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

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Transcatheter pulmonary valve replacement (TPVR) with the self-expanding Harmony valve is an emerging treatment for right ventricular outflow tract (RVOT) pulmonary regurgitation (PR).
• Limited real-world data exist since the U.S. Food and Drug Administration approval in 2021.

Purpose of the Study:

• To evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world patient cohort.
• Assess clinical and hemodynamic outcomes following TPVR for native RVOT PR.

Main Methods:

• A multicenter registry study included consecutive patients with native RVOT PR undergoing TPVR.
• The primary outcome was a composite of hemodynamic dysfunction and RVOT reintervention.
• Data were collected through April 30, 2022, at 11 U.S. centers.

Main Results:

• 243 patients underwent TPVR, with acute technical success in all but one case.
• Procedural serious adverse events occurred in 4% of cases; no device embolization or death.
• At 13 months median follow-up, 98% had acceptable hemodynamic function, with 99% freedom from the composite outcome at 1 year.

Conclusions:

• Self-expanding TPVR therapy demonstrated excellent short-term clinical and hemodynamic outcomes in a large, real-world multicenter experience.
• Ongoing follow-up is crucial for understanding the long-term efficacy and safety profile of this treatment.