Real-world outcomes and management considerations following surgical aortic valve replacement with the Trifecta valve

BACKGROUND: Bioprosthetic surgical aortic valve replacement (SAVR) using the Trifecta valve was frequently chosen because of its large opening area and low transvalvular gradient. However, long-term follow-up revealed the potential for early structural valve deterioration. To further assess the long-term clinical outcomes and management considerations for patients implanted with the Trifecta valve, a real-world study using Medicare fee-for-service claims data was conducted with a focus on Trifecta valve reintervention. METHODS: De-identified patients undergoing SAVR with the Trifecta™ valve (Abbott) in the U.S. between 1/1/2011-12/31/2021 were selected by ICD-9/10 procedure codes and then linked to a manufacturer device tracking database. All-cause mortality and freedom from Trifecta valve reintervention with repeat SAVR or valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) were evaluated at 10-years using the Kaplan Meier method. Independent predictors for reintervention and clinical outcomes following reintervention were assessed. RESULTS: Among 242,160 Medicare beneficiaries undergoing SAVR during the study period, 23,197 were implanted with the Trifecta valve. Mean age was 75.2 ± 7.4 years. At 10-years survival was 32.3 % (95 % CI, 31.4 %-33.3 %) and the freedom from valve reintervention was 82.4 % (95 % CI, 81.1 %-83.5 %). Independent predictors for reintervention included younger age, female, obesity, and implants with a small valve size (19 mm, 21 mm). Reintervention with ViV-TAVI (N = 796) was associated with better operative survival (3.8 % vs. 12.5 %, p < 0.001) than repeat SAVR (N = 577). CONCLUSION: This real-world nationwide study of Medicare beneficiaries receiving the Trifecta valve demonstrates >80 % freedom from all-cause valve reintervention at 10-years post-implant with reintervention using ViV-TAVI having improved operative survival compared to repeat SAVR.