Outcomes After Transcatheter Closure of Atrial Septal Defect Without Using a Balloon-Sizing Technique: A Randomized Controlled Comparison with Closures Using a Balloon-Sizing Technique.

ABSTRACT

BACKGROUND: The transcatheter closure of atrial septal defect could be completed without the balloon-sizing technique, so we evaluated long-term outcomes compared with closure using balloon sizing, which was the conventional method. Even without using the balloon-sizing technique, transcatheter closure of atrial septal defect might be safe and effective. METHODS: We included 124 patients with isolated atrial septal defects who underwent device closure without balloon sizing between 2012 and 2016, and we further included 257 patients as a control group. Patients who received closure with multiple devices or who experienced postoperative residual defects were excluded. Immediate procedural results, as well as long-term outcomes for closure without balloon sizing, were investigated and compared with the control group. RESULTS: The procedural success rate was 96.7%, and there were no mortalities. No embolization or cardiac erosions were observed; however, one patient experienced residual shunt, and another developed progressed mitral regurgitation during the follow-up period (983±682 days). Newly onset persistent atrial fibrillation developed in one patient (1.0%). There were no significant differences in procedures or follow-up between the study and control groups. Despite the shorter procedural time in the study group, fluoro time was not different. Atrial arrhythmias were more frequently observed in the control group, but the difference was not significant. Persistent atrial fibrillation was observed in two patients in the control group (0.8%). CONCLUSIONS: Transcatheter closure of atrial septal defect can be performed safely and effectively without using the balloon-sizing technique. The long-term outcomes were similar to outcomes with balloon sizing.