Failure of the new underexpansion criteria to predict outcomes after ACURATE neo2 valve implantation: results from an independent multicenter registry.

Abstract

Introduction and objectives: Suboptimal outcomes with the ACURATE neo2 valve have been attributed to valve frame underexpansion, reported in approximately 20% of cases according to 3 recently proposed angiographic criteria. We aimed to validate these criteria in an independent registry with a 2-year follow-up.

Methods: This registry included 696 patients with severe aortic stenosis treated with the ACURATE neo2 valve at 7 experienced centers. Underexpansion was defined as the presence of at least 1 of the 3 criteria; the boundary box method was also applied to assess postparallelism. The primary endpoint was a composite of all-cause mortality, stroke, or heart failure hospitalization at 2 years.

Results: The mean age was 81  ±  5.8 years. Based on the 3-criteria method, underexpansion was identified in 154 patients (22%). There were no significant differences in the primary endpoint between the 2 groups. The cumulative incidence of the composite outcome was 13.7% vs 11.0% at 1 year and 21.0% vs 17.4% at 2 years for the underexpanded and expanded groups, respectively (P =  .535). Similarly, no differences were observed with the boundary box method. On multivariable analysis, underexpansion was not independently associated with the primary endpoint (HR, 1.15; 95%CI, 0.73-1.80, P  =  .537). The only variables significantly associated with major adverse events at 2-years were atrial fibrillation, diabetes mellitus, and reduced glomerular filtration rate.

Conclusions: The presence of at least 1 angiographic underexpansion criterion after ACURATE neo2 implantation did not predict adverse outcomes at follow-up.