2023 Department of Pediatrics Academic Annual Report

One of these is a multi-institutional collaborative titled “Congenital Catheterization Research Collaborative.” Through this collaborative, researchers across the country have contributed data to better understand how neonates born with Tetralogy of Fallot are managed from a surgical/ interventional perspective. This collaborative has led to multiple publications comparing the management strategies of patients with symptomatic Tetralogy of Fallot. We received industry-sponsored funding for Edwards Lifescience and Medtronic pulmonary valve device studies. We are currently enrolling in the COMPASSION S3 Transcatheter Heart Valve as well as the Alterra Prestent for S3 implantation and Harmony post approval studies. We are also in the regulatory stages for additional device trials, one for a new generation Edwards pulmonary valve and one for a new ASD closure device with atHeart. We continue to serve as the Core Angiography Lab for a multi-institution trial that is the first of its kind. The COMPASS trial has randomized 27 patients to receive either a PDA stent or a surgical shunt as the initial palliation for their inadequate pulmonary blood flow. ADVANCED CARDIAC THERAPIES IMPROVING OUTCOMES NETWORK (ACTION) This is a national registry for all pediatric patients undergoing ventricular assist device placement. Jonathan Byrnes, M.D., has remained a key collaborator with the ACTION pediatric VAD network, resulting in a publication expanding the use of the HeartMate 3 ventricular assist device in pediatric and adult patients as well as one that showed the impact of weight on VAD outcomes in dilated cardiomyopathy patients. PEDIATRIC CARDIAC BIOREPOSITORY We continue to enroll subjects into our Pediatric Cardiac Biorepository (PCaB). Currently there are more than 500 patients’ samples stored in PCaB. PCaB collects prospective biological samples on cardiac surgical patients and stores them for future research. From our division, Ahmed Asfari, M.D., has performed analysis on samples from PCaB to identify biomarkers associated with acute lung injury (ALI) in neonates after cardiopulmonary bypass. This multiplex panel identified an enzyme, proteoglycan-4 (PRG-4), as being potentially related to ALI. These discoveries are leading to further investigation and collaboration for this particular biomarker. MULTI-INSTITUTIONAL COLLABORATIONS Several faculty have contributed data to multi-institutional, investigator-initiated, non-funded research projects that have increased the knowledge of particular areas within the heart center. Dr. Borasino collaborated with the NEPHRON collaborative for a study describing the epidemiology of neonatal acute kidney injury after cardiac surgery without cardiopulmonary bypass, a project describing the implications and outcomes of fluid accumulation after neonatal cardiac surgery, a descriptive study regarding site-specific practices regarding the use of peritoneal dialysis catheters after cardiac surgery, association of early postoperative weight-based fluid overload and worsening postoperative outcomes, the assessment of fluid balance after neonatal cardiac surgery, and the age at surgery and outcomes following neonatal cardiac surgery. He assisted with an interdepartmental project describing the prevalence, risk factors and outcomes of airway versus non-airway pediatric extubation failure. Dr. Borasino also participated in a multicenter study with the RESTORE collaborative, looking at a targeted analysis of serial cytokine measures and nonpulmonary organ system failure in children with acute respiratory failure. Dr. Asfari was able to use our institutional data to describe risk factors for prolonged post-operative hospital length of stays after cardiac surgery with cardiopulmonary bypass. Waldemar F Carlo, M.D., is our site principal investigator for the multi-institutional trial administering umbilical cord collected stem cell injections in patients undergoing Stage II palliation for hypoplastic left heart syndrome (HLHS) versus a control group of subjects who do not receive stem cell injections. Due to our success in enrollment into this trial, we have been asked to participate in the subsequent trial administering the umbilical cord stem cell injections in patients undergoing Stage III palliation for HLHS. He was also part of a multi-institutional project describing Fontan-associated liver disease after heart transplantation, Fontan immunophenotype and post-transplant outcomes in children, single-drug immunosuppression and its association with noninferior medium-term survival in pediatric heart transplant recipients, and racial and socioeconomic disparities in pediatric heart transplant outcomes in the era of anti-thymocyte globulin induction. Bennett Pearce, M.D., participated in a multi-institutional project describing contemporary outcomes of pediatric cardiac transplantation with a positive retrospective crossmatch. He and Leslie Collins, M.D., are involved in an industry-funded study of Mavacamten to evaluate the effects of this drug on left ventricular outflow tract obstruction in adolescents with symptomatic obstructive hypertrophic cardiomyopathy. This study is sponsored by Bristol Myers Squibb. PEDIATRIC HEART NETWORK We continued to participate in trials performed by the Pediatric Heart Network (PHN). Camden Hebson, M.D., is leading a study here at our site that is retrospectively and prospectively enrolling patients diagnosed with MIS-C post COVID-19 infection. He is also serving as PI for a post-Pfizer vaccine associated myocarditis study. Dr. Law continues as the core angiography director for a multi-institutional trial that will be the first of its kind to randomize neonates with insufficient pulmonary artery blood flow to either initial transcatheter intervention or surgical repair. HEART CENTER MULTIDEPARTMENT COLLABORATIONS In the recent Society of Thoracic Surgeons (STS) Congenital Heart Surgery reporting results, the Heart Center had an Observed/ Expected (O/E) ratio of .59 with the upper confidence limit of .92. Centers whose upper confidence is below 1 are designated as high performing. Based on these results, the center is one of 12 high performing centers out of 97 total centers. Drs. Byrnes, Borasino, Zaccagni, Law and Asfari collaborated with our perfusionists (Timpa, O’Meara C, Buckman, Maxwell) and the Cardiac Surgery team (Sorabella, Padilla, Cleveland DC, Dabal RJ) to publish our center’s experience with post-cardiotomy ECMO.

2023 Academic Annual Report

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