p. leprince, ct surgery institut of cardiology pitié-salpétrière group paris, france the total...
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P. Leprince,CT SurgeryInstitut of cardiologyPitié-Salpétrière GroupParis, France
The Total Artificial Heart Cardiowest:
Indications and Results
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DefinitionJarvik 7
Pneumatic Total Artificial Heart Polyurethane diaphragm & Medtronic mechanical valves External pneumatic console
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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
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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
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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
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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
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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
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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
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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
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Results% of transplanted patients
Patient Selection
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• 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
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0
10
20
30
40
50
60
Days
1986-1992
1993-1997
1998-2007
Median duration ondevice only intransplanted patients
Waiting time on TAH
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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
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Site of Infection
Mediastinitis 3
Blood stream infection 1
Driveline infection 1
Superficial exit driveline 2
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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
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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
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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%
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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
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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 »
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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%
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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%
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Transplantation
• 62% transplanted • Mean time on TAH: 100 days• Actuarial survival after transplantation
– 82%, 78%, 75%, 66% (1, 3, 5, 8 years)
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Portable drivers
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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
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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