De-Airing Procedure; Programming The Backup Controller To Match The Primary Controller; Hvad ® Pump Explant; At Transplant - HeartWare Ventricular Assist System Instructions For Use Manual

14.8 De-airing Procedure

1) Start ventilation.
2) Be sure that all IV catheters and pressure monitoring lines are closed to the atmosphere to reduce the possibility of air entering the heart and pump.
Reduce cardiopulmonary bypass flow to allow filling of the left ventricle and pump.
3)
4) Place a sterile 19-gauge (or smaller) needle into the outflow graft between the HVAD
CAUTION: Use the smallest possible needle for de-airing; 19 gauge is normally sufficient. Hypodermic needles have a cutting point which may result in blood
leakage and may require repair by suturing.
Start HVAD Pump at 1800 RPM by pressing the blue button labeled "START" on the monitor.
5) ®
WARNING: HVAD Pump flow estimation may not be accurate during the de-airing procedure.
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With the HVAD Pump at 1800 RPM, use TEE to assess air in the left ventricle and aorta.
6) ®
7) After all air is removed, remove the 19-gauge needle and oversew the needle hole with pledgeted sutures.
Release the outflow graft cross clamp.
8)
9) Gradually increase HVAD ® Pump speed to achieve the desired flow and wean from cardiopulmonary bypass as tolerated.
NOTE: Increase HVAD Pump speed in increments of 100 RPM with a 20-second interval between speed changes to gradually increase flow and to help prevent ventricular collapse.
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WARNING: All air must be removed from the HVAD

14.9 Programming the Backup Controller to Match the Primary Controller

A backup controller should always be available and programmed identical to the primary controller. The backup controller should be programmed before the implant procedure, prior to
patient transfer from the operating room, when the primary controller is replaced, and upon any parameter change to the primary controller.
Parameters include:
Pump speed
1)
Hematocrit setting
2)
3) VAD ID/Pump serial number
Lavare Cycle setting
4)
Suction Response setting
5)
See Section 14.1 for instructions on programming the controller and removing power from the backup controller.
15.0 HVAD PUMP EXPLANT
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15.1 At Transplant

1) Surgically expose the HVAD Pump and sewing ring.
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Place patient on cardiopulmonary bypass according to institutional guidelines.
2)
3) Connect the controller to the monitor and turn off the HVAD
Cross-clamp two (2) sections of the outflow graft.
4)

15.2 Myocardial Recovery/Pump Exchange

Surgically expose the HVAD Pump and sewing ring.
1) ®
2) Place patient on cardiopulmonary bypass according to institutional guidelines.
Connect the controller to the monitor and turn off the HVAD
3)
Cross-clamp two (2) sections of the outflow graft.
4)
5) Cut outflow graft between two (2) clamps.
Cut and remove the percutaneous driveline.
6)
At HVAD Pump explant the percutaneous driveline is not sterile; therefore ensure that the driveline does not contaminate the sterile field.
WARNING: ®
7) Excise the remaining outflow graft from the aorta and repair the anastomosis site.
8) Use the sewing ring wrench to loosen the sewing ring screw.
Remove the HVAD Pump.
9) ®
NOTE: During HVAD Pump removal for recovery or exchange it may be difficult to withdraw the pump from the left ventricle due to tissue ingrowth on the sintered portion of the
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inflow cannula. It may be necessary to excise tissue adjacent to the sintering potentially resulting in bleeding and/or air emboli.
For pump exchange, refer to section 14.5 (beginning with step #6). For myocardial recovery, follow the steps below.
10)
Repair the hole in the LV.
11)
Ventricular Assist System
® Pump and the outflow graft clamp.
Pump and its conduits to reduce risk of air embolus.
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6)
7)
8)
9)
5)
6)
® Pump. 7)
Pump.
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Controller date and time
Low Flow Alarm limit
High Power Alarm limit
Patient ID
Cut outflow graft between two (2) clamps.
Cut and remove the percutaneous driveline.
Remove the HVAD ® Pump with the heart.
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Instructions For Use 27