Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System

ABSTRACT Objectives To characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile Delivery System (DS). Background Key design modifications to the FlexNav™ DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in a vessel diameter ≥ 5 mm. Methods Patients were pooled from two concurrent prospective, multicenter, single-arm studies (FlexNav DS Study arm of PORTICO IDE trial, N=134; FlexNav DS EU CE Mark Study, N=46) for the analysis. Primary endpoint was VARC-2 defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30-days by an independent Clinical Events Committee and Echocardiographic core laboratory respectively. Results 140 High and 40 Extreme risk subjects enrolled between October 15, 2018 and December 10, 2019 from 28 sites in the United States, Australia and Europe that underwent an attempted transfemoral Portico™ valve implant were included. Mean age of subjects was 85.1 ± 5.6 years, 60% were female, mean STS score was 5.3% and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, major vascular complications rate was 5.0%; with 4.4% adjudicated as access-site related (3.3% TAVR DS access-site related). Death (0.6%) and disabling stroke (1.1%) were rare. New permanent pacemaker rate was 15.4%. Echocardiography revealed 7.0 ± 3.2 mmHg mean gradient, 1.78 ± 0.41 cm2 valve area and 4.1% moderate paravalvular leak at 30 days. Conclusions Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.