Grabitz R G, Neuss M B, Coe J Y, Handt S, Redel D A, von Bernuth G
Department of Pediatric Cardiology, Aachen University of Technology, Germany.
J Am Coll Cardiol. 1996 Oct;28(4):1024-30. doi: 10.1016/s0735-1097(96)00242-2.
We attempted to evaluate the efficacy and tissue reaction of a new miniature interventional ductal occlusion device in neonatal pigs.
A variety of devices are used to close persistent ductus arteriosus (PDA) by interventional measures. Because of the size of these devices, they have not been applied to term or preterm neonates. Newborn piglets are comparable in size and fragility to human term and preterm neonates.
Memory-shaped double-cone stainless steel coils were mounted on a titanium-nickel core wire. A snap-in mechanism attaches the coil to the delivery wire, allowing intravascular coil retrieval and repositioning. The system was placed through a 3F Teflon catheter. Two piglet models of PDA were used: 1) ductal patency maintained by stents (n = 6), and 2) ductal patency produced by angioplasty (n = 7) to avoid stent-coil interaction.
Placement of the coils within the PDA was possible in all piglets. Before final detachment, the coils were retrieved or repositioned, or both, up to eight times. In all but two piglets the ductus was closed within 1 h of the procedure. The coils were never dislocated and caused no infections or relevant aortic and pulmonary artery obstruction (95% confidence interval for missing complications [0 of 13] extends to 23%). Histologic and electron microscopic studies revealed endothelial coverage of the implants and histiocytic reaction but no local or systemic inflammation or erosion of the implant.
The device was effective in experimental models of PDA. The information obtained warrants initial trials of the device in neonates.
我们试图评估一种新型微型介入性导管封堵装置在新生猪中的疗效和组织反应。
多种装置用于通过介入措施关闭动脉导管未闭（PDA）。由于这些装置的尺寸问题，它们尚未应用于足月儿或早产儿。新生仔猪在大小和脆弱性方面与人类足月儿和早产儿相似。
记忆形状的双锥不锈钢线圈安装在钛镍芯线上。一种卡扣机制将线圈连接到输送导丝上，允许血管内线圈回收和重新定位。该系统通过一根3F聚四氟乙烯导管放置。使用了两种PDA仔猪模型：1）通过支架维持导管通畅（n = 6），以及2）通过血管成形术产生导管通畅（n = 7），以避免支架 - 线圈相互作用。
所有仔猪都能够将线圈放置在PDA内。在最终分离之前，线圈可被回收或重新定位，或两者兼而有之，多达八次。除了两只仔猪外，所有仔猪的导管在手术1小时内均被关闭。线圈从未脱位，也未引起感染或相关的主动脉和肺动脉阻塞（遗漏并发症的95%置信区间[13例中的0例]扩展至23%）。组织学和电子显微镜研究显示植入物有内皮覆盖和组织细胞反应，但没有局部或全身炎症或植入物侵蚀。
该装置在PDA实验模型中有效。所获得的信息为该装置在新生儿中的初步试验提供了依据。
