PERCUTANEOUS CLOSURE OF SECUNDUM ATRIAL SEPTAL-DEFECT WITH A NEW SELFCENTERING DEVICE (ANGEL WINGS)

Objective-To investigate the safety, efficacy, and clinical applicatio n of a new self centring device (''angel wings'') for closure of secun dum atrial septal defects (ASD II) and persistent foramen ovale in all age groups. Design-Multicentre, prospective, non-randomised study. Pa tients-Inclusion criteria: defects with an occlusive diameter of less than or equal to 20 mm and a surrounding rim of > 4 mm; body weight > 10 kg; and an indication for surgical closure of secundum atrial septa l defect. Additionally, there were compassionate indications for closu re in patients with persistent foramen ovale. Interventions-Defects we re closed by a transcatheter device consisting of two square frames ma de of superelastic nitinol wire. The frames are covered by elastic pol yester fabric, which is sewn together at a central circle. All procedu res, except for three interventions that were carried out under sedati on, were performed under general anaesthesia using transoesophageal ec hocardiography and fluoroscopy to monitor intervention. Results-Closur e was attempted in 75 (71%) of 105 patients. An ASD II was present in 35 children and 15 adults. A persistent foramen ovale was present in 2 5 adults with suspected paradoxical embolism. Transcatheter closure wa s unsuccessful in three children and crossover to surgery was required . Residual shunts were found in 20 patients (27%) immediately after th e procedure. A transient atrioventricular third degree block occurred in three patients (4%) and the right atrial disk was not fully deploye d in three. A minor shunt (< 3 mm) was present in only three (4%) of 7 2 patients during follow up of 1-17 months. Blood clots on the right a trial disks in two patients tone required lysis) were seen during foll ow up transoesophageal echocardiography. Serious complications demandi ng surgical removal of the device occurred in three patients. One pati ent had haemopericardial tamponade because of an aortic lesion. Left a trial thrombus formation due to an unfolded right atrial disk was foun d in a second patient and dislodgement of the left atrial disk resulte d in a large residual shunt in a third. Conclusions-Percutaneous closu re of a central ASD with a diameter less than or equal to 20 mm in pae diatric and adult patients is feasible and effective with this new dev ice. It is a promising alternative to surgical closure. Modifications of the design, however, seem to be mandatory as 4% of patients develop ed serious complications.