Download VENTRICULAR ASSIST DEVICES

VENTRICULAR ASSIST DEVICES
Arthur Hill, M.D.
Department of Surgery
Division of Cardiothoracic Surgery
University of California, San Francisco
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Questions:
► Does
IABP improve survival in AMI
complicated by Cardiogenic Shock?
► Does LVAD improve survival in AMI
complicated by Cardiogenic Shock?
► Is there Level I data to justify the use of
VAD as Bridge-to-Transplant?
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VENTRICULAR ASSIST DEVICES
► Definition
► Device Design
and Categorization of Assist Devices
► Established Indications for Use of Ventricular
Assist Devices
Acute Circulatory Support
► Percutaneous
Circulatory Support in the Catheterization Lab
Bridge-to-Transplant
Bridge-to-Recovery
Destination
► Patient
► Future
Selection
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VENTICULAR ASSIST DEVICE
Definition:
►
►
Mechanical Device which is
used to replace or reproduce
the pump function of the left
and/or right ventricle.
Basic Principle:
Improve arterial flow (end(endorgan perfusion)
Improve ventricular unloading
►
Price:
Blood element destruction
Thomboembolism
Infection
Cost
Outflow
tubing
Inflow
tubing
Propulsion
component
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VENTICULAR ASSIST DEVICE
Definition:
►Examples:
IABP
Thoratec
HeartMate I
HeartMate II
HeartMate III
Total Artificial Heart
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DEVICE DESIGN
►
Device components:
1. Propulsion component
•
•
2.
3.
4.
5.
Pulsatile Flow
Non-pulsatile Flow
Cannulas
Power Supply
Control Unit
Blood-to-Non-endothelial
surface contact materials
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DEVICE DESIGN
►
Device components:
1. Propulsion component
•
•
2.
3.
4.
5.
Pulsatile Flow
Non-pulsatile Flow
Cannulas
Power Supply
Control Unit
Non-endothelial surface
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DEVICE DESIGN
Device components:
1. Propulsion component
•
•
2.
3.
4.
5.
Pulsatile Flow
Non-pulsatile Flow
Cannulas
Power Supply
Control Unit
Non-endothelial surface
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DEVICE DESIGN
►
Device components:
1. Propulsion component
•
•
2.
3.
4.
5.
Pulsatile Flow
Non-pulsatile Flow
Cannulas
Power Supply
Control Unit
Non-endothelial surface
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DEVICE DESIGN
►
Device components:
1. Propulsion component
•
•
2.
3.
4.
5.
Pulsatile Flow
Non-pulsatile Flow
Cannulas
Power Supply
Control Unit
Non-endothelial
surface
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DEVICE DESIGN
►
Device components:
1. Propulsion component
•
•
2.
3.
4.
5.
Pulsatile Flow
Non-pulsatile Flow
Cannulas
Power Supply
Control Unit
Non-endothelial surface
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PROPULSION COMPONENT
► Pulsatile
Flow
(First Generation)
Pusher-plate
(displacement)
► Non-pulsatile
Flow
(Second Generation)
Axial Flow Pumps
Centrifugal Pumps
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PROPULSION
COMPONENT
► Pulsatile
Flow
Thoratec
Volume Displacement
Pusher-plate
HeartMate I
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VENTRICULAR DYNAMICS
► Pressure
Volume
Loop
► Pressure
Flow
Curve
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Figure 1 Adult (left) and pediatric (right) Berlin Heart Excor® (Berlin Heart AG,
Berlin, Germany) ventricular assist devices
Hetzer R and Stiller B (2006) Technology Insight: use of ventricular assist devices in children
Nat Clin Pract Cardiovasc Med 3: 377–386 doi:10.1038/ncpcardio0575
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PROPULSION COMPONENT
Non-pulsatile Flow
►Centrifugal
Pumps
►Axial Flow Pumps
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BioMedicus
Non-pulsatile Flow
►Centrifugal
Pumps
►Axial Flow Pumps
Ventritec
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Propulsion component
Impella
Non-pulsatile Flow
►Centrifugal
Pumps
►Axial Flow Pumps
For short-term use
For long-term use….
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Long Term
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Third Generation:
Magnetically Levitated
Centrifugal and Axial Pumps
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Short Term: Magnetically Suspended
Centrifugal and Axial Pumps
► CentriMag
Magnetically
suspended
centifugal pump
No bearings or
seals
9.9 L/min flow at
5000 rpm
Less blood shear
damage
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HeartMate III
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Long Term Centifugal Flow Pumps
•IDE approval 9/2008
IDEMark
approval
9/2008
•CE
12/08
CE Mark 12/08
•US
US Trials
Trials
Intra-Pericardial Implant
•Intra-Pericardial
Implant
BBT and D
•BBT
and D
10 L Flow
•10 L Flow
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Axial Flow Pumps
► The
HM II is establishing
itself for:
BTT
BTR
Destination
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HeartWare: Magnetically Levitated Axial Flow Pump
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HeartWare:
Magnetically Levitated Axial Flow Pump
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VAD LONGEVITY
► HM
I – 2 years
Pulsatile flow pump
► HM
II – 5 years
Axial Flow pump
► HM
III – 10 years
Magnetically Levitated
Centifugal Flow Pump
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VENTRICULAR ASSIST DEVICES
►
►
►
Definition
Device Design and Categorization of Assist Devices
Established Indications for Use of Ventricular Assist
Devices
Acute Circulatory Support
BridgeBridge-toto-Transplant
BridgetoBridge to-Recovery
Destination
► REMATCH
► INTrEPID
► HeartMate
►
►
II
Patient Selection
Future
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Mechanical Circulatory Support
► Established
Indications for Use of
Ventricular Assist Devices
Acute Circulatory Support
►Percutaneous
Circulatory Support in the Cath Lab
Intermediate to long-term circulatory support
►Bridge-to-Transplant
►Bridge-to-Recovery
►Destination
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PERCUTANEOUS MCS IN THE
CATHETERIZATION LAB
► Hemodynamically
assisted High-risk PCA
► Assisted percutaneous Valve repair and
Replacement
► Assisted arrhythmia ablation
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PERCUTANEOUS LEFT
VENTRICULAR ASSIST DEVICES
►
Cardiogenic Shock Accompanying MI1,2
7-10% of AMI3,4
►
►
7% STEMI
2.5% nonnon-STEMI
Improved Survival with Rapid Culprit Revascularization5,6
5050-70% Mortality4-7
►
Percutaneous Ventricular Assist
IABP – NO IMPROVEMENT IN SURVIVAL4-7
pVAD
►
►
TandemHeart
Impella
1. Goldberg RJ, Samad NA, Yarzebski J, et al. Temporal trends in cardiogenic shock complicating acute myocardial infarction. N Engl J Med 1999;
340:1162–1168.
2. Rogers WJ, Canto JG, Lambrew CT, et al. Temporal trends in the treatment of over 1.5 million patients with myocardial infarction in the US from 1990
through 1999: the National Registry of Myocardial Infarction 1, 2 and 3. J Am Coll Cardiol 2000; 36:2056–2063.
3. Holmes DR Jr, Berger PB, Hochman JS, et al. Cardiogenic shock in patients with acute ischemic syndromes with and without ST-segment elevation.
Circulation 1999; 100:2067–2073.
4. Hasdai D, Harrington RA, Hochman JS, et al. Platelet glycoprotein IIb/IIIa blockade and outcome of cardiogenic shock complicating acute coronary
syndromes without persistent ST-segment elevation. J Am Coll Cardiol 2000; 36:685–692.
5. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators.
Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock [see comments]. N Engl J Med 1999; 341:625–634.
6. Hochman JS, Sleeper LA, White HD, et al. One-year survival following early revascularization for cardiogenic shock. Jama 2001; 285:190–192.
7. Hochman JS, Buller CE, Sleeper LA, et al. Cardiogenic shock complicating acute myocardial infarction–etiologies, management and outcome: a report
from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol 2000; 36:1063–1070.
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PERCUTANEOUS LEFT
VENTRICULAR ASSIST DEVICES
► IABP
► pVAD
Tandem Heart
Impella
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Hemodynamic Advantage of
pVAD vs. IABP
pVAD
► Directly
unload the left
ventricle
► Reduce
myocardial
workload and oxygen
consumption
► Increase
cardiac output
and coronary and endorgan perfusion
IABP
+++
-
+++
++
+++
+
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PERCUTANEOUS LEFT
VENTRICULAR ASSIST DEVICES
► Tandem
Heart:
Trans-septal LA
inflow (21 F)
Femoral arterial
outflow (15-17 F)
3.5-4 L/min at 7500
rpm
Systemic
anticoagulation
Approved for shortterm support
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PRT TandemHeart
vs. IABP
►
►
►
►
University of Leipzig (2005)
CS p AMI with intention for PCI
PRT: TandemHeart (21) vs. IABP
(20)
Improved Hemodynamic
parameters
Cardiac Power Index
►
►
TandemHeart 0.22 0.37
IABP 0.22 0.28
p<0.004
►
Improved Metabolic Parameters
►
Complications
Serum Lactate (6 hours)
•Bleeding:
TH: n=19 vs.
IABP n=8
(p<0.002)
•Limb ischemia:
TH n=7 vs.
IAPB n=0
(p<0.009)
Increased Complications in TH vs.
IABP
►
Mortality (30 day)
TandemHeart 45%
IABP 43%
(P=0.86)
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TandemHeart vs.
IABP
► PRT
Multi-Center
(2006)
► Cardiogenic Shock
(70% AMI)
► TandemHeart (n=19)
vs. IABP (n=14);
“roll-in” (n=9)
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RESULTS:
► Hemodynamic
Parameters better
with TandemHeart
► Adverse events –
no difference
► 30 day mortality –
no statistical
difference (underpowered)
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PERCUTANEOUS LEFT
VENTRICULAR ASSIST DEVICES
► Tandem
Heart:
►Impella
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Impella
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Impella
►
Impella LP 2.5
13 F sheath (percutaneous
(percutaneous))
9 F cannula
2.5 L maximal flow
510K FDA approved for LV
support for up to 6 hours
Sold by AbioMed
►
Impella LP 5.0
21 F
Requires surgical
implantation
5.0 max flow
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Impella pVAD
► PRT;
November 2008
► 26 patients
13 IABP
12 Impella LP2.5
► Hemodynamics
IABP ∆CI 0.11
Impella ∆CI 0.49
► 30
day survival:
46% in both groups
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Impella
► Protect
II Trial
► MultiCenter Trial
► Elective High Risk PCI
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Use of MCS for Cardiogenic Shock
Complicating AMI
►
Experimental data shows:
Improved LV unloading
Reduction in infarct
extention and size
Improved Hemodynamics
►
Clinical data (17 papers)
shows:
Improved LV unloading
Possible reduction in infarct
extension and size
Improved hemodymamics
No mortality benefit
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Use of MCS for Cardiogenic Shock
Complicating AMI
What can be said about the
overall poor mortality data?
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Failure of Improvement of Mortality
using pVAD in the Cath Lab
► Sound
Technology
Effective
Ease of use
Low adverse event rate
► Improve
trial design:
Improved patient selection
Earlier application of pVAD
Registry
► Evolving
paradigm
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VENTRICULAR ASSIST DEVICES
► Established
Indications
for Use of Ventricular
Assist Devices
Acute Circulatory Support
BRIDGE-TOTRANSPLANT
Bridge-to-Recovery
Destination
THERE ARE
NO PRT’s
►REMATCH
►INtREPID
►HeartMate
II
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BRIDGE
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