O-5
Two-Year Outcomes in an Expanded Cohort of Harmony Transcatheter Pulmonary Valve Recipients
Presenter
Mary Hunt Martin, MD, FSCAI, University of Utah at Primary Children’s Hospital, Salt Lake, UT
Mary Hunt Martin, MD, FSCAI1, Matthew J. Gillespie, M.D., FSCAI2, John P. Cheatham, M.D., MSCAI3, Thomas K. Jones, M.D., MSCAI4, Daniel S. Levi, M.D., FSCAI5, Jeremy D. Asnes, M.D.6, Robert G. Gray, M.D.1, Allison K. Cabalka, M.D., FSCAI7, Lisa Bergerson, MD, MPH8, Lee N. Benson, M.D., MSCAI9, Daniel Haugan10 and Doff B. McElhinney, M.D., FSCAI11, (1)University of Utah at Primary Children’s Hospital, Salt Lake, UT, (2)Children's Hospital of Philadelphia, Philadelphia, PA, (3)Nationwide Children's Hospital, Plymouth, MA, (4)Seattle Children’s Hospital, Seattle, WA, (5)David Geffen School of Medicine at UCLA, Pacific Palisades, CA, (6)Yale University, New Haven, CT, (7)Mayo Clinic Health System Rochester, Rochester, MN, (8)Boston Children's Hospital, Boston, MA, (9)The Hospital for Sick Children, Toronto, ON, Canada, (10)Medtronic, Minneapolis, MN, (11)Stanford University Medical Center, Stanford, CA
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 the first FDA-approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). Our objective was to evaluate 2-year safety and effectiveness in patients from an expanded cohort of Harmony clinical trial participants.
Methods
The analysis included patients who received a commercially available TPV22 or TPV25 device as part of the Harmony Native Outflow Tract Early Feasibility Study (EFS), Harmony TPV Pivotal Trial, and Continued Access Study (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. One-year outcomes are reported here, and 2-year outcomes by valve type will be presented.
Results
Eighty-seven patients were implanted with a TPV22 (n=42) or TPV25 (n=45) device, all of whom remained implanted for >24 hours. Median (Q1, Q3) patient age at treatment was 29 (18, 39) years and 87% had an original diagnosis of tetralogy of Fallot. At 1 year, all patients were alive, and freedom from the composite of PR, stenosis, and reintervention (defined as ≥moderate PR, mean RVOT gradient >40 mmHg, device-related RVOT reoperation, and catheter reintervention) was 98% in the TPV22 group and 91% in the TPV25 group. One-year freedom from major stent fracture was 98% in the TPV22 group and 100% in the TPV25 group. None/trace or mild PR was present in 98% of TPV22 and 100% of TPV25 patients at 1 year. Two TPV22 patients from the EFS were explanted on Day 2 and Day 39, respectively. Two TPV25 patients from the CAS underwent valve-in-valve procedures on Day 0 and Day 303, respectively. Fourteen (3 TPV22, 11 TPV25) patients had nonsustained ventricular tachycardia (NSVT), which initiated during the implant procedure in 13 patients and at 1-day postimplant in 1 patient. There were no serious adverse events related to the NSVT.
Conclusions
Harmony TPV patients in this expanded analysis cohort had favorable clinical and hemodynamic outcomes across studies and valve types through 1 year, and the upcoming 2-year analysis will expand our understanding of this patient population.