Merit Medical HERO GRAFT Mode D'emploi page 6

Caution: Plan for increased bacteremia risk after an ipsilateral HeRO Graft placement or with femoral bridging catheters and treat
prophylactically with antibiotics knowing patients are at higher infection risk.
Caution: Apply antibiotic ointment to the bridging catheter exit site.
5. Prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.
6. Using ultrasound guidance, gain percutaneous access to the venous system using a 5F micropuncture set and standard Seldinger technique.
Caution: Use of the HeRO Graft was clinically studied using the internal jugular vein. Central venous access through any other veins,
for example the subclavian vein, has NOT been studied and may increase the risk of adverse events not encountered in the
clinical trial. When using the subclavian vein for venous access, consideration should be made to follow these patients with
clavicle imaging to monitor the potential of interaction of the clavicle and first rib with the Venous Outflow Component.
7. Using fluoroscopic guidance, advance a 0.035" guidewire, at least 145cm in length, to the inferior vena cava (IVC).
Caution: Maintain wire placement throughout the implantation of the Venous Outflow Component.
8. If performing venography to diagnose venous anatomy, select an appropriately sized introducer sheath.
9. Create a small incision at the exit site of the guidewire to aid in placement of the introducer sheath.
IMPLANTING THE VENOUS OUTFLOW COMPONENT
1. For patients undergoing general anesthesia, consider Trendelenburg position. Additionally, anesthesia personnel should force a positive breath to
reduce the potential for air embolus during implant.
NOTE: For conscious sedation patients, use the Valsalva maneuver to reduce air embolus potential.
2. Based upon venous anatomy, determine if serial dilation is required. If so, use the 12F and 16F dilators from the Accessory Component Kit as
needed for pre-dilation of the venous tract prior to inserting the 20F introducer.
NOTE: Balloon angioplasty may also be required for severely stenosed anatomy.
NOTE: Do not bend introducer sheath or dilator or use them to bypass stenosis.
3. Insert the short 20F introducer from the Accessory Component Kit over the guidewire. The long 20F introducer may be used if needed for
atypical accesses.
NOTE: Use of the shorter introducer may help prevent kinking since it cannot be advanced as far into the vessel.
4. Advance the dilator and sheath together over the guidewire into the vessel using a twisting motion.
NOTE: Do not insert the sheath/dilator too far. The tabs must extend well outside the body.
5. Using aseptic technique, open the Venous Outflow Component.
6. Flush the Venous Outflow Component with heparinized saline.
7. Apply sterile surgical lubricant to the 10F delivery stylet and advance through the silicone Luer end of the Venous Outflow Component.
8. Attach the Y-adapter onto the Luer end of the 10F delivery stylet and tighten the stopcock, if necessary.
9. Ensure the valve on the stopcock is in the open position and flush with heparinized saline, then close the valve.
10. To ease insertion into the sheath, apply sterile surgical lubricant to the exterior surface of the Venous Outflow Component.
11. While stabilizing the guidewire and 20F sheath, begin removing the dilator from the sheath. As soon as the dilator tip has exited the sheath,
immediately insert the hemostasis plug by grasping the grip between the thumb and index finger. Firmly insert the hemostasis plug into the
sheath alongside the guidewire. Ensure both plug seal rings are fully seated within the sheath. Fully remove the dilator over the guidewire.
12. Insert the Venous Outflow Component and delivery stylet assembly over the guidewire and advance up to the 20F sheath.
13. Quickly exchange the hemostasis plug for the Venous Outflow Component.
Caution: DO NOT advance the tip of the delivery stylet into the right atrium.
14. Under fluoroscopic guidance, advance the Venous Outflow Component to the superior vena cava (SVC) using a twisting motion. Holding the
delivery stylet fixed, continue to advance the Venous Outflow Component to the mid to upper right atrium.
NOTE: If resistance is felt, determine the cause before continuing to advance the Venous Outflow Component. Keep the sheath straight to prevent
it from kinking. If the sheath is bent, remove it and replace it with a new 20F sheath.
15. Confirm proper Venous Outflow Component tip placement in the mid to upper right atrium.
16. Gently pull up while peeling away the 20F sheath. Do not peel the sheath close to the incision site; only peel the sheath as it exits the incision
site. Verify that the sheath has been completely removed and that the tip of the Venous Outflow Component is in the correct location via
fluoroscopy.
17. Remove the guidewire and close the hemostasis valve on the Y-adapter.
18. Begin withdrawal of the 10F delivery stylet while maintaining Venous Outflow Component position. Prior to complete removal of the delivery
stylet from the Luer, clamp the Venous Outflow Component at the incision site.
NOTE: Be careful not to overclamp (i.e., do not advance past the locking tab on the clamp handle).
Caution: To avoid potential damage to the Venous Outflow Component, use only the atraumatic clamp provided in the Accessory
Component Kit.
19. Detach the Y-adapter from the delivery stylet. Open the stopcock and attach the Y-adapter to the silicone Luer on the Venous Outflow
Component.
ENGLISH
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