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

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• 作者：Sung-Han Yoon ; MD^a ; Thierry Lefè ; vre ; MD^b ; Jung-Ming Ahn ; MD^a ; ^{drjmahn@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Gidon Y. Perlman ; MD^c ; Danny Dvir ; MD^c ; Azeem Latib ; MD^d ; Marco Barbanti ; MD^e ; Florian Deuschl ; MD^f ; Ole De Backer ; MD^g ; Philipp Blanke ; MD^c ; Thomas Modine ; MD^h ; Gregor Pache ; MDⁱ ; Franz-Josef Neumann ; MD^j ; Philipp Ruile ; MD^j ; Takahide Arai ; MD^b ; Yohei Ohno ; MD^e ; Hidehiro Kaneko ; MD^k ; Edgar Tay ; MD^l ; Niklas Schofer ; MD^f ; Erik W. Holy ; MD^m ; Ngai H.V. Luk ; MD^g ; Gerald Yong ; MDⁿ ; Qingsheng Lu ; MD^o ; William K.F. Kong ; MD^l ; ^p ; Jimmy Hon ; MD^l ; Hsien-Li Kao ; MD^q ; Michael Lee ; MD^r ; Wei-Hsian Yin ; MD^s ; Duk-Woo Park ; MD^a ; Soo-Jin Kang ; MD^a ; Seung-Whan Lee ; MD^a ; Young-Hak Kim ; MD^a ; Cheol Whan Lee ; MD^a ; Seong-Wook Park ; MD^a ; Hyo-Soo Kim ; MD^t ; Christian Butter ; MD^k ; Omar K. Khalique ; MD^u ; Ulrich Schaefer ; MD^f ; Fabian Nietlispach ; MD^m ; Susheel K. Kodali ; MD^u ; Martin B. Leon ; MD^u ; Jian Ye ; MD^c ; Bernard Chevalier ; MD^b ; Jonathon Leipsic ; MD^c ; Victoria Delgado ; MD^q ; Jeroen J. Bax ; MD^q ; Corrado Tamburino ; MD^e ; Antonio Colombo ; MD^d ; Lars Sø ; ndergaard ; MD^g ; John G. Webb ; MD^c
• 关键词：mortality ; new device ; paravalvular leak
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：13 September 2016
• 年：2016
• 卷：68
• 期：11
• 页码：1195-1205
• 全文大小：1106 K

文摘

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)