Can Anything PREVENT the Momentum Revolution? · AV leaflet fusion AV regurgitation Low pulsatile...

Can Anything PREVENT the Momentum Revolution?

Simon Maltais, MD PhDMayo Clinic, Rochester

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

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

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

Pump Provider

Patient

Pump Provider

Patient

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

Recent CF Experience

Early CF Experience

PF Experience

Medical Rx

Adverse Event Profile:Continuous Flow versus Pulsatile Pump

Mechanical reliability

Infection

RV Failure

Adverse Event Profile:Continuous Flow versus Pulsatile Pump

Stroke

Bleeding

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

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!

• ↔ aortic pressure

• AX: ↑ unloading at rest and exercise

• AX: ↑ flow at maximal RPM

• CFG: ↓ power at similar flow

• AX: ↑ risk of suck-down

• AX: steeper HQ curves• ↓ sensitivity to preload and afterload

• ↑ risk of suck-down

• CFG: ↓ lower power consumption for given flow

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

Severity of vWF degradation by devices

vWF degradation more severe in patients with HM II

Maltais et al., ISHLT 2016

vWF HMWM Prague Analysis

Netuka et al: JHLT, 2016

multim

HMII HM3

Baseline Day 2 Day 7 Day 30 Day 45

P<0.001P<0.001

vWF HMWM Prague Analysis

Netuka et al: JHLT, 2016

HMII HM3

HMWM preserved 50% at 45 days

HMWM preserved <50% at 45 days

What do we know so far?

•Major physiologic differences

•Disparate biocompatability

•How does this translate into clinical outcomes?

Pump Provider

Patient

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

Patient #1

•45 year old ♀, NYHA IV, IDCM

•BSA 1.7, BMI 19 kg/m2

•No PMH, implant as BTT

•Cath: CVP 18, PAP 48/18 (28), PCWP 20

•↔ survival

•♀: ↑ RV failure, inotropes, RVAD, respiratory failure, renal failure

•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

Patient #2

•58 year old ♂, NYHA IV, ICM

•BTT

•Chronic AF, prior CVA, PVD

•Cath: CVP 10, PAP 48/18 (28), PCWP 25

Patient #2

•58 year old ♂, NYHA IV, ICM

•BTT

•Chronic AF, prior CVA, PVD

•Cath: CVP 10, PAP 48/18 (28), PCWP 25

•ASA < 81 mg

•Preoperative atrial fibrillation

Months post implant

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

ISHLT 2016 Oral Presentation, Baltimore, MD

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

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

Pump Provider

Patient

Make Mistakes, but DON’T repeat them

•41/45 pt with INR < 2.0

•21/41 pt with INR < 1.6

•1 TE event

•1 suspected PT

•10/331 thrombotic events

•58/331 hemorrhagic events

• INR < 1.5 40% ICVA

• INR > 2.5 ↑ bleeding

INR 1.5-2.5 appropriate

•3 groups of heparin bridging

•↔ ICVA, HCVA, PT

•↑ transfusion in heparin group

•Heparin use predicted bleeding

Mehra, JHLT 2014

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

Results - Primary Endpoint Confirmed Pump Thrombosis at 3 Months

10%P=0.003

References:1Starling, Moazami, Silvestry et al. NEJM 2014 Jan

2;370(1):33-40

PREVENT NEJM – 3 Center Study1

HVAD Thrombosis

Najjar et. Al. JHLT 2014, 33: 23-34

True Impact of Technology

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

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

June 2-3, 2016

Thank you

Maltais.Simon@mayo.edu

Can Anything PREVENT the Momentum Revolution? · AV leaflet fusion AV regurgitation Low pulsatile...

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