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经导管主动脉瓣置换术治疗中使用 Edwards SAPIEN™ 和 Medtronic CoreValve ReValving System® 装置时,性别对 VARC 结局的作用:米兰注册研究。

The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® devices: the Milan registry.

机构信息

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

出版信息

EuroIntervention. 2011 Sep;7(5):556-63. doi: 10.4244/EIJV7I5A91.

DOI:10.4244/EIJV7I5A91
PMID:21930459
Abstract

AIMS

To assess outcomes after transcatheter aortic valve implantation (TAVI) according to sex, with the two available valves and four recognised delivery approaches.

METHODS AND RESULTS

VARC outcomes are reported according to sex for 305 high-risk patients consecutively treated in our centre, via available access routes utilising the Edwards SAPIEN™/SAPIEN™ XT or the Medtronic CoreValve ReValving System® devices. Three hundred and five patients underwent TAVI: 52.1% male and 47.9% female. Females had a smaller body surface area (1.84±0.16 m² vs. 1.70±0.16 m²; p<0.001) and aortic annulus (24.4±1.6 mm vs. 22.6±1.7 mm; p<0.001) with increased symptoms (NYHA Class III/IV 61.6% vs. 73.6%; p=0.026). Conversely, men had more comorbidities: diabetes mellitus (35.2% vs. 21.9%; p=0.010), chronic kidney disease (41.8% vs. 23.3%; p=0.001), chronic obstructive pulmonary disease (45.3% vs. 30.1%; p=0.006) and previous myocardial infarction (28.3% vs. 14.4%; p=0.003). Thirty-day mortality was 4.7% with no difference between groups. There was a trend for females to develop more major vascular complications (11.9% vs. 19.9%; p=0.058). Notably, females required more blood transfusion (38.4% vs. 50.0%; p=0.041). No differences were observed in device success (92.5%; p=0.667), combined safety endpoint (61.8%; p=0.211) or combined efficacy endpoint (72.0%; p=0.889).

CONCLUSIONS

Female sex was a predictor of major vascular complications with females requiring more transfusion. No differences were noted amongst patients undergoing TAVI in composite safety and efficacy endpoints according to sex.

摘要

目的

根据性别评估经导管主动脉瓣置换术(TAVI)的结果,涉及两种可用瓣膜和四种公认的输送方法。

方法和结果

根据性别报告了 305 名高危患者在我们中心连续接受治疗的 VARC 结果,通过可用的入路途径使用 Edwards SAPIEN™/SAPIEN™ XT 或 Medtronic CoreValve ReValving System® 装置。305 名患者接受了 TAVI:52.1%为男性,47.9%为女性。女性的体表面积(1.84±0.16 m² vs. 1.70±0.16 m²;p<0.001)和主动脉瓣环(24.4±1.6 mm vs. 22.6±1.7 mm;p<0.001)更小,症状更严重(NYHA 分级 III/IV 61.6% vs. 73.6%;p=0.026)。相反,男性的合并症更多:糖尿病(35.2% vs. 21.9%;p=0.010)、慢性肾病(41.8% vs. 23.3%;p=0.001)、慢性阻塞性肺疾病(45.3% vs. 30.1%;p=0.006)和既往心肌梗死(28.3% vs. 14.4%;p=0.003)。30 天死亡率为 4.7%,两组之间无差异。女性发生主要血管并发症的趋势更高(11.9% vs. 19.9%;p=0.058)。值得注意的是,女性需要更多输血(38.4% vs. 50.0%;p=0.041)。器械成功率(92.5%;p=0.667)、综合安全性终点(61.8%;p=0.211)或综合疗效终点(72.0%;p=0.889)无差异。

结论

女性是发生主要血管并发症的预测因素,女性需要更多输血。根据性别,在 TAVI 患者的复合安全性和疗效终点方面没有差异。

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