CANINE ASD DEVICE

IMPORTANT: Device Selection is based on the balloon measured diameter of the defect (i.e., a 10 mm defect will require a 10 mm device).

Device Size (Diameter of ASD)	Recommended Delivery system
4 mm	6 French, 45º Curve
5 mm	6 French, 45º Curve
6 mm	6 French, 45º Curve
7 mm	6 French, 45º Curve
8 mm	6 French, 45º Curve
9 mm	6 French, 45º Curve
10 mm	6 French, 45º Curve
11 mm	7 French, 45º Curve
12 mm	7 French, 45º Curve
13 mm	7 French, 45º Curve
14 mm	7 French, 45º Curve
15 mm	7 French, 45º Curve
16 mm	7 French, 45º Curve
17 mm	7 French, 45º Curve
18 mm	8 French, 45º Curve
19 mm	8 French, 45º Curve
20 mm	9 French, 45º Curve
22 mm	9 French, 45º Curve
24 mm	9 French, 45º Curve
26 mm	10 French, 45º Curve
28 mm	10 French, 45º Curve
30 mm	10 French, 45º Curve
32 mm	12 French, 45º Curve
34 mm	12 French, 45º Curve
36 mm	12 French, 45º Curve
38 mm	12 French, 45º Curve
40 mm	12 French, 45º Curve

Implanting the Septal Occluder

This section outlines the basic steps of the suggested procedure for implanting an AMPLATZER Septal Occluder.

1. Patients should be fully heparinized throughout the procedure with a minimum active clotting time (ACT) of 200 seconds prior to device insertion.
   
   
2. Following percutaneous puncture of the femoral vein, perform a standard right heart catheterization.
   
   
3. Perform an angiogram in order to demonstrate the atrial communication. Catheterize the left atrium using a 45° LAO position and cranial angulation 35-45°, inject contrast medium into the right upper lobe pulmonary vein.
   
   
4. Introduce a .035” exchange “J” tip guidewire into the left atrium. Insert a compliant balloon catheter over the exchange wire into the left atrium and determine the diameter of the defect.
   
   
5. Sizing the defect:
   
   Using a balloon specifically designed for sizing atrial communications (i.e. AMPLATZER Sizing Balloon) the catheter is passed over the exchange guidewire directly through the skin. To facilitate this percutaneous entry, an assistant should apply forceful negative pressure with an attached syringe. Under fluoroscopic and echocardiographic guidance, the balloon catheter is placed across the defect and inflated with diluted contrast medium until the left-to-right shunt ceases as observed by echocardiography the balloon is deflated until flow is seen, and then re-inflated until the shunting ceases. Measurements can then be made using echocardiographic imaging, fluoroscopy or by using the sizing plate.
   
   WARNING: Do not inflate the balloon beyond the "stop flow" point or beyond the balloon's maximum inflation volume. Inflation beyond the stop flow point may cause distention of the defect (resulting in inaccurate sizing of the defect) and/or balloon damage.
   
   NOTE: A waist in the balloon could appear without the cessation of flow. This would occur if there is more than one ASD. Sizing should occur based on stop-flow, not just the appearance of a waist.
   
   NOTE: Always refer to the Instructions for Use that accompany each balloon catheter to insure that the recommendations of the manufacturer are followed.
   
   
6. Once the diameter of the defect has been determined, select an occlusion device equal or, if the identical size is not available, slightly larger than the defect. Therefore, the device should be stenting the defect.
   
   
7. Remove the balloon catheter leaving the .035” exchange guidewire in place.
   
   
8. Pass the delivery cable through the loader and screw the device to the tip of the delivery cable. Once securely attached, immerse the device and loader in saline solution and pull the device into the loader with a jerking motion. Flush via the side arm of the loader.
   
   
9. Insert the dilator into the delivery sheath and secure to the sheath with the locking mechanism. Introduce the dilator/delivery sheath assembly through the groin. Once the delivery sheath has reached the inferior vena cava, remove the dilator to allow back bleeding to purge all air from the system then connect the hemostasis valve and flush with a syringe before the left atrium is entered.
   
   WARNING: Always use the luer lock adapter when connecting the hemostasis valve to the sheath when using the 12 French delivery system.
   
   
10. Advance the sheath over the guidewire through the communication into the left upper pulmonary vein. Verify the correct position of the delivery sheath by a test hand injection of contrast medium or by echocardiography. Remove the exchange wire and flush the sheath with saline.
    
    
11. Attach the loading device to the delivery sheath. Advance the device into the sheath by pushing (not rotating) the delivery cable.
    
    
12. Under fluoroscopic and echocardiographic guidance, deploy the left atrial disc and part of the connecting waist and pull the device gently against the atrial septum, which can be felt and also observed by ultrasonography. With tension on the delivery cable, pull the sheath back and deploy the right atrial disk. Pull the sheath back by approximately 5-10 cm. A gentle “to and fro” motion with the delivery cable assures a secure position across the atrial septal defect, which can also be observed by ultrasound.
    
    
WARNING: Do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.


13. Confirm correct placement. If device placement is unsatisfactory or if the device does not reconfigure to its original shape, retract the device into the sheath and redeploy or replace with a new device.
    
    
14. Release the device. Attach the plastic vise to the delivery cable by tightening the screw on the vise. Release the device by rotating the vise counterclockwise as indicated by the arrow. In the unlikely event that this should not be possible, advance the sheath against the right atrial disc to secure the device, which will facilitate detachment.