnelli G et al. the incidence of DVT and proximal DVT was 33% and 13% for the group wearing ATS only compared with 17% and 5% in the group that received combined prophylaxis. In brief, IPC and ATS can be recommended for DVT prophylaxis in patients undergoing elective neurosurgery. Other possibilities that may be equally acceptable include postoperative LDUH and LMWH. The combination of LMWH and ATS is more effective than ATS alone, whereas the combination of LDUH with mechanical prophylaxis may also be more effective than either method on its own. Trauma Patients with polytrauma or major trauma have a risk of DVT that exceeds 50% in the absence of prophylaxis and fatal PE is found in about 0.4-2.0%. PE is the third most common cause of death in trauma patients who survive beyond the first day. Among the types of trauma, the greatest incidence of DVT has been observed in patients with fractures of the lower limbs (69%), of the spine (62%) and in those with severe head injuries (54%). A DVT incidence of 40% has also been documented in patients whose only major injury involved the face, the chest or the abdomen. Patients with non-orthopaedic trauma involving only one organ have a smaller risk of VTE compared with those with multiple injuries or fractures of the lower limbs. The specific risk factors that are associated independently with a greater incidence of thromboembolism include injuries of the spinal cord, 20-05-2009 14:33:40 Compression therapy and prophylaxis of venous thromboembolism pelvic or lower limb fractures, the need for surgery (in particular venous repair), advanced age, protracted immobility and prolonged hospitalisation. Although the risk of DVT increases with age, a major DVT and fatal PE can also occur in young trauma patients. Therefore, employment of prophylaxis should not be omitted in young patients. The mechanical methods of prophylaxis are used in trauma patients because these patients nearly always have a high risk of haemorrhage. We are not aware of any studies that have assessed ATS in the prophylaxis of patients with trauma. A recent study in 149 patients with trauma but without fracture of the lower limbs found a DVT in 6.5% of the group treated with IPC and in 21.0% of cases in another group treated with PPC (p=0.009). Various studies have shown that IPC provides protection equal to or less than that of LDUH. The major problems that often prevent the use of IPC are represented by the impossibility of applying it in about one third of patients with trauma (due to fractures of the lower limbs, plaster casts or dressings), poor compliance regarding the appropriate use of the devices by the patients and nursing staff and by the relatively high cost. Even if ATS and IPC cannot be recommended as routine prophylaxis in trauma (the former because of the lack of studies in this regard), these methods can be of benefit in patients with intracranial haemorrhage and probably also as initial prophylaxis in patients who are at high risk of haemorrhage at that time, until anticoagulants can be given at a later stage. In patients with contraindications to prophylaxis with LMWH, ATS and IPC should be taken into consideration. In these cases, in our view, given the ease of application and low cost, ATS are preferable, though they have not been studied in these patients, since they guarantee a significant action on the venous stasis induced by immobility and other risk factors, thus eliminating one of the causes of DVT and PE. After an initial period of mechanical prophylaxis, during which primary haemostasis is established, a regime including LMWH can usually be employed in these patients. Although the optimal duration of the prophylaxis is not known in the specific case, it should usually be continued until discharge from hospital. If hospitalisation (including rehabilitation) lasts beyond 2 weeks and there is an acute risk of thromboembolism, the need for continuing the prophylaxis in hospital with oral anticoagulants should be considered, on condition that there is no longer a major risk of haemorrhage and further surgical procedures are not planned. As regards acute spinal injury, although no controlled studies of DVT prophylaxis following severe acute spinal injury have been published, the very high risk of DVT and PE, together with the results of recently available studies, supports the aggressive use of early prophylaxis in COMPRESSION impa.indd 59 59 all patients with acute spinal injury. The use of LMWH is promising but further studies are needed. LDUH, IPC and ATS do not ensure suitable protection if used on their own. LMWH or a combination of LMWH or LDUH with IPC or ATS appears to be the best option available in the majority of cases. Burns Burn patients have a significant risk of VTE because of the presence of a systemic state of hypercoagulation and because of the fact that they have to remain confined to bed for a prolonged period and often undergoing repeated surgery, and also because of the frequent occurrence of sepsis, frequent use of central venous catheters and associated risk factors (age etc.). A certain number of autopsy studies has demonstrated that burn patients commonly have DVT and PE at the time of death, even if fatal PE has been described in only 0.1-0.5% of cases. Symptomatic VTE has been reported in only 0.4%-0.9% of burn patients in large case study reviews, but in some prospective studies the rates of DVT were between 12 and 53%. As far as we know, there are no studies on thromboprophylaxis in these patients and at the moment there are insufficient data to justify the routine use of thromboprophylaxis in burn patients. Nevertheless, it is reasonable to employ prophylaxis in patients with other risk factors such as concomitant trauma of the lower limbs, advanced age, obesity, prolonged confinement to bed and concomitant surgical procedures. Prophylaxis should therefore be employed using the same criteria that apply to high and very high risk patients and systematic use of ATS, when allowed by the location of the burns, seems to be the most rational solution together with pharmacological therapy in patients who do not have a haemorrhagic risk. Pregnancy and puerperium Pregnancy has a significant impact on Virchow’s triad, especially on the coagulation factors and venous stasis, as explained in the section devoted to that subject. Pregnant women have a risk of VTE about ten times greater than that of non-pregnant women of the same age, with the risk increased 2.5 times in pregnancy and 20 times in the puerperium. The incidence of DVT seems to be 0.13-0.5 per thousand in the ante-partum period and 0.61-1.5 per thousand in the post-partum period. In 1996, Macklon NS and Greer IA reported an incidence of DVT in pregnancy of 0.615 per thousand women aged less than 35 years and 1.216 in those aged over 35 years. A three-year report (1991-1993) on maternal mortality in Great Britain recorded 30 deaths due to PE divided equally between pregnancy and the post-partum period, with a homogeneous distribution during the trimesters of gestation. The 20-05-2009 14:33:40 60 COMPRESSION Table XIII – Mode of delivery and risk of VTE. Modified from: SISET Guidelines in Obstetrics and Gynaecology, Haematologica 2002 Mode of delivery VTE events/pregnancies Risk per thousand pregnancies 125 / 556.040 0,22 Elective caesarean delivery 23 / 33.779 0,68 Emergency caesarean delivery 47 / 55.839 0,84 All caesarean deliveries 70 / 89.618 0,78 Vaginal delivery greatest incidence of fatal events is found in the first two weeks after delivery but 40% occur between day 15 and day 42 of the puerperium, following discharge from hospital. The risk therefore increases in the post-partum period and even more after caesarean delivery: more than ¾ of deaths post-partum due to VTE occur after caesarean delivery. Operative delivery represents an important risk factor for developing VTE post-partum; overall, the risk associated with caesarean section is about 3 times greater than that associated with spontaneous delivery, even if the absolute risk is low (Table XIII). About 90% of DVT in pregnancy involves the left lower limb, compared with 55% in non-pregnant women and this seems to be explicable by the course of the ovarian arteries, which cross the internal iliac vein on the left, especially as the majority of DVT is iliaco-femoral rather than femoro-popliteal (72% vs. 9%). It is also known that in pregnancy there is an increase in coagulation factors (von Willebrand factor, factor VIII, factor V and fibrinogen), a reduction in protein S, acquired resistance to activated protein C and an increase in PAI-1 and PAI-2 produced by the placenta. Venous stasis is already apparent at the end of the first trimester and reaches its maximum levels in the 36th week. The risk of recurrent VTE during pregnancy in women with a previous history of DVT is between 4 and 15%. The Royal College of Obstetricians and Gynaecologists has defined the following risk catemedical-lsries in women undermedical-lsing caesarean section and they can also be utilised from the general aspect: –– Low risk: •• age<35 years; •• negative family and personal history; •• elective caesarean section in an uncomplicated pregnancy in the absence of risk factors. –– Moderate risk: severe varicose veins •• age>35 years; •• obesity (>80 kg); •• parity ≥4; •• immobility pre-operatively (>4 days); •• concomitant disease or infection; •• pre-eclampsia; •• emergency caesarean delivery. COMPRESSION impa.indd 60 –– High risk: •• presence of 3 or more moderate risk factors; •• major abdominal or pelvic surgery (e.g. caesarean section+hysterectomy); •• positive family history of DVT, PE or thrombophilia; •• confirmed thrombophilia; •• absolute immobility (e.g. paralysis of the lower limbs). The most frequent additional risk factors are obesity, cigarette smoking, age >35 years, thrombophilic states, threatened abortion with associated bed rest, caesarean delivery (hypotension induced by spinal or epidural anaesthesia) and venous insufficiency of the lower limbs. The recommendations for prophylaxis depending on risk are summarised in table XIV and have already been specified in the relevant section: prophylaxis with ATS should be carried out in all parturient women, started immediately pre-partum and continued throughout the puerperium. In the case of venous insufficiency of the lower limbs, the recommendations described in the section on the therapeutic elastic stocking apply. In view of current knowledge, primary prophylaxis should be in accordance with the following scheme: –– in women at low to moderate risk, it is useful to adopt non-pharmacological measures (early mobilisation, ATS); –– in women at high risk, pharmacological prophylaxis is necessary (LDUH 5000-7500 IU s.c. every 12 hours or LMWH), combined in every case with use of ATS; –– in women who are carriers of congenital thrombophilic states, prophylaxis with heparin throughout the pregnancy and certainly in the puerperium is useful, and should be combined with elastic compression and correction of any additional risk factors (smoking, obesity etc.); –– in women with (previous or intermittent) antiphospholipid antibody syndrome and a negative history of abortion or thrombosis, no treatment is recommended or else low-dose ASA (50-100 mg.), while in cases of previous thrombosis (whether or not in pregnancy), administration of LDUH or LMWH is recommended throughout the pregnancy and up to 4-6 weeks after 20-05-2009 14:33:40 Compression therapy and prophylaxis of venous thromboembolism 61 Table XIV – VTE prophylaxis in pregnancy and the puerperium. Clinical condition Recommendation Prolonged confinement to bed ATS for the entire period of confinement to bed Caesarean delivery ATS or LDUH or LMWH peri- and post-partum, early mobilisation Presence of additional risk factors (CVI) ATS + MCS 2nd class during and after pregnancy + LDUH or LMWH periand post-partum, early mobilisation Thrombophilic states LDUH or LMWH or OAT or ASA + ATS from the start of the pregnancy Abbreviations: ATS antithromboembolism stocking; MCS medical compression stocking; LDUH low-dose unfractionated heparin; LMWH low molecular weight heparin; OAT oral anticoagulant therapy; ASA acetylsalicylic acid. delivery (oral anticoagulant can also be used in this period) together with elastic compression therapy. General medicine Aspects of VTE prophylaxis in patients admitted to general medical departments have been studied less deeply compared with surgical patients despite the fact that 50-70% of symptomatic VTE events and 70-80% of fatal PE are found in the course of internal medical diseases. Autopsy studies have shown that among patients who died in hospital of pulmonary embolism 75% consisted of patients confined to bed because of disease of a medical nature (Sandler DA et al. 1989). These categories include myocardial infarction, stroke, serious infections, heart failure, respiratory insufficiency, cancer patients and those confined to bed for long periods. The most frequent risk factors (Table XV) are advanced age, previous episodes of VTE, heart failure (NYHA grade III-IV), exacerbation of chronic obstructive pulmonary disease (COPD), sepsis, malignancy and stroke. According to the “Medenox” study (1999) the incidence of VTE in medical patients considered to be high risk and not given prophylaxis is about 14.9%, much lower than in high-risk surgery. Even if clinical case series are generally limited in number, we currently have sufficient data for making recommendations on prophylaxis for many groups of non-surgical patients, as can be inferred from the ACCP guidelines 2001-2004, SIAPAV-SISET-SIDV-GIUV 2000, CIF 2001-2003-2004, SISET 2004. The only medical area for VTE prophylaxis where the effect of compression was assessed in acute myocardial infarction (Kierkgaard A et al. 1993) and a significant advantage of treatment compared with controls was observed. In the absence of studies of the efficacy of mechanical prophylaxis (IPC, ATS) in general medical patients, however, there are no reasons to believe that these methods are less effective than in surgical patients. Myocardial infarction The overall incidence of DVT is about 24% in patients with myocardial infarction (MI) not given antithrombotic treatment. Various randomised studies have demonstrated that full anticoagulation with heparin and oral anticoagulation after acute MI leads to a reduction in the incidence of DVT and PE diagnosed clinically compared with absence of prophylaxis or low-dose anticoagulants. In a study conducted by Kierkegaard A and Norgren L about 80 patients with acute MI (IMA) wore an ATS on one leg while the other leg acted as control. Eight control limbs had DVT demonstrated with the labelled fibrinogen test compared with no abnormality for the legs wearing the ATS (p=0.003). Based on the available data, LDUH and full anticoagulation reduce the incidence of VTE in patients with acute MI. The mechanical prophylaxis methods (ATS, IPC) are probably also useful in patients with IMA when antithrombotic agents are contraindicated. Nevertheless, current aggressive therapy of IMA with thrombolytic agents, unfractionated heparin, LMWH, anti-platelet agents or a combination of these drugs has rendered prevention of DVT a secondary aim. Ischaemic and haemorrhagic stroke Patients with stroke have a high risk of DVT in the paretic or paralysed lower limb with a cumulative DVT incidence of 55%. About 5% of early deaths following Table XV – Risk of VTE in medical patients SIAPAV-SISET-SIDV-GIUV 2000 guidelines, THRiFT II-Consensus Group 1998, IUA 1997. Grade of risk Low Minor medical disease Moderate Major medical disease: cardiac or pulmonary disease, heart failure, malignancy, inflammatory bowel disease. Minor medical disease combined with thrombophilia or history of VTE. Immobilised patient. High Major medical disease with thrombophilia or history of VTE. Paresis of the lower limbs (paraplegia, hemiplegic stroke). Stroke. Age >70. COMPRESSION impa.indd 61 20-05-2009 14:33:40 62 COMPRESSION stroke can be attributed to PE. In a prospective, nonrandomised study of 681 patients with ischaemic stroke, combined prophylaxis with LDUH + ATS + IPC demonstrated less symptomatic DVT and PE compared with the combination of LDUH + ATS. We are not aware of any studies of thromboprophylaxis in patients with haemorrhagic stroke. However, use of ATS or IPC is recommended for these patients. Cancer patients VTE is one of the most common complications encountered in patients affected by cancer and this may be due to the state of hypercoagulability that characterises malignant disease and/or the related treatment, which involves surgery, chemotherapy, radiotherapy and the insertion of central venous catheters. In cancer patients, prevention of VTE is a greater priority compared with patients who do not have a tumour as the diagnosis of DVT and PE is often more difficult, the treatment has lower chances of success and is associated with greater haemorrhagic complications. Cancer patients undergoing surgery have an almost doubled risk of postoperative DVT and more than three times the risk of fatal PE compared with non-cancer patients undergoing similar operations. Chemotherapy itself is closely linked with thromboembolic complications. The risk of thromboembolism in women with stage II breast cancer given chemotherapy is 7-11% and it drops drastically at the end of the treatment cycle. The anti-oestrogen tamoxifen increase the thrombotic risk of chemotherapy two- to sixfold in patients with breast cancer. In a randomised study of tamoxifen as adjuvant in stage I breast cancer, the risk of thromboembolism was six times greater in the group treated with tamoxifen compared with patients who took placebo. Tamoxifen used to prevent breast cancer is associated with an increase in the figures for DVT (relative risk = 1.6) and PE (relative risk = 3.0). Other forms of malignancy at the advanced stage which are associated with an elevated risk of thromboembolism include brain tumours and adenocarcinoma (colorectal, pancreatic, pulmonary, renal and ovarian). In brief, cancer patients who undergoing major surgery are at high risk of VTE and should receive aggressive prophylaxis as was recommended in table XI and in the sections on general surgery, gynaecology and urology. Patients in intensive therapy The majority of patients in intensive therapy have one or more risk factors for VTE. Even though there is a paucity of data on thromboembolism specific for this situation, the data presented above for the groups that constitute the majority of patients (in particular COMPRESSION impa.indd 62 general surgery, trauma and medical patients) are high relevant. In a study using the labelled fibrinogen test, DVT was found in 29% of 59 patients who did not receive any form of prophylaxis. In a recent double-blind study, duplex ultrasound was used every 72 hours up to discharge from the intensive care unit and found DVT in 21% of 390 control patients. In another prospective study, phlebography identified DVT in 28% of 85 patients. All patients should be assessed for the risk of thromboembolism and prophylaxis should be employed in the majority. In these patients it is important to make individual decisions regarding the start of the prophylaxis and the methods employed, based on each patient’s particular clinical condition. In general, in patients with a high risk of haemorrhage, mechanical prophylaxis with ATS, possibly combined with IPC, appears reasonable as a first choice until the risk of haemorrhage is reduced. For the others, the prophylaxis schemes described above are recommended for medical and surgical patients according to risk stratification. Management of compression therapy in the prophylaxis of VTE in surgery From an analysis of the most recent literature, there is sufficient evidence for recommending routine use of VTE prophylaxis by means of compression therapy for many groups of patients with diseases susceptible to surgical treatment. Risk stratification based on the type of surgery suggest use of compression therapy on its own in patients at low risk while in other classes at higher risk, its use is recommended in combination with current pharmacological protocols (Table XVI). In low-risk patients, the duration of the prophylaxis should cover at least the period of hospitalisation, in patients at high risk it should cover a period of 7 to 10 days and in patients at very high risk, a period of up to 30 days should be planned, depending on the disease. Conclusions VTE is an important problem on the social and healthcare level, which results in mortality, morbidity and a significant expenditure of resources. We believe that there is sufficient evidence for recommending the routine use of thromboprophylaxis with mechanical means (IPC and ATS) for many groups of patients. These groups include patients undergoing major procedures in general surgery, gynaecology and urology, arthroplasty of the lower limbs and hip fracture surgery, neurosurgery, patients admitted with major trauma or acute spinal cord injury and 20-05-2009 14:33:40 Compression therapy and prophylaxis of venous thromboembolism 63 Table XVI – Management of compression therapy in the prevention of VTE in surgery. Modified from: Kaboli PJ, Brenner A, Dunn AS. Prevention of venous thromboembolism in medical and surgical patients. Cleveland Clinic Journal of Medicine 2005; 72(S1):7-13. Surgery Risk Compression therapy Pharmacological therapy General surgery Low risk Medium risk High risk Very high risk Gynaecological surgery Low risk Medium risk High risk Urological surgery Low risk Medium risk High risk Orthopaedic surgery Pelvic fracture Hip arthroplasty Knee arthroplasty Neurosurgery Indicated + early mobilisation Indicated in combination with pharmacological therapy Indicated in combination with pharmacological therapy Indicated in combination with pharmacological therapy LDUH o LMWH LDUH o LMWH LDUH o LMWH Indicated + early mobilisation Indicated in combination with pharmacological therapy Indicated in combination with pharmacological therapy LDUH o LMWH LDUH o LMWH Indicated + early mobilisation Indicated in combination with pharmacological therapy Indicated in combination with pharmacological therapy LDUH o LMWH LDUH o LMWH Indicated in combination with pharmacological therapy Indicated in combination with pharmacological therapy LDUH o LMWH + OAT LDUH o LMW H+ OAT Indicated in combination with pharmacological therapy LDUH o LMWH + OAT Indicated in combination with pharmacological therapy LDUH o LMWH+ OAT Indicated in combination with pharmacological therapy LMWH Trauma Abbreviations: LDUH unfractionated heparin; LMWH low molecular weight heparin; OAT oral anticoagulant therapy. medical patients with risk factors for thromboembolism. Implementing suitably planned and evidence-based strategies for prophylaxis ensures benefit for the patients and will also support medical and nursing staff and the hospitals in their responsibilities before the law. The use of suitable protocols should be promoted in every clinical institution: the first essential act is to identify patients at greater risk of thromboembolic complications. Implementation of prophylaxis in a routine manner for all patients belonging to each target group should consistently follow risk stratification. A prospective study in 1994 documented an almost two-fold growth (from 29% to 52%) in prevention carried out in hospitalised patients at risk due to the use of educational strategies intended to increase awareness of the problem of VTE. The use of prophylaxis was significantly greater in hospitals where physicians took part in refresher courses on the subject, and where specific data were available for each hospital which demonstrated the potential benefits of the strategies employed. Use of mechanical methods in the prevention of VTE now finds a precise rationale because of the demonstrated efficacy and the ease of application combined with the low cost (especially as regards antithromboem- COMPRESSION impa.indd 63 bolism stockings) and should be promoted more and more through deepened knowledge of compression therapy, not only in phlebolymphology but also in all the medical disciplines involved in the prevention and treatment of VTE. The overall recommendation grade in evidence based medicine is 1A according to the scoring criteria of the International Grade Group (Guyatt G et al. Grading strength of recommendations and quality of evidence in clinical guidelines. Report from an American College of Chest Physicians Task Force. CHEST 2006). On the other hand, new studies on large numbers of patients should be conducted to provide a more accurate assessment of the efficacy of compression in patients at risk in specialties where it has been little assessed, such as urology, gynaecology, obstetrics and general medicine. Moreover, the optimal level of compression applicable at rest to obtain the greatest venous flow rate, that is, the primary efficacy end-point of mechanical therapy in the prophylaxis of VTE, should also be better defined. In addition, the role of compression methods in classes at greater risk, in combination with classical medical treatments such as oral anticoagulants and LMWH, should also be better defined. 20-05-2009 14:33:41 64 COMPRESSION Recommendations –– Patients should be stratified to identify the preoperative thromboembolic risk. –– Before the operation, the healthcare staff (doctors, nurses, etc.) should inform the patient, both verbally and in writing, of the risks of VTE and the efficacy of prophylaxis; of the symptoms and signs of DVT and PE, of the correct use of prophylaxis at home and of the implications of not carrying it out correctly. –– On admission, surgical patients at risk should be provided with ATS, which they should wear in the perioperative period and throughout the period of confinement to bed and according to the indications, and they should wear therapeutic stockings until complete resumption of ambulation (excluding patients with critical ischaemia or diabetic neuropathy of the lower limbs). –– Patients wearing ATS should be observed to ensure correct use and their use should be monitored by specialist staff after adequate training to avoid the consequences of incorrect use (lacing effect, removal of the ATS at night, etc.). –– Intermittent pneumatic and pneumatic plantar compression are devices that can be used as an alternative or in addition to the ATS until the patient is discharged. –– In the postoperative period, the healthcare staff should encourage the patient towards early mobilisation and patients confined to bed with disability should be provided with adequate physical rehabilitation of the lower limbs. –– Regional anaesthesia reduces the risk of VTE compared with general anaesthesia. In the case of regional anaesthesia, the start of the pharmacological prophylaxis should be well calculated in order to reduce the risk of haematoma to a minimum. –– Ensure that the patient does not become dehydrated in the postoperative period; the patient’s fluid balance is therefore important in order to reduce the risk of thromboembolism. –– Patients should be informed that prolonged immobilisation for more than 3 hours in the case of travel in the four weeks preceding or following the surgery can increase the risk of VTE. –– The healthcare staff should advise preventive suspension of the oral contraceptive pill four weeks before an elective surgical procedure. –– A caval filter should be utilised limitedly in surgical patients with a recent episode of VTE (less than one COMPRESSION impa.indd 64 –– –– –– –– –– –– –– –– –– –– –– –– month) in whom anticoagulant therapy is contraindicated. It is recommended that every hospital should draw up a formal strategy with the object of risk stratification of patients and prevention of thromboembolic complications. This strategy should be presented as a written programme for risk stratification and thrombosis prophylaxis; the clinical file should contain the instructions needed for risk stratification and any prophylaxis to be carried out. In patients at high haemorrhagic risk use of mechanical prophylaxis with ATS or IPC is always recommended. The use of ATS or IPC significantly reduces the incidence of VTE after low and medium risk surgery. The combination of ATS and heparin is more effective than ATS alone in patients at medium and high risk. In general medical patients, in the absence of studies of the efficacy of mechanical prophylaxis, there are no reasons why such methods should be less effective than in surgical patients. Use of prophylaxis with ATS and IPC is recommended in all patients confined to bed for more than 3 days. The efficacy of the ATS depends closely on the prescribed quality and size based on the circumference of the patient’s limb. Significant differences in efficacy have not been found between different versions of ATS, so that except in particular cases it is sufficient to use a below-knee model. The ATS should be worn by patients at risk in the peri- and postoperative period throughout the 24 hours and for at least four weeks or longer in the case of postoperative complications that prolong the recovery period, during prolonged confinement to bed and always according to the doctor’s prescription and instructions. The ATS is sterilisable (about 40 times) and can be reused for more hospitalised patients. The ATS exerts sufficient compression for VTE prophylaxis only in the patient who is confined to bed and therefore should be combined with a suitable MCS during patient mobilisation. It is recommended that mechanical prophylaxis (ATS or IPC) be utilised appropriately under the supervision of medical and paramedical staff ensuring that the patient uses it correctly. Bandaging is indicated in the prophylaxis of VTE only if carried out by highly skilled staff. 20-05-2009 14:33:41 65 Contraindications to compression therapy The absolute contraindications to compression can be summarised as follows: –– Obstructive arterial disease with a Winsor pressure index equal to or less than 0.55 (however, it is advisable to assess this after a stress test); –– Major neuropathy, since the absence or great reduction in skin sensation increases the risk of damage produced by the pressure exerted by the bandage; –– Extrinsic compression on veins (Baker’s cyst in the popliteal fossa, lymphadenopathy ...); COMPRESSION impa.indd 65 –– Decompensated heart failure (depletion of the peripheral venous pool towards the heart); –– Rheumatic fibromyalgia (marked intolerance of any pressure on the skin surface). The most frequently observed relative contraindications, apart from osteoarticular disorders, are represented by acrocyanotic syndromes and Raynaud’s phenomenon since intolerance of elastic stockings, even light ones, is often observed in these cases. 20-05-2009 14:33:41 66 General recommendations on compression therapy Bandages –– The non-elastic or short-stretch bandage has a more effective action on the superficial and deep venous system compared with medium- and long-stretch; the resting pressures are not low, as was believed, but the difference between the resting and working pressures is high. –– The pressure exerted by the bandage also depends on the structural characteristics of the bandage: every bandage has a specific hysteresis curve, which identifies the compressive power at the respective lengthening and compressed circumference; the maximum extensibility (short, medium and long stretch) is not a reliable index for identifying the compression ability of the bandages but only indicates a general difference between the working and resting pressures: lower stretch = greater difference in pressures. –– The difference between the working and resting pressures measured in vivo is an index of activity: high working pressures produce a greater effect deep down. –– Based on the considerations presented here, research and study of the indices of compression activity of the different bandages is advised in order to define better indications for their use. –– The bandage is indicated, in its various versions, in the treatment of phlebolymphological disorders in the acute phase, in the reduction of persistent oedema and in the complications. –– The bandage must be used with the greatest care in the event of arteriopathy, after accurately quantifying the peripheral arterial perfusion at rest and during exercise. –– The bandage should always be applied by skilled staff: the institution of training courses in bandaging is recommended for all involved healthcare professionals, with measurement in vivo of the pressures exerted. Medical compression stockings –– The therapeutic or medical compression stocking MCS is a stocking made with materials and methods according to standards defined by the legislation in force (currently the German RAL-GZ 387, the French NFG 30-102B IFTH and English BS7505), which COMPRESSION impa.indd 66 –– –– –– –– –– –– –– guarantees defined and graduated pressure along the limb within certain parameters, laid down according to the compression class, available in various models and sizes. The compression and compliance with the construction methods must be constantly certified by independent national institutes. Only the MCS has demonstrated certain efficacy in the prevention and treatment of phlebolymphological conditions in clinical trials and in the scientific literature: it is to all intents and purposes a medical device (Universal Medical Device Nomenclature System; medical stockings are identified with number 13-789). Elastic stockings that do not comply with the standards in whole or only in part but which can guarantee a pressure in mmHg at the ankle and/or in other parts of the lower limb, maintaining a certain graduation in pressure from below upwards are defined as elastic support stockings. All other types of stockings made with elastic fibres, which do not state the pressures in mmHg (for example stating denier or den) or which do not guarantee defined and graduated pressures should be defined simply as elastic stockings. The antithromboembolism stocking is a therapeutic elastic stocking made with partly different methods to make it tolerable at rest, which guarantees a pressure of 18 mmHg at the ankle (tolerance limits ± 3 mmHg), and the pressor profile along the lower limb should be graduated: 80-100% of the pressure at the ankle (B) at B1, between 60-80% at C and between 40-70% at F or G (CEN 1998, draft prEN 12719). The efficacy of the therapeutic or elastic stocking depends closely on the quality and the size prescribed on the basis of the circumference of the patient’s limb. It is recommended that doctors and healthcare staff prescribe the therapeutic elastic stocking accurately and instruct the patient in detail on its use. Compliance with treatment with a therapeutic elastic stocking is improved by correct prescription and accurate instruction of the patient. Compliance with the medical prescription by the authorised retailer is obligatory (binding codes for pharmacists and orthopaedic technicians), as for other medical and pharmacological devices. 20-05-2009 14:33:41 General recommendations on compression therapy 67 Tab. XVII – General indications for compression therapy. Summary Indications Bandage CEAP C0-C1 MCS Support stocking 1 Class • • C2 st 2 Class nd 3 Class rd • • • • • 4th Class ATS C3 elastic C4 short stretch eccentric compr. • • • at rest in combination with MCS C5 short stretch multilayer • • • in PTS at rest in combination with MCS C6 short stretch multilayer • • • in combination with MCS Surgery of VCI elastic/short stretch eccentric compr. Sclerotherapy of telangiectasias Sclerotherapy of varicose veins • elastic/short stretch eccentric compr. • in combination with MCS • • • • • • • Acute DVT short stretch • • PTS short stretch • • Pregnancy, delivery • Pregnancy, delivery with VCI • • VTE prophylaxis short stretch • Lymphoedema short stretch multilayer • Angiodysplasia VCI+PAD short stretch • • at rest in combination with MCS • • • • • • in combination with MCS (if it is necessary) • • • • • • • • Abbreviations: MCS medical compression stocking; ATS antithromboembolism stocking; VCI venous chronic insufficiency; DVT deep venous thrombosis; PTS post-thrombotic syndrome; VTE venous thromboembolism; PAD arteriopathy –– It is also recommended that the manufacturers establish a certified quality route from production to sale to the patient, by setting up professional qualification stages for intermediaries (advertising and sales staff) and authorised retailers (pharmacists, orthopaedic technicians etc.), with periodic confirmation of the COMPRESSION impa.indd 67 level of company quality, as happens in other European countries. –– The therapeutic elastic stocking is indicated in the control of symptoms due to venolymphatic insufficiency, for support of active treatments, in the maintenance of the results obtained and in prevention, and there- 20-05-2009 14:33:41 68 COMPRESSION fore not in the acute phases except for particular types of venous ulcers. –– The therapeutic action and duration of compression also depend on the materials used in manufacture; it is recommended that the manufacturers should provide more instructions on the activity of their products in the different diseases by providing a definition of the physical characteristics of the various materials and not only of the compression classes. –– It is recommended that appointed Italian institutions (UNI, Ministry of Health etc.) make medical-lsod the lack of an Italian standard on therapeutic elastic stockings, in order to make Italy equal to other European countries (Austria, France, Germany, Great Britain), in the interest of the patient’s health, by defining and inspecting production quality. –– It is recommended that physicians, while awaiting the necessary standard, should prescribe only MCS and, when indicated, support stockings, confirming the presence of specified quality marks, in order to safeguard the patient’s health and the dignity of the medical prescription. COMPRESSION impa.indd 68 Intermittent pneumatic compression –– It is recommended that mechanical compression always be carried out after an accurate diagnosis and under medical control because of the potential danger in the case of heart failure or current or previous venous or arterial thrombosis. –– Use of sequential devices is recommended whenever the squeezing of fluids is in the distal-proximal direction without producing reflux since the chambers are inflated sequentially one after the other, remaining inflated until all are deflated simultaneously. –– The cycle times must be rapid (about 30 sec) to allow a greater number of cycles in the same period of time (about 60 in 30 minutes with 20 effective minutes of treatment). –– However, it is recommended that pressures of 40-60 mmHg should not be exceeded (except in particular situations) in order to avoid damage to the lymphatic system and to alternate the sessions with bandage application when significant oedema has to be reduced, then switching to an elastic support of a suitable compression class in the maintenance phase. 20-05-2009 14:33:41 69 References Abu-Own A., Shami S.K., Chittenden S.J., et al. 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COMPRESSION impa.indd 82 20-05-2009 14:33:43 PRINTED BY EDIZIONI MINERVA MEDICA JUNE 2009 SALUZZO (ITALY) CORSO IV NOVEMBRE, 29-31 COMPRESSION impa.indd 83 20-05-2009 14:33:43 COMPRESSION impa.indd 84 20-05-2009 14:33:43