The International The International Consortium for Evidence- Consortium for Evidence- Based Perfusion: Moving Based Perfusion: Moving from Concept to Reality from Concept to Reality Robert A. Baker Robert A. Baker 1, 1, 2 , Timothy A Dickinson , Timothy A Dickinson 2 , Donald , Donald S Likosky S Likosky 2 , Kenneth G Shann , Kenneth G Shann 2 1 Flinders Medical Centre, Bedford Park, South Australia. Flinders Medical Centre, Bedford Park, South Australia. 2 Executive, International Consortium for Evidence Based Perfusion Executive, International Consortium for Evidence Based Perfusion
Transcript
The International Consortium for The International Consortium for Evidence-Based Perfusion: Evidence-Based Perfusion:
Moving from Concept to RealityMoving from Concept to Reality
Robert A. BakerRobert A. Baker1, 1, 22, Timothy A Dickinson, Timothy A Dickinson22, Donald S Likosky, Donald S Likosky22, , Kenneth G ShannKenneth G Shann22 11Flinders Medical Centre, Bedford Park, South Australia.Flinders Medical Centre, Bedford Park, South Australia.22Executive, International Consortium for Evidence Based PerfusionExecutive, International Consortium for Evidence Based Perfusion
Potential Conflicts of Potential Conflicts of InterestInterestResearch SupportResearch Support
Terumo, National Heart Foundation, Somanetics, Lunar Innovations
Travel and Conference SupportTravel and Conference Support Terumo, Medtronic, Cellplex, Bayer
Perfusion Downunder OrganisationPerfusion Downunder Organisation Deputy Chair Chair of the PDU Collaboration
OutlineOutline
What is the ICEBP?What is the ICEBP?Structure and ProgressStructure and ProgressHow and Why to get involved.How and Why to get involved.
What is the ICEBP?What is the ICEBP?
www.icebp.orgwww.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.
•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 International Consortium for Consortium for Evidence-Based Evidence-Based PerfusionPerfusion
Mission: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 Scientific SubcommitteeSubcommittee
Mission: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 Scientific SubcommitteeSubcommittee
Mission: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 Scientific SubcommitteeSubcommittee
Mission: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 Scientific SubcommitteeSubcommittee
Mission: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 Best Practices in PerfusionPerfusionTwo Successful Meetings:Two Successful Meetings:
2006 Seattle, 2006 Seattle, Washington (USA)Washington (USA)
Donald S. Likosky, PhD (USA)Donald S. Likosky, PhD (USA) Jeffrey B. Riley, MHPE, CCT Jeffrey B. Riley, MHPE, CCT
(USA)(USA) Dirck A. Rilla, LP, CCP (USA)Dirck A. Rilla, LP, CCP (USA) David J. Rosinski, CCP (USA)David J. Rosinski, CCP (USA) Kenneth G. Shann, CCP (USA)Kenneth G. Shann, CCP (USA) Alfred H. Stammers, MSA, CCP Alfred H. Stammers, MSA, CCP
Program Highlights - Program Highlights - 20072007 ICEBP guideline subcommittee updateICEBP guideline subcommittee update Quality improvement skills trainingQuality improvement skills training The World Society for Pediatric and Congenital The World Society for Pediatric and Congenital
Heart Surgery –Dr. TchervenkovHeart Surgery –Dr. Tchervenkov Adult & pediatric registriesAdult & pediatric registries Public reporting and transparencyPublic reporting and transparency Credentialing of perfusionists as a best practiceCredentialing of perfusionists as a best practice Abstracts on key aspects of best practiceAbstracts on key aspects of best practice Audience Response System utilizedAudience Response System utilized
International Attendees International Attendees - 2007- 2007 AustraliaAustralia BelgiumBelgium CanadaCanada JapanJapan GermanyGermany NetherlandsNetherlands New ZealandNew Zealand
PakistanPakistan Saudi ArabiaSaudi Arabia SpainSpain SwedenSweden United KingdomUnited Kingdom United StatesUnited States
Manufacturer Support - Manufacturer Support - 20072007
Bayer PharmaceuticalsBayer Pharmaceuticals The Medicines CompanyThe Medicines Company Terumo CardiovascularTerumo Cardiovascular Maquet-Dynamed Inc.Maquet-Dynamed Inc. Somanetics CorporationsSomanetics Corporations CAS Medical SystemsCAS Medical Systems Gish Biomedical, Inc.Gish Biomedical, Inc.
Global Blood ResourcesGlobal Blood Resources Luna InnovationsLuna Innovations Medtronic, Inc.Medtronic, Inc. Quest Medical, Inc.Quest Medical, Inc. Rocky Mountain Rocky Mountain
ResearchResearch Sorin GroupSorin Group Spectrum MedicalSpectrum Medical
Best Practices – 2008Best Practices – 2008
Date: Early October 2008Date: Early October 2008Location: Southern USALocation: Southern USA
San Antonio Galverston Dallas
Paediatric Paediatric SubcommitteeSubcommittee
The OpportunityThe Opportunity
“ “The professions caring for patients with The professions caring for patients with congenital heart disease have the unique congenital heart disease have the unique opportunity to create the first opportunity to create the first comprehensive comprehensive international databaseinternational database for a medical for a medical subspecialty.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.
Common Language = NomenclatureCommon Language = Nomenclature Mechanism of Data Collection (Database - Registry)Mechanism of Data Collection (Database - Registry) Mechanism of Evaluating Case ComplexityMechanism of Evaluating Case Complexity Mechanism to Verify Data Validity and AccuracyMechanism to Verify Data Validity and Accuracy Collaboration Between SubspecialtiesCollaboration Between Subspecialties
Multi-Societal Database Multi-Societal Database Committee for Committee for Pediatric and Congenital Heart Pediatric and Congenital Heart DiseaseDisease
The STS Congenital Database TaskforceThe STS Congenital Database Taskforce The EACTS/ECHSA Congenital Database Committee headed by Bohdan The EACTS/ECHSA Congenital Database Committee headed by Bohdan
MaruszewskiMaruszewski The STS Congenital Database Taskforce Core Users Group headed by Hal WaltersThe STS Congenital Database Taskforce Core Users Group headed by Hal Walters The STS Congenital Database Data Verification Subcommittee headed by Dave The STS Congenital Database Data Verification Subcommittee headed by Dave
ClarkeClarke The Aristotle Project headed by Francois Lacour GayetThe Aristotle Project headed by Francois Lacour Gayet The Multi-Center Panel of Experts for Cardiac Surgical Outcomes headed by Kathy The Multi-Center Panel of Experts for Cardiac Surgical Outcomes headed by Kathy
JenkinsJenkins The Congenital Cardiac Anesthesia Society (CCAS) Database headed by David The Congenital Cardiac Anesthesia Society (CCAS) Database headed by David
VenerVener The Joint Council of Congenital Heart Disease (JCCHD) headed by Gerard Martin, The Joint Council of Congenital Heart Disease (JCCHD) headed by Gerard Martin,
MD and representing the American Heart Association and the American College of MD and representing the American Heart Association and the American College of CardiologyCardiology
The Association of European Pediatric Cardiology Nomenclature Committee headed The Association of European Pediatric Cardiology Nomenclature Committee headed by Rodney Franklinby Rodney Franklin
Multi-Societal Database Multi-Societal Database Committee for Committee for Pediatric and Congenital Heart Pediatric and Congenital Heart DiseaseDisease
The Pediatric Cardiac Intensive Care Society (PCICS)The Pediatric Cardiac Intensive Care Society (PCICS) The VPS (Virtual Pediatric Intensive Care Unit Database System)The VPS (Virtual Pediatric Intensive Care Unit Database System) The International Consortium for Evidence Based Perfusion (ICEBP)The International Consortium for Evidence Based Perfusion (ICEBP) The International Working Group for Mapping and Coding of Nomenclatures for The International Working Group for Mapping and Coding of Nomenclatures for
Paediatric and Congenital Heart Disease (Nomenclature Working Group – NWG) Paediatric and Congenital Heart Disease (Nomenclature Working Group – NWG) headed by Christo Tchervenkovheaded by Christo Tchervenkov
The World Society for Pediatric and Congenital Heart Disease headed by Christo The World Society for Pediatric and Congenital Heart Disease headed by Christo TchervenkovTchervenkov
Center for Quality Improvement and Patient Safety of Agency for Healthcare Center for Quality Improvement and Patient Safety of Agency for Healthcare Research and Quality (AHRQ) of the United States Department of Health and Research and Quality (AHRQ) of the United States Department of Health and Human ServicesHuman Services
Birth Defect Branch of the Centers for Disease Control and Prevention (CDC) Birth Defect Branch of the Centers for Disease Control and Prevention (CDC) The National Association of Children's Hospitals and Related Institutions The National Association of Children's Hospitals and Related Institutions
(NACHRI )(NACHRI ) The National Quality Forum (NQF)The National Quality Forum (NQF)
Multi-Societal Database Multi-Societal Database Committee for Pediatric and Committee for Pediatric and Congenital Heart DiseaseCongenital Heart Disease
ICEBP Pediatric Committee is now a memberICEBP Pediatric Committee is now a memberAttend 3 meetings per yearAttend 3 meetings per year Involved with all projects Involved with all projects Implementation of perfusion specific variables Implementation of perfusion specific variables
into STS Congenital heart surgery databaseinto STS Congenital heart surgery database
Complications ProjectComplications Project
In congenital heart surgery, mortality in 2006 is 4%. In In congenital heart surgery, mortality in 2006 is 4%. In order to assess better quality of care involving the order to assess better quality of care involving the remaining 96% of patients, remaining 96% of patients, we must agree on we must agree on universally accepted definitions of morbidity.universally accepted definitions of morbidity.
Not all complications are caused by medical error and Not all complications are caused by medical error and not all medical error results in complications.not all medical error results in complications.
Not all complications are medical negligence or medical Not all complications are medical negligence or medical malpractice.malpractice.
Many subtypes of complications exist.Many subtypes of complications exist.
Complications ProjectComplications Project
ICEBP Pediatric Committee responsible for ICEBP Pediatric Committee responsible for CPB, ECLS, and VAD complication listCPB, ECLS, and VAD complication list
Biweekly conference calls Biweekly conference calls E-mailE-mail Multiple revisionsMultiple revisions Creation of manuscript to be submitted to Creation of manuscript to be submitted to
Cardiology in the Young alongside other organ Cardiology in the Young alongside other organ system complication lists (>1000) system complication lists (>1000)
Ongoing InitiativesOngoing Initiatives
Collaborative Database initiatives with the: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 STS Regional Congenital Database ReportsRegional Congenital Database Reports Data Verification Site Visit ProjectData Verification Site Visit Project Ongoing collaborative research to 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.
during bypassduring bypass– Nadir Hct - by genderNadir Hct - by gender
Traditional What you Can Vary
Guiding PrinciplesGuiding Principles
Quality over quantityQuality over quantity Definitions, definitions, definitionsDefinitions, definitions, definitions Validation of case count and statusValidation of case count and status Smart registrySmart registry
Center Thumbprint Assist in submissions to other registries Software independent Cross match to STS and PDUCDB
Lowest Hct on Pump
15%
20%
25%
30%
Nov-
05
Dec-
05
Jan-0
6
Feb-0
6
Mar-
06
Apr-
06
May-0
6
Jun-0
6
Jul-06
Aug-0
6
Sep-0
6
Oct
-06
Nov-
06
Month -Yr
Perc
en
t
One centerOne center’’s s experienceexperienceOne center’s experience
What is unique about these centers?
How We Can Learn from Each OtherHow We Can Learn from Each Other
TAKE HOME POINTS:The future depends on data collection, data feedback, and benchmarking
Areas of FocusAreas 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)
The mission of the guideline writing The mission of the guideline writing subcommittee is to develop evidence-based subcommittee is to develop evidence-based clinical practice guidelines for cardiovascular clinical practice guidelines for cardiovascular perfusion. 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
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 Platelet
Preservation:Preservation:Do perfusion Do perfusion
strategies really strategies really
make a difference?make a difference?Gordon R. DeFoe, BA, CCPGordon R. DeFoe, BA, CCP
Dartmouth-Hitchcock Medical CenterDartmouth-Hitchcock Medical CenterDartmouth Medical SchoolDartmouth Medical SchoolLebanon, NH, USALebanon, NH, USA
SectionChairs
Donny LikoskyKenny Shann
Techniques
Arno NierichKenny ShannLinda Shore
Technology
Dirck RillaGordon DeFoe
Monitoring
Jane OttensGordon DeFoe
Pharmacology
Tim DickinsonArno Nierich
Chris Mahoney
The Platelet Preservation The Platelet Preservation GroupGroup
Defining the problemDefining the problem
Statement:Statement: We believe that platelets are good. We believe that platelets are good. Can we physically and qualitatively preserve platelets Can we physically and qualitatively preserve platelets
during cardiopulmonary bypass?during cardiopulmonary bypass? Surface coatings or treatments Pump types Circuit components Cell salvage devices
Are there holes in our knowledge?Are there holes in our knowledge?
What are the steps?What are the steps? Evaluate the peer-reviewed medical literature in Evaluate the peer-reviewed medical literature in
a rigorous and consistent fashiona rigorous and consistent fashion Focus expertise on specific topicsFocus expertise on specific topics Develop an informed opinion regarding Develop an informed opinion regarding
effectiveness and assign levels of evidenceeffectiveness and assign levels of evidence Formulate a “finding” and a written summary for Formulate a “finding” and a written summary for
publicationpublication
Search methodologySearch methodology
NCBI - National Center For BioTechnology NCBI - National Center For BioTechnology Information - MEDLINE search, Information - MEDLINE search, ≥≥19961996
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 Evaluation of search resultsresults
An automated Excel spreadsheet was An automated Excel spreadsheet was automatically populated by NCBI searchautomatically populated by NCBI search
NCBI download includes abstract (if available)NCBI download includes abstract (if available) Reviewers can sift through references based Reviewers can sift through references based
upon abstract, or decide to review entire paperupon abstract, or decide to review entire paper Almost all citations retrievable on-lineAlmost all citations retrievable on-line Fate of all citations is tracked.Fate of all citations is tracked.
Classification of Classification of RecommendationsRecommendations
Class IClass I - Conditions for which there is evidence, general - Conditions for which there is evidence, general agreement, or both that a given procedure or treatment is agreement, or both that a given procedure or treatment is useful and effectiveuseful and effective
Class IIClass II – Procedure or treatment should be performed or – Procedure or treatment should be performed or administeredadministered
Class IIaClass IIa – Additional studies with focused objectives are – Additional studies with focused objectives are neededneeded
Class IIbClass IIb – Additional studies with broad objectives are – Additional studies with broad objectives are needed; additional registry data would be helpful needed; additional registry data would be helpful
Class IIIClass III – Procedure or treatment should not be performed – Procedure or treatment should not be performed or administered because it is not helpful and might be or administered because it is not helpful and might be harmfulharmful
Levels of evidenceLevels of evidence
Level ALevel A – Data is derived from multiple – Data is derived from multiple randomized clinical trialsrandomized clinical trials
Level BLevel B – Data is derived from a single – Data is derived from a single randomized trial or non-randomized studiesrandomized trial or non-randomized studies
Level CLevel C – Consensus opinion of experts – Consensus opinion of experts
Results of literature Results of literature searchsearch103 “hits” on MEDLINE103 “hits” on MEDLINE
All proved to be retrievable on-lineAll proved to be retrievable on-line
44 citations (inc. 2 review articles) were judged 44 citations (inc. 2 review articles) were judged to be relevant to the topic of “technology for to be relevant to the topic of “technology for platelet preservation on bypass”platelet preservation on bypass”
In all, we evaluated studies on 4,234 adult In all, we evaluated studies on 4,234 adult patients in 41 distinct trialspatients in 41 distinct trials
““Biocompatible” v Biocompatible” v “Standard”“Standard”
The clear preponderance of the evidence is The clear preponderance of the evidence is that coated circuits better preserve platelet that coated circuits better preserve platelet counts and reduce platelet deposition and counts and reduce platelet deposition and activation, when used in either the “tip-to-activation, when used in either the “tip-to-tip” or “all but cannula” modetip” or “all but cannula” mode
No clear benefit was observed when only No clear benefit was observed when only the oxygenator was coatedthe oxygenator was coated
Comparison of Comparison of technologiestechnologies
When different coatings were directly When different coatings were directly compared, there was no treatment that was compared, there was no treatment that was clearly better than any other in terms of clearly better than any other in terms of platelet preservationplatelet preservation
We did not find clear evidence that pump We did not find clear evidence that pump types or other component designs affected types or other component designs affected platelets directlyplatelets directly
Work still to be doneWork still to be done
Cochrane meta-analysis will be runCochrane meta-analysis will be runWrite discussion section for next Write discussion section for next
publicationpublicationThere are holes in our knowledgeThere 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 When used in either the “tip to tip” or “all but cannula” configuration, biocompatible cannula” configuration, biocompatible cardiopulmonary bypass circuits offer cardiopulmonary bypass circuits offer
superior preservation and protection of superior preservation and protection of platelets during and after cardiac surgery. platelets during and after cardiac surgery.
(Class TBD, Level TBD)(Class TBD, Level TBD)
The Inflammatory The Inflammatory Response: It’s not all Response: It’s not all about Pharmacological about Pharmacological InterventionIntervention
Rob BakerRob BakerFlinders Medical Centre and Flinders Flinders Medical Centre and Flinders University, Bedford ParkUniversity, Bedford ParkAdelaide, AUSTRALIAAdelaide, AUSTRALIA
Inflammation
Section Chair:Clive and Rob
Techniques
Richard*, Kimberle,David R, Joe S, Rob
Technology
Bob G*, Andy C, Heinz, Nick M
Pharmacology
John M, Clive*, John M, Jeremiah, Hiliary G
Cell SalvageIschemia
TemperatureEmbolism
UltrafiltrationPumps
Coated Circuits Hemolysis
Leukocyte Filtration
* Sub group Leaders
Do you think that cell salvage Do you think that cell salvage has an impact on has an impact on inflammation in the Cardiac inflammation in the Cardiac Surgical (on pump) patient?Surgical (on pump) patient?
Yes N
o
Abst
ain
82%
0%
18%
1.1. YesYes2.2. NoNo3.3. AbstainAbstain
Cell Salvage
134 papers
Abstract review identified 44
9 RCT’sI observational
4 + additional papers identified
Pubmed Searches
Emailed in ExcelFormat
RecommendationRecommendation
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 Who is currently involvedinvolved
David Rosinski, Richard Newland, Kimberle McGill; David Rosinski, Richard Newland, Kimberle McGill; Nicholas Mellas, Andrew Cleland, Bob Groom, Nicholas Mellas, Andrew Cleland, Bob Groom, Heinz Weitkemper, John Murkin, Jeremiah Brown, Heinz Weitkemper, John Murkin, Jeremiah Brown, John Motley, Hiliary Grocott, Kenneth Shann, Tim John Motley, Hiliary Grocott, Kenneth Shann, Tim Dickinson, Chris Brown Mahoney, Sander Dickinson, Chris Brown Mahoney, Sander Spanjersberg, Arno Nierich, Donny Likosky, Linda Spanjersberg, Arno Nierich, Donny Likosky, Linda Shore Brown, Gordon DeFoe, Dirck Rilla, Jane Shore Brown, Gordon DeFoe, Dirck Rilla, Jane Ottens, Huong Pham,Ottens, Huong Pham, Rob Baker Rob Baker
