Off-label use of Amplatzer devices in congenital heart disorders during childhood.

BACKGROUND

Certain medical devices used to treat congenital cardiac lesions in the cardiac catheterization laboratory are used on an off-label and non-routine basis. This article discusses the non-routine use of Amplatzer medical devices.

METHODS

In a retrospective study, from November 2006 to December 2011, Amplatzer devices used in our paediatric cardiology ward were reviewed.

RESULTS

Children (n = 436) were catheterized to close their defects (438 defects) using Amplatzer devices. The mean age and body weight of the patients were 5.87 +/- 4.2 years and 20.8 +/- 13.6 kg. On-label devices were used for 421 patients (96.1%) and off-label devices for 17 patients (3.9%). The off-label use indications and used devices were the Amplatzer septal occluder (aortopulmonary window closure), the muscular ventricular septal occluder (perimembranous ventricular septal defect occlusion, patent ductus arteriosus occlusion, and right pulmonary artery to left atrium fistulous connection closure), the vascular plug (coronary fistula occlusion, left ventricle pseudoaneurysm occlusion, atypical patent ductus arteriosus occlusion, and anomalous pulmonary venous drainage occlusion), and the ductal occluder (ventricular septal defect occlusion). These devices were successfully implanted in exclusively extraordinary, difficult, or extreme cases.

CONCLUSIONS

The use of a medical device outside of its approved purpose is commonly referred to as "off-label use". This study showed that the issue of off-label, non-routine use of devices exists in paediatric cardiology. Furthermore, the percutaneous closure of defects with non-routine Amplatzer devices is safe and effective, with a high success rate and a high follow-up term outcome.