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Off-label use of Amplatzer devices in congenital heart disorders during childhood
Osman Baspinar1, Ahmet Irdem, Metin Kilinc
1Gaziantep University, Medical Faculty, Department of Pediatric Cardiology, Gaziantep, Turkey. osmanbaspinar@hotmail.com
Insights
Off-label use of Amplatzer devices in pediatric cardiology is common for complex congenital heart defects. This retrospective study confirms that non-routine Amplatzer device use is safe and effective.
Area of Science:
- Cardiology
- Medical Devices
- Pediatric Cardiac Interventions
Background:
- Medical devices for congenital cardiac lesions are sometimes used off-label.
- This article focuses on the non-routine application of Amplatzer devices.
Purpose of the Study:
- To investigate the non-routine use of Amplatzer devices in pediatric cardiology.
- To assess the safety and efficacy of off-label device implantation.
Main Methods:
- A retrospective review of Amplatzer devices used in a pediatric cardiology ward from November 2006 to December 2011.
- Analysis of patient demographics, defect types, and device usage (on-label vs. off-label).
Main Results:
- 436 children underwent catheterization for 438 defects using Amplatzer devices.
- Off-label use occurred in 3.9% of cases for complex indications like aortopulmonary window and various septal defects.
- Devices were successfully implanted in challenging and extraordinary cases.
Conclusions:
- Off-label use of medical devices is a recognized issue in pediatric cardiology.
- Percutaneous closure of congenital heart defects using non-routine Amplatzer devices demonstrates high safety and effectiveness.
- Successful long-term outcomes were observed with non-routine device implantation.
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.
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