Sergio Bartakian1, Howaida G El-Said, Beth Printz, John W Moore. 1. Division of Cardiology, Department of Pediatrics, University of California, San Diego School of Medicine & Rady Children's Hospital, San Diego, California. Electronic address: nyyankeedr@yahoo.com.
Abstract
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVES: 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. METHODS: 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. RESULTS: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. CONCLUSIONS: 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.
Authors: Silvio Henrique Barberato; Minna Moreira Dias Romano; Adenalva Lima de Souza Beck; Ana Clara Tude Rodrigues; André Luiz Cerqueira de Almeida; Bruna Morhy Borges Leal Assunção; Eliza de Almeida Gripp; Fabio Villaça Guimarães Filho; Henry Abensur; José Maria Del Castillo; Marcelo Haertel Miglioranza; Marcelo Luiz Campos Vieira; Márcio Vinicius Lins de Barros; Maria do Carmo Pereira Nunes; Maria Estefania Bosco Otto; Renato de Aguiar Hortegal; Rodrigo Bellio de Mattos Barretto; Thais Harada Campos; Vicente Nicoliello de Siqueira; Samira Saady Morhy Journal: Arq Bras Cardiol Date: 2019-08-08 Impact factor: 2.000