Early Outcomes from a Multicenter Transcatheter Self-Expanding Pulmonary Valve Replacement Registry

Experts from the Heart Institute at UPMC Children’s Hospital of Pittsburgh recently published new research on transcatheter pulmonary valve replacement with the self-expanding Harmony valve (Medtronic) as a treatment for patients with right ventricular outflow tract (RVOT) pulmonary regurgitation in the Journal of the American College of Cardiology (JACC).

Bryan H. Goldstein, MD, director of the Cardiac Catheterization Laboratory at UPMC Children’s Hospital of Pittsburgh, served as the first author on this publication. Arvind Hoskoppal, MD, director of the Adult Congenital Heart Disease Center at UPMC Children’s, and Mary Schiff, PhD, biostatistician in the Heart Institute, were co-authors.

The purpose of this study was to evaluate the safety and short-term effectiveness of self-expanding transcatheter pulmonary valve replacement (TPVR). This was a multicenter study which followed 243 patients with native RVOT pulmonary regurgitation who underwent TPVR at 11 centers across the United States. The patients’ cardiac diagnoses included tetralogy of Fallot (71%), valvular pulmonary stenosis (21%), and other (8%). The primary outcome was a composite of hemodynamic dysfunction and RVOT reintervention.

Conclusion of Findings

Out of the 243 patients who underwent TPVR, acute technical success was achieved in all but one case. Adverse events during the procedure occurred in 4% of cases, with no device embolization of death. 86% of patients stayed in the hospital for one day.

At a median follow-up of 13 months, 98% of patients had acceptable hemodynamic function. Estimated freedom from the composite clinical outcome was 99% at one year. In this study, the short-term clinical and hemodynamic outcomes of self-expanding TPVR therapy were excellent.

This is the first manuscript to originate from a multicenter self-expanding pulmonary valve replacement registry hosted at UPMC Children’s Hospital of Pittsburgh. In addition to adding new participating centers and patients, UPMC Children’s researchers will continue to follow this cohort of patients to provide valuable insights into long-term clinical outcomes.

Reference

Goldstein BH, McElhinney DB, Gillespie MJ, et al. Early outcomes from a multicenter transcatheter self-expanding pulmonary valve replacement registry. J Am Coll Cardiol. 2024;83:1310–1321.