Current guidelines on cardiac markers - how should they be - - PowerPoint PPT Presentation

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Current guidelines on cardiac markers - how should they be - - PowerPoint PPT Presentation

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Current guidelines on cardiac markers - how should they be introduced and how should the implementation be evaluated Professor P. O. Collinson MA MB BChir FRCPath FRCP edin MD FACB EurClin Chem Consultant Chemical Pathologist and Professor of

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Current guidelines on cardiac markers

  • how should they be introduced

and how should the implementation be evaluated

Professor P. O. Collinson MA MB BChir FRCPath FRCP edin MD FACB EurClin Chem Consultant Chemical Pathologist and Professor of Cardiovascular Biomarkers, Departments of Chemical Pathology and Cardiology, St George’s Hospital, London

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Conflicts of interest

  • Member NICE Diagnostics Advisory Committee
  • National Clinical Lead National Laboratory Medicine

Catalogue UK

  • Advisory Boards for Siemens Healthcare Diagnostics and

Phillips.

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Acknowledgements

The CARMAGUE group

– Angelika Hammerer-Lercher – Kari Pulkki – Marja P van Dieijen-Visser – Hannsjörg Baum – Kristin Aakre – Michel Langlois – Christoffer Duff – Päivi Laitinen – A Stavljenic-Rukavina – Janne Suvisaari

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Acknowledgements

  • Everyone who participated in the CARMAGUE surveys
  • And a reminder to those that haven’t (yet)

– There is still time – Or the incoming president will make you an offer you can’t refuse – http://carmague.fi/2013

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Assess Analyse Change Evidence base Primary research Systematic review Outcome Cost Best practice Current practice Process Conclusions and recommendations Guidelines Audit cycle Compare

Collinson PO in Evidence-Based Laboratory Medicine. AACC press, Washington DC. 2007

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Current guidelines on cardiac markers

  • how should they be introduced

and how should the implementation be evaluated

  • What are the guidelines and where did they come from
  • Guidelines and reality – how do we use cardiac

biomarkers in Europe?

  • Barriers to implementation
  • Evaluation of implementation
  • Conclusions
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What are the guidelines and where did they come from

  • How do we get guidelines?
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Opinion leaders

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Opinion leaders

  • Opinion may be wrong even when widely held (and

enforced)

– The Sun rotates around the earth – The holy office had a short way with dissenters

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Opinion may be wrong

  • In 1843, Oliver Wendell Holmes published The Contagiousness of

Puerperal Fever.

  • He maintained:

– Puerperal fever was frequently carried from patient to patient by physicians and nurses – Hand-washing, clean clothing, and avoidance of autopsies by those aiding birth would prevent the spread of puerperal fever – Holmes' conclusions were ridiculed by many contemporaries, including Charles Meigs, a well-known obstetrician, who stated "Doctors are

gentlemen, and gentlemen's hands are clean.“

  • Both statements are probably untrue (still) in the era of MRSA
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Opinion may be wrong

  • In 1844, Ignaz Semmelweis appointed to Allgemeines

Krankenhaus in Vienna

  • He noticed

– His ward’s 16% mortality rate from fever was substantially higher than the 2% mortality rate in the Second Division, where midwifery students were trained. – That puerperal fever was rare in women who gave birth before arriving at the hospital. – The First Division performed autopsies each morning on women who had died the previous day but the midwives were not required

  • r allowed to perform such autopsies.

– A colleague, Jakob Kolletschka, died of septicaemia after accidentally cutting his hand while performing an autopsy.

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Opinion may be wrong

  • Instituted that all doctors and students working in the First

Division wash their hands in chlorinated lime solution before starting ward work, and later before each vaginal examination.

– The mortality rate from puerperal fever in the division fell from 18% in May 1847 to less than 3% in June–November of the same year. – He was treated with skepticism and ridicule . The combination of his abrasive personality and the hostility of the medical establishment in Vienna proved too much for him, and in 1851 he returned to Hungary as a professor of obstetrics in Budapest.

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Opinion leaders

  • Influenced by Industry?
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Opinion leaders

  • Opinion (consensus statements) is Class III level of

evidence in the evidence based hierarchy

  • And quite rightly so
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Peers

  • Peer opinion suffers from the same defects as opinion

leaders

  • But there are more of them
  • So we can all be wrong together
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Guideline development

  • Systematic evaluation of published material with an evidence

hierarchy

  • Limitations

– Publication bias

  • negative studies tend not to be published
  • It has been estimated that 65% of publications supporting guidelines are industry

sponsored

– Appropriateness of study populations

  • Clinical trial populations are selected and co-morbidities excluded. They are not

all comers real world studies

  • Clinical study populations may include inappropriate patient groups

» Collinson PO. Heart 2013;99:757-8. – Population selection including ST segment elevation MI

  • Trial design factors
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HPS Lancet 2002; 260:7-22

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The guidelines

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Evolution of Diagnostic Criteria for AMI using cTn

Diagnostic limit for CK-MB 97.5 centile or LLD

WHO NACB AHA/ESC

AMI Limit based on CK-MB (ROC equivalent) 99th centile

Unstable Angina Unstable Angina Unstable Angina Myocardial infarction MMD Myocardial infarction Myocardial infarction

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Evidence base?

  • For the shift to troponin
  • For the 99th percentile
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For the shift to troponin

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Major Cardiac Events during Hospitalization and Date of Occurrence.*

Hamm CW et al. N Engl J Med 1992;327:146- 150.

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Kaplan-Meier cumulative hazard function curves for unstable angina according to troponin T status and end points +Mantel- Haenszel statistic. ++Log rank statistic.

Stubbs P et al. BMJ 1996;313:262-264

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Meta-analysis data for cTnT (left) and cTnI (right) adapted from

Heidenreich PA et al J.Am.Coll.Cardiol. 2001;38:478-85

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For the 99th percentile

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Mills NL, Churchhouse AM, Lee KK et al. Implementation of a sensitive troponin I assay and risk of recurrent myocardial infarction and death in patients with suspected acute coronary syndrome. JAMA 2011;305:1210-6.

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Mills NL, Lee KK, McAllister DA et al. Implications of lowering threshold of plasma troponin concentration in diagnosis of myocardial infarction: cohort study. BMJ 2012;344:e1533.

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Biomarkers of myocardial necrosis

  • What is the audit standard
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Biomarkers of myocardial necrosis

  • Audit and reality – how do we use cardiac biomarkers in

Europe?

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Breadth of survey

50 100 150 200 250 300 350 400 2006 2010 2013 (prelim) Total University

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What markers are used for the primary diagnosis of AMI?

94 95 96.8 10 20 30 40 50 60 70 80 90 100 2006 2010 2013

cTn Other

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What other markers are used for the diagnosis of AMI (expressed as percentages)?

10 20 30 40 50 60 70 80 90 100 2006 2010 2013

CK CK-MB act CK-MB mass LD/HBD Myo AST

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Units

mg/L (cTnT) ng/L (cTnT) mg/L (cTnI) ng/L (cTnI)

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Where do laboratories get their information – decision limits for AMI

10 20 30 40 50 60

Data sheet National/International Peer-reviewed literature Locally derived

2013 2010 2006

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What decision limits for AMI are used (percentages)

17.9 3.4 39.3 9.4 16.4 5.3 8.2 10 20 30 40 50

10% CV 20% CV 99th percentile Locally derived Guidelines Other Do not know

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Interpretation

  • 99th percentile or decision limits?

– 33% used a “grey zone”

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Protocols

10 20 30 40 50 60 70 80 90 100 Protocol 2006 2010 2013

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Origin of protocol

Written agreement Verbal agreement Informal consensus Other

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Serial testing

  • Yes – 62.7%
  • Sometimes - 25.2%
  • No – 6.5%
  • 34% use a delta

– Absolute 26.9% – Relative 53.9% – Both 17.9%

3 h 6 h 10-12 h Other

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Conclusions

  • Troponin IS the biomarker for AMI
  • Encouraging trends in working with clinician colleagues
  • Time for a biomarker update for recommended standards
  • f practice
  • There is a clear need for education in

– Use of the 99th percentile – Use of delta values

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Barriers to implementation

  • Evidence base – lack of understanding of (hs) troponin
  • Lack of clinician-laboratory dialogue
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  • Collinson P, Pulkki K, Suvisaari J, Ravkilde J, Stavljenic-Rukavina A,

Hammerer-Lercher A et al. How well do laboratories follow guidelines on cardiac markers? The cardiac marker guideline uptake in Europe study. Clin Chem 2008;54:448-9.

  • Pulkki K, Suvisaari J, Collinson P, Ravkilde J, Stavljenic-Rukavina A,

Hammerer-Lercher A et al. A pilot survey of the use and implementation of cardiac markers in acute coronary syndrome and heart failure across Europe The CARdiac MArker Guideline Uptake in Europe (CARMAGUE) study. Clin Chem Lab Med 2009;47:227-34.

  • Collinson PO, Dieijen-Visser MP, Pulkki K et al. Evidence-based laboratory

medicine: how well do laboratories follow recommendations and guidelines? The Cardiac Marker Guideline Uptake in Europe (CARMAGUE) study. Clin.Chem. 2012;58:305-6.

  • Hammerer-Lercher A, Collinson P, Dieijen-Visser MP et al. Do laboratories

follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE). Clin.Chem.Lab

  • Med. 2013;1-6.

References

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Remember

– http://carmague.fi/2013 – It is not yet to late

EFLM