Transvasal closure of interatrial defects using the Babic double-umbrella occluder system.

The purpose of the study was to assess the feasibility and safety of closure of atrial septal defects and patent foramen ovale by means of a new interventional technique. Transvasal closure of ostium secundum atrial septal defect and patent foramen ovale was performed in 18 patients using an occluder system for atrial septal defects. Two patients had undergone unsuccessful direct surgical closure years before. Implantation and follow-up were controlled using radiographic views both with and without contrast injection, transthoracic and multiplane transesophageal echocardiographic imaging, color Doppler sonography, and computed tomography. The defect was closed in 16 patients using 19 procedures. Removal of the devices through the sheath was indicated in 4 patients because of placement failure. Intraprocedural complications were ventricular fibrillation in one patient and fixation of the device in Chiari's network in an additional one. During 7-26 months follow-up occluder damage was seen in two patients and perforation of the left atrium in one patient. Thickening on the occluder surface was observed in two patients. There was no death. The system for closure of atrial septal defect is feasible and safe in patients with defects < or = 27 mm in diameter. Long-term observation of outcome is limited yet.