Paravalvular Leak after Transcatheter Aortic Valve Implantation: Results from 3,600 patients.

Abstract

Background: Paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) is associated with poor outcomes. Mild PVL remains prevalent post-TAVI and its impact on long-term survival is unclear. This study aims to examine the incidence, impact on survival, and progression of PVL.

Methods: This was a retrospective, single-institution cohort study of TAVIs between 11/2012-1/2023. Patients were stratified by 30-day PVL severity: none/trace, mild, and ≥ moderate. Multivariable logistic regression was performed to identify risk factors associated with increasing PVL severity. Kaplan-Meier survival estimation and Cox proportional hazards regression were performed.

Results: 3600 patients underwent TAVI. Of these, 2719 (75.5%) had none/trace PVL, 808 (22.5%) had mild PVL, and 73 (2.0%) had ≥ moderate PVL at 30-days. On multivariable logistic regression, later years of valve implantation (2017-2023) were protective against PVL progression. Kaplan-Meier estimates of the three groups were significantly different (p<0.001) with the ≥ moderate group having reduced survival. On Cox regression, ≥ moderate PVL was associated with increased mortality (HR = 1.80, 95% Cl, 1.31-2.46, p<0.001) while mild PVL was not (HR = 1.01; 95% CI, 0.89-1.15; p=0.88) compared to none/trace PVL. For Kaplan-Meier estimates comparing the none/trace and mild PVL groups alone, landmark analysis showed reduced survival in the mild PVL group after 2-years (p=0.03); however, this late reduction in survival in the mild PVL group did not persist on multivariable analysis (p=0.14).

Conclusions: After TAVI, ≥ moderate PVL is associated with reduced survival compared to none/trace PVL. Mild PVL may result in a delayed survival reduction.