Post on 16-Jul-2020
transcript
3/1/2017
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Margarita Camacho MD, FACS
Surgical Director
Cardiac Transplant and Mechanical Assist Device Program
RWJ/Barnabas Health Heart Centers at
Newark Beth Israel Medical Center
Newark, NJ
Approaches to Cardiogenic ShockApproaches to Cardiogenic Shock
• Sunshine Heart, Inc. Consultant
DisclosuresDisclosures
1. JACC HF. 2013;1:1-20.
2. Rose EA, et al. Long-term mechanical left ventricular assistance for end-stage heart failure.
N Engl J Med. Nov. 2001;5;345(20):1435-43.4. Rogers, Butler, Lansman, et al. J Am Coll Cardiol. 2007;50:741-47.
5. Hershberger, Nauman, Walker, et al. J Card Fail. 2003;22:616-24.
6. Gorodeski, Chu, Reese, et al. Circ Heart Fail. 2009;2:320-24.
7. Data on file. Pleasanton, Calif: Thoratec Corp.
Heart failure is a growing issue in the US…
•~6.0 million adults (2.8%) in the US have heart failure
–670,000 new cases each year
•#1 reason for hospitalization in people >65
–After 4 hospitalizations, median survival is <6 months
• More costly than all forms of cancer combined
Heart Failure is a major driver of morbidity and mortality in the US1-7
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1. Current estimates of adult patients with advanced heart failure (HF) in the United States, with projected left ventricular assist device (LVAD) candidates. U.S. population estimate is derived from U.S. Census data. Estimate of HF prevalence is derived
from latest American Heart Association (AHA) statistics.2. UNOS Website: http://optn.transplant.hrsa.gov
3. O’Connell. Advanced Heart Failure Therapies Forum, Atlanta. 2013.
Transplants are considered the ‘gold standard,’ but the supply of donor hearts is limited1
“Proposing heart transplantation to cure heart failure is analogous to proposing the lottery to cure poverty.”
– LW Stevenson3
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Indications for Acute Support Indications for Acute Support
�Bridge to Recovery/Decision (mostly salvage cases)
�Cardiogenic shock due to refractory heart failure
�Bridge to Transplant (BTT)
�Bridge to Durable Device
�ECMO
�Veno-venous (VV) – pre-/post lung transplant, ARDS
�Veno-arterial (VA) – prolonged shock, post-cardiotomy
�Post-cardiotomy failure
� Bridge to Recovery
� Bridge to Another Device
� Bridge to Transplant
� Withdrawal of Support
Bridge to Recovery/Decision
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Timing – earlier referral is bestTiming – earlier referral is best
• Identify candidates who will benefit from MCS
• Avoid end-organ damage
• Improve quality of life
• More rapid post-operative recovery if referred
before co-morbidities begin to appear, i.e. renal
dysfunction
• If referred earlier, they can be kept on the radar
and receive timely intervention, rather than no
intervention due to “too late” referral
• Avoid patients who are “too sick” to benefit
Types of Assist Devices
• Short term support
• Percutaneous (Impella, Tandem Heart)
• Surgical (CentriMag, Impella LD and 5.0)
• ECMO (V-V / V-A)
• Unclear neurologic status
• Respiratory failure
• Acute renal and liver dysfunction
• Antithrombotic burden (antiplatelets, IIb/IIIa
inhibitors)
• Uncertain potential for cardiac recovery
• Unknown psycho-social status
Why not implant long term VAD support in
cardiogenic shock?
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Patients in refractory cardiogenic shock with relative
contraindications for permanent VAD can be:
1. Supported safely with temporary MCS devices.
2. Be bridged to a permanent VAD once
contraindications for permanent VAD no longer
exist.
3. Suitability for bridge to transplant ascertained while
on initial temporary support.
Reasonable Evidence to Justify
Short Term MCS
Short term devices provide an opportunity to “act” first and “ask” later
Cardiogenic shock MCS networkCardiogenic shock MCS network
• Hospitals in area contacted to establish open channel of communication
• Consider early transfer to hub facility (transplant/VAD)
• Potential for spoke centers to gain experience with implant
• Implant and transfer model
SpokeHospital
SpokeHospital
SpokeHospital
SpokeHospitalHub
Less than 250 miles
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ABIOMED AB5000 SystemABIOMED AB5000 System
• Bi-ventricular support (Both sides of heart)
• Off-pump, easy cannula placement @ all Heart Centers
• No Coring of the heart, lower bleeding vs. BTT VADs
• Elimination of seals and bearings
• Elimination of friction and heat generation in the
blood path reducing the risk for thrombus
formation and hemolysis
• Uniform washing of the rotor surface minimizes
areas of blood stagnation and turbulence in the
pump
CENTRIMAG MAGLEV PUMP
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CentriMag®
System Components
CentriMag®
System Components
Pump Motor Console
CENTRIMAG PUMPCENTRIMAG PUMP
CENTRIMAG PUMP & MOTORCENTRIMAG PUMP & MOTOR
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Bearingless Pump & MotorBearingless Pump & Motor
•Max. pump speed: 5500 RPM
•Max. flow: 9.9 LM•Rotor has magnetic core
•No bearing and seals
•Disposable pump head•31 cc priming volume
ECMO CIRCUITECMO CIRCUIT
CentriMag pump
Oxygenator
Venous cannula
Arterial cannula
Flow probe
Generally Femoral
vein to Femoral
artery
In adults 19-21 Fr
venous drainage
cannula and 19-21 Fr
arterial return
cannula
Percutaneous Cannulation(for ECMO)
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Left Heart CannulationLeft Heart Cannulation
© IHC 2005
LA Ao
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Bilateral SupportBilateral Support
© IHC 2005
RA
LA
PA
Ao
SURGICAL CANNULATIONSURGICAL CANNULATION
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Tandem Heart
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Tandem Extremity ProtectionTandem Extremity Protection
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• 117 patients with severe refractory cardiogenic shock
• 58 patients (48%) were undergoing active CPR at time
of insertion
• 80 patients with ischemic and 37 patients with non-
ischemic cardiomyopathy
• 60% 30-day survival and 55% 6-month survival
Tandem Heart
Texas Heart Experience
Tandem Heart
Texas Heart Experience
Tandem Heart
Texas Heart Experience
Tandem Heart
Texas Heart Experience
• Cardiac index increased from 0.5 to 3.0
• SBP increased from 75 to 100
• Mixed venous O2 saturation increased from 49% to 69%
• Urine output increased from 70 cc/day to 1,200 cc/day
Kar B, Gregoric I, Basra SS, et. Al. Percutaneous Ventricuar Assist DeviceIn Severe Refractory Cardiogenic Shock;JACC 57(6):688-96, 2011
Abiomed Impella 5.0Abiomed Impella 5.0
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Impella®
is the only percutaneous heart pump proven safe and
effective for hemodynamic stabilization to enable
Heart Recovery.
Indications now include Protected PCI and Cardiogenic Shock in the
setting of AMI and Postcardiotomy.
Heart Recovery is an improvement in heart muscle
function that enables a patient to sustain quality of
life at home with their native heart
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FDA IndicationFDA Indication
The Impella 2.5™, Impella CP®
, Impella 5.0 ™ and Impella LD ™ catheters, in conjunction with the Automated Impella Controller console, are intended for short-term use (<4
days for the Impella 2.5 and Impella CP and <6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction (AMI) or open heart
surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump.
The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of
residual myocardial function.
* Optimal medical management and conventional treatment measures include volume
loading and use of pressors and inotropes, with or without IABP
Data Supporting FDA IndicationsData Supporting FDA Indications
Scientific Evidence Total # of Patients # of Impella Patients
Recover I FDA Study 17 17
ISAR Shock RCT 26 13
U.S. Impella Registry 401 401
Literature review 2,537 692
Total 2,981 1,123
Protect I FDA Study 20 20
Protect II FDA Study 452 225
U.S. Impella Registry 1,322 637
Literature review 2,537 756
Total 4,331 1,638
HCS-PMA-PP00908-014 rC
Pro
tecte
d P
CI
24,000 Patients from FDA medical device reporting (MDR) database
Card
iogenic
Shock
Hemodynamic Stabilization with Impella®Hemodynamic Stabilization with Impella®
Unloads Left Ventricle& Coronary Perfusion
Right SideSupport
Escalation & Ambulation
End OrganPerfusion
Left SideImpella 2.5/CP/5.0
Right SideImpella RP
Seyfarth et al., JACC, 2008
Remmelink M et al., Cath Card Interv. 2007
Lima B. et al., Am J Cardiol 2016Anderson MB. et al., J Ht Lg Transplant. 2015Lam K. et al,. Clin Res Cardiol, 2009
Casassus et a., JOIC, 2015
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1. Dhaval Kolte et al. J Am Heart Assoc 2014 NATIONWIDE INPATIENT SAMPLE2. Centers for Medicare and Medicaid database, MEDPAR FY14
Incidence of Cardiogenic Shock
Growing
Incidence of Cardiogenic Shock
Growing
STEMI Cardiogenic Shock in Medicare
Age Increasing 2
Cardiogenic Shock in STEMI
Increasing 1
2010 2014
36,969
56,508
53%
Age >65 only, excludes non-Medicare population
Cardiogenic Shock Remains Leading Cause of Mortality in Acute Myocardial Infarction
Cardiogenic Shock Remains Leading Cause of Mortality in Acute Myocardial Infarction
2000 2001 2002 2003 2004 2005 20060
10
20
30
40
50
60
70
80
Death
Rate
, %
90
100
1. Jeger, et al. Ann Intern Med. 2008
2. Shah, et al. JACC 2016 NCDR Registry
High In-Hospital MortalityDuring AMI Cardiogenic
Shock1
… and Ongoing Hazard Post Discharge
after AMI Cardiogenic Shock2
Mo
rtality
% P
ost
Dis
ch
arg
e
N = 112,668N = 23,696
%
Mortality in PCI with Cardiogenic Shock
Remains a Clinical Challenge
Mortality in PCI with Cardiogenic Shock
Remains a Clinical Challenge
In-Hospital MortalityAMI Cardiogenic Shock
with PCI1
N = 32,598
Wayangankar, et al. JACC Int 2016 CATH-PCI Registry
p<0.0001
2005-2006 2011-2013
28%
31%
11%
AMI Cardiogenic Shock with PCI only; Overall mortality >50%
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IABP in AMI Cardiogenic Shock: No
Hemodynamic or Survival Benefit
IABP in AMI Cardiogenic Shock: No
Hemodynamic or Survival Benefit
1- Prondzinsky R. et al. Jn Critical Care Medicine IABP SHOCK I 2010 – Clinicaltrial.gov # NCT00469248
2- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036
IABP-SHOCK II Randomized Controlled Trial2
N = 600
IABP SHOCK IRandomized Controlled Trial1
N = 40
IABP Increased hazard risk of stroke, downgraded to Class III (harm), Level of Evidence A, ESC STEMI Guidelines 2014
IABP (n=19)
Medical Therapy (n=21)IABP (n=301)
Medical Therapy (n=299)
log-rank, p=0.92
41.3%
39.7%
CPO = MAP x Cardiac Output x 0.0022
Impella® ®
Heart Pump: How It WorksImpella® ®
Heart Pump: How It Works
Animation
Click here
Placement in Left Ventricle
Impeller and blood outflow
Improvement in Cardiac IndexISAR SHOCK Randomized Controlled Trial
Hemodynamic Stability & LV Unloading with Impella®
(L/min/m2)
Seyfarth et al., JACC, 2008
Augmented CI
Ventricular Unloading
Impella 2.5Native
Heart
Pre-Support
On Impella
1.71±0.45
2.20±0.64
1.73±0.591.84±0.71
Pre-Support On IABP
N.S.
P= 0.02
Native CI
N=26Impella 2.5 IABP
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Impella ON
Impella OFF
1. Remmelink, et. al. CCI, 20072. Aqel et. al. J Nuclear Cardiology, 2009
Improved Myocardial Perfusion with Impella®Improved Myocardial Perfusion with Impella®
Occluded
RCA/LCX
Territory
CTO of LCX and RCA untreated2
p<0.0001
Pre-Support
On Support
61
72
18%
Coronary Flow Velocity(cm/s)n=11
Bedside planar images with gamma camera
Improved End Organ Perfusion With Impella ®Improved End Organ Perfusion With Impella ®
Casassus, et. al, J Interven Cardiol, 2015
Reduction of Blood Lactate Concentration
Blo
od
Lac
tate
(m
mol/
L)
Numbers of days from Impella Implant
P<.0001
Which patient for an acute device?Which patient for an acute device?
• Cardiac arrest with ongoing CPR
• Cardiogenic shock, IABP-dependent on inotropes and pressors
• Intra-operative failure to wean from cardiopulmonary bypass
• Bridge to a decision: indeterminate neurologic status or other significant co-morbidity (i.e., possible incurable malignancy) with critical clinical deterioration
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Device Choices for
Cardiac arrest with ongoing CPR
Device Choices for
Cardiac arrest with ongoing CPR
• CentriMag
• AB5000
• Alternate: Impella 5.0 or Tandem Heart
Device Choices for
Cardiogenic shock, IABP-dependent on inotropes
and pressors
Device Choices for
Cardiogenic shock, IABP-dependent on inotropes
and pressors
• CentriMag
• Impella 5.0
• Tandem Heart
Device Choices for
Bridge to a decision: indeterminate neurologic status or
other significant co-morbidity (i.e., possible incurable
malignancy) with critical clinical deterioration
Device Choices for
Bridge to a decision: indeterminate neurologic status or
other significant co-morbidity (i.e., possible incurable
malignancy) with critical clinical deterioration
• CentriMag
• Impella 5.0
• Tandem Heart
• AB5000
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•CentriMag or AB5000 (in-patient only)
•Tandem Heart or Impella (consider axillary
approach, in-patient only)
Device Choices for
Biventricular
Bridge to Transplant (BTT)
Device Choices for
Biventricular
Bridge to Transplant (BTT)
2008: 38 year old mother of three children 2008: 38 year old mother of three children 2008: 38 year old mother of three children 2008: 38 year old mother of three children with sudden, unexplained cardiogenic with sudden, unexplained cardiogenic with sudden, unexplained cardiogenic with sudden, unexplained cardiogenic
shockshockshockshock
2008: 38 year old mother of three children 2008: 38 year old mother of three children 2008: 38 year old mother of three children 2008: 38 year old mother of three children with sudden, unexplained cardiogenic with sudden, unexplained cardiogenic with sudden, unexplained cardiogenic with sudden, unexplained cardiogenic
shockshockshockshock
• Was at a southern NJ hospital more than an hour away; EF 15%
• IABP placed for initial stabilization, allowed transfer to NBI
• Upon arrival, was on maximum pressors and inotropes with MAP 40-50, mixed venous O2 saturation 40%, extremities blue/grey, cold and clammy
• Intubated, following commands
What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??
• Sternotomy and place short-term LVAD off-pump
• Insertion of femoral V-A ECMO
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She was brought to the She was brought to the She was brought to the She was brought to the operating room……..operating room……..operating room……..operating room……..
She was brought to the She was brought to the She was brought to the She was brought to the operating room……..operating room……..operating room……..operating room……..
• CentriMag LVAD implanted off-pump
• Left IABP in overnight to augment BP
• IABP removed the next day; OOB on POD #2
• LVAD explanted 5 days later
• Discharged home after uneventful hospital recovery
2013: 41 2013: 41 2013: 41 2013: 41 y.oy.oy.oy.o male s/p male s/p male s/p male s/p HeartMateHeartMateHeartMateHeartMate II LVAD II LVAD II LVAD II LVAD followed by heart transplantfollowed by heart transplantfollowed by heart transplantfollowed by heart transplant
2013: 41 2013: 41 2013: 41 2013: 41 y.oy.oy.oy.o male s/p male s/p male s/p male s/p HeartMateHeartMateHeartMateHeartMate II LVAD II LVAD II LVAD II LVAD followed by heart transplantfollowed by heart transplantfollowed by heart transplantfollowed by heart transplant
• Seven months post-transplant, becomes non-compliant with immunosuppression meds
• Suffers 3B rejection with subsequent hemodynamic instability.
• IABP placed, results in improved mixed venous O2 sats and hemodynamic improvement
• Few days later, likely due to ongoing myocardial necrosis due to rejection, suffers recurrent VT storms that become more frequent, EF 20%
What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??What to do next ??
• Re-do sternotomy and insertion of CentriMag short-term LVAD• Concern: he is only 6-8 months s/p two
sternotomies – for HM II LVAD followed by heart transplant
• Insertion of femoral V-A ECMO
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He was brought to the operating roomHe was brought to the operating roomHe was brought to the operating roomHe was brought to the operating room……..……..……..……..He was brought to the operating roomHe was brought to the operating roomHe was brought to the operating roomHe was brought to the operating room……..……..……..……..
• Peripheral V-A ECMO established using cannulas surgically placed (open technique) in right femoral artery and right femoral vein
• Smaller re-perfusion catheter was placed in distal right femoral artery
• IABP left in place for BP augmentation
• ECMO removed 2 weeks later, EF 35%
�33 y.o. female, acute closure LAD, Impella
placed at outside hospital but not
functioning well, transferred in cardiogenic
shock on high-dose pressors and inotropes
Case PresentationsCase Presentations
�54 y.o. male admitted with recurrent VT,
stable during work-up, suffered Vfib arrest,
refractory Vfib, with ongoing CPR to OR
Case PresentationsCase Presentations
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Case PresentationsCase Presentations
�56 y.o. male awaiting heart transplant, Status
1A inpatient, EF 8%, decompensated CHF
refractory to IABP and high-dose inotropes
and pressors
� 55 y.o. acute aortic dissection involving rca,
underwent Bentall, had RV failure despite
additional SVG to RCA
Case Presentations:
Failure to Wean from cardiopulmonary bypass
Case Presentations:
Failure to Wean from cardiopulmonary bypass
Case Presentations:
Failure to Wean from Cardiopulmonary Bypass
Case Presentations:
Failure to Wean from Cardiopulmonary Bypass
�62 y.o. male suffered massive MI at outside
hospital, had IABP, intubated, two episodes
cardiac arrest, transferred in cardiogenic
shock, underwent emergency CABG