Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry

Abstract

Aims: The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications.

Methods and results: A total of 514 first-attempt percutaneous PVL closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively. In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29-5.54], p=0.008) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (≥10 mm vs. <10 mm, HR 3.077 [1.13-8.33], p=0.027). The overall major adverse events rate (death or emergency surgery or stroke) at 30 days was 5.6%; the only predictor for combined adverse events was New York Heart Association functional Class IV (HR 4.2 [1.42-12.34], p=0.009).

Conclusions: Percutaneous closure of PVL can be performed with a reasonable rate of procedural success and a low rate of major complications. The type of device used, the accumulated experience and the leak size are predictors of procedural success.