Transcatheter pulmonary valve implantation: Initial experience with self-expandable valve in patients with congenital heart diseases and comparison with balloon-expandable valve

Abstract

Introduction/Background

Self-expandable valves have emerged as an alternative option for transcatheter pulmonary valve replacement (TPVR) compared to balloon-expandable valves. However, their efficacy in patients with congenital heart diseases remains relatively unexplored.

Objective

This study aims to compare the characteristics and outcomes of patients who underwent TPVR with self-expandable valves versus balloon-expandable valves.

Methods

A prospective single-center analysis was conducted, encompassing all consecutive patients (n = 89) who underwent TPVR using either balloon-expandable valves (Sapien 3 valves, n = 63, 70%) or self-expandable valves (Venus-P, n = 26, 30%) between January 2022 and February 2024. Patient characteristics, procedural data, and short-term outcomes were compared. Electrophysiological studies were performed in all patients with tetralogy of Fallot (ToF) prior to the procedure.

Results

The median age of patients was 34 years for Sapien 3 (11 children, youngest: 8 years) and 46 years for Venus-P (one child aged 15 years), P = 0.014. Tetralogy of Fallot (ToF) was the primary diagnosis in 49 cases (55%, 32 with Sapien 3 and 17 with Venus-P valve, P = 0.041). Native or patched right ventricular outflow tracts were identified in 100% and 54% of patients with Venus-P and Sapien 3 valves, respectively, P < 0.001.

Valve implantation was successful in all patients. Major adverse events occurred in 4.5% of cases (3.8% in Sapien 3 vs. 4.7% in Venus P-valve group, P = 0.66). Ventricular ectopy necessitating medical therapy was more frequent in the Venus-P group (19% vs. 0%, P = 0.002) including one case of sustained asymptomatic ventricular tachycardia, managed with amiodarone therapy. No peri-procedural deaths were reported.

Conclusion

Self-expandable valves demonstrate efficacy for TPVR in patients with large native or patched right ventricular outflow tracts, accompanied by a low rate of major adverse events. However, an increased incidence of ventricular arrhythmias was noted compared to balloon-expandable valves, indicating the importance of long-term follow-up data to better understand outcomes.