News & Media

STS News, Summer 2019 — For cardiothoracic surgeons establishing their research programs or pursuing advanced surgical training, grants from The Thoracic Surgery Foundation (TSF) can serve as stepping stones to bigger endeavors. As the Society’s charitable arm, TSF provides funding for research, education, leadership courses, and surgical outreach missions and awarded $951,500 in grants for 2019. Applications for 2020 grants open soon (see sidebar for more details).  Two previous grant recipients have found that the support provided by TSF has had a significant impact on their careers. TSF Research Grant awardee Bryan A. Whitson, MD, PhD, received an R01 grant for his work with ex-vivo lung perfusion. Lung Transplant Research Grant Paves Way for R01 Study Bryan A. Whitson, MD, PhD, was awarded a $3.4 million, 5-year R01 grant from the National Heart, Lung, and Blood Institute last year—thanks in part to data generated from the TSF Research Grant he received in 2015. Dr. Whitson is the director of the Section of Thoracic Transplantation and Mechanical Circulatory Support at The Ohio State University Wexner Medical Center in Columbus. His research focuses on utilizing ex-vivo lung perfusion (EVLP) to improve the quality of donor lungs and lower the risk of primary graft dysfunction (PGD) after transplant surgery. While patients are continually added to the lung transplant waiting list, the number of available donor organs can’t keep up with demand. And once patients receive new lungs, severe PGD can occur in up to a third. PGD is thought to be caused by ischemia/reperfusion injury; Dr. Whitson and his colleagues theorized that using the protein MG53 during EVLP could help mitigate this injury by reversing damage to cell membranes. With the funding from the TSF grant, the researchers identified the ideal dose of MG53 to be used during EVLP and tested its regenerative and protective functions in rat models. "Not only did the TSF grant provide the financial resources to develop the preliminary data needed for my R01 application, but it also provided external validation to the National Institutes of Health that the research question and methods had merit," he said. "This financial support [from TSF] set the stage for my future research endeavors, allowed me to be promoted, and was absolutely critical to getting the R01 funding." Bryan A. Whitson, MD, PhD Over the course of the R01 grant, the researchers will use EVLP with MG53 to conduct lung transplants in porcine models, setting the stage for future clinical trials. They also will work to solidify an assessment signature that would identify lung injury more precisely than arterial blood gases. Dr. Whitson said his ultimate goal is for more patients to receive lung transplants and have better outcomes. As TSF prepares to open submissions for its 2020 award cycle, Dr. Whitson advised applicants to be persistent and seek strong collaborations. "TSF grants provide resources to advance the research and also bring recognition to the institution," he explained. "This financial support set the stage for my future research endeavors, allowed me to be promoted, and was absolutely critical to getting the R01 funding." Moritz C. Wyler von Ballmoos, MD, PhD, MPH, received the TSF Michael J. Davidson Fellowship to improve his skills in transcatheter therapies. Davidson Fellowship Expands Skills in Minimally Invasive Cardiac Procedures In addition to research awards, TSF currently offers five educational fellowships, including the Michael J. Davidson Fellowship, created in honor of the cardiothoracic surgeon who was killed in January 2015 at Brigham and Women’s Hospital in Boston. Dr. Davidson was a strong advocate for a future that would meld the cardiac catheterization lab with the operating theater, and the fellowship is awarded to early career cardiothoracic surgeons who share his passion for less invasive heart surgeries. 2018 Davidson Fellowship awardee Moritz C. Wyler von Ballmoos, MD, PhD, MPH, has a deep interest in this area, having previously completed fellowships in robotics and minimally invasive cardiothoracic surgery. "This is currently the most exciting and innovative domain of cardiac surgery in which to work," he said. "I have a passion for treating valvular heart disease, and I find the science and technology that we can leverage to improve patient outcomes in this field stimulating." During his yearlong Davidson Fellowship at Houston Methodist DeBakey Heart & Vascular Center in Texas, Dr. Wyler von Ballmoos implanted more than 350 transcatheter heart valves and performed more than 100 minimally invasive surgeries. He spent substantial time in the cath lab and hybrid OR, improving his skills in utilizing transcatheter technology to treat various conditions, including valve disease, paravalvular leak closure, and aortic pathologies. Dr. Wyler von Ballmoos also focused on minimally invasive cardiac surgery cases consisting mostly of mitral valve repair surgery, aortic valve replacement, and coronary artery bypass grafting surgery. He developed expertise in imaging for structural heart interventions, including advanced imaging technology (such as 3D image fusion) that also is useful for minimally invasive cardiac surgery. "Surgeons who are not experts in transcatheter treatments of these disease processes miss out on the opportunity to be the one unbiased advocate offering the full therapeutic spectrum to patients." Moritz C. Wyler von Ballmoos, MD, PhD, MPH "The time spent with thought leaders in the field has given me more breadth and depth in terms of my skillset and knowledge, allowing me to take better care of simple and complex cases alike," Dr. Wyler von Ballmoos said. He encouraged other cardiothoracic surgeons to apply for the Davidson Fellowship and advance their knowledge in transcatheter techniques. "As the Roman philosopher Seneca once said, 'Fate leads the willing and drags along the reluctant.' That is no different for the treatment of structural heart and aortic disease in the 21st century," Dr. Wyler von Ballmoos said. "Surgeons who are not experts in transcatheter treatments of these disease processes miss out on the opportunity to be the one unbiased advocate offering the full therapeutic spectrum to patients." Apply Today for TSF Grants Applications will open on July 15 for a number of awards, fellowships, and scholarships from TSF. Learn more at thoracicsurgeryfoundation.org/awards and submit your application by September 15, 2019. Contact TSF Executive Director Priscilla Kennedy via email or 312-202-5868 with any questions.

Elaine Weiss, JD CEO/Executive Director STS News, Summer 2019 — For most people, April 15 means IRS (tax day). For me, April 15 meant STS (first day on the job as Executive Director). Paying my taxes can be painful; joining STS has been joyful. For more than 25 years, I’ve worked on health care issues and/or been in the professional association management world. Combining my passion for both into one STS executive director position has been energizing, exhilarating, and only occasionally exhausting. Today more than ever, navigating the changing health care landscape while simultaneously ensuring that STS membership value remains strong, represents a significant challenge. Luckily, I savor a good challenge. And, as it turns out, STS produces a wealth of products, programs, and services that constitute a strong arsenal of tools to tackle the multiple issues that cardiothoracic surgeons face such as: A daunting array of regulatory and reimbursement complexities Rapidly emerging techniques and technologies Evolving workplace and employment arrangements Persistent legal liability pressures and increased media scrutiny Greater emphasis on patient safety and quality improvement Increases in both physician burnout and retirements Maintaining a robust pipeline of diverse and talented young physicians The professional challenges are clear. But in times of great challenge, the big question is whether STS is up to the task of facing these challenges and delivering for its members. No surprise; I believe my response is that STS is perfectly poised to tackle the challenges of today and take on the issues of tomorrow. First, STS physician leaders represent the titans of the specialty. The quality of our education through live programs, webinars, and podcasts involves cutting-edge issues and top-line experts. The clinical practice guidelines we develop, position statements we articulate, and mentoring we provide to the newest members of the specialty are powerful initiatives led by impressive professionals. Our visibility in Washington continues to grow as we solidify relationships and interactions with key policy leaders on the Hill, CMS, and the FDA. And when it comes to the RUC—where the entire House of Medicine gathers and establishes the relative value of medical procedures to inform payment decisions—one of our own, cardiothoracic surgeon Peter Smith, leads the entire group. (If this were the musical Hamilton, RUC meetings would definitely represent “the room where it happens.”) STS is perfectly poised to tackle the challenges of today and take on the issues of tomorrow. Nowhere is the STS arsenal more effective in bolstering the profession and its individual members than through the STS National Database. But even a gold standard program can become tarnished if not adequately polished. So, a rigorous process to deliver the next generation database is under way. This will not be “your father’s database” but our “STS National Database 2.0.” (See page 1.) Here at STS, we’re fine-tuning our operations, enhancing technology, and reaching out via social media to meet the changing needs of our members. But at the end of the day, the value of an association for its members still remains the personal interaction with colleagues, mentors, leaders, and future leaders. In today’s world when virtually everything is virtual, I truly believe that the joy of coming together to interact with professional colleagues who share a passion and pursuit of excellence cannot be replaced. Artificial intelligence may be the wave of the future for the practice of medicine, but associations and the role they play on behalf of their members remains based in the traditional yet powerful personal connections one makes throughout his or her career. From finding that first job to fine-tuning your skills to mentoring the next big name in the specialty, STS is “the room where it happens.” So, on April 15 I began my new journey. I’m thrilled to embark on this adventure and help bolster the Society as it serves a specialty that I quickly have come to respect and now proudly represent. I stand ready to do my part in partnership with our terrific surgeon leaders, led by STS President Robert Higgins. I am excited to work together with my impressive new STS colleagues. The good news is that April 15 no longer reminds me of the dreaded tax day. It now represents my anniversary with STS. The bad news is that I was so excited to begin my new role that I ended up filing for a tax extension.

STS News, Summer 2019 — The concept of “fair market value” is a centerpiece in physician employment compensation agreements as mandated by federal law. In this edition of STS News, Dr. G. Randall Green explores the challenges associated with the real-world application of this construct. Frank L. Fazzalari, MD, MBA, Chair, Workforce on Practice Management G. Randall Green, MD, JD, MBA Division Chief of Cardiac Surgery, Upstate Medical University, Syracuse, NY If physicians used clinical research the way that the health care industry uses physician compensation surveys, patient outcomes would be as unpredictable as practice valuations. Most market participants believe that compensation surveys establish a fair market value of physician compensation. Defining ranges of fair market value of physician compensation using these surveys, however, reveals a systemic misunderstanding of the data and leads to an indefensible valuation practice. Compensation market research lacks the rigor of the STS National Database to be used with the same confidence for valuation purposes. Survey data are drawn from voluntary samples, and specialty sample sizes reported can be comparatively small. Many commercial studies also are biased toward large, multispecialty groups providing data. By using a single questionnaire for every specialty, current surveys fail to capture specialty-specific and even subspecialty-specific drivers of value in each of these very different businesses. In our own specialty, consider the significant differences between adult cardiac, pediatric cardiac, and general thoracic surgery. Such incomplete data collection ultimately limits comparability. To use market research for physician compensation valuation, comparability of the survey data to the subject transaction is a threshold issue. Market participants routinely turn to physician productivity as the sole measure of comparability. Here, measures of productivity such as the much-derided wRVU percentile are used to identify a corresponding percentile of compensation. This practice assumes a relatedness between survey data tables and a linear correlation between productivity and compensation. Tim Smith of TS Healthcare Consulting, however, has shown using Medical Group Management Association data that productivity fails to account for as much as 60%-70% of physician compensation. Physician compensation follows a multifactor economic model, and survey instruments that fail to collect a comprehensive dataset limit comparability. The lack of scholarship on the physician compensation data itself limits our understanding and, therefore, the utility of the surveys. The importance of these studies should be clear to anyone in clinical practice. Although a few holdouts remain, the majority of STS members are now employed, leased, or in management positions and, therefore, have financial relationships with hospitals. The requirement that such relationships be at fair market value means that existing physician productivity and compensation market research will be used to establish levels of compensation. What may not be so clear to high-earning physicians is how survey data are used in regulatory compliance cases where hospitals and health systems are alleged to have paid above fair market value for physician services. In two notable cases, Tuomey and Halifax, the compensation valuation expert for the Department of Justice took the position that fair market value should be based exclusively on physician compensation survey data. Due to the nature of participation in voluntary surveys, it is possible that high-earning physicians compose a very small proportion of the sample used to construct currently available compensation data. As such, those same physicians fail to establish the true market for their professional services with resulting increased compliance risk. Although physicians cannot control how the data are used, the power to create a truly representative database of physician productivity and compensation lies with each one of us. As one of the first societies to collect our clinical data to improve clinical outcomes, perhaps it is time to lead once again by using our own practice data to serve our profession. Note: STS will conduct its quinquennial practice survey this fall. More information about this important survey will be provided in the coming months.

Robert S.D. Higgins, MD, MSHA STS News, Summer 2019 — My mother always said that we need to rise to the occasion when things seem challenging in our personal or professional life. Challenges met successfully enhance our ability to tackle the next big obstacle; she would say “pressure makes diamonds.” I later found out that my mother was not the only prophetic person to use this analogy. General George Patton said the same thing in 1944 during WWII. For our specialty, recent circumstances surrounding the public reporting of surgical outcomes have and will continue to create a beachhead and challenge our profession to rise to the occasion. At a recent STS National Database brainstorming session, surgeon leaders emphasized the importance of participation. Since 1989, the STS National Database has been the premier clinical outcomes registry in cardiothoracic surgery, focusing on quality assessment and process improvement, with more than 90%-95% penetration within the adult cardiac and congenital programs in the US. The four component registries that make up the Database have more than 7.9 million surgical records from more than 6,000 participating surgeons, anesthesiologists, and other physicians in 11 countries, making it the respected leader of clinical registries worldwide. We take that role seriously, and we continue to assess the foundations of appropriate risk-adjusted performance measurement while enhancing participant satisfaction, reducing data entry burden, and maximizing Database utilization and ease of use. The beneficiaries of STS National Database participation are widespread and include STS members, hospitals, patients, health care organizations, and federal regulators (CMS and FDA), as well as medical device, pharmaceutical, biotechnology, and insurance companies. It’s no surprise that recent high-profile articles critiquing congenital heart surgery programs reference the value of publicly reporting risk-adjusted outcomes using the Database. At this moment in time when the pressure to meet or surpass expectations is greatest, our specialty will rise to the occasion. But it’s not just about measurement; it’s about improvement. In my opinion, participation itself should not be the only goal; quality assessment and process improvement also are extremely valuable tenets. We strongly encourage our members and their programs to use their participant data to internally evaluate team performance and measure observed outcomes versus expected performance. Even though the risk-adjustment models are not perfect (they continually undergo upgrades and improvements), they give our profession the best means to measure and improve the morbidity and mortality associated with adult and congenital heart surgery. This has been the case with open heart surgery, as morbidity and mortality have been reduced significantly over the past 30 years! It’s not a perfect business. We understand and empathize with patients and families who have imperfect and complicated outcomes after open heart surgery. They deserve the best that our profession can offer. Reporting outcomes in a transparent and understandable format offers them the best chance to make informed decisions for a successful procedure and outcome. We are hopeful that the data reported through the STS Public Reporting system are a value-add to patients and programs. We recently modified our STS Public Reporting website to provide more accurate and clear delineations of how the star quality metrics are determined and to emphasize their value as internal, program-specific metrics for patients and professionals. The majority of adult and congenital heart programs (more than 90%) are ranked as two- or three-star programs. These reported outcomes allow patients, surgeons, and hospitals alike to determine their performance against industry norms. Some cardiothoracic surgery programs don’t meet their own expectations. But we are certain that these programs and others around the country will use their data to make improvements. At this moment in time where the pressure to meet or surpass expectations is greatest, our specialty will rise to the occasion, just as it has done over the past 30 years. By reviewing outcomes regularly and instituting better ways to take care of patients, we can continually enhance quality and potentially save lives. As we respond to today’s extraordinary challenges and pressures, quality assessment and improvement efforts led by The Society of Thoracic Surgeons will remain a “jewel” for modern health care in the years to come.

STS News, Summer 2019 — A major transformation is under way to the STS National Database that will change the way that participants interact with the Database, monitor performance, and use the Database for quality improvement initiatives at their own institutions. The Society will be using a new data warehouse, IQVIA, a leading global provider of advanced technology solutions. IQVIA’s extensive track record in the health care arena, along with its transformative solutions, will provide Database participants with: Cloud-based technology Interactive dashboards Unique insights using real-time results Resource savings through streamlined data collection The Duke Clinical Research Institute will remain an analytics center for the Database. “We’ve been working tirelessly on this extremely important initiative for more than a year,” said STS President Robert S.D. Higgins, MD, MSHA. “We listened to participant feedback and understood that we had a huge opportunity to modernize and optimize the Database. The Society has made a substantial financial commitment and is taking the necessary steps to roll out this next generation Database in early 2020.” Among the most important changes for the Adult Cardiac Surgery Database (ACSD) will be a reduction in data fields by at least 30%. “This reduction will save resources and make data abstraction far more manageable by removing minimally utilized fields and keeping those essential for quality improvement, risk assessment, and future analyses,” explained Vinay Badhwar, MD, chair of the STS Council on Quality, Research, and Patient Safety. Participants in all component databases can continue working with their current software vendors, but they won’t have to—unless they want to—after January 2020. Other improvements include new staging for the General Thoracic Surgery Database and STAT category and risk model updates for the Congenital Heart Surgery Database. “There will be something for everyone, and we look forward to vigorous beta testing and showing you the results,” said Dr. Higgins. “This is an exciting time for the specialty!” New dashboards will be demonstrated and additional information will be shared at the Advances in Quality & Outcomes: A Data Managers Meeting, October 23-25 in New Orleans. For more information on the AQO Meeting, visit sts.org/aqo. Advanced Outcomes and Research Capabilities Also on Horizon In addition to the new and innovative registry platform that will be offered to Database participants, the Society also is taking steps to enhance outcomes reporting and make the Database more impactful. STS is working on several initiatives that would supplement data available in the STS National Database with longitudinal death follow-up, cause-of-death, reoperation, and socioeconomic data. These changes will enable investigators to conduct research focused on long-term outcomes on a national scale, disparities, access to care, and cost-effectiveness. “We are on the verge of integrating National Death Index data with the Database to transform it into a powerful multiyear follow-up registry,” said Dr. Badhwar. “It would be a game changer for the specialty.” More information on all of these new projects will be available in the coming months.

STS News, Summer 2019 — With trends emerging and new data available, the time may have finally come to designate transcatheter aortic valve replacement (TAVR) as the preferred treatment for aortic stenosis in most patients. Since the first valve implantation in 2002, TAVR’s feasibility and effectiveness have consistently been substantiated by an accumulation of rigorous, evidence-based clinical experience. Simplification of the technique and improvements in valve design and delivery systems also have helped advance this rapidly evolving technology. Data from the STS/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry™ confirm that the number of TAVR procedures performed annually in the US is more than double the number of isolated surgical AVR procedures performed to treat aortic stenosis. In 2012, when the technology was first approved by the US Food and Drug Administration (FDA), fewer than 5,000 TAVR procedures were performed. Six years later, in 2018, more than 59,200 TAVR procedures were completed in the US, while an estimated 25,274 isolated SAVRs were performed. This is an “amazing and dramatic development,” according to Joseph E. Bavaria, MD, chair of the STS/ACC TVT Registry Steering Committee. At Penn Medicine in Philadelphia, where Dr. Bavaria is co-director of the Transcatheter Valve Program, between 400 and 500 TAVR procedures are performed each year. TAVR Could Benefit Low-Risk Patients First reserved only for inoperable patients or those at high surgical risk, TAVR has since expanded to intermediate-risk patients. Next in line for TAVR are patients who are at lower risk for surgery, explained Dr. Bavaria. At the most recent ACC annual meeting, researchers presented two randomized TAVR trials—PARTNER 3 and EVOLUT—that confirmed the benefits of TAVR in the lowest-risk patients to date and are expected to pave the way for a new low-risk indication for TAVR technology. “I anticipate that TAVR will be FDA approved for low-risk patients, and this will be an important advance as it will change the way aortic valve replacement is performed in 70% of all patients with aortic stenosis,” said Dr. Bavaria. In the PARTNER 3 study, researchers investigated the outcomes of 1,000 patients across 71 hospitals—half underwent traditional open heart surgery and the other half received TAVR. The data indicated a 46% reduction in death, stroke, and rehospitalization at 1 year for the TAVR group. In addition, postoperative or new-onset atrial fibrillation was reported in only 5% of TAVR patients, compared to approximately 40% of SAVR patients. It is important to note that the trial demonstrated outstanding results for open heart surgery, as well. “It is important that quality remains robust.” Joseph E. Bavaria, MD The EVOLUT study also supported TAVR as a safe alternative to traditional surgery. This research, which included 1,403 patients who randomly were assigned to undergo either TAVR (n=725) or SAVR (n=678), demonstrated that TAVR, when compared to open heart surgery for valve replacements, had a similar rate of disabling stroke or death at 2 years (5.3% versus 6.7%, respectively). Paired with the results of the PARTNER 3 trial, the EVOLUT findings suggest that low-risk patients do as well and maybe even better with TAVR than with SAVR after 2 years. Both the PARTNER 3 and EVOLUT studies were published in the New England Journal of Medicine (NEJM). Also important to shaping the future of TAVR is the TVT Registry. Often referred to as a “national treasure,” the Registry is an essential component in TAVR data collection. The list of published research using data from the TVT Registry continues to grow; very importantly, the research has provided essential information on new therapies and identified outcomes in groups of patients not treated in randomized clinical trials (such as those with bicuspid aortic valves). “One wonderful thing about the TVT Registry is that it includes all TAVR cases throughout the entire United States,” said Richard J. Shemin, MD, chief of cardiac surgery and the Robert and Kelly Day Professor of Surgery at UCLA Health and the David Geffen School of Medicine. “It’s real-world experience that continues to evolve and will help provide outcomes data as the patient populations and indications change. In addition, the data will allow hospitals and TAVR teams to compare themselves to other sites, ensuring high-quality results and appropriate indications for the procedure. I think this gives a lot of confidence to the people who will suffer from aortic valve disease and eventually need a TAVR.” The Value of Volume Included in the Registry are approximately 610 participating TAVR sites, with 130 added just in the past 2 years. Dr. Bavaria explained that experts expect an increase to more than 850 sites within a few years. This growth is noteworthy, especially since the volume-outcome relationship debate is ongoing and was a hot topic considered by the Centers for Medicare & Medicaid Services (CMS) as it finalized a new TAVR national coverage determination (NCD). For the latest on the TAVR NCD, see page 15. “TAVR will be the mainstay treatment for aortic stenosis. Period.” Joseph E. Bavaria, MD “With too many centers in the market, you work against the volume-outcome relationship, meaning that as cases get diluted over a lot of centers, each center does less TAVR volume,” said S. Chris Malaisrie, MD, co-director of the Bicuspid Aortic Valve Clinic and Thoracic Aortic Surgery Program at Northwestern Medicine in Chicago. “It’s been shown that the less you do, the worse the outcomes; the more you do, the better the outcomes.” A recent study published in NEJM supported a volume-outcome relationship. Dr. Bavaria and colleagues analyzed data from the TVT Registry, which included 113,662 TAVR procedures performed at 555 hospitals by 2,960 operators from 2015 to 2017. The investigators observed an inverse volume-mortality association, with mortality at 30 days higher and more variable at hospitals with a low procedural volume than at hospitals with higher volumes. The new NCD relaxes volume requirements, especially for hospitals looking to start a TAVR program. At the same time, CMS is trying to find the right balance between ensuring quality of care and maintaining sufficient access to TAVR. Dr. Bavaria explained that STS and ACC will work with CMS to develop “proper and sophisticated” metrics that will help guide the transition from a pure volume metric to an outcomes metric. This will help centers better determine areas of deficiency and hone in on specific outcomes measures that may be difficult to identify in day-to-day practice. “We want to help ensure, through the TVT Registry and with these new metrics, that low-volume sites are performing quality work. We also want to identify any sites—low or high volume—that are performing work that is below standard,” said Dr. Bavaria. “It is important that quality remains robust.” Future of CT Surgery With more and more centers offering TAVR and an increased number of patients opting for this procedure over open heart surgery, what does the future of heart surgery look like? Dr. Malaisrie explained that surgeons will have to adopt a new skillset to include interventional and catheter-based procedures. In addition, the expansion of TAVR will affect how the next generation of cardiac surgeons are trained. Dr. Bavaria agreed. “If you’re a cardiothoracic surgeon and you’re not involved with TAVR, your aortic valve treatment operations are going to decline. TAVR will be the mainstay treatment for aortic stenosis. Period.”