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Title: TheTotal Artificial Heart:


1
TheTotal Artificial Heart An Evolving Role in
the Management of End-Stage Heart Failure
Marvin J. Slepian, M.D. Sarver Heart
Center University of Arizona Tucson, Arizona
2008 - Brigham and Womens
2
Heart
Vital importance recognized for millenia 1528
Harvey Description of function 12,000 y o Cave
paintings in Spain Valentine Center of the
spirit Symbol of courage and Love Chinese
Organ of intellect Egypt Center of
conscience Plato Center of the soul Old and
New testament Aztecs Sacrificial organ
3
Congestive Heart Failure (CHF)
Final common pathway of most heart disease 5
million patients in USA 500,000 new cases
diagnosed/yr Incidence of advanced CHF increases
with age 80 of hospitalization in patients gt 60
yo High Mortality rate 5 yr mortality 75
male, 62 female (Framingham) NYHA Class
IV 75 mortality at 2yrs. Economic impact 20
Billion/yr.
4
Epidemiology of Heart Failure
5
Classification of HF Comparison Between ACC/AHA
HF Stage and NYHA Functional Class
ACC/AHA HF Stage1
NYHA Functional Class2
A At high risk for heart failure but
without structural heart disease or symptoms of
heart failure (eg, patients with hypertension or
coronary artery disease)
None
B Structural heart disease but without symptoms
of heart failure
I Asymptomatic
C Structural heart disease with prior or current
symptoms of heart failure
II Symptomatic with moderate exertion
III Symptomatic with minimal exertion
IV Symptomatic at rest
D Refractory heart failure requiring specialized
interventions
Carvedilol is indicated for use in patients with
mild to severe chronic HF and in patients with
HTN. 1Hunt SA et al. J Am Coll Cardiol.
20013821012113. 2New York Heart
Association/Little Brown and Company,
1964. Adapted from Farrell MH et al. JAMA.
2002287890897.
6
PROFILE-LEVEL Pts Yr 1 Official Shorthand General time frame for support
INTERMACS LEVEL 1 82 Crash and burn Hours
INTERMACS LEVEL 2 81 Sliding fast Days to week
INTERMACS LEVEL 3 18 Stable but Dependent Weeks
INTERMACS LEVEL 4 9 Frequent flyer Weeks to few months, if baseline restored
INTERMACS LEVEL 5 4 Housebound Weeks to months
INTERMACS LEVEL 6 3 Walking wounded Months, if nutrition and activity maintained
INTERMACS LEVEL 7 4 Advanced Class III
7
Congestive Heart Failure (CHF)Therapeutic
Options
Mild to Moderate CHF (NYHA Class I,II) Drug
Therapy ACE inhibitors, AR blockers Diuretic
s, Spironolactone Digitalis, Nitrates Beta
Blockers Severe and End Stage (NYHA Class III,
IV) BiV Pacing, ICD Drugs IV inotropes
Cardiac transplantation Devices - IABP, VADs,
TAH
8
Advanced/End-Stage CHFPatient groups
Advanced ischemic cardiomyopathy Advanced dilated
cardiomyopathy Cardiogenic shock Chronic CHF
with critical low output Post-MI Postcardiotomy
Chronic CHF - IV inotrope dependent Chronic CHF,
Class IV po Tx, low Na, hi BUN/Cr CHF with
refractory Ventricular arrhythmias Post-transplant
graft dysfunction
9
Accelerated Mortality Advanced CHF
NYHA Class IV 75 mortality at 2yrs.
10
Heart Transplantation
  • 125 US centers (75 in the rest of the world)
  • 2500 heart transplants performed in the US/yr
  • 1500 in the rest of the world
  • 1 year survival rate approaching 85, 5 year 70
  • 8000 pts/yr listed
  • A chronic shortage of donors exists/ timing issue
  • Many transplant-eligible patients die waiting
  • on the UNOS transplant list

11
UNOS Waiting ListDeaths/Patient Year
2004 14.7
1000 - 1200 patients/yr
12
Ventricular Support Concepts
TAH Replaces both ventricles.
LVAD Supports the left ventricle only.
13

Cardiac SurgeryAdvanced Heart Disease Early
1960s
Cardiac Transplantation
Cardiac Replacement
Advanced Heart Disease
Artificial Heart (TAH)
14
Advanced Heart DiseaseReplacement Tx
2 Camps
Cardiac Transplantation Barnard Kantrowitz Shumway
Bioprosthetic Artificial Organ (TAH) DeBakey Coole
y
15
Heart Transplantation
First Heart Transplant - December 3, 1967 (18d
survival) Groote Schuur Hospital, Cape Town,
South Africa 2nd Heart TX, Philip Blaiberg (563
d survival)
Dr Christian Barnard
Louis Washkansky (55)
16
December 15, 1967
17
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18
Cardiac Transplantation1970
170 Transplants - multiple medical centers 146
Deaths 17 survival rate
19
September 17, 1971
20
Willem Kollf MD PhD
Univ of Groningen (Holland) Cleveland Clinic Univ
of Utah
21
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22
1969 Akutsu Liotta
23
Theft, unethical, betrayal childish act
24
DeBakey MicroMed VAD
NASA
25
Over-Hyped Media Expectations
September 1981
26
December 2, 1982
27
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28
December 2, 1982 Barney Clark, a 61-year-old
retired dentist, becomes the first person to
receive a permanent artificial heart. In an
operation at the University of Utah Medical
Center in Salt Lake City, doctors replace Clark's
dying heart with an artificial heart made of
plastic named the Jarvik-7 after its creator, Dr.
Robert Jarvik. The artificial heart is slightly
larger than a human heart, but weighs about the
same. It is connected by hoses to its power
supply - a 375-pound external air compressor
carried in a large cart.
29
Total Artificial HeartsAlternative Designs
1969 LIOTTA
1981 AKUTSU
1985 PHOENIX
Early Designs ONE TIME USE
PENN STATE
BERLIN
BRNO
POISK
UNGER
4 IMP,1 TX 0 D/C
7 IMP, 2 TX 0 D/C
6 IMP, 3 TX 0 D/C
16 IMP, 3 TX 2 D/C
4 IMP, 2 TX 0 D/C
30
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31
Cyclosporin
June 13, 1972 discovered Approved 1983
11aa cyclic peptide
32
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33
Too Big A Leap!
34
Phoenix Heart Thomas Creighton
March 3, 1985
33 yo Auto mechanic MI x 2 Tx - failed
acutely CPR CPB 7h 41min Called for TAH Phoenix
implanted 11h 2nd HTX Shock Lung
35
Phoenix Heart March 1985
36
After the Phoenix Heart
37
Utah (Jarvik) 7-70 TAH
38
First Successful Bridge to Transplantation With
TAH (SYMBION Jarvik 7)
1985 MICHEAL DRUMMOND 9 DAYS
Mark Levinson Jack Copeland, Michael Drummond,
Richard Smith, August, 1985 (Time Magazine)
August 29, 1985
39
First Bridge to Transplantation in the World
1985 (going home)
All national television networks present at
University Medical Center, Tucson, Arizona
40
Michael Drummond 1986
41
1987 FDA Shut-Down of Symbion
Jarvik - CEO Credibility gap with the
FDA (submissions, conduct) Lack of planning and
control many false starts lack of management
depth lack of focus poor documentation
The Rock and Roll Heart of Robert Jarvik
42
Pfizer to End Lipitor Ads by Jarvik
TUESDAY, FEBRUARY 26, 2008
http//www.nytimes.com/pages/business/index.html
43
End-Stage CHF Cardiac Replacement
Moratorium Stanford/MCV
Initial Human Experience
Immunospression Cyclosporin
TX
1o Therapy
FDA Approval 2004
1st Successful BTT TAH 85 (Copeland)
POP Human 1 (Cooley 69)
Initial Destination Tx TAH (Devries)
1o Tx BTT BiVF
POP Human 1 (Cooley 81)
TAH
TAH IDE Study
HALT Political Societal Roadblock
1960
1990
2000
1970
1980
1979 Jarvik TAH
1993 CardioWest TAH
1959 Akutusu TAH
Slepian Univ of Arizona
44
CardioWestTM TAH History
  • Evolved from Univ. Utah / Jarvik
  • Significant early clinical experience
  • J7-100 TAH 44 patients / 6 patient years
  • J7-70 TAH 159 patients / 11 patient years
  • 1991 Tech transfer to Univ. of Arizona
  • Developed under CardioWest Technologies Inc.
  • 1993-2002 IDE trial
  • 1998 European CE approval
  • 2001 SynCardia founded
  • 2004 FDA approval

45
2000 SynCardia
Mission To complete the development and obtain
regulatory approval for the CardioWest TAH.
To complete the job.
Focus Quality system Technical Trial
completion PMA submission FDA approval CMS
46
Spectrum of Mechanical Support
BiVentricular Replacement/ Total Heart
GAP
CO
Ventricular Assist Device
IABP
47
CardioWestTM TAHAdvantages over LVAD
  • Complete biventricular replacement/performance
  • TAH obviates the following native heart issues
    that could affect a patient on a LVAD
  • 1) Arrhythmias
  • 2) Right ventricle function
  • Prosthetic Aortic Valve
  • Thrombus in ventricle
  • 5) Septal defects

48
Bi-Ventricular Failure
Initial presentation of CHF is frequently LV
failure RV failure (bi-ventricular) progresses
with time Eventually all LV failure pts develop
varying degrees of RV failure gt 50 of Class IV
CHF pts have RV failure RV failure often
occurs/declared once pt is on an LVAD
49
TAH Advantages
3
2
  • Decreased CVP
  • Overcome PA
  • Cardiac output
  • 4) Organ Recovery

1
4
50
SynCardia CardioWestTMTotal Artificial Heart
System
Implantable Full Cardiac Replacement Full
Normalization of Hemodynamics CE Approved -
Europe FDA approved - USA
51
SynCardia CardioWestTMTotal Artificial Heart
System
Implantable TAH
External Console
Drivelines
52
SynCardia CardioWestTM vs AbiocorTM TAH
53
CardioWestTmTotal Artificial Heart
  • Stroke volume 70 milliliters
  • Inflow valve 27 millimeter Medtronic-Hall
  • Outflow valve 25 millimeter Medtronic-Hall
  • Seamless blood diaphragm
  • Four(4) flexible polyurethane diaphragms
  • Maximum output gt9 liters per minute
  • Weight 180 grams

54
CardioWest TAH Characteristics
  • Implantable components - chest only
  • Shortest blood path and exposure to artificial
    surfaces
  • Full circulatory support
  • No dependence on native heart
  • Highest level of cardiac output
  • Normalizes hemodynamics
  • Effective on the sickest of patients
  • Implantable components simple and reliable

55
CardioWestTmTotal Artificial Heart
56
CardioWestTmTotal Artificial Heart System
57
External Console
58
CardioWestTmTotal Artificial Heart System
Fill phase
Eject phase
59
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60
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61
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62
SynCardia CardioWest TAHU.S. Pivotal Trial
AIMS
  • To examine the
  • Efficacy
  • Safety
  • of cardiac replacement with the CardioWest TAH in
    bridge to transplantation

Copeland ,.., Slepian NEJM 351859, 2004
63
The Clinical NeedWhen Medical Therapy Fails
Bi-Ventricular Failure End-Organ Decompensation
Cardiac Transplantation
Heart Available
Hemodynamic Stabilization Organ Recovery
TAH
Death
64
Hypothesis
Patients with irreversible biventricular failure,
could be saved utilizing the CardioWest TAH as a
bridge to transplantation
65
Study Design
  • Prospective, Non-randomized
  • Multi-center
  • Critically ill patients
  • Irreversible End-Stage CHF, NYHA Class IV
  • Transplant-eligible
  • Historical Controls
  • Patients meeting identical entry criteria

66
Study Design
Failing Bi-ventricular CHF
Cardiectomy
TAH removal
TAH implantation
Transplantation
1 mo
2o EPV
1oEPV
67
Study End Point Variables
Primary Efficacy Endpoint Treatment Success (at
30 days post-transplant) Alive, NYHA Class I or
II, Ambulatory Not on ventilator or
dialysis Secondary Efficacy Endpoints Survival
Hemodynamics End-Organ Function and
Ambulation Safety Parameters Adverse Events
68
Study Sites 5 Centers 12 Surgeons
  • University Medical Center, Tucson, AZ
  • Jack Copeland, Francisco Arabia
  • Loyola University Medical Center, Chicago, IL
  • Bryan Foy, Henry Sullivan, Alvaro Montoya
  • LDS Hospital, Salt Lake City, UT
  • James Long, Donald Doty
  • St. Lukes Medical Center, Milwaukee, WI
  • Alfred Tector, Terence Schmahl, David Kress
  • U of Pittsburgh Medical Center, Pittsburgh, PA
  • Bartley Griffith, Robert Kormos

69
Study Patients
70
Study Inclusion Criteria
  • Eligible for transplant
  • NYHA Class IV
  • BSA gt 1.7 m2 or T10 10 cm
  • Hemodynamic insufficiency

71
Hemodynamic InsufficiencyDemonstrated by A or B
below
Criteria A
Criteria B
Cardiac index ?2.0 L/min/m2 oneof the
following
Two of the following
  • Systolic arterial pressure ?90 mm Hg
  • Central venous pressure ?18 mm Hg
  • Dopamine ? 10 µg/kg/min
  • Dobutamine ? 10 µg /kg/min
  • Other drugs at maximum levels
  • Intra-aortic balloon pump (IAPB)
  • Cardiopulmonary bypass (CPB)

72
Study Exclusion Criteria
  • Use of any VAD
  • Pulmonary vascular resistance ? 8 Wood units (640
    Dynes-sec/cm5)
  • Dialysis in previous 7 days
  • Serum creatinine ? 5 mg/dl
  • Total bilirubin ? 5 mg/dl
  • Cytotoxic antibodies ? 10

73
Chosen for TAH rather than LVAD Because
Core
66
81
4
15
15
51
11
On HL machine,CPS/ECMO
CVPgt18 mmHg
RVEFlt20
All on IABP, max inotropes, and failing
hemodynamics. Two with V-tach, one with
mechanical aortic valve, and one with RV injury
at sternotomy
74
Representative Resected Heart
75
Control Group
UNOS Status 1 Patients Screened 635 Eliminated
as too small (BSA ?1.7) (47) Eliminated by
medical history (70) Eliminated as not sick
enough (324) Eliminated for use of other
VAD (159) Total meeting study criteria 35
No ethical option for randomization
76
Hierarchy of Support at Baseline
3 Drugs or CPS 66 Cores 20 Controls
2 Drugs 34 Cores 80 Controls
77
Primary End Point Treatment Success
  • Alive 30 days post TX
  • NYHA Class I or II
  • Ambulatory
  • Not on a ventilator
  • Not on dialysis

78
Survival
  • Clinical Utility TAH 95
    CI
  • Survival to transplant 79.1
    68.5-87.3
  • Survival to 30d post-transplant 71.6
    60.5-81.1
  • 1 year survival from study entry 70.4
    63.3-77.4
  • 1 year survival from transplant 85.9
    79.9-92.0

Compares favorably with published survival data
79
Survival to Transplantation
80
Time to Transplant (Mean)
Median 47 days (longest 414 days)
Total Study Days 6,411 Cores 299 Controls
Median 6 days
81
Overall Duration of Survival
82
Survival from Transplantation
83
Post-Transplant Survivalof Cardiac Recipients
Indicator Core Patients UNOS
Number transplanted 81 4481
Survival rate at 1 year Survival rate at 3 years 85.9 80.7 84.7 77.6
Survival rate at 5 years 63.8 69.8
84
Secondary Efficacy EndpointsHemodynamic Recovery
Pre Day 1 D
Cardiac index (L/min/m2) 1.9 2.9
Systolic arterial pressure (mm Hg) 92.8 121.7
Central venous pressure (mm Hg) 19.7 13.6
Organ perfusion pressure (mm Hg) 48.6 67.5
85
Cardiac Index
Cardiac Index (Mean 2SE)
(Core TAH)
86
Renal Function
Creatinine (Mean 2SE)
(Core TAH)
87
Hepatic Function
Total Bilirubin (Mean 2SE)
(Core TAH)
88
Ambulation(Core TAH)
Able to Get-out-of-Bed ( of Patients)
Able to Walk gt100 Ft ( of Patients)
From Kaplan Meier Estimates
89
Complications During Support
Takeback for bleeding 23/81
(28) Device malfunction 3/81 (4) Fit
complications 2/81 (2) Mediastinal
infections 3/81 (4) Visceral
embolus 1/81 (1) Dialysis 12/81
(15) Stroke 4/81 (5) linearized rate
0.068 strokes/pt-yr
90
Causes of Death Prior to Transplantation
Core Patients(17/81 21)
Multiple Organ Failure 7
Procedural / Technical 4
Bleeding 2
Sepsis 2
Pre-implantation Cardiac Arrest 1
Pulmonary Edema 1
2 coagulopathy after FIEBA administration,2
due to central line wedging in TAH tricuspid valve
91
Conclusions
Cardiac replacement with the CW TAH
effectively restores normal hemodynamics and
organ perfusion in critically ill end-stage CHF
patients allowing target organs (kidney, liver)
to recover. This strategy has afforded a high
level of bridge to transplantation (79) and
post-transplant survival (85). Cardiac
replacement with the CW TAH is safe and effective
as a means of bridging mortally ill patients to
transplantation.
92
Clinical Perspective
93
Right Ventricular Failure Caveats
  • RVF incidence 11-26 of pts on LVADs..
  • 1/3 to 1/2 of pts with RVF require an RVAD, i.e.
    biventricular support
  • More likely to occur in sicker patient,
    emergent vs elective or urgent
  • Affects outcomes decreasing the successful
    bridge to transplant rate
  • Prospective ability to predict..inaccurate in
    many situations

94
Biventricular Support
  • Hybrid systems..poor outcomes. only 1/3 of
    patients bridged
  • Paracorporeal Systems.flow limited, require
    competent aortic valve, limited by liability of
    the native heart pathology
  • Total Artificial Hearthigh flows, not limited by
    native heart pathology

Mehta, et al JHLT 14585-93, 1995
95
TAH vs BIVAD
INFLOW DIAMETER
1.2CM
2.7CM
INFLOW
DEVICE
OUTFLOW
INFLOW
DEVICE
OUTFLOW
BLOOD TRAVEL DISTANCE FOR A SINGLE VENTRICLE
24
24
45
21
3
8
93CM
23CM
MAXIMUM DEVICE OUTPUT
9.0 to 9.5 L/M
5.5 to 6.0 L/M
96
LVAD Risk Factors(Odds ratios) death if
present
  • Urine output lt 30 ml/h (3.9) 67
  • CVP gt 16 mmHg (3.1) 40
  • Mechanical Vent (3.0) 35
  • PT gt 16 s (2.4) 50
  • Reoperation (1.8) 33
  • Survival to transplantation 42/56 75
  • Oz, MC, et al Circulation 199592II 169-73.

97
Thoratec Single Predictor of Survival to
Transplantation
  • 46 survival to transplantation with BUN gt 40
    mg/dl
  • univariate (p0.02), multivariate (p0.016)
  • 76 survival to transplantation with BUN lt 20
    mg/dl
  • Farrar, DJ. J Heart Lung Transplant 19941393-101

98
Some Pre-Operative Characteristics of the
CardioWest Patients
  • Serum Creatinine 1.70.6 mg/dl
  • BUN 3619 mg/dl
  • CVP 207 mmHg
  • Mechanical Ventilation 42
  • Prothrombin time 164 sec
  • Reoperation 38
  • Serum Total Bilirubin 2.01.3 mg/dl
  • 23 of patients on CPB unable to wean

99
Clinical Need for TAH
  • Biventricular failure
  • Ventricular Thrombus
  • Ventricular Septal Defects
  • Ventricular rupture
  • Refractory Arrhythmias
  • Prosthetic Aortic Valves
  • Failed Cardiac transplant
  • Adult Congenital Heart disease
  • Cardiac Malignancies (rare)
  • Complex Reoperative

100
BIVAD/TAH Flow vs BSA
BSA
CardioWest TAH
Thoratec BIVAD
Flow L/M
101
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102
American Heart Association Top 10 Advances for
2004
  1. First Implantable Artificial Heart Approved.
  2. Drug improves heart failure survival among
    blacks.
  3. One-two punch open blocked brain vessels faster.
  4. Less invasive technique for stroke prevention.
  5. Artificial blood vessels work like the real
    thing.
  6. Public defibrillators a lifesaver.
  7. Preventing birth defects-in the womb.
  8. Genetic screening for heart disease.
  9. Human heart, repair thyself.
  10. One drug tackles two harmful habits.

103
3 yrs post-Transplant, 2004 El Tour de Tucson -
70km 4 month on CardioWest TAH
104
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105
CardioWestTM TAH Implants Per Year
Approval
IDE PMA Trial
106
TAH World Experience
Device Type Implants Days
Years
  • CardioWest 700 43,000 117
  • AbioCor 14 1650
    4.5
  • Misc 44 1300
    3.5

Total 758 45,950
125
107
Active Centers TAH Implants
  • North American Centers
  • Arizona 99
  • Barnes 1
  • Cleveland 8
  • Loyola 39
  • Maryland 2
  • Mayo-Phx 3
  • MCV 7
  • Michigan 4
  • Milwaukee 12
  • Montreal 10
  • Ohio St 4
  • Ottawa 32
  • Penn State 1
  • Sharp 7
  • Salt Lake City 8
  • U Penn 3
  • European Centers
  • Bad Oyenhausen 116
  • Berlin 28
  • Cologne 1
  • Erlagen 1
  • Frieburg 4
  • La Pitie 185
  • Leipzig 2
  • Muenster 1
  • Nantes 46
  • Bern
  • Goteborg
  • Hannover
  • Innsbruck
  • Naples
  • Padua

N 9
N 16
Total 25
108
Resource Reallocation of MCSBad Oeyenhausen
Experience
109
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110
SynCardia CardioWest TAH Evolution to Increased
Mobility
Improvement of Driver technology
111
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112
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113
SynCardia CardioWestTM TAH Implantation
2000 2001 2002 2003 2004 2005 2006 2007
US 11 13 3 2 5 11 17 23
Europe/ Canada 15 24 21 35 47 42 31 37
114
Discharged German Patients on TAH
115
TAH-t System Utilization Pathway
BTT
Acute salvage/ stabilization
Recovery/ ambulation
Stable/ Bridging
Stable/ Bridging
Out of Hospital (OOH)
In-Hospital (IH)
116
SynCardia New Replacement TAH-t DriverCompanion
System
117
Companion DriverTM
118
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119
TAH vs BiVAD in BTTPenn Arizona Experience
n 151 pts Class IV CHF with Biventricular
CHF 61 pts Arizona (TAH) , 90 pts Penn (BiVAD)
BiVAD TAH
BTT 46 77
Discharge 38 68
Reoperation 70 21
RF/ Dialysis 34 20
MOF Death 20 11
Stroke 29 5
2007
120
TAH AMI SubstudyPatient Characteristics
9 patients (male, mean age 53) (95-02) Acute MI
with persistent Cardiogenic Shock 9/9 Anterior
wall Pre-implant SBP (mean) 95 mmHg on
Inotropes Cardiac Index (mean) 1.6 L/min/m2 9/9
hi dose inotropes (2.3 Rx/pt avg) 6/9 IABP 4/9
ECMO 5/9 Cardiac arrest
121
Results TAH in AMI Cardiogenic Shock
Successful implantation 9/9 Peri-operative
death 0/9 Mean duration of support 38 d (5 -
108d) Death on TAH 2/9 (22) MOF
Death 2/2 Successful BTT 7/9
(78) Treatment success 7/9 (78)
122
ResultsPMA Trial vs AMI Subset
BTT
Treatment Success
PMA
AMI
PMA
AMI
123
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124
Total Systems Utilized n 35
Utilization of VADs vs.TAH Shock - Acute MI
  • VADs
  • TAH

n 26 9
125
VADs vs.TAH in Shock - Acute MI Survival
Total Survivors LVAD 8 5
BiVAD 1 1 FFBP (ECMO) 10
2 FFP LVAD or BiVAD 7 1 Total 26
9 (35) TAH 9 6 (66)
126
VADs vs.TAH in Shock - Acute MI Complications
VADs TAH Bleeding 6 (23) 2
(22) Neurological 9 (31) 0
Hemolysis 2 ( 8) 0 MOF Sepsis 14
(54) 3 (33)
127
Approach to AMI Cardiogenic ShockUniversity of
Arizona Strategy
AMI
Cardiogenic Shock
Medical Tx IABP Early Revasc
PCI
CABG
TAH Bailout
Persistent Shock
ECMO
Determine size
VAD/TAH
128
2008 Goal
To design a smaller version of the SynCardia
CardioWestTM TAH-t to address women and smaller
men
129
SynCardia CardioWestTM TAH-tIndications for
Use/Contraindications
Patients who do not have sufficient space in the
chest area vacated by the natural
ventricles. Generally these patients have a body
surface area of lt 1.7m2
130
Women and CHFEmerging Gaps
Pathophysiology Diagnosis Pharmacotherapy Transpl
antation Bridge to TX/ Bailout
CHF Prevalence gt 55 TX 20
Size 1.0 - 1.7m2
131
Heart Gender DifferencesHistoric
Strong, Hard, Fickle Tender, soft, resolute
132
Heart Gender DifferencesWith Aging and Heart
Failure
X
Strong, Hard, Fickle Tender, soft, resolute
Pumps Less, Relaxes More
X
Pumps Better, Relaxes Less
133
Designing a Smaller Heart
Male
Female
Small male
134
SynCardia CardioWestTM TAH-t-50Novel
Features/Considerations
Alteration of flow Inflow/Outflow orifice
cross-sectional area Material properties Thromboge
nicity
135
SynCardia CardioWestTM TAH-t-50
136
Friday February 1, 2008 MEDICARE PROPOSES
COVERAGE WITH EVIDENCE DEVELOPMENT FOR ARTIFICIAL
HEART DEVICES The Centers for Medicare
Medicaid Services (CMS) today proposed coverage
with evidence development of artificial heart
devices. CMS proposes to cover artificial heart
devices in Medicare beneficiaries who are
enrolled in Food and Drug Administration
(FDA)-approved studies. Our proposal relaxes a
long-standing non-coverage policy, gives access
to our beneficiaries and promotes evidence
development through FDA approved studies of this
advanced technology, said CMS Acting
Administrator Kerry Weems.
137
Summary
TAH-t
  • Immediate Hemodynamic Recovery for irreversible
    bi-ventricular failure
  • Lower mobidity/mortality than BiVADs
  • End-Organ Recovery
  • Saves lives
  • Higher BTT rate than any VAD/BiVAD
  • QOL/ Patients Out of Bed, Walking

The CardioWestTM TAH substantially increases the
quality of care
138
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139
Artificial Heart Timeline
  • 1964 U.S. Govt National Heart Initiative to
    produce TAH
  • 1969 Cooley -Texas Heart Institute first human
    artificial heart implant to bridge a patient for
    64 hours until a donor heart is transplanted.
  • 1981 Kolff, DeVries, and Jarvik - University of
    Utah
  • receive FDA approval to implant a TAH into a
    human for permanent application.
  • 1982 Barney Clark receives the Jarvik-7 device,
    lives 112 days.
  • 1983 Symbion acquires rights to manufacture
    Jarvik-7.
  • 1985 University Medical Center in Tucson implants
    the Phoenix TAH, opening the door for the FDA to
    approve the TAH as a bridge to transplant.

140
Artificial Heart Timeline
  • 1986 The smaller Jarvik-7-70 TAH is first
    implanted, expanding the use into most adults
    (including women)
  • 1990 The FDA withdraws the study of the Symbion
    Jarvik TAHs because of quality issues
  • 1991 Symbion transfers all the TAH assets to
    CardioWest /UMC Tucson
  • 1992 CardioWest receives FDA approval to begin a
    new study with a modified Jarvik-7-70 design.
  • 1993 First CardioWest C-70 TAH is implanted in a
    women at University Medical Center in Tucson. She
    was successfully transplanted after 186 days.
  • 1999 CardioWest receives CE mark approval for
    commercialization of the TAH in Europe.
  • 2001 SynCardia to commercialize TAH, File PMA.
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