The International Consortium
for Evidence-Based Perfusion:
Moving from Concept to Reality
Robert A. Baker1, 2, Timothy A Dickinson2, Donald S Likosky2,
Kenneth G Shann2
1Flinders
Medical Centre, Bedford Park, South Australia.
2Executive, International Consortium for Evidence Based Perfusion
Potential Conflicts of Interest
 Research Support
 Terumo, National Heart Foundation, Somanetics, Lunar
Innovations
 Travel and Conference Support
 Terumo, Medtronic, Cellplex, Bayer
 Perfusion Downunder Organisation
 Deputy Chair
 Chair of the PDU Collaboration
Outline
 What is the ICEBP?
 Structure and Progress
 How and Why to get involved.
What is the ICEBP?
 www.icebp.org
Mission Statement
The International Consortium for Evidence-Based Perfusion (ICEBP) partners and
collaborates with perfusion societies, professional medical societies, and interested
clinicians, to improve continuously the delivery of care and outcomes for our
patients.
Vision of the ICEBP
To achieve this mission, we will
• Evaluate current practice through a dedicated international perfusion registry.
Mission Statement
• Develop
and publish evidence based guidelines, and support their integration
The International
Consortium for Evidence-Based Perfusion (ICEBP) partners and
into clinical
practice.
collaborates with perfusion societies, professional medical societies, and interested
clinicians, to improve continuously the delivery of care and outcomes for our patients.
• Identify gaps in the medical literature and empower clinical teams to conduct
Vision of the ICEBP
research
in areas where evidence is lacking.
To achieve this mission, we will
• Identify
gaps between current and evidence-based clinical practice to promote
•Evaluate current practice through a dedicated international perfusion registry.
the improvement in patient care.
•Develop and publish evidence based guidelines, and support their integration
into clinical practice.
•Identify gaps in the medical literature and empower clinical teams to conduct
research in areas where evidence is lacking.
International Consortium for
Evidence-Based Perfusion
Pediatric Process
Improvement
Subcommittee
Clinically-Based
Registry
Subcommittee
Communication
Subcommittee
Steering
Committee
Scientific Sessions
Subcommittee
Adult Process
Improvement
Subcommittee
Evidence-Based
Guideline Writing
Subcommittee
Educational
Subcommittee
Research
Development
Subcommittee
Current practice
Evidence-based
practice
Current practice
Registry
Guidelines
Evidence-based
practice
Current practice
CQI
Registry
Research
Communications Education
Scientific Sessions
Evidence-based
practice
Guidelines
Members
Current practice
Members
CQI
Registry
Research
Communications Education
Guidelines
Scientific Sessions
Members
Evidence-based
practice
Members
Communications Subcommittee
Website – www.icebp.org
Website – Committee Pages
Committee Sites
Committee Sites
Website – Meetings / Events
Tools and Tips
Newsletters
www.icebp.org
Scientific Sessions
Planning Subcommittee
Scientific Subcommittee
 Mission:
 Develop and organize an annual scientific meeting
focused on meeting the goals of the ICEBP mission
statement. The scientific meeting will cover topics
related to all other subcommittees. In addition, the
subcommittee will be charged with examining areas
into which the meeting can grow to allow
demonstration of sustained improvement in the care
provided to patients.
Scientific Subcommittee
 Mission:
 Develop and organize an annual scientific meeting
focused on meeting the goals of the ICEBP mission
statement. The scientific meeting will cover topics
related to all other subcommittees. In addition, the
subcommittee will be charged with examining areas
into which the meeting can grow to allow
demonstration of sustained improvement in the care
provided to patients.
Scientific Subcommittee
 Mission:
 Develop and organize an annual scientific meeting
focused on meeting the goals of the ICEBP mission
statement. The scientific meeting will cover topics
related to all other subcommittees. In addition, the
subcommittee will be charged with examining areas
into which the meeting can grow to allow
demonstration of sustained improvement in the care
provided to patients.
Scientific Subcommittee
 Mission:
 Develop and organize an annual scientific meeting
focused on meeting the goals of the ICEBP mission
statement. The scientific meeting will cover topics
related to all other subcommittees. In addition, the
subcommittee will be charged with examining areas
into which the meeting can grow to allow
demonstration of sustained improvement in the care
provided to patients.
Scientific Subcommittee
 Mission:
 Develop and organize an annual scientific meeting
focused on meeting the goals of the ICEBP mission
statement. The scientific meeting will cover topics
related to all other subcommittees. In addition, the
subcommittee will be charged with examining areas
into which the meeting can grow to allow
demonstration of sustained improvement in the care
provided to patients.
Best Practices in Perfusion
 Two Successful Meetings:
2006 Seattle,
Washington (USA)
2007 Montreal,
Quebec (CAN)
Planning Committee - 2007
 Dwayne Jones, CPC, CCP,





RN (CAN)
Christos Calaritis, BSc, CPC,
CCP (CAN)
Gordon R. DeFoe, CCP
Timothy A. Dickinson, MS
(Chair) (USA)
Robert C. Groom, MS, CCP
(USA)
Deborah Hubble, CCP (USA)
 Donald S. Likosky, PhD (USA)
 Jeffrey B. Riley, MHPE, CCT





(USA)
Dirck A. Rilla, LP, CCP (USA)
David J. Rosinski, CCP (USA)
Kenneth G. Shann, CCP (USA)
Alfred H. Stammers, MSA, CCP
(USA)
Robert Baker, PhD, CCP (Aus)
Program Highlights - 2007
 ICEBP guideline subcommittee update
 Quality improvement skills training
 The World Society for Pediatric and Congenital
Heart Surgery –Dr. Tchervenkov
 Adult & pediatric registries
 Public reporting and transparency
 Credentialing of perfusionists as a best practice
 Abstracts on key aspects of best practice
 Audience Response System utilized
International Attendees - 2007
 Australia
 Pakistan
 Belgium
 Saudi Arabia
 Canada
 Spain
 Japan
 Sweden
 Germany
 United Kingdom
 Netherlands
 United States
 New Zealand
Manufacturer Support - 2007
 Bayer Pharmaceuticals
 Global Blood Resources
 The Medicines Company
 Luna Innovations
 Terumo Cardiovascular
 Medtronic, Inc.
 Maquet-Dynamed Inc.
 Quest Medical, Inc.
 Somanetics Corporations
 Rocky Mountain
 CAS Medical Systems
Research
 Sorin Group
 Spectrum Medical
 Gish Biomedical, Inc.
Best Practices – 2008
 Date: Early October 2008
 Location: Southern USA
 San Antonio
 Galverston
 Dallas
Paediatric Subcommittee
The Opportunity
“The professions caring for patients with
congenital heart disease have the unique
opportunity to create the first comprehensive
international database for a medical
subspecialty.”
Jacobs JP. International Congenital Heart Disease Nomenclature: Introduction to Mapping
and Computer Based Mapping Solutions. Presented at The International Summit on
Nomenclature for Congenital Heart Disease at The Third World Congress of Pediatric
Cardiology and Cardiac Surgery, Toronto, Canada, May 27, 2001.
Meaningful Multi-institutional
Outcomes Analysis
Requirements - Accomplishments


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
Common Language = Nomenclature
Mechanism of Data Collection (Database - Registry)
Mechanism of Evaluating Case Complexity
Mechanism to Verify Data Validity and Accuracy
Collaboration Between Subspecialties
Multi-Societal Database Committee for
Pediatric and Congenital Heart Disease









The STS Congenital Database Taskforce
The EACTS/ECHSA Congenital Database Committee headed by Bohdan
Maruszewski
The STS Congenital Database Taskforce Core Users Group headed by Hal Walters
The STS Congenital Database Data Verification Subcommittee headed by Dave
Clarke
The Aristotle Project headed by Francois Lacour Gayet
The Multi-Center Panel of Experts for Cardiac Surgical Outcomes headed by Kathy
Jenkins
The Congenital Cardiac Anesthesia Society (CCAS) Database headed by David Vener
The Joint Council of Congenital Heart Disease (JCCHD) headed by Gerard Martin,
MD and representing the American Heart Association and the American College of
Cardiology
The Association of European Pediatric Cardiology Nomenclature Committee headed
by Rodney Franklin
Multi-Societal Database Committee for
Pediatric and Congenital Heart Disease








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The Pediatric Cardiac Intensive Care Society (PCICS)
The VPS (Virtual Pediatric Intensive Care Unit Database System)
The International Consortium for Evidence Based Perfusion (ICEBP)
The International Working Group for Mapping and Coding of Nomenclatures for
Paediatric and Congenital Heart Disease (Nomenclature Working Group – NWG)
headed by Christo Tchervenkov
The World Society for Pediatric and Congenital Heart Disease headed by Christo
Tchervenkov
Center for Quality Improvement and Patient Safety of Agency for Healthcare
Research and Quality (AHRQ) of the United States Department of Health and
Human Services
Birth Defect Branch of the Centers for Disease Control and Prevention (CDC)
The National Association of Children's Hospitals and Related Institutions
(NACHRI )
The National Quality Forum (NQF)
Multi-Societal Database Committee for
Pediatric and Congenital Heart Disease
 ICEBP Pediatric Committee is now a member
 Attend 3 meetings per year
 Involved with all projects
 Implementation of perfusion specific variables
into STS Congenital heart surgery database
Complications Project
 In congenital heart surgery, mortality in 2006 is 4%. In
order to assess better quality of care involving the
remaining 96% of patients, we must agree on
universally accepted definitions of morbidity.
 Not all complications are caused by medical error and
not all medical error results in complications.
 Not all complications are medical negligence or medical
malpractice.
 Many subtypes of complications exist.
Complications Project
 ICEBP Pediatric Committee responsible for CPB,
ECLS, and VAD complication list
 Biweekly conference calls
 E-mail
 Multiple revisions
 Creation of manuscript to be submitted to
Cardiology in the Young alongside other organ
system complication lists (>1000)
Ongoing Initiatives
 Collaborative Database initiatives with the:



Congenital Cardiac Anesthesia Society (CCAS)
Joint Council of Congenital Heart Disease (JCCHD), representing ACC
and AHA
Pediatric Cardiac Intensive Care Society (PCICS)
 STS Regional Congenital Database Reports
 Data Verification Site Visit Project
 Ongoing collaborative research to


validate the Aristotle Basic Complexity Score
with the developers of both the Aristotle Basic Complexity Score (ABC
Score) and the Risk Adjustment for Congenital Heart Surgery (RACHS1) methodology with the goal of unifying these two systems.
 Complications Project
Registry Subcommittee
International Perfusion Registry
Perfusion Fields in the STS Registry
What Might Be Some Items on
My Data Form?
Traditional
• Preoperative
factors
– Age, comorbid conditions
• Intraoperative
factors
– Duration of cardiopulmonary
bypass
– Prime volume
• Outcome Variables
– Death x acuity, return to the OR
for bleeding
What Might Be Some Items on
My Data Form?
Traditional
• Preoperative
factors
– Age, comorbid conditions
• Intraoperative
factors
– Duration of cardiopulmonary
bypass
– Prime volume
• Outcome Variables
– Death x acuity, return to the OR
for bleeding
What you Can Vary
• Process variables
– Use of cell processing
– Use and type of arterial line
filter
– Type of circuit
– Prevention of air
entrainment
– Highest blood glucose level
during bypass
– Nadir Hct - by gender
Guiding Principles

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
Quality over quantity
Definitions, definitions, definitions
Validation of case count and status
Smart registry

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
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Center Thumbprint
Assist in submissions to other registries
Software independent
Cross match to STS and PDUCDB
How We Can Learn from Each Other
Lowest Hct on Pump
Percent
30%
25%
20%
Nov-06
Oct-06
Sep-06
Jul-06
Aug-06
Jun-06
May-06
Apr-06
Mar-06
Jan-06
Feb-06
Dec-05
Nov-05
15%
Month -Yr
OneOne
center
’s experience
center’s
experience
What is unique about these centers?
TAKE HOME POINTS:
The future depends on data collection, data feedback, and benchmarking
Areas of Focus
 Patient demographics
(to adjust for potential patient-level confounders)
 Compliance with perfusion guidelines that
were published in JTCVS
(amend the list as the ICEBP publishes guidelines)
 Cell processing and filtration
 Renal Management
 Factors influence low EF
(among patients with normal EF)
Guideline Writing Subcommittee
 The mission of the guideline writing
subcommittee is to develop evidence-based
clinical practice guidelines for cardiovascular
perfusion.
 Methodology used by the American College of Cardiology/American
Heart Association (ACC/AHA)
 Written and subsequently updated to remain concurrent with the
medical literature.
 Adoption of these guidelines in practice would be tracked through
the clinical registry subcommittee.
Guideline Writing Subcommittee
 Guidelines
 Involvement of representatives from each of the
participating perfusion organizations in the guideline
writing subcommittee should reduce any
un/anticipated hurdles for the endorsement of any
given guideline.
 Submitted to the participating perfusion
organizations for their review and endorsement
Platelet Preservation:
Do perfusion strategies
really make a difference?
Gordon R. DeFoe, BA, CCP
Dartmouth-Hitchcock Medical Center
Dartmouth Medical School
Lebanon, NH, USA
The Platelet Preservation
Group
Section
Chairs
Donny Likosky
Kenny Shann
Techniques
Technology
Monitoring
Pharmacology
Arno Nierich
Kenny Shann
Linda Shore
Dirck Rilla
Gordon DeFoe
Jane Ottens
Gordon DeFoe
Tim Dickinson
Arno Nierich
Chris Mahoney
Defining the problem
Statement: We believe that platelets are good.
 Can we physically and qualitatively preserve platelets
during cardiopulmonary bypass?




Surface coatings or treatments
Pump types
Circuit components
Cell salvage devices
 Are there holes in our knowledge?
What are the steps?
 Evaluate the peer-reviewed medical literature in
a rigorous and consistent fashion
 Focus expertise on specific topics
 Develop an informed opinion regarding
effectiveness and assign levels of evidence
 Formulate a “finding” and a written summary for
publication
Search methodology
 NCBI - National Center For BioTechnology
Information - MEDLINE search, ≥1996
 Search parameters
 ((platelet OR platelets OR flow cytometry) AND (cardiac surgery
OR ((("cardiopulmonary bypass"[TIAB] NOT Medline[SB]) OR
"cardiopulmonary bypass"[MeSH Terms] OR ("coronary artery
bypass"[TIAB] NOT Medline[SB]) OR "coronary artery
bypass"[MeSH Terms]) OR (valve OR valves OR valvular) AND and
surgery))) AND (biocompatible coated materials OR coated circuits)
Evaluation of search results
 An automated Excel spreadsheet was
automatically populated by NCBI search
 NCBI download includes abstract (if available)
 Reviewers can sift through references based
upon abstract, or decide to review entire paper
 Almost all citations retrievable on-line
 Fate of all citations is tracked.
Classification of Recommendations
 Class I - Conditions for which there is evidence, general
agreement, or both that a given procedure or treatment
is useful and effective
 Class II – Procedure or treatment should be performed
or administered
 Class IIa – Additional studies with focused objectives
are needed
 Class IIb – Additional studies with broad objectives are
needed; additional registry data would be helpful
 Class III – Procedure or treatment should not be
performed or administered because it is not helpful and
might be harmful
Levels of evidence
 Level A – Data is derived from multiple
randomized clinical trials
 Level B – Data is derived from a single
randomized trial or non-randomized studies
 Level C – Consensus opinion of experts
Results of literature search
 103 “hits” on MEDLINE
 All proved to be retrievable on-line
 44 citations (inc. 2 review articles) were
judged to be relevant to the topic of
“technology for platelet preservation on
bypass”
 In all, we evaluated studies on 4,234 adult
patients in 41 distinct trials
“Biocompatible” v “Standard”
 The clear preponderance of the evidence is
that coated circuits better preserve platelet
counts and reduce platelet deposition and
activation, when used in either the “tip-totip” or “all but cannula” mode
 No clear benefit was observed when only
the oxygenator was coated
Comparison of technologies
 When different coatings were directly
compared, there was no treatment that was
clearly better than any other in terms of
platelet preservation
 We did not find clear evidence that pump
types or other component designs affected
platelets directly
Work still to be done
 Cochrane meta-analysis will be run
 Write discussion section for next
publication
 There are holes in our knowledge




Roller versus centrifugal
Closed versus open
Role of pump suction versus IRCR
Is there a “best coating?”
Proposed “Finding”
When used in either the “tip to tip” or “all but
cannula” configuration, biocompatible
cardiopulmonary bypass circuits offer
superior preservation and protection of
platelets during and after cardiac surgery.
(Class TBD, Level TBD)
The Inflammatory Response:
It’s not all about
Pharmacological Intervention
Rob Baker
Flinders Medical Centre and Flinders
University, Bedford Park
Adelaide, AUSTRALIA
Inflammation
Section Chair:
Clive and Rob
Techniques
Technology
Pharmacology
Richard*, Kimberle,
David R, Joe S, Rob
Bob G*, Andy C,
Heinz, Nick M
John M, Clive*, John M,
Jeremiah, Hiliary G
Cell Salvage
Ischemia
Temperature
Embolism
Ultrafiltration
Pumps
Coated Circuits
Hemolysis
Leukocyte Filtration
* Sub group Leaders
Do you think that cell salvage has an
impact on inflammation in the Cardiac
Surgical (on pump) patient?
82%
1. Yes
2. No
18%
3. Abstain
ta
in
o
A
bs
N
Ye
s
0%
Cell Salvage
Pubmed Searches
134 papers
4 + additional
papers identified
Emailed in Excel
Format
Abstract review
identified 44
9 RCT’s
I observational
Recommendation
Cell salvage is reasonable for the
reduction of inflammatory markers in
CS blood prior to its return to the
patient. (Class TBD, Level TBD).
Who is currently involved
 David Rosinski, Richard Newland, Kimberle McGill;
Nicholas Mellas, Andrew Cleland, Bob Groom,
Heinz Weitkemper, John Murkin, Jeremiah Brown,
John Motley, Hiliary Grocott, Kenneth Shann, Tim
Dickinson, Chris Brown Mahoney, Sander
Spanjersberg, Arno Nierich, Donny Likosky, Linda
Shore Brown, Gordon DeFoe, Dirck Rilla, Jane
Ottens, Huong Pham,
Rob Baker