Structural Heart (Mar 2023)

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

  • Michel Pompeu Sá, MD, MSc, MHBA, PhD,
  • Xander Jacquemyn, BSc,
  • Jef Van den Eynde, BSc,
  • Panagiotis Tasoudis, MD,
  • Ozgun Erten, MD,
  • Serge Sicouri, MD,
  • Francisco Yuri Macedo, MD, MSc,
  • Tilak Pasala, MD, MRCP,
  • Ryan Kaple, MD,
  • Alexander Weymann, MD, MHBA, PhD,
  • Arjang Ruhparwar, MD, PhD,
  • Marie-Annick Clavel, DVM, PhD,
  • Philippe Pibarot, DVM, PhD,
  • Basel Ramlawi, MD

Journal volume & issue
Vol. 7, no. 2
p. 100118

Abstract

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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.

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