Contraindications - PFM Medical Nit-Occlud Le VSD Mode D'emploi

English
Image Artefacts:
In non-clinical testing according to ASTM F2119-07 in a GE Excite HDx 3.0T system (General Electric Healthcare, Milwaukee,
WI), software version 14X.M5 with whole body RF send/receive coil, the following image artefacts were detected:
1. l ocalized signal void extending max. 5mm over the actual size of the device for a T1-weighted spin echo (SE) pulse
sequence (repetition time 500 msec; echo time 20 msec; matrix size 256 X 256; section thickness 10 mm; field of view
24 cm; number of excitations 2; bandwidth 16 kHz)
2. l ocalized signal void extending max. 10mm over the actual size of the device for a gradient echo (GRE) pulse sequence
(repetition time 100 msec; echo time 15 msec; flip angle 30 degrees; matrix size 256 X 256; section thickness 10 mm;
field of view 24 cm; number of excitations 2; bandwidth 16 kHz)
Indication
Interventional occlusion of haemodynamically significant ventricular septal defects using catheter techniques. Ventricu-
lar septal defects are considered haemodynamically significant if transthoracic echocardiography shows enlargement of
the left heart chambers.

Contraindications

Pathological or physical conditions precluding the implantation of a Nit-Occlud® Lê VSD coil, such as:
• The distance between the rim of the VSD and the aortic annulus is at least 3.0 mm
• The minimum diameter of the VSD on its right-ventricular side is bigger than 8.0 mm, measured with echocardiography.
• The patient is younger than 12 months
• Associated cardiac anomalies requiring surgery
• Active endocarditis or active infection at time of implantation
• Thrombus near the intended implantation site
• T hrombus in a vessel through which access to the VSD is gained (unless the patient is protected with an embolic
protection device such as a vena cava filter).
• Vessels through which access to the VSD is gained cannot accommodate a sheath of 6 F resp. 7 F size.
• Potential spatial interference of intracardiac or intravascular structures by the device
• History of haemorrhagic diseases (coagulopathy, tendency towards haemolysis)
• History of hypersensitivity to contrast medium or nickel
• 2nd or 3rd degree AV block, atrial fibrillation, or atrial flutter
• Signs of a pulmonary vascular resistance greater than 4 Wood units
*An exception from this contraindication is the occlusion of a perimembraneous VSD with a pronounced aneurism; the ad-
herence to a certain clearance from the aortic valve is not compulsory in this case. The selected coil is to fill out the aneurism
in this case with it protruding into the left-ventricular outflow tract (LVOT)..
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