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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

2

11 2

1

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