Vascular Specialist–October 2021

8 EVS MEETING CLOUT registry Thrombus removal using the ClotTriever device and the context of chronicity

Vol.17 No.10 OCTOBER 2021 Official Publication

Featured in this issue:

www.vascularspecialistonline.com

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18–19

OUR BROKEN SYSTEM Malpractice and the medicolegal biosphere

MVSS New data on TCAR, patient encounters

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20–21

Corner Stitch

MEDICARE

CORNER STITCH Six tips for trainees this interview season

VALUATION

Vascular surgery as ‘an enabling service’ for health systems

Not all

CUTS disappear

BY BRYAN KAY

Overall cuts 3.75%

Vascular cuts

The return of looming cuts to the Medicare Physician Fee Schedule—estimated at 11.4% for vascular surgery practices overall and up to 22% in OBLs starting in 2022—are projected to hit the specialty particularly hard. This month, we take a look at efforts being made to stop them.

11.4%

OBLs

22%

Vascular surgery is as important as anesthesia in providing a safe operating room (OR), Richard Powell, MD, the vascular section chief at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, told an Eastern Vascular Society (EVS) annual meeting (Sept. 23–26) issues panel exploring how to demonstrate the value of the specialty to hospital administrators.

But the vascular surgical contribution to the wider healthcare system is not without costs, Powell’s presentation demonstrated: Indexed to family medicine doctors, vascular surgeons worked more hours than any other specialty in an analysis of annual physician work hours performed by 41 specialties and four broad specialty categories.

See page 6

OUR NEW SOLUTION FOR AV FISTULA CREATION Learn more about the Ellipsys system, including important risk information on page 5.

See page 8

The Ellipsys™ Vascular Access System.

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GUEST EDITORIAL

Our broken system: Medical liability in vascular practice

BY ANDREW J. MELTZER, MD

My last editorial, “How to succeed in vascular surgery: A guide for the aspiring outlier,” was more controversial than I expected. I naively believed that a critical expose of vascular surgery’s “1%” would be welcomed by roughly 99% of vascular surgeons.

Unfortunately, some read my satirical take on overutilization as an indictment of private practice and outpatient care in general. My intention was to expose a very small group of surgeons whose practice patterns were several standard deviations removed from the norm. I remain puzzled by the rank-and-file 99%ers who took issue with an impeachment of a few bad apples among our ranks.

I

t seems, however, that we have taken a cue from the national political scene and embraced divisiveness and discord in lieu of the unity that this moment requires.

So, it came as no surprise that when Dr. Malachi Sheahan offered me another editorial opportunity, he did so with the modest stipulation that any follow-up be unanimously embraced by the readership. While this may be a tall order in these contentious times, I do believe that there is one issue about which we can all agree. Irrespective of practice model, procedure venue, atherectomy enthusiasm, or Sunshine Act power ranking, we all share a common foe: our broken medicolegal system.

A brief history of medical liability and American litigiousness The concept of medical liability can be traced back to the Code of King Hammurabi (2030 BC), which proscribed that “if the doctor has treated a gentleman with a lancet of bronze and has caused the gentleman to die…one shall cut off [the doctor’s] hand.”

Obviously, our current system is somewhat less barbaric, except in the Andrew most litigious states— J. Meltzer like New York and

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 Marie Drudi, MD Executive Director SVS Kenneth M. Slaw, PhD Director of Membership, Marketing and Communications Tara J. Spiess, CAE Managing Editor SVS Beth Bales Marketing & Membership Specialist Anna Vecchio Assistant Marketing & Social Media Manager Kristin Crowe

2 | Vascular Specialist

New Jersey—where a plaintiff ’s verdict can still result in amputation of the offending surgeon’s hand.

Subsequent Egyptian and Roman laws added the prerequisite of “malpractice” to hold physicians legally culpable for bad outcomes. This ultimately informed English Common Law and American jurisprudence. For several thousand years the situation was quite sanguine.

Malpractice allegations were comparatively rare, and typically limited to cases of true negligence. Jury awards were proportionate. Physicians and lawyers peacefully coexisted, representing America’s aspirational professional class at suburban country clubs and European luxury car dealerships across the land. Willie Nelson even lumped us all together, advising mamas that their babies forsake the iconic cowboy lifestyle and pursue careers as “doctors and lawyers and such.” In recent years, however, the longstanding detente between doctors and lawyers has been threatened by an explosion in litigation.

Although documentation of Americans’ exceptional litigiousness dates back to Alexis de Tocqueville’s 19th-century observations, the so-called “litigation

explosion” is a relatively recent phenomenon. Legal scholars and social scientists have written volumes on this topic. Although a thorough analysis is beyond the scope of this piece, there are numerous social, political and structural causes contributing to what author Walter Olson deems America’s “sue-for-profit industry.” I’m just a simple surgeon (and ardent conspiracy theorist), so I prefer a reductive analysis that attributes the American litigation explosion to systemic collusion between trial lawyers and their cronies, who we dutifully elect to populate our state and federal governments.

James Copland, author and legal director for the Manhattan Institute, coined the term, “Trial Lawyers, Inc.,” to refer to America’s lawsuit industry. If you harbor any doubts about the magnitude of our litigiousness, consider his assertion that tort costs exceed 2% of our GDP. Moreover, 20% of this expenditure—more than $50 billion annually—represents plaintiff attorney fees.

That’s a lot of relative value units (RVUs). My guess is the plaintiff ’s bar isn’t grappling with the impending workforce issues that face vascular surgeons.

They do face different issues, of course. In a recent issue of Plaintiff magazine dedicated to medical negligence, one justice warrior laments: “The burden of proof is really quite a burden. It hangs over everything.” I’m no constitutional scholar, but isn’t this “burden” a cornerstone of our judicial system? Maybe I should be more empathetic to the plight of our paid-on-contingency friends. Perhaps I’ll start a GoFundMe site to help support unsuccessful plaintiffs’ attorneys who are frequently overwhelmed by the “burden” of proof.

Despite the impediments of “evidence” and “proof,” the plaintiff ’s bar benefits from a true ace in the hole: our country has always been governed by lawyers. Predictably,

Physicians and lawyers peacefully coexisted, representing America’s aspirational professional class at suburban country clubs and European luxury car dealerships across the land continued on page 4

Vascular Specialist is the official newspaper of the Society for Vascular Surgery and provides the vascular specialist with timely and relevant news and commentary about clinical developments and about the impact of healthcare policy. Content for Vascular Specialist is provided by BIBA Publishing. Content for the News From SVS is provided by the Society for Vascular Surgery.

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OCTOBER 2021

TRANSFORM YOUR AV FISTULA CREATION Ellipsys™ Vascular Access System

91.6% 18+ cumulative patency at two years1

peer-reviewed publications2

3,000+ HIGH successful endoAVF procedures2

technical success, maturation, and cannulation rates1,3,4

GUEST EDITORIAL

Our broken system: Medical liability in vascular practice continued from page 2

our elected officials dutifully indulge their former law school classmates (and their campaign contributions) with legislation that supposedly targets healthcare spending, while conveniently dodging the topic of tort reform. “Trial Lawyers, Inc.” isn’t just too big to fail; it’s too rigged to fail. Whether one chooses to blame the lawyers—or the other lawyers—for our current predicament, it should be clear that the medical malpractice division of “Trial Lawyers, Inc.” has been particularly successful.

Medical liability and healthcare spending Billions of dollars in litigation costs actually represent a relatively small proportion of annual healthcare spending attributable to our broken medicolegal system. Defensive medicine, a by-product of American litigiousness, is a colossal cost-driver to our healthcare system. By some reports, the annual cost of defensive medicine amounts to hundreds of billions of dollars. Multiple surveys across specialties suggest that physicians characterize over 20% of tests and procedures as clinically unnecessary interventions driven by fear of litigation.

Hospitalists have attributed close to 40% of inpatient costs to defensive practice.

I’ve done some research on this topic to evaluate its impact on vascular surgery.

In a 2013 paper published in Surgery, we identified a significant correlation between rates of inferior vena cava (IVC) filter placement and a medicolegal environment.

After adjusting for prevalence of venous thromboembolism and established clinical risk factors, a threefold variation in IVC filter use persisted, with comparative overuse in adverse medicolegal environments. A forthcoming publication from our group identifies a similar pattern in annual Medicare spending

References 1 Beathard GA, Litchfield T, Jennings WC. Two-year cumulative patency of endovascular arteriovenous fistula. J Vasc Access. May 2020;21(3):350-356.

2 Data on file at Medtronic.

3 Hull JE, Jennings WC, Cooper RI, Waheed U, Schaefer ME, Narayan R. The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access. J Vasc Interv Radiol. February 2018;29(2):149-158.e5.

4 Shahverdyan R. Comparison of Surgical (sAVF) and Percutaneous (pAVF) Arteriovenous Fistulae. Presented at LINC. January 2021.

Brief Statement Indications The Ellipsys™ system is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Contraindications The Ellipsys™ system is contraindicated for use in patients with target vessels that are < 2 mm in diameter. The Ellipsys™ System is contraindicated for use in patients who have a distance between the target artery and vein > 1.5 mm.

Warnings § The Ellipsys™ system has only been studied for the creation of an AV fistula

on diabetic patients. At the state level, every 1% increase in malpractice lawsuits is associated with a >10% increase in risk-adjusted, standardized spending per diabetic patient. The increased spending in states with adverse medicolegal environments is driven by more procedures, imaging tests, and hospital readmissions. Plaintiff magazine subscribers may be inclined to argue that defensive medicine—and the associated costs—lead to improved quality, but this argument has been repeatedly disproven.

A previously hidden cost For those in the corporate world, these lawsuits are merely another “cost of doing business” in an overly litigious society. While this might be the healthiest attitude to adopt, it’s not so easy for us.

Despite hospital administrators’ efforts to disempower surgeons, everyone knows that we are the proverbial captains of the ship.

We get accolades when things go well; we get subpoenas when they don’t.

Our recent study, “Malpractice allegations against vascular surgeons: Prevalence, risk factors and impact on surgeon wellness,” characterizes the personal toll of malpractice allegations.

Some 19% of vascular surgeons reported being named in at least one lawsuit in the preceding two years. Given the slow progress of the judicial system, many are actively defending against multiple malpractice allegations. Amortized over the course of one’s career, the average vascular surgeon (as always, my apologies for the oxymoron) can expect multiple opportunities to experience our bloated judicial system first-hand.

While it’s always a pleasure to educate plaintiffs’ attorneys about the nuances of complex vascular issues in accordance with the rules of a high-school debate competition (“Yes or no, doctor?”), these interactions subvert our wellbeing.

We identified a statistically significant association between malpractice allegations and symptoms of burnout. Moreover, malpractice allegations lead to higher rates of subsequent self-reported errors, suggesting an erosion of confidence in our abilities. The psychological impact of malpractice claims seems to persist regardless of the outcome. While plaintiff

using the proximal radial artery and the adjacent perforating vein. It has not been studied in subjects who are candidates for surgical fistula creation at other locations, including sites distal to this location. § The Ellipsys™ system is not intended to treat patients with significant vascular disease or calcification in the target vessels. § The Ellipsys™ system has only been studied in subjects who had a patent palmar arch and no evidence of ulnar artery insufficiency. § Use only with the Ellipsys™ Power Controller, Model No. AMI-1001. § The Ellipsys™ Catheter has been designed to be used with the 6 F Terumo Glidesheath Slender™*. If using a different sheath, verify the catheter can be advanced through the sheath without resistance prior to use. § Use ultrasound imaging to ensure proper placement of the catheter tip in the artery before retracting the sheath, since once the distal tip of the catheter has been advanced into the artery, it cannot be easily removed without creation of the anastomosis. If the distal tip is advanced into the artery at an improper location, complete the procedure and remove the catheter as indicated in the directions for use. It is recommended that a follow-up evaluation of the patient is performed using appropriate clinical standards of care for surgical fistulae to determine if any clinically significant flow develops that require further clinical action.

Precautions § This product is sterilized by ethylene oxide gas. § Additional procedures are expected to be required to increase and direct blood flow into the AVF target outflow vein and to maintain patency of the

courtroom verdicts are rare (5%), vascular surgeons described the outcome as “fair” in only 24% of closed cases.

We all make mistakes. I think it’s safe to make that admission in writing, provided I never attest that I consider Vascular Specialist to be “authoritative source.” (If you don’t get that legal reference, you will someday.) Furthermore, there are

We don’t have a quality problem.

We have a medicolegal system problem undoubtedly cases of true malpractice in which accountability is both appropriate and necessary to maintain standards.

Having said that, the ridiculous prevalence of malpractice allegations against us is inconsistent with objective data that speaks to the high quality of vascular care that we deliver. We are the last line of defense in the effort to preserve life and limb. We are better at achieving these objectives than ever before. Despite our successes, we have become the victims of a runaway medicolegal system that threatens the wellbeing of patients and doctors alike. We don’t have a quality problem. We have a medicolegal system problem.

What can be done?

We can’t match the political action committee (PAC) contributions of the trial lawyers’ advocacy groups (formerly known as the “National Association of Claimants’ Compensation Attorneys,” now the more

AVF. Care should be taken to proactively plan for any fistula maturation procedures when using the device. § In the Ellipsys™ study, 99% of subjects required balloon dilatation (PTA) to increase flow to the optimal access vessel and 62% of subjects required embolization coil placement in competing veins to direct blood flow to the optimal access vessel. Prior to the procedure, care should be taken to assess the optimal access vessel for maturation, the additional procedures that may be required to successfully achieve maturation, and appropriate patient follow-up. Please refer to the “Arteriovenous Fistula (AVF) Maturation” section of the labeling for guidance about fistula flow, embolization coil placement, and other procedures to assist fistula maturation and maintenance. § The Ellipsys™ System is intended to only be used by physicians trained in ultrasound guided percutaneous endovascular interventional techniques using appropriate clinical standards for care for fistula maintenance and maturation including balloon dilatation and coil embolization. § Precautions to prevent or reduce acute or longer-term clotting potential should be considered. Physician experience and discretion will determine the appropriate anticoagulant/antiplatelet therapy for each patient using appropriate clinical standards of care.

Potential Adverse Events Potential complications that may be associated with creation and maintenance of an arteriovenous fistula include, but may not be limited to, the following:

palatable and more opaque “American Association for Justice”). We can, however, take steps to promote more unity, more advocacy and more peer support.

The increasingly frequent frenzy over proposed Centers for Medicare & Medicaid Services (CMS) cuts has become a unifying issue. We rally against these cuts not only for our own financial wellbeing, but also because of the implications for patient access to vascular care. Our broken medicolegal system threatens patients with higher costs, unnecessary interventions and a fearful, burned out, disillusioned workforce. Tort reform is really in our patients’ best interests as well.

Furthermore, we can take a page from the neurosurgeons’ playbook—they really are the smart ones—and establish comprehensive guidelines and standards for expert testimony that pertain to impartiality, subject knowledge and compensation. We have some semiprofessional plaintiffs’ experts among us, whose comprehensive vascular knowledge allows them to speak authoritatively—for the right price—about procedures they rarely perform. I propose we celebrate these “experts” in our ranks and offer them some special distinction for their services: a scarlet “E” to denote their “expert” status, for example.

If we really want to win this fight, we need to start thinking like lawyers. For example, we’ve shown that malpractice allegations impact on our wellness. Ipso facto, the lawyers are causing us great distress. Is this not grounds for a class action lawsuit against the plaintiff ’s bar?

Perhaps this is a preposterous idea, but I’m sure we can find a litigator who isn’t overly concerned by that pesky “burden of proof ” to represent us.

Whichever strategies we employ, it should be obvious that we need to stop the infighting and abandon our beloved interspecialty turf wars. Our broken, bloated, predatory medicolegal system impacts us all. The time has come to rise up against this clear and present danger to our wellbeing. Join me in calling for our leadership to make this issue a top priority.

I rest my case.

ANDREW J. MELTZER is chair of vascular surgery at Mayo Clinic Arizona in Phoenix.

§ Total occlusion, partial occlusion or stenosis of the anastomosis or adjacent outflow vein § Stenosis of the central AVF outflow requiring treatment per the treatment center’s standard of care § Failure to achieve fistula maturation § Incomplete vessel ligation when using embolization coil to direct flow § Steal Syndrome § Hematoma § Infection or other complications § Need for vessel superficialization or other maturation assistance procedures.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.

medtronic.com/ellipsys UC202201743 EN ©2021 Medtronic.

Medtronic and the Medtronic logo are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. For distribution in the USA only. 06/2021

4 | Vascular Specialist

October 2021

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MEDICARE

COVER STORY

Not all

CUTS disappear ‘As vascular disease complexity increases, reimbursement for that complex care decreases’

BY BRYAN KAY

Outgoing Midwestern Vascular Surgical Society (MVSS) President Kellie R. Brown, MD, has seen fundamental changes to the way vascular surgery is practiced during her near 20 years as a surgeon: The advance of endovascular techniques. The arrival of the electronic medical record (EMR). An increasing move toward quality metrics.

S

he has also borne witness to the challenges that have ensued as the specialty has evolved. Now, with vascular surgery approaching another crossroads as impending cuts to Medicare draw into the near distance, Brown is facing up to another looming threat to the profession: As the complexity of vascular disease surgeons treat increases, “reimbursement for that complex care decreases—particularly in the officebased or OBL [office-based lab] setting, which is actually one of the most efficient, cost-effective centers with high patient and physician satisfaction,” Brown told attendees of the 2021 MVSS annual meeting in Chicago (Sept. 9–11).

She was speaking during her presidential address, entitled “Challenges to the health of vascular surgery,” in which she also drew attention to the dangers posed by an aging vascular physician workforce, how burnout is affecting the specialty, and the progress of diversity, equity and inclusion in shaping the future of the profession.

SVS task force continues fight to stop cuts

BY BETH BALES

The Society for Vascular Surgery (SVS) Medicare Cuts Task Force is continuing its work to stop the proposed cuts in physician reimbursement from going through as planned in 2022.

THE TASK FORCE WAS CREATED to respond to the proposed 2022 Medicare Physician Fee Schedule, which poses “a 6 | Vascular Specialist

“As I reflected on what I wanted to address today, The cut will hit three areas, Brown went on: Recent I thought about all the challenges facing vascular updates to the office-based evaluation and management surgery, including changing demographics, (E/M) codes shuffled money from procedures to E/M. reimbursement pressures and burnout,” she The second decrease comes from an adjustment to the told attendees. supplies and equipment data. And a pricing update to the “At least at our center,” explained Brown, a clinical labor staff payment rates increases the payment to professor in the division of vascular and endovascular practices for their staff—“which should be a good thing,” surgery at the Medical College of Wisconsin, she said, but, “given the budget neutral mandate for Milwaukee, “the vascular volume seems to keep Medicare physician payments, this increase to all physician growing, and the patients seem to keep getting practices came at the expense of areas with high direct sicker. It feels more overwhelming than it did practice expense, i.e. office-based procedures.”

20 years ago.”

Referring to the perils of the aging vascular surgeon She drew attention to an array of data population, burnout among its practitioners and the to illustrate the point: by 2030 there will be looming payment cuts, Brown implored: “We have an 82 million people in the United States who are issue with high work hours, workforce shortages, threats aged 65 years and older, she said—rising to 88 million of decreasing compensation, increased administrative in 2040 and continuing to increase until at least 2050, burdens and high prevalence of burnout. So what can we according to the U.S. Census Bureau. “This means more do about it? I would contend that ‘just keep swimming’ patients with vascular disease and therefore more volume is not an acceptable answer. Certainly, these are not all for us to take care of,” Brown continued. “In addition, individual issues—many stem from institutional or systems currently 80% of people aged 65 and older have at least problems. And they are all inter-related. Burnout is related one chronic condition, and nearly 70% have two or more. to increasing complexity in our work lives, which leads This means that vascular disease is likely to increase in to increased work hours, which increases burnout, which prevalence as many of these patients have hypertension, then increases attrition, harms recruitment, and leads to hypercholesterolemia and diabetes, conditions that carry more burnout.” with them a high risk of vascular disease.”

She offered a series of solutions—in the case of Obesity, too, is also on the rise, Brown said. “I don’t the threat of cuts to Medicare with a call to action. need to tell you that increasing prevalence “Reimbursement for the vascular surgeon of comorbidities and obesity along with is primarily dependent on the government, increasing age leads to higher complexity and as most of our patients have some type of possible complications. It’s no surprise then governmental insurance claim,” Brown said. that vascular surgery volumes are increasing.”

“The only way to combat these declining Against this backdrop come the proposed reimbursement numbers is to educate your Medicare cuts for 2022. The percentages government officials about the importance of confronting vascular surgery in particular are vascular surgery to the population at large, and stark. As a whole, the specialty faces an 11.4% how these cuts adversely affect our ability to drop in Physician Fee Schedule payments. care for patients.”

Some outpatient services—such The most effective avenue “The vascular volume as those performed in the OBL would be through a political action setting—are staring down as much committee (PAC), she added. seems to keep growing, as 22% in cuts.

“Unfortunately, lobbying via a PAC and the patients seem In tandem with these types of is really the way government works. percentages, Brown put a figure In addition, or as an alternative, you to keep getting sicker” on the increased vascular volume could contact your representatives — Kellie R. Brown she has witnessed during her time in Congress and the Senate about in practice in terms of the mean your concerns. These contacts number of work relative value units have most effect when they’re part (wRVUs): up 55% since the beginning of the millennium. of an organized campaign. However, efforts to educate “So, with increasing complexity, what is happening to your representatives and their support staff around your reimbursement?” she asked the MVSS gathering. “This concerns can be done at any time, and I highly recommend should be no surprise to any of you: While hospital and writing, calling or visiting your elected officials in an effort skilled nursing facility reimbursement has increased since to educate them about the role of the vascular surgeon 2000, physician reimbursement has not … and this may be and the effect the declining reimbursement has on our about to get even worse.” patients and our practices.”

real threat of harm to vascular surgery practices and patients. The projected cut to vascular surgery overall is -11.4%, but OBLs [office-based labs] and outpatientbased facilities bear a significantly higher burden with the cuts to specific services as high as -22%,” task force members said.

What the task force already has completed: ■ Submitted the Society’s official comment letter (view it at vascular. org/CMS22Comment), which includes SVS’ data-driven analysis, not only of what SVS opposes in the proposed fee schedule, but also how to move forward ■ Encouraged members to write their own letters about the effects of the proposed cuts to the Centers for Medicare & Medicaid Services (CMS), with letters sent from more than 180 SVS members

■ As part of a Surgical Care Coalition effort, urged members to send emails to their federal lawmakers to fight the cuts that threaten access to surgical care ■ Worked with other societies to write a letter to CMS on the effect of the cuts to patients’ access to healthcare. Visit vascular.org/JointCMSLetter to read it Task force leaders call the proposed cuts “a complex issue with many components to be addressed and many participants involved.” The next step is work on Congressional messaging and request meetings with lawmakers and administrators.

“The Society is committed to addressing all components as a united front, and we will continue to need member action and

support every step of the way. We are proud of the way our specialty is coming together as one to stand up for vascular surgery,” said Matthew Sideman, MD, of the Advocacy and Policy Council, who is co-chair of the task force. Work will continue, he said, urging members to donate to the SVS Political Action Committee (see story on page 23). “It is the only PAC dedicated to serving the interests of vascular surgeons and their patients.”

William Shutze, MD, of the Clinical Practice Council, co-chairs the task force, and Margaret Tracci, MD, (Advocacy and Policy Council) and Daniel McDevitt, MD, (Clinical Practice Council) are vice co-chairs. Learn more at vascular.org/ MedicareTaskForce.

October 2021

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INDICATIONS FOR USE The AURYON Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

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Catheter Cardiovasc Interv. 2019;94(7):1010-1017. 2. Shammas NW, Chandra P, Brodmann M, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-LaserTM , a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: results of the EX-PAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92.

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EVS

Vascular surgery as ‘an enabling service’ for health systems continued from page 1

He was quoting a study by J. Paul Leigh, PhD, et al published in JAMA Internal Medicine in 2011 that found those practicing the vascular specialty logged a mean of 888 more hours per year than those in family practice.

The difference between vascular surgery and the nearest competitor—critical care internal medicine—was about 200 hours, he noted.

Top, “and not by a little bit,” said Powell, who earlier this year led a research team that published “The value of the modern vascular surgeon to the healthcare system: A report from the Society for Vascular Surgery Valuation Work Group” in the Journal of Vascular Surgery.

“Some might say, ‘We’re first, that’s great,’” he remarked ironically before the EVS meeting in Charleston, South Carolina, “but for quality of life, and for attracting people into our specialty, we have to really think about how we do things.”

Powell pointed to a string of data showing “vascular surgery is an enabling service that broadens the scope of the types of procedures a healthcare system can offer.”

Many hospital administrators see vascular surgery through

the prism of the elective surgery revenue it generates—the “tip of the iceberg,” he said.

“What they may not see or appreciate is the role of vascular surgery in making a safe OR environment, the case mix index that we have—the measure of case complexity in which our patients are quite high—that has a good impact on revenue for the hospital, and how we support other services,” Powell continued.

One study that looked at off-service cases performed by vascular surgeons essentially showed that “basically every specialty will need vascular surgery help in the operating room.”

Powell described the now common refrain of vascular surgeons as the firemen of the OR as he referenced the type of procedures requiring vascular assistance—some that would likely result in patient death with no vascular surgeon presence. “The take home message here is vascular surgery is as important as anesthesia in providing a safe operating room,” he said.

“There are different types of assistance we provide besides our direct contribution margin for the vascular service line,” Powell explained. “We provide indirect help, off-service help, for non-vascular surgery services. These emergent cases can disrupt the elective OR schedule and our clinics. There are many cases that don’t require vascular reconstruction: You help a cancer surgeon pull a tumor off the iliac artery, you haven’t really done anything to the iliac. So there is not much of a CPT [Current Procedural Terminology] code for that.”

Powell pointed to a more elusive vascular contribution to the wider healthcare system: the “Hey, I-probably-won’tneed-you-but-will-you-be-around consult,” he calls it. “How do you value that?” he said.

“We don’t typically work like the acute care surgeons in a shift work model. Vascular practices need to maintain a full clinic and a full elective surgery schedule, and emergencies disrupt the clinic, resulting in angry dissatisfied patients. We postpone our electives until the evening in order to take care of the emergencies.”

Which recalls the kind of data showing that vascular surgeons work more hours than any other specialty contrasted against family medicine. “This has a significant impact on the quality of life for vascular surgeons,” Powell remarked.

“Hospital administration may lack an appreciation for the scope of vascular surgery, but in particular for the indirect service revenue, for the co-surgeries we do, our impact on patient safety, and the disruptive nature of these vascular emergencies,” he said. “They don’t have a good handle on the scope of what we provide to the healthcare system, and they don’t have inherent expertise in developing cardiovascular service lines so they frequently use outside consultants to do their strategy development.”

Ultimately, the specter of vascular surgery's prominence figures, Powell argued: “We do suffer from a branding crisis, so I think the key audiences are the C-suite and cardiovascular consulting services. We need to get involved with hospital leadership, something that we have not done as well as other specialties.”

Registry data show greater clot chronicity on postprocedure inspection than initially predicted

Thrombus removal with the ClotTriever device

BY BRYAN KAY

Nearly half of patients deemed pre-procedurally to be suffering an acute case of deep vein thrombosis (DVT) turned out to have a “much more” chronic classification of the condition following intraoperative imaging and thrombus inspection post-procedure, an interim analysis from the CLOUT registry demonstrated.

THE COHORT STUDY WAS intraprocedural (imaging) and presented at the Eastern Vascular post-thrombectomy (visual Society (EVS) annual meeting thrombus inspection).

(Sept. 23–26) held in Charleston, “When we look at South Carolina, by Thomas symptoms—based on patient Maldonado, a professor of history, complaints in the office— surgery at New York University we determined that nearly 38% Grossman School of Medicine, are acute,” said CLOUT registry Thomas New York. principal investigator Maldonado, Maldonado The subanalysis used CLOUT who disclosed a consulting fee data to compare indicators of from Inari. “But what happens thrombus chronicity (acute: less than two when you add imaging into this? Half of weeks; subacute: two to six weeks; and those are now characterized as subacute chronic: six weeks or greater), examining or chronic, and then even more so when both their effect on outcomes and removal we look at the visual inspection analysis— with the ClotTriever thrombectomy we see that there’s really a big mismatch system (Inari Medical)—the primary between what our clinical suspicion was effectiveness endpoint being equal to or for acute versus what in fact the thrombus greater than 75% removal of thrombus. was. This is something that was quite Patients were assessed at three stages: remarkable to me.” pre-procedural (symptom history), Some 69.1% of limbs were determined 8 | Vascular Specialist

to have acute thrombus, 22.2% sub-acute, and 8.7% chronic based on initial symptom assessment. Following pretreatment imaging, limbs were re-classified as 38.1% acute, 37.7% subacute, and 24.2% chronic, the data showed. Post-thrombectomy, limbs were re-classified further as 30.5% acute, 36.1% sub-acute and 33.5% chronic.

Complete or near-complete thrombus removal with the ClotTriever, meanwhile, was similar across chronicity classifications: 86.2% in acute, 78.1% in sub-acute and 81.7% in chronic.

The CLOUT registry is a prospective multicenter real-world evaluation of lower-extremity DVT patient outcomes after treatment with the ClotTriever

“The CLOUT registry shows excellent safety and effectiveness with a realworld DVT population” — Thomas Maldonado

device. Overall interim results for the first 250 patients presented at the New Cardiovascular Horizons annual meeting held in New Orleans ( June 1–4) showed 100% of blood clots removed in the majority of DVT patients without the need for thrombolytic drugs in short single-session procedures, Inari announced at the time. The registry has a target of enrolling up to 500 patients, with the summary results showing 85% effectiveness for outcome, Maldonado noted in Charleston.

Concluding, Maldonado told EVS meeting attendees: “The CLOUT registry shows excellent safety and effectiveness with a real-world DVT population with acute, subacute and chronic thrombus— and half of all thrombus that we deemed as acute is actually much more chronic than expected when we look at it visually and with imaging. But importantly, regardless of whether acute, subacute or chronic, the device appears to have excellent ability to clear that thrombus— even in the more chronic setting.”

October 2021

LOWER EXTREMITY

PTFE crural bypasses: ‘Very acceptable patency, excellent limb salvage is obtainable with a fairly aggressive approach’

BY BRYAN KAY

“The mantra I always use with fellows is bad vein, bad bypass.”

Those were the words of Gregg Landis, MD, system chief of vascular surgery at Northwell Health in New York, as he presented an 18-year experience of polytetrafluoroethylene (PTFE) bypasses to tibial and pedal arteries for limb salvage.

LANDIS WAS RESPONDING TO A comment from the floor at the Eastern Vascular Society (EVS) annual meeting (Sept. 23–26) in Charleston, South Carolina, that had pondered the utility of compromised vein bypasses and the “magic solution” to maintaining PTFE bypasses. They “rarely fail because they have a proximal stenosis or distal outflow; they just have failed whether you follow them closely or not,” the questioner said.

The bypasses that fail abruptly, commented Landis, fail early. The ones that tend to stay open are seen in patients “who rarely come

in.” Perhaps the early failures are down to patient-associated clinical factors, he added.

The study at hand was comprised of two parts: a single-center experience with 118 consecutive patients followed for up to five years from 2013 to 2018 at Landis’ own institution and 32 bypasses derived from five institutions. Among the single-center group, a large percentage were still active smokers at the time of their bypass, Landis pointed out. Further, 64% of the cases received a direct-to-artery anastomosis, while 36% had a vein patch. Landis showed that bypass patency was 69% at one year

and 40% out to five years, while Care Physicians, in Glens Falls, the corresponding limb salvage New York, placed the findings rates were 72% and “a very, very into context, saying: “For critical respectable 53%.” Twenty-one limb ischemia, autogenous singlepatients required reinterventions piece greater saphenous vein is to maintain graft patency and the conduit of choice for bypass. limb salvage. In terms of the Gregg Landis Sometimes, major leg amputation multicenter group of patients, is the only reasonable option in Landis explained that the research team the compromised patient. But before this looked at patients who had ultra-long-term point, most of us would agree that, do patency, amassing 32 patients who all had we use either interventional techniques, “angiographically proven patency.” Patency or non-autogenous conduits to obtain ranged from four to 13 years, with a mean salvage?” Previous papers, Paty continued, of almost six years and many requiring have shown that patency of prosthetic multiple reinterventions, he said. “Despite bypasses, “although poor, are still attended their poor current reputation, PTFE crural by limb salvage.” In the PREVENT III trial, bypasses are worthwhile for patients facing one-year patency of single-vein greater imminent amputation without other saphenous vein was 61%, he elaborated. therapeutic options. Mid-, long-, and ultra“Has prothetic bypass evolved to explain long-term patency and limb salvage for these improved patency results?” Paty such grafts are often achievable,” Landis asked. Landis said he did not believe PTFE and colleagues concluded. bypasses have evolved greatly, but rather his Designated discussant Philip Paty, MD, data exhibits the efficacy of old technology of Vascular Health Partners of Community allied with a “fairly aggressive approach toward surveillance.”

“The common theme in Another question from the floor queried what appeared to be the “cherry-picked” all of these patients was nature of the multicenter group of patients. the aggressive approach Landis agreed, explaining the difficulty in obtaining decade-long-type cases. “But I toward reintervention” think the common theme in all of these ­— Gregg Landis patients was the aggressive approach toward reintervention,” he said.

Intravascular lithotripsy ‘consistently’ treats real-world calcium in multiple peripheral vessel beds

iliac, common femoral, superficial femoral, popliteal and infrapopliteal arteries, 88% presented with moderate/ severe calcification, with an average calcified length of 127mm.

The use of IVL in these lesions resulted in a final residual stenosis of 24%, similar to the DISRUPT PAD III RCT finding of 22%, Armstrong told VIVA attendees. Patients also experienced minimal procedural

BY BRYAN KAY complications, with only 0.9% and 0.1% of patients experiencing final dissections and perforations, respectively.

An interim analysis from the DISRUPT PAD III observational study showed that “Notably, there were no instances of embolization, thrombus, no reflow or abrupt closure.” intravascular lithotripsy (IVL) performs “consistently well” across challenging peripheral The observational study completed enrollment in June vessels, lesions and subgroups of patients, Ehrin J. Armstrong, MD, medical director at 2021 with a total of 1,373 patients. Late-breaking session Adventist Heart and Vascular Institute in St. Helena, California, told a clinical trials latepanelist Benjamin W. Starnes, MD, the chief of vascular breaking session at Vascular Interventional Advances (VIVA) 2021 in Las Vegas (Oct. 5–7) surgery at the University of Washington (UW) in Seattle commented: “Your one-year nalysis of the full dataset contained in the further reported. “Patients follow-up data happened right study—reputedly the largest angiographic core with heavy calcification have in the middle of a pandemic— lab adjudicated real-world evidence for IVL in traditionally been excluded what was it like to conduct a heavily calcified peripheral arteries according to from endovascular treatment clinical trial in the setting of a Shockwave Medical, the company behind the device—is trials resulting in little available pandemic?” due to be presented next year. Findings from the first 752 evidence to provide guidance Armstrong said the dynamic patients included in the interim analysis demonstrated for treating this challenging of COVID-19 was initially that IVL “consistently” showed its ability to safely and patient population,” said challenging, explaining: “At our effectively modify superficial and deep calcium across Armstrong. “The DISRUPT own hospital, it was mandated multiple vascular beds, lesion types and in patients with PAD III [observational study] that the research coordinators critical limb ischemia (CLI), Armstrong reported. shows that, in common clinical not interact with patients IVL resulted in consistent reduction in the diameter of situations that physicians for the first few months, so I stenosis with no associated distal embolization, abrupt encounter daily, peripheral IVL conducted a lot of the followclosure or thrombotic events at any time, according performs consistently well in up myself. That being said, our to Shockwave. IVL outcomes were comparable to the a variety of peripheral vessels, Benjamin W. Starnes moderates late-breaking session patients with peripheral arterial at VIVA 2021 previously reported DISRUPT PAD III randomized lesions and subgroups. disease [PAD]—because they controlled trial (RCT) outcomes showing minimal “The observational portion have such complex issues—in procedural complications and consistent reduction in of DISRUPT PAD III is a prospective, multicenter, singlesome cases we flexed to doing virtual visits, but we were diameter stenosis. The technology was also successfully blind study of real-world patients, which augments the able to get these patients in in most cases with outstanding used in combination with adjunctive technologies, DISRUPT PAD III RCT. The interim analysis involves follow-up. Which, to me, really demonstrated the including specialty balloons and atherectomy, in the patients enrolled between November 2017 and June versatility of conducting research, despite dealing with all treatment of complex calcified lesions, the company 2019 at 18 global sites. Of the 852 lesions treated in the these different complexities in the setting of a pandemic.”

A

October 2021

vascularspecialistonline.com | 15

COMMENTARY

Prediabetes screening: ‘Target of reducing disparities should be geared towards advocacy’

BY YOUNG ERBEN, MD

On Aug. 24, the United States Preventive Services Task Force (USPSTF) published the newly updated recommendations regarding screening for prediabetes and type-2 diabetes mellitus.1,2 The recommendation has been graded B, which translates to at least fair evidence to suggest that screening for prediabetes improves health outcomes and benefits outweigh harms. This recommendation applies to nonpregnant adults aged 35 to 70 years seen in primary care settings who are overweight and obese (body mass index [BMI] ≥25kg/m2) without symptoms of diabetes.1 SECONDLY, IT ALSO EMPHASIZES that clinicians should consider screening at an earlier age in individuals from groups with disproportionately high incidence and prevalence of diabetes mellitus, including American Indian/ Alaska native, Asian American, Black, Hispanic/Latino or native Hawaiian/ Pacific Islander persons.3,4 Screening should follow the American Diabetes Association guidelines.5 These new recommendations are an update of the 2015 USPSTF guidance that recommended screening for abnormal blood glucose levels as part of cardiovascular risk assessment in adults aged 40–70 years who are overweight or obese. Evidence to support these new guidelines comes from the effects of interventions for those newly or recently diagnosed with type-2 diabetes or prediabetes—including overall mortality and cardiovascular-related mortality at 10 and 20 years after diagnosis.2 Among the harms reported in these studies supporting earlier screening were short-term increases in anxiety among persons screened and hypoglycemia events requiring intervention (approximately 1%). The value of these guidelines is significant to our diabetic patient

population since an excess of 30% of vascular patients have diabetes.6 These new guidelines will positively aid us in the earlier detection of diabetes and, as a result, prolong the appearance of secondary consequences in the vasculature, including large and small vessel disease—very typical in our peripheral arterial disease (PAD) patient population—and acute-on-chronic kidney disease patients.7 Several criticisms of the guidelines are that the racial/ethnic disparities noted are purely dependent on social—not biological—factors.8 Secondly, the benefits noted occur an extremely long time after detection of diabetes and, at times, beyond the study period.

In terms of the data available concerning racial/ethnic disparities, Peek et al8 published a comprehensive systematic review—and it is of utmost importance to highlight that the incidence and prevalence is reported at 7% in Americans. However, the prevalence among Hispanics and African Americans is 9% and 11%, respectively.

Furthermore, racial/ethnic minorities carry a two-to-four times greater rate of renal disease, blindness, amputations, and amputation-related mortality. These disproportionately higher rates of

complications may be a product of poor control of diabetes, as well as associated cardiovascular risk factors. While the reasons for disparities in prevalence and outcomes are multifactorial, there is evidence to suggest that lower quality of care may be an important contributor to the disparities.9,10 Whites are more likely than Hispanics to receive annual HbA1c and cholesterol testing along with hypertensive medications, despite having equal access to healthcare, as measured by insurance coverage, particular place for medical care and frequency of physician visits.11 Similar studies have found racial differences in the quality of care for comorbid conditions, and this includes both testing and treatment for hypertension and dyslipidemia among Hispanics and African Americans when compared to non-Hispanic whites.12,13 Although the intent of the USPSTF is based on earlier detection for minority groups, the target of reducing disparities should be geared towards advocacy14 and equal access to healthcare systems so that post-diagnosis management in these groups is improved, thus eliminating disparities in mortality and cardiovascularrelated mortality.

References 1. F orce USPST, Davidson K.W., Barry M.J., et al. Screening for Prediabetes and Type 2 Diabetes: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;326(8):736–743.

2. www.uspreventiveservicestaskforce.org/ uspstf/recommendation/screening-forprediabetes-and-type-2-diabetes.

3. www.cdc.gov/diabetes/library/spotlights/ diabetes-asian-americans.html.

4. Lee JW, Brancati FL, Yeh HC. Trends in the

“The value of these guidelines is significant to our diabetic patient population since an excess of 30% of vascular patients have diabetes mellitus”

prevalence of type-2 diabetes in Asians versus whites: results from the United States National Health Interview Survey, 1997– 2008. Diabetes Care. 2011;34(2):353-357.

5. American Diabetes A. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S14-S31.

6. Thiruvoipati T., Kielhorn CE, Armstrong EJ. Peripheral artery disease in patients with diabetes: Epidemiology, mechanisms and outcomes. World J Diabetes. 2015;6(7):961–969.

7. Squadrito G, Cucinotta D. The late complications of diabetes mellitus. Ann Ital Med Int. 1991;6(1 Pt 2):126–136.

8. Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007;64(5 Suppl):101S-156S. 9. Harris MI. Racial and ethnic differences in health insurance coverage for adults with diabetes. Diabetes Care. 1999;22(10):1679–1682.

10. Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type-2 diabetes.

Diabetes Care. 1999;22(3):403–408.

11. Hosler AS, Melnik TA. Populationbased assessment of diabetes care and self-management among Puerto Rican adults in New York City. Diabetes Educ. 2005;31(3):418–426.

12. Arday DR, Fleming BB, Keller DK, et al. Variation in diabetes care among states: Do patient characteristics matter?

Diabetes Care. 2002;25(12):2230–2237.

13. Hertz RP, Unger AN, Ferrario CM. Diabetes, hypertension, and dyslipidemia in Mexican Americans and non-Hispanic whites. Am J Prev Med. 2006;30(2):103–110.

14. Kraft AN, Thatcher EJ, Zenk SN. Neighborhood Food Environment and Health Outcomes in U.S. LowSocioeconomic Status, Racial/ Ethnic Minority, and Rural Populations: A Systematic Review. J Health Care Poor Underserved.

2020;31(3):1078–1114.

YOUNG ERBEN is an associate professor of surgery at the Mayo Clinic in Jacksonville, Florida.

PAD

Two-year Ranger DCB data: ‘Sustained, high rate’ of device efficacy PATIENTS TREATED WITH THE RANGER (Boston Scientific) drug-coated balloon (DCB) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year results from the RANGER II SFA randomized controlled trial have demonstrated, investigators revealed during a late-breaking session at Vascular Interventional Advances (VIVA) 2021 (Las Vegas, Oct. 5–7).

16 | Vascular Specialist

Principal investigator Ravish Sachar, MD, an interventional cardiologist at North Carolina Heart and Vascular at UNC REX Healthcare in Raleigh-Durham, delivered the data, telling attendees that subgroup analyses—covering women, patients with baseline chronic total occlusions [CTOs] and calcified lesions— also suggest “consistent benefit” of DCB treatment vs. standard percutaneous transluminal angioplasty (PTA).

Additionally, the two-year results showed no difference in mortality rate between the groups.

Sachar and colleagues found that the Ranger DCB exhibited a higher primary patency rate of 84% compared to 71.4% in patients treated with standard PTA (p=0.0129). Additionally, the subgroup analyses

found consistent benefit with greater long-term patency in patients with more complex lesions treated with the Ranger DCB, exhibiting an 89.1% vs. 72.4% primary patency rate in the moderate-to-severe calcium subgroup (p=0.0052) and a 76.6% compared to a 58.6% primary patency rate in patients with CTOs (p=0.1038).

The DCB also demonstrated a significant reduction in reinterventions at two years, with a freedom from target lesion revascularization (TLR) rate of 87.4% vs. 79.5% observed with standard PTA (p=0.0316). Additionally, there was no significant difference in all-cause mortality—5.7% for DCB patients and 3.2% in those treated with standard PTA (p=0.4218)— and no genderbased reintervention disadvantage.—Bryan Kay

October 2021

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MEDICAL

®

6/22/21 12:19 PM

STROKE

‘TCAR yields high technical success with extraordinarily low stroke and death rate at one year’

BY BRYAN KAY

Outcomes in a cohort of patients who consented to one year of follow-up after transcarotid revascularization (TCAR) treatment for carotid stenosis in the ROADSTER 2 trial showed a 97.4% rate of technical success, no incidences of ipsilateral stroke and a 2.6% mortality rate, the 2021 annual meeting of the Midwestern Vascular Surgical Society (Sept. 9–11) heard.

THE PROSPECTIVE, OPEN-LABEL, SINGLE-ARM, multi-registry study included 155 per protocol participants from 21 U.S. centers and one in Europe followed between June 2016 and November 2018 who were evaluated 365 days postoperatively.

The results were presented by Kristine L. So, MD, a vascular surgery fellow at University Hospitals Cleveland Medical Center in Cleveland, Ohio, with the research team concluding that “in patients with high-risk factors, TCAR yields high technical success with an extraordinarily low

stroke and death rate at one in the 30-day cohort, the year. Further comparative researchers noted. studies to CEA [carotid So acknowledged endarterectomy] limitations in the study, are warranted.” including the fact there were Senior author on the only 155 patients from the one-year outcomes study original 632 in ROADSTER was Vikram Kashyap, 2 who remained in the MD, chief of the division long-term follow-up study. of vascular surgery and “Additionally, the followendovascular therapy up period did not start and the co-director of until about a year and half the Vascular Center of following the initiation of the Harrington Heart the ROADSTER 2 trial,” & Vascular Institute at she added.

University Hospitals “Of the 11 subjects who Cleveland Medical Center. had initially consented to The early outcomes the long-term follow-up “This minimally invasive technique who had been excluded for section of the ROADSTER 2 study reporting the can [be] and is used safely in high- per protocol deviations— perioperative outcomes of within that, one did suffer risk patients with extracranial TCAR up to 30 days were from an ipsilateral stroke. carotid disease” — Kristine L. So promising, So said. “Over That patient was ultimately the course of approximately excluded. These limitations four years, the technical emphasize the need for success reached 99.7%, with the stroke rate, death rate and larger observational and comparative studies.” perioperative MI [myocardial infarction] rate all less than So said the research team’s long-term follow-up 1%. A composite 30-day stroke, death and MI rate was also analysis of the ROADSTER 2 cohort “provides evidence only 1.7%.” that TCAR is performed with low rates of mortality In the one-year follow-up cohort, So and colleagues and ipsilateral stroke. This minimally invasive technique found that the patient population included a similar can [be] and is used safely in high-risk patients with breakdown to the early outcomes group: asymptomatic extracranial carotid disease. There is, however, still a need (n=119, 76.8%) and symptomatic patients (n=36, 23.2%). for larger comparative controlled trials to confirm the They presented with a variety of high-risk anatomic safety and efficacy of TCAR.” (43.2%), physiologic (31.6%), or combined actors (25.2%).

The ROADSTER 2 post-approval study was launched No patient suffered perioperative MI or stroke. There to evaluate real-world usage of TCAR—the Enroute were four deaths (2.6%) and no ipsilateral strokes. Of the transcarotid stent when used with the Enroute transcarotid deaths, three occurred in asymptomatic patients, with neuroprotection system—in patients with significant one symptomatic. All deaths were from non-neurological carotid disease by physicians of varying experience with causes. These findings were comparable to early outcomes the transcarotid technique.

Study detects no difference in overall adverse outcomes based on balloon dilatation strategy used during TCAR

BY BRYAN KAY

Avoiding a strategy of post-stent balloon dilation during transcarotid artery revascularization (TCAR) may be unnecessary—a “contradistinction” to results shown in conventional transfemoral carotid artery stenting, new research has shown.

JONES THOMAS, MD, AN integrated vascular surgery resident at University Hospitals Cleveland Medical Center in Cleveland, Ohio, and colleagues analyzed data garnered from the ROADSTER trials, demonstrating that there was no difference in adverse outcomes between the type of balloon dilatation strategy: either pre-stent dilation only, post-stent dilation on its own or a combination of both.

Thomas and colleagues were prompted to study TCAR balloon dilation strategy outcomes in light of concerns over neurological risk and hemodynamic instability raised with post- and a combination of pre- and post-stent dilatation during transfemoral stenting.

18 | Vascular Specialist

This may not be applicable to TCAR, which uses cerebral blood flow reversal during stent deployment and balloon angioplasty, Thomas told the Vascular & Endovascular Surgery Society (VESS) Spring Meeting (Aug. 18), held Jones Thomas at the Vascular Annual Meeting (VAM).

He referenced studies that show a 2.4 times greater risk of stroke and 3.8 times increase in hemodynamic instability associated with the transfemoral approach. “Research has also shown hemodynamic instability can lead to increased myocardial infarction [MI], length

of stay and mortality,” Thomas said.

Analyzing primary outcome measures of stroke, death and MI at 30 days among 851 eligible patients from the prospective ROADSTER trials, the research team discovered overall results that showed 1.9% had a stroke, 0.5% died and 0.9% suffered an MI. “We saw that there was no difference in overall adverse outcomes between the three dilatation strategies,” Thomas explained. “We separated the cohort between symptomatic and asymptomatic patients, and while there were a larger number of adverse outcomes in the symptomatic arm, again, between the dilatation strategies, there were no differences.”

He highlighted limitations, including the non-randomized nature of the trial data and the fact choice and discretion regarding dilatation strategy was left up to the operator.

“Based on this prospective trial data, there does not appear to be any difference in neurological complication due to the balloon dilatation strategy, especially with post-stent dilatation during TCAR,” Thomas concluded.

“We feel that avoiding post dilation may be unnecessary during TCAR, which is a contradistinction to results from transfemoral carotid artery stenting.

Whether post dilation enhances stent durability, decreases restenosis, reduces reinterventions—that I think remains unknown at this time. But these findings at least support the need for longer-term studies to evaluate those factors.”

Speaking from the audience designated discussant Julie Duke, MD, an assistant professor and associate program director of the vascular residency and fellowship at the University of Minnesota in Minneapolis, queried Thomas about how the data had affected his team’s practice.

“This study gives two major things we can take away: reassurance, regardless of which dilation strategy you’re choosing to use at this time, that you’re not adversely affecting the patients,” he answered. “That being said, I think it also gives us some data to support the fact that, if we’re doing post-stent dilation, we’re not hurting the patient. That could be important when we look at stent deployment in other vessel beds.” Thomas added, “We think that now we have shown—at least in this population—that post dilation doesn’t lead to negative outcomes, then we should look into what the positive outcomes will be.”

October 2021

Vascular surgeons found to ask twice as many closedversus open-ended questions in patient encounters Patients reported they mostly felt their provider was adequate in terms of engaging in shared decision-making during asymptomatic vascular consults, according to a qualitative analysis carried out at the University of Iowa in Iowa City. Furthermore, vascular surgery compared favorably to other specialties across several aspects of interaction, researchers responsible for the study found.

N

evertheless, data obtained On average, patients strongly (+2) or from recorded and transcribed completely (+3) agreed that the doctors consults, along with SDM-Q-9 covered the nine criteria set out in the (the nine-item Shared Decision questionnaire, Willging and colleagues Making Questionnaire) surveys completed demonstrated. by patients, demonstrated that doctorThe study aimed to address how patient dialogue was “still largely patients and physicians perceive their physician-centered and one of the things roles as medicine has shifted away from a we really focused on was the checking paternalistic model of care toward one of for understanding in these conversations: shared decision-making.

Although it was variable, it was still “With these data, we found two relatively low compared to how often we significant correlations—one being the used formalized terminology, where it’s number of closed-ended questions asked more important to check by the physician with the Question type: for understanding,” first number of verification author Abbygale M. questions asked by the Willging, BS, a patient,” Willging told medical student MVSS 2021 attendees. from the “We also University of found there Iowa Carver was a negative College of correlation with Medicine, the number of revealed. She was emotional cues, and speaking before the amount of times Open Closed the 2021 Midwestern the physician responded Vascular Surgical Society positively to those cues—previous research (MVSS) annual meeting held in Chicago suggests those patients feel the need to (Sept. 9–11). repeat themselves when those emotions are Willging pointed out that the doctors in not addressed adequately the first time.” the study—participants consisted of five Comparing the vascular consults to vascular surgeons alongside eight patients results found in similar studies conducted with asymptomatic aortic aneurysms or in other specialties, Willging said the carotid stenosis—asked “far more” closedresearch established the vascular surgeons than open-ended questions.

“The amount of time our doctors took “The amount of time for understanding was highly variable, from our doctors took for one time in the consult up to 14 times,” Willging said. understanding was The data gathered showed the physicians highly variable, from spent an average of 19 minutes and 46 seconds on each patient and 10 minutes and one time in the consult 49 seconds talking to the patient; they used up to 14 times” — formalized language about 8.5 times an Abbygale M. Willging encounter; checked for understanding only 5.25 times; and asked more closed- than open-ended questions (11.13 vs. 4.625).

The researchers also found that providers analyzed spent more time with patients accounted for 46% of total utterances in their consults, had a lower prevalence and interrupted patients an average of 5.5 of closed- vs. open-ended questions and times per encounter. Patients and their responded positively to emotional cues companions asked an average of 10.6 more frequently. clarification questions, they reported.

However, she acknowledged the sample The average SDM-Q-9 Likert score per size and low emotional content “might patient was 2.79 on a range of -3 to +3, not be completely generalizable and none the data showed—with positive numbers of our physicians responded positively to indicating agreement and negatives dissent. emotions 100% of the time.”—Bryan Kay

11.13

October 2021

vs.

4.625

Physicians, industry urged to tackle multifactorial stroke risk after TEVAR

BY JAMIE BELL, JOCELYN HUDSON AND WILL DATE

As evidence builds on the importance of reducing the risk of stroke by removing residual air prior to thoracic endovascular aortic repair (TEVAR) procedures, the onus will be on surgeons and device manufacturers to minimize this risk, attendees of CX Aortic Vienna 2021 (Oct. 5–7, broadcast) heard.

TILO KÖLBEL, MD, OF HAMBURG, Germany, began this session by introducing the problem of cerebral damage following both TEVAR and transcatheter aortic valve implantation (TAVI) procedures—noting that the relatively low rate of postoperative stroke “does not tell the whole story,” as silent brain infarctions (SBIs) are far more prevalent and can lead to a range of neurological disorders later in life.

Following this, Fiona Rohlffs, MD, also of Hamburg, Germany, outlined the increased removal of residual air that can be achieved by introducing carbon dioxide to the standard, saline-based flushing technique often used in TEVAR. She went on to report preliminary results from the STEP (Stroke from thoracic endovascular procedures) study, which included the first cohort in which carbon dioxide-flushed devices had been deployed in endovascular aortic arch repairs, noting

an SBI incidence of about 50%—which compares favorably to the 80% rate reported in standard flushing without carbon dioxide. Session moderator Markus Steinbauer, MD, of Regensburg, Germany, stated that the industry is now taking notice of this research, with many companies that manufacture TEVAR devices currently attempting to introduce features like additional flush ports. This prompted session anchor Roger Greenhalgh, MD MChir, to claim that research from the STEP registry is paving the way for surgeons themselves to systematically consider how they can minimize stroke risks.

“Those who are working on this subject are influencing the industry.

And, the industry will do all it can, but surgeons will also have to do everything they can—it is a combined effort and, together, we are making progress,” Greenhalgh said.

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vascularspecialistonline.com | 19

COMMENTARY

Corner Stitch

6

This month: The match

Six top tips to help navigate interview season

BY CHRISTOPHER AUDU, MD

Ahh October… The air is a bit cooler; pumpkin spice is in everything; and leaf colors are more dazzling. It’s interview season! If you’re an applicant to vascular surgery residency programs, this month’s writeup is for you. There is such a thing as the “medi-clone”—you know, the typical applicant who looks just like the rest on paper: good grades, strong work ethic, maybe a publication, some hobbies. Well, how do you stand out from the crowd during interviews? What follows is not a 10-step formula but just some guidance on how to interview well and— hopefully—successfully this season.

1. Remember, love is a two-way street While it may seem that the interview is primarily about the program getting to know you, remember that you’re not, and should not be, a passive observer in the process. Come prepared to each program interview day—especially the programs that you’re excited about. What does this mean, practically? It means you research the program. Look up website information; reach out to friends at the institution, if you know any; do a quick PubMed search to find the most recent papers written by the attendings or residents. The prepared applicant will always outshine the one who’s just there for the vibes—always. The number one

question that should be going through your mind on interview day is whether you can see yourself as a resident there day-in, day-out for the next five-to-seven years. Put yourself in the current intern’s role. Ask them what it’s like, even if it’s your home institution; you’d be surprised at what you can learn about your program by investing time to truly know them.

2. If you wrote it, you should know it

If it’s in writing, it’s fair game for questioning. Don’t be the interviewee who lists things on their application they can’t talk about to some depth. Study your application and make sure you are

Journey of a trainee surgeon-scientist: Mentorship, passion and the importance of parallel projects In August, University of Michigan general surgery resident W. James Melvin, MD, picked up the coveted Society for Vascular Surgery (SVS) Foundation Resident Research Award for work investigating the role of the enzyme SETDB2 in diabetes patients infected

20 | Vascular Specialist

well versed in the experiences, research, or extracurricular activities that you list.

If you were only peripherally involved in something you listed, there is no shame in clarifying the role you played. Honesty is the best policy here. On this note, don’t be shy about “nerding” out when asked about your research, hobbies or interests.

Chances are good that the attending asking reviews for prestigious surgical or science journals and may be familiar with your work, or your hobby is a common interest. You never know. So, be passionate about your application.

3. Everybody counts

Respect everyone you meet on your interview day—from the administrative staff to the division chairperson. Think about it: these people are the ones you’ll interact with as a resident for the next few years. They’ll become your biggest cheerleader and keep you on track when you get overwhelmed with residency. Some of them even manage the program director’s schedule and have a level of access to the director you can only dream of. Therefore, on interview day, everyone’s opinion matters and the people whom you think rank lower on the pecking order, may actually wield more veto power than you realize.

Vascular is a small world and that is especially true within institutions.

4. What’s that in your background?

The era of virtual interviews means that programs get to glimpse a little bit about you in a way that they wouldn’t have been able to if you were in person.

Make sure that your background speaks to your strengths. Do you like to read?

Maybe have some of your favorite books in the background. Do you paint or do crafts? Displaying your work can be a neat icebreaker. My point here is that you should be aware of what’s in your virtual background and use it to your advantage.

with COVID-19. He quickly followed that up in September by collecting the Midwestern Vascular Surgical Society (MVSS) Charles C. Guthrie Award for Outstanding Research for work exploring the part the same enzyme plays in regulating abdominal aortic aneurysm (AAA) formation. Here, he discusses his journey as an aspiring surgeon-scientist so far—and what it takes to give yourself the best possible chance of success.

I REMEMBER ONE OF MY MENTORS DURING medical school told me that less than 3% of academic surgeons are successful at running a research lab. I had known it was difficult, but I didn’t realize the scope of the challenge until I had heard this statistic.

I am intimidated when I think of all the motivated

It’s an innocuous way to let programs know a little about you.

5. Consider the tangible intangibles

At some point midway through interview season, all programs will start to sound the same. The truth is that all programs have to meet accreditation standards in order to train you into a vascular surgeon.

As a result, you’ll get a standard surgical training wherever you end up. This is not to diminish the unique strengths of individual programs. My point here is that outside of academics, there are things you ought to consider during the interview.

For example: Where do most residents live? Do you need a car? How far away is the grocery store? How close are you to the outdoors? To an airport? Do you have family or friends nearby? How far away is the nearest gym? All of these things are what I call “tangible intangibles”—things that are seemingly surmountable but may wind up swaying your decision or impression of a program. Don’t sleep on this. Jot down your list after each interview. Trust me. It will help you later when you are ranking the amazing programs you interviewed at.

6. Be considerate

Finally, you may be one of the lucky few who get a lot of interviews. If that is you, and there are programs that you know don’t get you excited (or are in a place you would not consider for residency), then be considerate of your less fortunate peers and open up that spot for someone else. You’ll save yourself and the program time and energy and someone will be a grateful recipient of your largesse— even if they never find out. With this inexhaustive list, good luck this interview season!

CHRISTOPHER AUDU is an integrated vascular surgery resident at the University of Michigan in Ann Arbor, Michigan.

and talented surgeons who struggle to keep research going during their career. Thus, when I was looking at mentored research opportunities during the dedicated time of my surgery residency away from clinical work, I wanted to get the best training I could find—so that when I set out on my own in a few years I will be as prepared as possible. So far, I have learned that a couple of key factors are critical for success.

Most important is to find a mentor who can provide a stable financial foundation, the wisdom of experience, and an endless source of opportunity.

Ideally, they will have a successful track record of mentoring resident trainees with a similar background as yourself. Just as important, you should be thinking about whether your skills, goals, and personality match well with your prospective mentor. A strong relationship with them and aligned expectations for what your mentored experience will be like are key.

Second, passion for your work is paramount. Pick

October 2021

research questions and problems that have affected you research question, you will be at the mercy of multiple in the clinical realm and have a wide impact. For me, factors that are outside your control—not even counting seeing runaway inflammation in diabetic patients with how accurate your hypothesis may have been. You COVID-19 when I was redeployed to a pop-up intensive should look to start a dedicated research fellowship care unit (ICU) in the spring of 2020 gave me all the time with some preliminary data/hypotheses in several motivation I needed to search for answers. I would different domains, and then follow the data. Flex your imagine that working on a research project you aren’t focus to what is working, and then shift it when things interested in because it was assigned to you, or that is are not. just convenient, is not a recipe for success. Draw on your Lastly, find and form strong relationships clinical experience to latch with the team you onto hypotheses that you Draw on your clinical experience work with day to can relate to and get excited I have been to latch onto hypotheses that you day. about. When it comes time blessed with a can relate to and get excited about fantastic group to test therapeutics and present your work, this will of co-researchers pay dividends. Furthermore, and co-fellows. you will undoubtedly be more well-versed in the field if They have years of experience and have been you are interested in it, which is critical for rounding out instrumental in helping with the daily challenges your scientific work. After all, you may discover new or of basic science experiments. Don’t try to alternative techniques from reading about others’ work troubleshoot every assay yourself—get and add similar experiments to your own story. help and advice as soon as possible.

Third, running a few projects in parallel is important.

Then pay it back: include them on I have found that the need for troubleshooting and your publications and help them in W. James experimental delay is inherent to basic and translational return when you can.

Melvin science. If you are only dedicated to one project or Research is difficult—and

Melvin's prize-winning paper was presented at the 2021 MVSS annual meeting in Chicago

finding the right hypothesis can seem to be about luck sometimes. However, by finding a supportive and successful mentor, multiple research questions you are passionate about, and an experienced team of co-researchers, you can set yourself up to discover something new and make an impact for our vascular patients.

RADIATION

National survey exploring radiation safety in vascular trainees demonstrates a quarter received no feedback on radiation exposure

BY JOCELYN HUDSON

A collaborative effort is needed to establish and adhere to best practice guidelines for radiation safety and exposure, Jasmine Bhinder, MD, a general surgery resident at the University at Buffalo, New York, told attendees of the 2021 Vascular Annual Meeting (VAM) in San Diego as she presented data from a national survey of vascular surgery residents and fellows in which an “alarming” 25% of trainees reported no feedback on radiation exposure.

THE RESEARCH TEAM, WHICH included Bhinder and colleagues from the University at Buffalo, also found that single hospital programs are more effective at implementing radiation training and feedback and that formal training and monthly exposure feedback are associated with more consistent use of safety practices.

Bhinder relayed the rationale behind the present study: “In our program, it was brought to our attention that a number of residents and fellows had higher than recommended levels of radiation exposure. […] We felt this issue may be a concern at other U.S. institutions and were curious about the radiation safety practices across the country. So, the objective of this study was to evaluate radiation safety practices among senior vascular surgery residents and fellows across the United States.”

October 2021

The presenter detailed that the research team sent radiation safety practice surveys to all Accreditation Council for Graduate Medical Education (ACGME) program directors to be distributed to postgraduate year (PGY) four to seven vascular trainees.

The survey questions covered program type (single or multiple hospital site), formal radiation training, the use of safety equipment and dosimeters and frequency of radiation feedback. All responses were recorded electronically and anonymity was maintained, Bhinder informed the audience.

A total of 95 trainees responded to the survey, the speaker revealed, specifying that 55% were from single hospital programs and 45% were from multiple hospital programs. “What we found was that trainees from multiple hospital site programs were less likely to meet their radiation officer [21% vs. 71%], less

likely to receive formal radiation training to know, “How do we get to where we [62% vs. 92%] and less likely to receive want to go in terms of standardizing the radiation exposure feedback [53% vs. accreditation and safety of our residents 92%].” and attendings?” Bhinder responded: In addition, the researchers found that a “Globally, I think there is nothing in place greater percentage of those who received right now. In our own institution, we have formal radiation training routinely used come together and formalized radiation dosimeters [81% vs. 55%], lead table training that is not just available to the drapes [59% vs. 15%] and lead shields trainees but also to the attendings as well.

[59% vs. 15%]. They were also more It is provided in a small group setting likely to stand greater than six feet away instead of just via lectures, and so the during digital subtraction angiography residents and fellows also have hands-on (DSA; 81% vs. 52%) and use lower pulse training at all the facilities and are able to rate adjustments (66% vs. 24%). Bhinder play with the equipment before actually and colleagues found similar results when using it, which I think is important.” radiation exposure feedback was provided Melissa Kirkwood, MD, chief in the on a monthly basis and in trainees from division of vascular and endovascular single hospital programs compared to surgery at UT Southwestern Medical multiple hospital site programs.

Center in Dallas, said that radiation “This is very safety mandates important data,” vary by state, audience member noting, “Our Anil P. Hingorani, state of Texas MD, clinical mandates seven professor in the to eight hours department of of fluoroscopy surgery at NYU training.” She Grossman School also remarked of Medicine, New that radiation York, remarked, decreases as elaborating, “I trainees progress think it really and get more “We found that trainees comfortable, highlights the need for from multiple hospital standardized training noting that, and accreditation “It would be site programs were less for radiation safety interesting to likely to meet their across the nation, not send that survey radiation officer only for residents and out again later on trainees but also for and see how their [21% vs. 71%]” — physicians.” In light of dose drops off as Jasmine Bhinder these key findings, the they learn these VAM attendee wanted practices.”

vascularspecialistonline.com | 21

QUALITY

VQI launches fellowship in training program, announces scholarship

BY BETH BALES

The Society for Vascular Surgery’s Vascular Quality Initiative (SVS VQI) is launching a new SVS Patient Safety Organization VQI Fellowship in Training (SVS PSO FIT) program. It is for individuals completing their medical residencies or fellowships in any vascular disease-focused specialty, such as vascular surgery, cardiology, radiology or vascular medicine.

VQI ALSO HAS UNVEILED THE Jack L. Cronenwett, MD, Quality Improvement Scholarship Award, named in honor of the SVS VQI registry’s cofounder, vascular surgeon and educator.

The 12- to 18-month program, which will begin in January 2022, will be directed by the PSO and aims to foster an understanding of quality processes and metrics among vascular residents and fellows—known as trainees—through mentorship in the VQI in collaboration with the Association of Program Directors in Vascular Surgery (APDVS), American College of Cardiology and Society for Vascular Medicine.

Following completion of the program, up to five trainees per calendar year will be eligible to share in a portion of a $50,000 educational scholarship fund as part of the Cronenwett to support participation in PSO-approved activities.

“The program’s unique focus on the utilization of clinical performance data, available in the registries of the SVS VQI, will enable trainees to learn about quality improvement in healthcare,” says Jens Eldrup-Jorgensen, MD, medical director of the SVS PSO and a founding partner of VQI. “We’re particularly excited about the scholarship opportunity, which will be awarded to top applicants who want to gain in-depth knowledge of quality assessment and quality improvement.”

The scholarships honor Cronenwett’s contributions to improving and advancing vascular care. He is a professor of surgery

at the Dartmouth-Hitchcock Medical Center, professor of the Dartmouth Center for Health Care Policy and Clinical Research and chief medical officer for Fivos, VQI’s data management partner.

“The scholarship funds will help the next generation of vascular medicine scholars afford additional education and training and participate in patientsafety workshops that are essential to implementing best practices,” says Gary Lemmon, MD, SVS PSO associate medical director.

Since its inception in 2011, the SVS VQI has raised the bar for vascular care, quality improvement and patient outcomes. Today the Initiative includes participating medical centers, with more than 800 hospitals and ambulatory facilities contributing data on greater than 800,000 procedures on patients with vascular disease. More than 4,500 physicians have participated in the VQI’s 14 different vascular registries.

In addition to improving quality within hospitals and outpatient facilities, the VQI supports efforts to reduce costs and resource utilization as well as promoting vascular quality research.

VQI marks first decade with significant growth milestones The VQI has marked its 10th anniversary.

Fittingly, the initiative was holding its annual meeting in the two days prior to the anniversary date.

VQI provides oversight of data sharing arrangements, key outcome and quality measure analyses, and dissemination of information to participating providers.

Since its inception in 2011, VQI has emerged as a leading resource for vascular quality care and outcomes and has experienced multiple growth milestones, including: ■ A surge in participating medical centers, with more than 800 hospitals and ambulatory facilities overseeing 840,000+ procedures for individuals with vascular conditions ■ An expansion of provider partners, with more than 4,500 physicians, including vascular surgeons, cardiologists, radiologists and others, entering procedures into 14 different vascular registries ■ The creation of 18 Regional Quality Groups that meet on a semi-annual basis to review their data and discuss quality improvement projects ■ The establishment of an SVS VQI Annual Meeting, which celebrated its five-year anniversary as part of the SVS Vascular Annual Meeting ■ Increased utilization of Fivos’ Pathways clinical data performance platform to generate the real-time benchmarked reports of major clinical outcomes and process measures, as well as longitudinal tracking of center performance compared with regional and national standards ■ Collaboration with the FDA and manufacturers to better assess safety and efficacy of vascular devices ■ Expansion of clinical trials within the registry to facilitate a more efficient and cost-effective path for device analysis and reporting ■ Partnering with the American College of Cardiology, American Heart Association, Society for Vascular Medicine, American Venous Forum, Society for Vascular Ultrasound and Vascular Access Society of America to

Consensus established for appropriate use of IVUS in peripheral interventions A worldwide committee of 40 cross-specialty medical experts achieved the first-ever consensus for the appropriate use of intravascular ultrasound (IVUS) in peripheral vascular disease (PVD) interventions.

GLOBAL EXPERTS CONDUCTED A SYSTEMATIC and comprehensive review of key clinical IVUS scenarios and decision-making processes before voting.

The results were shared at a sponsored symposium during Vascular Interventional Advances (VIVA) 2021 (Las Vegas, Oct. 5–7). They established clinical consensus to identify optimal use of IVUS and potential gaps in a 22 | Vascular Specialist

bid to set a standard across clinical specialties and drive positive outcomes for patients.

The new consensus and recommendations are aimed at improving quality care in PVD and are based on evidence, expert practice standards, and clinical experience, according to a press release from Philips, the company behind IVUS.

better understand and improve the care of vascular patients ■ Creation of a new quality improvement training program for residents In 2022, VQI leaders plan to expand the organization’s educational mission, through the implementation of new programs that connect the next generation of vascular professionals with the tools and data these professionals need to enhance clinical quality and patient outcomes.

“When we launched the VQI, there were few organizations that

“The program’s unique focus on the utilization of clinical performance data, available in the registries of the SVS VQI, will enable trainees to learn about quality improvement in healthcare”— Jens Eldrup-Jorgensen brought together the high level of clinical expertise, analytics and quality improvement focus that was essential in raising the bar for vascular care in the United States,” said Jorgensen.

“Moving forward, we will continue our efforts to strengthen analytics, reporting and data integration to relieve the burden of data entry, provide easier access to data for quality improvement and make data even more valuable for our members.”

In addition to improving quality within hospitals and outpatient facilities, the VQI supports efforts to reduce costs and resource utilization as well as promote efforts towards vascular quality research.

VQI is governed by the SVS Patient Safety Organization (SVS PSO), a wholly owned subsidiary of SVS. Learn more about SVS Jens EldrupVQI at www.vqi.org.

Jorgensen

“The results of the cross-specialty expert consensus demonstrate strong support for the use of IVUS during peripheral interventions,” said Eric A. Secemsky, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston.

“Future efforts need to focus on improving IVUS implementation into clinical practice and streamlining procedural workflow to help improve our patient outcomes.”

Today, healthcare providers’ use of IVUS in PVD interventions is not standardized and is therefore inconsistent, Philips stated in the press release.

“The new appropriate-use expert consensus may help establish global standards of care to adopt into guidelines and improve quality care in PVD,” the company added.— Bryan Kay October 2021

SVS PAC

We need voices as well as opinions

BY NILESH BALAR, MD

I have a message for my colleagues on behalf of Society for Vascular Surgery (SVS) Political Action Committee (PAC), quoting the famous lines from Charles Dickens: "It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of light, it was the season of darkness.”

THIS IS HOW I FEEL ABOUT OUR CURRENT situation regarding proposed Medicare reimbursement cuts: in one word, chaos. Our vascular surgical society is composed of a very small group of surgeons in a specialized field of surgery. As a group, we have served patients with vascular issues and have developed and advanced science to serve the community we work in.

Most lawmakers are unaware of what we do and who we serve.

I personally have been involved in several activities in the SVS as a private practitioner over the past 20 years. During my time as member and chair of several committees, I have seen the SVS PAC work very hard to bring our legislative issues to the forefront. I own two outpatientbased facilities and multiple offices. Currently, it is most critical that we voice our concerns as a united group.

Divisions among us, in terms of our practice settings, and differences between academic and private groups will dilute our voice, weaken our willpower and not allow us to achieve things that are important to us.

Our Society includes only about 3,700-plus practicing vascular surgeons. We serve a population of 350 million people, which means we have only one vascular surgeon per 85,000 people.

Given vast geographic spread and pockets of large hospitals, we are never going to be able to serve the needs of society.

Apart from the fact that if the lawmakers on Capitol Hill do not understand our problems, do not know what we do and who we serve, then this becomes a huge disadvantage to us as a Society. It is our job to educate and make lawmakers aware of who we are and what we do, which can only be done by interacting with them via the SVS PAC. I would agree with Frank Veith’s presidential address of several years ago. He elaborated on Darwin’s theory that is the natural law of our current society—survival of the fittest. Dr. Veith said we would have to have a unified

We at SVS PAC have maintained political neutrality and have only worked to bring out the issues that affect our profession position as a Society for our own survival. I can promise that the SVS PAC has been laser-focused on achieving its stated goals. For my friends in private practice and owners

of office-based labs (OBLs), I would like to say that I could not find any discussion in the last 15 months where I remember conversations about private and academic physicians involving any bias to or for either group.

We at SVS PAC have maintained political neutrality and have only worked to bring out the issues that affect our profession.

In the post-COVID era, we face financial cuts that will prohibit us from practicing and maintaining access to our patients. We as a group have met with the lawmakers on either side of the aisle who are willing to support our cause. Due to our ongoing efforts, we have prevented major cuts.

This year’s agenda includes working on preventing further cuts, regulations affecting OBLs, preapprovals and adding fellowship positions. I would urge skeptical colleagues to reach out to PAC committee members to review these concerns.

In a democratic society it is good to have opinions but having a voice is also equally important. Your donations to the PAC—each and every cent—goes towards gaining your voice in the Capitol.

It is my humble request that we all please avoid rumors or hearsay, respect the statements opined by all members—whether they be agreeable or not agreeable—and remember that without the PAC, we have no voice. And without donations our work will suffer.

NILESH BALAR is a member of the PAC Steering Committee.

The ONLY Coding Course Devoted to Vascular Procedures Don’t let coding, documenting errors reduce your bottom line!

SVS 2021 Coding & Reimbursement Workshop December 5–6, 2021 OLC Education & Conference Center Rosemont, IL 60018

Register today: vascular.org/Coding21 October 2021

vascularspecialistonline.com | 23

AWARDS Three surgeons, who together bear decades of experience treating patients with vascular disease, have been honored for their service to these patients, communities and the profession.

JOHN KIRKLAND, DANIEL MCGRAW and Kenneth Schwartz received the 2021 Excellence in Community Service Award from the Society for Vascular Surgery (SVS) at the 2021 Vascular Annual Meeting (VAM). The award, in only its third year, honors surgeons who work in the community practice setting for their outstanding leadership within their community as a practicing vascular surgeon, who have exceptional personal integrity and reflect the highest standards of the profession.

Kirkland practices in Rome, Georgia; McGraw and Schwartz are both now retired—McGraw in Parkersburg, West Virginia, and Schwartz from his practice in Westchester County, New York.

Kirkland: In collaboration with a

colleague, Kirkland established a multispecialty vascular program at the Harbin Clinic in Rome, developing the first dedicated vascular surgery practice in Georgia outside of Atlanta and bringing vascular surgeon-led vascular care to the tri-state area of North Georgia, Tennessee and Alabama. This led to the development of the first accredited vascular laboratory in Georgia and the first true hybrid operating room in the southeast.

In collaboration with a local community college, he assisted in developing the fourth accredited training program for Registered Vascular Technologists (RVTs) in the country, which has subsequently trained more than 100 RVTs. Working through the state certificate of need program he and others authorized and developed a cardiac surgery program at Redmond Regional Medical Center in Rome in 1986, the first new program in Georgia in over 20 years.

“In these greater than four decades, he was instrumental in bringing modern vascular surgery to this rural community,” said a colleague. “Later in his career, he started the first dedicated outpatient vein center in this region, modernizing the care for this population and in 2017 developed and became the program director of a Transitional Year Residency at Redmond Regional Medical Center. Along the way, John has been instrumental in building awareness of vascular disease among the medical staff and community at large.”

McGraw: Now retired in New Braunfels,

Texas, McGraw practiced in Parkersburg, West Virginia. Seeing 80 to 100 patients a week, he established vascular surgery as an independent specialty from general surgery in his community. In collaboration with his hospital, McGraw designed and built the first community-based hospital hybrid room in the state of West Virginia.

He utilized television to educate the public on vascular disease, risk factors, prevention 24 | Vascular Specialist

Trio honored for excellence in community service

BY BETH BALES

and cutting-edge vascular care. In fact, said Schwartz: Now retired, a colleague, his work with local primary Schwartz was known care physicians, hospitals and organizations throughout his long career raised awareness of vascular disease. for pushing the specialty Through the outpatient hospital vascular forward, establishing standards laboratory he created, he provided low-cost of care and introducing innovations vascular testing to underserved patients. and new procedures in the field.

McGraw performed the first He practiced in Westchester County, endovascular aneurysm repair (EVAR) New York, at both a large hospital in the Mid-Ohio Valley and the first there and, later in his career, a large transcarotid artery revascularization multispecialty medical group. In both, (TCAR) in the WVU Medicine system; the he achieved leadership roles—including latter springing from his career-long focus section chief of vascular surgery and on carotid disease and director of “Dr. Schwartz worked medical its appropriate care. surgical specialties. tirelessly to create his He also obtained a Schwartz master’s degree from “immediately elevated vision, recruiting new Carnegie Mellon and the level of vascular staff with endovascular surgical skills in our participated in hospital administration, community (as) the training plus an focusing particularly recently trained interventional radiologist” first on quality. In solo dedicated vascular practice virtually his surgeon providing entire career, he made time to mentor high vascular surgical services at our hospital,” school students interested in medicine, two one nominator said of Schwartz’s arrival of whom were inspired to become trained in Westchester County following his vascular surgeons and are now members training. “Through his leadership role at of SVS. the hospital, he established standards for “His dedication to his community by vascular surgical care at the hospital and in bringing a state-of-the-art vascular practice the community, and introduced innovations – both open and endovascular – has been and new procedures in the field.” invaluable,” said a colleague in nominating He developed practice guidelines for McGraw. “Dr. McGraw has decreased rates preventive screenings and follow-up of amputation as well as preventing aortic of high-risk vascular patients, leading ruptures in his community while doing it to tracking and outreach programs to in a cost-effective manner for his patients.” improve the quality of the vascular care

Top: Daniel McGraw (right) pictured with the 2020 cohort of winners at VAM 2021.

Inset: John Kirkland

for its patients proactively. In addition, he trained hospital staff in complex vascular and endovascular procedures.

In 2012, he and colleagues performed the first percutaneous endovascular abdominal aortic aneurysm repair in Westchester County—“a particularly impressive example of his commitment to advancing the field of vascular surgery in our region,” said one of his colleagues.

“Dr. Schwartz worked tirelessly to create his vision, recruiting new staff with endovascular training plus an interventional radiologist,” said a colleague.

“He successfully planned and lobbied to build a state-of-the-art outpatient noninvasive vascular laboratory as well as accredited outpatient surgical suites to perform appropriate endovascular procedures outside of the hospital. This move has dramatically improved the quality of outpatient vascular surgical care in our community. Throughout his career, he always sought to implement the forefront of knowledge and procedures in vascular surgery, and, by bringing them to our community, [he has] had a major impact on the vascular surgical services provided to the patients.”

Applications open Oct. 1 for the 2022 Excellence in Community Service Awards.

Learn more at vascular.org/SVSAwards.

October 2021

VASCULAR HEALTH

SVS Foundation grows donation base, ‘yielding an impressive return on investment’ Dear members:

W

hat a year! We struggled with the pandemic and its effects; however, we were able to gather together at the Vascular Annual Meeting (VAM) once more. And the important work of the Society for Vascular Surgery (SVS) Foundation took some big steps forward, thanks to both the support and innovative ideas of our members.

I particularly want to offer a big thanks to Drs. Peter Nelson and Thomas Forbes for their hard work on the SVS Foundation Development Committee. The old saying—and one of my favorites—is “no money, no mission.” Over this past fiscal year, the SVS Foundation increased its member donations from 17% to 26% of SVS members, including contributions from 75% of past awardees. The endowment also survived the pandemic and is in good shape, although we always can use more endowment for our many new projects.

We launched a new initiative, VISTA—Vascular Volunteers In Service to All (with the moniker “lend a hand to save a limb”)—to address the significant disparities in access to vascular health care across the United States. Social scientists know that a person’s

ZIP code is a better predictor of health than his or her genetic code.

VISTA is a way to try to even the scales and put some much-needed balance into vascular health care.

The program is led by Jens EldrupJorgensen, MD, who proposed it to the SVS and Foundation several years ago.

Fortunately, the Foundation had already funded several pilot programs on limb ischemia in underserved communities, so those pilot programs have become the initial VISTA programs. The Foundation will provide outreach, screening and eventually free treatment, starting with our first pilot project in Oklahoma, which has one of the largest populations of underserved Native American chronic limb-threatening ischemia (CLTI) patients in the country.

We also are taking a look at all of our grants, awards and programs, to

assess their success and continued relevance, and we’re investigating new programs as well. Perhaps an idea or two now percolating below the surface will eventually help unlock the keys to vascular disease in the future.

The work we fund yields an impressive return on investment. As reported at VAM, the Foundation K Awards Program is highly effective in developing vascular surgeon-scientists, with a nearly 9.5-fold return on investment.

Despite those impressive results, retention of awardees in research is an important new focus of the Foundation. Remember that you are the key to the SVS Foundation.

Your participation is key, as well as the amount you give. We will not be satisfied until 100% of our members contribute! Please visit vascular.org/ SVSFoundation to learn more about our mission, programs and funds. Find something you are interested in and donate today. The future of our specialty Foundation and the vascular health of our society is counting on it.

“The K Awards Program is highly effective in developing vascular surgeonscientists, with a nearly 9.5-fold return on investment”

Yours, Peter Lawrence, MD Foundation chair

The Society for Vascular Surgery welcomes the following new SVS members, who have joined SVS this year.

FELLOWS OF THE SVS (ACTIVE MEMBERS) Yayman Ahmed, MD; Toledo, OH Omar Al-Nouri, DO; San Diego, CA Nathan Aranson, MD; Portland, ME Dean Arnaoutakis, MD, MBA; Tampa, FL Muzammil Aziz, MD; Shreveport, LA Sheila Blumberg, MD, MS, FACS, RPVI; Brooklyn, NY Clayton Brinster, MD; New Orleans, LA Kevin Chang, MD; Winston Salem, NC Mohammed Chaudry, MD; Bel Air, MD Michael Corey, MD; Marietta, GA Francis Cuozzo, MD; Portsmouth, VA Ghaleb Darwazeh, MD; Cincinnati, OH Ryan Deets, MD; West Burlington, IA Rishad Faruqi, MD, FRCS (Eng), FRCS (Ed), FACS; Santa Clara, CA Holly Graves, MD; Vineland, NJ Sukgu Han, MD, MS; Los Angeles, CA Donald Harris, MD; Renton, WA

Keith Jones, MD, FACS, RPVI; Carmichael, CA Daniel Kassavin, MD; Medina, OH Satishkiran Kedika, MD; Neptune, NJ Volodymyr Labinskyy, MD; Springfield, MA Kedar Lavingia, MD; Richmond, VA Phung Le, DO; Prescott, AZ Wei Li, MD; Lubbock, TX Melissa Loja, MD, MAS, RPVI, FACS; Fairfield, CA Kristyn A. Mannoia, MD; Loma Linda, CA Michael Miller, MD; Cullman, AL Doran Mix, MD; Rochester, NY Jason Moore, MD; Rockingham, VA Sourabh Mukherjee, MD, FACS, RPVI; Hattiesburg, MS John Westley Ohman, MD; Saint Louis, MO Mary Ottinger, MD; Tampa, FL Shahin Pourrabbani, MD, RPVI; Lynwood, CA

Bala Ramanan, MBBS, MS; Dallas, TX Richard Redlinger, Jr., MD; Beaver, PA Syed Rizvi, MD; San Antonio, TX Maher Sabalbal, MD; Windsor, ON Samuel Schwartz, MD; Colton, CA Jonathan Sexton, MD; Fort Gordon, GA Takuro Shirasu, MD, PhD; Charlottesville, VA Arash Shirvani, MD; Plano, TX Srikant Sivaraman, MD; Pueblo, CO Edic Stephanian, MD, MBA; Garland, TX Victor Tran, MD; Baton Rouge, LA Ryan Turley, MD; Austin, TX Chiranjiv Virk, MD; Shreveport, LA Jason Wagner, MD; Sarasota, FL Joy Walker, MD; Bexley, OH Justin R. Wallace, MD; Greensburg, PA Courtney Warner, MD; Albany, NY Tahlia Weis, MD, PhD; Marshfield, WI A. Sharee Wright, MD; Mt. Pleasant, SC Joseph Michael Zungia, MD; Hainesport, NJ

AFFILIATE MEMBERS Matthew DeCaprio, PA-C; Meriden, CT Jillian Hamlin, PA-C; Boston, MA Kevin Lapp, PA-C; Evanston, IL Connor Middlekauff, PA-C; Lynchburg, VA Kori Salcido, CNP; Albuquerque, NM Salvatrice Samarelli-Arm, MBA, MHA, BSN, RN; Durham, NC Heather Schuster, PA-C, CWS; Fort Worth, TX Sophie Shpritz, PA-C; Germantown, MD Farishta Yawary, MBA, PMP; Redwood City, CA INTERNATIONAL Alejandro Esperón, MD; Montevido, Uruguay Alexander Gombert, MD; Aachen, Germany Francisco Javier Moreno Gutierrez, MD, FACS; Zapopan, Mexico

1 MORE APPLICATION DEADLINE IN 2021 — There is still one additional opportunity this year to join the pre-eminent professional home for vascular surgeons and vascular health professionals, on Dec. 1.

See vascular.org/Join for more information and to apply.

October 2021

vascularspecialistonline.com | 25

NEWS BRIEFS

Grace period: Apply for $25.5B in COVID-19 provider funding

Midwestern Vascular unveils 2021–22 leadership changes The Midwestern Vascular Surgical Society (MVSS) announced a new slate of officers at its 2021 annual meeting held in Chicago (Sept. 9–11). Raghu Motaganahalli, MD, officially assumed the reins as MVSS president for 2021–22, taking over from Kellie Brown, MD, who led the society for a two-year term following the outbreak of the COVID-19 pandemic.

The new officers—and councilor—were unveiled during the MVSS business meeting that took place during the event. In addition to Motaganahalli, chief of vascular surgery at Indiana University in Indianapolis, Jeffrey Jim, MD, chair of vascular and endovascular surgery at Abbott Northwestern Hospital in Minneapolis, was named president-elect after completing his term as MVSS secretary. Ross Milner, MD, professor of surgery in the section of vascular surgery at the University of Chicago, Illinois was elected as the new secretary for a three-year term.

Bernadette Aulivola, MD, professor and chief of vascular surgery and endovascular therapy at Loyola University in Maywood, Illinois, continues as treasurer.

Dawn M. Coleman, MD, associate professor of surgery at the University of Michigan in Ann Arbor, was elected as a new councilor of the society, joining incumbents Patrick Muck, MD, vascular surgery program director at TriHealth Good Samaritan Hospital in Cincinnati, Ohio, and Michael Go, MD, associate professor of surgery at The Ohio State University in Columbus, Ohio.

Meanwhile, the MVSS meeting also heard from Jerome M. Adams, MD, the 20th surgeon general of the U.S., on the final day of the meeting.

As the society’s honorary guest lecturer, Adams— who served under President Donald Trump—covered a range of topics, including the COVID-19 pandemic, as well as the opioid crisis in the U.S. and the role vascular surgeons might play in tackling the problem.

At the outset of his lecture, Adams invited Coleman to the podium to honor the serving U.S. Army Reserve lieutenant colonel for her service on the occasion of the 20th anniversary of the 9/11 terrorist attacks.—Bryan Kay

26 | Vascular Specialist

Healthcare providers affected by COVID-19 can now apply for American Rescue Plan (ARP) rural funding and Provider Relief Fund (PRF) Phase 4 funds. An end date for applications has not been announced.

In addition, the Department of Health and Human Services has announced a final 60-day grace period for PRF reporting requirements for providers who missed the Sept. 30 deadline for the first PRF reporting time period. HHS will not initiate collection activities or similar enforcement actions for noncompliant providers during this grace period.

The $25.5 billion includes $8.5 billion in ARP resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP) or Medicare patients, and $17 billion for PRF Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.

PRF payments will be based on providers’ lost revenues and expenditures incurred between July 1, 2020, and March 31, 2021.

Providers will apply for both programs in a single application.

For more information, visit vascular.org/ PRFPhase4.—Beth Bales

Amazon purchases to benefit SVS Foundation initiatives Do you “smile?”

That would be smile as in AmazonSmile—designating the Society for Vascular Surgery (SVS) Foundation as the charity to benefit when shopping at the online giant.

For the third quarter of 2021, the Foundation received $87.16 from qualifying purchases made by those who selected it as their charity.

As of Aug. 27, the SVS Foundation had received a total of $765.52.

For those who shop online, it is easy to help the SVS Foundation at the same time. Simply start your shopping at smile.amazon.com, and be sure to designate the “Society for Vascular Surgery Foundation” to receive contributions.

Amazon will donate 0.5% of eligible purchases to the Foundation.

Smile away!—Beth Bales

Foundation seeks auction items for VAM 2022 Gala The SVS Foundation is planning what promises to be 2022’s party of the year—and needs the help of Society for Vascular Surgery (SVS) members.

The Foundation Gala is set for Friday, June 17, during the 2022 Vascular Annual Meeting (VAM) in Boston. This iteration of the Gala will be an extra-special part of the meeting, as it will be the high point of the year-long celebration of the SVS’ 75th anniversary. All proceeds will benefit the SVS Foundation.

A big part of the fun will be the Gala’s silent and live auctions, with scores of attractions donated by SVS members.

The sky’s the limit for the contributions, with suggestions including tickets to sporting events, concerts, museums and other attractions; vacation homes and destinations; fishing or hiking trips; designer handbags or sunglasses; artwork; fine wines; restaurant certificates; and gift cards.

“Put your thinking caps on to consider what you can offer,” urged Peter Nelson, MD, chair of the SVS Foundation Development Committee. “The 2019 Gala was spectacular— and we’re hoping the 2022 celebration will be even more so.

We thank you in advance for your help.”

More information on the gala will be publicized as it becomes available. The 2022 VAM will be held June 15–18, 2022, at the Hynes Convention Center in Boston.—Beth Bales

Re-visit VAM: Watch sessions you missed Registrants for the 2021 Vascular Annual Meeting (VAM) can now catch sessions they may have missed in San Diego—or otherwise review a critical presentation at their own leisure.

Select recordings of VAM sessions are now available on the SVS OnDemand page at SVSOnDemand.vascular.org.

These sessions are part of the VAM21 Collection.

The Vascular Quality Initiative (VQI) and Society for Vascular Nursing (SVN) meetings—as well as the Vascular Research Initiatives Conference (VRIC)— are all part of the recordings

available. Access is limited to the meeting for which conference attendees were registered.

Attendees registered for all three meetings will have access to all recordings.

In addition, LifeNet Health, a VAM exhibitor, has posted a video in the VAM Online Planner.

Attendees registered for all three meetings will have access to all recordings.

Recordings of VAM educational sessions do not provide Continuing Medical Education (CME) or Maintenance of Certification (MOC) Self-Assessment credits.

Access to the meeting sessions is an exclusive benefit of conference registration.

For more information email education@vascularsociety. org.—Beth Bales

October 2021

Endologix launches randomized study of Alto EVAR device Endologix has announced that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the company’s Alto abdominal stent graft system to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal aortic aneurysms (AAAs).

JAGUAR (Objective analysis to gauge EVAR outcomes through randomization in a real-world population) is a prospective, randomized, multicenter

study that will enroll approximately 450 patients at up to 60 sites worldwide.

The study is designed for at least 300 patients to be randomly allocated to the Alto cohort and 150 to the comparator group. All patients will be followed through five years.

Results from the study will be independently adjudicated by a third party, Endologix said in a press release.

“The availability of compelling clinical evidence for EVAR devices is crucial for making informed treatment decisions and improving patient outcomes,” said Jean Panneton, MD, a vascular surgeon with Sentara Vascular Specialists who treated the patient at Sentara Norfolk General Hospital in Virginia.

The clinical endpoint of the study is a composite of aneurysm-related complications: freedom from devicerelated interventions, conversion to open surgery, type I and III endoleaks, clinically significant device migration, aneurysm enlargement, occlusion, aneurysm rupture and aneurysm-related death. The study also bears an imaging endpoint related to proximal neck dilation over time, Endologix said.—Bryan Kay

Spotlight Vascular care on 9/11 Benjamin W. Starnes, MD, retells the experience of treating patients at the Pentagon on Sept. 11, 2001, in a new book—American Phoenix: Heroes of the Pentagon on 9/11—written by his brother Lincoln M. Starnes.

First patient enrolled in BIONETIC-I study of iliac artery treatment Biotronik has announced the first patient enrollment in the BIONETIC-I study of the safety and efficacy of the Dynetic-35 cobalt chromium, balloon-expandable stent system for the treatment of peripheral arterial disease (PAD) lesions in the iliac arteries. The study will also evaluate the use of the stent system in association with Biotronik’s Passeo-35 Xeo peripheral dilatation catheter. The first patient was enrolled by investigator Koen Keirse, MD, a vascular surgeon at the Tienen Medical Center in Tienen, Belgium.

The prospective, international, multicenter, single-arm, observational study will evaluate treatment of iliac lesions in approximately 159 patients with up to 60-month follow-up.

The primary endpoint is major adverse events (MAEs) at 12 months. MAEs include device- or procedure-related death within 30 days post-index procedure, clinically-driven target lesion revascularization and major index limb amputation up to 12 months post-index procedure.

The next-generation Dynetic-35 iliac stent system, which was launched in the European Union and other CE markaccepting countries last year, is 6F-compatible across the entire size matrix, and is indicated for the treatment of de novo or restenotic lesions in the iliac arteries.— Anthony Strzalek

Terumo Aortic announces first commercial implants of RelayPro in United States Terumo Aortic has announced the first commercial implants in the U.S. of its RelayPro thoracic stent-graft system. This follows the recent approval by the Food and Drug Administration (FDA) of a device designed to treat patients with fusiform and saccular aneurysms—as well as penetrating atherosclerotic ulcers (PAUs)— in the descending thoracic aorta.

The implants were performed by the co-national principal investigators of the pivotal RelayPro aneurysm study, Venkatesh G. Ramaiah, MD, chief of vascular and endovascular surgery at Honor Health Network in Scottsdale, Arizona, and Wilson Y. Szeto, MD, chief of cardiovascular surgery at Penn Presbyterian University of Pennsylvania Health System in Philadelphia.

“The low-profile delivery system is designed to accommodate patients with smaller access vessels,” said Ramaiah.

“The platform utilizes the same stent design, materials and dual-sheath technology of the proven RelayPlus system, delivering the accuracy, control October 2021

and confidence of RelayPlus without compromising device integrity and durability.”

Szeto added: “RelayPro is the only lower-profile device with a non-bare stent design available in the United States to treat aneurysms and penetrating atherosclerotic ulcers.

“The unique technology incorporated into the delivery system is integral to securing optimal wall apposition and allows for the effective treatment of patients with thoracic aneurysms.”

RelayPro received its CE mark in 2017, with FDA approval announced in August of this year.—Bryan Kay The RelayPro device vascularspecialistonline.com | 27

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