PFM Medical Nit-Occlud Le VSD Mode D'emploi page 13

WA R N I N G S
If a strong resistance is felt while pulling the system back into the implantation catheter, never tug
forcefully on the delivery system. This could cause premature release of the coil.
If a Nit-Occlud® Lê VSD coil is incorrectly positioned, pull it back into the implantation catheter and
repeat the implantation procedure. The coil may sometimes detach unexpectedly from the catheter,
creating an embolism. If this happens, the first option is an attempt to remove the coil with a snare
loop. If this is not successful, the patient should be fully heparinised and transferred to the opera-
tion theatre for an explantation operation. The operative closure of the ventricular septal defect can
then be carried out at the same time.
Never attempt to connect a detached coil with the delivery system.
❼
Coil Release
• F ollowing confirmation of the correct and stable config-
uration of the coil in the defect with ultrasound and an
angiogram, the release mechanism may be activated.
• F or this purpose, first remove the red safety pin by pull-
ing it pulling it off the the handle, single use only.
• ( Fig. 13) Then turn the blue handle / or blue hand grip
under fluoroscopic monitoring, until the coil detaches
from the delivery system.
• R emove the delivery system and implantation catheter,
and check that all components are present.
• F inally, take an angiogram and echogram of the left
ventricle and aorta to check and document the position
of the coil and the effectiveness of the occlusion.
• Remove the angiography catheter.
WA R N I N G
The catheter must not come into contact with the coil.
Closure of Muscular VSD
Preparation of Access via the Right Jugular Veins
Preparation is essentially the same as for perimembranous VSDs. Occasionally, it may be possible to probe the defect
from the right-ventricular side, but it will often be necessary to place an arteriovenous wire splint of the usual type. For
the closure of a muscular VSD, the tips of both the implantation catheter and the long sheath are positioned directly on
the ventricular septum on the left-ventricular side. The implantation catheter should protrude by approx. 3–5 mm. The
release of the coil must be performed well away from the mitral valve and papillary muscles or cords. Under fluoroscopic
monitoring, push the Nit-Occlud® Lê VSD coil out from the implantation catheter, using the metal cannula and single-
hand control, as far as the last two proximal windings. A further check on the number of windings released is provided by
the markings (Fig. 11). If the M2 marking is at the baseline point (bp), all but two windings have been released. Then pull
the complete system (long sheath and implantation catheter) back to cause the configured coil to adapt to the contours of
the defect (Fig. 13). Slowly pull the implantation catheter out of the left ventricle and into the right ventricle, simultane-
ously releasing the remaining 1–2 coil windings. Under fluoroscopic monitoring, and using the markers (Fig. 11), it is now
possible to check whether all windings have been released (Fig. 14 / 15).
GA053/Rev02_2019-04-18
Fig. 13: Coil release
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