Carmat updates

Transcription

Carmat updates
American Heart Association Scientific Sessions 2015
The Lasker Awardee Lecture
Contribution to the Challenge of Cardiac
Replacement in Patients Suffering From End-stage
Biventricular Failure
Alain CARPENTIER
Hôpital Européen Georges Pompidou, Paris
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End-stage Cardiac Insufficiency




Affects 5 millions people in the USA.
1/3 of the patients are younger than 65.
Mortality is 45% per year.
Heart transplantation is limited by the
shortage of donors, justifying the
development of total artificial hearts for
destination therapy.
2
Background - I
Pre-existing devices have been developed as:
 Bridge to transplant procedure - Cooley, Jarvik
 Ventricular assist - Frazier
3
Background - II
Alike cardiac valves existing artificial hearts
are confronted with thromboembolism 1
Clinical experience shows that valvular
bioprostheses display a superior
haemocompatibility 2
This stimulated our endeavour to use this biological
material in the construction of a total artificial heart
Grunkemeier GL, et al. Curr Probl Cardiol 2000;25:73-156
2 Carpentier A. Nat Med 2007;13(10):1165-8
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4
CARMAT* Bioprosthetic Artificial Heart
Characteristics
• Total artificial heart
• Biological material
• Physiological function
• Destination therapy
* CARpentier - MATra
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Development
First human
Human model II implantation
Dec. 18, 2013
Vol.: 0,75 l.
Human model I Weight: 850g
Animal model
Prototype
Vol.: 1l.
Weight : 900g
1980
Vol.: 1,25 l.
Weight: 1900g
Cons.: 100W
CETIM
Vol.: 1 l.
Weight: 1200g
Cons.: 70W
1993
Cons.: 30W
CARMAT
2014
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CARMAT Components
 2 separate ventricles
 2 pulsatile pumps
 4 bioprosthetic valves
 2 bioprosthetic membranes
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 All components motor pumps and electronics are incorporated
in a single compliance chamber
 Intrapericardial position
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Anatomical Constraints - I
Computer Assisted Conception
Animal model
Human model
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A-P distance (mm)
II - Virtual Fit Study
350
300
0% fit
250
78% fit
247 mm
200
Fit
No
Fit
150
22% fit
100
67% fit
308 mm
50
0
0
100
200
300
400
500
600
L-R distance (mm)
80% in male, 15% in female
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III – Anatomical Compatibility
Pre-implant
Post-implant
1
2
3
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Physiological Constraints - I
Bronchial shunt
Pulmonary
Systemic
Hydraulic test bench serves
to develop numeric
simulations
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II - Physiological Contraction
Algorithm of viscoelastic contraction
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III - Device Pump Output and Pulsatility
Arterial pressure and finger plethysmographic recordings Patient #1, POD 74
Carpentier et al. The Lancet July 29, 2015. http://dx.doi.org/10.1016/S0140-6736(15)60511-6)
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Haemocompatibility - I
I - CE Bioprosthetic valve
CE Bioprosthetic membrane
II - Flow pattern
Carpentier A. Nat Med 2007;13(10):1165-8
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II - Animal Studies: Explant
No visible intra-device clotting
Aurore, Jan.2013
The Control Agency (ANSM) authorized 4 clinical implantations (Sept. 2013)
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III - First Clinical Case
LV cavity static surface coated with
polytetrafluoroethylene (PTFE).
Pulsatile biomembrane exposed to blood:
No visible clot formation.
Bl
Pe
Pe
The biomembrane in contact with blood
is covered with a protein layer (Pr) which
provides haemocompatibility.
Carpentier et al. The Lancet July 29, 2015.
http://dx.doi.org/10.1016/S0140-6736(15)60511-6
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IV - Durability: Fatigue Tests
Motor pumps
Membrane
Sensors
250 M cycles* (n=20)
250 M cycles* (n=20)
240 M cycles* (n=20)
Fatigue test
membrane
Fatigue test pumps
* 90 M Cycles = 2 years
Fatigue test membrane
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Clinical Experience (n=3)
Hôpital Européen Georges Pompidou, Paris (Pts #1 & #3)
Thorax Institute, Nantes (Pt #2)
Age
LVEF (%)
SPAP/DPAP (mmHg)
Implant date
Support duration
Patient #1
76
21
18 Dec 13
74 days
Patient #2
68
15
42/19
5 Aug 14
270 days
Patient #3
73
10
87/56
8 Apr 15
215 days
Ongoing
Cumulative function: 559 days
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Clinical Experience – Blood Components
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Clinical Experience (n=3)
559 days of function
 No haemolysis
 No thromboembolism
 No acquired Willebrand syndrom
 No infection
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Wearable System
• Controller/monitor
• Batteries Li-ion
3 kg, 4 hours at 6 L/min
• Future: Hydrogen batteries, 10 hours
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Quality of Life
Assessed by the interview of patient #2
adressing the questions of how he feels,
is he bothered by the weight of the
prosthesis, or its noise?
And finally how is his physical condition
8 months after implantation?
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Merci for your invitation
Patient #1
Patient #2
Patient #3
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