In-hospital outcomes of Portico transcatheter aortic valve replacement with the FlexNav as compared to the first-generation delivery system

Introduction:
Technological advancements in transcatheter heart valve platforms are essential in order to achieve high standards of efficacy and safety in transcatheter aortic valve replacement (TAVR).

Aim:
To evaluate the performance of the new version of the Portico valve delivery system (FlexNav) as compared to the first-generation device.

Material and methods:
In this single-center, observational study consecutive patients undergoing Portico valve implantation with the new FlexNav delivery system (DS) were compared with patients treated with the first-generation delivery system (1^st gen DS). In-hospital outcomes were self-adjudicated according to the Valve Academic Research Consortium-3 definition.

Results:
Fifty patients were included in this study; 22 were treated with the FlexNav DS and the remaining patients with the 1^st gen DS. Clinical characteristics were similar between groups, except for older age (82.6 ±3.6 vs. 80.7 ±3.8; p = 0.07) and higher prevalence of female gender (68.2% vs. 39.3%; p = 0.04) in the FlexNav DS group as compared to the 1^st gen DS group, respectively. We observed similar rates of procedural success but higher rate of moderate-to-severe paravalvular leak in the 1^st gen DS as compared to FlexNav DS group (28.6% vs. 4.6%; p = 0.03); major vascular complications were reduced, although not significantly, in the FlexNav DS as compared to the 1^st gen DS group (4.5% vs. 10.7%; p = 0.64).

Conclusions:
Our data suggest that the FlexNav DS, thanks to its lower profile and enhanced stability during valve deployment, might be associated with reduced rates of vascular complications and moderate to severe paravalvular leak, thus improving procedural results.