HA TerritoryHA Territory--wide PCI wide PCI Audit 2003Audit 2003--0505

PCI Audit Working GroupPCI Audit Working GroupCentral Committee (Cardiac Services)Central Committee (Cardiac Services)

HA Convention 2006HA Convention 2006

PercutaneousPercutaneous Coronary InterventionCoronary Intervention

BackgroundBackgroundHA AP target 02/03, coordinated by PCI HA AP target 02/03, coordinated by PCI Working Group of Central Committee Working Group of Central Committee (Cardiac Services)(Cardiac Services)

Participants: All HA hospitals via Participants: All HA hospitals via CCLsCCLsMechanism: Prospective Comparative Mechanism: Prospective Comparative

AuditAuditAudit Period: 1 Jan 2003 Audit Period: 1 Jan 2003 –– 31 Dec 2005 31 Dec 2005

ObjectivesObjectivesAssess baseline characteristics of PCI procedures done Assess baseline characteristics of PCI procedures done in 2003in 2003--20052005

Compare crude/standardized mortality/complication Compare crude/standardized mortality/complication ratio among ratio among CCLsCCLs in HA hospitalsin HA hospitals

Identify preIdentify pre--intervention status/Cointervention status/Co--morbidity/Risk morbidity/Risk factors in relation to postfactors in relation to post--PCI mortality/complications PCI mortality/complications within 72 hourswithin 72 hours

Build a riskBuild a risk--adjusted model for postadjusted model for post--PCI PCI mortality/complicationsmortality/complications

Audit ToolsAudit Tools

PHCAPHCA’’ss audit formaudit formSupplemented bySupplemented by

Discharge summary Discharge summary ePRePR consultation note consultation note Laboratory resultsLaboratory resultsOnOn--site record check (randomly & site record check (randomly & on cases with major complications)on cases with major complications)

Audit Nurse Audit Nurse –– to ensure quality to ensure quality and completeness of dataand completeness of data

Baseline CharacteristicsBaseline Characteristics

234234279279

15021502

18891889

17961796

2204220429742974

34703470

29692969

No.No.20052005

5.05.05.95.9

32.032.0

40.340.3

38.338.3

47.047.063.463.4

73.973.9

63.363.3

%%

5.15.12522524.64.6180180Renal failureRenal failure8.48.44124127.67.6297297CVACVA

32.832.81604160432.132.112521252Previous PCIPrevious PCI

38.538.51882188236.936.914421442Age Age ≥≥ 7070

38.938.91903190339.839.815531553DMDM

52.552.52567256756.156.121912191Smoking historySmoking history65.665.63211321165.965.925732573HTHT

74.474.43639363973.573.528702870Male sexMale sex

76.176.13726372672.172.128152815HypercholesterolemiaHypercholesterolemia

%%No.No.%%No.No.2004200420032003

Case mixCase mix

Elective, 2975, 76.2%

ACS other than AMI, 678, 17.4%

Primary (for AMI), 152,

3.9%

Rescue (for AMI), 92,

2.4%

Unplanned redo PCI, 7,

0.2%

Elective, 3835, 78.4%

ACS other than AMI, 864, 17.7%

Primary (for AMI), 145,

3.0%

Rescue (for AMI), 44,

0.9%Unplanned redo PCI, 6,

0.1%

2003

(3904 cases)2004

(4894 cases)

Elective, 2584, 55.1%

ACS other than AMI,

1859, 39.6%

Primary (for AMI), 165,

3.5%

Rescue (for AMI), 85,

1.8%

2005

(4693 out of 4956 cases signed)

Severity of diseaseSeverity of disease

1 vessel attempted,

2664, 68.2%

2 vessels attempted,

1014, 26.0%

>2 vessels attempted, 226, 5.8%

1 vessel attempted,

3168, 64.7%

2 vessels attempted,

1349, 27.6%

>2 vessels attempted, 377, 7.7%

2003

(3904 cases)2004

(4894 cases)

1 vessel attempted,

3086, 65.9%

2 vessels attempted,

1307, 27.9%

>2 vessels attempted, 287, 6.1%

2005

(4680 cases)

(13 cases are excluded due to missing and invalid value)

Characteristics of the worst lesionCharacteristics of the worst lesion

Type B1, 806, 20.6%

Type A, 481, 12.3%

Type C, 1313, 33.6%

Type B2, 1304, 33.4%

Type B1, 1155, 23.6%

Type A, 440, 9.0%

Type C, 1672, 34.2%

Type B2, 1627, 33.2%

2003

(3904 cases)

2004

(4894 cases)Type B1,

1139, 24.3%

Type A, 239, 5.1%

Type C, 1438, 30.6%

Type B2, 1877, 40.0%

2005

(4693 cases)

Angiographic resultAngiographic result

46934693

126126

7777

44904490

No.No.

20052005

100.0100.0

2.72.7

1.61.6

95.795.7

%%

100.0100.048944894100.0100.039043904TotalTotal

2.92.91441443.53.5138138UnsuccessfulUnsuccessful

3.73.71821823.03.0115115Partially successfulPartially successful

93.393.34568456893.593.536513651SuccessfulSuccessful

%%No.No.%%No.No.

2004200420032003

Use of PCI devices/drugsUse of PCI devices/drugs

940940

151151

8080

4747

8181

77

3434

44034403

42104210

#case#case

20052005

20.020.0

3.23.2

1.71.7

1.01.0

1.71.7

0.10.1

0.70.7

93.893.8

89.789.7

%%

9.89.84784789.79.7379379Closure DeviceClosure Device

2.42.41161163.93.9154154GpGp 2b3a Inhibitor2b3a Inhibitor

2.22.21051051.71.76565IABP/CPSIABP/CPS

1.31.364641.51.55959ThrombectomyThrombectomy DeviceDevice

2.32.31111113.23.2123123Distal Protection DeviceDistal Protection Device

2.92.91431430.20.266DCADCA

1.11.155551.51.55959RotablatorRotablator

91.491.44472447281.881.831943194StentStent

91.191.14458445888.888.834683468BallonBallon

%%#case#case%%#case#case

2004200420032003

GENERNAL REPORTGENERNAL REPORT

81(1.73%)81(1.73%)

31(0.66%)31(0.66%)

12%12%

4,693*4,693*

20052005

95(1.94%)95(1.94%)

30(0.61%)30(0.61%)

12%12%

44,894,894

20042004

52(1.33%)52(1.33%)

23(0.59%)23(0.59%)

15%15%

33,904,904

20032003

1212--15%15%OnOn--site random site random checking checking

84(0.62%)84(0.62%)Total mortality Total mortality ((≤≤72 hours)72 hours)

228(1.69%)228(1.69%)Major Major complications complications reported reported (excluding death)(excluding death)((≤≤72 hours )72 hours )

13,49113,491Total no. of PCI Total no. of PCI cases performed cases performed in HA hospitalsin HA hospitals

20032003--55

*signed cases only (signed + unsigned cases = 4,965)

Major ComplicationsMajor Complicationson event basis in a total of 3904 , 4894, and 4693 cases for 200on event basis in a total of 3904 , 4894, and 4693 cases for 2003 , 3 , 2004, and 2005 respectively (direct and indirect procedure cause2004, and 2005 respectively (direct and indirect procedure causes s

included)included)

WorldWorld--wide %wide %

0.00.0

0.20.2

0.30.3

0.10.1

0.20.2

0.10.1

0.20.2

0.70.7

0.70.7

%%

11

1111

1212

44

88

44

1010

3131

3131

No.No.

20052005

Up to Up to 3%3%

0.10.1--2%2%

0.5%0.5%

1%1%

0.20.2--3%3%

0.40.4--3%3%

55--10%10%

0.50.5--1.41.4

0.00.0220.10.122Vascular Surgery or RepairVascular Surgery or Repair

0.30.314140.10.155Cardiac Cardiac TamponadeTamponade

0.20.210100.20.266BleedingBleeding

0.00.0220.00.000StrokeStroke

0.10.1660.30.31010Unplanned ReUnplanned Re--PCIPCI

0.10.1660.00.011Unplanned CABGUnplanned CABG

0.10.1550.20.277New QNew Q--wave MIwave MI

1.01.050500.50.52121New NonNew Non--Q MIQ MI

0.60.630300.60.62323DeathDeath

%%No.No.%%No. No.

2004200420032003

Complications :Complications :Patients with Primary PCI donePatients with Primary PCI done

00

11

11

22

11

00

11

00

1212

No.No.

20052005

00

0.60.6

0.60.6

1.21.2

0.60.6

00

0.60.6

00

7.37.3

%% (n=1(n=16565))

2004200420032003

00

0.70.7

0.70.7

00

1.41.4

00

0.70.7

0.70.7

7.67.6

%% (n=145)(n=145)

00

11

11

00

22

00

11

11

1111

No.No.

0000Vascular Surgery or RepairVascular Surgery or Repair

0000Cardiac Cardiac TamponadeTamponade

0000Bleeding with Bleeding with HbHb Drop Drop ≥≥ 3g/dl3g/dl

0000StrokeStroke

1.31.322Unplanned ReUnplanned Re--PCIPCI

0000Unplanned CABGUnplanned CABG

0000MIMI-- Q waveQ wave

0000MIMI--Non QNon Q

5.35.388DeathDeath

% (% (n=152)n=152)No.No.Major complicationsMajor complications

Complications: Complications: Patients with Patients with CardiogenicCardiogenic ShockShock

..

..

11

22

22

..

..

11

1818

No.No.

20052005

..

..

1.51.5

3.03.0

3.03.0

..

..

1.51.5

26.926.9

%% (n=(n=6767))

2004200420032003

..

4.74.7

3.13.1

..

..

..

..

1.61.6

21.921.9

%% (n=(n=6464))

..

33

22

..

..

..

..

11

1414

No.No.

....Vascular Surgery or RepairVascular Surgery or Repair

1.81.811Cardiac Cardiac TamponadeTamponade

....Bleeding with Bleeding with HbHb Drop Drop ≥≥ 3g/dl3g/dl

....StrokeStroke

....Unplanned ReUnplanned Re--PCIPCI

....Unplanned CABGUnplanned CABG

1.81.811MIMI-- Q waveQ wave

....MIMI--Non QNon Q

17.517.51010DeathDeath

% (% (n=n=5757))No.No.Major complicationsMajor complications

Crude and Standardized Crude and Standardized Mortality/Complication ratioMortality/Complication ratio

Comparison of crude and standardized Comparison of crude and standardized PostPost--PCI PCI mortalitymortality ratioratio,2003~05,2003~05

Standardized by Intercurrent Cardiogenic Shock and Primary PCI

after adjustmentbefore adjustment

Post

-PC

I mor

talit

y ra

tio

4.0

3.5

3.0

2.5

2.0

1.5

1.0

.5

0.0

Hospital variation was significantlyreduced after case mix adjustment

Hospital X

Crude and Standardized Ratio and 95% confidence intervalCrude and Standardized Ratio and 95% confidence intervalfor Postfor Post--PCI Mortality (Linear scale)PCI Mortality (Linear scale),2003~05,2003~05

Hospital

JIHGFEDCBA

7

6

5

4

3

2

1

0

-1

Upper limit

Lower limit

Crude ratio

Upper limit

Lower limit

Standardized ratio

After adjusting the case mix, there is no statistical difference between hospital performance against the overall norm

Comparison of crude and standardized Comparison of crude and standardized PostPost--PCI complication ratioPCI complication ratio,2003~05,2003~05

Standardized by Characteristic of worst lesion and

No. of Major Native Arteries with >=50% lesions

after adjustmentbefore adjustment

Post

-PC

I com

plic

atio

n ra

tio

1.4

1.2

1.0

.8

.6

.4

.2

Hospital X

Hospital variation wasreduced after case mix adjustment

Hospital

JIHGFEDCBA

2.5

2.0

1.5

1.0

.5

0.0

Upper limit

Lower limit

Crude ratio

Upper limit

Lower limit

Standardized ratio

Crude and Standardized Ratio and 95% confidence intervalCrude and Standardized Ratio and 95% confidence intervalfor Postfor Post--PCI PCI ComplicationsComplications (Linear scale)(Linear scale),2003~05,2003~05

After adjusting the case mix, there is still statistical difference between hospital performance against the overall norm butthe difference has been minimized

Potential risk factors for postPotential risk factors for post--PCI deathPCI death

FactorFactor pp--valuevalueAngina type Angina type p<0.01p<0.01MI MI p<0.01p<0.01Heart failureHeart failure p<0.01p<0.01VT/VFVT/VF p<0.01p<0.01EFEF p<0.01p<0.01CVACVA p=0.01p=0.01IndicationsIndications p<0.01p<0.01ThrombectomyThrombectomy device device p=0.01p=0.01IABP/CPSIABP/CPS p<0.01p<0.01Gp2b3a inhibitorsGp2b3a inhibitors p<0.01p<0.01Stress Test showing Reversible Ischemia Stress Test showing Reversible Ischemia p<0.05p<0.05AgeAge p<0.05p<0.05

Potential risk factors for complications Potential risk factors for complications (exclude death)(exclude death)

FactorFactor pp--valuevalueAngina typeAngina type p<0.01p<0.01Angiographic resultsAngiographic results p<0.01p<0.01ThrombectomyThrombectomy devicedevice p<0.01p<0.01IABP/CPSIABP/CPS p<0.01p<0.01Gp2b3a inhibitorsGp2b3a inhibitors p<0.01p<0.01Characteristic of worst Characteristic of worst leisonleison p<0.05p<0.05No of major arteries with >=50% No of major arteries with >=50% leisonsleisons p<0.05p<0.05IndicationsIndications p<0.05p<0.05

Variable excluded in logistic regression model for postVariable excluded in logistic regression model for post--operation mortality within 72 hoursoperation mortality within 72 hours

In order to maximize the use of death In order to maximize the use of death information in our data file, 3 explanatory information in our data file, 3 explanatory variables have to be excluded in regression variables have to be excluded in regression analysis even though they are significant analysis even though they are significant (p<0.25) in (p<0.25) in univariateunivariate analysisanalysis

Stress test:Stress test: 95.2% of total death cases (80 out of 84) 95.2% of total death cases (80 out of 84) from from ““Not doneNot done”” and and ““UnknownUnknown”” categories.categories.Ejection Fraction:Ejection Fraction: 3202 cases (23.7% of total 3202 cases (23.7% of total cases)with unknown EF. 14 (16.6% of total postcases)with unknown EF. 14 (16.6% of total post--PCI PCI death)of which are of postdeath)of which are of post--PCI mortality cases. PCI mortality cases. Hypercholesterolemia:Hypercholesterolemia: 18 death cases come from its 18 death cases come from its unknown category.(21.4% if total postunknown category.(21.4% if total post--PCI death)PCI death)

Notes for logistic regression model for postNotes for logistic regression model for post--operation operation complication within 72 hourscomplication within 72 hours

In order to maximize the use of complication In order to maximize the use of complication information in our data file, 2 explanatory information in our data file, 2 explanatory variables have to be excluded in regression variables have to be excluded in regression analysis even though they are significant analysis even though they are significant (p<0.25)in (p<0.25)in univariateunivariate analysisanalysis

Stress test:Stress test: 73.3% of total complication cases (154 73.3% of total complication cases (154 out of 210) from out of 210) from ““Not doneNot done”” and and ““UnknownUnknown””categories.categories.Ejection Fraction:Ejection Fraction: 3202 cases (23.7% of total cases) 3202 cases (23.7% of total cases) with unknown EF. 62 (29.5% of total postwith unknown EF. 62 (29.5% of total post--PCI PCI complication) of which are of postcomplication) of which are of post--PCI complication PCI complication cases. cases.

Logistic regression modelLogistic regression model

( ) ...XβXβXβαπ1

πLnLogit(Y) 332211 ++++=⎟⎟⎠

⎞⎜⎜⎝

⎛−

=

......

......

332211

2211

2211

1

,...)xX,xX ,xX|interest of outcome(yProbabilit

+++

+++

+=

=====

XX

XX

ee

Y

ββα

ββα

π

RiskRisk--adjusted (logistic regression) model for adjusted (logistic regression) model for postpost--PCI PCI mortality mortality within 72 hourswithin 72 hours

Odds RatioOdds Ratio pp--valuevalueUnstable AnginaUnstable Angina 7.37.3 0.00010.0001Procedures requiring IABP/CPSProcedures requiring IABP/CPS 5.85.8 <0.0001<0.0001CardiogenicCardiogenic ShockShock 4.84.8 <0.0001<0.0001HxHx of CVAof CVA 4.0 4.0 <0.0001<0.0001Sustained VT/VFSustained VT/VF 3.43.4 0.00040.0004Recent MI Recent MI ≤≤7 days7 days 3.13.1 0.00080.0008Unsuccessful Angiographic result 3.0Unsuccessful Angiographic result 3.0 0.00450.0045Renal FailureRenal Failure 2.92.9 0.00230.00232/3 vessel disease2/3 vessel disease 1.91.9 0.03450.0345

Receiver operating characteristic (ROC) curveReceiver operating characteristic (ROC) curveLogistic regression model for postLogistic regression model for post--PCI mortality PCI mortality

within 72 hourswithin 72 hours

Sensi t i vi t y

0. 0

0. 1

0. 2

0. 3

0. 4

0. 5

0. 6

0. 7

0. 8

0. 9

1. 0

1 - Speci f i ci t y

0. 0 0. 1 0. 2 0. 3 0. 4 0. 5 0. 6 0. 7 0. 8 0. 9 1. 0

The sharper the bend and the closer to the upper left corner, the

greater the accuracy of the model

C statistics=Area under the curve=0.945

A measure of the model’s ability to discriminate between those subjects who experience the outcome of interest versus those who do not

RiskRisk--adjusted (logistic regression) model for adjusted (logistic regression) model for postpost--PCI PCI complicationscomplications within 72 hourswithin 72 hours

Odds Ratio pOdds Ratio p--valuevalueProcedures requiring IABP/CPSProcedures requiring IABP/CPS 4.8 <0.00014.8 <0.0001Unsuccessful Angiographic result 3.9 <0.0001Unsuccessful Angiographic result 3.9 <0.0001Procedures requiring Procedures requiring GpIIb/IIIaGpIIb/IIIa 3.5 <0.00013.5 <0.0001

inhibitorsinhibitors>2 lesions attempted>2 lesions attempted 2.1 <0.00012.1 <0.0001HxHx of CVAof CVA 1.9 0.00261.9 0.0026Type B2/C lesionsType B2/C lesions 1.7 0.00741.7 0.0074Female sexFemale sex 1.5 0.0131.5 0.013

Receiver operating characteristic (ROC) curveReceiver operating characteristic (ROC) curveLogistic regression model for postLogistic regression model for post--PCI complication PCI complication

within 72 hourswithin 72 hours

Sensitivity

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

1 - Specificity

0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

C statistics=Area under the curve=0.720

ACCACC--NCDRNCDRRisk Adjustment Mortality ModelRisk Adjustment Mortality Model

Factors Factors assoasso. with increased risk of PCI mortality:. with increased risk of PCI mortality:Odds ratioOdds ratio

CardiogenicCardiogenic shockshock 8.498.49Increasing ageIncreasing age 2.612.61--11.2511.25Emergent salvageEmergent salvage 13.3813.38EmergentEmergent 5.755.75UrgentUrgent 1.781.78Decreased LVEFDecreased LVEF 0.870.87--3.933.93AMI AMI ≤≤24 hours24 hours 1.311.31DMDM 1.411.41Renal failureRenal failure 3.043.04COPDCOPD 1.331.33

Michigan PCI Mortality Prediction Michigan PCI Mortality Prediction ToolTool

Michigan PCI Mortality Prediction ToolMichigan PCI Mortality Prediction Tool

LongLong--term PCI Outcomesterm PCI Outcomes

1.62%1.62%

1.32%1.32%

0.66%0.66%

%%

7676

6262

3131

44,693,693

no.no.

20052005 20032003--552004200420032003

4545

4343

2323

33,904,904

no.no.

1.15%1.15%

1.10%1.10%

0.59%0.59%

%%

6262

5050

3030

44,894,894

no.no.

1.23%1.23%

1.02%1.02%

0.61%0.61%

%%

183183

155155

8484

13,49113,491

no.no.

0.90.9--2.9%2.9%1.15%1.15%InIn--hospital hospital mortalitymortality

11--3%3%

0.50.5--1.4%1.4%

WorldWorld--wide %wide %

1.36%1.36%3030--day day mortalitymortality

0.62%0.62%7272--hour hour mortalitymortality

Total no. Total no. of casesof cases

%%

LimitationsLimitations

No data on 6No data on 6--month redomonth redo--PCI for Target PCI for Target Lesion Revascularization (TLR)Lesion Revascularization (TLR)SelfSelf--reported casesreported cases2003 2003 –– a fulla full--time audit nurse to check time audit nurse to check data accuracydata accuracy20042004--5 5 –– a parta part--time audit nursetime audit nurse2006 onwards 2006 onwards –– data accuracy ensured by data accuracy ensured by individual institutionsindividual institutions

Way ForwardWay ForwardIndividual Individual CCLsCCLs responsible for data accuracyresponsible for data accuracy

A designated medical staff as point of contactA designated medical staff as point of contact

HalfHalf--yearly report feedback to individual yearly report feedback to individual CCLsCCLs

Collaborate with HI & IT TeamCollaborate with HI & IT Team

GRR for PCI reports integrating audit capability (All the 10 GRR for PCI reports integrating audit capability (All the 10 CCLsCCLsare using the GRR PCI reporting system since January 2005)are using the GRR PCI reporting system since January 2005)

Data Quality Data Quality –– crosscross--check with data warehouse e.g. death check with data warehouse e.g. death registry, LIS, MOEregistry, LIS, MOE

Continue HA territoryContinue HA territory--wide PCI audit to verify the riskwide PCI audit to verify the risk--adjusted adjusted modelmodel

Uphold the standard of PCI procedures performed in HA Uphold the standard of PCI procedures performed in HA hospitalshospitals

Interventional Cardiologists more willing to take up highInterventional Cardiologists more willing to take up high--risk risk casescases

Patients more wellPatients more well--informed of the risks of PCIinformed of the risks of PCI

AcknowledgementAcknowledgement

HK Public Hospital CardiologistsHK Public Hospital Cardiologists’’AssociationAssociationHA Central Committee (Cardiac Services)HA Central Committee (Cardiac Services)HAHO Statistics and Research SectionHAHO Statistics and Research SectionHAHO HI & IT TeamHAHO HI & IT TeamHAHO Clinical Effectiveness UnitHAHO Clinical Effectiveness Unit

Thank you !Thank you !