Transcatheter closure of muscular ventricular septal defects with the Amplatzer ventricular septal defect occluder: Initial clinical applications in children

OBJECTIVES The aim of this study was to close muscular Ventricular septal d efects (MVSDs) in children, with a new device, the Amplatzer ventricular se ptal defect occluder (AVSDO). BACKGROUND The design of previously used devices for transcatheter closure of MVSDs is not ideal for this purpose and their use has been limited by se veral drawbacks. METHODS Six patients, aged 3 to 10 years, with;MVSDs underwent transcathete r closure using the AVSDO. The device is a modified self-centering and repo sitionable Amplatzer device that consists of two low profile disks made of Nitinol wire mesh with a 7-mm connecting waist. The prosthesis size (connec ting waist diameter) was chosen according to the measured balloon stretched VSD diameters. A 6-F or 7-F sheath was used for the delivery of the AVSDO. Fluoroscopy and transesophageal echocardiography were utilized for optimal guidance. RESULTS The location of the defect was midmuscular in five patients and ben eath the pulmonary valve in one. The balloon stretched MVSD diameter ranged from 6 to 11 mm. Device placement was successful in all patients, and comp lete occlusion occurred in all six patients (95% confidence interval 54.06% to 100%). Two patients developed transient complete left bundle branch blo ck. No other complications were observed. CONCLUSIONS This encouraging initial clinical success indicates that the AV SDO is a promising device for transcatheter closure of MVSDs in children. F urther clinical trials and longer follow-up are needed before the widesprea d use of this technique can be recommended. CT Am Coil Cardiol (C) 1999 by the American College of Cardiology.