Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis
Journal
Journal of the American College of Cardiology
Journal Volume
68
Journal Issue
11
Pages
1195-1205
Date Issued
2016
Author(s)
Yoon S.-H.
Lefèvre T
Ahn J.-M.
Perlman G.Y.
Dvir D.
Latib A.
Barbanti M.
Deuschl F.
De Backer O.
Blanke P.
Modine T.
Pache G.
Neumann F.-J.
Ruile P.
Arai T.
Ohno Y.
Kaneko H.
Tay E.
Schofer N.
Holy E.W.
Luk N.H.V.
Yong G.
Lu Q.
Kong W.K.F.
Hon J.
Lee M.
Yin W.-H.
Park D.-W.
Kang S.-J.
Lee S.-W.
Kim Y.-H.
Lee C.W.
Park S.-W.
Kim H.-S.
Butter C.
Khalique O.K.
Schaefer U.
Nietlispach F.
Kodali S.K.
Leon M.B.
Ye J.
Chevalier B.
Leipsic J.
Delgado V.
Bax J.J.
Tamburino C.
Colombo A.
Søndergaard L
Webb J.G.
Park S.-J.
Abstract
Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in?patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May?2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n?= 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n?= 112) and 102?with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n?= 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n?= 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p?= 0.57). Overall, all-cause mortality rates were 4.3% at?30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p?= 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p?= 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p?> 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p?= 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p?= 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The?Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184) ? 2016 American College of Cardiology Foundation
Subjects
mortality; new device; paravalvular leak
SDGs
Other Subjects
acute kidney failure; aged; all cause mortality; aorta valve prosthesis; aorta valve stenosis; Article; bleeding; cerebrovascular accident; computer assisted tomography; controlled clinical trial; controlled study; device safety; disease severity; EuroSCORE; female; human; major clinical study; male; mortality; multicenter study; observational study; outcome assessment; paravalvular leak; priority journal; retrospective study; Society of Thoracic Surgeons score; transcatheter aortic valve implantation; vascular disease; abnormalities; aortic valve; aortic valve stenosis; clinical trial; complication; devices; equipment design; Heart Valve Diseases; transcatheter aortic valve implantation; Aged; Aortic Valve; Aortic Valve Stenosis; Equipment Design; Female; Heart Valve Diseases; Humans; Male; Transcatheter Aortic Valve Replacement
Publisher
Elsevier USA
Type
journal article