AGA AMPLATZER Gebrauchsanweisung Seite 5

Description
9-SB-018
9-SB-024
9-SB-034
Description
9-SB-018
9-SB-024
9-SB-034
Procedure
Carefully inspect the sterile pouch and verify that it is unopened and undamaged. Gently open the
sterile pouch and inspect the balloon catheter prior to use to verify that it is undamaged. Slowly
slide the protective cover off the balloon segment. Avoid acute bends or kinking of the AMPLATZER
Sizing Balloon II during removal from the packaging.
The procedure will vary according to the type of occlusion or measurement to be performed.
Because of the ultra thin plastic membrane, dilatation of the entry site is not necessary. For the
measurement of secundum atrial septal defects, the following steps are recommended:
1. Inflate the balloon with saline solution and purge the air in a position as shown in Figure 1 or
inflate with CO2 and aspirate. Flush the other lumen with heparinized saline.
2. Manipulate a 0.035 inch stiff exchange wire into the left upper lobe pulmonary vein. Introduce
the balloon catheter over the guidewire.
3. Introduce the balloon catheter over the exchange wire transcutaneously.
4. Advance the collapsed balloon through the defect. Position the sizing catheter to center the
balloon in the communication.
5. Partially inflate the balloon with contrast medium (diluted 3:1 or 4:1).
6. Observe the patient in a shallow left anterior-oblique position without cranial angulation.
7. Gradually move the imaging source to visualize the 0.4mm space between the pair of marker
bands in the center of the balloon (Figure 2). This aligns the imaging source with the balloon to
achieve the best angle for size measurement.
8. Inflate the balloon until the right-to-left shunt ceases and a stop-flow condition is observed
by Doppler observation. Slightly deflate the balloon, and gradually re-inflate to the minimum
balloon diameter that achieves a stop-flow condition. A minimal balloon "waist" may or may not
be present.
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.
9. Using echocardiography, adjust the image for best visualization, and measure the minimum
diameter between the septal wall contact points with the balloon (Figure 3). If a balloon waist is
detected, radiographic measurement may also be used to confirm defect diameter.
10. Forcefully aspirate all of the contrast medium and then remove the balloon catheter.
Proceed with recommended implantation protocol for the device.
Maximum Defect
Size (mm)
20
27
40
Shaft Size
(Fr)
6.0
7.0
8.0
Maximum Inflation
Volume (cc)
12
25
90
Usable Length
(cm/mm)
70/700
70/700
70/700
2 2
Balloon Length
(cm/mm)
3.5/35
4.5/45
5.5/55
Guidewire
(in)
0.035
0.035
0.035