HeartMate II Left Ventricular Assist Device (LVAD) Pivotal Trial

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

0BACKGROUNDVentricular assist devices (VADs) are a proven therapy as bridge-to-cardiac transplantation in Class IIIB and Class IV heart failure patientsThe 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 organsAs mean support duration for VADs increases, more VAD patients will be living in the communityHeartMate LVAD is approved as Destination Therapy (DT)

1HM II CANDIDATESFDA Approved 4.21.08Bridge-to-Transplant (BTT)

FDA Approved 1.20.10Destination Therapy (DT)

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Cored into LV

Outflow to aorta

Percutaneous tube

System Controller

Batteries HM II

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Anatomic Placement

4FUNCTION & CAPABILITYAxial (continuous) flow: ?NO PULSE/ ?BPOne moving part: RotorSmall400 gm125 cc60% smaller than HM I (XVE)QuietFlows: 3 10 lpmAnticoagulation required

5ADVANTAGESSize: Potential BSA of .8 m2

Only one moving part

Blood lubricated bearings

Designed for long term support

Lower infection rates (smaller perc tube)

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Pump HousingRotor

7PUMP ROTOR and STATORSInflow StatorInflow BearingsRotorOutflow BearinsOutflw StatorBLOOD FLOW

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9Controller + Back-up ControllerSYSTEM CONTROLLER

10FACE OF SYSTEM CONTROLLER

11 POWER MODULESupplies main power to LVAD

Provides 30 minutes of backup powerRepeats alarms generated by the System Controller

Serves as the electrical interface between the System Controller and the Display Module

12BATTERY CHARGER

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

14DISPLAY MODULE

Pump ModeFixedPower Saver

Pump Speed (rpm)

Pulse Index

Estimated Flow (lpm)Too low ---Too high +++

Power (watts)

Alarm Conditions Highest priority displayed

15AUTO MODE: only with Thoratec engineerEMERGENCY 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

16BATTERY ALARMSADVISORY ALARMSHAZARD ALARM

17BATTERY ALARMS BATTERY < 15 minutes of power BEEP Q SEC BATTERY < 5 minutes of power STEADY TONEDefaults to Power Saver ModePump defaults to Fixed Rate Mode of 8000 rpm, or fixed speed setpoint if lowerSystem will return to set speed once adequate power is restored

ACTION Replace batteries or switch to alternate power source

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SYSTEM DRIVER CELL LOW VOLTAGESYSTEM CONTROLLER CELL LOW VOLTAGE Yellow cell symbol Beep every 4 seconds

ACTION Replace cell battery and perform System Controller self test

19POWER CABLE DISCONNECTED

and FLASHINGPOWER CABLE DISCONNECTEDFlashing green power symbol & battery power barsBeep every second

ACTIONCheck cable connections to power sourceCheck power leads for damage, replace if necessary

20 LOW FLOW; NO OPERATION or INCORRECT OPERATIONLOW FLOW < 2.5 lpmPump not operating or not operating correctlyDecreased preload (right heart failure, tamponade, hypovolemia, bleeding, etc)Obstruction of pump inflow or outflowSystemic hypertensionACTIONAssess patientMonitor

21 DRIVELINE DISCONNECTED FROM CONTROLLER Check connections

ACTIONReconnect driveline to controller

STEADY TONE andNO SYMBOLNO POWER TO PUMP

ACTIONCheck system driver connections to pumpCheck system driver power connections to power sourceIf persist, seek additional help immediately

23CPR SHOULD NOT BE PERFORMED ON HEARTMATE LVAD PATIENTSUNLESS DIRECTED

24VT or VFSTABLEPatient may feel funny light headed or differentPump speeds and flows are normal, low normal, or very lowConsider cardioversion after consultation with Mechanical Assist Device Coordinator

UNSTABLEPatient unresponsiveTreat as unstable VT/VF

25LVAD PATIENT TRANSPORTTransport to assigned facilitySpare batteries, PBU and the display module should be brought to the hospital with the patientPBU weighs 29 pounds without batteriesAll modes of emergency transportation are acceptableAviation electronics will NOT interfere with LVAD and visa versa

26Thank You !!!