ventricular assist devices - continuing medical · pdf file · 2009-01-161...

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VENTRICULAR ASSIST DEVICESVENTRICULAR ASSIST DEVICES

Arthur Hill, M.D.Arthur Hill, M.D.

Department of SurgeryDepartment of Surgery

Division of Cardiothoracic SurgeryDivision of Cardiothoracic Surgery

University of California, San Francisco University of California, San Francisco

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Questions:Questions:

►►Does IABP improve survival in AMI Does IABP improve survival in AMI

complicated by complicated by CardiogenicCardiogenic Shock?Shock?

►►Does LVAD improve survival in AMI Does LVAD improve survival in AMI

complicated by complicated by CardiogenicCardiogenic Shock?Shock?

►►Is there Level I data to justify the use of Is there Level I data to justify the use of

VAD as BridgeVAD as Bridge--toto--Transplant?Transplant?

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►► DefinitionDefinition

►► Device Design and Categorization of Assist DevicesDevice Design and Categorization of Assist Devices

►► Established Indications for Use of Ventricular Established Indications for Use of Ventricular Assist DevicesAssist Devices�� Acute Circulatory SupportAcute Circulatory Support

►► PercutaneousPercutaneous Circulatory Support in the Catheterization LabCirculatory Support in the Catheterization Lab

�� BridgeBridge--toto--TransplantTransplant

�� BridgeBridge--toto--RecoveryRecovery

�� DestinationDestination

►► Patient SelectionPatient Selection

►► FutureFuture

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VENTICULAR ASSIST DEVICEVENTICULAR ASSIST DEVICE

Definition:Definition:

►► Mechanical Device which is Mechanical Device which is used to replace or reproduce used to replace or reproduce the pump function of the left the pump function of the left and/or right ventricle.and/or right ventricle.

►► Basic Principle:Basic Principle:�� Improve arterial flow (endImprove arterial flow (end--

organ perfusion)organ perfusion)

�� Improve ventricular unloadingImprove ventricular unloading

►► Price:Price:�� Blood element destructionBlood element destruction

�� ThomboembolismThomboembolism

�� InfectionInfection

�� CostCost

Inflowtubing

Outflowtubing

Propulsioncomponent

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VENTICULAR ASSIST DEVICEVENTICULAR ASSIST DEVICE

Definition:Definition:

►►Examples:Examples:

�� IABPIABP

�� ThoratecThoratec

�� HeartMate IHeartMate I

�� HeartMate IIHeartMate II

�� HeartMate IIIHeartMate III

�� Total Artificial HeartTotal Artificial Heart

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DEVICE DESIGNDEVICE DESIGN

►► Device components:Device components:

1.1. Propulsion component Propulsion component

•• Pulsatile FlowPulsatile Flow

•• NonNon--pulsatilepulsatile FlowFlow

2.2. CannulasCannulas

3.3. Power SupplyPower Supply

4.4. Control UnitControl Unit

5.5. BloodBlood--toto--NonNon--endothelial endothelial

surface contact materialssurface contact materials

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5.5. NonNon--endothelial surfaceendothelial surface

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Device components:Device components:

1.1. Propulsion componentPropulsion component



2.2. Cannulas Cannulas




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10









5.5. NonNon--endothelial endothelial

surfacesurface

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PROPULSION COMPONENTPROPULSION COMPONENT

►►Pulsatile Flow Pulsatile Flow (First Generation)(First Generation)

�� PusherPusher--plate plate (displacement) (displacement)

►►NonNon--pulsatilepulsatile Flow Flow (Second Generation)(Second Generation)

�� Axial Flow PumpsAxial Flow Pumps

�� Centrifugal PumpsCentrifugal Pumps

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PROPULSIONPROPULSION

COMPONENTCOMPONENT

►►Pulsatile FlowPulsatile Flow

�� Volume DisplacementVolume Displacement

�� PusherPusher--plate plate

HeartMate I

Thoratec

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VENTRICULAR DYNAMICSVENTRICULAR DYNAMICS

►►Pressure Volume Pressure Volume

LoopLoop

►►Pressure Flow Pressure Flow

CurveCurve

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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

Figure 1 Adult (left) and pediatric (right) Berlin Heart Excor® (Berlin Heart AG,

Berlin, Germany) ventricular assist devices

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PROPULSION COMPONENTPROPULSION COMPONENT

�� NonNon--pulsatilepulsatile FlowFlow

►►Centrifugal PumpsCentrifugal Pumps

►►Axial Flow PumpsAxial Flow Pumps

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BioMedicus

Ventritec

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Propulsion componentPropulsion component




Impella

For short-term use

For long-term use….

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Long Term

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Third Generation: Third Generation:

Magnetically Levitated Magnetically Levitated

Centrifugal and Axial PumpsCentrifugal and Axial Pumps

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Short Term: Magnetically Suspended Short Term: Magnetically Suspended

Centrifugal and Axial PumpsCentrifugal and Axial Pumps►► CentriMagCentriMag

�� Magnetically Magnetically

suspended suspended

centifugalcentifugal pumppump

�� No bearings or No bearings or

sealsseals

�� 9.9 L/min flow at 9.9 L/min flow at

5000 rpm5000 rpm

�� Less blood shear Less blood shear

damagedamage

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HeartMate III

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Long Term Centifugal Flow Pumps

IDE approval 9/2008CE Mark 12/08US TrialsIntra-Pericardial ImplantBBT and D10 L Flow

•IDE approval 9/2008•CE Mark 12/08•US Trials•Intra-Pericardial Implant•BBT and D•10 L Flow

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Axial Flow PumpsAxial Flow Pumps

►►The HM II is establishing The HM II is establishing

itself for:itself for:

�� BTTBTT

�� BTRBTR

�� DestinationDestination

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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 LONGEVITYVAD LONGEVITY

►► HM I HM I –– 2 years2 years

�� PulsatilePulsatile flow pumpflow pump

►► HM II HM II –– 5 years5 years

�� Axial Flow pumpAxial Flow pump

►► HM III HM III –– 10 years10 years

�� Magnetically Levitated Magnetically Levitated

CentifugalCentifugal Flow PumpFlow Pump

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►► DefinitionDefinition

►► Device Design and Categorization of Assist DevicesDevice Design and Categorization of Assist Devices

►► Established Established IndicationsIndications for Use of Ventricular Assist for Use of Ventricular Assist DevicesDevices�� Acute Circulatory SupportAcute Circulatory Support

�� BridgeBridge--toto--TransplantTransplant


�� DestinationDestination►► REMATCHREMATCH

►► INTrEPIDINTrEPID

►► HeartMateHeartMate IIII

► Patient Selection

►► FutureFuture

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Mechanical Circulatory SupportMechanical Circulatory Support

►►Established Indications for Use of Established Indications for Use of

Ventricular Assist DevicesVentricular Assist Devices

�� Acute Circulatory SupportAcute Circulatory Support

►►PercutaneousPercutaneous Circulatory Support in the Circulatory Support in the CathCath LabLab

�� Intermediate to longIntermediate to long--term circulatory supportterm circulatory support

►►BridgeBridge--toto--TransplantTransplant

►►BridgeBridge--toto--RecoveryRecovery

►►DestinationDestination

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PERCUTANEOUS MCS IN THE PERCUTANEOUS MCS IN THE

CATHETERIZATION LABCATHETERIZATION LAB

►►HemodynamicallyHemodynamically assisted Highassisted High--risk PCArisk PCA

►►Assisted Assisted percutaneouspercutaneous Valve repair and Valve repair and

ReplacementReplacement

►►Assisted arrhythmia ablationAssisted arrhythmia ablation

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PERCUTANEOUS LEFT PERCUTANEOUS LEFT

VENTRICULAR ASSIST DEVICESVENTRICULAR ASSIST DEVICES►► CardiogenicCardiogenic Shock Accompanying MIShock Accompanying MI1,21,2

�� 77--10% of AMI10% of AMI3,43,4

►► 7% STEMI7% STEMI

►► 2.5% non2.5% non--STEMISTEMI

�� Improved Survival with Rapid Culprit RevascularizationImproved Survival with Rapid Culprit Revascularization5,65,6

�� 5050--70% Mortality70% Mortality44--77

►► PercutaneousPercutaneous Ventricular AssistVentricular Assist�� IABP IABP –– NO IMPROVEMENT IN SURVIVALNO IMPROVEMENT IN SURVIVAL44--77

�� pVADpVAD►► TandemHeartTandemHeart

►► ImpellaImpella

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 1990through 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 coronarysyndromes 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 reportfrom 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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►►IABPIABP

►►pVADpVAD

�� Tandem HeartTandem Heart

�� ImpellaImpella

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Hemodynamic Advantage of Hemodynamic Advantage of

pVADpVAD vs. IABPvs. IABP

►► Directly unload the left Directly unload the left ventricle ventricle

►► Reduce myocardial Reduce myocardial workload and oxygen workload and oxygen consumption consumption

►► Increase cardiac output Increase cardiac output and coronary and endand coronary and end--organ perfusion organ perfusion

pVAD IABP

+++ -

+++ ++

+++ +

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►► Tandem Heart:Tandem Heart:�� TransTrans--septalseptal LA LA

inflow (21 F)inflow (21 F)

�� Femoral arterial Femoral arterial outflow (15outflow (15--17 F)17 F)

�� 3.53.5--4 L/min at 7500 4 L/min at 7500 rpmrpm

�� Systemic Systemic anticoagulationanticoagulation

�� Approved for shortApproved for short--term supportterm support

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PRT PRT TandemHeartTandemHeart

vs. IABPvs. IABP

►► University of Leipzig (2005)University of Leipzig (2005)

►► CS p AMI with intention for PCICS p AMI with intention for PCI

►► PRT: PRT: TandemHeartTandemHeart (21) vs. IABP (21) vs. IABP (20)(20)

►► Improved Hemodynamic Improved Hemodynamic parametersparameters�� Cardiac Power IndexCardiac Power Index

►► TandemHeartTandemHeart 0.22 0.22 �� 0.370.37

►► IABP 0.22 IABP 0.22 �� 0.280.28p<0.004p<0.004

►► Improved Metabolic ParametersImproved Metabolic Parameters�� Serum Lactate (6 hours)Serum Lactate (6 hours)

►► ComplicationsComplications�� Increased Complications in TH vs. Increased Complications in TH vs.

IABPIABP

►► Mortality (30 day)Mortality (30 day)�� TandemHeartTandemHeart 45%45%

�� IABP 43%IABP 43%(P=0.86)(P=0.86)

••Bleeding: Bleeding:

TH: n=19 vs.TH: n=19 vs.

IABP n=8 IABP n=8

(p<0.002)(p<0.002)

••Limb ischemia: Limb ischemia:

TH n=7 vs.TH n=7 vs.

IAPB n=0 IAPB n=0

(p<0.009)(p<0.009)

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TandemHeartTandemHeart vs.vs.

IABPIABP

►►PRT MultiPRT Multi--Center Center

(2006)(2006)

►►CardiogenicCardiogenic Shock Shock

(70% AMI)(70% AMI)

►►TandemHeartTandemHeart (n=19) (n=19)

vs. IABP (n=14); vs. IABP (n=14);

““rollroll--inin”” (n=9)(n=9)

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RESULTS:RESULTS:

►► Hemodynamic Hemodynamic

Parameters better Parameters better

with with TandemHeartTandemHeart

►► Adverse events Adverse events ––

no differenceno difference

►► 30 day mortality 30 day mortality ––

no statistical no statistical

difference (underdifference (under--

powered)powered)

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►►Tandem Heart:Tandem Heart:

►►ImpellaImpella

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ImpellaImpella

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ImpellaImpella

►► Impella LP 2.5Impella LP 2.5�� 13 F sheath (13 F sheath (percutaneouspercutaneous))

�� 9 F 9 F cannulacannula

�� 2.5 L maximal flow2.5 L maximal flow

�� 510K FDA approved for LV 510K FDA approved for LV support for up to 6 hourssupport for up to 6 hours

�� Sold by Sold by AbioMedAbioMed

►► Impella LP 5.0Impella LP 5.0�� 21 F21 F

�� Requires surgical Requires surgical implantationimplantation

�� 5.0 max flow5.0 max flow

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Impella Impella pVADpVAD

►► PRT; November 2008PRT; November 2008

►► 26 patients26 patients

�� 13 IABP13 IABP

�� 12 Impella LP2.512 Impella LP2.5

►► HemodynamicsHemodynamics

�� IABP IABP ∆∆CI 0.11CI 0.11

�� Impella Impella ∆∆CI 0.49CI 0.49

►► 30 day survival:30 day survival:

�� 46% in both groups46% in both groups

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ImpellaImpella

►►Protect II TrialProtect II Trial

►►MultiCenterMultiCenter TrialTrial

►►Elective High Risk PCIElective High Risk PCI

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Use of MCS for Use of MCS for CardiogenicCardiogenic Shock Shock

Complicating AMIComplicating AMI

►► Experimental data shows:Experimental data shows:�� Improved LV unloadingImproved LV unloading

�� Reduction in infarct Reduction in infarct extentionextention and sizeand size

�� Improved Improved HemodynamicsHemodynamics

►► Clinical data (17 papers) Clinical data (17 papers) shows:shows:�� Improved LV unloadingImproved LV unloading

�� Possible reduction in infarct Possible reduction in infarct extension and sizeextension and size

�� Improved Improved hemodymamicshemodymamics

�� No mortality benefitNo mortality benefit

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Use of MCS for Use of MCS for CardiogenicCardiogenic Shock Shock

Complicating AMIComplicating AMI

What can be said about the overall poor mortality data?

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Failure of Improvement of Mortality Failure of Improvement of Mortality

using using pVADpVAD in the in the CathCath LabLab

►►Sound TechnologySound Technology

�� EffectiveEffective

�� Ease of useEase of use

�� Low adverse event rateLow adverse event rate

►►Improve trial design:Improve trial design:

�� Improved patient selectionImproved patient selection

�� Earlier application of Earlier application of pVADpVAD

�� RegistryRegistry

►►Evolving paradigmEvolving paradigm

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►►Established Indications Established Indications for Use of Ventricular for Use of Ventricular Assist DevicesAssist Devices

�� Acute Circulatory SupportAcute Circulatory Support

�� BRIDGEBRIDGE--TOTO--TRANSPLANTTRANSPLANT


�� DestinationDestination►►REMATCHREMATCH

►►INtREPIDINtREPID

►►HeartMate IIHeartMate II

THERE ARE NO PRT’s

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BRIDGE

ventricular assist devices - continuing medical · pdf file · 2009-01-161...

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