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

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.