Outcomes of surgical bioprosthetic aortic valve replacement in patients ≤65 and >65 years of age
Kiaii BB, Moront MG, Patel HJ, et al. Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients ≤65 and >65 Years of Age [published online ahead of print, 2022 Jan 19]. Ann Thorac Surg. 2022;S0003-4975(22)00062-5. doi:10.1016/j.athoracsur.2021.12.057
BACKGROUND: Implantation of a bioprosthetic valve is a reasonable choice for patients aged >65 years. For middle-aged patients, there is less certainty about whether a mechanical or bioprosthetic valve is best. METHODS: The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial is evaluating the safety and efficacy of the Avalus bioprosthesis. We evaluated clinical and echocardiographic outcomes through 5 years of follow-up, stratified by age ≤65 and >65 years. RESULTS: Two hundred seventy-one patients (24.2%) were ≤65 years old, and 847 (75.8%) were >65 years old. Most patients in both groups were male (217 [80.1%] vs 623 [73.6%], respectively; p=0.031). Younger patients had a lower STS risk of mortality (1.1±0.9% vs 2.2±1.4%, p<0.001), better baseline New York Heart Association (NYHA) class (p=0.004), and fewer comorbidities than older patients. At 5 years, mortality was lower among younger than older patients (5.3% vs 14.0%, p<0.001), and there were no cases of SVD in either group. Effective orifice area (EOA) was similar between age groups (p=0.11), and mean gradient was 13.9±5.4 vs 12.0±4.1 mmHg (p<0.001). Multivariable linear regression identified several parameters associated with mean aortic gradient at 5 years, including age, stroke volume index and EOA at discharge and up to 30 days, and implanted valve size. Ninety-five percent of patients were in NYHA class I/II through 5 years in both age groups (p=0.85). CONCLUSIONS: Findings from this analysis demonstrate satisfactory safety, hemodynamic performance, and durability of the Avalus bioprosthesis through 5-year follow-up in patients ≤65 and >65 years of age.