PFM Medical Nit-Occlud Le VSD Mode D'emploi page 12

English
A s the system passes through the aortic valve, it is important to ensure that the coil retains its configuration, to
prevent any "accordion" effect. If the coil does lose its optimum configuration as it passes through the aortic valve, it
is recommended to pull the coil back into the implantation catheter in the vicinity of the ventricular septum. Then,
attempt to configure the coil in the left-ventricular outflow tract, close to the septum.
In some cases, the deployed coil may become caught on the aortic valve as it passes from the ascending aorta into the left
ventricle. In this situation, it is most important to first push the tip of the long sheath into the left ventricle. This makes
it easier to advance the implantation catheter, so that the coil can be released from the aortic valve. From this point, there
are two possible scenarios:
• T he implantation catheter and deployed coil are pushed back into the ascending aorta. Another passage from the
ascending aorta into the left ventricle can then be attempted.
• T he implantation catheter and deployed coil fall or tip over into the left ventricle. It is then possible to position the coil
carefully in the defect.
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Final Configuration of the Coil
• R echeck the coil position and size once more. If the released windings are well embedded in the VSD, push the proxi-
mal windings out of the implantation catheter so that they can apply themselves against the right-ventricular side of
the defect. The release manoeuvre should be performed as follows: slowly pull the implantation catheter out of the left
ventricle into the right ventricle, simultaneously releasing the remaining 1–2 coil windings. Under fluoroscopic moni-
toring, and using the markers (Fig. 11), it will now be possible to check whether all the windings have been released. It
is most important to ensure that the tip of the long sheath remains close to the right-ventricular opening of the VSD
during this manoeuvre, to avoid any interference or entanglement problems for the coil from the tricuspid valve.
• C orrect positioning can be checked with repeated injections of contrast agent via a pigtail catheter placed close to the
coil during the implantation procedure.
WA R N I N G
In the event of incorrect coil positioning, configuration, or selection, the coil may be pulled back into
the implantation catheter prior to activation of the release mechanism, and repositioned, exchanged
or removed.
In some cases, too many windings may be released on the right-ventricular side during placement of the coil in the VSD.
These surplus windings may affect the tricuspid valve, frequently leading to a residual shunt. This is best prevented by
pulling the coil back into the implantation catheter and simultaneously pushing the implantation catheter through the
VSD back into the LVOT. The implantation procedure can then be repeated.
If it is not possible to advance the implantation catheter into the LVOT, the coil must be fully pulled back into the cath-
eter. If this also proves impossible, pull the coil and implantation catheter back into the long sheath.
WA R N I N G
Never proceed with release of the coil if the coil size or configuration is not correct!
Repositioning:
To reposition the coil, pull back the delivery system into the implantation catheter using the one hand implantation
device.
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