Gałeczka Michał, Kapałka Michał, Chojnicki Maciej, Krawiec Michał, Tyc Filip, Fiszer Roland
Department of Paediatric Cardiology and Congenital Heart Defects, FMS in Zabrze, Medical University of Silesia in Katowice, Silesian Center for Heart Diseases, Zabrze, Poland.
Student Scientific Association at Department of Paediatric Cardiology and Congenital Heart Defects, FMS in Zabrze, Medical University of Silesia in Katowice, Poland.
Cardiol J. 2025;32(3):228-233. doi: 10.5603/cj.102639. Epub 2025 May 22.
Transcatheter closure has become the method of choice for treating patent ductus arteriosus (PDA) in a majority of patients. The only approved device for treating infants weighing less than 6 kilograms is the Amplatzer Piccolo Occluder (APO). The aim of this study is to summarize the experience of two centers in performing transcatheter PDA closure in infants weighing less than 6 kilograms.
Retrospective, descriptive, and nonrandomized analysis included all 45 infants weighing less than 6 kg who underwent transcatheter PDA closure between 2013 and 2023 at two tertiary centers, following the introduction of APO. Medical records, procedural outcomes, and one-month follow-up were analyzed. Applied devices were: APO in 37 (of whom 3 were off-label due to PDA size), Amplatzer Duct Occluder I (ADO) in 3, and Amplatzer Vascular Plug II (AVP) in 5 cases.
The overall success rate was 97.8%. There were 2 major complications (4.4%), including one device protrusion. A residual shunt was noted in one patient 24 hours after the procedure, but none were observed after one month. Off-label devices were implanted in insignificantly larger and longer PDAs. There were no significant differences between the labeled and off-label groups in terms of procedural success, major complications, or residual shunts.
APO is a safe and effective device to treat PDA in infants weighing less than 6 kilograms, however, off-label devices are needed in a considerable number of patients. Proper use of off-label devices yields comparable to APO results.
经导管封堵术已成为大多数患者治疗动脉导管未闭（PDA）的首选方法。唯一获批用于治疗体重小于6千克婴儿的器械是Amplatzer Piccolo封堵器（APO）。本研究的目的是总结两个中心对体重小于6千克婴儿进行经导管PDA封堵术的经验。
回顾性、描述性和非随机分析纳入了2013年至2023年期间在两个三级中心引入APO后接受经导管PDA封堵术的所有45例体重小于6千克的婴儿。分析了病历、手术结果和1个月的随访情况。使用的器械包括：37例使用APO（其中3例因PDA大小而属于超说明书使用），3例使用Amplatzer动脉导管封堵器I（ADO），5例使用Amplatzer血管塞II（AVP）。
总体成功率为97.8%。发生2例严重并发症（4.4%），包括1例器械突出。1例患者术后24小时发现残余分流，但1个月后未观察到残余分流。超说明书使用的器械植入了尺寸略大、长度略长的PDA中。在手术成功率、严重并发症或残余分流方面，说明书内使用组和超说明书使用组之间无显著差异。
APO是治疗体重小于6千克婴儿PDA的安全有效器械，然而，相当数量的患者需要超说明书使用器械。正确使用超说明书使用器械可产生与APO相当的结果。
