HeartMate 3™ Left Ventricular Assist Device

PUMP PARAMETER OVERVIEW

There are four parameters monitored on the HeartMate 3™ Left Ventricular Assist
Device (LVAD): Speed, Power, Flow and Pulsatility Index. No single parameter is a
surrogate for monitoring a patient’s clinical status. It is important to consider trends.
Pump parameter values are patient-specific.

SPEED

• The HeartMate 3 LVAD fixed speed range: 3,000–9,000 revolutions per minute (rpm)
• Speed can only be changed using the System Monitor or HeartMate Touch™
• The System Monitor displays the pump speed in rpm. This value matches the actual speed within ± 100 rpm
under normal conditions
• Starting at 4,000 rpm, the HeartMate 3 LVAD has an artificial pulse that is activated every 2 seconds
• The p icon beside the speed display on the system controller indicates Artificial Pulse mode is active

POWER

• Device power is a direct measurement of pump motor voltage and current. Changes in pump speed, flow or
physiological demand can affect pump power
GRADUAL POWER DECREASES MAY INDICATE
OBSTRUCTION OF FLOW AND SHOULD BE EVALUATED
 POWER MAY SIGNAL THROMBUS DEPOSITS
INSIDE THE PUMP OR AORTIC INSUFFICIENCY REPORT DOUBLE-DIGIT POWER DEMANDS ≥ 10.0 WATTS

FLOW

• Flow is an estimate that is derived from a calculation of fixed speed, power and the patient’s hematocrit value
 SPEED –  FLOW  SPEED –  FLOW

− If the flow estimate falls below 2.5 L/min, the HeartMate 3™ System Controller will alarm “low flow”
• At any given speed, increased blood pressure (BP) will decrease flow through the pump

PULSATILITY INDEX

• During systole, the left ventricle (LV) contracts, increasing ventricular pressure that causes increases in pump flow
− These flow pulses are measured and averaged over 15-second intervals
• The HeartMate 3 LVAD observed clinical Pulsatility Index (PI) range: 1–10
• PI values should be routinely monitored and should not vary significantly during resting conditions
• Under otherwise stable conditions, a significant drop in value may indicate a decrease in circulating blood volume

PI EVENT

• The HeartMate 3 LVAD employs PI detection to recognize and avert the LV collapse
• If a PI event is detected, the pump speed will automatically reduce to the low speed
limit and then gradually ramp back up to the fixed speed
− There are no audible alarms with a PI event

POSSIBLE CAUSES OF EVENTS: SUDDEN CHANGES IN POWER OR PUMP SPEED,

COUGHING/SNEEZING, ARRHYTHMIAS, BEAT-TO-BEAT VARIATIONS IN
LV VOLUME AND INTRA-AORTIC BALLOON PUMPS
CLINICAL CONSIDERATIONS
CONTINUOUS-FLOW PUMP VITALS PUMP ASSESSMENT
• The HeartMate 3™ LVAD has an BP: Assess if pump is running:
Artificial Pulse mode that “beats” • Automatic BP monitors may • Auscultate over the left upper
30 times per minute asynchronously not be accurate quadrant to assess whether the
with the heart • Manual auscultation with a pump is running
• Continuously unloads LV, Doppler is recommended • Any change in parameters
narrowing pulse pressure – The mean BP should be should be evaluated with all
• The HeartMate 3 LVAD may create < 90 mmHg clinical considerations taken
electromagnetic interference into account
Pulse: A palpable pulse may or may
with electrocardiogram (EKG) not be present • One single pump parameter is
monitoring not a surrogate for monitoring
Oxygen saturations: May be the overall clinical status of the
• Adjustment of EKG lead placement unable to obtain as pulse oximeter
may reduce the level of interference patient
technology is based on pulsatile flow

EMERGENCY
EQUIPMENT DRIVELINE
CARE
• Defibrillation or • The System Controller must be connected • Sterile dressing change per implant
cardioversion to the Power Module, Mobile Power Unit center protocol
allowed, if or 14-volt lithium ion batteries at all times – Report any signs of infection
necessary when connected to a patient
• Report any tears or separations in the
• Chest • Up to 10- to 17-hour battery life, per pair silicone or polyurethane on the driveline
compressions • The patient must always connect to the • Ensure the patient is using an anchoring
— Use clinical Power Module or Mobile Power Unit for system to prevent pulling of the driveline
judgment; there sleeping or when there is a chance of sleep
may be risks – Do not twist, kink or sharply bend
• A backup System Controller and charged the driveline
associated with
batteries must remain with the patient at
performing chest • Verify the modular cable in-line connection
all times
compressions is secure and that no yellow line is visible

INR MONITOR REVIEW AND DOCUMENTATION

• Goal: 2.0 to 3.0 Clinical Screen........ Review and Record: Speed, Flow, PI, Power
• International normalized Settings Screen.......Review and Record: Pulse Speed, Low Speed Limit and Hematocrit
ratio (INR) goal will vary Alarms Screen.........Review and Record: Active Alarms
for each patient
History Screen........Review Event and Periodic Logs

PATIENT QUESTIONS WARNINGS

• Any alarms? • Any weight gain or trouble breathing? • No magnetic resonance
• Any bloody stool or nosebleeds? • Any lightheadedness or dizziness? imaging
• Is urine dark in color? • Any returning symptoms of heart failure? • Avoid static electricity
• No swimming

HeartMate Touch™ Communication the use of the HeartMate 3 Left Ventricular Assist
Rx Only​
System Overview: The HeartMate System are: death, bleeding, cardiac arrhythmia,
Brief Summary: Prior to using these
Touch™ Communication System localized infection, right heart failure,
devices, please review the Instructions for
is intended for use by clinicians in respiratory failure, device malfunctions, driveline
Use for a complete listing of indications,
the hospital to wirelessly monitor infection, renal dysfunction, sepsis, stroke,
contraindications, warnings, precautions,
a patient’s HeartMate II™ Left other neurological event (not stroke-related),
potential adverse events and directions for
Ventricular Assist System or hepatic dysfunction, psychiatric episode, venous
use.​
HeartMate 3™ Left Ventricular thromboembolism, hypertension, arterial non-
Assist System. The HeartMate HeartMate 3™ LVAS Indications: The central nervous system (CNS) thromboembolism,
Touch Communication System is HeartMate 3™ Left Ventricular Assist pericardial fluid collection, pump pocket or
required during implant procedures System is indicated for providing short- and pseudo pocket infection, myocardial infarction,
and any time close monitoring long-term mechanical circulatory support wound dehiscence, hemolysis (not associated
of system operation is needed. It (e.g., as bridge to transplant or myocardial with suspected device thrombosis) or pump
provides clinicians with the ability recovery, or destination therapy) in patients thrombosis.​
to program system parameters such with advanced refractory left ventricular
™ Indicates a trademark of the
as pump speed, assess and track heart failure.​
Abbott group of companies. ​
alarm conditions, and view and save HeartMate 3™ LVAS Contraindications: ‡ Indicates a third party
performance data. The HeartMate 3 Left Ventricular Assist trademark, which is property
Abbott System is contraindicated for patients who of its respective owner.​
One St. Jude Medical Dr. cannot tolerate, or who are allergic to, © 2020 Abbott. All Rights
St. Paul, MN 55117 USA anticoagulation therapy.​ Reserved.​
Tel: 1 651 756 2000 ​ eartMate 3™ LVAS Adverse Events:
H MAT-2007803 v1.0 | Item
[Link]​ Adverse events that may be associated with approved for U.S. use only.