OBJECTIVE: The development of the Amplatzer Membranous VSD Occluder (AGA Medical Corp, Plymouth, Minn) for closure of the perimembranous ventricular septal defect has ameliorated many of the technical difficulties of previous devices. Application of this new technology requires comparative evaluation with the current standard of surgical repair. We report our experience of complete heart block associated with device closure of a large perimembranous ventricular septal defect with unequivocal indications for intervention. METHODS: We performed a retrospective review of 20 patients between January 2003 and August 2005 who underwent perimembranous ventricular septal defect device closure, 18 with hemodynamically large shunts meeting the surgical criteria for intervention. The median age was 1.6 years (range, 0.5-16.2 years), and the median weight was 9.7 kg (range, 6.2-43 kg). RESULTS: Acute complete shunt occlusion was achieved in all patients. There were no acute procedural complications. The median follow-up time was 23.1 months (range, 1-37.8 months). Four (22%) had complete heart block at 17 days, 4.2 months, 8.8 months, and 37.5 months after implantation, respectively. No risk factors were identified for development of complete heart block, including age, weight, trisomy 21, preceding conduction abnormalities, perimembranous ventricular septal defect size related to body surface area or device size, and progressive device flattening. CONCLUSIONS: Device closure of large perimembranous ventricular septal defects in infants and children with the Amplatzer Membranous VSD Occluder resulted in excellent closure rates but an unacceptably high rate of complete heart block.
OBJECTIVE: The development of the Amplatzer Membranous VSD Occluder (AGA Medical Corp, Plymouth, Minn) for closure of the perimembranous ventricular septal defect has ameliorated many of the technical difficulties of previous devices. Application of this new technology requires comparative evaluation with the current standard of surgical repair. We report our experience of complete heart block associated with device closure of a large perimembranous ventricular septal defect with unequivocal indications for intervention. METHODS: We performed a retrospective review of 20 patients between January 2003 and August 2005 who underwent perimembranous ventricular septal defect device closure, 18 with hemodynamically large shunts meeting the surgical criteria for intervention. The median age was 1.6 years (range, 0.5-16.2 years), and the median weight was 9.7 kg (range, 6.2-43 kg). RESULTS: Acute complete shunt occlusion was achieved in all patients. There were no acute procedural complications. The median follow-up time was 23.1 months (range, 1-37.8 months). Four (22%) had complete heart block at 17 days, 4.2 months, 8.8 months, and 37.5 months after implantation, respectively. No risk factors were identified for development of complete heart block, including age, weight, trisomy 21, preceding conduction abnormalities, perimembranous ventricular septal defect size related to body surface area or device size, and progressive device flattening. CONCLUSIONS: Device closure of large perimembranous ventricular septal defects in infants and children with the Amplatzer Membranous VSD Occluder resulted in excellent closure rates but an unacceptably high rate of complete heart block.
Authors: Nora Lang; Maria J Pereira; Yuhan Lee; Ingeborg Friehs; Nikolay V Vasilyev; Eric N Feins; Klemens Ablasser; Eoin D O'Cearbhaill; Chenjie Xu; Assunta Fabozzo; Robert Padera; Steve Wasserman; Franz Freudenthal; Lino S Ferreira; Robert Langer; Jeffrey M Karp; Pedro J del Nido Journal: Sci Transl Med Date: 2014-01-08 Impact factor: 17.956