Pediatric Heart Network: Follow-up of the Single Ventricle Reconstruction Trial

儿科心脏网络：单心室重建试验的后续行动

• 批准号: 7283589
• 负责人: William Hellenbrand
• 金额: $ 38.69万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-05 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7283589
• 关键词: Age; Age-Months; Age-Years; Aorta; Arrhythmia; Blood; Blood flow; Cardiac; Cardiac Catheterization Procedures; Cardiac Surgery procedures; Cardiopulmonary Resuscitation; Cardiovascular system; Catheterization; Cessation of life; Childhood; Class; Clinical; Clinical Research; Common Ventricle; Coronary; Coronary artery; Daphne plant; Data; Development; Echocardiography; Electrocardiogram; End Point; Enrollment; Follow-Up Studies; Fontan Procedure; Growth; Heart; Heart Transplantation; Heart failure; Height; Holter Electrocardiography; Hour; Hypoplastic Left Heart Syndrome; Image Enhancement; Incidence; Intelligence; Intervention; Length; Length of Stay; Lesion; Living Wills; Magnetic Resonance Imaging; Measures; Mechanical ventilation; Modification; Morbidity - disease rate; Motion; Motor; Myocardial; Myocardium; Neonatal; Neurological status; Nursery Schools; Operative Surgical Procedures; Outcome; Palliative Surgery; Patients; Performance; Pleural effusion disorder; Population; Postoperative Period; Procedures; Prospective Studies; Public Health; Pulmonary artery structure; Recording of previous events; Research Design; Research Personnel; Right pulmonary artery; Right ventricular structure; Right-On; Risk; Running; Score; Severities; Shunt Device; Subgroup; Survivors; Theft; Time; Transplantation; Tricuspid Valve Insufficiency; Ventricular; Ventricular Arrhythmia; Weight; abstracting; congenital heart disorder; day; design; follow-up; health related quality of life; improved; indexing; infancy; mortality; neonate; prospective; psychosocial; reconstruction; skills

DESCRIPTION (provided by applicant): Palliative surgery in neonates with a single right ventricle (RV), the Norwood 1 procedure, carries the highest risk for mortality and morbidity of all cardiac surgical procedures performed in infancy. The Single Ventricle Reconstruction (SVR) Trial is an ongoing Pediatric Heart Network (PHN) study designed to compare one year outcomes between two surgical modifications of the Norwood 1 procedure. The two modifications differ in their potential effect on RV myocardium: the modified Blalock-Taussig shunt (MBTS) results in a diastolic run-off of blood from the aorta to the pulmonary arteries that may compromise coronary blood flow, while the RV-to-pulmonary artery (RV-to-PA) shunt avoids this potential coronary artery steal phenomenon, but has a long term risk of right ventricular damage from a right ventriculotomy. The primary hypothesis of the SVR Trial is that the RV-to-PA shunt will have a lower incidence of death or transplant at one year of age. There is an ongoing risk of death or transplant extending beyond one year in this patient population, especially as planned open heart surgery is performed between 18 months and 3 years of age. This multicenter prospective follow-up study is designed to extend comparison of clinical outcome and RV performance between survivors of the RV-to-PA shunt and MBTS up to age 4 years. The primary aim is to compare the intermediate-term combined endpoint of death or transplant between the two groups with the hypothesis that the RV-to-PA shunt will have a lower incidence of death or transplantation compared the MBTS at 4 years of age. Secondary aims will include comparison of neurodelopmental outcome, health-related quality of life, RV function, somatic growth, pulmonary artery growth, the incidence heart failure, arrhythmias and the operative and post-operative course following Fontan completion. All subjects enrolled in the SVR Trial who survive to completion at 14 months of age will be eligible for inclusion. Data will be collected at the time of enrollment, at the time of the Fontan surgery (expected to occur between 18 months-3 years of age) and at age 4 years. An application to support a Clinical Research Skills Development Core is also included in this proposal. Relevance to public health: Surgery for hypoplastic left heart syndrome has the highest incidence of death or transplantation of all congenital heart disease lesions. The results of this multicenter, prospective study will provide important information regarding the optimal neonatal surgical intervention for this lesion. (End of Abstract)

描述(由申请人提供)： 在婴儿时期进行的所有心脏外科手术中，对单个右室(RV)的新生儿进行姑息手术，即Norwood 1手术，具有最高的死亡率和发病率。单心室重建(SVR)试验是一项正在进行的儿科心脏网络(PHN)研究，旨在比较诺伍德1号手术的两次手术改进的一年结果。这两种分流术对右室心肌的潜在影响不同：改良的Blalock-Taussig分流术(MBTS)导致血液从主动脉到肺动脉的舒张期流出，这可能会影响冠状动脉血流；而RV-to-PA分流术(RV-to-PA)避免了这种潜在的冠状动脉窃取现象，但存在右室切开造成右室损伤的长期风险。SVR试验的主要假设是RV-to-PA分流术在一岁时死亡或移植的发生率较低。在这些患者中，死亡或移植超过一年的风险持续存在，特别是在18个月至3岁之间进行有计划的心内直视手术。这项多中心前瞻性随访研究旨在扩大RV-to-PA分流术和MBTS幸存者之间的临床结果和RV表现的比较，最大可达4岁。主要目的是比较两组之间死亡或移植的中期联合终点，并假设RV-to-PA分流术与4岁时的MBTS相比死亡或移植发生率更低。次要目标将包括比较神经功能、与健康相关的生活质量、RV功能、躯体生长、肺动脉生长、心力衰竭、心律失常的发生率以及Fontan完成术后的手术和术后病程。所有在SVR试验中存活到14个月大的受试者都有资格被纳入。数据将在登记时、Fontan手术(预计发生在18个月至3岁之间)和4岁时收集。支持临床研究技能开发核心的申请也包括在这项提案中。与公众健康相关：在所有先天性心脏病病变中，左心发育不良综合征的手术死亡率或移植发生率最高。这项多中心前瞻性研究的结果将为这一病变的最佳新生儿外科治疗提供重要信息。(摘要结束)