Vascular Specialist February 2018

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Dr. Veith counsels an energetic effort to succeed.

Dr. Samson has a fantasy of the perfect day (not).

8 News From SVS Make VAM 2018 a team affair.

Learn and enjoy with your colleagues.

Similar outcomes for primary anastomosis and allografts in pancreatic surgery

BY MARK S. LESNEY FRONTLINE MEDICAL NEWS F ROM THE J O UR N A L O F VASCU LAR SUR G E RY: V E N O US AND LYM PH ATIC D ISE A SE S

Asymptomatic carotid in-stent restenosis?

Think medical management Dr. Jayer Chung

See Pancreatic Surgery · page 7

BY BRUCE JANCIN FRONTLINE MEDICAL NEWS EX P E R T AN ALY S I S F ROM T H E N OR T H WE S T E R N VAS C U L AR S Y MP OS I U M

CHICAGO – Modern medical management is as effective as carotid artery reintervention for stroke prevention in asymptomatic patients with a carotid in-stent restenosis in excess of 70%, Jayer Chung, MD, asserted at a symposium on vascular surgery sponsored by Northwestern University.

Vascular specialist 151 Fairchild Ave., Suite 2, Plainview, NY 11803-1709

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ancreatic tumor involvement with the superior mesenteric vein/portal vein (SMV/PV) is common and requires exploration and resection, which has now become an integral part of routine surgical treatment. The short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts was found to be comparable to that of reconstruction with primary end-to-end anastomosis, according to the results of a study

SETTLE FOR NOTHING LESS.

UC201802452-01 EN © 2018 Medtronic.

That, in his view, makes medical management the clear preferred strategy.

“A carotid intervention costs about $17,000. If we choose medical management, we can better allocate our resources. Furthermore, if it doesn’t really help, I don’t want to do one of these procedures to my patients. I want to avoid the periprocedural risks. Early on, the stroke and death rates are higher in the intervention arm,” explained Dr. Chung, a vascular surgeon at Baylor College of Medicine, Houston.

See Medical Management · page 5

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Gore cTAG IFU. 3 Lombardi JV, Cambria RP, Nienaber CA, et al. Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2011; 55(3):629-640.e2. doi: 10.1016/j.jvs.2011.10.022.

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FROM THE EDITOR

A fantasy

BY RUSSELL H. SAMSON, MD MEDICAL EDITOR, VASCULAR SPECIALIST

T

he day had gone very well. The vascular surgeon woke early excited for a morning in the OR and then an afternoon in the office. Driving to the hospital, he had planned out his day. A patient with a fempop at 7:30, an AV fistula at 10:30 am, a quick bite in the doctor’s lounge, and then to the office for two phlebectomies, a few new consults, as well as some returning patients.

Fortunately, he had purchased an advanced electronic medical record so that reviewing old records and inputting new data went smoothly. He had been on call for the local hospital’s ER, but he received no calls, so his day was not impacted. After a dinner with his wife, also a surgeon, he helped put their youngest baby to sleep, played with his older children, took the dog out for a walk, read the latest JVS and went to sleep. Despite being on call, the phone never rang, and he had an uninterrupted sleep.

Now, what really happened!

The vascular surgeon woke early in preparation for a day in the OR and office. Traffic slowed him down,

Dr. Samson is a physician in the practice of Sarasota Vascular Specialists and clinical professor of surgery, Florida State University, Tallahassee. He is also the medical editor of Vascular Specialist.

but he still arrived at the hospital just before his 7:30 start time. He expected his patient to be on the table prepped and ready for the procedure. But the OR supervisor informed him that new regulations required him to personally mark the site of surgery, update the H&P, and date and time the consent.

He was nonplussed. He had marked the patient last night and had signed the consent too. His PA had dictated a three-page H&P that was in the chart. However, the patient was still in the holding room. The surgeon rushed over, marked the leg again, and completed the required documentation.

“Well,” he thought, “I’ll run upstairs, discharge my carotid from yesterday, and by the time that’s done and I’ve changed into scrubs, my patient will be ready.” Impatiently he waited 5 minutes for

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 effectiveness 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 specific clinical findings (for example, enlarging aneurysm, endoleaks, migration, inadequate seal zone, or continued flow into the false lumen in the case of a dissection) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Valiant 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 effectiveness 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.

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FEBRUARY 2018

He played with his older children, took the dog out for a walk, read the latest JVS, and went to sleep. Despite being on call, the phone never rang, and he had an uninterrupted sleep.

the elevator, but it never arrived. So he elected to run up 10 floors and across to the other side of the hospital where the administrators had inconveniently placed the postop vascular patients. The patient was eager to leave. The vascular surgeon dictated the discharge note and signed into the hospital electronic medical record.

But the software insisted that he had to comply with numerous “safety” regulations before signing off. These required reviewing every medication and all discharge instructions. The patient was on 15 drugs, and the surgeon was unfamiliar with most. After 10 minutes of unsuccessfully trying to enter the relevant orders, he called a medical student over to help.

The patient was going to a skilled nursing facilFantasy continued on page 4

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 specific 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 toxicity, conversion to surgical repair, death, deployment difficulties / 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, fistula (including aortobronchial, aortoenteric, aortoesophageal, arteriovenous, and lymph), gastrointestinal bleeding /complications, genitourinary complications, hematoma, hemorrhage / bleeding, hypotension / hypertension, infection or fever, insertion or removal difficulties, 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 insufficiency, reoperation, respiratory depression / failure, sepsis, seroma, shock, spinal neurological deficit, 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.

CardioVascular LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 For distribution in the USA only.

FTSOP113326-22 Rev. 1B © Medtronic 2017. All rights reserved.

VASCULARSPECIALISTONLINE.COM • 3

Fantasy continued from page 3

ity. This required completing two more electronic forms. The software stubbornly refused to close the discharge section till he assigned the appropriate ICD-10 codes. After a few more frustrating minutes he finally clicked the proper boxes and completed the discharge.

It was 8:15 by the time he made the skin incision. The case went smoothly. He relaxed a little knowing that he probably would not run too late for the rest of his day. Finishing ahead of schedule, he dictated the note, spoke to the patient’s family, and went to preop his AV fistula scheduled for 10:30. Then back to the wards to complete rounds.

The first two patients were uncomplicated. The third had a fever requiring multiple orders in the EMR. Then heated conversations with the pharmacist and head of infection control, since the EMR would not allow him to prescribe the antibiotic of his choice. Back across the entire length of the hospital to see a patient with renal failure. But she was in dialysis at another distant location in the hospital.

At 10:30 he ran down to the OR ready to scrub.

Again, this patient was still in the holding area.

The patient’s potassium was 5.6, and the anesthesiologist wanted to run another blood test. Then the nurse had to go on break. Now there was confusion about whether a room would be available as another surgeon had a bump case.

Ultimately, he started at 11:30. During the procedure, his beeper went off constantly. There were already two consults in the ER. The fistula took a mere 30 minutes, but he had waited 90 minutes since finishing the fempop.

“Medicare should pay me for the time between cases, and I’ll do the procedure for free” he complained to a colleague as he passed her on the way to the ER to see the consults.

He sent the patient with the DVT home, but the patient with the infected foot would require later debridement. He admitted her and booked the OR for after office hours.

VASCULAR SPECIALIST Medical Editor Russell H. Samson, MD Deputy Medical Editor Malachi Sheahan III, MD Associate Medical Editors Bernadette Aulivola, MD, O. William Brown, MD, Elliot L. Chaikof, MD, PhD, Carlo Dall’Olmo, MD, Alan M. Dietzek, MD, RPVI, FACS, Professor Hans-Henning Eckstein, MD, John F. Eidt, MD, Robert Fitridge, MD, Dennis R. Gable, MD, Linda Harris, MD, Krishna Jain, MD, Larry Kraiss, MD, Joann Lohr, MD, James McKinsey, MD, Joseph Mills, MD, Erica L. Mitchell, MD, MEd, FACS, Leila Mureebe, MD, David Rigberg, MD, Clifford Sales, MD, Bhagwan Satiani, MD., Larry Scher, MD, Marc Schermerhorn, MD, Peter Scheider, MD, Murray L. Shames, MD, Niten Singh, MD, Frank J. Veith, MD, Robert Eugene Zierler, MD Resident/Fellow Editor Laura Drudi, MD. Executive Director SVS Kenneth M. Slaw, PhD. Director of Marketing and Membership SVS Justin Cogswell Managing Editor SVS Beth Bales

Vascular Specialist is the official 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 Communications Inc. 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 reflect 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.

4 • VASCULAR SPECIALIST

By the time he got to the doctors’ lounge all that was left was a half-eaten pack of Doritos and burned coffee.

He thought he would have a brief respite driving to the office. Then his surgeon wife called him in the car asking him to field a call from their son’s school since she was stuck in the OR. He arrived late to the office. The waiting room was filled with hostile-looking patients one of whom made a point of holding up her watch as if to re-

“Medicare should pay me for the time between cases, and I’ll do the procedure for free,” he complained to a colleague as he passed her on the way to the ER to see the consults. inforce his tardiness. There were already three additions to his schedule. Further, his nurse told him that there was some issue with the internet connection to the server. Thus, despite his expensive EMR, no records were available. She had informed the patients that there would be a “little” delay.

While they were waiting she brought in reams of documents that had come in the prior day and needed his signatures. He also used the time “productively” to answer emails. When the EMR was back online, he returned to his patients who by now were seething.

A patient brought in a CD of a CTA. He loaded it up on a computer, but the disc kept spinning relentlessly. Cursing, he loaded it on a second computer. The instructions were indecipherable. He could get a picture up but could not scroll through the images. The program froze. By the time he

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had evaluated the disc, he had wasted over 20 minutes. He was running even further behind.

The next patient was a second opinion from a physician in another state. She brought in over 200 pages of medical records describing a multitude of prior procedures. Politely he explained he would need to read them first and rescheduled her.

The ER called again with a patient with a cold leg. He canceled the rest of the office and snuck out through a back door, afraid to witness the consternation in the waiting room.

At the hospital, he argued briefly with the anesthesiologist who was reluctant to anesthetize the patient who had eaten 5 hours before. So the harried surgeon read some vascular labs, and visited a few less stable patients. Then back to the OR to revascularize the ER patient’s leg and later to debride the earlier patient’s foot.

He got home at 8:30 pm. His wife had also been delayed by a long surgery. They put the baby to bed. There was no time to play with the other children. The surgical couple barely had the energy left to microwave leftovers for dinner. He was too tired to take the dog out for its nocturnal pee. He went to his study, picked up the JVS, and fell asleep in his chair. He woke up with a start as he felt the dog urinate on his leg.

Exhausted he climbed into bed. It had been a good day, he told himself. After all the ER had not been too disruptive. He drifted off into a deep sleep. And then the phone rang. Ruptured AAA in the ER.■

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 Director, Production/Manufacturing Rebecca Slebodnik

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FEBRUARY 2018

Treating restenosis Medical Management from page 1

A growing body of evidence, mainly from nested cohorts within randomized controlled trials, indicates that the late ipsilateral stroke rate associated with post–carotid endarterectomy (CEA) restenosis is much higher than that for carotid instent restenosis (C-ISR). In a recent meta-analysis of nine randomized trials, the difference in risk was more than 10-fold, with a 9.2% stroke rate at a mean of 37 months of follow-up in patients with post-CEA restenosis, compared with a 0.8% rate with 50 months of follow-up in patients with C-ISR (Eur J Vasc Endovasc Surg.

2017 Jun;53[6]:766-75).

“These pathologies behave very, very differently,” Dr. Chung observed. “The C-ISR lesions tend to be less embologenic.”

C-ISR is an uncommon event.

Extrapolating from the landmark CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) and other randomized trials, about 6% of patients who undergo percutaneous carotid stenting will develop C-ISR within 2 years. But since the proportion of all carotid revascularizations that are done by carotid stent angioplasty has steadily increased over the past 15 years as the frequency of CEA has dropped, C-ISR is a problem that vascular specialists will continue to encounter on a regular basis.

Symptomatic C-ISR warrants reintervention; broad agreement exists on that. But there is a paucity of data to guide treatment decisions regarding asymptomatic yet angiographically severe C-ISR. Indeed, Dr. Chung was lead author of the only retrospective study of the natural history of untreated C-ISR, as opposed to carefully selected cohorts from randomized trials involving highly experienced operators. This study was a retrospective review of

59 patients with 75 C-ISRs of at least 50% seen at a single Veterans Affairs medical center over a 13-year period.

Three-quarters of the ISRs were asymptomatic.

Forty of the 79 C-ISRs underwent percutaneous intervention at the physician’s discretion. Those patients did not differ from the observation-only group in age, comorbid conditions, type of original stent, or clopidogrel use. Reintervention was safe: There was one stent thrombosis resulting in stroke and death within 30 days in the reintervention group and no 30-day strokes in the observation-only group. During a mean 2.6 years of follow-up, the composite rate of death, stroke, or MI was low and not statistically significantly different between the two groups. Indeed, during up to 13 years of follow-up only one patient with untreated C-ISR experienced an ipsilateral stroke, as did two patients in the percutaneous intervention group ( J Vasc Surg. 2016 Nov;64[5]:1286-94).

Dr. Chung does the math

According to data from the National Inpatient Sample, vascular surgeons do an average of 15 carotid angioplasty and stenting procedures per year. If 6% of those stents develop instent restenosis, and with a number needed to treat with revascularization of 25 to prevent one stroke, Dr. Chung estimated that hypothetically it would take the typical vascular surgeon 27 years to prevent one stroke due to C-ISR. “That’s a very long time to prevent one stroke, in my opinion,” he said.

How his study has affected his own practice

Dr. Chung now intervenes only for symptomatic C-ISRs, and only after an affected patient is on optimal medical therapy, including a statin

P E R SPEC T I VE by Peter Schneider, MD

Conservative use of repair sensible

P

rior to the developrecurrent stenosis ment of transfemwithout risk of cranial oral filter mediated nerve injury. carotid artery stenting Moving forward an(CAS), re-do carotid other 10–15 years, we endarterectomy was have a small but pera relatively common sistent challenge with operation for asympcarotid in-stent restetomatic post-CEA nosis. Although there restenosis. However, is not much data, several factors eventuDr. Chung provides ally lead to a relatively Dr. Peter Schneider, is a useful analysis of a vascular surgeon in conservative posture this subject. It stands practice in Honolulu. in most practices. to reason that, if asThese factors includymptomatic carotid ed; the recognition in-stent restenosis is that the pathology similar to other “reof post-CEA restenosis was more current” pathologies, the likelihood stable and likely less neurologically is that the lesion is more stable, is dangerous to the patient, that the less likely to embolize, and may repeat operation had a high risk possibly regress. Our options for of cranial nerve damage, and that treating this lesion are limited. Rerepeat surgery did not necessarily peat angioplasty may destabilize protect the patient from yet anoth- the lesion, repeat stent encroaches er recurrence. on the overall lumen and may trigIn the early 2000’s when CAS ger more restenosis, and surgical became widely available, it was repair would have the morbidity of applied more broadly to recurrent a fairly “high” cervical approach. post-CEA restenosis. This makes Since the risk of asymptomatic sense considering the low risk of carotid in-stent restenosis is not CAS in this particular subgroup, known and is probably less than de the low periprocedural morbidity, novo lesions, a relatively conservaand the opportunity to treat the tive use of repair makes sense.

and dual-antiplatelet therapy.

“I try to do an open procedure if possible, especially if the restenosis is above C-2. The ones I tend to do percutaneously are the post-irradiation stenoses or those with excessive scarring, and I use a cerebral protection device,” the surgeon explained.

He emphasized, however, that the final word on the appropriate management of C-ISRs isn’t in yet.

A standardized definition of C-ISR is needed, as are multicenter prospec-

tive registries of medically managed patients as well as those undergoing various forms of reintervention.

And a pathologic study is warranted to confirm the hypothesis that the histopathology of post-CEA and post-stent restenosis – and hence the natural history – is markedly different.

Dr. Chung reported having no financial conflicts regarding his presentation. ■ bjancin@frontlinemedcom.com

VEITH'S VIEWS

Energy: A key to success in vascular surgery

BY FRANK J. VEITH, MD

S

uccess and leadership in any profession are determined by many factors. Intelligence, creativity, interpersonal and communication skills, judgment, commitment, persistence, motivation, and ability to focus are all important assets. One factor rarely considered but probably as important as any of these is an individual’s

FEBRUARY 2018

intrinsic or cultivated energy level.

Why is this so important? A high energy level allows one to outwork the competition by using his or her other assets to a greater degree and with more vibrancy than others. Let’s look at the example of a former superstar in vascular surgery, Michael DeBakey, MD. Dr. DeBakey, who for many years was probably the best known surgeon in the world, was reputed to work more than 14 hours a

day and required little sleep. He was an innovative and busy surgeon. He published extensively and spoke widely. He was a most effective leader who created a uniquely famous and efficient surgical service which trained many of the leading vascular and cardiac surgeons across the globe.

On top of all these achievements, Dr. DeBakey managed to be a leader in his university, in governEnergy continued on page 6 VASCULARSPECIALISTONLINE.COM • 5

Energy continued from page 5

mental committees, and in his specialty organizations such as the SVS. He also served as a medical and surgical adviser to multiple U.S. presidents and other world leaders.

To fill all these roles effectively, to perform his highly complex and demanding job, to deal with the stresses involved in all these many events and arenas, the energy level required to stay focused and function efficiently had to be enormous – and it was.

Success and leadership in any chosen field are similarly largely dependent on an energy level that allows one to better display other assets. To be successful and become a leader in an occupation such as vascular surgery requires many internal assets. These include mastery of knowledge and technical aspects within the field, and the ability to deal well with other people, as well as organize and lead a group of colleagues. The vascular surgeon must also have the ability to communicate well orally and in writing and have the drive to see one’s efforts carried through to a suc-

cessful conclusion. Demonstration of these assets requires organization, hard work, persistence, and focused thinking.

The importance of a person’s high energy level becomes apparent when these assets are most efDr. Veith is professor of surgery at New York University Medical Center and Case Western Reserve University, and the William J. von Liebig Chair in Vascular Surgery at the Cleveland Clinic Foundation.

fectively used and displayed. Without such energy, an individual may achieve excellence in one or another aspect of his or her profession or business.

However, a successful leader must excel in all or almost all aspects of the work. This cannot happen

without a high level of energy, which enables one to function well in at least most key areas of a field simultaneously.

Admittedly having a high level of energy is a God-given asset which only a few might have.

However, by focusing one’s attention on a specified area, it is possible to maximize the energy that can be brought to bear on that area. If individuals zero in on key parts of their professional activities, they can achieve the high level of energy in those areas needed to achieve professional success.

So if young people want to become successful leaders in vascular surgery, they should ask themselves three questions. First, are they willing to make the sacrifices to achieve excellence in the many areas required? Second, do they have the talents or assets to do so? And third and most importantly, do they have the energy level to excel in all or most of these areas simultaneously? If the answer to these three questions is yes, with a little luck along the way, success and leadership in vascular surgery are quite attainable. ■

Pharmacomechanical thrombolysis does not reduce post-thrombotic syndrome risk

I

n patients with acute proximal deep vein thrombosis who were undergoing anticoagulation, adding pharmacomechanical catheter-directed thrombolysis did not reduce risk of the post-thrombotic syndrome, according to results of a phase 3, randomized, controlled trial.

Moreover, addition of pharmacomechanical thrombolysis increased risk of major bleeding risk, investigators wrote in a report published online in the New England Journal of Medicine.

The trial results contrast with recent reports from another randomized trial, known as CAVENT. The trial results contrast with recent reports from another randomized trial, known as CAVENT, which suggested that pharmacomechanical thrombolysis might help reduce incidence of post-thrombotic syndrome.

“Our trial, for uncertain reasons, did not confirm these findings,” wrote Suresh Vedantham, MD, of Washington University, St. Louis, 6 • VASCULAR SPECIALIST

and his coauthors.

Post-thrombotic syndrome is associated with chronic limb swelling and pain, and can lead to leg ulcers, impaired quality of life, and major disability. About half of patients with proximal deep vein thrombosis (DVT) will develop the post-thrombotic syndrome within 2 years, despite use of anticoagulation therapy, Dr. Vedantham and his colleagues noted.

Pharmacomechanical thrombosis is the catheter-directed delivery of a fibrinolytic agent into the thrombus, along with aspiration or maceration of the thrombus. The goal of the treatment is to reduce the burden of thrombus, which in turn might reduce risk of the post-thrombotic syndrome.

However, in their randomized trial known as ATTRACT, which included 692 patients with an acute proximal DVT, rates of post-thrombotic syndrome between 6 and 24 months after intervention were 47% in the pharmacomechanical thrombolysis group and 48% in the control group (risk ratio, 0.96; 95% CI, 0.82-1.11; P = .56), according to the report (N Engl J Med. 2017;377:2240-52). Control group patients received no procedural intervention.

Major bleeds within 10 days of the intervention were 1.7% and 0.3% for the pharmacomechanical thrombolysis and control groups, respectively (P = .049).

By contrast, in the CAVENT trial, catheter-directed thrombolysis reduced the risk of the post-thrombotic syndrome over 5 years of follow-up

(Lancet Haematol. 2016;3[2]:e64-71).

Dr. Vedantham and his coauthors suggested that factors potentially explaining the difference in outcomes include the number of patients enrolled (692 in ATTRACT, versus 209 in CAVENT), or the greater use of mechanical therapies in ATTRACT versus longer recombinant tissue plasminogen activator infusions in CAVENT. The study was supported by mul-

tiple sources, including the National Heart, Lung and Blood Institute, Boston Scientific, Covidien (now Medtronic), Genentech, and others.

Dr. Vedantham reported receiving grant support from Cook Medical and Volcano. Some of the other authors reported financial ties to Abbott Vascular, Boston Scientific, Medtronic, and other pharmaceutical and device companies. ■

courtesy wikiMedia coMMons /B ruce B laus /creative

BY ANDREW D. BOWSER FRONTLINE MEDICAL NEWS FROM NEW E N G L A N D J OU RNAL O F M E D ICIN E

FEBRUARY 2018

Vascular repair Pancreatic Surgery from page 1

performed by Dyre Kleive, MD, and his colleagues.

In order to assess the optimal method of reconstructing the portal vein during pancreatic surgery, Dr. Kleive and his colleagues performed a retrospective review of all patients undergoing pancreatic surgery with venous resection and reconstruction at a single center between January 2006 and December 2015.

the allograft group (26/42 [61.9%] vs.

13 of 66 [19.7%] for the anastomosis group; P less than .01). A subgroup analysis of 10 patients in the allograft

group showed the presence of donorspecific antibodies in all patients. This could indicate that graft rejection was a contributing factor to the statistically higher development of severe stenosis in allograft vs. anastomosis patients, the authors suggested.

“This study shows that the shortterm outcome of SMV/PV recon-

struction with interposed cold-stored cadaveric venous allografts is comparable to that of reconstruction with primary end-to-end anastomosis,” the researchers concluded.

Dr. Kleive and his colleagues reported that they had no conflicts of interest. ■ mlesney@frontlinemedcom.com

> C o me t o H I S T O R I C B O S T O N > JOIN US FOR THE

The short-term outcome of using cold-stored cadaveric venous allografts was comparable to doing primary endto-end anastomosis.

FEBRUARY 2018

JUNE 20–23 Home of the Vascular Team Partners in Patient Care

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A total of 857 patients underwent open pancreatic surgery during the study period, of whom 171 (20%) had vascular resection and reconstruction.

The study population comprised 42 patients treated with cold-stored interposition cadaveric allografts for reconstruction and 71 patients who had primary end-to-end anastomosis instead. Patients with other forms of reconstruction were excluded, according to an online report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (2017. doi: 10.1016/j. jvsv.2017.09.003).

Early failure at the reconstruction site was defined as the presence of thrombosis or no flow or low flow within the first 30 days after surgery.

Patients in the allograft group had statistically significantly longer mean operative times, more intraoperative bleeding, more frequent use of neoadjuvant therapy, and a longer length of tumor-vein involvement than the anastomosis group.

However, there was no statistically significant difference in the number of patients with major complications (42.9% for allografts vs. 36.6% for anastomosis) or early failure at the reconstruction site (9.5% for allografts vs. 8.5% for anastomosis) between the two groups, Dr Kleive and his colleagues reported.

The proportion of patients with grade C stenosis at last available imaging scan was significantly higher in

VSweb.org/VAM18

VASCULARSPECIALISTONLINE.COM • 7

NEWS FROM SVS

2018 VAM Reflects Member Feedback All members of the vascular team will find information of interest

S

Martin allred , nationwide PhotograPhers

VS members offered their thoughts and reduce session overlap recommendations about the Vascular • Programming of interest to all surgeons, Annual Meeting in several different whether they work in academia, a hospiformats. And those who plan VAM listened, tal setting or in private practice to build on the success of previous years and • Emphasizing the vascular team: This not create a meeting that every member of the only was requested by participants but also vascular team can envision attending. is a top strategic priority for SVS President The 2018 Vascular Annual Meeting inDr. R. Clement Darling III. The Vascular corporates a number of recommendations Quality Initiative and the Society for Vascuoffered in “person-on-the-street” interviews lar Nursing will hold their annual meetings held during VAM 2017, in conjunction with written evaluations and VAM and programa survey. VAM 2018, ming will be offered “Home of the Vascular for all members of Team – Partners in the vascular team, Patient Care,” will be including physician June 20-23 in Boston, assistants, vascular with scientific sessions nurses, nurse assisJune 21-23 and exhibits tants and technoloJune 21-22. Registragists. tion and housing will • Content for specific open in early March. needs: “Those in In compiling reacademic or hossponses, several pital settings want themes emerged, said discussions on cutSVS Program Comting-edge vascular mittee Chair Matt Eadevelopments and Gert J. De Borst, MD, and Marc gleton, M.D. “We are techniques,” said Dr. Schermerhorn, MD, enjoying the a complex specialty Eagleton. “Private camaraderie at VAM 2017. and, as such, we need practitioners need a complex program the applicability of that addresses multiple what they learn, information they can take audiences and disciplines,” he said. home and implement in their daily practices, related to clinical practice guidelines, Requests – and inclusions for 2018 – include: contracts, billing and coding and ‘How I • Opportunities for audiences in small Do It’ approaches. Our young surgeons, meanwhile, want to expand their knowlgroups to engage with presenters edge base and practically apply research, • Scientific sessions that emphasize not just particularly related to major trials and outthe science but also the translational value comes tracking, and technical content. of abstracts “We listened to you,” said Dr. Eagleton.

• Programming spread throughout all four “Come and be a part of this year’s VAM.” ■ days of VAM, particularly on Saturday, to

FOCUS ON RESEARCH:

T

he program is taking shape and registration is now open for an important SVS research-oriented event, the Vascular Research Initiatives Conference. It will be held May 9 at the Hilton San Francisco Union Square.

The one-day conference emphasizes emerging vascular science and encourages interactive participation. Four abstract sessions will center on stem cells and wound healing, peripheral arterial disease, vascular thrombosis, and vascular biology.

Other VRIC highlights include the Translational Panel and the Alexander W. Clowes Distinguished 8 • VASCULAR SPECIALIST

Build Your Own VAM Schedule With Custom Planning Tools A

revised and more full-featured website / planner will be a vital tool for VAM participants this year, allowing them to personalize their experience before ever heading to Boston. Along with a new mobile app and the On-Demand Library, the trio creates a trifecta of tools attendees will use before, during and after VAM. The website, vsweb.org/ VAMPlanner, will debut in early March, when VAM housing and registration open. Doubling as a planner, the website lets participants build their own schedule, “favoriting” sessions and presenters. Filters allow users to seek sessions on a particular topic or for a particular audience, and more. The favorited program schedule will integrate with the app for seamless planning and navigation of the meeting.

The website will also feature the most recent news and updates about the meeting itself, as the June meeting approaches.

Users will have a truly integrated dashboard for all things VAM. Before VAM: New to the website and planner are filters by which attendees can select their own VAM sessions of interest. “It’s one-stop session shopping,” said SVS Program Committee Chair Matt Eagleton, M.D. “Clicking on a session brings up a popup with such details as date and time, location, moderators, session summary, target audience, individual presentations, even learning objectives. Simply ‘favorite’ a session and it’s added to your personal schedule.”

During VAM: Items marked as favorites in an attendee’s planner will seamlessly transfer to the app, which also lets attendees take and share pictures, talk with other attendees, post comments on social media and take CME and MOC exams.

After VAM: Because many VAM sessions overlap, there’s no way to participate in person with all VAM has to offer. That makes the on-Demand Library – with audio and slide presentations of nearly all educational sessions – an essential post-VAM addition. It facilitates the magic of letting people, in essence, be in two places at one time. The On-Demand Library costs just $99 before and during VAM and can be purchased during registration in early March. At 5 p.m. Saturday, June 23, the price jumps to $199 for attendees and $499 for non-attendees.

The Library does not provide CMEs or MOCs. “The planner is an incredibly useful addition to VAM,” said Dr. Eagleton. “We think participants will find it invaluable for planning and navigating the meeting.” ■

Register for VRIC Lecture, being presented at the 2018 VRIC for only the second time. This year’s Translational Panel will discuss “The Road to Entrepreneurship.”

Speakers include Colleen M. Brophy, M.D.; Mary Albertson and Geoffrey C. Gurtner, M.D. Alan Daugherty, PhD, will present the Alexander W. Clowes Distinguished Lecture, named for the late Dr. Clowes, an outstanding surgeon-scientist and frequent presenter at VRIC. Dr. Daugherty’s lecture will focus on “Angiotensin II and Cellular Complexity of the Aorta: A Recipe for Aneurysmal Location.”

Dr. Daugherty has been principal investigator on a wide range of research studies and is currently PI for two National Institutes of Health projects, “Mechanisms of Thoracic Aortic Aneurysms” and “Adventitial-medial Interactions in Thoracic Aortic Diseases.”

To maximize attendees’ time and travel dollars, VRIC is held the day before and in the same location as the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology Scientific Sessions.

Those sessions take place May 10-12.

Learn more at vsweb.org/VRIC18. ■ FEBRUARY 2018

NEWS FROM SVS

Vascular Surgeons, Patients Earn Victory Over Pay Cuts for Ultrasound Procedures

WASHINGTON UPDATE:

A swift response from the SVS Washington office and a resulting grassroots letter-writing campaign

by SVS members helped win vascular surgeons members – and their patients – a major victory.

Surgeons will now receive fair reimbursement for imaging services, almost twice what had been proposed in one case, and their patients will have access to vital non-invasive ultrasound procedures.

The response, which also included working in close collaboration with the Society for Vascular

Ultrasound, followed a careful reading and interpretation by the SVS Policy and Advocacy Council and consultants of the 2018 Hospital Outpatient Prospective Payment System (HOPPS) Final Rule.

This rule had mistakenly reassigned several vascular ultrasound procedure codes, resulting in a reduction in reimbursement and jeopardizing access to the procedures for patient care.

Because the HOPPS rule also sets Medicare reimbursement rates for the technical component of the procedures, payments in both the hospital and office-based settings would have been affected.

This would further restrict access to these vital studies that determine the risk of stroke and aortic disease, among other pathologies.

The SVS believed that the Centers for Medicare and Medicaid Services (CMS) did not realize how devastating these cuts would be for patients and that these procedure codes had been mistakenly assigned to an incorrect Ambulatory Payment Classification (APC) level for reimbursement.

The Washington office responded swiftly, organizing a grassroots effort that included personal letters

Increased Brand Exposure Highlights SVS’ Growing Influence

2

017 was a great year for SVS public relations efforts.

SVS sent out a regular stream of press releases, pitches and media advisories aimed at both patients and professionals and responded to media requests for information.

One key measure of success is the number of requests SVS gets from media for interviews with vascular professionals.

These efforts are enhanced by expert comments and interviews provided by a Rolodex of on-call media experts from SVS. The progress made over the past three years are thanks to staff and the skilled oversight provided by the Public and Professional Outreach Committee.

In the two and a half years since our public relations program was revived, we have received an increasing number of requests for comments from vascular trades and public media outlets. In 2015 we had one incoming request for an interview or information; in 2016, we had nine and in 2017, we had 21.

SVS aims its public outreach at two primary audiences: medical professionals and patients. In 2017, SVS sent out 12 monthly, public-facing press releases about vascular health for an audience of patients and families and 21 professional-facing releases to medical professionals and medical trades.

The most successful public-facing release went out in Brand Exposure continued on page 10 FEBRUARY 2018

from many SVS members who described the negative impact these cuts would have on their ability to provide vascular ultrasound studies to their patients.

Physician members of Congress also signed a letter to CMS and Rep. Larry Bucshon (R-IN), M.D., called Administrator Seema Verma. These activities were instrumental in CMS issuing a correction notice to its 2018 HOPPS Final Rule. It includes reassigning CPT 93880 (duplex scan of extracranial arteries; complete bilateral study) to APC 5523 (x-ray and related services, level 3) from APC 5522 (x-ray and related services, level 2), with a payment rate of $232.31 for level 3 versus $118.74 for level 2.

Two other complete vascular ultrasound procedures, CPT 93930 (duplex scan of upper extremity arteries or arterial bypass grafts) and CPT 93978 (duplex scan of aorta, inferior vena cava, iliac vasculature or bypass grafts) were also reassigned to level 3. These reassignments were effective on Jan. 1.

This CMS action, stimulated by the SVS leadership, is a major victory for vascular surgeons, who will receive fair reimbursement, and patients, who will have access to vital non-invasive ultrasound procedures. ■

Applications for New Community Practice Grant Program Due March 1 T SVS FOUNDATION:

he clock is ticking to apply for a new SVS Foundation grant program aimed squarely at improving patient health by way of our community practice members.

Applications are due March 1 for the new Community Awareness and Prevention Project Grant, intended to help members in community practice environments conduct projects that address wellness and disease prevention and emphasize patient education, public awareness or risk assessment.

Awardees will receive up to $10,000 for an innovative, community-based initiative.

Priority will go to projects that will benefit under-served areas or that include community partnerships. Projects should lead to programs that can be replicated and include plans to go forward beyond the grant period.

Applicants must be active or candidate SVS members practicing in a community hospital or other community setting. They will be notified by May 1, and winners will be recognized at the Vascular Annual Meeting in June Read more at vsweb.org/ CommunityGrants.

The new program complements the Foundation’s expanded mission, which includes not only basic research but also increased public awareness about vascular disease and treatments and efforts to improve patient vascular care.

Other Award Applications Are Also Due Soon

Application deadlines are near for three other SVS Foundation awards: the Clinical Research Seed Grants and the E.J. Wylie traveling Fellowship (March 1); and the Wylie Scholar Award (March2), co-sponsored by Vascular Cures. Learn more at vsweb.org/SVSAwards. ■

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“M

y group manages eight hospital labs and a physician group-owned outpatient lab that provides services in nine outpatient clinics… We are critically dependent on appropriate reimbursement for vascular ultrasound services to be able to maintain the high-quality service we provide in the community.

The restructuring of these imaging APCs, which do not maintain the current level of reimbursement for complete vascular ultrasound procedures, will definitely impede our service and increase reliance on more expensive studies such as CTAs and MRAs.” – Letter to CMS from Vascular Surgeon

VASCULARSPECIALISTONLINE.COM • 9

NEWS FROM SVS

SVS, AVF Strengthen Collaboration Under New Agreement

First 2018 SVS Membership Application Deadline Is March 1

T

T

he leading organizations dedicated to diagnosis, treatment and research of arterial and venous disease have strengthened their partnership in pursuit of quality across the spectrum of vascular disease.

The Society for Vascular Surgery and the American Venous Forum signed an historic agreement that lays the groundwork for future collaboration. The Memorandum of Understanding was established in late 2017, signifying the two organizations’ united focus on quality, education advocacy, policy, education and research with a shared goal to ensure the highest quality care to patients.

“This new agreement benefits members of both AVF and SVS; together we will be more powerful in advocacy issues and in advancing education and research in arterial and venous disease,” said SVS President R. Clement Darling III, MD. “We share many of the same goals and together we are greater than the sum of our parts. To ensure the vascular specialty’s effectiveness and might, we need to collaborate and form closer relationships with organizations across the vascular spectrum.

The possibilities for collaboration are endless and movement in this direction will optimize the work we do on behalf of our patients. For example, when we have to testify at MEDCAC or before other governmental panels, we’re much stronger together.”

“Our core values are very similar,” said AVF President Marc Passman, MD. “This makes it very easy to partner with SVS to accomplish objectives, whether it’s guidelines or advocacy issues that arise, and see high-level, professional results with evidence and quality behind them.

“A relationship has always existed, but now it is more defined and the integration more seamless, particularly from an organizational standpoint,” Brand Exposure continued from page 9

February 2017, promoting the message that cardiovascular disease can affect the entire body, not just the heart. This release and messaging was picked up by 35 major media outlets, including HealthDay, U.S. News, MedlinePlus, WebMD, MedicineNet and Men’s Health.

Other top public press releases were “Vaping: E-cigs Have Their 10 • VASCULAR SPECIALIST

YOUR SVS:

AVF President, Dr. Marc Passman (l) and SVS President, Dr. Clem Darling

said Dr. Passman. “It provides the infrastructure for us to keep evolving the relationship.”

“Over the past several decades arterial and venous entities have almost grown into separate branches under the vascular care umbrella,” said Dr. Darling. “SVS is the world’s expert in vascular surgery and arterial procedures, while the AVF has become established as the world’s experts in venous care,” he said. “Together we’ll create greater efficiencies and better outcomes for the same group of patients by aligning our efforts.”

Various committees of each organization now include members of the other, and members of both organizations will meet periodically to actively look for potential collaborative opportunities.

The memorandum also facilitates expanded educational opportunities, such as co-branded programs at the AVF Annual Meeting and at the Vascular Annual Meeting.

Drs. Darling and Passman will celebrate the agreement during both annual sessions in February and June, respectively. ■ Own Risks,” “Don’t Fall for These 6 Internet Myths About Statins,” and “Have Diabetes? A Few Simple Steps May Keep Your Feet Healthy.”

In 2017, the SVS also partnered with JVS to increase visibility for the journal.

Dr. Paul DiMuzio, of Thomas Jefferson University Hospital, now writes a press release for every JVS and JVS Venous and Lymphatic Disorders issue and SVS edits and distributes them. Most

o improve access, efficiency and service to existing and future SVS members, the Society is now reviewing and approving membership applications quarterly, instead of yearly.

The first deadline for 2018 is March 1. Applicants should learn by mid to late April if they are accepted for membership, in time to attend the Vascular Annual Meeting at the discounted member rate.

Please note that registration fees are assigned based on the current membership status at registration. An adjustment can be made post-approval.

Why join? Simple: membership benefits include professional prestige, legislative advocacy, research opportunities and information, practice tools and resources, discounted registration for educational programs, free publications and networking. Active members are enrolled in the “Find A Specialist” referral program used by prospective patients. Become part of the largest professional vascular association dedicated to advancing the specialty.

Categories include active, international, associate and affiliate. (A new section within the affiliate category was created late in 2017 for physician

assistants.) Be part of the SVS vascular team. Learn more at vsweb.org/ JoinSVS and apply today.

The SVS is also the management home for the Society for Vascular Nursing, which welcomes nurses and nurse practitioners in the vascular setting. Visit svnnet.org.

Nominate an SVS Honoree

SVS is also accepting nominations through March 1 for its three highest honors. Recipients will be recognized at the 2018 Vascular Annual Meeting in June.

The SVS Lifetime Achievement Award recognizes an individual’s outstanding and sustained contributions to the profession and SVS as well as exemplary professional practice and leadership.

The SVS Medal for Innovation in Vascular Surgery honors individuals whose contributions have had a transforming impact on the practice or science of vascular surgery.

The Distinguished Fellow Designation recognizes members who have provided sustained contributions to vascular surgery through research, teaching, clinical and/or creative accomplishments.

For more information and to submit nominations online, visit vsweb.org/SVSAwards. ■

New Vascular Ultrasound Registry Announced

VQI:

T

he Society for Vascular Ultrasound, the Society for Vascular Surgery and Medstreaming-M2S have developed the Vascular Quality Initiative Vascular Ultrasound Registry. It expands the SVS VQI to combine noninvasive (vascular

ultrasound) testing data with vascular treatment and outcomes data, making it possible to analyze the relationships between diagnosis and patient care.

The registry will be piloted with

JVS releases then get published by Vascular News and Endovascular Today, Vascular Specialist online and other medical publications.

Our most successful professional release was the announcement on updated AAA guidelines, an effort boosted by Dr. Thomas Forbes’ availability for three requested media interviews in mid-December.

SVS contracts with two distribution

networks for sending press releases to media. Their data and daily feed information provide insight into successful pickups, which have steadily increased.

Our improved media exposure is the result of staff efforts and professional oversight by the Public and Professional Outreach Committee, all enhanced by expert comments and interviews provided by our SVS on-call media experts. ■

Ultrasound continued on page 11

FEBRUARY 2018

NEWS FROM SVS

Funding a Comfortable Retirement

M

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ost people want to live in retirement as they did during their working days. They have plans – travel, help fund grandchildren’s college educations, perhaps escape winter each year.

Look no further than the Kai-Zen strategy of retirement funding, an ex-

clusive product for SVS members.

This unique product helps members speed investment growth in their life insurance policies, using leverage that provides up to 60 percent more death benefit protection and 60 percent more supplemental

retirement income.

Kai-Zen combines financing and life insurance, with premiums jointly funded by lenders and the participant (or an employer). The life insurance provides the full security for the loan. No financial underwriting or loan documents are required if minimum application requirements are met. The policy repays the loan at the end of 15 years and is the ONLY collateral for the bank loan.

Assets grow tax-deferred, benefits can be taken tax-free and participants fund their retirement in just five years. The zero percent floor means in a down market, participants don’t share the losses.

The next 2018 deadline for Kai-Zen is March 1. Secure your lifestyle into retirement and look into Kai-Zen today.

Watch a video at vsweb.org/ KaiZenVideo. For more information, contact Mark Blocker at Mark@nationalaffinity.net or call 855-533-1776.

(Purchasing a product through the expanded SVS affinity program benefits not only you and your practice, but also SVS itself. Visit vsweb.org/ AffinityProgram.) ■

Articles of Interest from March JVS/JVS-VL

J

VS: High-dose angiotensin inhibitors benefit long-term mortality in patients with critical limb ischemia, according to a recent study from Harvard University, published in the March Journal of Vascular Surgery. It is free to review as an open-source document for SVS members and non-members from Feb. 22 through April 30 at vsweb.org/JVS-RAS.

JVS-VL: Read about venous insufficiency during pregnancy in March’s Journal of Vascular Surgery - Venous and Lymphatic Disorders at vsweb.org/ JVSVL-CVI. The article is open-source through April 30. ■ Ultrasound continued from page 10

eight to 12 hospitals collecting and analyzing data on carotid artery disease and will include actual ultrasound images.

It is anticipated the registry will promote vascular laboratory standardization and thereby improve patient care. The non-invasive testing is used for medical management decisions, but there is a lack of standardization in reporting results and delivering testing, said James Wilkinson, SVU executive director.

“Targeted, yet broad-based research

will significantly contribute to standardization efforts.”

Fundamental to the new registry is the ability to link technical data and images to the data collected from the SVS VQI’s existing registries. Adding the registry “will further aid the VQI’s mission of improving vascular care by enhancing the data we can make available to our members,” said Dr. Jens Eldrup-Jorgensen, medical director of the SVS Patient Safety Organization.

For more information on VQI, visit vsweb.org/VQI. ■

VASCULAR RESEARCH INITIATIVES CONFERENCE

Register for VRIC Today May 9, 2018 | San Francisco, California The Vascular Research Initiatives Conference brings together researchers to better understand the biology of vascular disease, with presentations and discussion of new research and possibilities.

ACCOMMODATIONS:

Hilton San Francisco Union Square REGISTRATION IS NOW OPEN

For more information visit vsweb.org/VRIC18

FEBRUARY 2018

VASCULARSPECIALISTONLINE.COM • 11

Burnout among surgical residents mitigated by traits of mindfulness RESIDENT'S FORUM:

BY THERESE BORDEN FRONTLINE MEDICAL NEWS FROM J OUR N A L O F THE A M E R ICA N COLLEGE O F SUR G E RY

G

eneral surgery residents reported high levels of stress linked to burnout, but those who exhibited characteristics of mindfulness were less likely to experience this dynamic, a survey-based study has found.

Carter C. Lebares, MD, of the department of surgery at the University of California, San Francisco, and her colleagues aimed to assess the prevalence and root causes of burnout as seen among surgical trainees.

They sent a survey questionnaire to 246 general surgery training

Burnout prevalence among general surgery residents was 69%, significantly higher than in agematched peers and practicing surgeons.

program directors and asked them to distribute the survey to their residents ( J Am Coll Surg. 2018 Jan;226[1]:80-90. doi: 10.1016/j.jamcollsurg.2017.10.010).

The investigators focused on the components of burnout as identified in the literature (emotional exhaustion, depersonalization, perceived stress, depression, anxiety, and alcohol misuse/abuse).

The survey, a voluntary and confi-

12 • VASCULAR SPECIALIST

dential exercise, was based on scales and tools to assess symptoms of burnout (Maslach Burnout Inventory), stress (Cohen’s Perceived Stress Scale), anxiety (Spielberger’s State Trait Anxiety Index), and depression/ suicidal ideation (Patient Health Questionnaire).

The researchers also looked at personality traits that could make the difference between the usual stress of residency and burnout in individual trainees (Cognitive Affective Mindfulness Scale–Revised).

A total of 566 surgery residents responded to the survey; 51% were female and 76% were based in an academic training program.

Overall, the survey found that burnout prevalence among general surgery residents was 69%, which confirms the findings of earlier studies of this population, and was significantly higher than rates seen in age-matched peers in the general population and among practicing surgeons.

Burnout was equally prevalent among men and women, but men appeared more likely to experience depersonalization (62% vs. 51%).

Emotional exhaustion was lower among lab trainees.

Alcohol misuse and abuse was found to be somewhat higher in women (58% vs. 41% and 40% vs.

26%, respectively).

Although symptoms of burnout were not strongly associated with training level, PGY3 residents experienced the most (58% reported higher stress, 16% suicidal ideation, 50% high anxiety, and 61% alcohol abuse).

A high level of stress was reported significantly less often by lab trainees, but alcohol misuse was significantly greater.

A high level of stress and emotion-

P E R S PEC T I VE by Laura M. Drudi, MD

Spiraling Downwards

R

esident and phyincidence of “burnsician burnout is out.”

REAL! This is undeWhat we really niable with several require is a study surveys and studies to address the root reporting high rates of causes of burnout burnout across medamong residents and ical specialties worldthen, most imporwide. tantly, subsequent A recent survey of proposals for mitigaover 500 general surgery Dr. Laura M. Drudi, is tion. residents in the United In my experience, the Resident Associate States had a prevalence I don’t think there Medical Editor for Vascular Specialist. of burnout of 69%. is one specific cause Accordingly, we but years and years must acknowledge that of striving for excelresident burnout is a lence, patient and major problem affecting all medimentor approval, need to perform cal specialties. Therefore, training research, need to publish, need programs should make every effort to find a job, and with all these to safeguard resident mental health professional concerns, personal and wellbeing. It has taken decades issues, chronic sleep deprivation, for the stigma of mental health to and poor physical health. It is a be dissipated yet we minimize the downward spiral leading straight to problem by implying we are simply burnout … unquestionably. “burned out.”

With the help of mentors and a It is more than being burned support network, my fellow resiout; it is depression, anxiety, subdents need to find a way to break stance abuse, and all the facets of this downward spiral and spiral mental health sometimes even re- upward toward well-being for oursulting in suicide. We don’t need selves, our patients, and our health another study to determine the care system.

al exhaustion and depersonalization were strongly linked. And all of these elements were strongly associated with moderate to severe depressive symptoms, suicidal ideation, and high anxiety.

“Stress is a double-edged sword, with a dose-response relationship between stress and performance described as an ‘inverted U-shaped curve.’

“Although stress is initially stimulating, there is a tipping point when demands outstrip resources and stress becomes overwhelming,” the researchers wrote. Surgical trainees purposefully join a high-stress profession and presumably thrive on a demanding environment, but “that does not make individuals immune to the effects of overwhelming stress.”

The study also found that personality traits had an impact on burnout risk.

“Greater dispositional mindfulness

was associated with an 85% decrease in the risk of high stress, and a greater trait resilience was associated with a 65% decrease in the risk of high stress.”

The investigators said that mindfulness and resilience can be taught and fostered in trainees.

They concluded: “Although it is imperative to understand the institutional factors contributing to this problem, recent meta-analyses suggest that interventions aimed at both institutional and individual factors might be required to arrest this alarming trend and guide necessary changes to the healthcare system as a whole.”

The researchers reported no relevant financial conflicts. ■ tborden@frontlinemedcom.com

SOURCE: J Am Coll Surg. 2018 Jan;226(1):80-90. doi: 10.1016/j.jamcollsurg.2017.10.010.

FEBRUARY 2018

MESENTERIC DISEASE

Pendulum swings on mesenteric venous thrombosis treatment

CHICAGO – Treatment of isolated acute mesenteric venous thrombosis remains a topic of controversy, with no established guidelines available, Thomas S. Maldonado, MD, observed at a symposium on vascular surgery sponsored by Northwestern University.

“There has been a pendulum swing. Earlier on there was a lot of excitement about surgical thrombectomy; then we tended to become more nonoperative and conservative, using just anticoagulation. But in recent years endovascular therapy has been gaining some traction and shows good preliminary results,” according to Dr. Maldonado, professor of surgery at New York University.

In addition to describing contemporary treatment of mesenteric venous thrombosis (MVT), he also highlighted the challenges posed in achieving prompt diagnosis of this life-threatening disorder whose incidence has steadily increased during the last several decades.

Today MVT accounts for 1 in 1,000 emergency department visits and 6%-9% of cases of acute mesenteric ischemia. Dr. Maldonado cited two reasons for the increasing incidence.

One is the widespread recognition that contrast-enhanced helical CT is the diagnostic imaging method of choice; it is being employed more liberally because of its ready availability and overall 95%-100% accuracy, which allows for rapid and reliable diagnosis with precise location of the thrombus.

The other factor is that bariatric surgery is booming. While the most common local etiologies of the hypercoagulable state predisposing to MVT remain cancer and intra-abdominal inflammatory diseases such as pancreatitis, there is no doubt that laparoscopic bariatric surgery is emerging as another contributing factor, according to the surgeon.

Diagnosis

MVT is an insidious and lethal disease. In most series, it has a mortality of at least 25%, and it doesn’t appear to be going down in recent years.

This is probably because of difficulty FEBRUARY 2018

in making a prompt diagnosis before bowel ischemia occurs. Multiple studies show that onset of symptoms typically occurs 6-14 days before patients present for care.

“I think this is really the Achilles heel of this diagnosis – that it can be delayed. The diagnosis can be elusive.

There is no constellation of signs or symptoms that is pathognomonic for MVT. This is where prompt recognition and a CT scan can really play an important role,” Dr. Maldonado said.

He and a coworker conducted a review of 37 studies on MVT published in 1997-2016 which underscored the challenges in making a prompt diagnosis. The most common presenting symptom was nonspecific abdominal pain out of proportion to findings on physical exam. Other possible symptoms included anorexia, nausea, vomiting, constipation, and/or passage of blood through the anus. The disease occurred most often in men aged 40-60. A history of unprovoked venous thromboembolism was often present ( J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:501-7).

The three-phase CT scan – arterial, venous, and delayed venous – not only locates the thrombus with precision, it also shows whether the occlusion is partial or complete, which is important information prognostically (see below).

The scan also provides information on bowel ischemia with at least 90% sensitivity and specificity. Bowel compromise shows up on CT as a thickened bowel wall with dilated lumen, mesenteric fat stranding, and ascites.

CT imaging has become so useful for rapid diagnosis of MVT that duplex ultrasound, although considerably less costly and radiation-free, has become relegated to a secondary role.

At most centers its use is restricted to follow-up surveillance to assess for thrombus resolution and vascular recanalization after the acute episode has been treated. Duplex ultrasound simply can’t match CT in the crucial task of assessment for bowel ischemia.

Treatment

The mainstay of treatment in patients with MVT without bowel ischemia is medical management: immediate anticoagulation with unfractionated or low-molecular-weight heparin bridging to warfarin, bowel rest, aggressive fluid resuscitation, and correction of electrolyte imbal-

ances. Most patients with nonocclusive MVT and no ischemic bowel can be managed in this way without surgical intervention. The newer oral anticoagulants haven’t yet been studied in patients with MVT. How long to continue oral anticoagulation is an unresolved issue. In Dr. Maldonado’s literature review, the median duration was 90 days. In his own practice, anticoagulants aren’t stopped until duplex ultrasound demonstrates recanalization of the mesenteric venous system. If residual thrombus is present or a patient has

currence rates and fewer bowel resections than with anticoagulation alone.

Indeed, Dr. Maldonado and his fellow vascular surgeons at New York University have recently developed a management algorithm whereby patients with occlusive MVT and no bowel ischemia undergo catheter-directed thrombolysis provided there are no contraindications, such as uncontrolled hypertension or a recent hemorrhagic stroke. The surgeons will also seriously consider catheter-directed lytic therapy in MVT patients with bowel ischemia who show no improvement after laparotomy, bowel resection, and open thrombectomy.

Prognosis

Bruce J ancin /F rontline Medical news

BY BRUCE JANCIN FRONTLINE MEDICAL NEWS EXPER T AN A LYSIS FR O M THE NOR TH W E STE R N VAS CU LAR SYM PO SIUM

Dr. Thomas S. Maldonado

an underlying hypercoagulable state, treatment continues indefinitely.

In a series of 50 noncirrhotic MVT patients treated at New York University using various strategies, 19, or 38%, were completely recanalized.

Recurrence of MVT after successful treatment occurred in only 2 of these 19 patients, in both cases upon discontinuation of anticoagulation.

“It speaks to the issue of length of treatment – or should it be discontinued at all?” the surgeon said.

Open surgical thrombectomy has fallen into disfavor because the thrombus tends to recur within 7 days post surgery. It is now best reserved for patients with acute MVT with a contraindication to thrombolytic therapy, such as cirrhosis or recent major surgery, according to Dr. Maldonado.

Multiple patient series using endovascular catheter-directed thrombolytic therapy with a transhepatic, transvenous, transarterial, or combined approach have reported high rates of successful recanalization – even in the 90% range – with low re-

A retrospective review by Dr. Maldonado and coinvestigators of 80 noncirrhotic patients with MVT managed at New York University raised a red flag regarding the high risk of portal hypertension as a longterm sequela. At a median follow-up of 480 days, fully half of patients with imaging results available displayed radiographic features of portal hypertension, although as yet none had developed frank clinical manifestations of cirrhosis.

The investigators identified two predictors of portal hypertension.

One was complete as opposed to partial thrombosis at the initial event.

Complete thrombosis was present in 73% of patients who eventually developed portal hypertension, compared with 43% of those who didn’t.

The other predictor was lack of successful recanalization: only 37% of patients who developed portal hypertension were successfully recanalized, compared with a 65% recanalization rate in those who remained free of this long-term complication ( J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:400-6).

These observations raise the possibility that initial complete thrombosis of the mesenteric vein and nonrecanalization with medical therapy might tip the balance in favor of endovascular lytic therapy as a potential means of preventing later portal hypertension.

“I don’t think we know the answer, but there’s certainly room for research,” Dr. Maldonado observed.

He reported having no financial conflicts regarding his presentation. ■ bjancin@frontlinemedcom.com VASCULARSPECIALISTONLINE.COM • 13

DVT & PULMONARY EMBOLISM

Evidence mounts for pulmonary embolism benefit from catheter thrombolysis

BY MITCHEL L. ZOLER FRONTLINE MEDICAL NEWS AT CHES T 2 0 1 7

TORONTO – Catheter-directed thrombolysis of pulmonary embolism using an ultrasound-assisted device led to significantly better outcomes in patients hospitalized for pulmonary embolism, compared with conventional systemic thrombolytic treatment, in a propensity score–adjusted analysis of nearly 3,400 patients.

Catheter-directed thrombolysis (CDT) “represents an opportunity to locally treat pulmonary embolism with significant thrombus burden with lower bleeding complications,” Abhishek Mishra, MD, said at the CHEST annual meeting. “I think we are underusing CDT,” said Dr. Mishra, a cardiovascular disease physician at Guthrie Robert Packer Hospital in Sayre, Pa. Although one CDT device, the EKOS endovascular system that uses ultrasound to facilitate pulmonary embolism (PE) thrombolysis, received Food & Drug Administration approval for U.S. marketing in 2014,

the trials that have with systemic thromcompared it with sysbolysis with 1,128 temic thrombolysis matched patients have been small, nottreated with CDT ed Dr. Mishra, and using tissue plasminnone have looked ogen activator. at whether CDT The analysis improves patient showed that in-hospisurvival, compared tal death was 15% in with standard treatthe systemic patients ments. The largest and 6% in the CDT DR. MISHRA report on CDT treatgroup, a relative risk ment of PE came reduction of 63%, from a single-arm, uncontrolled and 30-day readmissions occurred in study with 150 patients who re11% of the systemic patients and in ceived ultrasound-facilitated CDT 8% of those treated with CDT, a 30% ( JACC Cardiovasc Interv. 2015 relative risk reduction. Both were Aug;8[10]:1382-92). statistically significant differences for To better document the incremen- the study’s two primary endpoints, tal benefit from CDT, Dr. Mishra Dr. Mishra reported at the meeting. and his associates used data collectRates of intracerebral hemorrhage ed by the Nationwide Readmissions and gastrointestinal bleeds were both Database during 2013 and 2014, numerically lower with CDT, and both before and after a CDT device significantly lower for gastrointestinal became available for U.S. use. From bleeds. among 4,426 patients hospitalized The researchers also ran a mulwith a primary diagnosis of PE and tivariate analysis on their data that treated with thrombolytic therapy, showed CDT was linked with signifithey used propensity score matching cant relative reductions of about 60% to compare 2,256 patients treated for both in-hospital death and 30-day

readmissions, compared with patients on systemic therapy. The results Dr. Mishra reported also appeared in a published report (Am J Cardiol. 2017 Nov 1;120[9]:1653-61).

These findings help buttress the case for using CDT for at least some PE patients. “The key is which patients need it. What is the best way to stratify patients?” commented Victor F. Tapson, MD, a pulmonologist at Cedars-Sinai Medical Center in Los Angeles.

“Patients with PE and a normal right ventricle generally don’t need anything more aggressive than anticoagulation, and really sick patients with massive PE need systemic thrombolytics. Intermediate-risk patients” are best suited to CDT, but “the problem is that intermediate-risk patients are heterogeneous,” Dr. Tapson said in a video interview.

Future studies should establish a more specific subgroup of intermediate-risk patients who benefit from routinely employed CDT, he suggested. ■ mzoler@frontlinemedcom.com On Twitter @mitchelzoler

NEWS FROM FDA

New type of acoustic device approved for diabetic foot ulcers

BY RANDY DOTINGA FRONTLINE MEDICAL NEWS

T

he Food and Drug Administration has approved the marketing of a device that uses acoustic shock waves to boost wound closure in patients with diabetic foot ulcers (DFUs), an especially stubborn and dangerous condition.

The treatment, using the device known as dermaPACE developed by the Sanuwave company, is experimental, and only limited research into its effectiveness has been published.

DFUs are believed to affect as many as one in four people with diabetes over the course of their lifetimes. A 2014 report estimated that care of these wounds costs insurers as much as $13 billion a year in the U.S. alone (Diabetes Care. 2014 Mar;37[3]:651-8).

Current treatment options include debridement and, in more extreme cases, hyperbaric oxygen treatment. Amputation can be required if treatment is unsuccessful.

In a news release, the FDA said it examined the results of two studies of patients with diabetes 14 • VASCULAR SPECIALIST

who received usual DFU care along with either the shock wave therapy or a sham therapy. A total of 336 patients took part in the multicenter, randomized, double-blind studies.

According to the FDA, the studies found a 44% wound closure rate at 24 weeks in patients who had undergone one to seven shock wave treatments, compared with the 30% wound closure rate in those who received the sham treatment.

Side effects included pain while the device was applied, bruising and numbness, migraines, nausea, fainting, wound infection, fever, and infection beyond the wound such as cellulitis and osteomyelitis.

A company spokesperson said that the FDA expressed concern about “increased incidences of osteomyelitis at later points in the trials, particularly at the 10-week mark and later.”

In response to the agency’s concerns, warning statements were added to product's labeling, he said.

The FDA says the device is intended to be used in adults aged 22 and up with certain types of chronic DFUs. The Sanuwave company says patients should be treated with four to eight applications over 2-10 weeks.

The FDA approved the marketing of the device as part of its de novo premarket review pathway, which allows certain new types of devices to be approved by FDA, even when approved similar devices don’t yet exist for the purposes of comparison.

“A shortcoming in the field of wound care is that providers are typically not trained in a standardized fashion on when and how to a perform meticulous excisional sharp debridement of a wound,” said Bill Tettelbach, MD, systems medical director of Wound Care & Hyperbaric Medicine Services at Intermountain Healthcare in Salt Lake City.

“In the majority of cases, the better the debridement, the more rapidly the patient will obtain wound closure,” Dr. Tettelbach added.

This new therapy may provide a benefit as a secondary treatment, especially when the patient cannot tolerate extensive sharp debridement, he said. It also could potentially improve biofilm penetration of antimicrobial topical treatments, he said.

Dr. Tettelbach reported that he had no relevant disclosures. ■ FEBRUARY 2018

PAD & CLAUDICATION

Targeting PCSK9 inhibitors to greatest benefit ANAHEIM, CALIF. – Patients with symptomatic peripheral artery disease or a high-risk history of MI got the biggest bang for the buck from aggressive LDL cholesterol lowering with evolocumab in two new prespecified subgroup analyses from the landmark FOURIER trial presented at the American Heart Association scientific sessions.

“At the end of the day, not all of our patients with ASCVD [atheroscleDr. Marc P. Bonaca Dr. Marc S. Sabatine rotic cardiovascular disease] can have these expensive medications. These subgroup analyses will help clinicians which was 81% greater than the 7.6% rate in plato target use of PCSK9 inhibitors to the patients cebo-treated participants with a baseline history of who will benefit the most,” Lynne T. Braun, PhD, stroke or MI but no PAD, in an analysis adjusted commented in her role as discussant of the two for demographics, cardiovascular risk factors, kidsecondary analyses, presented back to back in a late-breaking science session. Dr. Braun is a profes- ney function, body mass index, and prior revascusor in the department of internal medicine at Rush larization.

The event rate was even higher in patients with University, Chicago.

PAD plus a history of MI or stroke, at 14.9%. EvoThe FOURIER trial included 27,564 high-risk locumab reduced that risk by 27%, compared with patients with prior MI, stroke, and/or symptomplacebo in patients with PAD, for an absolute risk atic peripheral arterial disease (PAD) who had an reduction of 3.5% and a number needed to treat LDL cholesterol level of 70 mg/dL or more on (NNT) of 29 for 2.5 years. high- or moderate-intensity statin therapy. They The benefit of evolocumab was even more prowere randomized in double-blind fashion to addnounced in the subgroup of 1,505 patients with on subcutaneous evolocumab (Repatha) at either 140 mg every 2 weeks or 420 mg/month or to pla- baseline PAD but no prior MI or stroke: a 43% relative risk reduction, from 10.3% to 5.5%, for an cebo, for a median of 2.5 years of follow-up. The evolocumab group experienced a 59% reduction in absolute risk reduction of 4.8% and a NNT of 21.

A linear relationship was seen between the LDL cholesterol, compared with the controls on background statin therapy plus placebo, down to a MALE rate during follow-up and LDL cholesterol level after 1 month of therapy, down to an LDL mean LDL cholesterol level of just 30 mg/dL. cholesterol level of less than 10 mg/dL. The clinAs previously reported, the risk of the primary ically relevant composite endpoint of MACE (macomposite endpoint – comprising cardiovascular jor adverse cardiovascular events – a composite death, MI, stroke, unstable angina, or coronary of cardiovascular death, MI, and stroke) or MALE revascularization – was reduced by 15% in the in patients with baseline PAD but no history of evolocumab group at 3 years. The secondary endpoint of cardiovascular death, MI, or stroke was re- MI or stroke occurred in 12.8% of controls and 6.5% of the evolocumab group. This translated to duced by 20%, from 9.9% to 7.9% (N Engl J Med. a 48% relative risk reduction, a 6.3% absolute risk 2017;376:1713-22). reduction, and a NNT of 16. The event curves in Evolocumab tamed PAD the evolocumab and control arms separated quite At the AHA scientific sessions, Marc P. Bonaca, early, within the first 90 days of treatment.

MD, presented a secondary analysis restricted to The take-home message: “LDL reduction to very the 3,642 FOURIER participants with symptomlow levels should be considered in patients with atic PAD. The goal was to answer two unresolved PAD, regardless of their history of MI or stroke, questions: Does LDL cholesterol lowering beto reduce the risk of MACE and MALE,” declared yond what’s achievable with a statin further reDr. Bonaca of Brigham and Women’s Hospital and duce PAD patients’ cardiovascular risk? And does Harvard Medical School, both in Boston. it reduce their risk of major adverse leg events Spotting the patients with a history (MALE), defined as a composite of acute limb ischemia, major amputation, and urgent revascu- of MI who’re at highest risk Marc S. Sabatine, MD, presented the subanalysis larization?

The answer to both questions turned out to be a involving the 22,351 FOURIER patients with a prior MI. He and his coinvestigators identified three resounding yes. high-risk features within this group: an MI within The rate of the composite endpoint comprising the past 2 years, a history of two or more MIs, cardiovascular death, MI, or stroke was 13% over and residual multivessel CAD. Each of these three 3 years in PAD patients randomized to placebo, FEBRUARY 2018

features was individually associated with a 34%-90% increased risk of MACE during follow-up. All told, 63% of FOURIER participants with prior MI had one or more of the high-risk features.

The hypothesis was that patients with these readily ascertainable clinical features placing them at higher cardiovascular risk would obtain greater benefit from evolocumab. This indeed proved to be the case.

The use of evolocumab in patients with at least one of the three high-risk features was associated with a 22% relative risk reduction and an absolute 2.5% risk reduction, compared with placebo. The event curves diverged at about 6 months, and the gap between them steadily widened during follow-up. Extrapolating from this pattern, it’s likely that evolocumab would achieve an absolute 5% risk reduction in MACE, compared with placebo over 5 years, with an NNT of 20, according to Dr. Sabatine, professor of medicine at Harvard Medical School and chairman of the Thrombolysis in Myocardial Infarction (TIMI) Study Group.

P hotos Bruce J ancin /Frontline M edical news

BY BRUCE JANCIN FRONTLINE MEDICAL NEWS EXPER T AN A LYSIS FR O M THE AHA SCIENTIFIC SE SSIO N S

Lingering questions

Dr. Braun was particularly impressed that the absolute risk reduction in MACE was even larger in patients with baseline PAD but no history of stroke or MI than in PAD patients with such a history. She added that, while she recognizes the value of selecting objectively assessable hard clinical MACE as the primary endpoint in FOURIER, her own patients care even more about other outcomes.

“What my patients with PAD care most about is whether profound LDL lowering translates to less claudication, improved quality of life, and greater physical activity tolerance. These were prespecified secondary outcomes in FOURIER, and I look forward to future reports addressing those issues,” she said.

Another unanswered question involves the mechanism by which intensive LDL cholesterol lowering results in fewer MACE and MALE events in high-risk subgroups. The possibilities include the plaque regression that was documented in the GLAGOV trial, an anti-inflammatory plaque-stabilizing effect being exerted through PCSK9 inhibition, or perhaps the PCSK9 inhibitors’ ability to moderately lower lipoprotein(a) cholesterol levels.

Simultaneous with Dr. Bonaca’s presentation at the AHA, the FOURIER PAD analysis was published online in Circulation (2017 Nov 13. doi: 10.1161/CIRCULATIONAHA.117.032235).

The FOURIER trial was sponsored by Amgen.

Dr. Bonaca and Dr. Sabatine reported receiving research grants from and serving as consultants to Amgen and other companies. ■ bjancin@frontlinemedcom.com VASCULARSPECIALISTONLINE.COM • 15

VAS_16.indd 1

3/29/2017 10:37:51 AM

DIABETES

Guidelines: Use cardioprotective antihyperglycemic drugs for patients with diabetes plus CVD

BY MICHELE G. SULLIVAN FRONTLINE MEDICAL NEWS EXPER T AN A LYSIS FR O M D IA B E TE S CA RE

R

ecent studies that confirm the cardiovascular benefit of some antihyperglycemic agents are shaping the newest therapeutic recommendations for patients with type 2 diabetes and comorbid atherosclerotic cardiovascular disease (ASCVD).

Treatment for these patients – as all with diabetes – should start with lifestyle modifications and metformin. But in its new position statement, the American Diabetes Association now recommends that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin or the glucagon-like peptide 1 (GLP-1) agonist liraglutide – to the regimens of patients with diabetes and ASCVD (Diabetes Care 2018;41 [Suppl. 1] S86-S104. doi: 10.2337/dc18-S009).

The medications are indicated if, after being treated with lifestyle and metformin therapy, the patient isn’t meeting hemoglobin A1c goals, said Rita R. Kalyani, MD, who led the ADA’s 12-member writing committee. But clinicians may also consider adding these agents for cardiovascular benefit alone, even when glucose control is adequate on a regimen of lifestyle modification and metformin, with dose adjustments as appropriate, she said in an interview.

“A1c remains the main target of sequencing antihyperglycemic therapies, if it’s not reached after 3 months,” said Dr. Kalyani of Johns Hopkins University, Baltimore. “But, it could also be that the provider, after consulting with the patient, feels it’s appropriate to add one of these agents solely for cardioprotective benefit in patients with ASCVD.” The recommendation to incorporate agents with cardiovascular benefit is related directly to data from two trials, LEADER and EMPA-REG, which support this recommendation. All of these cardiovascular outcome trials included a majority of patients who were already on metformin.

The ADA’s “Standards of Medical Care in Diabetes 2018” is the first position statement from any professional society to provide specific recommendations for the incorporation of these newer antihyperglycemic agents for their cardioprotective benefit in the treatment algorithm for type 2 diabetes. But the document provides much more than an algorithm for treating patients with concomitant ASCVD, Dr. Kalyani said. It is a comprehensive clinical guide covering recommendations for diagnosis, medical evaluation, comorbidities, lifestyle change, cardiovascular risk management, and treating diabetes in children and teens, pregnant women, and patients with hypertension.

The 2018 update contains a number of new recommendations; more will be added as new data emerge, since the ADA intends it to be a continuously refreshed “living document.” This makes it especially clinically useful, Paul S. Jellinger, MD, FEBRUARY 2018

said in an interview.

A member of the writing committee of the American Association of Clinical Endocrinologists’ diabetes management guidelines, Dr. Jellinger feels ADA’s previous versions have not been as DR. KALYANI targeted as this new one and, he hopes, its subsequent iterations.

“This is a nice enhancement of previously published guidelines for diabetes therapy,” said Dr. Jellinger, professor of clinical medicine at the University of Miami. “For the first time, ADA is providing some guidance in terms of which agents to use. It’s definitely more prescriptive than it was in the past, when, unlike the AACE Diabetes Guidelines, it was a palette of choice for clinicians, but with very little guidance about which agent to pick. The guidance for patients with cardiovascular disease in particular is big news because these antihyperglycemic agents showed such a significant cardiovascular benefit in the trials.”

While the document gives a detailed algorithm of advancing therapy in patients with ASCVD, it doesn’t specify a preference for a specific drug class after metformin therapy in patients without ASCVD. Instead, it provides a detailed table listing the drug-specific effects and patient factors to consider when selecting from different classes of antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors, thiazolidinones, sulfonylureas, and insulins).

The table notes the drugs’ general efficacy in diabetes, and their impact on hypoglycemia, weight gain, and cardiovascular and renal health. The table also includes the Food and Drug Administration black box warnings that are on some of these medications.

Another helpful feature is a cost comparison of antidiabetic agents, Dr. Kalyani noted. “Last year we added comprehensive cost tables for all the different insulins and noninsulins, and this year we added a second data set of cost information, to assist the provider when prescribing these agents.”

“In this document, ADA is urging providers of care to ask about whether the cost of their diabetes care is more than they can deal with. They present tables which compare the costs of the current blood glucose lowering agents used in the U.S., and it is plain to see that many patients, without insurance coverage, will find some of the medications unaffordable,” said Richard Hellman, MD, a past president of AACE. “They also provide data that show half of all patients with diabetes have financial problems,” and he suspects that medication costs are an important component of their financial insecurity.

The document also notes data from the 2017 National Health and Nutrition Examination Survey, which found that 10% of people with diabetes

have severe food insecurity and 20% have mild food insecurity (Diabetes Educ. 2017;43:260-71. doi: 10.1177/0145721717699890).

“Another thing the document points out is that two-thirds of the patients who don’t take all their medications due to cost don’t tell their doctor,” Dr. Hellman said. “The ADA is making the point that providers have a responsibility to ask if a patient is not taking certain medications because of the cost. We have so many better tools to manage this disease, but so many of these tools are unaffordable.”

While the treatment algorithm for patients with ASCVD will likely be embraced, another new recommendation may stir the pot a bit, Dr. Hellman noted. The section on cardiovascular disease and risk management sticks to a definition of hypertension as 140/90 mm Hg or higher – a striking diversion from the new 130/80 mm Hg limit set this fall by both the American Heart Association and the American College of Cardiology.

“This difference in recommendations is very important and will be controversial,” Dr. Hellman said, adding that he agrees with this clinical point.

Again, this recommendation is grounded in clinical trials, which suggest that people with diabetes don’t benefit from overly strict blood pressure control. The new AHA/ACC recommendations largely drew on data from SPRINT, which was conducted in an entirely nondiabetic population.

“These gave a clear signal that a lower BP target is beneficial to that group,” Dr. Hellman said.

But large well-designed randomized controlled trials of intensive blood-pressure lowering in people with diabetes, such as ACCORD-BP, did not demonstrate that intensive blood-pressure lowering targeting a systolic less than120 mm Hg had a significant benefit on the composite primary cardiovascular endpoint.

And while the ADVANCE BP trial found the composite endpoint was improved with intensive blood pressure lowering, the blood pressure level achieved in the intervention group was 136/73 mm Hg. “This recommendation is based on current evidence for people with diabetes,” Dr. Kalyani said.

“We maintain our definition of hypertension as 140/90 mm Hg or higher based on the results of large clinical trials specifically in people with diabetes but emphasize that intensification of antihypertensive therapy to target lower blood pressures (less than 130/80 mm Hg) may be beneficial for high-risk patients with diabetes such as those with cardiovascular disease. We are constantly assessing the evidence and will continue to review the results of new studies for potential incorporation into recommendations in the future.”

Dr. Kalyani and Dr. Hellman had no disclosures.

Dr. Jellinger has been a speaker for several pharmaceutical companies. ■ msullivan@frontlinemedcom.com

SOURCE: Kalyani R et al. Diabetes Care. 2018;41(Suppl. 1):S86-S104 doi:10.2337/dc18-S009.

VASCULARSPECIALISTONLINE.COM • 17

VENOUS DISEASE

Stenting improved outcomes for treating chronic IVC obstruction

BY TERRY L. KAMPS FRONTLINE MEDICAL NEWS FROM THE E UR O PE A N J O UR N A L O F VAS CU LAR A N D E N D O VA SCUL A R SUR G E RY

S

tenting improved outcomes in patients with chronic obstruction of the inferior vena cava (IVC), according to a retrospective analysis of medical records from March 2010 to September 2015.

In the study, 19 of 20 patients with chronic IVC obstruction had successful stent placement, with most resulting in improved and sustained clinical outcomes. The study, conducted by Ole Jørgen Grøtta, MD, and colleagues, was reported in the European Journal of Vascular and Endovascular Surgery (2017;54:620-8).

Dr. Grøtta and colleagues investigated 11 men and 9 women patients, with a median age 43 years, and with venography-verified chronic IVC obstruction. Most patients also were screened and found to be positive for thrombophilia. Median follow-up was 25 months (range, 3-70 months).

The researchers reported on 13 patients with IVC occlusion and 7 with stenosis. Patient clinical

status and symptom severity was assessed according to standardized CEAP (clinical, etiology, anatomy, and pathophysiology) classification and the venous clinical severity score (VCSS), respectively.

Sixteen patients presented chronic venous disease (CVD) symptoms in their lower limbs; of these,

“The endovascular approach with stent placement for chronic IVC obstructions is a safe treatment alternative.”

nine exhibited symptoms of an acute thrombosis and, based on their symptoms, seven were assigned to a specific CEAP category, ranging from C3 to C6.

The additional four patients included in the study had been referred to receive endovascular

treatment intervention based on symptoms consistent with physical activity–related reduced cardiac preload.

A total of 13 of 19 (68%) patients showed sustained and significant clinical improvement, seen as a shift from the baseline VCSS score of 8.5 down to 7.0 (P = .007) at final follow-up. This included all four of the patients identified as having reduced cardiac preload problems. The authors also reported that here were no periprocedural or long-term complications.

The need for an alternative treatment for patients with chronic obstruction of the IVC is exemplified by typically poor sustained clinical improvement outcomes and/or gradual clinical deterioration when using the traditional conservative approach of anticoagulants combined with compression stockings, according to the authors.

“The endovascular approach with stent placement for chronic IVC obstructions is a safe treatment alternative that should be offered to patients who otherwise have little opportunity for clinical improvement,” they concluded.

The authors reported that they had no conflicts of interest. ■

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18 • VASCULAR SPECIALIST

FEBRUARY 2018

VENOUS DISEASE

Topical timolol improved chronic leg ulcer healing

BY MARK S. LESNEY FRONTLINE MEDICAL NEWS FROM THE J O UR N A L O F VAS CU LAR SUR G E RY: V E N O US AND LYM PHATIC D ISO R D E R S

T

he use of topical timolol maleate as a treatment for chronic diabetic and chronic venous ulcers showed increased wound healing compared with controls, according to the results of a prospective observational study of 60 patients.

In the treatment group, 30 patients with chronic leg ulcer (15 diabetic ulcers; 15 venous) received topical application of 0.5% timolol maleate (a beta-blocker) plus conventional antibiotic and wound dressing therapy. In the control

group, 30 patients (identical split between diabetic and venous ulcers) were treated with conventional therapy alone, according to a report published in the November issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

Venous and diabetic leg ulcer healing rates were significantly better at 4, 8, and 12 weeks in the 30 timolol-treated patients than in the 30 patients who received conventional treatment alone, according to Bindhiya Thomas, MS, and colleagues at the Government Medical College, Kottayam, Kerala, India.

The researchers found no significant difference in healing rates due to sex, between smokers and

nonsmokers, or alcohol consumers vs. nonconsumers and they saw no major adverse effects due to timolol application ( J Vasc Surg: Venous and

maleate is an effective therapeutic option for the treatment of chronic diabetic ulcer and chronic venous ulcer patients to improve ulcer

Leg ulcer healing rates were significantly better at 4, 8, and 12 weeks in the 30 timolol-treated patients.

Lym Dis. 2017;5:844-50).

They reported that the limitations of their study included the lack of randomization and a formal power assessment.

“Topical application of timolol

healing by promoting keratinocyte migration,” the researchers concluded.

They reported having no relevant conflicts. ■ mlesney@frontlinemedcom.com

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2. U.S. Food and Drug Administration. Center for Devices and Radiological Health. FDA Summary of Safety and Effectiveness Data.

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