LVAD types - aldmd

VentrAssist
Left Ventricular Assist Device
Operation and Patient Management
VA-LVA3
DDD32329 Rev 1.0
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
1 st generation:
Pulsatile, with
valves, volumedisplacement
eg
Thoratec®,
Novacor®,
HeartMate I ®
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
LVAD
types
2 nd generation:
Small axial flow
pumps eg
HeartMate® II,
DeBakey VAD®,
and Jarvik 2000®
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
3 rd generation:
Rotary pumps with
non-contact
bearings
VentrAssist
1
Introduction
Introduction
2
Implanting the
pump
3
How the pump
works
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Clinical trials
•Contraindications
4
Other system
components
5
Patient
management
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
6
Medical
Emergencies
! primary right ventricular failure or primary pulmonary
hypertension
! recurrent ventricular arrhythmias
! active coagulopathy or infection
! mechanical heart valves
! severe valvular regurgitation
*see manual for complete list of criteria

1
Implanting the pump
Introduction
2
Implanting the
pump
3
How the pump
works
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Implant procedure
• on bypass
• pump positioned in left subdiaphragmatic
pocket
• native heart is not removed
• inflow cannula - left ventricular apex
• outflow cannula - ascending aorta
• percutaneous lead exits right
abdomen below ribs
4
Other system
components
5
Patient
management
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
6
Medical
Emergencies
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Inflow cannula
Choice of 40 or 60mm
length
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

Outflow cannula
Trim to correct
length
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Blood pump
• small size
• single moving part - rotor
• no shafts, seals, valves or
diaphragms
• titanium construction
• diamond-like carbon coating
• hydrodynamic suspension
(rotor is suspended by the
blood within the pump)
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
1
How the pump works
Introduction
2
Implanting the
pump
3
How the pump
works
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Drive system
• rotor contains high-strength magnets
• controller delivers electricity to copper
coils via percutaneous lead
• magnetic forces from the coils make the
rotor spin
4
Other system
components
5
Patient
management
Fig 2. Rotor within pump
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
6
Fig 1. Magnets and copper coils
Medical
Emergencies

The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
VentrAssist components
• implantable blood pump
• powered via a percutaneous lead
• battery or AC (mains) power supply
• laptop PC for clinician use
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
1
Other components
Introduction
2
Implanting the
pump
3
How the pump
works
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
4
Other system
components
VentraView Software
5
Patient
management
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
6
Medical
Emergencies

1
Introduction
Wearables
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Patient Management
2
Implanting the
pump
3
How the pump
works
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
4
Other system
components
5
Patient
management
6
Medical
Emergencies
Alarms*
Alarms are grouped according to priority:
Red light with continuous tone – high
Orange light with continuous beep – medium
Green light with intermittent beep – low
*see manual for detailed alarm information
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Hemodynamic targets*
• adequate systemic perfusion
• estimated LVAS flow 4.5 – 6 L/min
• doppler MAP 70 – 95 mmHg
• CVP 10 - 15 mmHg
• hemoglobin ! 10 g/dL (100 g/L)
*These values are guidelines only. Treating physician should adjust for individual patients
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

How flow is estimated
• Flow is estimated from known:
• pump speed
• pump power
• blood viscosity (hematocrit = HCT)
• Accurate flow estimate depends on correct HCT range being
entered
• Extremely high flows with no apparent cause are suspicious of pump
problems
Hb (g/L) X 0.3 ~ HCT eg. Hb 100 X 0.3 ~ 30
Hb (g/dL) X 3 ~ HCT eg. Hb 10 X 3 ~ 30
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Effect of treatments on flow
Pump is preload-dependent and afterload-sensitive
If preload remains the same but ! afterload, flows "
If ! preload and afterload remains the same, flows !
Any treatment which ! cardiac output should !
pump output
eg Inotropes, intravascular filling, pacing
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Assistance provided by the pump
Flow depends on:
• volume (coming into the pump)
• pressure (preload and afterload)
• speed (of the pump)
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Right Heart Support
• Minimize blood products
• Blood products =
"RV distension
"Release of proinflammatory cytokines = PH
"RV has to work harder, " difficulty moving blood to LV
"liver congestion – cycle
"Possibility lead to hypercoaguability
• Support right heart with inotropes
• Lower right heart afterload
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

Setting pump speed
• At low speeds, relief of heart failure symptoms
may not be maximized
• At high speeds, the risk of ventricular suction is
increased
• Examine the LV under echocardiography as the
speed is changed
• Speed adjustments usually made under medical
supervision
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Pulsatility Index (PI)
• typical range 20-45
(normal range for patient depends on cardiac function)
! contractility = ! PI
" contractility = " PI
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Clinical Indices
• Pulsatility Index (PI)
• Overpumping Index (OI)
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Overpumping Index (OI)
• indicates likelihood of overpumping
• sudden drops or spikes indicate possible problems
• typical values 50-65
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Pump Speed (rpm)
high
low
Suckdown
Ideal PI range
LVF symptoms
low
high
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Pulsatility Index (PI)

The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Underpumping
Clinical signs:
• elevated PI
• LVF on echo or XRay
• acute pulmonary edema
• pleural effusion
• respiratory insufficiency
• reduced peripheral perfusion
Management:
Increase pump speed
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
PI – Pump Speed relationship
Pulsatility Index (PI)
High
Low
Average
ventricle
Low
Poor ventricle
Good ventricle
Pump Speed (rpm)
High
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Overpumping
• PI trends down with a corresponding drop/loss of OI
•PI>OI (crossing over)
•PI changing erratically or spiking
Clinical signs:
• #CVP & PCWP
• $ blood pressure
• arrhythmias esp. ventricular
• $ pulsatility of flow on auscultation
• chest pain
Management:
Decrease pump speed
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Hemolysis
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
• risk due to mechanical damage to
blood cells which release
hemoglobin into plasma
• damages organs (ie. kidneys)
• plasma free Hb measurements
daily in ICU
Normal range:

Antibiotic cover
• All patients must have prophylactic antibiotics covering
gram positive and negative organisms
• Add antifungal therapy in conjunction with broad
spectrum antimicrobial coverage
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Anticoagulation
• Unfractionated Heparin commenced when patient
normothermic and bleeding

Regular management
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Wound Care
Percutaneous lead exit site care is vital to patient’s
outcome
• Belt to be worn within 24 hours post-op
• Dry dressing – allow wound to breathe
• eg Gauze, Primapore, Telfa Island
• Do not use an occlusive dressing
• eg Tegaderm, Opsite
• No showering until the exit site is completely healed, usually 3-
4 weeks
• Restrict showering to once per week thereafter
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Dressing the exit site
• Meticulous sterile technique – wear masks, 3 min hand scrub
• Protocol:
%Week 1: change dressing twice per day
%Week 2: change dressing daily
%Week 3-4: if drains out + wound clean and dry, change dressing
3 x per week
%Change dressing weekly thereafter if no drainage or sign of
infection
• If ANY sign of infection (redness, increased drainage, patient
pulls or moves drives line) administer antibiotics and increase
dressing changes to three daily for one week then reassess
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

Exit site: immobilization
Immobilization at exit
site and anchoring lead
are essential:
• promotes tissue ingrowth
• minimizes tissue injury
• reduces infection risk
1
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Medical Emergencies
Introduction
2
Implanting the
pump
3
How the pump
works
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
4
Other system
components
5
Patient
management
6
Medical
Emergencies
Percutaneous lead care
Damage to internal phase wires may be irreparable.
Avoid damage to the lead:
• kinking
• strain
• cleaning solutions
• other equipment eg XRay machine
Percutaneous lead damage
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Medical Emergencies
• ventricular suction
• defibrillation/CPR
• stopped pump
• controller change
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)

Ventricular suction
Act promptly:
• pump speed to 1800rpm
• flows should rise ! 2 L/min*
• improve RV output using standard therapy
*If output still

Defibrillation
Event:
• cardiac arrest
• defibrillation
• elective DCR
Corrective actions:
• activate CPR mode
• switch to battery power only
• perform resuscitation
• exit CPR mode and adjust
pump speed when pt stable
**Note: Laptop need not be disconnected prior to defibrillation/CPR**
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Changing controller
Adverse events:
• ‘backup control active’ alarm*
• ‘no pump’ alarm
• ‘pump stopped’ alarm
• no display on controller and pump
status uncertain after auscultation*
Procedure:
• swap connections in order:
grey, red, orange, black
(G - R - O - B)
• auscultate pump
• monitor pump via laptop until
patient stable
*Change controller immediately if any of these alarms occur and patient is compromised
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
Stopped Pump
Considerations:
• thrombus formation likely -
consider anticoagulant bolus
• restarting pump may cause
embolization
Summary
• Centrifugal pump
Corrective actions:
• confirm pump has stopped
(alarm, auscultation, patient
compromised)
• check all connections to controller
• change controller
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)
• Preload-dependent and afterload-sensitive
• PI, OI and auscultation are indicators of optimum pump
speed
• Exit site dressing and immobilization are of vital importance
The contents of this document are confidential and are not to be reproduced or made available to third parties without prior consent from Ventracor.
Caution: Investigational device - this device is limited by law to investigational use only in the US, Australia and NZ (under Federal Law in the US)