P86 IN–HOSPITAL OUTCOMES OF PORTICO TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE FLEXNAV AS COMPARED TO THE FIRST–GENERATION DELIVERY SYSTEM. (18th May 2022) - Marino, G
Abstract: Introduction: technological advancements in transcatheter heart valve platforms, along with increasing operator experience and careful patient selection, are essential to reach high standards of efficacy and safety in transcatheter aortic valve replacement (TAVR). Aim of this study was to evaluate the performance of the new version of the Portico valve delivery system (FlexNav) as compared to the first–generation device. Materials and Methods: we report the results of a single–center, observational study on patients with severe aortic valve stenosis undergoing TAVR with the Portico valve at our Institution. Consecutive patients treated with the new FlexNav delivery system (DS), available since May, 2020, were compared with patients treated with the first–generation delivery system (1st Gen–DS). In–hospital outcomes were self–adjudicated according to the Valve Academic Research Consortium–3 definition. Results: 50 patients were included in this study; 22 were treated with the FlexNav–DS and the remaining with the 1st Gen–DS. Clinical characteristics were similar between group, expect 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 FlexNav–DS group as compared to 1st Gen–DS group, respectively. We observed similar rates of procedural success but higher rate of moderate–to–severe paravalvular leak in 1st 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 1st Gen–DS group (4.5% vs 10.7%; p = 0.64). Conclusion: Our data suggest that the FlexNav DS, thanks to lower profile and enhanced stability during valve deployment, has the potential to allow for to better procedural and clinical results of TAVR with the Portico valve as compared to the 1st Gen–DS.