Open transapical approach to transcatheter paravalvular leakage closure: a preliminary experience.

BACKGROUND Significant prosthetic paravalvular leakage (PVL) could have serious clinical consequences and impairs survival. Reoperation is associated with a high mortality rate, and transcatheter closure is a new treatment modality for high-risk patients. The goal of this study was to determine safety and midterm clinical efficacy of transcatheter PVL closure using an open transapical approach. METHODS AND RESULTS All consecutive patients who underwent transcatheter PVL closure in our center were prospectively enrolled. Pre- and postprocedural quality of life and 6-minute walk test were ascertained. All outcomes were defined according to the Valve Academic Research Consortium-2 consensus document. In total, 37 consecutive patients (mean age 67±12 years, 65% male, logistic European System for Cardiac Operative Risk Evaluation 27±17%, Society of Thoracic Surgeons score 7±4%) with severe symptomatic PVL in mitral (81%) or aortic (19%) position underwent transcatheter PVL closure. Procedure success was 86%. Early safety at 30 days (ie, event-free survival) was 84%. The 1-year survival rate was 66%. New York Heart Association functional class and quality of life significantly improved. Clinical efficacy (ie, survival free of stroke, rehospitalization, New York Heart Association 3/4, and device-related dysfunction) was 49% at 3 months and 31% at 1 year. Moderate to severe residual PVL was associated with all-cause mortality (hazard ratio, 3.9; 95% confidence interval, 1.2-12.1; P=0.03). CONCLUSIONS The open transapical approach to PVL closure in high-risk patients has a high procedural success rate with an acceptable risk of adverse outcomes. This is the first study to prove an increased functional capacity and quality of life after transapical PVL closure. Residual PVL is associated with 1-year mortality.