Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041.
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.
This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices.
The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015.
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).
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).
很少有研究评估经导管主动脉瓣置换术（TAVR）治疗二叶式主动脉瓣狭窄（AS）患者的临床结果。特别是，比较新一代器械与早期器械治疗结果的数据有限。
本研究旨在评估二叶式 AS 患者使用新一代和早期器械行 TAVR 的临床结果。
二叶式 TAVR 登记研究是一项国际性多中心研究，纳入 2005 年 4 月至 2015 年 5 月期间接受 TAVR 的二叶式 AS 连续患者。
301 例患者中，199 例（71.1%）接受早期器械治疗（Sapien XT[爱德华兹生命科学公司，加利福尼亚州欧文]：n=87；CoreValve[美敦力，明尼苏达州明尼阿波利斯]：n=112），102 例接受新一代器械治疗（Sapien 3[爱德华兹生命科学公司]：n=91；Lotus[波士顿科学公司，马萨诸塞州马尔伯勒]：n=11）。平均胸外科医师协会评分（STS 评分）为 4.7±5.2，两组间无显著差异（4.6±5.1 与 4.9±5.4；p=0.57）。总体而言，30 天全因死亡率为 4.3%，1 年时为 14.4%。与早期器械相比，新一代器械无中度或重度瓣周漏且发生率显著更低（0.0%与 8.5%；p=0.002），这导致器械成功率更高（92.2%与 80.9%；p=0.01）。两组间卒中（2.5%与 2.0%；p>0.99）、危及生命的出血（3.5%与 2.9%；p>0.99）、主要血管并发症（4.5%与 2.9%；p=0.76）、2 至 3 级急性肾损伤（2.5%与 2.9%；p>0.99）、早期安全性终点（15.1%与 10.8%；p=0.30）和 30 天全因死亡率（4.5%与 3.9%；p>0.99）无差异。
二叶式 AS 患者 TAVR 的临床结果良好。新一代器械与早期器械相比，瓣周漏更少，因此器械成功率更高。（二叶式主动脉瓣狭窄行经导管主动脉瓣置换术后登记研究[Bicuspid TAVR]；NCT02394184）。
