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P. Leprince,CT SurgeryInstitut of cardiologyPitié-Salpétrière GroupParis, France
The Total Artificial Heart Cardiowest:
Indications and Results
DefinitionJarvik 7
Pneumatic Total Artificial Heart Polyurethane diaphragm & Medtronic mechanical valves External pneumatic console
Indications• Bridge to transplantation• Terminal Biventricular failure• End organ dysfunction• No hope for recovery• Special situations• VSD Cardiac graft rejection• Aortic regurg. LV thrombus• Valvular prosthesis Rythmic cardiopathy
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
1982-1985: Devries5 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
Jarvik Symbion CardioWest SynCardia1982 1983 1991 2002
La Pitié-Salpétrière• First implantation: April 1986
0
2
4
6
8
10
12
14
16
1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010
> 200
182 Patients
154 males, 28 females 38±13 yrs [15-64]
Terminal biventricular failureEnd-stage organ failureMean BSA: 1,8±0.15 m2
Thirty patients: BSA < 1.7m²
Group I (74.5%): classicalDilated Cardiomyopathy (135 Pts)
– Ischemic (46 Pts)– Idiopathic (89 Pts)
Group II (25.5%): miscellaneous (47 Pts)Acute rejection ValvularPrimary graft failure Acute MIPost-partum CongenitalHypertrophic CM
Indications
Pre PostMAP (mmHg) 70±8 87±21
CVP (mmHg) 18.7±10 14.6±4
WP (mmHg) 27±8 NA
Card. Index (L/min/m²) 1.9±0.4 3±0.5
Hemodynamic data
Results% of transplanted patients
Patient Selection
• Causes of death:– MOF 72%– Infections (Pulmonary) 19%– Hemorrhage
2– Tamponnade 2– Cerebral death 4
No. of organ MOF related Dysfunction death
< 3 29%
3 83% Non surv. Survivors
T.Bili 3.74 ± 2.1 1.81 ± 0.23p=0.004
0
10
20
30
40
50
60
Days
1986-1992
1993-1997
1998-2007
Median duration ondevice only intransplanted patients
Waiting time on TAH
Infections 15%
0
1
2
3
4
5
Number of patients with a DRI
staphylocoque doreméthi S
staphylocoque doréMéthi résistantproteus mirabilis
enterobacter cloaque
pseudomonasaeruginosa
candidat albicans
Site of Infection
Mediastinitis 3
Blood stream infection 1
Driveline infection 1
Superficial exit driveline 2
Cardiowest in small patients
• April 1986-May 2003• 149 patients• Group S: BSA < 1.7m² n=30• Group L: BSA 1.7m² n=119
Group S: 20 males Age: 34±18 yrs BSA: 1.58 ±0.1
Group L: 108 malesAge: 40±12 yrsBSA: 1.88 ±0.16m²
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
Survival transplanted and discharged alive
S S classical L L classical (21)
1986-1992 9% 30% 25% 30%
1993-1997 36% 43% 34.6% 42.8%
1998-2003 50% 60% 52% 60%
TAH Wordwilde experienceApril 10th 2011: 924
European CentersBad Oyenhausen 106Berlin 50Erlagen 1Frieburg 3La Pitie 200Leipzig 2Nantes 42
North American Centers
Arizona 115Barnes 1Cleveland 9Loyola 39Milwaukee 12Michigan 3Montreal 10Ohio St 4Ottawa 32U Penn 1Sharp 7VCU 37
J Copeland et al. N Engl J Med 2004;351:859-67.
81 TAH patients35 control patientsTransplantation: 79% vs 45%
« This device prevents death in critacally ill patients who have irreversible biventricular failure »
2000-2010n=82
• Age: 47 ± 13 years• Dilated Idiopatic: 45%• Ischemic: 28%• Other: 21%
Pre-implantationPrevious cardiac surgery: 21%Cardiac arrest: 9% Creat: 149±86µmolMechanical vent: 33% T Bili: 45±32 µmolECMO: 24%
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%
Transplantation
• 62% transplanted • Mean time on TAH: 100 days• Actuarial survival after transplantation
– 82%, 78%, 75%, 66% (1, 3, 5, 8 years)
Portable drivers
Excor Out of Hospital ExperienceAugust 2010
Center Implants Days on Excor
Bad Oyenhausen 33 10256
Berlin 25 8178
La Pitie 11 1555
Nantes 4 309
Padova 1 938
Rome 1 554
Freiburg 1 359
Muenster 1 293
Erlagen 1 275
Cologne 1 245
Leipzig 1 43
Total 81 23005
Freedom Driver, 2010Center Number Duration, days
La Pitie 3 94
Nantes 2 18
Phoenix 1 155
Moscow 1 76
Sydney 1 1
Total 8 344
Out of hospital patient with TAH: La Pitié Experience2006-201012 patients discharged to home with TAHMean duration at home: 220 days [79-403]No death10 transplanted: 1 death2 on device
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