Primary Outcomes of the Harmony Transcatheter Pulmonary Valve Pivotal Trial
Presenter
John P. Cheatham, M.D., MSCAI, Nationwide Children's Hospital, Plymouth, MA
Matthew J. Gillespie, M.D., FSCAI, Children's Hospital of Philadelphia, Philadelphia, PA, Daniel S. Levi, M.D., FSCAI, David Geffen School of Medicine at UCLA, Pacific Palisades, CA, Doff B. Mcelhinney, M.D., FSCAI, Lucile Packard Children's Hospital at Stanford, Los Altos, CA, Thomas K. Jones, M.D., MSCAI, Seattle Children’s Hospital, Seattle, WA, Robert G. Gray, M.D., The University of Utah, Salt Lake City, UT, Junjiro Kobayashi, M.D., National Cerebral and Cardiovascular Center, Osaka, Japan, Jeremy D. Asnes, M.D., Yale University, New Haven, CT, Shicheng Weng, MS, -, Mounds View, MN and John P. Cheatham, M.D., MSCAI, Nationwide Children's Hospital, Plymouth, MA
Keywords: TPVR/Pulmonary Valve
Background
The Harmony transcatheter pulmonary valve (TPV) is a self-expandable, porcine pericardial valve that accommodates the larger right ventricular outflow tract (RVOT) of patients with congenital defects who develop severe pulmonary regurgitation (PR) after surgical repair. The TPV is available in 22- and 25-mm sizes with differences in frame size and length. An Early Feasibility Study (EFS) with TPV 22 showed high procedural success, safety, and favorable device performance through 3 years.
Methods
This prospective, nonrandomized Pivotal Trial is ongoing at 12 sites in the US, Canada, and Japan. Patients with severe PR on echocardiography or PR fraction ≥30% by magnetic resonance imaging and an indication for surgical placement of a RV-pulmonary artery conduit or prosthetic PV were eligible. Forty patients were implanted (TPV 22, n=21; TPV 25, n=19). Ten patients subsequently received a modified TPV 25. The primary safety endpoint is freedom from procedure- or device-related mortality at 30 days. The primary effectiveness endpoint is acceptable hemodynamic function at 6 months, defined as mean RVOT gradient ≤40 mmHg on echocardiography, PR fraction <20% on magnetic resonance imaging; and no prior TPV reintervention. For the modified TPV 25, 30-day hemodynamic performance and safety will be reported.
Results
At baseline (n=40, Pivotal cohort), mean age was 27±10 years, mean weight was 73±24 kg, and 25 (63%) were male. The original diagnosis was tetralogy of Fallot in 36 (90%) patients, and the median number of prior open-heart surgeries was 1 (min, max: 0, 3). Mean baseline RVOT gradient was 9.7±5.5 mmHg. This presentation will report primary endpoints in the Pivotal Trial, as well as 30-day outcomes for the modified TPV 25 subset.
Conclusions
This new data set from the Harmony TPV Pivotal Trial expands on earlier findings from the EFS, which showed favorable outcomes with the device in patients with severe PR.