Long-Term Prognosis Value of Paravalvular Leak and Patient–Prosthesis Mismatch following Transcatheter Aortic Valve Implantation: Insight from the France-TAVI Registry

Abstract

Background: Transcatheter aortic valve implantation (TAVI) is the preferred treatment for symptomatic severe aortic stenosis (AS) in a majority of patients across all surgical risks. Patients and methods: Paravalvular leak (PVL) and patient–prosthesis mismatch (PPM) are two frequent complications of TAVI. Therefore, based on the large France-TAVI registry, we planned to report the incidence of both complications following TAVI, evaluate their respective risk factors, and study their respective impacts on long-term clinical outcomes, including mortality. Results: We identified 47,494 patients in the database who underwent a TAVI in France between 1 January 2010 and 31 December 2019. Within this population, 17,742 patients had information regarding PPM status (5138 with moderate-to-severe PPM, 29.0%) and 20,878 had information regarding PVL (4056 with PVL ≥ 2, 19.4%). After adjustment, the risk factors for PVL ≥ 2 were a lower body mass index (BMI), a high baseline mean aortic gradient, a higher body surface area, a lower ejection fraction, a smaller diameter of TAVI, and a self-expandable TAVI device, while for moderate-to-severe PPM we identified a younger age, a lower BMI, a larger body surface area, a low aortic annulus area, a low ejection fraction, and a smaller diameter TAVI device (OR 0.85; 95% CI, 0.83–0.86) as predictors. At 6.5 years, PVL ≥ 2 was an independent predictor of mortality and was associated with higher mortality risk. PPM was not associated with increased risk of mortality. Conclusions: Our analysis from the France-TAVI registry showed that both moderate-to-severe PPM and PVL ≥ 2 continue to be frequently observed after the TAVI procedure. Different risk factors, mostly related to the patient’s anatomy and TAVI device selection, for both complications have been identified. Only PVL ≥ 2 was associated with higher mortality during follow-up.