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经导管主动脉瓣植入术后的结构性瓣膜退变

Structural valve deterioration after transcatheter aortic valve implantation.

作者信息

Foroutan Farid, Guyatt Gordon H, Otto Catherine M, Siemieniuk Reed A, Schandelmaier Stefan, Agoritsas Thomas, Vandvik Per O, Bhagra Sai, Bagur Rodrigo

机构信息

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Heart Failure/Transplant Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.

出版信息

Heart. 2017 Dec;103(23):1899-1905. doi: 10.1136/heartjnl-2017-311329. Epub 2017 Jul 6.

Abstract

BACKGROUND

Transcatheter aortic valve implantation (TAVI), widely used to treat high-risk patients with severe symptomatic aortic stenosis, has recently been extended to younger patients at lower operative risk in whom long-term durability of TAVI devices is an important concern. Therefore, we conducted a systematic review and meta-analysis of observational studies addressing the frequency of structural valve deterioration (SVD) after TAVI.

METHODS

We searched Medline, Embase, Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to September 2016. We included observational studies following patients with TAVI for at least 2 years. Independently and in duplicate, we evaluated study eligibility, extracted data, and assessed risk of bias for SVD post-TAVI. Our review used the GRADE system to assess quality of evidence. We pooled incidence rates using a random effects model.

RESULTS

Thirteen studies including 8914 patients, with a median follow-up between 1.6 and 5 years, reported an incidence of SVD post-TAVI between 0 to 1.34 per 100 patient years. The pooled incidence of SVD was 28.08 per 10 000 patients/year (95% CI 2.46 to 73.44 per 100 patient years). Of those who developed SVD, 12% underwent valve re-intervention. Confidence in the evidence was moderate due to inconsistency among studies.

CONCLUSION

Structural valve deterioration is probably an infrequent event within the first 5 years after TAVI. Ascertaining the impact of SVD and the need for valve-related re-interventions to inform recommendations for patients with a longer life-expectancy will require studies including a large number of patients with longer follow-up (>10 years).

摘要

背景

经导管主动脉瓣植入术(TAVI)广泛用于治疗有严重症状的高危主动脉瓣狭窄患者,最近已扩展至手术风险较低的年轻患者,对于这些患者,TAVI装置的长期耐用性是一个重要问题。因此,我们对观察性研究进行了系统评价和荟萃分析,以探讨TAVI术后结构性瓣膜退化(SVD)的发生频率。

方法

我们检索了2002年至2016年9月期间的Medline、Embase、Cochrane系统评价数据库和Cochrane CENTRAL。我们纳入了对TAVI患者进行至少2年随访的观察性研究。我们独立并重复地评估研究的纳入标准、提取数据,并评估TAVI术后SVD的偏倚风险。我们的评价使用GRADE系统来评估证据质量。我们使用随机效应模型汇总发病率。

结果

13项研究共纳入8914例患者,中位随访时间为1.6至5年,报告TAVI术后SVD的发生率为每100患者年0至1.34例。SVD的汇总发生率为每10000患者/年28.08例(95%CI为每100患者年2.46至73.44例)。发生SVD的患者中,12%接受了瓣膜再次干预。由于研究之间存在不一致性,对证据的信心为中等。

结论

结构性瓣膜退化可能是TAVI术后头5年内的罕见事件。要确定SVD的影响以及瓣膜相关再次干预的必要性,以便为预期寿命较长的患者提供建议,需要开展包括大量患者且随访时间更长(>10年)的研究。

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