A growth-accommodating transcatheter pulmonary valve system for young children

适合幼儿生长的经导管肺动脉瓣系统

• 批准号: 10281840
• 负责人: Arash Kheradvar
• 金额: $ 19.63万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-07 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10281840
• 关键词: Address; Adult; Age; Animals; Area; Birth; Caliber; Caring; Catheters; Child; Chronic; Clinical; Common Ventricle; Congenital Heart Defects; Congenital atresia of pulmonary valve; Defect; Double Outlet Right Ventricle; Etiology; Europe; Failure; Functional disorder; Growth; Heart Valve Prosthesis; Heart Valves; Implant; Industry; Investments; Lead; Life; Lung; Medical; Medical Device; Miniature Swine; Obstruction; Operative Surgical Procedures; Patients; Performance; Pulmonary Valve Insufficiency; Pulmonary valve structure; Right Ventricular Dysfunction; Right ventricular structure; System; Techniques; Tetralogy of Fallot; Time; Truncus Arteriosus; Ventricular; Weight; aortic valve; base; first-in-human; hemodynamics; implantation; improved; infancy; new technology; novel; pediatric patients; prevent; pulmonary valve replacement; repaired; success

PROJECT SUMMARY/ABSTRACT Congenital heart defects (CHDs) occurs in ~1% of births in the U.S. and Europe. Owing to improved medical and surgical care, it is estimated that nowadays 83% of babies born with CHD in the U.S. survive infancy. Presently, it is estimated that at least 1 million children are living with CHD in the U.S. Most of these patients are born with some degree of right ventricular outflow tract (RVOT) abnormalities that at some point require pulmonary valve replacement to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). The RVOT obstruction often needs to be surgically relieved within the first few months of life. The surgery to relieve RVOT obstruction usually involves placing a transannular patch, which results in PVR that can lead to progressive RV dilation over time, and ultimately RV failure. Although progressive PVR must be addressed at a younger age, in patients who are as small as 10 Kg, the smallest available pulmonary heart valve can only be implanted in a child whose weight is at least 20 Kg. To address this unmet clinical need, we aim to develop, implant, and study the performance of a novel origami-based transcatheter pulmonary valve (TPV) system that can be implanted in a child as small as 8 Kg and accommodates the child's growth through a one-time balloon expansion. The proposed novel technology aims to address the current lack of options for children with progressive PVR whose weight is between 8 and 20 Kg, and will stop progressive RV dilation and ultimately avoid the occurrence of RV failure in these children. The overarching hypothesis of this exploratory application is that a growth- accommodating TPV developed based on origami concepts can be implanted in minipigs as small as 8-10 Kg, and through one-time balloon expansion it can be augmented to be suitable for minipigs weighing 20-22 Kg.

项目总结/摘要 在美国和欧洲，先天性心脏病（CHD）发生率约为1%。由于医疗条件改善， 和手术护理，据估计，如今美国83%的先天性心脏病婴儿能够存活下来。 目前，据估计，在美国至少有100万儿童患有CHD。 出生时就有一定程度的右心室流出道（RVOT）异常， 肺动脉瓣置换术，以减轻肺动脉瓣反流（PVR）对 右心室（RV）。 右室流出道梗阻通常需要在出生后的最初几个月内手术缓解。的手术 缓解右室流出道阻塞通常需要放置跨环补片，这会导致PVR， 随着时间的推移进行性RV扩张，最终RV衰竭。尽管进行性PVR必须在 年龄较小，在10 Kg以下的患者中，最小可用肺动脉心脏瓣膜只能 植入体重至少为20 Kg的儿童体内。为了解决这一未满足的临床需求，我们的目标是开发， 植入物，并研究一种新型折纸经导管肺动脉瓣（TPV）系统的性能， 可植入小至8公斤的儿童体内，并通过一次性气囊适应儿童的生长 扩张. 提出的新技术旨在解决目前缺乏选择的儿童进行性PVR 其体重在8至20 Kg之间，并且将停止进行性RV扩张并最终避免发生 右心室衰竭的几率这个探索性应用的首要假设是，一个增长- 基于折纸概念开发的适应性TPV可以植入小至8-10 Kg的小型猪， 通过一次球囊扩张，可扩大到适用于20-22公斤的小型猪。