Impella 5.5® with SmartAssist® Pump

Step-by-Step Direct Aortic Insertion

 

Overview Direct Aortic Insertion Procedure

  1. Create arteriotomy 
  2. Prepare, attach, and tunnel the graft
  3. Insert peel-away sheath, lubricate valve, and place Impella 5.5 with SmartAssist
  4. Confirm position and trim and secure the graft
  5. Re-confirm and adjust position
  6. Finish procedure and secure Impella 5.5 with SmartAssist with catheter locks
Download Step-by-Step Guide

Create Arteriotomy

  1. Use the sterile incision template to identify the location for the incision on the ascending aorta          7 cm above the plane of the aortic valve.
  2. Place a sidebiter clamp on the aorta and size the aortotomy to accommodate a 10 mm woven vascular Dacron graft for smooth delivery of Impella 5.5 with SmartAssist.

 

Prepare, Attach, and Tunnel the Graft

  1. Create a bevel on the 10 mm woven Dacron graft in accordance with your exit strategy. 
    Attach the graft using standard end-to-side anastomosis. 
  2. Clamp the graft above the anastomosis and confirm hemostasis.
  3. Create a 1.5-2 cm incision 2 cm superior and 2 cm lateral to the sternal notch, parallel to the clavicle. Multiple options exist for exteriorizing the catheter.
  4. Secure a traction suture to the end of the graft. Tunnel the graft from the ascending aorta superiorly, passing posterior to the lateral border of the manubrium and sternoclavicular joint and exiting the skin between the 2 heads of the sternocleidomastoid muscle.

 

Insert peel-away sheath, lubricate valve, and place Impella 5.5 with SmartAssist

  1. Insert the 23Fr peel-away sheath and use the included graft locks to secure the graft to the sheath. Alternatively, instead of using peel-away sheath, preload one 9 mm silicone plug onto the catheter, secure with a ligature tie, and proceed with Impella 5.5 with SmartAssist insertion.
  2. Insert the provided 8Fr silicone dilator, passing it 2 to 3 times to lubricate the hemostatic valve. 
  3. Load the Impella 5.5 with SmartAssist through the graft. 
  4. Release the clamp and advance Impella 5.5 with SmartAssist into the aorta. 
  5. De-air the graft via the sidearm on the 23Fr peel-away.

 

Confirm position and trim and secure the graft

  1. Under TEE guidance, advance the inlet past the aortic valve. Confirm the mid-inlet is approximately 5 cm below the aortic valve annulus.
  2. Once Impella 5.5 with SmartAssist is in position, place a soft jaw clamp above the graft anastomosis and gently pull any excess graft back through the incision site.
  3. Remove graft clamps and peel-away sheath. 
  4. Trim graft and remove any excess.

 

Confirm and adjust position

  1. Confirm that all slack has been removed. The catheter should be able to move freely. 
  2. Remove the yellow locking pin and confirm Impella 5.5 with SmartAssist is secured in position.
  3. If Impella 5.5 with SmartAssist position needs to be adjusted, press and hold the blue button while maintaining the angle of entry. The catheter should move freely.
  4. If needed, maintain the angle of the blue suture hub with folded four by fours before placing sterile dressing.

 

Finish procedure and secure Impella 5.5 with SmartAssist with catheter locks

  1. Close the chest and place a sterile dressing over the incision. 
  2. Secure Impella 5.5 with SmartAssist near the insertion site with commercial catheter locks and secure both sides of the red Impella plug.
  3. Do NOT clean the red Impella plug with alcohol or alcohol-based products.

 

Screenshots from Impella app surface. Screenshots from Impella app surface.

Access Additional Step-By-Step Guides — Introducing the New Impella® App

The newly redesigned Impella App provides key resources health care professionals can access pre- and post-procedure at the point of care from the cath lab, ICU, OR or while in transport to improve patient outcomes.

Learn more

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