HeartMate II Left Ventricular Assist Device (LVAD)  Pivotal Trial

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HeartMate II Left Ventricular

Assist Device (LVAD)

University of Washington Medical Center

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)

HM II CANDIDATES

FDA Approved 4.21.08

• Bridge-to-Transplant (BTT)

FDA Approved 1.20.10

• Destination Therapy (DT)

HM II

Cored into LV

Outflow to aorta

Percutaneous tube

System Controller

Batteries

Anatomic

Placement

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

ADVANTAGES

• Size: Potential BSA of .8 m 2

• Only one moving part

• Blood lubricated bearings

• Designed for long term support

• Lower infection rates (smaller perc tube)

Pump Housing

Rotor

PUMP ROTOR and STATORS

BLOOD FLOW

Outflw

Stator

Outflow

Bearins

Rotor

Inflow

Bearings

Inflow

Stator

SYSTEM CONTROLLER

Controller + Back-up Controller

FACE OF SYSTEM CONTROLLER

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

BATTERY 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

DISPLAY MODULE

Pump Mode

 Fixed

 Power Saver

Pump Speed (rpm)

Pulse Index

Estimated Flow (lpm)

 Too low “---”

 Too high “+++”

Power (watts)

Alarm Conditions

Highest priority displayed

Fixed Speed 9600 PI 5.5

Flow 4.5 Power 8.2

Fixed Speed 9600 PI 5.5

LOW FLOW for < 1 min

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

BATTERY ALARMS

ADVISORY ALARMS

HAZARD ALARM

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

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

POWER CABLE DISCONNECTED and FLASHING

POWER CABLE DISCONNECTED

 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

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

DRIVELINE DISCONNECTED

FROM CONTROLLER

• Check connections

ACTION

• Reconnect driveline to controller

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

CPR SHOULD NOT

BE PERFORMED ON

HEARTMATE LVAD

PATIENTS

UNLESS DIRECTED

VT or VF

• STABLE

– 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

LVAD PATIENT TRANSPORT

• Transport to UWMC

• 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

SHAUNA ANDRUS, RN

AMY UNGERLEIDER, RN

JANIE SHIVELY, RN

Mechanical Circulatory Support Coordinator

UNIVERSITY OF WASHINGTON MEDICAL CENTER

24/7 CONTACT

UW PAGING OPERATOR

206.598.6190

Ask for VAD Coordinator On Call

NAHUSH MOKADAM, MD

Assoc. Director Cardiac Transplant and

Mechanical Assist Device Programs

UNIVERSITY OF WASHINGTON MEDICAL CENTER office 206.543.3093

Paging operator 206.598.6190

MEDCON 800.326.5300

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