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11
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
3
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
7
First Cardiac ECMO Survival, 1972 – Dr.
Bartlett, 1 st successful post-cardiotomy support
8
9
Esperanza and Dr. Bartlett
10
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
11
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)
14
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.
15
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)
16
• 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.
17
SJM-EVT-0117-0177 | Item approved for U.S. use only.
18
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
19
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)
20
HEARTMATE I I SYSTEM
US-HM2-04150208(1)
21
HEARTMATE I I
PAT IENT MANAGEMENT
US-HM2-04150208(1)
22
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)
23
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)
24
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
25
B169-0313
26
B169-0313
Our Product Vision:
A 10 Year, Forgettable
System.
27
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
29
*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)
30
*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.
32
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.
33
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
34
Cardiogenic ShockOptions for revascularization
• PCI
• IABP
• Impella
• CentriMag/Centrifugal pumps for acute ventricular
support
• CPS/ECLS
35
36
ED Extracorporeal CPR
• Sharp Medical Center in San Diego
• University of Michigan Medical Center
• University of Chicago
CENTRIMAG AND PEDIMAG BLOOD PUMP
SYSTEMS
38
New Trend – Simpler Circuits• Very Simple and effective,
• Can be used for emergency CPS
• OR, ICU, Emergency Dept, CathLab
38
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
40
• 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.
44
CentriMag System Transporter
Compact design fits neatly into air or ground ambulance
FAA approved for air travel
2 hour battery life
45
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
46
…
Thank You