3
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.
Figure 2. Balloon alignment
Figure 3. Minimum diameter measurement
