Initial experience with the Crea Aortic Valve System - a first-in-human study.

Abstract

Background: Transcatheter aortic valve implantation (TAVI) is a minimally invasive option for severe aortic stenosis (AS). The Crea Aortic Valve (CAV) is a new self-expanding transcatheter aortic valve implant that has been successfully tested in preclinical studies.

Aims: We aimed to assess the technical success, device performance, and early safety of the CAV System in a first-in-human study for the device in patients with severe AS.

Methods: We prospectively evaluated the CAV using the Valve Academic Research Consortium (VARC)-3 criteria in three high-risk patients with severe AS. A computed tomography angiography and transthoracic echocardiographic (TTE) assessment were carried out, which was followed by TAVI according to standard protocol. TTE was performed before and after the procedure, before discharge, and at the 1- and 6-month clinical follow-ups to monitor the aortic valve area, the maximum velocity (Vmax), the mean (MG) and peak pressure gradients, and paravalvular leak (PVL).

Results: The CAV was successfully implanted, using the cusp-overlap technique for patient 1 and the coplanar view for patients 2 and 3, with good usability of the delivery system for optimal positioning, reduction of the Vmax to <2 m/s and MG to <10 mmHg, and trivial PVL. An atrioventricular block necessitating a permanent pacemaker occurred in one patient. There was no incidence of stroke, heart failure, or renal failure at 6 months of follow-up.

Conclusions: The CAV was implanted with success, and the system performed as intended as per VARC-3 criteria. The device should be evaluated in a larger clinical study for further efficacy and safety data.