Indications and Usage
The AMPLATZER® Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of Atrial Septal Defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.
Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (ie, 1.5:1 degree of left to right shunt or RV enlargement).
Contraindications
- Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
- Any patient known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
- Any patient known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
- Any patient whose size (i.e., too small for TEE probe, catheter size, etc) or condition (active infection, etc) would cause the patient to be a poor candidate for cardiac catheterization.
- Any patient known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
- Any patient where the margins of the defect are less than 5mm to the coronary sinus, AV valves or right upper lobe pulmonary vein.
Warnings
- Patients allergic to nickel may suffer an allergic reaction to this device.
- Do not use if the sterile barrier has been compromised in any way.
- The AMPLATZER® Septal Occluder and Delivery System should only be used by those physicians trained in transcatheter defect closure techniques.
- Physicians must be prepared to deal with urgent situations which require removal of embolized devices that result in critical hemodynamic compromise. This includes the availability of an on-site surgeon.
- Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
- Do not release the AMPLATZER® Septal Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
- The use of echocardiographic imaging is required (TTE, TEE, or ICE). Do not inflate the balloon beyond the cessation of the shunt (i.e., stop flow) or the visualization of a small waist in the balloon. DO NOT OVERINFLATE.
- Do not select a device size greater than 1.5 times the echocardiographic-derived ASD diameter prior to balloon sizing.
- Implantation of this device may not supplant the need for Coumadin in patients with ASD and paradoxical emboli.
Precautions
NOTE: The use of this device has not been studied in patients with patent foramen ovale.
Handling
- The AMPLATZER® Septal Occluder, Delivery System and TorqVue* Delivery System are for single use only. Do not reuse or resterilize.
Device Placement and Size Selection
- Device placement should only be done with the assistance of TEE or similar imaging equipment (ie, intracardiac echocardiography).
- Device size selection should be the same size or one size larger than the diameter of the defect.
Procedural
- Aspirin (3-5 mg/kg/day) is to be started at least 24 hours prior to the procedure. In the rare case of aspirin intolerance, two times 200 mg of Ticlopidin are given. Cephalosporin therapy is optional.
- Patients should be fully heparinized throughout the procedure with a minimum active clotting time (ACT) of 200 seconds prior to device insertion.
- Transesophageal echocardiography (TEE) or similar imaging equipment (ie, intracardiac echocardiography) is recommended as an aid in placing the AMPLATZER Septal Occluder. If TEE is used, the patient’s esophogeal anatomy must be adequate for placement and manipulation of the TEE probe.
Post-Implant
- All patients should be kept overnight for observation. A transthoracic echocardiogram (TTE) should be performed prior to discharge.
- Patients with any observed small pericardial effusion following device implantation should be closely monitored with serial echocardiograms performed until resolution of the pericardial effusion.
- Higher risk patients (identified in the Patient Selection section) should be followed more closely, including the following:
- Clinical follow-up with echocardiogram one (1) week following device implantation.
- Education of patients about the higher risk and the need for echocardiography with symptoms (i.e., chest pain or shortness of breath).
- Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
- Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post implant. The decision to continue antiplatelet/-anticoagulation therapy beyond 6 months is at the discretion of the physician.
MR Conditional1
- 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.
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.
1 MR Conditional as defined in ASTM F 2503-05