A comparative early outcome analysis of self-expandable and balloon-expandable valves in the management of dysfunctional right ventricular outflow tracts

Introduction

Self-expandable valves (SEVs) are emerging alternatives to balloon-expandable valves (BEVs) for transcatheter pulmonary valve replacement (TPVR) in patients with dysfunctional right ventricular outflow tracts (RVOTs), though their safety and efficacy remain underexplored.

Objective

To compare patient characteristics and outcomes of SEVs and BEVs in TPVR.

Method

Clinical and early follow-up data were prospectively analyzed for 139 patients who underwent TPVI between January 2022 and June 2024 using Edwards SAPIEN 3 (ES3) BEVs or Venus-P SEVs.

Results

Cohort: 59.7% male, median weight 65 kg; 66.2% received ES3 valves (n = 92) and 33.8% Venus-P (n = 47). Median age was 33.2 years (IQR: 19.7–42.8) for ES3 and 44.7 years (IQR: 32.6–54.1) for Venus-P (P < 0.001). Tetralogy of Fallot was the underlying diagnosis in 53.2%. Lesion types included stenosis (13.7%), pulmonary regurgitation (66.9%), and mixed (19.4%). Native RVOTs were present in 5.4% of ES3 and 31.9% of Venus-P cases, while patched RVOTs were found in 41.3% and 68.1%, respectively. Median valve diameter was 36 mm (IQR: 34–36) for Venus-P and 26 mm (IQR: 23–29) for ES3 (P < 0.001). All implantations were successful. Median fluoroscopy time was 18 min (IQR: 13–27) for ES3 and 22.6 min (IQR: 19–26) for Venus-P (P = 0.02). Postoperative median RVOT maximum velocity was 2 m/s (IQR: 1.6–2.5). Valve insufficiency was moderate in 4.3%, mild in 6.5%, and absent in 89.2%. Moderate adverse events occurred in 7.2% (3.3% ES3, 14.9% Venus-P; P = 0.01), and ventricular arrhythmias requiring therapy in 9.4% (2.2% ES3, 23.4% Venus-P; P < 0.001).

Conclusion

SEVs are effective for TPVR but have higher rates of adverse events and ventricular arrhythmias than BEVs, necessitating vigilant long-term follow-up.