1. P. Leprince, CT Surgery Institut of cardiology Pitié-Salpétrière Group Paris, France The Total Artificial Heart Cardiowest: Indications and Results

2. Definition Jarvik 7 Pneumatic Total Artificial Heart Polyurethane diaphragm & Medtronic mechanical valves External pneumatic console External pneumatic console

5. Indications Bridge to transplantationBridge to transplantation Terminal Biventricular failureTerminal Biventricular failure End organ dysfunctionEnd organ dysfunction No hope for recoveryNo hope for recovery Special situationsSpecial situations VSDCardiac graft rejectionVSDCardiac graft rejection Aortic regurg.LV thrombusAortic regurg.LV thrombus Valvular prosthesisRythmic cardiopathyValvular prosthesisRythmic cardiopathy

6. Special indications –Failure of the transplanted heart –Massive LV infarct –Acquired VSD –Ventricular Rupture –Diffuse mural thrombus –Some congenital conditions –Cardiac Malignancies –Severe hypertrophic cardiomyopathy –Severe valvular disease

7. 1982-1985: Devries 5 implants as destination therapy (10 to 620 days) Copeland JG et al. The total artificial heart as a bridge to transplantation. A report of two cases. JAMA. 1986 Dec 5;256(21):2991-5. FDA FDA Jarvik Symbion CardioWest SynCardia 1982 1983 1991 2002

8. La Pitié-Salpétrière First implantation: April 1986First implantation: April 1986 > 200

9. 182 Patients 154 males, 28 females 38±13 yrs [15-64] 38±13 yrs [15-64] Terminal biventricular failure End-stage organ failure Mean BSA: 1,8±0.15 m 2 Thirty patients: BSA < 1.7m² Terminal biventricular failure End-stage organ failure Mean BSA: 1,8±0.15 m 2 Thirty patients: BSA < 1.7m²

10. Group I (74.5%): classical Dilated Cardiomyopathy (135 Pts) –Ischemic(46 Pts) –Idiopathic (89 Pts) Group I (74.5%): classical Dilated Cardiomyopathy (135 Pts) –Ischemic(46 Pts) –Idiopathic (89 Pts) Group II (25.5%): miscellaneous (47 Pts) Acute rejection Valvular Primary graft failure Acute MI Post-partum Congenital Hypertrophic CM Group II (25.5%): miscellaneous (47 Pts) Acute rejection Valvular Primary graft failure Acute MI Post-partum Congenital Hypertrophic CMIndications

11. PrePost MAP (mmHg) 70±887±21 CVP (mmHg) 18.7±1014.6±4 WP (mmHg) 27±8NA Card. Index (L/min/m²) 1.9±0.43±0.5 Hemodynamic data

12. Results % of transplanted patients Patient Selection

13. Causes of death:Causes of death: –MOF72% –Infections (Pulmonary)19% –Hemorrhage2 –Tamponnade2 –Cerebral death4 Causes of death:Causes of death: –MOF72% –Infections (Pulmonary)19% –Hemorrhage2 –Tamponnade2 –Cerebral death4 No. of organ MOF related Dysfunction death < 329%  383% No. of organ MOF related Dysfunction death < 329%  383% Non surv. Survivors T.Bili 3.74 ± 2.1 1.81 ± 0.23 p=0.004

14. Waiting time on TAH

15. Infections 15% 48 Pts 7DRI 5 Transp. 2 death 3 alive 2 non transp 2 death

16. Site of Infection Mediastinitis3 Blood stream infection1 Driveline infection1 Superficial exit driveline2

17. Cardiowest in small patients April 1986-May 2003April 1986-May 2003 149 patients149 patients Group S: BSA < 1.7m²n=30Group S: BSA < 1.7m²n=30 Group L: BSA  1.7m²n=119Group L: BSA  1.7m²n=119 Group S: 20 males 20 males Age: 34±18 yrs Age: 34±18 yrs BSA: 1.58 ±0.1 BSA: 1.58 ±0.1 Group L: 108 males 108 males Age: 40±12 yrs Age: 40±12 yrs BSA: 1.88 ±0.16m² BSA: 1.88 ±0.16m²

18. Group L  Output: 5.4 ±0.7 L/min  CI: 2.8 ±0.3 L/min/m²  CVP: 14.5 ±4 mmHg  MAP: 88 ±19 mmHg Group S  Output: 5.5 ±0.8 L/min  CI: 3.6 ±0.6 L/min/m²  CVP: 14.7 ±3.8mmHg  MAP: 87 ±23 mmHg Post Implantation Haemodynamic

19. Survival  transplanted and discharged alive S S classical L L classical (21) 1986-19929% 30% 25%30% 1993-199736% 43% 34.6%42.8% 1998-200350% 60% 52%60%

20. TAH Wordwilde experience April 10th 2011: 924 European Centers Bad Oyenhausen106 Berlin 50 Erlagen 1 Frieburg 3 La Pitie200 Leipzig 2 Nantes 42 North American Centers Arizona 115 Barnes 1 Cleveland 9 Loyola39 Milwaukee12 Michigan 3 Montreal10 Ohio St 4 Ottawa 32 U Penn 1 Sharp 7 VCU 37

21. J Copeland et al. N Engl J Med 2004;351:859-67. 81 TAH patients 35 control patients Transplantation: 79% vs 45% « This device prevents death in critacally ill patients who have irreversible biventricular failure »

22. 2000-2010 n=82 Age: 47 ± 13 years Dilated Idiopatic: 45% Ischemic: 28% Other: 21% Pre-implantation Previous cardiac surgery: 21% Cardiac arrest: 9%Creat: 149±86µmol Mechanical vent: 33%T Bili: 45±32 µmol ECMO: 24%

23. Morbi-mortality on TAH Mean duration on TAH: 88±106 days Survival on TAH: –74%, 66%, 50% (30, 60, 180 days) Neurologic adverse event: 10% Mediastinitis:13% Reop for bleeding: 40%

24. Transplantation 62% transplanted Mean time on TAH: 100 days Actuarial survival after transplantation –82%, 78%, 75%, 66% (1, 3, 5, 8 years)

25. Portable drivers

26. Excor Out of Hospital Experience August 2010 CenterImplantsDays on Excor Bad Oyenhausen3310256 Berlin258178 La Pitie111555 Nantes4309 Padova1938 Rome1554 Freiburg1359 Muenster1293 Erlagen1275 Cologne1245 Leipzig143 Total8123005

27. Freedom Driver, 2010 CenterNumberDuration, days La Pitie394 Nantes218 Phoenix1155 Moscow176 Sydney11 Total8344 Out of hospital patient with TAH: La Pitié Experience  2006-2010  12 patients discharged to home with TAH  Mean duration at home: 220 days [79-403]  No death  10 transplanted: 1 death  2 on device