Intermediate-term results of Phase I Food and Drug Administration Trials of buttoned device occlusion of secundum atrial septal defects

Steele Memorial Children's Research Center, and Department of Pediatrics (Cardiology), University of Arizona, Tucson, USA. rzamora@peds.arizona.edu

OBJECTIVES: This study was conducted to evaluate the intermediate-term results of the multi-institutional U.S. trial of the buttoned device for transcatheter closure of atrial septal defects (ASDs). BACKGROUND: The trial was conducted in three centers (University of Arizona, University of Michigan and University of Wisconsin) under a Food and Drug Administration (FDA)-approved clinical trial with investigational device exemption. Only short-term follow-up is known. METHODS: All 46 patients who had successful implantation of the device were prospectively followed up. Patients were evaluated at 1, 6 and 12 months after device occlusion and yearly thereafter. RESULTS: This cohort was followed up from 51 to 68 months (mean 60.8, median 62). Patient ages ranged from 1 to 62 years (median 4); weights ranged from 10 to 105 kg (median 18); and stretched ASD sizes were 14 +/- 4 mm (left to right shunts) and 10 +/- 3 mm (right to left shunts). Of the 46 patients, 45 (98%) had effective occlusion of their ASD, and 34 (74%) had complete ASD closure. The incidence of residual shunts decreased from 65% (30 of 46 patients) at 1 month after device placement to 27% (12 of 45 patients) at last follow-up. All residual shunts were quantitated as trivial. Only two patients (4%) required reintervention for significant residual defects. There were no cases of endocarditis or thromboembolism in 224 patient-years of follow-up. CONCLUSIONS: In up to 5.5 years of follow-up, the buttoned device provided effective closure in 98% of patients in whom the device was successfully implanted. The incidence of residual shunts decreased during follow-up, and no instances of endocarditis or thromboembolism were observed.

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