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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 / Copyright

    Affiliations: Department of Cardiovascular Medicine, Hanchuan People's Hospital, Hanchuan, Hubei 431600, P.R. China, Department of Haematology, Hanchuan Hospital of Traditional Chinese Medicine, Hanchuan, Hubei 431600, P.R. China, Department of Critical Care Medicine, Hanchuan People's Hospital, Hanchuan, Hubei 431600, P.R. China
    Copyright: © He et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Pages: 3893-3904
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    Published online on: September 12, 2019
       https://doi.org/10.3892/etm.2019.8000
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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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Copy and paste a formatted citation
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
Copy and paste a formatted citation
x
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
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