Vascular Specialist February 2020

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Balance: Giving, taking, sharing, matching

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AAA screening guidelines mirror 2014 version

19 Surgical coaching Bridging gap to future success: Finding value in helping vascular peers VOL. 16 • NO. 2 • FEBRUARY 2020

BY FRANCESCO AIELLO, MD, AND MATTHEW SIDEMAN, MD

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he Centers for Medicare and Medicaid Services (CMS) has provided some light reading with the publication of the Physician Fee Schedule (PFS), Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems, as well as Quality Reporting Programs final rules for calendar year 2020. The combined updates are captured in thousands of pages, covering a wide variety of changes, updates and comments. We would like to focus our attention on those changes that will impact vascular surgeons.

The PFS lists all clinical services and procedures along with their relative value units (RVU) for the fiscal year. Those RVUs are converted to dollar amounts using the annual Medicare conversion factor (CF). In See Coding · page 4

Hotly-contested meta-analysis suggests a higher risk of death or amputation at one year when paclitaxel-coated balloons are used in infrapopliteal arteries

BY SUZIE MARSHALL AND JOCELYN HUDSON

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new meta-analysis, just published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly reduced amputation-free survival at one year when paclitaxel-coated balloons are applied in arteries below the knee for critical limbthreatening ischemia (CLTI) treatment, but some experts advise cautious interpretation of the results and question whether these data will impact practice. The new systematic review and study-level meta-analysis

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CMS publishes 2020 round of coding changes for vascular surgeons

of eight randomized controlled trials was conducted

by Konstantinos Katsanos, MD, assistant professor in the School of Medicine, University of Patras, Patras, Greece, and colleagues.

Several physician thought-leaders believe that the conclusions are not yet definitive, with multiple peripheral vascular interventionalists cautioning how these data should be interpreted. Most emphasized the challenge of teasing out scientifically meaningful information from a patient cohort that suffered See Meta-analysis · page 6

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GUEST EDITORIAL

Which one are you: Giver, sharer, taker or matcher?

Bhagwan Satiani is professor of clinical surgery in the division of vascular diseases and surgery, the department of surgery, in the Ohio State College of Medicine at The Ohio State University in Columbus. He is an associate medical editor of Vascular Specialist.

BY BHAGWAN SATIANI, MD

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hroughout our careers—indeed even in our personal lives—we struggle to achieve a proper balance between being a giver, sharer, taker or matcher.

Adam Grant, a professor specializing in organizational psychology in the Wharton School at the University of Pennsylvania, Philadelphia, in his bestseller book, “Give and Take,” separates people by their reciprocity style into givers, takers and matchers. Givers, as the word implies, give more than they take as they are more attentive to others’ needs than their own. Sharing knowledge is also a mark of a giver. In contrast, takers are selffocused and take more than they give because their own needs are more important in a competitive environment where they need to succeed and be one step ahead of others. Finally, matchers balance giving and taking in some imprecise proportion, preferring to view each action as a transaction and may even keep score. Whether in our personal or academic life, we may switch between these roles, trying to achieve an equilibrium.

So let’s now take a look at a few examples where there may be a clash between our expected role as givers versus what may be best for us as individuals.

Conundrums

As students or residents, we are usually—but not always—takers.

In academic or teaching roles, we are expected to be givers of information. Our role may be to help junior faculty or residents succeed in academic activities such as presenting a paper or achieving prime author roles. On the other hand, this requires giving up the limelight that otherwise could have been ours.

As faculty, we are perhaps gearing up for promotion. Most of the work on a major paper may be done by a junior individual who actually

VASCULAR SPECIALIST Medical Editor Malachi Sheahan III, MD Associate Medical Editors Bernadette Aulivola, MD, O. William Brown, MD, Elliot L. Chaikof, MD, PhD, Carlo Dall’Olmo, MD, Alan M. Dietzek, MD, RPVI, FACS, Professor Hans-Henning Eckstein, MD, John F. Eidt, MD, Robert Fitridge, MD, Dennis R. Gable, MD, Linda Harris, MD, Krishna Jain, MD, Larry Kraiss, MD, Joann Lohr, MD, James McKinsey, MD, Joseph Mills, MD, Erica L. Mitchell, MD, MEd, FACS, Leila Mureebe, MD, Frank Pomposelli, MD, David Rigberg, MD, Clifford Sales, MD, Bhagwan Satiani, MD, Larry Scher, MD, Marc Schermerhorn, MD, Murray L. Shames, MD, Niten Singh, MD, Frank J. Veith, MD, Robert Eugene Zierler, MD Resident/Fellow Editor Laura Drudi, MD

deserves to be named as the first author. What will our choice be?

Elsewhere, we may become an expert in the latest technical procedure, a scenario in which few others are our equal. So do we share these skills with our colleagues and thereby grow the competition? Or do we plow on for as long as we can in order to seek sole credit?

We could also be the go-to person on matters related to the business side of medicine. The head of a national surgical organization may favor a particular person as the subject expert, and this individual is then invited to discuss these issues nationwide. Meanwhile, a younger person with solid qualifications might then approach the organization, asking to participate alongside the senior individual. In the final analysis, the organization proceeds to slow walk the request, not wanting to upset the senior surgeon or possibly even at his direction. The message is clear: There will be no sharing of the limelight. What would you have done as the expert in this situation?

Then there are times when you are in matching mode. In this scenario, you have been a giver to someone whom you have repeatedly helped to progress in their career. Now, with roles reversed, you want a position in an organization and ask this individual—the hitherto taker—for a favor to

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.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher. The Society for Vascular Surgery and BIBA Publishing will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

help you. The taker in this case must think about whether they wish to reciprocate for the first time or otherwise avoid the issue until they are able to grab the role as their own. Therefore, as a taker, do we now change our role to one of a giver?

Setting up boundaries

In his book, Grant, the organizational psychology professor, also points out that one must distinguish the act of giving from attributes such as timidity, availability and empathy, and do so to a fault. Takers are best positioned to take advantage of givers when the givers are not assertive, making themselves available at a moment’s notice often as a show of empathy to support the taker. Time and knowledge are valuable currency. Spending both freely—often at a personal loss—benefits only one side.

For most of us, it is often hard to set boundaries: Delay helping a constant taker and you could risk being called rude, selfish or even an ogre! As an example, we receive calls or emails from distant relatives around the world asking for advice on matters related to themselves or their neighbors in specialties we know little about. Obtaining expert advice from colleagues and then answering these queries takes up valuable time. We are not thinking about being in a matching mode and simply assist any way we can.

So when do we give up some of the limelight to others? After our own personal goals have been achieved? Or do we believe Grant when he asserts that eventually givers come out ahead? Essentially, as a giver, you are offering your shoulders for others to stand on and rise. Advancing in academic medicine requires senior colleagues/mentors to give in order to help us reach our career goals.

In my case, as I was trying to carve out an academic presence at the same time as operating in private practice, I did not have people blocking for

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Giver continued on page 4

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FEBRUARY 2020

KNOWLEDGE

Giver

‘Paying it forward’

Continued from page 2

me. Those who did have these types of sponsors moved ahead. Later on as a member of senior faculty myself, having missed out on someone advocating on my behalf, I have felt an obligation to give and share with my junior colleagues as much as possible. In turn, this has been rewarded with respect and appreciation for the efforts I have made to advance their careers. In retrospect, it is also possible that in some instances I may have overdone it and hurt my own progress. Indeed, I often wonder if a time had come when I wanted a match, could I have expected reciprocation?

Now, I often try to assign a percentage to each of the modes of giver, taker and matcher if I am not in a teaching or mentoring role. It is a useful exercise. If I feel someone is repeatedly taking advantage of my giving, my default may be to match and then judge the reaction, which discourages the constant taker.

Coding Continued from page 1

2020, there will be a slight increase in the Medicare CF from $36.0391 to $36.0896. Changes to the CF are just one of the many things that affects reimbursement for vascular surgeons.

For example, CMS’ massive repricing of over 1,300 supplies and 750 equipment items has affected our highcost supplies, such as vein ablation catheters, atherectomy devices, vascular stents and intravascular ultrasound (IVUS) catheters. Because of this CMS initiative, our officebased labs (OBLs) will see decreases in reimbursement. These changes are being implemented over four years.

There are several changes in Current Procedural Terminology (CPT) codes affecting reimbursement for 2020.

The iliac branch endograft (IBE) changed from a category III code to a category I code on Jan. 1, 2020, bearing designated physician work RVUs (wRVUs). The appropriate CPT code will depend on if IBE is performed alone or in conjunction with an endovascular repair (EVAR) of an abdominal aortic aneurysm (AAA). When performed with select EVAR codes (34703, 34704, 34705, 34706), you would use the add-on code +34717. If performing a bilateral, then this code would be used twice.

If performing an IBE as a standalone code, then use code 34718 (with a -50 modifier if bilateral). The wRVU value for 34717 is 9.00 with a total facility RVU value of 12.94. Remember, add-on codes are not subject to the multiple-procedure reduction (50% reduction). The standalone code, 34718, has a wRVU value of 24.00 and total facility RVU of 36.08 with a 904 • VASCULAR SPECIALIST

Another way to be a giver is to simply share information or knowledge in which we may have become an expert. Knowledge is said to be power. There are two non-exclusive ways of power-sharing: closed-network sharing (or personto-person sharing) and open-network sharing (or sharing through a central open repository, or in the academic environment at meetings). My concern is focused on the lack of person-to-person sharing in our divisions, departments and medical centers.

My observation is that a lot of people, depending on the unique institutional culture, keep knowledge close to the chest. Even sharing information that may be useful to others is kept private. Senior physicians should share knowledge and be blockers to thwart obstacles for their younger colleagues.

The cycle of “paying it forward” may inspire them to do the same when their time comes.

From an organizational perspective, cultivating giving behavior should be rewarded, and not

day global period. These codes include the preoperative sizing, intraoperative catheter selection and imaging, and stent deployment in the ipsilateral common iliac, external iliac and internal iliac arteries.

Preoperative arterial and vein mapping for hemodialysis access will have a new code. Since 2005, G-code G0365 was used for the unilateral arm artery and vein mapping for patients who had never undergone creation of an arteriovenous access (graft or vein).

In 2020, this G-code will be replaced with two CPT codes. These new codes require assessment of both arterial inflow and venous outflow.

If only assessing arteries or veins, then the new codes will not apply.

CPT code 93985 is a duplex scan of arterial inflow and venous outflow for bilateral extremities while 93986 is a unilateral study.

These codes do not include physiologic studies and are also not limited to first-time evaluation for hemodialysis access creation and may be used for upper or lower extremities. The 2020 rates are more consistent with the resources used to deliver these services with an increase in wRVU from 0.25 for G0365, to 0.50 for 93986 and 0.80 for 93985.

The CPT codes for stab phlebectomy of varicose veins, 10–20 (37765) and more than 20 (37766), were identified in a high volume growth screen and slated for review.

A robust, multidisciplinary survey including all providers performing these procedures was undertaken.

The clinicians who completed these surveys reported a decrease of 25% in surgical time for 10–20 stab phlebectomies and 33% reduction to perform more than 20 stabs. As a

just through means of personal achievement or company metrics. The correlation between employee-giving and business outcomes is solid.

However, career advancements—be they titles or bonuses—are based on individual achievements and tend to encourage a race to the top between colleagues. Studies looking at links between productivity and givers have shown mixed outcomes.

Therefore, academic organizations and professional bodies such as the Society for Vascular Surgery must include giving and sharing as part of the mix when evaluating individuals for promotions, responsibilities and appointments to prestigious committees or leadership roles. Or am I being too naïve?

References

1. Grant, A. “Give and Take.” Penguin Books. 2014. ISBN: 0143124986, 9780143124986 2. Grant, A. In the company of givers and takers. Harvard Business Review. April 2013. https://hbr.org/2013/04/inthe-company-of-givers-and-takers

result, the wRVU saw a reduction in values. CMS also changed the global period for the stab phlebectomy codes from 90 days to 10 days. This change in global period reduced the total clinic visits from two to one, further impacting the wRVUs. However, with the changes in global period, clinicians are now able to bill and be reimbursed for the second visit when performed.

IVUS was re-reviewed due to concerns over increased expenditures driven by increased non-facility utilization. The Society for Vascular Surgery (SVS) offered extensive comments to CMS detailing the appropriate use and medical benefit of IVUS. Subsequently, CMS has agreed to maintain the current values and did not implement their proposed 14% reduction for IVUS of the initial noncoronary vessel (CPT 37252) and 17% reduction for IVUS of each additional vessel (37253).

Several angiography codes were flagged by CMS for high utilization: abdominal aortography (75625), abdominal aortography plus bilateral iliofemoral lower extremity (75630), angiography, visceral, selective or superselective (75726), and the addon code for each additional vessel studied with angiography (75774).

Through our concerted efforts on the SVS Coding Committee, using the RUC surveys completed by the SVS membership, we were able to obtain increased reimbursement for all four.

Abdominal aortography plus bilateral iliofemoral imaging will increase by 12% and abdominal aortography (75625) will see a 26% increase over 2019. Visceral angiography will see a 91% increase in wRVU value, while 75774 will see a 180% increase.

Finally, there will be significant

changes for exploration-withoutrepair codes for 2020. The previous codes for exploration not followed by surgical repair—with or without lysis of artery—have been condensed into three new codes. Previously carotid artery (35701), femoral artery (35721), popliteal artery (35741) and other (35761), they are now: 35701 for the neck (e.g., carotid, subclavian), 35702 for the upper extremity (e.g., axillary, brachial, radial, ulnar) and 35703 for the lower extremity (e.g., common femoral, deep femoral, superficial femoral, popliteal, tibial, peroneal).

The new codes will be valued at 7.50, 7.12 and 7.50 wRVUs, respectively.

There are several changes on the horizon that will affect reimbursemenrt in the future.

Evaluation and Management (E/M) reimbursement is a recurring topic of discussion at CMS and within the healthcare community. Significant changes are slated for 2021. CMS has stated that they do not intend to apply any E/M increases to the post-op visits included in the 10- or 90-day global packages. SVS, along with our surgical colleagues, will continue to work diligently to avoid the implementation of this inappropriate proposal.

These issues loom large for 2020.

RUC surveys sent to SVS members are essential to efforts for appropriate reimbursement but often only a minority is completed. We would ask all members to take them seriously.

Francesco Aiello is associate professor of surgery in the division of vascular and endovascular surgery at the University of Massachusetts Medical School in Worcester, Massachusetts. Matthew Sideman is a practicing vascular surgeon in San Antonio, Texas.

FEBRUARY 2020

PACLITAXEL

Meta-analysis Continued from page 1

from CLTI, which is associated with “mortality, amputation, and impaired quality of life.” They also point to the inclusion of unpublished data (which has therefore not gone through the peer-reviewed process); the inclusion of summary-level data; the inclusion of the IN.PACT DEEP data (which utilized a device that has long since been withdrawn from the market); as well as the study’s short-term followup period.

As reported in JVIR, the eight randomized controlled trials in this most recent summary-level analysis included 1,420 patients, of which 1,380 (97.1%) had CLTI. The primary safety and efficacy endpoint was amputation-free survival, defined as freedom from all-cause death and major amputation (above the ankle).

At one year, there was a 13.7% crude risk of death or limb loss among the 835 patients who had received treatment with paclitaxel-coated balloons—74 deaths and 40 major amputations. In comparison, the crude risk of death or limb loss in the cohort treated with an uncoated balloon was 9.4%—39 deaths and 17 major amputations. For the primary amputation-free survival endpoint, the number needed to harm was estimated to be 22 patients (95% confidence interval [CI] 11–94).

The authors claim that there was consistent evidence derived from the randomized studies that freedom from major amputation or death was significantly lower in cases with paclitaxel-coated balloons with a pooled hazard ratio (HR) of 1.52 (95% CI 1.12–2.07; p=0.008).

However, Katsanos et al also report consistent evidence that paclitaxel reduces the need for target lesion revascularization in below-the-knee arteries by approximately 40%. Target lesion revascularization constituted the secondary efficacy endpoint. The crude risk of target lesion revascularization was 11.8% (103 revascularization events among 875 cases) versus 25.6% (159 events among 620 control patients) for patients treated with a paclitaxel-coated balloon and an uncoated balloon, respectively. The calculated pooled risk ratio was 0.53 (95% CI 0.35–0.81; p=0.004), with a corresponding number needed to treat of eight patients (95% CI 4–25).

The study authors claim there is a dose–response relationship between paclitaxel and amputation-free survival. They compared outcomes with low and high doses of paclitaxel, and found significantly more deaths or amputations (lower amputation-free survival) in cases with high-dose devices, defined as 3–3.5µg/mm2 (HR 1.62; 95% CI 1.16–2.27; p=0.005).

In comparison, amputation-free survival was higher (fewer deaths or fewer major amputations) when a low-dose device (2µg/mm2) was used (HR 1.06; 95% CI 0.48–2.34). This low dose was found to be safe and effective, Katsanos et al report.

The authors of the present study say they performed a “comprehensive literature review” due to the “major concerns about systemic safety of paclitaxel” prolific in the endovascular community today as a result of their earlier meta-analysis published in the Journal of the American Heart Association (JAHA) in 2018. This concluded that there was an increased association of mortality beyond 6 • VASCULAR SPECIALIST

KIM HODGSON

RAMON VARCOE

two years through five years of follow-up when paclitaxel-coated balloons and paclitaxel-eluting stents were used in the femoropopliteal arteries.

Here, Vascular Specialist captures the immediate reaction of key thought leaders to the findings: Kim Hodgson, MD, president of the Society for Vascular Surgery (SVS); Southern Illinois University School of Medicine, Springfield, Illinois

“While this analysis of the efficacy and mortality of paclitaxel use in the infrapopliteal CLTI population has similar methodological limitations to the first Katsanos publication of paclitaxel used to treat claudication, it also reaches the similar concerning conclusion that paclitaxel use in peripheral vascular disease is associated with increased mortality. But this time the authors use the most relevant of clinical endpoints for this population—amputationfree-survival—to evaluate for the ultimate goal of an intact living patient. While it took use of this composite endpoint to achieve statistical significance, it is alarming that both mortality and amputation came very close to independently reaching statistical significance (p=0.1; p=0.09, respectively), and I suspect that with a larger sample size one or both may have. If further evidence confirms either that paclitaxel does not decrease the rate of amputation but does increase the mortality, then the prospects for its continued use appear bleak. The possible ray of sunshine in this cloud is the observation that the lowest dose paclitaxel device analyzed (Lutonix, BD) appeared to be free of increased mortality yet still effective, perhaps indicating that the dosing sweet-spot has yet to be found while acknowledging that we have no accurate way of measuring actual paclitaxel tissue delivery or systemic release. The complicated nature of paclitaxel delivery and its pharmacology, however, portend that this will remain a complicated mystery to unravel.

“There has been a significant shift towards the use of paclitaxel-delivering devices in treating

“The methodological limitations of this pooled analysis are divulged by Katsanos and are similar to those of his previous publication on the use of paclitaxel in the claudication population.”—Kim Hodgson

peripheral vascular disease since their introduction several years back. Given this and the ever-growing population of peripheral vascular disease patients being treated, it is critical that physicians know the full risk:benefit profile of the therapies they employ and always put the patient’s outcome first. The methodological limitations of this pooled analysis are divulged by Katsanos and are similar to those of his previous publication on the use of paclitaxel in the claudication population. Nonetheless, his prior report called attention to a signal that was, in fact, subsequently confirmed, though still not understood, so the findings of this analysis are highly relevant and need further analysis.

“When considering a risk like mortality, erring on the side of caution only makes sense, especially considering the multitude of other revascularization options available to most patients, the irreversibility of death and the risk of litigation. This is especially true when the effectiveness of the therapy itself is in question, as this analysis has suggested. Until we have greater clarity on the safety and efficacy of paclitaxel devices, I believe that most will opt to use them very selectively in the small subset of patients at high risk for restenosis and no other reasonable revascularization options.”

Ramon Varcoe, Prince of Wales Hospital and University of New South Wales, Sydney, Australia

“My first reaction was that it was good to see a group looking to define the risks of paclitaxel devices in the CLTI population. The CLTI group is very different to the claudicants evaluated in the previous meta-analysis and warrants specific attention. My reaction to the results was mixed.

The authors showed no difference in all-cause mortality or major amputation rates but when they combined the two as the endpoint amputationfree survival, they appeared to find a difference between drug-coated balloons and percutaneous transluminal angioplasty, with better amputationfree survival in the control group. The other positive finding was that they showed a 47% reduction in reinterventions, underlining the well-established effectiveness of these devices.

“It must be said from the outset that—with limited numbers and such short-term followup—care must be taken not to overreach in our conclusions. Moreover, taking a deeper dive into the meta-analysis revealed several methodological questions and important validity concerns.

“For example, why were only drug-coated balloons evaluated and not drug-eluting stents? This differed from the methodology of the previous meta-analysis and meant excluding the PADI trial, which has published five-year follow-up. This is the very group identified in the previous metaanalysis as having the most pronounced safety signal. Second, why was amputation-free survival determined to be the primary endpoint, when all-cause mortality was used in the previous metaanalysis? Why was no protocol published on the PROSPERO database to assure the reader that the endpoint was determined a priori, not after the analysis? Third, why were only below-the-knee studies included when the authors speculate it is the particulate embolization of the drug that provides Meta-analysis continued on page 7 FEBRUARY 2020

PACLITAXEL

Meta-analysis Continued from page 6

an explanation for the safety signal? Particulate embolization is known to occur when CLTI patients are treated for above- and below-the-knee disease.

However, ultimately these are questions for the authors, which may have a reasonable explanation.

“My major concern is the inclusion of unpublished data. This was the case in three of the eight studies pooled. We must take great care in including data that have not been peer reviewed.

It is common that event rates change between presentation and final publication, which may alter the findings of a meta-analysis and its conclusions.

This is particularly true for low-frequency endpoints such as amputation-free survival at six to 12 months.

It is also very difficult for the reviewers to grade the quality of evidence from a short congress presentation, as opposed to a peer-reviewed manuscript. However, including unpublished data is not unheard of, particularly when there are few published studies in the literature. What concerns me most is the glaring omission of the most significant study of drug-coated balloon use in below-the-knee arteries of CLTI patients.

The five-year results of the IN.PACT DEEP study were presented by Thomas Zeller at the AMP [Amputation Prevention] symposium last year (Aug. 14–17, Chicago, USA). Like the other three studies, it was unpublished in September 2019 when the systematic review was conducted. However, if you include some unpublished data you must include all.

“IN.PACT DEEP was a rigorously conducted trial that fulfilled all of the inclusion criteria for the meta-analysis, as evidenced by inclusion of its earlier 12-month results. In that study, amputation-free survival was numerically better in the drug-coated balloon group (drug-coated balloon 135/239 [56.5%] vs. percutaneous transluminal angioplasty 65/119 [54.6%]). The inclusion of such a study is important for two reasons. It provides long-term follow-up, which was linked to mortality in the original metaanalysis in claudicants, and it had a high number of events (death and amputation). Statistically, metaanalyses give additional weight to large studies with high event rates because observed differences are less likely to be due to chance. It is my view that if those contemporary results had been included in this meta-analysis, the conclusions regarding amputation-free survival and safety would have been very different.

“Given the reintervention-reducing benefit of drugcoated balloons, the authors have demonstrated we must get this right. A serious omission such as this must be corrected if we are to determine the truth— our very patients’ lives depend on it.

“These results are under a cloud due to methodological questions and the omission of the most important study. This should not impact anyone’s practice until those issues have been addressed.”

Michael Conte, MD, Heart and Vascular Center, University of California, San Francisco, San Francisco, California

“I don’t think this is really a big surprise, as the results from IN.PACT DEEP regarding a higher observed rate of major amputation in the PCB [paclitaxel-coated balloon] arm have been known, FEBRUARY 2020

MICHAEL CONTE

MICHAEL DAKE

and the only other reasonably large study (LutonixBTK) has yet to report one-year data. The other six trials are modest in size and the number of events is small. So the pooled data are dominated by the two larger trials, only one of which has reported one-year data with these effects known. There are and have been concerns about the adverse effects of paclitaxel embolization in CLTI patients, and this publication keeps the issue on the front-burner but doesn’t resolve it much further.

“CLTI is a major global health problem and current treatments have significant limitations, contributing to high morbidity and mortality rates in these patients. Interventions for infrapopliteal arteries in particular have high rates of failure, and thus there is considerable unmet need for more effective approaches. Thus, the interest in various methods to improve the results of angioplasty, such as drug elution, remains high.

“The limitations of this study relate to both the analysis itself and, more importantly, the state of the field it reflects. The meta-analysis involves pooled data and is not patient-level. Thus it is not possible to evaluate confounders (e.g. unbalanced comorbidities or clinical severity) that may be driving the outcomes. The actual event rates in these trials are lower than expected across the board, e.g. overall major amputation rate of 4%, suggesting that the degree of limb threat at presentation may have been modest. The two larger trials employed a 2:1 randomization ratio, leading to a significantly larger population with PCB exposure than controls. As stated above, the results are dominated by the two larger studies, and these studies have only reported short- to mid-term outcomes. This is particularly relevant for the death outcome. CLTI itself has a broad clinical spectrum, and the need for improved staging systems (e.g. the Society for Vascular Surgery WIfI classification system) is evident to allow for better trial designs and balanced randomization by limb severity.

Finally, one has to ask—where are the five-year data from IN.PACT DEEP and where are the one-year data from Lutonix-BTK? The vascular community deserves timely, complete and honest reporting from the trials.

“The conclusions are cautiously stated by the

“The limitations of this study relate to both the analysis itself and, more importantly, the state of the field it reflects.”—Michael Conte

authors and reflect the current data available. But the quality and quantity of data available in this space remains seriously lacking.

“No, [in my view, these data will not impact practice] because in the U.S. there are no currently approved PCBs for the infrapopliteal arteries at this time. It will be interesting to see if the final results of Lutonix-BTK are reported and whether they allow for regulatory approval by the FDA. Until then I believe it is reasonable to continue to conduct appropriately monitored, well-designed RCTs [randomized controlled trials] to evaluate the safety and efficacy of drug-eluting devices for CLTI given the significant unmet need.”

Michael Dake, MD, president-elect of the Society of Interventional Radiology (SIR); University of Arizona Health Sciences, Tucson, Arizona

“Aside from ‘The Godfather Part II,’ sequels are rarely as compelling as the original version, often with an impact that is a mere ripple of the force produced by the initial statement. Predictably, I suspect this will be the case for the current report, although its contribution to the medical literature will be of interest to many stakeholders in the field of vascular disease.

“The results of this meta-analysis of randomized controlled trials focused on patients with CLTI are more difficult to interpret than the earlier femoropopliteal publication. The medical complexity of the underlying disease and the vulnerability of CLTI patients contribute to a greater heterogeneity in the population studied.

Consequently, added caution must be exercised when attempting to make conclusions from this meta-analysis.

“In terms of the methodology used, the current study shares some of the frequently noted limitations of the original femoropopliteal metaanalysis. The lack of patient-level data available to the authors from the randomized studies included in the meta-analysis restricts evaluation of the total dose of paclitaxel used in individual patients and any correlation with mortality. In addition, the relatively small number of patients analyzed and [the] short follow-up (46% of the patients had only six-month follow-up) make any conclusions problematic. Unlike the first meta-analysis, however, an additional limitation is noted. The current report of pooled trials includes unpublished data. Results from three of the eight trials used in the analysis have not been published. This represents onequarter of the patients included.

“Nevertheless, the paper raises interesting points about the effect of drug-coated balloon treatment for patients with CLTI, and questions the possible association of downstream drug embolization and amputation in patients with compromised distal arterial circulation. In addition, it echoes the call after the earlier femoropopliteal publication for more data and an urgent need for adequatelypowered multicenter studies with longer follow-up.

Its effect on clinical practice for management of CLTI patients with limited treatment options is questionable. Most likely, future substantiation using larger, well-controlled trials will be required before changing strategies for the application of drugcoated balloons in treating CLTI.” VASCULARSPECIALISTONLINE.COM • 7

PACLITAXEL

SVS president presents point-by-point defense of Society position as paclitaxel controversy continues apace

BY BRYAN KAY

N

EW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery (SVS), delivered a robust defense of the SVS position on the drug-coated balloon (DCB) and drug-eluting stent (DES) issue enveloping the vascular community during the 2019 iteration of the VEITHsymposium (Nov. 19– 23) in New York.

During a session on new developments in lower-extremity related topics focused on the downsides of DCBs, Gary M. Ansel, MD, an interventional cardiologist with OhioHealth Heart and Vascular Physicians in Columbus, Ohio, and one of the session moderators, kicked off affairs by launching a broadside in the direction of the SVS over its stance on the paclitaxel issue, saying, “You are out of step with the times and isolationists.”

Once his turn to take the podium arrived, Hodgson, also chair in the division of vascular surgery at Southern Illinois University School of Medicine in Springfield, Illinois, wasted little time in firing back, responding, “Thanks Dr. Ansel for the wonderful comments about our ‘isolationist’ views, which I will take exception to.”

He continued: “All of the other speakers fly through [their] disclosures. I’m going to sit here for a minute and let you know that I have received no personal income or gifts from industry for over four years other than for compensation serving on trial [CECs, etc.] so I think that gives me a certain level of objectivity.”

Hodgson proceeded with a pointby-point breakdown of what the SVS is doing in light of the status of paclitaxel-coated devices and why the society has taken the stance that it has.

“Obviously when the Katsanos publication came out in 2018, it created a great deal of stir. The SVS response to this was to put together a group of experts largely based on our VQI [Vascular Quality Initiative] analysis and our quality programs, and to take a look at the study of this situation,” he explained.

Hodgson said he would not delve into the original meta-analysis in any great detail except to reiterate the five-year results “in the 863 patients available for study, which did show significant increasing mortality in that group of patients.” He went on: “So the FDA [Food and Drug Administration] response to this originally in January of 2019 was that the FDA believed the benefits continued to outweigh the risks. But two months later, they recommended alternative treatment options should generally be used for most patients.

“So what happened in that period of time? Well, 975 patients from the three trials with five-year data showed a 50% increase in five-year mortality— so the data that the FDA looked at—and on the basis of this the FDA announced that they’d be convening a panel of experts to further evaluate the issue. So this panel was held June 19–20 of 2019.”

Hodgson added: “The data analysis at that point in time showed the maintained hazard ratio somewhat lessened but still significant at 1.38.

The SVS focused on VQI analyses that

KONSTANTINOS KATSANOS

could answer these questions because we still believe there are significant questions that need to be answered.”

About six weeks later came the FDA’s third physician advisory letter, the SVS president pointed out, and that “reiterated the presence of the paclitaxel mortality signal and noted, however, that there were significant problems in this analysis—significant concerns about the scientific rigor of this analysis for the reasons mentioned here [during the session].”

Hodgson continued: “They went on to say, however, that for many patients alternative treatment options to paclitaxel-coated balloons and paclitaxel-ballooning stents provide a more favorable benefit-risk profile based on currently available evidence.

Well, the SVS response to the FDA panel conclusions—the SVS Paclitaxel Safety Task Force in collaboration with the Society for Clinical Vascular Surgery and the Vascular and Endovascular Surgery Society— concurred with the FDA decision to keep the devices available while more data are accumulated. We believe in

science. We also agreed that lifestyle changes, exercise, medical therapies and other revascularization techniques may provide equal or better effectiveness for claudication, which is the primary and label indication for use of these devices, and that this really needs to be part of a candid discussion that physicians have with their patients.”

Where do things now stand from an SVS point of view? Hodgson asked as he drew his presentation to a close.

“The paclitaxel mortality effect appears to be real but the mechanism of harm remains unknown,” he said.

“There are so many different drug formulations, doses, excipients used, doses actually delivered to patients depending upon the balloons and devices used—this is going to be a very challenging problem to sort out.”

Earlier in the session, the man whose research sparked the current debate, Konstantinos Katsanos, MD, of the School of Medicine, University of Patras, Patras, Greece, had given an update on his meta-analysis.

And during his slot, Michael Jaff, DO, vice president, clinical affairs, innovation and technology, peripheral interventions at Boston Scientific, Marlborough, Massachusetts, spoke of the “proven benefit” of DCBs and stents for patients, delivering a measured comment about Katsanos as he drew his presentation to a close.

“Dr. Katsanos has been quite clear on his position so I give him great credit in his standing towards his conviction that paclitaxel is guilty until proven innocent. None of us wants to use these devices to hurt patients. We all want to do the right thing.”

DCB question aired during SAVS opening session

BY BRYAN KAY

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ALM BEACH, Fla.—Discussion of the drugcoated balloon (DCB) issue was piqued during the opening session of the Southern Association for Vascular Surgery (SAVS) annual meeting ( Jan. 8–11) in Palm Beach, Florida.

William P. Robinson III, MD, professor and chief in the division of vascular surgery at East Carolina University’s Brody School of Medicine, Greenville, North Carolina, had delivered a lecture on the pro side of a debate entitled “Lower extremity: Endovascular first is always the best approach.”

The discussion was part of the “Controversies in Vascular Surgery” postgraduate course hosted 8 • VASCULAR SPECIALIST

by CME chair Richard F. Neville, MD, associate director of the Inova Heart and Vascular Institute, Falls Church, Virginia.

“Dr. Robinson, your slides lean heavily on drugcoated technology,” a questioner from the floor said. “Have you tweaked your consent in discussion with the patient at all based on that data?”

Robinson answered: “That’s a good point but I will point out that the only drug stuff I talked about was Zilver. It turns out, I had the same general sense that rationally this concern over mortality from these small doses of drug compared to what given in all sorts of other settings for cancer can make the mortality difference. I sort of have an inherent bias that this must be a statistical—not a

patient—phenomenon.

“The Zilver folks did publish a patient-level analysis, and I am concluding ... a new randomized study, like all of their previous studies that got Zilver approved, in response to this whole hubbub, and it did not show mortality in their data to date.

“But, that being said, I have changed my practice.

I do think it’s a liability—not because I believe it but from a liability standpoint.”

Neville, the chair, noted he and his colleagues, too, had changed their practice, coming up with a set of intrinsic guidelines. “What we have done in our institution is we no longer want people to use drug-eluting technology for claudication,” he told gathered delegates.

FEBRUARY 2020

AAA

Updated USPSTF recommendations on screening for AAAs remain faithful to 2014 guidance, adding new material to body of evidence

BY BRYAN KAY

U

pdated recommendations on screening for abdominal aortic aneurysms (AAAs) remain consistent with the 2014 guidance while incorporating new evidence.

The United States Preventive Services Task Force (USPSTF) recommendation statement, published in JAMA: The Journal of the American Medical Association, was authored by a research team led by Douglas K. Owens, MD, a professor of medicine at Stanford University, Stanford, California.

The authors set the scene: “The current prevalence of AAA in the United States is unclear because of the low uptake of screening. Most AAAs are asymptomatic until they rupture. Although the risk for rupture varies greatly by aneurysm size, the associated risk for death with rupture is as high as 81%.”

The statement’s top line advisory— its B recommendation—calls for one-time screening for AAA with non-invasive conventional abdominal duplex ultrasonography in men aged 65- to 75-years-old who have ever been a smoker.

However, the USPSTF recommends selectively offering screening among men in the same age bracket who have never smoked (the C recommendation).

In women 65–75 years, meanwhile, the D-graded recommendation calls for no screening in those patients who have never smoked and have no family history of AAA. With regards to women in the same age range who have ever smoked or have a family history of AAA, the USPSTF produced the following statement: “Evidence is insufficient to assess the balance of benefits and harms of screening for AAA with ultrasonography in women aged 65 to 75 years who have ever smoked or have a family history of AAA.” Owens et al point out that the recommendations apply to asymptomatic adults aged 50 years or older. “However, the randomized trial evidence focuses almost entirely on men aged 65 to 75 years,” they note.

Systematic review

To reach its conclusions, the USPSTF 10 • VASCULAR SPECIALIST

commissioned a systematic review in order to update its recommendation published five years before. The taskforce examined evidence on the effectiveness of both one-time and repeated screening for AAAs, the associated harms of screening as well as the benefits and harms of available treatments for small AAAs (3–5.4cm in diameter) that are picked up during screening. In this Recommendation Statement, the recommendations are stratified by “men” and “women,” although the net benefit estimates are driven by biologic sex (i.e., male/ female) rather than gender identity.

Ultrasonography, the primary method used to screen for AAA because of its high sensitivity (94– 100%), “is simple to perform and does not expose patients to radiation.”

Important risk factors for AAA include older age, male sex, smoking and bearing a first-degree relative with the condition, the research team writes. Others include a history of vascular aneurysms elsewhere, coronary artery disease, cerebrovascular disease, hypertension and atherosclerosis.

The presence of an AAA is typically defined as an aortic enlargement whose diameter is 3cm or larger. The USPSTF assessment of the magnitude of net benefit is listed as follows: Concludes with moderate certainty that screening for AAA in men aged 65 to 75 years who have ever smoked is of moderate net benefit Concludes with moderate certainty that screening for AAA in men aged 65 to 75 years who have never smoked is of small net benefit Concludes that the evidence is insufficient to determine the net benefit of screening for AAA in women aged 65 to 75 years who

have ever smoked or have a family history of AAA Concludes with moderate certainty that the harms of screening for AAA in women aged 65 to 75 years who have never smoked and have no family history of AAA outweigh the benefits USPSTF 2014 recommendation

The 2014 USPSTF recommendation bore a similar message: “This recommendation incorporates new evidence and replaces the 2014 USPSTF recommendation.

It is consistent with the 2014 USPSTF recommendation, which was a B recommendation for one-time screening for AAA with ultrasonography in asymptomatic men aged 65 to 75 years who have ever smoked, a C recommendation for selective screening in men aged 65 to 75 years who have never smoked, a D recommendation against routine screening in asymptomatic women who have never smoked, and [what's known as] an I statement for women aged 65 to 75 years who have ever smoked.”

In terms of treatment of AAAs picked up during screening, the authors write: “The majority of screen-detected AAAs (90%) are between 3 and 5.5cm in diameter and thus below the usual threshold for surgery. The current standard of care for patients with stable smaller aneurysms is to maintain ultrasound surveillance at regular intervals because the risk of rupture is small.

“Recommended surveillance intervals for monitoring the growth of small AAAs vary across guideline groups, and adherence with surveillance guidelines has been reported to be as low as 65%.

“The majority of screen-detected AAAs (90%) are between 3 and 5.5cm in diameter and thus below the usual threshold for surgery. The current standard of care for patients with stable smaller aneurysms is to maintain ultrasound surveillance at regular intervals because the risk of rupture is small.”—Douglas K. Owens et al

Repairing smaller aneurysms with a lower risk of rupture increases the harms and reduces the benefits of screening.”

The authors also drew attention to the recommendations of various medical societies, including the Society for Vascular Surgery.

“The American College of Cardiology and the American Heart Association jointly recommend onetime screening for AAA with physical examination and ultrasonography in men aged 65 to 75 years who have ever smoked or in men 60 years or older who are the sibling or offspring of a person with AAA,” they wrote.

“These organizations do not recommend screening for AAA in men who have never smoked or in women. The Society for Vascular Surgery recommends one-time ultrasonography screening for AAA in all men and women aged 65 to 75 years with a history of tobacco use, men 55 years or older with a family history of AAA, and women 65 years or older who have smoked or have a family history of AAA. “The American College of Preventive Medicine recommends one-time screening in men aged 65 to 75 years who have ever smoked; it does not recommend routine screening in women.”

SOURCE: DOI:10.1001/ JAMA.2019.18928 FEBRUARY 2020

COMMENTARY

Latest edition of USPSTF guidance produces essential reiteration, continuing to leave many patients at risk

BY KELLI L. SUMMERS, MD, AND MALACHI SHEAHAN III, MD

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he United States Preventive Services Task Force (USPSTF) recently released an update to their 2014 abdominal aortic aneurysm (AAA) screening recommendations. The update is essentially a reiteration. They recommend a one-time screening with ultrasonography in asymptomatic men aged 65 to 75 years who have ever smoked (grade B) and selective screening in men aged 65 to 75 years who have never smoked (grade C). They also recommend against screening in asymptomatic women who have never smoked (grade D), and state there is insufficient evidence to determine the benefit of screening women aged 65 to 75 years who have ever smoked.1 The recommendations are still based mainly on four large, population-based randomized controlled trials.2–5 These four trials have severe limitations that put their relevance to the U.S. population in question. The studies predominately include Caucasian men 65 years and older, are from outside the United States and are approximately two decades old. With a mortality rate of over 80% for ruptured AAAs, researchers should strive to identify which Americans are most at risk.6 Now consider that 34–41% of AAA-related deaths are in women, 22% are in nonsmokers and 9% in men younger than 65 years. None of these groups are covered under the updated USPSTF guidelines.7–9 The Society for Vascular Surgery (SVS) 2017 guidelines partially addressed this gap by also recommending screening in women 65 to 75 years with a history of tobacco use and men and women older than 75 years in good health with a history of tobacco use.10 Pushing this further, the United Kingdom’s National Institute for Health and Care Excellence (NICE) draft guidelines recommend screening men and women with more than one risk factor including smoking, male sex, age greater than 65 years, hypertension, chronic obstructive pulmonary disease, atherosclerotic cardiovascular disease and family history of AAA.11 The NICE recommendations were made, in part, due to a study showing that AAA screening is costeffective with a prevalence as low as 0.35–0.5%.12 The advent and advancement of endovascular aortic repairs (EVARs) have also increased the benefit of AAA screening. One study found select, healthy patients older than 75 years with AAA benefit from an EVAR and have an operative mortality of 1.4%.13 In a recent JAMA Surgery editorial, SVS member Marc Schermerhorn, MD, notes an important

With a mortality rate of over 80% for ruptured AAAs, researchers should strive to identify which Americans are most at risk.

FEBRUARY 2020

KELLI L. SUMMERS

MALACHI SHEAHAN III

clinical impact of the USPSTF guideline—private insurers are only mandated to cover grade A and B recommendations under the Patient Protection and Affordable Care Act.14 This means only men aged 65 to 75 years who have ever smoked would be covered. Therefore patients not in that category, but who have several high-risk factors for AAA, would have to pay out-of-pocket for screening.

Since 2014, there have been many published studies concerning AAA prevalence, screening and treatment, but they have not been of adequate caliber for the USPSTF to justify expansion.1 There is still a paucity of data regarding the prevalence of AAA, especially in the U.S. Therefore, current risk prediction and efficacy models are anemic.

In addition to evaluating the available evidence, the USPSTF assesses the benefit-to-risk ratio for screening exams. The risks of expanding the screening guidelines include increased number of operations and their inherent mortality, in addition to the economic burden that results. Research on psychological and quality of life harms from an AAA diagnosis have been conflicting and not clinically significant.3, 15–17 The USPSTF’s goal is to “[work] to improve the health of all Americans.” In this context, the aim is to save lives by preventing AAA ruptures and avoiding the associated mortality risk. Screening is the only practical method for achieving this objective. The USPSTF has identified key gaps in research that the community should diligently work to fill. In the meantime, physicians should still maintain a high index of suspicion in the following groups who may remain outside of the screening guidelines: Males ages 45–65 with a significant history of tobacco use Males ages 65–75 who have never smoked but have other risk factors Females ages 65–75 who have ever smoked Healthy males and females over the age of 75 References 1. Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, et al. Screening for Abdominal Aortic Aneurysm: US Preventive Services Task Force Recommendation Statement. JAMA. 2019;322(22):2211–8.

2. Lindholt JS, Juul S, Fasting H, Henneberg EW. Screening for abdominal aortic aneurysms: single centre randomised controlled trial. BMJ. 2005;330(7494):750.

3. Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA, et al. The Multicentre Aneurysm Screening

Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet. 2002;360(9345):1531–9 4. Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer CA, Tuohy RJ, et al. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ. 2004;329(7477):1259.

5. Scott RA, Wilson NM, Ashton HA, Kay DN. Influence of screening on the incidence of ruptured abdominal aortic aneurysm: 5-year results of a randomized controlled study. Br J Surg. 1995;82(8):1066–70.

6. Reimerink JJ, van der Laan MJ, Koelemay MJ, Balm R, Legemate DA. Systematic review and meta-analysis of population-based mortality from ruptured abdominal aortic aneurysm. Br J Surg. 2013;100(11):1405–13.

7. Egorova N, Giacovelli J, Greco G, Gelijns A, Kent CK, McKinsey JF. National outcomes for the treatment of ruptured abdominal aortic aneurysm: comparison of open versus endovascular repairs. J Vasc Surg.

2008;48(5):1092–100, 100 e1–2.

8. Kung HC, Hoyert DL, Xu J, Murphy SL. Deaths: final data for 2005. Natl Vital Stat Rep. 2008;56(10):1–120.

9. Longo C, Upchurch GR, Jr. Abdominal aortic aneurysm screening: recommendations and controversies. Vasc Endovascular Surg. 2005;39(3):213–9.

10. Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018;67(1):2–77 e2.

11. Excellence NIfHaC. Abdominal aortic aneurysm: diagnosis and management. online2018.

12. Glover MJ, Kim LG, Sweeting MJ, Thompson SG, Buxton MJ. Cost-effectiveness of the National Health Service Abdominal Aortic Aneurysm Screening Programme in England. Br J Surg. 2014;101(8):976–82.

13. O’Donnell TFX, Wade JE, Liang P, Li C, Swerdlow NJ, DeMartino RR, et al. Endovascular aneurysm repair in patients over 75 is associated with excellent 5-year survival, which suggests benefit from expanded screening into this cohort. J Vasc Surg. 2019;69(3):728–37.

14. Schermerhorn M. Updated US Preventive Services Task Force Recommendations for Abdominal Aortic Aneurysm—Are We Really Up To Date? JAMA Surg. 2019.

15. Spencer CA, Norman PE, Jamrozik K, Tuohy R, Lawrence-Brown M. Is screening for abdominal aortic aneurysm bad for your health and well-being? ANZ J Surg. 2004;74(12):1069–75.

16. Lucarotti ME, Heather BP, Shaw E, Poskitt KR. Psychological morbidity associated with abdominal aortic aneurysm screening. Eur J Vasc Endovasc Surg.

1997;14(6):499–501.

17. Lesjak M, Boreland F, Lyle D, Sidford J, Flecknoe-Brown S, Fletcher J. Screening for abdominal aortic aneurysm: does it affect men’s quality of life? Aust J Prim Health.

2012;18(4):284–8.

Kelli L. Summers is an integrated resident in vascular surgery at the Louisiana State University Health Sciences Center in New Orleans. Malachi Sheahan III is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at the same institution. He is the medical editor of Vascular Specialist.

VASCULARSPECIALISTONLINE.COM • 11

NEWS FROM SVS

VRIC agenda taking shape, poster sessions to return

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he biology of vascular disease—including molecular mechanisms and the immune system—will take center stage on May 4 in Chicago at the 2020 Vascular Research Initiatives Conference (VRIC) meeting of the Society for Vascular Surgery (SVS).

The conference, VRIC Chicago 2020: “From Discovery to Translation,” will be at the Hilton Chicago in Chicago.

“Quick-Shot” poster presentations will return.

The talks, highly successful in their first year in 2019, provide an additional chance for researchers to present their work, said Luke Brewster, MD. He chairs the SVS Research and Education Committee, which oversees VRIC. Mohammad Zayed, MD, will again oversee the poster sessions, which will be presented “in honor of our colleague and friend” Thomas Monahan, MD, who died in May 2019, explained Brewster.

Monahan, a nationally successful researcher, was a regular presence at VRIC meetings and also had been a member of the Research and Education Committee.

In addition to being on the faculty at the University of Maryland, Monahan had completed the rigorous Harvard-Longwood Research Training in Vascular Surgery, under the direction of SVS member Frank LoGerfo, MD, and had overseen projects with prestigious R01 funding from the National Institutes of Health.

He completed his fellowship at the University of California San Francisco shortly after fellow SVS member Jason MacTaggart, MD, who

will speak briefly about Monahan during the poster presentations.

The VRIC agenda also includes a total of four abstract sessions. They are: hemostasis, thrombosis and venous disease; vascular regeneration, stem cells and wound healing; aortopathies and novel vascular devices; as well as atherosclerosis, arterial injury and diabetes.

Philip S. Tsao, PhD, of Stanford University, will present the Alexander W. Clowes Distinguished Lecture on “Molecular Mechanisms of AAA Disease.” Tsao also is associate chief of staff for precision medicine at the VA Palo Alto Health Care System and director of the VA Palo Alto Epidemiology Research and Information Center for Genomics.

The Translational Panel will tackle the important topic of “Immunology and Vascular Disease,” and additionally will feature international leaders in the topic, said Brewster.

“Interaction between the immune system and vascular disease and vascular health has been accepted for a long time. However, the actual beneficial and pathologic mediators of vascular disease are not well-known—but they’re becoming more important.”—Luke Brewster

New registry to keep track of vascular patients launched

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registry to track management of new patients who are being treated medically for a number of vascular diseases has been launched by the Society for Vascular Surgery (SVS) Patient Safety Organization® and the Society for Vascular Medicine, in collaboration with the American Heart Association, for the Vascular Quality Initiative (VQI).

The VQI, a joint venture of M2S Inc. and the SVS, collects and analyzes data in order to help improve the quality of vascular care.

The Vascular Medicine Consult (VMC) registry will emphasize medication details and dosages, both risk factor and lifestyle modifications, nonoperative treatments and counseling those being treated medically for atherosclerotic carotid artery occlusive disease, abdominal aortic aneurysm and peripheral lower extremity 14 • VASCULAR SPECIALIST

arterial disease due to atherosclerosis or true aneurysm.

VMC’s value centers on the comparative effectiveness of surgery versus medically managing these vascular diseases.

“We are extremely excited about the introduction of the Vascular Medicine Consult registry,” said Jens Jorgensen, MD, VQI medical director.

“The effort and collaboration put into the VMC will provide a necessary platform for physicians to manage, analyze and improve outcomes for patients with peripheral arterial disease being treated with medical therapy. Data generated by the registry will directly support our goal of improving care for medically managed patients.”

Watch a webinar on VMC at vsweb. org/VMCWebinar.

The speakers include: Kathryn Moore, PhD, the Jean and David Blechman Professor of Cardiology (Medicine) and professor of cell biology at NYU Langone Medical Center, an international expert on the molecular pathogenesis of atherosclerosis and vascular disease; and Katey Rayner, PhD, director of the Cardiometabolic microRNA Laboratory at the University of Ottawa Heart Institute, an international expert on vascular inflammation and RNA biology “We are beyond thrilled to have these leaders in immunology-related vascular research and expect a great interactive session,” said Katherine Gallagher, MD, who helped organize this session on immunology-based vascular research with Jayer Chung, MD. Both are members of the Research and Education Committee.

“This is where I believe the future of our treatment modality will be,” said Brewster of the Translational Panel session. “Interaction between the immune system and vascular disease and vascular health has been accepted for a long time.

“However, the actual beneficial and pathologic mediators of vascular disease are not well-known— but they’re becoming more important. This session will bring two of the thought leaders in the field to our group for interactive discussion and, hopefully, stimulate collaboration among the attendees.”

The conference, said Brewster, “is going to be fantastic. We’re very excited to be in Chicago. And we not only have a great scientific program in store but also a fun social program as well. I encourage anyone interested in research or mentoring researchers to attend.”

For more information and to register, visit vsweb.org/VRIC20.

Around the SVS journals

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wo articles of interest from the Journal of Vascular Surgery (JVS) and JVS: Venous and Lymphatic Disorders are available, free, through April 14 (JVS-VL) and April 30 (JVS).

JVS: The anklebrachial index (ABI) may underestimate the severity of peripheral arterial disease (PAD) in patients with non-compressible vessels, according to a retrospective study in the March JVS. Authors conclude a resting ABI can mask the presence of PAD of the lower extremities and suggest patients with symptomatic PAD undergo further imaging to determine proper treatment.

JVS-VL: Acute iliofemoral deep

vein thrombosis and post-thrombotic syndrome are significant problems for pregnant and post-partum women. Percutaneous intervention for thrombus removal and venous stenting provides “a favorable alternative to conservative therapies.” Visit vsweb.org/JVSVL-Pregnancy.

FEBRUARY 2020

NEWS FROM SVS

Presenting public policy issues of importance to vascular surgeons: SVS PAC, Congress and you

BY CARLO A. DALL’OLMO, MD

D

efining the narrative. It’s a cliché among pundits, board members and anyone who has a point to make or a story to tell. It is the defining difference between success and failure in our life’s circumstances, depicting what is done in a positive, persuasive manner versus an unfavorable one. Yes, it can cut both ways, resulting in favorable or unfavorable results, depending on how the narrative is presented. For an organization such as the Society for Vascular Surgery (SVS), presenting the public policy issues of importance to vascular surgeons in a clear and concise manner to our elected officials is often the difference between success and failure.

As a member of the SVS, have you ever considered how critical controlling the narrative becomes when discussing our specialty’s needs and services with members of Congress? Think about that for a moment. Who will present our story—

Competition heats up for 2020 VAM The SVS PAC is again hosting a regional society competition based on the percentage of regional society members who have given to the committee alongside a separate competition for individual practice groups. If everyone in the group donates to the PAC, the group will be listed with distinction on the SVS PAC donor boards at the 2020 Vascular Annual Meeting (VAM). We will also announce these winners and present plaques at the SVS VAM 2020 Annual Business Meeting on Saturday, June 20.

CARLO A. DALL’OLMO

our history, our specialty, our services, our needs and those of the patients we serve to the public or healthcare policymakers? Who will challenge any misinformation about us that has been passed on to congressional aides and members of Congress so as to correct the errors? Who will be our conduits to educate these congressional members? Who will identify the unintended consequences of potential congressional mandates and legislation that affect our specialty, our patients and us?

The SVS does and will for its members—and the SVS Political Action Committee (SVS PAC) is critical, as it gives us the opportunity to attend fundraising events with members of Congress where we can discuss our issues with them directly.

Defining the information for policymakers on behalf of vascular surgeons is a process that does

not occur in a vacuum or by serendipity. The process requires continual discussions by our SVS representatives with members of Congress and their staffs. Some occasions are opportunities for discussion and for learning. One such event was a lunch in December for Rep. Ami Bera (D-CA), a physician-member of Congress. The SVS PAC attended with other medical society PACs. Bera shared information regarding his work on the socalled “Surprise Billing” issue and also let us know he is interested in working on physician wellness, burnout and opportunities for alternative training environments. The SVS Government Relations Committee is now following up on his interest with the work of the SVS Wellness Task Force.

Developing policy at the federal level can be a very time-consuming process; some issues take literally years to complete. The SVS PAC gives us another way to engage with members of Congress multiple times a year to continue to work together on issues of importance to vascular surgery. It is a vital link to the success of both our specialty and our practices.

Think about this when asked to donate to the PAC at vsweb.org/PAC. Who can provide information about vascular surgery better than us?

Nobody. If, however, we shirk our responsibility and do not contribute to the PAC, then someone else with no “skin in the game” will control our narrative. Then, when the unintended consequences start piling up and impacting our practices negatively, we can try to tell our staff why we refused to defend ourselves when we had the opportunity.

Carlo A. Dall’Olmo is former chair of the SVS Political Action Committee.

Deadline for Seed Grant applications falls March 1

Zero hour: SVS awards nominations come due

A

T

pplications for the SVS Foundation’s Clinical Research Seed Grant program are due March 1.

This program is designed to spur interest and development of clinical investigators among SVS members, particularly junior members with limited prior experience as principal investigators.

The grant provides direct support for pilot projects with the potential to become larger studies funded from either industry or government sources.

One awardee will be selected in the spring and will receive a $25,000 grant for direct costs for one year.

Clinical Research Seed Grant Challenge: A second recipient will FEBRUARY 2020

be selected for the Clinical Research Seed Grant Challenge during the Vascular Annual Meeting.

This is the second annual competition. In 2019, Efthymios (Makis) Avgerinos, MD, was declared the winner in the 90-minute challenge. Though stressful, it was rewarding, he said.

The competition sharpened everyone’s focus and prompted them to delve deeper into their research and eventually improve it, said Avgerinos. “I got some wonderful ideas on how to improve my project and how to move on to a bigger grant down the road.”

For more information, visit vsweb. org/ClinicalResearchSeedGrant.

he deadline is March 1 for nominating a fellow SVS member for the society’s Lifetime Achievement Award or Medal for Innovation in Vascular Surgery, and for applications for the Distinguished Fellow Designation.

All will be recognized at the Vascular Annual Meeting in June.

The Lifetime Achievement Award recognizes an individual’s outstanding and sustained contributions to both the vascular surgery profession and to the SVS, as well as exemplary professional practice and leadership.

The SVS Medal for Innovation in Vascular Surgery honors an individual or individuals whose

contributions have transformed the practice or science of vascular surgery.

The Distinguished Fellow Designation recognizes members who have provided sustained and substantial contributions to vascular surgery through research, teaching, clinical and/or creative accomplishments.

In addition, SVS Foundation awards with March 1 application dates include the Community Awareness and Prevention Project Grant, E.J. Wyle Traveling Fellowship as well as the Clinical Research Seed Grant.

Visit vsweb.org/Awards for more information.

VASCULARSPECIALISTONLINE.COM • 15

NEWS FROM SVS

'There is no perfect job': Benefits of working across VA system outlined by current practitioners Until summer 2019, my lab was based at the VA. My first career development award was through VA Merit Funding and it has been the major source of funding for my research. I have also received some institutional and regional funding through the VA as well, plus the VA system has recommendations for designated time in research related to the amount of grant funding, so I have had a portion of my time mapped to research.

I have been part of the VA for more than 25 years as an attending physician. As a new department chair, I decided to maintain a role at the Hines VA, for five hours per week, with predominantly a clinical support role. This allows me to continue a clinical role for this population of patients, as well as having a closer affiliation with the VA related to resident education and faculty recruitment and development.

BY PEGGE HALANDRAS, MD

M

any believe the adage, “There is no perfect job.” If your list of “musts” for a career in vascular surgery includes working with a completely unique patient population with unparalleled opportunities for career development, the VA (Department of Veteran Affairs) healthcare system may offer the perfect job for you. These opportunities are best illustrated by the reflections below of early-, midand late-career VA vascular surgeons.

William J. Yoon, MD, assistant professor, VA Northern California Health Care System and University of California, Davis Medical Center

I am a junior faculty member in an academic medical center with a flexible work schedule arrangement at the VA. One of the real joys of vascular surgery is learning new technologies and using the latest devices to benefit patients.

The VA has a good track record of offering new endovascular devices soon after they are introduced.

With access to state-of-the-art technologies, VA vascular surgeons have more options to offer patients. Additional advantages of working for the VA include the ability to have protected time for research and educational support, which gives young vascular surgeons room to grow in their careers. Best of all and importantly, vascular surgeons at the VA have the privilege of caring for veterans. The VA can offer you endless opportunities for growth and satisfaction.

Carlos Bechara, MD, associate professor, Edward Hines, Jr. VA Hospital and Loyola University Chicago Health System

Working at the Veterans Hospital will always be dear to my heart; taking care of our veterans is what makes it special. Veterans are the most grateful patients you will ever meet.

I started my clinical and academic career at the largest VA hospital in the country, the Michael E. DeBakey VA in Houston, and I’d do it all over again!

I always told people it is the only place where I can practice patient-centered and evidence-based medicine. It was truly multidisciplinary since we were not fighting over the same patient with other services; it allowed us to do what is right and best for the patient.

The complexity of the patients and the surgeries allowed me to gain confidence in a very short period but, at the same time, kept me humble.

And I am proud to say that we performed many procedures before or around the same time as with the other major academic hospitals.

We were involved there in multiple research projects, including the OVER [Open versus endovascular repair] trial and the learning-curve percutaneous endovascular aneurysm exclusion.

Finally, in terms of work environment, some of the best clinicians and researchers I met work at the VA. I get to work with some of the best nurses in 16 • VASCULAR SPECIALIST

PEGGE HALANDRAS

the country who I am proud to call “my sisters” for making my patients and me feel at home.

Vivian Gahtan, MD, professor, Edward Hines, Jr. VA Hospital, chair of the department of surgery, Loyola University Chicago Health System

While the VA is not always the easiest place to work, significant opportunities exist for someone who truly wants to develop an academic surgical career. I have been affiliated with a VA hospital since I was a medical student and have spent time at seven different VA hospitals.

It has been rewarding to take care of the veteran population, many of whom lack choices in where they obtain care. The early exposure to clinically complex cases was stimulating and valuable to my development. In contrast, a volume of complex cases came along later on the university side. My first clinical administrative leadership roles occurred at the VA, including chief of vascular surgery and director of the vascular lab. They were meaningful roles in-and-of themselves, but I also gained a foundation and credibility as I applied for and obtained other leadership roles.

“The VA is a unique environment in which to practice vascular surgery.

As is well recognized, the veteran population carries a substantial burden of vascular surgical disease.”

—Mohammed M. Moursi

Mohammed M. Moursi, MD, professor, division chief, Little Rock VA and University of Arkansas Medical Sciences

I came to the VA because, as a young surgeon, it gave me the ideal opportunity to become an academic “triple threat.” I was able to practice clinical vascular surgery, conduct both basic science and clinical research, as well as mentor students, residents and fellows.

The VA is a unique environment in which to practice vascular surgery. As is well recognized, the veteran population carries a substantial burden of vascular surgical disease. As such, the opportunities to help these patients and their families are abundant.

I have worked as a vascular surgeon at the VA for more than 25 years. I have seen the progression of our field advance from solely open operations to the complicated endovascular techniques that we employ today. The VA has been incredibly supportive of these advancements in terms of their dedication to maintaining state-of-the-art technology. For example, our VA had one of the first hybrid rooms in our state. This has enabled us to provide veterans with world-class care. It is incredibly gratifying to help those who have served our country.

The environment at the VA has enabled me to climb the academic ranks and establish myself as a senior vascular surgeon. While this could have been accomplished at a non-VA medical center, the support of the administration and the patient population itself made it much more of a rewarding and satisfying journey.

While some complain about a bureaucratic and inefficient system, I have rarely found that to be true. The VA’s commitment to young surgeons is very evident in my view. I would recommend any young vascular surgeon starting their career to seriously consider a VA position. They will find it—I assure you—rewarding.

Pegge Halandras is a member of the SVS VA Vascular Surgeons Committee.

FEBRUARY 2020

NEWS FROM SVS

SVS rolls out Leadership Development Program

T

he Society for Vascular Surgery (SVS) investment in accelerating the growth of vascular surgeonleaders has begun.

Some 25 SVS members have embarked on a six-month course in developing leadership skills, as the first cohort of the new SVS

Leadership Development Program.

For the past three years the SVS Leadership and Diversity Committee has been researching, studying and

presenting education at the Vascular Annual Meeting (VAM) regarding the science and discipline of leadership.

Committee members have written and published more than a dozen interviews of vascular surgeons about how to lead successfully. This new comprehensive course is the logical outgrowth of these past activities, aiming to accelerate the participants’ career advancement and leadership roles in vascular societies like the SVS. The SVS Executive Board embraced the concept, and with collaboration and support from the Vascular and Endovascular Surgery Society and the Society for Clinical Vascular Surgery, the Leadership Development Program was born. “We want to help our community of vascular surgeons make the most positive impact possible in our specialty, their workplaces and communities and other areas of importance in their lives,” said Kim Hodgson, MD, SVS president. “My only regret is that this kind of program was not in place early in my career, so I will be learning from this program as much as I can as well.”

The Leadership and Diversity Committee selected vascular surgeons who have five to 10 years in practice from among the applications received. Course activities will include self-study, monthly online education and a twoday live leadership skills course, plus recognition at the 2020 iteration of VAM in June. The program runs Jan. 6 to June 18.

The Inaugural Cohort is a diverse mix of vascular surgeons in various practice settings, locations and other key demographics, including:

Trissa Babrowski, Charles Bailey, Dawn Coleman, Young Erben, Uwe Fischer, Kristina Giles, Roan Glocker, Justin Hurie, Nii-Kaby Kabutey, Michael Lieb, Shang Loh, Fatemh Malekpour and Michael McNally.

Also: Nicolas Mouawad, Mark Patterson, Benjamin Pearce, Danielle Pineda, Ash Raju, Jean Marie Ruddy, Evan Ryer, Jonathan Schor, Marcus Semel, Megan Tracci, Mohamed Zayed and Jill Zink.

FEBRUARY 2020

VASCULARSPECIALISTONLINE.COM • 17

NEWS FROM SVS

Wider VAM 2020 schedule unveiled

Asf hin Skibba, MD; Knoxville, Tennessee Brigitte Smith, MD; Salt Lake City, Utah Gregory Stanley, MD; Charlotte, North Carolina Charles Thompson, MD; Orlando, Florida Austin Wagner, DO, RPVI; North Kansas City, Missouri Sean Wengerter, MD, RPVI; Pomona, New York

B

eyond the always popular scientific sessions detailing research and presented from the podium, the Vascular Annual Meeting (VAM) also stages more than 25 other educational offerings, many to smaller audiences and with questions and answers encouraged.

Details are available in the online schedule at vascular.org/VAM2020. The below lists some of the presentations.

Postgraduate Courses, all on Wednesday, June 17

“Modern challenges in hemodialysis access,” including complex access configurations, nonprosthetic alternatives, access in morbidly obese patients and techniques for access salvage “Venous updates, controversies and debates in 2020: Where do we stand?” in collaboration with the American Venous Forum “Pediatric vascular care,” including AV access in children, sports-related DVT/compressive syndromes in children, pediatric aortic injury and congenital vascular abnormalities “Clinical update in the management of aortic dissections,” which will include an update on SVS Reporting Standards for aortic dissection Ask the Experts

“Mentorship in vascular surgery: Insights from various environments and different stakeholders” “Explanting endografts: When, why, how?”

“Current controversies in endovascular therapy for PAD” “Mesenteric artery revascularization” “Type 2 endoleak management” Concurrent Sessions, June 17 to 20 Each 90 minutes long:

“Digital health advancements in vascular surgery” “Clinical trials: Tools for planning, executing and communicating” “Occupational hazards to the vascular surgeon” “Wound complications and management in vascular surgery,” in collaboration with Americas Hernia Society “Thoracic outlet syndrome” “Government and our vascular lives” Breakfast Sessions, from 6:30 to 8 a.m. Friday and Saturday

“Spine exposure for the vascular surgeon” “Management of acute deep vein thrombosis” “Congratulations, we have selected you as our next leaders: Lessons learned from vascular leaders at all levels” “Back to the future: Patient selection and techniques in open infrainguinal revascularization” “Combating challenges to vascular surgeon wellness,” this year’s presentation on surgeon wellness presented by the SVS Wellness Task Force “Publish and flourish,” a joint presentation by the editors of the Journal of Vascular Surgery, the European Journal of Vascular and Endovascular Surgery and JAMA Surgery 18 • VASCULAR SPECIALIST

Affiliate—PAs

Welcome to our new members T he Society for Vascular Surgery welcomes these new members, who joined the Society during the second half of 2019.

The first membership deadline for 2020 is March 1. Learn more at vsweb.org/JOIN. Active Members

Mohammed Al-Omran, MD; Toronto, Ontario Andrew Barleben, MD, MPH; La Jolla, California Jennifer Avise, MD; Stanford, California Julia Boll, MD; Nashville, Tennessee Jason Crowner, MD; Chapel Hill, North Carolina Sebastian DiDato, MD; Concord, New Hampshire Vincent Digiovanni, DO; Wynnewood, Pennsylvania David Dockray, MD; Ashland, Kentucky Sammy Eghbalieh, MD, FACS, FSVS, RPVI; Sherman Oaks, California James Evan, MD; Johnson City, Tennessee Behzad Farivar, MD; Cleveland, Ohio Christopher Goltz, MD; Flint, Michigan Daniel Han, MD; New York Sae Hee Ko, MD; Santa Rosa, California Kathryn Howe, MD, PhD, FRCSC; Toronto, Ontario ShihYau Grace Huang, MD, MSc; New Brunswick, New Jersey Ahmed Kayssi, MD; Toronto, Ontario Misaki Kiguchi, MD, MBA; Washington, D.C. Shyam Krishnan, MD; McLean, Virginia Norman Kumins, MD; Beachwood, Ohio Shameem Kunhammed, MD; Marshfield, Wisconsin Nathan Liang, MD; Pittsburgh, Pennsylvania Layla Lucas, MD; Tucson, Arizona Anuj Mahajan, MD, FACS; Johns Creek, Georgia Pallavi Manvar-Singh, MD; Bay Shore, New York Brent Marsden, MD; Indianapolis, Indiana Loren Masterson, MD; Akron, Ohio Edward McGillicuddy, MD; Lewiston, Maine Michael McNally, MD; Knoxville, Tennessee Roy Miler, MD; Cleveland, Ohio Sudhan Nagarajan, MD, RPVI; Gadsden, Alabama Garri Pasklinsky, MD, RPVI, FACS; West Islip, New York Moqueet Qureshi, MD; Carmichael, California Pritham Reddy, MD, FACS, RVT; Southfield, Michigan Kenton Rommens, MD, FRCSC; Alberta, Ottawa Jason Ryan, MD; Kalamazoo, Michigan Greg Salzler, MD, MS; Danville, Pennsylvania Saadat Shariff, MD; Bronx, New York Mrinal Shukla, MD; Augusta, Georgia

L. Nicole Brackbill, PA-C; Lancaster, Pennsylvania Shawna Bucchere, PA-C; South Weymouth, Massachusetts Megan Butzke, PA-C; Evanston, Illinois Megan Collins, PA-C; Winchester, Virginia Anika Cox, PA-C, MPH; Dallas, Texas Erin Dohlman, PA-C; West Des Moines, Iowa Bryan Foster, PA-C; West Des Moines, Iowa Richard Garibaldi, PA-C; Palm Beach Gardens, Florida Elizabeth Guerin, PA-C; Hartford, Connecticut Stephen Ingram, PA-C; Austin, Texas Krysten Kalutkiewicz, PA-C; Manchester, New Hampshire Jen Landis, PA-C; Nashville, Tennessee Kristin Leavy, PA-C, MSPAS; Bronx, New York Diane Less, PA-C; Chicago, Illinois Jaklyn Lynch, PA-C; Glencoe, Illinois Chia Yuan Mao, PA-C; Falls Church, Virginia Robert Montgomery, PA-C; Eau Claire, Wisconsin Sherry Mullins, PA-C; San Antonio, Texas Kelsey Nehrig, PA-C; Shawnee, Kansas Adam Peckinpaugh, PA-C; Maumee, Ohio David Roberts, PA-C; Fort Pierce, Florida Marisol Schultheis, PA-C; Ellenton, Florida Scott Shultz, PA-C; Martinsburg, West Virginia Kimberly Silverman, PA-C; Rochester, New York Sarah Soifert, PA-C; Manchester, New Hampshire Ann-Marie Williams, PA-C; Stratford, Connecticut Affiliate

Rachel Brobst, CRNP; Stroudsburg, Pennsylvania Christian Clark, FNP-C; Roanoke, Virginia Bianca Cutler, CRNP, FNP-C; Washington, D.C. Melonie Durkin, APRN; Fort Pierce, Florida Shanna Freeman, MSN, NP-C; Los Angeles, California Julia Gyampoh, AG-ACNP-BC, ANE, MSN, RN; Zion Crossroads, Virginia Jordan Jaynes, FNP-C; Asheville, North Carolina Jessica Perez, ARNP; Jacksonville, Florida Jill Sommerset, RVT; Vancouver, Wash.

Kathryn Staifer, MSN, APRN-CNP; Toledo, Ohio Elizabeth Wight, NP; Rochester, New York International

Oleksiy Gudz, MD, PhD; Ivano-Frankivsk, Ukraine Albert Kota, MS, MCh; Vellore, India Patrick Louie Maglaya, MD, DPBTCVS; Quezon City, Philippines Leonardo Martins Mota de Morais, MD; Federal District, Brazil Maarit Venermo, MD, PhD; Finland Angel Octavio Zambrano Macias, Jr., MD; Buenos Aires, Argentina Associate

Bo Liu, PhD; Madison, Wisconsin FEBRUARY 2020

NEWS FROM SVS

Bridging the gap to future surgical success: Surgeon-coaches can help colleagues thrive

BY MAX WOHLAUER, MD

W

hat is surgical coaching?

The Institute for Life Coach Training defines coaching as a professional relationship that helps people produce extraordinary results in their lives, careers, businesses or organizations, helping them to bridge the gap between where they are now and where they want to be. The International Coach Federation defines coaching as a cooperative process between a coach and their “coachees,” who participate in a thought-provoking and creative process that inspires them to maximize their personal and professional potential.

Coaching has been applied to sport, music and business to optimize performance. It is worth noting that surgical performance involves technical, cognitive and leadership skills that are all coachable activities.

Furthermore, improving a surgeon’s performance can improve quality and safety across the field in general.

Programs that have stepped in to fill this niche include the Wisconsin Surgical Coaching Program (WSCP).

Founded by Caprice Greenberg, MD, and led by her and a team of surgical colleagues at University of Wisconsin, the WSCP was developed to teach surgeons to become coaches to improve the technical performance of other surgeons.

The WSCP developed three distinct activities of a coach: goalsetting, encouraging/motivating and developing/guiding.

Coaching for surgeons targets performance improvement in three domains: technical skill, cognitive skill and non-technical skill. Examples of non-technical skills include situational awareness and mental readiness.

Judgment and decision-making are examples of cognitive skills. With the American Board of Surgery implementing lifelong learning, self-assessment and evaluation of performance as requirements for maintenance of certification, surgical coaching is emerging as an effective strategy to meet these requirements.

The WSCP developed a peer coaching program for practicing surgeons and, by doing so, uncovered insightful strategies to optimize performance.

Additionally, coaching has been shown to help improve quality of life.

FEBRUARY 2020

MAX WOHLAUER

What is peer coaching?

Peer coaching is a type of coaching in which peers at a similar level of knowledge engage in an equal, non-competitive relationship, a particularly effective strategy for surgeons in practice.

A peer coach facilitates selfreflection, offers constructive feedback, guides action planning and provides support for implementing and then evaluating changes in practice.

novices try to understand the activity and focus on avoiding making a mistake. With additional experience, in the middle phase of learning, mistakes become less frequent and movements smoother, and the movements become automatic.

As a result of more automated movements, the learners lose conscious control over execution of the skill, making intentional modifications more difficult. Coaches can be particularly effective at this level. Expert performers have reached a level of training and can reproduce their superior performance in everyday practice.

What are the barriers and benefits to seeking a coach?

Atul Gawande described the awkward moment he introduced his patient to his surgical coach. The willingness to receive help is outside the cultural norm for most surgeons, who are expected to show strength rather than vulnerability.

The desire to optimize performance ultimately overcomes the fear of showing vulnerability in coaching program participants. Having a coach is a way for surgeons to engage in deliberate practice in a safe space, free from the vulnerability of the behavior being judged by patients or peers.

In addition to optimizing performance, coaching can improve well-being. In a recent study, participants in a professional coaching program showed a significant reduction in emotional exhaustion and overall symptoms of burnout. Progress is inevitable, and the field of vascular surgery is moving forward rapidly.

Whether optimizing surgical performance or enhancing well-being, coaching is an established technique in order to spark professional development. Why haven’t we thought of this sooner?

Max Wohlauer is a member of the SVS Wellness Task Force.

What is the process for becoming an expert?

Nobody becomes an expert without extensive, exhausting practice. At the same time, putting in the sweat equity does not guarantee that one becomes an expert.

While the most frequent explanation is that, on a professional level, skill acquisition is limited by an individual’s innate talent, Swedish psychologist K. Anders Ericsson describes the importance of deliberate practice in professional development.

Ericsson’s research suggests that highly motivated professionals have more influence on elevating their attained performance levels than was previously imagined. Skill acquisition is a conscientious and orderly process.

Expert performance is mediated by complex integrated systems of execution, monitoring, planning and analyzing performance. This makes deliberate practice an effective strategy to improve performance.

How does an average performer reach the level of expert?

During the first phase of learning,

VASCULARSPECIALISTONLINE.COM • 19

INNOVATION

Medical education requires a reboot in the digital age, argues stent-grafting pioneer large cohorts of individuals and stringently control for clinically phenotyped outcomes, or by mapping genetic overlap between different diseases involving shared pathogenic elements and comorbidity risks.”

Illustrating the idea of genetic phenotype mapping with an example, he cited a study published in Nature Genetics in 2018 by Rainer Malik of the Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany, et al that identified a genetic overlap between stroke and related vascular traits at 32 genome loci in 521,612 people. Some 22 of these loci were new to the designation “stroke risk.” This is one example of the “tremendous opportunities” afforded to researchers with access to large datasets, Dake said.

BY SUZIE MARSHALL

L

AS VEGAS—Medical education is confronted by huge opportunities with the coming of what has been termed the fourth industrial revolution—that of the intersection where “big biology and big medicine” meet “big data.”

Those were the sentiments of Michael Dake, MD, senior vice president at the University of Arizona Health Sciences in Tucson, Arizona, when he addressed delegates at the Vascular and Interventional Advances (VIVA) conference, Nov. 4–7, 2019, in Las Vegas in a keynote lecture entitled “The future of medicine and medical education: How do we prepare the next generation?”

“Big biology and big medicine is meeting big data,” said Dake, who is responsible for the integration of undergraduate and graduate education at his institution. “Some have called it the fourth industrial revolution, where we have an accelerated, exponential convergence of data science, physical science and life sciences.

These are creating enormous opportunities but also challenges—for all of us. Our main task as educators is to figure out how to integrate large-scale, multidisciplinary datasets into our education.”

He spoke of a fraught but fruitful future. “We are in a period of great innovation,” Dake went on. “There are tremendous opportunities, and these will continue to grow with technological advances that promise to impact clinical practice and transform medicine and medical education.

The pace of change is rapid; thinking outside the box is essential. The potential impact on medical education and medical care is enormous.”

Dake, known globally for pioneering imageguided therapies and novel approaches in interventional therapy in the fields of vascular imaging, venous thromboembolic disease, aortic aneurysms and dissection, talked about a key role for artificial intelligence (AI). “How do we drive precision medicine and data-driven healthcare into routine clinical practice?” he asked. “Where AI can really help in the future of healthcare,” he said, “is with merging these two dominant trends: precision medicine and digital medicine.”

Lower costs

Dake detailed how new technology platforms that use profiling, automation and computing to provide deep phenotyping and risk profiling will interact with the “expanded care space— wearables, sensors, telemedicine, social media and lifestyle metrics, data on consumer patient engagement—to enable remote monitoring of patient health status. This interaction will be mediated by machine learning algorithms.” The potential power of AI in this context, Dake said, is to provide analytics for improved decisions and clinical outcomes at lower cost.

Indeed, the cost of big data has decreased dramatically over the last decade. Showing a graph 20 • VASCULAR SPECIALIST

Not without hurdles

MICHAEL DAKE

plotting the cost of data relative to speed versus data consumption, Dake demonstrated that the cost of data per second has dropped from nearly $3 per Mbps in 2004 to less than $0.1 per Mbps by 2013, while data consumption per subscriber per month rose from less than 10MB a month in 2006 to 225MB a month in 2013. “We can feel confident that at least computation comes cheaply. All this big data certainly is not as expensive to process as it was years ago,” he said. “That is good for us.”

He continued: “Everyone in any healthcare centre or academic community is aware of the buzzwords around precision medicine. There is a lot of emphasis on deep phenotyping: taking largescale datasets, predicting complex traits and disease risk, whether it is by a variety of ‘omics’ that take

“We have limits to our individual abilities to multidimensionally evaluate data, we have limits to our sensory systems, cognitive experiences and perceptions, and limits to our objective decision-making. This is where AI, deep learning and machine learning can come to help us.”—Michael Dake

Yet, there are also several challenges presented by the emergence of big data, Dake conceded. “The problem with real world data,” he said, “is that it is, indeed, real world,” explaining how people analytics and large-scale databanks had blurred the boundaries between medical research, clinical care and daily life, rendering every monitored event as a potential data point, every individual as a data node and research asset. Social spaces are also becoming quantifiable, and with sufficient data, investigators could reveal increasingly predictable behavior and individual risk patterns. “This blurring of private and public spaces could lead to complex ethical and legal issues,” Dake commented, noting that consent, privacy, security and surveillance were factors society was “only beginning to address,” and that they would be “increasingly important as areas of focus.”

For AI, one of the key benefits is that it can overcome the bandwidth limits of humans, Dake noted. “There is currently a data deluge,” he said.

“Our cognitive bandwidth is certainly challenged and overwhelmed, but I think there is great promise in decision support, and ways that we really can impact the future of medical education for the better.”

Dake told the VIVA audience that society was on the cusp of the “era of cognitive computing and decision-support systems.” Using AI algorithms can help draw patterns and sense from such large datasets. “Clearly we have limits to individual expertise,” Dake said. “We have limits to our individual abilities to multidimensionally evaluate data, we have limits to our sensory systems, cognitive experiences and perceptions, and limits to our objective decision-making. This is where AI, deep learning and machine learning can come to help us.”

Envisioning the future of medicine as made possible by AI and big data, Dake predicted: “As we evolve from qualitative, descriptive information of variable quality and provenance to quantitative data of known provenance and validated quality, [we will] change from a complex ecosystem of Medical education continued on page 21 FEBRUARY 2020

CV DISEASE

'Cardiovascular disease at crossroads': Authors make call for definitive trial comparing prevention methods

BY BRYAN KAY

T

he prospect of death rates from cardiovascular disease once again ticking upward after more than a half century of decline has led to a call for a randomized trial comparing the two new—and distinct—approaches to prevention: precision medicine and the polypill method.

The argument was made in an opinion paper by Michael J. Joyner, MD, and Nigel Paneth, MD, published in JAMA: The Journal of the American Medical Association.

“These two conceptually different approaches should be compared using equivalent standards of measure in a randomized prevention trial so that physicians and health systems can implement the most effective strategy as soon as possible,” the authors wrote.

Joyner, of the department of anesthesiology and perioperative medicine, the Mayo Clinic, Rochester, Minnesota, and Paneth, of the departments of epidemiology and biostatistics at Michigan State University, College of Human Medicine, East Lansing, Michigan, penned the viewpoint, entitled “Cardiovascular disease prevention at a crossroads: Precision medicine or polypill?,” in light of evidence that disease death rates, having leveled off since 2016, “may even be

rising slightly.”

This, Joyner and Paneth argue, necessitates consideration of the next phase of how to address cardiovascular disease. “Currently, prevention options are to advocate broadly for primary prevention and to test for conventional risk factors and assign an estimated risk as the basis for treatment (secondary prevention),” they write.

“Although clinicians can continue to do what they have always done to encourage patients to adhere to traditional [cardiovascular disease] prevention strategies, a major crossroads in prevention has arrived with two very different options for moving forward.”

While several formulations have been suggested for polypill, they write, it commonly involves low doses of “off-patent statins and more than one class of antihypertensive agents, sometimes combined with low-dose aspirin, with the goal of

“A trial comparing precision medicine vs. the polypill will help determine whether an approach involving complexity vs. simplicity will be more effective in meeting the ongoing challenge of preventing [cardiovascular disease].”—Joyner and Paneth

Medical education Continued from page 20

largely unconnected data sources to an evolving, interconnected network of data sources for robust decisions and improved care.”

Digital Darwinism

“If you are teaching today what you were five years ago, either the field is dead or you are,” the father of modern linguistics Noam Chomsky famously said. Sharing this quote, Dake added, “Noam Chomsky is 95 years of age, and he is aware of this—so should we be.”

Dake highlighted a shift in medical education, from being science-centric in the 20th century, to becoming more data-centric between 2000 and the present day. Extrapolating this trend, he said that education will next become network-centric, stressing the importance of students gaining mastery of escalating complexity and massive data.

“There is a digital Darwinism looming,” Dake warned. “Understanding data structure and application to improve decisions and outcomes will FEBRUARY 2020

reducing elevated levels of lowdensity lipoprotein cholesterol and blood pressure.”

Precision medicine, meanwhile, “is a form of secondary prevention, adding genomic information to the array of tools available to health professionals to decide who, when and how to treat with the goal of preventing [cardiovascular disease],” Joyner and Paneth point out. The precision medicine approach is individualized and driven by measurement of risk factors like cholesterol, blood pressure and blood glucose levels, they add.

Both bear limitations, the authors went on.

For the polypill approach, these include overtreatment, exposing individuals at low risk to drugs with known adverse effects and the difficulties of going to market in the current pharma ecosystem. Yet, Joyner and Paneth write that initial reports suggest these factors are not insurmountable.

become a critical institutional competency. With major skill gaps and predicted personnel shortages, we are going to have to train a new cadre of data scientists­—both medical and nonmedical— and institutions that lack adequate computation infrastructure and are not committed to this training are going to suffer ‘cognitive starvation’ and relegation to competitive irrelevance.”

So how will medical education adapt to this demand? Dake outlined his thoughts on curricular emphasis in the 21st century, believing that knowledge capture and creation, not information retention, should be the priority, and that students should be taught to distinguish between information and knowledge.

He said that he would like to see future physicians have a deep understanding of probabilistic reasoning, as well as collaboration with and management of AI applications. Lastly, he underlined the importance of cultivating empathy and compassion in the next generation of doctors, emphasizing the “very real” issue of physician burnout, and advocating for a more holistic curriculum prioritizing students’ mental health.

“Potential limitations to the precision approach include marginal patient adherence with complex costly drug regimens, the costs of individual screening and patient case management, the fact that many events will occur in individuals deemed at lower risk, and the administrative burden (perhaps exacerbated by electronic medical records) associated with managing such efforts,” Joyner and Paneth observe.

The authors acknowledge the existence of a pair of trials—one a multinational study of polypill strategy that is primarily taking place in lesser-resourced countries, and another more modest-sized trial that took place in the state of Tennessee which they considered to be underpowered.

They argue, therefore, that a more definitive study with three intervention groups, both large and long enough to power key outcomes, is required.

“A trial comparing precision medicine vs. the polypill will help determine whether an approach involving complexity vs. simplicity will be more effective in meeting the ongoing challenge of preventing [cardiovascular disease],” they wrote in conclusion.

SOURCE: DOI:10.1001/ JAMA.2019.19026

The University of Arizona has implemented a program to “future-proof ” its graduates, Dake recounted, taking all of these factors into account.

The institution is following a health sciences strategic plan, comprised of 26 initiatives, which cover a range of topics, from reducing student debt, to increasing the number of nurses and primary care physicians, to also creating more flexible learning pathways.

While every institution will need to explore ways of tackling its own unique and specific challenges, Dake said, his keynote lecture could serve as a blueprint for building a comprehensive medical curriculum that is capable of reimagining the physicians of the future.

“Institutions should make every effort to take advantage of the strategic synergies that can arise by creating a virtuous cycle connecting education with research and patient care in a continuous feedback loop,” he concluded.

“The ultimate goal is the creation of a real-time learning health system, in which the practice and teaching environments learn from each other and are informed by research.”

VASCULARSPECIALISTONLINE.COM • 21

OPERATING ROOM

Integration of 3D imaging and optimized 3D robotic control set to be 'important' part of vascular surgery future

BY BRYAN KAY

N

EW YORK—The marriage of 3D imaging and robotics in hybrid operating suites promises to be a pivotal aspect of the future in vascular surgery—part of advances in the field that down the road will see surgeons look back on the static image era with a sense of puzzlement.

Those were among the sentiments delivered by Alan Lumsden, MD, the medical director of Houston Methodist DeBakey Heart & Vascular Center in Houston, during a presentation at VEITHsymposium in New York (Nov. 19–23, 2019) entitled, “Future advances in hybrid operating suites: What is on the horizon and beyond.”

“Robotics—we think—are going to be a very important part of this future,” he told delegates. “We are very excited that robotics [here at Houston Methodist], through the catheter platform, will start to be integrated into the imaging system.

“There is no point in having great 3D imaging if you don’t have great 3D control, or optimized 3D control if you don’t have 3D imaging. It’s the integration of these two things that are very important that you utilize,” he said, adding, “I think you’re going to see increasingly these remote control capabilities.”

Lumsden opened with what he

called a significant disclosure, drawing attention to his institution’s imaging partner, Siemens, with which it formed a partnership to create its translational imaging research center, and Corindus Vascular, partner on its catheter robot.

Moving on to the subject at hand, he spoke of the importance to Houston Methodist of the capabilities these advances bring. “In an academic center like ours, it is important to be able to record, it’s important to be able to broadcast, and that’s something you need to consider at the time you’re actually planning these,” Lumsden explained.

Recalling his stint at Emory University Health Center in Atlanta, he described how proud he and the team there were of the operating room at that point in time.

But with the passage of time, the prospect of great leaps forward emerges. “What really formed vascular surgery was real-time angiographic imaging,” Lumsden went on. “With an operating room

ALAN LUMSDEN

that allowed surgeons to get the imaging, the platform was formed for the next generation of advances.”

He advised his colleagues in the audience who may be starting to build such suites that planning for procedures now starts with preprocedure acquisition of imaging, such as optimizing CT (computerized tomography) scans.

Lumsden went on: “Understanding how these images are acquired is going to be very important. Because no longer is it just the CT scan you

“There is no point in having great 3D imaging if you don’t have great 3D control, or optimized 3D control if you don’t have 3D imaging.”—Alan Lumsden

look up on the wall and you figure out how you’re going to do an open aortic aneurysm. We are actively engaging and fusing these images. So if the preoperative imaging is not of a high quality, you can’t get these nice holograms that you’ve seen, and you can’t get optimal fusion.

“And so getting involved in optimizing the preoperative imaging is very important. And one of the things we’ve been very interested in is dynamic MR [magnetic resonance].

The idea that we take such a dynamic structure as the vascular system and use static images when we look at aortic dissection: We’ll look back on this and think that it’s crazy. We work on the most dynamic structures that exist in the cardiovascular system. I urge you to start pushing whoever is controlling the preoperative imaging into acquiring dynamic images.”

Before finishing, Lumsden spoke briefly of another development in the imaging arena arousing his team’s interest. “The other thing that’s happened in the imaging revolution that we’re really interested in is socalled cinematic rendering,” he said.

“Forgive me for this but ultrasound, CT scans—they were designed basically to help magicians try to interpret them,” adding, “What’s happened now is you’ve started to create anatomical rendering of these images.”

FDA keeps close watch on heparin dosing reports

BY BRYAN KAY

T

he Food and Drug Administration (FDA) is closely monitoring reports of higher than usual doses of heparin being required to achieve activated clotting times (ACT) during cardiac procedures.

The FDA “is aware of spontaneous adverse event reports submitted to FDA’s MedWatch” and “continues to closely monitor adverse event reports for heparin,” the agency said in a statement sent to Vascular Specialist.

Clinicians started to notice difficulty in reaching optimal ACT with the widely used anticoagulant earlier this year. “Reports describing a requirement of higher than usual doses of heparin, or the opposite, of bleeding following heparin administration, are not historically unusual for this drug,” the FDA statement continued.

“FDA review of these reports is ongoing, but to date, the reporting has not had a consistent pattern suggesting deficient product quality. FDA laboratory testing of finished heparin product has 22 • VASCULAR SPECIALIST

been conducted when samples were provided. All samples tested to date have been within United States Pharmacopeia (USP) specification.

“FDA continues to execute a robust surveillance program for heparin—including surveillance of spontaneous adverse event reports and quality testing of imported crude heparin, active pharmaceutical ingredient (API), and finished dosage forms—from all source countries to make sure the drugs meet quality standards.”

Since being introduced into clinical practice more than 70 years ago, unfractionated heparin has been administered during non-cardiac arterial procedures in order to prevent thromboembolic complications. Vascular surgeons and interventional radiologists use a standardized bolus of 5,000IU of heparin during non-cardiac arterial procedures. This stands in stark contrast to cardiac interventions, where heparin is used in higher dosages.

The federal agency said clinicians who suspect product quality defects to file a report to its MedWatch program and to manufacturers.

The FDA believes that “variability in heparin response may be attributed to individual patient or healthcare system factors, and not a heparin product quality defect.”

Last year, researchers found that implementing a method of heparinization guided ACT—with a goal of 200–220 seconds—provides a “promising” increase in safety and may decrease risk of thromboembolic events while not increasing bleeding complications during vascular procedures.

Arno Wiersema, MD, a vascular surgeon in Hoorn, the Netherlands, presented the findings of the pilot ACTION trial, stating he and his colleagues “believe it is time to upgrade one of the foundations of vascular surgery to optimize patient care and to prove that ACT-guided heparinization results in far fewer thromboembolic complications.”

Speaking at Charing Cross (CX) in April last year, Wiersema said, “The success of open and endovascular arterial interventions depends on a delicate balance between coagulation and anticoagulation.”

FEBRUARY 2020

VASCULAR PRACTICE

Presence of outpatient wound care center leads to significant decrease in amputation rates, says Stanford specialist

BY BRYAN KAY

N

EW YORK—The opening of an outpatient wound care center has a positive impact on affiliated vascular surgery practice, with a significant increase in the number of peripheral interventions and a significant decrease in amputation rates, attendees of the 2019 VEITHsymposium (Nov. 19–23) were told during a session on issues related to vascular outpatient centers, office-based labs and medical ethics.

In addition, Venita Chandra, MD, clinical associate professor of vascular surgery at Stanford University School of Medicine, Stanford, California, outlined several other potentially positive impacts: lower length of stay, and lower mortality, complication and readmission rates. She was giving a talk highlighting the advantages to a vascular surgery practice of having a wound care center.

These conclusions are derived from a study carried out by Chandra et al into a now six-year-old wound care center opened at her institution that analyzed data from three years before its doors swung open and three years afterward.

Setting the scene, she drew attention to the scale of the problem at hand: “The incredibly large number of non-healing chronic wounds has a huge impact in not just United States costs in healthcare but worldwide,” Chandra said.

By way of example, she made reference to those patients whose limbs are under threat as “perhaps the most complicated and complex that you deal with and require all of our resources. Many experts in our division and within our field come up with

VENITA CHANDRA

strategies to help reduce the risk of amputation and help those complex patients. Almost all of them involve multidisciplinary teams and are shown to significantly decrease amputation rates.

Wound care, however, with standardized weekly debridement and management of offloading and edema, has clearly been shown to be a key aspect of that multidisciplinary [approach].”

The payoff may lurk down the road with potential downstream revenue impacts in a vascular surgery practice, said Chandra.

The Stanford study produced some interesting

findings. “In the cohort after the wound care center opened, we had a 20% overall increase in volume of cases in that period,” Chandra went on. “However, if you specifically look at the percentage of lower extremity interventions, the increase was 64%, a statistically significant increase.”

She continued: “Not surprisingly, over this period of time we had an increasing number of patients treated for diabetic foot ulcers and incidentally a decrease in the relative percentage of patients treated for claudication. We essentially started treating critical limb ischemia more often.”

In terms of outcomes, the institution’s minor amputation rate went up while its one-year amputation rate went down.

“When we did multivariable analysis, adjusting for demographics and co-morbidities and indications, you can see there remains a statistically significant impact of the opening of a wound care center on our amputation rates,” Chandra explained.

The data also yielded intriguing findings on referral patterns, she said. “What we found was actually only 35% of the patients started in the wound care center came to the vascular surgery practice, and actually 65% seen first in the vascular surgery practice [were] sent to the wound care center.”

Chandra then turned to findings not covered specifically by the study. Comparing Stanford to other academic hospitals in California, she said “we have one of the lowest lengths of stay and the lowest 30-day readmission rate for patients who are being treated for lowerextremity revascularizations.”

Initial results from first-in-man trial of prosthetic VenoValve demonstrate promise, investigator tells SAVS meeting

BY BRYAN KAY

P

ALM BEACH, Fla.—The initial results of an ongoing first-in-man study in Colombia that saw the implantation of a prosthetic venous valve in 15 patients appear promising, with improvement in clinical outcomes and quality of life evaluation, delegates at the Southern Association for Vascular Surgery (SAVS) annual meeting ( Jan. 8–11) heard.

There was also a marked reduction in pain among a complex and difficultto-treat patient population, trial investigator Jorge H. Ulloa, MD, of Universidad de los Andes in Bogota, Colombia, told the scientific session.

In the United States, 2.4 million people are affected with chronic venous insufficiency, Ulloa et al noted in their abstract. One million are

FEBRUARY 2020

treated for venous stasis ulcers, with few options available to patients who develop post-thrombotic disease secondary to deep venous reflux.

The new venous prosthetic valve, known as the VenoValve, is a combination of a stainless-steel frame and porcine aortic monocusp leaflet, and was developed to be surgically implanted into the deep venous system—the femoral popliteal vein— of patients with C5–C6 disease.

The endpoints of the study were to evaluate safety, “which is very important in a first-in-man study,” said Ulloa. He also listed “reflux by duplex ultrasound and femoral popliteal vein as well as clinical assessment by a vascular surgeon. Also: pain scoring, the VAS [visual analog scale] score and quality of life outcomes were evaluated by the patients during this study.”

In the trial, the researchers included actual venous reflux greater than one second in C5 and C6 patients.

Ulloa went on to explain that just three weeks prior to his presentation at the SAVS podium, the research team had completed its 11th case.

He drew attention to six patients who averaged at least six months of follow-up. “We have seen a 40% reduction in reflux, a 61% improvement in [the] VCSS [Venous Clinical Severity Score] score or have significant clinical improvement and all patients at six months have noted a significant reduction in their pain by the VAS score. Patient six increased the VAS and VCSS due to poor anticoagulation therapy and by lack of compliance.”

Ulloa continued: “All cases have demonstrated a marked improvement in the reflux, with most of them

reaching baseline except in patient six. Significant clinical improvements were also observed. Many patients went from moderate to severe to mild disease by clinical assessment.”

Summing up, Ulloa concluded, “Our results of this feasibility study are on the way. We will evolve to a second phase, which will include a pivotal trial with more recruiting centers and increasing the number of cases to assess the performance of this prosthetic valve as an option for patients for C4B to C6 disease. Reflux quality calculations will be included in the next phase.”

In discussion, Seshadri Raju, MD, of the RANE Center in Jackson, Mississippi, praised the investigators but identified a flaw. “One criticism of the study is that clinical improvement data collection seems to have been rather rudimentary,” he said.

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