Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Am J Cardiol. 2011 Jun 15;107(12):1824-9. doi: 10.1016/j.amjcard.2011.02.315. Epub 2011 Apr 8.
Outcome after transcatheter aortic valve implantation (TAVI) depends on the patient risk profile, operator experience, progress in technology, and technique. We sought to compare the results of TAVI during the initiation phase and after certification to perform TAVI with the Medtronic CoreValve System without proctoring. A total of 165 consecutive patients was categorized into a first cohort of 33 patients treated before certification (November 2005 to December 2007) and a second cohort of 132 patients treated after certification (January 2008 to October 2010). The study end points were selected and defined according to the Valve Academic Research Consortium recommendations. Compared to cohort 2, the patients in cohort 1 more frequently had New York Heart Association class III-IV (100% vs 71%, p <0.001), hypertension (67% vs 39%, p = 0.004), and aortic regurgitation grade III-IV (46% vs 22%, p = 0.006) before TAVI. Over time, the patients in cohort 2 more frequently underwent a truly percutaneous approach (98% vs 82%, p = 0.002) without circulatory support (96% vs 67%, p <0.001) but with more concomitant percutaneous coronary intervention (11% vs 0%, p = 0.042) than the patients in cohort 1. They also more often received a 29-mm prosthesis (72% vs 24%, p <0.001), required less postimplantation balloon dilation (10% vs 27%, p = 0.008), and had less aortic regurgitation grade III-IV after TAVI (12% vs 30%, p = 0.010). The clinical outcome showed a nonsignificant reduction in the combined safety end point (30% to 17%) but a significant reduction in cerebrovascular events (21% to 7%, p = 0.020) and life-threatening bleeding (15% to 5%, p = 0.044) in cohort 2. However, the reduction in overall bleeding and vascular complications (25% and 14%, respectively) was not significant. In conclusion, TAVI became significantly less complex and was associated with better results over time but remained associated with a high frequency of periprocedural major cardiovascular complications.
经导管主动脉瓣植入术（TAVI）的结果取决于患者的风险状况、术者的经验、技术的进步和技术。我们旨在比较在无指导情况下使用美敦力 CoreValve 系统进行 TAVI 的启动阶段和认证后的结果。共有 165 例连续患者分为第一队列 33 例，在认证前（2005 年 11 月至 2007 年 12 月）治疗，第二队列 132 例在认证后（2008 年 1 月至 2010 年 10 月）治疗。研究终点根据 Valve Academic Research Consortium 建议进行选择和定义。与队列 2 相比，队列 1 中的患者更频繁地患有纽约心脏协会（NYHA）心功能分级 III-IV 级（100% vs 71%，p<0.001）、高血压（67% vs 39%，p=0.004）和主动脉瓣反流 3-4 级（46% vs 22%，p=0.006）。随着时间的推移，队列 2 中的患者更频繁地采用真正的经皮方法（98% vs 82%，p=0.002），无需循环支持（96% vs 67%，p<0.001），但更多地同时进行经皮冠状动脉介入治疗（11% vs 0%，p=0.042）。与队列 1 相比，他们也更常接受 29 毫米假体（72% vs 24%，p<0.001），植入后球囊扩张的需求更少（10% vs 27%，p=0.008），TAVI 后主动脉瓣反流 3-4 级更少（12% vs 30%，p=0.010）。临床结果显示，复合安全性终点（30%降至 17%）无显著降低，但显著降低了脑血管事件（21%降至 7%，p=0.020）和危及生命的出血（15%降至 5%，p=0.044）。然而，总出血和血管并发症的减少（分别为 25%和 14%）并不显著。总之，TAVI 变得明显不那么复杂，随着时间的推移结果更好，但仍与围手术期主要心血管并发症的高发生率相关。
