Vascular Specialist July 2018

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2 Dr. Samson bids his fond farewell as medical editor.

Dealing with liability with nurses, physician assistants.

10 News from SVS Dr. Gregorio Sicard received the SVS Lifetime Achievement Award at VAM 2018.

APDVS requests new ACGME Review Committee for Vascular Surgery

Crawford Critical Issues Forum: The national shortage of vascular surgeons

BY MALACHI SHEAHAN III, MD DEPUTY MEDICAL EDITOR, VASCULAR SPECIALIST

See ACGME · page 3

DR. MICHEL S. MAKAROUN

BY MARK S. LESNEY MDEDGE NEWS

T

his year’s E. Stanley Crawford Critical Issues Forum addressed the current status of the vascular surgery workforce, its existing geographic distribution, the potential for a worsening shortage, and proposed solutions to ensure future vascular care delivery.

As is tradition, the forum was organized and moderated by the SVS president-elect, this year Michel S. Makaroun, MD, codirector of the UPMC Heart and

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O

n June 22, 2018, Amy Reed, MD, the president of the Association of Program Directors in Vascular Surgery, submitted a proposal for the creation of a new Residency Review Committee for Vascular Surgery.

The proposal came with the overwhelming support of vascular surgery program directors and a written endorsement from R. Clement Darling III, MD, then president of the Society for Vascular Surgery.

Vascular Institute in Pittsburgh. The session began with an overview from Dr. Makaroun on the critical nature of the growing problem.

He described how the current shortage of vascular surgeons is projected to worsen for two main reasons: First, newly trained vascular surgeons are not entering the workforce in adequate numbers to meet the increased demand presented by the nation’s aging population, even with the improvements projected from the new 0-5 training program; second, there is a large See Crawford · page 3

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FROM THE EDITOR

Endofill and the “Last Editorial”

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

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his marks my last editorial as medical editor of Vascular Specialist. It has been more than a privilege to have been offered this position.

After all, how lucky am I to be provided with an opportunity to rant about things that annoy me or laugh in print at some of the absurdities of our professional life.

Before I put down my pen, or should I more correctly say close my word processor, I would like to add an epithet that I have yet to coin publicly. I am suggesting that we lay to rest the term “Endoleak” and replace it with “Endofill.”

At the outset, I must commend doctors White, Yu, and May for recognizing and publicizing this important potential complication of aortic endografts (White GH, Yu W, May J., J Endovasc Surg. 1996.3:124-5). However, the term “Endoleak”that they used to describe the continuation of free-flowing blood within the aneurysm sac has created confusion amongst nonvascular surgeons and the lay public. Often such misunderstanding has resulted in deleterious consequences. I’m sure many vascular surgeons have been summoned to the emergency room after an emergency physician incorrectly interpreted a radiologist’s report of an Endoleak as a life-threatening rupture. Others may have had to explain to a referring physician that an Endoleak does not imply the vascular surgeon had performed an inadequate procedure. Further, patients have absolutely no concept of the meaning of this term and are often frightened when they learn they have an Endoleak. So prior to consenting them for an endograft, I always bring out a plastic model of an aneurysm with an endograft

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.

2 • VASCULAR SPECIALIST

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.

in place and go through a time-consuming explanation. Seldom do they remember this account.

When I see patients back who have an Endoleak, I once again find myself placating terrified individuals who think they are about to die.

So that is why we should replace the alarming “Endoleak” with the less disturbing and more descriptive “Endofill.” After all, there is no “leak” but rather a “filling” of the sac with blood. Certainly, a Type 1 “Endofill” is still dangerous, but I doubt the uninitiated would consider it an immediate problem. “Endofill” may still take some explaining, but it is less likely to cause patient anxiety or an overzealous panic in a referring physician.

Let’s face it. Even the term “leak” has led to many errors in the treatment of patients with an abdominal aortic aneurysm. For example, it is not unusual that an emergency room physician, hospitalist, or internist will triage a “leaking” aneurysm as nonurgent because it has not “ruptured.”

I think we should ban “leaking” and “leak” from the medical vernacular. Let Washington politicians use the words. Rather, vascular surgeons and radiologists should describe exactly what is happening when

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a limited amount of blood escapes the wall of an aneurysm by using the term “contained rupture.” I’m sure that will get the nonvascular surgeon's attention!

I’m hopeful that you will also remember some of my other epithets and aphorisms from columns.

Such as “Vascular surgeons Operate, Medicate and Dilate,” that TLR (Target Lesion Revascularization) should really be “The Least Relevant.” That a nervous surgeon will not be proficient so “The most important heart in the Operating room is the surgeon’s.” That vascular surgeons are all “Knights of the rectangular table,” and that rapacious doctors are committing “White Coat Crime.” That atheroembolism to the buttocks should be called “Trash Can.” That we should always ask for longterm outcomes before accepting new technologies otherwise, we would be encouraging “Premature congratulation.” That Societies that refuse to rein in their members by refusing to use the word “inappropriate” are being “Anti-semantic.” Further, that shared decision making is essential but that “Insecurity is the price patients must pay for sharing in the decision-making process.” And, of course, my request that we all join the SOS, the “Save Our Saphenous” society.

I am also hopeful that, with time, my exhortations will aid Vascular Surgery in getting the recognition that it deserves. I have suggested many ways we can expedite this goal including possibly changing the name of the Society to The American College of Vascular Surgery and offering members the opportunity to refer to themselves as Fellows of that College. I have encouraged all who are trying to achieve a separate Residency Review Committee, and I fully support an independent American Board of Vascular Surgery.

Editor continued on page 4

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JULY 2018

Surgeon shortage percentage of vascular surgeons currently practicing who are expected to retire in the next decade, with estimates reaching 35%-45%. He detailed the results of the 2017 survey of vascular surgeons that showed this and other concerning factors.

“We do not take vacations,” he said. “We have significant overwork.”

In addition, “half of the surgeons who said they would retire, said they would retire before the age of 65.”

In fact, nearly 50% of those surveyed have firm retirement plans, and nearly 20% were planning on retiring within the next 5 years.

“To summarize, we have a pipeline, which at maximum would, within the next 5 years introduce 608 new vascular resident and fellow graduates into the workforce, and at the same time we’ll be losing the same number of practicing vascular surgeons. So, at best, we will stay even,” said Dr. Makaroun.

“The Current Landscape of the Vascular Surgery Recruitment Mar-

In his talk, “Where Did the Vascular Surgeons Go? Seven Years of Futile Recruitment Attempts,” Gerald Goldstein, MD, of the Western Maryland Health System, addressed the problem of attracting new vascular surgeons. His talk was key in pointing out the problems of large health care facilities in poor and rural areas. “We’re not a Band-Aid station. ... we’re a big hospital, we serve a large geographic area and a large cohort of patients,” he said. Still they have failed to recruit a single vascular surgeon. He pointed out how places such as his could not compete for vascular surgeons against more desirable urban centers with more amenities and sufficient backup surgeons to provide lower workloads and improved quality of life, which includes time off, not being on call, and collaboration and teamwork. He was not optimistic about solutions and was fighting the final solution: hospital contraction of services.

“Workforce Targets: How Can We

“Half of the surgeons who said they would retire, said they would retire before the age of 65.” ket” was addressed by Jeremy Robinson of Merritt Hawkins. He pointed out the market evidence for a large scarcity of vascular surgeons, with a huge number of positions going unfilled, more than half of new trainees receiving more than 100 offers, and bidding wars going on among employers, including offering expansive salaries and benefits to vascular surgeons as part of recruitment efforts.

Know Whether We Have Enough Vascular Surgeons?” was discussed by Mark Friedberg, MD, of the RAND Corporation. Dr. Friedberg pointed out that it was important to define what was meant by a shortage of vascular surgeons, asking whether a surgeon/population metric was the most valuable or should it include other components, such as geographic considerations, quality of care

Review Committee ACGME from page 1

The proposal will be reviewed by the ACGME Board of Directors at their September 2018 meeting.

Dr. Reed stated, “Recognition of vascular surgery training programs through an independent Vascular RRC will improve the clinical care and safety of patients with vascular disease by holding programs to established standards of care and quality initiatives in vascular surgery.

“Program directors feel strongly that vascular training programs JULY 2018

should be rigorously reviewed by a committee of vascular surgeons rather than other surgical subspecialists as currently exists on the surgery RRC. “Only vascular surgeons have experience with all phases of vascular care – medical, percutaneous and surgical options – and are therefore in the best position to judge how the next generation of vascular surgeons should be trained.”

Review Committees (RC) set

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Crawford from page 1

Panel members discuss the challenges in the vascular surgery work force and possible solutions during the E. Stanley Crawford Critical Issues Forum. From left: Jeremy Robinson, Mark Friedberg, MD; Anton Sidawy, MD; and Gerald Goldstein, MD.

issues, patient waiting times, and more. In addition, he asked, for any metric chosen, how was the decision made in choosing the optimal level?

What is the best ratio of vascular surgeons to population, and how do you decide it?

Finally, Anton Sidawy, MD, of the George Washington University Hospital, Washington, looked at possible solutions to the problem in his talk, “Pathways to Alleviate Shortages and Maldistributions of Vascular Surgeons.” Dr. Sidawy stressed the need for a multifaceted approach, including government at the federal, state, and local levels, as well as medical schools and training programs.

He particularly stressed the need for improving the distribution of vascular surgeons to underserved rural areas, such as described by Dr. Goldstein. However, this would require thinking outside the box, perhaps involving redistribution of training to

more underserved areas of the country as well as recruitment of more individuals from those areas. This is more likely to produce vascular surgeons willing to remain or return to such areas to practice, as has been well documented.

Another possibility is to provide incentives for older vascular surgeons to delay retirement, perhaps with a lowered workload, freedom from being on-call, and other benefits.

But perhaps his most radical suggestion is the idea of rethinking the role of vascular surgeons entirely, to include the ability to perform more general surgery operations, allowing them more flexibility to take on roles in smaller communities and organizations that could not afford a narrowly defined specialist.

The forum concluded with a panel discussion in which the panelists addressed questions from the audience. ■ mlesney@mdedge.com

the requirements and accreditation guidelines for training programs under the auspices of the ACGME. Currently, issues related to vascular surgical training are handled by the Surgery RC. In addition to vascular surgery fellowships (5+2) and integrated residencies (0+5), the Surgery RC also covers General Surgery, Surgical Critical Care, Pediatric Surgery, Complex General Surgical Oncology, and Hand Surgery.

Of all the medical specialties that issue a primary Board certificate, Vascular Surgery is the only discipline without a separate RC. ■ MDEDGE.COM/VASCULARSPECIALISTONLINE • 3

MEDICOLEGAL ISSUES

Liability with nurse practitioners and physician assistants

BY S.Y. TAN, MD, JD

Question: A nurse practitioner evaluated an elderly patient who arrived in the hospital clinic with a 3-day history of cough, tactile fever, myalgia, and malaise. Several members of the patient’s family have the “flu.”

His temp was 99.8 degrees, and the chest x-ray was negative. The NP diagnosed a viral upper respiratory infection and discharged the patient without antibiotics. The supervising physician verbally agreed with the NP’s diagnosis and treatment, but did not personally examine the patient. A week later, the patient was hospitalized for pneumonia and sustained additional complications of empyema, sepsis, and respiratory failure. The NP is an employee of the hospital, whereas the physician is an independent contractor.

Which of the following is incorrect?

A. All three parties – NP, physician, and hospital – will all be named as codefendants under various theories of direct and indirect liability.

B. NPs are only licensed to work under the supervision of a physician, and they do not have prescriptive authority.

C. The hospital is vicariously liable under “respondeat superior,” as the NP is an employee.

D. Under state law, the physician will likely share the NP’s liability, even if the physician had no contact with the patient.

E. Medicare services rendered by an NP cannot be billed under a physician’s National Provider Identifier (NPI) unless certain specific requirements are met.

Answer: B. Nurse practitioners and physician assistants (PAs) have historically worked under the direct super-

practice. According vision of a physician. to PIAA, a trade asNPs have graduate sociation of medical nursing degrees, and malpractice insurers, they are now licensed there were only 351 for independent pracclosed claims involvtice in a number of ing NPs between 2001 states, including the and 2010, compared authority to write with more than prescriptions. Some 174,000 physician form of physician claims. From 1991 “collaboration,” such DR. TAN through 2007, the as chart reviews, still probability of making applies, together a malpractice payment was 12 times with certain restrictions, e.g., having less for PAs and 24 times less for NPs. clearly delineated protocols and desFor all three providers, a missed diagignated triggers for a referral. PAs, nosis was the leading reason for the who have less training than NPs, do not typically have the same degree of malpractice action. There were no observations or trends to suggest that independence. They are individually PAs and NPs increase liability.3 licensed to work under a specific Although every licensed employphysician, with a limited scope of ee is directly liable for his or her practice under direct supervision.

Statutes governing scope and restric- substandard care, the employer also shares in that liability. This is known tions of practice differ from state to state, and one should obviously consult as vicarious liability, where liability is the relevant jurisdictional laws and reg- imputed to the employer, although the tortious action originated excluulations for any given situation.1 As an example, NPs in Hawaii may sively from the employee. Responpractice independently from physideat superior, or “let the master cians and may prescribe drugs and answer,” is the legal doctrine underSchedules II-V controlled substances, pinning vicarious liability. The idea as well as medical devices if within behind this rule is to ensure that the the NP’s specialty. A health insurance employer, as supervisor, will enforce company may recognize a participat- proper work standards to avoid risk ing NP as a primary care provider. of harm. The employer is also better In the case of a PA, the supervising able to shoulder the cost of compenphysician determines supervision sating the victim or insure against requirements as well as the scope of workplace injuries. practice in a written document deFor vicarious liability to arise, the veloped on site, to include adequate employee’s act must have occurred means of communication between during and within the scope of PA and supervising physician. A PA employment, and the risk of harm may prescribe drugs, including conforeseeable. Where there is no fortrolled substances, if delegated by the mal employment agreement and the supervising physician.2 wrongdoer is an independent conNurse practitioners and physician tractor, then vicarious liability does assistants are rarely sued for malnot apply.

Editor continued from page 2

Over the last 5 years, I have penned almost all that I believe needs to be said about vascular surgery, vascular surgeons, our patients, and the Society for Vascular Surgery. However, although my contract still allows one more year as medical editor, I felt it was time for new insights from a new generation of surgeons.

It is with great pleasure, therefore, that I pass the reins to Malachi Sheahan III, MD. Vascular Specialist has become the primary news source for our Society, and its educational articles and news items offer learning experiences not found in 4 • VASCULAR SPECIALIST

peer-reviewed journals. I encourage all to submit interesting news items for print, add some unusual Tips and Tricks, write letters to the editor, and tell us about your accomplishments inside and out of vascular surgery.

Please also volunteer to write Point/Counter Point articles. Vascular Specialist is your resource, and it’s not only in print but also in all forms of electronic and social media. It is up to you to make sure that it continues to thrive as a valuable resource for all our members.

I want to publicly thank the Associate Editors for their many contributions. This magazine

Thus, litigation frequently revolves around the question as to whether there exists an employer-employee relationship. The chief test is evidence of degree and extent of control over the worker in matters such as work schedule, duties, and salary.

Some jurisdictions have used the principal-agent construct in the absence of an employment contract to justify a finding of vicarious liability.

Liability can take many forms when physicians work with NPs and PAs.4 Negligent supervision is a favorite plaintiff allegation, whereas the defense predictably denies physician negligence in the absence of an established physician-patient relationship. In Quirk v. Zuckerman, an NP treated a patient in the emergency department for an upper extremity complaint, which was misdiagnosed as a tennis elbow. In fact, the patient had a compartment syndrome with evident swelling and ended with an amputation.5 The NP testified that she had discussed the case with the attending physician, and the physician had signed the plaintiff ’s medical chart as well as a prescription for a painkiller.

However, he did not personally speak to or examine the patient.

The relevant New York statute governing NP practice provides that collaborative medical services be rendered in accordance with a written practice agreement and protocols.

Because there was no written protocol by the hospital, the ultimate responsibility for the diagnosis and treatment was held to rest with the physician. The court opined that the practice of a registered nurse practitioner is always in collaboration with a qualified licensed physician, and Liability continued on page 5

would not be the same without their insightful comments. However, in the background is the actual “hero,” Mark Lesney. Mark has been the editor who sends Mal and me news items to review, urges us to be punctual, and is responsible for putting Vascular Specialist together. He works tirelessly under the pressure of producing a monthly periodical. Vascular Specialist is indebted to his efforts.

Finally, I want to thank you all so much for bearing with my rantings these last few years. Your letters and emails of appreciation have been an inspiration. ■ JULY 2018

Liability continued from page 4

given the circumstances, concluded that an implied physician-patient relationship did exist between Dr. Zuckerman and the patient.

Most jurisdictions have similar statutes regarding collaboration and supervision. For example, in Tennessee, the law provides that physician assistants act under the oversight of a licensed physician, and that the supervising physician shall be responsible for ensuring compliance with the applicable standard of care. Its Supreme Court has ruled that a supervising physician can be held vicariously liable for the negligence of his assistant in a case where there was a missed diagnosis of mitral valve disease and cardiomyopathy.6 The court characterized the relationship as one of principal and agent, whose negligence is imputed to the physician.

The standard of care by which the assistant is judged, however, differs from that expected of a physician,

just as a paralegal is not held to the same standard as his or her supervising attorney.

Other areas of potential liability when working with nurse practitioners and physician assistants include abetting in the unauthorized practice of medicine, and misrepresentation by these providers as physicians. One caveat: If a hospital “lends” the services of its employee to a physician, who then directs his/her work, this makes the nurse practitioner or physician assistant a “borrowed servant.” The borrowing physician will then assume legal responsibility, freeing the hospital from liability.

Another area deserving of attention: violation of the federal False Claims Act. Federal statute defines the requirements that must be met for supervising physicians to bill for services provided by other qualified nonphysician providers.

For office visits under Medicare Part B, physicians may bill for nurse

practitioner or physician assistant services as “incident to” the service of a physician using the physician’s own National Provider Identifier. However, certain prerequisites must be met, e.g., services are furnished under the physician’s direct personal supervision (on-site presence and immediate availability), and the physician must perform the initial service and subsequent services with a frequency that reflects his or her active participation.7 If these and other stipulated requirements have not been met, the services are to be billed under the nurse practitioner’s or physician assistant’s own provider number, which comes with a lower, 85% reimbursement rate.

Physicians will do well to carefully review all Medicare billing rules to avoid a charge under the False Claims Act, which can carry stiff penalties and criminal prosecution.8 ■ Dr. Tan is emeritus professor of medicine and former adjunct professor of law at

the University of Hawaii, Honolulu.

This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Prescribing Law: A State-by-State Summary.” Medscape, Jan. 4, 2018.

2. Hawaii Admin. Rules §16-89, §1685, and Hawaii Rev. Stat. §431:10A125.

3. Hooker R. Journal of Medical Licensure and Discipline 2009; 9:6-16.

4. Szalados JE. “PAs and NPs: the scope of physician liability.” ED Legal Letter, Aug. 1, 2006.

5. Quirk v. Zuckerman, 196 Misc. 2d 496 (N.Y. Misc. 2003).

6. Cox v. M.A. Primary and Urgent Care Clinic, 313 S.W.3d 240 (Tenn. 2010).

7. “Incident-to billing: Clearing up the confusion.” Medical Economics, April 24, 2014.

8. Medicare Carriers Manual (Part 3, Chapter II, section 2050).

P E R S P E CT I V E by o. William Brown, Md, Jd

Dealing with liability

D

r. Tan addresses several important legal concepts in his article entitled “Liability with nurse practitioners and physician assistants.” The first is that of the physician-patient relationship. If an attorney is to prevail in an action for medical malpractice, he/she must satisfy four basic requirements: The plaintiff ’s attorney must establish the standard of care with which the physician defendant must comply. The attorney must then show that this standard was breached. The third requirement is that the plaintiff must show that the patient suffered damages.

Finally, the plaintiff ’s attorney must show that the breach of the standard of care was the proximate cause of the damages that the patient incurred. If any one of these four components is absent, as a matter of law, the suit must fail. As pointed out by Dr. Tan, direct patient contact by the physician is not required to establish a physician-patient relationship. As in this case, a phone call is sufficient. However, it should be emphasized that, as a potential consultant, simply discussing a case with a colleague does not necessarily establish a physician-patient relationship. If the potential consultant is not on call, and has no duty to see the patient, the discussion of the case is most often looked upon as

JULY 2018

a “sidewalk consult.” physician assistants and These types of connurse practitioners, it is sults do not result in a best if those employees physician-patient relaare covered by separate tionship and, therefore, malpractice insurance do not impart liability policies. upon the consultant.

Another importIt is important to ant legal concept to remember that the consider is that of plaintiff ’s attorney will apparent authority. If O. William Brown, MD, attempt to focus upon a physician assistant JD, is a professor of a defendant with “deep surgery at the Oakland or a nurse practitioner pockets.” is an employee of the University/William The term “deep hospital, but it appears Beaumont School of Medicine and an adpockets” simply refers to the patient that the to a defendant with the junct professor of law physician extender is at the Michigan State potential to provide working directly for University College of substantial payment to the patient’s physician, the plaintiff. Therefore, Law, East Lansing, and the patient’s physician an associate medical plaintiff ’s attorneys may be deemed to editor for Vascular will commonly athave liability under Specialist. tempt to include phythe legal theory of sicians and hospitals in apparent authority. It any claim for medical malpractice is, therefore, prudent for physicians filed against ancillary providers. to clearly discuss with the patient Plaintiff ’s attorneys, therefore, are which members of the treatment particularly interested in establishing team are employed by the physician, liability of nurses, physician assisand which are not employed by the tants, and physicians who are emphysician. ployed by the hospital. As noted in Lastly, as Dr. Tan correctly pointDr. Tan’s article, whereas physician ed out, it is imperative that the assistants and nurse practitioners physician avoid violating the Federal may not be individually at risk for False Claims Act. To be deemed liability, they are targeted as a means to have violated the Federal False of establishing vicarious liability.

Claims Act, the government must Therefore, if a physician employs establish that the defendant:

1. Made or presented a false, fictitious, or fraudulent claim to a department of the United States.

2. Knew such claim was false, fictitious, or fraudulent, and 3. Did so with the specific intent to violate the law or with a consciousness that what he was doing was wrong.

While it is clear from the case law that specific intent to defraud is not required for conviction, it remains controversial as to whether willfulness is required for conviction. As in most legal controversies, it is best to avoid the issue completely and refrain from submitting any claims that could conceivably be viewed as violating the false claims act.

The use of physician extenders has both helped to decrease the burden of medical care on physicians, while at the same time providing care for patients who may not have access to any type of physician care.

Unfortunately, for physicians, this assistance in the care of patients is associated with an increase in medicolegal liability. A thorough knowledge of both state and federal regulations governing the use of physician extenders, and the realization that physicians may be held liable for the actions of these extenders should hopefully decrease the risk to the supervising physician.

MDEDGE.COM/VASCULARSPECIALISTONLINE • 5

NEWS FROM SVS

SVS Lifetime Achievement Award Winner: Dr. Gregorio Sicard, a ‘Surgeon’s Surgeon’ and cardiology could be a part of it, but they couldn’t take it over.”

Part of the reason their efforts were successful, he believes, is because the Society for Vascular Surgery and the American Association for Vascular Surgery had gone through a difficult but necessary merger just before his term as SVS president.

“You never know, but I doubt that this same outcome would have occurred,” he said, “if we R. Clement Darling, MD, (left) presents didn’t have one voice, one the SVS Lifetime Achievement Award to society, one very coordiGregorio Sicard, MD. nated effort, strategically managed by leadership. We survived an existential challenge, and since then the growth of the ensuring that the Centers for Medicare society has been astronomical.” and Medicaid Services didn’t lose sight His efforts to keep vascular surgery of the important role that vascular at the political table were just one of surgeons play in endovascular procethe reasons for his award, the highest dures.” honor bestowed by the SVS each year.

The son of a surgeon, Dr. Sicard “With this award, Dr. Sicard joins the grew up in rural Puerto Rico, and list of luminaries whom we call ‘the gi- earned his medical degree at the Uniants of vascular surgery,’” explained Dr. versity of Puerto Rico. Though he R. Clement Darling III, now past-presnow is officially retired, Dr. Sicard, ident of the SVS. “He has achieved so 73, still reports regularly to his Washmuch it’s hard to know where to start. ington University office to attend As president of the SVS in 2004-2005, vascular conferences and rounds and he was instrumental in smoothing the has been passionate about training the merger of two competing vascular next generation of surgeons. societies. He has mentored 50 fellows, “I always took that very seriouspublished hundreds of articles and ly,” Dr. Sicard said. “If you live long book chapters, and was instrumental in enough, you have to train the next NatioNwide PhotograPhers

B

ack at the dawn of the endovascular revolution, many other surgical specialties were vying to dominate minimally invasive endovascular procedures. Vascular surgery, the standard bearer of open vascular surgery, could have gone the way of buggy whips.

But this year’s Lifetime Achievement Awardee, Dr. Gregorio Sicard, was one of a dedicated group of vascular surgeon leaders who kept that from happening.

“I did not want to see vascular surgery be born and die within my lifetime,” said Dr. Sicard, who was honored with the 2018 Lifetime Achievement Award at the 2018 Vascular Annual Meeting.

In the early 1990s, the Food and Drug Administration and the Centers for Medicare and Medicaid Services were seeing a lot of technological advances and were being lobbied by many powerful stakeholders. Dr. Sicard, who chaired the SVS Outcomes Committee after his term as SVS president, spent many long hours in Maryland along with other members of the committee, explaining to federal agencies the importance of evidence-based, patient-centered decision-making.

“We were able to gain the trust of the FDA and CMS and to have a voice at the table,” Dr. Sicard recalled. “The committee pointed out the importance of patient safety and expected outcomes which led to these agencies trusting us. We weren’t saying this field only belongs to us. Radiology

generations, it’s your duty.” Dr. Sicard was instrumental in forming the first fellowship program at Washington University in the 1980s.

He is particularly proud of his mentees. “A lot of them have become heads of their own programs, both in the United States and internationally, from countries like Spain, Chile and Colombia. One of my proudest achievements is that I had about 150 residents from Spanish-speaking countries who spent anywhere from a month to two years in our program.”

Vascular surgeons worldwide have traveled to Barnes-Jewish Hospital and Washington University over the decades to learn from him because of his skills in surgery and patient care. In 2011, a Distinguished Professorship was named for him at Washington University in St. Louis.

Dr. Anton Sidawy, one of the surgeons who nominated Dr. Sicard, said, “Greg is what one may call a quadruple-hitter. He excels in all areas of academic surgery; clinical care, teaching, scholarship and administration. He is a superb, innovative, and skilled surgeon. The Wash. U. Vascular Surgery group is one of the very active, most comprehensive and versatile academic groups in the country; Greg put that group together over 30 years.

“He is a surgeon’s surgeon,” Dr. Sidawy added. “I have met fellows that trained under him; every single one of them raved about his operative skills.” ■

Saving the Community’s Health, One Project at a Time

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handful of SVS members will vascular health, awareness and presoon begin implementing projvention. ects to improve community health This year’s projects aim to: in three areas throughout the Unit• Reduce emergency department ed States. visits and hospitalizations for The plans are the result of the diabetic foot infections, in part new SVS Foundation Community by providing comprehensive diaAwareness and Prevention Project betic preventive care for those at Grants. The first recipients were risk for such infections. Leaders announced during the SVS Vascular are Marcus Semel, MD, MPH; Annual Meeting in June. and Edward Marcaccio, MD, both The grants provide up to $10,000 of South Shore Hospital and to three community-based vascular Brigham and Women’s Hospital DR. SEMEL surgeons, each of whom proposed near Boston. an innovative, community-based • Champion public awareness initiative. The awards are part of the Foundation’s of vascular disease through empowering high expanded mission to include projects that impact school students in upstate New York to under10 • VASCULAR SPECIALIST

stand the impact of vascular risk factors and disease and help diagnose diseases in family members. This project also hopes to increase awareness of vascular surgeons and their expertise in treating vascular disease. SVS project leader is Manish Mehta, MD, MPH, of Queensbury, N.Y. • Expand a long-established Wellness Check held across the Excela Health service area in Pennsylvania, adding a Vascular Health Awareness and Screening event. SVS project leader is Elizabeth L. Detschelt, MD, director of vascular surgery for Excela Health, Westmoreland County and parts of Fayette and Indiana counties in Pennsylvania.

Vascular Specialist will describe the projects in greater detail next month. ■ JULY 2018

NEWS FROM SVS

Members Asked to Complete New Survey on Burnout

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eaders of the SVS Wellness Task Force urge all SVS members to complete a new survey on physician burnout, this one aimed at physical debility.

The burnout survey is in an email from the Mayo Clinic, which is assisting with distribution and tabulation.

DR. SHEAHAN It is the second survey the task force has distributed, all aimed at ascertaining burnout and wellness statistics from SVS members.

“We need evidence,” said Malachi Sheahan, MD, who is vice chair of the group with Dawn Coleman, MD. as

chair. “We can’t make change without evidence.”

He issued a “Societal Call to Action” to SVS members at the end of a session at the Vascular Annual Meeting addressing burnout issues.

Dr. Sheahan disclosed statistics from the first task force survey, completed by 860 members. Collectively, members worked an average 73.5 hours a week, with five hours completing electronic medical records and 5.5 hours of administrative/scholarly activities added to 63 hours in the office.

“Eighty-nine percent feel burned out on occasion, everyone thinks they’re working too hard and when there are conflicts between work and personal life, they’re resolved in favor of the personal side only 8 percent of the time,” he said of the recently released data.

He believes EMR will be the No. 1 conflict of vascular surgeons, with surgeons reporting they spend one hour charting for every one hour of patient time. “It’s just not working out,” he said of the records system.

Twenty percent of physician respondents said they had been sued for malpractice within the past two years, 37 percent reported being depressed within the month prior to completing the survey and the 8 percent who reported suicide ideation within the past year is double the national rate, Dr. Sheahan said.

The second survey, launched in midJune, focuses on physical debility as a result of the stress on the body vascular surgeons face and should take fewer than 10 minutes to complete. It is expected to close in late summer.

“Look for the Mayo Clinic survey, and please take it,” he said. He added that there are initiatives going forward that aim to change the environment

“Eighty-nine percent feel burned out on occasion.” and change the culture. These include the SVS task force and the American Board of Surgery’s new lifelong learning initiative. “This is a call to action,” Dr. Sheahan said. “The main thing I want to say is that this is changeable.

I don’t want you to think or say that we can’t do it. We can. We just need evidence.” ■

JVS: Statin Therapy after AAA Repair

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tatin therapy can boost survival rates in patients undergoing repair of abdominal aortic aneurysms, according to an article in the August issue of Journal of Vascular Surgery.

Researchers studied patients without documented statin intolerance undergoing AAA repair in the Vascular Quality Initiative between 2003 and

2017. The researchers concluded, “Preoperative statin therapy is associated with higher long-term survival but not perioperative mortality and morbidity in patients undergoing AAA repair, and initiating statin therapy in previously statin-naive patients is associated with markedly higher survival.”

AAA patients who are statin-tolerant should receive statin therapy and those patients not taking a statin at the time of surgery should be

considered for such therapy before discharge. The article is open source through Sept. 30. Visit vsweb.org/ JVS-Statins. ■

JVS Publications to Debut 4th Research Journal

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new Journal of Vascular Surgery Elsevier, which publishes the JVS pepublication, “JVS: Vascular Sciriodicals, assessed the need for such a ence” is planned to launch in early journal, Dr. Dardik said. “It will answer 2019, Drs. Peter Gloviczki the need for high-quality and Peter Lawrence anscientific studies that address nounced at the Society for the fundamental questions Vascular Surgery’s Vascular of patients with vascular Annual Meeting. disease.

The publication will fo“We’re very excited cus on multi-disciplinary about it,” he said. “We basic and translational anticipate that we will vascular research studies. draw both from within our DR. DARDIK The two doctors’ goal community of vascular “is that the publication surgeon-scientists as well becomes the pre-eminent research as from the great community of scijournal for our Society, and that it entists who study vascular biology. will complement the other three JVS We also expect this new journal to journals,” said Alan Dardik, MD, be the premier and preferred publiPhD, who will serve as editor. Drs. cation conduit for the SVS Vascular Gloviczki and Lawrence will serve Research Initiatives Conference.” as editor-in-chief and senior editor, Dr. Dardik encouraged anyone, respectively, as they do for the exist- including the Society’s younger suring three publications. geon-scientists, interested in particiBoth JVS leadership and the staff of pating in the journal, to contact him. ■

JULY 2018

SVS Job Bank

Specializing in Vascular Surgery Positions

Job Seekers

Find your next great role!

Search for a new position, create search alerts, post your resume, or browse our resources for career, interviewing, and networking advice

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Customize a package, with price discounts for SVS members SVS Career Site Post to reach our specialized niche Job Flash™ email to 1,000 vascular surgery professionals Network postings to Healthcare or Vascular Job Board Network Banner ads on 10 most popular pages visited by job seekers

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MDEDGE.COM/VASCULARSPECIALISTONLINE • 11

NEWS FROM SVS

SPOTLIGHT ON LEADERSHIP:

VAM Contest Winners Announced

Interview with Peter K. Henke, MD Modeling the Way; How to Sustain Credibility and Integrity in Leadership

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ongratulations to the winners of our Vascular Annual Meeting Scavenger Hunt and the SVS Booth drawing.

Both took place in the Exhibit Hall. Winners are:

BY SHIPRA ARYA, MD, SM ON BEHALF OF THE LEADERSHIP DEVELOPMENT AND DIVERSITY COMMITTEE

Scavenger Hunt

• First Place: Abbey Modlin, $3,000 in tickets from American Airlines • Second Place: Andrew Rogers, $1,500 Apple gift card • Third Place: Michelle Budge, $500 Amazon gift card

T

SVS Booth

N atioNwide PhotograPhers

• First Place: Deepak Deshmukh, DO, free SVS membership for 2018 • Second Place: Shernaz Dossabhoy, free 2018 registration for VAM 2019 • Third Place: Oleksiy Gudz, MD, PhD, free 2018 VAM on Demand

Participants enjoyed the VAM scavenger hunt in the Exhibit Hall.

FOCUS ON RESEARCH:

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esearch focusing on potential new therapies, along with a discussion of entrepreneurship and the second annual Alexander W. Clowes Distinguished Lecture highlighted the recent SVS Vascular Research Initiatives Conference.

Presentations emphasized some of the latest research in vascular biology, offering a glimpse into the future.

“We hope that the research presented at this meeting will evolve over the next 10 to 20 years into therapies for vascular disease,” said Edith Tzeng, MD, chair of the SVS Research and Education Committee, which oversees the annual conference. It was held in mid-May in San Francisco.

Of course, it’s not typically clear which peeks into the future have staying power. Dr. Tzeng remembered that years ago she dismissed drug-coated balloons – now common – when the idea was presented as research. “I thought, ‘Well, that will never work!’ “ The one-day conference, held the

12 • VASCULAR SPECIALIST

he SVS Leadership Development and Diversity Committee began this column in 2016 to highlight leadership skills in leaders of the SVS and create this opportunity to allow members of the committee to interact with SVS leaders. In this way, we are accomplishing one of our main goals, which is to disseminate leadership skills within the society. Based on 25 years of research by Kouzes and Posner in their book “The Leadership Challenge,” we are focusing on five “practices” routinely embraced by successful leaders: 1. Modeling the Way: Leading by example, with consistency, credibility and integrity.

2. Challenging the Process: The courage to question the status quo and thoughtfully test new paradigms.

3. Enabling Others to Act: Optimizing teams and team members by delegating power and authority so they can reach new heights of success 4. Encouraging the Heart: Taking the time to celebrate key accomplishments and ensure the team stay connected to mission or purpose; 5. Inspiring a Shared Vision: Envisioning a

positive future and appealing to the shared goals of others.

As part of this program, I had the honor of interviewing Dr. Peter Henke, Leland Ira Doan Research Professor of Vascular Surgery and Professor of Surgery, University of Michigan Medical School. He graduated from the University of Wisconsin with a Bachelor of Science degree in Biochemistry and Molecular Biology in 1988, and from the University of Wisconsin School of Medicine in 1992. He did his general surgery residency at the University of Louisville, where he was honored with the Chairman’s Award for Personal Scholarship and the C. M. Edelen Award for best resident paper of the year in 1997. He joined the University of Michigan for his Vascular Surgery fellowship, and graduated to join the faculty in 2000.

Over his 18-year career-to-date, Dr. Henke has served in many leadership roles at the University of Michigan and in national societies.

He is the past Chief of Surgery at the Ann Arbor VA, co-director of the Blue Cross Blue Shield Medical (BCBSM) Vascular Intervention Collaboration and the past president of the American Venous Forum. He has served as the basic science editor for the Journal of Vascular Surgery. He has had an actively funded research program since 2004 focusing on the Henke continued on page 13

VRIC a Big Success

day before the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology meeting, typically draws early- to mid-career surgeon-scientists.

They presented a mix of basic and translational vascular research, generally with an emphasis on clinical applications.

Abstract sessions covered stem cells and regeneration, peripheral arterial disease, vascular endothelium and thrombosis, and vascular inflammation and injury.

VRIC also included two special presentations: the annual Alexander W. Clowes Distinguished Lecture and the Translational Panel.

This was just the second year for the Alexander W. Clowes Distinguished Lecture, named for the late Dr. Clowes, a frequent VRIC presenter, outstanding surgeon-scientist and mentor to many.

Speaker Alan Daugherty, PhD, Dsc, FAHA, presented “Angiotensin II and Cellular Complexity of the Aorta: A Recipe for Aneurysmal Location.”

“It was very clinically relevant,” said Dr. Tzeng of Dr. Daugherty’s lecture. He discussed how drugs that stop activity of the angiotensin II are currently used to treat blood pressure and congestive heart failure but may also be useful to treat aortic diseases as well. His current research focuses on how angiotensin II works as a regulator of producing and propagating aortic bulges. His studies have also revealed unique embryologic origins to the layers of the thoracic aorta that may underlie the pathogenesis of aortic dissection.

This year’s Translational Panel, “The Road to Entrepreneurship,” talked less about research and more

about taking that research and bringing it to market. It addressed not only how to know if a researcher has something that he or she should develop and patent but also how to go about that process.

“Frequently researchers don’t think of their work as intellectual property,” she said. “But a great deal of what is not considered ‘common knowledge’ can – and should – be protected. If a scientist is working on genetics, for example, and identifies something that causes disease, that information can be used to develop treatments.

“Researchers have to think, ‘Should this information be protected?’ and then need to work on interesting a company in the research and potential therapies.”

To view a slideshow of VRIC photos, visit vsweb.org/VRIC18Pix. To learn more about the lecture and to contribute to its funding, visit vsweb. org/ClowesLecture. ■ JULY 2018

Henke continued from page 12

basic mechanisms of deep vein thrombosis resolution as well as the effect of the vein wall and is the co-Principal Investigator for the T32 vascular training program at the University of Michigan that has trained many vascular surgeon scientists over the years.

Thus, it is with great pleasure that I was given the task of interviewing Dr. Henke on “Modeling the Way.” Q: We tend to learn a lot about leadership through observation of others. As you think about one-two role models you desired to emulate, what attributes come to mind as being most important to you? Why? I have observed levels of leadership including Chief of Staff, Chief of Surgery and Section Heads over the years and found that a common denominator is that the leader has to have both integrity and transparency. When you start with that foundation, then people are willing to trust the leadership for whatever may come about. Secondly, I think the leader needs to be data-driven and decisive to address various situations and tackle problems. It’s always important to build consensus, but at times one side needs to be chosen over another on whatever issue it may be, and being fair and objective is best done when backed up by data. Another attribute of successful leaders I have observed is that when beginning a new project or addressing a difficult issue, stating what the overall overarching mission is first, and agreeing on this together is helpful. This strategy helps keeps one’s eye on the ball moving forward, and decreases the chance of getting distracted and sidelined.

Q: Which leadership skills have you found to be most critical in your day-to-day leadership success?

Why? Can you give me a brief example?

In terms of day-to-day leadership skills, one of the major skills is the ability to organize and triage. Everyone is very busy but controlling the chaos is key. Fortunately, we all get this training by the nature of our being a surgeon. I think that to get things done, organization of tasks and priorities, circling back on these, and reassessing the progress are a key to keeping the momentum going for any given large or small project.

Generally, I make up a weekly list of things to get done with some small tasks and some bigger tasks. This keeps me on point and prevents me from forgetting important issues and allow my teams to stay engaged.

Q: Which have been the most difficult for you to acquire? Why? What JULY 2018

avenues have you found helpful co-directing this collaborative. This in developing the “leading by exhas been a great experience because ample” behaviors (e.g. leadership we interfaced with our state vascular courses/coaches)? medical society that merged those I think for me a difficult skill to acquire participating in both the BMC2 and and practice is the ‘cheerleading’ role the Vascular Quality Initiative (VQI). of being a leader. Motivating others This ultimately was a win-win, but with an enthusiastic and positive attook a lot of work from everyone to titude can, at times, be hard, as my organize and focus these meetings overall nature is to be pretty realistic and the data distribution and quality about most everything and at times pessimistic.

The current reality of the exponential increase in documentation is not good any way you look at it, but you still have to motivate people to take on tasks that may not be very pleasant or appealing. I think leading from the front as best as you can does inspire DR. HENKE DR. ARYA your team. I believe leadership courses are worthwhile. At the University of Michigan, projects. Lastly, being president of the surgery department has an excelthe American Venous Forum (AVF) lent course over a year, committing to was also a good learning experience one Friday per month, where various with society leadership, particularly aspects of leadership, emotional intelli- in terms of getting a group of very gence, coaching and financial analysis strong personalities to agree on issues are taught. This has been very helpful and move various initiatives forward. to consider totally different perspectives Being the president of an academic and learn additional skills. surgical society means that you are basically responsible for most everyQ: You have held numerous leadthing good and bad that happens. You ership roles including chief of again have to motivate team members surgery at the Ann Arbor VA, to get things done and make sure all co-director of the BCBSM Vascular the details are paid attention to. I was Intervention Collaboration and lucky we had an excellent executive the president of the American Vecouncil and administrative staff during nous Forum. These roles have been my time. unique in their cross-disciplinary nature. What leadership advice to Q: A unique attribute for you is “model the way” would you have the path of leadership balancing a for vascular surgeons seeking simi- clinical role and research lab. How lar leadership roles? is leading by example different for As one goes through their academic you as a scientist running an activecareer, I think it is important to say ly funded basic and translational “yes” more often than to say “no,” laboratory? What are one to twobut keeping that in balance to try to practical pieces of advice you can prevent burnout can be a challenge. provide aspiring surgeon-scientists Each of the leadership roles described to save them time and discomfort? above are very different. Nonetheless, I think leading a research lab requires I would do them all again, and am a different set of skills than the clinical currently still involved with one of teams. It’s a smaller group with a wider these leadership positions. The chief range of backgrounds of experience of surgery at the VA was an opporand certainly most of them are not tunity that unexpectedly arose about MDs. To keep this team functioning seven years into my career. I wanted well requires truly making quality time to learn what leadership would be for the lab (during normal hours), and like in the VA system, knowing in part can be a challenge when emergencies what it would entail. It was actually and unexpected clinical problems arise. a rewarding job because the local VA The leadership role here is keeping team of surgeons, nurses and supthe focus of the experiments that will port staff was excellent. Dealing with hopefully produce results that are valid central office unfunded mandates, and understandable, as well as providbureaucratic rules and dealing with ing troubleshooting. I think really one VISN level directives was definitely of the biggest challenges is to prevent challenging but a learning experithe clinical enterprise from eroding ence. In terms of the Blue Cross Blue into research lab time, and it’s just so Shield Vascular Surgery QI, I am still important to keep those blocks of time

protected. It means sometimes doing clinical cases on other days that you normally would not, including weekends. Taking time to celebrate the lab with a night out is also appreciated and fun.

Q: How can SVS best support development of surgeon-scientists?

I think the Society for Vascular Surgery (SVS) and the SVS Foundation have done a great job in engaging, promoting and funding surgeon-scientists. Certainly the SVS’co-sponsored Mentored Clinical Scientist Award has really allowed vascular surgeons to compete at a very high level, as many of these K08 awardees have gone on to R funding that has continued. The Vascular Research Initiatives Conference (VRIC) meeting has really been a good addition by combining it with the Arteriosclerosis, Thrombosis and Vascular Biology meeting (now called Vascular Discovery Meeting). This collaboration has promoted networking and allows interactions with vascular biologists and other non-surgeons who are important to network with for success. I think one thing the SVS should continue to do is to profile basic and translational research at the Vascular Annual meeting (VAM) each year to prevent it to being lost from the majority of the SVS membership who are not surgeon-scientists.

Q: As you think about the future of vascular surgery and vascular disease in the population, how can vascular surgeons and surgeon-scientists best position themselves to lead effectively?

We really need to be “at the table” in nonsurgical organizations. This really is important for us, because vascular surgery and general surgery are now quite separate, including different training paradigms. I think it is important to be involved with societies such as the American Heart Association, the American Venous Forum and the International Society for Thrombosis and Hemostasis, as well as other sub meetings from the AHA that might be relevant, such as epidemiologic and health services meetings. This is really where many of our grant reviewers and manuscript peer reviewers come from, as compared with surgical societies. One major area where surgeon scientists can grow and lead is in clinical trials (not just device trials), but also medical and surgical therapies. This is an important area for young people to jump into and get training and lead us forward. ■

MDEDGE.COM/VASCULARSPECIALISTONLINE • 13

NEWS FROM SVS

Views From the Vascular Annual Meeting Pictured at left: EJ Wylie Traveling Fellowship awardee Omid Jazaeri, MD, and Mentored Clinical Scientist Research Career Development awardee Bao-Ngoc Nguyen, MD.

Distinguished Fellows

Leadership Grants

The 2018 SVS Distinguished Fellows honored at VAM were, from left: Drs. William Patrick Robinson, Ahmed M. Abou-Zamzam, Jr., Christopher J. Abularrage, John A. Curci, Mohammad H. Eslami, Ulka Sachdev, Karen Woo and Matthew T. Menard.

2018 SVS Women's Leadership Training Grant awardees: Dawn Coleman, MD, (left) and Bao-Ngoc Nguyen, MD.

Photos courtesy

Award Winners

This year's recipients of the SVS Presidential Citation Award are, from left, top row: Drs. Larry W. Kraiss, Michael C. Dalsing, Alan Dardik, Frank B. Pomposelli and Robert M. Zwolak; bottom row: Drs. Brad L. Johnson, Amy Reed, Kellie R. Brown and Edith Tzeng.

a ll

Presidential Citation

N atioNwide PhotograPhers

Here are just a sample of the photos from VAM18. See them all, and find your own photo at vsweb.org/VAM18pics.

SAVE THE DATE! June 12–15, 2019 National Harbor, Md. (Outside Washington, D.C.)

14 • VASCULAR SPECIALIST

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

2019 VASCULAR ANNUAL MEETING AN WASHINGTON, D.C.

JULY 2018

DIABETES

Renal denervation Diabetic foot ulcer healing is for hypertension predictable by WIfI stage scores rebounds

BY TERRY L. KAMPS MDEDGE NEWS FROM THE J O UR N A L O F VAS CU LAR SUR G E RY

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iabetic foot ulcer healing is predictable with the Wound, Ischemia, and foot Infection (WIfI) classification system when used alone or with multivariable risk-adjustment analysis, according to a study published in the Journal of Vascular Surgery.

The research was conducted by Caitlin W. Hicks, MD, of Johns Hopkins University, Baltimore, and her colleagues as a retrospective study using prospective database information from enrolled type 1 and type 2 medication-dependent diabetic patients presenting to the multidisciplinary diabetic limb preservation service at Johns Hopkins Hospital from June 2012 to July 2017. The cohort of 310 patients with diabetic foot ulcer (DFU) in the study had a median age of 59 years and was composed of 60.3% men, with 60.0% of patients being black.

All patients were assessed for baseline characteristics and DFUs at entry into their treatment program and at each follow-up visit by an integrative primary team consisting of a vascular surgeon, surgical podiatrist, endocrinologist, physician assistant, wound care nurse, and prosthetist.

Infectious disease, plastic surgery, and orthopedic foot and ankle consultations were provided as needed. Individuals with evidence of peripheral artery disease (PAD) were provided lower extremity revascularization as determined to be appropriate by the primary vascular surgeon.

The 709 presented DFUs were assessed by x-ray imaging and follow-up MRI as needed.

Wounds were debrided to clean margins and antibiotic treatments were administered as appropriate. At each visit the primary team assessed and assigned each wound a WIfI classified stage of 1-4 according to the calculation based on previously accepted Society of Vascular Surgery definitions, with PAD considered separately in final multivariable model analysis.

The association between WIfI stage and wound characteristics and healing was tested by univariable analysis. Multivariable Cox proportional hazards models that included sociodemographic, comorbidity, and wound characteristics were subsequently created to test WIfI stage as an independent predictor for wound healing after adjusting for those variables. Differences between models were related to wound location.

JULY 2018

Most of the treated wounds occurred on toes, with the least common wound location being the leg/ankle. Of the 709 treated wounds, 32.4% (n = 230) were WIfI stage 1, 19.9% (n = 141) were stage 2, 25.2% (n = 179) were stage 3, and 22.4% (n = 329) were stage 4.

Differences between the stages included larger increases in mean wound area size, wound depth, and mean time from wound onset to initial assessment as WIfI stages increased from 1 to 4.

Healed wounds were defined as “maintained complete epithelialization with the restoration of sustained functional and anatomic continuity for 6 weeks after complete healing.”

The researchers found that wound healing time significantly increased with increasing WIfI stage, with a mean wound healing time of 96.9 days for WIfI stage 1 wounds, increasing to 195.1 days for WIfI stage 4 wounds (P less than .001). The authors found a likelihood of 94.1% for stage 1 wounds to be healed at 1 year, decreasing to a low of 67.4% for stage 4 wounds (P less than .001).

In univariable and risk-adjusting multivariable analysis, WIfI stage had an independent negative association with wound healing.

With inclusion of risk adjustment, the probability of wound healing at 1 year was significantly lowered for stage 4 wounds, compared with stage 1 wounds (hazard ratio, 0.44). The three most prominent independently associated factors associated with poorer wound healing results include concomitant PAD (HR, 0.73), increasing wound area (HR, 0.99 per 1 cm2 area increase), and longer time from wound onset to initial assessment (HR, 0.97 per month). The strongest predictors for poor wound healing were increasing wound area (z score, –3.14), WIfI stage 3 (z score, –3.11), and WIfI stage 4 (z score, –5.40).

In this expanded study of previous work, the authors stated that they were the first to provide validating evidence for use of the WIfI classification system in giving “wound healing prognoses regardless of patient risk factors, comorbidities, and wound location.”

Their findings also demonstrated that this classification system has broader applications than its original purpose to provide prognostic information and risk expectations for major amputation for patients presenting with foot wounds, Dr. Hicks and her colleagues concluded.

The authors reported no conflicts of interest. ■ SOURCE: Hicks CW et al. J Vasc Surg. 2018 Apr 2. doi: 10.1016/j.jvs.2017.12.079.

BY BRUCE JANCIN MDEDGE NEWS R E P OR T ING F ROM E U ROP C R 2 0 1 8

PARIS – Endovascular device– delivered renal denervation has been dramatically resuscitated as a promisingly safe and effective nonpharmacologic treatment for hypertension on the basis of two rigorous positive, prospective, sham-controlled, randomized trials presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“These two trials are proof of concept. They were not intended to show superiority of denervation over drug therapy. They provide the proof of principle that when we interfere with the renal sympathetic nervous system we are able to lower blood pressure,” according to Felix Mahfoud, MD, an interventional cardiologist at Saarland University Hospital in Homburg, Germany, who was a coinvestigator in both trials.

As a longtime investigator in the field, he was selected by the EuroPCR 2018 organizers to present an official statement to attendees in conjunction with presentation of the two late-breaking clinical trials. The essence of the official commentary was that, despite what physicians have heard based on earlier major setbacks, renal denervation (RDN) therapy for hypertension is alive and well; it’s an active area of investigation; and it holds promise for addressing the vast unmet need for better control of hypertension.

“It’s an interesting field.

EuroPCR is committed to further support of the field. Stay tuned; there’s more to come.

It’s been a bumpy road up until now, but I think we’re back on track with renal denervation,” Dr. Mahfoud said.

A few years ago RDN was widely dismissed as a failed treatment strategy on the basis of the negative results of the phase 3 SYMPLICITY HTN-3 trial conducted in patients with

multidrug-resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). Since then, two European consensus conferences on device-based hypertension therapies were held in 2015 and 2017. Those

DR. MAURI

meetings analyzed key mistakes in earlier research and identified three key confounders that need to be standardized in order for high-quality research to move forward: The use of antihypertensive medications, or lack thereof, must be fixed and consistent; patients with severe treatment-resistant hypertension for whom basically nothing works are not the population to study initially; and key trial design and procedural details for the various endovascular therapies in development must be agreed upon.

The two sham-controlled trials presented at EuroPCR 2018 utilized different ablative energy sources: The RADIANCE-HTN SOLO study employed an ultrasound catheter, while the SPYRAL HTN-ON MED trial used a radiofrequency device. Both devices remain investigational. Each aims to ablate both the afferent and efferent renal sympathetic nerves located in the adventitia that run to and from the brain.

RADIANCE-HTN SOLO

Laura Mauri, MD, professor of medicine at Harvard Medical School, Boston, reported on 146 patients with mild to moderate hypertension at 39 U.S. and European centers, all of whom were deemed anatomically suitRenal continued on page 16

MDEDGE.COM/VASCULARSPECIALISTONLINE • 15

Renal continued from page 15

able for device therapy on the basis of the results of renal angiography. After a 4-week antihypertensive medication washout period, by which point their average blood pressure had climbed to 150/93 mm Hg, they were randomized in single-blind fashion to endovascular ultrasound RDN using ReCor Medical’s Paradise system or to renal angiography as a sham procedure.

The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months’ follow-up post procedure in an intent-to-treat analysis. The RDN group had an 8.5mm Hg reduction from baseline, compared with a 2.2-mm Hg reduction in sham-treated controls.

In a per protocol analysis excluding the five patients in the RDN group and 13 controls who required antihypertensive medication during the 2-month follow-up period, the average reduction in daytime ambulatory SBP was 8.5 mm Hg in the RDN group and 0.1 mm Hg in controls.

Similar statistically significant and clinically important placebo-con-

A reliable predictor of response is desirable so that likely nonresponders to RDN aren’t needlessly exposed to the procedure. trolled reductions in blood pressure were seen in all other endpoints, including 24-hour ambulatory, office, and home blood pressure.

“To put this in context, the magnitude of effect observed both on ambulatory blood pressure as well as office blood pressure is comparable with differences in blood pressure associated with reduction in cardiovascular events in population-based studies and meta-analyses of antihypertensive medication randomized trials,” Dr. Mauri observed.

At 2 months, 20% of the RDN group had a blood pressure below 135/85 mm Hg in the absence of antihypertensive medication, compared with 3% of controls.

No major adverse events such as renal failure, major vascular complications, embolism with end organ damage, or hypertensive crisis occurred during 2 months of follow-up.

Follow-up will continue out to 3 years to evaluate the durability of therapeutic benefit.

16 • VASCULAR SPECIALIST

pharmacotherapy and independent The Paradise ultrasound system of adherence issues,” he added. achieves circumferential ablation at a And speaking of adherence, a key controllable depth of 1-6 mm in order to interrupt renal nerve traffic. Two or feature of SPYRAL HTN-ON MED was that the trial inthree ablations, each corporated periodic lasting 7 seconds, are drug adherence mondelivered to each of itoring using both the main renal arterurine and blood testies. The arterial wall ing. The results, Dr. is protected by water Kandzari said, were circulating through the eye opening: At any balloon. The results given time, roughly were published simul40% of patients in taneously with Dr. both study arms were Mauri’s presentation nonadherent to their (Lancet 2018 May 23; DR. KANDZARI antihypertensive meddoi: 10.1016/S0140ications. Moreover, 6736[18]31082-1). nonadherence was dynamic: It was SPYRAL HTN-ON MED not predictable for any single patient David E. Kandzari, MD, reported at any time point. on the first 80 patients to complete This 40% nonadherence rate was 6 months of prospective follow-up surprisingly high given that particin this ongoing international, sinipants in SPYRAL HTN-ON MED gle-blind, randomized trial of more were volunteers eager to participate in than 400 patients with inadequately a non–drug treatment study and were controlled hypertension on one to informed up front that they would be three commonly prescribed antihyundergoing adherence testing. pertensive medications. Participants As in RADIANCE-HTN SOLO, no are being randomized to RDN via safety issues arose during follow-up circumferential radiofrequency abin SPYRAL HTN-ON MED. The relation using Medtronic’s Symplicity sults were published simultaneously Spyral catheter or a sham control with Dr. Kandzari’s presentation procedure. Although in this trial (Lancet 2018 May 23; doi: 10.1016/ patients remain on their antihyperS0140-6736[18]30951-6). tensive medications, an earlier ranOne difference between the two domized trial established proof of technologies is that, unlike the ReCor principle for efficacy in the absence Paradise ultrasound catheter, which of antihypertensive drugs. ablates in the main renal arteries, the In the real RDN group, 24-hour Medtronic radiofrequency device is ambulatory blood pressure fell from placed in the side branches. baseline to 6 months of follow-up Asked whether he sees RDN, providto a statistically significant and clinied it is established as safe and effective, cally meaningful degree: by 9.0 mm being used primarily in hypertensive Hg systolic, compared with 1.6 mm patients who are on or off medication, Hg in controls, and by 6.0 mm Hg Dr. Kandzari replied that his personal diastolic versus 1.9 mm Hg with the view is it will have a role in both. Some sham procedure. Similarly, office patients would prefer not to take drugs. blood pressure fell by 9.4/5.2 mm Hg For others with uncontrolled hypertenwith RDN, compared with 2.6/1.7 sion despite multidrug therapy, RDN mm Hg in controls. could serve as adjunctive therapy that Notably, 24-hour ambulatory systolic reduces their need for medication. blood pressure was significantly lower Unanswered questions in the RDN group around the clock.

Additional studies of both technol“This may have important conogies are ongoing, and pivotal large siderations with regard to pharmaphase 3 trials are being planned, with cotherapies with pharmacokinetic peaks and troughs in the early morn- results expected in the next year or 2.

Asked if regulatory agencies are going hours and late evening, or pering to require large, long-term trials haps for groups with hypertension with hard cardiovascular endpoints as who are at especially high risk for a condition for approval, Dr. Mauri cardiovascular events, such as those said a strong case can be made for with nocturnal or early morning hybypassing this step. pertension,” observed Dr. Kandzari, “Blood pressure is remarkable,” she director of interventional cardiology replied. “It’s one of the strongest surand chief scientific officer at the rogate endpoints that we have in the Piedmont Heart Institute in Atlanta. medical literature. It’s supported by “This raises the concept of an ‘almultiple randomized trials of antihyways on’ effect for renal denervation pertensive therapies, which have shown therapy that may be in distinction to

that reductions in blood pressure are associated with reductions in mortality from cardiovascular events. That’s really the gold standard for a surrogate endpoint. So I think it’s convincing.

That being said, I would be very interested to also see hard endpoints in the long term, but that will take time.”

And time is a luxury in light of the escalating global hypertension pandemic. Dr. Mahfoud noted that it’s estimated that in 2015, 950 million people around the world had a systolic blood pressure in excess of 140 mm Hg. By 2025, that figure is expected to climb to 2.5 billion people. The Centers for Disease Control and Prevention estimates that more than 360,000 deaths per year in the United States have hypertension as the primary or a contributing cause. Blood pressure control rates remain unacceptably low, in the 50% range. Nonadherence is high. So there is a pressing unmet need for new forms of treatment.

Dr. Mahfoud cited three major remaining research priorities for RDN therapy. There is a need for some form of intraprocedural feedback to inform the interventionalist while still in the catheterization lab that the denervation is successfully completed. A reliable predictor of response is desirable so that likely nonresponders to RDN aren’t needlessly exposed to the procedure. And of course, the sustainability of benefit for RDN requires longer-term study.

Dr. Kandzari reported receiving institutional research support and consulting fees from Medtronic and several other medical device companies. Dr. Mauri reported receiving institutional research support from ReCor and other device companies and serving as a consultant to ReCor and Medtronic; in addition, she has accepted a position as a vice president at Medtronic to begin in September. ■ bjancin@mdedge.com

JULY 2018

ANEURYSMS

Screening for AAA: More harm than help?

BY MICHELE G. SULLIVAN MDEDGE NEWS FROM THE L A N CE T

D

eaths from abdominal aortic aneurysm among Swedish men are going down – but not because they’re being screened for the potentially fatal condition.

Although the death rate has decreased by 70% since the early 2000s, screening only saved 2 lives per 10,000 men screened. It did, however, increase by 59% the risk of unnecessary surgery, Minna Johansson, MD, and colleagues wrote in the Lancet.

“Screening had only a minor effect on AAA mortality,” wrote Dr. Johansson of the University of Gothenburg (Sweden). “In absolute numbers, only 7% of the benefit estimated in the largest trial of AAA screening was observed. The observed large

P E R S P E CT I V E by Stefan Acosta, MD

Risks from screening not so bad?

T

he study by Johansson et al. indicates a significant risk of overdiagnosis associated with routine screening for abdominal aortic aneurysm: Those risks may not be as clinically harmful as might be assumed, Stefan Acosta, MD, wrote in an accompanying editorial (Lancet 2018;391:2394-95).

“Although I agree that having a small AAA that needs long-term follow-up might be associated with negative psychological consequences, there could also be a window of opportunity [e.g., with statins, antiplatelet therapy, and blood pressure reduction], for individuals with increased burden of cardiovascular disease. Indeed, screening for AAA,

authors noted, is relatively short. A 2016 review of the Swedish Nationperipheral artery disease, and hywide Abdominal Aortic Aneurysm pertension, with the initiation of Screening Program determined relevant pharmacotherapy, if posithat significant mortality benefit tive, reduces all-cause mortality and could take 10 years to materialize some evidence suggests (Circ 2016;134:1141Dr. Acosta is a vascular that this approach of 8). disease researcher at multifaceted vascular The full impact of Lund (Sweden) Universcreening instead of Sweden’s remarkable sity. He had no financial isolated AAA screening decrease in smoking disclosures. should be considered.” is almost certainly When performed according to the making itself known in these outestablished criteria for elective AAA comes – smoking is implicated in surgery, the procedure is associated 75% of AAA cases. with less than 1% postoperative “The decreased prevalence of mortality, “mainly because of wide smoking in Sweden, from 44% of implementation of endovascular an- the population in 1970 to 15% in eurysm repair, a minimally invasive 2010, should be viewed as the main method.” cause of the decreasing incidence The 6-year follow-up time, as the and mortality of AAA.”

AAA continued on page 18

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ANEURYSM

Ruptured abdominal aortic aneurysm repair: Preop measures that predict death

BY TERRY L. KAMPS MDEDGE NEWS FROM THE J O UR N A L O F VA SCUL A R SURG ERY

F

our preoperative variables – age over 76 years, creatinine concentration greater than 2.0 mg/ dL, pH less than 7.2, and lowest ever systolic blood pressure less than 70 mm Hg – predicted 30day mortality following repair of ruptured abdominal aortic aneurysms (rAAAs), in a retrospective study of 303 patients treated at Harborview Medical Center at the University of Washington, Seattle.

AAA continued from page 17

reductions in AAA mortality were present in both the screened and nonscreened cohorts and were thus mainly caused by other factors – probably reduced smoking. … Our results call the continued justification of AAA screening into question.”

In Sweden, all men aged 65 years are invited to a one-time ultrasound abdominal aorta screening. Most par-

Risk scores for rAAA mortality outcomes provide helpful guides for patient care.

Brandon T. Garland, MD, and his colleagues at Harborview, reviewed the data set of patients, noting 50% were aged older than 76 years and 80% were male. Many patients had typical vascular risk factors: 65% had hypertension, 39% had coronary

ticipate. Anyone with an aneurysm is followed up at a vascular surgery clinic, with surgery considered if the aortic diameter is 55 mm or larger.

Dr. Johansson and her colleagues plumbed national health records to estimate the risks and benefits of this routine screening. The study comprised 25,265 men invited to join the AAA screening program in Sweden from 2006 to 2009. Mortality data were

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18 • VASCULAR SPECIALIST

artery disease, and 22% had chronic obstructive vascular disease. Patients who were treated for rAAA after 2007 and had preoperative computed tomography scans were assessed for endovascular

compared with those from a contemporaneous cohort of 106,087 men of similar age who were not invited to screen. Finally, the mortality data were compared with national trends in AAA mortality in all Swedish men aged 4099 years from 1987 to 2015.

A multivariate analysis adjusted for cohort year, marital status, educational level, income, and whether the patient already had an AAA diagnosis at baseline.

From the early 2000s to 2015, AAA mortality among men aged 65-74 years declined from 36 to 10 deaths per 100,000. This 70% reduction was similar in both screened and unscreened populations; in fact, the decline began about a decade before population-based screening was introduced and continued to decrease at a steady rate afterward.

After 6 years of screening, there was a 30% reduction of AAA mortality in the screened population, compared with the unscreened, translating to an absolute mortality reduction of two deaths per 10,000 men offered screening.

Screening increased by 52% the number of AAAs detected. The absolute difference in incidence after 6 years of screening translated to an additional 49 overdiagnoses per 10,000 screened men.

Looking back into the mid-1990s, the investigators saw the numbers of elective AAA surgeries rise steadily. In the adjusted model, screened men were 59% more likely to have this procedure than unscreened.

The increased risk didn’t come with an equally increased benefit, though. There was a 10% decrease in AAA ruptures, “rendering a risk of overtreatment of 19%, or 19 potentially avoidable elective surgeries

Predict continued on page 19

per 10,000 men,” the team noted.

“Sixty-three percent of all additional elective surgeries for AAA might therefore have constituted overtreat.”

The findings are at odds with large published studies that found a consistent benefit to screening.

“Compared with results at 7-year follow-up of the largest trial of

In absolute numbers, only 7% of the benefit estimated in the largest trial of AAA screening was observed. screening for abdominal aortic aneurysm [Multicentre Aneurysm Screening Study (MASS)], we found about half of the benefit in terms of a relative effect and 7% of the estimated benefit in terms of absolute numbers [2 vs. 27 avoided deaths from AAA per 10,000 invited men]. Compared with previous estimates of overdiagnosis and overtreatment, we found a lower absolute number of over-diagnosed cases [49 vs.176 per 10,000 invited men] and fewer overtreated cases [19 vs. 37 per 10,000 invited men]. However, since the harms of screening decreased less than the benefit, the balance between benefits and harms seems much less appealing in today’s setting.”

None of the authors had any financial disclosures. ■ msullivan@mdedge.com

SOURCE: Johansson et al. Lancet 2018;391:2441-7.

JULY 2018

Predict continued from page 18

aneurysm repair (rEVAR) based on infrarenal neck length and diameter and access vessel size. Noneligible patients and all patients treated prior to 2007 had open repair (rOR) surgery.

A primary screen of selected preoperative variables included age, hematocrit, systolic blood pressure values, use of cardiopulmonary resuscitation, pH, international normalized ratio, creatinine concentration, temperature, partial thromboplastin time, weight, history of coronary artery disease, and loss of consciousness at any time.

The four statistically significant associations were age over 76 years (odds ratio, 2.11; P less than 0.11), creatinine concentration over 2.0 mg/ dL (OR, 3.66; P less than .001), pH less than 7.2 (OR 2.58; P less than .009) and lowest ever systolic blood pressure less than 70 mm Hg (OR, 2.70; P less than .002) Each of the four predictive preoperative rAAA variables was assigned a value of 1 point. Individualized scores are simply calculated by totaling the number of preoperative risk predictors.

Of the original 303 patients, 154 were alive at 30 days following rAAA repair, and there was a significant benefit from using rEVAR. Overall, patients with 1-, 2-, 3-, and 4-point mortality scores had 30day mortality risks of 22%, 69%, 80%, and 100%, respectively. rEVAR mortalities dropped to 7% for a 1-point score and to 70% for a 3-point score.

There were no 30-day survivors with 4-point risk scores regardless of whether they had rEVAR or rOR procedures.

The predictive risk scores for rAAA mortality outcomes provide helpful guides for patient care recommendations, and can be used to supplement the rOR-validated Glasgow Aneurysm Score, Hardman index, and Vascular Study Group of New England risk-predicting algorithms to “aid in clinical decision-making in the endovascular era,” the researchers wrote. The scores also add “prognostic information to the decision to transfer patients to tertiary care centers and aid in preoperative discussions with patients and their families.”

Dr. Garland and his colleagues reported that

they had no financial conflicts of interest.

SOURCE: Garland BT et al. J Vasc Surg. 2018 May 9. doi: 10.1016/j.jvs.2017.12.075.

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