Ventricular Assist Devices Flashcards

1
Q

Carrell and Lindbergh and Demikhov

A

1930s Experimented with mechanical support in animal models

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2
Q

Gibbon

A

1953
O 1st use of CPB
O Inability to wean fueled interest in prolonged mechanical support in order to promote myocardial recovery

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3
Q

Spencer

A

1963 Reported using a roller pump to support a patient to recovery
O Roller pumps aren’t good VADS O Limitations
O Tethering, Blood trauma, Adjust pump speeds due to changes in heart pressures.

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4
Q

de bakey

A

1966 O 1st successful clinical application of a true
VAD
O Pneumatically driven diaphragm pump
O Paracorporeal O LA to Axillary Artery
O 37yo patient who could not be weaned from CPB s/p AVR/MVR
O Supportedfor10days O Weaned and Discharged

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5
Q

Klaus

A
  1. Introduced the concept of atrial counter
    pulsation
    O Rapid systolic unloading of the ventricle with diastolic augmentation.
    O Lead to the development of the balloon pump which was developed in 1963 and applied clinically in 1967.
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6
Q

1958–

A

O Total artificial heart was used in a dog model O Supported for 90 min.

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7
Q

1962

A

Reporting survival up to 24 hours with TAH

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8
Q

cooley

A

1969 – 1st used a TAH to temporarily support a patient to transplant O 47yo man with failure to wean from CPB s/p LV Aneurysm repair O TAH had only been tested for up to 12 hours in an animal model O Implanted the “Liotta Heart” which was a pneumatic device O Supported the patient for 64 hours.

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9
Q

first in the world to implant a permanent TAH on 12/2/1982.

A

university of Utah

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10
Q

Jarvik 7 TAH performed by

A

Dr. William DeVries

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11
Q

first person to receive TAH

A

Implanted into Dr. Barney Clark, 61 yo dentist with
end stage idiopathic dilated cardiomyopathy
O Died of complications from aspiration pneumonia, Renal failure, colitis with septicemia.
O Was supported for 112 days.

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12
Q

5 patients received permanent TAH under FDA trial

O Longest survival

A

620 days

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13
Q

– Copeland at the University of

Arizona

A
  1. 1st planned TAH implant as a Bridge to Transplant (BTT)
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14
Q

Syncardia, Cardiowest – Tucson, AZ

A

Drs.OlsenandCopelandrevivedthe
model
O Modifiedandrenamed–Cardiowest C70
O Received FDA Approval as a BTT in 2004

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15
Q

Norman

A

1978 Device used for 5 days of support O Intracorporeal pneumatic device O Patient died of multi-organ system failure s/p transplant.

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16
Q

Early 1980s

A

ansplantation became a widely applied therapy.
O 30% of patients died on the list
O Became an incentive to develop devices that could be used for patients with acute cardiac decompensation while awaiting transplantation.

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17
Q

1980–NIHsentoutrequestforproposals

A

To develop an “implantable, integrated, electrically powered left heart assist system” that could be used on a long term basis and allow extensive patient mobility.

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18
Q

9/1984–StanfordUniversity

A

Oyer and Colleagues – Implanted the Novacor
LVAD O 1st successful transplant s/p BTT with LVAD
O Followed by Hill and colleagues who implanted a Pearce-Donachey pneumatic LVAD.

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19
Q

1992 – Frazier and colleagues

A

1st to report successful BTT with Thoratec
Heartmate IP VAD O Implantable pneumatic
O Restorednearnormalhemodynamics.

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20
Q

limitations of thoratec heartmate ip

A

O Devicesdependentonlargeconsolesforpower and controller function
O Patients confined to hospital until transplantation despite being fully ambulatory.

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21
Q

Kormos at University of Pittsburg

A

1990 Developed a program to transfer VAD patients to a monitored outpatient setting until transplantation.

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22
Q

Frazier at Texas Heart Institute

A

1991 First to use an untethered vented electric LVAD for long term support
O 33y/opatient O Battery operated Heartmate VE O 500 days of support O Patient died of embolic cerebral vascular accident.

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23
Q

1990s – FDA sponsored

A

several multi- institution trials of assist devices as bridge to transplant and bridge to recovery.

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24
Q

1994 – Heartmate

A

LVAD was the first FDA approved implantable device for bridge to transplant.

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25
Q

Biological Barriers to VAD design

A

Blood versus Foreign surface
O Blood contact surface cannot harm the patient
O Minimum generation of blood clots

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26
Q

Changes to patients anticoagulation and immune system over time in response to the mechanical pump

A

O Coagulopathy immediately after implantation because of bypass
O Period of hypercoagulability
O Returning to baseline

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27
Q

Pharmacologic modifications

A

(Heparin, Coumadin, ASA)

O Need to anticoagulate on some level.

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28
Q

Indications for VAD

O Bridge to Transplant

A

Worsening hemodynamics despite high level of IV inotropic support and/or vasodilator therapy or refractor arrhythmias.

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29
Q

Indications for VAD Destination Therapy

A

Patients who are not transplant candidates. Have an EF less than 25% and NYHA Class IV symptoms despite optimal therapy.

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30
Q

Contraindications

A

High surgical risk O Recent/evolving stroke O Neurological deficits impairing the ability to manage device O Coexisting terminal condition O Abdominal aortic aneurysm (greater than 5 cm) O Active infection O Fixed pulmonary hypertension O Severe pulmonary dysfunction O Multisystem organ failure O Inability to tolerate anticoagulation O HIT O Psychiatric illness O Lack of social support O pregnancy

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31
Q

design requirements

A

Devices need to be configured for their eventual application
O Shorter term versus partial assist versus long term support versus total support.
O Different uses and device requirements impact design. O Anatomicallycompatible
O Used over large variations in body mass, chest size/ shape, abdominal girth, etc.
O Structurally stable in a corrosive saline environment O Operate continuously without regular maintenance for
years. O Cannot fail under increased stress conditions O Reduce power requirements to save battery life O Must be efficient – reduce heat waste.

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32
Q

2 different types of pumps

A

Positive displacements O Usually pneumatic

O Rotary

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33
Q

Comparison of Pump Types

Prime Volume:

A

Positive Displacement: Large Prime Volume O Rotary: Smaller Prime Volu

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34
Q

flow ranges for different pump types

A

Both plagued with thrombosis with decreased flow and hemolysis with increased flow

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35
Q

afterload differences between pumps

A

Positive Displacement: Unaffected by changes in

afterload O Rotary: Flow drops with increased SVR

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36
Q

preload differences between pumps

A

Positive Displacement: Passive filling, output
follows venous return
O Rotary: Flow increases with increased VR, but no active suction applied

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37
Q

Positive Displacement pumps

O Propels fluid by

A

changing the internal volume of a pumping chamber.

O Compression of a sac/membrane, etc. O Provides pulsatile flow O Requires 1 way valves to produce forward flow

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38
Q

Positive Displacement pumps specs

A

Flow is about 5-10 liters per minute O Mean bp = 100-150 mmHg O Rate is <120 bpm O Mean filling pressure is appx 20mmHg.`

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39
Q

Thoratec PVAD/IVAD

A

FDA Approved as a BTT since 1995 O Provides support for the right, left or both
ventricles.

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40
Q

10% of thoratec Lvad will need

A

RVAD

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41
Q

BiVAD is common after

A

transplant failure, postpartum Cardiomyopathy, Acute MI, Myocarditis. Used least with idiopathic CM and Ischemic CM.

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42
Q

According to the Thoratec Registry, 25% received BiVAD support with

A

hybrid RVAD and LVAD or Thoratec BiVAD.

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43
Q

BiVADusehasincreased

A

18%since2000.

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44
Q

Preop risk factors for RHF

A

Hemodynamics – Low CI with inc. RA pressure not necessarily an indicator of Rt. Heart failure.
O May improve when LV is unloaded with LVAD
O Ability of RV to generate pressure
O Low pulse pressure with high CVP – indicator of BiVAD

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45
Q

Indicators of BiVAD

A

Early insertion of LVAD before significant major organ dysfunction
O Less likely to need RVAD too. O Higher pre-op bilirubin O Higher pre-op creatinine
O Normalize w/in 2-3 weeks after implant of VAD O Emergent Implant O Intraop Bleeding
O Greater transfusion requirements increases pulmonary vascular resistance and promotes the development of right heart failure.
O Post op bleeding is common for BiVAD patients O Related to the severity of hepatic failure

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46
Q

Thoratec PVAD/IVAD STROKE VOLUME

A

65 mL

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47
Q

Thoratec PVAD/IVAD BEATS/FLOW

A

40-110bpm, 1.3-7.2Lpm

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48
Q

THORATEC PVAD/IVAD placed

A

the anterior abdominal wall with cannulas crossing into the chest wall to connect the VAD to the heart and great vessels. Externallocationissuitableforuseinsmallerpatients O BSA >0.73m2

49
Q

THORATEC PVAD/IVAD actuated by

A

DDC for in hospital use and portable TLCII for ambulatory use
O TLCII approved in 2003

50
Q

Pump considerations for Implant: Thoratec PVAD/IVAD

A

Ideally use bicaval cannulation O Normothermic O w/o cardioplegia or XC O LV Vented
O De-aired via LV Apex cannula before connecting to the VAD
O Ultrafiltrate to keep hematocrit greater than 30% (in case clotting factors are needed to assist coagulation)

51
Q

Anticoagulation : Thoratec PVAD/IVAD

A

Chronic Warfarin Anticoagulation
O INR=2.5-3.5
O Starts with heparin – PTT 1.5x baseline until GI function is stable and show low bleeding risk (10-14 days)
O Switch to warfarin and ASA

52
Q

Thoratec IVADs

A

Intracorporeal VAD (or Implantable VAD) O Used when longer term support is anticipated O Approved in 2004 by the FDA as a BTT or BTR O BSA>1.3m2b/cofintracorporealposition

53
Q

Thoratec IVADs Difference from PVAD

A

Polished Titanium Body – makes it implantable O Reducedweight
O 339gms vs. 417 gms O Narrower Percutaneous leads O 9mm vs. 20mm

54
Q

Heartmate XVE

O Placed in

A

5000 patients worldwid

55
Q

Heartmate XVE Textured inner surface

O Circulatoryassistancewithout

A

anticoagulation except an antiplatelet agent

56
Q

Heartmate XVE Promotes

A

Promotes

57
Q

Heartmate XVE CON

A

mmunologicallyactive

O Limit transplant candidacy due to increase in immunologic reactivity.

58
Q

WHAT TYPE OF PUMP IS HEARTMATE XVE

A

Positive displacement pump
O Made of titanium with a polyurethane diaphragm and a pusher plate actuator (which is responsible for producing mechanical energy).

59
Q

HOW IS HEARTMATE XVE POWERED AND CANNULATION TECHNIQUE

A

Powered pneumatically (emergency) or electrically
O Cannulate LV Apex (apical cannula) O Dacron conduit with 25mm porcine valve
O Cannulate ascending aorta O 20mm Dacron outflow graft with porcine valve

60
Q

Heartmate XVE

O Pneumatic

A

Uses 9kg driver console

O Small emergency hand pump O Actuatespusherplateviadriveline

61
Q

Heartmate XVE Electric Motor

A

Rotates and displaces pusher plate
O Air that is displaced by the diaphragm is vented to the atomosphere
O Wherethehandpump/pneumaticdriverplugsin. O Vent filter in place with electric motor operation.

62
Q

Heartmate XVE POWER

A

2 batteries (4-7hours of use) O External controller

63
Q

Heartmate XVE

O Stroke Volume

A

83mL

64
Q

Heartmate XVE MODES

A

Fixed and Auto Modes. Auto - SV maintained at 97% full O Flow–4-10Lpm
O Fixed – stroke volume depends upon filling
O Rate is adjusted manually to keep stroke volume between 70-80mL

65
Q

Heartmate XVE

O Psuedointima

A

Titaniummicrospheresandfibrillartextured
surface O Promotespseudointima
O Thin layer of biologic matrix that resists thrombogenesis

66
Q

Heartmate XVE

O Psuedointima COMPOSED OF

A

cellular elements, collagen, and cells derived from circulating progenitor cells.
O Immunologically active microenvironment
O Heightened susceptibility to opportunistic infections.

67
Q

Heartmate XVE

O Implantation

A

Dacron grafts must be pre-clotted
O Placed intraperitoneal or in peritoneal pocket in left upper quadrant
O Must go through diaphragm with cannulas O Percutaneous leads exit to the right O AI and MS must be corrected at implantation O PFOs must be closed at implanation O Requires CPB O No cardioplegia or cooling O BSA: >1.5m2 O Anticoagulation – ASA only

68
Q

Heartmate XVE

Identification of pump malfunctions is important because

A

Bearings wear out in 18-24 months
O Requires replacement
O Vent filters are changed regularly and sent to Thoratec for evaluation
O Test for signs of motor dust
O Excessive motor dust is an indication of bearing wear
O Other signs of bearing wear/ failure O Increaseincurrentusage O Change of pump motor sounds/ rhythm
O If pump shows signs of wear, patients must be admitted in case of failure
O Pneumatic driver at bedside.

69
Q

Heartmate XVE: BTT Survival

A

65% survive to transplant/ recovery O If they survive the first month, they have an
85% chance of a successful outcome. O Success is related to patient selection:
O LVAD screening scale

70
Q

Heartmate XVE

O Limitation to XVE

A

O Devicemalfunction

71
Q

Rotary VAD in _____ 1st described continuous flow circulatory pumps.

A

1960

72
Q

developed a small axial flow LVAD that went into clinical trials in 1998.

A

DeBakey and Noon

73
Q

axial flow LVAD was followed by

A

Jarvik 2000 in 1999. O Nimbus/ HMII axial flow pump in 2000.

74
Q

Rotary pumps

O Uses

A

rotating impellers to propel blood forward

O Supported with bearings O Powered by spinning shaft/ magnetic forces

75
Q

Micromed

advantages

A
limited contact surface area
O Fewer moving parts
O Reduces cost
O Potentially more
durable? Expands the pool of qualified patients
O	Simplifies implantation
76
Q

micromed design

A

O Axial flow design O Smaller size

77
Q

Development of Micromed- DeBakey

O Collaboration between

A

NASA engineers and Dr. DeBakey and Dr. George Noon
O Establishedin6/1996withNASAlicense O Implanted in 1998 in Europe
O Clinical evaluations as a BTT in Europe and the US

78
Q

Micromed- DeBakey DESCRIPTION

A

Mini electromagnetically actuated titanium pump with ball and cup bearings weighing less than 93 grams
O Has Elbow shaped inflow cannula, pump housing unit, dacro outflow, ultrasonic flow probe encircling outflow graft, flexible drive line to controller.

79
Q

Micromed- DeBakey anticoagulation

A

Coumadin

80
Q

Heartmate II what type of device

A

Axial flow device (2nd generation VAD)

O Reduced size/ weight compared to XVE

81
Q

Heartmate II developed in_____ by______

A

theearly1990s O Collaboration between engineers at Nimbus, Inc and
Univeristy of Pittsburg O Initially developed thru NIH gran

82
Q

Heartmate II motor

A

Electric Motor O Rotor spins within magnetic field on inlet
and outlet of bearings O Only moving part of pump
O Dacron grafts may require pre-clotting

83
Q

heartmate 2 power and flow

A

PBU for power and to charge batteries
O Same system monitor and PBU as HM XVE
O Flow is an ESTIMATE

84
Q

heart mate 2 flow estimate because

A

Relationship between pump motor RPM speed and time-varying electrical power consumption of pump motor
O Not accurate when flow is less than 3LPM

85
Q

Heartmate II

O Implant is below

A

the L. Costal Margin under the rectus abdominus muscle

O Leave LV Apex to diaphragm to pump

86
Q

heartmate 2 issues

A

Thrombus formation

O See abnormal power increase unrelated to change in pump flow

87
Q

heart mate 2 Other variations

A

Jarvik 2000

88
Q

Ventr Assist

A

Ventracor Ltd, NSW, Australia O 3rd generation device. Sadly, device development stopped due to lack of company funds.

89
Q

Heartware HVAD

A

Small continuous flow rotary pump with a centrifugal and non- contact bearing design.
O Impellar is held in place by passive magnetic and hydrodynamic bearing systems, avoiding mechanical contact and wear.
O Physical contact between the housing and the impeller is prevented by thin blood film generated by the hydrodynamic bearings.

90
Q

Heartware HVAD placed in

A

pericardial cavity at the apex of the LV O No need for abdominal pocke

91
Q

DuraHeart LVAS by

A

Terumo Heart, Inc. O 2nd gen (DH II) Acquired by Thoratec July 2013

92
Q

DuraHeart LVAS type of flow

A

continuous rotary

93
Q

duraheart LVAS upper housing

A

levitation system and impeller

94
Q

duraheart LVAS BOTTOM housing

A

containing the external-drive motor

95
Q

duraheart LVAS FLOW RATES

A

2-8lpm with motor speeds of 1200-2400rpm.

O Flow rate can vary with physiological changes

96
Q

duraheart LVAS First device to reach clinical trial that combined

A

centrifugal pump and magnetic levitation technology

97
Q

duraheart LVAS Placed in

A

abdominal pocket

98
Q

Levacor VAD

O By

A

WorldHeartCorp.

99
Q

Levacor VAD TYPE OF PUMP

A

Bearinglesscentrifugalpumpwithanimpellercompetely

magnetically levitated.

100
Q

LEVACOR VAD Implanted

A

in small subcostal, pre-peritoneal space

101
Q

Feb 9, 2011 – announced a pause to the study pending FAA

review of “device refinements”

A

Projections of the inflow cannula into the ventrical
O Elimination of false alarms leading to controller change outs
O Optimization of surface finishing/ coating manuracturing processes

102
Q

Abiomed Impella 2.5/5.0

A

Intracatheter VAD
O Can pump 2.5/5.0 Lpm
O Pulls blood from the LV tip to the aorta.

103
Q

Abiomed Abiocor

O First completely

A

self- contained replacement heart

104
Q

Abiomed Abiocor capable of pumping

A

12 liters per minute

105
Q

Abiomed Abiocor motor and battery

A
Internal motor O Internal rechargeable
battery
O External battery pack
O Labeled as a destination device???
O FDA Approval under an HDE
106
Q

Tandem Heart

A

10cc hydrodynamic centrifugal pump

O Integratedmotor

107
Q

Tandem Heart flow

A

8LPM flow
O Cannuladependent O Tandem Heart transeptal cannula
and 17fr arterial cannula = 5LPM

108
Q

Tandem Heart floats on

A

fluid bearing

109
Q

tandem heart saline drip

A

10cc/hr saline drip into lower chamber

O Cools and lubricates

110
Q

Tandem Heart controller

A

Step by step setup on screen
O 21 pounds O Mounts on standard iv pole at
bedside

111
Q

Tandem Heart battery backup

A

1 hour

112
Q

tandem heart other characteristics

A

Transonic flow probe
O Selfdiagnostic O Displays alarms and problems
O Integrated air bubble detector

113
Q

Syncardia TAH flow

A

9.5 liters per minute through both ventricles

114
Q

Syncardia TAH after implant is stable

A

fter implant and stable, patient is moved to

1A , top of the l

115
Q

syncardia device failures

A

In 30 years, no device failures

116
Q

syncardia electronics

A

all outside body

117
Q

syncardia driver

A

pneumatic

118
Q

Berlin Heart FDA approved in

A

2011

119
Q

Berlin heart originally used as

A

for compassionate use
O Apply for approval, order from Germany
O Now can stock all sizes of devices in hospitals
O Bridge to Transplant