phenox p64 MW Instrucciones De Uso página 6

possible, be asked if they know what the presumed patient's will would be. Otherwise, in case of
emergency, the rules of emergency care for incapacitated patients apply, subject to different institutional
or national requirements.
3. Promptly take all measures necessary for suitable pretreatment with drugs to ensure the
inhibition of platelet aggregation.
Based on current knowledge, dual antiplatelet therapy when implanting the p64 MW (HPC) and similar
products is suitable for the prevention of thrombus formation caused by the implant. For this purpose,
100 mg of ASA and 75 mg of Clopidogrel can be administered orally every day for at least 3 days before
the planned intervention. Alternatively, 500 mg of ASA and 600 mg of Clopidogrel can be administered
orally as one-off doses on the day before treatment.
Preloading with high dosage might be less reliable than loading with the regular dosage for several days
in terms of protection against thrombus formation. High-dosage preloading may result in hyper-response
which may cause hemorrhagic complications (e.g., intracerebral and subarachnoid hemorrhage).
In vitro test results and anecdotal clinical experience demonstrate that the version p64 MW HPC
can provide a reduced surface thrombogenecity. If required and justified by individual circumstances,
the reduced thrombogenicity of p64 MW HPC may allow the implantation under single antiplatelet
medication. It is recommended to discuss this procedure with the patient and his or her legal
representatives. In this case, particular attention has to be paid to a pretreatment for at least three days
prior to the treatment. The achieved platelet inhibition is stronger by using P2Y12 inhibitors (Prasugrel,
Ticagrelor) than by using ASA.
If ASA is used as a single medication, 2 x 100 mg ASA PO daily (1-0-1) is recommended. If a P2Y12
receptor inhibitor is used, Prasugrel is apparently more efficacious than Clopidogrel and Ticagrelor.
Prasugrel might increase the risk of hemorrhagic complications if compared to Clopidogrel. If Ticagrelor is
used the short-acting time of this drug has to be considered. The regular dosage is 2 x 90 mg Ticagrelor
PO daily (1-0-1). Inconsistent intake of Ticagrelor is associated with an increased risk of thromboembolic
events.
The safety of the treatment is increased if the effective inhibition of platelet function is verified by means of
an appropriate test (e.g. Multiplate, VerifyNow, PFA) before the intervention. Regarding substitutes in case
of resistance to Clopidogrel and the use of Gp IIb/IIIa antagonists, we refer you to the respective current
scientific publications. See also chapter "Medication".
4. A CT or MRI examination of the cranium and, where necessary, the throat is advisable beforehand, in
order to ensure a comprehensive preliminary diagnosis.
5. The diagnostic angiography and endovascular treatment should be carried out under general anesthesia with
neuromuscular relaxation and invasive hemodynamic monitoring. During anesthesia, aim to maintain suitable
systolic blood pressure values.
6. After preparing both groins, a 6F or 8F catheter is inserted, preferably into the right femoral artery.
7. Then moderate heparinization should begin, which should also last for the duration of the intervention.
An intravenous dose of between 3000 and 5000 units of heparin has proven suitable in practice. Where
available, determining the ACT ("activated clotting time") is advisable.
8. Angiographic visualization of the internal and external carotid arteries on both sides and of the vertebral
artery on at least one side is recommended, along with the respective dependent vessels. Enlarged
images and, where necessary, oblique images of the affected vessel(s) are recommended.
9. The target vessel(s) for the endovascular treatment must be defined.
10. A 6F guide catheter or the combination of an 8F guide catheter and a suitable extension catheter or
distal access catheter is inserted into the afferent cervical vessel, taking steps to avoid vasospasm.
11. It is important that the implant is only inserted into target vessels of suitable size.
Measure the diameter of the target vessel, where the distal and proximal ends of the p64 MW (HPC) are
to be anchored, as accurately as possible.
Carefully observe and respect the specifications regarding the minimum and maximum vessel diameters
on the packaging, as well as the instructions regarding selection of a model of the correct size (see
Information on size selection). The length of the p64 MW (HPC) must be selected so that the implant
covers the lesion at the distal and proximal ends by at least a few millimetres.
Introduction of microcatheter
12. Never probe against resistance!
Insert a suitable microcatheter with a corresponding microguidewire into the target vessel using a
hemostatic valve and pressurized irrigation. Here, the use of so-called "road map" technology is
advisable. Aim to position the tip of the microcatheter 10–15 mm distal to the treatment target.
Once the target vessel treatment segment has been reached, carefully pull on the microcatheter
in order to remove any excess catheter length and straighten the catheter.
13. Remove the microguidewire from the microcatheter under X-ray fluoroscopy.
Preparation and introduction of p64 MW (HPC)
14. Take the sterile device in its dispenser snail out of the packaging. Release the proximal end of p64 MW
(HPC) and pull it together with introducer sheath out of the dispenser snail.
15. With the aid of a tight-closing hemostatic valve and under continuous pressurized irrigation with heparinized
physiological saline solution, the p64 MW (HPC) is transferred from its introducer sheath into the
microcatheter. For this purpose, the hemostatic valve is opened. The introducer sheath of the p64 MW
(HPC) is inserted through the open valve. The hemostatic valve is closed carefully and the introducer sheath
of the p64 MW (HPC) is flushed by retrograde entry of the irrigation fluid.
16. Once the introducer sheath of the p64 MW (HPC) is completely flushed in this manner, it is advanced
carefully until it reaches the distal end of the hub adapter of the microcatheter. The introducer sheath is
held fixed in this position. The p64 MW (HPC) is then advanced from the introducer sheath into the
microcatheter using the transport tube to which the implant is fixed. This process is continued until the white
Flourosafe Marker of the transport tube reaches the proximal end of the introducer sheath.
17. The introducer sheath is then pulled back proximally as far as the handle on the transport tube. (During
the further procedure the sheath stays on the delivery system.)
The p64 MW (HPC) is pushed further forward until the Flourosafe Marker of the Transport tube reaches
the entry of the hemostatic valve. This procedure does not need fluoroscopy because the Flourosafe
Marker identifies the position to which the device can be advanced without the device tip leaving the
microcatheter.
The process of inserting the p64 MW (HPC) generally corresponds to that of inserting other similar
implants. Should you encounter particular resistance which can only be overcome with effort, the implant
and possibly also the microcatheter must be removed and the vessel accessed once more.
18. Never push the p64 MW (HPC) delivery system tip beyond the distal tip of the microcatheter.
This can lead to a dissection or perforation of the target vessel.
6 B871B p64 MW IFU / 2019-12-17
The p64 MW (HPC) is slowly advanced to the tip of the microcatheter under continuous fluoroscopy.
The distal tip of the delivery system should reach the tip of the microcatheter.
Deployment of p64 MW (HPC)
19. Release the implant fully by carefully and very slowly withdrawing the microcatheter up to point that the
implant can still be recovered back into the microcatheter. The point of maximum implant deployment
that allows for implant recovery is indicated by a platinum marker at the distal end of the transport tube:
As long as marker is located inside the microcatheter the implant can be completely recovered.
Once the distal end of the implant is fully expanded and anchored in the distal vessel, continue to deploy
the implant by continuously pushing on the delivery system in order to facilitate the expansion of the
p64 MW (HPC). In order to ensure optimal wall apposition, the deployment must be a coordinated
effort of continuous pushing of the delivery system and adjustments (advancing or withdrawing) of the
microcatheter so that the microcatheter is centralized longitudinally along the vessel. The release of the
p64 MW (HPC) should take place under fluoroscopy in order to ensure that the implant is properly
deployed and the distal end has not moved.
Repositioning of distal delivery wire tip (optional)
20. Note that the distal delivery wire tip moves distally during implant deployment!
To counteract this movement and to avoid, e.g., the entry of the delivery wire tip into distal sensitive vessels,
the delivery wire tip can be moved proximally after the torquer is released while the implant is not completely
deployed. To do this the white torquer at the proximal end of the delivery system is loosened and replaced
by any standard torquer (compatible with a 0.014 inch or 0.016 inch (0.36 or 0.41 mm) microguidewire); this
torquer is then locked more proximally to the end of the delivery wire. The delivery wire is then withdrawn out
of the transport tube. The transport tube has an additional handle at its proximal end for easier handling.
Continuation of deployment
21. The p64 MW (HPC) is self-expanding and, when properly deployed, apposes itself against the vascular
wall. The implant may over-expand at the neck of the aneurysm due to the increased diameter at that
point. Correct deployment can be verified by visualizing the platinum-filled braiding wires of the implant.
22. Injecting approx. 6–10 ml of X-ray contrast medium through the guide catheter allows one to check
whether the aneurysm/dissection/target vessel has been satisfactorily covered by the deployment and
release of the p64 MW (HPC).
23. If the radial deployment of the p64 MW (HPC) is insufficient or the position or the model size selected is
unsuitable, the implant can be recovered into the microcatheter, if the distal marker of the transport tube is still
inside the microcatheter, in order to allow the implant to be repositioned, redeployed or completely removed.
If the delivery wire tip was moved proximally before, it must be ensured that the distal wire tip is placed
again distally to the distal compressed implant end and the white torquer is locked again on the transport
tube.
For repositioning or removal the microcatheter is advanced while the delivery system is slowly
withdrawn.
Detachment of p64 MW (HPC)
24. Due to the radial expansion of the proximal end, a slight shortening of the implant takes place!
If the position and deployment of the p64 MW (HPC) are satisfactory, the implant is immediately fully
deployed and detached by complete withdrawal of the microcatheter.
The proximal implant end is thus exposed and it can fully expand.
When using DSA systems with a digital detector and CT technology ("flat panel detector CT", e.g. DynaCT
[Siemens], XperCT, VasoCT [Philips]), the implant can be visualized on the sectional image. This has
proven particularly effective in the evaluation of the deployment and apposition to the vessel wall.
25. Remove the delivery system by gently withdrawing.
26. Insufficient deployment of the p64 MW (HPC) can be improved by means of a subsequent balloon
dilatation. As far as possible, the p64 MW (HPC) should appose against the vascular wall.
Implantation of another p64 MW (HPC)
27. After the first p64 MW (HPC) is detached, if a subsequent telescoping device is required, gently
advance the microcatheter through the p64 MW (HPC). When the microcatheter tip is distal to the
p64 MW (HPC), gently retract the wire tip into the microcatheter and remove the delivery system
completely out of the microcatheter. The microcatheter is now in position for a subsequent p64 MW
(HPC) to be advanced and deployed.
28. Injecting approx. 6–10 ml of X-ray contrast medium through the guide catheter allows one to check once
more, if necessary, whether the target vessel has been sufficiently covered by the application of the
p64 MW (HPC). This check should be repeated 10 to 15 minutes later where necessary.
Platelet aggregation ingibition and responder testing
29. Take steps to ensure adequate inhibition of platelet aggregation. Proven medications following
implantation include a 1 x 100 mg oral dose of ASA every day on an ongoing basis and a 75 mg oral
dose of Clopidogrel every day for at least 12 months, but longer when necessary or on an ongoing basis.
Be mindful of possible interactions with other medications (e.g. with proton pump inhibitors, Ibuprofen,
Metamizole).
In vitro test results and anecdotal clinical experience demonstrate that the version p64 MW HPC can
provide a reduced surface thrombogenicity. In justified exceptional cases, the reduced thrombogenicity can
allow the implantation under single antiplatelet medication, only if no reasonable alternative therapy is given.
Here particular attention is to be paid to at leat three days medication prior to treatment. The achieved platelet
inhibition is more intensive by using P2Y12 inhibitors (Prasugrel, Ticagrelor) than by using ASA.
For safety reasons, the efficacy of the antiplatelet medication is always to be verified by means of
appropriate tests (e.g. Multiplate, VerifyNow, PFA).
Single antiplatelet medication may have an increased risk of thromboembolic events if multiple devices
have been implanted in a telescoping fashion. The risk of thrombus formation may be increased after
subarachnoid hemorrhage, after trauma, during pregnancy, after major surgery, during inflammatory
diseases, fever, thrombocytosis.
See also chapter "Medication".
Precautions
• Microcatheters with other inner diameters (ID) than 0.021 inch (e.g., 0.017 or 0.027 inch) do not work
at all. p64 MW (HPC) used in microcatheters with too large IDs lead to premature detachment of the
implant inside the microcatheter.
• The p64 MW (HPC) may be deployed up to three (3) times in the target vessel. It must be considered
that each deployment only occurs up to the point that the distal marker of the transport tube is still inside
the microcatheter!