Open Access

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

  • Authors:
    • Chenglin He
    • Lang Xiao
    • Junli Liu
  • View Affiliations

  • Published online on: September 12, 2019     https://doi.org/10.3892/etm.2019.8000
  • Pages: 3893-3904
  • Copyright: © He et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

The aim of this study was to systematically search literature and conduct a meta‑analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66‑1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83‑3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = ‑3.96; 95% CI, ‑4.61 to ‑3.31; P<0.00001, I2=0%] and peak (random; MD = ‑6.85; 95% CI, ‑8.22 to ‑5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30‑day mortality (OR, 1.32; 95% CI, 0.45‑3.87; P=0.62; I2=0%) or 30‑day stroke outcomes (OR, 0.76; 95% CI, 0.32‑1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short‑term complications. The differences between the 2 devices for post‑operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi‑center randomized controlled trial to provide stronger evidence on this subject.
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November-2019
Volume 18 Issue 5

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Spandidos Publications style
He C, Xiao L and Liu J: Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis. Exp Ther Med 18: 3893-3904, 2019
APA
He, C., Xiao, L., & Liu, J. (2019). Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis. Experimental and Therapeutic Medicine, 18, 3893-3904. https://doi.org/10.3892/etm.2019.8000
MLA
He, C., Xiao, L., Liu, J."Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis". Experimental and Therapeutic Medicine 18.5 (2019): 3893-3904.
Chicago
He, C., Xiao, L., Liu, J."Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis". Experimental and Therapeutic Medicine 18, no. 5 (2019): 3893-3904. https://doi.org/10.3892/etm.2019.8000