D. Pfeiffer et al., TRANSVASAL CLOSURE OF INTERATRIAL DEFECTS USING THE BABIC DOUBLE-UMBRELLA OCCLUDER SYSTEM, The thoracic and cardiovascular surgeon, 46(3), 1998, pp. 134-140
The purpose of the study was to assess the feasibility and safety of c
losure of atrial septal defects and patent foramen ovale by means of a
new interventional technique. Transvasal closure of ostium secundum a
trial septal defect and patent foramen ovale was performed in 18 patie
nts using an occluder system for atrial septal defects. Two patients h
ad undergone unsuccessful direct surgical closure years before. Implan
tation and follow-up were controlled using radiographic views both wit
h and without contrast injection, transthoracic and multiplane transes
ophageal echocardiographic imaging, color Doppler sonography, and comp
uted tomography. The defect was closed in 16 patients using 19 procedu
res. Removal of the devices through the sheath was indicated in 4 pati
ents 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 oc
cluder damage was seen in two patients and perforation of the left atr
ium in one patient. Thickening on the occluder surface was observed in
two patients. There was no death. The system for closure of atrial se
ptal defect is feasible and safe in patients with defects less than or
equal to 27 mm in diameter. Long-term observation of outcome is limit
ed yet.