Percutaneous pulmonary valve implantation (PPVI) is an option for dysfunctional right ventricular outflow tract (RVOT) in patients with native or surgically repaired anatomies. Several self-expanding valve platforms, including Venus-P-Valve, Alterra Harmony and Pulsta, all with different frame geometries and anchoring strategies are now available. But nowadays comparative data remain limited. The aim of the study is to systematically evaluate procedural success, early, mid-term, and late outcomes of self-expanding PPVI systems and to explore differences in complication profiles.

A systematic review and meta-analysis was conducted including clinical studies reporting outcomes of self-expanding PPVI. Articles published between 2000 and 2025 were identified through database searches. Patients with congenital heart disease undergoing PPVI for regurgitation and/or stenosis of the RVOT were eligible. Primary endpoints were procedural success and major complications rate. Secondary endpoints included total complications. The complications were stratified as early (< 30 days), mid-term (30 days–1 year) and late ( > 1 year). Pooled proportions were calculated using a random-effects model with logit transformation and continuity correction for rare events. Heterogeneity was assessed using I ² and τ ² .

Fifty-two studies comprising 1404 patients were included. Most patients were repaired Tetralogy of Fallot or pulmonary valve stenosis/atresia. Overall procedural success was 95.1% (95% confidence interval [CI] 92.3–97.1%), with no significant difference between devices. Early complications occurred in 9.7% of patients, whereas severe early complications were uncommon (3.4%), mainly device embolization, vascular injury, or pericardial effusion; early mortality was not reported. Anedoctical cases of coronary injuries has been reported. Mid-term total and severe complications occurred in 11.8 and 4.6% of patients, respectively; endocarditis (1.7%) was the leading severe event. Late complications and severe late events occurred in 13.9 and 5.8% of patients.

PPVI with self-expanding devices shows high and comparable procedural success across all valve types with a low rate of severe and total complications.