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Perfusion Opportunities - The

Expanding Role of CPS &

VAD with Perfusion ®

Wayne Calder, Acute Product Specialist,

CCP Emeritus

June 2, 2017

USA VERSIONPart # L022-0713

• More complex cardiac procedures on CPB

• Standby for:

• Transcatheter Aortic Valve Replacement

• Transcatheter Mitral Valve Repair

• Transcatheter Mitral Valve Replacement

• Transcatheter Valve-in-Valve procedures

• Increased Acute Ventricular Support, OR and Cath Lab, Hybrid Rooms.

• Increased Chronic/Durable (implantable Ventricular Assist Devices)

• Increased use of CPS/ECLS for respiratory patients, ICU, Cath Lab – high risk PCI patients, and Cardiogenic Shock patients, OR - post-cardiotomy, ER/ED, Ambulance, Transport of patients on acute devices

• STS Database and other Data-bases, perfusion-company databases

• Working in Industry – Clinical Specialists, Sales, , Marketing, Field Research, Product Managers, Management

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Advances in Materials Science

• development of spiral coil silicone membrane

oxygenator allowed for prolonged bypass

support outside operating room

• •Use of silicone membrane led to the term

extracorporeal membrane oxygenation (ECMO)

4

Kolobow Coiled Membrane Oxygenator

5

1972 Santa Barbara, CA

• Dr. Don Hill, motorcycle

accident

6

Robert H. Bartlett, MD - Father of ECMO

Developed the concept of titrating heparin which substantially reduced bleeding complications.

Refined circuit design.Championed notion that ECMO was well suited to

allow healing time in respiratory failure.Robert H. Bartlett, MD“, Father of ECMO

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First Cardiac ECMO Survival, 1972 – Dr.

Bartlett, 1 st successful post-cardiotomy support

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9

Esperanza and Dr. Bartlett

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Expansion of Pediatric ECMO

• 1983: only 3 centers regularly performing pediatric ECMO

• U. Michigan

• U. Pittsburgh

• Medical College of Virginia.

• •1986 →nineteen centers

• •1989 voluntary alliance of centers and steering committee formed

• •ELSO (Extracorporeal Life Support Organization) was born

• EuroELSO

• Asia-Pacific

• Latin America

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11

THE BURDEN OF ADVANCED HEART

FAILURE ®

US-HM2-04150208(1)

Treating Advanced

Heart Failure With

HeartMate II®

US-HM2-04150208(1)

HEARTMATE II (Thoratec)

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Cardiac Transplantation

• Remains the most effective therapy for end-stage heart disease, although donor shortage limits its use

– 1-year survival: 86% (2002)

– 5-year survival: 71%

– 10-year survival: 46%

Vitali E, Colombo T, et al. Surgical therapy in advanced heart failure. Am J Cardiol 2003;91(suppl):88F-94F Taylor et al. J Heart Lung Transplant 2003;22:616.American Heart Association. Heart Disease and Stroke Statistics-2009 Update.

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1. Current estimates of adult patients with advanced heart failure (HF) in the United States, with projected left ventricular assist device (LVAD) candidates. U.S. population estimate is derived from U.S. Census data. Estimate of HF prevalence is derived from latest American Heart Association (AHA) statistics.

2. UNOS Website: http://optn.transplant.hrsa.gov3. O’Connell. Advanced Heart Failure Therapies Forum, Atlanta. 2013.

Transplants are considered the

‘gold standard,’ but the supply of

donor hearts is limited1

“Proposing heart transplantation to cure heart failure is analogous to proposing the lottery to cure poverty.”

– LW

Stevenson3

2

11 2

1

US-HM2-04150208(1)

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• Flexible Inflow

CannulaInserted into the

apex of the left

ventricle

• Outflow GraftAnastomosed to

the ascending

aorta

• Flow3 to 10 LPM –

covering

the full cardiac

output of a

healthy heart

HeartMate II Design Features

The HeartMate II pump is implanted in the left upper quadrant, between the rectus muscles

US-HM2-04150208(1)

Over 24,000 patients have been implanted with the HeartMate II™ LVADMore than 9,100 patients receiving ongoing support*

*Based on clinical trial and device tracking data as of September 26, 2016. Zinc report #SJM-HM-1016-0032.

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SJM-EVT-0117-0177 | Item approved for U.S. use only.

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More than 15,000 patients worldwide

have now been implanted with the

HeartMate II LVAS.

Over 6,500 patients on ongoing support

Worldwide HeartMate II® Clinical

Experience

As of Oct 2013*Based on clinical trial and device tracking data

HeartMate II®

System11

25

124

300

720

1,521

2,921

5,102

≥4 years of support

≥5 years of support

≥6 years of support

≥7 years of support

≥8 years of support

≥1 year of support

≥2 years of support

≥3 years of support

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NYHA Improvement

• 100% of patients NYHA

Class IIIB/IV at baseline

• 81% of patients

improved to NYHA Class

I or II by 24 months

HeartMate II Trial: 6 Minute Walk Test Improvement

• Only 16% of patients able to complete test at baseline

• 94% of HeartMate II recipients completed the test at 6

months

HeartMate II patients do more

than survive,

they thrive!

1. Park SJ, et al. Outcomes in advanced heart failure patients with LVAD for DT. CircHeart Fail. 2012;5(2):241-248.

2. John R, et al. Continuous flow LVAD outcomes in commercial use compared with the prior clinical trial. Ann Thorac Surg. 2011;92(4):1406-1413.

US-HM2-04150208(1)

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HEARTMATE I I SYSTEM

US-HM2-04150208(1)

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HEARTMATE I I

PAT IENT MANAGEMENT

US-HM2-04150208(1)

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P A T I E N T S E L E C T I O N :R E V E R S I N G T H E C O U R S E W I T H H E A R T M A T E I I

US-HM2-04150208(1)

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24-months post HeartMate II

implant Baseline 24

Months

Post

Implant

NYHA Class IV I

Cardiac output (LPM) 2.4 7.1

Serum creatinine (mg/dL) 2.3 1.8

BUN (mg/dL) 43 21

Total bilirubin (mg/dL) 0.6 0.5

Minnesota Living With

Heart Failure Score

72 21

Kansas City

Cardiomyopathy Score

49 87

Destination Therapy case study:

post implant Art Pierskalla, age 71

“I am busy all the time and I don’t

seem to have much free time. I’m

always working!”

Art is active and enjoying life• Gardening at the farm and

baking raspberry pie

• Wood working and traveling

• Playing with grandchildren • Driving the “old folks” to

church

9 years post HeartMate II implant

US-HM2-04150208(1)

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B189-0312

• Bridge-to-Transplantation

• Nonreversible left heart failure

• Imminent risk of death

• Candidate for cardiac transplantation

• Destination Therapy

• NYHA Class IIIB or IV heart failure

• Optimal medical therapy 45 of last 60 days

• Not candidate for cardiac transplantation

HeartMate II Indications for Use

ArtHeartMate II recipient

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B169-0313

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B169-0313

Our Product Vision:

A 10 Year, Forgettable

System.

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B169-0313

HeartMate® III

*In development. Not approved for sale.

HeartMate 3 with Full MagLev™ Flow

Technology

Designed for Hemocompatibility

CAUTION – Investigational device. Limited by US Federal law to investigational

ClinicalTrials.gov Identifier: NCT02224755US-HM3-04150222

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*Caution: Investigational device. Limited by Federal US law to investigational use

What is Full MagLev?

Uses magnets to support all six degrees of freedom of the rotor, such that the rotor remains essentially fixed except

for rotation.

(Doesn’t use physical or hydrodynamic/blood bearings)

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*Caution: Investigational device. Limited by Federal US law to investigational use

HeartMate III*

Designed to be Hemocompatible

Leveraging Full MagLev™ Technology

Features

•Full MagLev

•Large, consistent pump gaps designed to reduce blood trauma

•Artificial pulse

•Wide range of operation

•Full support (2 – 10 L/min)

•Textured blood contacting surfaces

• Advanced Design for Surgical Ease

•Engineered apical attachment

•Modular Driveline

•Designed for an Active Lifestyle

•Pocket Controller™

US National Library of Medicine, National Institute of Health• Cardiogenic shock continues to be the most common

cause of death in patients hospitalized with acute myocardial infarction

• Despite emerging innovative treatments, in-hospital mortality in patients with cardiogenic shock continues to be as high as 70-80%. Other studies have quoted mortality rates of around 50% to 80%

• Left ventricular dysfunction (LVD) is the most frequent cause of cardiogenic shock. In a recent trial, it was highlighted that LVD was the main etiology occurring in 74.5% of patients.

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Cardiogenic Shock

Cause and Prevalence

• Cardiogenic shock (CS) occurs in ≈5% to 8% of patients hospitalized with ST-elevation myocardial infarction (STEMI).

• Currently, 40,000-50,000 cases per year in the United States

– Recent research has suggested that the peripheral vasculature and neurohormonal and cytokine systems play a role in the pathogenesis and persistence of CS.

• Early revascularization for CS improves survival substantially.

• MI with LV failure remains the most common cause of CS.

– It is critical to exclude complicating factors that may cause shock in MI patients. Chief among these are the mechanical complications.

– Mechanical complications must be strongly suspected in patients with CS complicating nonanterior MI, particularly a first MI.

– Early ECHO should be performed, unless the diagnosis is extensive anterior MI and the patient is undergoing prompt percutaneous coronary intervention (PCI).

• The detection of valvular disease before angiography may alter the revascularization approach.

Reynolds and Hochman. Circulation 2008;117:686-697.

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Cardiogenic Shock

A Spectrum

37.5

21

42

80

0

20

40

60

80

100M

ort

alit

y (%

)

Inotrope Dosing

Adapted from Kar et al. Circulation 2012;125:1809-1817.

Pre-shock Mild Shock

Profound Shock Severe, Refractory Shock

IM 4 IM 3 IM 2 IM 1

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Cardiogenic ShockOptions for revascularization

• PCI

• IABP

• Impella

• CentriMag/Centrifugal pumps for acute ventricular

support

• CPS/ECLS

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36

ED Extracorporeal CPR

• Sharp Medical Center in San Diego

• University of Michigan Medical Center

• University of Chicago

CENTRIMAG AND PEDIMAG BLOOD PUMP

SYSTEMS

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New Trend – Simpler Circuits• Very Simple and effective,

• Can be used for emergency CPS

• OR, ICU, Emergency Dept, CathLab

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3939

Benefits of Magnetic Levitation

Technology

Completely bearingless

Rotor not in contact with any other mechanical part

Large blood pathway Low Shear forces

Minimal blood stagnation

Minimizes friction and heat generation

Minimizing hemolysisMinimizing thrombus No particle generation

Minimizing thrombus

Low requirement for anticoagulation, Improved clinical outcomes, Varied clinical Applications

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• The Primary Console console can

support patients of any size from 1.3 Kg

– >100Kg

CENTRIMAG BLOOD PUMP SYSTEM:

OVERVIEW2ND GENERATION SYSTEM: REQUIRED

EQUIPMENT

Motor

• Each pump

requires a

separate

motor

Monitor

• Optional

component

• View and Adjust

Values

Primary Console

• Each primary

console operates

one CMag pump

Opti

onal

Blood Pump

• 31mL

• Disposable

• Fully

Magneticall

y Levitated 2nd Generation CentriMag Systm Operating Manual

(US), pg 10, 25, 30-32

© 2013 Thoratec- Document No. PL-0047, Rev 06

Function: To hold CentriMag and Accessory equipment necessary for BiVAD support, including backup equipment

• Accommodates 1st or 2nd Gen equipment

• CentriMag System Cart consists of:

– Three shelves (two adjustable)

– 1 Accessory Drawer

– Oxygen bottle holder

• Size D or E

• Oxygen bottle not included

– Two adjustable IV poles

– Lockable wheels

CENTRIMAG BLOOD PUMP SYSTEM: 1 ST

GENERATION CENTRIMAG SYSTEM CART

CentriMag Primary Console Operating Manual, pg 43

©2010 Thoratec Corporation- Document No. PL-0074,

Rev 05 (Feb 2010)

CENTRIMAG SYSTEM

TRANSPORTER Designed to safely and compactly

transport CentriMag equipment

Console

Pump + Motor

Oxygenator

4 bracket sizes available to

accommodate any size and

shape of oxygenator.

Brackets sold separately

Oxygen bottle

U.S. - M9 (C) or smaller

EU – 2 Liter or smaller

Three piece modular design. Can

remove both side modules if do not

need oxygen bottle or oxygenator.

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CentriMag System Transporter

Compact design fits neatly into air or ground ambulance

FAA approved for air travel

2 hour battery life

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1. Magnet ic Levi tat ion…designed to be gent le on blood

• Have you seen the

data from the

literature1,2

demonstrating a low

hemolysis rate (e.g.,

5%) and device failure

rate (0%)?

1 Zhang J, Gellman B, Koert A, et al. Computational and experimental evaluation of the fluid dynamics and hemocompatibility of the CentriMag blood pump. Artif Organs. 2006;30(3):168-177

2 Ranjit John, MD, James W. Long, MD, H. Todd Massey, MD, Bartley P. Griffith, MD, et al. Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support. The Journal of Thoracic and Cardiovascular Surgery; April 2011

CentriMag / PediMag / PediVASOver 50 peer reviewed articles

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…

Thank You