O-6
One-Year Outcomes in an Expanded Cohort of Harmony Transcatheter Pulmonary Valve Recipients
Presenter
Daniel S. Levi, M.D., FSCAI, David Geffen School of Medicine at UCLA, Pacific Palisades, CA
Daniel S. Levi, M.D., FSCAI, David Geffen School of Medicine at UCLA, Pacific Palisades, CA, Matthew J. Gillespie, M.D., FSCAI, Children's Hospital of Philadelphia, Philadelphia, PA, Doff B. McElhinney, M.D., FSCAI, Stanford University Medical Center, Stanford, CA, Thomas K. Jones, M.D., MSCAI, Seattle Children’s Hospital, Seattle, WA, Lisa Bergersen, M.D., MPH, FSCAI, Boston Children's Hospital, Stowe, VT, Lee N. Benson, M.D., MSCAI, The Hospital for Sick Children, Toronto, ON, Canada, Athar M. Qureshi, M.D., FSCAI, Texas Children's Hospital, Houston, TX, Henri Justino, M.D., FSCAI, Rady Children's Hospital, San Diego, CA, Daniel Haugan, Medtronic, Minneapolis, MN and John P. Cheatham, M.D., MSCAI, Nationwide Children's Hospital, Plymouth, MA
Keywords: Congenital Heart Disease (CHD), Right Ventricular Outflow Tract (RVOT), Structural Heart Disease (SHD) and TPVR/Pulmonary Valve
Background
The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). Our objective was to evaluate 1-year safety and effectiveness in patients from the Early Feasibility Study (EFS), Harmony TPV Pivotal Study, and Continued Access Study (CAS), representing the largest cohort to date of Harmony TPV recipients.
Methods
Data were pooled from the Harmony Native Outflow Tract EFS, Pivotal Trial, and CAS. Eligible patients had severe PR by echocardiography or PR fraction ≥30% by cardiac magnetic resonance imaging and a clinical indication for pulmonary valve replacement. Twenty EFS patients received TPV22 valves, and 67 Pivotal and CAS patients received TPV22 or mTPV25 valves. Additionally, 19 Pivotal patients received an early iteration of the 25-mm valve (clinical TPV25) that was later found to have less predictable deployment and was discontinued. The primary safety endpoint was freedom from procedure- or device-related mortality at 30 days. The primary effectiveness endpoint was the percentage of patients with acceptable hemodynamic function at 6 months (mean RVOT gradient ≤40 mmHg and PR fraction <20%). Adverse events were adjudicated by a Clinical Events Committee.
Results
A total of 108 patients were catheterized, 106 underwent TPV implants, and 104 remained implanted for >24 hours. The 2 patients who had surgical explantation within 24 hours had received a clinical TPV25 valve. Mean (SD) patient age at baseline was 28.8 (12.6) years; 62.3% were male and 85.8% had an original diagnosis of Tetralogy of Fallot. At 6 months, freedom from all-cause mortality and TPV dysfunction was 100% and 87.5%, respectively. The percentage of patients with acceptable hemodynamic function at 6 months was 88.2% (90/104), and 92.3% (84/91) had none/trace paravalvular leak. One-year outcomes by valve type will be presented.
Conclusions
Harmony TPV patients in this expanded analysis cohort had favorable clinical and hemodynamic outcomes, confirming earlier results and demonstrating continued device safety and effectiveness across studies and valve types at 1 year and beyond.