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Background <p>This study aimed to evaluate clinical outcomes after surgical aortic valve replacement with third-generation Edwards (Edwards Lifesciences, Irvine, CA, USA) 19-mm-labeled aortic valve bioprostheses, including a rapid-deployment sutureless valve (Intuity valve) for small aortic annuli at a high-volume Japanese heart center.</p> Methods <p>We retrospectively analyzed the outcomes of adult patients with symptomatic aortic valve stenosis, regurgitation, or valve deterioration who underwent 19-mm-labeled aortic valve bioprostheses replacement (Edwards products: Inspiris, Magna, and Intuity) for small aortic annuli at our center between January 2015 and August 2024. The primary and secondary endpoints were all-cause mortality after implantation and major adverse cardiac and cardiovascular events (MACCE), respectively. We also analyzed the hemodynamic performances of the different aortic bioprostheses.</p> Results <p>Overall, 137 patients (median age, 76&#xa0;years [interquartile range (IQR): 72 − 80]; 122 females [89%]) underwent surgical aortic valve replacement with 19-mm Edwards aortic valve bioprostheses (Inspiris, n = 58; Magna, n = 69; Intuity, n = 10). The median follow-up duration was 71&#xa0;months (IQR: 34 − 103). Overall survival rates at 1, 3, and 5&#xa0;years after valve replacement were 91.9%, 86.5%, and 84.8% (95% confidence interval [CI]: 85.9 − 95.5; 79.4 − 91.3; 77.4 − 89.9), respectively. Freedom from MACCE at 1, 3, and 5&#xa0;years was 94.8%, 89.8%, and 88.8% (95%CI: 89.4 − 97.5; 83.0 − 93.9; 81.7 − 93.2), respectively. Among the three types of valves, the survival and rate of freedom from MACCE did not differ significantly (p = 0.29 and p = 0.48, respectively). Furthermore, no significant differences in hemodynamics were observed among the different aortic bioprostheses.</p> Conclusion <p>Surgical replacement using 19-mm-labeled Edwards aortic valve bioprostheses for small aortic annuli is a feasible therapeutic option in this population, demonstrating favorable early- and mid-term hemodynamic parameters.</p>

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Mid-term outcomes and hemodynamic performance of Edwards 19-mm-labeled aortic valve bioprostheses: a single-center retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月25日

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  • Takayuki Gyoten,
  • Takayuki Akatsu,
  • Taro Kuroda,
  • Yu Kumagai,
  • Yuko Gatate,
  • Akihiro Yoshitake

摘要

Background

This study aimed to evaluate clinical outcomes after surgical aortic valve replacement with third-generation Edwards (Edwards Lifesciences, Irvine, CA, USA) 19-mm-labeled aortic valve bioprostheses, including a rapid-deployment sutureless valve (Intuity valve) for small aortic annuli at a high-volume Japanese heart center.

Methods

We retrospectively analyzed the outcomes of adult patients with symptomatic aortic valve stenosis, regurgitation, or valve deterioration who underwent 19-mm-labeled aortic valve bioprostheses replacement (Edwards products: Inspiris, Magna, and Intuity) for small aortic annuli at our center between January 2015 and August 2024. The primary and secondary endpoints were all-cause mortality after implantation and major adverse cardiac and cardiovascular events (MACCE), respectively. We also analyzed the hemodynamic performances of the different aortic bioprostheses.

Results

Overall, 137 patients (median age, 76 years [interquartile range (IQR): 72 − 80]; 122 females [89%]) underwent surgical aortic valve replacement with 19-mm Edwards aortic valve bioprostheses (Inspiris, n = 58; Magna, n = 69; Intuity, n = 10). The median follow-up duration was 71 months (IQR: 34 − 103). Overall survival rates at 1, 3, and 5 years after valve replacement were 91.9%, 86.5%, and 84.8% (95% confidence interval [CI]: 85.9 − 95.5; 79.4 − 91.3; 77.4 − 89.9), respectively. Freedom from MACCE at 1, 3, and 5 years was 94.8%, 89.8%, and 88.8% (95%CI: 89.4 − 97.5; 83.0 − 93.9; 81.7 − 93.2), respectively. Among the three types of valves, the survival and rate of freedom from MACCE did not differ significantly (p = 0.29 and p = 0.48, respectively). Furthermore, no significant differences in hemodynamics were observed among the different aortic bioprostheses.

Conclusion

Surgical replacement using 19-mm-labeled Edwards aortic valve bioprostheses for small aortic annuli is a feasible therapeutic option in this population, demonstrating favorable early- and mid-term hemodynamic parameters.