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 (Medtronic). 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%) >65 years old. Most patients in both groups were men (217 [80.1%] vs 623 [73.6%], respectively; P =.031). Younger patients had a lower Society of Thoracic Surgeons risk of mortality (1.1% ± 0.9% vs 2.2% ± 1.4%, P <.001), better baseline New York Heart Association class (P =.004), and fewer comorbidities than older patients. At 5 years mortality was lower among younger than older patients (5.3% vs 14.0%, P <.001) and no cases of structural valve deterioration occurred in either group. Effective orifice area was similar between age groups (P =.11), and mean gradient was 13.9 ± 5.4 vs 12.0 ± 4.1 mm Hg (P <.001). Multivariable linear regression identified several parameters associated with mean aortic gradient at 5 years, including baseline age and mean aortic gradient, discharge stroke volume index and EOA, and implanted valve size. Ninety-five percent of patients were in New York Heart Association class I/II through 5 years in both age groups (P =.85). Conclusions: Findings from this analysis demonstrate satisfactory safety, hemodynamic performance, and durability of the Avalus bioprosthesis through a 5-year follow-up in patients aged ≤ 65 and >65 years.
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine