Patent ductus arteriosus closure in patients weighing 2 to 6 kilos. Monocentric comparison between surgical and transcatheter closure

M. Gloanec, F. El Louali, C. Gran, M. Lenoir, V. Fouilloux, C. Ovaert
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Abstract

Introduction

Transcatheter closure of patent ductus arteriosus (PDA) is expanding due to the fast development of new techniques and new materials. Miniaturization of devices currently allows transcatheter closure of ducts in very small patients. Few published data are however available in the 2 et 6 kilograms population.

Objective

This study aims to evaluate recent practices in our department and eventually prove the non-inferiority of transcatheter closure in this population.

Methods

Observational retrospective monocentric study comparing percutaneous and surgical duct closure in children weighing between 2 et 6 kilos, at the University Hospital of la Timone enfants, Marseille, France. This work is part of a large international study, still on-going. Clinical and catheterization/surgical data were analysed. Success was defined as absent residual shunt. The cost of the procedure, based on reimbursement endorsed by the national social security, was compared.

Results

Between 2014 and 2021, 31 patients weighing 2 to 6 kg, had percutaneous closure and 29 patients had surgical closure of the PDA. Mean age was respectively 20 (± 10) and 13 weeks (± 8), mean weight 4,5 kg (± 1) and 3,5 kg (± 1,3). The success rate was 77,42 % (n = 24/31) for the transcatheter group versus 96,43 % (n = 27/28) for the surgical group. Complication rate was 29 % (n = 8) and 7,14 % (n = 2) respectively. One major adverse event was observed in the percutaneous group (3,2 %). Hospitalisation stay was longer in the surgical group (p < 0,0001). Surgery might be more expensive (p < 0,0001). In univariate analysis, pre-procedural ventilation was a risk factor for complications (p = 0,04).

Conclusion/Perspectives

In our experience, percutaneous closure remained less efficient than surgery in the 2 to 6 kg patients. Results are however promising and the procedure seems safe. The hospital stay is shorter and the procedure might be less expensive. However, our small numbers do not allow us to make strong conclusions. Larger, multicentre studies are needed.

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体重2 - 6公斤患者的动脉导管未闭。手术与经导管闭合的单中心比较
由于新技术和新材料的快速发展,经导管动脉导管未闭(PDA)的治疗正在扩大。设备的小型化目前允许在非常小的患者中进行经导管导管闭合。然而,很少有关于2至6公斤人群的公开数据。目的本研究旨在评价我科最近的实践,最终证明经导管关闭术在这一人群中的非劣效性。方法观察性回顾性单中心研究,比较体重在2 ~ 6 kg的法国马赛蒂莫内儿童大学医院的经皮导管闭合和手术导管闭合。这项工作是一项仍在进行的大型国际研究的一部分。分析临床和导管/手术资料。成功定义为没有残留分流。这一程序的费用是根据国家社会保险核准的报销情况进行比较的。结果2014年至2021年,31例体重2 ~ 6kg的患者行经皮闭合术,29例行手术闭合术。平均年龄分别为20(±10)和13周(±8),平均体重分别为4,5 kg(±1)和3,5 kg(±1,3)。经导管组的成功率为77,42% (n = 24/31),而手术组的成功率为96.43% (n = 27/28)。并发症发生率分别为29% (n = 8)和7.14% (n = 2)。经皮组观察到一个主要不良事件(3.2%)。手术组住院时间更长(p <0, 0001)。手术可能更昂贵(p <0, 0001)。在单因素分析中,术前通气是并发症的危险因素(p = 0,04)。结论/观点根据我们的经验,对于体重2 - 6公斤的患者,经皮缝合术的疗效仍低于手术。然而,结果是有希望的,而且手术似乎是安全的。住院时间更短,手术费用也更低。然而,我们的人数太少,不能让我们得出强有力的结论。需要更大规模的多中心研究。
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来源期刊
Archives of Cardiovascular Diseases Supplements
Archives of Cardiovascular Diseases Supplements CARDIAC & CARDIOVASCULAR SYSTEMS-
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发文量
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期刊介绍: Archives of Cardiovascular Diseases Supplements is the official journal of the French Society of Cardiology. The journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles, editorials, and Images in cardiovascular medicine. The topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Additionally, Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.
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