Impella 5.5® with SmartAssist® Pump
Step-by-Step Axillary Insertion
Overview Axillary Insertion Procedure
- Assess vessel size and create arteriotomy
- Attach graft and insert sheath
- Advance guidewire, lubricate valve, and place Impella 5.5 with SmartAssist
- Confirm position and trim and secure graft
- Confirm and adjust position
- Finish procedure and secure Impella 5.5 with SmartAssist with catheter locks
Assess vessel size and create arteriotomy
- Insertion of Impella 5.5 with SmartAssist requires a 7 mm axillary artery.
- Once the axillary artery is exposed, use proximal and distal vessel loops, or a vascular clamp, to maintain hemostasis.
- Create an arteriotomy large enough to accommodate a 10 mm vascular graft.
Attach graft and insert sheath
- Create a 60°-70° bevel on the 10 mm woven Dacron graft to allow Impella 5.5 with SmartAssist to smoothly transition straight into the vessel.
- Attach the graft using standard end-to-side anastomosis. Clamp the graft, reperfuse the vessel, and assess the integrity of the anastomosis.
- Insert the 23Fr axillary sheath and use the included graft locks to secure the graft to the sheath.
- De-air the graft via the sidearm on the 23Fr peel-away.
Advance guidewire, lubricate valve, and place Impella 5.5 with SmartAssist
- Advance 0.035” standard J-wire with a diagnostic catheter through the ascending aorta and across the aortic valve. Replace 0.035” guidewire with provided 0.018” wire.
- Once 0.018” wire is in the apex of the ventricle, remove the diagnostic catheter and clamp the graft above the anastomosis to control bleeding.
- Insert the provided 8Fr silicone dilator, passing it 2 to 3 times to lubricate the sheath valve.
- Backload Impella 5.5 with SmartAssist and introduce it through the hemostatic valve of the sheath. Once the motor housing is through the valve, release the clamp and advance catheter to the aortic valve.
Confirm position and trim and secure graft
- Under fluoroscopy and TEE guidance, advance the Impella 5.5 inlet across the aortic valve until the mid-inlet is approximately 5 cm below the aortic valve annulus.
- Once Impella 5.5 with SmartAssist is in position, place a soft jaw clamp above the graft anastomosis. Remove graft clamps and peel-away sheath.
- Use a soft jaw clamp near the anastomosis and trim and remove any excess graft. Use proximal vessel loops to control bleeding.
- Remove clamp and advance the blue suture hub completely into the graft. Secure the blue suture hub to the suture ribs with a heavy silk tie and suture down the blue suture hub.
Confirm and adjust position
- Confirm that all slack has been removed. The catheter should be able to move freely.
- Remove the yellow locking pin and discard. Confirm Impella 5.5 with SmartAssist is secured in position.
- 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.
- If needed, maintain the blue suture hub angle with folded 4” by 4” gauze pads before placing sterile dressing.
Finish procedure and secure Impella 5.5 with SmartAssist with catheter locks
- Close the incision and place a sterile dressing.
- Using a 3-point fixation technique, secure Impella 5.5 with SmartAssist near the insertion site, along with both sides of the red Impella plug, using commercial catheter locks.
- Do NOT clean the red Impella plug with alcohol or alcohol-based products.
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.
NPS-3994