0. HeartMate II Left Ventricular Assist Device (LVAD)
Courtesy University of Washington Medical Center

1. BACKGROUND
Ventricular assist devices (VADs) are a proven therapy as bridge-to-cardiac transplantation in Class IIIB and Class IV heart failure patients
The dramatic increase in the use of VADs has been unavoidable for those patients suffering end-stage heart failure due to the consistent shortage of donor organs
As mean support duration for VADs increases, more VAD patients will be living in the community
HeartMate LVAD is approved as Destination Therapy (DT)

2. HM II CANDIDATES FDA Approved 1.20.10 FDA Approved 4.21.08
Bridge-to-Transplant (BTT)
FDA Approved
Destination Therapy (DT)

3. HM II Cored into LV Outflow to aorta Percutaneous tube
System Controller
Batteries

4. Anatomic Placement

5. FUNCTION & CAPABILITY Axial (continuous) flow: ?NO PULSE/ ?BP
One moving part: Rotor
Small
400 gm
125 cc
60% smaller than HM I (XVE)
Quiet
Flows: 3 – 10 lpm
Anticoagulation required

6. ADVANTAGES Size: Potential BSA of .8 m2 Only one moving part
Blood lubricated bearings
Designed for long term support
Lower infection rates (smaller perc tube)

7. Pump Housing
Rotor

8. PUMP ROTOR and STATORS BLOOD FLOW Inflow Bearings Inflow Stator
Outflw Stator
Outflow Bearins
Rotor

10. SYSTEM CONTROLLER
Controller + Back-up Controller

11. FACE OF SYSTEM CONTROLLER

12. POWER MODULE Supplies main power to LVAD
Provides 30 minutes of backup power
Repeats alarms generated by the System Controller
Serves as the electrical interface between the
System Controller and the Display Module

13. BATTERY CHARGER

14. BATTERIES
14v Li-Ion
6 – 10 hours of support *Patients report up to 15 hrs of battery power
Up to 4 hour recharge for fully discharged battery
3 years or 360 charges

15. DISPLAY MODULE Pump Mode Pump Speed (rpm) Pulse Index
Fixed
Power Saver
Pump Speed (rpm)
Pulse Index
Estimated Flow (lpm)
Too low “---”
Too high “+++”
Power (watts)
Alarm Conditions
Highest priority displayed
AUTO MODE: only with Thoratec engineer

16. EMERGENCY POWER PACK (EPP)
Single use battery pack in a plastic carrying case with a shoulder strap
Provides battery power in the event of extended power outage
Approximately 12 hours of support
Must be replaced if used for a period exceeding three hours

17. BATTERY ALARMS
ADVISORY ALARMS
HAZARD ALARM

18. BATTERY ALARMS BATTERY < 15 minutes of power BEEP Q SEC
BATTERY < 5 minutes of power STEADY TONE
Defaults to ‘Power Saver Mode’
Pump defaults to Fixed Rate Mode of 8000 rpm, or fixed speed setpoint if lower
System will return to set speed once adequate power is restored
ACTION
Replace batteries
or switch to alternate power source

19. SYSTEM DRIVER CELL LOW VOLTAGE
SYSTEM CONTROLLER CELL LOW VOLTAGE
Yellow cell symbol
Beep every 4 seconds
ACTION
Replace cell battery and perform
System Controller self test

20. POWER CABLE DISCONNECTED and FLASHING
Flashing green power symbol & battery power bars
Beep every second
ACTION
Check cable connections to power source
Check power leads for damage, replace if necessary

21. LOW FLOW; NO OPERATION or INCORRECT OPERATION
LOW FLOW < 2.5 lpm
Pump not operating or not operating correctly
Decreased preload (right heart failure, tamponade, hypovolemia, bleeding, etc)
Obstruction of pump inflow or outflow
Systemic hypertension
ACTION
Assess patient
Monitor

22. DRIVELINE DISCONNECTED FROM CONTROLLER
Check connections
ACTION
Reconnect driveline to controller

23. STEADY TONE and NO SYMBOL
NO POWER TO PUMP
ACTION
Check system driver connections to pump
Check system driver power connections to power source
If persist, seek additional help immediately

24. CPR SHOULD NOT BE PERFORMED ON HEARTMATE LVAD PATIENTS UNLESS DIRECTED

25. VT or VF STABLE UNSTABLE
Patient may “feel funny” “light headed” or “different”
Pump speeds and flows are normal, low normal, or very low
Consider cardioversion after consultation with Mechanical Assist Device Coordinator
UNSTABLE
Patient unresponsive
Treat as unstable VT/VF

26. LVAD PATIENT TRANSPORT
Transport to assigned facility
Spare batteries, PBU and the display module should be brought to the hospital with the patient
PBU weighs 29 pounds without batteries
All modes of emergency transportation are acceptable
Aviation electronics will NOT interfere with LVAD and visa versa

27. Thank You !!!