Vascular Specialist March 2020

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Faith and flaw: the replication crisis is here

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Role of SVS VQI data in paclitaxel clinical practice

12 Your SVS Storming into 2020 and horizons beyond following year of significant progress VOL. 16 • NO. 3 • MARCH 2020

Newly FDAapproved device for central venous occlusions hailed as exciting advance

‘No evidence’ to suggest spinal cord injury is decreased by prophylactic drainage during EVAR procedures

BY BRYAN KAY

H

See Surfacer · page 10

Gustavo S. Oderich (center) speaking at Critical Issues America

BY BRYAN KAY

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IAMI—Cerebrospinal fluid (CSF) drainage is a key component in the treatment of spinal cord injury but the evidence that prophylactic drainage decreases such injury during endovascular repair (EVAR) is “at best weak,” Gustavo S. Oderich, MD, told the Critical Issues America annual meeting in Miami, Florida, held Feb. 7–8.

Last year, Oderich et al, of the Mayo Clinic in Rochester, Minnesota, published a study in the Journal

Vascular Specialist 9400 W. Higgins Road, Suite 315 Rosemont, IL 60018

OUSTON—These are exciting times in the theater of dialysis access, expert in the field Eric Peden, MD, mused in the latter part of last year—“and that’s not always been easy to say because dialysis has had not too much change for many decades.”

That’s starting to change, the division chief and program director for vascular surgery at Houston Methodist DeBakey Heart & Vascular Center said.

And so it was that, in the middle of February, one of those latest developments gained Food and Drug Administration (FDA) approval. The new piece of technology, named the Surfacer Inside-Out Access Catheter System and developed by private medical technology company Bluegrass Vascular Technologies (BVT), was designed to help patients with central venous occlusions.

of Vascular Surgery that discovered severe complications from placement of cerebrospinal fluid drains (CSFD) during first-stage thoracic endovascular aortic repair (TEVAR) and fenestrated-branched endovascular repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). At that point, Oderich and colleagues found they were occurring at an “alarming rate” in their prospective, nonrandomized study.

In this latest presentation, Oderich sought to answer the question: “Are preoperative spinal drains necessary?”

See Drainage · page 4

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FROM THE EDITOR

The replication crisis is here Malachi Sheahan III is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at Louisiana State University Health Sciences Center in New Orleans. He is the medical editor of Vascular Specialist.

BY MALACHI SHEAHAN III, MD

I

n 2011, a new research study proved the existence of precognition, also known as Extra-Sensory Perception (ESP). The manuscript was published in the Journal of Personality and Social Psychology, a well-regarded peer-review journal with a highimpact factor. The author was Daryl Bem, a star in the field of psychology, best known for his highly influential self-perception theory of attitude.

Bem performed his ESP testing over 10 years, enrolling 1,000 subjects. The trial design consisted of nine separate mini-experiments. In one, participants were told to pick between two curtains on a computer screen, one of which was obscuring a photograph. The location of the photo was then determined at random after the participant made their choice. Subjects who could reliably choose the correct curtain must, therefore, have knowledge of the future. Of the nine similar mini-experiments performed, eight reached statistical significance.

The results of Bem’s research forced scientists to make a daunting choice. Should they accept the data and believe the impossible? Or reject it, which would also mean rejecting most of their faith in scientific method? That was the catch; Bem’s study design and statistical analysis were nearly flawless.

The report would have fundamentally changed modern science, except for one problem: It could not be reproduced. As other researchers quickly attempted to confirm Bem’s amazing findings, most were unsuccessful. These failures spurred wider attempts to duplicate other psychological experiments. Again, most results could not be repeated. An entire scientific field was collapsing.

Bem’s study was the birth of the “replication crisis” in psychology.

Many scientists and physicians were not surprised by these developments, labeling psychology a pseudo-science. The trouble with dismissing

VASCULAR SPECIALIST 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, 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 Director of Membership, Marketing and Communications Angela Taylor Managing Editor SVS Beth Bales

2 • VASCULAR SPECIALIST

psychology research is that most of the methods and statistics used are universal to science. Would other medical fields be subject to the same dilemma of faith? The answer came quickly. In 2011, Bayer Healthcare attempted to reproduce the results of 47 cancer projects; they were successful in less than 25%. In 2012, Amgen tried to confirm the findings of 53 landmark cancer trials; they succeeded in six.

To understand why our research methods may be fundamentally flawed, it is helpful to look at how they became standard practice in the first place.

Genesis

The birth of modern medical statistics can be traced to a small agricultural research lab in 1920s London, where a young woman preferred to have her tea prepared just so. That woman was Muriel Bristol, an algae biologist. One afternoon during a break at the lab, a mathematician named Ronald Fisher offered Bristol a cup of tea. She refused the cup, noting that Fisher had poured the milk first and the tea second. Bristol stated that she preferred the milk to be added to the tea, and not the reverse.

Fisher was a brilliant scientist and well versed in thermodynamics. There was absolutely no way that the order of the ingredients mattered. Bristol simply insisted that she could tell the difference. It was here that William Roach, a chemist, intervened. Roach

proposed a test, eight cups prepared, four with milk first and four with tea first. Then the cups would be randomly presented to Bristol for tasting.

After sampling, Bristol correctly identified the preparation method of each of the eight cups.

The secret, unbeknownst to any of them, is that when milk is poured into tea, more surface area is exposed to the hot water. At temperatures above 160°F, the whey proteins in milk denature and produce a caramel flavor. This process is minimized when the milk is poured first. Regardless of the reason, Bristol could clearly and reliably identify the tea preparation by taste. The experiment had lifelong implications for each of them. Bristol and William Roach were married. Ronald Aylmer (R.A.) Fisher birthed modern statistical theory.

Fisher became obsessed with the results of the trial. Based on the study, he calculated that the odds that Bristol could not discern the tea preparation by taste were one in 70. But what if she had made a mistake? If she had only correctly identified six of eight cups, then the odds would increase to one in four. Therefore, the sample size was too small; having 12 cups would have been a better design to account for error.

Fisher also realized that it was harder to prove something than to disprove it. If one were to hypothesize that Bristol could identify the tea preparation with 100% accuracy, even a 100-cup sample size could not confirm this with absolute certainty. Yet only one incorrect guess would disprove the statement. This was the origin of the null hypothesis. Fisher began to apply his burgeoning theories of study design to his career in agriculture. In their research lab, different fertilizers were compared by putting one on plot A and another on plot B, and so forth. Fisher realized this method was useless because it was “confounded” by the conditions of the plots. What Research continued on page 4

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 healthcare policy. Content for Vascular Specialist is provided by BIBA Publishing. Content for the News From SVS is provided by the Society for Vascular Surgery.

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MARCH 2020

CAROTID DISEASE

Patients with asymptomatic severe carotid stenosis may be successfully managed medically, researchers find ‘relatively high’ long-term survival

BY BRYAN KAY

S

TEAMBOAT SPRINGS, Colo.— High-risk patients with asymptomatic severe carotid stenosis may be successfully managed medically, delegates at the winter meeting of the Vascular & Endovascular Surgery Society (VESS) held in Steamboat Springs, Colorado, Jan. 30–Feb. 2, were told.

That was the nub of findings delivered by Jeffrey Siracuse, MD, of the division of vascular and endovascular surgery, Boston Medical Center, Boston University School of Medicine, Boston, in a presentation entitled, “Selective non-operative and delayed management of severe asymptomatic carotid artery stenosis.”

“Reasons for non-operative and delayed operative management of severe asymptomatic carotid stenosis were commonly due to comorbidities and advanced age,” Siracuse et al found. “However, a subset of patients was never referred to vascular surgeons or interventionalists. Adverse neurologic events due to carotid stenosis were not observed during follow-up and patients had relatively high long-term survival.”

Randomized controlled trials, such as the Asymptomatic Carotid Stenosis Trial-1 (ACST-1), have shown the benefit of intervention in asymptomatic patients with carotid artery stenosis, Siracuse considered, but patients with a greater degree of stenosis have been shown to benefit more from carotid endarterectomy [CEA] than medical therapy.

“However, these data are older and may not reflect the contemporary patient population and modern medical therapy regimens.”

Extrapolating on the background to his research, Siracuse continued with discussion that asymptomatic patients on modern medical therapy have a lower ipsilateral stroke rate compared to historical cohorts. As such, he went on, some providers have advocated for only medical management of asymptomatic carotid disease. But several single-center studies have demonstrated that medical therapy alone may be inadequate given that almost 25% of patients with moderate to severe carotid stenosis develop symptoms.

“Additionally, the threshold of

MARCH 2020

JEFFREY SIRACUSE

stenosis severity at many centers to treat asymptomatic carotid disease has changed over time.”

The paper on which the talk was based was a single institution retrospective analysis that looked at 35 internal carotid arteries in 35 patients with severe asymptomatic carotid (80–99%) stenosis on duplex ultrasound from 2011–2018 that did not undergo intervention.

“Reasons for no/delayed intervention were classified as severe medical comorbidities (48.6%), no referral for intervention (14.3%), advanced age (11.4%), patient refusal (11.4%), other severe concomitant cerebrovascular disease (8.6%), and active/advanced cancer (5.7%),” they wrote. “Over a median follow-up of 35.2 months, no patients experienced TIAs [transient ischemic attacks]/strokes attributable to carotid stenosis.”

Severe

Siracuse and colleagues had set out to assess the reasons for and outcomes of non-operative/delayed operative management of asymptomatic severe carotid stenosis.

They utilized institutional vascular laboratory data from across the eight-year period outlined, looking

for all patients who underwent a carotid duplex ultrasonography.

They included patients with severe asymptomatic carotid stenosis (80– 99%), defined “by an end diastolic velocity >140cm/sec on duplex ultrasound in patients without TIA/strokes <six months prior to imaging.” The authors went on to explain that non-operative/delayed operative management was defined as not having undergone CEA or carotid artery stenting (CAS) <six months after imaging. “Reasons for nonoperative management or delayed intervention as well as subsequent TIA/stroke and survival were determined.”

Among 225 patients with severe asymptomatic carotid stenosis, 35 (15.5%) were managed nonoperatively or with delayed operation.

The mean age in this subset was 72.6±11.4 years, with the majority female (57.1%).

Background

Furthermore, the group had a smoking history (74.3%) and were on statins (62.9%) at the time of index duplex ultrasound. “One patient had a multifocal bilateral stroke after a cardiac arrest and prolonged resuscitation,” the authors noted. “No patients developed carotid occlusion.

A subset of patients underwent delayed CEA (8.6%) or CAS (2.9%).

Four-year survival after initial imaging was 79%.”

The investigators delved into the literature. “Previous studies have looked at those who had delayed intervention after detection of carotid stenosis,” they found. “One single institution study used a more liberal definition (70–99%) and found that 24.6% developed symptoms with 45% of these being strokes.

“The majority developed neurological symptoms within the first year of image detection. This rate is much higher than what we see in our analysis with a longer follow-up

“Adverse neurologic events due to carotid stenosis were not observed during followup and patients had relatively high longterm survival.”—Jeffrey Siracuse et al

time and what has been reported in other asymptomatic patients. Survival in this cohort was 69.8% at five years, similar to our analysis.”

Autonomy

Although they recommended intervention, Siracuse et al pointed out, “preservation of patient autonomy is important, especially since CEA or CAS are prophylactic operations with potentially devastating complications and given disagreement on the best course of action.”

They continued: “Additionally there was a subset of patients who were not referred. It is unclear if these patients had appropriate risk-benefit discussion with their primary care provider, if the results were not followed up on, or if there was a misinterpretation of the results or what the available options were during that time.

Concomitant disease was also another reason for delayed referral. These patients with tandem lesions and proximal common carotid disease have been shown to be at high risk for intervention of asymptomatic disease.”

The research team pointed out some of the limitations to study. They included the fact that medication compliance throughout the study could not be determined; carotid duplexes are routinely obtained during follow-up at their institution but patients whose lesions progressed in between scans may not have been captured; and patients who were seen during follow-up without additional duplexes were considered not to have documented progression.

“Additionally,” they noted, “practice varies amongst physicians which may impact treatment and follow-up provided to patients.

“Plaque detail that could be obtained from MRI [magnetic resonance imaging] was not available for this retrospective study as many of our patients only have duplex as their imaging modality.”

Still, Siracuse et al were convinced that their research produced robust evidence. “Despite these limitations, our study reflects contemporary medical management of patients with asymptomatic severe ICA [internal carotid artery] stenosis,” the researchers noted.

VASCULARSPECIALISTONLINE.COM • 3

TRIALS

Research Continued from page 2

if plot A was more naturally fertile?

Fisher then introduced a new concept.

The fertilizers would have to be randomized to different plots. Still, that would not be enough to determine if the differences measured were real or random. Fisher’s answer to this problem was a method called analysis of variance, or ANOVA. Now scientists had a statistical tool to differentiate association from causation—to finally figure out what causes what.

Thwarted

Fisher attempted to publish these new methods, but his early career was stifled by Karl Pearson. Pearson was the editor of Biometrika, the only statistical journal at that time. Fisher had a combative style and his wars with Pearson severely hindered his academic progress. In one instance, Pearson was trying to design a formula to estimate the effects different variables had on each other when only a small sample size was available. The math was extremely complicated, and Pearson spent years working on individual scenarios.

Fisher looked at the problem and, within a week, submitted a solution that was applicable for all cases.

Despite it being correct, Pearson initially rejected Fisher’s submission.

Even after publishing the highly

influential “Statistical Methods for Research Workers” in 1925, Fisher could not get an academic appointment. Finally, in 1933, Karl Pearson retired and Fisher received an appointment in eugenics at University College London. The position only came with the caveat that he was forbidden to teach statistics; that role was given to Egon Pearson, Karl’s son.

Fisher went on to receive many accolades, including the Copley Medal, the Royal Medal and the presidency of the Royal Statistical Society. In 1952, he was knighted for his contributions

by Queen Elizabeth II. Despite his accomplishments, Fisher never held an academic position in statistics.

Fisher’s methods have their limits.

In the years before his death, he came out on the wrong side of one of the most important public health debates of the 20th century.

In 1944, the British Medical Research Council commissioned Austin Hill to investigate the rising mortality from lung cancer in men. Hill had recently headed a large study on the use of antibiotics for tuberculosis, which became the first randomized controlled trial ever published. Hill and his co-researcher Richard Doll set out to find the cause of the lung cancer epidemic. Pollution, better detection methods and smoking were the leading suspects. Hill realized that a randomized controlled trial would be impossible in this instance.

Drainage Continued from page 1

He opened by taking gathered delegates back a couple of decades.

“The story always starts in the early 1990s and this is the first prospective randomized trial,” Oderich explains. He is referring to a study carried out by E. Stanley Crawford, MD, that randomized 98 patients with extent I to extent III TAAAs. “It’s amazing to see the very high rate of spinal cord injury at 30% at that point and how much improvement we have made over the years in open surgical techniques,” he said.

“Of course, we are taught we should use a spinal drain for every extensive thoracic coverage, and that’s actually largely based on another paper, by Joseph Coselli, MD, another prospective randomized study of 145 patients with extent I and II TAAAs. “They had a more liberal use of drainage with an average of 64mL intraoperatively and 260mL postoperatively for two days, or two additional days in those patients who had sustained injury.”

Oderich went on: “There was a remarkable improvement in spinal cord injury. That is, 2.6% with drainage and 13% without drainage.

“Based on that, we started using drains and a lot of other agents, and in fact none have been 4 • VASCULAR SPECIALIST

Instead, he and Doll interviewed 1,400 hospitalized patients, half of whom were ill from lung cancer. They recorded complete medical, social and family histories looking for possible associations. Doll’s initial hypothesis was that lung cancer was related to the use of tar on modern roads. About two-thirds of the way through the study, however, Doll was convinced by the data to quit smoking. Hill and Doll published their results in the British Medical Journal in 1950. Conclusively, smokers were more likely to have lung cancer—and there seemed to be a dose-dependency related to the number of cigarettes smoked.

Correlation or causation?

While Hill and Doll attempted to match their control group for age, sex and location of residence, other confounding factors were possible.

Therefore, a second study was conducted which followed a large group of doctors, some of whom smoked. Mortality data were collected prospectively. The first 36 doctors to die of lung cancer were all smokers. In 1957, the Medical Research Council and the British Medical Journal declared that the most reasonable explanation for the results of these trials is that smoking causes lung cancer.

Fisher was now recently retired and an avid pipe smoker. He had the time and motivation for war.

Fisher denounced Hill and Doll as

shown with level one data or even close to level one data to be beneficial. A lot of them have been incorporated in the late learning curve of centers and therefore we become biased and assume these things are essential to prevent spinal cord injury.

“But, in fact, when we look at rates of injury in the endovascular literature it’s appalling to see the wide range of 2–50% and the rate of paraplegia of 0–29% in these publications.”

Why might that be? Oderich pointed to possible variances in honesty when reporting, going on to opine: “But I think that in a number of cases people mix pararenals extent IV with extent I–III TAAAs.” The bottom line, he said, is that “there is no prospective randomized trial.”

Oderich then turned his attention to another, as-yet-unpublished piece of research in which he was one of the investigators that delivered further interesting findings.

“We had one mortality among 232 consecutive cases,” he explained. “We had an overall rate of spinal injury of 4%.

“Note that in group one and two, [the figure] was 10% but note that at the end of the day, there was a 2% rate of persistent paraplegia,” adding, “I think what was disappointing on this paper was we found out that 20% of our paraplegias were actually due to spine hematomas.”

Oderich continued: “We then looked at the

spreading anti-tobacco propaganda and suppressing contrary evidence.

In a letter to Nature, he conceded that smoking and lung cancer were correlated, but he disputed the causation. What if those suffering from the inflammatory effects of lung cancer were using cigarettes to ease their pain? What if a third factor led to both smoking and lung cancer? Was there a shared genetic proclivity to both?

Fisher was able to convince many others to his side. Even the president of the American Cancer Society was a skeptic. Fisher died in 1962, never conceding this point. To Fisher, the null hypothesis was never disproven.

Followers of Fisher’s methods are often called frequentists. Most of the scientific research performed today is conducted with frequentist techniques.

The replication crisis has exposed many potential problems with these methods. Most frequentist approaches require conducting scientific studies in isolation, without incorporating data from prior knowledge.

So Fisher could attack each lung cancer study in isolation while ignoring the mounting preponderance of evidence. Frequentists have also come to rely disproportionately on p values—a tool even Fisher said should be supplementary. Next month in Vascular Specialist, we will explore current flaws in study design and statistical methods that could lead to a replication crisis in vascular surgery.

literature and indeed there is this systematic review with 4,717 patients, 6,593 procedures, open and endo, 34 studies and note here that the rate of any complications was 10%.

“The most frequent one is headache requiring a blood patch but also very serious complications such as spine hematomas.”

Where do things stand now?

“There is a rationale for prophylactic drainage: we assume it prevents spinal cord injury and that placement of drains after the repair are potentially risky because of possible coagulopathy, and they are not always possible to do,” Oderich said.

“Probably over 90 or 95% of the patients actually don’t need the drain to begin with. There are also projected unnecessary risks.

“Not all the drains work. How many times have you had a patient paraplegic with a drain? The drain is actually not draining or is clogged. Or it leaks. Not all the spinal cord injuries improve with a drain. How many times have you had a patient with a drain wake up paraplegic or became paraplegic and didn’t improve?”

Oderich added, “We know that 10% of the drains cause serious complications ... I can tell you there is nothing like an unhappy patient the next day when you tell them they’re going to lay flat for two days or maybe with some improved drains they can move a little more.”

MARCH 2020

EMR

Minority of patients in population of 4M demonstrate rapid progress of carotid stenosis, SAVS prize-winning paper finds

BY BRYAN KAY

P

ALM BEACH, Fla.—While the overall incidence of rapid carotid stenosis progression is low, patients who show any degree of a worsening condition may warrant closer followup—especially if they bear associated risk factors for such rapid progress.

That was a core conclusion of the 2020 Founders’ Award paper presented by Carney Chan, MD, at the Southern Association for Vascular Surgery (SAVS) annual meeting held in Palm Beach, Florida, Jan. 8–11.

Entitled “Rapid progression of carotid stenosis is rare in a large integrated healthcare system over an eight-year period,” Chan and colleagues aimed to examine the natural progression of the condition, identify a subset of patients with rapid development of the stenosis and evaluate specific risk factors.

Each year, the SAVS Founders’ Award recognizes trainees presenting papers of either original, clinical or basic science at the association’s annual meeting, with Chan, a fellow at the Ochsner Clinic in New Orleans, collecting his award at the close of his presentation from William Jordan, MD, SAVS secretary/treasurer, and Adam Beck, MD, the 2020 SAVS meeting program chair. By way of background Chan et al pointed out the current Society for Vascular Surgery guidelines suggest screening for asymptomatic carotid stenosis in a select group of high-risk patients. The researchers said there was “a

WILLIAM JORDAN, CARNEY CHAN AND ADAM BECK

paucity of data” on rapid progression on a large scale.

They identified patients in a large integrated health system who had received two or more carotid duplex ultrasounds for stenosis between August 2010 and August 2018, using a novel algorithm to identify which of them displayed the rapid progression and, additionally, to determine associated risk factors and comorbidities.

An electronic data warehouse bearing 4 million unique patients for all carotid ultrasounds was

accessed. Filtering saw the retention only of those patients with two or more examinations.

Sharing their results, Chan noted: “With an initial cohort of over 4 million patients, the algorithm identified 4,982 with two or more duplex ultrasounds,” and this involved 10,037 carotid arteries having undergone 29,363 ultrasounds.

“Over the course of the study, 4,103 (82.4%) patients did not show any progression,” he said, “while 879 (17.6%) patients had some level of progression.

“We found 639 (12.8%) patients progressed one level, 164 (3.3%) two levels, 50 (1%) three levels and 26 (0.5%) progressed four levels. Of those that progressed, 116 (2.3%) progressed to level four (80– 99% stenosis) from any starting level over a median time of 11.5 months, with an average starting level of 2.1 (40–59% stenosis).

Summing up, Chan pointed out that the 17.6% who showed some degree of progression statistic was consistent with prior studies but that only 3.6% were rapid. “We identified younger age, Caucasian race, lower BMI [body mass index], diagnosis of PAD [peripheral arterial disease] and diagnosis of TIA [transient ischemic attack] as risk factors for rapid progression,” they found. “Lastly, while EMRs [electronic medical records] have been linked with physician burnout, we demonstrated appositive and novel use of this technology to understand the natural history of the diseases, as this approach could be applied for other disease processes.”

Cost of burnout on physician health and surgical performance explored

BY BRYAN KAY

N

EW YORK—It’s the recurring theme on the conference circuit that stubbornly refuses to subside but one whose toll is great and lasting.

At the VEITHsymposium in New York (Nov. 19–23, 2019), it was the turn of Samuel R. Money, MD, of the Mayo Clinic and based in Scottsdale, Arizona, to take up the baton in a talk entitled, “Vascular surgery burnout: Why it occurs. Is it related to occupational or ergonomic ailments and pain? What can be done to prevent and fix the problem?”

Money first turned to workload statistics derived from Society for Vascular Surgery (SVS) surveys. “The average vascular surgeon in North America works 63 hours per week,” he said. “That includes 10-and-a-half hours of work at home. Average call days per week: two-and-a-half to three.

If that doesn’t make you tired looking at it I’m not sure what else will.”

Some 41% of vascular surgeons have reached the criteria of being burnt out, Money went on. He referenced a recent study focused 6 • VASCULAR SPECIALIST

on how much pain surgeons were in after a day of operating. The majority, 78.3%, had moderate to severe physical pain after a full day.

Furthermore, the SVS ergonomic survey looked at different types of surgery as having different amounts of pain, Money elaborated, with surgeons who perform open surgery (predominantly neck and back) having the most and those who undertake endovenous the least.

Some 40% of vascular surgeons are in chronic pain, he said. “Physical pain, we have demonstrated, correlates with burnout. More pain yields more burnout symptoms.

“We did a little experiment where we looked at posture in the OR [operating room]. We know that the more you lean forward the worse your posture is, the more weight there is, for example, around your neck, around your back. Stand straight, and your head weighs 10–12Ilbs.

Lean forward to look at your phone like most of us do, and your head increases in weight to almost 60Ilbs.”

Money and colleagues used a system of four categories—mild,

moderate, high and severe stress—to calculate time spent in each range.

“If you look at the neck posture, a one on the scale is basically neutral.

A four is leaning forward or back probably to the maximum,” he said.

The results, he explained, were striking. “Three quarters of the time while operating, [among] 15 surgeons doing 35 cases or so, the neck is in a high or severe stress position—the trunk approximately 40% of the time in a high stress position.”

The solutions to this reality for surgeons range from easy to not so easy, said Money, and are grouped into three classes: pre-op, peri-op and lifestyle. He listed some: Padded floor mats. Good footwear. Screens should be 10–20 degrees below eye level.

Table height should be adjusted.

If you can sit down in a case, use an adjustable surgical chair up and down rather than straining the back and neck. Posture awareness. Regular exercise. Yoga. “There’s even a group in Denmark that’s developing a surgical specific exercise routine,” Money added.

He concluded, “Remember more than half of us feel that physical

discomfort we suffer during surgery will affect our ability to perform surgery. We have to reduce this.”

In other settings in recent times, meanwhile, doctors have sought to quantify revenue loss from burnout.

Anita Blanchard, MD, associate dean of faculty wellness programs at the University of Chicago, told the American Society for Dermatologic Surgery annual meeting (Oct. 24–27, 2019) in Chicago: “Burnout doesn’t just begin when you become an attending physician,” she said. “It happens as early as medical school.

There’s something about what we’re doing with training; in some ways, our system creates the problem.”

She referenced a Stanford University survey that showed 21% of physicians with symptoms of burnout left within two years compared with 10% of physicians with low burnout symptoms. Carrying out a similar survey at her institution, Blanchard and colleagues probed a five-year period among those who had resigned or retired. They found that it costs $250,000 to replace someone and make up for the lost revenue.

MARCH 2020

AORTA

Elevated risk of AAAs among individuals suffering depression post-risk factor adjustment discovered in HUNT study

BY BRYAN KAY

P

eople with depressive symptoms have a significantly higher risk of incident abdominal aortic aneurysms (AAAs) after adjustments for established risk factors, a study published in the Journal of the American Heart Association found.

“Symptoms of depression and risk of abdominal aortic aneurysm: A HUNT study” sought to probe the association of the condition with AAAs given its connection to cardiovascular diseases.

A team led by Linn Åldstedt Nyrønning, MD, of the department of vascular surgery at St. Olavs Hospital in Trondheim, Norway, conducted the study against a backdrop of scarce evidence of a link. The researchers considered the background of AAA. The potentially life‐threatening disease occurs in 1–3% of the adult population, and, left untreated, they said, ruptured AAAs are associated with almost 100% mortality. Smoking, age, heredity and male sex have been identified as risk factors for the disease, with strong associations having been found with conditions such as hypertension and hyperlipidemia. “The pathogenesis of AAA is not fully understood, and it is highly likely that unknown factors that have yet to be discovered may influence development of this disease.”

In a population-based prospective study, some 59,136 participants (52.4% women) aged 50 to 106 years from the HUNT (Norwegian Nord‐Trøndelag Health) study, staged in the northern European country, were mined in pursuit of the central aim of determining whether individuals with depressive symptoms have increased risk of AAA. “Symptoms of depression were assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS),” Nyrønning et al wrote.

“During a median follow‐up of 13 years, there were 742 incident cases of AAA (201 women). A total of 6,401 individuals (12.3%) reported depressive symptoms (defined as HADS depression scale [HADS‐D] ≥8); (52.5% women).

“The annual incidence rate of AAA was 1 per 1,000 individuals. At all ages, the estimated proportion of individuals diagnosed with AAA was higher among those with depressive symptoms (log‐rank test, p<0.001). People with HADS‐D ≥8 were older than those with HADS‐D <8 (median 57.8 vs. 52.3 years, p<0.001) and a statistically significantly higher proportion of them (p<0.001) were smokers, overweight or obese, and reported a history of coronary heart disease [CHD], diabetes mellitus and hypertension. In a Cox proportional hazard regression model adjusted for these factors, individuals with depressive symptoms had a ≈30% higher risk of AAA than those without (HR 1.32; 95% confidence interval [CI] 1.08–1.61; p=0.007).”

Setting the scene, the authors noted: “To our knowledge, only one previous study has reported a possible association between depression and development of AAA. This study showed a weak but increased risk of AAA in a subgroup with a history of depression.”

The HUNT study is a large multiphase affair

MARCH 2020

LINN ÅLDSTEDT NYRØNNING

conducted in the county of Nord‐Trøndelag in central Norway. The overall response rate was 89.4% in HUNT1 (1984–1986), which involved 77,212 participants; 69.5% in HUNT2 (August 1995–1997), including 65,237 people; and 54.1% in HUNT3 (2006–2008), capturing 50,807 participants.

The population of Nord‐Trøndelag County (n=127,000 during HUNT2) is representative of the Norwegian population as a whole, the researchers noted. Since, the population has been found to be relatively stable and homogeneous, making it suitable for epidemiological studies, they write.

The investigators continued: “The present study population includes 59,136 individuals who participated in HUNT2 and/or HUNT3 (53.8% participated in both), with no prior diagnosis of AAA, and who reached the age of 50 years before the study ended on Dec. 31, 2014.

“Among the 59,136 individuals (52.4% women), 742 incident (27.1% women) AAAs were detected (1.2%). Median age at initial HUNT participation was 53.7 years (range 31.6–101.4 years). For each HUNT survey, participants completed questionnaires regarding clinical and demographic parameters and underwent clinical examination.

The date of AAA diagnosis was obtained from hospital medical records. The unique personal identification number was used to link data on AAA diagnoses and death with exposure data from the HUNT study.

“In total, 622 cases of AAA (166 women) were identified among the 50,657 (51.2% women) individuals with complete data on all risk factors.”

“To our knowledge, only one previous study has reported a possible association between depression and development of AAA. This study showed a weak but increased risk of AAA in a subgroup with a history of depression.”

—Linn Åldstedt Nyrønning et al

In discussion of their findings, the investigators noted that the number of individuals with severe depressive symptoms was low in their study population, which they said might have resulted from a recruitment bias. Individuals with depression, particularly severe depression, tend to not attend screening programs or population‐ based studies upon invitation, they wrote. Only five of 622 AAA individuals had a HADS‐D score that was ≥15. “It is possible that this may have led to an underestimation of the association between depressive symptoms and AAA (selection bias).”

The authors considered that depression has been found to be more prevalent among patients diagnosed with AAA than in the general population.

“To our knowledge,” they wrote, “only one previous study has shown that depression might be a risk factor for AAA. Thus, our study adds evidence supporting that a bidirectional relationship may also exist between depression and AAA.” The authors weighed the strengths and limitations of their study. On one hand they highlighted the prospective design, the size of the study population, and the duration of follow‐up as making “it possible to address the association between depression and the risk of AAA, adjusted for a comprehensive range of potential confounding factors.”

The access to repeated measurements of risk factors made it possible to account for changes in the exposure levels during follow‐up, they added.

“The numbers at risk within a particular risk group are then more correctly defined, thereby reducing potential bias in the risk estimates because of misclassification of the exposure variable.”

On the other hand, the evaluation of depression and other risk factors was largely based on self‐ reported questionnaires, potentially leading to information bias, the researchers admitted.

“Symptoms of depression may vary over time, and we did not have repeated measures on all individuals in our cohort,” they wrote.

“Thus, potential misclassification might have occurred, despite the use of time‐dependent covariates. However, possible misclassification is likely to have been random, most probably resulting in an underestimation of relative risk estimates. There was no information about use of antidepressants, family history of AAA or physical activity, and unmeasured unknown confounding is always a limitation.”

The authors believe their work provides new support “to include assessment of depression in the evaluation of risk of AAA, which could potentially be especially important when screening subgroups at increased risk of this disease.”

In conclusion, Nyrønning et al were succinct in their analysis. “Depression has previously been linked to the risk of CHD and stroke,” the authors wrote. “In this large population‐based, prospective study, individuals with symptoms of depression had significantly higher risk of AAA, even after adjustment for established risk factors.”

SOURCE: DOI.ORG/10.1161/JAHA.119.012535 VASCULARSPECIALISTONLINE.COM • 7

COMMENTARY

Early adaptation of SVS, STS TBAD joint document will drive robust body of work for comparison

BY JOSEPH V. LOMBARDI, MD

T

he Society for Vascular Surgery (SVS) and the Society of Thoracic Surgeons (STS) recently published a joint document on reporting standards for type B aortic dissection (TBAD). The purpose of this document was to establish a standardized language for presentation, anatomy, procedural and postoperative follow-up in manuscripts dealing with patients treated for TBAD. Both the SVS and STS were represented by seven members, including co-chairs from each society.

The document is categorized according to the various stages of the patient’s management, from presentation to long-term follow-up.

The chronicity classification now ranges from hyperacute to chronic, whereby chronic dissections are now considered as patients with more than 90 days spanning from their initial presentation.

Among the many changes to convention and suggestions, the most pivotal contribution of this work is the introduction of the SVS/STS Dissection Classification System. This classification scheme now allows the aorta to be described in detail and with ease, while keeping in mind the novel operative techniques today, including endovascular management.

The classification now uses entry tear location to determine a type A vs. a type B dissection, while subscripts denote the proximal and distal extent of the dissection process, including areas of intramural hematoma (see Figure 1).

The patient’s presentation in terms of acuity has been categorized into three varieties: uncomplicated (patients without high-risk criteria), high risk and complicated (rupture and malperfusion). It was felt the use of the term uncomplicated in the past was variable and loosely applied in high-risk situations where comparisons could not be accurately made from one manuscript to another. Hence, a third high-risk category was defined such that investigations on operative vs. conservative management in these patients can be better communicated and compared to glean accurate clinical guidelines.

Patency of the false lumen was also adjusted to reference the entire aorta 8 • VASCULAR SPECIALIST

JOSEPH V. LOMBARDI

FIGURE 1

in its description.

A patent false lumen is defined as flow present throughout the entire aortic false lumen on the arterial phase or delayed contrast imaging.

Partial thrombosis is defined as clot within the aortic false lumen but with a residual patent flow channel on the arterial phase or delayed contrast imaging. Complete thrombosis is defined as complete thrombosis of the aortic false lumen on arterial and delayed-phase imaging.

Further descriptions of the false lumen are sources of persistent flow.

What was commonly referred to as an endoleak, a term used in the context of endovascular aneurysm repair, is now “entry flow,” which better describes—physiologically—the various sources of flow back into the false lumen.

There are only three types of entry flow described: types 1, 2 and R. Type 1 has two varieties representing flow into the false lumen from proximal (a) and distal (b) seal zones. Invariably, type 1b entry flow represents a stent graft-induced entry tear (SINE); type 2 entry flow via arch vessel branches (innominate, carotid, subclavian) or thoracic bronchial/intercostal arteries into the false lumen; and type R entry

FIGURE 2

flow from intercostal arteries, visceral or renal arteries, lumbar arteries, iliac branches or septal fenestrations (see Figure 2).

Aortic remodeling was also a buzzword that needed refinement in definition. Changes in the aorta over time can be defined as positive or negative aortic remodeling and must describe the entire aorta—not just the area stent grafted. Positive aortic remodeling is defined as either false lumen reduction in maximal diameter or volume and no growth in total aortic diameter or volume; true lumen expansion in maximal diameter or volume and no growth in total aortic diameter or volume; or total aortic maximal diameter reduction with variable changes in true and false lumen diameters. Negative aortic remodeling would represent the opposite behaviors, or a failure to demonstrate any of these descriptions.

Last but by no means least, the document covers end-organ ischemia (spinal, visceral, stroke), etiologies, outcome and complication reporting, with suggestions on imaging protocols.

The document was ultimately vetted by both societies along with

its members during a public feedback period as well as by the Food and Drug Administration before final approval. Early adaptation of these reporting standards will ensure a robust body of work for comparison from manuscript to manuscript.

Joseph V. Lombardi is a professor and chief of vascular surgery at the Cooper Medical School of Rowan University in Camden, New Jersey, where he is also director of the Cooper Aortic Center.

SOURCE: DOI.ORG/10.1016/J. JVS.2019.11.013

TBAD standards

The SVS and STS reporting standards document on TBADs is being co-published in the Journal of Vascular Surgery (JVS) and The Annals of Thoracic Surgery. This combined effort by the SVS and STS provides a unified consensus on reporting, nomenclature and classification of TBAD. While Joseph V. Lombardi performed the role of co-chair on the SVS side, Chad Hughes, MD, was his counterpart from the STS. MARCH 2020

NEWS FROM SVS

How SVS-STS tandem developed TBAD reporting standards

T

he Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) teamed up to release new reporting standards in order to ensure patients with type B aortic dissections (TBADs) receive appropriate treatment and care.

The care of patients with type B dissections has evolved over time and now includes medical, surgical and endovascular therapies, often in a multidisciplinary environment, and performed by several specialties, including vascular surgery, cardiothoracic surgery, interventional radiology as well as cardiology.

However, TBAD treatment has been confused by differences in nomenclature and terminology. This combined effort provides a unified consensus on reporting, nomenclature and classification of TBAD and was led by Joseph V. Lombardi, MD, on the SVS side and Chad Hughes, MD, on the part of STS. The SVS/STS Reporting Standards introduce a new classification system with several new and

easy-to-use features created by combining previous classification systems with the well-known anatomic zones of the aorta.

“The new classification system provides an easy way to be descriptive of patients’ anatomy using language that is relevant to the way we currently treat patients,” explained Lombardi as the standards were first announced.

Another important area described is the need for a clear and consistent definition of chronicity of aortic dissections.

The new standards also provide definitions of “uncomplicated” and “complicated” dissections, and includes a new “high-risk” category of dissections that is defined by the presence of specific ominous clinical and radiographic features when a patient presents with a TBAD. The standards also provide strict definitions of the common clinical complications of dissections and how they should be described and reported.

The document has been more than a year in the making, calling upon an extensive writing team of experts drawn from across both of the organizations.

“The multidisciplinary input from both vascular and cardiothoracic surgeons is unique and has resulted in a document that will define proper reporting for this complex topic,” said Hughes.

“Uniform reporting will allow standardized comparisons across series between different institutions worldwide with the goal being data that will best inform outcomes and guide best practices going forward.

“The purpose of this document is to provide structure to the reporting of TBAD, with particular attention to those attributes of TBAD which, based on the best available evidence to date, would appear to impact outcomes.”

The new guideline can be accessed at vsweb.org/ TBADreporting.

VRIC discussion agenda: Immune cell dysfunction and immunotherapy for vascular disease D rugs and therapies that target immune cells and pathways within the body already exist to fight a number of diseases. Can vascular disease join the list?

Internationally renowned immunologists and vascular biologists, Kathryn J. Moore, PhD, and Katey Rayner, PhD, will lead the Translational Panel at this year’s Vascular Research Initiatives Conference (VRIC), May 4, in Chicago. Moore is a professor of cell biology and the director of the New York University Cardiovascular Research Center.

Rayner is an associate professor in the departments of biochemistry and microbiology and immunology at the University of Ottawa Heart Institute in Canada.

“The immune system and its critical role in inflammation is proving itself to be more and more relevant in all vascular disease,” said Katherine Gallagher, MD, a member of the Society for Vascular Surgery (SVS) Research and Education Committee, which oversees VRIC. She and fellow committee member Jayer Chung, MD, championed the panel topic, “Immunology and Vascular Disease.” Gallagher will moderate.

Some of the concepts will be applicable “to every disease we treat,

MARCH 2020

PAD [peripheral arterial disease], AAA [abdominal aortic aneurysm], carotid disease, and all forms of atherosclerosis,” she said. “All of these diseases have some form of immune system dysfunction and, once identified, these pathways can be targeted with therapeutics.”

Moore and Rayner are investigating pathways and applying immune therapy to vascular disease, said Gallagher. “Their work is changing the field and identifying so many new targets for therapy.”

Drugs could target a particular cell or the pathway the cell is activating. Therapies could block the pathway or “flip it” into becoming a “good” cell, she said. “A lot of these immune pathways are being targeted already in treating other diseases, with cancer probably the most common. FDA [Food and Drug Administration]-approved drugs already are out there.”

That fact might speed the translation to treating vascular

disease, Gallagher theorized. “It makes sense to develop things that have been found useful in another human disease.”

The session will focus on the immunology-based mechanisms in vascular disease, with an eye on some of the translations that will be coming in the next five to 10 years.

Innovations are coming quickly, said Gallagher. “It’s only been in the past 15 to 20 years that our level of knowledge of the immune system and its role in disease has increased dramatically,” she said.

VRIC Chicago 2020: “From Discovery to Translation” will be Monday, May 4, at the Chicago Hilton in downtown Chicago. It is scheduled the day before and in the same location as the American Heart Association’s Vascular Discovery Scientific sessions. VRIC emphasizes emerging vascular science, with interactive participation with presenters and attendees. For more information visit vsweb.org/VRIC20.

VSIG webinar from APDVS coming soon

M

uch has been made of the impending shortage of physicians in the United States, with worrying predictions that it could be as soon as 2030. The driving force is a rising, aging population and an upsurge in chronic disease such as diabetes and obesity.

Not surprisingly, the vascular surgery specialty is predicted to suffer the greatest shortage. The Society for Vascular Surgery (SVS) and the Association of Program Directors in Vascular Surgery (APDVS) have taken strides to help combat this through medical student and resident outreach.

From 5:30 to 6:30 p.m. CDT on March 26, the APDVS Recruitment of Medical Students and Residents Committee will present a free informational webinar called VSIG Live! This will give all U.S. medical students the opportunity to experience a Vascular Surgery Interest Group (VSIG) meeting and to learn more about vascular surgery.

The webinar will highlight vascular surgery training options, how to start a VSIG at your institution, presentations from current trainees and more. This is a great opportunity for practising surgeons to host or sponsor a simple dinner for interested medical students at their local schools. The webinar will work best if vascular surgeons take interest at a local level. Impact the future and help make this event a success. Visit vsweb.org/VSIGLive.

VASCULARSPECIALISTONLINE.COM • 9

DIALYSIS ACCESS

Surfacer Continued from page 1

As Peden, also an associate professor of cardiovascular surgery, explained, he and his colleagues had a front row seat as the device was trialed in the U.S. The Surfacer System, which employs a novel inside-out approach, is the first FDA-cleared medical device that facilitates upper-body central venous access for patients with venous obstruction. The approval came by way of the results of the SAVE-US (Surfacer System to facilitate access in venous occlusions–United States) trial, with Houston Methodist one of seven sites where the research was conducted.

The brainchild of interventional cardiologist John Gurley, MD, of the University of Kentucky Medical Center, the Surfacer System received CE Mark approval in 2016 followed by a Post-Market Registry (SAVE Registry) on 30 patients, proving to be safe without mortality, Peden went on.

Similarly, the stateside trial confirmed that, of the 30 enrolled patients, 90% met both primary and secondary efficacy endpoints, with no adverse events related to the device reported.

The prospective, non-randomized controlled trial saw Houston Methodist contribute 10 of the patients involved in the study.

How it works

The device, as Peden outlines, works thus: “John said, ‘You can take one of my central venous accesses, and that’s it,’” explains Peden. “‘And after that, I want a device that takes me back to the right side of the neck every time.’

And that’s what he created.

“It’s kind of a unique thing because we wind up obliterating much of the central venous circulation in these dialysis patients.”

Peden drew attention to the

ERIC PEDEN

coming advance in a talk entitled “New solutions to dialysis access” held at the Houston Methodist in October last year.

He demonstrated how the device is used. “You come from below—and [John’s] done this through the liver and other things—but in this case the SVC [superior vena cava] or brachiocephalic veins are occluded. And we’re coming from below, through the heart, and the SVC stem … You can see collateral veins coming in from below.

“You would get what we would call a sheath. This is our first case. You get this large sheath up there and make sure it is embedded. You have to give up wire access at this point, which is a little disconcerting to most of us.

Then you advance this device, which is a straight metal rod, with a blunted tip. It tells the sheath where to go because it’s a fairly stiff device. You advance it out of that, up through the soft tissues … get above the clavicle and poke out. You put a skin marker

up on top so you can aim this device.”

It’s an exciting development, Peden said. “Because for most of these patients, they were relegated to going down to leg access or being stuck with catheters only down the legs, etc., and this for patients with uncrossable venous lesions.”

It poses some interesting questions, he said, continuing: “If the right side is occluded, should you put the catheter on the left or should you use this device to go through on the right side and not injure the left side?

[Here’s what] we know [about] leftsided catheters in dialysis patients: Remember, these are big catheters, these are 15Fr, that stay there a long time—and patients already have coagulopathy and disorders, and then go on to occlude their left side. So now they have both sides occluded, which is a real problem.”

One of the Houston cases in the stateside version of the trial was aborted. This occurred because the team “couldn’t direct the catheter in the right direction,” explained Peden.

Image intensive

This brought the surgeon to a larger point on what he described as an imaging-intensive procedure. “Is anything ever as easy as it appears?”

Peden asked. “Someone comes and shows you this slick device. You say, ‘Wow, it’s great, I’m going to try that.’ There’s lots of behind-thescenes manipulation with approaching commercially available devices.”

Summing up, Peden hailed the

“If the right side is occluded, should you put the catheter on the left or should you use this device to go through on the right side and not injure the left side?”—Eric Peden

device as an important new piece of the dialysis puzzle, explaining: “It’s really exciting technology for really challenged dialysis patients. I’m not sure though it’s going to be widely applicable to every single patient. My own personal bias is that it is image intensive. In our case we have always had cardiac surgery on standby at the time.”

He added: “I think it needs a generation two device that’s steerable but that’s going to allow central venous access in patients who otherwise couldn’t have it. It is pretty easy to perform but the potential hazards are very real and I think it needs careful attention.”

The interventional radiologist and SAVE-US lead principal investigator Mahmood Razavi, from St. Joseph Hospital, Orange, California, said: “The Surfacer System offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites.”

The current approach to treat venous obstruction is to use an alternative vein. This process results in increased catheter days and costs due to the reduced ability to place and mature a functioning fistula.

Milestone

Bluegrass Vascular CEO and president Gabriele Niederauer said: “We are thrilled BVT has reached this important milestone. For the first time ever, physicians in the U.S. can offer patients a reliable and repeatable solution to treat central venous obstructions and restore access to the right internal jugular vein, the preferred access site.

“Through our experience in Europe and other international sites, the Surfacer System has consistently demonstrated a positive clinical impact. We are eager to bring the Surfacer System and its important benefits to patients in the U.S.”

FDA official delivers government agency’s early reaction to latest contentious meta-analysis on paclitaxel-coated devices

BY SUZIE MARSHALL AND BRYAN KAY

H

OLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting significantly reduced amputation-free survival at one year when paclitaxel-coated balloons are applied in arteries below the knee for critical limb-threatening ischemia (CLTI) treatment.

Speaking at the 2020 International Symposium on Endovascular Therapy (ISET) held in Hollywood, 10 • VASCULAR SPECIALIST

Florida, Jan. 17–20, Ryan Randall, of the FDA’s peripheral interventional devices team, said given that it had been only a week since the study from Konstantinos Katsanos, MD, and colleagues had been released, they had not yet fully discussed and analyzed the publication internally but continued to work to understand the paclitaxel signal.

“We do note, though, that none of the devices included in this study are available in the U.S.,” he said. “There are currently no stents or drug-coated balloons approved for use below the knee in the U.S.” Randall summed the FDA position thus: “Our

current thinking regarding approved devices is that paclitaxel devices may remain on the market given that benefits may outweigh the risks for some patients based on clinical judgement.”

He said the FDA recommends doctors continue to discuss all treatment options with patients.

“Regarding ongoing and future trials, we have worked to update informed consent forms to ensure patients are informed of the risk,” Randall said.

“We’ve worked to closely monitor enrolled patients and worked to improve the collection of data and minimize missing data for these trials.”

MARCH 2020

COMMENTARY

Deploying robust, detailed SVS VQI data to help better define role of paclitaxel technology in clinical practice

BY DANIEL BERTGES, MD, AND JENS ELDRUP-JORGENSEN, MD

I

n December 2018, the Journal of the American Heart Association published “Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta‐ analysis of randomized controlled trials” by Konstantinos Katsanos et al.

This hotly-discussed and -contested article reported an increased mortality rate with the use of paclitaxel devices for the treatment of femoropopliteal artery disease. These findings were subsequently validated by a Food and Drug Administration (FDA) analysis—a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products compared to patients treated with uncoated devices. In response, the FDA released three communications ( Jan. 17, March 15 and Aug. 7, 2019) to healthcare providers about the use of paclitaxel devices. In June 2019, the FDA convened a panel with expert input to assess safety and further recommendations regarding paclitaxel devices. Since that time, there have been multiple publications reviewing the trial data as well as administrative databases which have not confirmed the mortality signal.

In September 2016, the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) began recording device-specific data (including paclitaxel devices) in the Peripheral Vascular Intervention (PVI) registry. VQI is the only clinical registry that records devicespecific information which allows identification of paclitaxel technology and correlation with detailed patient, clinical and outcomes data.

An early analysis of VQI data was presented at the FDA panel and at the SVS Vascular Annual Meeting in June 2019, reporting lower one-year mortality in claudicants treated with paclitaxel devices compared to nonpaclitaxel devices (1.6% vs. 4.4%; HR=0.59; 95% CI, 0.39–0.89, p=0.01).

Similar mortality was observed in patients with chronic limb-threatening ischemia for paclitaxel vs. nonpaclitaxel devices (12.8% vs. 15.5%;

MARCH 2020

DANIEL BERTGES

JENS ELDRUP-JORGENSEN

LOWER EXTREMITY

HR=0.85; 95% CI 0.72–1.0; p=0.05).

In brief, the mortality signal associated with paclitaxel technology was not seen in the PVI registry at a median of 17 months (range 10–22 months). The study has undergone peer review and is anticipated for publication in Circulation: Cardiovascular Interventions.

As the SVS VQI PVI registry is in the unique position of being the only clinical registry to have device identification and line-by-line patient clinical and outcomes data, it is important to use this information to further study the potential mortality signal. In response to this need, the SVS Patient Safety Organization (PSO) developed two studies to investigate paclitaxel outcomes in real-world practice.

First, we have engaged the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a coordinated registry network with proven methodology to match VQI patients to Medicare claims. VISION is supported by the Medical Device Epidemiology

Network (MDEpiNet), a global publicprivate partnership with the aim of advancing a national patient-centered medical device evaluation and surveillance system.

VISION is led by Phil Goodney, MD, and Art Sedrakyan, MD, who directs the MDEpiNet Coordinating Center at Weill Cornell Medicine in New York under a cooperative agreement with the FDA and its Center for Devices and Radiological Health (CDRH).

One of the limitations of the VQI registry is that most follow-up is limited to one year. Linking VQI patient data in a protected manner to CMS claims data allows investigators to extend the period of study prior to device identification in the VQI and beyond the one-year VQI follow-up.

The VISION analysis is examining mortality, reintervention and major amputation after paclitaxel treatment.

This ongoing analysis will leverage the strengths of the VQI PVI registry with the Medicare claims database.

Second, we have launched an active surveillance program of

paclitaxel mortality using Data Extraction and Longitudinal Trend Analysis (DELTA) in collaboration with Frederic Resnic, MD, at Lahey Hospital & Medical Center in Burlington, Massachusetts. DELTA is an open source software application for risk-adjusted analysis of clinical registry outcomes. DELTA is designed for early signal detection and will allow real-time monitoring of any mortality signal.

If identified, this would be immediately reported to the VQI membership. Further details about the study are available on clinicaltrials.gov under the identifier NCT04110288. We anticipate being able to report the results to VQI members in the coming months.

One of the values of the VQI is it is a large, robust and clinicallydetailed registry that allows analysis of relevant outcomes in a real-world population. In collaboration with our partners at VISION and DELTA, we hope to use VQI data to help better define the role of paclitaxel technology in clinical practice.

In brief, the mortality signal associated with paclitaxel technology was not seen in the PVI registry at a median of 17 months (range 10–22 months). The study has undergone peer review and is anticipated for publication in Circulation: Cardiovascular Interventions.

Daniel Bertges is associate professor of surgery at the University of Vermont Medical Center in Burlington, Vermont, and chair of the SVS VQI PVI Committee.

Jens Eldrup-Jorgensen is professor of surgery at Tufts University School of Medicine in Boston and a vascular surgeon at Maine Medical Center in Portland, Maine. He is the SVS PSO medical director.

VASCULARSPECIALISTONLINE.COM • 11

NEWS FROM SVS

Your SVS: Storming into 2020 and horizons beyond SurgeonMasters. Check it out on SVSConnect

BY KENNETH M. SLAW, PHD

W

ith significant progress made on many fronts in 2019, the Society for Vascular Surgery (SVS) is looking forward to the next horizon in 2020.

In late January, I updated the Strategic Board of Directors on progress to date on strategic priorities for the past year. The board also set priorities for 2020–21.

In six areas, 85% of strategic planning objectives were accomplished or experienced significant progress. Highlights include: Strengthening SVS

The Vascular Surgery Branding Campaign is on the launchpad and the countdown has begun for an initial soft launch at the Society for Clinical Vascular Surgery (SCVS) 48th annual symposium in March with a formal launch to follow at the Vascular Annual Meeting (VAM) in June. The initial focus is on referral sources and development of a member toolkit for local branding SVS, in collaboration with the Vascular and Endovascular Surgery Society (VESS) and SCVS, has formally launched its inaugural Leadership Development Program.

A cohort of 25 vascular surgeons has begun a six-month longitudinal leadership skills-building program culminating at VAM 2020 Speaking of collaboration, SVS has initiated an outreach program seeking to develop and codify collaborations across vascular societies. SVS leadership has met regularly with national vascular surgery leaders and leaders of regional societies SVS has completed its move to new home headquarters in

Advancing quality

KENNETH M. SLAW

Rosemont, Illinois. In the first year, an unprecedented 125-plus SVS members have visited the space, fulfilling the Executive Board’s vision of a member-centric HQ SVS celebrated the one-year birthday of SVSConnect, the new member online community Addressing practice issues

The Vascular Valuation Study was launched. The SVS engaged SG2 to complete a comprehensive assessment and consulting report on the valuation of vascular surgery services. More than 525 SVS members responded to an essential survey, with results and a final report to be delivered at VAM The Document Oversight Committee (DOC) produced three additional published guidelines this past year, has six in the pipeline and is actively working to streamline the guideline development process The SVS Wellness Task Force completed phase one of its work focused on researching the issue in vascular surgery and presented several abstracts at VAM and other societies’ meetings. Phase two, focused on member support services, has launched with

The SVS and American College of Surgeons are on the launching pad to pilot the Vascular Center Verification and Quality Improvement Program (VCV & QIP) in Spring 2020. A broader launch plan will be announced at VAM The Alternative Payment Models Task Force completed its work and presented its final report and recommendations The SVS Patient Safety Organization/Vascular Quality Initiative completed another stellar year hitting milestones of 650 subscribed data collection sites and 665,000 cases and has successfully launched the new Vascular Medicine Consult Registry in collaboration with the American Heart Association and the Society for Vascular Medicine, and Venous Stent and Varicose Vein Registries with the American Venous Forum Excellence in education

SVS is working with the Association of Program Directors in Vascular Surgery (APDVS) to address future training and education gaps regarding open surgical skills and with APDVS, VESS and SCVS, on an integrated approach and career support for medical students and vascular surgery trainees The SVS Learning Management System is nearly ready for launch.

The SVS online education portal is on the launch ramp and will be ready to debut at VAM VAM is evolving into “Future VAM.” Come and experience an ever-changing, ever more robust and exciting VAM in Toronto, June

17–20, featuring more ask-theexperts sessions, a new Practice Pavilion for hands-on education and, of course, the best new and original science in the field of vascular surgery Aggressive advocacy

Vascular surgery is facing unprecedented cuts in payment with new Centers for Medicare and Medicaid Services rules, and the SVS Advocacy and Policy Council, Coding Committee, Government Relations Committee and Political Action Committee are front and center fighting for your patients, quality and the value of vascular surgery. They need your help and engagement. If you have given to the SVS Political Action Committee (PAC), now is the time to double your donation, and, if you have never given, if ever there was a time, this is it!

Research

The Vascular Research Initiatives Conference (VRIC) hit a new record with more than 200 submitted abstracts SVS, working with Elsevier, launched its newest edition to the Journal of Vascular Surgery portfolio, JVS-Science, a basic science journal Many of the bold signature programs developed by the SVS Strategic Board over the past two years have hit the implementation stage. It is going to be an exciting year thanks to the foresight and support of the SVS leadership and membership.

The only thing more exciting is the next horizon for SVS. Thank you.

Kenneth M. Slaw is the SVS executive director.

O Canada: VAM 2020 housing, registration now open

R

egistration and housing for the 2020 Vascular Annual Meeting (VAM) are now open.

The 2020 Society for Vascular Surgery (SVS) meeting will be held June 17 to 20 in Toronto, Canada. VAM starts with a full day of educational programming June 17, including six postgraduate courses, a number of international events, abstract presentations from the Vascular and Endovascular Surgery Society, an “Ask the Expert” session on mentorship in vascular surgery and a concurrent session on digital health advancements in the field of vascular surgery.

12 • VASCULAR SPECIALIST

Also happening Wednesday is the hugely popular simulation training for medical students and general surgery residents, followed by a welcome reception for those attendees.

Wednesday continues with the first day of the Society for Vascular Nursing’s annual conference and the second—and final—day of the Vascular Quality Initiative (VQI) annual meeting, VQI@VAM. Scientific sessions will be held June 18 to 20, and the Exhibit Hall will be open June 18 to 19.

The second annual SVS Foundation “Vascular

Spectacular Gala: Northern Lights” will be Friday, June 19.

To register and obtain housing, and for the VAM schedule at a glance, visit vsweb.org/VAM2020.

As a reminder, most VAM attendees will need a passport to travel to and from Canada. For additional information (including passport requirements for international travelers), please visit the Canada Border Services Agency information page at vsweb.org/CanadaDocuments.

MARCH 2020

NEWS FROM SVS

Leadership: Developing mission, vision and strategy return fulfills strategic visions. The key to success is building great teams not only in the provider staff but with everyone in your vascular department.

BY JAMES ELMORE, MD

M

ission, vision and strategy are necessary to develop a cutting-edge vascular surgery program. To maintain such a program, one needs to implement an overall long-term strategic plan, as well as meticulously oversee the administration of day-to-day details.

It was a pleasure to talk to Edward Woo, MD, director of the MedStar vascular program. He also is the chairman of vascular surgery, MedStar Washington Hospital Center and MedStar Georgetown University Hospital, and professor of surgery at Georgetown University. He supervises vascular surgery at 10 hospitals in the Washington, D.C., and Baltimore regions, including both university and community hospital systems.

Q. When do you get your best strategic visions?

A. Your mind must be on all the time. You always have to be ready to capitalize on thoughts. Strategic visions rarely occur in the middle of a ruptured abdominal aortic aneurysm

MARCH 2020

JAMES ELMORE

EDWARD WOO

(AAA) but frequently do occur when I am driving or at home in the middle of the night.

Q. How do you remember these after-hours ideas the next day?

A. I email myself or my partners in the middle of the night about my thoughts. I have told my colleagues not to respond to my emails in the off hours, but this keeps my thoughts written down.

Q. What has been your greatest strategic success while at MedStar?

A. The recruitment of high-quality individuals. I feel that these individuals are my greatest reward. When you work with great people, you end up developing great programs, which in

Q. What has been your greatest learning experience while working on a strategic initiative?

A. You have to be prepared for the worst-case scenario to happen unexpectedly at any time. Any of the strategic initiatives that you develop could face unforeseen challenges at any time and you must be ready to respond to such fast-moving problems.

Q. The world seems to move faster and faster. How do you work with your colleagues in dealing with multiple strategic initiatives that demand your immediate attention?

A. Collaboration with administration is the key to success. No one will win without it. The vascular surgeons must understand the administratorsâ&#x20AC;&#x2122; view of these issues and then we can work together on the initiatives. For example, value-based purchasing, quality initiatives and patient experience are strategic initiatives that

we all face; we must understand the reasoning behind the initiative and then work together on the projects.

Q. What strategy have you used with competing departments that provide vascular care to patients?

A. If you are a great vascular surgeon, you will always win over other specialties. Vascular surgeons have better solutions than all the other competing departments since we can offer both open and endovascular solutions to problems. It is my experience that primary care providers prefer to refer to vascular surgeons and we need to continue to be available to them and their patients.

My solution for the readers is simple: Be the best vascular surgeon you can be, and patients will continue to come to your office for vascular care.

James Elmore is chair of the vascular surgery department at Geisinger Medical Center in Danville, Pennsylvania. He wrote this article on behalf of the Society for Vascular Surgery Leadership and Diversity Committee.

VASCULARSPECIALISTONLINE.COM â&#x20AC;˘ 13

NEWS FROM SVS

SVS PAC donations and Congressional committees of most impact

BY MICHAEL C. DALSING, MD

W

hile I may be the Society for Vascular Surgery (SVS) Political Action Committee

(PAC) chair, I find I still need a refresher from time to time regarding the members of Congress serving on committees that deal with healthcare issues where the SVS PAC needs to

dedicate the most time and resources.

So, as the second session of the 116th Congress is now getting into full swing, I wanted to share information on the three major committees

that deal with healthcare policies influenced by the legislative process.

The House Committee on Energy and Commerce has the broadest jurisdiction of any authorizing committee in Congress. It deals with issues including healthcare, substance abuse and health insurance. It has oversight of biomedical research and development, device and drug safety and consumer protection/ product safety. It deals with electronic communications and the internet as well as privacy, cybersecurity and data security. The House Ways and Means Committee exercises jurisdiction over revenue and related issues, including Medicare and Social Security. On the Senate side, the Committee on Finance is concerned with taxation and other revenue matters, including the health programs under the Social Security Act. Many of the topics of concern and need for patient advocacy reside in these committees, so one can well imagine that legislation must be monitored, and advocacy efforts, feedback and direct contacts considered. This basic knowledge helps to explain where our donations are most used and how it affects our scorecard (visit vsweb.org/ PACscorecard). The “Doctors Caucus,” meanwhile, is composed of medical providers in Congress who utilize their medical expertise to develop patient-centered healthcare policy and often support SVS goals.

There are many voices in the ears of our legislators. They want to do the right thing for their constituents, but most are not healthcare experts.

Certainly, the hospitals, the insurers, the lawyers and industry have an opinion, and are actively seeking to gain lawmakers’ attention. Here are some of the top PACs and their contributions to candidates in 2019: American Bankers Association, $1,402,700; Blue Cross Blue Shield, $1,115,500; and American Hospital Association, $662,945.

These groups are willing to support that quest for a place at the table.

Are we? We must be present as the voice of reason and a trusted ally in the effort to provide the best vascular care. That is the mission of all of us and that of our larger group, the SVS. The SVS PAC needs your support to protect our patients. Donate today at vsweb.org/PAC. Michael C. Dalsing is the chair of the SVS PAC.

14 • VASCULAR SPECIALIST

MARCH 2020

NEWS FROM SVS

Mysteries of market forces and surprise billing

BY GREGORY KASPER, MD

O

ver my last 25 years in the healthcare industry, medical pricing has been a mystical process. When I was in residency, a surgeon’s fees were an analytical exercise of trying to collect approximately 75% of charges. If you priced services below this rate you were leaving money on the table. If priced above, you would encounter growing accounts receivable and bloated overhead from increased collection activity. Goods and services in mature industries achieve market price when there is a balance between supply and consumer demand. While the healthcare industry is mature, it does not subscribe to traditional economic principles surrounding pricing.

Surprise medical billing has made headlines over the last year. There are many stories detailing patients left with thousands of dollars of medical bills after receiving medical care they thought was covered by their insurance. An analysis of large employer plans revealed that 18% of all emergency visits and 16% of in-network hospital stays resulted in at least one out-of-network bill. This increase is reflective of the prevalence of narrow networks since the passage of the Affordable Care Act. It’s estimated that narrow network plans account for more than 70% of the healthcare exchange market. The payor benefits from a narrow network in the form of better cost control. It is unclear if these savings are

GREGORY KASPER

passed on to the consumer. It is established that narrow network plans limit access and choice.

Not all specialties contribute equally to this phenomenon. Surprise billing most commonly involves anesthesiologists, pathologists, emergency medicine physicians and radiologists, but surgeons are not excluded.

A recent Washington Post article bore the headline, “The health-care industry is letting surgeons behave like muggers.” While I do have a colleague who has been mugged by a former patient, I don’t think

performing life-saving surgery in the middle of the night is a congruent comparison. The article references a general surgeon, but vascular surgeons also perform a large number of urgent cases.

When markets fail, we often enact legislative policies. Fair market value is defined as the price for a service or product on which the consumer and seller agree. Surprise billing occurs because payor rates are fair to one side. Congress needs to address this problem with a comprehensive solution—one that must avoid the long-term consequences of setting payment benchmarks, provides a fair and accessible independent dispute resolution process, increases insurance plan transparency and addresses network adequacy to level the playing field between physicians and insurers.

Americans’ belief that healthcare is a right doesn’t allow acceptance that essential health services may not be available or affordable because health plans and suppliers couldn’t agree on a price. Americans also object to the lack of choice in selecting providers or hospitals. This lies at the heart of the controversy over surprise billing. Receiving a surprise bill without warning for an out-of-network essential service just adds insult to this injury.

Gregory Kasper is a member of the SVS Government Relations Committee. Committee chair Megan Tracci, MD, also contributed to this report.

Purchase tickets today for 2020 VAM ‘Spectacular’ Gala

G

et ready for another “Spectacular” evening at the 2020 Vascular Annual Meeting (VAM).

Ticket sales began in February for the second annual Society for Vascular Surgery (SVS) Foundation “Vascular Spectacular Gala: Northern Lights.”

As last year’s gala sold out in six weeks, Gala Committee chairs Cynthia Shortell, MD, and Benjamin Starnes, MD, are urging those who want to attend this year to reserve their seats early.

Ticket prices are $250 each. For each ticket, $100 is a tax-deductible contribution to the SVS Foundation, which supports and promotes vascular research and improving patient vascular health. Tables are $2,500.

The party gets started with a cocktail reception at 6:30 p.m., followed by a sit-down dinner and both live and silent auctions.

Magician extraordinaire Peter Gloviczki, MD, has agreed to pack up his cape, gloves and magic wand, and once again wow the assembled crowd with his deft sleight of hand. The evening ends with the all-important “Raise the Paddle” to

generate vital monies for the SVS Foundation and dancing to a DJ. “Remember, nearly every single dollar raised via the auctions and the Paddle Raise go directly into the SVS Foundation coffers,” said Shortell.

The SVS Foundation provides a range of scholarships, grants and public education projects, including patient fliers.

These include: Mentored research career development awards programs to those who have already received National Institutes of Health grants Other research grants for researchers at all career levels The Community Awareness and Prevention Project Grant is for community practitioners to conduct communitybased projects that address vascular health, wellness and disease prevention The E.J. Wylie Traveling Fellowship, providing the chance for a vascular surgeon to visit vascular surgery centers worldwide and bring home that knowledge Learn more and purchase tickets at vsweb.org/Gala2020.

Spotlight BRIAN SANTIN, MD, has been named Chief Medical Officer for Clinton Memorial Hospital in Wilmington, Ohio.

MARCH 2020

VASCULARSPECIALISTONLINE.COM • 15

COMMENTARY

Wellness: Of dreaming in blood and the 'moral injury' contained in a healthcare setting

BY DAWN M. COLEMAN, MD

H

ave you ever “dreamt in blood”? A vivid, waking nightmare that reminds you of exsanguinating hemorrhage that can’t be stopped? I have. An Iraqi war fighter that sustained catastrophic explosive lower extremity and truncal wounds and required far-forward damage control resuscitation with an emergent aortic cross clamp and diverting colostomy in a dirty, fly-infested surgical tent visits me periodically. My boots still bear his blood. A ruptured supra-renal aneurysm patient with coagulopathy, another with profound ischemia-reperfusion and hepatic insufficiency following aortic endarterectomy for acute on chronic mesenteric ischemia… thankfully my civilian list is short.

Ironically, the compounding burden that keeps me awake at night is the patients that I can’t help: The out-of-state pediatric patient whose insurance provider won’t authorize necessary aorto-visceral reconstruction out of network despite multiple lengthy peer-to-peer review calls and appeals; my homeless patient that lacks the physical, financial or emotional means to comply with medical treatment of his cardiovascular comorbidities and now faces homelessness as an amputee; the ruptured aneurysm patient sitting in a small, rural hospital with back pain that I can’t accept and treat because our hospital is full.

Frontline

Vascular surgeons continue to serve at the frontline of healthcare, frequently responding to crisis and balancing life and limb. As chair of the Society for Vascular Surgery (SVS) Wellness Task Force, and a busy vascular surgeon, I am acutely aware of our collective resilience.

We have self-selected ourselves for the privilege of this vocation, perhaps blissfully ignorant to the rising challenges thrust upon us (not limited to excessive electronic medical record-keeping, regulatory compliance, billing mandates, adherence to standardized practice guidelines and public reporting) by a medical system that isn’t prioritizing the “physician experience.”

The concept of “moral injury” was first described in service members returning from the Vietnam War with symptoms that vaguely complied with a diagnosis of post-traumatic stress disorder (PTSD), but which did not respond to standard PTSD treatments.1,2 These soldiers had “experienced repeated insults to their morality and had returned questioning whether they were still, at their core, moral beings.” Moral injury occurs when we perpetrate, bear witness to or fail to prevent an act that transgresses our deeply held moral beliefs.

As physicians, our deeply held moral belief is the Hippocratic Oath—put the needs of patients first.

“So long as I maintain this Oath faithfully and without corruption, may it be granted to me to partake of life fully and the practice of my art, gaining the respect of all men for all time. However, 16 • VASCULAR SPECIALIST

DAWN M. COLEMAN

should I transgress this Oath and violate it, may the opposite be my fate,” reads the translation from the Greek medical text, by Michael North, at the National Library of Medicine, 2002.

The moral injury of healthcare is not the offense of killing another human in the context of war, but is being unable to provide highquality care and healing in the context of healthcare Routine

The moral injury of healthcare is not the offense of killing another human in the context of war, but is being unable to provide high-quality care and healing in the context of healthcare.3 Every time we are forced to make a decision or treatment omission that transgresses our patients’ best interests, we feel moral injustice which amasses with repetition into moral injury. This routine experience of suffering hurts providers and the repetitive betrayals of patient care and trust represents Lingchi (a “slow process,” or “lingering death”). Essentially, a “death by a thousand cuts”—in that any one injury, delivered alone, may heal but the incessant and continuous incidents culminate into the moral injury of healthcare. Moral injury is discrete from

burnout, and the treatment for such remains challenging as moral injury degrades an individual’s view of themselves in relation to society. Therapy aims to restore a sense of worthiness and selfesteem.4 Prevention must be prioritized.

Simon Talbot suggests: “Physicians are smart, tough, durable, resourceful people. If there was a way to MacGyver themselves out of this situation by working harder, smarter, or differently, they would have done it already.”3 He follows that “the simple solution of establishing physician wellness programs or hiring corporate wellness officers won’t solve the problem. Nor will pushing the solution onto providers.” Leadership and healthcare must allow for self-regulation and patient-directed care; thoughtful and compassionate care must be prioritized.

This requires high-level intentionality—to match the wellness of patients with that of providers.

There is a well-described business case to address physician burnout, financially incentivize clinician satisfaction and an urgent need to re-establish a sense of community among clinicians.2,5 I am deeply committed to our SVS membership; the SVS Wellness Task Force will continue to work and advocate for our members. Please look forward to our April Peer Support module on SVSConnect, “Moral Injury,” and consider joining one of our future live calls or webinars in collaboration with the SurgeonMasters coaching team.

References 1. J. S. Moral Injury. Psychoanal Psych. 2014;31(2):182–91 2. Dean W, Talbot S, Dean A. Reframing Clinician Distress: Moral Injury Not Burnout. Fed Pract. 2019;36(9):400–2 3. Talbot SG, Dean W. Opinion S-F, editor. https://www. statnews.com/2018/07/26/physicians-not-burning-outthey-are-suffering-moral-injury/2018 4. Jones E. Moral injury in time of war. Lancet.

2018;391(10132):1766–7 5. Shanafelt TD, Dyrbye LN, West CP. Addressing Physician Burnout: The Way Forward. JAMA. 2017;317(9):901–2

Dawn M. Coleman is an associate professor of surgery and pediatrics at the University of Michigan, Ann Arbor, Michigan, where she serves as the program director for the Integrated Vascular Residency Program and Fellowship.

Join the conversation

The SVS has partnered with SurgeonMasters to bring professional coaching and peer support to its members. This is a first of its kind program and its success depends on member involvement. Please join us at SVSConnect either online or through the MemberCentric app. This is an excellent opportunity to become involved with wellness initiatives, whether you are interested in learning about the benefits or becoming a leader in your community.

MARCH 2020

SAVS

Sternbergh: On his journey of self-awareness, overcoming tragedy and achieving work-life balance

BY BRYAN KAY

P

ALM BEACH, Fla.—In an address that ran the gamut of emotions—from success to tragedy and back again—W. Charles Sternbergh III, MD, may have delivered a salutary lesson in both life and work for posterity, one from which vascular surgeons of every vintage could draw.

He began by asking for his audience’s indulgence. This was to be a deeply personal address, a break from the purely scientific and the clinical.

It was, Sternbergh warned, primarily about his “personal quest for contentment, understanding and fulfilment.” Lessons learned, ah-ha moments, his journey of selfdiscovery—“all in the pursuit of happiness.”

As its 43rd president, Sternbergh was delivering the presidential address at the Southern Association for Vascular Surgery (SAVS) 2020 annual meeting ( Jan. 8–11) in Palm Beach, Florida. And he quickly turned the mirror on himself.

Sternbergh started by relating the tale of his search for self-awareness in his early years. “I believe that the mastery of self-awareness is rare. Many people don’t have great self-awareness and the irony is glaring. Folks just don’t know what they don’t know.”

Personally, the professor and chief of vascular and endovascular surgery at Ochsner Health in New Orleans, admitted, he wasn’t blessed with great self-awareness.

“Here’s a great example,” Sternbergh said: “Convincing myself that my choice of college and medical school had nothing to do with the fact that my father had attended the same institutions: I really believed and would try to convince anybody who would listen there was no connection.”

The journey continued three years out of his fellowship training in New Orleans, at the time of the earliest minimally invasive endografts for aortic aneurysm repair. Given his junior status, he said, he “had no illusions about getting a piece of the clinical trial data for presentation.

“But I thought, hey, what about an economic paper about costs of this new technology. Well, cost papers are now omnipresent in healthcare delivery, though not a topic explored much 20 years ago. My working hypothesis was that EVAR

MARCH 2020

W. CHARLES STERNBERGH (ON LEFT) WITH FAMILY MEMBERS

[endovascular aneurysm repair] was going to be less costly than open repair given the radically reduced length of stay.”

Triumph

As Sternbergh related, he took delivery of the summary data the afternoon before the Society for Vascular Surgery (SVS) deadline for abstracts.

“I was floored to find my hypothesis had been completely wrong. AAA [abdominal aortic aneurysm] management with EVAR was actually more costly, primarily because the endograft cost was going to be 50% of the total hospitalization cost.

“I knew immediately that these data were abstract gold and spent the rest of that evening writing. So now is where it gets interesting.

The abstract was highly ranked by the program committee and initially placed as the second podium presentation at the opening session.

“But then we received word that at the direction of the SVS president our abstract had been removed entirely from the program. Notably, the SVS president also happened to be the national primary investigator for that trial.

“But this was before the age of conflict of interest disclosures.

While we were successful in getting our abstract back on the program, the patient level data and cost methodology were suddenly no longer available.”

Who was the discussant for said paper? The aforementioned SVS president, Sternbergh said.

Accusations of fabricated cost data were levelled, he went on, as well as attempts to block its publication.

He was further “encouraged” to withdraw the manuscript. The accusations, Sternbergh said, “cut me to the bone. Integrity is everything to me. So, I took this very personally.”

Following this denouement, a selfexplanatory epilogue, he said: The paper was published and reproduced down the years. And within a year of this episode, formal conflict of interest disclosures were mandated for the Journal of Vascular Surgery.

Personal growth—and tragedy

“Although I did not realize it at the time, this episode helped me along the path of self-awareness, providing a concrete example of understanding and conscious knowledge of one’s own character.”

So goes personal growth. For Sternbergh, unbearable personal trauma was just around the corner,

“As vascular surgeons, we excel at cerebral, thought-directed activities but we are frequently challenged when it comes to accessing and processing our feelings, especially ones that are painful.”—W. Charles Sternbergh

laying bare for him the challenges of life. This period of his life helped him underscore what he described as a central part of self-awareness: “Being able to locate, access and process your feelings. As a head-directed person, that has frequently been a challenge.”

A couple of decades down the road, he said, “I feel more self-aware and perhaps a bit farther along that path in the pursuit of happiness.”

He then turned the lens on his gathered colleagues, challenging them to consider what pains, grief, loss or sadness they might be holding on to. “As vascular surgeons,” said Sternbergh, “we excel at cerebral, thought-directed activities but we are frequently challenged when it comes to accessing and processing our feelings, especially ones that are painful.

“I urge each of you to look inward and embrace the challenging emotional work of processing those hurts that many of us bear.”

Sternbergh recalled one other moment in his life, this time at the 2007 winter meeting of the Vascular & Endovascular Surgery Society (VESS) in Steamboat Springs, Colorado. He had fallen and suffered a tibia-fibula fracture. The attending surgeon informed him he would require emergency surgery and six-to-eight weeks laid-up. His response? To worry about his following week’s schedule.

Work-life balance

“Did that response demonstrate great self-awareness? Not so much. But it did expose a classic Baby Boomer characteristic. A mantra of work ethic and duty above all else.”

Too often in the U.S., Sternbergh said, people live to work. “As vascular surgeons we are driven and ambitious, and too many of us—myself included—have fallen into this former category. We Boomers have plenty to learn from the Gen Xers and Millennials who in my opinion have a healthier approach to work-life balance.”

That said, Sternbergh highlighted the idiosyncratic nature of a discipline he loves. “As vascular surgeons, we are fortunate to be in a position to make a real difference in people’s lives. That satisfaction and the genuine gratitude of patients still puts a smile on my face. I’m quick to point out to medical students and trainees that vascular surgery is one of the very few surgical specialties which provides longitudinal care in connection with our patients.”

VASCULARSPECIALISTONLINE.COM • 17

COMMENTARY

Advocate or adversary? Perils baked into the relationship between physicians and patients

BY ARTHUR E. PALAMARA, MD

P

atients with complex illnesses may not be eligible for hospital admission unless their diagnoses meet InterQual Criteria or Milliman Care Guidelines—hurdles patients must first pass through in order to be admitted. Forget how bad the patient feels; an admission may be denied until the individual reaches the point where third parties agree that one is needed or unavoidable lest they be sued. At that stage, patient recovery may be beyond retrieval. What, then, is a physician’s responsibility when admission is denied?

Consider the following example as a means of answering this question.

While walking down the street, an elderly gentleman felt a sudden, severe pain in his left knee. He could go no further. Supported by his wife, he stumbled home, which fortunately was not far. For the next month, he languished in a lounge chair with his legs dependent on others. His wife did all she could to assist him, barely meeting his minimal needs. Small in stature but indominable in constitution, she supported her husband. Physically assisting him was a chore. She developed strength she didn’t know she had.

Early in his illness, he was evaluated by a “midlevel” at his primary care provider (PCP) office who directed him to an orthopedist where a left knee meniscus tear diagnosis was made. A magnetic resonance imaging (MRI) scan was ordered but never done.

No better, the patient deteriorated in his lounge chair, becoming progressively weaker. He was not seen again in his PCP’s office. His wife’s ability to care for him during that month defies comprehension. As expected, the authorization process consumed some time and a month later he was permitted to go for an MRI. The MRI tech was a pleasant but small young lady who lacked the physical strength required to assist the heavyset patient onto the MRI table. So the test was cancelled.

Although annoying, the cancellation proved to be a hidden benefit since it provoked the wife to call me and ask what she should do next. I sensed the desperation in her voice. As much as she loved her husband, she had reached the end of her physical and mental ability to provide care at home. I instructed her to take him to the emergency room in an adjoining building.

Prone

I found my friend’s husband lying on a stretcher, in the hall, against a wall. The emergency room (ER) was crowded. He was no longer the strong but gentle individual I had known, but now a bit confused and obviously ill. Whatever his problem, his illness was much more complex than a torn meniscus. Both swollen legs resembled mushy cantaloupes. The left knee was tender but not deformed. It could be flexed with moderate pain.

There was no ecchymosis. He could—albeit 18 • VASCULAR SPECIALIST

ARTHUR E. PALAMARA

weakly—lift his legs. I could find no evidence of focal neurological loss or radicular signs: He appeared to have generalized weakness, as one would find in a patient with protracted illness. An ultrasound of the painful leg revealed calf-vein thrombosis. He was placed on an anticoagulant.

The ER physician was sympathetic and recommended admission, if only for the deep vein thrombosis. It was obvious to him that, at the very least, he needed evaluation. It was abundantly obvious that a work-up was not going to occur as an outpatient. Her husband being so weak, it was amazing that the wife was able to care for him so long.

The type of admission was left undetermined.

Most patients don’t know that categories of admission are more complex than quantum physics and infinitely more mystifying.

While mathematics may be a pure science, hospital admissions are not. Admission policies have more variations than rabbis interpreting the Torah.

There is no unimpeachable source. But there is an overriding principle: Keep an insured patient out

In reality, hospitals maximize their reimbursements while insurance companies try to reduce theirs. It’s an ongoing contest. Lost in this shuffle is the physicianpatient relationship.

of the hospital and use every contrivance available.

While hospitals love to admit insured patients, it is only after criteria for admission are met and hospitals are guaranteed payment. Regretfully, patients are the casualties of the war between insurance companies and hospitals.

The health maintenance organization (HMO)contracted hospitalist could not promptly diagnose the patient. Neither of us had an explanation for the bilateral leg edema, weakness, newonset mental confusion—let alone the inability to walk. Within the first 24 hours, he received a computerized tomography (CT) scan with contrast of his abdomen and pelvis.

Except for a few non-obstructing renal calculi, no major problem was found. Nor did it explain his lower-extremity edema. Routine lab work found little amiss. Hepatic enzymes and hemoglobin were near-normal. He had mild renal failure.

The hospitalist suspected a lumbar radiculopathy, although the neurological exam revealed no major deficits. The MRI of the back failed to find spinal stenosis. There was an annular fissure. A “side-walk” consult with a neurosurgeon opined— without looking at the MRI—that the tear could be responsible for the patient’s left leg pain.

Physiotherapy was recommended. But since the patient was still labeled under “observation,” he was not eligible for physiotherapy.

Discharge

The hospitalist decided to discharge the patient to a nursing home where he could receive physiotherapy, such as it is. My experience with rehabilitation facilities is not edifying. They are more accurately called nursing homes where elderly people are warehoused, bedded in foul-smelling rooms and entertained by a ceaseless barrage of CNN or Fox News blaring from incessant televisions. Physiotherapy at these institutions is often a euphemism. Patients are wheeled into the rehab room, asked to stand, perhaps take a few steps and then sat down. See you tomorrow! Then it’s off back to bed where they vegetate until the next session.

My friend, who had only slightly improved, was to be relegated to this level of care. With elevation, the lower-extremity edema had improved but had not completely resolved. His attempts to stand and ambulate were not successful. Deprived of these functions for over a month, they were not to be easily regained.

To say that I objected to his premature discharge would be an understatement. Whatever caused his debilitation had not yet been diagnosed and certainly not treated. Nor was there any expectation that his condition, largely ignored for a month, would be rapidly cared for as an outpatient. Nor do nursing homes show much proclivity for investigating and treating underlying maladies.

What patients come in with they go out with—or not. This is not a very compassionate way to treat Advocate continued on page 19 MARCH 2020

VENOUS DISEASE

Study: Lumbar spine stabilization surgery may be a risk factor in symptomatic venous outflow obstruction lesions

BY BRYAN KAY

L

umbar spine stabilization surgery may be a risk factor in the development of symptomatic venous outflow obstruction lesions, a study published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders has found.

Furthermore, writes lead author Peter J. Pappas, MD, et al during venography and stenting in patients with anterior lumbar interbody fusion approaches, “significant scarring may be encountered, resulting in a residual stenosis after stent placement.”

Pappas—of the Center for Vein Restoration and the Center for Vascular Medicine, who is based in Morristown, New Jersey—and colleagues had set out to determine whether there is an association between spine stabilization surgery and the development of symptomatic iliac vein outflow lesions.

The study, entitled “Spine stabilization is a risk factor for the development of pelvic iliac vein lesions,” was a retrospective chart review of prospectively collected data from the team’s electronic medical record system in which the investigators identified patients who

underwent venography with or without venous stenting and had a history of previous lumbar spine stabilization. It was funded by a grant from the Lakhanpal Foundation.

“Open lumbar spine stabilization surgery often requires mobilization of the left and right common iliac veins (CIVs) and the placement of plates and screws that can impinge on them,” the authors write. “We reviewed our venography experience of the past three years to determine whether there is an association between spine stabilization surgery and the development of symptomatic iliac vein outflow lesions.”

Patient demographics, medical comorbidities, venograms and intravascular ultrasound (IVUS) data were collected and analyzed.

Advocate Continued from page 18

our elderly, but perhaps there is no redemption from our human frailty.

Meanwhile, the patient remained in his bed but became more interactive; his swollen legs and mental acuity improved. The cause of his left leg pain remained undiagnosed. He could not stand, partially as a result of disuse.

Then three days into the admission, the hospitalist ordered an MRI of his left knee and finally hit paydirt: The patient had a non-displaced tibial plateau fracture. Perhaps if his fracture had been diagnosed earlier, he could have avoided a month of decline and the cost of hospitalization.

Points of contention

There are several issues worthy of discussion. One is our desire to constrain costs has imposed a barrier to ordering expensive tests like MRIs. If dedicated to patient care, physicians are challenged to overcome the insurance hurdles, fight with scheduling secretaries, obtain authorizations from medical directors, meet all the imposed requirements, review test results and figure out how to treat the patient. This process usually takes a month. If the patient requires admission, similar barriers are erected. Hospitals and insurance companies hope MARCH 2020

From January 2014 to April 2018, venography was performed in 1,713 limbs in 1,245 patients at the Center for Vascular Medicine.

“Of the 1,245 patients, 18 had a history of lumbar spine stabilization procedures: five anterior-posterior and 13 posterior,” they note. “Nine had single-level and eight had two- or three-level fusions.

All 18 patients demonstrated pelvic lesions. These included one left CIV aneurysm, five left CIV stenoses, three bilateral CIV stenoses, two left CIV and inferior vena cava occlusions, and two external iliac vein stenoses.

The aneurysm patient was treated with anticoagulation, eight patients underwent stenting, one patient refused stenting because of relocation to another country and one inferior vena cava-CIV occlusion could not be crossed.”

They add: “Lesions in anterior

that the patients will get better and not need the test or admission. Or, indeed, experience a more final solution. Some patients will not get better, as in the case of this patient, who languished at home waiting for the “system” to give him the care that he needed.

Each of his diagnoses—tibial fracture, deep vein thrombosis, immobility, lower-extremity edema, hospital-acquired bilateral erysipelas and a right ankle ulcer—do not qualify for in-patient admission.

Since he was admitted for observation, the HMO was not responsible for his hospitalization. Even worse, without an in-patient admission, his HMO would not pay for his nursing home.

Although none of the individual diagnoses were worthy of admission, one would expect the aggregate of all the diagnoses would justify admission according to InterQual and Milliman criteria? Such a determination would have eased the burden of admission and the cost—now assumed by the patient—which seems patently unfair.

The second issue: To whom does the physician owe a greater obligation—the patient or the insurance company? If he wants to keep his job, he’d better support their policies. In reality, hospitals maximize their reimbursements at the same time as insurance companies try to reduce theirs. It’s an ongoing contest.

Lost in this shuffle is the physician-patient

lumbar interbody fusion patients were extremely stenotic, required predilation, and resulted in a residual stenosis requiring venoplasty at a second setting in one patient.”

The researchers conclude: “Predilation venoplasty, before stent deployment, is recommended to prevent stent migration.

“Furthermore, a history of spine stabilization surgery in patients presenting with pelvic symptoms, lower extremity pain or swelling, or post-thrombotic symptoms, should prompt consideration of a pelvic venous duplex ultrasound examination to determine whether an iliac venous outflow lesion is present.”

They provided advice for patients who report under certain circumstances.

“Patients presenting with symptomatic lower extremity pain, swelling and venous stasis skin changes who have a history of a previous lumbar interbody fusion should have a pelvic ultrasound examination to evaluate the iliac veins for a possible iliac venous outflow lesion,” the authors add.

SOURCE: DOI.ORG/10.1016/J. JVSV.2019.08.018

relationship. Since the hospitalist has only a transient relationship with the patient, they often fail to appreciate the patient as a person and consider them an unresolved clinical problem.

Tradition and the American Medical Association (AMA) Code of Ethics obligate the doctor to advocate on behalf of the patient, but economic pressures place the physician in conflict with his employer and, indeed, the hospital. Physicians’ failure to advocate on behalf of their patients is a blow to the foundation of the medical profession.

European countries offer much more robust care and do not seem to suffer this conflict. Their costs are half of ours and they have better outcomes (by many criteria).

Our fragmented, expensive public-private, confused system appears to be the most important issue facing voters in the 2020 election. Most beneficiaries are unhappy with their current coverage (or lack thereof ) for a variety of reasons.

They have lost faith in their insurance companies but retain confidence in their physician. We as doctors don’t want to abuse that trust.

Arthur E. Palamara is a vascular surgeon in Hollywood, Florida, and is associated with Memorial Regional Hospital, part of Memorial Healthcare System in the same city.

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