Transcatheter Versus Surgical Closure of Ventricular Septal Defect: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Rate of Transthoracic Echocardiography residual ventricular septal defect shunts
研究概览
简要总结
The aim of this study is to compare Safety, efiicacy and clinical effects of surgical versus transcatheter closure of ventricular septal defect (VSD ).
The outcome of interest is success rate, residual shunts, effect on tricuspid and aortic valves, need for blood transfusion, length of hospital and intensive care unit ( ICU ) stay, complications especially complete heart block, affection of kidney functions due to the procedure length caused by Cardiopulmonary bypass in case of surgical group or by the dye used in the group of transcatheter closure.
详细描述
Both of transcatheter and surgical closure of VSD is a well-established procedure. Despite the wide using of both procedures, there is a defect in the evidence comparing the short-term outcome and the value of both techniques. Our multicenter study aims to compare the immediate outcome of both procedures in Egypt.
- INTRODUCTION/ REVIEW with variable degrees of successes. Perimembranous VSDs have more intensiveLock et al in 1988 . Ventricular septal defects are the most common congenital heart diseases in children and are the second most common congenital abnormality in adults(1). nearly accounting for one-third of all cases. The extent of the opening may vary from the pin size to complete absence of the ventricular septum. There are 4 main types of VSD, the most common one of them is membranous type which accounts for almost 80% of all VSDs (2). Most isolated muscular and perimembranous VSDs (pm VSDs) are small and close spontaneously. Large eccentric pmVSDs were recommended to be closed for fear of infective endocarditis, aortic regurgitation, and pulmonary hypertension(3). Surgical closure is still considered the gold standard management since being first reported in 1955(4). However, transcatheter closure of some types of VSDs has been introduced into the clinical practice as an alternative to the surgical repair. Transcatheter closure of VSDs were initially made with the occluders of atrial septal defect (ASD) & patent ductus arteriosus (PDA) as reported by Lock in 1988 (5) with variable degrees of successes. Perimembranous VSD have more intensive demands on device design due to their nearness to the aortic valve. Hijazi et al. were first to report a successful closure of perimembranous defects with the occluder in six patients.(6) AMPLATZER muscular VSD occluder still the most common used device for transcatheter closure of muscular VSDs with generally accepted results.(7) However, The high cost of catheter closure, as well as device-related complications such as complete heart block (CHB), device embolization, aortic and tricuspid valves regurgitation, had limited its use (8) . nonetheless, the outcomes of using the transcatheter procedure to treat Perimembranous ( pm) VSD have been improved significantly in recent years because of improvement in device design and operator skills (9).
Superiority of one procedure over the other is still an issue of debate. Consecutively, it is now possible to compare the outcome of both techniques as the data comparing the outcome of them are so limited. 2. METHODOLOGY:
Patients and Methods/ Subjects and Methods/ Material and Methods. Type of Study: Prospective purposed comparative study. 3. Study setting:
The study will be conducted at both of Academic institute of cardiac surgery and National Heart Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 6 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ventricular septal defect: All patients who have congenital VSD which require intervention and accepting the selected measure of intervention. Surgery closure for Perimembranous VSD which is not suitable for catheter closure, muscular VSD. Catheter closure for Perimembranous VSD with at least 4 mm distal from aortic valve, mid muscular, anterior muscular.
- •Age: Pediatric age group with minimum age of 10 months to 18 years old.
- •Gender: both males and females.
- •Intervention classification: Elective.
- •NYHA classification: I - III
- •weight more than 8 Kg.
- •left to right shunt with Qp/Qs more than 1.5.
排除标准
- •Non-congenital VSD.
- •severe pulmonary hypertension with right to left shunt.
- •ischemic stroke
- •hemorrhage stroke
- •systemic thromboembolism
- •heart failure
- •rheumatic heart disease
- •cardiac valvular abnormalities
- •infective endocarditis
- •high degree atrioventricular block
- •atrial fibrillation, atrial flutter
- •paroxysmal supraventricular tachycardia
- •endocardial cushing syndome,
- •Ebstein's anomaly
- •hemodynamically significant atrial septal defect
- •transposition of great vessels
- •tetralogy of Fallot.
结局指标
主要结局
Rate of Transthoracic Echocardiography residual ventricular septal defect shunts
时间窗: One year
two-dimensional Transthoracic Echocardiography for Detection of persistent residual Ventricular septal defect shunt flow - physiological parameter
次要结局
- length of hospital or ICU stay(One month)
- % of patients with need for blood transfusion(One week postoperative)
- Rate of Electrocardiogram complete heart block(One month)
- Incidence of Transthoracic Echocardiography tricuspid and aortic valves regurgitation detect(One year)
