Yousef Altayyeb, Simard Trevor, Webb John, Rodés-Cabau Josep, Costopoulos Charis, Kochman Janusz, Hernández-Garcia José M, Chiam Paul T L, Welsh Robert C, Wijeysundera Harindra C, García Eulogio, Ribeiro Henrique B, Latib Azeem, Huczek Zenon, Shanks Miriam, Testa Luca, Farkouh Michael E, Dvir Danny, Velianou James L, Lam Buu-Khanh, Pourdjabbar Ali, Glover Christopher, Hibbert Benjamin, Labinaz Marino
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Int J Cardiol. 2015;189:282-8. doi: 10.1016/j.ijcard.2015.04.066. Epub 2015 Apr 11.
We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV).
BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients.
We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint--a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year.
A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%)--mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality--Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants.
In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.
我们试图评估经导管主动脉瓣植入术（TAVI）在二叶式主动脉瓣（BiAV）患者中的安全性和有效性。
BiAV仍然是TAVI的相对禁忌证，导致被排除在TAVI试验之外，从而限制了关于经导管瓣膜在这些患者中临床性能的数据。
我们对接受TAVI的BiAV患者的结局进行了一项国际患者水平的多中心分析。该研究的主要结局是早期安全性复合终点——30天死亡率、中风、危及生命的出血、急性肾损伤、冠状动脉阻塞、主要血管并发症和瓣膜相关功能障碍的综合指标。次要终点包括主要终点的各个组成部分以及TAVI后瓣周漏（PVL）、再住院、新起搏器植入以及30天和1年时的装置成功率。
在2005年1月至2014年3月期间，在加拿大、西班牙、意大利、波兰和新加坡的21个中心共识别出108例接受TAVI的BiAV患者。复合主要结局发生在四分之一的患者中（26.9%）——主要由瓣膜位置异常的再次干预驱动（9.3%）。30天和1年死亡率分别为8.3%和16.9%，9.6%的患者出现AR≥3+。85.2%的病例实现了装置成功，19.4%的患者植入了起搏器。虽然PVL与30天或1年死亡率增加无关——左右瓣叶融合的I型BiAV解剖结构的结局明显优于其他瓣膜变体。
在选定的BiAV和严重主动脉瓣狭窄患者中，TAVI似乎既安全又可行，临床结局可接受。有必要对该患者群体进行TAVI的临床研究。
