Removable Stents for Neonates with Cyanotic Congenital Heart Disease(CCHD)

描述（由申请人提供）：目前许多形式的先天性心脏病的治疗需要在出生后不久开始多次外科手术，伴随着高发病率和潜在死亡率。一种有希望的替代治疗方法是在动脉导管未闭（PDA）中放置支架，以延迟最终修复，直到孩子长大，风险降低。提出了一种专门设计用于植入新生儿PDA的新型支架，以克服临床医生在新生儿中使用这种新手术时遇到的困难，以及由于所用支架并非为此目的而设计而引起的并发症。由工程师和儿科心脏病专家组成的跨学科团队将（1）确定/记录在新生儿PDA中植入支架的要求，包括取出;（2）使用体模进行分析和体外研究，以确定最有希望的支架和取出工具的候选设计;（3）在合适的动物模型中进行体内初步研究，以评价展开、可回收性、可跟踪性和不透射线性;以及（4）进行长期初步动物研究，以评估安全性和有效性。在后一项研究中，将在PDA通畅性维持、组织炎症和存在粘附内皮组织时从PDA中安全取出方面，将拟定支架设计与目前使用的支架进行比较。这些研究将形成一个令人信服的基础，完成开发的PDA支架治疗紫绀型先天性心脏病的新生儿。 公共卫生相关性：虽然冠心病的治疗已经取得了显着的改善，包括在过去十年中死亡率降低了30%，但还有很长的路要走，而且作为一个整体，这一领域的资金严重不足。一种专门设计用于新生儿PDA植入的新型支架的成功开发，将为实现这一目标做出重大贡献，为治疗紫绀型先天性心脏病提供更安全、侵入性更小的方法，包括左心发育不良综合征（HLHS），这是生命第一年内所有先天性心脏病中最致命的一种。目前，这些新生儿的生存需要他们在出生后不久接受侵入性和高风险的心内直视手术，而安全有效的PDA支架的可用性将允许延迟侵入性手术，直到孩子处于低得多的风险的年龄。

DESCRIPTION (provided by applicant): Current treatment of many forms of congenital heart disease requires multiple surgical procedures starting shortly after birth, with attendant high morbidity and potential mortality. A promising alternative treatment calls for placing a stent in te patent ductus arteriosus (PDA), in order to delay definitive repair until the child is older and wil have a lower risk. A novel stent specifically designed for implantation in the neonate PDA is proposed, in order to overcome the difficulties that clinicians have experienced with this new procedure in newborns, complications arising from the fact that the stents used were not designed for this purpose. An interdisciplinary team of engineers and pediatric cardiologists will (1) identify/document the requirements for a stent to be implanted in the newborn PDA, including removal; (2) perform analytical and in vitro studies with phantoms to identify the most promising candidate designs for the stent and removal instrumentation; (3) conduct an in vivo pilot study in a suitable animal model to evaluate deployment, recaptureability, trackability and radiopacity; and (4) conduct a pilot long-term animal study to assess safety and efficacy. In this latter study, proposed stent designs will be compared with stents currently being used, in regard to maintenance of patency of the PDA, tissue inflammation, and safe removal from the PDA in the presence of adherent endothelial tissue. These studies will form a compelling foundation for completing development of a PDA stent for treatment of Cyanotic Congenital Heart Disease in neonates. PUBLIC HEALTH RELEVANCE: While significant improvement in treatment of CHD has already been made, including a 30% reduction in mortality over the past decade, there is a still a long way to go and as a whole this area has been significantly underfunded. Successful development of a new stent, specifically designed for implantation in the PDA in neonates, would represent a major contribution toward this end, providing a safer and less invasive means for treating cyanotic congenital heart disease, including hypoplastic left heart syndrome (HLHS), the deadliest of all congenital heart diseases during the first year of life. Currently, the survivl of these neonates requires that they undergo invasive and highly risky open-heart procedures shortly after birth, whereas the availability of a safe and effective PDA stent for would permit delay of invasive surgery until an age when the child is at much lower risk.