Paravalvular leak closure with the Amplatzer Vascular Plug III device: immediate and short-term results.

Introduction And Objectives: Percutaneous paravalvular leak closure is a complex procedure with varying success rates; the lack of closure devices specifically designed for this purpose has hampered this technique. The characteristics of the Amplatzer Vascular Plug III appear to be well suited for paravalvular leak closures; however, the available data are limited to case reports or small series of patients. The aim of this study was to analyze the feasibility and efficacy of paravalvular leak with this device.

Methods: The immediate and 90-day safety and efficacy of mitral and aortic paravalvular leak closures performed with this device at our hospital were analyzed.

Results: Percutaneous repair of 34 paravalvular leaks (27 mitral, 7 aortic) was attempted in 33 patients. The device was successfully implanted in 93.9% (in 2 patients, a second planned procedure was needed), and successful closure (defined as regurgitation reduction ≥ 1 grade) was achieved in 90.9% of patients. Complications included emergency surgery due to disc interference (n=1) and blood transfusion (n=3). There were no reports of procedure-related death, myocardial infarction, or stroke. At 90 days, survival was 100%, and 90.3% of patients showed significant clinical improvement; 4 patients developed vascular complications (pseudoaneurysm).

Conclusions: Mitral and aortic paravalvular leak closure with the Amplatzer Vascular Plug III is feasible and safe, with high clinical and echocardiographic success rates.