Early Outcomes of Self-Expandable Versus Balloon-Expandable Valves for Managing Dysfunctional Right Ventricular Outflow Tracts.

BACKGROUND

Self-expandable valves are emerging complements to balloon-expandable valves for transcatheter pulmonary valve replacement in dysfunctional right ventricular outflow tracts, though their safety and efficacy remain underexplored. We aim to compare patient characteristics and outcomes of self-expandable valves and balloon-expandable valves in transcatheter pulmonary valve replacement.

METHODS

Baseline and early follow-up data were prospectively analyzed for 145 patients who underwent transcatheter pulmonary valve replacement with Edwards SAPIEN 3 (ES3) balloon-expandable valves or Venus-P self-expandable valves (January 2022-December 2024). An independent adjudication expert analyzed and classified adverse events.

RESULTS

Cohort: 58.6% males, median weight of 65 kg, median age of 36.3 years; 64.1% of ES3, 35.9% of Venus-P. Tetralogy of Fallot was present in 55.2%, with native/patched right ventricular outflow tracts in 41.9% of ES3 and 100% of Venus-P cases (P<0.001). Severe pulmonary regurgitation was found in 64.5% of ES3 and 100% of Venus-P (P<0.001). Median valve diameter was 26 mm (Q1-Q3: 23-29) for ES3 and 36 mm (32-36) for Venus-P (P<0.001). All implantations were successful, with no significant difference in procedure or fluoroscopy times between groups. Postoperative median right ventricular outflow tract maximum velocity was 2.2 m/s (1.9-2.6) for ES3 and 1.6 m/s (1.1-1.8) for Venus-P (P<0.001). Procedural and vascular-access adverse events occurred in 14 patients (ES3: 9.7%, Venus-P: 9.6%; P=0.992), including 8 moderate and 1 major (ES3: 5.4%, Venus-P: 7.7%; P=0.582). New-onset ventricular arrhythmias occurred in 14 patients (ES3: 3.2%, Venus-P: 21.1%; P<0.001), including 5 classified as moderate adverse events, all in Venus-P (P=0.002). All arrhythmias resolved with short-term therapy; no permanent antiarrhythmics or ablations were needed.

CONCLUSIONS

Self-expandable valves are effective for transcatheter pulmonary valve replacement but linked to higher transient arrhythmic adverse event rates than balloon-expandable valves in the early postoperative period.