Paravalvular leak one year after transcatheter aortic valve implantation: incidence and late outcome. Results the Italian Registry

Abstract Background: Post-procedural paravalvular leak (PVL) is a common finding after transcatheter aortic valve implantation (TAVI), and we previously identified it as an independent predictor of late mortality (between 30 days and 1 year) in the Italian CoreValve Registry. Our aim was to evaluate the incidence and predictors of PVL after CoreValve implantation (Medtronic, MN, USA), and to assess its impact on late mortality and left ventricular (LV) remodeling. Methods and Results: Between 2007 and 2010, 984 consecutive patients were enrolled in our Registry; of these, 821 patients undergoing successful CoreValve implantation and discharged alive, were followed-up for >1 year. After TAVI, 647 patients (78.8%) showed no/mild PVL (Group PVL<2), while 174 (21.2%) showed moderate/severe PVL (Group PVL≥2). The independent predictors of PVL≥2 were: LV outflow tract diameter (P=0.02), and low CoreValve implantation level (P=0.03). PVL≥2 was associated with a 70%-increase in risk of late mortality (HR=1.67, 95%CI 1.07–2.62; P=0.02), with a 1-year survival of 81.6±2.9% vs. 89.3±1.2% in Group PVL<2 (P=0.005). Moreover, re-hospitalization for cardiac causes (15.5% vs. 6.9%, P=0.0003) and aortic valve reintervention (2.3% vs. 0.1%, P=0.001) occurred more frequently in Group PVL≥2. At 1-year follow-up, LV remodeling was less evident in Group PVL≥2, in terms of decrease in LV end-diastolic diameter (P=0.004), LV end-diastolic volume (P=0.05), and LV mass (P=0.09). Conclusions: PVL≥2 is an independent predictor of late mortality after CoreValve implantation, and impairs the favorable LV remodeling occurring after TAVI. Great care is warranted in the choice of prosthesis size and implantation technique to minimize PVL.