Amplatzer Amulet Gebrauchsanweisung Seite 12

100105566_Amulet.book Page 5 Tuesday, May 20, 2014 1:05 PM
25. Continue to deploy the lobe by pushing the cable forward and/or pulling the sheath back.
Stop when the lobe is fully deployed within the left atrial appendage at the intended
landing zone.
CAUTION: Do not advance the delivery cable or the sheath after the lobe is fully
deployed.
26. The device lobe should be perpendicular with the axis of the left atrial appendage at the
intended landing zone (see F4).
27. Maintain a slight tension on the delivery cable while retracting the delivery sheath to
expose the disc (see F4). The device disc should cover the orifice. Do not leave a gap
between the orifice and the disc (see F5).
28. Confirm proper device placement using echocardiography and fluoroscopy. Indications of
proper device placement include:
- The orientation of the device lobe must be consistent with the axis of the intended
landing zone in the left atrial appendage (see figures F4–F6).
- The device lobe should be slightly compressed and have good apposition to the left
atrial appendage wall.
- The disc will have a concave shape.
- The disc must be separated from the lobe (see F4).
- At least 2/3 of the device lobe should be distal to the left circumflex artery on
echocardiography (see F6).
29. If device repositioning is required:
- Partially recapture the device by pulling the delivery cable to retrieve the disc and part
of the lobe while readvancing the delivery sheath until the platinum thread marker is
aligned with the distal edge of the delivery sheath's marker band (see F3). Do not
retract the device any farther to prevent damaging the delivery sheath.
WARNING: If the device is retracted farther than the radiopaque markers, do not
readvance the device or perform injections. The device and the delivery sheath must
both be removed and replaced.
- Reposition and redeploy the device (see steps 23–28).
Note: The device can be partially recaptured and redeployed a maximum of 3 times. If the
device position is still unsatisfactory, then remove and replace both the device and the
sheath.
30. Perform echocardiography and fluoroscopy to confirm that the device is in place.
31. When proper device placement is confirmed the device may be released:
- Detach the device by turning the delivery cable/delivery cable vise counter-clockwise.
CAUTION: Do not exceed 8 rotations. If difficulty occurs while attempting to release the
device, stop and release the built up tension. Advance the cable until it is perpendicular
with the device and attempt to release.
32. Remove the delivery cable and delivery sheath from the patient.
33. Perform echocardiography and fluoroscopy to confirm that the device remains in place.
Device Reloading Procedure
34. Insert loading cable through the distal loader tip.
35. Attach distal end screw to loading cable.
36. Rotate the loading cable vise clockwise until resistance is felt, ensuring that the loading
cable is secured to the device.
37. Immerse the device and hub end of loader in sterile saline to remove air from both
components.Device may be massaged to help remove air.
38. Pull the loading cable vise until the lobe is fully retracted within the loader, but stop before
the disc is loaded.
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