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.