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

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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

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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