Experience of percutaneous closure of small to large patent ductus arteriosus with Nit-Occlud® device in a tertiary referral hospital in Colombia.

Sandra R Galvis-Luna, Carlos A Guzmán-Serrano, Isabella Olave-Rueda, Valentina Mejía-Quiñones, Jaiber Gutierrez-Gil, Walter Mosquera-Álvarez
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Abstract

Background: The decision to close patent ductus arteriosus should always be individualized and taken together with the child's family once the risks and benefits of both choices have been exposed.

Objective: This study aims to report the experience and outcomes in patients undergoing endovascular closure of small to medium-size PDA with a Nit-Occlud® device in a tertiary referral hospital in Colombia.

Methods: Longitudinal descriptive study, which included all patients under 18 years of age who underwent percutaneous ductal closure with Nit-Occlud® device between January 1, 2011, and February 1, 2023. Patients with associated complex congenital heart disease requiring surgical management, pregnant patients, and patients with incomplete data regarding studied variables were excluded from the study.

Results: Eighty-seven patients were documented, with a mean age, weight, and height at closure of 51 months, 14 kg, and 95.83 cm, respectively. About 70% of the patients (n = 61) were female, 76% were under 6-years-old and only one patient was over 15. The average size of the ductus at the pulmonary end was 2 mm. Four of the total number of patients did not achieve PDA closure during the procedure. Of the remaining 83, complete immediate closure was achieved in 81 patients. A device exchange for a larger device was required during the same procedure in one of the cases. Two patients presented residual shunt of 0.5 mm during follow-up, and one required a new procedure for device closure 10 months later. Only one device presented repeatedly embolization to the aorta, requiring surgical removal. As a technical difficulty, one device presented repeated passage into the aorta, so it was decided to remove it before releasing it to avoid complications, and given the complex anatomy of the ductus, surgical closure was indicated. Among the complications, one patient presented a hematoma of the subcutaneous tissue in the right thigh, which improved with medical management, and no deaths related to the procedure were registered.

Conclusions: Using the Nit-Occlud® device to close small to moderate-sized ductus remains a safe and effective strategy with successful closure rates at 1-year follow-up irrespective of age, weight, height, or whether it involves a small or medium-sized duct. Despite our limitations, results concerning adverse effects are comparable to those observed in multicentric studies conducted in other regions.

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哥伦比亚一家三级转诊医院使用 Nit-Occlud® 装置经皮闭合小到大的动脉导管未闭的经验。
背景:关闭动脉导管未闭的决定应始终因人而异,并与患儿家属共同做出,一旦两种选择的风险和益处都暴露无遗:本研究旨在报告哥伦比亚一家三级转诊医院使用 Nit-Occlud® 装置对中小型 PDA 进行血管内闭合手术的经验和结果:纵向描述性研究,包括 2011 年 1 月 1 日至 2023 年 2 月 1 日期间接受 Nit-Occlud® 装置经皮导管闭合术的所有 18 岁以下患者。研究排除了需要手术治疗的伴有复杂先天性心脏病的患者、孕妇以及研究变量数据不完整的患者:记录的 87 名患者的平均年龄、体重和闭合时的身高分别为 51 个月、14 千克和 95.83 厘米。约 70% 的患者(n = 61)为女性,76% 的患者年龄在 6 岁以下,只有一名患者超过 15 岁。肺端导管的平均尺寸为 2 毫米。在所有患者中,有 4 名患者在手术过程中未实现 PDA 闭合。其余 83 名患者中,有 81 人实现了立即完全闭合。其中一例患者需要在同一手术中更换更大的装置。两名患者在随访期间出现了 0.5 毫米的残余分流,其中一名患者需要在 10 个月后重新进行手术以关闭装置。只有一个装置反复出现主动脉栓塞,需要手术取出。由于技术上的困难,一个装置反复进入主动脉,因此决定在释放前将其取出,以避免并发症。在并发症中,一名患者的右大腿皮下组织出现血肿,经药物治疗后有所好转,没有出现与手术相关的死亡病例:结论:使用 Nit-Occlud® 装置闭合中小型导管仍然是一种安全有效的策略,无论患者的年龄、体重、身高如何,也无论涉及的是小型导管还是中型导管,1 年随访时的闭合成功率都很高。尽管我们的研究存在局限性,但有关不良反应的结果与在其他地区进行的多中心研究中观察到的结果相当。
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