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The International Consortium for Evidence-Based Perfusion: Moving from Concept to Reality. Robert A. Baker 1, 2 , Timothy A Dickinson 2 , Donald S Likosky 2 , Kenneth G Shann 2 1 Flinders Medical Centre, Bedford Park, South Australia.

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the international consortium for evidence based perfusion moving from concept to reality

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
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
Outline
  • What is the ICEBP?
  • Structure and Progress
  • How and Why to get involved.
what is the icebp
What is the ICEBP?
  • www.icebp.org
slide5

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.
  • 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.
  • Identify gaps between current and evidence-based clinical practice to promote
  • the improvement in patient care.
  • 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.
  • 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.
  • Identify gaps between current and evidence-based clinical practice to promote
  • the improvement in patient care.
international consortium for evidence based perfusion
International Consortium for Evidence-Based Perfusion

Communication Subcommittee

Pediatric Process Improvement Subcommittee

Clinically-Based Registry Subcommittee

Evidence-Based Guideline Writing Subcommittee

Steering Committee

Scientific Sessions Subcommittee

Educational Subcommittee

Adult Process Improvement Subcommittee

Research Development Subcommittee

current practice
Current practice

Evidence-based practice

current practice1
Current practice

Registry

Guidelines

Evidence-based practice

current practice2
Current practice

Communications

CQI

Registry

Research

Education

Guidelines

Scientific Sessions

Evidence-based practice

current practice3
Current practice

Members

Members

Communications

CQI

Registry

Research

Education

Guidelines

Scientific Sessions

Evidence-based practice

Members

Members

scientific 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 subcommittee1
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 subcommittee2
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 subcommittee3
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 topicsrelated 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 subcommittee4
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
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)

Planning Committee - 2007
program highlights 2007
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

Belgium

Canada

Japan

Germany

Netherlands

New Zealand

Pakistan

Saudi Arabia

Spain

Sweden

United Kingdom

United States

International Attendees - 2007
manufacturer support 2007
Bayer Pharmaceuticals

The Medicines Company

Terumo Cardiovascular

Maquet-Dynamed Inc.

Somanetics Corporations

CAS Medical Systems

Gish Biomedical, Inc.

Global Blood Resources

Luna Innovations

Medtronic, Inc.

Quest Medical, Inc.

Rocky Mountain Research

Sorin Group

Spectrum Medical

Manufacturer Support - 2007
best practices 2008
Best Practices – 2008
  • Date: Early October 2008
  • Location: Southern USA
    • San Antonio
    • Galverston
    • Dallas
the opportunity
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
Meaningful Multi-institutional Outcomes Analysis

Requirements - Accomplishments

  • 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
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 disease1
Multi-Societal Database Committee for Pediatric and Congenital Heart Disease
  • 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 disease2
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
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 project1
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
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 (RACHS-1) methodology with the goal of unifying these two systems.
  • Complications Project
what might be some items on my data form
What Might Be Some Items on My Data Form?
  • Preoperative factors
    • Age, comorbid conditions
  • Intraoperative factors
    • Duration of cardiopulmonary bypass
    • Prime volume
  • Outcome Variables
    • Death x acuity, return to the OR for bleeding

Traditional

what might be some items on my data form1
What Might Be Some Items on My Data Form?
  • Preoperative factors
    • Age, comorbid conditions
  • Intraoperative factors
    • Duration of cardiopulmonary bypass
    • Prime volume
  • Outcome Variables
    • Death x acuity, return to the OR for bleeding

Traditional

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
Guiding Principles
  • Quality over quantity
  • Definitions, definitions, definitions
  • Validation of case count and status
  • Smart registry
    • Center Thumbprint
    • Assist in submissions to other registries
    • Software independent
    • Cross match to STS and PDUCDB
how we can learn from each other
How We Can Learn from Each Other

One 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
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
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 subcommittee1
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

Platelet Preservation:Do perfusion strategies really make a difference?

Gordon R. DeFoe, BA, CCP

Dartmouth-Hitchcock Medical Center

Dartmouth Medical School

Lebanon, NH, USA

defining the problem
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
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
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
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
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
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
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
“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-to-tip” or “all but cannula” mode
  • No clear benefit was observed when only the oxygenator was coated
comparison of technologies
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
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
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
The Inflammatory Response: It’s not all about Pharmacological Intervention

Rob Baker

Flinders Medical Centre and Flinders University, Bedford Park

Adelaide, AUSTRALIA

slide72
Do you think that cell salvage has an impact on inflammation in the Cardiac Surgical (on pump) patient?
  • Yes
  • No
  • Abstain
slide73

Cell Salvage

Pubmed Searches

134 papers

4 + additional

papers identified

Emailed in Excel

Format

Abstract review

identified 44

9 RCT’s

I observational

recommendation
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
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
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