Subramanian Anand, Paraswanath Bharath A, Mahimarangaiah Jayranganath
Paediatric Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bangalore, India.
Paediatric Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bangalore, India.
Heart Lung Circ. 2022 Dec;31(12):1677-1684. doi: 10.1016/j.hlc.2022.07.007. Epub 2022 Sep 8.
The Occlutech duct occluder (ODO) with a novel design has been available for closure of patent ductus arteriosus (PDA) since 2011. Available data on initial experience with the ODO have shown that operators continue to choose device sizes based on their experience with conventional duct occluders (CDO). This study postulated that occlusion of the pulmonary arterial (PA) end of the ductus should achieve satisfactory PDA closure without additional complications. Accordingly, the size of the ODO was chosen such that the larger PA diameter in the new design exceeded the PA end of the ductus by 2-3 mm and 2-4 mm for normotensive and hypertensive ducts, respectively. It sought to examine the feasibility and safety of such an approach, and compared ODO and CDO devices with respect to device sizes deployed, to ascertain if the newer design had any advantages.
This prospective study enrolled 105 infants, children and a few adults with various duct morphologies and PA pressures for ductal closure using the ODO from 2018-2020. The control group consisted of 105 ducts closed with CDO. A comparison of the two groups with respect to duct diameter and implanted device sizes was performed using appropriate statistical software.
The study found that 40% of the ducts had moderate-to-severe pulmonary hypertension. Most ducts measured between 3-4 mm in both groups. The mean weight of the subjects in both groups was 12 kg. Although there was no change in the way that duct occluders were chosen in both groups (2-3 mm over the pulmonary artery diameter), ODO could be significantly downsized in most ducts measuring between 2.5-6.4 mm in diameter (p<0.05).
This study found successful closure of relatively larger PDA in infants and children using smaller ODO compared with CDO, without embolisation or aortic narrowing. It also demonstrated that a different device size selection technique may be safely employed with the ODO.
自2011年以来，具有新颖设计的Occlutech动脉导管封堵器（ODO）已可用于封堵动脉导管未闭（PDA）。关于ODO初始使用经验的现有数据表明，操作人员仍根据其使用传统动脉导管封堵器（CDO）的经验来选择器械尺寸。本研究推测，封堵动脉导管的肺动脉（PA）端应能实现令人满意的PDA封堵，且无额外并发症。因此，选择ODO的尺寸时，对于血压正常和高血压的动脉导管，新设计中较大的PA直径分别超过动脉导管的PA端2 - 3毫米和2 - 4毫米。本研究旨在检验这种方法的可行性和安全性，并比较ODO和CDO器械在所用器械尺寸方面的差异，以确定新设计是否具有任何优势。
这项前瞻性研究纳入了2018年至2020年期间105例患有各种动脉导管形态和PA压力的婴儿、儿童及少数成人，使用ODO进行动脉导管封堵。对照组由105例用CDO封堵的动脉导管组成。使用适当的统计软件对两组在动脉导管直径和植入器械尺寸方面进行比较。
研究发现，40%的动脉导管有中度至重度肺动脉高压。两组中大多数动脉导管的直径在3 - 4毫米之间。两组受试者的平均体重均为12千克。尽管两组选择动脉导管封堵器的方式没有变化（超过肺动脉直径2 - 3毫米），但对于大多数直径在2.5 - 6.4毫米之间的动脉导管，ODO的尺寸可显著减小（p<0.05）。
本研究发现，与CDO相比，使用较小的ODO可成功封堵婴儿和儿童相对较大的PDA，且无栓塞或主动脉缩窄。研究还表明，ODO可安全采用不同的器械尺寸选择技术。
