Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients Y 65 and >65 Years of Age

Abstract

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.

Keywords: age; surgical aortic valve replacement; bioprosthetic pericardial valve.