The Follow Up Of Transcatheter Closure Of Perimembranous Ventricular Septal Defect With Modified Doubel-disk Occluder Device

Objective:To evaluate the efficacy and adverse effect of transcatheter closure of perimembranous ventricular septal defect(pmVSD) with Modified Doubel-disk Occluder device(MDVO) in early,intermediate and long term after procedure.Methods:Between December 2001 and December 2008,604 patients(306 men,298 women) underwent percutaneous closure of a pmVSD using MDVO at our department.The mean age of patients was 17.7±13.4 years and the mean weight 41.8±20.6 kgs.All patients were diagnosed by transthoracic echocardiography(TTE) and left ventriculography before the transcatheter closure.In the 604 patients,558 had VSDs,17 had postoperative residual shunt of VSDs,29 had VSD with other congenital heart disease(ASD,PDA,PS ect.) All patients were treated using domestic-made occluder device through the percutaneous procedure under fluoroscopy,angiography and TTE.All patients immediately underwent left ventriculography,ascending aortography and TTE after procedures to evalue immediate efficacy.All subjects underwent clinical examination,electrocardiography,chest-X-rays,and TTE before discharge and at 1,6,and 12 months after the procedure and yearly thereafter.Results:576 patients were successfully placed with 583 VSD occluders,with an immediate success rate of 95.4%.The following additional catheter interventions were performed simultaneously:device closure of ASD in 17 patients,of PDA in 9 patients, of ASD+PDA in 1 patient,device closure of ASD +balloon pulmonary valvuloplasty in 1 patient,device closure of PDA + balloon aortic valvuloplasty stenting coarctation in 1 patient.The mean diameter of VSD measured by left ventriculography during procedure was 5.07±2.82mm.The device diameter was 7.38±3.4(4-26) mm.Trival to small residual shunts were found in 69 patients(12%).The residual shunts disappeared in 31 patients and remained unchanged in 38 patients(6.6%) 7 days after procedures.Aortic regurgitation developed in 5 patients(from trivial developed to small regurgitation in 2, from small developed to moderate regurgitation in 3),and tricuspid regurgitation was present in 35 patients(trivial to small regurgitation in 32,moderate regurgitation in 3). Conduction block occurred in 81 patients,including RBBB in 56 patients,LBBB in 14 patients,complete heart block occurred in 11 patients,permanent pacemaker was inserted in 2 patients(one had transientⅢ°AVB before the procedure,the other simultaneously closure VSD and ASD).31 patients developed transient nonparoxysmal ventricular tachycardia after the procedure.5 patients developed haemolysis,only 1 of them retrieved the device by catheter,the other recovered 3-14 days later. Pseudoaneurysm of femoral artery occurred in 1 patient,and disappeared by pressure dressing.Device embolization occurred in 1 patient,the device was retrieved by catheter and pulled out;a second device was successfully implanted.Device misplacement occurred in 1 patient,another device was successfully implanted.There were no episodes of endocarditis,thromboembolism,or deaths in early,intermediate term after procedure.Follow-up data were obtained from 271 patients.The median duration of follow-up was 35.6 months(range:6-81 months).There were no device embolization,episodes of endocarditis,thromboembolism,or deaths during the follow-up.The cardiac dysfunction occurred only in 1 case because of myocarditis during the follow-up.We gained the complete follow-up data of 174 patients.The median follow-up duration of them was 33.4 months.In these patients,trival to small residual shunts were found in 7 patients. Aortic regurgitation developed in 2 patients(from trivial developed to small regurgitation in 1,from small developed to moderate regurgitation in 1),Tricuspid regurgitation was present in 29 patients(trivial to small regurgitation in 26,moderate to large regurgitation in 3,1 patient with the cardiac dilatation and cardiac dysfunction ), and trivial to small bicuspid regurgitation was present in 12 patients.During the follow-up,the arrhythmias disappeared in 35 patients,but occurred in 14 patients(including RBBB in 9 patients,LAFB in 4 patients,LBBB+I°AVB in 1 patient).The severe complications of the MDVO in our study were less than the Amplatzer device reported in the literature no matter in early,intermediate or long term after procedure.Conclusions:It is safe and effective to close congenital ventricular septal defect with domestic-made occluder device.The longer follow-up are required to assess the late complications,particular the valve regurgitation and the late conduction block.