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Perf Tech 3 > 9. VADs- Exam 2 > Flashcards

9. VADs- Exam 2 Flashcards

1
Q

year?
Carrell and Lindbergh and Demikhov
-Experimented with mechanical support in animal models

A

1930s

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2
Q

Year?
Gibbon
-1st use of CPB
-Inability to wean fueled interest in prolonged mechanical support in order to promote myocardial recovery

A

1953

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3
Q

year?
Spencer, et al.
-Reported using a roller pump to support a patient to recovery
-Roller pumps aren’t good VADS

A

1963

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4
Q

why are roller pumps not good VADs

A

Tethering
Blood trauma
Adjust pump speeds due to changes in heart pressures

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5
Q

year?
DeBakey
-1st successful clinical application of a true VAD
-Pneumatically driven diaphragm pump
-Paracorporeal= LA to Axillary Artery
-Supported for 10 days, weaned and discharged

A

1966

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6
Q

year?
Klaus, et al.
-Introduced the concept of atrial counter pulsation
–Rapid systolic unloading of the ventricle with diastolic augmentation

A

1960s

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7
Q

what did the introduction of atrial counter pulsation by Klaus in the 1960s lead to

A

Lead to the development of the balloon pump which was developed in 1963 and applied clinically in 1967

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8
Q

year?
Total artificial heart was used in a dog model
-Supported for 90 min

A

1958

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9
Q

year?

Reporting survival up to 24 hours with TAH

A

1962

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10
Q

year?
Cooley
-1st used a TAH to temporarily support a patient to transplant
-Implanted the “Liotta Heart” which was a pneumatic device
-Supported the patient for 64 hours

A

1969

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11
Q

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

A

University of Utah investigators

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12
Q 
for the 1st implanted TAH by the university of utah:
what was the name of the device?
what doctor performed the procedure?
name of the patient and their condition?
how long did it support the patient?
A
  • Jarvik 7 TAH
  • performed by Dr. William DeVries
  • Implanted into Dr. Barney Clark, 61 yo dentist with end stage idiopathic dilated cardiomyopathy. Died of complications from aspiration pneumonia, Renal failure, colitis with septicemia.
  • Was supported for 112 days.
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13
Q

how many patients received permanent TAH under FDA trial and what was the Longest survival

A

5 patients

620 days

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14
Q

who did the 1st planned TAH implant as a Bridge to Transplant (BTT)? year?

A

1985 – Copeland at the University of Arizona

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15
Q

what happened to the Syncardia, Cardiowest TAH from Tucson, AZ?

A

Device implanted in Tucson had issues with the manufacturer, so the FDA withdrew the FDA exemption for implantation

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16
Q

after the FDA withdrew the FDA exemption for implantation of the Syncardia, Cardiowest TAH, what happened to it

A

Drs. Olsen and Copeland revived the model
Modified and renamed – Cardiowest C70
Received FDA Approval as a BTT in 2004

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17
Q 
year?
Norman
-Device used for 5 days of support
-Intracorporeal pneumatic device
-Patient died of multi-organ system failure s/p transplant
A

1978

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18
Q

when did Transplantation became a widely applied therapy.

A

early 1980s

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19
Q

in the earlt 1980s when Transplantation became a widely applied therapy–how many patients died on the list

A

30%

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20
Q

year?
NIH sent out request for proposals
-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

A

1980

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21
Q

year?
Stanford University
-Oyer and Colleagues – Implanted the Novacor LVAD
-1st successful transplant s/p BTT with LVAD

A

9/1984

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22
Q

who followed Stanford University’s 1st successful transplant s/p BTT with LVAD

A

Followed by Hill and colleagues who implanted a Pearce-Donachey pneumatic LVAD

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23
Q 
year?
Frazier and colleagues
-1st to report successful BTT with Thoratec Heartmate IP VAD
-Implantable pneumatic
-Restored near normal hemodynamics
A

1992

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24
Q

what were the limitations to frazier and colleagues BTT with Thoratec Heartmate IP VAD

A
  • Devices dependent on large consoles for power and controller function
  • Patients confined to hospital until transplantation despite being fully ambulatory
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25
Q

year?
Kormos at University of Pittsburg
-Developed a program to transfer VAD patients to a monitored outpatient setting until transplantation

A

1990

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26
Q

year?
Frazier at Texas Heart Institute
-First to use an untethered vented electric LVAD for long term support

A

1991

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27
Q

describe the untethered vented electric LVAD Frazier did at Texas Heart Institute in 1991

A

Battery operated Heartmate VE
500 days of support
Patient died of embolic cerebral vascular accident

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28
Q

year?

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

A

1990s

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29
Q

year?

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

A

1994

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30
Q

what are some

A
  • Blood versus Foreign surface
  • Moving parts
  • Changes to patients anticoagulation and immune system over time in response to the mechanical pump
  • Pharmacologic modifications
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31
Q

why is Blood versus Foreign surface a Biological Barriers to VAD design

A

Blood contact surface cannot harm the patient

Minimum generation of blood clots

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32
Q

why is Changes to patients anticoagulation and immune system over time in response to the mechanical pump a Biological Barriers to VAD design

A

Coagulopathy immediately after implantation b/c of CPB
Period of hypercoagulability
Returning to baseline

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33
Q

why is Pharmacologic modifications a Biological Barriers to VAD design

A

(Heparin, Coumadin, ASA)

Need to anticoagulate on some level

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34
Q

Indications for VAD:

Bridge to Transplant=

A

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

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35
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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36
Q

name 5 contraindications for VADs

there are 14 on slide 17

A
  • Neurological deficits impairing the ability to manage device
  • Coexisting terminal condition
  • Abdominal aortic aneurysm (greater than 5 cm)
  • Active infection
  • Inability to tolerate anticoagulation
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37
Q

name 5 design musts

there are more on slide 18

A
  • Structurally stable in a corrosive saline environment
  • Operate continuously w/o regular maintenance for years.
  • Cannot fail under increased stress conditions
  • Reduce power requirements to save battery life
  • Must be efficient – reduce heat waste.
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38
Q

Positive Displacement VS Rotary Pump:

Flow and Pressure

A

Positive Displacement: Change volume in the chamber

Rotary: Rotating Impeller

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39
Q

Positive Displacement VS Rotary Pump:

Source of Energy

A

Positive Displacement: Air pressure/ Electricity

Rotary: Electricity

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40
Q

Positive Displacement VS Rotary Pump:

Size

A

Rotary is smaller with a smaller cannula

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41
Q

Positive Displacement VS Rotary Pump:

Prime Volume

A

Positive Displacement: Large Prime Volume

Rotary: Smaller Prime Volume

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42
Q

Positive Displacement VS Rotary Pump:

Flow Ranges

A

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

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43
Q

Positive Displacement VS Rotary Pump:

Afterload

A

Positive Displacement: Unaffected by changes in afterload

Rotary: Flow drops with increased SVR

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44
Q

Positive Displacement VS Rotary Pump:

Preload

A

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

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45
Q

how do Positive Displacement pumps work

A
  • Propels fluid by changing the internal volume of a pumping chamber. (Compression of a sac/membrane_
  • Provides pulsatile flow
  • Requires 1 way valves to produce forward flow
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46
Q

Positive Displacement pumps: flow

A

5-10 liters per minute

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47
Q

Positive Displacement pumps: mean BP

A

100-150 mmHg

48
Q

Positive Displacement pumps: rate (bpm)

49
Q

Positive Displacement pumps: Mean filling pressure

A

appx 20mmHg

50
Q

Thoratec PVAD/IVAD has been approved by the FDA for a BTT device since what year

51
Q

Thoratec PVAD/IVAD provides support for what

A

Provides support for the right, left or both ventricles

52
Q

what % of of LVADs will need an RVAD

53
Q

a BiVAD is common after what?

A 
transplant failure
postpartum Cardiomyopathy
Acute MI
Myocarditis
Used least with idiopathic CM and Ischemic CM
54
Q

According to the Thoratec Registry, __% received BiVAD support with hybrid RVAD and LVAD or Thoratec BiVAD

55
Q

BiVAD use has increased __% since 2000

56
Q

Preop risk factors for Right Heart Failure include?

A
  • Hemodynamics – Low CI with inc. RA pressure not necessarily an indicator of Rt. Heart failure. (May improve when LV is unloaded with LVAD)
  • Ability of RV to generate pressure
  • Low pulse pressure with high CVP – indicator of BiVAD
57
Q

Indicators of BiVAD include what 6 things

A
  1. Early insertion of LVAD before significant major organ dysfunction
  2. Higher pre-op bilirubin
  3. Higher pre-op creatinine
  4. Emergent Implant
  5. Intraop Bleeding
  6. Greater transfusion requirements increases pulmonary vascular resistance and promotes the development of right heart failure.
58
Q

why is Early insertion of LVAD before significant major organ dysfunction an indicator for a BiVAD

A

Less likely to need RVAD too

59
Q

why is Higher pre-op creatinine an indicator for a BiVAD

A

Normalize w/in 2-3 weeks after implant of VAD

60
Q

why is Post op bleeding is common for BiVAD patients

A

Related to the severity of hepatic failure

61
Q

Thoratec PVAD/IVAD: internal mechanics

A
  • 65 mL Stroke volume pump chamber
  • Made of Thoralon Polyurethane
  • 2 mechanical valves
  • Alternate positive and negative air pressure by console/ Portable driver
62
Q

Thoratec PVAD/IVAD: bpm and lpm

A

Beats 40-110 bpm

Flow is 1.3-7.2 Lpm

63
Q

Thoratec PVAD/IVAD: is placed where?

A
  • Placed in the anterior abdominal wall with cannulas crossing into the chest wall to connect the VAD to the heart and great vessels.
  • External location is suitable for use in smaller patients
  • BSA >0.73m2
64
Q

what are the 6 Pump considerations for Implant: Thoratec PVAD/IVAD

A
  1. Ideally use bicaval cannulation
  2. Normothermic
  3. 0w/o cardioplegia or XC
  4. LV Vented
  5. De-aired via LV Apex cannula before connecting to the VAD
  6. Ultrafiltrate to keep hematocrit greater than 30% (in case clotting factors are needed to assist coagulation)
65
Q

describe the Anticoagulation for Thoratec PVAD/IVAD

A

Chronic Warfarin Anticoagulation: INR= 2.5-3.5

  • Starts with heparin – PTT 1.5x baseline until GI function is stable and show low bleeding risk (10-14 days)
  • Switch to warfarin and ASA
66
Q

Worldwide survival from implant to transplant/ recovery:
RVADs %
BIVADs %
LVADs %

A
  1. 2% of RVADs
  2. 6% of BIVADs
  3. 8% of LVADs
67
Q

why can the PVAD be used in pediatrics

A

due to being paracorporeal

68
Q

how many peds patients as of 1/2005 have received a PVAD

69
Q

what are the adverse events to the PVAD

A

Thromboembolism

Hemorrhage (more common than in adults)

70
Q

what is the % survival rate for PVADs

71
Q

Intracorporeal VAD (or Implantable VAD)=

A

Used when longer term support is anticipated
Approved in 2004 by the FDA as a BTT or BTR
BSA >1.3m2 b/c of intracorporeal position

72
Q

how are IVADs different from PVADs

A 
Polished Titanium Body – makes it implantable
Reduced weight
339gms vs. 417 gms
Narrower Percutaneous leads
9mm vs. 20mm
73
Q

the Heartmate XVE has been placed in how many patients world wide

74
Q

benefits of the Heartmate XVE

A
  • Textured inner surface
  • Circulatory assistance without anticoagulation except an antiplatelet agent
  • Promotes pseudointimal layer= Limits thrombogenesis
75
Q

cons of the Heartmate XVE

A

Immunologically active

-Limit transplant candidacy due to increase in immunologic reactivity.

76
Q

describe the mechanics of the Heartmate XVE

A
  • Positive displacement pump
  • Made of titanium with a polyurethane diaphragm and a pusher plate actuator (which is responsible for producing mechanical energy).
  • Powered pneumatically: 9kg driver console, batteries (4-7hours of use)
77
Q

where is the Heartmate XVE cannulated

A
  1. Cannulate LV Apex (apical cannula)
    - Dacron conduit with 25mm porcine valve
  2. Cannulate ascending aorta
    - 20mm Dacron outflow graft with porcine valve
78
Q

Heartmate XVE: stroke volume

79
Q

Heartmate XVE: fixed vs auto mode

A
  1. Auto - SV maintained at 97% full. Flow – 4-10 Lpm

2. Fixed – stroke volume depends upon filling. Rate is adjusted manually to keep stroke volume between 70-80mL

80
Q

describe the pseudointima promoted by the Heartmate XVE

A
  • Thin layer of biologic matrix that resists thrombogenesis
  • Composed of cellular elements, collagen, and cells derived from circulating progenitor cells.
  • Immunologically active microenvironment
  • Heightened susceptibility to opportunistic infections
81
Q

describe the implantation of Heartmate XVE (6)

A
  • Dacron grafts must be pre-clotted
  • Placed intraperitoneal or in peritoneal pocket in left upper quadrant. Must go through diaphragm with cannulas
  • AI, MS and PFOs must be corrected at implantation
  • Requires CPB, No cardioplegia or cooling
  • BSA: >1.5m2
  • Anticoagulation – ASA only
82
Q

when do the bearing wear out on the Heartmate XVE

A

18-24 months

83
Q

with the Heartmate XVE, Vent filters are changed regularly and sent to Thoratec for evaluation. Why?

A
  • Test for signs of motor dust

- Excessive motor dust is an indication of bearing wear

84
Q

Heartmate XVE: BTT Survival

__% survive to transplant/ recovery. If they survive the first month, they have an __% chance of a successful outcome.

85
Q
  • DeBakey and Noon developed a small axial flow LVAD that went into clinical trials in ____
  • Followed by Jarvik 2000 in ____
  • Nimbus/ HMII axial flow pump in ____
A

1998
1999
2000

86
Q

how do Rotary pumps work

A

Uses rotating impellers to propel blood forward
Supported with bearings
Powered by spinning shaft/ magnetic forces

87
Q

describe the Micromed

A
  • Mini electromagnetically actuated titanium pump with ball and cup bearings weighing less than 93 grams
  • Has Elbow shaped inflow cannula, pump housing unit, dacro outflow, ultrasonic flow probe encircling outflow graft, flexible drive line to controller
88
Q

describe the development of the Micromed by Debakey

A
  • Collaboration between NASA engineers and Dr. DeBakey and Dr. George Noon
  • Established in 6/1996 with NASA license
  • Implanted in 1998 in Europe
89
Q

what is used for anti-coagulation for the micromed

90
Q

what are some management issues of micromed

A
  • Fibrin deposition on Impellar leading to thrombus formation=Could lead to pump stoppage or Back flow
  • Treatment is TPA and Heparin
  • Possible device change out
91
Q

when was the Heartmate II developed? describe the collaboration

A

early 1990s
Collaboration between engineers at Nimbus, Inc and Univeristy of Pittsburg
Initially developed thru NIH grant

92
Q

Heartmate II=

A

Axial flow device (2nd generation VAD)

Reduced size/ weight compared to XVE

93
Q

describe the internal mechanics of the heartmate II

A
  • Electric Motor
  • Rotor spins within magnetic field on inlet and outlet of bearings-Only moving part of pump
  • Dacron grafts may require pre-clotting
94
Q

with the heartmate II, Flow is an ESTIMATE and is not accurate under what floe

95
Q

where is the heartmate II implanted

A

Implant is below the L. Costal Margin under the rectus abdominus muscle
Leave LV Apex to diaphragm to pump

96
Q

when was the heartmate II approved as a Destination Therapy device.

97
Q

heartmate II 1 and 2 year survival %

A

Survival to 1 year was 68%

Survival to 2 years was 58%

98
Q

what the longest duration of use for the heartmate II

A

6+ years (patient still on device)

99
Q

bsa range for the heartmate II

A

BSA: 1.14-3.16m2

100
Q

heartmate II: ___% have either been transplanted, recovered or supported to 6 months

101
Q

when did the Randomized Evolution of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Trial start

102
Q

REAMATCH trial=

A
  • Provided evidence for FDA to approve the device for Destination Therapy in 2002
  • Medicare approved device for permanent implantation in 2003
  • Set the stage for multiple clinical trials of other devices as permanent therapy for heart failure
103
Q

VentrAssist=

A

3rd generation device (from Australia)

device development stopped due to lack of company funds

104
Q

Heartware HVAD=

A

Small continuous flow rotary pump with a centrifugal and non-contact bearing design

  • First human implant – 2006
  • Approved November 20, 2012
105
Q

where is the heartware HVAD implanted

A

Placed within the pericardial cavity at the apex of the LV

-No need for abdominal pocket

106
Q

DuraHeart LVAS=

A

By Terumo Heart, Inc.: 2nd gen

Continuous-flow rotary pump

107
Q

DuraHeart LVAS flow rate and motor speed

A

Flow rates of 2-8lpm

motor speeds of 1200-2400rpm

108
Q

Levacor VAD=

A

By WorldHeart Corp.

-Bearingless centrifugal pump with an impeller competely magnetically levitated

109
Q

where is the Levacor VAD implanted

A

Implanted in small subcostal, pre-peritoneal space

110
Q

Abiomed Impella 2.5/5.0=

A

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

111
Q

First completely self-contained replacement heart=

A

Abiomed Abiocor

112
Q

VAD Capable of pumping 12 liters per minute=

A

Abiomed Abiocor

113
Q

Tandem Heart=

A

10cc hydrodynamic centrifugal pump

  • Integrated motor
  • 21 pounds
  • 1 hour backup battery
114
Q

Tandem Heart flows

A

8LPM flow
Cannula dependent
-Tandem Heart transeptal cannula and 17fr arterial cannula = 5LPM

115
Q

Syncardia TAH=

A
  • After implant and stable, patient is moved to 1A , top of the list
  • 6 moving parts – inflow and outflow valves, and the diaphragm
  • All electronics outside the body
  • Utilizes a pneumatic driver
116
Q

syncardia TAH flows

A

9.5 liters per minute through both ventricles

117
Q

Berlin Heart=

A

December 16, 2011 – FDA approved Berlin Heart (Excor Pediatric System)

Perf Tech 3 (15 decks)

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