First results from ACURATE neo 2 aortic valve system post market clinical follow up study. - Boston Scientific.

The findings, which included a high procedural success rate of 98.4% and low rates of mortality and paravalvular leak (PVL), were presented during a late-breaking clinical trial session at PCR London Valves 2022 and published simultaneously in EuroIntervention.

In this European study, the primary safety endpoint of all-cause mortality was 0.8% at 30 days. The data also demonstrated that no patients experienced greater than moderate PVL ( paravalvular leak), 1.9% experienced moderate PVL and 18.9% experienced mild PVL. Other notable findings from the study included a low 6.5% rate of new pacemaker implantation 30 days post procedure, with no incidence of disabling stroke or acute kidney injury.

The single-arm, prospective ACURATE neo2 PMCF study includes 250 patients with severe aortic stenosis from 18 European centers and will evaluate outcomes for five years following the procedure. It also includes a primary imaging endpoint to assess the visually apparent thickening of the prosthetic valve leaflets (HALT), a phenomenon with theoretical potential effects on valve durability or thrombotic complications. The reported HALT rate of 24.5% at 30 days post procedure falls within the range presented in previous TAVR trials with competitive devices.

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See- "Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2."- EuroIntervention 2022;18:804-811. DOI: 10.4244/EIJ-D-22-00289- Andrea Scotti Andrea Scotti,, MD; Matteo Pagnesi, MD; Won-Keun Kim4, MD; Ulrich Schäfer, MD; et al.,|