Impella® Skills Video: Impella 5.5® with SmartAssist® Insertion with Axillary Insertion Kit

This Impella skills video demonstrates insertion of the Impella 5.5 with SmartAssist using the axillary insertion kit. The axillary insertion kit includes the following components:

• 23Fr peel-away sheath with hemostatic valve
• 2 graft locks to facilitate fixation of a 10mm vascular graft to the sheath
• 8Fr silicone-coated dilator

The vascular graft is not included in the kit. Abiomed recommends using a Hemashield Platinum® graft.

The video is a simplified version of the insertion, highlighting the primary steps of the procedure.

1. Isolate and expose the axillary artery and obtain control via proximal and distal vessel loops.

2. Attach a 10 mm diameter x 20 cm long vascular graft to the axillary artery using a standard end-to-side anastomosis. NOTE: Abiomed recommends using a Hemashield Platinum graft and recommends using at least a 60-degree bevel on the end of the graft to facilitate passage of the rigid motor housing into the artery.

3. Clamp the graft with a vascular clamp just above the anastomosis and loosen the vessel loops to allow blood to flow into the graft to assess for hemostasis at the anastomosis.

4. Insert the introducer into the graft and secure it with one (1) provided graft lock. To place the graft lock, open it and place it between the retainers and the hub on the introducer to prevent the introducer from sliding out of the graft. NOTE: If a graft other than the Hemashield Platinum® is used, 2 graft locks may be required to maintain hemostasis between the graft and the introducer. Correct positioning of the second graft is illustrated in the Impella 5.5 with SmartAssist Instructions for Use, Figure 5.13.

5. Secure the graft lock by pressing both the outside tabs together. When fully closed, the graft lock provides hemostasis. If hemostasis is not achieved, make sure to press the two tabs together to fully close the graft lock as shown in the Impella 5.5 with SmartAssist Instructions for Use, Figure 5.14. The graft lock cannot be damaged by over closing. NOTE: The graft may also be secured over the introducer using heavy sutures or umbilical tape.

6. Remove the vascular clamp on the graft and insert a 0.035 inch diagnostic guidewire with a 4–6 Fr diagnostic catheter into the introducer, taking care to center the wire and catheter in the center of the hemostatic valve. Advance the guidewire and catheter into the left ventricle.

7. Remove the diagnostic guidewire and exchange it for a stiff 0.018 inch placement guidewire. With the 0.018 inch placement guidewire properly positioned in the left ventricle, remove the diagnostic catheter.

8. Administer heparin, bivalirudin, or argatroban, per institutional protocol. When the ACT is greater than or equal to 250 seconds, remove the dilator.

9. Remove the protective sleeve on the provided 8 Fr silicone-coated lubrication dilator, being careful to avoid getting silicone on your hands. Insert the dilator into the introducer over the 0.018 inch placement guidewire to coat the hemostatic valve with silicone oil to facilitate insertion of the Impella Catheter through the hemostatic valve assembly. Once fully inserted, remove the dilator, keeping the 0.018 inch placement guidewire in place.

10. Clamp the graft with a vascular clamp just above the anastomosis to avoid blood loss through the pump cannula during insertion through the valve.

11. While maintaining guidewire position, backload the Impella Catheter onto the 0.018 inch placement guidewire and advance the catheter over the guidewire through the introducer into the graft such that the entire pump cannula and motor housing resides in the graft and only the catheter shaft is seen exiting the valve.

12. Remove the vascular clamp and continue inserting the Impella Catheter into the aorta. Continue advancing across the aortic valve using fluoroscopic imaging to properly position the cannula bend at the aortic valve annulus, placing inlet approximately 5 cm deep into ventricle. Remove the placement guidewire and initiate Impella Catheter support as described later in this section.

13. Clamp the graft adjacent to the axillary artery with a soft jawed vascular clamp or have an assistant apply digital pressure to control bleeding at the base of the graft so that the introducer can be removed and the graft shortened. NOTE: To ensure the soft jaw vascular clamp is completely sealing over the graft and the 9 Fr catheter, open the sidearm flush valve on the introducer and verify blood is not leaking from the system.

14. Slide the repositioning sheath back to the red Impella plug. NOTE: For the 23F x 6cm peel-away introducer, it may be necessary to pull the introducer over the repositioning sheath to remove the peel-away completely from the artery

15. To remove the introducer, release the graft lock by pressing the two adjacent long tabs together as shown in the Impella 5.5 with SmartAssist Instructions for Use, Figure 5.15 and remove it from the graft.

16. Slide the introducer fully out of the graft prior to peeling it away. To peel the introducer off the catheter shaft, crack the hub by applying pressure to the thumb tabs and then peel the sheath off the catheter. NOTE: When breaking the hemostatic valve in the sheath hub, the valve may stretch before separating.

    1. Grasp the two “wings” and bend back until the valve assembly comes apart. Continue to peel the two wings until the introducer is completely separated from the catheter shaft (see Impella 5.5 with SmartAssist Instructions for Use, Figure 5.16).

17. Trim any excess graft and slide the blue suture hub into the graft. NOTE: The hub should be at the skin level and the length of the remaining graft material should be just long enough to secure the graft around the blue suture hub with all of the graft buried beneath the skin.

18. Using heavy silk suture, secure the graft around the blue suture hub so that the position of the Impella Catheter can still be adjusted. Remove the vascular clamp adjacent to the axillary artery.

19. The wound should be closed over the trimmed graft with the end of the blue suture hub clearly visible. Anchor the hub securely to the skin.

20. If there is slack in the catheter, follow steps a-d below.

    1. Loosen the Tuohy-Borst, pull the catheter back until an aortic waveform is present on the placement screen.

    2. When the aortic waveform is present, pull the catheter back an additional 3cm for Impella 5.5 with SmartAssist. (The distance between adjacent markings on the catheter is 1 cm.)

    3. RE-TIGHTEN THE TUOHY BORST

    4. The catheter should now be positioned correctly.

21. Extend the sterile sleeve. Attach one end to the repositioning hub and anchor the other to the catheter.

Hemashield Platinum is a registered trademark of MAQUET Cardiovascular LLC