Mid-Term Clinical Outcomes and Hemodynamic Performance of 19-mm Bioprostheses Following Aortic Valve Replacement: A Single-Institution 10-Year Experience.

Abstract

Background: Data on the clinical outcomes and hemodynamic performance of the smallest commercially available bioprostheses (19 mm) in Japan for aortic valve replacement (AVR) remain limited.

Methods and results: We analyzed the data of 187 adults (median age, 76 [interquartile range (IQR): 73-80] years; 165 women [88%]; median follow-up, 65 [IQR: 32-95] months) with symptomatic aortic valve stenosis, regurgitation, and valve deterioration who underwent surgical AVR between January 2015 and July 2024 with the Avalus (n=7), Magna (n=77), Epic (n=26), Inspiris (n=58), or Mosaic (n=27) bioprosthesis because of having small aortic annuli. The primary and secondary endpoints were all-cause death and major adverse cardiac events, respectively. Moderate-to-severe prosthesis-patient mismatch occurred in 53 patients (28%). The overall survival rates (95% confidence interval [CI]) at 1, 3, and 5 years after valve replacement were 93.0% (88.3-95.9%), 87.0% (81.0-91.2%), and 85.7% (79.5-90.1%), respectively. The rates of freedom from major adverse cardiac and cerebrovascular events (95% CI) at 1, 3, and 5 years were 96.2% (92.1-98.2%), 90.2(84.5-93.9%), and 88.7(82.5-92.7%), respectively. Four patients required re-intervention (3, re-AVR and 1, medication). No significant differences were observed in either outcomes or hemodynamics among the different aortic bioprostheses.

Conclusions: Surgical replacement with 19-mm third-generation aortic valve bioprostheses for small aortic annuli is feasible with favorable early and mid-term hemodynamics.