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经导管房间隔缺损封堵术后成年人的长期结局:系统评价和荟萃分析。

Long term outcomes among adults post transcatheter atrial septal defect closure: Systematic review and meta-analysis.

机构信息

Peter Munk Cardiac Centre, Toronto General Hospital, Canada; Health Sciences North, Sudbury, Ontario, Canada.

Peter Munk Cardiac Centre, Toronto General Hospital, Canada; The Institute for Clinical Evaluative Sciences, Canada.

出版信息

Int J Cardiol. 2018 Nov 1;270:126-132. doi: 10.1016/j.ijcard.2018.06.076. Epub 2018 Jul 12.

Abstract

BACKGROUND

Transcatheter Closure (TC) has become the main stay therapy for many secundum atrial septal defects (ASD) based on short and intermediate term outcome data. Long-term safety and efficacy of this approach among adult patients however, is not well established.

METHODS AND RESULTS

A comprehensive search of major electronic databases for studies reporting the long-term (≥5 year) outcomes post TC among adults yielded 114 studies, 9 of which had met the inclusion criteria. This included 1015 patients with a mean age of 45 years ± 5.5 years, two third were female with a mean follow up duration 6.4 years ± 2.7 years. The weighted proportions of long-term mortality and stroke with 95% confidence intervals (CI) were 2.4% (95%CI 0.9%-6.1%) and 2.1% (95%CI 0.7%-5.7%) respectively. Atrial arrhythmia occurred in 6.5% (95%CI 3.5%-11.7%) and atrial fibrillation in 4.9% (95%CI 1.9%-11.7%). ASD related re-interventions were encountered in 2.3% (95%CI 1.0%-5.4%) and residual shunt in 4.2% (95% CI 1.3%-12.4%), with 1 case of suspected device erosion 0.9% (95%CI 0.4-2.2%). Frame fractures and late migrations were observed at 4.2% (95%CI 1.5%-11.5%) and 1.2% (95%CI 0.3%-4%) respectively. No cases of occluder endocarditis or thrombosis were reported.

IN CONCLUSION

This is the first study that systematically analyzes the long-term outcomes after TC providing important estimates for various clinical and occluder related outcomes. The analysis suggests preserved long-term safety post TC; however, this is limited due to the variable quality of available evidence and requires further assessment by larger studies with more comprehensive follow-up data.

摘要

背景

基于短期和中期结果数据,经导管闭合术(TC)已成为治疗大多数继发房间隔缺损(ASD)的主要方法。然而,成人患者接受这种方法的长期安全性和疗效尚未得到充分证实。

方法和结果

对主要电子数据库中报道成人 TC 后长期(≥5 年)结局的研究进行了全面检索,共检索到 114 项研究,其中 9 项符合纳入标准。这包括 1015 名平均年龄为 45±5.5 岁的患者,其中三分之二为女性,平均随访时间为 6.4±2.7 年。长期死亡率和卒中的加权比例及其 95%置信区间(CI)分别为 2.4%(95%CI 0.9%-6.1%)和 2.1%(95%CI 0.7%-5.7%)。心房性心律失常发生率为 6.5%(95%CI 3.5%-11.7%),心房颤动发生率为 4.9%(95%CI 1.9%-11.7%)。ASD 相关再介入发生率为 2.3%(95%CI 1.0%-5.4%),残余分流发生率为 4.2%(95%CI 1.3%-12.4%),有 1 例疑似器械侵蚀发生率为 0.9%(95%CI 0.4%-2.2%)。框架骨折和晚期移位的发生率分别为 4.2%(95%CI 1.5%-11.5%)和 1.2%(95%CI 0.3%-4%)。未报告封堵器心内膜炎或血栓形成病例。

结论

这是第一项系统分析 TC 后长期结局的研究,为各种临床和封堵器相关结局提供了重要的评估。该分析表明 TC 后具有长期安全性;然而,由于可用证据质量的差异,这是有限的,需要进一步通过具有更全面随访数据的更大规模研究进行评估。

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