Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study

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• 作者：Gidon Y. Perlman ; MD^a ; Philipp Blanke ; MD^a ; Danny Dvir ; MD^a ; Gregor Pache ; MD^b ; Thomas Modine ; MD^c ; Marco Barbanti ; MD^d ; Erik W. Holy ; MD^e ; Hendrik Treede ; MD^f ; Philipp Ruile ; MD^b ; Franz-Josef Neumann ; MD^b ; Caterina Gandolfo ; MD^g ; Francesco Saia ; MD^h ; Corrado Tamburino ; MD^d ; George Mak ; MD^a ; Christopher Thompson ; MD^a ; David Wood ; MD^a ; Jonathon Leipsic ; MD^a ; John G. Webb ; MD^a ; ^{John.webb@vch.ca" class="auth_mail" title="E-mail the corresponding author}
• 关键词：aortic stenosis ; bicuspid ; transcatheter aortic valve replacement
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：25 April 2016
• 年：2016
• 卷：9
• 期：8
• 页码：817-824
• 全文大小：528 K

文摘

This study evaluated the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS) using a new-generation TAVR device.

Background

A bicuspid AS is often considered a relative contraindication to TAVR. Although initial reports have demonstrated feasibility using early-generation devices, outcomes have not matched those seen with tricuspid AS. Paravalvular aortic regurgitation (AR) has been particularly problematic.

Methods

We collected baseline characteristics, procedural data, and 30-day clinical follow-up findings from 8 centers in Europe and Canada that had performed TAVR in bicuspid AS using the SAPIEN 3 valve.

Results

51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation AR was none/trivial in 63% and mild in 37%. There were no cases of moderate or severe AR. At 30-day follow-up, there were 2 deaths (3.9%), 2 major vascular complications, and 12 patients (23.5%) required pacemaker implantation.

Conclusions

TAVR in bicuspid AS using a new-generation device was feasible and effective with favorable valve performance and no cases of moderate or severe AR.