Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: Comparison with first, second and third generation devices

OBJECTIVES The purpose of this study was to assess safety and effectiveness of the fourth generation buttoned device in closing atrial septal defects (ASDs) and to test the hypothesis that introduction of double button reduce s unbuttoning rate without reducing effectiveness. BACKGROUND Because of the high unbuttoning rate (7.2%) with first, second a nd third generation buttoned devices, the device was modified (fourth gener ation) so that there were two radiopaque spring buttons 4 mm apart on the b utton loop attached to the occluder. METHODS During a four-year period ending in September 1997, 423 patients, a ges 1.5 to 80 years (median 16 years), underwent closure of ASD at 40 medic al centers around the world. RESULTS The ASD size varied between 5 and 30 mm (median 17 mm). The device size varied between 25 and 60 mm. Unbuttoning occurred in 4 (0.9%) of 423 p atients. Effective occlusion, defined as no (n = 343) or trivial (n = 34) r esidual shunt on echo-Doppler studies performed within 24 h of the procedur e, was demonstrated in 377 patients (90%). Thus, the unbuttoning rate (0.9 vs. 7.2%) decreased (p < 0.01) while effective occlusion rate (90 vs. 92%) remained unchanged (p > 0.1) with this device, compared with earlier genera tion devices. During follow-up from one month to five years (23 +/- 15 mont hs), 21 (5%) of 417 patients required surgical (n = 12) or transcatheter (n = 9) reintervention, mostly to treat significant residual shunt. In the re maining patients there was gradual reduction and disappearance of the resid ual shunt. No wire integrity problems were observed. CONCLUSIONS These data suggest that the fourth generation buttoned device i s as effective as earlier generation devices, but without significant unbut toning. Follow-up results remained good, with a reintervention-free rate of 89% at five years. (C) 2000 by the American College of Cardiology.