The American journal of cardiology
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Multicenter Study Clinical Trial
Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial).
A clinical trial was conducted of the buttoned device for transcatheter closure of ostium secundum atrial septal defect. Occlusion was attempted in 57 patients aged 1 to 62 years (median 5). The procedure was abandoned in 7 patients after 1 or more unsuccessful attempts, and devices were released in 50 patients. ⋯ An episode of asymptomatic atrial flutter was noted in a 46-year-old patient which may have been related to device implantation, but which has not recurred. There have been no cases of endocarditis or thromboembolism in 350 patient-months of follow-up. The buttoned device provided effective closure of the atrial septal defect in 45 of 57 patients (79%) in whom implantation was attempted and in 45 of 46 patients (98%) in whom device implantation was successfully accomplished.(ABSTRACT TRUNCATED AT 250 WORDS)