Complications and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement With Edwards SAPIEN & SAPIEN XT Valves: A Meta-Analysis of World-Wide Studies and Registries Comparing the Transapical and Transfemoral Accesses

J Interv Cardiol. 2015 Jun;28(3):266-78. doi: 10.1111/joic.12201. Epub 2015 May 20.


Introduction: Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta-analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions.

Methods: We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1-year mortality, 30-day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury.

Results: Seventeen studies were included in the meta-analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30-day mortality (RR 0.61; 95%CI 0.46-0.81; P = 0.001), 1-year mortality (RR 0.68; 95%CI 0.55-0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38-0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30-day stroke, pacemaker implantation, and major or life-threatening bleeding. Studies utilizing the VARC definitions and those pre-dating VARC yielded similar results.

Conclusion: This meta-analysis demonstrates a decreased 30-day and 1-year mortality in TF TAVR as compared to TA TAVR. Post-procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Acute Kidney Injury / etiology
  • Heart Valve Prosthesis*
  • Hemorrhage / etiology
  • Humans
  • Pacemaker, Artificial
  • Renal Replacement Therapy
  • Stroke / etiology
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / methods*
  • Transcatheter Aortic Valve Replacement / mortality