Prospective Randomized Trial of Transthoracic Echocardiography Versus Transesophageal Echocardiography for Assessment and Guidance of Transcatheter Closure of Atrial Septal Defects in Children Using the Amplatzer Septal Occluder

Abstract

This study sought to determine whether transthoracic echocardiography (TTE) can provide safety and efficacy equivalent to transesophageal echocardiography (TEE) for assessment and guidance of transcatheter atrial septal defect (ASD) closure in pediatric patients. We performed a prospective randomized trial of ASD closure using the Amplatzer septal occluder (ASO) from March 2008 to April 2012. Inclusion criteria were isolated secundum ASD, age 2 to 18 years, and adequate TTE windows. Forty patients were enrolled and randomized to either TEE or TTE. In the TEE group, we used "stop flow" balloon sizing to determine device size. In the TTE group, we used the average ASD diameter times 1.2 (scaled). Patients were followed up to 1 year. Patient general and hemodynamic characteristics were similar in both groups. Procedural success was 100% in both groups. The average TEE stop flow diameter was similar to the scaled TTE diameter (15.35 ± 4.62 mm vs. 16.57 ± 5.47 mm; p = 0.46). Device size (16.0 ± 4.94 mm vs. 16.37 ± 5.05 mm, p = 0.82) and ratio of device to defect size (1.0 ± 0.06 vs. 0.99 ± 0.03, p = 0.52) were also similar. Total procedure (70.6 ± 22.98 min vs. 51.1 ± 17.61 min, p = 0.005), room (126.8 ± 28.41 min vs. 95.7 ± 20.53 min, p = 0.0004), and fluoroscopy (13.6 ± 6.17 min vs. 8.9 ± 8.45 min, p = 0.007) times were all significantly shorter in the TTE group. Neither group had significant complications during the procedure nor in follow-up. Rates of shunt resolution were similar between groups. This study suggests that in selected pediatric patients, use of TTE is as efficacious and safe as TEE for assessment and guidance of ASD occlusion using the ASO. TTE also may offer the additional safety benefit of reduced fluoroscopy exposure.