Feasibility of transcatheter prosthetic paravalvular leakage closure: a single-center, exploratory safety evaluation study of transcatheter closure of prosthetic paravalvular regurgitation in Japan (STOP PARA study).

Objective: The standard treatment of prosthetic paravalvular leakage (PVL) accompanied by heart failure or hemolytic anemia is repeat open surgery. Although favorable outcomes for transcatheter prosthetic PVL closure in patients with a high surgical risk for repeat open surgery have been reported, procedural feasibility has not been examined in Japan. Methods: From March 2015 to November 2015, transcatheter PVL closure in mitral position was performed in four patients (age range 41–78, three females) with high surgical risk due to history of repeated surgeries, chest radiation and reconstruction of the mitral annulus after debridement of abscess owing to infective endocarditis. All procedures were performed via a transapical approach under general anesthesia. Results: Of four patients, the indications for PVL closure of two patients were heart failure, and those of the others were hemolytic anemia. There were no major complications, mortalities, or prolonged intensive care unit or hospital stays. Technical success was achieved in two patients. Moderate paravalvular regurgitation persisted in one patient, although regurgitation reduction of one grade was obtained. In one patient, occluder devices were not deployed because the wire could not cross the defect. Improvement in New York Heart Association functional class compared with that at baseline was observed in two patients. Conclusions: The safety and acute technical success rates of transcatheter mitral PVL closure via a transapical approach were confirmed in Japanese patients. In Japan, transcatheter PVL closure may be an alternative option for patients with PVL who have a high surgical risk. [ABSTRACT FROM AUTHOR]