Center for Perinatal Research, Nationwide Children's Hospital, Columbus, Ohio; Center for Cardiovascular and Pulmonary Research, Nationwide Children's Hospital, Columbus, Ohio; The Heart Center, Nationwide Children's Hospital, Columbus, Ohio; Department of Pediatrics at Nationwide Children's Hospital, Columbus, Ohio.
Mid-America Heart Institute, Kansas City, Missouri.
JACC Cardiovasc Interv. 2017 Sep 11;10(17):1729-1737. doi: 10.1016/j.jcin.2017.05.018. Epub 2017 Aug 16.
The authors sought to identify risk factors associated with major adverse events (MAEs) in infants <6 kg undergoing transcatheter patent ductus arteriosus (PDA) occlusion.
Transcatheter PDA occlusion is among the safest of interventional cardiac procedures in adults and older children, but use among infants <6 kg has not been characterized adequately.
Using the IMPACT (IMproving Pediatric and Adult Congenital Treatments) registry, we identified infants <6 kg undergoing transcatheter PDA occlusion (January 1, 2011, to March 1, 2015). Using mixed-effects multivariate regression, the authors assessed characteristics predictive of MAE or composite failure (procedural failure or MAE). Individual safety metrics (e.g., embolization, malposition) were also examined for differences across weight thresholds: extremely low weight (LW) (<2 kg), very LW (2 to <4 kg), and LW (4 to <6 kg).
Transcatheter PDA occlusion was attempted in 747 infants <6 kg at 73 hospitals. Rate of procedural success was 94.3%. MAEs were observed in 12.6% of cases; the most common events were acute arterial injury and device embolization in 3.5% and 2.4% of cases, respectively. Younger age (<30 days) was associated with greater risk of a MAE (risk ratio: 3.3; 95% confidence interval: 1.5 to 7.6) and composite failure (risk ratio: 3.0; 95% confidence interval: 1.4 to 6.7). Risk of embolization was higher among extremely LW (10.5%) than very LW or LW infants (1.6% and 2.5%, respectively; p = 0.050).
Among infants <6 kg, transcatheter PDA occlusion is technically feasible, but risks of MAE are noteworthy. These findings may help inform patient selection and procedural approach for transcatheter PDA occlusion and direct targeted research efforts to support the practice of evidence-based medicine.
作者旨在确定体重<6kg 的婴儿行经导管动脉导管未闭（PDA）封堵术的主要不良事件（MAE）的相关风险因素。
经导管 PDA 封堵术在成人和大龄儿童中是最安全的介入心脏手术之一，但<6kg 的婴儿的使用情况尚未得到充分描述。
作者利用 IMPACT（改善儿科和成人先天性治疗）登记处，确定了体重<6kg 且行经导管 PDA 封堵术的婴儿（2011 年 1 月 1 日至 2015 年 3 月 1 日）。作者使用混合效应多变量回归评估了预测 MAE 或复合失败（程序失败或 MAE）的特征。还检查了个体安全性指标（例如栓塞、错位）在体重阈值上的差异：极低体重（LW）（<2kg）、非常 LW（2-<4kg）和 LW（4-<6kg）。
在 73 家医院中，747 名体重<6kg 的婴儿尝试行经导管 PDA 封堵术。手术成功率为 94.3%。MAE 发生率为 12.6%；最常见的事件分别为急性动脉损伤和器械栓塞，发生率分别为 3.5%和 2.4%。年龄较小（<30 天）与 MAE（风险比：3.3；95%置信区间：1.5 至 7.6）和复合失败（风险比：3.0；95%置信区间：1.4 至 6.7）的风险增加相关。极低体重（10.5%）婴儿的栓塞风险高于非常 LW（1.6%）或 LW（2.5%）婴儿（p=0.050）。
在体重<6kg 的婴儿中，经导管 PDA 封堵术在技术上是可行的，但 MAE 的风险值得关注。这些发现可能有助于为经导管 PDA 封堵术的患者选择和手术方法提供信息，并为循证医学实践提供针对性的研究支持。
