Transcatheter closure of perimembranous ventricular septal defects with the Amplatzer Vascular Plug-II.
OBJECTIVE
The aim of this study was to evaluate the safety and efficacy of the Amplatzer Vascular Plug-II used for the closure of perimembranous ventricular septal defects.


BACKGROUND
There are no FDA-approved transcatheter devices for the closure of perimembranous ventricular septal defects. Several studies have reported on the use of various devices either off-label or under clinical trial protocols. However these reports have described significant adverse events including residual shunts, complete heart block, arrhythmia, and new valve regurgitations. Thus far, no study on the Amplatzer Vascular Plug-II has been reported.


METHODS
We conducted a 4-year retrospective chart review from August, 2010 to August, 2014, of patients with perimembranous ventricular septal defects associated with ventricular septal aneurysm who underwent transcatheter closure using the Amplatzer Vascular Plug-II.


RESULTS
A total of 16 patients underwent Amplatzer Vascular Plug-II transcatheter closure of their perimembranous ventricular septal defects. The median age was 2.56 years (range: 0.5-27.3). Their median weight was 13.0 kg (range: 6.9-71.6). The left ventricular median defect size was 9.3 mm (range: 5.9-14.4). The right ventricular median defect size was 3.6 mm (range: 2.3-5.8). All the patients underwent successful device implantation with 83% of the patients having complete echocardiographic closure at the 1-year follow-up; however, one procedure was complicated by early device embolisation. The device was successfully retrieved and replaced with a larger device. There were no device-related outflow tract obstructions, rhythm abnormalities, or haemolysis.


CONCLUSIONS
Application of the Amplatzer Vascular Plug-II for closure of perimembranous ventricular septal defects appears to be a safe and effective treatment option. Prospective clinical trials and longer follow-up periods are warranted.
1UCSF Fresno Pediatric Residency Program,Fresno,California,United States of America.
Nancy
N
Hua
2Department of Cardiology and Cardiothoracic Surgery,Valley Children's Hospital,Madera,California,United States of America.
Paolo
P
Aquino
2Department of Cardiology and Cardiothoracic Surgery,Valley Children's Hospital,Madera,California,United States of America.
Carl Y
CY
Owada
D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006345:Heart Septal Defects, Ventricular / Q000000981:diagnostic imaging* / Q000601:surgery*; D006801:Humans; D007223:Infant; D008297:Male; D012189:Retrospective Studies; D055989:Septal Occluder Device / Q000592:standards*; D016896:Treatment Outcome; D055815:Young Adult
Paediatric interventions; congenital heart disease; transcatheter device closure