The Cardiogenic Shock Initiative (NCSI): Care Process ... · 1. Data on file. Abiomed Impella...
Transcript of The Cardiogenic Shock Initiative (NCSI): Care Process ... · 1. Data on file. Abiomed Impella...
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