Insertion

Impella RP Flex® IJ Insertion into Cadaver

 

This video demonstrates how to insert the Impella RP Flex® via the internal jugular (IJ) vein of a patient using a cadaver model. The steps are summarized below. Refer to the Instructions for Use (IFU) for complete instructions.

First, the video describes the steps for obtaining internal jugular access and preparing to insert the Impella RP Flex.

  1. Abiomed recommends using a micropuncture kit and ultrasound for obtaining initial internal jugular access prior to inserting a 5-8 Fr introducer.
  2. Place a hemostatic suture without securing in place to be used for maintaining hemostasis after the Impella RP Flex has been inserted prior to upsizing to the Impella® 23 Fr x 11 cm sheath. Once ACT is 250 or greater the dilator and wire may be removed. Aspirate and flush the sheath.
  3. Under fluoroscopic guidance, insert a 0.035” compatible balloon-tipped catheter, advancing it into right or left pulmonary artery (PA).
  4. Form a curve on the 0.027” placement guidewire and insert it into the balloon-tipped catheter. Under fluoroscopic guidance, advance the placement guidewire deep into the PA branch until wire prolapses.
  5. Utilize a fixed wire technique to remove the balloon-tipped catheter over the 0.027” guidewire, leaving the wire in the PA branch.

 

The video then describes the steps for inserting the Impella RP Flex and initiating support.

  1. Insert the placement guidewire into the red EasyGuide lumen at the tip of the pigtail. Advance the guidewire until it exits the red lumen tip near the label. Remove the EasyGuide lumen by gently pulling the label in line with the catheter shaft while holding the Impella® Catheter.
  2. Wet the cannula with sterile water and advance the catheter through the hemostatic valve using a fixed-wire technique. Under fluoroscopic guidance, follow the catheter as it enters the right ventricle to direct the cannula tip upward and across the pulmonary valve. Position the outlet of the cannula above the pulmonic valve at approximately the level of the pulmonary artery bifurcation.
  3. Slowly remove the placement guidewire under fluoroscopic guidance. Reconfirm position under fluoroscopy after wire is removed.
  4. After confirming that the guidewire has been removed, initiate Impella support. Increase P-level slowly until you reach the desired P-level. Verify placement with fluoroscopy. Evaluate catheter position and remove any excess slack.
  5. Ensure a hemostatic suture has been placed prior to removal of the 23 Fr peel-away sheath. Under fluoroscopic guidance, remove the 23Fr peel-away introducer completely from the body. Visualize that the distal portion of the catheter remains in good position while the sheath is removed. Hold pressure to maintain hemostasis.
  6. Once the sheath is completely out of the body, grasp the 2 wings and bend back until the valve assembly splits. Continue to peel the 2 wings until the introducer is completely separated from the catheter shaft. Release pressure holding hemostasis then slide the repositioning sheath over the catheter shaft and advance it into the vein to the sheath hub. Under fluoroscopic guidance, visualize that the distal portion of the catheter remains in good position while the repositioning sheath is inserted.
  7. Tie down the previously placed hemostatic suture. Secure the repositioning sheath by suturing it to the skin using the suture ring on the sheath. A circumferential suture secured around sheath and to the skin offers ideal securement of the sheath.
  8. Attach the anticontamination sleeve to the repositioning sheath. Lock the anchoring ring in place by turning it clockwise.
  9. Confirm correct position with fluoroscopy and reposition the catheter as necessary.
  10. Ensure the device is secured with the Tuohy-Borst. Carefully extend the anticontamination sleeve to maximum length and secure the end closest to the blue Impella plug by tightening the anchoring ring.

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IMP-7046

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