Short term follow up of percutaneuos closure of perimembranous ventricular septal defects using the second generation amplatzer occluders

Background: No devices are currently available in the USA for percutaneous closure of perimembranous (Pm) ventricular septal defects (VSDs). The earlier device was withdrawn from clinical trial because of development of heart block possibly related to over sizing and/or device rigidity. New, softer devices are available for vascular occlusions as the Amplazer Vascular Plug II (AVP II) and the Amplatzer Duct Occluder II (ADO II). We previously submitted our initial experience in occluding Pm VSDs using AVP II & ADO II in 10 patients (pts) using AVP II in 6 and ADO II in 4. This is follow up (f/up) of these pts and additional pt. Methods: F/up data of these pts. were reviewed specifically assessing for the development of heart block, residual flow through the device, presence of aortic insufficiency (AI) and device embolization or fracture or the occurrence of late adverse events (AE). Results: Review of F/up data of these pts. was performed specifically assessing for the development of heart block, residual flow through the device, presence of aortic insufficiency (AI) and device embolization or fracture or the occurrence of late adverse events (AE). Results: F/up clinical evaluations, chest x-rays and echocardiograms were available for all patients expect 1 who did not undergo chest x ray because of pregnancy. F/up period ranged from 0-13 months with a median of 5.5 + 5. New AI was seen in 3 patients graded as mild in 1 and trivial in 2. In 1 patient the AI could have been preexisting and masked by the VSD flow. 1 patient had mild new Tricuspid regurgitation. There was no incidence of device fracture or late embolization and no clinical evidence of hemolysis, sub-acute bacterial endocarditis or any serious AE. No patient developed heart block. In 1 patient with elongated tunnel type VSD, the device took the configuration of the defect. 1 patient had residual flow through the device which disappeared on follow up. I patient has additional small VSD. Conclusions: In our series, percutaneous closure of PmVSDs using the softer new generation devices as the AVP II and the ADO II appears to be safe in the short term. Flow seen through the device usually disappears as the device endothelializes.