Predictors of clinical success after transcatheter para-valvular leak closure: an international prospective multicentre registry

Abstract Background Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and haemolysis, for which the standard treatment is open-heart surgery with the attendant risks to the patient. Transcatheter closure has emerged as an alternative. Patient selection criteria for the best option are needed. We aimed to identify predictors of clinical success after transcatheter PVL closure. Purpose We aimed to identify predictors of clinical success after transcatheter PVL closure. Methods Consecutive patients referred to 24 European centres for transcatheter PVL closure in 2017–2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. Results We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. The prosthesis was mechanical in 53.3% and biological in 45.3% of procedures. All patients were symptomatic with heart failure, haemolytic anaemia, and the association of both conditions in 48.9%, 7.8% and 43.3%. One, two and three PVL were addressed during the same procedure in 69.6%, 26.6% and 3.8% respectively. Mitral and aortic PVL were severe in 35.3% and 13.8% (p