Author + information
- Lee N. Benson1,
- Lisa Bergersen2,
- Brian T. McHenry3,
- Matthew Gillespie4,
- John P. Cheatham5 and
- Jessica Dries-Devlin6
- 1The Hospital for Sick Children, Toronto, Ontario, Canada
- 2Boston Children’s Hospital, Boston, Massachusetts, United States
- 3Medtronic, Minneapolis, Minnesota, United States
- 4Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
- 5Nationwide Children's Hospital, Columbus, Ohio, United States
- 6Medtronic Inc., Saint Paul, Minnesota, United Statesa
The Harmony Transcatheter Pulmonary Valve (HTPV) (formerly the Native TPV) was designed for the native outflow tract of patients who require pulmonary valve replacement. This population comprises 3/4 of patients with congenital heart disease (CHD) with right ventricular outflow tract (RVOT) anomalies.
Three sites enrolled patients in a non-randomized, prospective study utilizing a single novel device design to accommodate the complex anatomy of the RVOT in the first FDA approved early feasibility study (EFS). Candidates were evaluated by a screening committee after an engineering assessment was performed to determine implant eligibility based on the patient’s anatomy. Procedural feasibility, safety, and TPV performance were assessed. One-year clinical outcome data will be available at the time of presentation.
From 66 patients enrolled, 21 were approved for implant with 20 undergoing HTPV implantation. One patient had unsuitable hemodynamics at cath and was not implanted. Sample post-procedure images are in the Figure. Initial results to 6 months revealed significant improvements in hemodynamic parameters, with no patient having more than mild PR. Clinical data one-year following HTPV will be available at the time of presentation.
Initial results from the first EFS revealed high procedural success, and favorable acute hemodynamics. One-year data will provide insights into longer-term outcomes in the first cohort implanted with the Harmony TPV. Percutaneous management of patient with RVOT anomalies will have significant implications in a large segment of patients with CHD.
STRUCTURAL: Congenital and Other Structural Heart Disease