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Venous Times - Dendrite Clinical Systems.
Venous Times
Nanofibre borate
glass – the next
treatment for
venous stasis
wounds
Reporting the latest news regarding venous diseases, conditions and treatments
Issue 9
Page 12
June 2011
In this issue…
USGF sclerotherapy
and SF ligation
Evi Kalodiki
presents the
five year
results from a
randomised
controlled trial
comparing
USGF
sclerotherapy
combined with SF ligation to
surgical treatment for varicose
veins.
4
CCSVI and MS debate
continues
The controversy rages on as to
whether CCSVI is a cause or a
results of MS.
6
Cost cutting varicose
vein warning
Olle Nelzén
warns that
varicose vein
cost-cutting
measures
could lead to
a reduction in
a patient’s
QoL and
ultimately, become a larger
burden on resources.
8
EVISTA-DVT
Mohsen Sharifi presents data
showing that stenting is safe
and more effective than
balloon venoplasty alone for
patients with DVT in the
femoropopliteal vein.
10
CVD seriously impacts
QoL
Armando
Mansilha
reports on the
results from a
that CVD has
a serious
effect on
patients’ lives
and that the disease affects
women’s quality of life more
severely than men.
12
Laser-assisted IVC
filter retrieval
According to the preliminary
results from a study, the
techniques developed for
cardiac device lead extraction
also works when retrieving IVC
filters.
16
Thrombolytic agents
no more effective than
traditional therapy
According to the results from
the RIETE
registry,
thrombolytic
agents do not
appear to be
any more
effective than
traditional
blood thinners
for the treating PE.
22
Journal watch
10
News in brief
20
Continuing warfarin
during EVLT is safe
American Venous Forum
launches IVC filter Registry
Page 10
Page 14
New US guidelines for the
evaluation and treatment
of varicose veins
Nine recommendations focus on the evaluation and treatment
of varicose veins of the lower limbs and pelvis
A joint Venous Guideline Committee of the Society for
Vascular Surgery (SVS) and the American Venous Forum
(AVF) has recently published new guidelines for the
management of varicose veins and associated chronic venous
disease (CVD) in a supplement to the Journal of Vascular
Surgery (J Vasc Surg 2011;53(5 Suppl):2S-48S), Journal of
the Society for Vascular Surgery.
t is estimated 23% of the adult population in the US has varicose veins
and 6% has more advanced chronic
venous disease, including skin changes
and healed or active venous ulcers.
“Improved technology and new surgical
techniques, many of which can be done
in an office setting, have led to dramatic changes in the treatment of varicose
veins,” said Peter Gloviczki, Professor of
Surgery, Division of Vascular and
Endovascular Surgery, Mayo Clinic,
Rochester, who chaired the Venous
Guideline Committee and is the VicePresident of the SVS and past-President
of the AVF. “The new treatment options
can significantly improve patient outcomes. They can experience less discomfort, improved quality of life and
earlier return to work than was previously possible.”
I
Key recommendations
The guidelines entitled, “The care of
patients with varicose veins and associated chronic venous diseases: Clinical
practice guidelines of the Society for
Vascular Surgery and the American
Venous Forum”, feature nine key recommendations, on the management of
superficial and perforating vein incompetence in patients with associated,
more advanced chronic venous diseases
(CVDs), including edema, skin
changes, or venous ulcers. The strength
of each guideline varies based on the
benefits as compared to the risks, burdens and costs.
Recommendations of the Venous
Guideline Committee are based on the
Grading
of
Recommendations
Assessment,
Development,
and
Evaluation (GRADE) system as strong
(Grade 1) if the benefits clearly outweigh
the risks, burden, and costs. The suggestions are weak (Grade 2) if the benefits
are closely balanced with risks and burden. The level of available evidence to
support the evaluation or treatment can
be of high (A), medium (B), or low or
very low (C) quality. The authors assert
that “under no circumstance should
Peter Gloviczki
these guidelines be construed in practice
or legal terms as defining ’standards of
care’ which is solely determined by the
condition of the individual patient,
treatment setting and other factors.”
Treatment review highlights; metaanalysis points to the need for more
research. The guidelines were based on
evidence gained from prospective randomised studies, large case-series and
Continued on page 2
The key recommendations of these guidelines are:
n That in patients with vari-
nous vein (GSV), they reccose veins (Grade 2C) but
tence in patients with
cose veins or more severe
ommend endovenous thernot as the primary treatsimple varicose veins
CVD, a complete history
mal ablation (radiofrequenment if the patient is a
(CEAP class C2; Grade
and detailed physical
cy or laser) rather than
candidate for saphenous
1B), but suggest treatment
examination are complehigh ligation and inversion
vein ablation (Grade 1B).
of pathologic perforating
n Compression therapy
mented by duplex ultrastripping of the saphenous
veins (outward flow durashould be utilised as the
sound scanning of the
vein to the level of the
tion ≥500ms, vein diameprimary treatment to aid
deep and superficial veins
knee (Grade 1B).
ter ≥3.5mm) located
healing of venous ulcera- n Phlebectomy or sclerother(Grade 1A).
underneath healed or
n That the CEAP classificaapy is also recommended
tion (Grade 1B).
active ulcers (CEAP class
n To decrease the recurtion is used for patients
to treat varicose tributarC5-C6; Grade 2B).
rence of venous ulcers,
with CVD (Grade 1A) and
ies (Grade 1B) and suggest n When treating pelvic congestion syndrome and
they recommend ablation
that the revised Venous
foam sclerotherapy as an
pelvic varices, they recomof the incompetent superClinical Severity Score is
option for the treatment
mend the use of with coil
ficial veins in addition to
used to assess treatment
of the incompetent sapheembolization, plugs or
compression therapy
outcome (Grade 1B).
nous vein (Grade 2C).
n Compression therapy is
n They recommend against
transcatheter sclerothera(Grade 1A).
recommended for patients n For treatment of the
selective treatment of perpy, used alone or together
incompetent great saphewith symptomatic variforating vein incompe(Grade 2B).
EVF in Ljubljana 2011
The 12th Congress of the European Venous
Forum (EVF) has been organised in cooperation
with Slovenian Society of Vascular Disease and
Department of Vascular Disease, University
Clinical Centre Ljubljana, and takes place in the
very heart of Ljubljana, capital of Slovenia.
he major aim of this meeting is to bring together clinicians and scientists
working in the field of phlebology. It will provide an opportunity
to present new findings in the
field of vascular disease, to discuss controversies, to listen
and to learn, and finally to cre-
T
ate guidelines for management
of patients with venous disease.
EVF 2011 will be one of the
most outstanding vascular scientific meetings in Europe.
Beside selected oral presentations, the didactic sessions
with outstanding invited speak-
ers will provide an excellent
scientific programme dedicated to prevention and treatment
of deep venous thrombosis, to
management of thrombophlebitis and postthrombotic
syndrome. Further, the efficacy
and value of new drugs in
management of venous disease will be presented, and the
advantages in comparison to
standard drugs will be discussed.
Therefore, the organisers
believe that 12th EVF meeting
will serve as an opportunity for
presenting the best on-going in
both clinical and basic phlebology.
Professor Pavel Poredos
President of the EVF Meeting
EVF Invited lecturer,
Peter Neglén
June 2011
2
New US guidelines
Continued from page 1
a systematic review and meta-analysis of the treatments for varicose
veins, led by M Hassan Murad, et al,
from Mayo Clinic. These authors
summarised the best available evidence about the benefits and harms
of the different available treatments.
The review compared results of liquid and foam sclerotherapy, laser,
radiofrequency ablation and surgery
of varicose veins.
The reviewers concluded that the
available treatments for varicose
veins appear to be safe with rare side
effect, but they noted that the only
treatment with long-term effectiveness data is still open surgery. The
other less invasive treatments are
associated with shorter disability and
less pain, but only short and medium
term effective data exists.
In addition, the reviewers noted
that there is an “apparent need for
randomised trials of newer and less
invasive therapies, such as laser,
radiofrequency ablation and foam
therapy to compare their durability,
efficacy and safety to that of the standard procedure of ligation, stripping
and multiple phlebectomies.” They
also noted that additional studies
should stratify patients by the severity of their symptoms in order to
obtain the most useful results and
that they should focus on cost and
long term benefit.
UK recommendations
These recommendation come
months after the UK Venous Forum
published its own set of guidelines
for uncomplicated C1-C6 disease.
Those guidelines stated:
For patients presenting with C1C3 disease, the recommendations
are that most can be managed in primary care with reassurance, advice
on exercise, weight loss, elevation
and the use of compression hosiery.
Furthermore, patients whose primary concern is cosmetic should not
normally be offered treatment in the
NHS; such patients are well catered
for in the private sector.
However, patients with troublesome lower limb physical symptoms
that are impairing HRQL and are
likely to be due to CVI that have not
responded to conservative therapy in
primary care should be referred to a
vascular surgeon for clinical and
duplex ultrasound assessment and
offered intervention if deemed
appropriate by the surgeon and the
patient. In addition, the recommendations support the current NICE
referral guidelines that encourage
urgent referral for patients with
superficial thrombophlebitis, bleeding from varicosities and complicated (C4-6) disease. It is believed that
most patients would benefit from
and should receive treatment aimed
at the eradication of superficial
venous reflux.
In regards to C4-C6 disease the
recommendations state that the ability to reliably predict which patients
with uncomplicated (C1-C3) CVI
will go on to develop ulceration
‘remains elusive’. However, it is clear
that the development of skin changes
(C4 disease) is associated with a significantly increased risk of CVU.
These observations strongly suggest
that withholding treatment for
patients with C4 disease will increase
the future burden of CVU. Therefore,
the paper recommends that:
n All C4 patients and all patients
with history of suspected CVU (C5
patients) should be referred to a
vascular surgeon for a full clinical
and duplex ultrasound assessment
supported by other diagnostic tests
as deemed appropriate; and
n All patients with a break in the
skin below the knee that has failed
to heal within two weeks (potential C6) patients should be referred
urgently (within two weeks) to a
vascular surgeon. It is anticipated
that most patients so referred will
benefit from and should receive
treatment aimed at the eradication
of superficial venous reflux.
The recommendations also state
that guidance on the use of specific
techniques has been set out in
recent publications from the
National Institute for Clinical
Excellence and the Royal Society of
Medicine Venous Forum (Venous
Intervention Project). On-going
research will continue to refine the
clinical understanding of which
techniques are optimal for different
clinical indications.
AngioJet® Solent™ Family of Thrombectomy Catheters
PRODUCT ANNOUNCEMENT
edrad Interventional (Indianola, PA)
announces the most recent addition to the Solent Family of
thrombectomy catheters, designed for
large, difficult-to-remove thrombus for
peripheral vasculature. The Solent Omni
joins the family in a 120 cm length, offering
a longer reach as compared to the 90 cm
Solent Proxi. The Solent catheters are
enabled for Power-Pulse Delivery, allowing
them to be used to power-infuse lytic into
the thrombus. The family is part of the
growing portfolio of specialized thrombectomy devices available for use with the
AngioJet Ultra System. In response to
requests from interventionalists, the Solent
catheters offer the highest clot-removing
power in the AngioJet range and are the
first to allow swapping of guide-wires during
the procedure. A port with stop cock has
been added to the catheter’s hub to facilitate in situ contrast injection. The Solent
catheters are also constructed with flexible,
polymer-clad spiral shafts and hydrophilic
coating on the distal section to improve
handling compared to earlier designs.
Like all AngioJet thrombectomy
catheters, the Solent catheters are based
on the AngioJet Cross-stream® technology—utilizing high-speed saline jets contained inside the catheter tip to create a
powerful low-pressure zone that entrains
and removes clot.
M
For important safety information, please visit
http://tinyurl.com/3plrdbz
The Solent catheters utilize patented Cross-Stream® action to capture and remove thrombus from even large vessels.
Contrast injection port with stop cock provided in the Solent Proxi (left)
and Omni catheters.
Power Pulse Delivery enables infusion of medication directly into the
clot, saturating the thrombus. The action of Power Pulse Delivery helps
disrupt difficult thrombus and prepare it for rapid removal using the
Solent catheters.
The AngioJet Solent Proxi catheter (left) is 90 cm long and the AngioJet Solent
Omni is 120 cm long. Both are 6 French and track over a 0.035" guide wire.
Managing Director:
Peter K H Walton
[email protected]
Managing Editor:
Editorial Board
Editor-in-Chief:
Alun Davies
UK
Eberhard Rabe
Germany
Jean Jerome Guex
France
Armando Mansilha
Portugal
Niels Bækgaard
Denmark
Arkadiusz Jawien
Andre van Rij
Roberto Simkin
Bo Eklöf
Poland
New Zealand
Argentina
USA
Owen Haskins:
[email protected]
Editor:
Peter Myall:
[email protected]
Designer:
Peter Williams
[email protected]
Venous Times is published by
Dendrite Clinical Systems
Dendrite Clinical Systems
Head Office
The Hub, Station Road, Henley-onThames, RG9 1AY, UK
Tel: +44 (0) 1491 411 288
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Website: www.e-dendrite.com
2011 Copyright ©: Dendrite Clinical Systems Ltd and the Editorial Board. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, transmitted in any
form or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of the Managing Editor. The views, comments and opinions
expressed within are not those of Dendrite Clinical Systems or the Editorial Board.
June 2011
4
Combination of thrombolytics and
thrombectomy recommended for
proximal DVT
combination of thrombolytic drugs and mechanical
devices should be considered for patients with proximal
deep vein thrombosis (DVT), instead of the currently
accepted practice of systemic anticoagulation, according to
researchers at Stony Brook University Medical Center.
In a presentation at the “Controversies and Updates in
Vascular Surgery” in Paris, France, Professor Nicos
Labropoulos, Professor of Surgery and Director of the Vascular
Laboratory at the Medical Center ’s Division of Vascular
Surgery, said “While anticoagulant treatment does prevent the
propagation of blood clots, it does little to preserve the integrity of the vein, and often results in the development of reflux or
obstruction.” Development of such underlying pathophysiology
results in venous hypertension, which leads to post-thrombotic syndrome (PTS).
Patients with proximal DVT are at significantly higher risk of
developing PTS when compared to distal DVT. The use of modern procedures on selected proximal DVT patients would,
claimed Labropoulos, improve their quality of life compared to
anticoagulants, while minimizing the risk of bleeding endemic
to the use of thrombolytics. Current treatment options include
a combination of thrombolytic drugs and mechanical devices.
Until 2008, the use of anticoagulants was the only treatment
recommended by the American College of Chest Physicians
(ACCP). Current clinical practice guidelines, published in the
journal Chest in 2008 (Chest June 2008 133:6 suppl 110S112S; doi:10.1378/chest.08-0652), endorse the use of thrombolytics in the case of patients with extensive proximal DVT
and a low risk for bleeding. However, Labropoulos said, the ACC
are basing their recommendations on data derived from old
methods, which involved the systemic use of thrombolytics
rather than newer, localized techniques made possible by the
application of thrombectomy devices. These methods result in a
lower infusion time, which lowers the chance of bleeding.
Labropoulos claimed that anticoagulant treatment does not
always fully retinalise a clotted vein, which can result in a higher risk of recurring DVT. In a study by Prandoni et al (Ann
Intern Med 2002;137:955-60), of the 58 patients with recurrent
DVT, 41 had residual thrombus from the first episode.
Traditional methods of thrombolysis are known for leaving
residual clotting; however, catheter directed thrombolysis (CDT)
A
has been shown to be more efficient at leaving the blood vessel
completely unobstructed.
Aggressive treatment of DVT with CDT has been shown to be
more efficient than anticoagulation at leaving the blood vessel
completely unobstructed. A report on the use of CDT for the
treatment of proximal DVT (Sillesen H, et al, Eur J
VascEndovascSurg 2005;30:556-562) showed that, out of 45
patients, 42 (93%) were treated successfully. At 24 months there
were no cases of recurring thrombosis; only two of the 42 successfully treated patients developed reflux during the follow-up
portion of the study (Table 1).
through a registry from multiple institutions) to 30 patients
treated with anticoagulation (identified through medical chart
review). Patients who underwent thrombolysis reported better
overall physical functioning, less stigma, less health distress and
fewer post-thrombotic symptoms when compared to the anticoagulation group. Quality-of-life results were directly related to
the initial success of thrombolysis.
The use of mechanical devices has been shown to improve
results of thrombolysis, while minimizing the risk of bleeding
associated with the use of thrombolytics. In 2008, the American
College of Chest Physicians (ACCP) recommended the use of
pharmaco-mechnical thrombolysis (PMT) over CDT, because of
the faster treatment time and lower use of thrombolytics.
PMT fragments the thrombus and creates a central flow channel through the occluded vein, increasing surface contact with
the thrombolytics. Labropoulos stated that studies have shown
that PMT requires 30-40% less thrombolytics than a systemic
approach, a lower infusion time – 12-24 hours – and a shorter
hospital stay, generally requiring a single outpatient procedure.
Reports into PMT since 2005 have recorded bleeding complica-
Table 1: Results of thrombolytic therapy after a median of
24 months follow-up
Number of patients treated
Technical success (thrombus lysed)
Number of patients discharged with open deep veins
Number of re-occlusions after discharge
Number of patients without venous reflux
45
42 (93%)
42 (93%)
0
39 (96%)*
*One patient had pathologically fast venous refilling time demonstrated five years before
thrombolysis and thus, most probable venous reflux already.
Table 2: Venous functions after six months of the treatment
Anticoagulant
Non-obstruction or reflux
2 (12%)
Moderate obstruction
5 (29%)
Severe obstruction
10 (59%)
Reflux (obstruction)
7 (41%)
A
Table: Sillesen H, et al, Eur J Vasc Endovasc Surg 2005;30:556-562
Labropoulos also pointed to a study by Elsharawyet al (Eur J
VascEndovascSurg 2002;24:209-214) to show that CDT is more
effective in preventing reflux and obstruction (Table 2). Patients
in the study who had a combination of CDT and anticoagulants
had greater success at restoring unobstructed blood flow than
anticoagulants alone, showing a better vascular patency rate
than those who had anticoagulant therapy (72% vs 12%;
p<0.001), as well as a lower occurrence of venous reflux (41%
compared to 11%; p=0.042). (Table 2)
Another study, by Schweizer et al (J Am Coll Cardiol
2000;36:1336-43) randomized 250 patients to thrombolysis or
anticoagulation. They found that systemic thrombolysis had
higher rates of recanalization and lower rates of reflux and PTS at
12 months of follow-up than anticoagulation alone, although this
happened at the expense of increased bleeding complications.
Labropoulos used evidence from Comerota et al (J Vasc Surg
2000;32:130-7) to support his claim that CDT improves quality of life more than anticoagulation. Comerota compared 68
patients treated for proximal DVT with CDT (identified
underwent sapheno-femoral ligation
under local anaesthesia and concurrent sclerotherapy. Assessments
included CEAP classification, ultrasound, VCSS, AVVQ and SF36
She
stated
that
previously scores, and follow-up was at 24, 36,
Bountouroglou et al (Eur J Vasc 48 and 60 months.
Endovasc Surg 2006;3:93-100) have
reported the results from a prospec- Results
tive randomised controlled trial com- The outcomes reveal that CEAP was
paring sapheno-femoral ligation, similar between groups, C2-6. On
great saphenous stripping and multi- the 59 legs with completed ultraple avulsions with sapheno-femoral sound, reflux at 3-5 years is presentligation and ultrasound guided foam ed (Table 1).
sclerotherapy to the saphenous vein.
In the surgery group, 40% legs
They concluded that (USGF) scle- required 25 additional foam sessions
rotherapy combined with sapheno- with a mean volume of 11ml (total
femoral ligation was less expensive, 154ml). In the foam group, 47.5%
involved a shorter treatment time legs required 33 sessions, mean voland resulted in more rapid recovery ume 9ml (total 207ml). Preoperatively
compared to sapheno-femoral liga- the VCSS score was equivalent
tion, saphenous stripping and phle- between the two groups (medianbectomies.
range-IQR, surgery group: 5-3 to 12-3
In this study, a total of 73 patients and the foam group:4.5-2 to 15-2,
(82 legs) were enrolled in the trial: 39 p=0.359 Mann-Whitney U-test).
legs (M:F=16:23, age 47 [23-76])
However, after treatment there was
underwent sapheno-femoral ligation, improvement within both groups
stripping and multiple phlebectomies (median-range-IQR for the surgery
under general anaesthesia; and 43 group:1-0 to 9-5, p=0.001, and for
legs (M:F=11:32, age 49 [26-42]) the foam group:1-0 to 9-2, p<0.0005
Table 1: Ultrasound result on 59 completed legs (1=occluded, 2=competent, 3=reflux)
Group Surgery
n=26
Group Foam
n=33
Mann-Whitney
U-Test
Venous
Status
1
2
3
1
2
3
p=
3 years Above
Knee n (%)
17 (65.4)
2 (7.7)
7 (26.9)
16 (48.5)
6 (18.2)
11 (33)
p=0.298
p-value
<0.001
0.627
0.001
0.042
Table: Elsharawy M, Elzayat E. Early Results of Thrombolysis vs Anticoagulation in
IIiofemoral Venous Thrombosis. A Randomised Clinical Trial. Eur J Vasc Endovasc Surg
2002;24:209-214.
tions in <5% of patients.
One of the largest PMT series used the Trellis system to break
down DVT. Data presented at the 35th Annual Veith
Symposium in 2008 showed that out of 1,409 limbs treated in
1,304 patients, Grades II and III lysis with restoration of patency in patients with all clot chronicities were achieved in 95% of
cases; the typical treatment time for patients was around 20
minutes, and normally no follow-up treatment was needed.
There were no reported bleeding complications, and the dosage
of thrombolytic drugs was reduced by 30% compared to CDT.
Labropoulos said that while there is sufficient evidence to
change the most recent recommendations of the Chest guidelines to include thrombolysis in the management of patients
with proximal acute DVT, there is a lack of randomized data
that illustrates long-term results. However, they expect this to
change with the publication of the results of the Washington
University in St Louis’ School of Medicine’s ATTRACT study,
which is randomizing patients to either anticoagulation or
PhMT plus anticoagulation.
4.97-6.19 p<0.0005 Wilcoxon). The
improvement on the AVVQ score
before and after treatment was similar in both groups, p=0.703, MannWhitney U-Test). The SF36 mental
scoring over three years improved in
the surgery group (p=0.04) .
However, there was no change in the
physical scores in both groups
(surgery; p=0.361, foam:p=0.889) or
the
mental
score
in
foam
group:p=0.285. Furthermore, there
was no difference in the changes on
the physical and mental score
between the treatment groups due to
treatment (physical p=0.724, mental
p=0.354, Mann-Whitney U-Test).
USGF sclerotherapy with SF
ligation is equal to surgery
ccording to the five year
results from a randomised
controlled trial comparing
ultrasound guided foam (USGF) sclerotherapy combined with saphenofemoral (SF) ligation to surgical treatment for varicose vein treatment,
foam is equal to surgery with both
groups reporting significant improvements at three and five years.
Presenting the data at the American
Venous Forum meeting in February,
Professor Evi Kalodiki, Ealing
Hospital, Imperial College, London,
UK, began by stating that the study
started in 2004 and as a result it is
somewhat unique, as at this time
sclerotherapy was not readily available in the UK. “Though many centres have studied larger numbers of
patients this study, to our knowledge,
is the only randomised controlled trial
of surgery versus saphenofemoral ligation in combination with foam with
such a long follow-up.”
Thrombolysis
13 (72%)
4 (22%)
1 (6%)
2 (11%)
5 years Above
Knee n (%)
14 (53.8)
3 (11.5)
9 (34.6)
19 (57.6)
1 (3.0)
13 (39.4)
p=0.194
3 years Below
Knee n (%)
6 (23.1)
6 (23.1)
14 (53.8)
15 (45.5)
4 (12.1)
14 (42.4)
p=1.000
5 years Below
Knee n (%)
10 (38.5)
7 (26.9)
9 (34.6)
8 (24.2)
11 (33.3)
14 (42.4)
p=0.341
Evi Kalodiki
Wilcoxon). Changes in VCSS before
and at three years (p=0.504) and the
absolute VCSS scores (p=0.313) were
similar between both groups. The
VSDS score improved in both groups
due to treatment (Table 2).
The AVVQ score also improved
within both groups median-IQR preoperatively vs three years (surgery
group:16.32-4.7 vs 8.94-11.51,
p=0.003, foam group:12.28-10.37 vs
Conclusion
“At three to five years follow up the
treatment was equally effective
between the two groups, as demonstrated with VSDS, VCSS and AVVQ
score improvements. The additional
foam sessions were also similar and
the majority of recurrence was
asymptomatic and was detected via
duplex examination,” said Kalodiki.
“Since surgery may not provide a
definitive treatment solution, foam
sclerotherapy should be offered like a
dental care treatment, as and when
the problem appears.”
Table 2: Venous Disease Severity Score up to five years between groups on
70 patients
Pre-treatment
3 years
5 years
Friedman
Group Surgery
Median (IQR)
1.0 (1.3)
0.5 (1.0)
1.0 (1.0)
p<0.0005
Group Foam
Median (IQR)
1.0 (1.0)
1.0 (1.0)
0.25 (1.0)
p<0.0005
Mann-Whitney
U-Test
p=0.518
p=0.780
p=0.388
June 2011
6
Cause or effect –
CCSVI and MS
debate continues
The latest results from a study assessing the relationship
between multiple sclerosis (MS) and chronic cerebral
venous insufficiency (CCSVI), has reported that found that
CCSVI may be a result of MS, not a cause. The study,
conducted by Robert Zivadinov, Associate Professor of
Neurology in the UB School of Medicine and Biomedical
Sciences and P resident of the International Society for
Neurovascular Disease, is first author on the paper,
appears in the April 2011 issue of Neurology, the journal
of the American Academy of Neurology.
need. Our results indicate that only
56.1% of MS patients and 38.15 of
patients with a condition known as
clinically isolated syndrome (CIS), an
individual’s
first
neurological
episode, had CCSVI,” said Zivadinov.
“While this may suggest an association between the MS and CCSVI,
association does not imply causality.
In fact, 42.35 of participants classified as having other neurological diseases (OND), as well as 22.7% of
healthy controls involved in the
study, also presented with CCSVI.
CSVI is a complex vascular
These findings indicate that CCSVI
condition discovered and
does not have a primary role in causdescribed by Dr Paolo
ing MS. Our findings are consistent
Zamboni, from Italy’s University of
with increased prevalence of CCSVI
Ferrara. It is characterized by narrowin MS, but substantially lower than
ing of vessels draining blood from the
the sensitivity and specificity rates in
cranium and Zamboni hypothesized
MS reported originally by the Italian
that this narrowing restricts the norinvestigators.”
mal outflow of blood from the brain,
“The higher prevalence of CCSVI
resulting in alterations in the blood
in progressive MS patients suggests
Robert Zivadinov that CCSVI may be a consequence,
flow patterns within the brain that
eventually cause injury to brain tisrather than a cause, of MS,” said Dr
sue and degeneration of neurons, showed a CCSVI prevalence of 62.5% Bianca Weinstock-Guttman, co-prinleading to MS. Zamboni’s original in MS patients, 45.8% in those with cipal investigator of the study and UB
investigation in a group of 65 patients OND, 42.1% in CIS, and 25.5% in Professor of Neurology. Therefore,
and 235 controls showed that CCSVI healthy controls. When borderline the possibility that CCSVI may be a
appeared to be strongly associated cases were included as negative for consequence of MS progression canwith MS, increasing the risk of hav- CCSVI, prevalence figures were not be excluded and should be further
ing MS by 43 fold.
56.15 in MS patients, 42.3% in those investigated.
The results of the UB study are with OND, 38.15 with CIS and
“Several studies have reported that
based on 499 participants in the 22.7% in healthy controls.
patients with progressive MS show
Combined
Transcranial
and
When all cases that met at least decreased blood flow through the
Extracranial
Venous
Doppler one of the five VH criteria were brain’s neuronal tissue, indicating
Evaluation (CTEVD) study, which included in the analysis, CCSVI that CCSVI may be secondary to
began at the university in April 2009. prevalence was 81.35 in MS cases, reduced perfusion,” she added. “In
The study group consisted of 289 per- 76.25 in CIS patients, 65.4% in OND addition, we recently showed an assosons with MS, 163 healthy controls, cases and 55.2% in healthy controls. ciation between the severity of
26 with OND and 21 with CIS. MS
The highest prevalence was seen in CCSVI and reduced cerebral blood
patients also were defined by disease relapsing primary-progressive MS flow in brain parenchyma of MS
type: relapsing-remitting (RR), sec- (89.4%), followed by non-relapsing patients in an published pilot study.”
ondary progressive (SP), primary-pro- secondary-progressive MS (67.2%),
E Ann Yeh, UB assistant professor
gressive (PP), progressive-relapsing NMO (66.6%), primary-progressive of neurology and a major collaborator
(PR) and MS with neuon the study, noted
romyelitis optical (NMO), a
that of the ten pae“While this may suggest an association
type of MS that affects the
diatric MS patients
optic nerves and spinal cord between the MS and CCSVI, association
who participated
exclusively.
in the study, five
All patients underwent does not imply causality.” Robert Zivadinov
presented
with
transcranial and extracraCCSVI
(50%),
nial echo-Doppler scans of
yielding prevalence
the head and neck. Persons were con- MS (54.5%) and relapsing-remitting similar to that in adult MS patients.
sidered ‘CCSVI-positive’ if they met MS (49.2%). CCSVI prevalence was “Although the sample size was too
two or more of five venous hemody- substantially higher in progressive small to draw any firm conclusions,
namic (VH) criteria. Prevalence rates MS than in non-progressive MS these results suggest that CCSVI is
were calculated in three groupings: patients. In addition, patients with a also present in children and is not the
only subjects with positive and nega- progressive MS disease subtype had result of aging,” she said.
tive CCSVI diagnoses; only border- higher CCSVI prevalence than those
“The differences between our
line cases included in the negative with non-progressive MS.
study, the original Italian CCSVI
group; and subjects who fulfilled any
“Given the intense interest in the study and other recently published
of the five criteria.
hypothesis that CCSVI is a possible studies also emphasize the need for a
When only positive and negative cause of MS, independent evaluation multimodal approach for the assessCCSVI cases were considered, results of CCSVI was identified as an urgent ment of CCSVI. In addition to
C
First medical device to both prevent and detect
venous obstruction receives FDA clearance
he ActiveCare+Dx, the
first device with the ability to both detect and
prevent venous obstructions,
has been given marketing
clearance by the FDA.
The device, created by
Medical Compression Systems
T
(MCS), is claimed to be the
only product which can simultaneously prevent venous
obstruction and detect when
prevention has failed during
prophylactic therapy, alerting
the wearer when a clot has
formed. It is currently planned
to be released in 2012.
Prevention of deep vein
thrombosis fails 5%-6% of the
time among post-orthopedic
surgery patients undergoing
preventative drug or device
therapy. MCS claim that the
use of ActiveCare+Dx will
Doppler sonography, use of selective
venography, magnetic resonance
venography
and
intraluminal
Doppler methods can provide more
evidence for the true prevalence of
CCSVI in MS,” concluded Zivadinov.
Meanwhile, Dr Kenneth Mandato,
an interventional radiologist at
Albany Medical Center in Albany,
NY, has stated that angioplasty is a
safe treatment for widening veins in
the neck and chest to improve blood
flow should encourage additional
studies for its use as a treatment
option for individuals with multiple
sclerosis. He presented the latest data
at the Society of Interventional
Radiology’s 36th Annual Scientific
Meeting in Chicago, IL.
In a retrospective study, 231 MS
patients (age range, 25 to 70 years
old; 147 women, 84 men) underwent
this endovascular treatment of the
internal jugular and azygos veins
with or without placement of a stent.
The results showed that such treatment is safe when performed in the
hospital or on an outpatient basis,
with 97% treated without incident.
Complications included abnormal
heart rhythm in three patients and
the immediate re-narrowing of treated veins in four patients. All but two
of the patients were discharged within three hours of receiving this minimally invasive treatment.
“There are few treatment options
that truly improve the quality of life
of those with the disease, and some of
the current drug treatment options
for MS carry significant risk,” said
Mandato. “Our study, while not
specifically evaluating the outcomes
of this endovascular treatment, has
shown that it can be safely performed, with only a minimal risk of
significant complication. It is our
hope that future prospective studies
are performed to further assess the
safety of this procedure.
SIR position
The Society of Interventional
Radiology issued a position statement
in 2010 supporting high-quality clinical research to determine the safety
and effectiveness of interventional
MS treatments, recognizing that the
role of CCSVI in MS.
“This is an entirely new approach
to the treatment of patients with neurologic conditions, such as multiple
sclerosis. The idea that there may be
a venous component that causes
some symptoms in patients with MS
is a radical departure from current
medical thinking,” said Dr Gary P
Siskin, Chair of the Radiology
Department at Albany Medical
Center and the co-Chair of the SIR
Research Consensus Panel on MS
that was held in October 2010.
“It is important to understand that
this is a new approach to MS. As a
result, there is a healthy level of scepticism in both the neurology and
interventional radiology communities about the condition, the treatment and the outcomes,” said Siskin.
“Interventional radiologists have
allow the quicker identification of failed prevention, leading to earlier treatment and
the reduced occurrence of lifethreatening symptoms.
Adi Dagan, the CEO of MCS,
said: “We are happy to receive
FDA
clearance
for
ActiveCare+Dx. This product
meets a significant need, especially in the market of deep vein
thrombosis prevention, where
Gary Siskin
been performing venous angioplasty
for decades and have established
themselves as pioneers in this area of
vascular intervention. Patients are
learning about this therapy and the
role of interventional radiology in
venous angioplasty through the
Internet. They are discussing it
among themselves through blogs and
social networking sites and then
turning to interventional radiologists
for this treatment. This is a new entity and one where researchers are
clearly very early in their understanding of both the condition and the
treatment.”
SIR’s position statement agrees with
MS advocates, doctors and other caregivers that the use of any treatment
(anti-inflammatory, immunomodulatory, interventional or other) in MS
patients should be based on an individualized assessment of the patient’s
disease status, his or her tolerance of
previous therapies, the particular
treatment’s scientific plausibility, and
the strength and methodological quality of its supporting clinical evidence.
“When conclusive evidence is lacking, SIR believes that these often difficult decisions are best made by individual patients, their families and
their physicians,” notes the society’s
position
paper,
“Interventional
Endovascular Management of Chronic
Cerebrospinal Venous Insufficiency in
Patients With Multiple Sclerosis: A
Position Statement by the Society of
Interventional Radiology, Endorsed by
the
Canadian
Interventional
Radiology Association.” SIR stresses
the importance for MS patients to
continue an ongoing dialogue with
their neurologists to discuss their
treatment care.
While the use of angioplasty and
stents cannot be endorsed yet as a
routine clinical treatment for MS,
SIR agrees that the preliminary
research is very promising and supports studies aimed at understanding
the role of CCSVI in MS, at identifying methods to screen for the condition and at designing protocols for
exploratory therapeutic trials. “If
interventional therapy proves to be
effective, MS patients should be treated by doctors who have specialized
expertise and training in delivering
image-guided venous treatments,”
said Siskin.
Mandato noted that research still
needs to be done concerning patient
selection, technique and the outcomes after this procedure, including
improvement in symptoms and quality of life and the durability of the
response.
complications could be fatal.
“About 90% of the deep vein
thrombosis cases are invisible
and will not be diagnosed until
clinical signs and symptoms
are already presented,” said
Dagan. “Their first presenting
symptom can be pulmonary
embolism or death.”
The new product is a development of MCS’ first device,
the ActiveCare+S.F.T, which is
marketed as the only nonpharmaceutical mechanical
therapy on the market with
published data. Intended as an
alternative to anticoagulant
drugs, it works through applying intermittent, sequential
compression to the legs in a
systematic pattern, increasing
the speed of blood flow in the
veins and reducing the risk of
clot formation.
June 2011
8
Rotarex and Aspirex catheters approved
for abdominal and venous use
traub Medical’s Rotarex S and
Aspirex S ranges of catheters
have earned class-III CEMark approval, clearing them for
use in abdominal vessels. The new
approval rating also allows for the
Aspirex S range to be used venously.
rotational
endovascular
The
catheters, which were released in
2010 with class-II CE-mark approval,
were originally indicated for the treatment of occlusions of peripheral
arteries. The new rating means that
they are now indicated for the percutaneous transluminal removal of
material from occlusions of blood
vessels outside the cardiopulmonary,
coronary and cerebral circulations.
S
Dirk Dreyer, Director of Global
Sales & Marketing at Straub,
claimed that their catheters allow for
rapid vessel reopening and immediate restoration of blood flow without
the potential risks of bleeding when
administering thrombolytics, of
inducing barotraumata or embolisations when dilating the lesion with a
balloon, or of vessel trauma and
neointima
hyperplasia
when
implanting a stent.
“Even if the occlusion occurs in a
previously stented region of the blood
vessel or in a bypass, our catheters
can be used to safely reopen these
segments again,” Dreyer said.
“The successful upgrade to a CE
McLafferty
elected
President
of the VDF
Robert McLafferty
r Robert McLafferty has been
elected President of the Vascular
Disease Foundation (VDF) board
of directors at their meeting held in
March. Dr Robert B McLafferty, is currently Professor in the Division of
Vascular Surgery in the Department of
Surgery at the Southern Illinois
University School of Medicine.
McLafferty has been a member of
VDF’s board of directors since April
2005 and previously served on the
Venous Disease Coalition’s steering
committee as treasurer. In his new role
as President, he will continue to lead
efforts to increase awareness of vascular
disease which affects over 40 million
Americans.
“Dr McLafferty’s commitment and
dedication to improving the health care
of those affected by vascular disease has
been important,” said Sheryl Benjamin
VDF Executive Director. “In his new
role as president, he will lead VDF to
become the leading resource of vascular
disease information. He has a passion
to bring vascular disease to the forefront of the national health dialogue.
We are honoured to have him serve as
our new President.”
D
class-III product and the approval of
the enhanced indication underline
the safety and effectiveness of our
devices”, said Dr Walter Mayerl,
Director of Regulatory Affairs at
Straub Medical.
Both Rotarex and Aspirex catheters
are indicated for native blood vessels
or vessels fitted with stents, stent
grafts or native or artificial bypasses.
While Aspirex catheters are intended
to be used for the removal of fresh
thrombotic or thromboembolic
material, Rotarex catheters are
intended for removal of thrombotic,
thromboembolic and atherothrombotic material from fresh, subacute
and chronic occlusions.
Aspirex
Guido Karges, Managing Director
of Straub, said that he hoped that the
enhanced indications and products
for arterial and venous use would
allow them to expand their interventional treatment to patients who previously would not have had that
treatment option.
“The enhanced approval together
with the venous indication for
Rotarex
Aspirex S greatly accelerate Straub
Medical's evolution as a leading
provider of devices for the treatment
of vascular occlusive disease,” said
Karges. “Being established as one of
the market leaders in the treatment
of peripheral arterial occlusive disease, we now aim to widen the portfolio of both products and indications.”
Disinvestment in varicose
veins could result in severe
long term problems
enous specialists have been warned that
varicose vein cost cutting measures
implemented by national health services, could lead to a reduction in a patient’s QoL
and ultimately, become a larger burden on
resources. The stark warning was made by Dr
Olle Nelzén, Associate Professor of Vascular
Surgery, Skaraborg Leg Ulcer Center and
Department of Vascular Surgery, Skaraborg
Hospital/KSS, Skövde, Sweden, speaking at the
recent UK Venous Forum meeting in London,
UK.
In his presentation entitled, ‘What will be the
clinical and economic effects of a disinvestment
in the treatment of varicose veins on the future
burden of chronic venous insufficiency?’,
Nelzén examined issues such as clinical symptoms, quality of life, NHS statistics, possible
effects of chronic venous insufficiency and
whether there is a ‘cost saving when all things
are considered?
V
ment for relatively low extra cost (£733 vs. £345
– total NHS cost per patient £388).
Varicose vein progression
Rabe et al reported in the Bonn Vein Study
(2003) that approximately 2% of varicose vein
patients progresses into a higher CEAP Clinical
class each year, although varicose vein intervention is likely to prevent such progression and
Nelzén stated that most patients with venous
ulcers also have varicose veins and they are close
to a prerequisite for an ulcer to develop.
According to the latest NHS statistics on varicose vein surgery (Lim et al 2011) there has
been a steady decline in the number of procedures performed (from 46,000+ in 2002 to
33,000 in 2009) and there was a ‘postcode lottery’ as the frequency of varicose vein proceOlle Nelzén
dures varied considerably from 34 to 142 operations per 100,000 of the population (Swedish
calculations put the ideal frequency at 125-150 showed that SEPS combined with superficial
per 100,000).
venous surgery results in a low recurrence rate
Surgery vs. conservative management
in patients with open and healed venous ulcers,
He began by citing the study by Michaels et al Venous ulcers
and emphasizes the importance of varicose vein
‘Cost-effectiveness analysis of surgery versus “Varicose veins are involved in most cases with surgery in preventing venous ulcer recurrence.
conservative treatment for uncomplicated vari- venous ulcers and those ulcers caused by variNelzén then present the number of patients
cose veins in a randomized clinical trial’ (British cose veins alone are dominating,” said Nelzén. that need to be treated to prevent one venous
Journal Surgery et al 2006; 93;175-81), which “And venous ulcers are the most costly compli- ulcer (Table 1) and the possible English scenario
showed that surgery was significantly better for cation to varicose veins with an expected annu- based on 25,000 fewer operations (Table 2). He
symptom relief (aching, heaviness, itching, al NHS cost of £3,000 per patient.”
estimates that if there were 25,000 fewer variswelling and cosmetic concerns), compared with
But is surgery better than treatment? He stat- cose vein interventions, the cost saving for surconservative treatment (p<0.05). Moreover, the ed that the answer is ‘yes’ as the ESCHAR study gery would be at least £20milion, with the
study also reported that patient dissatisfaction (Barwell
et
al.
Lancet,
2004
Jun added cost of conservative management (£8 milrates also favoured surgery (5% vs. 50%, 5;363(9424):1854-9) reported. In this trial com- lion) and extra cost for venous ulcers (£1-9 milp<0.05). “This study and addition studies by paring compression vs. superficial vein surgery lion), providing a net benefit for NHS spending
Baker (1995), smith (1999), Durkin (2001), and compression although there was no differ- of between £3 to £11 million.
Mackenzie (2002) and Beresford (2003) have ence in healing between the two groups, surgery
demonstrated that varicose vein surgery resulted in a significantly reduced recurrence Table 2: The possible English scenario
based on 25,000 fewer operations
improves the patients’ quality of life,” said rate at one (12% vs 24%) and four years (31% vs.
C2
C3
C4
C5
Nelzén. “And there is a strong correlation 51%).
Per
cent
30%
40%
20%
10%
between clinical severity of venous incompeIn addition, a Swedish study by Nelzén et al
7,500 10,000
5,000 2,500
tence and the reduction in the quality of life, as entitled, ‘True long-term healing and recurrence Surgery
not
performed
shown in the Edinburgh Vein study (Ruckley el of venous leg ulcers following SEPS combined
at, 2002).”
with superficial venous surgery: A prospective (In this example the reduction affected all clinical cases equally)
Expanding on this point, he added that quali- study (Euro Journal of Vasc & Endovasc
“This estimate does not include indirect costs
ty of life is affected negatively by recurrence and Surg,34;5;605-612;2007) that assessed the longpatients with recurrent varicose veins have a term healing and recurrence rates of leg ulcers and patients’ suffering, nor does it include the
significantly lower quality of life compared with following surgical intervention with combined factors that will affect the expected cost savings
patients having primary varicose veins Subfascial Endoscopic Perforator Surgery (SEPS) negatively,” said Nelzén. “Such as an increased
(Mackenzie, 2002 and Beresford, 2003). and superficial venous surgery, reported that the number of patients will develop venous ulcers,
Furthermore, Ratcliffe et al (BJS 2006) reported three- and five-year recurrence rates were 8% patients with eczema and skin changes as well
that surgery offers a modest health improve- and 18%, respectively. This study clearly as sever swelling are likely to require more
health cost resources and time lost fro work is
Table 1: The number of patients that need to be treated to prevent one venous ulcer
likely to increase for these patients.”
Cohorts
Est. target pop. in Sweden (in England)
Number needed to treat
“Therefore, a disinvestment in the treatment
Varicose veins
2 million (11 million)
400
of varicose veins is both from the patients and
Symptomatic varicose veins
500 000 (2.8 million)
100
the NHS perspective, a dangerous road to folVaricose veins with edema
400,00 (2 million)
80
low,” he concluded. “There is a substantial risk
Skin changes
80, 00 (400,000)
8
for a sever backlash, both regarding the quality
Source; Nelzén et al, Svensk Kirurgi 2009;48(3);112-6 and Nelzén et al, J Vasc Surg. 2010; 52 (5 Suppl);39s-44s
of life for patients and the NHS cost spending.”
June 2011
10
Continuing warfarin during EVLT is safe
ccording to research presented at the annual meeting of the American Venous
Forum, endovenous laser therapy
can be safely performed in patients
taking warfarin. The results from
the single-centre study were presented by Dr Paul J Riesenman,
Division of Vascular Surgery and
Endovascular Therapy Emory
University Atlanta, GA, on behalf
of his colleagues Drs Steve G
Konigsberg and Karthikeshwar
Kasirajan.
He began his presentation by
stating that oral anticoagulation
with warfarin is routinely discontinued before venous surgery to
avoid potential bleeding complications and explained that there
are perioperative thromboembolism risk and the cessation of
warfarin therapy may necessitate
an alternative form of bridging
anticoagulation before and after
the intervention in order to minimize the risk of perioperative
thromboembolic complications
from pre-existing medical conditions.
“This practice adds cost and
complexity to the operative planning. But in many patients, minimising the perioperative time
period off the anticoagulation may
be required to safely perform the
A
procedure,” said Riesenman. He
added that endovenous laser therapy is minimally invasive and
bleeding
complications
are
uncommonly reported.
The researchers hypothesized
that non-interruption of warfarin therapy in these patients
could simplify pre-operative
planning and minimise the risk
of perioperative complications,
although how the presence of
therapeutic anticoagulation may
affect the technical success of
this ablative procedure is
unknown. As a result, the investigators sought to define outcomes among patients undergoing endovenous laser therapy at
their institution while continuing on oral anticoagulation with
warfarin at the time of their
intervention.
Between September 2004 and
July 2010, 518 patients underwent 770 lower-extremity EVLT
(endovenous laser therapy) procedures. Of these, five patients
ranging in age from 31 to 69
years underwent 12 separate
EVLT procedures without interruption of warfarin therapy. The
great saphenous vein was targeted in eight procedures, and the
small saphenous vein in the
remaining four. Concomitant
procedures included phlebectomies during five interventions
and ultrasound-guided sclerotherapy during an additional
five procedures. There were various indications for anticoagulation, many of these patients fit
the profile for high thromboembolic risk. All but one underwent
treatment to both lower extremities.
“At Emory, EVLT is routinely
done in an office setting using a
55- or 80-cm inducer sheath
placed in the target vessel and we
use an 810-nm wavelength system run on continuous operating
mode at 14W,” said Riesenman.
“Once successful ablation of the
target vessel is confirmed by
ultrasound and any additional
venous interventions are performed, a two-layer compression
bandage is applied and the patient
receives a 20- to 30mmHg compression stocking. Follow-up with
ultrasound is performed at one
and eight weeks.”
The preprocedural INRs were
largely therapeutic (2.59 – 1.93 to
3.76) and the mean energy used
was 84.3J. The target vessel was
the greater saphenous in eight
and the short saphenous in four.
Ten concomitant venous procedures were performed consisting
Three stages of the EVLT procedure
Paul J Riesenman
of either stab phlebectomies or
ultrasound-guided sclerotherapy
Results
The outcomes showed that no
intra-procedural bleeding complications were observed in the five
patients, and no excessive ecchymosis was documented at oneweek follow-up. Successful ablation of the target vessels was confirmed by ultrasound at one and
eight weeks in all patients. One
patient did report severe lower
extremity pain at her eight week
follow-up. There were no concerning physical or ultrasound findings
at that time and her one week follow-up had been unremarkable
with no reported pain problems.
Interestingly during this follow-up,
this same patient inquired about
when her contralateral extremity
could
be
treated.
Riesenman concluded that
EVLT “Can be safely and effectively performed on patients undergoing oral anticoagulation therapy
with warfarin. We recommend
that warfarin not routinely be
interrupted when patients undergo this procedure.”
Stenting more effective than
balloon venoplasty alone
ccording to the results from the
EVISTA-DVT (Endovenous InfraInguinal Stenting and Angioplasty
in Deep Vein Thrombosis) randomized
trial, stenting is safe and more effective
than balloon venoplasty alone for patients
with deep vein thrombosis (DVT) in the
femoropopliteal vein.
Principal investigator, Dr Mohsen Sharifi,
Arizona Cardiovascular Consultants, said
that previously percutaneous endovenous
intervention with stenting and other strategies has been shown to be an effective way to
treat acute proximal DVT. The TORPEDO
trial (Venosu Times issue 8), which Sharifi
presented in 2010 at the Transcatheter
Cardiovascular Therapeutics meeting, was
the first randomized trial to show that percutaneous endovenous intervention reduced
post-thrombotic syndrome and recurrent
venous thromboembolism. “However, data
had been lacking regarding the use of stents in
the femoropopliteal vein,” he added.
The EVISTA-DVT trial enrolled 141
patients with high-grade residual stenosis of
more than 70% in the femoropopliteal vein
after percutaneous endovenous intervention
and thrombolytic therapy. Patient were randomised to either the stenting group (71
patients) or balloon venoplasty alone (70
patients). The mean age of the participants
A
was 65 and 56% were men. The 71 patients in
the stenting group received a total of 85 stents.
The average length of follow up was 35
months and patients underwent venous
duplex scanning every six months or sooner if
they became symptomatic and yearly x-rays.
Those with suspected recurrent DVT underwent venography with intravascular ultrasound evaluation. All patients were on warfarin and daily aspirin for six months; 42
patients were also on clopidogrel (Plavix) for
two–four weeks. The researchers advised all of
the patients to wear 30–40mmHg compression stockings.
During follow up, six patients in the stenting group and 15 in the control underwent
invasive evaluation for DVT. Ultimately, 4% of
the stenting group and 10% of the control
group had recurrent DVT that was either
asymptomatic or mildly symptomatic and was
easily managed with re-do percutaneous
endovenous intervention.
“The first option for DVT is some form of
mechanical or pharmacologic intervention.
Once that has been accomplished, and if there
is residual stenosis, then the practitioner
should think about stenting, even if the lesion
is below the inguinal ligament,” said Sharifi.
“The mechanism of stent thrombosis was different in these patients versus what would be
seen with stents in the arterial circulation.
Mohsen Sharifi
Thrombosis was caused by thrombus extension from adjacent non-treated sites and external compression due to venosclerosis. There
was no neointimal proliferation. The message
is that after appropriate thrombolysis, if there
is residual significant stenosis in the infrainguinal segment, you should feel free to move
ahead and take care of those significant
lesions.”
Being tall and obese may significantly
increase risk of VTE
Being tall and obese may increase a patient’s
risk of venous thromboembolism (VTE)
according
to
new
research
in
Arteriosclerosis, Thrombosis and Vascular
Biology: Journal of the American Heart
Association.
Compared with short (5 feet, 7.7 inches
or less) and normal-weight men (body mass
index < 25kg/m2), the age-adjusted risk of
VTE was:
n 5.28 times higher in obese and tall men
n 2.57 times higher in normal-weight and
tall men (at least 5 feet, 11.7 inches tall)
n 2.11 times higher in obese and short
men
The amount of risk conferred by being both
obese and tall was comparable to other
known risk factors for VTE, including pregnancy, the use of oral contraceptives, and
carrying one gene for an inherited predisposition to clotting called Factor V Leiden.
Compared with short (5 feet, 2.6 inches
or less) normal-weight women, the ageadjusted risk of VTE was:
n 2.77 times higher in obese and tall
women
n 1.83 times higher in obese and short
women
n Not increased in normal-weight and tall
women (more than 5 feet, 6 inches)
Researchers said more studies are needed to
determine the mechanisms of the association between tall stature, excess weight and
the combination on the risk of VTEs. The
research team analyzed data from the
Tromsø study, which conducts periodic
health surveys of adults 25-97 years old in
the Norwegian town. Researchers collected
height and obesity measures on 26,714 men
and women followed a median of 12.5 years
between 1994 and 2007. During that time,
461 VTEs occurred.
The researchers previously found a strikingly similar rise in clot risk along with
height in American men, and believe that
the height cut-offs would apply to
Caucasian populations in other regions.
Stroke patients not getting preventive
therapy for blood clots
Patients with strokes, brain tumours and
spinal cord injuries are at high risk for lifethreatening blood clots, but many do not
receive
preventive
therapy,
Loyola
University Health System researchers report
in the February 2011 issue of the American
Academy of Neurology journal Continuum.
Neurologic and neurosurgical patients are
prone to blood clots because they are immobile or because their blood is more likely to
coagulate. But physicians often fail to recognize blood clots in such patients. And even
when a blood clot is diagnosed, physicians
sometimes fail to treat it with blood-thinning medications due to the risk of haemorrhage. Twenty-five percent of patients with
DVT die as a result of subsequent pulmonary embolism, and the seven-day mortality from PE is 75%.
“In the long run, the benefits in preventing recurrent VTE outweigh the risk of
bleeding complications," wrote the authors.
“In most neurologic and neurosurgical
patients, beginning therapy with heparin
blood-thinning medications within 24 to 48
hours is both safe and effective.”
However, they added that there is a wealth
of evidence such prophylactic measures
reduce the frequency of DVT, PE and death
in hospitalized patients, and because neurologic and neurosurgical patients represent a
high-risk subgroup because of underlying
disease and immobility, aggressive intervention for prevention and treatment of DVT is
imperative.
June 2011
12
R
Borate glass nanofibres
had been unhealed for more than a
year. One patient had the same
wound for three years,” she said.
“After using the glass fibre product for
a few months, we were able to repair
the skin in eight of the patients.
Remarkably, the other four have
made a lot of progress and all of their
wounds should be healed soon, too.”
PCRMC approved the trial in July
2010, and nurse Taylor saw her first
patient one month later. Once the
study was underway, the company
provided Taylor with individual, foilsealed packets containing pads made
of the glass fibres. She says the material is easy to apply. “It gets kind of
squished in the packs, but you can
form it, pick it, make it into any kind
of shape you need out of it. I used
tweezers to pack the material up into
all of the recesses before filling the
rest of the wound. I didn’t pack it
hard, but enough to fill all the
crevices. Once it was in place, I covered it with a secondary covering or
compression wrap.”
Taylor acknowledges that under her
care, the wounds would have probably
healed without the glass material, but
they would have required expensive
vacuum-assisted healing systems that
must be carried by patients at all times.
Portuguese survey reveals
effect of CVD on quality of life
new study into the effects of chronic
venous disease (CVD) on the quality of
life of sufferers has revealed that more
than 50% of Portuguese patients over the age
of 40 feel that CVD has seriously affected
their life.
Speaking at the “Controversies and Updates
in Vascular Surgery” meeting in Paris, France,
Armando Mansilha, Secretary General of the
Portuguese Society of Angiology and Vascular
Surgery (SPACV), who carried out the survey,
reported that CVD has a serious effect on
patients’ lives, and that the disease affects
women’s quality of life more severely than men.
Mansilha revealed that SPACV found that
there was little data available on CDV’s impact
on suffers’ quality of life beyond the international RELIEF study (Janet G, Angiology
2002;53:245-56). He said that quality of life
metrics are increasingly seen as an important
outcome measure in treatment studies, and
that they provide important information on
patients’ own perception of the illness that is
not captured with traditional physician-based
scales like visual analogue scales, and numerical or verbal scales.
Accordingly, SPACV decided to create their
own quality of life survey for CDV sufferers.
They studied 5,617 patients, of whom 60%
were women, using a shortened form of the
patient-generated Chronic Venous Disease
Quality of Life Questionnaire (CIVIQ), in a survey called “What do you know about your
A
veins?”. The survey,
the first in Portugal
to investigate the
impact of CDV on
quality of life, was
carried out in order
to collect updated
information about
CVD in Portugal,
and to raise awareness in Portugal of
Armando Mansilha
the symptoms of
CVD and its impact
on sufferers’ quality of life.
In the overall population over 40, 50% reported having their quality of life significantly
affected by CVD. In the population over 50, the
percentage of the population whose quality of
life was significantly affected by CVD increased
to 54% (figure 1). The survey showed that CVD
progressively affected sufferers’ quality of life as
the sample’s age increased (see Figure 1).
In addition, the quality of life for significantly decreased for both women and men as the
sample’s age rose. However, women’s quality of
life was affected by CVD than men’s at all ages.
The CIVIQ questionnaire was chosen for its
ubiquity, having already been deployed in 13
languages, and its range, examining a patient’s
quality of life in terms of physical, psychological, social and pain. Patients were asked to
answer the following 15 questions on a scale
from 1 to 5, where 1 means “Never” and 5
Delbert Day
Besides low cost and ease of use,
Taylor says the glass fibres seem to
offer another stunning benefit: low
scarring. “All but one of the patients
in the trial were elderly and had a lot
of skin discolouration, but we healed
wounds that show nothing or negligible scarring,” she says.
Jung, who now works as a senior
researcher for Mo-Sci, says that the
next step is expanded human trials,
which will be conducted in partnership with the Center for Wound
Healing and Tissue Regeneration at
the University of Illinois at Chicago.
He says the centre has agreed to
begin testing the material in the
summer of 2011.
“We are extremely fortunate to
have the three key ingredients needed to take research from the idea
stage to the commercial product
stage,” said Day, who also invented
TheraSphere, a glass product now
used to treat patients with liver cancer at more than 100 sites worldwide, including Barnes Jewish
Hospital in St. Louis. “We have the
university, which provides the
research expertise, Phelps County
Regional Medical Center for the clinical trials, and Mo-Sci for the manufacturing and commercialization.”
Day foresees expanding the clinical
trials to include patients with other
types of wounds, such as burn victims.
20
Male
Female
High
25
Quality of Life score
particular borate glass composition
(called 13-93B3 glass) one that MoSci, a glass technology company
founded by Day, already knew how to
form into cottony glass fibres, 300
nanometers to five micrometers in
diameter. After animal tests showed
no adverse effects, Mo-Sci obtained a
license to the material from Missouri
S&T, named the borate glass material
DermaFuse, and approached Phelps
County Regional Medical Center
(PCRMC) about starting the smallscale human test.
Clinical trials at PCRMC began in
the third quarter of 2010 with 13
subjects. One dropped out early in
the process. All suffer from diabetes
and had wounds that had been
unhealed for more than a year.
Depending on the severity of the
wound, Day said the wounds can
heal within a few weeks to several
months after the material is applied.
According to Peggy Taylor, the
PCRMC registered nurse who administered the treatments, all of the volunteers in the trial are enthusiastic about
the use of the glass fibre product. All of
the patients suffered from problems
associated with venous stasis.
“All of the participants had diabetes
and several of them had wounds that
30
35
40
45
Low
50
<29
30–39
40–49
50–59
60–69
70+
Age (years)
Figure 1: Main result. After 50 years, 64% of Portuguese women felt their quality of life significantly affected by CVD
means “Always”:
1 In the last four weeks, have you felt pain in
your ankles or legs?
2 During the last four weeks, to what extent
did you feel affected in your work or everyday
activities by problems in your legs?
3 During the past four weeks, have you had difficulty sleeping due to problems in your legs?
During the past four weeks, to what extent
have problems in your legs affected / limited
you in the activities listed below?
4 Standing or sitting for long periods
5 Climbing stairs
6 Bending your knee
7 Fast walking
8 Social events (weddings, christenings,
clubs)
9 Strenuous sport
The problems in the legs can also affect your
state of mind. To what extent do the following
phrases match how you felt during the past four
weeks?
10 “I feel nervous, tense.”
11 “I am a burden to others.”
12 “I am ashamed to show my legs.”
13 “I am easily annoyed.”
14 “I'm handicapped”
15 “I don’t feel like walking (leaving the
house).”
Reporting on the conclusions of the study,
Mansilha said that the survey showed that
CVD specific quality of life instruments are
valuable indicators of patient perspective, being
reliable and also appreciated by practitioners.
He also said that it would be interesting to
develop quality of life questionnaires that could
be applied specifically to patients recovering
from surgical procedures.
Sociedade Portuguesa de Angiologia e Cirurgia Vascular
esearchers
at
Missouri
University of Science and
Technology have developed a
glass fibre material that could become
glass the next treatment for venous
stasis wounds, wounds in the battlefield by medics or emergency medical
technicians. Details about the trials
and the material were published in
the May 2011 issue of the American
Ceramic Society’s Bulletin magazine.
The material, a nanofibre borate
glass, was developed in the laboratories of Missouri S&T’s Graduate
Center for Materials Research and
the Center for Bone and Tissue
Repair and Regeneration. Dr Delbert
E Day, Curators’ Professor Emeritus
of Ceramic Engineering and a pioneer
in the development of bioglass materials and Dr Steve Jung, developed the
material over the past five years.
Other bioactive glass materials are
formed from silica-based glass compositions and have been used primarily
for hard-tissue regeneration, such as
bone repair. However, Day and Jung
experimented with borate glass, which
early lab studies showed reacted to fluids much faster than silicate glasses.
“The borate glasses react with the
body fluids very quickly. They begin to
dissolve and release elements into the
body that stimulate the body to generate new blood vessels,” said Day.
“This improves the blood supply to
the wound, allowing the body’s normal healing processes to take over.”
“We thought it might be advantageous to have a material that could
mimic the microstructure of fibrin
that forms the basis of a blood clot,”
said Jung. “We reasoned that if the
structure could imitate fibrin, it
might trap blood platelets and allow
the formation of a wound cover that
could support the healing process.”
Jung and Day finally settled on a
Photo: B A Rupert, Missouri S&T
Is nanofibre borate glass the next
treatment for venous stasis wounds?
June 2011
14
AVF launches IVC filter module for American Venous Registry
he American Venous
Forum has launched
the inferior vena cava
(IVC) filter module for its
American Venous Registry.
The American Venous
Registry,
launched
in
February 2011, standardises
the collaborative collection
and analysis of clinical information about venous disease.
According
to
Uchenna
Onyeachom, administrator,
American Venous Registry,
this is the first and only
national registry of IVC filters
placed and retrieved in the
United States.
It is hoped that by identifying
practice patterns for venous disease diagnosis and treatment
across the US and across varied
specialties, the Registry will facilitate the assessment of functional outcomes and comparative
analyses of different clinical
approaches to venous disease
management. This makes it a
powerful tool for the development
of treatment guidelines, evidencebased modification of public policy,
and re-direction of health care
resources.
The IVC filter module will enable
physicians to enter and track the
indications for which they are placing
filters, the types of filters they are
using, how frequently they are
retrieving filters and any complications. They will be able to compare
this information from their patients
with the national aggregate.
T
Brajesh K Lal
“The IVC filter module is launching at an extremely appropriate
time as the FDA, doctors and
patients are struggling with critical
questions about who should get filters, how many retrievable filters
are actually getting retrieved, and
which filter designs are associated
with complications,” said Dr
Brajesh K Lal, Chairman of the
American Venous Registry, and
Associate Professor and Chief of
Vascular Surgery, Physiology &
Bioengineering,
University
of
Maryland, Baltimore. “Despite
venous disease affecting such a large
segment of our population, there has
been no platform available to collaboratively evaluate our procedures
and outcomes using common language. The American Venous
Registry fills that important need.”
“By tracking specific aspects of the
IVC filter practice nationally, physicians will get a better idea of how
these filters are being used, determine
their complications and filter
retrieval rates, and compare these
aspects of their practices to the experience of other physicians,” says Dr
John Rectenwald, Assistant Professor
of Vascular Surgery, University of
Michigan Health System, and Chair
of the IVC filter module of the
American Venous Registry.
The American Venous Forum is an
international consortium of venous
and lymphatic specialists dedicated
to improving patient care. Its mission
is to promote venous and lymphatic
health through innovative research,
education and technology.
The American Venous Forum created the American Venous Registry
to:
n Standardise the collection and
analysis of clinical information on
venous disease;
n Identify practice patterns for
venous disease diagnosis and treatment nationwide;
n Answer research questions prioritised by the American Venous
Forum; and
n Provide a real-time clinical practice tool to assist the practices of
individual participating physicians.
The Registry will be comprised of five
modules; two have been launched
and three are under development.
Each module focuses on one particular aspect of venous disease and offers
several clinical practice tools and the
ability to run specific benchmarking
queries in real time. The modules
are:
n Varicose vein module, launched in
February 2011
n IVC filter module, launched on 16
June 2011
n Stent module
n Deep vein thrombosis thrombectomy/lysis module
n Upper extremity deep vein thrombosis module
For more information about the
American Venous Forum, log on to
www.veinforum.org
For more information about the
American Venous Registry, log on to
www.venousregistry.org
American Venous Registry
Improving Tomorrow’s Outcomes With Today’s Data
Have you registered yet?
The American Venous Registry has been established to identify practice patterns for
the treatment of venous disease across North America.
Objectives
Which treatments can you enter?
Web-based registry
To analyze the aggregate data and
produce an annual publication that will
outline important demographic
features including:
n Risk factors
n Disease patterns
n Diagnostic characteristics
n Treatment preferences
n Treatment outcomes
n Free reports to all contributors
From June 2011, registered users can enter
data on the following procedures:
n
Varicose veins
Venous stenting
IVC filter placement
n
n
n
n
n
n
n
“This registry will benefit individual
clinicians and the field by creating a
means for collaborative pooling of
clinical data across North America.”
Dr Joann Lohr, Past President AVF
Safe and secure access
Free and easy to use
A ‘real-time’ clinical database with web-based clinicalpractice tools, that will assist the practices of individual
participants
Free and automated generation of letters to referring
doctors and patients
Helps to record and meet CMS standards for quality
You can enter information from any location with an
internet connection
You can enter as many cases as you wish
You can also enter retrospective data
To register for the AVR, please go to: www.venousregistry.org
For any scientific or clinical questions please contact Uchenna
Onyeachom at [email protected]
June 2011
16
European Venous Forum
First hands-on workshop on venous disease
4-6 November 2010, Larnaca, Cyprus,
Michel Perrin, Clinique Du Grand,
Decines, France
he first course and hands-on
workshop on venous disease
instituted by the European
Venous Forum was held in Larnaca,
Cyprus, 4–6 November 2010. The
organizing committee comprised the
leaders in venous disease from
Europe and the United States,
namely Bo Eklöf, Athanasios
Giannoukas, Peter Neglen, Andrew
Nicolaides and Stylianos Papas with
a faculty of 30 members representing 12 countries. The program consisted of lectures and case reports in
the morning followed by hands-on
workshops in the afternoon
T
sary for understanding alternative
diagnostic findings according to the
differential diagnosis.
Lower limb with superficial incompetence. The participants were able
to detect reflux in the great saphenous vein (GSV), small saphenous
vein (SSV) and their tributaries; also,
recognise the connections between
the GSV and SSV and understand
their significance in relation to
patient management.
Lower limb with deep incompetence.The participants were able to
detect reflux in the deep veins,
obstruction in the deep veins and
separate acute from chronic obstruction; also, recognize the impact of
Lectures
The lectures covered the following
topics: Basic principles, treatment of
varicose veins (conservative and operative), diagnosis and treatment of
chronic venous insufficiency (C3C6), management of acute deep vein
thrombosis (Conservative: anticoagulation, compression. Operative:
thrombus removal, inferior vena cava
filters). Comments by the chairmen
and discussion from the floor followed each presentation and generated sometimes passionate debates. In
addition to the 28 lectures a special
session on future education in venous
disease with emphasis on the value of
simulators was organized.
plete a placement of IVC filter in a
model and perform an IVC retrieval.
Medrad – Angiojet device. By the
end of the session the participants
were able to assemble and dismantle
the Angiojet device and correctly handle the catheter, know the correct
indications for the use of Angiojet
device, appropriately use adjuvant
infusion of thrombolytic agents
(Power Pulse), successfully perform
thrombectomy by using the Angiojet
thrombectomy device in a simulator
and understand the advantages and
possible side effects of using the
Angiojet device.
Covidien-Trellis. By the end of the
session the participants were able to
Figure 1
Case Reports
There were 14 case reports in total
(15 minutes each) were presented at
the beginning of the afternoon. They
were a stimulating mental exercise
after the gorgeous lunch served on the
terrace in front of the sunny beach.
Hands-on Workshops
The hands-on workshops were the
most original part of the meeting.
Every attendee was given a place in
a group of four people. The group
visited all 24 workshop stations
spending half an hour at the site.
After a demonstration by the faculty
member and/or industry expert in
charge, the group had the opportunity to practice under expert supervision, allowing each member to
have dedicated and personalized
advice on the procedure. (Figures 1,
2, 3, 4)
The hands-on workshops covered
many key venous disease topics
including Duplex investigations, inferior vena cava (IVC) filter
placement/thrombectomy, saphenous
ablation, compression techniques,
IVUS/stenting and stockings.
Duplex investigations
General objectives. By the end of the
session, the participants were able to
identify the anatomy of the veins and
the surrounding tissues, recognize
the ultrasonographic criteria for diagnosis of acute and chronic venous
disease and be acquainted with nonvenous pathology that may mimic
venous disease.
Lower limbs – normal findings.
The participants were able to identify superficial, deep and perforating
veins, use different testing manoeuvres for detecting reflux or/and
obstruction, recognize important
anatomic landmarks that are neces-
Figure 3
the superficial reflux on the deep
vein function.
Lower limb with perforator incompetence. The participants were able
to detect reflux in perforating veins
and recognize impact on the superficial vein function.
Abdominal and pelvic veins investigations. The participants were able to
identify the main deep veins from the
diaphragm to the inguinal ligament,
detect the compression of the veins
such as found in cases of nutcracker
and iliac vein compression syndromes, identify ovarian veins and
internal iliac veins and use different
testing manoeuvres to detect reflux.
Inferior vena cava (IVC) filter
placement/ thrombectomy
ALN – Optional filter. By the end of
the session the participants were able
to perform ALN IVC filter placement
in a model, acquire the specific techniques of filter placement including
tips and tricks to assure an efficient
position, and learn the techniques of
filter extraction including tips and
tricks to achieve filter retrieval and
avoid complications.
Cook – IVC filter. By the end of the
session the participants were able to
develop an IVC retrieval programme,
know the steps for placement of Cook
filter via jugular and femoral
approach including their respective
advantages and disadvantages, com-
identify the patients suitable for
treatment, satisfactorily prepare,
insert and use the Trellis device and
learn ancillary tips and tricks that
can improve thrombus extraction.
Saphenous ablation
AngioDynamics – laser ablation. By
the end of the session the participants were able to plan treatment,
decide dosage of energy, adjust the
generators accordingly, handle the
equipment adequately in collaboration with the nurse, access the vein
using micro puncture under ultrasound guidance, accurately place the
tip of the fibre at the saphenofemoral
junction under ultrasound guidance,
inject tumescent anaesthesia and
perform
the
ablation
using
VenaCureEVLT.
KLS Martin Group – laser ablation.
By the end of the session the participants were able to plan treatment by
the KLM laser generator, calculate
dosage, and set the correct parameters on the generator; also to access
the saphenous vein and place an
intra-luminal fibre under ultrasound
guidance in collaboration with a
nurse and ablate the saphenous vein
using the correct dosage.
Covidien-Radiofrequency ablation.
By the end of the session the participants were able to cannulate a vein
under ultrasound guidance, appropriately place the ClosureFast catheter
at the sapheno femoral confluence
using ultrasound, infiltrate adequate
tumescent anaesthesia and perform
saphenous ablation with the
ClosureFast catheter.
STD – foam sclerotherapy. By the
end of the session the participants
were able to correctly mix a sclerosing
agent with air to produce foam, make
a treatment plan for foam sclerotherapy, perform Duplex ultrasoundguided injection of foam, and apply
an appropriate compression bandage
following sclerotherapy.
understand best practices in venous
stenting procedures.
BCSI – Wall stent. By the end of the
session the participants were able to
understand the impact of the special
properties of a WALLSTENT on
stent placement, choose an appropriate stent length and size, know how
to use the IVUS to guide stent placement and adequately place a WALLSTENT in the femoro-illio-caval
vein segment.
Volcano – IVUS. By the end of the
session the participants were able to
understand the functionality of the
Volcano s5 IVUS tower, know the
multi-array design technology, identify the vessel lumen, locate side
branch or collateral vessels, identify
stenosis and access completeness of
treatment on IVUS images.
Compression techniques
CircAid Medical Products. By the
end of the session the participants
were able to understand the principles of inelastic, adjustable compression and the technology behind it,
understand the scientific background
to measurable therapeutic compres- Stockings
sion levels of CircAid technology and Bauerfeind – stocking. By the end
of the session the participants were
able to measure a leg, find the appropriate stocking-size by from tables,
apply long and short stretch medical
compression stocking, with and
without fitting aid, and differentiate
between highly elastic stockings and
short stretch stockings with high
working pressure.
BSN Jobst – stocking. By the end of
the session the participants were
able to select the right compression
system for the individual patient
and learn about different available
products, know how to measure a
Figure 2 leg and apply the appropriate stocking by hands-on experience, learn
about appropriate wound care
according to the wound status and
understand the benefit of medical
skin care.
Medi Germany – stocking. By the
end of the session the participants
were aware of the various qualities
and differences of different products
by measuring and trying on stockings
on each other; also, they learned the
appropriate size and indication of different types of compression stockings.
Sigvaris – stocking. By the end of the
session the participants were be able
Figure 4 to choose the correct compression
class for the proper indication, fill out
learn and practice how to apply the a prescription for stockings and place
Juxta-Fit line of CircAid products.
and remove a stocking using the state
Innothera – Tubulcus. By the end of of the art technique.
the session the participants were able
to apply Multilayer compression sys- Delegates
tem with Tubulcus, measure sub- The 2010 EVF workshop attracted
bandage pressure values using 114 delegates including angiologists,
Picopress and Kikuhime devices and phlebologists, vascular, general surto determine static stiffness index geons and vascular technologists
and achieve different levels of sub- from 38 countries. The feed back
bandage pressure using Multilayer from participants, faculty and induscompression system with Tubulcus.
trial partners was enthusiastic. The
Lohman and Rauscher – bandage. interaction between the three parties
By the end of the session the partici- was stimulating and something new
pants were able to apply a good short for the industry. A pre- and post
stretch bandage which could stay on MCQ test showed an improvement
the leg for one week, register and feel from 38% to 70% which is signifithe resting and working pressures on cant. The aim of this first EVF
their own leg and understand the hands-on workshop to give the parmode of action of a haemodynamical- ticipants a global experience of the
ly effective compression.
new procedures in acute and chronic
Mentice – Simulator. By the end of venous disease was accomplished.
the session the participants were able The second EVF hands-on workshop
to understand the use of a Mentice will take place in Vienna, Austria
VIST-C simulator for vascular train- October 20-22, 2011. I recommend
ing, become familiar with the differ- that you apply early to secure a slot –
ent concepts of IVC filters and were last year more than 50 applicants
able to perform the steps for place- were too late.
ment of an Angiotech IVC filter in
Workshop contact details: [email protected] simulator.
IVUS/ stenting
Cook – Zilver Vena Stent. By the end
of the session the participants were
able to deploy a Zilver Vena stent in a
vein, place the Zilver Vena stent adequately in the iliofemoral vein and
peanvenousforum.org, www.euroeanvenousforum.org
Corresponding author:
M Perrin,
Clinique Du Grant, 2 Avenue Leon
Blum, 69150 Decines, France.
Email: [email protected]
June 2011
17
Save the date!
28–30 June 2012
13th annual meeting of the
European Venous Forum
Florence, Italy
President:
Professor G Mosti
For further details please contact
Anne Taft
European Venous Forum, PO Box 172,
Greenford, Middx, UB6 9ZN, UK
Tel/Fax: +44 (0)20 8575 7044
email: [email protected]
www.europeanvenousforum.org
Second EVF Hands-On Workshop
on Venous Disease
Eventhotel Pyramide, Vösendorf, Vienna, Austria
20–22 October 2011
We invite you to participate in the 2nd EVF Hands-on workshop in
Vienna. The first workshop in Cyprus November 2010 was, according
to evaluation of participants, faculty and our industrial partners, very
successful. We accepted only 100 participants and had to deny another 50 applicants the opportunity to attend.
We will offer a unique opportunity to get a global hands-on experience
on the new methods to diagnose and treat acute and chronic venous
disease such as duplex ultrasound scanning, saphenous ablation using
laser, radiofrequency, steam or foam sclerotherapy, insertion of stents
and IVC filters, use of venous IVUS, pharmacomechanical thrombectomy and compression techniques.
The participants will interact with the renowned faculty and skilled
industry representatives, who will all be available at the 20 workstations during the entire three days.
The daily format is morning presentations (30) followed by illustrative
clinical problem cases discussed in dialogue with the participants (14).
15 hours in the afternoons are dedicated to hands-on workshops.
Registration fee is £500. Attendance is limited to 100 delegates and
will be on a first come basis.
Organizing Committee:
Bo Eklöf
Peter Neglén
Andrew Nicolaides
Jan Christenson
Alfred Obermayer
Bernhard Partsch
For further details please contact
Anne Taft
European Venous Forum, PO Box 172,
Greenford, Middx, UB6 9ZN, UK
Tel/Fax: +44 (0)20 8575 7044
email: [email protected]
www.europeanvenousforum.org
June 2011
18
ous harm from filter migration and fracture.
Excimer laser-assisted
IVC filter retrieval
ccording to the preliminary results from a
study that examined
excimer laser-assisted inferior
vena cava (IVC) filter retrieval,
the techniques developed for
cardiac device lead extraction
also works when retrieving filters that could not be removed
with conventional retrieval
methods.
Presenting the research from
the first 25 consecutive cases
attempted at the Society of
Interventional Radiology meeting, Dr William Kuo, Stanford
University Medical Center, in
Palo Alto, CA, and colleagues,
said the 10 men and 15
women needed their IVC filters removed to reduce risks
associated with prolonged
implantation or because complications such as symptomatic filter-related caval
thrombosis, chronic IVC
occlusion and bowel penetration had already occurred.
Most of the patients sought
A
treatment at Stanford, which
specializes in complex filter
removal, only after standard
methods to snare the device
and pull it into a sheath for
extraction failed at other hospitals.
There, Kuo's team used
ablative laser blasts from a
catheter tip designed for
lead extraction. Some of
the IVC filters removed
had been in place for
years, including one that
had been in place for
more than 18 years.
The procedure failed
in only one of the
25 cases
attempted
(4%). The
failure
involved
an
Optease
filter
that had
been
implanted 188
days prior.
One major complication
occurred when the laser dislodged material resulting in an
acute thrombus, which was
treated by thrombolysis.
Another three cases of small
leakages of blood from the
treated vessel wall
occurred but were selflimited and didn't require
treatment. One adverse
event, coagulopathic
retroperitoneal haemorrhage, was seen at followup 126 days after the
procedure.
Kuo said that
this use of
the laser
system
was
experimental
and that
every
complex
filter
William Kuo
removal case presents unique
challenges. "The majority of
filters come out without any
difficulty. But for the few
stuck by tissue overgrowth
people have reported serious
complications by trying to
remove these by force, and
that's not what should be
done."
He predicted that the problem will become less common
now that the FDA has drawn
attention to the need to follow
patients and remove IVC filters as soon as the risk of pulmonary embolism and other
venous embolic events has
subsided to reduce risk of seri-
Increasing filter
retrieval rates
Dr Ramona Gupta,
Northwestern University in
Chicago, , MD, and colleagues
have reported at the Society of
Interventional Radiology meeting, that by establishing a clinic dedicated to IVC filter management, the filter retrieval
rate increased from 29% to
62% (p<0.001).
Taken together -- the higher
patient retention and longer
filter use -- maximized the filter's availability to fight thromboembolic risk during the high
risk period while at the same
time reducing possible complications by prompt removal
once that period is over, she
suggested.
According to Gupta,before
Northwestern instituted a filter clinic in January 2009,
there had been no routine
coordinated follow-up for these
patients. The clinic employed
dedicated interventional radiologists and a dedicated clinical
nurse coordinator, who did
most of the work phoning
After a follow-up conducted at 35 days (to
determine the superiority of rivaroxaban), the
study team saw that rivaroxaban performed
significantly better than enoxaparin followed
by placebo, with 4.4% of patients experiencing the primary efficacy outcome compared
to 5.7%, respectively (relative risk ratio
0.771, p=0.0211 for superiority, two-sided).
n extended course of the oral anticoWhen the team examined the primary safeagulant rivaroxaban may prevent
ty outcome, however, they found that the
venous thromboembolism (VTE)
enoxaparin group demonstrated a significantbetter than the current standard treatment
ly reduced rate of bleeding than the rivaroxafor acutely-ill medical patients, claim
ban group at both ten and 35 days.
researchers. However, the better efficacy
Specifically, 1.2% of patients in the enoxacame at the cost of increased bleeding when
parin group experienced some kind of clinicalthe drug was used.
ly relevant bleeding at the ten-day point, comAccording to research presented by Dr
pared to 2.8% of patients in the rivaroxaban
Alexander T Cohen, King's College London,
group (relative risk ratio=2.3; p<0.0001). At
UK, at the American College of Cardiology’s
35 days, 1.7% of patients in the enoxaparin
60th Annual Scientific Session in April, matic thromboembolic events and 70% to group experienced clinically relevant bleeding,
rivaroxaban, a direct factor Xa inhibitor, 80% of fatal pulmonary embolism occur in compared to 4.1% of patients in the rivaroxashowed non-inferiority to subcutaneous non-surgical patients,” said Dr Cohen. ban group (relative risk=2.5; p<0.0001).
enoxaparin over ten days, and superiority to “Thus, this study population of acutely ill Therefore, a consistent net clinical benefit
enoxaparin followed by placebo in long-term medical patients is an important group in with rivaroxaban could not be established in
use over 35 days, in the prevention of VTE which to test the optimal therapy for pre- the heterogeneous population studied.
in acutely ill hospitalised patients.
venting VTE.”
Cohen said that while rivaroxaban’s signifHowever, despite finding low levels of
The MAGELLAN study used 8,101 icantly higher bleeding rate was a surprising
bleeding across the study, Cohen and his col- patients from 52 countries, treating half finding, the rates of other adverse events –
leagues reported that there was a statistical- with rivaroxaban for 35 days and half with including cardiovascular problems, impacted
ly significant increase in the rate of bleeding enoxaparin for ten days. Both groups also liver function, and mortality – were similar
associated with rivaroxaban, compared to received either an oral or subcutaneous in both groups.
enoxaparin.
placebo to counteract any possible effect of
He emphasised, however, that the
Cohen said that the mixed results called the different methods of administration.
researchers were not using the usual
for the further study into the efficacy of
The study’s primary efficacy outcome was Thrombolysis in Microcardial Infarction cririvaroxaban. “As observed in previous stud- a composite of asymptomatic proximal deep teria, and had a much broader definition
ies in this area, we found an ongoing risk of vein thrombosis (detected by ultrasonogra- encompassing a fall of haemoglobin of 2g/dL
VTE past the initial period of hospitaliza- phy), symptomatic deep vein thrombosis, or more and transfusion of two or more units
tion,” he said. “We did not see
of blood, along with fatal cases. Dr
a consistently positive benefit- We did not see a consistently positive
Byron Lee, University of California
risk balance with rivaroxaban
San Francisco, and co-chair of the
use, and thus further analysis benefit-risk balance with rivaroxaban use”
Scientific Session, said that if the
is required to identify which
group had chosen to define bleedgroups of patients may derive
ing risk more in line with other tribenefit from thromboprophylaxis with symptomatic
non-fatal
pulmonary als, the difference in results would have led to
rivaroxaban.”
embolism, and VTE-related death. The pri- the study supporting rivaroxaban.
“The drug did work,” he added. “We had mary safety outcome was a composite of
Subgroup analyses might determine which
very low bleeding rates, but we still had more treatment-related major bleeding and clini- patients get more net benefit from rivaroxableeding.”
cally relevant non-major bleeding.
ban, Cohen suggested.
The researchers used data from the MAGAfter a follow-up conducted at ten days (to
But he cautioned against generalising
ELLAN study, a phase III clinical trial that determine the non-inferiority of rivaroxa- these results to other populations, since the
compared rivaroxaban with subcutaneous ban), the researchers found that the two sick patients included in MAGELLAN may
enoxaparin in patients admitted to the hos- drugs performed to the same level with head home to a low mobility lifestyle after
pital for an acute medical condition (includ- regard to the primary efficacy outcome, with leaving the hospital.
ing acute heart failure, acute infectious dis- 2.7% of patients in both drug cohorts experiThe study was funded by Bayer
ease, and acute respiratory insufficiency).
encing this endpoint (relative risk HealthCare, the manufacturers of rivaroxa“VTE is often associated with recent sur- ratio=0.968; p=0.0025 for non-inferiority, ban, and Johnson & Johnson Pharmaceutical
gery or trauma, but 50% to 70% of sympto- one-sided).
Research & Development.
MAGELLAN study ambivalent
on long-term superiority of
rivaroxaban over enoxaparin
A
patients and keeping track of
them in a comprehensive database.The clinic contacted referring physicians and patients
two weeks after filter placement and the correspondence
continued until the filter was
removed or converted to permanent status as a result of a
clinical decision.
Only 0.6% of the 165 IVC
filter patients seen in 2009
after the clinic was established
were lost to follow-up compared with 10% of the 369
with IVC filters placed from
2000 to 2008 before the clinic
(p<0.0001).The duration of
implantation rose from 0.55 to
1.13 months between the two
periods as well (p<0.001),
which Gupta suggested maximised the benefit of the
device.
The increase in filter
retrievals did not appear to be
related to technical failures
and was against a backdrop of
rates in the pre-clinic period
that were not out of the ordinary, compared with historic
controls.The researchers did,
however, caution that their
data were limited and based on
retrospective review.
First medical
device to both
prevent and
detect venous
obstruction
receives FDA
clearance
he ActiveCare+Dx, the first device with the
ability to both detect and prevent venous
obstructions, has been given marketing
clearance by the FDA.
The device, created by Medical Compression
Systems (MCS), is claimed to be the only product
which can simultaneously prevent venous obstruction and detect when prevention has failed during
prophylactic therapy, alerting the wearer when a
clot has formed. It is currently planned to be
released in 2012.
Prevention of deep vein thrombosis fails 5%-6%
of the time among post-orthopedic surgery
patients undergoing preventative drug or device
therapy. MCS claim that the use of
ActiveCare+Dx will allow the quicker identification of failed prevention, leading to earlier treatment and the reduced occurrence of life-threatening symptoms.
Adi Dagan, the CEO of MCS, said: “We are
happy to receive FDA clearance for ActiveCare+Dx.
This product meets a significant need, especially in
the market of deep vein thrombosis prevention,
where complications could be fatal.
“About 90% of the deep vein thrombosis cases
are invisible and will not be diagnosed until clinical signs and symptoms are already presented,”
said Dagan. “Their first presenting symptom can
be pulmonary embolism or death.”
The new product is a development of MCS’ first
device, the ActiveCare+S.F.T, which is marketed
as the only non-pharmaceutical mechanical therapy on the market with published data. Intended as
an alternative to anticoagulant drugs, it works
through applying intermittent, sequential compression to the legs in a systematic pattern,
increasing the speed of blood flow in the veins
and reducing the risk of clot formation.
T
June 2011
20
Gene variant links colorectal cancer
with thrombosis
Researchers at the German Cancer
Research
Center
(Deutsches
Krebsforschungszentrum, DKFZ) in
Heidelberg, led Professor Hermann
Brenner have been studying six gene variants of different clotting factors for a possible connection with colorectal cancer risk.
In a large study, they analyzed the occurrence of these six variants in approximately 1.800 colorectal cancer patients and in
the same number of healthy control persons.
The team found the most obvious connection for a variant that substantially
increases the risk of thrombosis and which
is known as factor V Leiden (FVL). Study
participants who carry this genetic variant
on both copies of their chromosome 1 were
found to have a six fold increase in colorectal cancer risk compared to participants
who carry two copies of the ’standard variant’ of factor V. If only one copy of chromosome 1 had the FVL variant, bowel cancer
risk was not elevated.
Another connection with bowel cancer
prevalence was found by the research team
for a particular gene variant of clotting factor XIII: People with this mutation are
slightly more rarely affected by venous
thrombosis than those who carry the factor XIII standard version. Now the DKFZ
team has shown that their colorectal cancer risk is also 15 percent lower. For the
other four gene variants studied the team
found no connection with bowel cancer
risk.
It is believed that understanding these
connections is the first prerequisite for
finding out whether and for whom drugs
that affect blood clotting may prevent
bowel cancer.
Menstrual cycle could affect varicose
vein diagnosis
According to a small exploratory study presented at the Society of Interventional
Radiology meeting, where a woman is in
her menstrual cycle may affect varicose
vein diagnosis. Women complaining of
classic symptoms of varicose veins but no
abnormalities in the long saphenous vein
presented a very different picture when
they returned right before their menstrual
period or when symptomatic, according to
researchers Drs Praveen Anchala and Scott
Resnick both of Northwestern University.
In a study of five such women, four had
significant saphenous vein insufficiency
on subsequent evaluation, they reported
here. Long saphenous vein diameter rose
73% on average between the evaluations.
Progesterone, which peaks in the week
or so prior to menstruation, may be to
blame, Anchala noted. The hormone has
been shown to dilate veins throughout the
body, possibly because of effects on nitric
oxide, he explained. Older studies have
supported greater venous distensibility in
women relative to their menstrual cycle.
He added that the menstrual cycle may
be just one variable to add to the multifactorial diagnosis and cautioned that an even
bigger problem than confounding in the
small study was likely recall bias.
All five of the women with repeat testing
after an initially ‘normal’ venous classification were asked to return because they said
something that made the clinician think
the menstrual cycle was involved. The
mean age of 36 among the four women
whose return evaluations revealed saphenous vein insufficiency not apparent initially contrasted with that of the one
patient, age 50, who still showed no reflux
on return.
VenUS II: Ultrasound does
not aid ulcer healing rates
According the results from the VenUS II randomised controlled trial (Use
of weekly, low dose, high frequency ultrasound for hard to heal venous leg
ulcers) recently published in the British medical journal (EA Nelson. BMJ,
2011; 342), low dose, high frequency ultrasound administered weekly for
12 weeks during dressing changes in addition to standard care did not
increase ulcer healing rates, affect quality of life or reduce ulcer recurrence.
ccording to the study authors from the
University of Leeds, VenUS II was
undertaken to assess the clinical effectiveness of weekly delivery of low dose, high frequency therapeutic ultrasound in conjunction
with standard care for hard to heal venous leg
ulcers.
Leg ulceration is a chronic, recurring condition that affects 1.5–1.8% of adults in industrialised countries (with venous leg ulcers representing up to 84% of leg ulcers) and has a considerable impact on health and quality of life.
High compression bandaging is effective treatment, healing most new venous leg ulcers (<6
months’ duration) within a year. The priority is
now to increase healing in ulcers with poorer
prognostic profiles (bigger and older ulcers).
Ultrasound therapy is a standard treatment
option for soft tissue injuries in physiotherapy
clinics, and it is used in some centres for the
management of chronic wounds and is recommended in some clinical practice guidelines. It
is thought that using low intensity ultrasound
(≤3 W/cm2) can be used to stimulate normal
physiological responses to injury to aid repair.
Other ultrasound regimens, delivered in a water
bath, have been used with the primary aim of
debriding wounds.
To investigate this further, they conducted a
randomised controlled trial to compare the
effect of standard ulcer care alone with standard
care plus ultrasound treatment. Time to healing
of the reference ulcer, health related quality of
life, proportion of participants with ulcers
healed at 12 months, percentage and absolute
change in ulcer size, adverse events, and cost of
treatments were all recorded.
A
was inestimable. There was no significant difference between groups in the proportion of participants with all ulcers healed by 12 months
(72/168 in ultrasound group v 78/169 in standard care group, p=0.39) nor in the change in
ulcer size at four weeks by treatment group
(0.05 (95% CI –0.09 to 0.19)).
Of the 133 participants with photographically confirmed healing of their reference ulcer,
124 were successfully contacted later to ascertain whether their ulcer had recurred. The
remaining participants were not contacted for
various reasons (including invalid or changed
ence in adverse events due to treatment
received (model estimate 0.23 (–0.34 to 0.79),
p=0.39) or baseline use of compression bandaging (model estimate –0.16 (–0.98 to 0.65),
p=0.66). The investigators found weak evidence that larger baseline ulcer area and longer
baseline ulcer duration were associated with
more serious adverse events (model estimates
0.19 (–0.03 to 0.40), P=0.08, and 0.22 (–0.02
to 0.45), P=0.06, respectively).
The number of non-serious adverse events
was significantly associated with the treatment
received, with more events in the ultrasound
group than the standard care group (model estimate 0.35 (0.02 to 0.67), p=0.04) but was not
related to baseline ulcer area (model estimate
0.05 (–0.08 to 0.17), p=0.42), baseline ulcer
duration (model estimate 0.08 (–0.06 to 0.22),
p=0.24), and baseline compression use (model
estimate −0.003 (–0.46 to 0.47), p=0.99).
Conclusions
The researchers concluded that there is no evidence of a benefit in terms of time to ulcer healing, probability of ulcer having healed at 12
months, rate of reduction in ulcer area, or
health related quality of life for people with hard
1.0
Standard care only
Ultrasound plus standard care
Proportion with unhealed ulcer
NEWS IN BRIEF
0.8
0.6
0.4
0.2
0
0
50
100
150
200
Time (days)
250
300
350
Figure 1: The time to healing of the reference leg ulcer
telephone number, telephone not answered, and
patient moved). Overall, the reference ulcer had
recurred in 31 (25%) of the 124 participants (14
Study design
(45%) from the standard care group, 17 (55%)
Between January 2006 and December 2008, from the ultrasound group). There was no sig1,488 people with leg ulcers were screened nificant difference in the recurrence rates
across 12 centres, and 337 (22.6%) were ran- between the two groups (P=0.68 for Fisher’s
domised to receive a weekly administration of exact test).
low dose, high frequency ultrasound therapy
There was no difference in time to complete
(0.5 W/cm2, 1MHz, pulsed pattern of 1:4) for up healing of all ulcers (p=0.61), with median
to 12 weeks plus standard care (n=168), com- time to healing of 328 days (95% CI 235 to
pared with standard care alone (n=169). The inestimable) with standard care and 365 days
patients received their treatment via a district (224 days to inestimable) with ultrasound.
nurse led services, community leg ulcer clinics, There was no evidence of a difference in rates
and hospital outpatient leg ulcer clinics in 12 of recurrence of healed ulcers (17/31 with
urban and rural settings (11 in the United ultrasound vs. 14/31 with standard care,
Kingdom and one
p=0.68). There
in the Republic of
was no differ“There really is no need for the
Ireland). Patients
ence
between
recruited to the
the two groups
NHS to provide district nurses
study presented
in health related
with at least one
quality of life,
with ultrasound machines. This
venous leg ulcer
both for the
of >6 months’
would not be money well spent.” physical compoduration or >5
nent
score
cm2 area and an
(model estimate
ankle brachial pressure index of ≥0.8.
0.69 (–1.79 to 3.08)) and the mental compoThe primary outcome was time to healing of nent score (model estimate –0.93 (–3.30 to
the largest eligible leg ulcer. Secondary out- 1.44)), but there were significantly more
comes were proportion of patients healed by 12 adverse events in the ultrasound group (model
months, percentage and absolute change in estimate 0.30 (0.01 to 0.60)). There was also a
ulcer size, proportion of time participants were significant relation between time to ulcer healulcer-free, health related quality of life and ing and baseline ulcer area (hazard ratio 0.64
adverse events.
(0.55 to 0.75)) and baseline ulcer duration
(hazard ratio 0.59 (0.50 to 0.71)), with larger
Results
and older ulcers taking longer to heal. In addiThe two groups showed no significant differ- tion, those centres with high recruitment rates
ence (Figure 1) in the time to healing of the ref- had the highest healing rates.
erence leg ulcer (p=0.61). After adjustment for
There were 88 serious adverse events in 64
baseline ulcer area, baseline ulcer duration, use participants: 29 participants (45%) in the stanof compression bandaging, and study centre, dard care group and 35 (55%) in the ultrasound
there was still no evidence of a difference in group. There were 445 non-serious adverse
time to healing (hazard ratio 0.99 (95% confi- events in 153 participants: 67 (44%) were in the
dence interval 0.70 to 1.40), P=0.97). The standard care group and 86 (56%) in the ultramedian time to healing of the reference leg ulcer sound group. There were no significant differ-
to heal ulcers treated with weekly administration of low dose, high frequency, adjuvant ultrasound therapy (0.5 W/cm2, 1MHz, pulsed pattern of 1:4) for up to 12 weeks.
“The ‘healing energy’ of low-dose ultrasound
can make a difference to some medical conditions but with venous leg ulcers, this is simply
not the case,” said Professor Andrea Nelson
from the University of Leeds’ School of
Healthcare, who led the study. “The key to care
with this group of patients is to stimulate blood
flow back up the legs to the heart. The best way
to do that is with compression bandages and
support stockings coupled with advice on diet
and exercise.”
The researchers concentrated on 'hard to
heal' ulcers that had not cleared up after six
months or longer. Drawing on patients from
across the UK and Ireland, they found that
adding ultrasound to the standard approach to
care -- dressings and compression therapy -made no difference to the speed of healing or
the chance of the ulcers coming back.
Ultrasound also raised the cost of care per
patient by almost £200.
"Rising levels of obesity mean that the number of people who suffer from legs ulcers is likely to grow. We do need to find ways to helping
those patients whose ulcers won’t go away, but
our study shows that ultrasound is not the way
to do that. We need to focus on what really matters, which is good quality nursing care,” concluded Nelson. “There really is no need for the
NHS to provide district nurses with ultrasound
machines. This would not be money well spent.
Implications for clinicians are that there is no
evidence to support the addition of ultrasound
therapy to treatments for people with hard to
heal leg ulcers.”
The study was funded by the National Institute for
Health Research (NIHR) Health Technology
Assessment Programme (HTA) and can be downloaded at:
http://www.hta.ac.uk/fullmono/mon1513.pdf
June 2011
22
CT scans unnecessary
for the diagnosis of
venous thromboembolism
sing computed tomography (CT) to scan the
pelvis is not necessary for the diagnosis of
venous thromboembolism (VTE) in patients
suspected of having a pulmonary embolus, according to
a new study.
Eliminating its use decreases the dose of radiation the
patient receives without significantly affecting the diagnosis, said Dr Charbel Ishak, the leader of the study.
"Radiologists and technologists can eliminate pelvic
imaging while acquiring only images of the lower
extremities with CT venography, starting from groin to
below the knee,” Ishak said. “We believe that by stopping the imaging of the pelvis, we can decrease patient
radiation dose without significantly affecting the diagnosis of VTE."
Presenting his findings at May’s American Roentgen
Ray Society in Chicago, Ishak, of the Nassau University
Medical Center in New York, said that said that he and
his team had reviewed data on 1,527 consecutive
U
patients who visited their large community medical
center between 2006 and 2008 and who had concomitant CT pulmonary angiography (CTPA) and CT lower
extremity venography (CTLV) to assess for pulmonary
embolism (PE) and VTE in the pelvis and bilateral lower
extremities.
The study found that only five out of 1,527 patients
(0.3%) presented with isolated pelvic VTE after pulmonary embolism was ruled out of the CT protocol.
The investigators also found that isolated pelvic VTE
was present in 3.3% of all CTLV showing evidence of
VTE. They found no significant statistical difference in
the detection of VTE that resulted from the inclusion or
exclusion of the pelvis in the CTLV.
Presenting his findings at May’s American Roentgen
Ray Society in Chicago, Ishak said that his study was
promising for helping radiologists implement new protocols for pelvic examination and reducing further radiation in patients.
New pulmonary embolism
diagnostic algorithm developed
new diagnostic algorithm for
acute pulmonary embolism (PE)
has been developed by
researchers from the Université
Européenne de Bretagne. A trial of the
system gave a noninvasive diagnosis in
the majority of outpatients with suspected PE and “appeared to be safe”,
according to the researchers.
A
The algorithm uses clinical probability
assessment, plasma D-dimer testing,
then sequential testing to include lower
limb venous compression ultrasonography, ventilation perfusion lung scan, and
chest multidetector computed tomography (MDCT) imaging. Its use avoids
invasive methods like pulmonary
angiography.
"Our study allows safe and noninvasive exclusion of the diagnosis in the
vast majority of outpatients with suspected PE without the use of chest
MDCT scan," said Dr Pierre-Yves
Salaun, leader of the study.
The algorithm, which was described
in the June issue of Chest (Chest June
2011 139:6 1294-1298), was tested on
INDORSE study shows ‘alarming’
rates of DVT among Indian population
he outcomes from the INDORSE (Indian
Observational Survey Of VenousThromboembolism Risk and Prophylaxis
(prevention) in the Acute Care Hospital Setting)
survey have shown that 67% of hospitalized
patients in India are at risk of deep vein thrombosis (DVT).
Supported by the Sanofi-Aventis Group, the
INDORSE survey aimed to identify hospitalized patients across the country at risk of VTE
T
and determine the proportion of patients who
received any mode of VTE prophylaxis (prevention). It further aimed to determine the rate of
prophylaxis based on risks such as age, immobilisation, obesity; and disease-related risks like
sepsis, stroke and major surgery.
The 2009 survey showed that of the 7.481
hospitalized patients from 46 hospitals across
11 states in India, 67% were at the risk of DVT
and only 19% of these patients were given any
321 consecutive patients with clinically
suspected PE and positive d-dimer or
high clinical probability. Patients in
whom venous thromboembolism was
deemed absent were not given anticoagulants and were followed up for three
months.
Ultrasonography established the diagnosis of PE in 43 patients (13%), and
kind of prophylaxis (prevention). The southern
states showed the highest rate of DVT prophylaxis and the north-east region the least.
VTE is no longer a rarity in India and its mortality rate is significantly underestimated as
80% of the disease is asymptomatic, and hospitalised patients most prone to risk.
Thromboprophylaxis is a common error of
omission in hospitalised patients.
“This data clearly shows the discrepancy that
exists with regards to DVT prophylaxis in India
as compared to Western countries. In the global
ENDORSE study, it was seen that 52% of hospitalised patients are at risk of DVT with 505
receiving ACCP-recommended DVT prophylax-
is. In the Indian data, INDORSE, though we
have 67% of hospitalised patients at risk of DVT,
only 19% received prophylaxis. We thus need to
put in concerted efforts to improve patients' safety in hospitals through thromboprophylaxis,”
says Dr Muruga Vadivale, Senior Director,
Medical & Regulatory, Group Sanofi-Aventis.
At least 98 per cent of the patients
screened, age was considered as the most
common risk factor for DVT prophylaxis, 60
per cent of the patients were between 40 and
70 of age with a low prophylaxis rate of 20 per
cent. The data showed the discrepancy with
regards to DVT prophylaxis in India as compared to Western countries.
RIETE registry: Thrombolytic agents no more
effective than traditional therapy for PE
ccording to a study conducted
by researchers in Spain and
the US, thrombolytic agents
do not appear to be any more effective
than traditional blood thinners for
the treating pulmonary embolism
(PE). The thrombolytic agents also
appear to increase the risk of death in
patients with normal blood pressure.
The study utilized data from
patients enrolled in the Registro
Informatizado de la Enfermedad
Trombo Embólica (RIETE registry), a
computerised registry of patients who
have thrombosis, including PE. The
researchers reviewed the health information of 15,944 registry enrolled
patients with confirmed symptomatic acute PE to determine if
thrombolytic therapy caused an effect
on patient mortality during the first
three months after diagnosis.
A
The researchers analysed data from
15,944 patients with acute PE
enrolled in the RIETE registry.
Thrombolytic therapy had been used
in 2.7% (430) of the patients. In general, those patients were younger, had
fewer comorbid conditions, and more
signs of clinical severity. In order to
overcome that bias, a propensity
analysis was conducted in order to
match patients for those differences.
Comparing
94
propensity
score–matched patients with systolic
hypotension who received thrombolysis with 94 patients who did not,
there was a non-significant trend in
reduction in all-cause mortality with
thrombolytic therapy (odds ratio of
0.72).
For two groups of 217 normotensive patients each who received or did
not receive thrombolysis, there was a
statistically significant increased risk
of death for those receiving thrombolysis (odds ratio 2.32). However, when
missing troponin and echocardiogram data were added to the analysis,
the effect of thrombolysis was no
longer significant (odds ratio 1.67).
“The reasons for the increased risks
from thrombolysis for normotensive
patients with PE are not entirely
clear,” said study author David
Jiménez, Senior Consultant for the
Respiratory Department at the
Ramón y Cajal Hospital and Alcalá
de Henares University in Madrid.
Jimenez said that because the risk
of dying from pulmonary embolism is
low among normotensive, haemodynamically stable PE patients, those
patients’ risk of dying from thrombolysis is therefore elevated by comparison and approaches that of hypoten-
lung scanning associated with clinical
probability was diagnostic in 243 (76%)
of the remaining patients. Only 35
(11%) of the patients in the study
required MDCT to diagnose PE.
The 3-month thromboembolic risk in
patients deemed not to have PE under
the diagnostic strategy was 0.53%
(95% CI, 0.09-2.94).
sive patients. Only half of all patients
with PE actually die of the embolism,
while the rest die of other causes such
as infections, cancer and bleeding.
“The results of our study do not
support the use of thrombolytic
agents in most patients with acute
symptomatic pulmonary embolism,”
said Jiménez. “The primary finding of
the study was expected, as there are
no large randomized clinical trials
that demonstrate the benefit of
thrombolytic therapy on patient survival,” said Jiménez. “However, it was
surprising to note that thrombolytic
therapy was associated with worsened survival in PE patients with stable blood pressure.Unless further
information that suggests otherwise
becomes available, the guidelines for
treatment of patients with PE should
not recommend thrombolytic therapy
for patients who have normal blood
pressure,” he said.
“Investigators also should conduct
prospective studies to assess if cardiac
biomarkers and/or imaging testing
might identify those patients with
low blood pressure who are at highest
risk of death and who might benefit
from thrombolytic therapy.”
The study investigators are currently carrying out a study and hope
to enrol 1,000 patients at 12
European centres, with the aim of
publishing data by the end of 2012.
June 2011
23
Forthcoming events
If you would like to list your events here please email the details to:
[email protected]
20–22 October
Second EVF Hands-On Workshop on
Venous Disease
Eventhotel Pyramide, Vösendorf,
Vienna, Austria
July 1–3
12th Annual Meeting of the
EUROPEAN VENOUS FORUM (EVF)
in collaboration with the Slovenia
Society of Vascular Disease
Ljubljana, Slovenia
Contact information
Email: [email protected]
or [email protected]
www.europeanvenousforum.org
Contact information
Anne Taft
Phone: +44 (0)20 8575 7044
Fax:
+44 (0)20 8575 7044
email: [email protected]
www.europeanvenousforum.org
November 4–7
Los Angeles, California
www.acpcongress.org
For your FREE subscription delivered
as a pdf or mailing copy (provide
mailing address), please email:
[email protected]
Alternatively, please email us if you
would like to see past issues.
Contact information
Phone: +44 (0)20 7973 0306
Fax:
+44 (0)20 7430 9235
Email: [email protected]
June 28–30 2012
13th annual meeting of the
European Venous Forum
Florence, Italy
Prague, Czech Republic
Phone: +420 224 942 575, 224 942 579
Fax:
+ 420 224 942 550
E-mail: [email protected]
Web: www.iupcongress2011.cz
Contact information
November 16–20
VEITHsymposium
New York City, USA
Phone: +1 845 368 0069
Fax:
+1 845 368 2324
Email: [email protected]
or [email protected]
Not only is Venous Times mailed to our readers (as
either a pdf or postal copy), we also distribute the
newspaper at all of the major venous and phlebology
meetings in the conference calendar.
Brighton, UK
The UIP European Chapter Meeting
Contact information
Venous Times is the only newspaper dedicated
solely to the diseases and conditions of the
venous system and its various treatments.
Although there are a number of newspaper
publications concerning the arterial system,
there is no other publication that focuses
exclusively on the venous system. This unique
publication reports on new developments, key
opinions and the latest news from conferences,
including expert opinions, debate,
controversies and much more…
Vascular Society of Great Britain &
Ireland
American College of Phlebology
Contact information
September 15–17
November 23–25
Anne Taft
Phone: +44 (0)20 8575 7044
Fax:
+44 (0)20 8575 7044
email: [email protected]
www.europeanvenousforum.org
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