1. The SynCardia CardioWestTM Total Artificial Heart
Marvin J. Slepian, M.D.
Sarver Heart Center
University of Arizona
Tucson, Arizona
2010

3. SynCardia CardioWest TAH: Indication for Use
As an in-hospital bridge to transplantation in cardiac transplant candidates at imminent risk of death due to irreversible biventricular failure

4. CardioWestTM TAH: Advantages 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

5. TAH Advantages 3 2 Decreased CVP Overcome PA Cardiac output
4) Organ Recovery 1 4

6. SynCardia CardioWestTM Total Artificial Heart System
Implantable
Full Cardiac
Replacement
Full Normalization
of Hemodynamics
CE Approved - Europe
FDA approved - USA
The CardioWest

7. SynCardia CardioWestTM Total Artificial Heart System
Implantable
TAH
External
Console
Drivelines

8. CardioWestTm Total Artificial Heart
Stroke volume 70 milliliters
Inflow valve 27 mm., Medtronic Hall
Outflow valve 25 mm., Medtronic-Hall
Seamless blood diaphragm
Four flexible polyurethane membranes
Maximum output > 9 liter per minute
Weight 180 grams

9. 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

10. CardioWestTm Total Artificial Heart System
Fill phase
Eject phase

11. Hypothesis
Patients with irreversible biventricular failure, could be saved utilizing the CardioWest TAH as a bridge to transplantation
Copeland….Slepian NEJM 361:859, 2004

12. Study Design Failing Bi-ventricular CHF Cardiectomy TAH removal TAH
implantation
Transplantation
1 mo
2o EPV
1oEPV
5 Centers, 12 Surgeons
N=130, 95 TAH, 35 “Control”
Copeland….Slepian NEJM 361:859, 2004

13. 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
Copeland….Slepian NEJM 361:859, 2004

14. Primary End Point: Treatment Success
Alive 30 days post TX
NYHA Class I or II
Ambulatory
Not on a ventilator
Not on dialysis
Copeland….Slepian NEJM 361:859, 2004

15. Compares favorably with published survival data
Clinical Utility TAH % CI
Survival to transplant % %-87.3%
Survival to 30d post-transplant % %-81.1%
1 year survival from study entry % %-77.4%
1 year survival from transplant % %-92.0%
Compares favorably with published survival data
Copeland….Slepian NEJM 361:859, 2004

16. Survival to Transplantation
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0 10 20 30 40 50 60 70
Time (weeks)
Proportion Alive
Control
Core TAH
Copeland….Slepian NEJM 361:859, 2004

17. Time to Transplant (Mean)
Median = 47 days (longest 414 days)
Total Study Days
6,411 Cores
299 Controls
Median = 6 days
Copeland….Slepian NEJM 361:859, 2004

18. Survival from Transplantation
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0 2 4 6 8 10 12
Control
Core TAH
UNOS
Proportion Alive
Time (years)
Copeland….Slepian NEJM 361:859, 2004

19. Able to Get-out-of-Bed
Ambulation (Core TAH)
Able to Get-out-of-Bed
(% of Patients)
Able to Walk >100 Ft
(% of Patients)
From Kaplan Meier Estimates
Copeland….Slepian NEJM 361:859, 2004

20. LVAD Mortality Risk Factor Profile vs TAH Cohort Baseline
Odds Ratio {Death} TAH Cohort
Urine output < 30 ml/h (3.9) {67%}
BUN > {54%}
CVP > 16 mmHg (3.1) {40%}
Mechanical Vent (3.0) {35%} %
PT > 16 s (2.4) {50%} Reoperation (1.8) {33%} %
Oz, MC, et al Circulation 1995;92:II
Farrar, DJ. J Heart Lung Transplant 1994;13:93-101

21. 52 risk factors
5 centers
Ann Thoracic Surg
85:1639, 2008

22. TAH vs BiVAD in BTT: Penn + 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
11%
Stroke
29% 5%

23. BIVAD/TAH: Flow vs BSA
BSA
CardioWest
TAH
Thoratec
BIVAD
Flow L/M

24. Active Centers: TAH Implants
North American Centers
Arizona
Barnes
Cleveland
Loyola
Maryland
Mayo-Phx
MCV
Michigan
Milwaukee
Montreal
Ohio St
Ottawa
Penn State
Sharp
Salt Lake City
U Penn
European Centers
Bad Oyenhausen
Berlin
Cologne
Erlagen
Frieburg
Hannover 1
La Pitie
Leipzig
Muenster
Nantes
Padua
Bern
Goteborg 2
Innsbruck 1
Naples
Rome
Sydney
N = 16
N = 17
> 830 implants
Total = 33
9/09

25. Official as of May 1, 2008 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.
Official as of May 1, 2008

26. 2008

31. TAH Discharge Experience
Largely Germany, > 35 pts
78 yrs of outpatient
experience
56% of Total TAH experience
At home de facto DT
Have more data at home than in hospital !
Inpt
TAH
44%
Outpt
TAH
56%

32. Evolution of SynCardia “Mobility” Drivers
The Future
“ “

33. SynCardia New Replacement TAH-t Driver “Companion System”

34. Companion DriverTM

37. SynCardia Freedom Driver

38. Blurring Short term support Bridge to Transplant Destination Tx
Changing Landscape
Bridge to Recovery
Bridge to Decision
Bridge to Bridge
Short term support
Bridge to Transplant
Destination Tx
Long term support
Blurring
Time vs Dictated Outcome

39. The CardioWestTM TAH substantially increases the quality of care
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
New driver technology - enhanced mobility/discharge
The CardioWestTM TAH substantially
increases the quality of care