Chen Ying-Hwa, Chang Hsiao-Huang, Chen Po-Lin, Weng Zen-Chung, Chen I-Ming, Leu Hsin-Bang, Huang Chun-Yang, Lin Su-Man, Wu Mei-Han
Division of Cardiology, Department of Internal Medicine, Taipei Veterans General Hospital.
School of Medicine, National Yang-Ming University.
Acta Cardiol Sin. 2017 Jul;33(4):339-349. doi: 10.6515/acs20170620a.
This is the first study of a Taiwanese population reporting transcatheter aortic valve implantation (TAVI) outcomes of the first 100 cases from a single center offering two different transcatheter heart valve technologies via six types of approaches. We herein report the 30-day and one-year outcomes in our first 100 TAVI patients at Taipei Veterans General Hospital.
From May 2010 to April 2016, 100 consecutive patients with severe aortic stenosis (AS) who were considered unsuitable or at high risk for surgical aortic valve replacement underwent TAVI. Patient outcomes were classified according to the Valve Academic Research Consortium-2 (VARC-2) definitions. The device performance was assessed using transthoracic echocardiography by independent investigators.
The mean patient age was 81.1 years, where 54% were female, and the mean Logistic EuroSCORE was 21.5%. The Medtronic CoreValve was used in 84 patients and the Edwards Sapien or Sapien XT valve (ESV) in 16. The transfemoral approach was the most frequently used route (83%), followed by transapical (9%) access. Overall, there was no procedural death. The VARC-2 outcomes were as follows: device success, 95%; stroke, 1%; major vascular complication, 3%; a need for pacemaker implantation, 5.1%. At discharge, the incidence of postoperative mild, moderate or severe paravalvular leak was 30%, 3% and 0%, respectively. At one year, the all-cause mortality rate was 14.0%, and no valve-related dysfunction was observed. Through multivariable analysis, non-transfemoral access [hazard ratios (HR) 4.81; 95% confidence interval (CI) 1.66-14.09; p = 0.004] and advanced chronic kidney disease (stages 4-5), (HR 3.13; 95% CI 1.07-9.09; p = 0.036) were independently associated with an increased risk of one-year mortality.
We demonstrated that TAVI shows good early and mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance in high-risk patients with severe AS.
这是第一项针对台湾人群的研究，报告了一家单一中心通过六种方法提供两种不同经导管心脏瓣膜技术的前100例经导管主动脉瓣植入术（TAVI）的结果。我们在此报告台北荣民总医院首批100例TAVI患者的30天和一年结果。
2010年5月至2016年4月，100例连续的严重主动脉瓣狭窄（AS）患者被认为不适合或手术主动脉瓣置换术风险高，接受了TAVI。患者结局根据瓣膜学术研究联盟-2（VARC-2）定义进行分类。由独立研究人员使用经胸超声心动图评估器械性能。
患者平均年龄为81.1岁，其中54%为女性，平均逻辑欧洲心脏手术风险评估系统（Logistic EuroSCORE）为21.5%。84例患者使用美敦力CoreValve，16例使用爱德华兹Sapien或Sapien XT瓣膜（ESV）。经股动脉途径是最常用的途径（83%），其次是经心尖途径（9%）。总体而言，无手术死亡。VARC-2结果如下：器械成功率为95%；卒中发生率为1%；主要血管并发症发生率为3%；需要植入起搏器的发生率为5.1%。出院时，术后轻度、中度或重度瓣周漏的发生率分别为30%、3%和0%。一年时，全因死亡率为14.0%，未观察到瓣膜相关功能障碍。通过多变量分析，非经股动脉途径[风险比（HR）4.81；95%置信区间（CI）1.66 - 14.09；p = 0.004]和晚期慢性肾病（4 - 5期）（HR 3.13；95% CI 1.07 - 9.09；p = 0.036）与一年死亡率增加独立相关。
我们证明，对于严重AS高危患者，TAVI在生存、技术成功、瓣膜相关不良事件和血流动力学性能方面显示出良好的早期和中期结果。
