mcsrn mechanical circulatory support research network stulak jm, davis me, haglund n, dunlay s,...

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


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

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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)

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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

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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

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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

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Intraop Clinical CharacteristicsIntraop Clinical Characteristics


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

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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


560 299 164 94 59 31174 65 25 13 1 1

GI Bleeding by DeviceGI Bleeding by Device


Per

cen

t

p=0.006


560 299 164 94 59 31174 65 25 13 1 1

Stroke by DeviceStroke by Device


Per

cen

t

p=0.039


560 299 164 94 59 31174 65 25 13 1 1

Any Infection by DeviceAny Infection by Device


Per

cen

t

p=0.14


560 299 164 94 59 31174 65 25 13 1 1

Driveline Infection by DeviceDriveline Infection by Device


Per

cen

t

p=0.35


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”

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mcsrn mechanical circulatory support research network stulak jm, davis me, haglund n, dunlay s,...

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