Vascular Specialist November 2018

17

6 Dr. Sheahan takes aim at the EHR problem.

Renal ultrasound topped RF ablation for resistant HTN.

12 News From SVS Dr. Norman Rich is recognized for his many contributions to vascular surgery in the military.

Smoking neglected in patients with PAD

BY MARK S. LESNEY MDEDGE NEWS FROM THE J O UR N A L O F THE AM ERICAN HE A R T A SSO CIATIO N

P

atients with claudication consulting a peripheral arterial disease provider are often active smokers, rarely receive evidence-based cessation interventions, and frequently relapse if they do quit, according to a report published online in the Journal of the American Heart Association.

More than one-third of patients with claudication consulting PAD specialists are active smokers, as seen in a data analysis of an international registry, wrote Krishna K. Patel, MD, of the department of cardiology, University of Missouri–Kansas City, and her colleagues.

The authors assessed 1,272 patients See Smoking · page 7

Vascular emergencies on the rise, but more patients surviving DR. TODD VOGEL

BY KARI OAKES MDEDGE NEWS REP OR T I N G F ROM MI D WES T ERN VAS C U L AR 2018

ST. LOUIS – A patient with a nontraumatic vascular emergency is significantly less likely to die today than a decade ago, with few exceptions, according to a new national analysis looking at 10 years of data. Unsurprisingly, endovascular surgery rates climbed over the study period, as did rates of acute limb ischemia, said Todd Vogel, MD, who discussed the study at the annual meet-

NEWS

Briefs

ing of the Midwestern Vascular Surgical Society.

With an objective of evaluating trends for management of nontraumatic vascular emergencies in the United States, Dr. Vogel, who is chief of vascular and endovascular surgery at the University of Missouri–Columbia, and his colleagues examined frequencies of vascular emergencies, mortality rates, and how open versus endoscopic procedure technique affected the data.

To do this, the investigators used the U.S. National Inpatient Sample from 2005 to 2014 to identify nontrauSee Surviving · page 7

SVS Announces New Marks of Distinction for Members The SVS Executive Board has announced that all SVS Active Members in good standing will now be considered Fellows of the Society of Vascular Surgery™ (FSVS™). The trademarked designation is a public acknowledgment that a surgeon has met the high standards SVS requires. (See p. 14.)

Column Continued on page 7

Courtesy D r. toDD V ogel

VOL. 14 • NO. 11 • NOVEMBER 2018

Vascular specialist 10255 W Higgins Road, Suite 280 Rosemont, IL 60018

CHANGE SERVICE REQUESTED

Presorted Standard U.S. Postage PAID Permit No. 384 Lebanon Jct. KY

FROM THE EDITOR

Death of a sales pitch The EHR and our troubled health care system, Part 1

BY MALACHI G. SHEAHAN III, MD MEDICAL EDITOR, VASCULAR SPECIALIST

I

n 2000, the Institute of Medicine published “To Err Is Human,” a landmark study that warned that as many as 98,000 people die annually as a result of medical errors. One conclusion of the report stated, “When patients see multiple providers in different settings, none of whom has access to complete information, it becomes easier for things to go wrong.” Government and public reaction to the study resulted in the rushed integration of electronic health records into the U.S. medical system. EHR vendors promised solutions that included a dramatic reduction of preventable errors, a simplified system of physician communication, and the consolidation of a patient’s salient medical information into a single, transferable file. Now, almost 20 years later, these promises remain mostly unfilled. How did we get here?

Systems of medical records have been in place since 1600 B.C. For thousands of years, they consisted mainly of the patient’s diagnosis and the physician’s treatment. In 1968, the New England Journal of Medicine published the special article “Medical Records That Guide and Teach” by Lawrence L. Weed, MD. In the report, Dr. Weed advocated for the organization of medical records by problems rather than by a single diagnosis.

This was the birth of our modern system. Medical records would now include lists of symptoms, findings, and problems that would organize the physician’s planning and allow third parties to con-

VASCULAR SPECIALIST Medical Editor Malachi Sheahan III, MD Associate Medical Editors Mark A. Adelman MD, 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, Frank Pomposelli, MD, David Rigberg, MD, Clifford Sales, MD, Bhagwan Satiani, MD., Larry Scher, MD, Marc Schermerhorn, 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. Interim Director of Membership, Marketing and Communications Angela Taylor 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.

6 • VASCULAR SPECIALIST

Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.

firm the initial diagnosis. Nearly concurrent with this publication, the next major innovation was developing in a very unusual location.

In 1999, Fortune magazine labeled Jack Welch “Manager of the Century” for his innovative work as CEO of General Electric. His techniques involved cutting waste and streamlining his workforce. While these methods were somewhat controversial, GE’s market value increased dramatically under his watch. The publishers at Fortune became interested in finding similar innovators in other fields. In this pursuit, they sent journalist Philip Longman to find the “Jack Welch” of health care.

Mr. Longman had recently lost his wife to breast cancer and was becoming obsessed with medical errors and health care quality integration. He set out to discover the best health care system in the United States. After months of research, Mr. Longman reached a startling conclusion. By nearly every metric, the Veterans Affairs system produced the highest quality of care. The key factor in upholding that quality appeared to be the EHR system VistA (Veterans Information Systems and Technology Architecture).

POSTMASTER Send changes of address (with old mailing label) to Vascular Specialist, Subscription Services, 10255 W Higgins Road, Suite 280, Rosemont, IL 60018-9914.

RECIPIENT: To change your address, contact Subscription Services at 1-800-430-5450. For paid subscriptions, single issue purchases, and missing issue claims, call Customer Service at 1-833-836-2705 or e-mail custsvc.vasc@fulcoinc.com.

The Society for Vascular Surgery headquarters is located at 633 N. St. Clair St., 22th Floor, Chicago, IL 60611.

Vascular Specialist (ISSN 1558-0148) is published monthly for the Society for Vascular Surgery by Frontline Medical Communications Inc., 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609.

Phone 973-206-3434, fax 973-206-9378 Subscription price is $230.00 per year.

National Account Manager Valerie Bednarz, 973-206-8954, cell 973-907-0230, vbednarz@mdedge.com Digital Account Manager Rey Valdivia 973-206-8094 rvaldivia@mdedge.com Classified Sales Representative Drew Endy 215-657-2319 cell 267-481-0133 dendy@mdedge.com Senior Director of Classified Sales Tim LePella, 484-921-5001, cell 610-506-3474, tlapella@mdedge.com Advertising Offices 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609 973-206-3434, fax 973-206-9378 Letters to the Editor: VascularSpecialist@vascularsociety.org Editorial Offices: 2275 Research Blvd, Suite 400, Rockville, MD 20850, 240-221-2400, fax 240-221-2548 ©Copyright 2018, by the Society for Vascular Surgery Scan this QR Code to visit vascularspecialistonline.com

The development of VistA was a grassroots effort begun in the 1970s. Using Tandy computers and Wang processors, the VA “hardhats” sought to develop an electronic system for medical records and communication. This effort was initially opposed and driven underground by the central bureaucracy. Laptops were confiscated, people were fired. Still, development continued, and in 1978, the Decentralized Hospital Computer Program was launched at 20 VA sites. The national rollout occurred in 1994 under the name VistA. VistA was developed by doctors, for doctors, and it routinely enjoys the highest satisfaction rates among all available EHRs. VistA also is an opensource model; its code is readily available on the VA website. After seeing the evidence of VistA’s efficacy, Representative Pete Stark (D-CA) introduced HR 6898 on Sept. 15, 2008. The bill would establish a large federal open-source health IT system that private hospitals could leverage. The bill also mandated that only open-source solutions would receive federal funding. As opposed to proprietary systems, open-source models allow for rapid innovation, easy personal configuration, and incorporation of open-source apps from unlimited numbers of contributors.

HR 6898 never passed, despite initial bipartisan support. By relying on lobbyists, marketing, and money, the proprietary EHR vendors killed the Stark bill.

After a 4-month scramble, the Health Information Technology for Economic and Clinical Health Act (HITECH) passed, with EHR vendor support. HITECH established a certification system for EHRs. While the Stark bill envisioned a single, opensource network, there were soon hundreds of certified EHR systems in the United States.

Death continued on page 17

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

FRONTLINE MEDICAL COMMUNICATIONS Corporate President/CEO Alan J. Imhoff CFO Douglas E. Grose SVP, Finance Steven J. Resnick VP, Operations Jim Chicca VP, Sales Mike Guire VP, Society Partners Mark Branca VP, Editor in Chief Mary Jo M. Dales VP, Editorial Director, Clinical Content Karen Clemments Chief Digital Officer Lee Schweizer VP, Digital Content & Strategy Amy Pfeiffer President, Custom Solutions JoAnn Wahl VP, Custom Solutions Wendy Raupers VP, Marketing & Customer Advocacy Jim McDonough

VP, Human Resources & Facility Operations Carolyn Caccavelli Data Management Director Mike Fritz Circulation Director Jared Sonners Corporate Director, Research & Comms.

Lori Raskin Director, Custom Programs Patrick Finnegan AllMedx President Douglas E. Grose Executive Vice President, Sales John Maillard Editorial Director/COO Carol Nathan In affiliation with Global Academy for Medical Education, LLC President David J. Small, MBA

NOVEMBER 2018

Emergencies rising Surviving from page 1

matic vascular emergencies.

Using ICD-9 clinical management diagnosis and procedure codes allowed the investigators to capture a wide array of vascular emergencies, Dr. Vogel said. These included ruptured abdominal, thoracic, and thoracoabdominal aortic aneurysms (rAAAs, rTAAs, and rTAAAs, respectively), as well as acute limb ischemia, acute mesenteric ischemia, and ruptured visceral artery aneurysms.

Among the outcomes analyzed in the study was a trend analysis looking at how outcomes changed over time and an analysis of in-hospital mortality. Dr. Vogel and his colleagues also examined hospital resource utilization including length of stay and total hospital cost, with inflation adjusted to 2014 costs.

The prevalence of endovascular intervention increased sharply over the study period, as one would expect, Dr. Vogel said. “At the beginning, we had about 24% of patients getting endovascular intervention for vascular emergencies, and currently, it’s 36%.”

(P for trend, less than .0001).

Mortality dropped steeply overall, with overall mortality going from 13.80% to 9.14% during the study period (P less than .0001). Much of this decrease could be attributed to mortality for open procedures decreasing by over a third, from 16.5% to 10.7%, over the study period (P less than .0001). Endovascular procedure– related mortality decreased from 8.3% to 7.9% (P = .03).

Ruptured abdominal and thoracic aortic aneurysms were much less likely to be fatal in 2014 than in 2005. The overall mortality rate for rAAA went from 41.4% to 27.6% (P

less than .0001) and rates for rTAAs dropped overall from 41.2% to 23.0% (P = .002).

However, endovascular rTAA repair mortality jumped from 14.9% to 27.4% (P = .0003) while mortality for open procedures plummeted from 51.3% to 16.7% (P less than .0001).

In-hospital mortality for some conditions didn’t change much over time: rTAAA mortality, for example, increased, but by a nonsignificant amount (44.7% vs. 47.6%; P = .06).

“Mortality rates for rTAAA have remained static, despite the advances in treatment,” Dr. Vogel said.

Discussing these “concerning” results, Dr. Vogel noted that the increase in mortality “suggests an increased use of endovascular repair on higher-risk patients.” The mortality rate for ruptured visceral artery aneurysms did not change significantly either (16.7% vs. 6.7%; P = .09).

Overall, patients were 44% female and 66% white. “Over half of the patients were aged 70 or greater,” he said.

Acute limb ischemia was by far the most common vascular emergency, accounting for 82.4% of the total.

Next most common were rAAAs, which made up just 10.79% of the vascular emergencies studied.

Looking at hospitalization trends over time, acute limb ischemia showed a slight trend up over the study period, from an occurrence rate of about 8.2 per 100,000 individuals at the beginning to about 9.0 per 100,000 by 2014.

Acute mesenteric ischemia also trended up, from an occurrence rate of about 4 per 1 million individuals in 2005 to about 6 per 1 million in

2014; rAAAs trended down, from about 13 per 1 million to a little over 9 per 1 million over the study period.

Among the other vascular emergencies incurring hospitalization, rTAAAs and ruptured visceral artery aneurysms were both rare, occurring in fewer than 7 per 10 million individuals, but both showed a slight upward trend over the study period.

Slightly more common were rTAAs, which occurred at a rate of about 12 per 10 million individuals at the beginning of the study period and at slightly less than 15 per 10 million by the end.

Looking at hospital resource utilization, length of stay dropped significantly (P less than .004), but costs, unsurprisingly, increased over the study period, from about $25,000 to about $30,000 per occurrence (P less than .0001).

“The overall frequency of vascular emergencies has significantly increased over time,” Dr. Vogel said, “but in subgroup analysis ruptured abdominal [aortic] aneurysms are decreasing.” As endovascular procedures have increased, “The overall mortality has decreased, so we actually are doing better.” Some of this drop “may be due to improved perioperative care” as well as the increase in endovascular utilization, he noted.

In sum, though mortality has generally improved as endovascular procedures have become more common in vascular emergencies, “increased implementation of endovascular repair may not always improve outcomes,” Dr. Vogel said, especially in the context of an increasingly complex and aging patient population.

Dr. Vogel reported no conflicts of interest and no outside sources of funding.

Smoking from page 1

NOVEMBER 2018

Briefs November Is Diabetes Awareness Month

A new flier on diabetes and vascular disease is now available in English and Spanish as an instant download. This is the second new flier produced by the SVS Foundation as part of its awareness and prevention mission. Please download and share this important information. (See p. 13).

VEITHsymposium

The 2018 VEITHsymposium was held Nov. 13-17 in New York. The symposium featured the latest pharmacologic, radiologic, surgical, and endovascular techniques and technologies, updates on clinical trials, and discussions of when treatments modalities are justified and indicated and when they are not. Follow our coverage at mdedge/vascularspecialistonline.com and in upcoming issues of Vascular Specialist.

Upcoming Meetings

(Check https://vascular.org/ meetings for details) World Federation Vascular Societies Congress 2018 XXXII Latin-American Congress of Vascular Surgery The Congress is being held in Montevideo, Uruguay Dec. 5-8, 2018.

International Vein Congress The Congress is being held at, Miami Beach, Fla., on April 2527, 2019.

koakes@mdedge.com

Peripheral arterial disease with PAD and new or worsening claudication who were enrolled at 16 vascular specialty clinics from 2011 to 2015 in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry (clinicaltrials.gov: NCT01419080).

In-person interviews obtained smoking status from patients and information on cessation interventions at baseline and at 3, 6, and 12 months. At baseline, 474 (37%) patients were active, 660 (52%) were former, and 138 (11%) were never smokers.

Among active smokers, only 16% were referred to cessation counseling, and only 11% were prescribed pharmacologic treatment.

At 3 months, the probability of quitting smoking was 21%. Those who kept smoking had a probabil-

NEWS

ity of quitting during the next 9 months that varied between 11% and 12% (P less than .001). The probability of relapse was high, with more than one-third of initial quitters (36%) resuming smoking, and at 12 months, 72% of all original smokers continued to smoke, according to the authors.

The high level of initial smoking and the failed efforts at attempting cessation are clinically important because cigarette smoking is the most important and modifiable risk factor for PAD, and patients with PAD who smoke have higher rates of disease progression, according to Dr. Patel and her colleagues.

“Few patients receive formal cessation interventions. The dynamic nature of these patients’ smoking practices also underscores the need for ongoing

assessment of smoking, even among those who report that they have quit, and consistent offering of evidence-based cessation support. Future research should focus on identifying optimal strategies for implementing consistent cessation support,” the researchers concluded.

The study was funded by grants from the Netherlands Organization for Scientific Research and an unrestricted grant from W. L. Gore. One of the authors owns the copyright for a Peripheral Artery Questionnaire used in the study and serves as a consultant to United Healthcare, Bayer, and Novartis, with research grants from Abbot Vascular and Novartis. Another author is supported by an unrestricted research grant by Merck and Boston Scientific. The remaining authors reported having no disclosures. mlesney@mdedge.com

SOURCE: Patel KK et al. J Am Heart Assoc.

2018;7:e010076. doi: 10.1161/JAHA.118.010076.

MDEDGE.COM/VASCULARSPECIALISTONLINE • 7

PAD AND CLAUDICATION

Rivaroxaban gains indication for CAD/PAD

BY CATHERINE HACKETT MDEDGE NEWS

T

he direct oral anticoagulant rivaroxaban is now approved for prevention of major cardiovascular events in patients with chronic coronary or peripheral artery disease when taken with aspirin, Janssen Pharmaceuticals announced on October 11.

The Food and Drug Administration’s approval was based on a review of the 27,000-patient COMPASS trial, which showed last year that a low dosage of rivaroxaban (Xarelto) plus aspirin reduced the combined rate of cardiovascular disease events by 24% in patients with coronary artery disease and by 28% in participants with peripheral artery disease, compared with aspirin alone. (N Engl J Med. 2017 Oct 5;377[14]:1319-30) The flip side to the reduction in COMPASS’s combined primary endpoint was a 51% increase in major bleeding. However, that bump did not translate to increases in fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.

COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) studied two dosages of rivaroxaban, 2.5 mg and 5 mg twice daily, and it was the lower

dosage that did the trick. Until this approval, that formulation wasn’t available; Janssen announced the coming of the 2.5-mg pill in its release.

The new prescribing information states specifically that Xarelto 2.5 mg is indicated, in combination with aspirin, to reduce the risk of major cardiovascular events, cardiovascular death, MI, and stroke in patients with chronic coronary artery disease or peripheral artery disease.

This is the sixth indication for rivaroxaban, a factor Xa inhibitor that was first approved in 2011. It is also the first indication for cardiovascular prevention for any factor Xa inhibitor.

Others on the U.S. market are apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa).

COMPASS was presented at the 2017 annual congress of the European Society of Cardiology. At that time, Eugene Braunwald, MD, of Harvard Medical School and Brigham and Women’s Hospital in Boston, commented that the trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease.” He added that the results are “an important step for thrombocardiology.”

P ER S PEC T I VE by Linda Harris, MD

First major change for added PAD medication in over 2 decades

T

his landmark it would be beneficial study was termiin this population. nated early due to a The higher rate of significant difference bleeding, 3.1% vs in outcomes. Prior to 1.9%, was primarily this point, aspirin and GI, however, caution statins have been the should be used if mainstay of decreaspatients are felt to ing long-term adverse be at increased risk outcomes. The COM- Dr. Linda Harris is chief, of bleeding. These PASS study has found findings suggest a division of vascular sura decrease in commajor change in the gery, State University bined cardiovascular guidelines and manof New York at Buffalo adverse events when agement for the maand an associate medical editor for Vascular Rivaroxaban 2.5 mg jority of our patients Specialist. was combined with with PAD. Certainly low-dose aspirin in we should look to patients with stable add this data point to PAD or CAD over aspirin alone. the VQI to gather further data and This is the first major change sup- confirm the findings in real world porting use of additional medicause. It is unclear whether this tions for PAD in over 2 decades, benefit will be unique to rivaroxwhen statins were found to impact aban, or whether other Direct Xa outcomes. The differences were inhibitors will have similar effects. not impacted by gender, age or I will certainly be adding ribarrace. Patients with ESRD were oxaban to patients at low risk for excluded, so it is unclear whether bleeding based on this data.

chackett@mdedge.com

PAD AND CLAUDICATION

Six PAD diagnostic tests vary widely in patients with diabetes

BY MARK S. LESNEY MDEDGE NEWS FROM PRIM A RY CA R E D IA B E TE S

S

ix different clinical tests used to identify peripheral arterial disease (PAD) were found to be significantly different in their ability to detect PAD in a population of 50 patients with diabetes, according to a report published online in Primary Care Diabetes.

This study assessed the same group of participants with each of the following six tests: Doppler Waveform, toe-brachial pressure index (TBPI), ankle-brachial pressure index (ABPI), posterior tibial artery pulse (ATP), transcutaneous oxygen pressure (TCPO), and pulse palpation. The right and left foot were assessed in each participant, yeilding100 limbs for analysis, according to Yvonne Midolo Azzopardi, MD, of the University of Malta in Msida and her colleagues.

The highest percent of participants who were

8 • VASCULAR SPECIALIST

found to have PAD was 93%, as detected by Doppler Waveform, followed by TBPI (72%), ABPI (57%), ATP (35%), TCPO (30%), and pulse palpation (23%). The difference between these percentages was significant at P less than .0005.

“Use of only one screening tool in isolation could yield high false results, since it is clear that these tests do not concur with each other to a large extent.”

“The reported observations suggest that use of only one screening tool in isolation could yield high false results, since it is clear that these tests do not concur with each other to a large extent,” the authors stated.

Dr. Azzopardi and her colleagues pointed out that the use of more specialized tools, such as du-

plex scanning, could be compared with these six modalities to detect PAD but that such methods were unlikely to be routinely available to primary care physicians who are at the front lines of making the determination of PAD in patients with diabetes.

“The authors advocate for urgent, more robust studies utilizing a gold standard modality for the diagnosis of PAD in order to provide evidence regarding which noninvasive screening modalities would yield the most valid results. This would significantly reduce the proportion of patients with diabetes who would be falsely identified as having no PAD and subsequently denied beneficial and effective secondary risk factor control,” Dr. Azzopardi and her colleagues concluded.

The authors reported that they had no conflicts of interest. mlesney@mdedge.com

SOURCE: Azzopardi YM et al. 2018. Prim Care Diabetes. doi: 10.1016/j.pcd.2018.08.005.

NOVEMBER 2018

PAD AND CLAUDICATION

Obesity tied to improved inpatient survival of patients with PAD

BY MARK S. LESNEY MDEDGE NEWS FROM CLINICA L N UTR ITIO N

T

he obesity paradox appears alive and well in the treatment of peripheral arterial disease (PAD), according to the results of a 10-year, 5.6-million patient database study.

The study found that coding for obesity is associated with lower in-hospital mortality in PAD patients relative to normal weight or overweight. This obesity survival paradox was independent of age, sex, and comorbidities and was seen in all obesity classes, wrote Karsten Keller, MD, University Medical Center Mainz (Germany), and his colleagues.

In total, 5,611,827 inpatients aged 18 years or older with PAD were treated between 2005 and 2015 in Germany, 5,611,484 of whom (64.8% men) were eligible for analysis. Among these, 500,027 (8.9%) were coded with obesity and 16,620 (0.3%) were coded as underweight; 5,094,837 (90.8%) were in neither classification (considered healthy/overweight) and served as the reference group for comparison, according to Dr. Keller and his colleagues.

Obese PAD patients were younger, more frequently women, and had less cancer but were diagnosed more often with cardiovascular disease

risk factors such as diabetes and hypertension, compared with the reference group. In addition, there were higher levels of coronary artery disease, heart failure, renal insufficiency, and chronic obstructive pulmonary disease (COPD) in obese patients.

Obese patients had lower mortality (3.2% vs.

5.1%; P less than .001), compared with the reference group, and showed a reduced risk of in-hospital mortality (odds ratio, 0.617; P less than .001).

Univariate logistic regression analyses showed the association of obesity and reduced in-hospital mortality was consistent and significant, even with adjustment for age, sex, and comorbidities.

In contrast, underweight patients were significantly more likely to die than those in the reference group (6% vs. 5.1%; P less than .001), according to the researchers. Underweight was associated with an increased risk for in-hospital mortality (OR, 1.18; P less than .001), and this was consistent throughout univariate analysis.

Underweight PAD patients also had significantly higher frequencies of cancer and COPD but lower rates of diabetes mellitus, hypertension, coronary artery disease, and heart failure, compared with the reference group. Both obese and underweight PAD patients stayed longer in the hospital than the PAD patients who were not coded as underweight/obese.

Obese PAD patients had slight but significantly higher rates of MI (3.9% vs. 3.4%; P less than .001) and venous thromboembolic events and more often had to undergo amputation surgery (8.3% vs. 8.1%; P less than .001), including a higher relative number of minor amputations (6.3% vs. 5.5%; P less than .001).

However, major amputation rates were significantly lower in obese patients (2.6% vs. 3.2%; P less than .001), with univariate analysis showing a significant association between obesity and a lower risk of major amputation (OR, 0.82; P less than .001), which remained stable after multivariate adjustment.

Limitations of the study reported by the researchers included a lower than expected percent obesity in the 10-year database, compared with current rates, and the inability to follow tobacco use or the socioeconomic status of the patients.

“Obesity is associated with lower in-hospital mortality in PAD patients relative to those with normal weight/overweight. ... Therefore, greater concern should be directed to the thinner patients with PAD who are particularly at increased risk of mortality,” the researchers concluded.

The authors reported they had no disclosures. mlesney@mdedge.com

SOURCE: Keller K et al. Clin Nutr. 2018 Oct 3. doi: 10.1016/j.clnu.2018.09.031.

N OW AC C E P T I N G A B S T R AC T S

2019 Call for Abstracts Abstract & Video Submissions Accepted from: November 12, 2018–January 16, 2019 vsweb.org/2019abstracts

Redefining Vein Care April 25-27, 2019 Miami Beach, FL Course Directors: Jose I. Almeida, MD, FACS, RPVI, RVT Edward G. Mackay, MD, FACS, RPVI, RVT Lowell S. Kabnick, MD, RPhS, FACS FACPh

Now in its 17th year, IVC 2019 will offer a 3-day powerhouse program brimming with clinical updates, controversy, innovation, and consensus.

The 2019 meeting will include:

Scientific Sessions: June 13–15, 2019 Exhibits: June 13–14, 2019

Live Cases

Practice Management

Ask the Experts

Register Today! www.ivcmiami.com And Many More Activities Covering the Spectrum of Venous Disease!

Watch the entire 2018 meeting and more on VeinGlobal.com

Housing & Registration to Open in Early March 2019

NOVEMBER 2018

MDEDGE.COM/VASCULARSPECIALISTONLINE • 9

CAROTID DISEASE AND STROKE

Updated AHA recommendations favor adding nonstatin therapy for cholesterol control for some Recommendations

BY GREGORY PALKO, MD, AND NEIL SKOLNIK, MD

Importance

While statins remain the foundation for treating high cholesterol in order to reduce cardiovascular risk, new evidence has led to important revisions in the American Heart Association’s recommendations for treatment of hypercholesterolemia in patients at very high cardiovascular risk (secondary prevention) with the addition of specific nonstatin agents. We will briefly review the AHA 2013 guideline recommendations, the relevant new information, and the updated AHA recommendations.

American Heart Association 2013 guidelines

The 2013 American College of Cardiology/AHA cholesterol guidelines recommend either high- or moderate-intensity statin therapy for patients in the four statin benefit groups: 1. Adult patients older than 21 years of age with clinical atherosclerotic cardiovascular disease (ASCVD).

2. Adults older than 21 years of age with low-density lipoprotein cholesterol (LDL-C) above 190 mg/dL. 3. Adults aged 40-75 years without ASCVD but with diabetes and with LDL-C 70-189 mg/dL. 4. Adults aged 40-75 years without either ASCVD or diabetes, with LDL-C 70-189 mg/dL and an estimated 10-year risk for ASCVD of over 7.5% as determined by the Pooled Cohort Equations.

At the time of the 2013 guidelines, there was little evidence to recommend the use of medications other than statins.

Recent evidence

The IMPROVE-IT trial1 was a double-blind, randomized trial involving 18,144 men and women who were older than 50 years and hospitalized for an acute coronary syndrome within the preceding 10 days. They were randomized to either simvastatin plus ezetimibe or simvastatin plus placebo.

The primary endpoints were a composite of death from cardiovascular disease, a major coronary event (nonfatal MI, unstable angina requiring admission, or coronary revascularization), or nonfatal stroke. At 1 year, the mean LDL was 69.9 mg/ dL in the simvastatin-monotherapy group and 53.2 mg/dL in the simvastatin-ezetimibe group (P under .001), representing a 24% decrease in LDL between the two groups. The rate of the primary endpoints was significantly lower in the simvastatin plus ezetimibe group with a hazard ratio of 0.936 (P = .016). The risk of MI was significantly decreased with an HR of 0.87 (P = .002), and the risk of ischemic stroke significantly decreased, with an HR of 0.79 (P = .008). Prespecified safety endpoints showed no significant difference between the two groups.

The FOURIER trial2 examined the PCSK-9 inhibitor, evolocumab. FOURIER was a randomized, 10 • VASCULAR SPECIALIST

Dr. Palko (left) is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Hospital. Dr. Skolnik is a at Jefferson Medical College, Philadelphia, and at Abington Jefferson Health.

double-blind, placebo-controlled study involving 27,564 patients with atherosclerotic cardiovascular disease and LDL levels of 70 mg/dL or higher who were receiving statin therapy (at least atorvastatin 20 mg or equivalent with/without ezetimibe).

Patients were between 45 and 80 years old with a history of history of MI, nonhemorrhagic stroke, or symptomatic peripheral arterial disease. Patients were randomized to receive subcutaneous injections of evolocumab or matching placebo.

The primary endpoints were similar to that of IMPROVE-IT: a composite of cardiovascular death, myocardial infarction, stroke, unstable angina hospitalization, and coronary revascularization.

The median LDL on entry was 92 mg/dL for both groups.

At 48 weeks, the evolocumab group showed a 59% decrease in LDL, compared with placebo, with a decrease in median LDL from 92 mg/dL to 30 mg/dL. The primary endpoint occurred in 9.8% of the evolocumab group and 11.3% in the placebo group, for a hazard ratio of 0.85 (P less than .001), which represented a total risk reduction of 13.2%. The risk of MI or stroke and need for revascularization were significantly lower values in the evolocumab group, compared with placebo. Cardiovascular death did not show significant changes. There was no significant difference in rate of serious events.

The ODYSSEY trial3 reported on another PCSK9 inhibitor, alirocumab, in a randomized, double-blind, placebo-controlled trial involving 18,924 patients who had acute coronary syndrome in the prior 12 months. At the median follow-up (2.8 years), the LDL of the alirocumab group was 53.3 mg/dL, compared with 101.4 mg/dL in the placebo group. The primary endpoints for cardiovascular risks were similar to those in the FOURIER trial: a risk of 9.5% in the alirocumab group and 11.1% in the placebo group, for a total risk reduction of 14.4%. This suggests the class of PCSK-9 inhibitors have a strong correlation with reducing LDL levels 54%-59% and reducing major cardiac adverse events by 13%-15%.

The American College of Cardiology released a focused update that integrated the new evidence regarding the use of nonstatin therapy. The current focused update recommends an overall 50% or greater reduction in LDL for patients with clinical ASCVD. If this reduction is not achieved, ACC suggests that one consider the addition of nonstatin therapy with either ezetimibe or a PCSK-9 inhibitor.4 If a patient requires less than 25% additional LDL reduction, consider ezetimibe; if a patient requires more than 25% additional LDL reduction, consider a PCSK-9 inhibitor. Specifically, the guideline states: “If the patient still has less than 50% reduction in LDL-C (and may consider LDL-C above 70 mg/dL or non–HDL-C above 100 mg/dL), the patient and clinician should enter into a discussion focused on shared decision making regarding the addition of a nonstatin medication to the current regimen.”

The other group that is mentioned in the recommendations, with an acknowledgment that the evidence for benefit in primary prevention is not available, is individuals who have an LDL above 190 mg/dL even while compliant with a maximally effective statin regimen. The guidelines make further but less strong recommendations about a number of risk groups, but the largest and strongest change, based on strong evidence, is the recommendation to consider nonstatin therapy in individuals with established ASCVD, as described above.

Bottom line

Recent trials show significant reductions in LDL, leading to significant reductions in cardiovascular endpoints, with ezetimibe and PCSK-9 inhibitors. This has led to an additional ACC recommendation to consider the use of nonstatin therapy in addition to maximal statin therapy in selected patients with established cardiovascular disease.

References

1. Cannon C et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387-97.

2. Sabatine M et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-22.

3. ODYSSEY Outcomes: Results suggest use of PCSK9 inhibitor reduces CV events, LDL-C in ACS patients. Article from American College of Cardiology. ACC News Story. 2018 Mar 10.

4. Lloyd-Jones DM et al. 2017 Focused update of the 2016 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: A report of the American College of Cardiology task force on expert consensus decision pathways. J Am Coll Cardiol. 2017 Oct 3;70(14):1785-1822. Epub 2017 Sep 5.

NOVEMBER 2018

EXPERIENCE THE DIFFERENCE IN

BELOW THE KNEE PROCEDURES Choose the distinctive performance of our balloon dilatation catheters 0.014"

0.018"

Engineered to provide best-in-class PUSHABILITY* with a small profile for accessing target lesions1

Demonstrated excellence in CROSSABILITY with a low deflation time1

Complete support for complex BTK cases PINNACLE® DESTINATION®

NAVICROSS®

GLIDEWIRE ADVANTAGE®

GLIDEWIRE® GOLD

Guiding Sheath

Support Catheters

Peripheral Guidewires

Hydrophilic Coated Guidewire

*Tested against select leading competitors When RX tested against Boston Scientific Sterling™ Monorail™ and OTW tested against Bard Ultraverse® 0.018"

RX ONLY. Refer to the product labels and package inserts for complete warnings, precautions, potential complications, and instructions for use.

Reference: 1. Data on file. ©2018 Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of their respective owners. PM-00233

VAS_11.indd 1

9/27/2018 1:27:38 PM

NEWS FROM SVS

Veteran’s Vietnam Registry Contributions Still Resonate Half-Century Later (Note: Veterans Day is celebrated every November. The day, created to commemorate the end of World War I, now honors all those who have served in the United States armed forces, in times of peace and in times of war. In honor of our many SVS veterans, we highlight the story of Dr. Norman Rich. He served in Vietnam, retired from the Army as a colonel, headed up the Uniformed Services University of the Health Sciences for a quarter-century, was a professor of surgery for 42 years and also created and sustained the Vietnam Vascular Registry for more than 50 years.)

Dr. Rich (shown at left while serving in Vietnam) created the Vietnam Vascular Registry. Each person treated received a registry card (above).

C ourtesy Dr . NormaN riCh

D

r. Norman Rich decided his career path early in life, listening to the doctor who delivered him relay the horrors of the amputations of World War I. “ ‘Someday, blood vessels will be repaired,’ he told me,” said Dr. Rich of his early mentor, Dr. Otto Utzinger of Ray, Ariz. “And I thought, ‘I’d like to be involved with that.’ It set my career!”

He perhaps never dreamed as a young boy and man just how closely he would come to be associated with vascular injuries as well as treatments that would save a leg savaged by vascular trauma, avoiding the amputation that had so disturbed Dr. Utzinger.

Dr. Utzinger was just one of Dr. Rich’s mentors.

Others include some of the giants of vascular surgery: Drs. Michael DeBakey, Carl Hughes, Frank Spencer, Emile Holman and others. From them Dr. Rich was exposed to some of the groundbreaking treatments of vascular trauma drawn from necessity on the battlefields of World War II and Korea. These ranged from Mobile Army Surgical Hospital units close to battlefields, quick evacuation via helicopters and abandoning ligation in favor of arterial repairs, saving many legs from amputation.

Dr. Hughes had, while serving in Korea, cataloged on a large piece of cardboard the vascular cases he treated. Dr. Rich himself cataloged his own vascular trauma cases and later created the Vietnam Vascular Registry, a formal database of vascular injuries surgeons in Vietnam saw over the course of approximately eight years. Developing and maintaining the Vietnam Vascular Registry of injuries for more than 7,500 people, said Dr. Rich, is one of his proudest achievements.

Each person treated for arterial and, eventually, venous injuries received a registry card. Within the registry, individual records included the progres-

sion from injury through treatment through evacuation until point of discharge or entry into the VA system; many records even include notes from the original battlefield doctors.

“A Marine Corps general told me, in the middle of the mud, in the middle of the monsoons, ‘If you can make something good out of this horrible mess, go to it,’” said Dr. Rich. “He told me the Vietnam Vascular Registry was my chance.”

Dr. Rich’s goal was to: • Document the details of the injury as closely as possible • Obtain and add long-term follow-up to each entry “to see if what we did worked.”

Beyond arterial injuries, the VVR also cataloged venous injuries. “No one had had much interest in that,” Dr. Rich said. “But I kept saying, ‘Blood flows in a circle. It goes back to the heart through a vein.’ ” This addition led to some significant surgical treatments and saves. “I felt very good about that contribution,” he said.

He served at Walter Reed, including as head of the vascular surgery service at Walter Reed Army Medical Center, and then was tapped to found and chair the surgery department of the Uniformed Services University of the Health Sciences in Bethesda, Md., a kind of academy for military physicians. This long-term posting – unusual for military personnel who tend to move

Pivotal Long-Ago Moment To Be Retold on PBS

R

eporter Ann Curry highlighted Dr. Rich’s registry on the Nov. 13 PBS show “We’ll Meet Again.”

The show helps “people find someone whose actions changed the course of their lives,” according to its website, and features reunions of people whose lives crossed at pivotal moments.

The reunion shown that night is just one of at least six or seven the registry has facilitated, said Dr. Rich.

The show airs at 8 p.m. Eastern and 7 p.m. Central time. Be sure to check local listings and the PBS website for repeat showings.

12 • VASCULAR SPECIALIST

around a great deal – enabled him to maintain the VVR. The registry has had a lasting impact. During the first Gulf War, Dr. Rich was told, “You know, that database might be of value. Weapons haven’t changed that much, and treatments haven’t either.”

Interest in his registry increased.

Dr. Rich teamed with Dr. Frank Spencer, whose work in Korea revolutionized treatment of vascular injuries, to write “Rich’s Vascular Trauma,” which included VVR statistics collected up to that point. Two editions have followed, with additional statistics; the second with Ken Mattox and Asher Hirshberg of Houston and the third, by Todd E. Rasmussen, MD, FACS, and Nigel R. M. Tai, QHS, MS FRCS (GEN), includes civilian and international statistics as well. “It makes me very glad that there has been some legacy to the registry,” said Dr. Rich.

He downplayed his own overall role, saying, “I was merely a scribe for 600,000 young American physicians who served during an eight-year period in Vietnam.”

Beyond technical information on injuries, treatments and results, Dr. Rich’s registry has accomplished important human connections as well.

The records have led to more than half-a-dozen soldier reunions. For example, not long ago a U.S. Department of Defense article related the wish of a former Army Specialist to thank the surgeons who had treated him in Vietnam in 1969. John Fogle had kept his VVR registry card through the decades, and with it, Dr. Rich was able to access Fogle’s medical records, including the names of his doctors. Fogle and one of his surgeons met up in May. Dr. Rich is now retired from the Army and from his career. His registry remains a passion. “My remaining job, is to pass my knowledge on to someone else who would be interested.” ■ NOVEMBER 2018

NEWS FROM SVS

Download Diabetes Patient Information Flier

T

he SVS Foundation is releasing its second new patient information flier – on diabetes and vascular disease – just in time for National Diabetes Month in November.

The fliers are great for sharing with your patients and other physicians or for anytime you provide information to the public. The SVS Foundation is producing a total of nine new fliers in English and Spanish on common topics for vascular patients. A flier on PAD was released in September.

PURCHASE TODAY!

Each flier is available in several formats – low-resolution digital for email and web use, and high-resolution for professional printing of larger quantities. The new fliers come in two versions, one with a personalization area for your name and contact information and the other with a link to the SVS “Find a Surgeon” web page.

Visit vsweb.org/FoundationFliers to access all versions of the fliers, including both high- and low-resolution versions. ■

NEW WITH THIS EDITION: u A companion app for off-line use (Apple only) u Syncing between the app and desktop version u Expanded bookmarking and annotation u Easier navigation u Simplified tracking of CME/MOC certificates

Who can benefit from using VESAP4?

Courtesy sVs

u Surgeons who need to meet CME/MOC requirements

FROM JVS:

Obesity Complicates OAR Recovery

O

bese patients undergoing elective open aortic repair face an increased risk of renal failure and wound infections, according to a study published in the December issue of the Journal of Vascular Surgery. However, no similar findings of major adverse outcomes were found in obese patients undergoing endovascular aneurysm repair.

Read more at vsweb.org/JVS-Obese. ■ NOVEMBER 2018

u Surgeons preparing for qualifying, certification and recertification vascular surgery exams u Residents and fellows preparing for ABSITE and VSITE exams u Vascular health professionals who want to stay current with the specialty Both Individual Module and Comprehensive Package Pricing Available

Contact education@vascularsociety.org or 800-258-7188 for more information or visit vsweb.org/VESAP4.

MDEDGE.COM/VASCULARSPECIALISTONLINE • 13

NEWS FROM SVS

YOUR SVS:

SVS Announces New Marks of Distinction for Members Are you an active member or Distinguished Fellow?

Let everyone know

The SVS Executive Board has announced that all SVS Active Members in good standing will now be considered Fellows of the Society of Vascular Surgery™ (FSVS™). The trademarked designation is one of the benefits of SVS membership and is a public acknowledgement that a surgeon has met the high standards SVS requires of its members and has shown a professional commitment to the field of vascular surgery.

Active members in good standing may add the initials FSVS™ after their name in any usage, such as signature lines, letterhead and door

signage. For example: • Dr. Mary Smith, MD, FSVS • Dr. John Jones, DO, PhD, FSVS, FACS This applies to vascular surgeons in the United States or Canada who have been approved for membership by the Society and are up-to-date on their dues. Such members can begin using the designation immediately.

If your dues have lapsed or you aren’t yet an Active Member, please contact membership@vascularsociety.org to reinstate your Active membership or to apply before using the designation. The final membership application deadline for 2018 is Dec. 1 (with the first 2019 deadline set for March 1, 2019). Get application infor-

mation at vsweb.org/JoinSVS. Distinguished Fellow of the Society of Vascular Surgery™ (DFSVS™)

SVS has long recognized Distinguished Fellows™, members who have distinguished themselves in a sustained manner by making substantial contributions in two of three categories: research, service or education. In addition to referring to themselves as Distinguished Fellows, these honorees can now use the distinctive mark, “DFSVS™.”

Current Senior, Active and International SVS members are eligible to apply for Distinguished Fellow status.

(The annual deadline is typically

March 1, with Distinguished Fellows recognized at the Vascular Annual Meeting.) The process is rigorous; upon approval, Distinguished Fellows may list the initials after their name in any usage, such as signature lines, letterhead, door signage, etc. For example: • Dr. Mary Smith, MD, DFSVS • Dr. John Jones, DO, PhD, DFSVS, FACS Members must be up-to-date on their dues to use the designations. If your dues have lapsed or you aren’t yet a Distinguished Fellow, please contact membership@vascularsociety.org to reinstate your Active membership or apply for Distinguished Fellow status before using the designation. ■

A Summary of Advanced Business Degrees for Vascular Surgeons, from the SVS Community Practice Committee Master of Business Administration (MBA)

BY SCOTT S. BERMAN, MD, MHA, FACS SVS COMMUNITY PRACTICE COMMITTEE

The MBA curriculum generally consists of a foundation of core classes divided along the traditional business verticals of strategy, operations, finance, marketing, leadership and human resource management. Elective courses delve into industry or country/region-specific topics such as health care operations, provider strategy and medical device commercialization. The electives develop both analytical and soft skills, such as model and simulation building and negotiation, respectively. An MBS’s cost ranges from approximately $10,000 for an exclusively online program to more than $150,000 for the executive program at the University of Pennsylvania’s Wharton School of Business. The usual course of study is 12 to 16 months with complete online or combined online and limited in-residence options.

T

he dynamic environment in which vascular surgeons are currently practicing has created abundant opportunities for physicians to move into administrative leadership positions across the spectrum of healthcare. An advanced business degree teaches a surgeon the “language” of health care business. Moreover, the degree can provide the surgeon an important level of credibility in dealing with non-physician business contemporaries working in the healthcare space.

This article summarizes features of the common advanced business degrees sought by practicing surgeons through online or executive programs.

jgroup /t hiNkstoCk

Master of Health Care Administration (MHA)

14 • VASCULAR SPECIALIST

Accredited MHA programs of study typically require students to complete applied experiences as well as course work in areas such as population health, healthcare economics, health policy, organizational behavior, management of healthcare organizations, healthcare marketing and communications, human resource management, information systems management and assessment, operations assessment and improvement, governance, leadership, statistical analysis and application, financial analysis and management, and strategy formulation and implementation. Costs range from $10,000 to more than $50,000 and, like MBA programs, the degree can be earned completely online or through an executive program that requires some time in residence at the parent institution.

Degree completion typically takes 16 to 28 months.

Master of Medical Management (MMM)

The MMM is targeted towards physicians with leadership potential who are already in administrative positions or plan on taking on an administrative role. MMM programs consist of courses (e.g. health policy, organizational management, health economics, operations management, health finance, quality management, health care law) that are very similar to those offered in other health/business administration masters programs such as the MHA or MBA. MMM programs are currently offered at two universities: the University of Southern California and Carnegie Mellon University. Both consist of a combination of traditional and online courses.

A degree at USC will cost $61,000 and take 12 to 18 months; tuition for Carnegie Mellon was not available online. ■ References

Turner, A. D., Stawicki, S. P., & Guo, W. A. (2018).

Competitive Advantage of MBA for Physician Executives: A Systematic Literature Review. World journal of surgery, 42(6), 1655-1665.

Zheng, F., Mouawad, N. J., Glass, N. E., & Hamed, O. (2012). Advanced degrees for surgeons and their impact on leadership. Bull Am Coll Surg, 97(8), 1923.

MBA vs MHA vs MPH: What’s the Difference? Retrieved Oct. 6, 2018, from vsweb.org/ CompareDegrees.

Morris, S. (May 10, 2016). Become a Health Care Leader with a Master of Medical Management.

Retrieved Oct. 6, 2018, at vsweb.org/ MMMDegree.

NOVEMBER 2018

NEWS FROM SVS

T

he turkey has been reduced to sandwiches and a wishbone and the mashed potatoes are just a memory. And between the frenzy of Black Friday and Cyber Monday shopping promotions, you’ve put a dent in your holiday shopping.

#GivingTuesday – and a contribution to the SVS Foundation – give you the chance to do something for others. #GivingTuesday is a global day of giving to kick off the charitable season, when many people focus on holiday and year-end giving. It is celebrated annually on the Tuesday following Thanksgiving, coming closely on the heels of Black Friday and Cyber Monday.

The SVS Foundation makes it easy to give, online or by check. Donations can include cash, stocks and an IRA rollover, plus through such sources as a will, life insurance, revocable trusts, a charitable gift and annuities.

Donors may direct their dollars to specific areas of interest. For some, that is research that can unlock cures and treatments for circulatory disease.

Others may prefer funding community

health initiatives or disaster relief, or the unrestricted Greatest Need fund, known as the Annual Fund.

Why give? Simply put, “because:” – Because research today can lead to breakthroughs tomorrow.

– Because the SVS Foundation provides resources to improve community health and raise awareness.

– Because patients need information on important aspects of vascular health.

– Because a vascular surgeon’s care today means a patient might live to see many more beautiful tomorrows: a grandchild’s wedding, a baby’s first steps, more family holidays.

– Because all of life’s moments matter.

Read more about the SVS Foundation’s efforts, plus more “Because” answers, in the SVS Foundation Annual Report, at vsweb.org/SVSF_Annual_Report_2018.

On Thanksgiving, enjoy family, football, turkey and the trimmings. Take advantage of weekend and Cyber Monday sales to start your holiday shopping.

And on #GivingTuesday, think of the patients you treat and who have more life to live BECAUSE of you and the work you do; then donate to the SVS Foundation at vsweb.org/GIVE. ■

YOUR SVS Dues Statements Distributed

Membership dues reminders were distributed earlier this month to all members who have not yet paid their 2019 dues. To continue to receive all the valuable benefits of SVS membership, all outstanding dues should be remitted by Dec. 31. To view the numerous benefits, visit vsweb.org/ MemberBenefits. To pay dues, visit vascular.org/invoices or call the SVS Membership Department, 312-334-2313.

Foundation Donations

Don’t forget that while paying dues, members can also make a donation to the SVS Foundation, which touches every single SVS member through its disease prevention efforts, community health projects and research grants for every stage NOVEMBER 2018

SVS Creating Private Online Community

T

he Society for Vascular Surgery is creating a private online community, SVSConnect, with a number of resources for SVS members and their peers. This new collaborative online community will let members connect and engage with, and learn from, fellow members and peers on an infinite number of topics. It is expected to launch by late 2018.

achieve professional and personal goals.

Resource Sharing: See attachments posted to discussions, archived in a dedicated Resource

aelitta /g etty i mages

Please Give on #GivingTuesday, and During the Holiday Season

Members will enjoy:

Member Directory Search: Locate colleagues by name, location, practice or area of interest User-Friendly Forums: Connect and communicate with fellow members on topics large and small via computer, phone or table.

Mentor Match: Share resources and experiences as a mentor or mentee, and work together to

Library. Members can add documents to share at any time.

SVS will tell members more about this exciting addition via Pulse, the SVS website, email and Vascular Specialist. Be on the lookout for more information about this new community! ■

EDUCATION of a surgeon-scientist’s career.

While in their SVS “shopping cart,” members simply need to add the donation at “Please consider making a gift to the following funds.” The donation will be added into a combined invoice.

Read the 2018 SVS Foundation Annual Report, “Because …,” which highlights 2018 accomplishments, at vsweb.org/ SVSF_Annual_Report_2018.

Submit Abstracts for VRIC, VAM

G

et ready to submit research for two SVS annual meetings in 2019, the Vascular Research Initiatives Conference and the Vascular Annual Meeting.

Dec. 1: Final membership application deadline for 2019.

See vsweb.org/JoinSVS; email questions to membership@vascularsociety.org.

VRIC: The submission site for VRIC opened Oct. 30 and will close Jan. 15, 2019. The conference focuses on emerging vascular science and will be held May 13, 2019, in Boston. The theme is “Hard Science: Calcification and Vascular Solutions.” VRIC is held in conjunction with the American Heart Association’s Vascular Discovery Scientific Sessions, May 14 to 16, 2019.

Visit vsweb.org/VRIC19 for more information.

Dec. 31: Deadline for claiming credits for the 2018 Vascular Annual Meeting. Visit vsweb. org/ClaimCME. ■

VAM: The VAM abstract submission site opens Monday, Nov. 12 and will close Jan. 16, 2019. Abstract guidelines are now available.

2 Other Deadlines Approach

Submission categories include: aortic disease; cerebrovascular (including Great Vessels); complications; dialysis access; educational/training credentialing; peripheral arterial disease; practice management; renal/visceral disease; vascular laboratory and imaging; vascular medicine; vascular trauma: aortic, arterial, venous; venous disease; and basic research (poster competition only).

See the guidelines at vsweb.org/ Guidelines19. Learn more about VAM at vsweb.org/VAM19.

The meeting will be held June 12-15, 2019, at the Gaylord National Resort & Convention Center in National Harbor, Md., outside Washington, D.C. Scientific sessions will be held June 13 through 15 and exhibits will be open June 13 and 14.

Housing and registration will open in early March. ■

MDEDGE.COM/VASCULARSPECIALISTONLINE • 15

Check out the latest news online at www.mdedge.com/vascularspecialistonline Follow us on Twitter @VascularTweets

VAS_16.indd 1

10/30/2018 4:47:20 PM

RENAL ARTERIES

Ultrasound denervation tops RF ablation for resistant hypertension avoid futile” procedures, and define “specific anatomic predictors associated with a more effective” renal denervation, Dr. Lurz and his team said in their study report.

SAN DIEGO – Denervation of the main renal The researchers noted that “the present study arteries with ultrasound is more effective than included patients with larger renal arteries” – at radiofrequency (RF) ablation at lowleast one renal artery 5.5 mm or ering blood pressure in patients with greater in diameter – “based on resistant hypertension, according the assumption that sympathetic to a single-center, randomized trial fibers are in greater distance from from Germany. the lumen than in smaller arteries, Dubbed RADIOSOUND–HTN, it and therefore ... higher penetration was the first time the two emerging depth would be more relevant ... technologies have been pitted against Results might have differed in a coeach other. At 3-month follow-up, the hort of patients with smaller renal 42 patients randomized to ultrasound artery diameters.” ablation with the Paradise catheter Both Paradise and Spyral are in (ReCor Medical) had a mean systolic pivotal trials for Food and Drug daytime blood pressure reduction of Administration approval.

13.2 mm Hg on ambulatory monThe subjects were an average of itoring, vs. 6.5 mm Hg among 39 64 years. The majority were men, patients randomized to RF ablation and there were no significant differwith Medtronic’s Symplicity Spyral ences in baseline characteristics becatheter (P = .043). tween the arms. The mean baseline Meanwhile, 39 patients randomdaytime blood pressure was 153/86 ized to both main artery and side mm Hg despite treatment with branch ablation with the Spyral had three or more classes of antihypera mean reduction of 8.3 mm Hg, tensives dosed to at least 50% of Dr. Philipp Lurz, cardiologist, University of Leipzig, Germany slightly better than RF ablation of their maximum. There was no drug the main renal arteries alone, but the testing to confirm patients were takdifference was not statistically significant, and “no Also, the Paradise catheter – an endovascular ing their medications, but their general practitioners definite conclusion on the value of an additional balloon device inflated to fit the lumen – delivers vouched for their adherence. side branch ablation can be drawn,” said senior fully circumferential, ringlike ablations with each One patient in the ultrasound arm group develinvestigator Philipp Lurz , MD, PhD, a cardiologist application, while the Spyral catheter delivers four oped a pseudoaneurysm treated successfully by at the University of Leipzig, Germany, and his ablations simultaneously in a spiral pattern, and recompression. One of the RF subjects developed a colleagues (Circulation. 2018 Sep 25. doi: 10.1161/ quires more ablations to create a similar effect, said postprocedural intracapsular and retroperitoneal circulationaha.118.037654).

Dr. Lurz. hematoma that resolved spontaneously. No renal Denervation was probably more complete About two-thirds of patients in all three arms vascular complications or stenoses were detected with the Paradise catheter, which might explain responded to treatment, meaning at least a 5 mm at follow-up. the results. Ultrasound energy penetrates about Hg drop in systolic blood pressure. Among the There was no industry funding for the work. Dr. 6-7 mm from the lumen, reaching up to 90% nonresponders, it’s possible that their hypertension Lurz is a speaker and consultant for both ReCor of sympathetic nerve fibers, while RF energy wasn’t caused by sympathetic overdrive. “Future Medical and Medtronic. penetrates 3-4 mm; indeed, the idea of going trials should focus on identifying these patients to aotto@mdedge.com

into the branches with RF ablation is because nerve fibers are closer to the lumen surface, Dr. Lurz said at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, where he presented the study, which was simultaneously published in Circulation.

M. A lexAnder OttO/Md edge news

BY M. ALEXANDER OTTO MDEDGE NEWS REPOR TING FR O M TCT 2 0 1 8

Death continued from page 6

Before the HITECH Act, many EHRs existed, but several barriers blocked full implementation. Early systems were essentially electronic filing cabinets. Their developers had not anticipated the lack of standardization among physicians and hospital systems. The need for custom EHR bases frustrated the vendors.

The question of marketing was omnipresent. Who was the actual customer? An economic model develNOVEMBER 2018

oped in which clinicians would bear the time and even financial costs as the benefits would be passed on to insurers, hospitals, and, presumably, the patients.

EHRs needed to become practical, affordable, and interoperable, but who was demanding this? Where was the financial motivation? In the beginning, vendors of EHRs had to convince doctors, the public, and the government of their worth. Now, essentially mandated by the HITECH

Act, they only had to sell themselves to hospital administrators, who often had a different motive. Profits.

Many of today’s EHRs are simply modified billing platforms, and doctors are paying the price. The Meaningful Use standards were meant to provide financial incentives for EHR adoption. Stage 2 required EHRs to be able to transport clinical information from one system to another.

Looking at our actual practices can provide a master class in the gap between “be able to” and “actually doing.” Again, who does the EHR vendor see as the customer? Certainly not the physician. My patients can

list every type of inferior vena cava filter (or at least those with pending legal action), but most of them have never heard of an EHR. Just like “service lines,” EHRs can make it very difficult for patients to seek care outside of their primary system. Who would see this barrier in communication as a perk and not a deficiency?

Hospital administrators. The free transfer of medical records is bad for business. Therefore, hospitals don’t prioritize it in their EHRs. The EHR vendors also benefit since an easy transfer of records would simplify a hospital’s transition from one EHR Death continued on following page

MDEDGE.COM/VASCULARSPECIALISTONLINE • 17

Death continued from previous page

to another. So, as with most deficiencies in the EHR, physicians are left to find ways around these problems.

Sometimes, we need to go to comical lengths.

Two months ago, a patient pointed to a large machine behind our checkin desk. “What is that?” he asked incredulously; it was a fax machine.

While my competence with this apparatus is marginal (my office staff has taken to yelling “doctor faxing!” to alert one another that I am about to inadvertently copy or scan my documents into oblivion), faxes remain a mainstay of medical care. Abandoned by modern business practices as a relic of the 1980s, why are we constantly faxing medical information?

Because we are not the customer.

Disruption is now a favorable term in business. Doctors are busy people. BUSY people. Most of us walk

a tightrope, a razor-thin timeline.

Will we see the next patient in time, the next surgery? Will we get the medical records done today? Will we get the dictations done before being suspended? Will we make the com-

“EHRs are incontrovertibly associated with burnout. ... EHRs cause physicians harm.” mittee meeting, the conference call, the next clinic across town? Will we have dinner with our spouse or see our kids today? Will we make it to the parent-teacher conference inexplicably scheduled for 10:45 a.m. on a Tuesday??!! When deciding between work commitments and family, we side with work overwhelmingly (and

depressingly). Explaining this to a layperson is an impossible feat. I have stopped trying, stopped making excuses. Only we know how catastrophic “disruption” can be. Disruption in a 40-patient clinic. Disruption in the trauma bay. I have seen physicians reduced to tears by this disruption. Some activities need disruption.

Typing with your back to the patient.

Onerous documentation to facilitate billing. Faxing medical records. Will these be disrupted? Who is the customer?

In 1999, the Institute of Medicine started this process, telling us, “To err is human.” I now respond with another Alexander Pope quote, “The same ambition can destroy or save.”

The money and influence of EHR vendors destroyed the chance to nationalize the most successful EHR our country has ever seen. What happens now? EHRs are incontrovertibly associated with burnout. Burnout is

incontrovertibly associated with outcomes ranging from early retirement to suicide. EHRs cause physicians harm. Major vendors can follow the Big Tobacco play book and deny the obvious, but the burden of proof is shifting to them. With their billions of dollars in profits, what have they done to study this problem? To help?

Who is their customer? ■ References

Institute of Medicine (US) Committee on Quality of Health Care in America. 2000. To Err Is Human: Building a Safer Health System.

Washington: The National Academies Press.

Weed LL. Medical records that guide and teach. N Engl J Med. 1968 Mar 14;278(11):593-600.

Longman P. “Best Care Anywhere: Why VA Health Care Is Better Than Yours.” (Oakland: Berrett-Koehler Publishers).

ADVERTISING

INDUSTRY INFO TERUMO MAXIMIZE RADIAL SOLUTIONS TO PERIPHERAL CHALLENGES – INTRODUCING RADIAL TO PERIPHERAL (R2P™) by TERUMO

From the leaders in radial access, Radial to Peripheral (R2PTM) is the first and only portfolio of longer-length radial devices specifically designed for peripheral procedures, including Above-the-Knee (ATK) and PAD/CLI vascular interventions.

SPONSORED PRODUCTS AND INDUSTRY NEWS

• R2P™ DESTINATION SLENDER® Guiding Sheath o 6 Fr Size o 119 cm and 149 cm lengths • R2P™ SLENGUIDE® Guiding Catheter o 7 Fr Size o 120 cm and 150 cm lengths • GLIDEWIRE® Hydrophilic Coated Guidewire o Straight, Angled, 1.5 mm and 3 mm J Tip o 350 cm, 400 cm, and 450 cm lengths • GLIDECATH® Hydrophilic Coated Catheter o 4 Fr Size o 150 cm length • NAVICROSS® Support Catheters o Straight, Angled o 135 cm and 150 cm lengths

With the introduction of R2P™, TERUMO continues to advance procedural solutions, enabling physicians to utilize a comprehensive radial to peripheral approach to perform more peripheral procedures for more patients: • Optimize entry site management with Slender Technology™ • Enable the potential for quicker ambulation, improved patient comfort, and satisfaction • May increase cath lab efficiencies and decrease overall costs per procedure The R2P™ portfolio is comprised of: • GLIDESHEATH SLENDER® Hydrophilic Coated Introducer Sheath o 7/6 Fr Size o 10 cm and 16 cm lengths 18 • VASCULAR SPECIALIST

• R2P™ METACROSS® RX PTA Balloon Dilatation Catheter o 3-8 mm diameter x 20-200 mm length o 200 cm shaft length MISAGO®

• R2P™ RX Self-expanding Peripheral Stent o 6-8 mm diameter x 40-150 mm length o 200 cm shaft length o Coming in 2018—contact a TERUMO representative for availability Indications The MISAGO® RX Self-expanding Peripheral Stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic lesions or occlusions of the Superficial Femoral Artery (SFA) and/or proximal popliteal

artery with reference vessel diameters ranging from 4 to 7 mm and lesion length up to 150 mm.

Important Safety Information Do not use this device in pregnant patients or patients who may be pregnant, patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/ after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients with known allergy to nickel-titanium alloy, gold or contrast media, vessels in which there may be a residual stenosis of 50% diameter or larger in the target vessel after the planned intervention, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, a lesion through which a guide wire cannot pass. This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques and stent implantation.

• TR BAND® Radial Compression Device o Regular 24 cm and Long 29 cm Discover what’s next in peripheral intervention--learn more at www.terumois.com/r2p.

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use. ©2018 Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of Terumo. PM-00531 NOVEMBER 2018

PAD AND CLAUDICATION

Lower-limb atherosclerosis predicts long-term mortality in patients with PAD

BY MARK S. LESNEY MDEDGE NEWS FROM THE E UR O PE A N J OU RNAL O F VA SCUL A R A N D ENDOVASC UL A R SUR G E RY

T

he location and extent of lower limb atherosclerosis predicts long-term mortality in patients with peripheral arterial disease (PAD), according to the results of a retrospective cohort study

performed in England.

Comprehensive infrainguinal arterial imaging that used duplex ultrasound to determine the overall and site-specific burden of atherosclerotic disease predicted long-term outcomes in this patient group, according to a report published online in the European Journal of Vascular and Endovascular Surgery.

“Not only does such imaging pro-

Canagliflozin approved for cardiovascular event risk reduction

BY LUCAS FRANKI MDEDGE NEWS

T

he Food and Drug Administration has approved canagliflozin (Invokana) as a way to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular disease, according to Janssen Pharmaceuticals.

The sodium–glucose cotransporter 2 inhibitor was first approved in 2013 to improve glycemic control in adults with type 2 diabetes.

FDA approval was based on results from the CANVAS (Canagliflozin Cardiovascular Assessment Study) trial, which included more than 10,000 adults with type 2 diabetes who either had cardiovascular disease or were at risk for cardiovascular disease. Overall, patients who received canagliflozin had a 14% lower risk of experiencing a major cardiovascular event over the control group, and patients with established cardiovascular disease had an 18% lower risk.

The most common adverse events associated with canagliflozin include female genital mycotic infections, urinary tract infection, and increased urination. Notably, canagliflozin also increases the risk of lower-extremity amputation, especially in those with a history of amputation.

“Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes. With this approval, Invokana now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events,” Ralph A. DeFronzo, MD, professor and division chief of medicine and diabetes at the University of Texas, San Antonio, said in the press release.

The new indication applies to all formulations of canagliflozin.

Find the full press release on the Janssen website. lfranki@mdedge.com

vide anatomical information to guide intervention, but it may also provide information to further risk-stratify patients with regard to long-term cardiovascular risk,” wrote Paul J.W. Tern, MD, of Addenbrooke’s Hospital, Cambridge, England, and his colleagues.

A retrospective cohort study was performed on a consecutive series of 678 patients undergoing a lower limb arterial duplex scan during October 2009–June 2011 at Addenbrooke’s Hospital. Patients had a median age of 74 years and were followed for a median of 70 months.

A total of 307 patients died, which was the primary end point. Independent predictors of all-cause mortality included total Bollinger score (odds ratio, 1.11; P less than .001), femoropopliteal Bollinger score (OR, 1.34; P = .05); and crural Bollinger score (OR, 1.03; P = .03).

The Bollinger score has been found to be a validated tool when used to

determine overall lower limb atherosclerotic burden, the authors stated.

Dr. Tern and his colleagues also found that mortality was significantly associated with age, a history of ischemic heart disease, a history of congestive cardiac failure, and chronic renal failure (chronic kidney disease), although statin and antiplatelet therapy were found to be protective.

“This study has shown that infrainguinal atherosclerotic site and burden are independent predictors of poor outcome in patients; it is straightforward to determine and as such could be used to further risk-stratify patients and influence the intensity of cardiovascular risk modification,” the researchers concluded.

The authors reported that they had no conflicts of interest. mlesney@mdedge.com

SOURCE: Tern PJW et al. Eur J Vasc Endovasc Surg. 2018 Oct 1. doi: 10.1016/j.ejvs.2018.07.020.

GORE® VIABAHN® Endoprosthesis INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis

is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm, in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm, and in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts.

CONTRAINDICATIONS The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for noncompliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events.

Products listed may not be available in all markets.

GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. ©2011, 2017, 2018 W. L. Gore & Associates, Inc. AQ0162-EN3 JANUARY 2018

NOVEMBER 2018

MDEDGE.COM/VASCULARSPECIALISTONLINE • 19

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*

OPEN MORE POSSIBILITIES Lesions across the elbow Chronic total SFA occlusions Complex iliac lesions In-stent restenosis of the SFA PTA failures of AV graft lesions Long SFA lesions Thrombosed AV grafts

Occluded right iliac

ISR of the SFA Lesion across the elbow

Left SFA CTO

Long diffuse right SFA

Durable outcomes and unmatched versatility across a broad range of complex cases.

See the results at goremedical.com/viabahn/possibilities * Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface.

Images courtesy of Robert Minor, MD; Barry Weinstock, MD; Sapan Desai, MD; Bruce Gray, MD; and James Persky, MD. Used with permission.

W. L. Gore & Associates, Inc. | Flagstaff, AZ 86004 | goremedical.com Please see accompanying prescribing information in this journal.

Products listed may not be available in all markets.

CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2018 W. L. Gore & Associates, Inc. AX1510-EN1 OCTOBER 2018

VAS_20.indd 1

10/26/2018 2:39:08 PM