EXTENDING THE LIMITS OF TRANSCATHETER CLOSURE OF ATRIAL SEPTAL-DEFECTS WITH THE DOUBLE UMBRELLA DEVICE (CARDIOSEAL)

Objective-To report initial findings from a selected group of patients with morphological variations of the atrial septal defect who underwe nt transcatheter closure with a second generation redesigned double um brella device. Patients-Two patients with abnormal location of the ova l fossa and partial deficiency of the septal rim, three patients with multiple defects, and two patients with a multiperforated aneurysm of the interatrial septum (age range, 3.6-25.5 years). Methods-Defects we re closed with the double umbrella device (CardioSEAL) consisting of t wo sets of flexible arms (with central and two mid-arm hinges) covered with sewn Dacron patches. The implantation procedure was monitored by transoesophageal echocardiography. Results-The diameter of the defect measured during transoesophageal echocardiography ranged from 7-18 mm and the balloon stretched diameter ranged from 13-21 mm. The size of the devices varied from 28-33 mm and the ratio of device size to defec t size varied from 1.6-2.1. Two devices (23 and 28 mm) were chosen in a patient with two separated defects. No complications or serious arrh ythmias were observed during implantation or follow up (median, 1.8 mo nths). Residual shunting was trivial in three patients and mild in one patient (inferiorly located additional defect). Conclusions-To extend the selection critera of an isolated central interatrial defect for t ranscatheter closure, some modifications of the implantation technique are needed. Using the redesigned double umbrella device, effective cl osure in patients with multiple or irregularly shaped atrial septal de fects was achieved, indicating a broadening of the spectrum of transca theter closure.