经导管主动脉瓣膜置换临床结果及随访分析

Pilot exploration of transcatheter aortic valve replacement for patients with severe aortic stenosis and follow-up analysis

目的:分析单中心经导管主动脉瓣置换(TAVR)的临床安全和有效性。方法:总结2012年9月至2018年1月间,单中心实施的TAVR手术麻醉方式及临床结果。Kaplan-Meier曲线描述总生存时间,Cox回归校正影响综合死亡的危险因素。结果:本组TAVR手术总体成功率为91.4%(170/186)。手术相关死亡为3.2%,二次置入率8.8%,中位手术时长118 min,中位麻醉时长161 min,术后64.1%清醒直接回病房,35.9%回重症加强监护病房(ICU),中位ICU停留时间为3 d,术后中位住院时间为8 d。中位随访时间为2年。术后30 d和1年综合病死率分别为2.9%和7.6%,新发永久性起搏器置入率为12.4%和14.7%,新发高度房室传导阻滞为12.9%和14.1%,主要血管并发症为4.7%和5.3%,30 d和1年的卒中率均为4.7%,新发心房颤动率均为6.5%。术后1年随访显示,主动脉峰值射流速度平均下降(2.5±0.73) m/s;收缩期最大压差下降(71.89±25.12) mmHg(1 mmHg=0.133 kPa),平均有效瓣口面积提高(1.068±0.458) cm^2(P<0.001)。Kaplan-Meier曲线分析总体生存时间为(4.28±0.13)年。Cox回归分析显示术前肾功能不全、术后30 d内卒中影响综合病死率,差异有统计学意义(P<0.05)。结论:严重主动脉瓣膜狭窄患者实施TAVR安全有效,术后患者可以获得满意的近中期临床结果。

Objective: To assess the safety and effectiveness of transcatheter aortic valve replacement(TAVR) for patients with severe aortic stenosis. Methods: All consecutive patients who were scheduled to undergo elective TAVR at our institution from September 2012 to January 2018 were enrolled. The data of operation and following-up was collected. The Kaplan-Meier curves were utilized to describe survival function, and Cox regression adjusting for the predicted risk of long-term mortality. Results: The total success rate of TAVR was 91.4%(170/186). The procedure-related mortality was 3.2%, and multiple valves implantation was 8.8%. The median duration of operation was 118 minutes and duration of anesthesia was 161 minutes. Conscious sedation was adopted in 109(64.1%) patents and general anesthesia in the other 61(35.9%) patients. The median duration of intensive care unit was 3 days and hospital stay 8 days. The median follow-up duration was 2 years. Individual 30-day and 1-year events included all-cause mortality(2.9% and 7.6%, respectively), new pacemaker implantation(12.4% and 14.7%, respectively), major vascular complication(4.7% and 5.3%, respectively), stroke(4.7%, both), new atrial fibrillation(6.5%, both). The following-up of echocardiography indicated improved average aortic effective valve area, peak velocity, and peak systolic gradient(P<0.001). The Kaplan-Meier survival analysis showed mean survival time was(4.28±0.13) years. Cox regression recognized pre-operative renal insufficiency(HR=3.05, 95% CI: 1.023-9.064, P=0.045), postoperative stroke within 30 days(HR=6.30, 95%CI: 1.56-25.44, P=0.01) were the predictors for long-term mortality. Conclusions: TAVR was safe and effective treatment for the patients with severe symptomatic aortic stenosis. The patients following TAVR may achieve improved mid-term outcomes.