Outcomes for 15,259 US Patients With Acute MI Cardiogenic Shock (AMICS) Supported With Impella William O’Neill, MD, FACC Medical Director Structural Heart Disease at Henry Ford Hospital, MI
High In-Hospital Mortality During AMI Cardiogenic Shock3
1. Sandhu A, McCoy l, Negi S, et al. Use of Mechanical Circulatory Support in Patients Undergoing Percutaneous Coronary Intervention; Insights from the National Cardiovascular Data Registry. Circulation, 2015;132:1243-1251
2. Acute Cardiac Assist Report, Health Research International – August 2015 3. Jeger, et al. Ann Intern Med. 2008
N = 23,696
7435578954 78500 79823
8058582626
8669289923
2009 2010 2011 2012 2013 2014 2015 2016
US AMI/CGS cases per year1,2
AMI Shock Mortality Unchanged in > 20 years
Impella Quality (IQ) Database Methods • Abiomed clinical personnel collecting real world data from
>98% of US cases since 2009; >50,000 patients
• >15,000 patients with AMI-CGS
• FDA Approval 2016, AMI/CGS therapy and heart recovery
• Audited by Abiomed Heart Team (Cardiologists and CV Surgeon)
• HIPAA compliant data collection, FDA Maude protocol compliant
• “Exempt” status by Henry Ford Hospital IRB
• Survival tracked to device explant
HRPCIElec+ve&Urgent
47%(n=1275)
CardiogenicShock40%
(n=1090)Other13%
(n=339)
IQ Program Data Resources
HRPCIElec+ve&Urgent
48%(n=22,678)
CardiogenicShock32%
(n=15,259)
Other19%
(n=9012)
cVAD Registry Data2N=2,704
Observational IQ Database IRB Registry Data
• IRB Exempt / HIPAA Compliant • 1,010 US Impella Centers; 2009-2017 • Abiomed Heart Team Physicians Audited • All Devices, All Indications
• IRB approval at all institutions (65) • Retrospective (‘09 to ‘15); Prospective (‘16) • FDA protocols and CEC Events Adjudication • All Devices, All Patients Enrolled
Abiomed Impella Quality (IQ) Database1
N=46,949
1. Abiomed Impella Quality (IQ) Database, Danvers MA 2. cVAD Registry Data of Patients Undergoing PCI for Acute Myocardial Infarction Complicated by Cardiogenic Shock as of September 2015
AMI/CGS Impella Patient Demographics
• Age – Mean: 63.6 y/o – Range: (19 – 99)
• Gender – 73% Male
• Duration Of Support – Mean: 3.78 Days – Median: 2.7 Days – Max: 94 Days
• Survival to Explant
N=3549 N=9693
IQ Database1 cVAD Registry2
• Age – Mean: 66.3 y/o – Range: (19 – 95)
• Gender – 76% Male
• Duration Of Support – Mean: 1.63 Days – Median: 1.1 Days – Max: 10.6 Days
• Survival to Explant, Discharge & 30 days
1. Abiomed Impella Quality (IQ) Database, Danvers MA 2. cVAD Registry Data of Patients Undergoing PCI for Acute Myocardial Infarction Complicated by Cardiogenic Shock as of September 2015
Impella Utilization in AMI Shock
1. Acute Cardiac Assist Report, Health Research International – August 2015 2. Sandhu A, McCoy l, Negi S, et al. Use of Mechanical Circulatory Support in Patients Undergoing Percutaneous Coronary Intervention; Insights from the National Cardiovascular
Data Registry. Circulation, 2015;132:1243-1251 3. Data on file. Abiomed Impella Quality (IQ) Database, US AMI/CGS Jan 2009 – Dec 2016. Danvers, MA: Abiomed.
74355 78954 78500 79823 80585 8262686692
89923
43% 45%42% 41% 39% 41% 42% 42%
0% 1% 1% 2% 2% 3% 4% 6%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0
10000
20000
30000
40000
50000
60000
70000
80000
90000
100000
2009 2010 2011 2012 2013 2014 2015 2016
% Impella Supported Patients 3
% IABP Supported Patients 2
Total AMI/CGS US Patients 1,2
1stQuartile 0.41667Median 0.533333rdQuartile 0.64286Maximum 1.00000
0.51673 0.54190
0.51314 0.54545
0.17187 0.18970
A-Squared 1.60P-Value < 0.005
Mean 0.52931StDev 0.18034Variance 0.03252Skewness -0.147967Kurtosis 0.303483N 791
Minimum 0.00000
Anderson-Darling NormalityTest
95% ConfidenceIntervalforMean
95% ConfidenceIntervalforMedian
95% ConfidenceIntervalforStDev
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%ConfidenceIntervals
SummaryReportforSurvivalVariation in Impella AMI/CGS Outcomes
1. 791 sites supporting >4 AMICS patients, 15,529 patients total. Data on file. Abiomed Impella Quality(IQ)Data, AMI/CGS Jan 2009 – Dec 2016. Danvers, MA: Abiomed. 2. Top 20% performing sites have higher volume of Impella utilization 3. Greater than 90% of survivors were explanted with native heart recovery in 2016 4. Mean survival of 58% in 2016. Improvement of 14% (relative) since FDA approval
Distribution of Impella Site Outcomes1
Top 20% of sites have mean survival of 76%2
Bottom 20% of sites have mean survival of 30%
SurvivaltoExplant3
#ofSites
20164
62%
67%
IABP/InotropesPre-PCI ImpellaPre-PCI
cVAD Registry2
N=164
52%
59%
IABP/InotropesPre-PCI ImpellaPre-PCI
IQ Database1
Impella Pre-PCI associated with Improved Survival in AMI/CGS
1. Abiomed Impella Quality (IQ) Database, US AMI/CGS Apr 2009– Jan 2017. Survival to Explant. Danvers, MA: Abiomed. 2. 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
P<0.001
N=121N=2450N=3121
P<0.001
Hemodynamic Monitoring associated with Improved Survival in AMI/CGS
68%76%
NoHemodynamicMonitoring
HemodynamicMonitoring
cVAD Registry2
49%
63%
NoHemodynamicMonitoring
HemodynamicMonitoring
IQ Database1
N=516N=634N=5217N=8767
P<0.0001
P=0.002
1. Abiomed Impella Quality (IQ) Database, US AMI/CGS Apr 2009– Jan 2017. Survival to Explant. Danvers, MA: Abiomed. 2. cVAD survival to explant 2009-2016
32%
54%65% 65%
74%
0 1 2 3 4+
Mortality and Number of Inotropes from cVAD Registry1 P<0.001 (N=287)
Number of Inotropes/Pressors
1. 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
Increased Inotrope Exposure is associated with Mortality in AMI/CGS
Samuels LE et al , J Card Surg. 1999
Mortality
Detroit Cardiogenic Shock Initiative
DETROIT CSI
Detroit CSI AMI/CGS Pilot Study
0.56WaRs
0.96WaRs
CPOPre-Impella CPOOnImpella
P<0.001
N=21 N=27
58%increase
• July 2016 to February 2017 – all sites performed >10 AMICS cases w/
Impella within last calendar year
• Enrolled 37 patients – Age 63 +/- 13 years (36-87)
• Rapid Door to Unloading times (average 82 minutes)
• 62% supported w/ Impella Pre-PCI
• RHC use 84%
• 86% of patients established TIMI III flow
• Decrease Inotropic/Vasopressor use in 80% of cases
Hemodynamic Improvement On Support
Cardiac Power Output1 (CPO = MAP x CO)
1. Fincke, et al., Cardiac Power Is the Strongest Hemodynamic Correlate of Mortality in Cardiogenic Shock: A Report From the SHOCK Trial Registry. JACC, Vol. 44, No. 2, 2004
51%
89% 84%
SurvivaltoExplantMetroDetroitBeforeStudy
SurvivaltoExplantDetroitCSI
SurvivaltoDischargeDetroitCSI
Outcomes
100% Native Heart Recovery in Survivors
100% Native Heart Recovery In surviving Patients (31/31)
1 2 2
1. AbiomedImpellaQuality(IQ)Database,Jan2015toJuly2016forAggregateDTWMetroHospitalsAMI/CGSSurvivaltoExplant2. FeasibilityofEarlyMechanicalSupportDuringMechanicalReperfusionofAcuteMyocardialInfarctCardiogenicShock;W.O’Neill,M.Basir,S.Dixon,KPatel,TSchreiber,S.Almany;InPressJACCIntervenXons
Conclusions • AMI CGS mortality remains unchanged despite major advances in
cardiac care in past 20 years
• Despite FDA PMA approval, Impella is used in ~5% of US AMI Shock Cases
• There is a wide institutional variation in AMI CGS outcomes with Impella use
• Key Observations Associated with Improved Outcomes: ‒ Increased institutional use of Impella ‒ Impella use prior to PCI ‒ Reduced exposure to high dose inotropes ‒ Protocol using hemodynamic monitoring to guide escalation and weaning
• Prospective, systematic adoption of best practices (DCSI) markedly improves survival and native heart recovery
Thank You
EarlyIdenVficaVon
UnloadPriortoPCI(DTU)
HemodynamicMonitoring
ProtocolDrivenTreatment
EscalaVon
DetroitCSI@h]s.org