First results from the ACURATE Prime XL human feasibility study.

BACKGROUND/PURPOSE: This prospective, open-label, single-arm study evaluated transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis with ACURATE Prime XL, an iteration of the ACURATE neo2 device designed with improved radial force and adaptations for compatibility with a larger annulus diameter (≥ 26.5 mm and ≤ 29 mm based on pre-procedure diagnostic imaging). METHODS: The composite primary device success endpoint was based on Valve Academic Research Consortium (VARC)-2 criteria. The primary safety endpoint was a composite of all-cause mortality and all stroke at 30 days. Aortic valve (AV) performance, including mean AV gradient, AV area, and grade of paravalvular leak (PVL), was assessed by an independent core laboratory. RESULTS: 13 male patients were enrolled at 3 Australian centers (mean age: 83.1 years; 10 of 13 were considered high/extreme operative risk). 61.5 % of patients met the primary device success endpoint. At 30 days, no patients experienced death or stroke; one patient received a permanent pacemaker. Mean AV gradient improved from baseline (42.7 ± 11.0 mmHg) to discharge (7.7 ± 2.5 mmHg) and through 30 days (7.2 ± 2.3 mmHg). Mean AV area was 0.8 ± 0.1 cm2 at baseline, 1.9 ± 0.3 cm2 at discharge, and 1.7 ± 0.3 cm2 at 30 days. Per core-laboratory adjudication, no patient had moderate or severe PVL at 30 days; 91.7 % had no/trace PVL and 8.3 % had mild PVL. CONCLUSIONS AND RELEVANCE: In this first-in-human feasibility study of the ACURATE Prime XL valve, there were no safety concerns, and no deaths or strokes within 30 days. Valve hemodynamics were favorable, and no patient had >mild PVL.