Comparative Safety and Efficacy of Transcatheter Versus Surgical Repair for Paravalvular Leak: An Updated Systematic Review and Meta-Analysis

Abstract

Objectives: Paravalvular leak (PVL) is a clinically significant complication following prosthetic valve replacement. Our aim was to compare the safety and efficacy of transcatheter versus surgical repair for PVL through an updated systematic review and meta-analysis of comparative studies. Methods: We conducted a systematic search of MEDLINE, Embase, CINAHL, and AMED from inception to the date of the final search. Comparative double-arm studies evaluating transcatheter repair (including closure and valve-in-valve procedures) versus open surgical repair were included. Primary outcomes were 30-day and one-year all-cause mortality, stroke or transient ischemic attack (TIA), and major bleeding. Secondary outcomes included acute kidney injury (AKI), vascular complications, residual PVL, heart failure readmission, symptomatic improvement, pacemaker insertion, and conversion to surgery. Results: Ten retrospective comparative studies comprising 1,616 patients (721 transcatheter; 895 surgical) were included. Transcatheter repair was associated with significantly lower 30-day mortality (3.6% vs 11.5%; OR 0.31, 95% CI 0.19–0.49), lower 30-day stroke/TIA (2.1% vs 5.8%; OR 0.36, 95% CI 0.20–0.67), and reduced AKI (3.2% vs 13.3%; OR 0.24, 95% CI 0.11–0.54). However, transcatheter intervention demonstrated higher rates of immediate residual PVL (26.7% vs 12.5%; OR 2.58, 95% CI 1.07–6.22), vascular complications (6.2% vs 2.3%; OR 2.54, 95% CI 1.15–5.63), and one-year heart failure readmission (25.5% vs 3.4%; OR 9.62, 95% CI 3.73–24.81). One-year mortality and long-term symptomatic improvement were comparable between groups. Overall certainty of evidence ranged from low to very low. Conclusions: Transcatheter PVL repair offers a favourable short-term safety profile compared with surgical repair but is associated with lower procedural success and higher rates of heart failure readmission. While transcatheter intervention represents a reasonable alternative for appropriately selected high-risk patients, further prospective comparative studies with standardised outcome definitions are required to clarify long-term durability and optimal patient selection.