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STS News, Winter 2021 — Nine years after the US Food and Drug Administration (FDA) approved the first transcatheter aortic valve replacement (TAVR) device, TAVR therapy volume is skyrocketing and patient outcomes continue to improve. TAVR case volumes have risen steadily since 2011 and, in 2019, the state-of-the-art therapy exceeded all forms of surgical aortic valve replacement (SAVR), according to a report using data from the  STS/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. “This report summarizes massive amounts of data about the US TAVR experience and includes 276,316 patients treated from 2011 to 2019,” said John D. Carroll, MD, chair of the STS/ACC TVT Registry Steering Committee and lead author of the report. “In addition to volume, the data document a substantial improvement in quality of care over the last 9 years.” In 2019, TAVR case volume exceeded all forms of SAVR, positioning TAVR as the dominant form of AVR. Expanded Patient Access TAVR now is a treatment option for most aortic stenosis patients. In 2011, it was indicated only for those at extreme risk for surgery. In 2012, high-risk patients were added, followed by intermediate-risk patients (2016), and low-risk patients (2019). These risk categories importantly have helped shape clinical trial design and regulatory approval, as well as real-world practice. The report, published in The Annals of Thoracic Surgery and the ACC journal, showed that from 2011 to 2018, extreme- and high-risk patients remained the largest group undergoing TAVR, but in 2019, intermediate-risk was the leading patient group. It’s worth noting that in the first year of FDA approval for low-risk patients, the TAVR population included 8,395 low-risk patients—a likely contributor to SAVR case volume falling behind TAVR. When the FDA first approved use in low-risk patients, experts widely predicted that it would pave the way for an even more rapid TAVR expansion, with the transcatheter-based therapy replacing a significant portion of SAVR procedures in the years to come. Nonetheless, the number of people undergoing any form of AVR—transcatheter or surgical—grew by 94% from 2012 to 2019. This likely is due to greater disease awareness and an aging population, which results in more people being treated. TAVR Programs Offered in All 50 States In response to the demand, more and more hospitals are launching TAVR programs. In 2020, Wyoming saw its first site open, extending TAVR’s reach to all 50 states and 730 participating centers. The number of TAVR procedures performed per site varies, but as the number of sites has increased, so has the total annual volume. In 2019, most centers performed an average of 84 TAVR procedures, while 161 sites each performed fewer than 50 cases. “The TVT Registry allows us to see major trends occurring in the real-world TAVR patient population, including a rapid growth in both the number of hospital sites performing TAVR and case volume as we treat a broader spectrum of patients,” said Dr. Carroll. Voluntary public reporting for TAVR programs will be available in fall 2021. See page 13 for more information. The data on outcomes after TAVR show a substantial improvement in quality of care over the last 9 years. Outcomes Improve Over Time While SAVR traditionally has been the standard treatment for severe aortic stenosis, TAVR has emerged as a strong alternative treatment, providing promising patient outcomes. Since the early days, there has been steady and dramatic improvement in TAVR mortality. In 2012, in-hospital mortality was 5.7%, falling to 1.3% in 2019. The 30-day mortality also decreased—from 7.5% to 2.5% during that same period. Hospital stays for patients also improved—from 7 days to 2 days. More specifically, low-risk patients had a median length of stay in 2019 of only 1 day—an overnight hospital stay—with some patients discharged the same day. In the early TAVR period, most patients were discharged to another care facility; however in 2019, 90.3% of patients were discharged home, while only 6.6% were discharged to a rehabilitation or extended care facility and 2.5% to a nursing home. “The transformation of care for patients with aortic stenosis has been dramatic,” said Dr. Carroll. Two areas in which experts said they want to see improvement are stroke rates and the 30-day pacemaker implantation rate. Although the stroke rates showed a small, downward trend, the in-hospital stroke rate was 1.6% and the 30-day rate was 2.3%. The 30-day pacemaker implantation rate remained relatively unchanged since 2011. The early rate was 10.9%, it peaked in 2015 at 15.1%, and then slowly declined to 10.8% in 2019. The state of TAVR report documented a clear shift in vascular access.   Patient-Reported Quality of Life The TVT Registry has been innovative in gathering patient-reported data on quality of life, using a questionnaire tool before treatment. The survey provides a measure of the patient’s perception of his/her health status, including symptoms, impact on physical and social function, and quality of life. In 2018—the most recent year with 1-year patient-reported outcomes data—80.7% of all patients who were alive 1 year after TAVR, reported a good quality of life. In addition, a subgroup analysis revealed that a favorable outcome was achieved in 77.7% of high-risk patients, 83.6% of intermediate-risk, and 85.8% of low-risk patients. “The routine use of patient-reported health status using the questionnaire has allowed this new metric to emerge,” said Dr. Carroll. “A better understanding of a patient’s baseline status and the impact of their aortic valve disease is possible. It also provides an assessment of whether the intervention has caused an improvement in the patient’s life.” Racial Disparities in TAVR Racial minorities are underrepresented among patients undergoing TAVR in the US, according to the report. For all years, TAVR patients were predominantly white. While the number of black patients receiving TAVR increased from 504 during the early TAVR period to 2,948 in 2019, only 4% of all patients receiving TAVR were black—this has not changed in the past 9+ years. Possible contributing factors include access to primary care, referral for further testing, and bias at a treatment level, as well as insurance, socioeconomic factors, cultural beliefs, and patient preferences. Researchers said that they expect these gaps to stimulate further research. “The TVT Registry can monitor whether there are unexpected differences among people of different races, ethnic groups, and rural residency,” said Dr. Carroll. “While it cannot ascertain causes, the Registry can assess whether there are changes associated with variables such as expansion in the number of sites, campaigns to alter disease awareness, and other mechanisms to reduce disparities in care.” COVID-19 Challenge And finally, the COVID-19 pandemic has had an impact on all programs, but especially on those performing TAVR with urgent clinical indications. The report stated that the coronavirus “impaired submission of data” from some sites in 2020. As a result, researchers expect to see major decreases in the number of patients being treated. The Centers for Medicare & Medicaid Services has already announced that it will not hold hospitals and physicians responsible for meeting volume requirements mandated for reimbursement for a range of procedures, including TAVR. According to the researchers, "further growth is expected with recovery of the health care system" after COVID-19. The report, “STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement,” is available at annalsthoracicsurgery.org.

STS News, Winter 2021 — The first public reporting results are expected to be available in October for transcatheter aortic valve replacement (TAVR) procedures in the United States. More than 300,000 TAVRs have been performed since the Food and Drug Administration’s first TAVR device approval in 2011 and the subsequent Medicare reimbursement requirement that all TAVR procedures be reported to the STS/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. “When we first considered public reporting for TAVR, we started off by asking the question, ‘Do we need to do this?’,” explained Nimesh D. Desai, MD, PhD, chair of the STS TVT Registry Risk Model Work Group. “We found that the answer was ‘Yes’ because early data show a variation in mortality outcomes between hospitals. We don’t know if it relates to volume or something else, but there certainly is site-level variation in outcomes after TAVR.” Public reporting through the STS National Database and other registries has shown that the activity encourages transparency of outcomes, attention to quality metrics by hospitals and physicians, contributions to national registries, and increased choice by consumers—more shared-decision making between caregivers and patients. The new TVT Registry public reporting website will include information on a participant’s first TAVR procedure, the number of cumulative procedures performed, and average annual volume over a 3-year rolling period. It also will show a distribution of the participating hospital’s annual volume compared to that of other hospitals in the TVT Registry. Outcomes will be a 30-day composite reflecting 30-day death, stroke, life-threatening major bleed, acute kidney injury, moderate to moderately severe paravalvular leak, or none of the above. Each site will be categorized as having results that are better than expected, as expected, or worse than expected. “TAVR technology is changing rapidly, but more importantly the patients that we are operating on are changing rapidly,” said Dr. Desai. “We are performing TAVR on younger and healthier patients, so we needed to develop a risk model that not only would be predictive of outcomes in 2020, but also would adapt and evolve to what things might look like in 2025 and beyond.” The methodology for the risk model is expected to be published this spring. For more information on the state of TAVR, see page 14.

STS News, Winter 2021 — A year after the next generation STS National Database was launched, providing landmark advancements for the most robust clinical outcomes registry in cardiothoracic surgery, significant new features continue to roll out, helping participants with self-assessment, quality improvement, and—most important—patient care. Risk-adjusted dashboards for the Adult Cardiac Surgery Database (ACSD) and General Thoracic Surgery Database (GTSD) are anticipated later this month. These dashboards will allow participants to compare their risk-adjusted institutional results with benchmarked STS aggregate data. Also expected soon are the highly anticipated longitudinal dashboard reports, which have been undergoing careful development and extensive testing. “The ACSD longitudinal dashboard will be launched first, followed by the GTSD and CHSD,” explained Felix G. Fernandez, MD, MSc, chair of the STS Workforce on National Database. “Participants will be able to view outcomes such as risk-adjusted mortality rates and observed-to-expected mortality ratios over time. The goal is to provide meaningful and actionable data to aid with continuous performance improvement, as well as help facilitate informed decision-making conversations with patients.” The ACSD also was first to experience a data specification upgrade in the new platform. Now with that upgrade firmly in the rearview mirror, beta testing and refinements are a focus for the GTSD data specification upgrade (v5.21), which is expected to go live in July. “This new version includes upgrades in the staging of thoracic malignancies and greater detail on thoracic operations, including more specificity on minimally invasive approaches,” said Dr. Fernandez. “Importantly, grading scales have been added for operative complications in the GTSD. This will allow for the relative severity of a complication to be ascertained from minor to life threatening. This approach may, in the future, refine definitions of major morbidities in thoracic risk models.” Also important for the GTSD is the lung cancer composite that was added to the portfolio of performance measures to complement the lobectomy for lung cancer measure. “Lung cancer can be removed with varying extents of pulmonary resection from wedge to pneumonectomy; extent of resection impacts operative risk and may be at the discretion of the operating surgeon. Therefore, it was important to create a lung cancer resection model that encompasses all extents of pulmonary resection for a more comprehensive measure of lung cancer surgery,” said Dr. Fernandez. Detailed information on the new composite is expected to be published soon in The Annals of Thoracic Surgery. A separate article in The Annals will focus on analyses conducted on the impact of smoking status and surgical approach (thoracotomy vs. minimally invasive) on lung cancer resection outcomes. Indian Society Joins ACSD The newly formed Society of Coronary Surgeons in India and all of its member surgeons are now participants in the ACSD. Although sites in India previously participated in the CHSD, this is a first for the ACSD and provides a great opportunity for collaboration with surgeons who perform high volumes of cardiac procedures. This collaboration will extend not only to quality assessment and improvement, but also may involve research. Data Harvests and Public Reporting During the first year of the Database transition, COVID-19 greatly impacted hospitals. Data harvest deadlines were extended, harvest reports were delayed and public reporting was put on hold in order to carefully review the impact of the pandemic on cardiothoracic surgical patients. The 2020 hiatus in public reporting provided an opportunity to revamp the public reporting website to allow increased search functionality, as well as new outcomes results. The release of the updated website is planned for early 2021. And as the ACSD, GTSD, and CHSD prepare to resume public reporting, the STS/ACC TVT Registry is taking steps for its first foray into public reporting (see page 13). Future Innovations Behind the scenes, many surgeon volunteers, STS staff, vendors, and others are working tirelessly on future innovations and game-changing practice improvement tools and programs for the STS National Database and its approximately 4,300 surgeon participants. These projects include using artificial intelligence to assist with data entry, a site visit program for participants who want help with process improvement, and implementation of supplemental datasets for even more comprehensive outcomes analyses. Through a collaboration with Northwestern University, National Death Index (NDI) follow-up data were acquired for more than 2.6 million unique patient records in the ACSD, GTSD, and CHSD. After data adjudication and merging, three subspecialty analytic datasets will be created for use through the STS Research Center. In addition to death data, STS has acquired socioeconomic status data on 4.2 million records in the Database. Socioeconomic data tables mapped to specific geocodes are now available to STS for linking to project-specific datasets. The derived geocodes also will be used to calculate an Area Deprivation Index measure for use in research and quality initiatives. “Data enhancements such as the NDI and socioeconomic status are central to our mission to deliver high-quality and long-term value to our patients and the public,” said Kevin W. Lobdell, MD, LTC, MC, USAR, chair of the STS Workforce on Research Development. For the latest on the STS National Database, go to sts.org/database. For more information on the STS Research Center projects, visit sts.org/researchcenter.  

An internationally renowned cardiothoracic surgeon known for his humility and civility passed away on November 20 at the age of 93. Vincent L. Gott, MD, became the Society’s 27th President in 1992 after having served as the Society’s Vice President. An STS member for more than 50 years, he also held positions on several committees. In his STS presidential address, “And It Happened During Our Lifetime…,” Dr. Gott discussed several pioneer surgeons and asked what they all had in common. “The descriptors I would use include brilliance, courage, dogged determination, and unbelievable creativity,” he said. Not surprisingly, those are some of the same words that his colleagues and friends now use as they remember him. STS Past President, William A. Baumgartner, MD, who was a longtime associate of Dr. Gott, said, "Vince was really a man for all seasons—he was an incredible clinical surgeon, an amazing innovator, and he was gracious, compassionate, and a model of civility. When you think of Vince, a smile comes on your face." Born in Wichita, Kansas, Dr. Gott had the privilege of spending time with a prominent plastic surgeon in his hometown and observing some of his operations. This experience influenced him to pursue a career in plastic surgery. But all that changed with a sketch and a surgery. After receiving his medical degree from Yale University School of Medicine, Dr. Gott completed his internship and surgery residency at the University of Minnesota Hospitals. There, Dr. Gott was invited to observe C. Walton Lillehei, MD, as he repaired a congenital heart defect. Dr. Gott later sketched a procedural drawing of the surgery and added it to the patient's record. The skill and detail of the sketch so impressed Dr. Lillehei that he invited Dr. Gott to join his research laboratory. From that point on, Dr. Gott knew that cardiothoracic surgery was his future. In 1965, Dr. Gott became an associate professor of surgery at The Johns Hopkins University School of Medicine and chief cardiac surgeon for The Johns Hopkins Hospital, where he practiced for 55 years. During his career, Dr. Gott collaborated with some of the greatest minds in medicine, which led to extraordinary contributions. He was the first to perform experiments proving that an electronic stimulator could jump-start the heartbeats of patients—a discovery that led to the development of modern pacemakers. Dr. Gott also revolutionized heart valve designs and performed the first heart transplant operation at The Johns Hopkins Hospital. In addition, Dr. Gott was an expert in treating potentially deadly aortic aneurysms caused by Marfan syndrome.

STS News, Winter 2021 — Imagine this: You’re standing beside renowned surgeon Robert J. Cerfolio, MD, MBA, in an operating room at NYU Langone Health in New York City. You are watching every move he makes during a robotic lobectomy. You are listening intently as he talks you through his thought processes. You are looking around and able to see who is in the operating room, where they are standing, and what equipment is being used. And, almost unbelievably, you are doing all of this while sitting in front of your computer at home or in the office. That’s exactly what attendees can expect from “Immersive Video Experiences”—a new and exciting course series offered during STS 2021. “This is an amazing opportunity to bring the outside world into your operating room,” said Dr. Cerfolio. “Attendees will not only witness the technical aspects of a procedure, but they also will see and feel how you lead, how you inspire those around you to perform at their optimal levels, and how you make everyone in that room understand that although this is just another day of work for them, it’s that patient's only operation.”   In the OR with… The series, scheduled for Friday morning of STS 2021, will open with visits to the operating rooms of five different surgeon luminaries. These “In the OR” sessions will offer an interactive and visceral way to experience a robotic lobectomy, a congenital heart surgery, a valve-sparing aortic root procedure (reimplantation), a video-assisted thoracoscopic (VATS) lobectomy, a transcatheter aortic valve replacement (TAVR), and a transcatheter mitral valve-in-valve replacement. Alongside world-class surgeons—Dr. Cerfolio, Joseph A. Dearani, MD, from the Mayo Clinic in Rochester, Minnesota, Joseph E. Bavaria, MD, from Penn Medicine in Philadelphia, Shanda H. Blackmon, MD, MPH, from the Mayo Clinic in Rochester, Minnesota, and Vinod H. Thourani, MD, from Piedmont Heart Institute in Atlanta, Georgia—attendees will experience these procedures from start to finish and be able to take in the entire operating room environment in a way that they’ve never been able to do before—at least from in front of a computer screen. With the use of specialized 360° cameras, participants will observe not just the insides of the chests, but they also will witness all of the outside happenings, including the sights and sounds of the surgeries—all real-life, no avatars, drawings, or animations—just as though they are in the room. Dr. Cerfolio explained that the series makes available “all of the optics” in the operating room: How do the team members get along? How do they move around the OR? What’s the culture in the room? How is the OR set up? What's being said during the surgery? What is the leadership style of the surgeon? Is it effective? “The immersive video experiences don’t offer a myopic view that just studies the surgical field and the technical exercise of the operation. But more so, the series offers additional unique features that help participants really understand how surgery is a team sport,” he said. During the sessions, the surgeons will talk through the actual operative techniques, as well as demonstrate the difference between good outcomes and masterful ones. A moderator will discuss with the surgeon key aspects of the procedure, drive the 360° views, and engage the audience during interactive discussion periods. “While traditional videos of surgical or transcatheter procedures offer only a unidimensional experience, this program allows participants to be engrossed within all aspects of the procedures and is guaranteed to enhance the learning of these complex surgeries for not only practicing physicians, but also residents and the entire heart team,” said Dr. Thourani. Deep Dives into... Following the “In the OR with...” series will be 11 “Deep Dive” courses. In these sessions, expert surgeons will share comprehensive dives into particular procedures, using a combination of video segments and interactive group discussions. The detailed descriptions, in-depth explanations, and meaningful conversations will provide participants with a full-bodied understanding of the following topics: Essentials of TAVR Valve-Sparing Aortic Root Procedure (Reimplantation) VATS Lobectomy Robotic Lobectomy Transseptal Puncture for Surgeons Minimally Invasive Mitral Valve Surgery Minimally Invasive Esophagectomy Chest Wall Reconstruction after Tumor Resection Ross and Ross-Konno–Preventing Neoaortic Root Dilatation Navigating Initial Nights on Call: A GPS Guide for Residents How can I get out of this operating room? Valve Replacement Strategies in Neonates and Infants The Immersive Video Experiences are an optional add-on program that can be secured during STS 2021 registration for an extra fee and include both the “In the OR with…” and “Deep Dives into...” sessions (16 in all). For more information, visit sts.org/annualmeeting.    

Joseph A. Dearani, MD STS News, Winter 2021 — It’s finally 2021. I’m glad that 2020 is in the rearview mirror. 2020 took a toll on everyone—from the global pandemic and greater awareness about social injustices, to wildfires, hurricanes, and other natural disasters. No one was immune from stress, exhaustion, and uncertainty. Cardiothoracic surgeons rose to the challenge, however, and showed their grit throughout the year. Every day, I am proud that I chose this profession. I am proud of my colleagues, especially those on the front lines who have consistently shown great compassion and strength. I also am proud to be an STS member. During a most difficult and disruptive year, volunteer leaders and staff forged ahead with initiatives that were already in process and used their ingenuity to introduce new ways of supporting the specialty and helping members with their day-to-day needs. Not only did the various phases of the next generation STS National Database push forward and continue to evolve and advance the specialty (see page 12), but we also offered a series of online educational opportunities that included basic and advanced virtual courses, hour-long webinars, 8-minute microlearning videos, and the long-awaited launch of the STS Cardiothoracic Surgery E-Book (see fall 2020 issue of STS News). In mid-December, on the day that a US Food and Drug Administration committee recommended approval of the first COVID vaccine, Dr. Melanie Edwards and I hosted an evening webinar during which we talked to three high-profile infectious disease experts who offered their expertise, advice, and guidance. We discussed COVID therapeutics, various nuances about the vaccine, how to keep health care workers safe, and talking points for our patients. If you didn’t have a chance to watch the webinar, it is available on the STS YouTube Channel or via the STS website at sts.org/covid-19. Because it will take months to distribute and administer vaccines around the world, Dr. Deborah Birx, from the White House Coronavirus Task Force, emphasized the importance of vigilant prevention. I echo her concerns that the presence of effective vaccines may lead some to act recklessly.   Please tell your family, friends, and patients to wear their masks, practice social distancing, and maintain routine health care. It’s also important to get a flu shot. Having coinfection with flu and COVID could be devastating. Life will get back to normal, but not any time soon. We need to be patient for a little longer, but I am confident that we again will rise to the challenge—as we have before—and we will get through this. Every day, I am proud that I chose this profession. I am proud of my colleagues, especially those on the front lines who have consistently shown great compassion and strength.  Joseph A. Dearani, MD STS 2021 In a few short weeks, STS will hold its annual meeting. Although STS 2021 will be virtual, that doesn’t mean it will be an online version of what you would experience in a convention center. Yes, you still will have the opportunity to hear about late-breaking research and witness pioneers and luminaries in our field discuss and debate important topics. But we’ve embraced technology and developed a program that will make the most of that online experience. The meeting will be interactive, allow you to see inside an operating room during a procedure, ask questions, chat with friends, and take part in social and wellness activities (see cover story).  A few months ago, when the Board of Directors made the very difficult decision to convert STS 2021 into a virtual meeting, we didn’t know how long the pandemic would last. Many of us were reluctant to change an event that we look forward to every year. We now know that we made the right decision. I want to express my gratitude to the Workforce on Annual Meeting, under the direction of Dr. Juan Crestanello and task force chairs Drs. Mara Antonoff, Tom Nguyen, Usman Ahmad, and Sloane Guy, for their strong work with the STS staff to create what will be an unforgettable experience. Advocacy Victory Before I sign off on my last STS President’s Column, I also want to thank my colleagues who worked tirelessly to fight—and beat—the unfortunate and misguided CMS decision to significantly cut Medicare reimbursement for cardiothoracic surgeons. We, again, rose to the challenge; we won the initial battle, but the fight is far from over. See page 18. Finally, I want to thank you and all STS members for their support and feedback. I am honored to have served as STS President for the past year. I look forward to seeing you virtually at STS 2021. Be well and be safe.