Who Still Gets Ligated? Reasons for Persistence of Surgical Ligation of the Patent Ductus Arteriosus Following Availability of Transcatheter Device Occlusion for Premature Neonates

Julia K. Hoffmann, Zahra S H Khazal, W. Apers, Puneet Sharma, C. Weismann, Kira Kaganov, Craig R. Wheeler, Michael Farias, Diego Porras, Philip T Levy, Sarah U. Morton
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Abstract

(1) Background: To identify reasons for the persistence of surgical ligation of the patent ductus arteriosus (PDA) in premature infants after the 2019 Food and Drug Administration (FDA) approval of transcatheter device closure; (2) Methods: We performed a 10-year (2014–2023) single-institution retrospective study of premature infants (<37 weeks) and compared clinical characteristics and neonatal morbidities between neonates that underwent surgical ligation before (epoch 1) and after (epoch 2) FDA approval of transcatheter closure; (3) Results: We identified 120 premature infants that underwent surgical ligation (n = 94 before, n = 26 after FDA approval). Unfavorable PDA morphology, active infection, and recent abdominal pathology were the most common reasons for surgical ligation over device occlusion in epoch 2. There were no differences in demographics, age at closure, or outcomes between infants who received surgical ligation in the two epochs; (4) Conclusions: Despite increasing trends for transcatheter PDA closure in premature infants, surgical ligation persists due to unfavorable ductal morphology, active infection, or abdominal pathology.
谁还在结扎?早产新生儿经导管设备闭塞术问世后,仍坚持手术结扎动脉导管未闭的原因
(1) 背景:找出2019年美国食品和药物管理局(FDA)批准经导管设备闭合术后早产儿动脉导管未闭(PDA)手术结扎持续存在的原因;(2)方法:我们对早产儿(<37周)进行了一项为期10年(2014-2023年)的单一机构回顾性研究,比较了在FDA批准经导管闭合术之前(纪元1)和之后(纪元2)接受手术结扎的新生儿的临床特征和新生儿发病率;(3)结果:我们确定了 120 例接受手术结扎的早产儿(FDA 批准前为 94 例,FDA 批准后为 26 例)。不利的 PDA 形态、活动性感染和近期腹部病变是第二纪元手术结扎而非器械闭塞的最常见原因。两个时期接受手术结扎的婴儿在人口统计学、闭合年龄或预后方面没有差异;(4)结论:尽管早产儿经导管关闭 PDA 的趋势越来越明显,但由于导管形态不佳、活动性感染或腹部病变等原因,手术结扎仍然存在。
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