® Patrice Wendling/Frontline Medical n eWs THE OFFICIAL NEWSPAPER OF THE Dr. Thomas C. Bower said that EVAR infections “are uncommon, but we are seeing more of them.” Planning, creativity key to EVAR infection care Frontline Medical News CHICAGO – Successful management of infected aortic endovascular grafts requires careful operative planning and execution, meticulous postoperative care, and a fair bit of creativity, according to Dr. Thomas C. Bower, chair of vascular and endovascular surgery at Mayo Clinic, Rochester, Minn. “I’ve found the operations to be more challenging and more difcult than explanting portions or total graft excision when the infection has occurred in a hand-sewn graft.” Unlike the typical bimodal distribution seen with handsewn graft infections, infec- tion following endovascular repair of aortic aneurysms occurs from days up to 3 years after surgery. “These infections are uncommon, but we are seeing more of them,” he said at a symposium on vascular surgery sponsored by Northwestern University. Roughly two-thirds of patients will present with fever, nonspecifc abdominal or back pain, malaise, weight loss, or night sweats. If time permits, preoperative assessments include echocardiography for left ventricular function, arterial blood gases for pulmonary function since many patients are smokers, and renal ultrasound if creatinine is ≥1.5 mg/dL after See EVAR · page 16 Vascular specialist 151 Fairchild Ave., Suite 2, Plainview, NY 11803-1709 BY PATRICE WENDLING VOL. 11 Private-academic surgeon salary gap raises concerns Would you pick academia if you stood to lose $1.3 million over your career? BY PATRICE WENDLING Frontline Medical News LAKE BUENA VISTA, FLA. – Academic surgeons earn an average of 10% or $1.3 million less in gross income across their lifetime than surgeons in private practice, an analysis shows. Some surgical specialties fare better than others, with academic neurosurgeons having the largest reduction in gross income at $4.2 million (–24.2%), while academic pediatric surgeons earn $238,376 more (1.53%) than their private practice counterparts. They were the only ones to do so. Several academic surgical specialties did not make the 10% average, including trauma surgeons whose lifetime earnings were down 12% or $2.4 million, vascular surgeons at 13.8% or $1.7 million, and surgical oncologists at 12.2% or $1.3 million. “The concern that we have is that the academic surgeons are where the education of the future lies,” lead study author Dr. Joseph Martin Lopez said at See Gap · page 10 • NO. 3 • MARCH 2015 I N S I D E Opinion Editors Weigh In Our associate editors give their own take on the PAD stenting issue. • 4 He Got Letters SVS President Peter Lawrence received an outpouring of member letters regarding his New York Times article response last month. • 6 Point/Counterpoint Renal Artery Occlusive Disease Dr. George Hamilton and Dr. Matthew A. Corriere debate the proper treatment of renal artery stenosis. • 8 News From Washington FDA Says OK Two new devices, a transcarotid angioplasty system and a new adhesive for use in varicose veins, were approved. • 17 FROM THE EDITOR More on the PAD stenting issue BY RUSSELL SAMSON, M.D. Medical Editor I suspect that most members of the SVS are aware of the recent New York Times article entitled “Medicare payments surge for stents to unblock blood vessels in limbs” and which was the subject of our front page news article last month (http://vswebn.org/NYTstents). In that article Dr. Peter Lawrence, the President of the SVS, described steps that the SVS has taken to address the appropriateness of vascular interventions. It was his inspired leadership that led to his devoting the Stanley Crawford symposium at last year’s Vascular Annual Meeting specifcally to the problem of unnecessary procedures. Those of you who have read my editorials over the last year will recognize that I also have See PAD · page 3 CHANGE SERVICE REQUESTED Presorted Standard U.S. Postage PAID Permit No. 384 Lebanon Jct. KY MEASURED IN RESULTS. C O N F I D E N C E T H R O U G H C L I N I C A L LY P R O V E N P E R F O R M A N C E 8% 100% 0% All-cause mortality at 30-day endpoint Technical success at implant Coverage of primary entry tear at implant Ruptures at 30-day and 12-month The U.S. Medtronic Dissection Trial evaluating the Valiant Captivia System met its primary safety endpoint The Valiant stent graft delivers clinically proven performance, with over 50,000 patients treated worldwide over 15 years* Get results at aortic.medtronicendovascular.com *Data on fle at Medtronic, Inc. Source: Valiant Captivia IFU UC201405091aEN © Medtronic, Inc. 2014. All Rights Reserved. VAS_2.indd 1 Innovating for life. 3/4/2015 9:55:26 AM OPINION VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 Stenting issue PAD from page 1 been on a campaign against the indis- that may be less efective. However, criminate use of both venous and en- most vascular surgeons who utilize dovascular procedures, especially by such centers will nevertheless do non–vascular physicians. what is best for the patient However, we must acin spite of higher costs. knowledge that even some Further, patients may benof our own are abusing the eft from these centers besystem for fnancial gain. cause of convenience and One of the major points for the provision of a more made by the New York personable environment Times article is that many than can be found in a hosof these unnecessary pital inpatient or outpatient procedures are being perfacility. Additionally, since DR. SAMSON formed by cardiologists in the risk of complications outpatient centers with litfrom complex interventle or no oversight. In full disclosure tions, which can be difcult to manI must admit that my group does age in an outpatient facility, most lease space in an outpatient center. ethical physicians will ensure that I have also published on the benefts only the safest procedures are underof such a center and the mechanism taken. Personally, I have performed for its installation ( J. Vasc. Surg. 2009; more than 500 procedures in our 49:1073-6). facility over the last 7 years and have The reimbursement for a procenever encountered a pseudoaneudure performed in a physician-owned rysm, retroperitoneal hematoma, or or -leased outpatient facility is far other complication needing hospitalgreater than can be achieved in a hos- ization. pital-owned facility. However, since It is my belief that the excessive the physician is responsible for the procedures delineated in the New expenses incurred in such outpatient York Times article are probably not facilities, there is a fnancial incentive representative of the majority of to do more with inexpensive devices such centers. It is, however, quite Indications The Valiant® Thoracic Stent Graft with the Captivia® Delivery System is intended for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy, including: • iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; • nonaneurysmal aortic diameter in the range of 18 mm to 42mm (fusiform and saccular aneurysms/penetrating ulcers), 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and • nonaneurysmal aortic proximal and distal neck lengths ≥ 20mm (fusiform and saccular aneurysms/penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected. Contraindications The Valiant Thoracic Stent Graft with the Captivia Delivery System is contraindicated in: • Patients who have a condition that threatens to infect the graft. • Patients with known sensitivities or allergies to the device materials. Warnings and Precautions The long-term safety and efectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specifc clinical fndings (for example, enlarging aneurysm, endoleaks, migration, inadequate seal zone, or continued fow into the false lumen in the case of a dissection) should receive enhanced follow-up. Specifc follow-up guidelines are described in the Instructions for Use. The Valiant true that there is no oversight or ombudsman to protect the patient in these outpatient facilities. Hospital-employed or university vascular surgeons may correctly imply that there is more oversight of procedures performed in hospital facilities and that this should limit unnecessary procedures. Needless to say, that is not the case in all institutions. In our 600-bed municipal hospital, there is limited peer review and the few times when it has been applied it has, on occasion, resulted in legal suits against the reviewing medical staf. Additionally, institutions that reward practitioners based on relative value units may also induce a perverse incentive to overuse procedures. As Dr. Lawrence describes in his article, site of service may not be the only driving force behind unnecessary interventions. In fact the Clinical Council of the SVS has seized upon appropriate care in offce-based centers and is working on constructive suggestions to ensure not only that site of service is convenient for patients, but also that it provides appropriate high quality care. For the time being the SVS recognizes that we need improved oversight and peer review in these physician-owned centers, and that Thoracic Stent Graft with the Captivia Delivery System is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Strict adherence to the Valiant Thoracic Stent Graft sizing guidelines as described in the Instructions for Use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. As cautioned in the Instructions for Use, a balloon should never be used when treating a dissection. The safety and efectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details. MRI Safety and Compatibility Non-clinical testing has demonstrated that the Valiant Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under specifc conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use. Adverse Events Potential adverse events include, but are not limited to access failure, access site complications (e.g. spasm, trauma, bleeding, rupture, dissection), adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aortic expansion (e.g. aneurysm, false lumen), aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia/infarction, bowel necrosis, bowel obstruction, branch vessel occlusion, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA) / stroke, change in mental status, coagulopathy, congestive heart failure, contrast we should not simply abandon them because of the abusive behavior of a few unethical practitioners. The New York Times article and Dr. Lawrence’s article and letter to the New York Times struck a chord with our membership. It has provoked an outpouring of comments and suggestions from our membership. Some of these are to be found in this edition as letters to the editor. It is apparent that many of us are horrifed by what we are seeing, not only in outpatient facilities but also in hospitals. I believe this is such an important issue that I have requested our associate editors to write a brief comment on their views on the matter and to specifcally identify methods of rectifying the current overuse of vascular procedures (see the following 2 pages). I am hopeful that the NY Times article and the responses we publish will instigate vascular surgeons to stand up for our profession and the well-being of our patients. For if we do not, we will continue to be marginalized by newspaper reporters and government agencies. They will continue to lump us together with interventionalists who may not follow the same ethical road that most of us travel. toxicity, conversion to surgical repair, death, deployment difculties / failures, dissection / perforation / rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion / erosion, failure to deliver stent graft, femoral neuropathy, fstula (including aortobronchial, aortoenteric, aortoesophageal, arteriovenous, and lymph), gastrointestinal bleeding /complications, genitourinary complications, hematoma, hemorrhage / bleeding, hypotension / hypertension, infection or fever, insertion or removal difculties, intercostal pain, intramural hematoma, leg /foot edema, lymphocele, myocardial infarction, neuropathy, occlusion – venous or arterial, pain / reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, perfusion of the false lumen, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural / post-procedural bleeding, prosthesis dilatation / infection / rupture / thrombosis, pseudoaneurysm, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufciency, reoperation, respiratory depression / failure, sepsis, seroma, shock, spinal neurological defcit, stent graft material failure (including breakage of metal portion of device) / migration / misplacement / occlusion / twisting / kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, wound infection. Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. www.medtronic.com www.aortic.medtronicendovascular.com Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 USA Product Services Support Center Tel: 888.283.7868 Fax: 800.838.3103 CardioVascular LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 3 For distribution in the USA only. FTSOP113326-22 Rev 1A © Medtronic, Inc. 2014. All Rights Reserved. 4 OPINION MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T FROM THE EDITORS The associate editors weigh in Editor’s Note: The associate editors of Vascular Specialist were asked to provide their perspectives on the stenting controversy. Here is a selection. Dr. Frank J. Veith: The recent lead article in the New York Times on excessive implantation of lower extremity stents highlights one key point. Vascular surgeons and all vascular specialists who treat lower extremity occlusive disease should always clearly inform patients with intermittent DR. VEITH claudication that one acceptable treatment option is medical and lipid-lowering therapy without any invasive treatment of their arterial blockage. They should be informed that the condition almost never leads to limb loss and that invasive treatment can safely be delayed until such progression occurs. Given such honest reassurance and the option to choose their treatment, most patients with claudication will choose a conservative rather than an invasive approach, and unnecessary stent/angioplasty and other lower extremity interventional procedures, as described in the Times article, will be minimized. Dr. John F. Eidt: The truth is we all bear responsibility. The treatment of lower extremity peripheral artery disease (PAD) has largely defed prior efforts to defne appropriate care. Even the SVS document recommending risk factor modifcation in the initial management of intermittent claudication leaves substantial room for individualized judgment. The appropriateness of intervention is largely in the eye DR. EIDT of the beholder. “Lifestyle-limiting” claudication can be invoked as justifcation for intervention in virtually anyone. But I do believe that vascular surgeons are more wary of the adverse consequences of vascular intervention for one important reason – we do amputations. We are unique among vascular specialists in that we deal with the tragedies of unwarranted vascular procedures. For vascular surgeons, failure of intervention means more than binary restenosis or increased target lesion revascularization. Performing an amputation after failed intervention in VASCULAR SPECIALIST Medical Editor Russell Samson, M.D. Associate Editors Mark A. Adelman M.D., O. William Brown, M.D., Elliot L. Chaikof, M.D., Ph.D., Alan M. Dietzek, M.D., RPVI, FACS, Professor HansHenning Eckstein, M.D., John F. Eidt, M.D., Rob Fitridge, M.D., Larry Kraiss, M.D., Joann Lohr, M.D., James McKinsey, M.D., Erica L. Mitchell, M.D., M.Ed., FACS, Mark Morasch, M.D., Frank Pomposelli, M.D., Luis A. Sanchez, M.D., FACS, Larry Scher, M.D., Murray L. Shames, M.D., Cynthia Shortell, M.D., Frank J. Veith, M.D., Robert Eugene Zierler, M.D. a claudicant leaves an indelible mark on each of us and may underlie our inherently conservative approach to PAD. But we need to be fearless in speaking the truth and serving as advocates for exemplary patient care. Continuing a relationship with a source of carotid and aortic referrals while turning a blind eye to meddlesome lower extremity intervention sends the wrong message. Our silence constitutes tacit approval. Too frequently I hear a patient say “my cardiologist says there is nothing else he can do, go see a vascular surgeon.” Despite years of branding eforts by the SVS, surveys of primary care providers and the public alike confrm that many remain uncertain of our skills. We need to do a better job of spreading the word that vascular surgeons are “leaders in the minimally invasive treatment of PAD.” Not the last resort. Dr. Frank Pomposelli: I could not agree more with Dr. Eidt. It’s easy to indict the outpatient labs for obvious reasons but I personally agree that the root of the problem lies in the overly aggressive DR. POMPOSELLI posture being taken toward treatment of claudication. It just so happens that outpatient labs are flled POSTMASTER Send changes of address (with old mailing label) to Vascular Specialist, Subscription Service, 151 Fairchild Ave., Suite 2, Plainview, NY 11803-1709. The Society for Vascular Surgery headquarters is located at 633 N. St. Clair St., 22th Floor, Chicago, IL 60611. Vascular Specialist (ISSN 1558-0148) is published monthly for the Society for Vascular Surgery by Frontline Medical Communications Inc., 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609. Phone 973-206-3434, fax 973-206-9378 Subscription price is $230.00 per year. with claudicants since they are most likely to have the least complex disease – match made in heaven or hell, depending on your perspective. One cardiologist quoted in the N.Y. Times piece said patients with claudication have been “grossly under treated” – a convenient posture to take when billing Medicare $4.5 million a year. The other cardiologist who was the focus of the investigation called the charges “baseless and fction” and stated his center had the lowest rate of amputation in the country. It gets back to Dr. Eidt’s point how it’s easy for the nonsurgeon to dismiss amputation as an occasional unfortunate byproduct of a busy practice when you never have had to tell a patient they need one and sufer with them through the emotional and physical trauma that always follows. I was taught like many of you, I suspect, that any amputation after treatment for claudication should be considered not only an unacceptable complication but also a failure of the trust the patient placed in me. My mentor was a militant nihilist when it came to surgery for claudication but that concept is always in my mind whenever I treat a patient and has always tempered my decision making. I like to think our recently published practice guidelines will help but am skeptical that it will make a positive impact where it is most needed; on those who are primarily driven by fnancial gain. I’d also point out that Dr. Darren B. Schneider was quoted as a Continued on following page Frontline Medical coMMunications society Partners Director, FMC Society Partners Mark Branca Editor in Chief Mary Jo M. Dales Executive Editors Denise Fulton, Kathy Scarbeck Managing Editor Mark S. Lesney Creative Director Louise A. Koenig Print Production Manager Rebecca Slebodnik Editorial Offces 5635 Fishers Lane, Suite 6100, Rockville, MD 20852, 240-221-2400, fax 240-221-2548 Resident/Fellow Editor Laura Drudi, M.D. Executive Director SVS Rebecca Maron Director of Marketing and Membership SVS Keri Kramer Managing Editor SVS Kay Severinsen Vascular Specialist is the offcial newspaper of the Society for Vascular Surgery and provides the vascular specialist with timely and relevant news and commentary about clinical developments and about the impact of health care policy. Content for Vascular Specialist is provided by Frontline Medical CommunicationsInc. Content for the News From the Society is provided by the Society for Vascular Surgery. The ideas and opinions expressed in Vascular Specialist do not necessarily refect those of the Society or the Publisher. The Society for Vascular Surgery and Frontline Medical Communications Inc. will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein. National Account Manager Artie Krivopal, 973-206-2326, cell 973202-5402, [email protected] Senior Director of Sales Tim LePella, 484-921-5001, cell 610-5063474, [email protected] Classifed Sales Representative Linda Wilson, 973-290-8243, [email protected] Advertising Offces 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609 973-206-3434, fax 973-206-9378 Letters to the Editor: [email protected] ©Copyright 2015, by the Society for Vascular Surgery Scan this QR Code to visit vascularspecialistonline.com FRONTLINE MEDICAL COMMUNICATIONS Stephen Stoneburn, Chairman Douglas E. Grose, EVP Digital Business Development/CFO Alan J. Imhoff, President/CEO JoAnn Wahl, President, Custom Solutions, 973-206-8989 jwahl@ frontlinemedcom.com Dennis Quirk, VP, Finance Jim Chicca, Executive Director, Operations Jim McDonough, VP, Marketing & Customer Advocacy Carol Nathan, VP, Custom Programs Lori Raskin, Corporate Director, Research & Communications Donna Sickles, VP, Audience Development Subscription Inquiry Line 1-800-480-4851 In affliation with Global Academy for Medical Education, LLC. Sylvia H. Reitman, MBA, VP, Medical Education & Conferences David J. Small, MBA, VP, Events OPINION VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 Continued from previous page member of the Society for Vascular Medicine. I guess we need to work harder on our branding. Dr. Mark Morasch: Remember, all politics are local, and any meaningful change needs to come from the grass roots. Experts can write guidelines, specialty societies can make statements, and newspapers can print articles but DR. MORASCH the most infuential transaction occurs in the exam room when we are face to face with our patients. Remember, even though we are a small group, we can have great infuence when we always, always, always do what we know is right. Dr. Alan M. Dietzek: Dear Patient, Let me introduce myself. I am a Board-Certifed Vascular Surgeon. My specialty is unique in that I am well versed and formally trained in both the medical and surgical management DR. DIETZEK of peripheral vascular disease. No other specialist can make this claim. Most often, vascular problems can be managed conservatively with a combination of risk factor and lifestyle modifcation, and occasionally prescription medications, all of which I can outline and or prescribe for you. When necessary, however, I am prepared to treat your vascular problem with either a minimally invasive procedure or open surgery depending on which treatment will provide you with the best outcomes. Again, only a vascular surgeon is capable of ofering you these treatment options. I am dedicated to your well-being. I am a Board-Certifed Vascular Surgeon. Dr. Murray L. Shames: The recent New York Times article, “Medicare payments surge for stents to unblock blood vessels in limbs,” brings up a critical issue in how we train our residents to think and practice in the future. Our current generation of residents is faced with a tremendous fnancial burden of medical school debt, and they are being ofered highly competitive salaries after gradua- tion. The motivation to join groups with outpatient vascular centers is certainly attractive: Why not have autonomy from the hospital, control your work environment, and increase efciency. As educators we must continue to use clinical evidence and societal guidelines DR. SHAMES ( J. Vasc. Surg. 2015:1-40) to guide our clinical practice. As vascular surgeons we have been trained to manage asymptomatic PAD and intermittent claudication nonoperatively due to it’s relatively benign natural history; endovascular interventions have dramatically increased the treatment of claudication, even in our own hands. We must continue to teach our residents restraint and to consider the impact of the interventions we perform. That way we can maintain our status as the leaders in vascular disease management and not just “interventionalists” that treat lesions. Dr. Joann Lohr: The presence of a stenotic lesion does not mandate treatment either with a stent or surgical intervention but needs critical assessment of the impact on the patient’s quality of life. Risk factor modifcation needs to be undertaken before any intervention and will improve outDR. LOHR comes and durability of repairs. The only outcome that matters is the patient’s. “How does treatment of this lesion change my lifestyle?” is a question that needs to be answered for each patient. Treating physicians need to establish long-term relationships. Never be afraid to tell patients a procedure is not the frst line of treatment. Thoughtful application of new technology is needed in all areas of medicine. Just because we can, should we? Appropriate individualized treatment plans and goals need to be established for each patient we treat. Dr. Larry Kraiss: Vascular surgeons provide the full spectrum of care for PAD from medical management through intervention to the unfortunate situations when amputation is necessary. The more sobering of these experiences have imbued most of us with a healthy respect for how an intervention can go wrong. If you haven’t had to explain to a patient or family why an amputation is necessary, you probably don’t have the same concern. Thus, many of us have a very DR. KRAISS conservative approach to PAD intervention; primum non nocere is the governing principle. This principle is supposed to guide the actions of all physicians but I can’t help but wonder if something happened to primum non nocere on the way to the outpatient endovascular center. When physicians become fnancial stakeholders in these enterprises, a pernicious incentive is introduced that is almost impossible to exclude from daily clinical decision making. Hospital-based physicians are also subject to temptation to perform unnecessary yet lucrative procedures but at least these are being done more in the open. I suspect that the development of these centers has allowed much activity to occur that would rightly be condemned under the scrutiny of one’s hospital peers. Dr. Laura Drudi: It really comes down to adequately informing the patient. I always fnd it astounding how many patients I encounter asking me in a timid tone, “What exactly did I have done on my leg?” I question what patients actually understand and retain after being overwhelmed by the informed consent we have prior to an intervention. I see frst hand the catastrophic failures of interDR. DRUDI vening on severe claudication leading to limb loss and worsening of quality of life. It’s disheartening to see adverse outcomes following vascular interventions either by vascular surgeons or other interventionalists, but I believe that if you are performing an intervention you should have the expertise and technical skills to deal with the complications. The best interventionalists know when not to intervene and that should be the mantra we live by. We should be advocates for our patients at a local institutional level as well as a public level. I believe that following the New York Times article the pub- 5 lic will be more aware of the potential for inappropriate or unnecessary interventions, many of which are being performed by specialists other than vascular surgeons. The Society and individual vascular surgeons should capitalize on this opportunity to educate patients as to the benefts of consulting with a vascular surgeon before undertaking any endovascular procedure. Dr. Elliot L. Chaikof: Both government and private payers have a vested interest in ensuring that patients receive the highest quality care, while reducing the unsustainable rate of increase in health care costs. In Massachusetts and elsewhere in the United States, this has led to the introduction of new risk contracting models that feaDR. CHAIKOF tures a global payment with incentives linked to efciency and quality. At our institution, approximately 60% of patients are now in such risk contracts. Primary care physicians are most directly incentivized and, along with government and private payors, are highly motivated to ensure that our population of patients receives the right care, at the right time, from the right physician. The U.S. health care system continues to be in a state of fux with substantial regional variations in the delivery of care and how that care is fnanced. Despite these challenges, the Society for Vascular Surgery can best serve our patients through advocacy and education, including promoting the need for full transparency of costs to our patients and their physicians. This would be most efective in active partnership with primary care providers, along with regional and national payors. Dr. Erica L. Mitchell: The line separating a business from a profession is not entirely clear when professionals engage in business practices that serve to benefit the individual finanDR. MITCHELL cially. One crucial difference distinguishing the profession of medicine from other Continued on following page 6 OPINION MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T LETTERS TO THE EDITOR Editors note: The following letters are a selection of responses from the SVS membership sent to Dr. Peter Lawrence based upon his article in last month’s Vascular Specialist (February 2015, p. 1) on the topic of the abuse of peripheral artery disease stenting in Medicare patients. D espite the unfortunate press, we as a more global medical vascular community are unable to police our own. I have been involved in two specific instances in which inappropriate and overuse of endovascular therapy has been addressed. Unfortunately, these practitioners continue to perform unindicated procedures while hospitals and state medical boards refuse to act. What is Medicare to do when our own medical regulatory bodies fail to act on behalf of patients and the payor? The two routes of targeting practitioners through Medicare high outliers and legal recourse for poor outcome in unindicated procedures will remain until our societies (this includes SVIR and ACC) decide to collaborate and ensure appropriate practice. Simply stating that SVS has guidelines in place will not solve the problem. Jason M. Johanning, M.D. Omaha, Neb. M y ofce of fve vascular surgeons actually has an in-ofce procedure suite. We have converted about 30%-40% of our minimally invasive patient care to this setting. In review of what we have done, we have actually decreased the cost of patient care as there is no facility or hospital addon charge. Our cost per patient is actually about one-third of what is typically Continued from previous page professions is that physicians have a fiduciary duty toward those whom they serve. This means that we have a legal duty to provide services to our patients that place the patient’s interest above our own financial interest. This article highlights how legal and ethical issues arise if health care professionals forgo their fduciary duties for personal gain. Unethical physicians should be held account- charged by the hospital, and our quality based on our independent QA is the same in our ofce setting as it is in the hospital. These types of settings can signifcantly reduce health care costs if done in the proper fashion. Dennis Fry, M.D. West Des Moines, Iowa T he comments in the article that hospitals confer a greater degree of oversight seems to come right from the AHA. The problem is not ofce-based procedures but the ethics of fraudulent practices, something that occurs in and among hospitals as well. Hospitals can be as much driven by case volume, even at academic centers, as are the practices of private outpatient procedures. Paul Gagne, M.D. Darien, Conn. I cannot help but wonder how our specialty’s lack of identity – and thus lack of appreciation of its responsibility and role in public awareness – has contributed to this scenario. Our inclusion under the umbrella of the American Heart Association, again without any designation of our separate identity, leads only to more confusion about our specialty in the eyes of the public. The SVS must address its lack of a public identity in a more forceful able for unethical practices. Dr. Larry Scher: The recent article by Julie Creswell and Reed Abelson in the Jan. 29, 2015, DR. SCHER New York Times highlights a recent problem in the care of patients with peripheral vascular disease. Vascular surgeons have been treating manner. Unfortunately, it’s biggest hurdle in this may well be the hospital-employed vascular surgeons who cannot fght the administrators marketing theme of “Heart and Vascular,” implying to the public that we are all one, “like the cardiologists do” as many patients state. This is not to fault anyone, but it is to awaken our leadership to the need to establish a separate, independent “awareness” vehicle to better craft our identity as a separate specialty to the entire nation. It will take time but will be a project which, when done properly, we will never regret. It calls for a board heavily weighted toward the independent vascular surgeons, who try daily, with limited resources, to accomplish this. Carlo Dall’Olmo, M.D. Flint, Mich. We have struggled locally with the belief that we, as ethical and well-reasoned providers, should have some obligation to report these providers to someone. However, there are no acceptable mechanisms with which to do so, and there is a sense that this would not be accepted well by our colleagues. We also do not want to be written of as disgruntled competitors. Physicians have never done a good job of policing themselves. Maybe articles like this can be a springboard to discuss ways to reign in the outlier providers in our communities. Steven Merrell, M.D. Murray, Utah I think most members of SVS have intimate knowledge of a handful of physicians in their communities whose practices would be considered abusive, if not overtly suspect. agree with Dr. Lawrence 100%. We need the SVS to be a major speaker in this debate. We have to give patients the confidence that they are being cared for by physicians who are not only capable to diagnose the problem but are also able to care for it in the most appropriate fashion. We need to silence the naysayers and the media hogs by developing a method so that surgeons who care for vascular patients in an offce-based vascular suite are certifed by the Society in the form a Center of Excellence designation. Initial certifcation would be followed by ongoing proactive reviews on a serial basis. I would ask that the leaders of our society take a step toward developing the concept of this certifcation body as soon as possible. We need to police ourselves and this may be the way to do it. Thank you in advance for your attention and ongoing vigilance for the vascular surgical community. Khash Salartash, M.D. Galloway, N.J. peripheral arterial disease for over 50 years and have generally adopted a conservative approach toward patients with claudication, emphasizing risk factor modifcation and exercise. This is based on an understanding that the disease is benign, rarely progressive, and only occasionally disabling to the point that intervention is indicated for symptom relief. With new minimally invasive techniques available and specialists other than vascular surgeons performing peripheral catheter based procedures we seem to have forgotten all that vascular surgeons have learned over the past 5 decades. Most patients with claudication do not beneft from and may be harmed by interventions when long-term rather than shortterm outcomes are analyzed. Although practitioners such as those identifed in this article may believe they are pioneers in the treatment of peripheral arterial disease and specifcally claudication, I would consider them cowboys who have forgotten the lessons of the past. W hat the article misrepresents is that this happens only in outpatient labs. The same thing occurs, albeit to a lesser degree, in our hospitals. I am glad to see no vascular surgeons were named. I am also glad they are starting to shine a light on the massive ongoing problems with EVLT and RF ablation procedures. This is particularly bad in Florida. I wonder if SVS can come up with some response to suggest ways to police this behavior. None of us want more government oversight, but it seems like something needs to be done at the state board level to better regulate these procedures. Geofrey L. Risley, M.D. Jacksonville, Fla. I VAS_7.indd 1 3/10/2015 10:43:22 AM POINT/COUNTERPOINT 8 MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T POINT/COUNTERPOINT Renal artery occlusive disease – To treat or not to treat? ASTRAL and CORAL trials show no indication to treat percutaneously. There are still indications to treat renal artery occlusive disease. when added to comprehensive, multifactorial medical therapy, inercutaneous treatment of renal tervention yielded no beneft. artery occlusive disease is unSo are there certain patient necessary and should be abangroups who might beneft more doned, except in pediatric cases. from intervention? Among listed This position is supported by indications are high-grade stenosis fndings from both the ASTRAL tri- (which doesn’t apply any longer); al (N. Engl. J. Med. 2009;361:1953short history of progressive failure 62) and the CORAL trial (N. Engl. (which is quite rare); ACE-induced J. Med. 2013 Nov. 18 [doi:10.1056/ renal failure (which is also quite NEJMoa1310753]). rare); difcult-to-control hypertenThe ASTRAL trial, a prospective, sion (there really is no such thing randomized comparison of best now, except in a tiny percentage of medical therapy with and without patients); and – the least challenged stent angioplasty in more than 800 indication – fash pulmonary edepatients, was the largest trial to ma. These remaining indications date when it began back move our interventions in the 1990s. The wellinto a very high-risk known results showed group of patients. no diference in time The current debate is to frst renal event, frst focused almost entirely vascular and cardiovason endovascular intercular events, and overall vention, but a systematic survival. Furthermore, review showed that there there was no diference is long-term beneft in in these outcomes among terms of renal function DR. HAMILTON patients with greater and hypertension with than 90% stenosis, with open procedures. Althe exception of a possible diferthough overall there is increased ence in mortality, which trended mortality, this risk is minimized – toward improvement among those and not signifcantly diferent from with high-grade stenosis. endovascular procedures – in those We concluded that revasculariza- having only renal revascularization tion in the vast majority of patients vs. those having concomitant aortic is unlikely to improve hypertension procedures. So open surgery recontrol or renal function, and that mains a possible treatment option. renal artery stenosis is not pathoindeed a recent level 1 study comphysiologically important. We also paring stenting and open surgery; concluded that there is no point in showed better long-term results screening for asymptomatic disease; with open surgery ( J. Vasc. Surg. this was back when every patient 2009;49:667-75). The authors conwas getting screened, and treated cluded that surgical reconstruction primarily on the basis of fnding a remains the gold standard in treatrenal arterial stenosis. ing renal artery stenosis. Although Finally, we concluded that propnational data suggest an overall erly applied best medical therapy mortality of about 10%, it is much alone was an extremely good treat- lower at specialist, high-volume ment. centers with mortality rates similar Several faws in the trial garnered to those of stent angioplasty. extensive criticism, however, and Renal stenting is not a low-risk the more rigidly designed CORAL procedure. In all-comers the comtrial was expected to address them. plication rates, serious complication The fndings confrmed those of rates, and mortality rates are signifthe ASTRAL trial. In more than 900 icant with short-term equivalence patients from 88 centers, there was between focused renal arterial absolutely no beneft of intervention surgery and percutaneous intervenwith respect to primary and section. ondary outcomes, including among Returning to the debate, are eithose with high-grade stenosis. ther methods of revascularization We can now see on the basis appropriate? Probably not. HAMILTON continued on following page of extensive level 1 evidence that inclusion within a randomized trial with change in renal function as its lthough renal artery revasprimary outcome is problematic for cularization has been grossly the same reason. overutilized and is not indicatASTRAL also had an additional, ed in the majority of patients with somewhat unorthodox inclusion renal artery stenosis, I perform recriterion: uncertainty on the part of nal artery revascularization as part the treating physician that the patient of my routine clinical practice and “defnitely would have a worthbelieve that there are many instanc- while clinical beneft from revascues where revascularization should larization.” Exclusion of patients be considered, particularly when considered likely to beneft from patients have severe symptoms revascularization would seem to endespite aggressive medical therapy. sure a selection bias favoring the null While neither ASTRAL nor CORhypothesis; this approach may also AL observed any beneft associated explain the large proportion of particwith revascularization, both have ipants with relatively mild occlusive important limitations disease (40% had stenotic that should be kept in lesions that were <70% in mind when interpreting severity). the results of these trials. A high rate of both These limitations can technical failure (12%) be broadly categorized as and adverse events (20%) mismatch between indicaassociated with revascutions for revascularization larization, asymmetric and clinical endpoints, crossover between treatselection biases favoring ment groups (86 of the DR. CORRIERE enrollment of patients 110 patients who did not with relatively mild sympreceive their randomized toms, and inconsistencies between intervention were in the revasstudy protocols and contemporary cularization group), and lack of decision-making strategies. standardized protocol for medical Given that ASTRAL’s primary therapy further limit the concluoutcome was change in renal func- sions that can be drawn from the tion (defned by a 20% or greater ASTRAL results. reduction in the mean slope of the Although this trial does not proreciprocal of serum creatinine), vide us with compelling evidence it is important to remember that that renal revascularization should the inclusion criteria were renal be abandoned for patients failartery stenosis with unexplained ing appropriate medical therapy, renal dysfunction or poorly conASTRAL demonstrated that no trolled hypertension. Patients who beneft should be expected from had hypertension in the absence nonselective use of revascularizaof signifcant renal dysfunction tion, which can be associated with were therefore eligible, and 40% signifcant rates of both technical of the randomized participants failure and major adverse events. had preserved baseline renal funcThe CORAL trial overcame many tion (based on a serum creatinine of the design limitations for which of <150 micromol/liter). Unlike ASTRAL drew criticism. CORAL’s patients with baseline renal dysprimary endpoint (freedom from function (which, in theory, might major adverse cardiovascular or reimprove with revascularization), nal events) allowed potential beneft these patients with normal renal for participants with either systolic function who were treated with hypertension or chronic kidney revascularization risked decline in disease as their indication for treatrenal function resulting from proce- ment. Although participants with dure-related adverse events without systolic hypertension as their incluany real chance of renal function sion criterion had to be on at least improvement. It would certainly two antihypertensive medications, be difcult to justify revascularizait is important to acknowledge the tion for the sake of renal function growing number of indications for CORRIERE continued on following page salvage in these patients, and their BY GEORGE HAMILTON, M.D. P BY MATTHEW A. CORRIERE, M.D. A VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 HAMILTON continued from previous page Even in fash pulmonary edema, there is little evidence to support revascularization. Few papers exist suggesting a beneft of revascularization in reduction of fash pulmonary edema, but the patient numbers were small, and there was no beneft in terms of preserCORRIERE continued from previous page these medications related to cardiovascular risk reduction in the setting of diabetes, heart disease, and other diagnoses that may be unrelated to any specifc blood pressure target. Number of antihypertensive medications is therefore often a crude and potentially invalid indicator of hypertension severity or control. In CORAL, the initial hypertension inclusion criterion of 155 mm Hg was subsequently abandoned during the trial, suggesting that hypertension in many of these patients may have been mild and/ or well controlled. Although medical therapy in CORAL was standardized, it also is notable that all patients had their medical therapy adjusted prior to randomization during a roll-in phase to achieve target blood pressure goals of 130/80 in patients with CKD and/ or diabetes or 140/90 otherwise. I would suggest that achievement of these blood pressure targets on the study medications (candesartan ± hydrochlorothiazide plus amlodipine-atorvastatin) might be appropriately considered success of medical therapy for patients with hypertension in the absence of renal dysfunction, making it challenging to defend proceeding with revascularization in this scenario. The study protocol, although well designed from the perspective of attempting to isolate the efect of renal artery angioplasty and stenting, therefore did not uniformly refect what would be considered responsible utilization of renal revascularization in a real-world environment. Patient enrollment in CORAL was also very selective; only 947 of the 5,322 patients who were screened went on to be enrolled and randomized. It is likely that at least some of those patients who were not enrolled (especially those who declined to participate or were withdrawn by their physicians) were failing aggressive POINT/COUNTERPOINT vation of renal function. The history of evolution and evaluation of the role of renal revascularization is remarkably similar to that of renal denervation, initially and with considerable conviction thought to be a cure for hypertension. However, when properly assessed by prospective randomized comparison, there was found to be absolutely no beneft. So, given the considerable objective evidence from two major trials and revisiting the basics of the pathophysiology of atherosclerotic renovascular disease, to expect beneft from treating the osteal component of renal artery occlusive disease is at best naive, in my opinion. There remains little clinical evidence of beneft for any indication, with the possible exceptions of ACE-induced renal failure and possibly fash pulmonary edema in the presence of bilateral renal arterial stenoses. medical therapy and therefore unwilling to being excluded from angioplasty and stenting through randomization. These limitations aside, however, CORAL does provide some very useful observations that should inform treatment decisions. The results demonstrate the efcacy of contemporary medical therapy for many patients, and show that revascularization ofers no additional beneft when medical therapy achieves an acceptable clinical response (defned by stable renal function and reasonable blood pressure control). Additional subgroup analyses of the CORAL data are anticipated, but will likely be underpowered to draw conclusions in the absence of identifed revascularization efects. So when should revascularization be considered for patients with atherosclerotic renal artery stenosis? In general, medical therapy is adequate for most patients and should be implemented prior to any consideration of procedural intervention. Revascularization should be considered only for patients who have failed appropriate, aggressive medical therapy; the medications used in CORAL can certainly be regarded as adequate initial therapy for symptomatic renal artery stenosis, but many providers (including myself ) would argue that additional agents should be considered before proceeding with revascularization. When decline in renal function is the indication for considering revascularization, alternative causes (such as intrinsic renal disease) should diminish enthusiasm for proceeding with angioplasty and stenting, particularly when the anatomic disease distribution does not afect the entire renal mass (as in patients with two kidneys and unilateral stenosis). Appropriate candidates for revascularization include patients with severely impaired renal function (particularly in the setting of a precipitous functional decline) or severe acute blood pressure ele- vation associated with hypertensive emergency (such as acute congestive heart failure, encephalopathy, acute coronary syndrome, or other signs and symptoms of target organ damage resulting from hypertension and/ or volume overload). Continuation of failed medical therapy is often unacceptable to these “no-options” patients as well as their providers, both of whom presumably would be unlikely to accept randomization to ongoing medical management. Other populations that are not represented within these trials include patients with renal artery restenosis and those with nonatherosclerotic disease; it is therefore important to exercise caution when generalizing these study results to these distinct groups of patients. Enrolling pa- tients with severe symptoms who have failed medical therapy will likely remain challenging for future randomized studies in the absence of alternative treatment options. Although the benefts of renal angioplasty and stenting for these “no-options” patients remain to be proved, the uncertainty of response to revascularization is often easier to accept than the ongoing morbidity and mortality associated with staying the course when medical therapy has failed. Dr. Hamilton is a professor at the Royal Free London Hospital, University College London. Dr. Corriere is a vascular surgeon at Wake Forest University School of Medicine, Winston-Salem, N.C. This article developed from a debate held at the 2014 Vascular Annual Meeting. has not only a new look, but new features, with the goal of providing you the latest in vascular and medical news beyond the print edition. 9 10 RESIDENTS’ FORUM MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T Private vs. academic salaries PERSPECTIVE Gap from page 1 Not just the money the annual scientifc assembly of the Eastern Association for the Surgery of Trauma (EAST). Every year a new class of surgeons is faced with the question of academic practice or private practice, The worse fnancially you make it to be an academic surgeon, the more it risks our mode of training. DR. LOPEZ but they are also struggling with increasing student loan debt and longer training as more surgical residents elect to enter fellowship rather than general practice. This growing fnancial liability coupled with declining physician reimbursement could rapidly shift physician practices and thus threaten the fscal viability of certain surgical felds or academic surgical careers. “The more fnancially irresponsible you make it to become an academic surgeon, the more we put at risk our current mode of training,” Dr. Lopez of Wake Forest University in Winston-Salem, N.C., said. To account for additional factors outside gross income, the investigators ran the numbers using a second analysis, a net present value calculation, however, and came up with roughly the same salary gap to contend with. Net present value (NPV) calculations are commonly used in business to calculate the proftability of an investment and also have been used in the medical feld to gauge return on investment for various careers. The NPV calculation accounts for positive and negative cash fows over the entire length of a career, using in this case, a 5% discount rate and adjusting for infation, Dr. Lopez explained. Both the lifetime gross income and 5% NPV calculation used data from the Medical Group Management Association’s 2012 physician salary report, the 2012 Association of American Medical Colleges physician salary report, and the AAMC database for residency and fellow salary. The NPV assumed a career length of 37-39 years, based on a retirement age of 65 years for all specialties. Positive cash fows included annual salary less federal income tax. Negative cash fows included the average principal for student loans, according to the AAMC, and interest at 5%, the average for the three largest student loan lenders in 2014, he said. Student loan repayment was calculated for a fxed-rate loan to be paid over 25 years beginning after residency or any required fellowship. The average reduction in 5% NPV across surgical specialties for an academic surgeon versus a privately employed surgeon was 12.8% or $246,499, Dr. Lopez said. Once again, academic neurosurgeons had the largest reduction in 5% NPV at 25.5% or a loss of $619,681, followed closely by trauma surgeons (23% or $381,179) and surgical oncologists (16.3% or $256,373). Academic pediatric surgeons had the smallest reduction in 5% NPV at 4.2% or $88,827. During a discussion of the provocative poster, attendees questioned whether it was fair to say that private surgeons make more money without acknowledging the risk they face, Market pressures unaccounted for in the model can dramatically infuence a surgeon’s salary over a lifetime. DR. ZARZAUR compared with surgeons employed in an academic setting. Dr. Lopez countered that, increasingly, even private surgeons are no longer truly private surgeons. “More and more surgical groups are being bought up by hospitals, and even the private surgical groups are being bought up by hospitals, which does stabilize your income to some extent,” he said. “We all still have [relative value unit] goals to meet and RVU incentives that make it so you can get paid a little more, but it’s something that’s a consideration. It is a risk-reward to be a private surgeon. Depending on how your contract is structured or how your group decides to pay the partners, it may be that if you don’t take very much call or take that many cases, you’ll end up on the short end of the stick.” Dr. Ben L. Zarzaur, a general surgeon at Indiana University in Indianapolis who comoderated the poster discussion, pointed out that market pressures unaccounted for in the model can dramatically infuence a I n the United States, academic vascular surgeons earn 13.8% or $1.7 million less than private vascular surgeons. This fnancial incentive may infuence graduating residents and fellows to enter into private practice. This article indicates that this fnancial disparity may cost academic institutions the expertise needed to train future physicians. Unfortunately, I believe this analysis falls into one of the many myths between academic and private practice; that is, it’s not only about making the most money possible. The ongoing debate of academic versus private practice shouldn’t surgeon’s salary over a lifetime. Dr. Lopez agreed, citing how the increasing number of stent placements by cardiologists, for example, has impacted the bottom line of cardiothoracic surgeons. The NPV calculation was specifcally used, however, because it gets at market forces such as infation and return on investment, not addressed by gross income fgures alone. Finally, Dr. Zarzaur turned and asked the relatively young crowd what they would do if ofered $600,000 a year, but had to work 110 hours a week or could get $250,000 and work only 40 hours a week. Most responded that they’d choose the former to repay their student loans and then switch to the lower-paying position. Responders made much of job satisfaction, work-life balance, and the really be a debate at all. It is all about personal choices concerning research, education, work-life balance, and fnances to name a few. In the end, anyone can shape the ideal practice they want to have. There are many private practices that are involved in resident education, publish extensively and present at national and international meetings. No job is weaved perfectly, but there will usually be a job that fts an individual’s specifc goals and desires. Dr. Laura Drudi is the resident medical editor for Vascular Specialist. ability of surgeons in academic practice to take time away from clinical work to conduct research, their ready access to continuing medical education, and their ability to educate the next generation of surgeons. “Any time we see this academic-private disparity, you have to think about these secondary gains,” Dr. Zarzaur said. “This is really interesting work. It gets into why we choose what we do, why we’d take $600,000, work 110 hours a week, and get our rear ends kicked. The fip side is, if I saw this, why would you ever go into academics? But people still choose to do it. I’m in academics so there’s a bias, but we choose to do it anyway up to a point. I don’t know where that point is, but up to a point we do.” [email protected] PERSPECTIVE Lifestyle choice important T he basic fnding of the disparity is in fact true leaving aside the fawed methodology of too many assumptions by including all academic ranks, practitioners of diferent durations in practice, diference in benefts, tuition assistance, and assuming student loans for all surgeons plus a risk free rate that is too high. Our analysis of both vascular and general surgeon compensation points to a larger disparity at junior academic ranks over the last decade. With our own studies showing a shortage of vascular sur- geons, retention of practitioners is paramount for all health systems. Academic centers rely on faculty giving up a percentage of their compensation for the pleasure of teaching, research and intellectual stimulation. The unanswered question is: How much of a disparity will junior academic surgeons tolerate, and how do they value lifestyle against additional compensation? Time will tell. Dr. Bhagwan Satiani is a professor of vascular surgery at the Wexner Medical Center, Ohio State University. VAS_11.indd 1 3/11/2015 9:09:59 AM 12 NEWS FROM SVS MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T ACA – What it takes for surgeons to survive and succeed E ach year, one of the highlights of the Vascular Annual Meeting is the lively Crawford Critical Issues Symposium, headed this year by Dr. Bruce Perler of Johns Hopkins Hospital Division of Vascular Surgery. His topic, “How You Can Succeed Under the Affordable Care Act,” will be addressed by stakeholders from all sides of the issue. • Dr. Bruce Landon, professor of health care policy, Harvard Medical School, discussing how ACA may impact vascular surgeons • Dr. Dan Clair, chair, Department of Vascular Surgery, the Cleveland Clinic, discussing how vascular surgeons can succeed as hospital employees DR. BRUCE PERLER Vascular Specialist asked Dr. Perler to tell us more about this event, scheduled for 10:30 a.m. to noon on Thursday, June 18. VS: Why did you pick this topic? Dr. Perler: There is no more important and overarching issue for all vascular surgeons today than the rapidly changing contemporary health care environment related to the AffordContinued on following page Register now for the Vascular Annual Meeting R egistration is now open for the 2015 Vascular Annual Meeting, which is scheduled for June 17-20 in Chicago, Ill. Thanks in part to revised deadlines for submissions, this year we received a record 705 abstract and video submissions. This should ensure that you will be attending invigorating sessions with lively discussions. Registration fees vary depending on your category, from $650 for active members to $300 for candidates, international physicians, and non-member residents. Early birds - This year, there will be more to do on Wednesday, which SVS ANNUAL MEETING 705 Record-breaking total submissions of VIDEOS and ABSTRACTS. HOTEL OPTIONS WITH SPECIAL RATES Speakers will be – • Dr. Stephen Ondra, senior vice president and CMO of Health Care Service Corporation, ofering the viewpoint of the insurance industry • Larry Boress, president and CEO, Midwest Business Group on Health, an agency that helps employers choose and manage health care benefts for employees 5 THINGS TO KNOW ABOUT THE features hands-on interactive workshops and lots of international events. An excellent lineup of postgraduate courses will be ofered, which are included in your registration fee. Self-assessment credit – Credits will be available for all plenary sessions and attendees can claim credits online following the meeting. You will need to attend all seven plenary sessions to apply for self-assessment credit. Q. Who can beneft from attending the SVS annual meeting? A. Attendance can benefits active Register continued on page 14 3 • Sheraton Chicago Hotel and Towers: $279 single/$299double. • Hyatt Regency McCormick Place: $296 single/double. • Holiday Inn Mart Plaza: $189 single/double. AMA PRA CATEGORY 1 CREDITS™ you can earn up to 30.75 5 PLAYERS ON THE TEXAS RANGERS who have been diagnosed with THORACIC OUTLET SYNDROME. The Chicago White Sox will play the Rangers twice that weekend. TICKETS: http://vsweb.org/Baseball ATTENDEES in 2011, the last time that VAM was in Chicago. 3,020 NEWS FROM SVS VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 Continued from previous page able Care Act. Quite honestly, for a number of reasons and in large part due to these changes, I believe the lines of demarcation between private and academic practice are increasingly blurring. The pressures, external threats, and challenges to achieving a satisfying and economically viable practice are quite similar today irrespective of practice type or location. The increasing movement to full-time hospital employment, the increasing emphasis on quality outcomes, impending changes in reimbursement models, and the emergence of Accountable Care Organizations (ACOs) are factors afecting the practices of all vascular surgeons. I therefore believed that this was a most appropriate topic to address at the 2015 Crawford Critical Issues Symposium. “How You Can Succeed Under the Afordable Care Act” will provide strategies that our members can follow to not only survive but thrive in this new health care order. VS: What takeaways do you hope attendees will have at the end of the session? Dr. Perler: We will be bringing together in one forum a world class group of nationally recognized experts and stakeholders in health care to share their knowledge about, and expectations for, the immediate and mid-term future of health care economics. The panel includes individuals with diverse backgrounds and interests including the perspectives The lines of demarcation between private and academic practice are increasingly blurring. The challenges to achieving a satisfying and economically viable practice are quite similar. of the employer, the payor, public health policy-makers, and the practicing institution-employed vascular surgeon. We believe these presentations and the opportunity for our attendees to engage these leaders in a question-and-answer session will provide education about the expectations these stakeholders have of clinicians and therefore allow our members to develop strategies that they might incorporate in their own practices to continue professionally satisfying and economically productive practices. While all medical practitioners are afected by these changes inherent in the Afordable Care Act, because of our relatively small numbers and the increasing multispecialty completion that vascular surgeons face, including for many participation in multispecialty cardiovascular centers as well as increasing hospital employment, I believe that these issues are particularly relevant to our specialty. VS: You have an interesting line-up of panelists, what were your reasons for selecting each? Dr. Perler: There are clearly multiple stakeholders or components in our health care system with unique backgrounds, interests, and agendas. Each of them will bring to the Crawford Symposium a perspective from his specifc component of the system, the insurer, the employer, the hospital-employed surgeon, and someone with specifc expertise in Accountable Care Organizations and knowledge of vascular surgical practice. It was my expectation to bring these experts together in one setting to not only provide useful information for our attendees, but to allow them to engage in a collective discourse that should provide an unparalleled educational experience for our attendees. 13 VS: Where do you think their biggest areas of agreement, and of disagreement, will be during the discussion? Dr. Perler: That’s a great question and the short answer is I can’t precisely predict. In general, I would assume that there will be a consensus that rising health care costs must come under control and physician reimbursement in the future will be increasingly linked to quality outcomes rather than pure case volume. There also may be a consensus on the importance of longitudinal patient care. Beyond the obvious, however, the key question is whether or how the health care system will align reimbursement to the distinctive competencies of vascular surgeons as the only truly comprehensive vascular specialists who provide the totality of care including diagnosis as well as medical, surgical, and endovascular therapy. Will employers and insurers recognize the value of the comprehensive care that only vascular surgeons provide? Will ACOs factor that competency into specialty referral patterns? Further, will payors and hospitals recognize the unique leadership that vascular surgeons can provide in the care of cardiovascular patients in the hospital environment? NEWS FROM SVS 14 MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T Study: Surgery offers chance to adjust vascular medications P atients who are treated at sites with longer participation in the VQI had better medical management and this was associated with higher survival rates, according to a new study reported in the April 2015 issue of The Journal of Vascular Surgery. Further, surgery at a VQI site may relate to optimized medications with the goal to improve survival rates. Led by Dr. Randall R. De Martino, a team of researchers studied medical management for vascular surgery patients at sites participating in the Vascular Quality Initiative and associated patient survival rates. Two key outcomes were noted: Site participation in VQI is associated with improved use of antiplatelets and statin medication for that site’s patients undergoing vascular procedures; and, treatment with AP and statins is associated with a 14 percent survival advantage for patients at fve years postsurgery. “Medical therapy for patients with vascular disease remains important for their long-term prevention of cardiovascular events,” noted Dr. De Martino. “The surgical encounter provides an excellent opportunity to ensure that appropriate medications are prescribed. As our data demonstrate, many patients remain medically undertreated and this is associated with worse long-term survival. Importantly, participating in a quality improvement initiative, like the VQI, is associated with improvements in medical management. This highlights how we can use a quality improvement collaborative to improve care for our patients.” Since up to 75 percent of patients with peripheral arterial disease will ultimately die of cardiovascular causes, it seems that medical management is a strong tool to ensure patient survival. Additional authors are Drs. Andrew W. Hoel, Adam W. Beck, Jens Eldrup-Jorgensen, John W. Hallett, Gilbert R. Upchurch, Jack L. Cronenwett, and Philip P. Goodney. Register continued from page 12 members and non-members, senior and retiree members, candidates, students, residents, and fellows. Professionals in related felds, such as podiatrists, allied health professionals, PhDs and researchers, vascular nurses, international professionals, and exhibitors, can also beneft. Q. Can I still submit an abstract? A. The deadline has passed, however there will be an opportunity to submit late-breaking abstracts. Visit vsweb.org/VAM15 for details. from popular Navy Pier and the shopping along Magnificent Mile. Or enjoy the free concerts offered at the nearby Jay Pritzker Pavilion in Millennium Park on Wednesday and Friday evenings. Take a tour by Segway or trolley or by boat along the Chicago River. Enjoy the city’s blues and jazz night clubs and fabulous dining. Sample local delicacies such as Italian beef sandwiches or deep dish pizza. Check out the free Lincoln Park Zoo, or the lakeside beaches. Q. How do I get to McCormick Place in Chicago? A. See our travel page online at http://vsweb.org/Travel. Q. I’m not an active member yet. Why should I come? A. The Vascular Annual Meeting has a vastly expanded program for fellows, residents. Find out more at http://vsweb.org/RSF. And you get a big discount. Q. Should I bring the family? A. Sure, why not? June is one of Chicago’s best weather months, and the Sheraton is just blocks Research and San Francisco? What’s not to like? Sign up now for VriC...May 6, 2015 in the heart of San Francisco There’s nothing abstract about the Vascular Research Initiatives Conference – it’s specifcally designed to foster interaction and encourage new researchers. This year’s translational session, “Biomarkers for Vascular Disease Prediction and Therapeutic Screening,” will feature Drs. William R. Hiatt, Alberto Figueroa, and Lars Maegdefessel. The one-day conference is scheduled the day before the AHA ATVB meeting at the same location. MOC credits available. regiStration iS now open To register, visit: http://vsweb.org/VRICRegister Pricing: Member: $275 / Non-Member: $300 / Resident: $125 aCCoMMoDationS Hilton San Francisco Union Square, 333 O’Farrell St. Special room rate: $229/night single/double occupancy; frst come, frst serve. Reservations: http://vsweb.org/VRIC15hotel or 800-HILTONS. International guests may call: 415-771-1400. ® Be sure to mention you are attending the AHA ATVB meeting. NEWS FROM SVS VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 15 Growing Medicare penalties start this year A long with the usual threat of cuts to physician payment using the Sustainable Growth Rate (SGR) formula, which sets payment rates through a formula based on economic growth, physicians are also facing other potential cuts. Physician Quality Report System (PQRS) – for eligible professionals (EPs), which include vascular surgeons, who do not successfully report nine quality measures: 1. 2015 – 1 percent payment adjustment 2. 2016 and beyond – 2 percent payment adjustment 3. According to the American Medical Association, only 35 percent of EPs are participating in PQRS Meaningful Use of Electronic Health Record Incentive Program – for EPs who fail to participate: 1. 2015 – 1 percent payment adjustment 2. 2016 – 2 percent payment adjustment 3. 2017 – 3 percent payment adjustment 4. Hardship exemptions – insufcient Internet access, new physician, natural disaster or other unforeseeable barrier, lack of face-to-face or telemedicine interaction or lack of follow-up needed with patients and lack of control over availability of certifed EHR technology 5. According to a 2014 Medscape Report, 22 percent of physicians are opting out of Meaningful Use Value-Based Payment Modifer – for physicians who do not meet the benchmark for both cost and quality data: 1. 2015 – 1 percent payment adjustment for physicians in group practices of 100 or more EPs under a single tax identifcation number based on 2013 data 2. 2016 – 2 percent payment adjustment for physicians in group practices of 10 or more EPs based on 2014 data 3. 2017 – 4 percent for physicians in group practices of 10 or more EPs/2 percent for physicians in group practices under 10 EPs based on 2015 data Sequestration – 2 percent acrossthe-board cut on Medicare to reduce the defcit The result – penalties go as high as 11 percent in 2017 for these programs According to the Medical Group Management Association survey conducted in October 2014 with 1,000 physician group practices in which 48,000 physicians practice: 1. 84 percent do not believe that Medicare’s quality reporting programs enhance physicians’ ability to provide high quality patient care 2. 71 percent rated the regulatory complexity of the quality reporting programs as very or extremely complex 3. 74 percent are concerned with their practices’ ability to successfully g n i l l i b r o f e r u c A headaches... rse u o C g in d o C S V S 5 1 The 20 2015 , 8 1 – 7 1 l ri p A : N E H W nois li Il t, n o m e s o R : E R E WH l Airport) participate in Medicare quality reporting programs in 2015 SVS supports replacing the three programs with a Merit-Based Incentive Payment System, which was included in last year’s SGR repeal and reform bill. Even though there is bipartisan, bicameral support for this legislation, Congress will likely enact another SGR “patch” for six months before the current patch expires on March 31; otherwise, there will be a 22 percent cut that would take efect on April 1. in presenters Avoid costly errors. Jo rt Zwolak, Drs. Sean Roddy, Robe d coding Sunita Srivastava an mano for an consultant Teresa Ro orkshop on intensive, two-day w ding and the most pressing co s. reimbursement issue eb.org/Coding15 Details: http://vsw e Internationa (near Chicago O’Har ® 16 ANEURYSMS MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T Managing infection PERSPECTIVE EVAR from page 1 T rehydration. These tests are important because preoperative chronic obstructive pulmonary disease and renal dysfunction correlate with worse postoperative outcomes, he said. Computed tomography angiography (CTA) is the most important step of preoperative preparation, with the sine qua non of infection being air around the graft. Unlike hand-sewn grafts where infections can be localized, typically there is total graft involvement in these cases because the device is left inside the aneurysm sac. Aneurysms or pseudoaneurysms also have been seen above the infected device, including at the top end of suprarenal stents. “This clearly has an impact on how we approach patients, but what’s become very apparent to me is that CTA often underestimates the amount of periaortic infammation, especially at the juxta- and pararenal locations.” The Mayo group initially used in situ antibiotic-soaked prosthetic grafts for explanting EVAR devices, which yielded “acceptable mortality and reinfection rates, but primarily outstanding patency rates.” However, cryopreserved aortoiliac grafts have now become their frst choice, he said. An ABO match is not imperative, preparation takes roughly 45 minutes, branch closures done in the lab are buttressed with sutures, and the graft is turned over to keep the lumbar arteries anterior, which offers an easy fix if there is bleeding, rather than having it on the posterior wall. Cryopreserved grafts, however, can dilate 40% and lengthen 10% under pressure. “I’ve been burned more than once where the graft elongates more than I think, and I end up having to cut a small piece out to foreshorten it,” he said. Surgeons should have several plans for reconstruction, including routing a graft through a remote path, remembering that CTA will underestimate the amount of periaortic infammation. Separate bypasses of the renal or visceral arteries are performed frst before the aortic clamp is applied to reduce physiologic stress. This requires knowledge of the supraceliac and pararenal aorta exposures, which really begins with the correct choice of incisions, Dr. Bower said. This is based on the aortic segment to be treated, position of the new graft, the aortic clamp site, and patient body habitus. Most patients with EVAR infections are approached with a midline ab- dominal incision extended along the xiphoid process, which is the linchpin for allowing upward and lateral retraction of the abdominal wall, he said. Choosing an incision that allows a more vertical orientation to where the new aortic anastomosis and clamp site will be, rather than operating in a keyhole, is important. The second step is to open up the pararenal space by moving the viscera out of the way. This begins by ligating the inferior mesenteric vein and adjacent lymphatics, which allows incision of an avascular plane along the base of the left transverse colon. Retractor blades are set to allow the upward and lateral retraction of the small bowel, the left colon, and pancreas. Exposure of the suprarenal or supramesenteric aorta requires mobilization of the left renal vein after ligation and division of its branches. “If that vein is intensely involved in infammation, don’t ligate the branches in case you have to divide that vein at the caval confuence. Otherwise, you’ll run into some dysfunction of that left kidney.” For a secure place for the aortic cross clamp, the crura must be divided on either side of the diaphragm at or above the supramesenteric aorta, he added. Key steps in total graft explantation are to drain abscesses prior to surgery to lower the bacterial burden and thus reduce the postop infammatory response; bypass renal/visceral arteries frst, if needed; remove the infected graft; debride the aorta to healthy tissue; place the new graft and cover it with omentum; and repair the bowel, if needed. A piece of proximal aortic wall should be sent to pathology to ensure absence of bacteria or microabscesses. Organism-specifc antibiotics are given intravenously for 6-8 weeks followed by lifelong oral antibiotics. An earlier report involving 24 patients with infected aortic endografts showed potential contributors to infection were endovascular reintervention in eight, aortoenteric fstula/ erosion in four, and various remote infections (J. Vasc. Surg. 2013;58:371-9). Rifampin-soaked grafts were used in 15 patients, cryopreserved grafts in 4, femoral vein in 2, and axillofemoral grafts in 3. At 14 months follow-up, patient survival, graft-related complications, and reinfection rates were 79%, 13%, and 4%, respectively. Dr. Bower had disclosures. [email protected] he expert opinion from the Northwestern Vascular Symposium regarding the management of EVAR infections reminds us of the importance of appropriate patient selection, proper performance of the planned procedure, and long-term follow-up. As EVAR has become the treatment of choice for more than 80% of patients with infrarenal AAAs in the United States, the rate of patients that return with EVAR infections, although rare, is increasing and their management can be more challenging than that of a primary or aortic graft infection as suggested by Dr. Bower in this opinion. The planning for these cases is critical with multiple options for treatment currently available and endorsed by a variety of investigators. From an evaluation standpoint, CTA is critical for diagnosis and case planning. Air around the graft is considered the “sine qua non” of infection but if it presents in the frst month after EVAR it can be due to trapped air introduced into the sac during the intervention. Patients with air in the sac at the initial postprocedure evaluation should be considered for early follow-up to make sure this fnding resolves. Further assessment that will change the management of the patient includes the type of EVAR device, infra- or suprarenal, since the entire removal of a suprarenal device usually requires supraceliac cross-clamping with its associated morbidity and mortality. Drainage of the infected cavity, as suggested by Dr. Bower, can help lower the bacterial burden and provide information regarding the ofending organism. That information will help the vascular surgeon decide if an in-line reconstruction or an extra-anatomical one is more appropriate in the patient’s situation, as more virulent organisms tend to be associated with higher reinfection and complication rates when in-line reconstructions are performed. The diferent options for aortic access need to be evaluated based on the anatomy of the patient. A transabdominal approach is best for most patients as it allows access to the iliac arteries bilaterally for removal of the entire graft, debridement of the infected bed, aortic and/or visceral reconstruc- tion, and omental coverage of the in-line graft or aortic stump if an extra-anatomical reconstruction is selected. The retroperitoneal approach should be considered for patients that will require extensive perivisceral work, as may be necessary from suprarenal or fenestrated devices, but limitations exist accessing the right iliac system and potentially intraabdominal targets for visceral or renal reconstructions. The best confguration to reconstruct these patients remains largely undetermined based on the literature. The published experience from the Mayo Clinic ( J. Vasc. Surg. 2013;58:371-9), in which some of the opinions of Dr. Bower are based, suggested excellent results in 24 patients mostly treated with rifampin-soaked in-line reconstructions with a periprocedural mortality of 4%. Cryopreserved aortic grafts “have become the conduit of choice for the group at this time,” stated Dr. Bower, to try to further decrease the reinfection rates in their patient population. There are limited data regarding the use of cryopreserved aortoiliac segments for aortic infections and less for EVAR infections. The most recent and largest series ( J. Vasc. Surg. 2014;59:669-74) included 220 patients with aortic infections with a perioperative mortality of 9% and cryopreserved graft complications in another 12%-15% of patients. In summary, aortic infections associated with EVAR are challenging problems that should be addressed in regional centers with experience. Renal and visceral reconstructions as well as supravisceral clamping are associated with signifcantly higher periprocedural morbidity and mortality based on the extensive experience at the Cleveland Clinic with EVAR explants ( J. Vasc. Surg. 2014;59:88693). The choice of the reconstruction and the material used should be based on the ofending organism, type of EVAR device, extent of the infectious process, and the expertise of the treating physician. Dr. Luis A. Sanchez is chief, section of vascular surgery and Gregorio A. Sicard Distinguished Professor of Surgery and Radiology, Washington University, St. Louis, and an associate medical editor for Vascular Specialist. He had no relevant disclosures. TIPS & TRICKS VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 17 NEWS FROM WASHINGTON Transcarotid angioplasty device approved The Food and Drug Administration has approved a minimally invasive angioplasty system that enters the carotid artery adjacent to a blockage, and captures embolic debris by extracorporeal filtration of blood near the blockage. The ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) is inserted into the artery near the stenotic region. As the stent is deployed, the system draws blood down the tube and away from the brain under high pressure. An extracorporeal flter traps any emboli, and the fltered blood is returned via the femoral vein. ENROUTE TNS was approved on the basis of the successful ROADSTER trial (Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure). In this study, there was a 3.5% rate of stroke, heart attack, and death among patients treated with the device – significantly lower than the study’s primary outcome goal of 11%. The rate of adverse events was about 14%; these included excessive bleeding or injury at the device insertion site, hypotension, and thrombosis. The system’s benefits include its minimally invasive approach and the ability to successfully navigate severe carotid tortuosity. It also may be more successful than traditional arterial angioplasty for patients with difficult anatomy of the aortic arch, according to an FDA statement. Manufactured by Silk Road, Sunnyvale, Calif., the ENROUTE TNS device was approved through a 510(k) submission, which provides an approval pathway for low- to moderate-risk devices that are substantially equivalent to a legally marketed device. According to the FDA statement, ENROUTE TNS is equivalent to a currently marketed flow-reversal system that uses similar technology and has the same intended use, but is designed to be introduced through the groin. –Michele G. Sullivan Adhesive for varicose veins The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial vari- cose veins, the Food and Drug Administration announced on February 20. “This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added. Continued on following page 18 TIPS & TRICKS Continued from previous page The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system compo- MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T nents include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes. Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted. The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing. VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has already been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year. –Elizabeth Mechcatie ADVERTISING Industry Info: Sponsored Products and Industry News Forty Years of Innovation Gore vascular devices address previously unmet clinical challenges while maximizing patient outcomes. Since 1975, engineers at W. L. Gore & Associates (Gore) have worked closely alongside the world’s leading physicians to develop and consistently improve upon a portfolio that answers the call of the most demanding clinical challenges. Putting patients frst, Gore’s versatile device family elevates what is possible in therapy, now afording minimally invasive treatment options to a wider range of patients. Longest Stent-Graft Available The GORE® VIABAHN® Endoprosthesis is the lowest profle, most fexible, self-expanding, small-diameter endoprosthesis available. A result of nearly two decades of continuing evolution, it is the only stent-graft to receive approval for the SFA (de novo, restenotic, and in-stent restenotic disease), iliac artery, and arteriovenous access revision. In October 2013, the GORE® VIABAHN® Endoprosthesis became the longest stent-graft approved by the FDA, with a maximum length of 25 cm. The 25 cm endoprosthesis is designed to cover long segment lesions in the SFA, reducing the need for multiple devices. A multi-center European trial supported the FDA’s approval of the 25 cm device. Low Profle, Time-Proven Design With more than 16 years and 190,000 devices distributed worldwide, the GORE® EXCLUDER® AAA Endoprosthesis has elevated what is possible in the treatment of abdominal aortic aneurysms (AAAs), providing physicians with minimally invasive endovascular solutions for a wide range of patient anatomies. In 2014, Gore lowered the profle of the 23 mm and 26 mm trunk-ipsilateral leg devices and the 23, 26, and 28.5 mm aortic extenders. The profle reduction allows these ipsilateral legs and aortic extenders to be used with a 16 Fr GORE® DrySeal Sheath. No changes have been made to the GORE® EXCLUDER® Device—instead, an innovative process using ePTFE materials has been used to constrain the device on the catheter. This exemplifes Gore’s commitment to improving patient safety while maintaining ease-of-use for the delivery of the GORE® EXCLUDER® Device. Novel Solutions with Distinct Capabilities Introduced in November 2013, the GORE® EXCLUDER® Iliac Branch Endoprosthesis is the frst complete, fully engineered iliac system (iliac main body device and internal iliac component) intended for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The device—used in conjunction with GORE® EXCLUDER® AAA Endoprosthesis components— is built on Gore’s proven technology platform and designed using the same durable, expanded polytetrafuoroethylene (ePTFE) graft. The GORE® EXCLUDER® Iliac Branch Endoprosthesis has CE mark and is in clinical study in the US: Equipped for a Wider Range of Patient Anatomies In September 2013, the Conformable GORE® TAG® Thoracic Endoprosthesis received FDA approval for endovascular repair of acute and chronic Type B dissections, making it the frst device to receive FDA approval for this indication. The Conformable GORE® TAG® Device ofers conformability and ease of use, while accommodating tortuous and tapered anatomy. The device resists compression and has a broad oversizing window ranging from 6 to 33 percent. Physicians are able to choose the appropriate oversizing for the patient anatomy, which is particularly important in dissection patients due to the nature of the disease. As Gore continues to modify and add new treatment capabilities to its collection of devices, it further demonstrates its commitment to providing physicians with some of the most innovative devices available. Lombard Medical Aorfx™ Endovascular Stent Graft Lombard Medical Technologies Inc., located in Irvine, CA, is global medical technology company focused on providing innovative endovascular products. The Aorfx™ Endovascular Stent Graft combines both an innovative design and technology that result in outstanding clinical performance C ourtesy L ombard Gore Vascular Devices in EVAR patients with complex anatomy including highly angulated necks and tortuous iliacs. Aorfix is the only AAA graft with global regulatory approvals for the treatment of aortic neck angulations from 0-90 degrees, and is commercially available in the US, Europe, Latin America, Canada, and Japan. Lombard Medical recently received FDA approval for Aorfix™Plus, an expansion of the Aorfix product line that treats aortic necks up to 32mm in diameter. For more information on Aorfix and Lombard Medical, visit www.lombardmedical.com. Medtronic Endurant® II Abdominal Stent Graft In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic Inc. ofers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease. One of these innovations, the Endurant® II Stent Graft System, is built on Medtronic’s 15 plus years of aortic stent graft experience and is proven in more than 150,000 implants world-wide.1 In October 2014, Medtronic received approval from the U.S. Food and Drug Administration for Endurant IIs. Endurant IIs is part of Medtronic’s innovation portfolio and extends its AAA product line. This 3-piece system leverages the proven design of the market leading Endurant II Abdominal Stent Graft, while having the same indications and being designed to treat the same patient populaContinued on following page ADVERTISING VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5 tion. The Endurant IIs Stent Graft System uses the existing Endurant II delivery system allowing accurate placement and controlled deployment.2 The Endurant IIs Stent Graft System also brings the unique benefit of expanding anatomical customization options.3 The system allows physicians to utilize Medtronic’s full suite of limb options on the patient’s ipsilateral and contralateral sides. Endurant IIs offers the ability to have in-situ sizing on the ipsilateral side with select limbs for adjustment during the case.3 Additionally, this new stent graft, Endurant IIs, provides up to a 20% reduction in distal diameter compared to select Endurant II bifurs4 and may provide simpler pre-case planning.3 Both the Endurant II and Endurant IIs systems perform in a broad range of patients, including those with short or angulated infrarenal aortic necks, and those with tortuous iliacs. Physicians can remain confdent in the clinical performance of all of the Endurant® products, as evidenced in the 3-year clinical results of the ENGAGE Registry C ourtesy m edtroniC Continued from previous page ling and durable clinical results through 3 years in both short (10 to <15mm) and standard (15 to <20mm) necks: 0% and 0% rupture, 0% and 0% conversion, 0% and 1.3% secondary endovascular procedures to correct Type I/III endoleaks, and 0% and 0% migration, respectively . The Endurant II Stent Graft System delivers consistent results in patients with both straightforward and challenging anatomies,7 as the registry showed no statistical diference between short and standard necks7, delivering compelling evidence that the Endurant II product line is Durable, Consistent, and Proven.7 -------------------------------------- (the ENGAGE Registry evaluated the Endurant Stent Graft System).5 The ENGAGE Registry represents clinical data of a real-world patient population that is unmatched in breadth, depth and quality. This registry comprises over 1200 patients in 79 high volume centers worldwide and is unprecedented in size and scope with planned follow-up through 10 years.6 The registry recently delivered compel- 1. Medtronic Product Detail Report September 2014, data on File at Medtronic 2. Medtronic FS156 QA Statement, data on fle at Medtronic 3. Endurant IIs Instructions for Use (IFU) 4. Data on fle at Medtronic 5. Verhagen, Hence. Device design and infuence on hostile neck outcomes: how far can we go?, Charing Cross 2014. 6. VEITH Report 2013 – data on fle at Medtronic 7. Verhagen, Hence. Device design and infuence on hostile neck outcomes: how far can we go?, Charing Cross 2014. CLASSIFIEDS Also available at MedJobNetwork.com Vascular Surgeon Southern, NJ (Philadelphia Suburbs) * * * * * Due to growth, Virtua Surgical Group in Southern, NJ, seeks a Vascular Surgeon to join its well-respected and established surgical practice located in the Moorestown/Medford, NJ area. You will be joining 4 very busy surgeons who enjoy a large referral base which will assist you in rapid practice growth. A competitive salary, production bonus, full benefits and retirement plan are offered. The practice is employed by Virtua, a comprehensive healthcare system headquartered in Marlton, NJ. Virtua consists of four hospitals (Berlin, Marlton, Mt. Holly, and Voorhees). This group performs its surgery primarily at the Mt. Holly campus. Southern New Jersey offers the culture and nightlife of Philadelphia, as well as many of the country’s finest restaurants, intriguing historical sites, fantastic shopping districts, exciting sports teams, captivating music venues, beautiful theater productions, and worldclass museums. Just a short drive away you can also find yourself in the glitter and excitement of Atlantic City or the sun and sand of New Jersey’s many wonderful shore resorts. South Jersey also has many charming towns with unique shops, superb dining, recreational events, and community celebrations. With the world-renowned Pine Barrens and many other state parks, New Jersey has a wonderful array of places for camping, boating, and hiking or any outdoor activity you desire. For more information, please contact Ken Sammut at 800-261-2638; email at [email protected] or visit our website at www. cejkasearch.com Disclaimer 19 VASCULAR SPECIALIST assumes the statements made in classified advertisements are accurate, but cannot investigate the statements and assumes no responsibility or liability concerning their content. The Publisher reserves the right to decline, withdraw, or edit advertisements. Every effort will be made to avoid mistakes, but responsibility cannot be accepted for clerical or printer errors. EXPLORE NEW HORIZONS Vascular Surgery Opportunity at the Beach Imagine working where award-winning healthcare goes hand-in-hand with an exceptional quality of life! Beebe Healthcare is an expanding, progressive, not-for-proft community health system with a 210-bed hospital and numerous satellite facilities throughout southern Delaware. Q Board certifed, experienced Vascular Surgeon Q Well-established vascular program with reputation for excellence Q Read all studies in Non-Invasive Vascular Lab Q RPVI certifcation required Exceptional location, with close proximity to Baltimore, DC, Philly, NYC. Family-oriented Southern Delaware Beaches rank among Top 10 Beaches/Boardwalks (Parents Magazine, National Geographic, Travel and Leisure, American Profles Magazine). Come discover Beebe, where you will make a diference! 424 Savannah Road l Lewes, DE 19958 l www.beebehealthcare.org Email cover letter and CV to: [email protected] Visit www.beebehealthcare.org to view additional physician opportunities. FOR INFORMATION ON CLASSIFIEDS: Contact: Linda Wilson Call (973) 290-8243 or Email ad to: [email protected] VAS_20.indd 1 3/10/2015 3:35:23 PM
© Copyright 2024