Backes Carl H, Rivera Brian K, Bridge Jeffrey A, Armstrong Aimee K, Boe Brian A, Berman Darren P, Fick Tyler, Holzer Ralf J, Hijazi Ziyad M, Abadir Sylvia, Justino Henri, Bergersen Lisa, Smith Charles V, Kirpalani Haresh
Centers for Perinatal Research,
Cardiovascular and Pulmonary Research, and.
Pediatrics. 2017 Feb;139(2). doi: 10.1542/peds.2016-2927. Epub 2017 Jan 13.
Patent ductus arteriosus (PDA) is a precursor to morbidity and mortality. Percutaneous (catheter-based) closure is the procedure of choice for adults and older children with a PDA, but use during infancy (<1 year) is not well characterized.
Investigate the technical success and safety of percutaneous PDA closure during infancy.
Scopus, Web of Science, Embase, PubMed, and Ovid (Medline) were searched through December 2015 with no language restrictions.
Publications needed to clearly define the intervention as percutaneous PDA closure during infancy (<1 year of age at intervention) and must have reported adverse events (AEs).
The study was performed according to the Systematic Reviews and Meta-Analysis checklist and registered prospectively. The quality of the selected studies was critically examined. Data extraction and assignment of AE attributability and severity were independently performed by multiple observers. Outcomes were agreed on a priori. Data were pooled by using a random-effects model.
Thirty-eight studies were included; no randomized controlled trials were found. Technical success of percutaneous PDA closure was 92.2% (95% confidence interval [CI] 88.8-95.0). Overall AE and clinically significant AE incidence was 23.3% (95% CI 16.5-30.8) and 10.1% (95% CI 7.8-12.5), respectively. Significant heterogeneity and publication bias were observed.
Limitations include lack of comparative studies, lack of standardized AE reporting strategy, and significant heterogeneity in reporting.
Percutaneous PDA closure during infancy is feasible and associated with few catastrophic AEs; however, the limitations constrain the interpretability and generalizability of the current findings.
动脉导管未闭(PDA)是发病和死亡的先兆。经皮(基于导管的)封堵术是患有PDA的成人和大龄儿童的首选治疗方法,但在婴儿期(<1岁)使用该方法的相关情况尚无充分描述。
研究婴儿期经皮PDA封堵术的技术成功率和安全性。
检索了Scopus、科学网、Embase、PubMed和Ovid(Medline)数据库至2015年12月的数据,无语言限制。
纳入的文献需明确将干预措施定义为婴儿期(干预时<1岁)经皮PDA封堵术,且必须报告不良事件(AE)。
本研究按照系统评价和Meta分析清单进行,并进行了前瞻性注册。对所选研究的质量进行了严格审查。由多名观察者独立进行数据提取以及AE归因和严重程度的判定。事先确定了结局指标。采用随机效应模型汇总数据。
纳入38项研究;未发现随机对照试验。经皮PDA封堵术的技术成功率为92.2%(95%置信区间[CI]88.8 - 95.0)。总体AE和具有临床意义的AE发生率分别为23.3%(95%CI 16.5 - 30.8)和10.1%(95%CI 7.8 - 12.5)。观察到显著的异质性和发表偏倚。
局限性包括缺乏对照研究、缺乏标准化的AE报告策略以及报告中的显著异质性。
婴儿期经皮PDA封堵术是可行的,且极少发生灾难性AE;然而,这些局限性限制了当前研究结果的可解释性和可推广性。