MCSRNMechanical Circulatory Support
Research Network
Stulak JM, Davis ME, Haglund N, Dunlay S, Stulak JM, Davis ME, Haglund N, Dunlay S, Cowger J, Shah P, Pagani FD, Aaronson KD, Cowger J, Shah P, Pagani FD, Aaronson KD,
Maltais SMaltais S
MCSRNMechanical Circulatory Support
Research Network
A Multi-Institutional Comparison of A Multi-Institutional Comparison of Adverse Events in Contemporary Adverse Events in Contemporary
Continuous Flow LVADContinuous Flow LVAD Significant Differences Exist?Significant Differences Exist?
DisclosuresDisclosures
•Research Funding (FDP, KA, SM)
•NHLBI
•HeartWare
MCSRN
BackgroundBackground
• INTERMACS 6th annual report• 8 years, >10,000 pt, accrual 2,000pt/yr
•Very few comparisons of 2nd and 3rd generation LVADs• Aaronson et al., 2012 (n=499 vs. 140)
• Lalonde, et al., 2013 (n=13 vs. 33)
• Pagani, et al., 2015 (n=148 vs. 297)
MCSRN
AimAim
•Evaluate outcomes in a large, multicenter cohort with an “all comers” approach
•Stratify outcomes according to contemporary 2nd and 3rd generation LVAD
•Report overall incidence and time-related cumulative risk of AE’s
MCSRN
MethodsMethods
• IRB approval
•Retrospective review of prospectively collected database
•Outcomes• Survival
• Bleeding, TE events
• Neurologic events
• InfectionMCSRN
PatientsPatients
157157
AgeAge
1818 8282
57 yr57 yr
n =734n =734560 HMII, 174 HVAD560 HMII, 174 HVAD
Sept 2014Sept 2014May 2004 May 2004
577577MCSRN
HMIIHMII HVADHVAD pp
Age at implantAge at implant 60 60 58 58 0.020.02
INTERMACSINTERMACS 2.8 2.8 2.9 2.9 0.0450.045
CreatinineCreatinine 1.4 1.4 1.3 1.3 0.0040.004
MaleMale 83% 83% 72% 72% 0.0020.002
HTNHTN 47% 47% 58% 58% 0.0130.013
BTTBTT 53% 53% 81% 81% <0.001<0.001
Preop IABPPreop IABP 48% 48% 37% 37% 0.0110.011
Preop Clinical CharacteristicsPreop Clinical Characteristics
MCSRN
HMIIHMII HVADHVAD pp
Redo sternotomyRedo sternotomy 33% 33% 31% 31% 0.510.51
TV surgeryTV surgery 38% 38% 21% 21% <0.001<0.001
AV surgeryAV surgery 9% 9% 5% 5% 0.220.22
Temporary RVADTemporary RVAD 5% 5% 4% 4% 0.440.44
MCSRN
Intraop Clinical CharacteristicsIntraop Clinical Characteristics
HMIIHMII HVADHVAD pp
Early mortalityEarly mortality 7.4% 7.4% 7.5% 7.5% 0.950.95
DialysisDialysis 10% 10% 10% 10% 0.960.96
Postop inotropesPostop inotropes 6 days 6 days 5 days 5 days 0.30.3
LOSLOS 20 days 20 days 16 days 16 days <0.001<0.001
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Early Postop OutcomeEarly Postop Outcome
Follow-upFollow-up
1,120 patient-years of support
Median, 1 yrs.
Max., 10.4 yrs.
n = 680
MCSRN
Years
Per
cen
t
560 299 164 94 59 31174 65 25 13 1 1
HeartMate IIHeartWare HVAD
Survival by DeviceSurvival by Device
p=0.96
Follow-up time, years
Per
cen
t
p=0.18
HeartMate IIHeartWare HVAD
560 299 164 94 59 31174 65 25 13 1 1
GI Bleeding by DeviceGI Bleeding by Device
Follow-up time, years
Per
cen
t
p=0.006
HeartMate IIHeartWare HVAD
560 299 164 94 59 31174 65 25 13 1 1
Stroke by DeviceStroke by Device
Follow-up time, years
Per
cen
t
p=0.039
HeartMate IIHeartWare HVAD
560 299 164 94 59 31174 65 25 13 1 1
Any Infection by DeviceAny Infection by Device
Follow-up time, years
Per
cen
t
p=0.14
HeartMate IIHeartWare HVAD
560 299 164 94 59 31174 65 25 13 1 1
Driveline Infection by DeviceDriveline Infection by Device
Follow-up time, years
Per
cen
t
p=0.35
HeartMate IIHeartWare HVAD
560 299 164 94 59 31174 65 25 13 1 1
Pump Thrombus by DevicePump Thrombus by Device
Hazard ratio
Thrombus
Survival
Stroke
Infection
GI bleed
Driveline
AE Risk ComparisonAE Risk Comparison
vs. HeartMate II
HMIIHMII HVADHVAD ppDLIDLI 0.12 0.12 0.06 0.06 00510051
StrokeStroke 0.11 0.11 0.26 0.26 0.050.05
Pump thrombusPump thrombus 0.1 0.1 0.2 0.2 0.090.09
AE Comparison (EPPY)AE Comparison (EPPY)
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Multivariable ModelMultivariable Model
• Survival p=0.27
• GI bleeding p=0.63
• Any infection p=0.32
• DLI p=0.1
• Stroke p=0.003 (HVAD, H.R.:1.8)
• Pump thrombus p=0.64
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Summary and ConclusionsSummary and Conclusions
• Large, multicenter collaborative analysis to stratify outcomes between devices with “all comers” strategy
•HeartWare HVAD ↑ stroke risk
•EPPY (trends)
•HeartMate II ↑ DLI
•HVAD ↑ stroke, pump thrombus
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PerspectivePerspective
•Understanding differences enhances preop counseling and postop management
•Need for more collaborative efforts
•Ultimate result?
•Guidelines, “best practices”
MCSRN
MCSRNMechanical Circulatory Support
Research Network