12 COMMENT System outage alert Cyberattack transports Medicine back to the paper age
Vol.17 No.02 FEBRUARY 2021
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Featured in this issue:
HOW TO SUCCEED FOR THE ASPIRING ONE PERCENTER
71.6%
of the calls involved assisting in the open surgical setting
26.1%
involves an endovascular intervention
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FIREFIGHTERS CRUCIAL VASCULAR ASSISTANCE
LYMPHEDEMA SEVERE CASES OF END-STAGE DISEASE
Appropriate use BY BRYAN KAY
ATHERECTOMY Are high reimbursement amounts incentivizing inappropriate medical provider care? BY BRYAN KAY
UTILIZATION RATES
REIMBURSEMENT-PER-PROCEDURE for femoropopliteal atherectomy and stenting has increased at about the same rate for national providers as a whole and for vascular surgeons specifically— at the same time as much higher rates were recorded for radiologists and general surgeons, an analysis of Medicare reimbursement trends from
2012–2017 demonstrates. The data, presented by Matthew Haffner, MD, a general surgery resident at St. Barnabas Medical Center in Livingston, New Jersey, at the 2021 Vascular & Endovascular Surgery Society (VESS) virtual winter annual meeting ( Jan. 21–24), set out to answer the question: Are high reimbursement amounts possibly continued on page 6
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GUEST EDITORIAL
How to succeed in vascular surgery: A guide for the aspiring outlier BY ANDREW J. MELTZER, MD
Disclaimer: The views expressed here do not reflect those of Mayo Clinic, the Society for Vascular Surgery, Vascular Specialist, or even the author, for that matter. It’s satirical— everybody relax. Our recent paper, “Practice patterns of vascular surgery’s 1%” created a bit of a stir on social media and the medical blogosphere (see news story on page seven). In the event you’ve been too busy performing indicated and appropriate surgical procedures to keep abreast of every #VascTwitter discussion, permit me to provide an update: 1% of U.S. vascular surgeons account for 15% of Medicare reimbursement to our specialty.
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he average vascular surgeon (excuse the oxymoron) receives $271,000 in Medicare payments annually. Meanwhile, the most highly reimbursed 31 surgeons—“1%” of the roughly 3,100 vascular surgeons in the U.S.—receives an average of $3.1 million in annual Medicare reimbursement. This is a staggering statistic. Presumably, at this point you’re all asking the same questions: Who are these elite practitioners of our trade? How do I join this illustrious fraternity? (It does appear to be exclusively male at this point.) How do I increase my Medicare reimbursement to 10 times that of my peers? And so forth. The devil, of course, is in the details. As one might imagine, you can’t join the 1% just by working harder, practicing medicine in an ethical and appropriate manner as you currently do. The highest-earning members of our specialty have dramatically different practice patterns to the “average vascular surgeon” (again, my apologies). While we, the 99%, toil away in the hospital, the elites spend their days in luxurious outpatient endovascular suites. While we struggle to make ends meet with our inpatient evaluation and management (E&M) and open
VASCULAR SPECIALIST Medical Editor Malachi Sheahan III, MD Associate Medical Editors Bernadette Aulivola, MD, O. William Brown, MD, Elliot L. Chaikof, MD, PhD, Carlo Dall’Olmo, MD, Alan M. Dietzek, MD, RPVI, FACS, Professor Hans-Henning Eckstein, MD, John F. Eidt, MD, Robert Fitridge, MD, Dennis R. Gable, MD, Linda Harris, MD, Krishna Jain, MD, Larry Kraiss, MD, Joann Lohr, MD, James McKinsey, MD, Joseph Mills, MD, Erica L. Mitchell, MD, MEd, FACS, Leila Mureebe, MD, Frank Pomposelli, MD, David Rigberg, MD, Clifford Sales, MD, Bhagwan Satiani, MD, Larry Scher, MD, Marc Schermerhorn, MD, Murray L. Shames, MD, Niten Singh, MD, Frank J. Veith, MD, Robert Eugene Zierler, MD Resident/Fellow Editor Laura Marie Drudi, MD Executive Director SVS Kenneth M. Slaw, PhD Director of Membership, Marketing and Communications Angela Taylor Managing Editor SVS Beth Bales
2 • Vascular Specialist
surgery, the 1% are completely immersed in the treatment of peripheral arterial “disease” with atherectomy. For the uneducated and uninitiated, peripheral arterial “disease” (PA“D”) primarily refers to preclinical claudication. Often manifest only as a subjectively weak pedal pulse, this condition requires expeditious intervention to prevent the late sequelae of a normal ankle-brachial index (ABI) measurement.
interventions! If you are unclear as to why this is the case, it is imperative that you familiarize yourself with the overwhelming body of evidence to support its use. Every single study has confirmed that atherectomy reimburses better than other techniques of comparable or superior effectiveness. An unwavering commitment to this clinically effective-ish technology garnered these 31 surgeons $60 million in atherectomy reimbursement in a single year. Think of that the next time you are in the middle of a distal bypass, harvesting arm vein for rubles! The 1% are so consumed with the treatment of PA“D” that they barely have time to engage in the Performance and Interpretation of Noninvasive Vascular Studies of Questionable Necessity (PINVSQN). As everyone knows, PINVSQN was heretofore the only means by which properly motivated members of vascular surgery’s working class could ascend to the 1%. We all remember those wonderful Horatio Alger tales from our youth in which an upstart vascular surgeon was able to build a PINVSQN practice so robust that he one day rose to become famous in our field. Alas, those days are gone. Declining reimbursement and increasing regulatory requirements have severely curtailed the billing potential of the noninvasive vascular laboratory. While interpretation of these studies may account for 24% of your total reimbursement from Medicare, the 1% can’t be bothered with such mundane pursuits.
One percenters Speaking of atherectomy, this technology essentially defines the 1%. Perhaps you occasionally employ one of these magical devices in your efforts to treat selected patients. You are not alone; the data show that selective atherectomy use is somewhat commonplace among the proletariat. Meanwhile, the 1% utilizes atherectomy in 80% of peripheral Andrew J. Meltzer
Trailblazers Even venous procedures, which have historically provided easy access to an exciting career in overutilization, are eschewed by the 1%. After all, the typical Medicare beneficiary only has four veins that can be ablated in the name of bilateral lower-extremity edema mitigation. Furthermore, as we have previously reported in the Journal of Vascular Surgery, providers without any formal training in vascular disease dominate the landscape of endovenous ablation overuse. These trail-breaking dermatologists, anesthesiologists, and semi-retired cardiac surgeons are working night and day to limit the global supply of great continued on page 4
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February 2021
EXTREMITIES
Upper-extremity vascular injuries associated with ‘increased prevalence’ of nerve deficits BY BRYAN KAY
Vascular injuries of the upper extremity are associated with a lower rate of limb loss but have an increased prevalence of nerve deficits after trauma, a new analysis comparing vascular trauma of the extremities reveals. THE INVESTIGATORS BEHIND the study—delivered at the Vascular & Endovascular Surgery Society (VESS) annual winter meeting ( Jan. 21–24)—set out to fill a gap in the peripheral vascular trauma literature, particularly with regard to upper-extremity injuries.
“The vast majority of these investigations focuses on trauma to the lower-extremity vasculature, despite the fact that upper-extremity arterial injuries comprise 30–40% of all vascular extremity injuries,” says Lindsay Gallo, the firstnamed author on the research team from Emory University in Atlanta that carried out the analysis. “Peripheral vascular trauma is frequently associated with concordant injuries, and thus presents with unique challenges to injury management,” explained Gallo, a fourth-year medical student at Emory. “Possibly because of these complex injury patterns, survivors often suffer poor functional outcomes and long-term disability.” The researchers delved into a level I trauma center’s registry to directly compare injury characteristics, surgical interventions and functional outcomes of upper- and lower-extremity vascular injuries. They performed a retrospective analysis of all patients aged 18 and over who were diagnosed with traumatic peripheral vascular injuries requiring surgical intervention between January 2011 and December 2019. Indications for intervention included active bleeding or ischemia of the extremity. A total of 535 patients were included,
with 234 (43.8%) having undergone upperextremity repair. The data revealed that patients with upper-extremity injuries were more likely to be female (16.7% vs. 9%; p=0.007), have a pre-hospital tourniquet applied (21.8% vs. 12%; p=0.002), have associated nerve injuries (40.2% vs. 4.7%; p<0.0001), or present with bleeding (76.1% vs. 64.1%; p=0.002). However, vascular injuries of the upper extremity were less commonly associated with concomitant fractures (25.6% vs. 39.9%; p=0.0006). In terms of operative management, injuries to the upper extremity were more likely to be managed with vessel ligation (38% vs. 17.6%; p<0.0001), and less likely to be managed with concomitant fasciotomies (13.3% vs. 56.5%; p<0.0001), the authors demonstrated. Postoperatively, upper-extremity injuries were associated with persistent nerve deficits (21.7% vs.
“Survivors often suffer poor functional outcomes and longterm disability”— Lindsay Gallo
10%; p=0.0002), while those of the lower extremity had a higher incidence of 30day limb loss (5.7% vs. 1.3%; p=0.008), the researchers found. There were no significant differences in mortality, unplanned vascular reinterventions, or 30day readmissions, they added. “Upper-extremity vascular injuries were more likely to present with active bleeding and preoperative nerve deficits—and more frequently managed with vessel ligation. Upper-extremity injuries are associated with a lower limb-loss rate, but have an increased prevalence of nerve deficits after trauma,” the group concluded. Summarizing, Gallo ruminated on why such functional deficits are seen. “It’s possible that because upper-extremity vascular injuries less frequently present with ischemia and have lower rates of limb loss, there may be a delay in diagnosis, which could affect functional outcomes,” she said. “The complex presenting injury patterns resulting from the concordant injuries seen with peripheral vascular trauma may also contribute to these functional deficits. Regardless, it’s paramount to maintain a high level of suspicion preoperatively and intraoperatively to identify the associated nerve injuries and to improve long-term functional outcomes.”
NEWS FROM SVS
SVS Foundation’s new initiative to address disparities in vascular health
grant project in Oklahoma. Working directly with the large Native American population there, the emphasis will be on peripheral arterial disease (PAD). Podiatrists, wound care specialists, nurses and others are included in the project. The SVS Foundation anticipates the development of additional pilot projects in phase one. Future phases are aimed towards providing wound care and the full spectrum of vascular care, with the intent of engaging vascular surgeons to work alongside other health professionals to highlight factors that contribute to PAD.
BY BETH BALES
Significant disparities in healthcare services in the United States result in unnecessary limb loss, stroke and death. Vascular health professionals are developing new programs to address these inequities, through the Society for Vascular Surgery (SVS) Foundation. THE SVS FOUNDATION VOLUNTEERS IN SERVICE To All (VISTA) program will provide outreach, screening and other resources to those who are impacted by lack of access, inadequate resources and/or distance from modern healthcare facilities. Many SVS members have expressed an interest in addressing disparities in care. Building on the Foundation’s successful grant programs for community awareness and prevention, VISTA will provide opportunities for members to make a direct impact. This program focuses on bringing vascular care to areas of need—particularly underserved populations, e.g., African Americans, Hispanics, Native Americans and others who lack access due to low socioeconomic status. VISTA is being implemented in phases, with the first phase focusing on awareness, education and prevention through pilot projects. The first pilot project has been approved and builds on a previous Community Awareness and Prevention Program February 2021
How can you 'Lend a Hand, Save a Leg' now? •R espond to the upcoming call for volunteers to staff a VISTA Steering Committee subcommittee. For information about the committees and how to apply, please contact the Foundation at SVSFoundation@vascularsociety.org. We ask that our volunteers also support the Foundation through a donation (of any amount) to the SVS Foundation. Earmark your gift for awareness and prevention to make an immediate impact. • Make a contribution to the SVS Foundation and earmark it for awareness and prevention to help plant the seeds for future outreach. • Respond to future Foundation calls for support and participation in addressing disparities in vascular care in underserved areas. For more information, please contact the SVS Foundation at SVSFoundation@vascularsociety.org. And remember, Please Lend a Hand (or give a dollar) and Save a Leg.
vascularspecialistonline.com • 3
VASCULAR PRACTICE
How to succeed in vascular surgery: A guide for the aspiring outlier Continued from page 2
saphenous vein for future use. Another reason that the 1% remains comparatively disinterested in veins is the fact that veins accrue no plaque and cannot be atherectomized. Or can they? If you just looked for a Current Procedural Terminology (CPT) code to check the reimbursement for “venous atherectomy,” you are well on your way to joining the 1%. I salute you. Furthermore, if you hope to join this esteemed group, you’ll have to stop performing carotid endarterectomies and repairing juxtarenal aneurysms immediately. The reimbursement for these surgeries is inadequate to justify your time. The 1% obtains just 0.5%
In these days of oversight and transparency, is it safe and wise to aspire to such affluence? Absolutely, my ambitious colleague! of their total Medicare reimbursement from open surgery, having abandoned these more durable procedures for more ephemeral interventions with truncated global periods. And lastly, while our most recent study did not specifically address this issue, recommending supervised exercise therapy to your claudicants will condemn you and your heirs to lives of poverty and anonymity. Surely by this point you are wondering if your efforts to join the 1% will jeopardize your reputation. In these days of oversight and transparency, is it safe and wise to aspire to such affluence? Absolutely, my ambitious colleague! You have nothing to fear. Our fee-for-service model is as strong as ever, and this “value” craze will disappear, like a previously normal outflow vessel after atherectomy.
Anti-capitalists The Ivory Tower Academics will criticize your preventative transpedal atherectomy for pre-claudication. You must learn to ignore these anti-capitalists! Fortunately, their collective attention is easily diverted by salacious discussion of surgeon swimwear preferences. Meanwhile, the Appropriateness Politburo is yet another threat to the 1%. These self-righteous surgeons believe their precious “evidence” should guide your practice. Outrageous! Every one percenter knows that the most dangerous aneurysms are 4.9cm—because if you don’t fix it, someone else will. Perhaps someday the state medical boards and federal government will intercede. There is, of course, good precedent for such supercilious overreach in the name of “fraud detection” and/or “public health.” But there are so many atherectomies to be performed before that day arrives. Good luck, and bon voyage! Your ascension to the 1% begins today. Andrew J. Meltzer is chair of vascular surgery at Mayo Clinic Arizona in Phoenix.
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VAM shifted to August amid COVID pandemic, vaccination rollout BY BETH BALES
To enhance the chances of being able to hold the 2021 Vascular Annual Meeting (VAM) in-person, the Society for Vascular Surgery (SVS) has moved the conference, lock, stock and barrel to mid-August.
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his pre-eminent event for vascular effort on Debbie’s part to make this a practical education now will take place Aug. alternative.” 18–21 in San Diego, with educational programming on all four days and the (NOTE: The SVS continues to plan full speed ahead Exhibit Hall open Aug. 19–20. Registration is for an in-person, high-impact meeting where colleagues expected to open in early May. can once again connect and learn from each other. The “Members have shared that they really miss Society is hoping it won’t be necessary, but, if it is, we the in-person camaraderie, the reunions, the will be ready to convert the meeting to an innovative and informal networking, the ability to follow up engaging virtual format. The protection and safety of with presenters, to catch up with industry, the attendees remains our top priority.) affiliated meetings—everything that went by the wayside out of necessity in 2020,” said Ronald L. Dalman, SVS president. “Our feeling was that the best chance we had to put on an in-person meeting was to move it to later in the summer.” Post-Labor Day, regional and other meetings begin to fill the calendar. Thus, the mid-August dates, still more than two-and-a-half months after the original timeframe, offered the best compromise, reducing risks to everyone, he said. He noted that COVID-19 vaccinations have begun. He is hopeful the process will “rapidly pick up speed, efficiency and efficacy.” Of course, an in-person meeting isn’t guaranteed. Some attendees may remain reluctant to fly and travel, and some may not be permitted to do so. “There’s still the possibility of a hybrid meeting, or a virtual one. But the vast majority of responses we received is that members are really excited about having “ This talk was originally slated to be an in-person meeting,” added Dalman. presented at the VAM last June, In addition, the San Diego venue so it looks like we passed up an provides the perfect opportunity for members to combine attendance with opportunity to not go to Toronto for a family vacation, to take advantage of an opportunity to not go skiing”— all that Southern California has to offer, he said. He praised the efforts of staff, Malachi Sheahan III, MD, particularly director of meetings Debbie prefacing research on open surgical Wallentin and meetings manager competency among trainees at the Lynette Dummer, for their work with VESS winter annual meeting all the details of changing the dates. “Essentially, our entire hotel reservation blocks and all the on-site people we hire to run the meeting—everything—was moved en bloc to the end of August. It was a remarkable
“Our feeling was that the best chance we had to put on an in-person meeting was to move it to later in the summer”— Ronald L. Dalman
Heard at VESS 2021
Submission Deadlines Extended With the move to August, the deadlines to submit abstracts and to apply for the SVS Foundation Resident Research Award both have been extended to Feb.17. Learn all about the 2021 VAM at vascular.org/VAM.
February 2021
COVER STORY
Continued from page 1
incentivizing inappropriate medical provider care? “Radiologists are making up an ever-increasing number of overall providers that are accounting for an increasing amount of reimbursement—7% of providers accounting for 7% of reimbursement in 2012 to 10% of providers accounting for 15% reimbursement in 2017—and the average radiologist performs significantly more procedures than any other profession,” Haffner told Vascular Specialist. There is heightened focus on appropriateness in care among teams of investigators as well as at the level of the Society of Vascular Surgery (SVS). Immediate past president Kim Hodgson, MD, made the issue a central focus of his presidency. VAM 2019 heard from Caitlin W. Hicks, MD, assistant professor of surgery at John Hopkins Medicine in Baltimore, about how new methodology had identified a significant number of physicians whose practice patterns might indicate failure to adhere to guidelines of care. Further research from Hicks et al followed at SVS ONLINE in 2020, revealing a higher use of atherectomy during peripheral vascular interventions among nonvascular surgery specialists and physicians working primarily in outpatient settings. Haffner and colleagues probed the Medicare Provider Utilization and Payment database for femoropopliteal atherectomy and stent placement procedures carried out during the study period using the relevant current procedural terminology code. He drew attention to raw numbers: In 2017 alone, he said, the procedure resulted in $120 million in reimbursements. In 2020, femoropopliteal atherectomy and stenting rates came in between $12,000–$20,000. And total Medicare reimbursement for the procedure across the study period was $480 million. “Are there any trends in data for this procedure that could help explain its increased rate of reimbursement?” he asked. Vascular surgeons and cardiologists comprise the majority of Medicare reimbursement, he pointed out—but noted the relative increase in radiologist reimbursement. “On cursory analysis, the proportions of provider types seems to match with the proportion of Medicare reimbursement,” Haffner explained. “Radiology accounts for an increasing amount of Medicare reimbursement compared with the amount of provider percentage ... The opposite is true for cardiology: 45% of providers accounting for 42% of reimbursement and 37% of providers accounting for 29% of reimbursement.” Haffner then probed whether there were relatively more radiologists performing the procedure—Are radiologists performing more procedures? “The number of providers has more than doubled from 2012 to 2017,” he said. “The number of procedures has more than doubled from 2012 to 2017 as well. Will the rate of increase in providers or procedures explain the increase in Medicare spending? It appears that this increased spending is not explained by simply more providers performing the procedure, or more procedures being performed.” The data show that the rate of increase in total providers and total procedures are closely related, Haffner pointed out—both showing a slower rate of increase compared with overall reimbursement. “However, the proportion of provider types has changed over time,” he said. “Could this possibly explain the increased spending? Perhaps if there is a relative increase in overall procedures performed by
6 • Vascular Specialist
specialties that are reimbursed at higher rates and a relative decrease in those with lower rates on reimbursement.” He then showed comparisons between the proportion of providers and the relative proportion of procedures performed by each specialty. This demonstrated no direct correlation between increased providers within a specialty and the number of procedures that that specialty performs, Haffner said. Regarding average procedures per provider, Haffner et al went on to compare individual specialties to the national average.
“Radiologists are making up an ever-increasing number of overall providers that are accounting for an increasing amount of reimbursement”— Matthew Haffner This demonstrated that the average radiologist “is consistently performing more procedures than any other specialist,” he said, noting that the average vascular surgeon tends to perform the procedure approximately at or just below the national average rate. The investigators posed another question: Are the reimbursement rates of individual specialists changing at different rates—and if this is the case, could it help explain some aspects of the overall increase in Medicare spending? Haffner and colleagues returned to the overall rate of increase in Medicare reimbursement for femoropopliteal atherectomy and stenting—a relatively consistent increase over time. “The rate of increase of vascular surgery reimbursement closely follows the national average rate of increase,” Haffner told the VESS meeting. “The rate of increase in reimbursement for cardiology is at a slower rate than the national average, and the rates for reimbursement for radiology and general surgery have increased at a rate much faster than the
national average.” Yet, rate of increase does not directly translate into an increased reimbursement rate, Haffner considered. Reimbursement rates by specialty showed that those surpassing—or very close to—the national average include vascular surgery, radiology, as well as general surgery. “Are there differences between the number of interventions per patient between specialties?” Haffner and colleagues wondered. “Is this high reimbursement rate possibly incentivizing providers to perform more interventions on patients?” Vascular surgeons have a relatively constant procedure rate per patient, they found, whereas the other specialties noted tended to have more variability and higher overall procedure rates per patient. The average cardiologist, the researchers noted, are consistently performing more procedures on the average patient than each year prior. “With a reimbursement rate in excess of $8,000 per procedure, the temptation to overbill or over-perform procedures with monetary motivation may come into play within the billing process,” Haffner said. But do the data bear aspects of this out? “I chose the dividing line of 1.5 procedures per patient, as this would translate to equal to three interventions on two people,” he explained. “This number represents the annual average. Being as this intervention can only be performed two times on one person at a time, it seemed a decent starting point to look for discrepancies within the data.” After 2013, the researchers found, vascular surgeons— “who are arguably the specialty that would or should be called upon for the more challenging cases that have a higher likelihood of multiple interventions”—have a much lower percentage of providers with intervention rates greater than or equal to 1.5 when compared with the national average, radiologists and general surgeons. “So while vascular surgeons are performing less than the national average of interventions per patient, they still account for an increasing amount of total procedures,” Haffner added. Commenting further on the findings, Haffner told Vascular Specialist: “I believe I demonstrated some rough patterns of change within Medicare reimbursement for this procedure that showed areas of possible concern moving forward, both from an overall Medicare perspective and a vascular surgery perspective. “With the current environment of procedure reimbursement, the elevated rates of reimbursement for more specialized surgeons—including vascular surgeons—and the rapid increase in Medicare spending in general, it is reasonable that areas that can potentially decrease inappropriate Medicare spending will be investigated more fully moving forward.”
MATTHEW HAFFNER
Atherectomy: Are high reimbursement amounts incentivizing inappropriate medical provider care?
Figure 1: Medicare reimbursement rate of increase across specialties
February 2021
Vascular surgery's 1%: 'An an inordinate amount' of total Medicare payments go to small group
31
1
THE %
39% $59.7M 49%
The 31 surgeons comprising the 1% performed 39% of all these services, amounting to $59.7 million or 49% of all payments for atherectomy
BY BRYAN KAY
Just 1% of vascular surgeons receive “an inordinate amount” of the total Medicare payments that flow toward the specialty, with disproportionate use of outpatient atherectomy in a small number of providers raising concerns on appropriateness and overutilization, another investigation of provider utilization data discovered.
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hose were among the findings of “Practice patterns of vascular surgery’s ‘1%’” by William W. Sheaffer, MD, a fellow in the division of vascular surgery at Mayo Clinic Arizona, Phoenix, and colleagues published in the January issue of the Annals of Vascular Surgery. The backdrop to their work is stark. “Variation in healthcare utilization is an established driver of healthcare costs,” the team of researchers—which is headed up by Mayo Clinic Arizona vascular surgery chair Andrew J. Meltzer, MD—point out. “Recent publications in the lay media and medical literature have identified tremendous variation in treatment intensity and costs. Cardiovascular procedures, some which are disproportionately reimbursed, have received attention from mainstream media outlets including the New York Times and Wall Street Journal.” The team plumbed the 2016 Medicare Physician Utilization Data File to identify all services and payments to vascular surgeons for commonly performed services among beneficiaries. Payments uncovered for these commonly performed services were then placed into arbitrary categories such as dialysis access, endovascular, inpatient evaluation and management, outpatient evaluation and management and noninvasive vascular laboratory, the authors note. Among all surgeons, the top 1% of earners (31 surgeons) was identified based on total payments received during 2016, with a comparative analysis of practice patterns carried out. “Special attention was paid to specific endovascular interventions,” Sheaffer et al write. The investigators created aortic, lowerextremity, upper-extremity, venous and other subcategories. Lower-extremity interventions were categorized by the anatomic site as well as specific procedure: that is to say, atherectomy versus percutaneous transluminal angioplasty (PTA) and stent. Highly reimbursed and frequently performed procedures among the 1% were further analyzed and compared with the remaining workforce. Specific data included total procedures
February 2021
performed, location service that was provided, and specific intervention. Sheaffer and colleagues found that 3,136 surgeons were identified who in total earned $589 million during the 12-month window for commonly performed vascular surgery services. Among all vascular surgeons, 31—or the 1%—earned $90 million. That equates to 15% of all payments for commonly performed services in 2016, they note. This group of surgeons received mean payments of $3.1 million with a range of $2 million to $6.4 million compared with $271,000 to all vascular surgeons, Sheaffer et al write. Furthermore, the highest contributions in payments came from endovascular procedures ($225 million, 38%), noninvasive laboratory services ($125 million, 21%), office evaluation and management ($80 million, 14%), and varicose vein procedures ($56 million, 10%). There were statistically significant differences between the 1% and the remaining workforce, in proportions of payments for all categories (p<0.001), the researchers discovered. “Specific dramatic differences included endovascular payments (85% vs. 30%), noninvasive laboratory (6% vs. 24%), office evaluation and management (3% vs. 16%), and varicose vein (3% vs. 11%).” Still further, lower-extremity procedures accounted for the greatest proportion of payments in the endovascular category for the so-called 1%. They added up to 83% of all endovascular payments. The authors again found statistically significant differences for specific levels of interventions between the two groups of surgeons. “Specifically, tibial interventions accounted for 44% of all services and 29% of payments within ‘the 1%’ compared with 27% of services and 20% of payments in the remaining workforce,” they report. In terms of atherectomy, statistically significant differences were realized when providing a
comparison of the proportion of PTA and stent versus utilization of atherectomy, Sheaffer and colleagues continue. Atherectomy represented a significantly higher proportion of all lower-extremity interventions in the 1% versus the rest of the vascular surgeon workforce (80% vs. 35%, p<0.001) and 93% of payments for all lower-extremity interventions among the former group of providers. The researchers then illustrate how this boils down in dollar terms: “When evaluating all atherectomy services accounted for in 2016, there were 19,341 services providing nationwide accounting for $121 million in total payments. The 31 surgeons comprising ‘the 1%’ performed 39% of all these services, accounting for $59.7 million or 49% of all payments for atherectomy.” The findings draw firm conclusions from the authors. “This study highlights a significant disconnect between the practice
patterns of a small number of vascular surgeons who receive disproportionate payments from Medicare and the remainder of vascular surgeons,” the research team write. “The top earners in vascular surgery have a primarily outpatient endovascular practice with increased utilization of atherectomy and tibial interventions compared with the remaining workforce. While patient characteristics cannot be accounted for, the dramatic differences in practice patterns raise concern for potential overuse of specific, highly reimbursed services. With this publicly available data, strong consideration needs to be given to provider and societal-level self-regulation to avoid external forces from driving practice patterns within vascular surgery.” SOURCE: DOI.ORG/10.1016/J. AVSG.2020.07.010
Not Appropriate! Florida healthcare fraud case highlights inappropriateness in care The latest research around practice patterns and appropriateness in care came shortly after a criminal case in Florida at the tail end of last year in which the owner of an outpatient catheterization lab pled guilty to committing healthcare fraud, conspiracy to committing healthcare fraud and aggravated theft—all to the tune of $29 million. MOSES DEGRAFT-JOHNSON, MD, was behind Thorvasc PA, which operated as the Heart and Vascular Institute of North Florida, according to the U.S. Attorney’s Office for the Northern District of Florida. Atherectomy procedures figured at the heart of the case. As part of his plea on Dec. 18, 2020, deGraft-Johnson acknowledged engaging in a wide-ranging and consistent pattern of performing angiography procedures—one on each leg—on hundreds of his patients, whether they were indicated or not, the U.S. Attorney’s Office reported in a statement. “When his patients returned for follow-up office visits, deGraftJohnson submitted fraudulent claims to their insurance companies stating he performed
atherectomies during the appointments. Using this scheme, deGraft-Johnson admits he falsely claimed to have performed over 3,000 of these surgical procedures to clear blockages in arteries in as many as 845 of his patients’ legs.” The fraud to which deGraft-Johnson pled guilty funded an exorbitant lifestyle, according to details revealed by the prosecutors. “Over the course of almost four years, beginning in late 2015 or early 2016 until his arrest in February 2020, deGraftJohnson did significant harm to hundreds of patients living in the Tallahassee area,” the U.S. Attorney’s Office statement explained. “Many of these innocent victims underwent unnecessary and invasive surgical procedures, while others were victimized through medical records reflecting procedures he did not perform—erroneous and misleading records that could cause doctors in the future to determine a mistaken course of medical treatment for many patients.”— Bryan Kay
vascularspecialistonline.com • 7
VASCULAR RESOURCES
Vascular firefighters: New data highlight ‘essential hospital resource’ BY BRYAN KAY
New data that analyze the preoperative and intraoperative assistance vascular surgeons provide to other surgical subspecialties underscores “the essential hospital resource” vascular surgery represents.
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team of researchers from Robert Wood Johnson Medical School at Rutgers University and Robert Wood Johnson University Hospital in New Brunswick, New Jersey, reported the findings at the Vascular & Endovascular Surgery Society (VESS) virtual winter annual meeting ( Jan. 21–24). Furthermore, the research demonstrates the importance of ensuring that “trainees are comfortable with both open and endovascular techniques because when they’re called to assist for their colleagues they’re using both to assist,” first-named author, Cassandra Soto, a fourth-year medical student at Rutgers, told the VESS gathering. Soto et al set out to build upon previous research showing vascular surgeons— often referred to as the firefighters of the operating room (OR) owing to their breadth of training across open,
endovascular and hybrid techniques—were most commonly called into assist surgical oncology and cardiothoracic surgery for intraoperative complications across elective, urgent and emergent cases. Called in for revascularization, to control bleeding and dissections “We wanted to evaluate not only the intraoperative consultations but also those where surgeons were being called preoperatively and informed that they would be needed for vascular assist in the case—we wanted to focus on the more urgent setting,” explained Soto. The research team evaluated 484 cases retrospectively at a single institution between 2011 and 2020, with 100 vascular specialists listed as a secondary surgeon and a non-vascular physician as primary. The investigators excluded 350 elective cases. A total of 49 classified as urgent (with the patient heading to the OR
within six hours) and 85 as emergent (with patients taken to the OR within one hour) were included. Soto and colleagues found that those who primarily called for vascular help were orthopedic surgeons, acute care surgery and cardiothoracic surgery, followed by the likes of general surgery, surgical oncology and plastic surgery. About 44.8% of the cases where vascular surgery was called in to assist involved the relevant surgeons being informed preoperatively they would be needed for assistance, while the remaining 55.2% were intraoperative consultations. Acute care and cardiothoracic surgery were the subspecialties mostly calling for intraoperative consultations, while orthopedic surgery more often called preoperatively in need of vascular assistance, Soto said. She further explained that about 28.4% of the cases occurred after hours, while, in terms of type of assistance required some 35% were for revascularization followed by 33% for bleeding. Interestingly, added Soto, about 13.4% of the overall cases were for
71.6%
of the calls involved assisting in the open surgical setting
Patients with depression ‘less likely’ to go home after CLTI revascularization BY JOCELYN HUDSON
A recent analysis established an association between depression and non-home discharge after revascularization for chronic limb-threatening ischemia (CLTI)—providing further evidence, the authors say, that an increased awareness of mental health is fundamental to care for vascular surgery patients. JOEL L. RAMIREZ, A RESIDENT IN THE DIVISION of vascular and endovascular surgery at the University of California, San Francisco, James C. Iannuzzi, MD, a vascular surgeon in the same department, and colleagues write in an online Journal of Vascular Surgery (JVS) article that these results “provide further evidence of the negative impact that comorbid depression has on patients undergoing revascularization for CLTI,” and propose that future studies should examine whether treating depression can improve outcomes in this patient population. “Recent evidence suggests that depression in patients with peripheral arterial disease (PAD) is associated with increased postoperative complications,” the authors begin, noting that problems can include decreased primary and
8 • Vascular Specialist
secondary patency after revascularization and increased risk of major amputation and mortality. Ramirez et al note that the impact of depression on non-home discharge after vascular surgery remains unexplored, despite this being “an important outcome” for patients. They hypothesized that depression would be associated with an increased risk for non-home discharge following revascularization for CLTI. The investigators identified endovascular, open, and hybrid cases of revascularization for CLTI from the 2012– 2014 National (Nationwide) Inpatient Sample, which they explain is “a patient-level administrative claims database that is published annually by the Agency for Healthcare Research and Quality and represents approximately
inferior vena cava (IVC) filter placements. Drilling down further, the researchers discovered that 71.6% of the calls involved assisting in the open surgical setting, with only about 26.1% involving an endovascular intervention. “Very few required a hybrid approach,” Soto said. The reasons that drive other subspecialties to call on vascular assistance will vary by institution, Soto concluded, but the ability of vascular surgeons to use open, endovascular and hybrid techniques means they are prepared to respond and intervene in non-vascular cases when unexpected vascular compromise, iatrogenic injury or challenging exposures are encountered. “What this does is emphasize that vascular surgery is an essential hospital resource, especially for institutions that provide urgent-emergent care,” Soto related. “And that it’s important to ensure that trainees are comfortable with both open and endovascular techniques because when they’re called to assist for their colleagues, they’re using both to assist.”
26.1% involved an endovascular intervention
20% of discharges from U.S. hospitals.” They write that a hierarchical multivariable binary logistic regression controlling for hospital level variation examined the association between depression and non-home discharge and controlled for confounders meeting p<0.01 on bivariate analysis. They identified 64,817 cases, of which 5,472 (8.4%) were diagnosed with depression, and 16,524 (25.5%) required non-home discharge. The researchers relay that patients with depression were younger, more likely to be women, white, have multiple comorbidities, a non-elective admission, and experience a postoperative complication. The authors report that, on unadjusted analyses, patients with depression had a 7% absolute increased risk of requiring non-hospital discharge (32.1% vs. 24.9%, p<0.001). On multivariable analysis, they found that patients with depression had an adjusted 50% increased odds for nonhospital discharge (odds ratio [OR]=1.5; 95% confidence interval [CI]=1.4–1.61; c-statistic, 0.81) compared to those without depression. After stratification by operative approach, Ramirez et al identified that depression had a larger effect estimate in endovascular revascularization (OR=1.57; 95% CI=1.42– 1.74) compared to open (OR=1.45; 95% CI=1.3–1.62). SOURCE: DOI.ORG/10.1016/J.JVS.2020.12.079
February 2021
PACLITAXEL
FDA representatives respond to SWEDEPAD interim analysis, highlight need for continued study
'Ample' data unable to replicate link
BY BRYAN KAY
Representatives from the Food and Drug Administration (FDA) referenced “important and reassuring” results from the recent interim analysis of the SWEDEPAD clinical trial in which patients with peripheral arterial disease (PAD) received treatment with paclitaxel-coated or uncoated endovascular devices. HOWEVER, WRITING IN A PERSPECTIVE published in the New England Journal of Medicine (NEJM), Andrew Farb, MD, Misti Malone, PhD, and William H. Maisel, MD, from the FDA’s Center for Devices and Radiological Health cautioned that along with recent analyses of additional data from nonrandomized studies that have not identified an increased mortality risk associated with paclitaxel-coated devices, these newer studies are “comforting” but “limited by the duration of follow-up.” The SWEDEPAD interim analysis “did not show a difference between the [paclitaxel-coated and uncoated] groups in the incidence of death” during one to four
February 2021
Misti Malone
years of follow-up, authors Mårten Falkenberg, MD, Joakim Nordanstig, MD, of Gothenburg University, Gothenburg, Sweden, and colleagues had reported in the NEJM last year. In their perspective, entitled “Drugcoated devices for peripheral arterial disease,” Farb et al outline the benefits of devices coated with drugs like paclitaxel. “Percutaneous revascularization procedures can improve claudication symptoms, and devices coated with antiproliferative drugs (drug-coated balloons and stents) reduce neointimal proliferation after revascularization procedures,” they write. “Pivotal randomized, controlled trials (RCTs) of paclitaxel-coated devices in
Ample published data from from large, observational datasets, randomized-controlled trial (RCT) subgroup analyses and long-term follow-up from pivotal paclitaxel-coated device RCTs have not been able to replicate an association between such devices and mortality, an expert analysis recently published online by the American College of Cardiology (ACC) concludes. The authors, Anna Katherine Krawisz, MD and Eric Alexander Secemsky, MD, reference the numerous studies that failed to demonstrate an increase in mortality among patients treated with paclitaxel-coated devices compared with those treated with non-coated devices— including one in the Vascular Quality Initiative (VQI) registry.—Bryan Kay
patients with femoropopliteal PAD reveal significantly reduced repeat revascularization rates as compared with use of uncoated devices. Reasonable assurance of device safety and effectiveness at one year has led the FDA to approve six [paclitaxel-coated devices] to date, and their use has become common in symptomatic patients.” In SWEDEPAD, fewer than 300 patients have been followed for four years, Farb et al note. “In contrast, 1,090 participants were available for analysis at five years in the FDA’s meta-analysis of the pivotal RCTs of the approved paclitaxel-coated devices. This gap underscores the importance of continued patient follow-up for ongoing randomized trials.” They added: “Because of the demonstrated short-term benefits of the devices and the limitations of the available data, the FDA believes that clinical studies of these devices should continue and should collect long-term mortality data. Similarly, the FDA now routinely reviews longer-term data for [paclitaxel-coated devices] for which market authorization is being sought when they are intended to treat patients with PAD, and the agency requests that trials capture information on adjunctive antithrombotic therapy and medications indicated for patients with atherosclerosis.” SOURCE: DOI:10.1056/ NEJMP2031360
vascularspecialistonline.com • 9
COMMENTARY
System outage alert: Cyberattack sends medicine back to paper age BY DANIEL J. BERTGES, MD, GEORG STEINTHORSSON, MD, AND ANDY STANLEY, MD
O
n Oct. 28, 2020, the University of Vermont Health Network, consisting of six hospitals in Vermont and upstate New York, was hit by a cyberattack.1 Leading up to the attack, the U.S. Cybersecurity and Infrastructure Security Agency (CISA) released a warning regarding ransomware targeting healthcare facilities across the country.2 On Twitter, CISA stated “there is an imminent and increased cybercrime threat to U.S. hospitals and healthcare providers.” The FBI and the Department of Health and Human Services warned of credible information about imminent cybercrime affecting at least five hospitals that could affect hundreds more.3,4 This technological invasion was the result of a malware scheme that affected the information technology infrastructure and significantly curtailed our processes of care including the Epic-based electronic medical record (EMR), picture archiving and communication system (PACS), Outlook email, network computers and printers. Providers at all levels were quickly thrown back into the “paper age” of medicine and scrambled to adapt. Simple activities such as note writing, ordering and reviewing laboratory values and images were thrown into disarray. Pen and paper quickly replaced keyboard and mouse clicks. In response, hospital volumes decreased by approximately 20%. Trauma patients were diverted and elective imaging, such as cancer surveillance and screenings, were postponed. The surgery department reviewed scheduled operations daily and was able to maintain the operating room at 60–70% capacity. Hands-on human checks became paramount as day of surgery admissions were limited, staggered starts were implemented, and turnover was prolonged.
VASCULAR LIMITS The vascular division responded by limiting procedures to those deemed necessary and doable in this environment. Similar to the early days of the pandemic, our ability to triage cases became paramount. After evaluating the systems capabilities, we decided to divert ruptured aneurysms except for those presenting to our main hospital emergency room. Complex procedures were postponed out of concern for our ability to promptly respond to any intraoperative or postoperative complications. Our dependence on the catalog of PACS images was a liability for vascular surgery and other services such as neurosurgery and orthopedics. With prior computed tomography angiography (CTA) and arteriograms, unavailable surgeons were forced to weigh the merits of delaying scheduled procedures or repeating images. In response, workstations manned by live radiologists were stood up for review of new imaging and compact discs, a 1980s technology, became a necessity. The convenience and efficacy of reviewing internal and external images from the clinic, office, or home was lost.
COMMUNICATION BREAKDOWN Communication was one the first “casualties” of the attack. With network email and intranet access inoperable, hospital, departmental and division leaders and program directors were challenged to inform employees, residents and fellows about the evolving situation. Frequent 12 • Vascular Specialist
conference calls, Zoom meetings and word of mouth replaced other means of communication. Many services resorted to text messaging and WhatsApp to for nonpatient related communications. Face-to-face sign-in and sign-out meetings took on added importance. The vascular team resorted to a “war room” atmosphere with a whiteboard to track patient location and clinical progress. The inability to review the medical history was partly mitigated by converting to the Vermont Information Technology Leaders (VITL) Access which allowed providers limited review of recent notes and reports.5 Two weeks into the cyberattack a read-only version of Epic was brought online, greatly assisting clinicians. This EMR was eerily frozen in time but was functional enough to inform providers about patient histories, medications, lab and radiology reports. The current generation of medical students, residents and fellows have “grown up” in a paperless work environment. Many had never handwritten a prescription or been trained in the proper documentation for handwritten notes. Hard stops and safety measures ingrained in the medical record were rendered ineffectual. It is clear that our house staff, advanced care practitioners, pharmacists, laboratory staff and nurses shouldered the largest burden and stress during this time. The Graduate Medical Education Office held regular Zoom calls to discuss and respond to our trainees needs. Teaching conferences, already virtual, temporarily focused on how to effectively support our residents and fellows.
This EMR was eerily frozen in time but was functional enough to inform providers about patient histories, medications, lab and radiology reports PREPARATION We hope that our experience will educate others about their own vulnerabilities and act as the impetus for hospital leadership to prepare contingencies. Healthcare systems are relatively behind other industries in cybersecurity and have focused, understandably, more on data privacy, than data security. According to one report, only 37% of hospitals perform annual cyberattack response exercises.6 Awareness and prevention are a key component as up to one in seven hospital employees have been reported to open phishing emails.7 While the ability of any one surgeon, division or department to prepare is limited, individuals acting collectively can make the most of a bad situation. For example, simple backup measures such as the physical availability of paper forms and prescription pads, despite the hospital going electronic years ago, was indispensable. It will be necessary and important to
retrospectively examine the impact of the cyberattack on patient care. While no serious events have been reported, previous attacks on healthcare facilities have impeded care and, in one high-profile case in Germany, led to the death of a patient from delay in transfer to the appropriate facility.8 At a minimum, cyberattacks can be of substantial financial consequence as illustrated by the WannaCry attack on the British National Health Service.9, 10 Other issues such as the potential impact on wireless vital sign monitors and medical devices should he considered. Fortunately, at the time of this writing, the coronavirus pandemic was under reasonable control in the state and the University of Vermont Medical Center COVID-19 volume was low. There may well be unintended consequences of the cyberattack, including a new appreciation for the oft-maligned EMR and a greater sense of community within the hospital arising from a shared experience. Countless individuals rose to the challenge in a cooperative, constructive manner, and adapted to the situation in the best interest of their patients and colleagues, proving once again that medicine is a human endeavor, not one born out of technology. References 1. https://www.uvmhealth.org/medcenter/news/ cyberattack-statement-uvm-health-networkpresident-and-ceo-john-brumsted-md 2. Ransomware Activity Targeting the Healthcare and Public Health Sector. https://us-cert.cisa.gov/ ncas/alerts/aa20-302a Accessed Nov. 13, 2020. 3. https://www.cnn.com/2020/10/28/politics/hospitalstargeted-ransomware-attacks/index.html 4. https://www.nytimes.com/2020/10/28/us/ hospitals-cyberattacks-coronavirus.html 5. https://www.vitl.net 6. Cybersecurity in Hospitals: A Systematic, Organizational Perspective. Jalali M.S., Kaiser J.P. J Med Internet Res. 2018 May 28;20(5):e10059. doi: 10.2196/10059.PMID: 29807882 7. Assessment of Employee Susceptibility to Phishing Attacks at U.S. Health Care Institutions. Gordon W.J., Wright A., Aiyagari R., Corbo L., Glynn R.J., Kadakia J., Kufahl J., Mazzone C., Noga J., Parkulo M., Sanford B., Scheib P., Landman AB. JAMA Netw Open. 2019 Mar 1;2(3):e190393. doi: 10.1001/ jamanetworkopen.2019.0393.PMID: 30848810 8. https://www.theguardian.com/technology/2020/ sep/18/prosecutors-open-homicide-caseafter-cyber-attack-on-german-hospital 9. Ghafur S., Kristensen S., Honeyford, K. et al. A retrospective impact analysis of the WannaCry cyberattack on the NHS. npj Digit. Med. 2, 98 (2019). https://doi.org/10.1038/s41746-019-0161-6 10. Cyberattack on Britain's National Health Service—A Wake-up Call for Modern Medicine. Clarke R., Youngstein T. N Engl J Med. 2017 Aug 3;377(5):409-411. doi: 10.1056/ NEJMp1706754. Epub 2017 Jun 7. PMID: 28591519
Daniel J. Bertges is associate professor of surgery and medicine at the University of Vermont Medical Center in Burlington and program director of the vascular surgery fellowship. Georg Steinthorsson is the institution’s chief of vascular surgery. Andy Stanley is a vascular surgeon and deputy chair of surgery at the University of Vermont and the University of Vermont Medical Center.
February 2021
After a technological invasion, providers at all levels were quickly thrown back into the “paper age” of medicine and scrambled to adapt
February 2021
vascularspecialistonline.com • 13
INTERVIEW
Lymphedema: NYC vascular surgeon explains experience tackling severe cases with a modified Charles' procedure
doctors, and slowly we started to build a referral.” Thus far, Singh and colleagues have carried out about 25 severe cases. He reports “excellent” long-term results, with no recurrences and no limb losses. The first case—the original patient— involves nine years of follow-up, with the shortest about six months. “We have one patient who was bed bound for about six months and is now ambulating,” he says. “Another great story we have is about a musician who has worked with many big acts, who lost a lot of potential to become a bigname background musician, because he had chronic drainage and terrible smell from his lymphedematous leg. He was so
changes (very painful) are needed because they require circumferential skin grafts to the leg, which can be very difficult to manage. A knowledgeable, dedicated team is a must or you’re sure to end up with complications. A wound VAC seems to make a big, big difference, especially immediately post-op. We tend not to do any skin grafts until we see perfect granulation because you’re limited to how much skin you can graft, especially if you have to do bilateral legs. At some point, you’re going to runout of places to take skin. We tend to wait five-to-seven days to ensure there is granulation tissue and no infection that can destroy the grafts.”
BY BRYAN KAY
Kuldeep Singh, MD, calls them a labor of love. They are tough—the patients having endured repeated hospitalizations, infections, embarrassment: The sorts of severely affected lymphedema cases he ends up treating find individuals in the end stage of the disease and almost out of options.
T
he director of limb salvage surgery and peripheral vascular interventions at Staten Island University Hospital/Northwell Health in New York is gaining a reputation for taking on seemingly impossible cases—and getting positive results. Visual representations of his work have become a semi-recurrent feature and conversation point in the world of #VascTwitter among fellow vascular surgeons. To tackle these cases, Singh carries out radical debulking of skin and soft tissue—essentially a modified Charles’ procedure using a specially created protocol. But until about 10 years ago, it was a surgery theretofore he hadn’t performed. Now, explains Singh, he confidently takes on such extreme cases. “I encountered this patient who came to see me as a second or third opinion; she had gone to multiple centers down in Baltimore. Then she came up here [to NYC],” he tells Vascular Specialist. “Her one leg was massively swollen; it was to about threeto-four times her other leg, getting bigger over time, with multiple, weeping ulcers. Kuldeep Singh
14 • Vascular Specialist
It affected her life, she ended up getting divorced, lost her job, and was clinically depressed, all because of the affected leg. Every center she went to essentially said, ‘Well, this is a disease that we really don’t take care of; it has poor outcomes.’ She couldn’t find anybody to help her. She had gone to multiple vascular and plastic surgeons. When she came to me, she was crying in my office and said that I could just take the entire leg off.” That’s when he informed her of a procedure he could potentially undertake in partnership with a burn surgeon at his institution—albeit, he explained, one that he had never before attempted. “I told her about total debulking of skin and fatty tissue circumferentially, all the way down to the fascia, multiple skin grafts, and a long stay in the hospital. I told her that there may be a chance that she could lose her leg, because I’m not sure whether this will work or not,” Singh relates. “She agreed to it, and said that she had no other hope. So, with that understanding, we went ahead and did the procedure, and she had a wonderful result. For 20 years, she wished to fit in normal clothing, and now she was finally able to do so.
More cases “Coincidentally enough, she happened to have a friend who had the exact same issue. She came to me, we carried out the procedure, and we had another wonderful outcome. The first patient told multiple doctors, the doctors that she visited, the second patient did the same thing, and those doctors told other
Kuldeep Singh and colleagues tackle a severe case
“When she came to me, she was crying in my office and said that I could just take this whole leg off”— Kuldeep Singh embarrassed to go to rehearsals that he ended up quitting. “He’s about three years out from the procedure with a great result, and now he’s back doing what he loves.”
Case series Singh and colleagues are currently in the process of putting together submissions on their case series for peer-reviewed publication. Along the way, they have learned a number of key lessons that he says are essential for best outcomes when conducting the procedure. “The length-of-stay for these patients can be pretty long—at a minimum three weeks,” he explains. “Multiple dressing
Protocol Singh’s team operate under their own Singh-Cooper protocol. “We have the patient admitted the night before; we wash the legs because there can be wounds in skin folds that you can’t see; the patient is placed on weight-based heparin because we keep them at bed rest; a DVT [deep vein thrombosis] on the leg could prove to be catastrophic,” he says. “Additionally, some of the intraoperative issues we have encountered include cutting through the tissue: This is end-stage lymphedema, so the fat may eventually becomes calcified and sometimes indistinguishable from the fascia and muscle.” The lessons learned extend to scalpel choice, Singh adds. “A LigaSure scalpel has proven to be instrumental with its ability to limit some of the blood loss,” he explains. There are huge venous tributaries which can cause a significant amount of bleeding. That’s something that we’ve learned over time. “Aside from the condition itself, it’s sad to know that most patients don’t know where to get help, and doctors don’t know where to refer, since there are only a handful of centers in the U.S. willing to tackle such a problem.
February 2021
GOVERNMENT
Democrats take control with Biden presidency, majorities in both chambers BY NICOLAS MOUAWAD, MD
Democratic victories for Georgia’s two Senate seats in the runoff election Jan. 5 have solidified the Democrats’ control of the federal government for the next two years. The victories by Democrats Rev. Raphael Warnock over incumbent Sen. Kelly Loeffler and by Jon Ossoff over incumbent Sen. David Purdue have created a 50–50 tie in the Senate. With Vice President Kamala Harris casting tie-breaking votes, Democrats acquired control. WITH A SIMPLE 51 MAJORITY VOTE, THE Democrats will be able to approve Cabinet nominees and judicial appointments, including any nominees to the U.S. Supreme Court. Senate Democrats could also pass legislation related to the federal budget and spending
February 2021
through the reconciliation procession, which requires only a simple majority vote. This process cannot be used to pass legislation unrelated to the budget, which is still subject to the filibuster rules requiring 60 votes for passage. Republicans used reconciliation for their 2017 tax package and Democrats employed it to pass a significant portion of the Affordable Care Act in 2010. With the 50–50 split, new Majority Leader Chuck Schumer (DNY) and Minority Leader Mitch McConnell (R-KY) will have to negotiate a powersharing agreement that will determine committee membership, leadership roles and resources. Democrats could decide to evenly divide the membership of Senate committees between the two parties to reflect the 50–50 Senate split or could appoint more Democrats to the committees. Formal announcements about the organization and leadership roles for Senate committees have not yet been made, but those dealing with healthcare matters are expected to be:
Senate Finance Committee Chair: Sen. Ron Wyden (D-OR) Ranking Republican: Sen. Mike Crapo (R-ID)
Senate Health, Education, Labor and Pensions (HELP) Committee Chair: Sen. Patty Murray (D-WA) Ranking Republican: Either Sen. Rand Paul (R- KY), who is an ophthalmologist, or Sen. Richard Burr (R-NC) In the House of Representatives, Democrats are maintaining control with a slimmer 221–211 majority, with two unfilled vacancies as the new Congress is sworn in. The leadership positions for House
committees with jurisdiction over health issues are:
Energy & Commerce Committee Chair: Rep. Frank Pallone (D-6th-NJ) Ranking Republican: Rep. Cathy McMorris Rodgers (R-5th-WA), who replaced retiring Rep. Greg Walden. Joining the Committee in the 117th Congress is Kim Schrier (D-8th-WA), a pediatrician re-elected to her second term and an SVS PAC fund recipient
Veterans Affairs Committee Chair: Rep. Mark Takano (D-41st-CA) Ranking Republican: Rep. Mike Bost (R-12th-IL), who replaced Rep. Phil Roe
Ways & Means Committee Chair: Rep. Richard Neal (D-1st-MA) Ranking Republican: Rep. Kevin Brady (R-8th-TX) With control for the first two years, Democrats are poised to move several of the President’s healthcare priorities on party-line votes. Democrats’ support will also be critical for providing long-term answers to payment issues related to the Medicare Physician Fee Schedule. We also expect additional Republicans to be named to House committees soon. Two physician members, John Joyce (RPA) and Neal Dunn (R-FL), have been working on being appointed to the Energy & Commerce Committee. SVS PAC has supported Dunn in the past. Nicolas Mouawad is a member of the SVS Government Relations Committee.
vascularspecialistonline.com • 15
NEWS FROM SVS
SVS PAC recaps 2020, offers goals for 2021 BY HASAN ALDAILAMI, MD, AND ANDREW BARLEBEN, MD
It is difficult to put 2020 into words. However, despite everything bad that has gone on in the U.S. and nationally, the SVS PAC was lucky to have some successes. AT THE BEGINNING OF 2020, THE PAC WAS losing ground on some key issues. We were struggling to improve our membership support and, more importantly, we were staring down the barrel of a cut of 7–11% in Medicare reimbursement. With multiple specialties potentially affected, we joined forces to advocate against the change. Despite biblical-level atrocities and a catastrophic plague affecting the world, SVS membership banded together and the PAC contributed to a fairly substantial success. The PAC hit the ground running, pushing to have SVS members’ voices heard. This was accomplished through PAC advocates speaking at meetings, publishing articles supporting our causes, and holding virtual town halls with members of Congress. For the two-year 2019–2020 election cycle, the SVS PAC progressed in a positive way. We achieved record-level donations – $191,993. And we achieved that even with shutting down fundraising for three months because of the pandemic. The SVS PAC already is setting its sights higher for this 2022 election cycle. As a comparison, here are PAC
16 • Vascular Specialist
contributions from other societies: National Association of Spine Specialists, $216,968; Society of Thoracic Surgeons, $375,505; American Association of Interventional Pain Physicians, $207,394; and the American College of Cardiology: $753,102. Improvements were made year-overyear.
2019/2020 election cycle:
• $ 191,993 donated; highest in SVS history • 4 03 members contributed to the PAC; highest in SVS history • 7 5 Capitol Club donors (contributing $1,000 or more) donated $120,586 • S ingle-time donors (241) brought in $64,231 • R ecurring donors (163) brought in $127,762 • 1 66 first-time donors or donors who haven’t donated since 2015 contributed $49,090
2017/2018 election cycle:
• $ 124,280 donated • 2 86 members contributed • 8 2 Capitol Club donors donated $148,120 • S ingle-time donors (118 people) contributed $31,985 • R ecurring donors (167 members) contributed $169,660 One of the most crucial metrics above is the percentage of members contributing to the PAC. Obviously the more SVS members who support the PAC, the stronger our voice. Many members of Congress are less likely to open their doors to a PAC unless the PAC has the support of a high percentage of its members. This last cycle, we had 403 members contribute (7% of membership), whereas last year we had 286 members (5%). Our goal for the 2022 cycle is 10% of SVS members contributing and we hope to start off strong in January 2021. But likely the greatest achievement we had last year was to stave off the Medicare cuts. Initially it was not looking good. There
was not a lot of interest during the time of COVID to protect reimbursements of surgical procedures. But after a lot of hard work and perseverance reaching out to those in Congress and offering SVS members a quick and easy way to interface directly with their own lawmakers, we had success. We have a temporary reprieve from reimbursement cuts for procedures, tied into the COVID relief package. This issue will require continued work to make permanent and is just one of many reasons why members and the SVS PAC must remain engaged.
The coming year Nationally and internationally, we still face difficult times. Political unrest, new COVID variants and other issues will definitely affect the lives of SVS members, in addition to the continued potential for reimbursement cuts in 2022 and beyond. Our goals rolling into the 2021-22 election cycle are to continue our relationships with those in Congress we have already gotten to know, engage newly elected lawmakers and/or lawmakers on committees with jurisdiction over health-care issues, and increase awareness of SVS member issues. COVID will continue to affect our practices. As vascular surgeons, we are integral to the care of COVID patients. Our legislators must hear our voice, and we need your continued support to do so. So please stay engaged and be a part of our recurring donation pool. You can donate once a year or monthly; this this will allow us to appear strong in support of our PAC into the new year. Visit vsweb.org/PAC. Hasan Aldailami and Andrew Barleben are members of the SVS PAC Committee.
February 2021
EDUCATION
New SVS online portal heralds vascular education ‘on the go’ BY BETH BALES
To great excitement on the part of leaders and members, the Society for Vascular Surgery (SVS) has launched its new Education Portal, the online hub for all SVS education content.
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he portal links to SVS’s live education offerings, the new SVS OnDemand learning management system (LMS), the Video Library, and includes hours of on-demand lectures, videos and educational resources. “Education is right in your hands,” said Kellie Brown, MD, chair of the Education Committee, which spearheaded the project. “It’s a great resource for vascular surgeons to learn on the go.” Online learning starts on the new SVS Education website page (vascular.org/ Education). The new portal is the home for all of members’ educational needs, including links to live meetings and courses, such as the Vascular Annual Meeting, the Vascular Research Initiatives Conference (VRIC), and Coding and Reimbursement Workshop. It is also the place to find the new SVS OnDemand and SVS Video Library; links to all SVS educational resources such as Journal of Vascular Surgery publications, guidelines and reporting standards; the Vascular Educational Self-Assessment Program (VESAP); the popular Audible Bleeding podcast; and more. The two newest components to the site are SVS OnDemand and the Video Library. SVS OnDemand is the Society’s new platform for online lectures from previous iterations of the Vascular Annual Meeting (VAM), courses, and webinars. It also contains access to Vascular Atlas, with “just-in-time” surgical technique guides. Just-
the time of its launch, SVS members will have access to nearly 300 sessions from previous VAM meetings, VRIC 2020 and the new Vascular Atlas. “This is our easy, one-stop location for all SVS educational content,” said Brown. “The site makes it easy for our members to access quality information in their own time.” Online access has become especially important since the onset of COVID-19, when in-person gatherings were canceled and content needed to be moved online to ensure SVS still met the educational needs of the vascular community, Brown added. “Much thought went into not only organizing the content but also making sure the interface is accessible and user-friendly and the log-in process seamless,” she said. (Members log in with their SVS credentials.) The committee has already started to lay the groundwork for phase II of the site development. That will include the addition of nonsurgery-related topics, such as practice management, wellness for vascular surgeons, even financial literacy. “These are things surgeons need to know, in addition to clinical content,” said Brown. Though launching the site was a big moment, “this is, in truth, an evolution.” “We’re excited that in the future, members will be able to contribute their own content for their fellow members to learn from and
“This is our easy, one-stop location for all SVS educational content”—Kellie Brown in-time learning is an approach to individual or organizational learning and development that promotes need-related training to be readily available exactly when and how it is needed by the learner. The Video Library contains 54 procedural videos on surgical techniques that were presented at prior annual meetings. The SVS hopes to add member, peerreviewed technique videos in the future. At February 2021
to provide members with an additional SVS resource to obtain CME credit. This site will change and continue to grow. The committee looks forward to member feedback and suggestions for other content.” To visit the site, click on vascular.org/Education. To share any feedback, email education@vascularsociety.org.
Kellie Brown
Q&A: Education Committee chair drills down on the details SVS Education Committee chair Kellie Brown, MD, sits down with Beth Bales to answer some questions about the new SVS education platform. Q. P ortal? Website? SVS OnDemand? I keep hearing these terms. What’s what? A. The new Education Portal, vascular.org/Education, provides links to SVS’s Live Education, the new SVS OnDemand, the Video Library, and other education resources. These resources include hours of on-demand lectures, videos and justin-time learning resources, as well as individual or organizational learning and development that is readily available exactly when and how it is needed by the learner. Q. T ell me more about SVS OnDemand and the new SVS Video Library. A. It also links to the new SVS OnDemand. This currently contains close to 300 select educational activities from the 2019 and 2020 annual meetings; materials from the 2020 VRIC and the new Vascular Atlas. The Video Library includes 54 videos that are “how I do it” videos
and videos from the plenary session. Q. How much does it cost? A. During this inaugural launch, SVS members in good standing will be able to access VAM 2019, VRIC 2020, the Video Library and the Atlas for free. SVS ONLINE 2020 meeting content will be free to ONLINE attendees. Others may purchase access to that content via member/nonmember pricing. Trainees may access all materials for free. Q. C an I earn Continuing Medical Education or Maintenance of Certification credits via SVS OnDemand? A. Not currently, but this will be available in the future. Q. I am a non-member. Can I access the materials? A. You can purchase VAM 2019 and 2020 content. All other content is a member benefit. Q. C an I use a mobile device to access the content? A. Yes Q. H ow do I access everything? A. Start at vascular.org/ Education. Use your SVS log-in credentials to access materials. Q. What if I have questions? A. The new SVS OnDemand site includes a “help page,” with the most frequently asked questions.
For additional assistance, email education@vascularsociety.org.
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NEWS BRIEFS
Upcoming symposium for fellows: ‘Building a successful vascular practice’ A symposium designed to educate graduating vascular fellows on succeeding in a community or private practice, as well as an academic setting, is set to take place at the end of February. The virtual 2021 Mote Symposium, hosted by the Mote Vascular Foundation in association with Sarasota Vascular Specialists in Florida, is built around the tagline, “Building a successful vascular practice: What you were not taught in your fellowship.” Participation—limited to 100 attendees—is free for vascular fellows and Society for Vascular Surgery (SVS) members. The symposium takes place Feb. 27 and 28, with the SVS as a co-sponsor. “As economic conditions as well as government regulations change the medical industry, many private vascular practices are having to shut down,” the Mote Vascular Foundation says. “Coupled with a decrease in applications to fellowship programs, this can lead to significant manpower issues for vascular health in this country. In order to help future vascular surgeons succeed, the meeting will incorporate multiple subjects which will allow participants to provide a successful, ethical and highly functional practice to their patients.”—Bryan Kay For more information or to register for the symposium, visit motevascular.com.
Foundation donors Cohort selected for second year of meet challenge Leadership Development Program The SVS Foundation received an extra infusion of contributions in late 2020, thanks to more than 40 new donors and the generosity of four members who matched a portion of these donations. The Foundation received $11,878 from new donors during the year-end Matching Gift Challenge, with the four—William Shutze, MD, Thomas Forbes, MD, Peter Nelson, MD, and Jens Eldrup-Jorgensen, MD— providing an additional $10,000 in matching funds. The Greatest Need Fund garnered $9,910 from 37 new donors, with three members providing an additional $8,000 in matching funds. New donors also contributed $2,468 to the Awareness and Prevention Fund for community health initiatives, with a fourth SVS member providing an additional $2,000 in matching funds. Shutze kicked off the matching challenge, hoping to help earlyand mid-career surgeons develop the “giving habit.” He himself is a latecomer as a Foundation donor, becoming more involved when he saw that the Foundation and its projects impact all SVS members. That was his impetus for sponsoring a Matching Gift Challenge in late 2020, matching donations by firsttime donors up to $5,000 for the Foundation’s Greatest Need Fund. Forbes, Nelson and Jorgensen are pleased with the success of the venture. “Thanks to my SVS colleagues who took up the challenge in support of the SVS Foundation,” said Forbes.—Beth Bales
Congress delays steep Medicare payment cuts Both the House of Representatives and Senate approved legislation to delay steep Medicare cuts that were set to take effect Jan. 1, 2021. This action follows thousands of hours of effort by the SVS Government Relations and PAC Steering committees, Advocacy Council and staff, as well as an unprecedent level of member involvement. Nearly 800 members engaged in grassroots efforts to write their lawmakers and urge their support for stopping the cuts. In four separate efforts to engage with Congress, members sent 2,627 messages to their lawmakers. One campaign, urging Congress to act on bills directed at stopping the cuts, garnered 925 calls to action, an SVS record. “We thank the hundreds of SVS members who responded to our call for action on behalf of their patients – an unprecedented demonstration of the power of the SVS and Surgical Care Coalition to drive our shared legislative agenda," said Ronald L. Dalman, SVS president. "Thanks as well to the SVS Advocacy staff, Policy and Advocacy Council, and Government Relations and PAC Steering committees for their commitment to this effort over the past year. There's more work to do but step one – stopping the draconian and arbitrary cuts – achieved.”—Beth Bales
18 • Vascular Specialist
The Society for Vascular Surgery (SVS) has selected 24 members for the year-two cohort of the Leadership Development Program. Because of the pandemic, the program will include virtual webinars, with an in-person acknowledgement of the group at the 2021 Vascular Annual Meeting. The Leadership Development Program grew out of a need and desire to foster leaders and to create an SVS-branded course relevant to practicing vascular surgeons, who will then be able to make an impact within the specialty. Content highlights such diverse topics as the business and economics of health care, the science and physics of leadership, personality styles and emotional intelligence, conflict resolution and negotiation strategies, as well as a deep dive into the five practices of exemplary leadership as defined by authors James Kouzes and Barry Posner. Faculty members include Bernadette Aulivola, MD, Ali Azizzadeh, MD, Melissa Kirkwood, MD, Amy Reed, MD, and Kenneth M. Slaw, PhD, SVS executive director..—Beth Bales • Babak Abai, MD, Thomas Jefferson University, Plymouth Meeting, Pennsylvania • Nathan Aranson, MD, Maine Medical Center, Portland, Maine • Jonathan Bath, MD, University of Missouri, Columbia, Missouri • Elizabeth Blazick, MD, Maine Medical Center, Portland, Maine • Kathryn Bowser, MD, Christiana Care Health Services, Avondale, Pennsylvania • LeAnn Chavez, MD, University of New Mexico, Albuquerque, New Mexico • Randall DeMartino, MD, Mayo Clinic, Rochester, Minnesota • Yana Etkin, MD, Zucker School of Medicine at Hofstra/Northwell, Brooklyn, New York • Eric Hager, MD, University of Pittsburgh Medical Center, Glenshaw, Pennsylvania • Joseph Hart, MD, Medical College of Wisconsin, Department of Surgery, Milwaukee • Fernando Joglar, MD, University of Puerto Rico School of Medicine, San Juan • Erin Koelling, MD, Walter Reed National Military Medical Center, Bethesda, Maryland • Kimberly Malka, MD, Maine Medical Center, Falmouth, Maine • Loren Masterson, MD, Cleveland Clinic Akron General, Akron, Ohio • Patrick Muck, MD, TriHealth-Good Samaritan Hospital, Montgomery, Ohio • Mary Ottinger, MD, University of South Florida, Tampa, Florida • Michael Siah, MD, University of Texas Southwestern, Dallas • Matthew Smeds, MD, St. Louis University, St. Louis • Tze-Woei (Kevin) Tan, MD, University of Arizona, Tucson, Arizona • Ashley Vavra, MD, Northwestern University Feinberg School of Medicine, Chicago • Yolanda Vea, MD, PeaceHealth Southwest Medical Center, Camas, Washington • Gabriela Velazquez, MD, Wake Forest University School of Medicine, Baptist Health, Winston-Salem, N.C. • Courtney Warner, MD, Albany Medical Center, Malta, New York • Timothy Wu, MD, Jefferson Health New Jersey, Voorhees, New Jersey
Journal supplement outlines updated guidelines, reporting standards The Society for Vascular Surgery (SVS) is starting 2021 with updated guidelines and reporting standards for three vascular conditions. Guidelines on chronic mesenteric ischemia have been developed to provide the best possible evidence for the diagnosis and treatment of patients with chronic mesenteric ischemia (CMI) from atherosclerosis, the guidelines focus on six specific areas, including the diagnostic evaluation, indications for treatment, choice of treatment, perioperative evaluation, endovascular/
Bernadette Aulivola
Melissa Kirkwood
Kenneth M. Slaw
open revascularization and surveillance/ remediation. In addition to highlighting areas for further research, these guidelines are intended to help guide the optimal care of patients with CMI. In the guidelines on thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysms, the authors provide 36 important recommendations on the use of TEVAR for descending thoracic aortic aneurysm (TAA). The reporting standards for endovascular aortic repair of aneurysms involving the renal-mesenteric arteries clarify and update terminology, classification systems, measurement techniques and end-point definitions. All are outlined and reported in a supplement to the January issue of the Journal of Vascular Surgery. Visit vsweb. org/Jan21Supplement.— Beth Bales February 2021
AORTA
Fluoroquinolones linked to increased incidence of aortic aneurysms among US adults BY BRYAN KAY
Fluoroquinolones—one of the most commonly prescribed antibiotic classes in the United States—were associated with increased incidence of aortic aneurysm formation among adults in the United States, a new study published in JAMA (Journal of the American Medical Association) Surgery found.
“T
his association was consistent across adults aged 35 years or older, sex, and comorbidities, suggesting fluoroquinolone use should be pursued with caution in all adults, not just in high-risk individuals,” authors Emily R. Newton, MD, of the department of surgery at the University of North Carolina at Chapel Hill et al conclude. The researchers point to recent studies probing the safety of fluoroquinolones among patients in Taiwan, Sweden and Canada—and a paucity of data assessing the U.S. population and the true extent of what defines those at highest risk. A Food and Drug Administration (FDA) warning was updated in 2018 to include that fluoroquinolone use in highrisk populations should be limited, the research team wrote. “Recent international studies have called into question the safety of this class of antibiotics, with reports showing a possible association with acute aortic aneurysm and dissection development,” they add. Despite such studies and warnings, fluoroquinolones remain the most commonly prescribed antibiotic in longterm care facilities, suggesting minimal practice change, the investigators continue. Newton and colleagues identified prescription fills for fluoroquinolones or a comparator antibiotic from 2005 to 2017 among commercially insured individuals
February 2021
aged 18–64 years in a retrospective analysis of MarketScan health insurance claims. The study included nearly 28 million U.S. adults—or 47.5 million antibiotic episodes—with no known previous aortic aneurysm or dissection, no recent antibiotic exposure and no recent hospitalization. The primary outcome was 90-day incidence of aneurysm and aortic dissection per 10,000 antibiotic fills. Of 47.5 million fills, 9 million (19%) were fluoroquinolones. The median of those with fluoroquinolone fills was 47 vs. 43 with comparator antibiotic fills. Women comprised 61.3% of fluoroquinolone fills and 59.5% of comparator antibiotic fills, the researchers found. Before weighting, the 90-day incidence of newly diagnosed aneurysm was 7.5 cases per 10,000 after fluoroquinolones compared with 4.6 cases in the case of comparator antibiotics. After weighting for demographic characteristics and comorbidities, fluoroquinolone fills were associated with increased incidence of aneurysm formation (hazard ratio [HR], 1.20; 95% confidence interval [CI] 1.17–1.24).
“More specifically, compared with comparator antibiotics, fluoroquinolone fills were associated with increased 90-day incidence of abdominal aortic aneurysm (HR, 1.31; 95% CI, 1.25–1.37), iliac artery aneurysm (HR, 1.60; 95% CI, 1.33–1.91), and other abdominal aneurysm (HR, 1.58; 95% CI, 1.39–1.79), and adults were more likely to undergo aneurysm repair (HR, 1.88; 95% CI, 1.44–2.46)," Newton and colleagues write. Furthermore, the investigators found that when stratified by age, all adults 35 years or older appeared at increased risk, they demonstrate—18–34 years: HR, 0.99 [95% CI, 0.83–1.18]; 35–49 years: HR, 1.18 [95% CI, 1.09–1.28]; 50–64 years: HR, 1.24 [95% CI, 1.19–1.28]; p=0.04. In an associated invited commentary on the study, Amanda C. Filiberto, MD, a general surgery resident at the University of Florida in Gainesville, and Gilbert R. Upchurch Jr., MD, the same institution’s chair in the department of surgery, observed that though contradictory studies have been published recently, “this large cohort study of a U.S. population suggests it is time once again to rethink the use of this class of antibiotics for patients with or without aortic disease.” They added their agreement that fluoroquinolone use “should be pursued with caution in all adults, not just in highrisk individuals,” and also a add a note of
encouragement for the FDA to broaden their warning recommendations. Concluding, Newton and colleagues write that ”fluoroquinolone use in the U.S. and internationally has been associated with an increase in immediate incidence of aortic aneurysm formation.” They continue: “Although the overall incidence of aneurysm formation detected in the present study was low, the aneurysm incidence after a fluoroquinolone fill was 20% higher than that of comparator antibiotics, and consistent among all adults age 35 years or older. “When examining specific anatomic sites, there was a 31% higher incidence of abdominal aortic aneurysm and a 60% higher incidence of iliac artery aneurysm after fluoroquinolone use.” The researchers noted that one limitation of their work involves the fact they were unable to capture undiagnosed aneurysms, in addition to abdominal imaging not having been routinely performed. The authors believe—“contextualizing these data”—the current FDA black-box warnings are warranted “but may need to be expanded to include younger adults with other risk factors.” SOURCE: DOI:10.1001/ JAMASURG.2020.6165
“Recent international studies have called into question the safety of this class of antibiotics”—Emily R. Newton et al
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