1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement Results From the First WIN-TAVI Registry
1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement Results From the First WIN-TAVI Registry
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DOI：
10.1016/j.jcin.2017.09.034
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发表时间：
2018-01-08
影响因子：
11.3
通讯作者：
Mehran, Roxana
中科院分区：
文献类型：
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作者：
Chieffo, Alaide;Petronio, Anna Sonia;Mehran, Roxana
目的：本研究旨在研究当代经导管主动脉瓣置换术（TAVR）在全女性TAVR人群中的安全性和性能，并进一步研究女性性别特异性特征对1年综合临床结果的潜在影响。背景：女性占TAVR患者的50%。一些数据显示，对于有明显症状的主动脉瓣狭窄，TAVR与手术主动脉瓣置换术相比没有劣效性，但迄今为止还没有研究专门用于检测性别差异。WIN-TAVI （Women’s INternational Transcatheter Aortic Valve Implantation，女性经导管主动脉瓣植入术）登记是一项跨国、前瞻性、观察性登记，涵盖了2013年1月至2015年12月期间欧洲18个地点和美国1个地点因主动脉瓣狭窄而接受TAVR的女性。主要的瓣膜学术研究联盟(VARC)-2疗效终点是死亡率、中风、心肌梗死、因瓣膜相关症状或心力衰竭或瓣膜相关功能障碍住院超过30天的综合指标。次要终点包括复合1年死亡或卒中。使用Cox回归方法确定1年预后的预测因子。结果共纳入1019名中高危女性，平均年龄82.5 +/- 6.3岁，欧洲心脏手术风险评估系统（EuroSCORE） I平均评分17.8 +/- 11.7%，胸外科学会（Society of Thoracic Surgeons）平均评分8.3 +/- 7.4%。90.6%的TAVR采用经股通道，42.1%的TAVR采用新一代装置。主要VARC-2疗效复合终点出现在111例（10.9%）超过30天的患者和167例（16.5%）1年的患者中。1年内死亡或中风的发生率为13.9% （n = 141）。127例（12.5%）患者死亡，22例（2.2%）患者中风。既往冠状动脉血运重建（风险比[HR]: 1.72； 95%可信区间[CI]: 1.17 ~ 2.52; p = 0.006）和EuroSCORE I（风险比：1.02;95% CI: 1.00 ~ 1.04; p = 0.027）是VARC-2疗效终点的独立预测因子。同样，EuroSCORE I （HR: 1.02; 95% CI: 1.00 ~ 1.04; p = 0.013）、基线心房颤动（HR: 1.58; 95% CI: 1.07 ~ 2.33; p = 0.022）和既往经皮冠状动脉介入治疗（HR: 1.50; 95% CI: 1.03 ~ 2.19; p = 0.035）是1年内死亡或卒中的独立预测因子。调整后，没有观察到妊娠史或任何性别特异性因素与1年TAVR结果之间的显著关联。结论：在首次全女性TAVR登记中，中高风险女性的1年VARC-2综合疗效终点为16.5%，1年死亡率和卒中发生率较低。既往血运重建术和EuroSCORE I是VARC-2疗效终点的独立预测因子，而EuroSCORE I、基线房颤和既往经皮冠状动脉介入治疗是1年死亡或卒中的独立预测因子。(C) 2018年由爱思唯尔代表美国心脏病学会基金会出版。
OBJECTIVES This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes.BACKGROUND Women comprise >= 50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex.METHODS The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods.RESULTS A total of 1,019 intermediate to high-risk women, with mean age 82.5 +/- 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 +/- 11.7% and mean Society of Thoracic Surgeons score 8.3 +/- 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [ HR]: 1.72; 95% confidence interval [ CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.027) were independent predictors of the VARC-2 efficacy endpoint. Similarly, EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.013), baseline atrial fibrillation (HR: 1.58; 95% CI: 1.07 to 2.33; p = 0.022), and prior percutaneous coronary intervention (HR: 1.50; 95% CI: 1.03 to 2.19; p = 0.035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes.CONCLUSIONS Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke. (C) 2018 Published by Elsevier on behalf of the American College of Cardiology Foundation.