Impact of Paravalvular Leak on Outcomes After Transcatheter Aortic Valve Implantation: Meta-Analysis of Kaplan-Meier-derived Individual Patient Data

Michel Pompeu Sá; Xander Jacquemyn; Jef Van den Eynde; Panagiotis Tasoudis; Ozgun Erten; Serge Sicouri; Francisco Yuri Macedo; Tilak Pasala; Ryan Kaple; Alexander Weymann; Arjang Ruhparwar; Marie-Annick Clavel; Philippe Pibarot; Basel Ramlawi

doi:10.1016/j.shj.2022.100118

Impact of Paravalvular Leak on Outcomes After Transcatheter Aortic Valve Implantation: Meta-Analysis of Kaplan-Meier-derived Individual Patient Data

Struct Heart. 2022 Nov 14;7(2):100118. doi: 10.1016/j.shj.2022.100118. eCollection 2023 Mar.

Authors

Michel Pompeu Sá^{1

2}, Xander Jacquemyn³, Jef Van den Eynde³, Panagiotis Tasoudis², Ozgun Erten², Serge Sicouri², Francisco Yuri Macedo⁴, Tilak Pasala⁴, Ryan Kaple⁴, Alexander Weymann⁵, Arjang Ruhparwar⁵, Marie-Annick Clavel^{6

7}, Philippe Pibarot^{6

7}, Basel Ramlawi^{1

2}

Affiliations

¹ Department of Cardiothoracic Surgery, Lankenau Heart Institute, Lankenau Medical Center, Main Line Health, Wynnewood, Pennsylvania, USA.
² Department of Cardiothoracic Surgery Research, Lankenau Institute for Medical Research, Wynnewood, Pennsylvania, USA.
³ Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.
⁴ Division of Structural Heart Disease, Department of Medicine, Hackensack University Medical Center, Hackensack, New Jersey, USA.
⁵ Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University of Duisburg-Essen, Essen, Germany.
⁶ Quebec Heart & Lung Institute, Université Laval, Québec City, Québec, Canada.
⁷ Department of Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada.

Abstract

Background: Paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) is frequent and the impact of mild PVL on outcomes remains uncertain. Our study aimed to evaluate the impact of PVL on TAVI outcomes.

Methods: To analyze late outcomes of patients after TAVI according to the presence and severity of PVL, PubMed/MEDLINE, EMBASE and Google Scholar were searched for studies that reported rates of all-cause mortality/survival and/or rehospitalization and/or cardiovascular mortality accompanied by at least one Kaplan-Meier curve for any of these outcomes. We adopted a 2-stage approach to reconstruct individual patient data based on the published Kaplan-Meier graphs.

Results: Thirty-eight studies with Kaplan-Meier curves met our eligibility criteria including over 25,000 patients. Patients with any degree of PVL after TAVI had a significantly higher risk of overall mortality (hazard ratio (HR), 1.52; 95% confidence interval (CI), 1.43-1.61; p < 0.001), rehospitalization (HR, 1.81; 95% CI, 1.54-2.12; p < 0.001), and cardiovascular mortality (HR, 1.52; 95% CI, 1.33-1.75; p < 0.001) over time. These findings remained consistent when we stratified the results for the methods of assessment of PVL (i.e., echocardiography vs. angiography) and PVL severity. Both moderate/severe PVL and mild PVL were associated with increased risk of overall mortality (p < 0.001), rehospitalization (p < 0.001), and cardiovascular mortality (p < 0.001) during follow-up.

Conclusions: Patients with PVL, even if mild, experience higher risk of all-cause mortality, rehospitalization, and cardiovascular mortality following TAVI. These findings provide support to the implementation of procedural strategies to prevent any degree of PVL at the time of TAVI.

Keywords: Aortic valve disease; Cardiac surgical procedures; Cardiovascular surgical procedures; Heart valve prosthesis implantation; Meta-analysis; Transcatheter aortic valve replacement; heart valves.