Abstract

Introduction: The third generation transcatheter heart valve system aimed to improve the safety of transcatheter aortic valve replacement (TAVR). We performed systematic review and meta-analysis to compare clinical outcomes after TAVR with Edwards Sapien 3 (ES3) and Evolut series (MER). Methods: A systematic search was conducted by 2 independent researchers in MEDLINE and EMBASE for studies comparing clinical outcomes after TAVR with ES3 and MER. 1 randomized controlled trial and 11 observational studies met the inclusion criteria. Mantel-Haenszel odds ratios were calculated, and for heterogeneity I 2 statistics were reported. Results: 12 studies with total 7,749 patients were included for final analysis. ES3 and MER were implanted in 4,333 and 3,416 patients respectively. ES3 showed statistically significant decrease in permanent pacemaker implantation at 30-days (OR: 0.60; 95% CI: 0.52-0.70; p< 0.05). Furthermore, TAVR with ES3 showed non-statistically significant trend towards decreased all-cause mortality at 30 days (OR: 0.73; 95% CI: 0.51-1.02; p=0.07), and stroke at 30 days (OR: 0.55; 95% CI: 0.27-1.10; p=0.09). Cardiovascular mortality (OR: 1.03; 95% CI: 0.50-2.15; p=0.93), and acute kidney injury (OR: 1.08; 95% CI: 0.83-1.41; p=0.56) did not show statistically significant difference. Conclusions: While ES3 and MER had similar clinical outcomes, patients undergoing TAVR with ES3 had statistically significant decrease in permanent pacemaker implantation and hence may be favored in patients with pre-existing conduction system disease.

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