1. The document describes the development and use of a clinical database to analyze outcomes from cardiac surgeries at Cheng-Hsin General Hospital. 2. Variables were collected from medical records and organized in the database, including demographics, diagnoses, procedure details, and postoperative outcomes. 3. Analysis of the database showed that higher EuroSCORE values, which estimate surgical risk, predicted worse outcomes such as mortality and complications. The database allowed identification of factors associated with postoperative complications.

1. Clinical Database
--From Basic to
Application
陳勁辰

2. Motivation
• How well did we do?
• From our experience, how is your
operation risk?

3. Solution
• A: Past data
• B: Data analysis
• A + B = Clinical database!

4. Database Example
4

5. Data Variables
(Computer)
• Text
• Number
• Date
• Administrative data

6. Data Variables
(Epidemiology)
• X1, X2, ..., Xn -> Y
• Predictor: Xi
• Outcome: Y

7. Data Variables
(Statistics)
• Scale: Continuous. eg. body weight
• Ordinal: Grading. eg. severity
• Nominal: Category. eg. side

8. Data Variables
(Surgery)
• Demographics
• Baseline
• Preop
• Op
• Postop
• Outcome

9. Variable Definition
• Yes / No
• Timing
• Category
• Measurement

10. Database Example
10

11. Paperwork
• Question
• Chart review
• Paper writing
• Data key-in
• Analysis

12. Hospital Information
System (HIS)
• Help from IT
• Variable definitions
• SQL (Structured Query Language)
–SELECT [X1], [X2] FROM [DB]
WHERE [X3] ? [X4]
–Xi? DB?

13. Data Collection from
HIS
• Diagnosis: ICD9
• Operation: NHI
• Procedures: NHI
–IABP, MV, HD,...
• Drugs: ?

14. Cheng-Hsin General
Hospital
ICD-9 Codes and Diagnoses
 DM=250.*
 COPD=490-492.* or 496
 PAOD=443.*-444.*
 CVA 434.91 or 434.11 or 997.02
 Acute renal failure=584.*
 Chronic renal failure=586.*-588.*
 Critical=785.51 or “shock” or “IABP” or “ECMO”
 UA=413.* or “angina”
 LV dysfunction = 428.* or “critical” or “CHF” or “ICMP”
 AMI=410.* or “AMI” or “infarction”
 PHT=416.* or “pulmonary hypertension”
 IE=424.*

15. Cheng-Hsin General
Hospital
Nat’l Health Insurance Codes
Operations Postop Course
 CABG*1= 68023
 CABG+LIMA= 68023X1/2
 CABG*2=68024
 CABG*3=68025
 MVA/TVA=68015
 AVR/MVR/TVR=68016
 DVR=68017
 AVR+MVR+TVR=68018
 Redo=68003
 Ventilator=57001
 IABP=33079
 HD=58001
 CVVH=58014
 “Text data-mining”

16. Database Steps
• Data collection
• Data validation
• Data analysis

17. Interface: Data Entry
• V1, V2, ..., Vn
• Q1: V1’
• Q2: V2’
• Q3: V3’

18. Data Analysis:
Statistics
• Descriptive (敘述性): Tables, Graphs
• Inferential (推論性): p-values

20. Inferential Statistics
• Different or not?
• Related or not?
• Predictor or not?

21. Different?
• Group
• Variable to compare

22. Related?
• Correlation
• Variable-1
• Variable-2

23. Predictor?
• Predictor variables X1, X2,...Xn
• Outcome variable Y
–Scale
–Event (Y/N)
–Time-event

26. EuroScore Calculator
http://www.euroscore.org
Nashef SA et al: European system for cardiac operative risk
evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999
Jul;16(1):9-13

27. EuroScore Calculator, Additive
http://www.euroscore.org
Nashef SA et al: European system for cardiac operative risk
evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999
Jul;16(1):9-13

28. EuroScore Calculator, Logistic
Nashef SA et al: European system for cardiac operative risk
evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999
Jul;16(1):9-13
Roques F et al: The logistic EuroSCORE. Eur Heart J. 2003 May;24(9):882-3

29. • EuroScore since 1995, 15 years old
• 36 Questions
–Patient details
–Patient
–Heart
–Operation
–Outcome
EuroScore 2010

36. Commercial Package
• “Interface”
• Data Entry
• Data Analysis

37. Customization
• Which variables
• Possible questions

38. People Factors
• Work-flow
• Work-load
• Motivations

39. Cheng-Hsin General
Hospital
ICD-9 Codes and Diagnoses
 DM=250.*
 COPD=490-492.* or 496
 PAOD=443.*-444.*
 CVA 434.91 or 434.11 or 997.02
 Acute renal failure=584.*
 Chronic renal failure=586.*-588.*
 Critical=785.51 or “shock” or “IABP” or “ECMO”
 UA=413.* or “angina”
 LV dysfunction = 428.* or “critical” or “CHF” or “ICMP”
 AMI=410.* or “AMI” or “infarction”
 PHT=416.* or “pulmonary hypertension”
 IE=424.*

40. Cheng-Hsin General
Hospital
Nat’l Health Insurance Codes
Operations Postop Course
 CABG*1= 68023
 CABG+LIMA= 68023X1/2
 CABG*2=68024
 CABG*3=68025
 MVA/TVA=68015
 AVR/MVR/TVR=68016
 DVR=68017
 AVR+MVR+TVR=68018
 Redo=68003
 Ventilator=57001
 IABP=33079
 HD=58001
 CVVH=58014
 “Text data-mining”

41. Cheng-Hsin General
Hospital
Definition of Isolated CABG
1. CABG without any cardiac procedures such as
valvular, aortic, Af ablation, etc.
2. Excluding redo-CABG
3. Not excluding pacemaker implantation or
vascular procedures such as carotid
endarterectomy or PAOD bypass.

42. Cheng-Hsin General
Hospital
Results: Overall
 From 2006-01-1 to 2008-12-31
 CABG-included operations N=1066
 Combined cardiac procedures: 22.0%
 Concomitant double-valve replacement, Bentall’s
operation, heart transplantation, redo, etc.
22%
78%
N=1,066
Combined
CABG only

43. Cheng-Hsin General
Hospital
Results: Isolated CABG
 Included Isolated CABG N=757
 EuroScore (additive)= 3.1 (2.9~3.2)
 EuroScore (logistic)= 3.3% (2.9%~3.6%)
 Early graft failure: N=3 (0.4%)
 Redo CABG within the 3-year period
 On-pump arrest method: N=703 (92.9%)
 Off-pump or on-pump beating method: N=54
(7.1%)

44. Cheng-Hsin General
Hospital
On-pump Arrest CABG—Preop Data
 First-time on-pump arrest CABG: N=703
 EuroScore (additive)= 2.9 (2.7~3.1)
 EuroScore (logistic)= 3.0% (2.7%~3.2%)
 Female: 23.8% (20.6%~26.9%)
 Age at operation: 63.9±10.3 years (63.1~64.6)
 Concomitant carotid endarterectomy: 2.4%
(1.3%~3.6%)
 Emergent: 8.7% (6.6%~10.8%)
 LM-involved disease: 16.1% (13.4%~18.8%).

45. Cheng-Hsin General
Hospital
On-pump Arrest CABG--Op Data
 LIMA use: 68.9% (65.4%~72.3%)
 No. of distal anastomosis: 3.7±1.0 (median=4,
range=1~7)
 Op time : 8.0±1.5 hr (7.9~8.1)
 Pumping time: 135.0±44.2 min (131.7~138.3)
 Ischemic time: 83.2±30.0 min (81.0~85.4)

46. Cheng-Hsin General
Hospital
On-pump Arrest CABG--Postop
Data
 New postop IABP: 2.7% (1.5%~3.9%)
 Lung complication (atelectasis –infection): 9.5%
(7.3%~11.7%)
 Reopen for bleeding: 1.9% (0.9%~2.8%)
 New-onset CVA (symptomatic): 2.3%
(1.2%~3.4%)
 New-onset acute renal failure (hemodialysis):
3.7% (2.3%~5.1%)

47. Cheng-Hsin General
Hospital
On-pump Arrest CABG--Postop
Data
 Surgical mortality (within 30 days): 1.6%
(0.6%~2.5%)
 Hospital mortality (in the same in-hospital
course): 1.9% (0.9%~2.8%)
 Excluding surgical mortality and postop CVA
(N=703)
 Off ventilator within 24 hr: 67.1% (63.7%~70.6%)
 Median ICU stay: 5 days
 Median hospital stay: 15 days.

48. Cheng-Hsin General
Hospital
On-pump Arrest CABG--All-
Cause Mortality
 Kaplan-Meier curve for freedom from all-cause
mortality
 1-year: 97.3% (95.7%~98.3%)
 2-year: 96.8% (94.7%~98.1%)
 3-year: 96.2% (93.6%~97.7%)

49. Cheng-Hsin General
Hospital
Variables for EuroScores
Age Unstable angina
Gender LV dysfunction
COPD Recent MI
PAOD Pulm. HTN
CVA
Redo Emergent op
Renal insufficiency Combined proc.
IE Op on thoracic Ao
Preop critical Post. Infarct VSR

50. Fresh On-pump Arrest CABG--
All-Cause Mortality

51. Cheng-Hsin General
Hospital
Variables Included in the
Regression Analyses
EuroScore (additive)
EuroScore (logistic)
LM disease
Carotid procedure
Operation time
Ischemia time
Pumping time
No. of distal anastomoses
LIMA use (elective cases)

52. Cheng-Hsin General
Hospital
Predictors for Surgical
Mortality (Within 30 Days)
Predictor OR 95% CI P-value
EuroScore
(additive)
1.3 1.1~1.6 0.003
EuroScore
(logistic)%
1.1 1.04~1.2 0.002

53. Cheng-Hsin General
Hospital
Predictors for Hospital
Mortality (Same Hosp. Course)
Predictor OR 95% CI P-value
EuroScore
(additive)
1.6 1.3~1.9 <0.001
EuroScore
(logistic)%
1.14 1.07~1.23 <0.001
Ischemia Time
(hr)
2.9 1.1~7.7 0.037
Pumping Time
(hr)
2.9 1.5~5.7 0.002
LIMA (non-ER) 0.26 0.07~0.92 0.036

54. Cheng-Hsin General
Hospital
Predictors for All-Cause
Mortality (Up to 3 Years)
Predictor HR 95% CI P-value
EuroScore
(additive)
1.4 1.2~1.6 <0.001
EuroScore
(logistic)%
1.1 1.05~1.13 <0.001
LIMA (non-ER) 0.3 0.10~0.74 0.011

55. Cheng-Hsin General
Hospital
Predictors for Off-Ventilator
Within 24 Hours
Predictor OR 95% CI P-value
EuroScore (additive) 0.8 0.74~0.85 <0.001
EuroScore (logistic)% 0.85 0.81~0.9 <0.001
Carotid Op 0.14 0.046~0.44 0.001
Operation Time (hr) 0.75 0.67~0.84 <0.001
Ischemia Time (hr) 0.60 0.43~0.82 0.001
Pumping Time (hr) 0.59 0.47~0.74 <0.001
No. Anastomosis 0.80 0.68~0.93 0.005

56. Cheng-Hsin General
Hospital
Predictors for Postop Lung
Complications
Predictor OR 95% CI P-value
EuroScore
(additive)
1.23 1.13~1.35 <0.001
EuroScore
(logistic)%
1.11 1.05~1.17 <0.001

57. Cheng-Hsin General
Hospital
Predictors for Postop New
IABP
Predictor OR 95% CI P-value
EuroScore
(additive)
1.3 1.1~1.5 0.001
EuroScore
(logistic)%
1.1 1.03~1.2 0.005

58. Cheng-Hsin General
Hospital
Predictors for Postop New-
Onset CVA
Predictor OR 95% CI P-value
EuroScore
(additive)
1.3 1.1~1.5 0.004
EuroScore
(logistic)%
1.1 1.03~1.2 0.006
Carotid Op 6.4 1.3~30.7 0.020

59. Cheng-Hsin General
Hospital
Predictors for Postop New-
Onset Acute Renal Failure
Predictor OR 95% CI P-value
EuroScore
(additive)
1.16 1.01~1.33 0.037
EuroScore
(logistic)%
1.08 1.02~1.14 0.010
LIMA (non-ER) 0.34 0.14~0.82 0.016

60. Cheng-Hsin General
Hospital
EuroScores Predict Outcomes
 Higher EuroScores predict worse outcomes.
 Morality
 Surgical mortality (within 30 days)
 Hospital mortality (in the same hosp. course)
 All-Cause mortality (up to 3 years)
 Complications
 Lung complications (atelectasis-infection)
 Prolonged ventilator use over 24 hours
 Postop new IABP
 Postop new-onset CVA
 Postop new-onset acute renal failure