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©2016 MFMER | 3400384-1
Can Anything PREVENT the Momentum Revolution?
Simon Maltais, MD PhDMayo Clinic, Rochester
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I will not discuss off label use and/or
investigational use of the following
drugs/devices
The following relevant financial
relationships exist related to my role
in this session: Consultant for Abbott
and Medtronic.
Disclosures
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Cut to the Chase
•We may NOT have reached the “perfect pump”; but were are closer
•We still need to gather data…good one
•Pump is only one dweller in a very complex system
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Non-physiologic blood flowin ascending aorta Aortic root dilation AV closure AV leaflet fusion AV regurgitation
Low-pulsatile or non-pulsatile flow to end-organs AVM formation GI bleeding Epistaxis
Shear stress of blood Hemolysis Acquired vWd
Risk of infection Driveline infection Pocket infection
Need for anticoagulation System thrombosis Increased risk of
thromboembolism (e.g. stroke, renal infarcts, ischemic bowel, MI)
“Continuous Flow Pump Disease”
Patient Milieu Sex, age, BMI, prior
stroke, ischemic etiology, AF, hypercoaguabledisorder
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Pump Provider
Patient
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Pump Provider
Patient
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CF – centrifugal flow
CF – axial flow
Pulsatile Technology
FDA Approved
BTT 1998
DT 2002
FDA Approved
BTT 2008
DT 2010
Bearings
Bearings with
stator
Bearingless with
Magnetic and
hydrodynamic
levitation
FDA Approved
BTT 2013
DT Pending
Advances in Technology
Enrollment
Complete
CAP ongoing
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Recent CF Experience
Early CF Experience
PF Experience
Medical Rx
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Adverse Event Profile:Continuous Flow versus Pulsatile Pump
Mechanical reliability
Infection
RV Failure
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Adverse Event Profile:Continuous Flow versus Pulsatile Pump
Stroke
Bleeding
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How they are the same….
•Similarities do exist with current 2nd and 3rd generation pumps
•↑ survival vs. OMM (DT pts)
•↑ quality of life
•Physiological similarities also exist
•Decongestion, ↑ RV function
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PHYSIOLOGIC IMPACT IS VASTLY DIFFERENT!
•Wealth of literature to support this
•Different in MANY different areas• Unloading
• Hemocompatibility• vWF, hemolysis profiles
•Physiologic differences exist, so patient OUTCOMES will be different!
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• ↔ aortic pressure
• AX: ↑ unloading at rest and exercise
• AX: ↑ flow at maximal RPM
• CFG: ↓ power at similar flow
• AX: ↑ risk of suck-down
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• AX: steeper HQ curves• ↓ sensitivity to preload and afterload
• ↑ risk of suck-down
• CFG: ↓ lower power consumption for given flow
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One Month Post-LVAD All LVADs HMII HVAD P
Pre-LVAD 7±3 7±3 7±3 0.93
One Month Post-LVAD 87±84 153±100 45±280.0002
Three Months Post-
LVAD160±340 252±473 75±89
0.016
Severity of vWF degradation by devices
vWF degradation more severe in patients with HM II
Maltais et al., ISHLT 2016
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vWF HMWM Prague Analysis
Netuka et al: JHLT, 2016
Resid
ual H
MW
multim
ers
(%
)
HMII HM3
0
20
40
60
80
100
Baseline Day 2 Day 7 Day 30 Day 45
P<0.001P<0.001
P<0.001P<0.001
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vWF HMWM Prague Analysis
Netuka et al: JHLT, 2016
0
20
40
60
80
100
HMII HM3
HMWM preserved 50% at 45 days
HMWM preserved <50% at 45 days
Pa
tie
nts
(%
)
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What do we know so far?
•Major physiologic differences
•Disparate biocompatability
•How does this translate into clinical outcomes?
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Pump Provider
Patient
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Patient #1
•45 year old ♀, NYHA IV, IDCM
•BSA 1.7, BMI 19 kg/m2
•No PMH, implant as BTT
•Echo: LV EF 15%, mod RVD, no AR, TR
•Cath: CVP 18, PAP 48/18 (28), PCWP 20
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Patient #1
•45 year old ♀, NYHA IV, IDCM
•BSA 1.7, BMI 19 kg/m2
•No PMH, implant as BTT
•Echo: LV EF 15%, mod RVD, no AR, TR
•Cath: CVP 18, PAP 48/18 (28), PCWP 20
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•↔ survival
•♀: ↑ RV failure, inotropes, RVAD, respiratory failure, renal failure
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•Death from stroke/bleeding: 1.9
•Death from sepsis: no cut off
•1 yr survival
•<1.9 43%
•>1.9 83%
Eur J Cardio-Thoracic Surgery 2013;43:1036-42
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Patient #2
•58 year old ♂, NYHA IV, ICM
•BTT
•Chronic AF, prior CVA, PVD
•Echo: LV EF 15%, mod RVD, no AR, TR
•Cath: CVP 10, PAP 48/18 (28), PCWP 25
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Patient #2
•58 year old ♂, NYHA IV, ICM
•BTT
•Chronic AF, prior CVA, PVD
•Echo: LV EF 15%, mod RVD, no AR, TR
•Cath: CVP 10, PAP 48/18 (28), PCWP 25
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•ASA < 81 mg
•Preoperative atrial fibrillation
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Months post implant
Cu
mu
lati
ve in
cid
en
ce
Ischemic 539 244 125 61 35 22 12 5 4 1 1Non-ischemic 606 291 147 73 39 17 6 3
P=0.008
Ischemic
Non-ischemic
MCSRN
ISHLT 2016 Oral Presentation, Baltimore, MD
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Neurological Events
HR P value
Age (per 10y increase) 6.54 0.09
Female vs. Male 0.38 0.54
BMI 0.71 0.87
INTERMACS 1 vs. others 6.91 0.07
Ischemic etiology 4.60 0.03
Device type factor
(HVAD:HMII)
4.30 0.04
Creatinine 8.00 0.05
MCSRN
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Choosing the RIGHT pump
•“Tailoring” pump therapy based on numerous considerations, this will continue to stay true with HMIII
•Device therapy could be optimized in various pt populations
•Enhance late outcomes
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Pump Provider
Patient
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Make Mistakes, but DON’T repeat them
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•41/45 pt with INR < 2.0
•21/41 pt with INR < 1.6
•1 TE event
•1 suspected PT
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•10/331 thrombotic events
•58/331 hemorrhagic events
• INR < 1.5 40% ICVA
• INR > 2.5 ↑ bleeding
INR 1.5-2.5 appropriate
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•3 groups of heparin bridging
•↔ ICVA, HCVA, PT
•↑ transfusion in heparin group
•Heparin use predicted bleeding
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Mehra, JHLT 2014
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PREVENT Recommendations
References:1Adamson RM, Mangi AA, Kormos RL, J Card Surg. 2015 Mar;30(3):296-92Klodell CT, Massey HT, Adamson RM. J Card Surg. 2015 Oct;30(10):775-80
Surgical Recommendations1 Medical Recommendations2
Anticoagulation • In patients without
persistent bleeding, bridge
with heparin; goal PTT of
40-45 sec (48 hours); PTT
of 50-60 sec (96 hours).
• Initiate warfarin within 48
hours; Target INR: 2.0-2.5.
Antiplatelet • Initiate ASA therapy (81-
325 mg daily), 2-5 days
post HMII implantation.
Pump Speed • Maintain > 9000 RPM and
Avoid < 8600 RPMs.
Blood Pressure • Maintain mean arterial
pressure (MAP) < 90
mmHg.
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Results - Primary Endpoint Confirmed Pump Thrombosis at 3 Months
0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%P=0.003
2.9 %
8.4%1
References:1Starling, Moazami, Silvestry et al. NEJM 2014 Jan
2;370(1):33-40
Perc
en
t o
f P
um
ps
PREVENT NEJM – 3 Center Study1
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HVAD Thrombosis
Najjar et. Al. JHLT 2014, 33: 23-34
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True Impact of Technology
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REVOLUTION will depend on OUTCOMES
•Outcomes depend on pump technology…..but also provider and patient factors
•Subgroup analysis needs to be data driven and we have lo be critical; move past anecdotes
•Study of similar pump technology
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Conclusions
•Story of MCS has been one of progressive improvements
•While we are much closer, the data to date shows we can continue to improve
•Thinking we have will result in stagnation
