Quality control in Europe

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Quality control in Europe

• Sabine H. Daebritz
• Cardiac Surgery, University Hospital Munich
• (University Hospital Muenster)

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Requirements

• Evaluation of quality of care is a duty
• A common language (nomenclature)
• Database (registry)
• Parameters for comparison (complexity)
• Data verification (validation)

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Congenital heart surgery

• Quality assessment is particularly complex
• 150 surgical procedures
• 200 diagnoses
• Comparison of several hundred factors

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Birth of the Aristotle Score

• Started in 1999 facing several problems
• Multi-institutional databases (EACTS and STS)
  just started
• Absence of risk-adjustment ? prominent centres
  reluctant to send their data
• Any risk-adjustment was subjective

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The Aristotles philosophy

• When there is no scientific answer available,
  the opinion perceived and admitted by the
  majority has value of truth
• (Rhetoric, Book 1, 350 BC)

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Development of the Aristotle Score

• Concept Complexity based on complexity factors
• It is a constant, at a given time for a given
  procedure in a given patient, whatever the center
  and its global location
• Complexity x Outcome Performance
• Constant Variable Variable

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The constant of skiing slopes
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Defining different performances

• Complexity x Long-term result Quality
• Constant Variable Variable
• Complexity x Pt. evaluation Pt.
  satisfaction
• Constant Variable Variable
• Complexity x Cost Financial
  performance
• Constant Variable Variable

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Aim of the Aristotle Score

• Precicely score the complexity of each procedure
  (not of diagnosis)
• Produce a comprehensive scoring applied to all
  procedures
• Develop a system that is applicable worldwide

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Defining complexity of a single procedure

• The potential of hospital mortality
• The potential of post - operative morbidity,
  defined as ICU stay
• Technical difficulty, defined as surgical
  expertise required

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Complexity MortalityMorbidityTechn. difficulty

• Complexity Score Mortality Morbidity Techn.
  Difficulty
• 1 point lt 1 ICU 0-24 h elementary
• 2 points 1-5 ICU 1-3 d simple
• 3 points 5-10 ICU 4-7 d average
• 4 points 10-20 ICU 10-20 d important
• 5 points gt20 ICU gt20 d major

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The basic Aristotle Score

• Collection of the opinion of experts of 50
  centers in 23 countries
• Scoring the complexity of 145 procedures from 1,5
  to 15 with regard to mortality, morbidity and
  technical difficulty ( 4 levels)
• Finished in 2003
• Free for participants of STS and EACTS database

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The comprehensive Aristotle Score

• Procedure dependent factors
• Procedure independent factors
• for mortality, morbidity and technical difficulty
  
• adding 10 points or two levels

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1999-2003 14493 procedures from 26 centres
30-day mortality 4.8
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EACTS Database worldwide input 2000-2004

• Italy 11190
• Poland 4686
• Netherlands 4069
• Germany 2912
• Turkey 2325
• Spain, Belgium, Greece, Portugal, Ireland gt 1000
• Slowakia, Israel, Norwegen, RPA, Finland,
  Russia, Hungary, Australia, Sweden, Columbia gt
  500

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Input 2005-2006

• Germany
• 2005 9 institutions with 547, 416, 363, 284,
  261, 164, 92, 7, 2 data
• 2006 so far 4 institutions
• gt300, gt200, gt200 and lt100 data
• International
• Poland 3562
• Germany 2992
• Netherlands 815
• Saudi Arabia 647
• Austria 624

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Joint EACTS-STS International Congenital Heart
Surgery Nomenclature and Database

• Operations n, cumulative 40844
• 18928 STS (http//www.sts.org)
• 21916 EACTS (http//www.echsa.org)
• EACTS STS
• Neonates n 4273 3988
• ASO n 885 (20.7) 472 (11.8)
• ASO mortality 5.2 7.4
• Norwood stage I 297 (6.6) 575 (14.4)
• Norwood mortality 35.5 26.0
• TOF with palliation 70.0 61.6
• Age at TOF repair 2.2 years 1.1 years

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Results Risk of surgery in GUCH pts.

• Operations n, cumulative 2012
• Mean age 34.4/-14.5 years
• Corrective procedures 1509 75
• Isolated ASD II 649 32.2
• Reoperations 464 23.1
• Overall hospital mortality 2
• Risk factors
• Cyanosis, arrhythmias, NYHA class III-IV

Vida VL et al, Ann Thorac Surg 200783161-8
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Development of Aristotle Score

• Expansion of participation (with EACTS / STS
  nomenclature) to Asia / Japan
• Founding by Transatlantic Network of Excellence
  in Cardiovascular Research
• Foundation of the Aristotle Institute Inc.
• Development of inlcusion of pediatric
  interventions
• Validation of the Comprehensive Score
  (finished 10 centres in USA, 10 in Europa,
  Asian, 1 Austr., 1 Southam. ? Audits)

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Comments on RACH Score

• Multivariable model using data from pediatric
  cardiac care consortium
• Cardiac procedure groups in 6 categories
• Stratified by age and diagnosis
• Prematurity and major noncardiac anomalies are
  included
• Specifically designed to predict mortality
• RACHS may correlate better with mortality, but
  less sensitive and complete than Aristotle
• If Aristotle is fit to RACHS, curves almost
  identical

Surg Ann Sem Thorac Cardiovasc Surg
20047180-4 Editorial EJCTS 200629989-990 Jenki
ns KJ, Risk adjustment for Congenital Heart
Surgery The RACHS-1 Method. Ped Card
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Comments to the Aristotle Score

• Verification of the completeness of data is
  crucial
• UK CCAD 21.6 of 30-d-mortality was detected by
  tracking and not by volunteered data
• Goal Further involvement of Africa, Asia and
  Australia
• Overall goalImprove congenital heart surgery
  outcome analysis with the long-term objective of
  continued upgrade in the quality of surgery for
  congenital heart disease worldwide

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References

• Lacour-Gayet F et al The Aristotle score a
  complexity adjusted method to evaluate surgical
  results, EJCTS 200425911-24
• Lacour-Gayet F et al. The Aristotle Score in
  Congenital Heart Surgery. Ped Card Surg Ann Sem
  Thorac Cardiovasc Surg 20047185-191
• Lacour-Gayet F et al. The Aristotle method a new
  concept to evaluate quality of care based on
  complexity. Curr Opin Ped 200517412-7
• Jacobs JP et al. Current Status of the EACTS and
  STS Congenital Heart Surgery Database. Ann Thorac
  Surg 2005802278-84

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Neuschwanstein
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Complexity of a single procedure

• The potential of hospital mortality
• The potential of post - operative morbidity,
  defined as ICU stay
• Technical difficulty, defined as surgical
  expertise required

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The constant of skiing slopes