Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

Sung Han Yoon, Thierry Lefèvre, Jung Ming Ahn, Gidon Y. Perlman, Danny Dvir, Azeem Latib, Marco Barbanti, Florian Deuschl, Ole De Backer, Philipp Blanke, Thomas Modine, Gregor Pache, Franz Josef Neumann, Philipp Ruile, Takahide Arai, Yohei Ohno, Hidehiro Kaneko, Edgar Tay, Niklas Schofer, Erik W. HolyNgai H.V. Luk, Gerald Yong, Qingsheng Lu, William K.F. Kong, Jimmy Hon, Hsien Li Kao, Michael Lee, Wei Hsian Yin, Duk Woo Park, Soo Jin Kang, Seung Whan Lee, Young Hak Kim, Cheol Whan Lee, Seong Wook Park, Hyo Soo Kim, Christian Butter, Omar K. Khalique, Ulrich Schaefer, Fabian Nietlispach, Susheel K. Kodali, Martin B. Leon, Jian Ye, Bernard Chevalier, Jonathon Leipsic, Victoria Delgado, Jeroen J. Bax, Corrado Tamburino, Antonio Colombo, Lars Søndergaard, John G. Webb, Seung Jung Park

Research output: Contribution to journalArticlepeer-review

126 Scopus citations

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)

Original languageEnglish (US)
Pages (from-to)1195-1205
Number of pages11
JournalJournal of the American College of Cardiology
Volume68
Issue number11
DOIs
StatePublished - Sep 13 2016
Externally publishedYes

Keywords

  • mortality
  • new device
  • paravalvular leak

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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