Early Outcomes Following Transcatheter Closure With the Amplatzer Vascular Plug and Duct Occluder for Mitral Paravalvular Leak in Japanese Patients.

Background: Transcatheter closure of paravalvular leak (PVL) has become an established treatment for patients at prohibitive surgical risk. However, few studies have examined the feasibility of transcatheter closure using Amplatzer occluders in Japanese patients with mitral PVL.

Methods and results: Twelve patients (mean [±SD] age 78±7 years) with heart failure, hemolytic anemia, or both after surgical mitral prosthetic valve replacement (mechanical valve, 75%) underwent transcatheter PVL closure with Amplatzer Vascular Plug II (AVP-II)/Amplatzer Duct Occluder II (ADO-II) between 2014 and 2021 at Toho University Ohashi Medical Center. We examined procedural, in-hospital, 30-day, and 1-year outcomes. All procedures were performed under general anesthesia using an antegrade transseptal approach, and the procedures were successful in all cases. The mean (±SD) number of Amplatzer occluders deployment per patient was 2.9±1.1, and in 2 patients the combined use of ADO-II was required. The mitral PVL grade decreased notably from 3+ to 1+, with residual PVL being mild or absent in 9 patients. There were no all-cause mortalities, major adverse events, or device-related complications at the 30-day follow-up. At 1 year, all-cause mortality was 16.7% and 3 (25%) patients required reintervention because of the recurrence of clinical symptoms.

Conclusions: Our findings suggest that transcatheter PVL closure with AVP-II/ADO-II can be feasible and safe in Japanese patients with mitral PVL, leading to satisfactory early clinical outcomes.