The Cardiogenic Shock Initiative (NCSI): Care Process Implementation

leads to Improved Survival and Native Heart Recovery

William W. O’Neill, M.D., FACC, MSCAI

Medical Director

Center for Structural Heart Disease

Henry Ford Health SystemDetroit, MI

DisclosuresConsultant: Abiomed, MDT, Edwards Lifesciences, Abbott, BCSI

Cardiogenic Shock Causes

Advanced CHF STEMI

NON STEMI

VSD

MRStress

Myocarditis

OHCA

AcuteMyocarditis

(3) Evidence Based Treatment AMICS – ESC September 2017

Indicated I Consider IIa Neutral IIb Avoid III

PCI B

Fibrinolysis when PCI not

available C RHC CRoutine

IABP B

Arterial Line CIABP for VSD/MR C Inotropes C

Multi-Vessel PCI

(non-infarct artery) B

Echo Doppler C

Short term MCS C

Treat VSD/MR C

74%65% 65%

54%

32%

4+ 3 2 1 0

P<0.001 (N=287)

Number of Inotropes/Pressors

Basir M, Schreiber T, Grines C, et al. Effect of Early Initiation of Mechanical

Circulatory Support on Survival in Cardiogenic Shock. Am. J. of Cardiology,

2016.

Invasive Hemodynamics & Decreased Inotropes associated with Survival in AMI/CGSM

ort

alit

y

63%

49%

No HemodynamicMonitoring

Hemodynamic Monitoring

P<0.0001

Abiomed Impella Quality (IQ) Database, US AMI/CGS Apr 2009– Jan

2017. Survival to Explant. Danvers, MA: Abiomed cVAD survival to explant

2009-2016

Mo

rtal

ity

SMARTASSIST® PLATFORM COMPONENTS

• Peak flows up to 4.3 L/min

• New hemodynamic sensors for confident positioning

• Faster, simplified set up

• Weaning trends of LVEDP and MAP

• Real-time display of intelligent metrics

• Displays and calculates cardiac power output

• Real-time remote viewing of Impella console

• Access to clinical expertise

• Customized notifications

Advanced Metrics

Impella® Heart Pump

Impella Connect®

Advanced MetricsIntelligent metrics assist weaning and optimize

pump management

• Weaning assisted by LVEDP and MAP trends

• Only percutaneous heart pump that calculates and

displays Cardiac Power Output

• Real-time display of left Ventricular placement signal

SMARTASSIST® ADVANCED METRICS

• Cardiac Power Output (CPO) is the #1 correlate to

mortality in AMI Cardiogenic Shock.1

•

CPO= (MAP x Cardiac Output) / 451

Fincke, et. al. JACC, 2004 SHOCK TRIAL *Metrics are for informational purposes only. Any change in the trend should be

verified independently using a cleared or approved diagnostic device.

1.0

Basir M, Schreiber T, Grines C, et al. Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock. Am. J.

of Cardiology, 2016

Delay in MCS associated with Mortality in AMI/CGS

<75 mins >4 hrs

RAPID Identification of Cardiogenic Shock

Cath Lab Activation

AMI/CS Confirmed

MCS

DoorTo

SupportTime

Target< 90

minutes

NATIONAL CSI ALGORITHM

Femoral Access

AMI/CS UnconfirmedLHC*RHC*Echo*

*As needed to confirm diagnosis

MCS

PCI

Right Heart CathCPO < 0.6 CPO ≥ 0.6 andPAPI > 0.9

Continue to Titrate ↓ Pressors/Inotropes

PAPI < 0.9

Possible RV Failure

Consider RV Support

RV Normal

Consider ↑ LV Support

PAPI > 0.9

CARDIAC POWER OUTPUT(CPO)

CPO = MAP x CO / 451

PULMONARY ARTERY PULSATILITY INDEX

(PAPI)PAPI = sPA – dPA / RA

Calculate PAPI

National Cardiogenic Shock Initiative59 y/o Male: Collapsed @ work, anterior STEMI

VariableSample

SizeAge Inotropes

Cardiac Arrest

HR BP LactateLactate ≥

2mmol/l

Survival

SHOCK 302 66 99 28 102 89/54 N/A N/A 53

IABP SHOCK

600 70 90 45 92 90/55 4.1 74% 60

Culprit SHOCK

686 70 90 54 91 100/60 5.1 66% 49

NCSI 171 63 82 42 89 79/51 5.3 77% 72

NCSI- 98% Native Heart Recovery

achieved in survival group

Pre-MCS Post-MCS 12 Hours 24 Hours

HR (bpm) 89 93 88 89

SBP (mmHg) 79 114 106 107

DBP (mmHg) 51 78 73 68

LVEDP (mmHg) 29 (n=76) - - -

dPA (mmHg) 25 (n=52) 24 (n=79) 20 (n=91) 19 (n=79)

Lactate (mg/dL) 5.3 (n=99) - 3.9 (n=125) 2.9 (n=93)

CPO (W) 0.67 (n=57) 0.89 (n=128) 0.85 (n=117) 0.88 (n=82)

Hemodynamic Trends within the First 24 Hours

# Inotropes

0 1 ≥2

≤0.6 67% 57% 33%

0.6 to <0.8 100% 60% 50%

≥0.8 85% 79% 57%

Car

dia

c Po

wer

Ou

tpu

t (W

)

Survival Post MCS/PCI Based on CPO and Inotrope Usage (N=113)

Predictors of Survival at 12-24 hours (N=127)LA

CTA

TECARDIAC POWER OUTPUT ON IMPELLA SUPPORT

> 0.6

≥4

<4

≤ 0.6

50% Survival(n=18/36)

31% Survival(n=4/13)

65% Survival(n=11/17)

95% Survival(n=58/61)

www.henryford.com/cardiogenicshock

Progress in the Treatment of Cardiogenic Shock

National CSI

• Protocolized Approach

• Feasibility of Early MCS

• Development of the Shock Team

• Early Predictors (CPO/Lactate)

cVAD

• MCS Pre-PCI

• Door to Support

• Anoxic Brain Injury

IQ Database

• Right Heart Cath

• MCS Pre-PCI

• Use of Impella CP

Medical Community - EDUCATE

• Right Heart Cath

• MCS Pre-PCI

• Use of Impella CP

• Escalation pathway

1 st Quartile 0.41667

Median 0.53333

3rd Quartile 0.64286

Maximum 1 .00000

0.51673 0.54190

0.51314 0.54545

0.17187 0.18970

A-Squared 1 .60

P-Value <0.005

Mean 0.52931

StDev 0.18034

Variance 0.03252

Skewness -0.147967

Kurtosis 0.303483

N 791

Minimum 0.00000

Anderson-Darling Normality Test

95% Confidence Interval for Mean

95% Confidence Interval for Median

95% Confidence Interval for StDev

90.0%75.0%60.0%45.0%30.0%15.0%0.0%

Median

Mean

55.0%54.0%53.0%52.0%51 .0%

95% Confidence Intervals

Summary Report for Survival

Wide Variation in AMI/CGS Outcomes

Survival to ExplantCenters supporting > 4 pts

Impella® Centers

Data on file. Internal Clinical Quality Data, US AMI/CGS Jan 2009 – Dec 2016. Danvers, MA: Abiomed.

n=15,259

N=1069 N=10808 N=2107

23.8%

52.3%

78.4%

Tercile 1 Tercile 2 Tercile 3

Mean Survival(N=# of Patients)

(P<0.001)

N=1069 N=10808 N=2107

Survival to ExplantCenters supporting > 4 pts

0% 20% 40% 60% 80% 100%0% 20% 40% 60% 80% 100%

Increasing Adoption of Best Practices Improving Overall

AMICS Outcomes

# of Sites

1. Data on file. Abiomed Impella Quality(IQ)Data, AMI/CGS Apr 2009 – Jun 2018. Danvers, MA: Abiomed.

2. 791 centers supporting >4 AMICS patients, 15,259 Patients Total

3. 948 centers supporting >4 AMICS patients, 11,411 Patients Total

4. Greater than 90% of survivors were explanted with native heart recovery

Distribution of Impella Site Outcomes1

59%51%

Prior Report2 Current Report3

P<0.001

(Centers >80%

survival increased

from 7% to 15%

P<0.0001)

Increasing Adoption of Best Practices Improving Overall

AMICS Outcomes

# of Sites

1. Data on file. Abiomed Impella Quality(IQ)Data, AMI/CGS Apr 2015 – Jun 2018. Danvers, MA: Abiomed.

2. 376 centers supporting >4 AMICS patients, 3111 Patients Total

3. 140 centers supporting >4 AMICS patients, 1137 Patients Total

4. Greater than 90% of survivors were explanted with native heart recovery

Distribution of Impella Site Outcomes1

0% 20% 40% 60% 80% 100%

63%

0% 20% 40% 60% 80% 100%

51%

PrePMA2 PostPMA (Year 3 YTD)3

P<0.001

(Centers >80%

survival increased

from 11% to 19%

P=0.027)

Conclusion:

• The adoption of best practices in patients being treated

for AMICS with Impella has significantly increased over

time

• Increase in best practices associated with

1) Improved survival to explant and

2) Increase in the number of centers achieving >80% survival to

explant

3) Native heart recovery in majority of survivors