Meta-analysis Comparing Early Outcomes Following Transcatheter Aortic Valve Implantation With the Evolut Versus Sapien 3 Valves

Am J Cardiol. 2021 Jan 15:139:87-96. doi: 10.1016/j.amjcard.2020.10.041. Epub 2020 Oct 24.

Abstract

We aimed to compare the early (in-hospital/30-day) outcomes (major periprocedural complications, device success/valve performance, and mortality) following transcatheter aortic valve implantation with the Sapien 3 versus Evolut transcatheter valve systems. This was a systematic review from PubMed and EMBASE databases for studies reporting raw data or estimates. The outcomes analyzed were (1) in-hospital/30-day major periprocedural complications, (2) device success and valve performance, and (3) mortality. The outcomes were defined according to VARC-2 criteria. A total of 24,628 transcatheter aortic valve implantation patients from 9 studies (1 randomized, 8 observational [5 case- or propensity-matched analyses]) were included: 12,411 and 12,217 patients had Sapien 3 and Evolut valve implantation, respectively. There were no differences between devices regarding in-hospital/30-day stroke (risk ratio [RR] 0.95, 95% confidence interval [CI] 0.34 to 2.66), major vascular complications (RR 1.03, 95% CI 0.63 to 1.68), acute kidney injury (RR 1.17, 95% CI 0.78 to 1.77), device success (RR 1.00, 95% CI 0.97 to 1.04) and moderate-severe residual aortic regurgitation (RR 0.49, 95% CI 0.20 to 1.17). Sapien 3 recipients exhibited lower risk of permanent pacemaker implantation (RR 0.66, 95% CI 0.55 to 0.80), a higher risk of life-threatening bleeding (RR 1.82, 95% CI 1.18 to 2.80), and higher residual transvalvular gradients (mean difference 3.95 mmHg, 95% CI 3.37 to 4.56). A lower risk of in-hospital/30-day mortality was observed for Sapien 3 (RR 0.79, 95% CI 0.69 to 0.90). In conclusion, the similarities in device success rate and major periprocedural complications (except for a higher and lower risk of permanent pacemaker implantation and life-threatening bleeding, respectively, with the Evolut system) support the lack of a valve type effect accounting for the increased mortality risk observed with the Evolut valve.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / surgery*
  • Global Health
  • Heart Valve Prosthesis*
  • Humans
  • Incidence
  • Postoperative Complications / epidemiology*
  • Prosthesis Design
  • Risk Factors
  • Transcatheter Aortic Valve Replacement*
  • Treatment Outcome