3
• Patient Selection
Certain patients may be at higher risk for complications such as tissue erosion and device
embolization. If higher-risk patients have devices implanted, closer follow-up is warranted
(see the Post-Procedure Instructions section). Higher risk patients include:
- Patients with deformation of the device at the aortic root.
- Patients with high defects (minimal aortic and superior rims).
- Patients with IVC rim deficiency (risk of device embolization).
Patients with multiple ASDs
Closure of multiple ASDs should only be attempted by physicians who have gained
sufficient experience (more than 10–15 cases) to undertake more technically
challenging procedures.
- If 2 large ASDs are separated by more than a 7 mm rim of tissue implantation of 2
devices may be justified.
- If multiple fenestrations are close to each other, one device may be used to cover all
defects when placed in the largest defect.
• Use in specific populations
- Pregnancy – care should be taken to minimize the radiation exposure to the fetus and
the mother.
- Nursing mothers – there has been no quantitative assessment of the presence of
leachables in breast milk.
• MR Conditional
1
Through non-clinical testing, AMPLATZER™ devices have been shown to be MR
Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely
immediately after placement of the device under the following conditions:
- Static magnetic field of 3 T or less
- Spatial gradient magnetic field of 720 G/cm or less
- Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of
3 W/kg for 15 minutes of scanning
During testing, the device produced a clinically non-significant temperature rise at a
maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/
kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.
MR image quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the device. Therefore, optimization of MR imaging
parameters to compensate for the presence of this device may be necessary.
Adverse Events
Observed Adverse Events – Tissue Erosion
Tissue erosion refers to the erosion or abrasion of the tissue of the atrium, primarily in the area of
the roof of either or both atria, and or the adjacent aortic root (non-coronary sinus). The estimated
incidence of tissue erosion based on retrospective meta-analyses has been reported in literature
to be as high as 0.1 to 0.3%.
2
Tissue erosion, while rare, is a surgical emergency due to the
impending risk or the actual occurrence of hemodynamic instability resulting from cardiac
tamponade, and may lead to severe morbidity or death. Absence of the retro-aortic rim and device
oversizing may be associated factors relating to the incidence of erosion.
1. MR Conditional as defined in ASTM F 2503-05.
2. Crawford GB, Brindis RG, Krucoff MW, et al. Percutaneous atrial Septal Occluder devices and
cardiac erosion: A review of the literature. Article first published online: 2 MAY 2012. DOI: 10.1002/
ccd.24347
100092311_ASD.book Page 3 Monday, January 6, 2014 11:00 AM
