The Efficacy And Follow-up Study Of Transcatheter Ventricular Septal Defect Closure With Domestic-made Occluder Device

Objective:To evaluate the clinical efficacy and adverse effect of transcatheter closure ofventricular septal defect (VSD) with domestic-made occluder device in early, intermediateand long term after procedure.Methods:Between July 2003 and April 2007, 223 patients with congenital ventricular septaldefect(VSD) in the Department of Cardiology, The First Affiliated Hospital of KunmingMedical College were selected for this study. The mean age of patients was 12．1±9．2 (1．9～49．0) years and the mean weight 30．5±15．7 (11．0～69．0) kgs. All patients were diagnosed bytransthoracic echocardiography (TTb) and left ventriculography before the transcatheterclosure. In the 223 patients, 140 patients had an associated aneurysm of the membranousseptum, 13 patients associated left ventricular-right atrium shunts, 9 patients associatedatrial septal defect(ASD), 12 patients associated patent foramen ovale(PFO), 5 patientsassociated patent dutus arteriosus(PDA), 10 patients associated other abnormalities whichneed not be treated in cardiac surgery. 223 patients were treated using domestic-madeoccluder device through the percutaneous procedure under fluoroscopy, angiography and TTE.All patients immediately underwent left ventriculography, ascending aortography and TTEafter procedures to evalue immediate efficacy. Follow-up evaluation was performed with TTE,ECG, X-ray and clinical examination at 3-day, 3-month, 6-month, 1-year and more longerafter closure to evaluate the efficiency.Results:212 patients were successfully placed with VSD occluders and the success rate of theprocedure was 95．1%. The minimum diameter of VSD measured by left ventriculography during procedure was 8．4±2．8 (3．3～19．4) mm. Simultaneously, 7 patients associated ASD,3 patients associated PFO and 5 patients associated PDA were closed with domestic-madeoccluder device. 213 VSD occluder devices were implanted and the mean diameter of VSDdecice was 9．8±3．2mm (4．0～20．0 mm) . There were immediate complete closures of thedefects in 182 patients and trivial to small residual shunts were found in 30 patients whodisappeared in 24 patients 3 days after procedures. In follow-up periods, major complicationsoccurred in 10 patients including complete atroventricular block (CAVB) in 8, hemolysis in 2．The 7 patients with CAVB were completely recovered to normal sinus rhythm. Surgicalinterventions was in 2 haemolytic patients. Minor complications occurred in 71 patientsincluding residual shunts in 8, arrhythmias in 30, tiny tricuspid regurgitation in 13, tinyaortic regurgitation in 14, trivial mitral regurgitation in 3, aortic stenosis in 2 and rightventricular outflow tract stenosis (RVOTS) in 1 patient. During 7 days to 2 years follow-up,all patients with cardiomegaly before procedures came back except 1 patient withhypertension and 1 patient with dilated cardiomyopathy, and there were no complications ofembolication of the device, endocarditis, thromboembolism, and sudden death.Conclusions:It is safe and effective to close congenital ventricular septal defects with domestic-madeoccluder device.