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

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 m2
• 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
Inflow
Bearings 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
Fixed Speed 9600 PI 5.5
Flow 4.5 Power 8.2
•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
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