Dr. Andrea Scotti of the Montefiore Medical Center (New York) presented data on the current-generation aortic valve system at TVT: The Structural Heart Summit. It was simultaneously published in EuroIntervention.
In an investigator-driven study, retrospective registry data from 2,026 patients across 34 European centers compared outcomes with the previous generation Acurate neo valve from the NEOPRO registry (1,263 patients in 18 centers) with outcomes for the Acurate neo2 valve from the NEOPRO2 registry (763 patients in 16 centers).
Results demonstrated a significant reduction in moderate or severe paravalvular aortic regurgitation (PAR) for the Acurate neo2 valve 2% vs. 5% with Acurate neo), meeting the primary endpoint with a higher Valve Academic Research Consortium 3 (VARC-3) intended valve performance at 96% vs 90%.
According to a spokesperson working on behalf of Boston Scientific, the findings were driven by the superior performance of Acurate neo2 in patients with heavy aortic valve calcification. It also demonstrated a significant reduction in mild PAR for patients with Acurate neo2 and had similar 30-day results for VARC-3 technical success, device success and one-year survival after transcatheter aortic valve replacement (TAVR), reaching the secondary endpoint.
Positive data for Acurate neo 2 follows last month’s reported initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves. That study demonstrated that commissural alignment can be achieved safely, effectively and quickly.
Additionally, data from the ITAL-neo registry showed that Acurate Neo2 produced superior performance compared to the previous generation (Acurate Neo), reinforcing the enhanced ability of the valve to minimize paravalvular leak (PVL) with its sealing technology. The study met its primary endpoint with a three-fold reduction in more-than-mild paravalvular aortic regurgitation with Acurate Neo2 (11.5% for the first generation valve, 3.5% for Acurate Neo2).
There was also a numerically higher in-hospital technical device success rate and improved success and safety outcomes at 90 days — the secondary endpoints for the registry — for Acurate Neo 2.