Vascular Specialist April 2020

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COVID-19: Its impact on medical education's future

Moral distress, coronavirus and surgeon burnout

17 E/M coding 'Note bloat' culture: Fresh rounds of coding changes continue to filter through VOL. 16 • NO. 4 • APRIL 2020

Vascular surgeons urged to avoid admissions not an immediate threat to life and limb

BY BRYAN KAY

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BENJAMIN W. STARNES

NITEN SINGH

COVID-19: Focusing minds on need to act as virus tears path across North America

BY BENJAMIN W. STARNES, MD, AND NITEN SINGH, MD

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EATTLE—We live in unprecedented times. On Jan. 19, patient zero arrived in the United States at Seattle-Tacoma International Airport after returning from a visit to his family in Wuhan, China. He tested

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

ascular surgeons were issued with a plea to support the health of the U.S. population “by immediately reducing resource expenditure, avoiding all surgical admissions unless immediately life- or limb-threatening and, most importantly, by staying home” from a prominent membership body.

The advisory came in the form of a statement from the Vascular and Endovascular Surgery Society (VESS) on COVID-19, designed to help foster understanding of changes being put in place to allow use of telemedicine so specialists can continue to treat patients and mitigate exposure risk.

The VESS executive committee, the statement assured, “supports the decision of surgical providers to rapidly curtail surgical services in response to the public health threat posed by COVID-19 patients to overwhelm hospital resources in the next weeks.”

positive for COVID-19 on Jan. 20. Fast forward one month, and the heroic efforts of Helen Chu, MD, at the University of Washington, who, despite running against a cease-and-desist order by the federal government, ran COVID-19 tests on 2,500 sputum samples being used for See Seattle · page 4

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GUEST EDITORIAL

Of moral distress, coronavirus and implications for burnout

BY BHAGWAN SATIANI MD, AND DAVID P. WAY, MED

Bhagwan Satiani is professor of clinical surgery in the division of vascular diseases and surgery, the department of surgery, in the Ohio State College of Medicine at the Ohio State University in Columbus.

He is an associate medical editor of Vascular Specialist.

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oral distress has been described as “as a phenomenon in which one knows the right action to take but is constrained from taking it.”1 Continuous exposure to moral distress leads to moral injury. The term “moral injury” was first described in combat soldiers who were forced to commit, witness or participate in acts that conflicted with their moral beliefs, and, as such, caused long-term psychological or spiritual injury.2 If the moral injury is sufficiently severe, it resembles post-traumatic stress disorder.

As the U.S. healthcare system takes on the worst pandemic in recent history, there exists the possibility that many physicians may be deputized to take care of sick patients with COVID-19. In a worstcase scenario, up to 60% of the U.S. population may be infected. If we assume even a more modest 40% rate of infection, a 12-month transmission curve and the freeing up of 50% of currently occupied hospital beds for COVID-19 patients, we can expect more than 20 million Americans to require hospitalization and 4.4 million to require intensive care.3 Should we be called into service during this pandemic, we must face the real possibility of exposure to moral distress.

Despite the existence of institutional guidelines designed to facilitate challenging ethical decisionmaking, physicians, nurses and other healthcare workers may confront intense pressure to make difficult decisions that contribute to moral distress and injury.4 Such decisions that need to be made in a crisis include: Who do we treat? Who do we admit to the hospital or to the precious intensive care units?

How do we decide? With constraints on resources, we may be forced or persuaded to provide care that does not meet our standards for quality or safety.

There is a relationship between burnout and quality of care. One compilation of several studies

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

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David P. Way is an educational resource specialist with 27 years of experience in medical education and interests in measurement and performance assessment.

He is in the department of emergency medicine at the Ohio State University Wexner Medical Center.

showed an inverse relationship between a high level of burnout, and quality of care and safety for patients.5 While burnout is multifactorial, moral injury can be a major contributor to burnout in physicians.6 Symptoms

Physicians and surgeons who face moral distress on a regular basis begin to display the classic symptoms of burnout. They become cynical, depersonalize their patients and lose enthusiasm for their profession. Vascular surgery is documented as being a high-risk specialty for burnout. Yet, if given the chance, three out of four would choose to be a surgeon again.

Vascular surgeons are put in distress in many ways separate from the current pandemic. A few years ago, I—Bhagwan Satiani—was called to treat a blind 80-year-old African American woman with severe back pain, hypotension and a few comorbidities. A computerized tomography (CT) in the emergency room confirmed a ruptured abdominal aortic aneurysm (AAA). This was early in the era of the institutional monitoring of physician complication rates and the start of the cost-constraint era. After explaining the choices to the woman and her daughter, the thought occurred to me about the high mortality rate in this type of patient—but only briefly. The daughter seemed to be leaning towards comfort care when the patient spoke up and advocated for herself, saying she was functioning relatively well. I chose to operate on her. She was extubated one day after surgery and discharged about six days later with no complications. We all have examples like this. This type of moral distress is short-lived in my opinion and prolonged only if extraneous factors are inserted into patient care.

As surgeons, the patient-centered, ethical, internal decision-making process we utilize is a fundamental part of our training—and a fundamental part of our professional identity.

Today, great pressure is placed on surgeons, who are given score cards by young MBA and MHA graduates with graphics listing not only mortality and complications rates, but color-coded symbols of length of stay (i.e., institutional cost).

Undoubtedly, there is purely internal financial data generated about us that is then not shared with us. Subsequently, the moral distress is amplified significantly due to extraneous factors largely unrelated to direct patient care itself, both in terms of quality and safety. Yes, end-of-life care— or difficult decisions about life and limb in our specialty—do wear us down over time. And, yes, Burnout continued on page 4

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APRIL 2020

CORONAVIRUS

Vascular specialists retool practice amid rigors of pandemic

BY BRYAN KAY

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he coronavirus has placed enormous pressure on healthcare, not least vascular surgery. Here, Linda Harris, MD, a vascular surgeon with the UBMD Physicians Group in Buffalo, New York, gives Vascular Specialist insight into what life is like on the ground.

VS: How has your vascular practice been impacted?

LH: Currently, we have massively decreased office/clinic to only our patients with urgent issues. We are attempting telehealth as an option, but this is not currently going over well with our patients. Most prefer to postpone. All patients are being contacted prior to appointments, and those with regular follow-up appointments are being postponed unless they have concerning symptoms. Patients are also being queried as to any signs or symptoms of COVID-19. If they have any signs or symptoms, they are advised to be tested prior to being seen in the office for their vascular issues. My hospital has completely shut down elective cases. All hospitals in my region have completely shut down all elective procedures/surgery. We are also considering shifting all vascular care to one hospital in the system to decrease the number of faculty exposed. Older faculty have been removed from the call schedule.

VS: Which procedures are being placed on the back burner?

LH: Patients without lowerextremity tissue loss—i.e., those with claudication—are being postponed.

Patients with smaller aneurysms are being delayed. Asymptomatic carotids are being postponed. Access for hemodialysis is being done as needed and delaying when temporary access is already in place—as are patients with tissue loss, symptomatic carotids or large aneurysms. Patients with emergent symptoms—ischemic limbs, rupture, stroke—are being treated.

VS: What trends are you seeing among colleagues at other institutions?

LH: Trying to determine which of

APRIL 2020

our patients still warrant intervention can be difficult—i.e., when to operate on a rapidly growing aneurysm.

However, we all need to be cognizant that it is not just our current patients that are at stake, but maintaining supplies like gowns, gloves, appropriate masks, hospital and ICU beds, adequate nursing staff to care for the patients, etc.

VS: What role should vascular surgeons play as this crisis escalates?

LH: While vascular surgeons often serve as the firemen and firewomen of the hospital, in this case the pulmonary, critical care, emergency and infectious disease doctors will be called on primarily. We should reach out to hospital leadership and make ourselves available in any way we can to help with the crisis. This may mean helping in areas that we have not practiced in years—decades for some of us. This may also mean sharing our allied health providers with services more in need as we see a decrease in patient census while they see a marked upswing. We need to maintain our vascular lab accessibility, while ensuring appropriate protective gear for our technologists.

COVID-19 tends to cause severe respiratory failure, progressing to multisystem organ failure in severe cases. As we know, patients with multisystem organ failure (MSOF) often display signs of peripheral ischemia. Further, complications of COVID-19 include arrhythmias, occurring in up to 16% of sick patients, and myocardial depression, both of which may compromise peripheral perfusion, either by embolization or decreased perfusion, especially in those who already may have some underlying peripheral arterial disease (PAD). We need to be prepared for emergent procedures on very sick patients, while assessing patients carefully, and comparing risk

ILLUSTRATION OF COVID-19

of limb loss with loss of life prior to any interventions.

VS: How is this impacting trainees and training programs?

LH: An additional concern with COVID-19 is our ability to continue to train residents and fellows. Grand rounds and M&M (morbidity and mortality) conferences have been cancelled in many—if not most— institutions, while we adjust to remote education. While my current senior residents and fellows have met case requirement numbers, this may not be true across the country. Some trainees may find themselves just short of required case minimums due to the cancellation of many— perhaps most—elective procedures.

Any required quarantine time has the potential to lengthen training, depending on the decisions of the Vascular Board. In addition, trainees who are currently looking for jobs

“We need to be prepared for emergent procedures on very sick patients, while assessing patients carefully and comparing risk of limb loss with loss of life.”—Linda Harris

may be impacted by their lack of ability to travel. We are all required to notify the hospital and GME of any travel. Business travel is banned.

All interviews must be remote. If people engage in personal travel despite state regulations, they must report and expect quarantine for 14 days, even without symptoms.

Childcare is another issue for some trainees. Scholarly activity is also impacted. Four of my trainees were scheduled to present at the cancelled Society for Clinical Vascular Surgery (SCVS). While the trainees can certainly publish scholarly activity, this clearly impacts their educational experience of having the opportunity to present data in nationally and get feedback from experts outside their own institutions. The full impact of COVID-19 on our trainees is yet to be seen. We will hear more from the Vascular Board and the Association of Program Directors in Vascular Surgery as this progresses. VamCall schedules are also being modified to allow for infection in our workforce and continuous coverage. COVID-19 is massively impacting our ability to recruit for the next fellowship class as all of the program directors struggle to figure out how to do remote interviews.

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COMMENTARY

Seattle Continued from page 1

another study on the flu virus. She found the first community-acquired case in a 17-year-old asymptomatic boy who was about to return to high school in Renton, Washington. The school was closed immediately after the information was verified.

By March 9, 11 days ago, there were 172 confirmed cases in Seattle and an alarming 22 deaths due to an outbreak in a skilled nursing facility in nearby Kirkland. On that day, Dean Paul Ramsey, MD, and the leadership of UW Medicine decided to cancel all work-related travel from university employees. Three days later, on March 12, UW Medicine made the decision to cancel all elective surgeries. On that day, there were 387 confirmed cases—despite minimal testing—and 30 deaths in the Seattle metropolitan area. Our hospital began to conserve masks, eliminate medical students and nonessential observers from using surgical masks to observe our cases.

As chief and associate chief of the division of vascular surgery at the University of Washington, we immediately made the decision to continue to offer surgery to abdominal aortic aneurysm (AAA) patients with diameters over 5.5cm, dialysis access and surgery for critical limb-threatening ischemia (CLTI) with a potential for limb loss. That decision quickly changed. On Sunday, March 15, when the case count was by now 642 cases and 40 deaths, we made the decision to call two friends in Italy, a country hard-hit by COVID-19 and in a state of lockdown and panic.

Pierantonio Rimoldi, MD, and Germano Melissano, MD, based in

Milan in the country’s north, gave us the terrifying news. Their healthcare system was completely overrun.

These are the notes we took away: 90% of the workload in all hospitals is related to COVID-19. The remaining 10% involves urgent/ emergent patients. He carried out a ruptured AAA yesterday (March 19) Every intensive care unit (ICU) is filled with COVID-19 patients They have cancelled all surgeries except true emergency cases—they do not carry out elective AAA, CLTI patients or dialysis patients Everyone is isolated at home. The only places people are allowed to go are local pharmacies or food markets.

If caught on the street without permission papers, they receive a large fine or three months in jail The Italian doctors say the only way to control COVID-19 is for people to stay home Their very first case—patient zero— was Feb. 20, some 24 days ago. Our first reported case in the U.S. was Jan. 21, and first death Feb. 29 They said they do not have enough ventilators for all who require them.

We asked what their triage criteria were: – Age 80 and older—do not resuscitate (DNR) – Age 70 to 80—if there are any significant comorbidities (congestive heart failure, chronic kidney disease, chronic obstructive pulmonary disease, diabetes): DNR. For all others, a decision is made on a case-by-case basis – All ventilators are reserved for people who have a strong chance of survival Almost all of the deaths are to be found among the elderly

Burnout Continued from page 2

we do understand the national healthcare resources wasted on the elderly at the end of their lives. But our true north is to give our patients and their families the optimum service and quality of care that they deserve. Period.

Blame

Physicians are awash with headlines about burnout.

We blame ourselves thinking we are not resilient enough to handle patient care, taking resiliency training in order to ameliorate burnout.

However, the cynicism ascribed to surgeons in surveys may be more related to the healthcare system itself. This has reduced our autonomy, demanded that we keep silent when we should be speaking out and limited the insurance coverage for the tests and procedures our patients need. Rather than resiliency training, perhaps we should be 4 • VASCULAR SPECIALIST

They said surgeons do nothing except urgent or emergent cases.

They are not being utilized in ICUs or wards because they simply get in the way. It’s like a pediatrician volunteering to come scrub-in on a case to “help”—they would just get in the way outside their area of expertise These represent frightening statistics, altering our mentality completely.

We immediately implemented the following changes to our service line: Cancelling all elective cases, including the ones listed above.

Our patients fall into the category of high risk when contracting COVID-19. So exposing them and using up resources was not the right thing to do We will perform only emergent cases. Cases performed over the weekend were a ruptured AAA and a gunshot wound to a carotid artery Cancelling clinic to avoid exposure of our patients, staff and surgeons to COVID-19. If we are exposed and need to quarantine for two weeks, that could quickly decimate a vascular service Restructuring our faculty and residents such that one attending surgeon and resident will cover for a week at a time, with back-up as required for those that contract or are exposed to COVID-19—as well as the potential for multiple operations at the same time Eliminating any unnecessary time in the hospital. We have a daily Zoom morning report. Our weekly division conference, monthly faculty meeting and resident conference are also staged via Zoom Understanding our role in

The replication crisis, part 2

As mentioned in the “From the Editor” section of Vascular Specialist last month, we had planned to bring you part 2 of an editorial entitled “The replication crisis is here” by medical editor Malachi Sheahan III, MD. However, the increasing seriousness of the coronavirus pandemic demanded comprehensive coverage. Rest assured, we intend to run part 2 of the series in an upcoming issue of Vascular Specialist.

talking more about the moral distress we confront on a daily basis.

While physical exhaustion or issues related to direct patient care are contributory, burnout from moral distress is real. The moral distress comes in large part, not from caring for our patients, but coping with what the healthcare system has become.

This is accompanied by our inability to get ordinary people the care they deserve in a way that

preserving the “3Ss,” as they say here at UW (staff, space and stuff ).

The projections at our hospital for the peak in three weeks’ time is sobering—potentially close to 1,000 inpatients in our system. We would imagine this is the same in other cities Preparing our residents to understand that some may be called to assist in ICU roles if our medical colleagues require the help Accepting that this is a crisis and truly understand what an emergent case is. We have never crashed a patient from clinic to the operating room. So any patient who is seen in the clinic is not an emergent case We may have patients who will rupture a AAA or suffer an amputation. We need to accept that today’s mentality is not the same as a week ago—and certainly not a month ago, so on and so forth.

As of the time of writing on March 20, here in Washington state we had 1,376 confirmed cases and 74 deaths, which we believe is just the tip of the iceberg. We expect our hospitals to experience a surge in COVID-19 patients by April 9. As two vascular surgeons with extensive combat military experience and experience working in resource-constrained environments, we desperately plead with all service chiefs across the U.S. to act this minute in order to conserve our resources and save lives.

Don’t sit on your hands.

Benjamin W. Starnes is professor and chief—and Niten Singh is professor and associate chief—in the division of vascular surgery at the University of Washington, Seattle.

also fits our values. Keep this message in mind as you are called into service in this COVID-19 crisis.

We chose to become healers. As the American writer Dale Carnegie put it, “Our fatigue is often caused not by work, but by worry, frustration and resentment.” Let us remember that as we go on to care for our patients. They are not the problem.

References 1. Jameton, A. (1984). “Nursing practice: The ethical issues.”

Englewood Cliffs, NJ: Prentice-Hall.

2. https://www.sciencedirect.com/science/article/abs/pii/ S0272735809000920 3. https://www.healthaffairs.org/do/10.1377/ hblog20200317.457910/full/ 4. https://www.thehastingscenter.org/ ethicalframeworkcovid19/ 5. https://link.springer.com/ article/10.1007%2Fs11606-016-3886-9 6. https://www.statnews.com/2018/07/26/physicians-notburning-out-they-are-suffering-moral-injury/ APRIL 2020

COMMENTARY

Digital future beckons for medical education as coronavirus compounds financial pressures

BY ALAN LUMSDEN, MD

T

he meeting, the seminar and the symposium: Collectively, this triumvirate of forum types forms one of the core elements of postgraduate medical education. These crucial arenas in which we get together with colleagues to present data and share experiences vary between local, regional and large international gatherings.

For many, great advantage is perceived from this kind of collective education process. Without doubt, major benefits are derived from receiving information delivered by our field’s experts alongside the to-and-fro discussion that occurs when we meet directly with our colleagues.

Yet, for some time now we have been starting to question whether this traditional form of education can survive some of the pressures now being applied.

While largely financial up to this point, the latest threat comes from the travel restrictions being applied in the wake of the novel coronavirus outbreak.

The emerging philosophy gaining currency says that travel is not necessary when the reality of a meeting might be that attendees are simply placed in a seat to be given a talk. Of course, this is a lecture that can be delivered remotely through a variety of electronic media. On the other hand, the expense of travel can be justified when a technical skill is under instruction, or where the educator maximizes the amount of direct interaction with faculty.

We are all highly aware of the increasing financial challenges that limit participation, particularly expensive international travel. Medical device companies can no longer fund many of the international flights that have in the past brought attendees to the larger meetings. Increasingly, hospitals and universities are questioning how funds are being used, the real educational value in funding such trips and are raising concerns regarding conflicts of interest. These are the background sources of pressure we have all experienced.

Now, along comes the coronavirus to compound matters. While we all watched the emergence of the disease in Wuhan province, central China, and its spread across the country and beyond, until recently we here in the Western Hemisphere had been minimally affected or infected. Not now, of course. Regardless, in the case of such an outbreak in this part of the world, we all have colleagues in China—and there are some major cardiovascular meetings in the Asian behemoth. In addition, many of our industry partners have manufacturing plants, distributors and customers suffering disruption amid the outbreak. Now the same measures that had been applied to travel involving China are in place in the U.S. and Europe. The bottom line is this: Educational interaction with China—and increasingly Japan and South Korea, too— will be drastically curbed.

And what of Europe? Just before the coronavirus enveloped the continent, I visited Rome to watch an international rugby game between Italy and Scotland. I arrived on a Friday morning to learn of a small number of cases in Northern Italy, none 6 • VASCULAR SPECIALIST

ALAN LUMSDEN CONDUCTS CONFERENCE REMOTELY (BOTTOM LEFT AND TOP); HOME STUDIO

We have always believed­­—and now even more strongly— that remote surgical viewing is the future delivery platform for medical education. of which was in the Italian capital. I attended the match in Rome’s Olympic stadium along with another 53,000 fans. After three days, the number of cases had skyrocketed close to 300—though still none of them in Rome. Italy was designated a Level 2 risk country by the Centers for Disease Control and Prevention (CDC) at that point in time (it has since risen to Level 3). Then, on the morning of my return to work, our hospital banned all professional travel to Italy, strongly discouraged personal travel and, furthermore, thought since I was in a stadium, I should not come to the hospital.

Whereupon panic set. The reason? I was set to run a symposium—the inaugural DeBakey CV

Congress: Advanced Interventional Cardiovascular Imaging and Robotics (Feb. 26–27)—over the course of the following two days. How could I possibly participate? Additionally, we had recently planned for four surgeons from Singapore to visit and watch our colorectal group perform robotic surgery. But the call was made. Attendance at the hospital would not be permitted. Of course, as we have seen since, this is only the beginning as the virus continues to spread, particularly now that it has crippled life and economic activity in our own backyard.

There was, however, a silver lining to these difficulties. In both of the situations outlined, the educational experience was salvaged using remote surgical viewing and remote delivery of a lecture. We have always believed—and now even more strongly—that this is the future delivery platform for medical education. Building out these capabilities is critical for the future of our profession. The coronavirus pandemic will accelerate this direction of travel massively.

Alan Lumsden is the medical director of Houston Methodist Heart & Vascular Center in Houston.

APRIL 2020

AORTIC INTERVENTION

Aortic neck dilation after FEVAR leads to little clinical impact, new mid-term study data reveal

BY BRYAN KAY

M

IAMI—Data, gathered in a study on the impact of aortic neck dilation after fenestrated endovascular aortic aneurysm repair (FEVAR), show that the process does indeed occur after the procedure—but with minimal clinical implications.

For principal evidence, the researchers pointed out, look to the lack of a type 1a endoleak in the entire series covered in their investigation.

The findings were presented at the Critical Issues America (CIA) annual meeting in Miami (Feb. 7–8) during a session on renal and mesenteric concerns

by Benjamin W. Starnes, MD, the professor and chief of vascular surgery at the University of Washington School of Medicine in Seattle.

Before delving into the data, Starnes set the scene by referring to a case report from his institution, published in the Journal of Vascular Surgery—“Longterm durability of a physician-modified endograft.”

“It’s pretty neat, because we had an 82-year-old gentleman about 10 years ago who entered our study, was treated, completed the study after five years and then, seven years after his implantation at the age of 88, he was driving in Halfway, Oregon, and was in a car accident,” explained Starnes. “He always told his wife that ‘When I die, I want you to return my aorta to Dr. Starnes.’

“So I got a call from a mortician, who asked me what I wanted—and they put the retroperitoneum in a box and mailed it to me,” he continued. “We did a lot of analysis of this, and it was a pretty rare event. You can see on the CT slices at the level of the SMA (superior mesenteric artery) from pre-op all the way out to five years, we have complete stability of this graft. When we did vivisection and dissection of this graft and digested the tissue, the graft was in perfect condition compared with the pre-operative—or day-of-surgery—photographs.”

Seal zone

This finding raises the whole concept of effective seal zone, said Starnes. “The effective seal zone length of a FEVAR is the circumferential graft seal zone length plus the infrarenal neck length.”

With the research team’s mid-term results now published, the proximal seal zone length has been revealed as an average of 41mm.

“When you look at the results compared to other registries that are published, our rate of type 1a endoleak is zero. That’s with a final seal zone length of 41mm,” Starnes said. “So aortic neck dilatation occurs at a reported rate of 0.7mm plus/minus 2.1mm in the first year after standard EVAR.” Starnes et al have already reported and published on aortic neck dilatation, specifically the infrarenal neck associated with fenestrated EVAR, and found “that the infrarenal aortic neck expands over time; it dilates over time, but only to the nominal diameter of a stent graft that you put in.” They measured the infrarenal neck diameter at the lowest renal artery, defining aortic neck dilatation as ≥3mm.

APRIL 2020

BASE OF LOWEST RENAL ARTERY

“So, we posed this question specifically for this meeting: In our prospectively collected IDE (investigational device exemption), with all of this data that we have, does aortic dilation occur in the paravisceral segment and to what degree?” Starnes said.

Further questions followed: If aortic dilation does occur, what are the clinical implications of this?

“We already know that we have had no type 1a endoleaks, so the clinical implications are few.” He further posed: “How does degree of oversizing affect aortic dilation? What impact, if any, does device selection have on aortic dilation? And does graft diameter have any influence on aortic dilation?”

In a near decade-long study—since April 2011— patients were selectively recruited based on a neck length of at least 2mm, requiring a “good” paravisceral segment. In addition to measuring aortic diameter at the lowest renal artery, the investigators also did the same at the mid-SMA level.

“We looked at pre-op, 30 days, six months and annually out to five years,” Starnes explained. “We analyzed the overall cohort and we completed subgroup analysis to look at the degree of oversizing. We divided these into quartiles: less than 10% oversizing, 10–15% oversizing, 15–20% and greater than 20%.”

Devices

Three different devices were implanted in their IDE—the Cook Zenith, the Medtronic Endurant and Bolton Treovance. Furthermore, graft diameters were divided into small, medium and large categories.

The results showed that of 166 patients enrolled, 101 underwent at least one year of follow-up, while 73, 56, 38 and 21 patients received two, three, four and five years of follow-up, respectively. Oversizing for the entire cohort registered at a mean 14.1%.

Results by graft type were revealed as 50 for the Cook Zenith device, 13 for the Medtronic Endurant and 38 for the Bolton Treovance with at least oneyear follow-up.

With regards to aortic dilation at the SMA with

one year of follow-up, “the mean aortic increase in our series was 1mm plus/minus 2.2mm for a 5% increase,” Starnes said, recalling a 1998 study on standard EVAR that reported a dilation of 0.7mm at plus/minus 2.1mm. “So very, very similar results,” he added.

“At two years, we were up to 2.2mm plus/minus 2.4mm, and this is where the dilation stops. This is where it peaks: at two years. Because at three years, we drop down to 6.9%—mean aortic increase of 3mm. At four years, we’re down to 6.7%, and out to five years we’re down to 4.1% aortic neck dilation.”

What about oversizing? “When we divide these patients based on their oversizing, if you look at those patients who had less than 10% oversizing, their aortic dilation over three years was 1%; 10–15%, it was 4.6%; 15–20%, it was 7%; and greater than 20% oversizing, it was up to 15.4% aortic neck dilation. So it increases with increasing degrees of oversizing.”

Device selection yielded interesting findings.

Starnes continued: “With the Medtronic Endurant graft, out to three years, average oversizing was 8.5% and the aortic neck at the region of the SMA dilated to 8.3%, so to the nominal diameter of the Endurant graft. If we look at the Bolton Treovance, the oversizing was an average of 12.9% and the aortic neck dilatation that occurred was 11.7%. Again, the aortic neck is dilating to the nominal diameter of the stent graft. However, with the Cook graft, which is a different platform—the Bolton and Medtronic are nitinol-based frames and the Cook Zenith is a stainless-steel frame—there was 17.5% oversizing, and yet only a 7% increase in aortic neck dilatation.”

Surprise

Starnes next turned to graft diameters. “This was interesting,” he mused. “I thought for sure that if we were treating patients with large diameter grafts [36mm], that means we’re treating diseased large necks, and that those patients would dilate more.

Actually, we didn’t find that. What we found was very similar among all three graft sizes. So if you had a 22–26mm graft, you dilated at 7%; 28–30mm, 8.6%; 32–36mm, you only dilated up to 6%.”

Concluding, Starnes expanded on his chief finding of minimal clinical implications of dilation after FEVAR. “Aortic dilation seems to plateau at two years and then gradually abate over time,” he said. “Graft size has no influence on aortic dilation at all. And there is a difference between nitinol- and stainless steel-based platforms.

“We can also say from this dataset that increased oversizing increases aortic dilation, and so it calls into question how to design a fenestrated endograft if you knew you could get an average seal zone length of not 15mm, but 40mm of effective seal every single time.

“That’s a 167% increase in seal zone length based on the standard IFU requirement of 15mm. So if you could guarantee that long a length of seal, would we have to oversize as much as we do? Maybe we can treat these patients with just 10% or less of oversizing.”

VASCULARSPECIALISTONLINE.COM • 7

AAA

NICE guidelines recommend physician-patient discussion prior to offer of any treatment

BY JOCELYN HUDSON

T

he final U.K. National Institute for Health and Care Excellence (NICE) recommendations, published in March 2020, indicate that NICE has listened to the physician community’s concerns to recognize that endovascular aneurysm repair (EVAR) is sometimes the only option in certain patients. The new guidance places the onus upon the physician to discuss all management options for unruptured aneurysms with the patient— conservative management, open surgical repair and EVAR. It is notable that there is a recommendation for following patients in the U.K.’s National Vascular Registry (NVR) to learn more about results.

The responsibility now appears to be on physicians to discuss the known current shortcomings of EVAR with patients, which these final guidelines emphasize. EVAR has operative mortality and early mortality benefit for patients over open repair, but was found in trials to have inadequate return for follow-up. This meant that failing EVARs with endoleak and secondary rupture were not picked up with consequent unacceptably high abdominal aortic aneurysm (AAA)-related mortality, a finding more marked after eight years of follow-up.

Recommendations in focus

In the new section on elective repair of unruptured aneurysms (1.5), the NICE board states in recommendation 1.5.1 that aneurysm repair for patients with an unruptured AAA should be considered if it is symptomatic, asymptomatic, larger than 4cm and has grown by more than 1cm in one year (measured inner-to-inner maximum anterior-posterior aortic diameter on ultrasound), or asymptomatic and 5.5cm or more, but measured inner-to-inner. The guidelines here rely on the U.K. Small Aneurysm Trial (UK SAT) and ADAM trial that identified one of the criteria for intervention as growth of more than 1cm per year. Notably, however, they also use a 5.5cm inner-to-inner measurement in the recommendation. In the UK SAT, a smaller measurement was used—5.5cm outer-to-outer.

Recommendation 1.5.2 focuses on discussing the benefits and risks of repair or conservative management.

It states: “When discussing aneurysm repair with patients who have an unruptured AAA, explain the overall balance of benefits and risks with repair and with conservative management, based on their current health and their expected future health.

The decision on whether repair is preferred over conservative management should be made jointly by the patient and their clinician after assessment of a number of factors.” These include aneurysm size and morphology, the patient’s age, life expectancy, fitness for surgery, and other conditions they have, the risk of AAA rupture if they do not have repair, the short- and long-term benefits and risks, and other disadvantages of repair, as well as the uncertainties around estimates of risk for AAAs larger than 5.5cm, again measured inner-to-inner.

8 • VASCULAR SPECIALIST

SOPHIE RENTON

“I am pleased that the final NICE guidance recognizes the importance of patient choice and gives greater autonomy to the doctor-patient relationship.”—Sophie Renton Recommendations 1.5.3 to 1.5.5 consider open surgical repair, standard EVAR, or conservative management. The guidelines suggest healthcare professionals offer open surgical repair for patients with unruptured AAAs “meeting the criteria in recommendation 1.5.1, unless it is contraindicated because of their abdominal copathology, anesthetic risks, and/or medical comorbidities,” (1.5.3) “who meet the criteria in recommendation 1.5.1 and who have an abdominal copathology […] that may make EVAR the preferred option,” (1.5.4) and “meeting the criteria in recommendation 1.5.1 who have anesthetic risks and/or medical comorbidities that would contraindicate open surgical repair.” (1.5.5) Finally, recommendations 1.5.6 and 1.5.7 outline complex EVAR diagnosis and management. If open surgical repair and complex EVAR are both suitable options (1.5.6), or for patients who have anesthetic risks and/or medical comorbidities that would contraindicate open surgical repair (1.5.7), two factors should be taken into consideration.

Firstly, only consider EVAR if the risks of complex EVAR compared with the risks of open surgical repair, and the uncertainties around whether complex EVAR improves perioperative survival or longterm outcome, when compared with open surgical repair, have been discussed. Secondly, only consider

IAN LOFTUS

complex EVAR if it will be performed with special arrangements for consent, and for audit and research that will determine the clinical and cost-effectiveness of complex EVAR when compared with open surgical repair, and all patients are entered onto the NVR. Comment

Reacting to the new guidelines, Ian Loftus, MD, consultant vascular surgeon at St. George’s University Hospital NHS Foundation Trust, London, U.K., and past president of the Vascular Society of Great Britain and Ireland (VSGBI), told Vascular Specialist: “This has clearly been a very difficult process for NICE and for the professions involved as stakeholders. It would have been without precedent to see a recommendation to completely stop such an established therapy as EVAR. The final version of the guidelines recognizes the difficulties faced when a clinician sits with the individual patient, and the need for patient and clinician choice. It allows the flexibility to still proceed with endovascular repair in circumstances where that is felt to be an appropriate course of action.”

Loftus added: “This should be seen, however, as a wake-up call to endovascular practitioners and industry. We need to ensure that endovascular therapies are performed in appropriate patients, in an appropriate environment. Most importantly, we must work together to ensure long-term durability of aneurysm repair. The collection of robust outcomes data, through the National Vascular Registry, is a vital part of the final guidelines.”

Sophie Renton, MBBS, consultant vascular surgeon at London North West University Healthcare NHS Trust, London, U.K., and secretary to the VSGBI, said: “I am pleased that the final NICE guidance recognizes the importance of patient choice and gives greater autonomy to the doctor-patient relationship.”

APRIL 2020

MEDICAL EDUCATION

Future is now: Surgical simulation utilizing 3D printing has potential to help cut medical errors, according to surgeon-innovator “Just looking at these times is very telling. The attendants spent about an hour doing a carotid endarterectomy.

That’s pretty good, about what they’d spend on a human.”

The resident time, on the other hand, stood at 140 mins. Thus, patients, he muses, might quickly identify which surgeon they want performing their procedure.

BY BRYAN KAY

H

OUSTON—The picture as Jonathan Stone, MD, describes it couldn’t be more stark. Medical error, according to recent publications, he says, now sits at third place among the leading causes of death. “Right behind heart disease and cancer there is medical error,” explains the assistant professor in the department of neurosurgery at the University of Rochester in Rochester, New York.

Stone was giving a talk on “Surgical simulation utilizing 3D printing” at the inaugural DeBakey CV Congress: Advanced Interventional Cardiovascular Imaging and Robotics in Houston (Feb. 26–27).

It’s a branch of research he entered in conjunction with the department of vascular surgery at his parent institution. Significantly, he has skin in the game as an innovator-owner. Since first developing hydrogel phantoms by exploiting polymer chemistry and 3D printing, he spun out his simulation advances into a company that sells the product. He is both CEO and surgeon.

During his talk, Stone laments the model of surgical training as still essentially taking the form of an apprenticeship. The future, he says, favors simulation. He can’t be sure of the type of platform that will take over surgical education. Perhaps virtual reality, he considers. Or perhaps a more physical model like his 3D printed simulations, in which human organs are sculpted out of hydrogels.

Practice

“We practice every single day and spend our careers getting better and better at what we do,” Stone tells the DeBakey CV Congress.

“Unfortunately for patients, that means at some point we’re using them as tools. It was back in 1927 Will Mayo, MD, said, ‘There is no excuse today to practice on patients.’

“Even back then, what he was talking about was visiting other surgeons and observing them rather than trying to do it yourself. Fast forward to today, we still have much of an apprenticeship model of surgical education. The reason is we don’t have a good platform for open surgical education.

APRIL 2020

New technology

JONATHAN STONE

“There have been many advances in virtual reality and augmented reality, but there is still nothing that provides the good habits and the ability to build technical skills outside the operating room.”

The imperative is real, Stone says, and “becoming increasingly important because of the awareness around patient safety and quality of healthcare delivery.”

Surgeons and healthcare delivery agents like him, he goes on, show that they’re actively attempting to reduce medical errors.

“When it comes to surgeries, there are two classes,” he says. “You have the regular with low surgical error rate. Yes—as you do more you get better. Then you have these complex surgeries where, when you first start, there’s a very high complication rate.”

How are complex surgeries broken down to the regular level? This is where Stone posits a role for 3D simulations, describing the range of technology available.

Using regular 3D printers—from as little as $1,000 (or even less), up to $350,000—hydrogel-built models are produced, using the geometry of

the organs in order to create realistic representations, he says.

Advances

Stone and his team have come a long way since they started out, he explains. The colors are more realistic.

The textures, too. The simulations are multilayered. They’re now putting in engineering in the shape of fine wires so electrical conductivity can be measured. “You can ultrasound them … CT [computerized tomography] them,” he adds.

Stone thens turns to one of the alternatives to his form of simulation.

“You see a lot of these virtual reality systems coming out where you’re holding these controls that aren’t real tools,” he says. “I feel like using the real tools is a critical step.”

He touched on vascular applications.

“We spend a lot of time on the plaque interface with our carotid models so you can really get down to the details … You can do angiography on them, deploy stents.”

Do the data back up the utility of 3D simulations? “We had a study published looking at attending vs. resident performance,” he explains.

“You see a lot of these virtual reality systems coming out where you're holding these controls that aren't real tools.”—Jonathan Stone

Stone highlighted 3D simulation’s ability to allow for the practice of new and emerging technology.

He draws on an intriguing example. “When we first did TCAR [transcarotid artery revascularization] at our institution about five years ago, before we put it in a human—we put it in one of these models. We did a complete procedural rehearsal, and you were able to run through all the steps, skin-to-skin, and make sure we were comfortable with that procedure.”

He adds, “We really look forward to an opportunity for people to practice rare scenarios or emergent scenarios where the training step is usually pushed aside because it’s a lifethreatening situation.”

The next step for 3D surgical simulation lies in patient-specific solutions, Stone goes on, where an individual’s particular anatomical component is recreated by converting DICOM images into stereolithography files and 3D printing components for assembly. That would allow for practice of that patient-specific surgery prior to the actual event.

But the conundrum, admits Stone, is this: Who do you need to rehearse these procedures—and how often— without doubling workload?

“The complex [procedures], the difficult tumors, the complex aortic aneurysms, those are the obvious uses,” he says. “That’s what we’re trying to figure out: The right patient population that necessitates this patient-specific simulation.”

The future, it seems, is already here. For Stone, it’s all about progress. “As we look forward, we use a combination of patient-specific and idealized simulation to train the resident staff and gain new skills with advancing technology.”

VASCULARSPECIALISTONLINE.COM • 9

NEWS FROM SVS

MMMMMMM 2020

VASCULARSPECIALISTONLINE.COM • 11

CLAUDICATION

Study: Link between IC revascularization and progression to CLTI established alongside rising rate of amputation

BY BRYAN KAY

P

ALM BEACH, Fla.—Revascularization of intermittent claudication (IC) patients is associated with an increased rate of progression to critical limb-threatening ischemia (CLTI)—as well as an increased rate of amputation.

Those were the main findings of a study presented in a scientific session at the Southern Association for Vascular Surgery (SAVS) annual meeting in Palm Beach, Florida ( Jan. 8–11).

Delivered by Vashisht Madabhushi, MD, of the University of Kentucky in Lexington, Kentucky, attendees heard how the research had set out to determine if the rate of IC progression to CLTI— and amputation rates among patients initially diagnosed with the former—were influenced by treatment method.

“The most common symptomatic presentation of PAD [peripheral arterial disease] is [IC],” the researchers pointed out. “The natural progression of symptoms of IC is fairly low at 7–9% the first year and 2–3% each year thereafter, and IC portends an amputation rate of 1–3.3% at five years.”

Despite the proven benefits of mitigation by medical therapy, Madabhushi continued, a rapid growth in invasive treatment of IC has ensued.

The team’s single center, retrospective study reviewed the records of all patients who first had IC between November 2003 and April 2019, with the method defined as endovascular or open repair.

Madabhushi et al stratified time to CLTI diagnosis and amputation by revascularization status.

VASHISHT MADABHUSHI SPEAKS AT SAVS

Some 1,137 patients with IC were identified, with 109 excluded due to prior diagnosis of CLTI and 19 owing to revascularization prior to IC diagnosis, Madabhushi noted.

“There was no significant difference in age, smoking status or comorbidities between the two groups other than the revascularized group had a higher rate of COPD [chronic obstructive pulmonary disease] (15% vs. 23%; p<0.05),” Madabhushi continued. “After risk adjustment, there was a five-fold increase in the progression to CLTI in the revascularized IC group (6% vs. 35%; p<0.001) and amputation rates were nearly five times higher in the revascularized IC group (3% vs.

14%; p<0.001).”

TCAR outperforms transfemoral carotid artery stenting, ‘significantly’ lowering stroke and death risk

BY BRYAN KAY

A

study that set out to determine whether there was a lesser stroke or death risk by deploying transcarotid artery revascularization (TCAR) over the transfemoral approach among patients receiving treatment for carotid stenosis suggested a statistically significant advantage for the former.

The researchers behind the analysis, led by Marc Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, uncovered a 1.6% vs. 3.1% level of risk in favor of TCAR when comparing the two methods of carotid artery stenting.

Schermerhorn et al carried out a propensity score-matched analysis of prospectively collected data from 12 • VASCULAR SPECIALIST

the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI), Transcarotid Revascularization Surveillance Project and Carotid Stent Registry of both asymptomatic and symptomatic patients in the United States and Canada who were receiving treatment via TCAR and transfemoral stenting for carotid stenosis from September 2016 to April 2019.

The study, published by JAMA: The Journal of the American Medical Association, involved 5,251 patients who underwent TCAR and 6,640 who received transfemoral stenting. After matching, 3,286 pairs of patients were identified.

The main finding—that TCAR was associated with a lower risk of in-hospital stroke or death (1.6% vs.

3.1%)— bore an absolute difference of -1.52% (95% CI, -2.29 to -0.75) and a

Furthermore, a Cox multivariable regression analysis that included factors such as age, gender, body mass index, COPD and tobacco use, among others, identified revascularization of IC patients a significant risk factor on two fronts: the progression to CLTI with a hazard ratio (HR) of 6.25 (95% CI 4.01–9.73) and amputation (HR 6.16; 95% CI 2.83–13.42). Reflecting further on the findings, Madabhushi noted that further studies are needed to identify which—if any—IC patients benefit from revascularization procedures. “Given the results of this study, we believe that IC patients should be treated with SET [supervised exercise therapy] and BMT [best medical therapy],” Madabhushi et al concluded.

Discussant Malachi Sheahan III, chair in the division of vascular and endovascular surgery at the Louisiana State University Health Sciences Center in New Orleans, said he believed Madabhushi and colleagues were on the precipice of a landmark paper.

But he noted some unanswered questions— the chief of which involved selection bias, “where the patients who were selected for treatment were more likely to have more severe disease, and therefore at risk for progression.”

Sheahan also highlighted a need to return to the study charts to ascertain different treatment methods employed and their respective outcomes in order to identify any hazardous activity. “I think it would be very elucidating if you can determine if there is any difference in outcome based on the specialty of the treating provider,” he added.

relative risk (RR) of 0.51.

Stroke alone yielded a risk comparison of 1.3% vs. 2.4%, an absolute difference of -1.10% (95% CI, -1.79 to -0.41) and an RR of 0.54, while death registered at 0.4% vs.

1.0% with an absolute difference of -0.55% (95% CI, -0.98 to -0.11) and an RR of 0.44.

“There was no statistically significant difference in the risk of perioperative myocardial infarction between the 2 cohorts (0.2% for transcarotid vs. 0.3% for the transfemoral approach; absolute difference, -0.09% [95% CI, -0.37 to 0.19]; RR, 0.70,” the researchers wrote.

Furthermore, at one year TCAR was again shown to provide lower risk of ipsilateral stroke or death (5.1% vs. 9.6%). However, the transcarotid method was associated with a higher risk of access site complication, resulting in interventional treatment (1.3% vs. 0.8%), the authors found.

The transfemoral approach, on the other hand, resulted in more radiation.

The stakes are high. A number of trials have observed higher rates

of perioperative stroke following transfemoral carotid artery stenting compared with carotid endarterectomy. The TCAR approach, which comes with flow reversal, was recently introduced for carotid stenting, the investigators pointed out, and specifically developed to decrease stroke risk. “However, its outcomes, compared with transfemoral carotid artery stenting, are not well characterized,” they wrote by way of introduction.

But the initial question—is TCAR or transfemoral carotid artery stenting associated with a lower risk of stroke or death among patients undergoing treatment for carotid artery stenosis?— got an answer.

“Among patients undergoing treatment for carotid stenosis, transcarotid artery revascularization, compared with transfemoral carotid artery stenting, was significantly associated with a lower risk of stroke or death,” the authors concluded.

SOURCE: DOI:10.1001/ JAMA.2019.18441 APRIL 2020

NEWS FROM SVS

What has SVS PAC ever done for you?

BY PETER CONNOLLY, MD, AND MARK MATTOS, MD

I

magine that you are telling your lay friends about what you do for a living. You have to explain the difference between arteries and veins.

And then you find that you need to clarify that you do not, in fact, operate on the heart.

It doesn’t get too much farther down the road than this, when, under usual circumstances, you are met with a combination of awe and indifference. Awe because— well—people like gory stories, and

indifference because, in the end, they can’t ever really relate to it.

Now imagine telling the same story to someone who could affect your livelihood. The story would actually be very different. You might focus on the trials and tribulations of your profession, flaws in healthcare delivery and difficulty with fair reimbursement. The problem under this scenario is that, usually, you confront difficulty in finding someone to listen to you.

The Society for Vascular Surgery (SVS) Political Action Committee (PAC) was formed for just this

purpose—to provide a voice for vascular surgeons in Congress. It gives us the opportunity to shape legislation that affects the way we provide patient care. Indeed, it greatly impacts on our very livelihood.

Currently, only 5% of members of the SVS donate to the PAC. Why not consider taking the time to familiarize yourself with some of the legislative priorities for SVS? Help make a difference. Please give to the PAC. Peter Connolly and Mark Mattos are members of the SVS PAC Steering Committee.

PAC takes pause in fundraising efforts In view of the worldwide COVID-19 pandemic and resulting public health crisis, and engagement of SVS members to address the crisis, the PAC Steering Committee will pause active fundraising for several weeks and reassess in May. The PAC thanks all donors and remains focused on utilizing contributions to advocate aggressively for the needs of vascular surgery and all members.

For more, visit vascular.org.

Quality: Global Vascular Guidelines now available in pocket guide format

BY BETH BALES

T

he Global Vascular Guidelines (GVG), extensively researched and written by an international committee of leading vascular experts, are now available as a pocket guide.

The guidelines recommend the use of the Society for Vascular Surgery (SVS) Threatened Limb Classification

APRIL 2020

System for clinical staging and propose the Global Anatomic Staging System for defining the extent and complexity of peripheral arterial disease (PAD) along the Target Artery Pathway.

This guide will help physicians in diagnosing, staging and treating patients with chronic limb-threatening ischemia (CLTI). It lists key points of the guidelines and algorithms to

assist in diagnosis and staging patients.

The guide also includes a summary of recommendations and gaps in research.

The digital version is free for SVS members, who will also receive printed copies of the spiral-bound pocket guide. Additional printed copies start at $8.99.

The guidelines were created over

a four-year period by representatives of the SVS, the European Society for Vascular Surgery and the World Federation of Vascular Societies. They were published in June 2019.

SVS partners with Guidelines Central for the pocket guides. To view all guides and order printed versions, see vsweb.org/ PocketGuides.

VASCULARSPECIALISTONLINE.COM • 13

NEWS FROM SVS

VAM adds Career Fair for 2020

L

ooking into job opportunities? Just want to see what’s out there in terms of career moves to another part of the country?

This year’s Vascular Annual Meeting (VAM) attendees will want to take advantage of the new Career Fair, set for 9:30 a.m. to 5 p.m. Friday, June 19, in the Exhibit Hall. Community Brands, which runs the SVS online job board, is operating the fair.

The SVS Community Practice and Young Surgeons committees endorse the event as a way to provide SVS members exposure to a number of opportunities to change their careers.

“Even if someone isn’t actively looking for a new job, he or she might want to explore possibilities for the future,” said Daniel McDevitt, MD, chair of the Community Practice Committee. “People don’t necessarily take a linear path through life.”

Besides on-site representatives, other organizations will be included in a digital recruitment guide, accessible via the meeting’s app.

Technology drives vascular future

BY BETH BALES

D

ecades ago, “picture” phones were an idea straight out of science fiction.

As the saying goes, the future is now. FaceTime and Skype are common; similar technology permits doctors to visit patients via telemedicine.

In other health technological advancements, “wearables” track steps, heart rates and more. Scientists mull over artificial intelligence. A Society for Vascular Surgery (SVS)branded app is being developed for those overseeing Supervised Exercise Therapy (SET) for patients with peripheral arterial disease (PAD).

An educational session at the Vascular Annual Meeting (VAM) will cover such digital health advancements. Entitled “Digital health advancements in vascular surgery,” Judith Lin, MD, chair of the SVS Health Information Technology Task Force, and Donald Baril, MD, SVS Program Committee member, will co-moderate the session and panel discussion, set for 4:30 to 6 p.m.

Wednesday, June 17.

Edward Brown, MD, founder and CEO of the Ontario Telemedicine Network, will present “Virtual care: The front door to patient-centered care.” The network has conducted more than 1 million virtual visits with 353,000 patients in Canada.

Although telemedicine is focused on primary care, it may be performed in all medical and surgical specialties.

Brown is an emergency room physician and a past president of the

American Telemedicine Association.

Thus far, the surgical field has not embraced telemedicine as widely as have other healthcare providers, she said. With more than 200 virtual care visits of her own completed, Lin knows telemedicine works.

“You can engage patients, see patients virtually, have face-to-face conversations,” she said. With certain platforms, both patient and surgeon can view the imaging simultaneously, allowing the surgeon to point out various areas of concern—such as a blood clot or aneurysm— on ultrasound or computerized tomography (CT) scans.

Telemedicine could permit surgeons to expand their practices and offer second opinions to patients even in other states, she said. Qualified physicians can see patients in multiple states through the Interstate Medical Licensure Compact, depending on a particular state’s telemedicine laws

and participation in the consortium.

“The ramifications are enormous,” said Lin. “Ultimately, it’s going to help the patients. They don’t have to drive or travel far.”

Other topics for the session include using mobile device apps in vascular care; translating tracked activity into outcomes, interventions and surveillance for PAD; using artificial intelligence (AI) to risk-stratify vascular patients.

Apps and wearables are already part of the present. The SVS SET app is expected to be available by June and will be featured at the session.

Surgeons may be able to manage care with help from point-of-care and portable ultrasounds, such as devices that connect to mobile phones and permit specialists to view imaging.

“Physicians can see what therapy might be needed” said Lin. “We have a lot of data. But can we leverage AI to predict those patients at higher risk of re-intervention after endovascular aneurysm repair? Could AI assess normal versus abnormal structures on a CT scan or ultrasound study? Using patient risk factors, can AI predict which patients are more likely to develop limb loss from PAD? Can AI evaluate physicians for appropriate use in peripheral vascular intervention and venous ablation?

There are lots of possibilities.”

Lin pointed to the anticipated vascular surgeon shortages of the future. “Physicians are spread too thin. We need to leverage digital health technology to take better care of our patients and improve wellness among physicians.”

Vascular Trainee Program redesigned for VAM 2020

BY BETH BALES

H

elping vascular trainees successfully transition from education and training to clinical or academic practice is the central goal for the Vascular Trainee Program at the 2020 Vascular Annual Meeting (VAM).

The Society for Vascular Surgery (SVS), the Society for Clinical Vascular Surgery (SCVS) and the Vascular and Endovascular Surgery Society (VESS) are working together to create the program, redesigned substantially from 2019.

“There are nuanced and nonclinical skills required to successfully make that transition that are important to highlight,” said Dawn Coleman, MD, SVS representative for the program.

The program includes four didactic sessions on Thursday and Friday, June 18 and 19. Topics 14 • VASCULAR SPECIALIST

and times are: Academic Vascular Surgery, 1:30 to 2:30 p.m. Thursday; Transition to Independent Clinical Practice, 4 to 5 p.m. Thursday; Conflict Management, 8 to 9 a.m. Friday; Leadership and the Young Surgeon, 1:30 to 2:30 p.m. Friday.

The presentations will highlight “interactive sessions with a free exchange of questions and answers,” geared to both clinicians and researchers.

A “micro-mentoring” luncheon will be held from 12:15 to 1:30 p.m. Friday. Planners envision several tables, each hosting a different trainee-related topic.

In addition, vascular trainees will have their own area for conversation and networking with leaders at the Thursday evening opening reception, 5:30 to 6:30 p.m.

The transition to independent practice “can be anxiety-provoking” and not all programs/ curriculum comprehensively prepare trainees for all

that is required, said Coleman. The team doctors brainstormed on content they thought would be useful for rising surgeons—essentially, “what we wish we had known, what we wish someone had told us,” said Coleman.

They knew they wanted to include leadership as a topic and skill. Many surgeons “underestimate that we all lead at many levels, even without a title of authority. We lead clinical and research teams, we interact with medical students and residents daily,” said Coleman. The vascular trainee program fills a gap. “We wanted something for vascular trainees, particularly ‘senior learners’ close to that transition to independent practice,” she said. The program has also been tailored to accommodate feedback from the 2019 Fellows Program.

For planning purposes, participants must register for the Friday luncheon. Visit vascular.org/VAM. APRIL 2020

VENOUS DISEASE

Elder statesman of venous disease delivers golfing metaphor for fortitude, wellness

BY BRYAN KAY

A

MELIA ISLAND, Fla.—As a podium talk at the annual meeting of the American Venous Forum (AVF), it represented a bit of an outlier. It was, the presenter admitted, the only non-scientific talk on the program. But the speaker was no mere upstart, the particular session not an ordinary rundown of figures.

Venous disease was indeed on the menu—but on this occasion through the prism of golf. The man at the helm was Thomas O’Donnell, MD, the erstwhile AVF president, current professor of surgery at the Tufts School of Medicine, Boston, and a former hospital CEO. O’Donnell was speaking during the March 3–6 conference’s Sumner Session: “The wisdom and experience of the past presidents of the AVF” with a talk entitled “Venous disease and famous golfers”—the Floridian backdrop of Amelia Island being conducive to the topic at hand.

The presentation was a walk through the history of both the game and venous treatment over the years, but what O’Donnell also delivered was an example of fortitude and, ultimately, wellness.

Vascular surgeon burnout and associated problems, of course, are omnipresent, backed up by studies highlighting the pressures doctors operate under, the individuals who succumb and the financial consequences of these pressures.

Why this topic? O’Donnell mused. What is it doctors do outside of their professional functions?

So: “Are sports and hobbies beneficial to MD, doctor health?” O’Donnell pondered. “Yes, I think they are—for mental and physical reasons.”

The passionate sportsman outlined some of the duels with colleagues he’s enjoyed on the tennis court and golf course down the years, before turning to the core of his talk: a motley crew of Bobby Jones, Ben Hogan and Casey Martin, each of whom had different forms of venous disease. “The purpose of the remainder of the talk,” O’Donnell told the audience, “is to talk about three forms of venous disease affecting three top golfers and focus on the medical problem to see how the disease and its morbidity influenced their game and life.”

Bobby Jones

First up, Bobby Jones. “He was the consummate amateur; he never became a professional. He was emblematic of the Grand Slam, winning the four major titles as an amateur, all in one year—1930,” he explained. Before, at the age of 28, O’Donnell added, “he said, ‘I’ve had enough,’ and retired.”

But what Jones also possessed, O’Donnell continued, was an “odd” approach to his health.

He suffered from a nervous disposition, spending his nights smoking and drinking whisky heavily in order to relax. “During a major tournament, he would usually lose between 12 and 18 pounds, and occasionally had fits of vomiting—like some of the residents going in to do their first case,” O'Donnell APRIL 2020

joked. “What a lot of people don’t know is Jones had some very bad varicose veins. They were crippling.”

In the 1920s, aged just 18, he had had four operations on the condition, and at that time most likely underwent the Keller invagination procedure, which, O’Donnell said, probably accounts for his morbidity and the number of times he was operated on.

Jones was educated, O’Donnell went on. He attended Harvard College, though he could neither get on the institution's golf team owing to his status as a golfer nor take on the manager’s role, instead ending up as assistant manager to get his Harvard letter. Much later on, by now in his 40s, Jones was part of the Normandy landings during World War II, despite the presence of the varicose veins that had undercut his golfing journey and having been declared 4F—or unfit for military service.

Ben Hogan

O’Donnell then moved onto Ben Hogan, one of the all-time greats who won all four major tournaments in the pro game. But the native Texan was almost cut down in his prime when in 1949 he was involved in a road traffic accident.

“Ben was with his wife driving to a golf tournament when a greyhound bus pulled out and hit his car,” O’Donnell began. “He was told he would never walk again. The reason he survived is he saw the bus coming and threw himself onto the lap of his wife— either that or the engine would have gone right through him.

“His injuries were a double fracture to the pelvis, a fractured collar bone, and then two days prior to planned discharge, he had severe chest pain. The chest X-rays showed typical findings of PE [pulmonary embolism]. He was treated with heparin, standard treatment at the time, but then

had a recurrent PE manifested by tachycardia and a drop in blood flow.”

The titan of PE at the time was summoned to the hospital in El Paso, Texas, where Hogan was being treated. The surgeon in question was Alton Ochsner, MD, who made it out west from New Orleans amid difficult weather on a specially reserved military aircraft to treat Hogan.

“When he finished, Hogan had typical postthrombotic syndrome,” explained O’Donnell.

“Despite this, he went on to play at the U.S. Open 16 months later.” Needless to say, Hogan won the tournament.

Casey Martin

Lastly, O’Donnell turned to the less familiar Casey Martin, a three-time All-Pac 10 and member of Stanford University’s NCAA Championship team in 1994.

“He had Klippel-Trenaunay-Weber Syndrome but it was a little different in that its major involvement was of the bones. His doctor said, ‘His bones look like Swiss cheese,’” O’Donnell said. “Because of the pain and his disability, he was unable to walk. So, he sued the PGA under the American Disabilities Act, saying ‘You must accommodate this disability, I’ve got to use a golf cart.’ The Supreme Court ruled in favor of Martin, despite Jack Nicklaus and Arnold Palmer saying you shouldn’t be able to use a cart.”

As O’Donnell pointed out, Martin did not go on to win many golf tournaments, but he did contribute to golf by going on to coach an NCAA team at the University of Oregon.

All of which is to say: Each confronted great difficulty to succeed in their game of choice. “We have three golfers, all with different manifestations of venous disease; all caused disability but it was amazing how they all overcame it.”

VASCULARSPECIALISTONLINE.COM • 15

AORTA

Transabdominal open AAA repair linked to more reinterventions

BY JOCELYN HUDSON AND BRYAN KAY

R

epair-related reinterventions and readmissions are lower after

retroperitoneal compared with transabdominal open abdominal aortic aneurysm (AAA) repair, according to data gathered in a large

multicenter retrospective review.

The findings were contained in a paper published in the January edition of the Journal of Vascular Surgery.

For those patients undergoing open surgical repair of AAA, the decision as to how to approach the aneurysm surgically is multifactorial.

Familiarity with the approach, access to intra-abdominal organs, and the right iliac system, favors the transabdominal method. Conversely, avoidance of a hostile abdomen, access to the visceral aorta and potential early return of bowel function favors the retroperitoneal approach.

“There is very limited data with regards to comparing these approaches long term,” said first author Sarah Deery, MD, of the the Massachusetts General Hospital in Boston.

“Our aim in this study was to evaluate late mortality, readmissions and reinterventions, including aneurysm-related reinterventions, for both approaches, thus allowing surgeons and patients to consider these factors in their decision-making.”

A multicenter team, led by Marc Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, used prospectively collected data from the Vascular Quality Initiative (VQI) linked to Medicare data in order to compare the two approaches. VQI collects and analyses data so as to improve the quality of vascular care.

Researchers evaluated 1,282 patients whose operation was performed between 2003 and 2015. The transabdominal approach was utilized in 914 patients (71%) versus the retroperitoneal in 368 patients (29%).

Meanwhile, long-term (five-year) outcomes were revealed. Survival was similar (62% for transabdominal, 61% for retroperitoneal).

Repair-related reintervention and readmission were significantly higher for the transabdominal approach (42% vs. 34%). Abdominal wall reoperations were significantly higher for transabdominal (13% vs. 6%).

This important series provides long-term data that enhances decisionmaking, the authors said.

But there were also words of caution. “These data must be interpreted in the context of the study design,” the authors conceded.

“Clinical registries often have incomplete data and limited variable definitions, and in particular, the VQI contains only limited long-term follow-up information.”

SOURCE: DOI.ORG/10.1016/J. JVS.2019.03.045

16 • VASCULAR SPECIALIST

APRIL 2020

NEWS FROM SVS

Evaluation and management coding: Dizzying rounds of changes continue to filter through

BY MATTHEW SIDEMAN, MD AND SUNITA SRIVASTAVA, MD

I

n an effort to combat the “note bloat” culture, the Centers for Medicare and Medicaid Services (CMS) made changes to the evaluation and management (E/M) office visit codes for 2020. This culture is largely a result of the “check-box” nature of trying to meet documentation requirements.

The changes eliminated requirements for clinicians to re-record elements of history and physical exam when there is evidence that the information has been reviewed and updated, and affected codes 99201–99215.

More changes to office E/M codes are in store for 2021, including revisions to CPT (Current Procedural Terminology) code descriptors and code selection criteria. Below are some highlighted changes that have occurred and others that are anticipated: Elimination of history and physical as elements for code selection: While the physician’s work in capturing the patient’s pertinent history and performing a relevant physical exam contributes to both the time and medical decision-making (MDM), these elements alone should not determine the appropriate code level. The code descriptors were revised to state that providers should perform a “medically appropriate history and/or examination” Permission for physicians to choose whether their code selection is based on medical decisionmaking (MDM) or total time: The three current MDM components are not anticipated to change

MATTHEW SIDEMAN

SUNITA SRIVASTAVA

materially. However, there will be extensive edits to the elements for code selection and revised definitions in the E/M guidelines. Additionally, for both new and established patients, only two out of three components will be required.

The definition of time will be total time, not typical time, and represents total physician and/ or qualified healthcare professional (QHP) faceto-face and non-face-to-face time on the date of service. These definitions only apply when code selection is primarily based on time and not MDM Deletion of CPT code 99201 Creation of a shorter prolonged service code: This new add-on code would be reported for an additional 15 minutes of physician/QHP face-toface and non-face-to-face time on the date of the encounter and only reported with 99205 or 99215 when time is used for code selection.

In addition, major changes to the reimbursement for these E/M office codes have been proposed.

Significant shifts within the Medicare system, such as these proposed changes for E/M reimbursement, will have a ripple effect throughout the entire Medicare system. Due to Medicare budget neutrality, there will be major shifts in total specialty payments, not just to E/M services.

While aspects of these changes will serve vascular surgeons well (i.e., reduced documentation requirements, MDM clarification, etc.) SVS is gravely concerned with the potential impact on overall vascular surgery reimbursement.

SVS has been actively engaged with CMS, the American Medical Association’s CPT/RUC (RVS Update Committee) E/M Workgroup, the American College of Surgeons and the Surgical Coalition to advocate for fair and appropriate guidelines and reimbursement for the services we provide to our patients. We are working to adjust the current proposals to more accurately align payments with the resources consumed.

Vascular surgeons should learn more about the anticipated 2021 changes to office E/M coding and prepare their practices for change. Will your Electronic Health Record system be ready? Will your coders be ready? Will your budget be ready?

The Society for Vascular Surgery (SVS) will keep the members informed of changes. Questions?

Contact the SVS Coding Committee at mmalek@ vascularsociety.org.

Matthew Sideman (chair) and Sunita Srivastava are members of the SVS Coding Committee.

Journal watch: Open-source papers on deck 30 days and one year in the treatment of rupture and malperfusion in the setting of acute, complicated TBAD (vsweb.org/JVS-STABLE).

JVS, May

The economic burden and clinical impact of preoperative opioid dependence for patients undergoing lower extremity bypass surgery (vsweb.org/JVSOpioidDependence); and five-year results of endovascular AAA repair with the Ovation abdominal stent graft (vsweb.org/JVS-Ovation).

JVS-VL, May

T

he Journal of Vascular Surgery (JVS) and JVS: Venous and Lymphatic Disorders (JVS-VL) have a number of open-source articles available in the April and May issues. A sampling follows.

APRIL 2020

JVS, April

STABLE clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite design device, showing favorable clinical and anatomical outcomes at

View the updated Clinical-EtiologyAnatomy-Pathophysiology (CEAP) classification system, the work of the American Venous Forum’s CEAP Task Force, created in 2017. The revision adopts the revised Delphi process. See vsweb.org/JVSVL-CEAP.

In memoriam

S

VS member H. Gordan Page, MD, 102, professor emeritus, surgery, in the College of Medicine at the University of Vermont, Feb. 9, 2020.

In 1991, the university’s department of surgery established the H. Gordon Page Surgical Clinical Award for his dedication and commitment to patient care.

Sir Norman Browse, MD, 87, former president of the Royal College of Surgeons of England, who founded the Research Fellowship Scheme, in September 2019.

VASCULARSPECIALISTONLINE.COM • 17

VASCULAR PRACTICE

Deep venous stenting presents advantage over ablation in achieving better ulcer healing rates, AVF told

BY LIAM DONOVAN

A

MELIA ISLAND, Fla.— “Venous leg ulcers (VLUs) secondary to deep venous stenosis represents a distinct class of patients who require a unique treatment paradigm,” said Abhisekh Mohapatra, MD, an integrated vascular resident at the University of Pittsburgh Medical Center in Pittsburgh, presenting results of a multicenter retrospective study of patients presenting with VLUs— between 2013–2017—that favored deep venous stenting over ablation.

Speaking to attendees at the 2020 annual meeting of the American Venous Forum (AVF) , held March 3–6, in Amelia Island, Florida, Mohapatra begun his talk by noting that venous leg ulceration can arise from the individual incidence of deep,

superficial or perforator vein disease, or a combination thereof.

He said: “Compression is the mainstay of therapy in all of these patients and is always important, regardless of the other interventions performed. When deep venous stenting is performed, it can significantly improve venous hypertension in the leg and aid in wound healing for these patients.

However, multiple problems often exist, and in this situation it is not clear which veins should be treated first.”

The aim of the study, which included data for 832 patients across 11 centers in the U.S., was not only to determine whether the presence of deep venous stenosis affects the wound healing trajectory of VLU patients, but also to understand which treatment strategies affect ulcer healing in those diagnosed with deep venous stenosis.

ABHISHEK MOHAPATRA SPEAKING AT AMERICAN VENOUS FORUM (AVF) 2020 IN AMELIA ISLAND, FLORIDA

According to Mohapatra, investigators focused on the cohort of patients with deep venous stenosis; baseline characteristics, anatomy of venous disease and wounds, treatments performed, and wound healing trajectories, were all studied.

Furthermore, the primary outcome was successful healing of the largest index ulcer.

Of the 832 patients in the dataset, 16.1% (n=134) had stenosis in the deep venous system. The demographics of these patients showed that those with deep venous stenosis were more likely to have a history of deep venous thrombosis (47% vs. 23.6%; p<0.001), have a hypercoagulable state (27.6% vs. 10.7%; p< .001) and be receiving anticoagulation (71.6% vs 25.5%; p<0.001). Moreover, patients with deep venous stenosis were more likely, on average, to have multiple ulcers

(20.2% vs 9.9%; p=0.002).

Out of the 134 deep venous stenosis patients, stenting was performed in 70.9% (n=95), truncal ablation in 44.8% (n=60) and perforator ablation in 20.9% (n=28); when both stenting and truncal ablation were performed, stenting was undertaken first in 53.5% of cases.

“As this was a large, multicenter database, collecting data from multiple sites often requires limiting the number of variables that are collected to limit the burden of data entry, so there is some lack of granularity with respect to these patients,” Mohapatra acknowledged. “One of the things we wanted to know, but could not from the dataset, was whether the deep veins that were stenotic or re-stented were femoral or iliac veins, or the inferior vena cava.”

Concluding, Mohapatra confirmed that stenting improved wound healing rates, whereas ablation of pathologic superficial or perforator veins did not.

Furthermore, he made the argument that routine imaging of the iliocaval segment may help the clinician to pursue early deep vein stenting in order to maximize ulcer healing and then avoid unhelpful truncal and perforator interventions.

Open AAA repair volume appears to be more impactful on outcomes than years of experience, investigators reveal

BY BRYAN KAY

P

ALM BEACH, Fla.— The more open aortic repair (OAR) case volume vascular surgeons take on, the more it seems to be “impactful” on OAR outcomes than a physician’s accumulated years of practice experience.

The finding was revealed by Salvatore T. Scali, MD, a vascular surgeon of the University of Florida, Gainesville, Florida, and colleagues in a scientific session at the Southern Association for Vascular Surgery (SAVS) annual meeting ( Jan. 8–11) down the state’s Atlantic coast in Palm Beach.

Scali et al had been keen to explore—as the title of their SAVS presentation outlines—“The intricate association between case volume and years of practice experience on open AAA [abdominal aortic aneurysm] repair.”

The backdrop is a familiar one: the widespread adoption of endovascular aneurysm repair (EVAR) having led to a decline in OAR. This has impacted both vascular surgery trainees and experienced practitioners alike, Scali pointed out.

“While the volume-outcome relationship has been studied extensively,” he told SAVS, “little remains known about the complex interaction of surgeon experience versus case volume on patient selection, procedural characteristics and postoperative complications associated with OAR.” 18 • VASCULAR SPECIALIST

The researchers dipped into the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) for all infrarenal OARs (n=11,900) from 2003– 2019. Of them, 71.4% were elective, with the balance nonelective.

Surgeon experience was defined as years in practice after training, with the level categorized chronologically. They were ≤5 (n=1,667), 6–10 (n=1,887), 11–15 (n=1,806) and ≥16 (n=6,540) years, respectively. Annual case volume, meanwhile, was set as the number of OARs performed by a surgeon during a year, with a median of five.

Years in practice had little effect on adjusted mortality for elective and nonelective procedures (30-day death: elective p=0.2; nonelective p=0.3).

For one year, the results were similar (elective p=0.2; nonelective p=0.2). The authors did note, however, that more experienced surgeons had few complications after elective open repair. The rate for ≥16 years of experience was 25% vs. 29% for those with ≤5 (p=0.004).

On the other hand, when surgeons were stratified by case volume and years in practice, those carrying out more than five case per year had consistently lower mortality and complication rates.

“Increasing surgeon experience was significantly associated with performing a greater proportion of elective procedures,” Scali said. The statistics produced flesh out the point: for elective, 73% ≥16

years vs. 62% for ≤5 (p<0.0001); for nonelective, 38% ≤5 years vs. 27% for ≥16 years (p=0.0001)."

Perhaps most interesting of all: “Notably,” Scali et al said, “high-volume, early-career surgeons had outcomes similar to older, low-volume surgeons.”

Concluding, the investigators said: “To assure optimal OAR outcomes nationally, early practice designation, mentorship strategies for onboarding early-career surgeons and low-volume aortic surgeons should be considered.”

Kenneth J. Cherry Jr., MD, of the University of Virginia in Charlottesville, Virginia, the presentation’s designated discussant, recalling his days as a fellow, posed an intriguing conundrum by way of observation.

“There was a vascular surgeon in California who routinely and continuously sent [my mentor] the worst-known cases you can imagine,” he explained.

“Later in the year, I asked, ‘Does it surprise you that this person who has been practicing vascular surgery all these years, continues to do this?’ And he looked at me like I had bricks for brains, and said, ‘No, it doesn’t surprise me at all.’ Twenty years of experience is vastly different than one year’s experience 20 times.

“What that brings to mind is that I don’t know that there’s any other thing you can look at except years of practice, but it doesn’t really tell us if someone is clinically astute or technically excellent.”

APRIL 2020

RESEARCH

Study suggests some 90% of highly-cited aortic aneurysm manuscripts do not reveal physician conflicts of interest

BY BRYAN KAY

S

TEAMBOAT SPRINGS, Colo.— Almost 90% of authors who received industry-reported payments did not disclose a financial conflict of interest in their manuscript, a study exploring the issue of compensation made to physicianspecialist authors of highly-cited aortic aneurysm papers discovered.

The finding was highlighted

by Tiffany Bellomo, BS, from the department of surgery, Section of Vascular Surgery, at the University of Michigan, at the winter annual meeting of the Vascular and Endovascular Surgery Society (VESS) in Steamboat Springs, Colorado ( Jan. 30–Feb. 2) “There is no standardized process to guarantee disclosure,” said Bellomo— part of a research team led by Matthew A. Corriere, MD, the Frankel professor of cardiovascular surgery at the University of Michigan—on the huge percentage who received payments but did not disclose. “This

could be for multiple reasons, such as author interpretation as not relevant to the topic, or that smaller dollar amounts were not relevant to disclose.

However, this interpretation is left up to each individual author and is not monitored.”

Bellomo outlined the rationale: that financial conflicts of interest potentially influence interpretation of study results. “Scientific journals often require author disclosure of relevant conflicts, but commonly leave disclosure up to author discretion and seldom include detailed quantification of compensation.”

Bellomo et al see no reason to believe vascular specialists are immune to the problem. “Despite widespread industry sponsorship for trials of treatments for aortic aneurysms, little is known about the prevalence and accuracy of disclosures in related research publications,” she noted.

The investigators aimed to evaluate such conflicts among highly-cited publications related to treatment of aortic aneurysms and identify the scope and prevalence of industryrelated payments received whether or not authors self-reported.

The top 99 most-cited publications were “abstracted” for author selfreports. The combined list of authors was then used to query the ProPublica Dollars for Docs— a database containing payments from pharmaceutical and medical device companies to doctors and teaching hospitals—to identify payments.

“The average disclosure per author was around 0.4 disclosures, but we found no significant difference

between mean disclosures per author separated by manuscript type,” she said. Some 1,368 authors were listed in 99 manuscripts, Bellomo continued. “There were 1,264 unique authors, and of those 105 were identified by ProPublica as having received industry compensation.

Interestingly, of those 105, 14 selfreported a financial conflict of interest. That means almost 90% of authors identified as having received industry compensation reported no financial conflict of interest in their manuscript.”

More than 13,489 payments were made to the 105 authors, breaking the $6 million mark. “Non-disclosed author [financial conflicts of interest] are uncommon, but may be associated with significant payments,” Bellomo concluded. “Public reporting of industry payments allows for greater transparency. Greater understanding of [such conflicts] in vascular research will allow additional insight into potential bias and appropriate interpretation of research findings.”

Consensus statements: Intravenous contrast media use in kidney disease patients not as risky as once thought

BY BRYAN KAY

T

he reputed risk of administering modern intravenous iodinated contrast media in patients with reduced kidney function has been “overstated.”

That is the headline takeaway from consensus statements released by the American College of Radiology and the National Kidney Foundation on the use of intravenous iodinated contrast media in patients with kidney disease.

The research team, led by Matthew S. Davenport, MD, of the departments of radiology and urology at the University of Michigan, published the statements simultaneously in Radiology and Kidney Medicine.

Davenport et al elaborated on why they believe deployment not to be as much of a risk as is often thought.

“This is primarily because of the conflation of contrast-associated acute kidney injury (CA-AKI) with contrastinduced acute kidney injury (CI-AKI) in uncontrolled studies,” they wrote.

“Although the true risk of CI-AKI APRIL 2020

remains unknown, prophylaxis with intravenous normal saline is indicated for patients without contraindication (e.g., heart failure) who have acute kidney injury (AKI) or an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 who are not undergoing maintenance dialysis.

“In individual high-risk circumstances, prophylaxis may be considered in patients with an eGFR of 30–44mL/min/1.73m2 at the discretion of the ordering clinician. The presence of a solitary kidney should not independently influence decisionmaking regarding the risk of CI-AKI.” Iodinated contrast media are commonly used with computerized tomography (CT) to evaluate disease and determine treatment response.

“Ad hoc lowering of contrast media dose below a known diagnostic threshold should be avoided due to the risk of lowering diagnostic accuracy,” Davenport et al added.

SOURCE: DOI.ORG/10.1148/ RADIOL.2019192094 VASCULARSPECIALISTONLINE.COM • 19