Quality Improvement

A must-see session for pediatric surgeons will showcase the first study that analyzes multiple factors impacting survival of young patients with ventricular assist devices (VADs) over the last decade.  “Variables Affecting Survival in Pediatric Patients Supported with VADs: A Special Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report,” will be presented at 11:30 a.m. PT on Sunday, January 22, 2023, during the STS Annual Meeting. The presentation is part of the STS “Current Controversies in Congenital Transplantation and Mechanical Circulatory Support” session. Awais Ashfaq, MD, from Johns Hopkins All Children’s Hospital in St. Petersburg, Florida, will report on findings. Although 10 leading children’s hospitals conducted the study, the analysis includes all 47 hospitals in the Pedimacs database of children and adolescents under age 19.  The group reviewed Pedimacs data back to the registry’s inception in 2012 through the end of December 2021, covering 1,109 patients, and identified that illness at time of VAD implantation, diagnosis, support strategy, and VAD device type all affected mortality. This study is the first step to create evidence-based guidance on VAD device choices and other decisions in care management. For instance, one finding indicates that infants and older pediatric patients with paracorporeal continuous device support, congenital heart disease, biventricular support, and Intermacs profile 1 (cardiogenic shock) had worse overall survival after six months. "For anyone in our field, and especially for those who have an interest in pediatric mechanical support, Pedimacs is invaluable,” Dr. Ashfaq says. “There is so much to learn from the data available in the database.” Pedimacs became part of The STS National Database™ in 2018 and is a joint effort among the National Heart, Lung, and Blood Institute, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and others. The North American clinic registry includes patients who receive an FDA-approved mechanical circulatory support device to treat advanced heart failure. Due to its exponential growth in terms of participation and stature, the STS National Database has become the gold standard for clinical outcomes registries among health care administrators, government officials, and payers. Dr. Ashfaq adds that the group will be taking their results and expanding them into a web-based tool to help physicians decide if patients will benefit from VADs and which device to choose.  

With too few donor hearts available for transplantation, surgeons will present a novel solution to heart allocation on Day 2 of STS 2023, with an aim at serving the growing population of eligible patients in their 70s. On Sunday, January 22, at 3:30 p.m. PT, “The Use of Donor Hearts 50 Years or Older to Septuagenarians in Heart Transplant: The Potential of Expanding the Donor Pool in Older Patients and Increasing the Availability of Younger Hearts” will uncover a potential new group of heart donors who have been previously overlooked. The presentation, part of the session “Expanding the Donor Pool in Heart Transplantation: Current Strategies and Future Perspectives,” will be thought-provoking for surgeons who want to open the door for organ donation to older recipients. Suguru Ohira, MD, PhD, from Westchester Medical Center Heart & Vascular Institute in Valhalla, New York, will present this study to consider donor patients in their 50s for an emerging segment of heart recipients ages 70-79.  Several key factors, including advances in cardiac transplantation and the 2018 modified guidelines from the Organ Procurement and Transplantation Network (OPTN), make more and more patients in their 70s eligible for cardiac transplantation. This study is the first to present a feasible solution to serve these patients without compromising the entire pool of heart recipients. In the United Network for Organ Sharing system, 1,036 heart transplants occurred between January 2011 to December 2021 in patients 70 years or older. Of these, 861 patients received hearts from donors under age 50 and 175 patients received hearts from donors ages 50 and older. Survival was comparable between both recipient groups: One-year and five-year survival rates for patients who received hearts from donors over age 50 were 89.4% and 76.6%, respectively. One- and five-year survival rates for patients who received hearts from donors ages 50 or under were 86.2% and 71.1%, respectively. “Although these hearts from advanced age donors might not be the best hearts for younger recipients who are in their 30s or early 40s, they could be a reasonable option for candidates in their 70s,” Dr. Ohira says. “Yet these hearts are often not recovered, just because of ‘donor age,’ even though their functions and structures are normal.”  Dr. Ohira says this study, conducted with six colleagues from Westchester Medical Center and New York Medical College, was undertaken following excellent outcomes at their institution with transplants for septuagenarians using hearts from donors in their 40s and 50s. STS 2023 is being held in person, and there is still time to register at sts.org/annualmeeting.  

The trusted data in the STS National Database™ has been a cornerstone for scientific research and quality improvement for more than three decades—and recently its General Thoracic (GTSD) and Congenital Heart (CHSD) surgery databases made major leaps toward demonstrating their importance across the United States.  GTSD Participants Can Earn Credit for Transparency US News & World Report recently announced its decision to create a new Public Transparency measure to be used in its Best Hospitals rankings in Pulmonology & Lung Surgery. The measure will be based on whether a hospital elects to publicly report its lobectomy outcomes on the GTSD public reporting website as of February 12, 2023.   “This is a boon for high-performing hospitals who participate in the GTSD,” said Vinay Badhwar, MD, chair of the STS Council on Quality, Research, and Patient Safety. “Those who already are publicly reporting their outcomes to the Database now have the option to earn Transparency best rankings, and GTSD participants who were not publicly reporting were given the means to opt in last month.” Dr. Badhwar added, “For hospitals who are not GTSD participants, the time to join is now.” The next edition of Best Hospitals will feature the new Public Transparency measure, and the measure will have a weight of 3% in the adult Pulmonology & Lung Surgery specialty rankings. “The same measure will be included in the Procedures & Conditions statistical analysis, and it likely will be used in calculating the Lung Cancer Surgery ratings,” wrote US News’ Ben Harder.  This means that, by simply enrolling in the STS National Database Public Reporting initiative, hospitals can receive the transparency credit.  More than 100 thoracic surgery programs nationwide are already publicly reporting their surgical outcomes. US News will review the GTSD public reporting site in February 2023, and they release their Best Hospitals lists once a year.  If a hospital joins GTSD in 2023 and enrolls in public reporting, they will be eligible to receive the transparency credit in 2024.  "For hospitals who are not GTSD participants, the time to join is now." Vinay Badhwar, MD CHSD Makes History with Infant Surgical Trial In a first-of-its-kind multicenter, NIH-funded randomized trial within a registry, investigators have found that infants undergoing cardiopulmonary bypass surgery experienced no difference in outcomes when they received prophylactic glucocorticoids versus placebo. Results from the study, made possible by the CHSD and 24 participating sites, appeared last month in the New England Journal of Medicine.  “With an NIH award of over 5 million dollars, our team successfully conducted a multicenter, prospective, randomized, placebo-controlled, registry-based clinical trial with participants enrolled at 24 sites participating in the CHSD,” said Jeffrey P. Jacobs, MD, principal investigator for the grant, titled “Leveraging existing registry resources to facilitate clinical trials.” With data curated in the CHSD, researchers were able to randomize outcomes for 1,200 infants and newborns undergoing open-heart surgery. Glucocorticoids have been used for decades in this surgical population, but until now, their benefits have remained unconfirmed. With this CHSD analysis, the research team assessed a primary outcome composite of operative mortality, 13 individual major complications, and postoperative length of stay.  “Among infants undergoing surgery with cardiopulmonary bypass, prophylactic methylprednisolone did not significantly decrease the likelihood of a worse outcome in adjusted analysis,” the authors wrote, noting that methylprednisolone additionally was associated with increased postoperative hyperglycemia requiring insulin.  The publication of these results is a reflection of the quality and power of the Database, said Dr. Jacobs, who served on STS’s Workforce on National Databases and as chair of its Congenital Heart Surgery Database Task Force. Based on his experiences, he emphasized, “The STS Congenital Heart Surgery Database is the premier registry in the world for pediatric quality assessment and research.” Database Makes Never-Before-Seen Science Possible at STS 2023 At the upcoming STS Annual Meeting in San Diego, presenters will unveil novel scientific discoveries gleaned from the robust data curation in the STS Adult Cardiac, Congenital, General Thoracic, and Intermacs/Pedimacs Databases, including Frozen elephant trunk versus traditional limited repair in acute type 1 aortic dissection Variables affecting survival in pediatric patients supported with ventricular assist devices Targeted molecular therapy and immunotherapy for lung and esophageal cancer Postcardiotomy shock and 30-day outcomes in patients with severe left ventricular systolic dysfunction Survival outcomes for patients undergoing lung transplant Establishment of an STS adult congenital heart surgery risk model The impact of surgical strategy on isolated tricuspid valve outcomes Practice patterns in the management of tetralogy of Fallot

STS News, Fall 2022 — With nearly as many women as men presenting with signs of ischemia in today’s health care settings, clinicians should keep in mind that coronary artery disease (CAD) goes beyond vessel obstruction, especially in female patients—and should take advantage of tools like advanced imaging to see past anatomic walls. “More and more, I think we're recognizing that, when they’re designed for the identification of primarily obstructive CAD, conventional approaches can lead to repeated testing, especially in women,” said Viviany R. Taqueti, MD, MPH, from Brigham and Women’s Hospital in Boston, Massachusetts. “And yet, often without differentiating who’s truly at risk.” Obstructive CAD is just one phenotype of ischemic heart disease, and perhaps just the tip of the iceberg when physicians take into consideration the entirety of coronary circulation, Dr. Taqueti said. A physician needs to spot other pathologies such as diffuse non-obstructive CAD and coronary microvascular dysfunction, which can certainly impact patients’ cardiovascular outcomes, she explained. As an example, Dr. Taqueti referred to a study in Denmark that presented observational data from a large registry of more than 11,000 patients who were referred for coronary angiography. The investigators found that up to a 32% of the male patients—and a startling 65% of female patients—had no significant obstructive disease to explain their symptoms. “We need a more sophisticated toolbox that looks beyond regional wall motion abnormality or even regional perfusion abnormalities to consider and quantify absolute blood flow in the heart and quantify coronary flow reserve, or CFR,” said Dr. Taqueti. Coronary microcirculation is of course too small to be directly imaged in vivo, and it needs to be evaluated indirectly by perturbing function. A variety of technologies make this possible. Coronary microvasculature, especially in female patients, represents the future of prognosis after procedures like CABG, say experts. "Conventional approaches can lead to repeated testing, especially in women. And yet, often without differentiating who’s truly at risk.” Viviany R. Taqueti, MD, MPH In the invasive realm, historically, catheter-guided wire-based testing has provided measurements of CFR and microcirculatory resistance. But noninvasive methods, including cardiac magnetic resonance, Doppler ultrasound, and—the current gold standard—positron emission tomography, are revealing just how prevalent coronary microvascular dysfunction is in patients with angina or signs of ischemia. Data from more angiography studies demonstrated that just under half of the patients had no obstructive disease. “And these were evaluated quite objectively, using fractional flow reserve normal values above 0.8,” Dr. Taqueti explained. But from that group, a large majority—76% to 89%—had some evidence of objective coronary vasomotor dysfunction on testing. “The vast majority of these had coronary microvascular dysfunction, with a minority having pure vasospasm,” said Dr. Taqueti. “This is important because we know that impaired flow reserves—that can certainly be manifestations of coronary microvascular disease—are associated with worse outcomes in terms of cardiac mortality in our patients.” More revelations come with observational data that span multiple research centers: Even in patients with no obvious obstructive lesions or inducible ischemia on stress testing, impaired CFR is independently associated with major adverse events.  In those with significant obstructive CAD, CFR also modifies the outcome of coronary revascularization procedures, especially coronary artery bypass grafting (CABG), Dr. Taqueti pointed out. With long-term cardiovascular outcomes, patients with a severely reduced CFR who underwent CABG did as well as those with a preserved CFR to begin with (adjusted p for interaction = 0.03), suggesting that impaired CFR may serve as a marker for CABG benefit akin to diabetes or SYNTAX score, said Dr. Taqueti.     When severely impaired, coronary flow reserve is even more prognostically significant in women—and may be as useful of a marker for CABG benefit as diabetes or SYNTAX score. In women, severely impaired CFR appears to be even more prognostically significant. “You can see the divergence of the hazard for men and women with a significant interaction for sex as CFR values fall substantially below 2,” Dr. Taqueti explained. “Women appear to fare even worse at the very low range of CFR despite the fact that, when you look at anatomic findings, they are much less likely to have multivessel obstructive disease. In contrast, men were much more likely to have impaired CFR in the presence of multivessel disease—perhaps explaining their impaired flow reserves.” Dr. Taqueti encouraged physicians to consider how these factors reframe their approach to understanding CAD, and to emphasize appropriate diagnostic testing to identify risk, which can help to curb repeated conventional testing in patients at low risk. These recommendations were presented as part of the STS Coronary Conference this summer, in a session devoted to noninvasive diagnostic techniques for evaluation of high-risk ischemic heart disease. The conference united faculty and attendees from 18 countries with a multidisciplinary approach. Course director Marc Ruel, MD, MPH, who serves as STS Canadian Director, touted the camaraderie displayed by participants of all backgrounds. “Surgeons have to be the top experts at understanding the very reason why they operate—or not—on a patient,” Dr. Ruel said. “It comes down to much more than ‘I can do this,’; rather, it should be ‘It is a good idea to be doing this for the patient, and I have the skills to do it.’ The Coronary Conference aimed to achieve this: Expert knowledge and skills in the huge, knowledge-intensive area of coronary surgery.” Strong surgeons need strong cardiologists, anesthesiologists, radiologists, and other experts, Dr. Ruel said. “This is why we made the Coronary Conference so multidisciplinary and team-based, with a focus both on advanced practical knowledge and on advanced technical skills.” “We need to understand microvascular disease in order to better treat ischemia in both women and men,” Dr. Taqueti added. “Coronary microvasculature represents an exciting new frontier in cardiovascular disease reduction, and the future is pointing toward a role for coronary microcirculation in macrovessel disease prognosis. That’s something we need to think about in all our practices.”