Impact of Aortic Annulus Size on Outcomes After Aortic Valve Replacement: The PARTNER 3 Trial.

BACKGROUND

There are limited studies comparing the impact of transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) by annular size.

OBJECTIVES

The aim of this post hoc analysis from the PARTNER (Placement of Aortic Transcatheter Valves) 3 trial was to assess the relationship between annular size and outcomes among patients with severe aortic stenosis (AS) who underwent TAVR or SAVR.

METHODS

Low-risk patients with severe, symptomatic AS were randomized to TAVR using the balloon-expandable SAPIEN 3 valve or SAVR. Patients were stratified by computed tomographic angiography-derived aortic annular area (small, ≤430 mm2; large, >430 mm2). The primary endpoint was the composite of death, stroke, or rehospitalization. Interactions among annular size, treatment strategy, and adjudicated 5-year clinical outcomes were assessed.

RESULTS

Of the 925 patients with available computed tomographic angiography-derived annular size, 293 had small and 632 had large aortic annuli, respectively. Median follow-up duration was 5.2 years (Q1-Q3: 5.0-6.0 years). Five-year rates of the primary endpoint were similar for TAVR and SAVR in the overall cohort, results that were consistent for patients with small (21.2% vs 31.0%; OR: 0.60; 95% CI: 0.35-1.02) and large (23.5% vs 25.5%; OR: 0.90; 95% CI: 0.62-1.29) annuli, without effect modification by annular size (P for interaction = 0.22). Rates of bioprosthetic valve failure were similar and low at 5 years, without effect modification by annular size. Five-year health status was also similar between treatment modalities across annulus strata (P for interaction = 0.12).

CONCLUSIONS

TAVR with the SAPIEN 3 valve led to similar 5-year clinical and health status outcomes compared with SAVR, irrespective of annular size. (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3]; NCT02675114).