Jihad Mustapha, MD
Transcription
Jihad Mustapha, MD
NCVH Continues to Focus on Patient Care, Global Reach Thursday Highlights A 7:00 – 7:50 a.m. Breakfast Symposium Crescent City Ballroom, Mezzanine Level 8:00 a.m. – 6:00 p.m. General Session Crescent City Ballroom, Mezzanine Level 9:00 a.m. – 4:00 p.m. Exhibit Hall Open Roosevelt Ballroom, Mezzanine Level 10:00 a.m. – 5:00 p.m. The Business of Wound Care Chambers I & III, Mayor’s Suite Level 10:00 a.m. – 7:00 p.m. Multidisciplinary Nursing for Limb Preservation Orpheum Ballroom, Second Level 12:10 – 12:50 p.m. Lunch Symposia 1:30 – 6:00 p.m. Coronary Artery Disease: Update for Primary Care Physicians Chambers II & IV, Mayor’s Suite Level Attendees focus on the live case presentation led by Dr. Frank Bunch on Wednesday morning, as the panel discusses the case with Dr. Bunch. Today’s Live Case Schedule 8:40 – 9:00 a.m. Thomas Zeller, MD UniversitätsHerzzentrum Freiburg Bad Krozingen Bad Krozingen, Germany 9:00 – 9:20 a.m. Jihad Mustapha, MD Metro Health Hospital Wyoming, MI 10:40 – 11:00 a.m. Thomas Zeller, MD UniversitätsHerzzentrum Freiburg Bad Krozingen Bad Krozingen, Germany 10:50 – 11:10 a.m. Jihad Mustapha, MD Metro Health Hospital Wyoming, MI Inside This Issue Clinical Data................. 3 Podiatry/Wound Care... 4 AAA Outreach............11 MLMC 5k....................12 12:20 – 12:40 p.m. D. Christopher Metzger, MD Wellmont CVA Heart Institute Kingsport, TN (Chambers I and III) 12:20 – 12:40 p.m. Jihad Mustapha, MD Metro Health Hospital Wyoming, MI (Orpheum Ballroom) 1:250 – 2:10 p.m. D. Christopher Metzger, MD Wellmont CVA Heart Institute Kingsport, TN s NCVH grows in scope, the mission remains the same: to bring different specialties together and establish peripheral artery disease (PAD) as a marker of high risk for cardiovascular death and disability. “This was an idea born out of simply helping patients, and originally educating locals, and now it has spread over the world,” said NCVH Course Chairman Craig Walker, M.D., as he welcomed attendees on Wednesday morning. “We’re not just this meeting. With regional meetings, three in China and one in Latin America, we have formed a family. It’s beyond what we ever dreamed.” And attendees are taking what they learn back to their patients. Dr. Walker said they receive letters from past attendees reporting that attending NCVH has resulted in better patient care at their facilities. PAD patients who were once out of options are now receiving treatment. “There’s been an explosion in the number of endovascular procedures being performed,” said Dr. Walker. “There have been profound advancements in technologies and treatment options for helping treating PAD. These breakthroughs allow for safer and more effective treatment. We can now treat patients who previously had no options.” Improving care for PAD patients continues to be the conference’s mission. “PAD is more than just leg pain, it’s a matter of life and death.” 2:10 –2:30 p.m. Jihad Mustapha, MD Metro Health Hospital Wyoming, MI 4:40 – 5:10 p.m. D. Christopher Metzger, MD Holston Valley Medical Center Kingsport, TN Live case presentations occur in the Cresecent City Ballroom unless noted. REDEFINING INNOVATION Dr. David Slovut, far left, moderates the live case panel discussion during the Multidisciplinary Nursing session on Wednesday morning. PLEASE VISIT US BOOTH #102 / PREMIER SUITE (NAPOLEAN ROOM MESSANINE LEVEL) Endurance under pressure Fortrex ™ 0.035” OTW PTA Balloon Catheter DELIVERABILITY PREDICTABILITY EFFICIENCY Predictable high pressure treatment for AV access and arterial lesions Learn more about the Fortrex balloon at Booth 104. www.covidien.com/fortrex CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. DC00010364 New Cardiovascular Horizons 2015 Thursday, May 28, 2015 Attendees Hear Latest Data from EXCITE ISR Trial, VISION Study and JETSTREAM-ISR Feasibility Study C linical data drives innovation. NCVH was the site of three clinical data presentations – driving home the conference’s positon to remain on the cutting-edge in the industry. EXCITE ISR Trial Twelve-month data from the EXCITE ISR clinical trial were presented by NCVH Chairman Craig Walker, M.D., who was one of the trial’s principle investigators. Results of the landmark study show that Spectranetics’ laser atherectomy devices used with PTA (also known as balloon angioplasty), are safer and more effective than PTA alone for treating femoropopliteal (FemPop) in-stent restenosis (ISR), demonstrating continued durability in 12-month results. “Instent restenosis (ISR) is a plague – it’s a plague that’s really hitting us hard,” said Dr. Walker, adding that with stent volume estimated to grow 6-7 percent annually, ISR occurrence is rising. “ISR has been very hard to treat,” said Dr. Walker. “Anytime we spoke on this, we were speaking out of line because nothing was approved.” Factors that he said need to be considered before attempting fempop, instent restenosis intervention: • Length of lesion • Type of stent (covered vs bare metal) • Stenosis versus occlusion • Stent fractures • Location of lesion (in-stent or edge stenosis) • Runoff vessel status • Location in the artery The EXCITE ISR trial was a randomized control study that looked at safety and efficacy of exicmer laser atherectomy, and was concluded prematurely because it reached its primary endpoints. “Why is this significant? We’ve seen a lot of trials performed outside the U.S.,” said Dr. Walker. “When we do the trials here, we often don’t see the same results.” He explained that in the study, there were no lesion length limits, multiple stents were allowed, stent fractures were common (grades 1-3), and popliteal stents were included. “Procedural success was higher in laser plus angioplasty group – which is highly statistically significant,” said Dr. Walker. Critical data findings include: • Treatment using Turbo-Tandem resulted in significantly less residual stenosis and need for bailout stenting. • 92.9% procedural success rate using Turbo-Tandem with PTA vs. 81.7% with PTA alone (p<0.01). • Primary safety endpoint, major adverse events (MAEs) rates at 30 days 5.4% vs. 20.8% with PTA alone (p<0.001). • Primary efficacy endpoint, freedom from target lesion revascularization (TLR) through 6-months 78.3% vs. 58.9% with PTA alone (p=0.002) • Excimer laser atherectomy with adjunctive PTA was associated with a 43% reduction in TLR through 12-months. (Hazard Ratio 0.57; 95% CI 0.38-0.84; p=0.005). “Looking at the safety and efficacy endpoints, this proved to be safer with less events and more effective than balloon angioplasty,” said Dr Walker. “I think this is a very promising therapy – and we’re just beginning to pry open this enigma that is ISR.” VISION Clinical Study Patrick Muck, M.D., presented 30day interim results for the Avinger VISION clinical study. VISION is designed to evaluate the safety and efficacy of the Pantheris™ system to perform directional atherectomy, while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. VISION interim results demonstrated that following Pantheris treatment residual stenosis of less than or equal to 50% was achieved in 96% of lesions, surpassing the primary efficacy endpoint performance goal. Both blood flow measurement (Ankle Brachial Index) and symptom-based (Rutherford Classification) outcomes measures showed statistically significant improvement across all patients undergoing 30-day follow-up. Safety data at the time of procedure and through 30 days also indicated an extremely favorable acute safety profile, with zero dissections and zero perforations related to the use of the Pantheris catheter as adjudicated by an independent Clinical Events Committee (CEC). The study’s primary safety endpoint is defined as freedom from a composite of major adverse events (MAEs) through six-month follow-up. While not representative of six-month results, 7% of patients in the VISION trial had experienced an MAE through 30 days. “With this device, you can see what you want to cut,” Dr Muck said. “Often times with angiography, you’re not certain if it’s a flap or a dissection.” He reviewed the major inclusion and exclusion criteria of the study, which enrolled 128 patients, for a total of 164 lesions. Two patients were lost to follow-up. Looking at the co-morbidites and demographics, he said “these are real world patients.” Continued on page 11 Dr. Nicolas Shammas presents data from the JETSTREAM-ISR Feasibility Study. NCVH New Cardiovascular Horizons UPCOMING EVENTS 2015 New Jersey 2016 AUG ATLANTIC CITY 01 Birmingham AUG ALABAMA Detroit MICHIGAN St. Louis MISSOURI California REDDING NCVH at GW-ICC BEIJING, CHINA NCVH at CEC SHANGHAI, CHINA Shreveport 29 SEPT 12 SEPT 19 OCT 24 OCT - NOV 29-01 NOV 05-08 NOV LOUISIANA 21 Florida DEC MIAMI 05 JAN Baton Rouge LOUISIANA 23 Mobile FEB 27 ALABAMA MAR Florida ORLANDO 05 NCVH at CIT MAR BEIJING, CHINA 17-20 MAR HATTIESBURG 19 MISSISSIPPI APR Latin America 6-9 MONTERREY, MÉXICO MAY Fellows Course 31 NEW ORLEANS NCVH Annual Conference NEW ORLEANS JUNE 01-03 NCVH Vein Forum NEW ORLEANS Join our online community for upcoming discounts, contests, and announcements! For more information: [email protected] JUNE 04 • 3 4 • Thursday, May 28, 2015 What do you hope to take away from NCVH’s comprehensive wound care/podiatry program? Brian Cain, DPM Marrero, La. “I’m here to learn about new innovations. I work at LSU, and on the West Bank, we have a high rate of amputations. We actually beat the national average. Financially, the health care system can’t sustain such a high number of amputations. This conference is a great value. NCVH has nationally known speakers and multi-faceted information, and I come every year.” Jo-Anna McGrath, CNS Chicago, Ill. “I’m an advanced practice nurse, and we see a lot of patients with wound care issues. My education didn’t cover the care of long-term wounds, which is why this session is valuable. I enjoy the breakouts of various aspects of care here at NCVH.” Justin Green, DPM New Iberia, La. “I try to keep up on emerging technology and treatments. I believe in a team approach, so this conference is ideal because it is so well rounded and covers all disciplines. Wound care is a big deal, which is why I attend this session. Here in Southern Louisiana, diabetes is prevalent, but I’m shocked by how many patients don’t fit the stereotype.” New Cardiovascular Horizons América Latina Monterrey, México | 6 a 9 de Abril 2016 New Cardiovascular Horizons 2015 Podiatry/Wound Care Track Highlights Diagnostic Technologies T he Podiatry/Wound Care two-day session opened on Wednesday morning with a focus on the diagnosis and treatment of vascular disease. Different diagnostic techniques, both established and emerging, were featured in the session, which was moderated by Frank Tursi, DPM. Dr. Tursi opened the session with personal stories that he said hoped would “highlight the enormity of what peripheral artery disease (PAD) means to me.” After the loss of a patient who had no symptoms or history prior to consulting with Dr. Tursi, he said he became more passionate about treating the condition. The numbers are staggering: PAD is more prevalent and has a higher mortality rate than HIV and all forms of cancer combined, according to Dr. Tursi. And, with modifiable risk factors, Dr. Tursi believes that PAD is preventable, even though about 60 percent of PAD patients have no symptoms. Early detection and treatment of PAD can have a huge financial impact on the industry. “$3 billion per year can be saved with just a 25 percent reduction in amputations,” said Dr. Tursi. He believes that initial detection is a crucial component in limb salvage. According to Guy Pupp, DPM, Doppler ultrasounds are a helpful tool in early PAD detection. A Doppler device can record arterial flow, and the procedure is non-invasive, one of its biggest attributes. Vascular Doppler ultrasounds can establish how fast blood flows by measuring the rate of change in pitch and frequency. Doppler measurements can be used to diagnose: • Blood clots • PAD • Heart valve defects “The more you know,” said Dr. Pupp, “the more you can battle for your patients.” Dr. Pupp also stressed the importance of limb salvage for patient quality of life. “There are psychological, social and financial repercussions of Dr. Robert Coronado discusses venous insufficiency during the Podiatry/Wound Care session. amputation, and we need to get back to early detection and aggressive treatment of PAD.” Robert Coronado, M.D., followed Dr. Pupp with a discussion of the diagnostic tools available for venous reflux disease (VRD), which he called the “most prevalent cardiovascular disorder today.” Dr. Coronado said that one in four people have visible symptoms of venous insufficiency, including varicose veins and skin ulcers. VRD is five times more prevalent than PAD and twice as common as CAD, according to Dr. Coronado, and the U.S. spends about $3 million annually dealing with venous ulcers. He believes compression is the easiest way to reduce the symptoms of VRD. Continuing on the same ideas, Alan Block, DPM, discussed chronic venous insufficiency, which he said has been recognized since ancient times. Dr. Block said that 80 percent of leg ulcerations are venous in nature, and many don’t require surgery. Besides the reduction of ulcer reoccurrence, Dr. Block said that surgery is no better than compression in reducing the symptoms of VRD. Venous compression, he said, “may achieve narrowing of veins, restoration of valvular competence or acceleration of venous flow.” Cheryl Bongiovanni, Ph.D., also be- Foro Interdisciplinario de Terapia Endovascular Co-Chairmen: Dr. Alejandro Fabiani | Dr. Miguel Montero-Baker Dr. Antonio Muñoa | Dr. Luis Sanchez Escalante Dr. Craig M. Walker www.ncvh.org/latinamerica Dr. Jeffrey Niezgoda discusses pain management on Wednesday afternoon. lieves in non-invasive techniques as a first step of PAD treatment. According to Dr. Bongiovanni, the symptoms of PAD can be separated into two categories: macrovascular and microvascular. Arterial ultrasonography may help medical professionals measure arterial pressure accurately. The pros of arterial ultrasonography, said Dr. Bongiovanni, are that the technology permits the “mapping” of sites of arterial flow restriction. It also allows a medical professional to establish the degree of stenosis caused by visible lesions, both physically and hemodynamically. There are cons to the technology as well. Dr. Bongiovanni cited downsides to arterial ultrasonography, including the fact that the mapping is time-consuming, and the testing is only reimbursed when performed by certified personnel. Charles Andersen, M.D., expanded on Dr. Bongiovanni’s ideas while discussing fluorescence imaging and the limitations of PAD diagnosis using typical modalities. “The measurement of tissue perfusion is critical to every component of a limb preservation initiative,” said Dr. Andersen. One of the limiting factors of a fluorescein angiography is that it requires an IV injection of Indocyanine Green (ICG). However, Dr. Andersen said that positive attributes of ICG is that the substance is safe for clinical use and has a 3-5 minute half-life. Fluorescein angiography can help answer many questions, said Dr. Andersen, including: • Is revascularization required? • Did revascularization provide adequate tissue perfusion to the involved angiosome? • What is the optimal time for a secondary procedure? Dr. Andersen believes that fluorescein angiography offers an added option to measure tissue perfusion. “We believe that fluorescence imaging has become a critical component of limb preservation,” said Dr. Andersen. CAPTURE What Matters SpiderFX™ Embolic Protection Device Goose Neck™ Snare and MicroSnare • #1 Embolic Protection device on the market1 • #1 Snare and MicroSnare on the market2 • The use of the SpiderFXTM device is strongly associated with lower costs, shorter inpatient hospital stays, lower ICU utilization rate, and shorter OR times.3 • First to market with single-loop 90° design Learn more at Booth 104. References: 1 Embolic Protection Market IMS data Q1-2013 to Q4-2014. 2 Snare Market IMS data Q1-2013 to Q4-2014. 3 Dippel EJ, Parikh N, Wallace KL, Use of SpiderFXTM Embolic Protection Device vs. Distal Embolic Event: Health Economic study in inpatient and hospital outpatient settings of care, ISET Poster, 2015. CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. © 2015 Covidien. DC00010430 6 • Thursday, May 28, 2015 New Cardiovascular Horizons 2015 Speakers Look at Approach, Device Options E ndovascular surgery requires a lot of decisions to be made, including procedural approach and device selection. Wednesday morning’s session, Global Summit for Advanced Aorto-Iliac and Femoral Interventions for Peripheral Artery Disease, featured presentations went into these choices in greater detail. Carlos Mena, M.D., spoke about the factors that lead to the decision to treat aortoiliac occlusions with stenting, as opposed to bypass surgery. “The endovascular approach has become the preferred way to proceed,” said Dr. Mena. “And more so as new devices become available. Cost effectiveness can also be superior.” He reviewed the minimum requirements needed to perform interventions, and warned the audience to recognize the dangers and complications that can develop. “It is important to assess the anatomy to plan your approach,” said Dr. Mena. With a carefully devised plan and the right equipment, he said the percutaneous approach can achieve good results. The internal iliac artery anatomy was described by Craig Walker, M.D., as “the forgotten artery. It does not affect your pulses or ABI, but it does impact a lot of other things.” He looked at the present indications for internal iliac intervention, which include buttock claudication, impotence, internal iliac aneurysm, colonic ischemia and penis salvage. Dr. Walker stressed the importance of asking male patients about impotence, because it’s not something they often will openly admit to. He also reviewed the results of the ZEN Trial, zotorolimus eluting stent for erectile dysfunction. Louis Salvaggio, M.D., then turned the focus to device selection. He provided a comprehensive overview of guidewires. “We have many different tools as interventionists in the lab, and the guidewire is most often the least un- derstood,” he said. Among the attributes impacting guidewire selection are: • Wire length • Wire diameter • Tip penetrance • Shaft support •Visibility • Device compatibility •Cost •Durability He also went into greater detail on the six building blocks of guidewires – core material, core diameter, core taper, tip design, coils and covers and coatings. Dr. Salvaggio urged attendees to not limit their knowledge to one guidewire. “When you are familiar with a multitude of wires, you are more apt to succeed,” he said. “Understanding a wire’s technical attributes will help select the right wire for the right case.” Hinan Ahmed, M.D., opened his presentation on techniques and tools for chronic total occlusions (CTOs) with a statistic: CTOs are estimated to be found in 40 percent of patients presenting with CLI. “CTOs are anatomically challenging,” he said. “CTOs have a lower procedural success – failure to cross is the primary method of failure.” Dr. Ahmed stressed the importance of planning and preparation in the cath lab. He said you must know the anatomy, have a plan, choose your access and have all the equipment available (wires, catheters, crossing devices and reentry devices.). Before taking attendees through a detailed look at the features of different crossing devices currently on the market, he urged practice. “The more you practice, the better you get,” said Dr. Ahmed. “It’s important to become familiar with the different options.” He also warned that it could be slow going in the beginning, but urged patience. “Some of our first cases took three to four hours, now they take about 60 minutes.” Dr. Pradeep Nair looks at the role of ultrasound guidance in gaining femoral and popliteal access during his presentation on Wednesday morning. Dr. Christopher Zarins discusses a human predisposition for the development of atherosclerosis. The Big Picture: PAD by the Numbers, Role of Medical Therapies and Radial Access Y esterday’s speakers presented statistics that do not paint a pretty picture – peripheral artery disease (PAD) is an epidemic. “At almost 20 million in 2015, PAD [cases] exceeds coronary disease and cancer,” said Mary Yost of the Sage Group. Each year, Yost sets the stage for three days of cutting-edge education with her presentation on the numbers associated with PAD. “PAD continues to be underdiagnosed, undertreated and underestimated,” she said. “Early diagnosis and treatment are important because costs rise with disease severity. PAD’s economic burden is higher than diabetes, coronary disease and all cancers.” Yost reported that hospital costs represent between 65-90% of PAD costs. She also looked at critical limb ischemia (CLI), including amputation rates and factors that may impact the decision to perform an amputation on a CLI patient. “Today most limb salvage experts would argue that most CLI patients should not undergo primary amputation,” she said. Christopher Zarins, M.D., took the audience back to Egypt more than 3,500 years ago to look at coronary atherosclerosis. “It’s a common belief that atherosclerosis is a lifestyle-related disease,” said Dr. Zarins. He presented data from the HORUS Study, which looked at the evidence of atherosclerosis in ancient Egyptian mummies. The study found that almost half, 45 percent, had evidence of atherosclerosis. “The study showed that cardiovascular disease was quite common in ancient Egypt,” he said, further explaining that this data raises the question of a human predisposition for the development of atherosclerosis. “The mummies tell us that atherosclerosis is not a lifestyle-related disease of modern civilization. It has been with us for more than 4,000 years. Atherosclerosis may be inherent to the process of human aging.” Alvaro Alonso, M.D., discussed the role of medical therapies as a PAD treatment option. “PAD is more prevalent and deadly than many leading diseases,” he said. “The goals of medical therapy are to improve the patient’s ability to walk and prevent progression to CLI and amputation.” He looked at the roles of smoking cessation, antiplatelet therapies, blood pressure control and glycemic control. “When patients do require revascularization, patients should continue with medications, smoking cessation and exercise to control other cardiovascular risk factors,” he said. “The goals of medical therapy are to improve cardiovascular outcomes and manage symptoms.” Cezar Staniloae, M.D., presented data to support the radial access approach. “Radial access is an ideal access site – easily accessible even with patients with severe PAD,” he said, adding that the United States lags behind other countries in the adoption of radial access. His presentation included an illustration on the anthropometric measurements for reaching the popliteal and iliac arteries. He also looked at when carotid artery stenting via transradial access (TRA) is, and is not, the best approach. He reviewed the technical considerations for TRA for other procedures, including: • Abdominal vessels • Renal artery stenting • Iliac artery stenting • CFA interventions Dr. Staniloae said the limitations of radial access are device-related. “New frontiers for radial access include SFA/popliteal,” he said. “But there are currently severe limitations due to lack of equipment.” Minimize Fluoroscopy Exposure The new Ultraverse® 035 PTA Dilatation Catheter is the first Bard Peripheral Vascular catheter to offer GeoAlign™ Marker Bands. Intended to function as a reference tool on the PTA Dilatation Catheter shaft, GeoAlign™ Markers Bands are designed to increase procedure efficiency by minimizing fluoroscopy exposure†. To find out more about the Ultraverse® 035 PTA Dilatation Catheter or other novel ideas designed to improve patient care from Bard Peripheral Vascular, please visit BardPV.com. Labeled distance from the distal catheter tip GEOALIGN™ Marker Bands are denoted every 1cm † When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation Please consult product labels and package inserts for indications, contraindications, warnings, precautions, complications, and information for use. Bard, Advancing Lives and the Delivery of Health Care, GeoAlign, and Ultraverse are registered trademarks of C. R. Bard, Inc. Copyright © 2015, C. R. Bard, Inc. All Rights Reserved. Bard Peripheral Vascular, Inc. | 1 800 321 4254 | www.bardpv.com | 1625 W. 3rd Street Tempe, AZ 85281 S120492R1 Advancing Lives and the Delivery of Health Care™ Supera ® Peripheral Stent System Clinically Proven, Widely Studied, with Excellent Outcomes to 3 Years > 1,100 Real-world patients analyzed worldwide in 7 retrospective analyses3 264 Patients studied in the SUPERB Trial4 1. Garcia, L., The SUPERB Trial, 3-Year Results, VIVA 2014 2. Supera® Peripheral Stent System Instructions for Use. Data on file at Abbott Vascular. 3. 1,152 patients analyzed retrospectively, see Scheinert, et al., Real world perspectives of treating complex SFA-Pop lesions, Results from the SUPERA-500 (including Leipzig SFA, Leipzig Popliteal and S500 LL) Registry, LINC 2013, 495 patients; Goverde, et al., AURORRAregistry: Experience with high radial force interwoven nitinol stents in femoropopliteal arteries, LINC 2013, 117 patients; Molenaar, et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical Limb Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., HK Single-centre Results of Femoro-popliteal Revascularization using Helical Interwoven Nitinol Stents, LINC 2013, 75 patients; Pacanowski, et al., RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; Kovach, R., SAKE, Supera Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience, LINC 2013, 100 patients. 4. Garcia, L., Rosenfield, K., et al. SUPERB Pivotal IDE Trial, 12-Month Results, TCT 2012. *When deployed at +/- 10% of labeled stent length. INDICATIONS The Supera Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm. For Important Safety Information, see page XX. 83% Overall freedom from TLR in SUPERB at 3 years1 94% when nominally deployed1* 86.3 % Patency (K-M) in SUPERB at 12 mo2 90.5 % when nominally deployed2* 0 Fractures at 1-yr across all analyses3,4 REDEFINING INNOVATION PLEASE VISIT US BOOTH #102 Supera® Peripheral Stent System INDICATIONS The Supera Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm. CONTRAINDICATIONS The Supera Peripheral Stent System is contraindicated in: • patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system • patients who cannot receive antiplatelet or anticoagulation therapy. Based on in vivo thrombogenicity testing, the device should not be used in patients who cannot be anticoagulated as there may be some thrombus formation in the absence of anticoagulation. WARNINGS • This device is intended for single-use only. Do not reuse. Do not resterilize. Do not use if the package is opened or damaged. • Use this device prior to the “Use By” date as specified on the device package label. Store in a dry, dark, cool place. • DO NOT use if it is suspected that the sterility of the device has been compromised. • Persons with known hypersensitivities to Nitinol and/or its components (e.g. nickel titanium) may suffer an allergic reaction to this implant. • Administer appropriate antiplatelet therapy pre- and post- procedure. • Careful attention should be paid when sizing and deploying the stent to prevent stent elongation. In the SUPERB clinical study, stent elongation was associated with a decrease in patency at 12 months. POTENTIAL ADVERSE EVENTS Potential adverse events include, but are not limited to: • Abrupt stent closure • Allergic reaction (contrast medium; drug; stent material) • Amputation or limb loss • Aneurysm or pseudoaneurysm in vessel or at vascular access site • Angina or coronary ischemia • Arrhythmia (including premature beats, bradycardia, atrialor ventricular tachycardia, atrial or ventricular fibrillation) • Arteriovenous fi stula • Bleeding complications from anticoagulant or antiplatelet medication requiring transfusion or surgical intervention • Death • Detachment of a system component or implantation in an unintended site • Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent) • Fever • Hematoma or hemorrhagic event, with or without surgical repair • Hypertension/Hypotension • Infection, local or systemic, including bacteremia or septicemia • Ischemia requiring intervention (bypass or amputation of toe, foot, or leg) • Ischemia or infarction of tissue or organ (e.g., occlusion of SFA/ PPA or distal vasculature) • Myocardial Infarction • Pain (leg, foot, and/or insertion site) • Partial stent deployment • Pulmonary embolism • Renal failure insuffi ciency secondary to contrast medium (with or without treatment including dialysis) • Restenosis of vessel in stented segment • Shock • Stent malapposition or migration, which may require emergency surgery to remove stent • Stent strut fracture • Stent thrombosis or occlusion • Stroke • Thrombosis/occlusion at the puncture site, treatment site or remote site • Transient ischemic attack • Venous Thromboembolism • Vessel dissection, perforation or rupture. PRECAUTIONS The Supera Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device. • The long-term safety and effectiveness of the Supera Peripheral Stent System has not been established beyond two years. • The safety and effectiveness of the Supera Peripheral Stent System has not been established in patients who: • are less than 18 years old • are pregnant or lactating • have instent restenosis of the target lesion • have known hypersensitivity to any component of the stent system (e.g., nickel) • cannot tolerate contrast media and cannot be pre-treated • have uncontrolled hypercoaguability and/or other coagulopathy • This device is not designed for use with contrast media injection systems or power injection systems. • The fl exible design of the Supera stent may result in variation in the deployed stent length. Magnetic Resonance Imaging (MRI) Non-clinical testing has demonstrated the Supera Stents are MR Conditional for lengths up to 250 mm. A patient with this stent can be scanned safely, immediately after placement, under the following conditions: • Static magnetic field of 1.5 or 3.0 Tesla • Highest spatial gradient magnetic fi eld of 2,500 Gauss/cm or less • Maximum MR system reported whole body averaged specific absorption rate (SAR) of 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus 1 W/kg for landmarks below the umbilicus and above the mid-thigh 0.5 W/kg for landmarks below the mid-thigh for 15 minutes of scanning (per pulse sequence), operating in the Normal Operating Mode (i.e., MR system mode of operation where there is no physiological stress to the patient). Abbott Vascular 3200 Lakeside Dr., Santa Clara, CA 95054 USA, Tel: 1.800.227.9902 Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use at www.abbottvascular.com/ifu for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Photos taken by and on file at Abbott Vascular. Supera is a trademark of the Abbott Group of Companies. www.AbbottVascular.com ©2015 Abbott. All rights reserved. AP2940860-US Rev B. New Cardiovascular Horizons 2015 Nonprofit Raise AAA Awareness E ducation and awareness, regardless of the medical condition targeted, will go a long way towards screening and diagnosis of fatal diseases. AAAneurysm Outreach, exhibiting at NCVH, is the only nonprofit organization dedicated to raising awareness of abdominal aortic aneurysms (AAA). Founded by AAA advocate Sheila Arrington, who lost her father to a ruptured AAA and has a strong family history herself, the organization stresses the need for early detection in at-risk populations. “My dad was the victim of an AAA rupture,” said Arrington. “I understand how horrible this is.” The organization was established in 2000, and held its first screening event in Baton Rouge, La., in 2001. “We’re one-of-a-kind,” she said. “We create partnerships so we can provide free screenings. To date, we have saved more than 300 lives. Early detection is critical with AAA – rupture entails a 70-90% fatality rate.” During a four-hour screening, the goal is to have 288 ultrasounds performed. “When we screen the targeted population, we always find a AAA.” When a AAA is found during a screening, the patient will learn about the importance of regular ultrasounds. “The doctor will confirm the finding, and then the patient enters the watchful waiting period,” said Arrington. “It could take 10-25 years for the AAA to rupture. Early detection is critical.” Last year, the organization created a primary care provider initiative that provides kits with a large AAA poster and risk assessment cards. NCVH attendees are encouraged to visit the AAA tabletop, located outside the Roosevelt ballroom to learn more about the organization’s mission and pick up education materials that explain the risk factors that go along with AAA. “Our goal at NCVH is to inform people of the services we provide as an organization and how they can become involved in our program, specifically getting physicians involved in our life-saving screenings,” said Arrington. “We want to take the lead in educating this unaware public by creating partnerships to provide free AAA screening programs for those most at risk throughout the country.” For more information on the organization, including a schedule of upcoming screening events, visit www. aoutreach.org. Trial Data Dr. Shammas, the study’s principle investigator, reported that the study met both its primary and secondary endpoints: • Primary: acute procedural success, less than or equal to 30% residential narrowing, with no serious adverse events. • Secondary: acute device success. The inclusion criteria were included: • Lesions of more than 50% stenosis • No lesion length limit. He reported that device success was 75.9%, and procedural success (no SAE) was 90.6%. The primary safety endpoint was met at both 30 days and 6 months. At 30 days, amputation was 0%, and at six months, it was also 0%, and sixmonth patency was 72%. “The data is highly encouraging,” said Dr. Shammas. “It appears to be safe, and when we look at patient improvement and ABI, symptoms improved.” He concluded that one-year data is currently being collected, and while these results are encouraging, the data will need to be validated in a larger trial. Porcine data, he added, will be published in Endovascular Today in the next six months. Continued from page 3 Dr. Muck said the take-home message from the study: “cut what you want to cut and leave what you want to leave.” JETSTREAM-ISR Feasibility Study The JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions (JetStreamISR) study hypothesized that simultaneous tissue excision and aspiration using the JetStream Navitus device can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up. Nicolas Shammas, M.D., presented the study’s six-month data on Wednesday, noting as he began that this is an offlabel application. He cited statistics showing that fempop ISR occurs in 20-30% of stented patients at 1 year and up to 49% at 2 years. The study enrolled 29 patients (32 limbs) at two clinical sites between October 2012 and August 2014 in the United States, using angiographic core lab adjudication. He noted that one patient died (two limbs) and one patient withdrew (one limb). Thursday, May 28, 2015 • 11 PAID LISTINGS New Product Showcase Advanced Catheter Therapies Booth #422 The FDA Cleared Occlusion Perfusion Catheter™ (OPC) creates a localized treatment chamber for the delivery of various types of therapeutic agents for the treatment of different disease states. The OPC’s multi‐lumen design temporarily occludes a specific region from blood flow. Isolating and flushing the treatment chamber eliminates ad mixture of agent and blood. Therapeutic agents delivered by the OPC are designed to be used for treating stenosis/restenosis, DVT, dialysis access, venous insufficiency, and solid tumors. Treatment chamber pressure is monitored in real- time. Broad range of sizes allows for ability to treat long or multiple lesions. Visit the OPC at booth 422. Bard Peripheral Vascular Booth #202 Bard Peripheral Vascular, Inc. launched the LUTONIX 035 Drug Coated Balloon PTA Catheter for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm. LUTONIX 035 was proven safe and effective in LEVANT 2, a rigorous, randomized, blinded, controlled clinical trial that studied 476 patients with femoropopliteal disease at 54 trial sites. At 12 months, treatment with LUTONIX 035 resulted in superior primary patency compared to PTA, quality of life improvements versus PTA, and noninferiority to PTA in terms of safety. ThermopeutiX, Inc. Booth # 426 The PRIMI™ and SECONDI™ provide guidewire support and exchange capabilities for complex interventions, including chronic total occlusions and retrograde access. They are unique in that they have the ability to sub-selectively inject contrast media and/or other diagnostic and therapeutic agents during the intervention, without removing the guidewire. Use of these catheters may significantly minimize the amount of contrast and radiation used. The Secondi™ features dual wire use and exchange capabilities, which greatly facilitates wiring bifurcations, and may be uniquely valuable in avoiding subintimal dissection and untoward collateral/side-branch selection, commonly encountered in complex vascular intervention. Have you connected with NCVH on Twitter? @NCVHonline Are you tweeting today? Be sure to use the hashtag #NCVH! 12 • Thursday, May 28, 2015 New Cardiovascular Horizons 2015 Finding Patients, Growing Your Practice: Marketing, New Avenues T o take a closer look at the economic impact of these diseases, NCVH added a preconference course, “Understanding the Business of Peripheral Interventions.” Beyond the financial implications of peripheral artery disease (PAD), there’s a constant need for healthcare providers to expand their reach, to both grow one’s practice and reach more patients. Alan Block, DPM, and Frank Bunch, M.D., tag-teamed the topic of marketing: how to get these patients into treatment before amputation. Advocating for yourself and establishing credibility among other specialties treating PAD is very important. “If you don’t educate me, I can’t make your practice better,” said Dr. Block. “If I know you want that patient, I will seek you out.” Early detection is still the best approach. “We are saving people that yesterday we couldn’t,” he said. “I tell my residents, even though we are podiatrists, the first thing you do when you are with a patient is look up.” In addition to educating other specialties to raise awareness, communication amongst a patient’s different providers is a must. “When I finish with a patient, I call the family physician, the internal medicine doctor, even the dentist,” said Dr. Block. “It’s also important that the patient be involved in their care.” Dr. Bunch followed, by first characterizing the role of cardiologists in the care of PAD patients. “Cardiologists are tenacious,” he said. “Cardiologists learn the global approach to vascular disease, from head to toe. Treatment strategies to treat vascular disease in the lower extremities are very similar to those used when treating the heart.” He advised the audience to get to know their patient populations. “You need to know what you’re going to be treating,” he said. “You need to know your area medical providers. Some of my best referrers are nurse practitioners.” He echoed Dr. Block’s comments about communication, with the patient, their medical providers and Dr. Frank Bunch offers tips on marketing your practice. Practice What You Preach: Run the My Leg My Choice 5K on Saturday H inan Ahmed, M.D., physician chairman, encourages NCVH attendees to join him on Saturday, May 30, at the My Leg My Choice 5K. “I think the concept of PAD is really connected to walking and running and what patients can do – it’s the perfect ending to this meeting,” he said. Dr. Ahmed is an avid runner, completing approximately 2-3 full marathons and 20 half marathons annually. He also works to share his love of running of others, forming running groups at his clinics. “I’ve have had patients start running after interventions who have gone on to complete 5ks.” He advocates for run/walk programs for many different reasons. “In addition to the obvious benefits, it’s scientifically proven that long term symptom relief comes from regularly walking,” he said. “It also improves cardiovascular risk factors Dr. Hinan Ahmed is all smiles at the first My Leg My Choice 5K, held at the conclusion of NCVH 2014. and helps patients live happier, longer and healthier lives.” Asked for his final message to his fellow attendees,: “Come support this good cause,” he said. “And what other way is there to see beautiful downtown New Orleans.” Dr. Elias Kassab looks at the growth of outpatient labs in the endovascular arena on Tuesday afternoon. staff (yours, theirs, hospital). “The patient needs to know what you can do for them,” he said. “Give the patients a reasonable expectation on what they are going to get.” Dr. Bunch said, the best marketing tool you have is good results. “From results comes word of mouth – and word of mouth spreads,” he said. “You can go tell people what you do, but if you have bad results – that will get out there too.” The growth of the venous field set up Rob Coronado, M.D., to share his experiences on developing a successful venous practice. “If you’re going to go into this field, you have to believe there’s a true need to treat these patients,” he said. “Is there enough substrate? What’s the competition like?” He reported that venous reflux disease is five times more prevalent than PAD, and two times more prevalent that coronary artery disease. “Venous insufficiency is a true vascular abnormality, not just a cosmetic disorder,” said Dr. Coronado. He encouraged attendees to pursue training in all aspects of venous vascular care, and to learn all of the modalities and their indications – ablation, sclerotherapy and microphlebectomy. “If you are going to build a successful vein practice, train in areas that include adjunctive therapies,” he said. “Once you have the fundamentals, inform your community and care providers. You then have to educate the medical community and care providers.” Dr. Coronado advocated for directto-consumer advertising. “These patients are ignored – but have all these symptoms,” he said. “When the patient is convinced that they need something done, they will come to you. When you put the ad out there – this is the ROI of all marketing.” To deliver your message, Dr. Coronado said it is important to dispel the myths associated with venous disease: • True disorder – not just cosmetic • Covered by most insurance plans • Recovery or downtime is usually a matter of minutes • No need for hospitalization or even any sedation • Venous stripping is not the way to treat the disorder “When patients realize you are paying attention and treating a problem that they have had, and no one else has treated, they will greatly appreciate it.” Another practice-building concept is the growth of the office-based lab. Elias Kassab, M.D., shared a wealth of information on the trend towards outpatient labs. “Today there are more than 450 outpatient endovascular centers in the United States,” he said. “Most are privately owned and were originally opened to provide outpatient management of dialysis.” Among the drivers of the growth of office-based surgery that he covered included the development of minimally invasive surgical techniques, new forms of anesthesia and patients being drawn to the advantages of office-based surgery. “When appropriately screened, almost all peripheral interventions can be performed in the office with minimal complications,” he said. “We’re gaining momentum.” Office-based procedures are convenient for both the patient and physician, and less costly. They can also increase the provider’s productivity by cutting out travel time and the need to wait for a hospital procedure room to be free. “It creates a continuity of care,” he said. “It’s flexible to schedule and offers a friendly and familiar environment for the patient.” Are there limitations to what can be performed in an office setting? Yes. “You cannot do carotid stenting or cardiac interventions, but you can do a lot,” he said. “We’re here to stay.” In terms of setting up an officebased practice, Dr. Kassab reviewed the pros and cons of starting a solo practice, creating a joint venture with a hospital or partnering with a management company. JETSTREAM TM Atherectomy System CUT THE CRUD. DELIVER THE DRUG. CALCIUM. PLAQUE. THROMBUS. Vessel Preparation to remove this crud is often needed prior to delivering adjunctive therapies, such as Drug Coated Balloons. Optimize Vessel Prep with the Jetstream™ System. - CONCENTRIC LUMENS creating a uniform delivery zone for DCB and other adjunctive therapies - DEBULKING WITH ACTIVE ASPIRATION to remove mixed morphology Visit us at our booth CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. Jetstream™ System INDICATIONS: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature. CONTRAINDICATIONS: No known contraindications. WARNINGS: The Jetstream Catheter and Control Pod may only be used with the PV Console. PRECAUTIONS: Do not manipulate the Catheter against resistance unless the cause for that resistance has been determined. Use only listed compatible guidewires and introducers with the Jetstream System. The use of any supplies not listed as compatible may damage or compromise the performance of the Jetstream System. Prior to use of the Jetstream System, confirm the minimum vessel diameter proximal to the lesion per the following table: Jetstream SC Atherectomy Catheter 1.6 : Minimum Vessel diameter proximal to lesion: 2.5mm • Jetstream SC Atherectomy Catheter 1.85: Minimum Vessel Diameter Proximal to Lesion 2.75 mm • Jetstream XC Atherectomy Catheter 2.1/3.0: Minimum Vessel Diameter, Blades Down 3.0 mm • Minimum Vessel Diameter, Blades Up 4.0 mm • Jetstream XC Atherectomy Catheter 2.4/3.4: Minimum Vessel Diameter, Blades Down 3.5 mm • Minimum Vessel Diameter, Blades Up 4.5 mm ADVERSE EVENTS: Potential adverse events associated with use of this device and other interventional catheters include, but are not limited to the following (alphabetical order): Abrupt or sub-acute closure • Amputation • Bleeding complications, access site • Bleeding complications, non-access site • Death • Dissection • Distal emboli • Hypotension • Infection or fever • Perforation • Restenosis of the treated segment • Vascular complications which may require surgical repair • Thrombus • Vasospasm Jetstream PV Console INDICATIONS: The PV Console is designed for use only with the Jetstream Catheter and Control Pod. See the current revision of the applicable Catheter and Control Pod Instructions for Use for further information. PRECAUTIONS AND WARNINGS: WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Do not open either pump door during operation of the System. Doing so could result in loss of aspiration and/or infusion and will halt device activation. • Ensure the PV Console display is visible during the entire procedure. Observe normal safety practices associated with electrical/electronic medical equipment. • Avoid excessive coiling or bending of the power cables during storage. • Store the PV Console using appropriate care to prevent accidental damage. • Do not place objects on the PV Console. • Do not immerse the PV Console in liquids. Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. PI-294806-AB MAR2015 14 • Thursday, May 28, 2015 New Cardiovascular Horizons 2015 Managing Ulcers at Forefront of Multidisciplinary Nursing Session L A packed house watches live cases on Wednesday. Exhibitor News Exhibitor News features items submitted by companies advertising in What’s on the Horizon? NCVH and CustomNEWS are not responsible for this content. The Next-Generation Solution for AV Access and Arterial Lesions The Fortrex™ 0.035” OTW PTA balloon catheter is the next-generation high pressure solution for AV access and arterial lesions. The Fortrex PTA balloon can crack the short, fibrous lesions that can block AV access, and also treat lesions in the peripheral vascular system. Engineered around three primary areas of interventional need—deliverability, predictability, and efficiency—the Fortrex PTA balloon offers physicians several desired product features and procedural advantages. First, the low tip entry profile and robust, flexible shaft design combine to enable tight tracking to the wire and successful navigation in tortuous vessels. Second, the balloon material and design permit shape retention at rated burst pressure, ensuring focused pressure on the lesion for controlled, targeted and predictable treatment. Finally, the combination of balloon material and wall thickness enables reliable balloon rewrap and reinsertion along with a rapid deflation time, all of which contribute to the efficiency of an interventional procedure. To learn more about the Fortrex PTA balloon, visit Booth 104 or www. covidien.com/fortrex. See the Latest Jetstream™ Atherectomy System at Boston Scientific’s NCVH Booth Boston Scientific’s 2014 acquisition of Bayer Interventional products includes the Jetstream Atherectomy System. Physicians who haven’t used the system lately will learn that the product has evolved since its first introduction. Recent innovations include the launch of “SC” and “XC” catheters, improved ergonomics, and simplified wire management. As the only atherectomy system with active aspiration, Jetstream is designed to debulk mixed morphology such as calcium, plaque, and thrombus. Front-cutting expandable “XC” blades deliver concentric lumens, optimizing Vessel Prep prior to delivering adjunctive therapies such as Drug-Coated Balloons. Stop by the booth to see the latest iteration and experience a hands-on demo. The Bayer Interventional acquisition also includes the AngioJet™ Thrombectomy System, an advanced system designed to restore blood flow to a wide range of thrombosed arteries and veins. Used in over 700,000 cases worldwide, the system offers reliable and predictable performance to treat clots in vessels as small as 1.5 mm to the largest clot burdens in iliofemoral veins. Boston Scientific’s Peripheral Interventions division develops and commercializes products to treat the 27 million people worldwide who suffer from peripheral vascular disease. The portfolio of technologies features products used for a variety of therapies, including restoring and preserving blood flow to the peripheral vasculature. Other devices are used in the treatment of liver cancer, to help maintain dialysis access or to occlude blood vessels selectively. For more information, stop by the booth or visit www.bostonscientific. com imb preservation is one of the key subjects NCVH attendees want to learn about, and Wednesday afternoon’s Multidisciplinary Nursing for Limb Preservation II included plenty of multi-faceted information, including the benefits of hyperbaric oxygen therapy (HBOT) and even the use of medical-grade honey on wound healing. Cheryl Bongiovanni, Ph.D, stressed the importance of nursing in regards to wound care. “Without nurses, there is no wound healing,” Dr. Bongiovanni said. “You guys are the key element.” Opening the session, Helen Gelly, M.D., called amputation the “big elephant in the room.” Dr. Gelly presented two lectures on Wednesday, and her first focused on care of the diabetic foot. Diabetes both directly and indirectly impacts wound healing, according to Dr. Gelly. The good news in the field of amputations, Dr. Gelly said, is that amputations are on the decline. The downside is that 47 percent of amputees have a 5-year mortality rate. In order to reduce that number, foot management and ulcer prevention are important considerations, said Dr. Gelly. Many types of ulcer management were discussed in the session. Julio Garcia, RN, laid out the nursing considerations of HBOT. This type of therapy can increase blood flow, as oxygen has physiologic effects on the body that can lead to accelerated wound healing, and not only for diabetic foot ulcers: A mechanical effect in the reduction of bubble size and increase of partial pressure of oxygen in all the tissues of the body. Garcia implored that HBOT is not appropriate for every patient, however. Nurses should be aware of the hemodynamic changes that occur in a hyperbaric chamber, which include: • Decreases in cardiac output by 24 – 35 percent • Increases afterload by 30 – 60 percent • Decreases in left ventricular index by 11 – 30 percent Dr. Gelly also reminded the attendees that HBO under pressure is a drug and should be treated as such. HBO is dose-dependent and has a discrete life. With patients who are not a good fit for HBOT, surgery may be an option. Frank Tursi, DPM, showed concrete results of the use of human amniotic membranes in wound healing. One patient, a 60-year-old male, chose membrane use after he did not respond to other treatment types, including HBOT. After one application, said Dr. Tursi, the patient’s ulcer was completely healed three weeks later. Melinda Oberleitner, DNS, offered a more unique treatment option, one that she said has been in use for more than 4,000 years. “There is a re-emergence in the use of honey in wound care because there is evidence of increasing resistant pathogens,” she said. Medical-grade honey has been reported to have an inhibitory effect on approximately 60 species of bacteria, including: • Aerobes • Anaerobes • Gram-positive organisms • Gram-negative organisms The difference between edible honey and medical-grade honey is that the medical variety is processed with gamma radiation, so contaminants have been removed. While not all the data is conclusive, Oberleitner did say that there is high-quality evidence that honey heals partial thickness burns about 4-5 days more quickly than conventional dressings. One of medical-grade honey’s most important attributes is that, unlike antibiotics, patients do not develop resistance to honey. Among the information attendees took away from the Limb Preservation session was the major differences and similarities of ulcer types. Dr. Bongiovanni discussed the various types of ulcers, including pressure, autoimmune, arterial and venous. She believes, however, that most ulcers are not completely discrete. “Single-etiology ulcers are uncommon,” she said. “Always suspect arterial involvement in any ulcer accompanied by diabetes.” Be sure to visit the exhibit hall, open today from 9:00 a.m. to 4:00 p.m. SAV E LI M B The only 2.9 Fr system below the knee Micropuncture® 2.9 Fr Pedal Introducer Access Set .014” 2.3, 2.6 Fr Approach CTO Microwire Guide 2.5 Fr CXI® Support Catheter Advance Micro™ 14 Ultra Low-Profile PTA Balloon Catheter 2.9 FR SYSTEM TECHNOLOGIES FOR BELOW THE KNEE www.cookmedical.com © COOK 05/2015 D19621-EN-F D A APPROV E G N OO DRU C L · FIRST · D F You’re Invited to a Lunch Symposium OA TED BA L Not All DCBs Are Created Equal: Side By Side PreClinical Evaluation of Leading DCBs Presented by: Renu Virmani, MD CVPath Institute, Inc. | Gaithersburg, MD A First Look and Interim Analysis of 12 Month Outcomes from the Real World Global SFA Registry Presented by: Marcus Thieme, MD MEDINOS Hospital | Sonneberg, Germany Live Case Presented by: Jihad Mustapha, MD Metro Health Hospital | Grand Rapids, MI Thursday, May 28, 2015 12:00-1:00pm Orpheum Room 2nd Floor of the Roosevelt Hotel RSVP to JoAnn Dirtadian 480.303.2754 | [email protected] The AdvaMed Code of Ethics limits attendance at company-sponsored events to healthcare professionals with a bona fide interest in the program. Spouses or significant others may not attend this event. Additionally, we ask that you adhere to state and/or hospital policies of your employer if they prohibit you from participating in company-conducted programs or receiving meal/refreshments provided by Bard Peripheral Vascular, Inc. in connections with this education event. Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions. Bard, Advancing Lives and the Deilvery of Health Care, and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. Copyright © 2015, C. R. Bard, Inc. All Rights Reserved. Illustration by Mike Austin. Copyright © 2014. All Rights Reserved. Bard Peripheral Vascular, Inc. | 1625 W. 3rd Street Tempe, AZ 85281 | 1 800 321 4254 | www.bardpv.com G71492R0 Advancing Lives and the Delivery of Health Care™