Safety profile of an intra-annular self-expanding transcatheter aortic valve and next-generation low-profile delivery system
Fontana GP, Bedogni F, Groh M, Smith D, Chehab BM, Garrett HE Jr, Yong G, Worthley S, Manoharan G, Walton A, Hermiller J, Dhar G, Waksman R, Ramana RK, Mahoney P, Asch FM, Chakravarty T, Jilaihawi H, Makkar RR. Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2467-2478. doi: 10.1016/j.jcin.2020.06.041. Epub 2020 Jul 20. PMID: 33153563
OBJECTIVES: The aim of this study was 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 vessels with diameter ≥5 mm.
METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-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 an echocardiography core laboratory, respectively.
Results: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days.
CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.