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亚洲患者早期经导管主动脉瓣植入治疗的结局、危险因素及新型瓣膜的单中心分析

A single-center analysis of outcomes, risk factors, and new valves in Asian patients treated with early transcatheter aortic valve implantation.

作者信息

Liang Ying, Wang Wei, Wang Xu, Hei Feilong, Guan Yulong

机构信息

Department of Extracorporeal Circulation, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Department of Structural Heart Disease, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

出版信息

Cardiovasc Diagn Ther. 2021 Aug;11(4):967-979. doi: 10.21037/cdt-20-928.

Abstract

BACKGROUND

Transcatheter aortic valve implantation (TAVI) continues to expand as an optimal treatment in Western countries; however, Asian countries have been slower to adopt this procedure. This research aimed to explore the outcomes and status of early TAVI performed at a single center in Asia, and provide comparative outcomes of the newly designed Chinese valves.

METHODS

We enrolled 175 consecutive patients who successfully underwent TAVI from September 2012 to January 2018 at Fuwai Hospital (Beijing, China). After a preliminary assessment of age, we included 109 older patients (≥69 years) who underwent surgical aortic valve replacement (SAVR) during the same period. The primary endpoint was all-cause mortality. The inverse probability of treatment weighting (IPTW) was used to reduce potential bias. Cox regression was used to identify the risk factors of a poor prognosis.

RESULTS

The TAVI cohort had higher rates of all-cause mortality [11.4% 2.4%, hazard ratio (HR): 4.79, 95% confidence interval (CI): 1.47 to 15.57, IPTW-adjusted P=0.009] and permanent pacemaker implantation (PPI; 14.6% 1.6%, HR: 9.98, 95% CI: 2.71 to 36.67, IPTW-adjusted P<0.001) at 3 years than the SAVR cohort. In the multivariable Cox regression analysis based on the entire sample, liver disease was associated with all-cause mortality (HR: 5.080, 95% CI: 1.067 to 24.174, P=0.041). A smoking history was associated with an increased risk of postoperative heart failure (HF) (HR: 4.902, 95% CI: 1.265 to 18.999, P=0.022). Additionally, age (HR: 1.141, 95% CI: 1.010 to 1.288, P=0.034) and diabetes (HR: 7.301, 95% CI: 2.414 to 22.079, P<0.001) were identified as predictors of postoperative stroke. In the new valve subgroups, the 1-year composite endpoints were 38.2% (Venus A), 35.3% (TaurusOne), 34% (J-Valve), and 28% (VitaFlow) (P=0.857).

CONCLUSIONS

Not all TAVI procedures had satisfactory outcomes compared with SAVR when initiated. At first, our center faced some challenges in delivering TAVI, and this is probably one of the reasons why the use of TAVI has developed slowly in Asia. Further investigations are needed to explore the underlying factors precluding the rapid expansion of TAVI in Asia.

摘要

背景

经导管主动脉瓣植入术(TAVI)在西方国家作为一种最佳治疗方法,其应用范围持续扩大;然而,亚洲国家采用该手术的进程较为缓慢。本研究旨在探讨亚洲某单一中心早期TAVI的治疗效果及现状,并提供新设计的国产瓣膜的对比疗效。

方法

我们纳入了2012年9月至2018年1月期间在阜外医院(中国北京)成功接受TAVI的175例连续患者。在对年龄进行初步评估后,我们纳入了同期接受外科主动脉瓣置换术(SAVR)的109例老年患者(≥69岁)。主要终点为全因死亡率。采用治疗权重反概率法(IPTW)以减少潜在偏倚。使用Cox回归分析确定预后不良的危险因素。

结果

TAVI队列在3年时的全因死亡率[11.4% 对2.4%,风险比(HR):4.79,95%置信区间(CI):1.47至15.57,IPTW调整后P = 0.009]和永久起搏器植入率(PPI;14.6% 对1.6%,HR:9.98,95% CI:2.71至36.67,IPTW调整后P < 0.001)均高于SAVR队列。在基于整个样本的多变量Cox回归分析中,肝病与全因死亡率相关(HR:5.080,95% CI:1.067至24.174,P = 0.041)。吸烟史与术后心力衰竭(HF)风险增加相关(HR:4.902,95% CI:1.265至18.999,P = 0.022)。此外,年龄(HR:1.141,95% CI:1.010至1.288,P = 0.034)和糖尿病(HR:7.301,95% CI:2.414至22.079,P < 0.001)被确定为术后卒中的预测因素。在新瓣膜亚组中,1年复合终点分别为38.2%(Venus A)、35.3%(TaurusOne)、34%(J-Valve)和28%(VitaFlow)(P = 0.857)。

结论

与SAVR相比,并非所有的TAVI手术一开始都能取得令人满意的效果。起初,我们中心在开展TAVI时面临一些挑战,这可能是TAVI在亚洲发展缓慢的原因之一。需要进一步研究以探索阻碍TAVI在亚洲快速推广的潜在因素。

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