Weber H S, Baylen B G, Banaszak P, Abt A B
Section of Pediatrics (Cardiology), The Pennsylvania State University Childrens Hospital, Hershey, 17033, USA.
J Am Coll Cardiol. 1996 Jul;28(1):241-6. doi: 10.1016/0735-1097(96)00128-3.
This study sought to establish and maintain patency of the ductus arteriosus by a new method of transvascular formalin infiltration of the ductus arteriosus wall.
Maintaining patency of the ductus arteriosus postnatally is necessary with many forms of congenital heart disease to ensure survival until definitive surgical repair. A variety of approaches have to date met with variable success.
Seven newborn lambs underwent catheterization at 1 to 5 days of age. A functionally closed ductus arteriosus was traversed with a specially designed porous balloon catheter, and the wall was infiltrated with 10% formalin. The ductus was then further dilated with either a 7- or 8-mm diameter balloon.
The ductus arteriosus wall was successfully infiltrated and dilated in all animals. Two lambs were euthanized within 24 h with congestive heart failure from a large ductus, and one lamb was electively euthanized 5 days after transvascular infiltration. Four lambs underwent serial follow-up catheterizations, one of which required repeat balloon dilation 47 days after infiltration. At latest follow-up (mean age [+/- 1 SD] 83 +/- 34 days, range 33 to 108), the pulmonary/systemic flow ratio (2.7 +/- 1.2) was unchanged from immediately after infiltration (1.9 +/- 0.5, p > 0.1). The narrowest diameter of the ductus arteriosus (4.3 +/- 0.4 mm vs. 6.9 +/- 2.6 mm, p > 0.1) and its ratio to that of the adjacent descending aorta (0.5 +/- 0.1 vs 0.4 +/- 0.1, p > 0.1) were also unchanged at latest follow-up. No systemic toxicity was observed. At postmortem study, the ductus was patent, and histologic analysis showed variable intimal and medial destruction, endothelial regeneration, loss of elastic tissue and calcification. Adjacent pulmonary artery and aorta were normal. Based on the small sample size and the observed maximal effect size of 70%, the power of the study is at most 40% to detect significant differences.
To our knowledge, this is the first time that transvascular formalin infiltration of the ductus arteriosus wall has been applied successfully to maintain ductal patency in the newborn lamb. This method may provide a means of palliation for neonates with certain forms of congenital heart disease.
本研究旨在通过一种经血管向动脉导管壁内注入甲醛的新方法来建立并维持动脉导管通畅。
对于多种先天性心脏病，出生后维持动脉导管通畅对于确保存活至进行确定性手术修复是必要的。迄今为止，多种方法取得了不同程度的成功。
7只新生羔羊在1至5日龄时接受了导管插入术。使用专门设计的多孔球囊导管穿过功能上已闭合的动脉导管，并向其壁内注入10%的甲醛。然后用直径为7或8毫米的球囊对动脉导管进一步扩张。
所有动物的动脉导管壁均成功实现了甲醛注入和扩张。2只羔羊在24小时内因动脉导管粗大导致充血性心力衰竭而实施安乐死，1只羔羊在经血管注入甲醛5天后被选择性安乐死。4只羔羊接受了系列随访导管插入术，其中1只在注入甲醛47天后需要再次进行球囊扩张。在最新一次随访时（平均年龄[±1标准差]83±34天，范围33至108天），肺/体循环血流量比值（2.7±1.2）与注入甲醛后即刻（1.9±0.5，p>0.1）相比无变化。动脉导管最窄直径（4.3±0.4毫米对6.9±2.6毫米，p>0.1）及其与相邻降主动脉直径的比值（0.5±0.1对0.4±0.1，p>0.1）在最新一次随访时也无变化。未观察到全身毒性。尸检研究显示动脉导管通畅，组织学分析显示内膜和中膜有不同程度的破坏、内皮再生、弹性组织丧失和钙化。相邻的肺动脉和主动脉正常。基于样本量小以及观察到的最大效应量为70%，该研究检测显著差异的效能最高为40%。
据我们所知，这是首次成功应用经血管向动脉导管壁内注入甲醛的方法来维持新生羔羊的动脉导管通畅。该方法可能为患有某些形式先天性心脏病的新生儿提供一种姑息治疗手段。
