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经导管主动脉瓣植入术后的早期和中期生存:14 项研究的系统评价和荟萃分析。

Early and intermediate survival after transcatheter aortic valve implantation: systematic review and meta-analysis of 14 studies.

机构信息

HTA Unit, Estav Centro Toscana, Regional Health Service, Firenze and Prato, Italy.

出版信息

BMJ Open. 2013 Jan 11;3(1):e001770. doi: 10.1136/bmjopen-2012-001770.

Abstract

BACKGROUND

Transcatheter aortic valve implants (TAVIs) is indicated as an alternative to surgical valve replacement for patients unfit for surgery. No systematic review has studied survival after 2 years and limited information is available on between-study heterogeneity.

OBJECTIVES

A systematic review and meta-analysis on intermediate survival after TAVI.

DATA SOURCES

PubMed, EMBASE, Scopus and references of selected articles.

STUDY ELIGIBILITY CRITERIA

Clinical studies evaluating TAVI, published between 2010 and 2012, reporting survival at 2 or more years.

PARTICIPANTS

About 3500 patients from 14 studies.

STUDY APPRAISAL AND SYNTHESIS METHODS

Proportion meta-analysis with 95% CI and heterogeneity assessment (I(2) and Cochran's Q). Meta-regression analysis was performed as well.

RESULTS

Pooled immediate postoperative death rate was 7.8% (95% CI 6.2% to 9.8%, I(2)=40.8%; Cochran's Q=97.7 with 92.9 df, p<0.0001) and stroke rate was 3.8% (95% CI 2.8% to 5.0%, I(2)=34.3%; Cochran's Q=96.5 with 92.9 df, p<0.0001). Pooled death rates at 1, 2 and 3 years were 23.2%, 31.0% and 38.6%, respectively. Among studies reporting on concomitant percutaneous coronary intervention, pooled death rates at 30 days, 1 year and 2 years were 6.3%, 17.8% and 25.8%, respectively.

LIMITATIONS

Although our analysis examined a total of about 3500 patients, only a minority of these were actually followed up after 2 years.

CONCLUSIONS

Pooled survival rates after TAVI (at 2 years: 69.0%; at 3 years: 61.4%) can be considered excellent, particularly in the light of the high-risk profile of this patient population. IMPLICATIONS OF KEY FINDINGS: The favourable intermediate outcome in patients subjected to TAVI seems to justify its use in patients unfit for surgery. Such pooled results indicate that TAVI is a valid alternative to surgical valve replacement, but lack of data on late durability after TAVI prevents its use in low-risk patients with long expectancy of life.

摘要

背景

经导管主动脉瓣植入术(TAVI)适用于不适合手术的患者作为手术瓣膜置换的替代方法。没有系统评价研究过 TAVI 后 2 年的生存率,并且关于研究间异质性的信息有限。

目的

对 TAVI 后中期生存率进行系统评价和荟萃分析。

数据来源

PubMed、EMBASE、Scopus 和选定文章的参考文献。

研究入选标准

评估 TAVI 的临床研究,发表于 2010 年至 2012 年之间,报告 2 年以上的生存率。

研究对象

来自 14 项研究的约 3500 名患者。

研究评估和综合方法

采用 95%CI 和异质性评估(I²和 Cochran's Q)的比例荟萃分析。还进行了荟萃回归分析。

结果

汇总的术后即刻死亡率为 7.8%(95%CI 6.2%至 9.8%,I²=40.8%;Cochran's Q=97.7,92.9 自由度,p<0.0001),卒中发生率为 3.8%(95%CI 2.8%至 5.0%,I²=34.3%;Cochran's Q=96.5,92.9 自由度,p<0.0001)。1、2 和 3 年的死亡率分别为 23.2%、31.0%和 38.6%。在报告同时进行经皮冠状动脉介入治疗的研究中,30 天、1 年和 2 年的死亡率分别为 6.3%、17.8%和 25.8%。

局限性

尽管我们的分析共纳入了约 3500 名患者,但只有少数患者在 2 年后实际接受了随访。

结论

TAVI 后的汇总生存率(2 年:69.0%;3 年:61.4%)可以被认为是优异的,特别是考虑到该患者人群的高风险特征。

主要发现的意义

接受 TAVI 的患者的中期结果良好,似乎证明了 TAVI 在不适合手术的患者中的应用是合理的。这些汇总结果表明 TAVI 是手术瓣膜置换的有效替代方法,但缺乏 TAVI 后晚期耐久性的数据,限制了其在预期寿命长的低风险患者中的应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c74/3549234/6b3134d4a7a5/bmjopen2012001770f01.jpg

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