Safety and Long-Term Outcome of Modified Intracardiac Echocardiography-Assisted "No-Balloon" Sizing Technique for Transcatheter Closure of Ostium Secundum Atrial Septal Defect

Background: The need for sizing the secundum atrial septal defect (ASD) with the balloon sizing technique is still debated at least in adult patients. We sought to prospectively evaluate the effectiveness of intracardiac echocardiography (ICE)-aided sizing technique for transcatheter closure of secundum ASD, without using a balloon sizing. Methods: In a prospective 5-year registry, we enrolled 81 patients (mean age 48 +/- 13.7 years, 54 females) who had been referred to three different centers for catheter-based closure of secundum ASD. Eligible patients underwent ICE study and closure attempt. In a preliminary group of 21 patients, sizing balloon was performed under ICE guidance to assess the value of rim thickness necessary for device anchorage. In the remaining 60 patients, the retrieved value of the rim thickness was measured on ICE and used as key points to measure the defect and select the device. Results: In the preliminary group of patients, the value of thickness at point of initial deflection by the balloon was 1.23 +/- 0.1 mm. ASD diameter in the study group was measured at the point of rim with at least 1.2 mm and the mean ASD diameter was 26.2 +/- 10.1 mm. Rates of procedural success, predischarge occlusion, and major complications rate were 100%, 93.3%, and 0%, respectively. On mean follow-up of 5.4 +/- 1.8 years, the occlusion rate was 98.7% with no long-term complications. Conclusions: Our novel ICE-sizing technique appears to be safe and effective in adult patients, thus eventually minimizing overestimation, costs, and potential complications of balloon sizing. (J Interven Cardiol 2012;25:628634)