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