Interventional Registries

The Audit and Research Potential of the BCIS CCAD Registry

Peter F Ludman

NO CONFLICT OF INTEREST TO DECLARE

Audit: Background

• Clinical Governance– The systematic approach to maintaining and

improving the quality of patient care in a health system

• Recognisably high standards of care• Transparent responsibility and accountability

for those standards• A constant dynamic of improvement

Clinical Governance• Education and training

– continued professional development

• Clinical effectiveness– the appropriateness, efficacy, cost effectiveness and safety of different

therapies.

• Research and development– the application of new research findings into clinical practice and

guideline development.

• Openness– Poor practice can thrive if it occurs out of the scrutiny of peers, and

while openness is important, it must respect appropriate individual patient and practitioner confidentiality.

• Risk management– addressing and minimising risks to patients, physicians and

organisations.

• Clinical audit

Clinical Audit

• Greatest potential to assess quality of care

• Domains– Structure– Appropriateness– Process– Outcomes

SCTS

Aim:Harmonise datasetsDesign medical audit systemBased on principles of quality assuranceTo be used Nationally

BPEG

British Paediatric Cardiac Association

CCAD formed May 1996 DoH fundingPilot for 3 years

6 Specialist Groups

1999 onwards Funding viaNHS IA

Data Collection

• BCIS-CCAD dataset 5.5.6 (113 fields)

Spreadsheet csv file spec

CCAD Mechanism

Hospital 1

Hospital 2

Hospital 3

Hospital n

CCAD Server

encryption

Internetencryption

encryption

encryption

.

.

Central Cardiac Audit Database Domains

PCI MINAP Adult Surgery

Paedtrc

Surgery

Heart

Failure

EP

Pacing

ICD

Rehab Ambulance

audit

BCIS RCP SCTS BPCA BSH HRUK BACR / BHF

ASA

CCADNHS Central

Register

HeartValve registry

Central Cardiac Audit Database Domains

PCI MINAP Adult Surgery

Paedtrc

Surgery

Heart

Failure

EP

Pacing

ICD

Rehab Ambulance

audit

BCIS RCP SCTS BPCA BSH HRUK BACR / BHF

ASA

CCADNHS Central

Register

HeartValve registry

Procedure Specific AnalysisParticipation in CCAD

2009 data: Ludman

Total No. of Centres

Data to CCAD

Participation

England NHS 77 74 96%

Private 16 5 31%

Wales 3 3 100%

N Ireland 3 2 67%

Scotland NHS 7 6 86%

Private 1 0 0%

CCAD dataUK PCI data in CCAD as % of Reported Totals

0 50 100 150 200

LBH. London Bridge HospitalAEI. Royal Albert Edward InfirmaryRCH. Royal Cornwall HospitalRAD. John Radcliffe HospitalNHB. Royal Brompton HospitalERI. Royal infirmary of EdinburghWHC. Whipps Cross University HospitalWAL. Walsgrave HospitalAMG. Wycombe General HospitalSAN. Sandwell District General HospitalHHW. Wellington HospitalMPH. Taunton & SomersetLIN. Lincoln County HospitalLGI. Yorkshire Heart CentreWYT. Wythenshawe HospitalMRI. Manchester Royal InfirmaryBAS. Basildon HospitalBHH. Rochdale InfirmaryBHL. Liverpool Heart and Chest HospitalBOU. Royal Bournemouth GeneralCGH. Conquest HospitalCHN. Nottingham City HospitalDER. Derby Royal InfirmaryDGE. Eastbourne DGHFRM. Frimley Park HospitalGRL. Glenfield HospitalKGH. Kettering General HospitalKSX. Kent & Sussex HospitalNIN. Ninewells HospitalNTH. Northampton General HospitalQEB. Queen Elizabeth HospitalSCM. James Cook University HospitalSPH. St Peter's HospitalSTM. St Mary's HospitalUCL. University College HospitalVIC. Victoria HospitalWRC. Worcestershire Royal HospitalRDE. Royal Devon & Exeter HospitalLIS. Lister HospitalSTH. St Thomas' HospitalHH. Harefield HospitalBRD. Bradford Royal InfirmaryGJH. Golden Jubilee HospitalPAP. Papworth HospitalBHR. Royal Berkshire and Battle HospitalMAY. Mayday University HospitalPLY. Derriford HospitalWHH. William Harvey HospitalMOR. Morriston HospitalNHH. North Hampshire HospitalSTO. North Staffordshire HospitalWEX. Wexham Park HospitalUHW. University Hospital of WalesEBH. Birmingham Heartlands HospitalFRE. Freeman HospitalNGS. Northern General HospitalNOR. Norfolk & Norwich HospitalCHG. Cheltenham General HospitalCHH. Castle Hill HospitalTOR. Torbay HospitalDUD. City HospitalBRI. Bristol Royal InfirmaryHSC. Harley Street ClinicCLW. Glan Clwyd DGH TrustDVH. Darent Valley HospitalRSC. Royal Sussex County HospitalWDH. Dorset County HospitalWRG. Worthing HospitalWAT. Watford General HospitalSUN. Sunderland Royal HospitalFRY. Frenchay HospitalKCH. King's College HospitalPMS. The Great Western HospitalRFH. Royal Free HospitalNCR. New Cross HospitalSGH. Southampton General HospitalGEO. St George's HospitalHAM. Hammersmith HospitalRIA. Aberdeen Royal InfirmaryRVB. Royal Victoria HospitalBAL. Barts and the LondonQAP. Queen Alexandra HospitalNPH. Northwick Park HospitalCRG. Craigavon Area HospitalBAT. Royal United Hospital BathESU. East Surrey HospitalANT. St Anthony's HospitalPHB. BMI Priory HospitalAHM. BMI Alexandra HospitalBFT. Belfast City HospitalBMI. BMI Meriden HospitalCBS. BUPA Hospital SouthamptonCRO. Cromwell HospitalEAL. Ealing HospitalGWH. Queen Elizabeth Hospital,HAI. Hairmyres HospitalHBP. BUPA Hospital, Hull & East RidingIND. London Independent HospitalKMH. Kings Mill HospitalLEB. BUPA Hospital LeedsLNH. Leeds Nuffield HospitalMHO. Manor HospitalPHN. BMI Park HospitalRHH. Ross Hall HospitalYKC. Capio Yorkshire Clinic

2009 data: Ludman

As August 2010

CCAD dataUK PCI data in CCAD as % of Reported Totals

0 50 100 150 200

LBH. London Bridge HospitalAEI. Royal Albert Edward InfirmaryRCH. Royal Cornwall HospitalRAD. John Radcliffe HospitalNHB. Royal Brompton HospitalERI. Royal infirmary of EdinburghWHC. Whipps Cross University HospitalWAL. Walsgrave HospitalAMG. Wycombe General HospitalSAN. Sandwell District General HospitalHHW. Wellington HospitalMPH. Taunton & SomersetLIN. Lincoln County HospitalLGI. Yorkshire Heart CentreWYT. Wythenshawe HospitalMRI. Manchester Royal InfirmaryBAS. Basildon HospitalBHH. Rochdale InfirmaryBHL. Liverpool Heart and Chest HospitalBOU. Royal Bournemouth GeneralCGH. Conquest HospitalCHN. Nottingham City HospitalDER. Derby Royal InfirmaryDGE. Eastbourne DGHFRM. Frimley Park HospitalGRL. Glenfield HospitalKGH. Kettering General HospitalKSX. Kent & Sussex HospitalNIN. Ninewells HospitalNTH. Northampton General HospitalQEB. Queen Elizabeth HospitalSCM. James Cook University HospitalSPH. St Peter's HospitalSTM. St Mary's HospitalUCL. University College HospitalVIC. Victoria HospitalWRC. Worcestershire Royal HospitalRDE. Royal Devon & Exeter HospitalLIS. Lister HospitalSTH. St Thomas' HospitalHH. Harefield HospitalBRD. Bradford Royal InfirmaryGJH. Golden Jubilee HospitalPAP. Papworth HospitalBHR. Royal Berkshire and Battle HospitalMAY. Mayday University HospitalPLY. Derriford HospitalWHH. William Harvey HospitalMOR. Morriston HospitalNHH. North Hampshire HospitalSTO. North Staffordshire HospitalWEX. Wexham Park HospitalUHW. University Hospital of WalesEBH. Birmingham Heartlands HospitalFRE. Freeman HospitalNGS. Northern General HospitalNOR. Norfolk & Norwich HospitalCHG. Cheltenham General HospitalCHH. Castle Hill HospitalTOR. Torbay HospitalDUD. City HospitalBRI. Bristol Royal InfirmaryHSC. Harley Street ClinicCLW. Glan Clwyd DGH TrustDVH. Darent Valley HospitalRSC. Royal Sussex County HospitalWDH. Dorset County HospitalWRG. Worthing HospitalWAT. Watford General HospitalSUN. Sunderland Royal HospitalFRY. Frenchay HospitalKCH. King's College HospitalPMS. The Great Western HospitalRFH. Royal Free HospitalNCR. New Cross HospitalSGH. Southampton General HospitalGEO. St George's HospitalHAM. Hammersmith HospitalRIA. Aberdeen Royal InfirmaryRVB. Royal Victoria HospitalBAL. Barts and the LondonQAP. Queen Alexandra HospitalNPH. Northwick Park HospitalCRG. Craigavon Area HospitalBAT. Royal United Hospital BathESU. East Surrey HospitalANT. St Anthony's HospitalPHB. BMI Priory HospitalAHM. BMI Alexandra HospitalBFT. Belfast City HospitalBMI. BMI Meriden HospitalCBS. BUPA Hospital SouthamptonCRO. Cromwell HospitalEAL. Ealing HospitalGWH. Queen Elizabeth Hospital,HAI. Hairmyres HospitalHBP. BUPA Hospital, Hull & East RidingIND. London Independent HospitalKMH. Kings Mill HospitalLEB. BUPA Hospital LeedsLNH. Leeds Nuffield HospitalMHO. Manor HospitalPHN. BMI Park HospitalRHH. Ross Hall HospitalYKC. Capio Yorkshire Clinic

2009 data: Ludman

As August 2010

UK E&W (NHS)

Scotland

(NHS)

N. Ireland

PCIs 83,130 71,277 7,153 3,049

In CCAD 77,578 69,074 5,896 1,577

Missing 5,552 2,203 1,257 1,472

% Missing 6.7% 3.1% 17.6% 48.3%

% Completeness12 fields required for risk adjusted outcome NWQIP

Top score potential = 1200

2006 2007 2008 2009

Audit Potential

• Structure

• Appropriateness

• Process

• Outcome

Audit Potential

• Structure

• Appropriateness

• Process

• Outcome

No PPCI

PPCI day

PPCI 24/7

Angiography (76)

PCI (105)

No PPCI

PPCI day

PPCI 24/7

Angiography (76)

PCI (105)

Audit Potential

• Structure

• Appropriateness

• Process

• Outcome

Appropriateness

Primary PCI - ? Case selection% Cases over 80 (2009 data)

2009 data: Ludman

11.7%

Number of PPCI procedures

% o

f ca

ses

with

age

ove

r 80

yrs

Primary PCI - ? Case selection% Cases over 80 (2009 data)

2009 data: Ludman

11.7%

Number of PPCI procedures

% o

f ca

ses

with

age

ove

r 80

yrs

Appropriateness

73426

0%

20%

40%

60%

80%

100%

All Cases

2008 data: Ludman

Under analysis

Accepted asappropriate

Appropriateness

73426

40117

33309

0%

20%

40%

60%

80%

100%

All Cases Stable / Acute

2008 data: Ludman

Acute

Appropriateness

40117

33309

0%

20%

40%

60%

80%

100%

All Cases Stable / Acute

Of Stable Cases

0%

20%

40%

60%

80%

100%

CCS

4

3

2

1

0

UnK

2008 data: Ludman

Appropriateness

40117

33309

0%

20%

40%

60%

80%

100%

All Cases Stable / Acute

Of Stable Cases

0%

20%

40%

60%

80%

100%

CCS

4

3

2

1

0

UnK

2008 data: Ludman

Appropriateness

40117

Unk

33309

0%

20%

40%

60%

80%

100%

All Cases Stable /Acute

CCS

Of Stable of CCS 0 or 1

944

1887

910

1070

189

0%

20%

40%

60%

80%

100%

NonInvasive

3. MPI

2. ETT

1. Rest ECG

0. No

UnK

2008 data: Ludman

Appropriateness

40117

Unk

33309

0%

20%

40%

60%

80%

100%

All Cases Stable /Acute

CCS

Of Stable of CCS 0 or 1

944

1887

910

1070

189

0%

20%

40%

60%

80%

100%

NonInvasive

3. MPI

2. ETT

1. Rest ECG

0. No

UnK

2008 data: Ludman

Appropriateness

40117

Unk

33309

0%

20%

40%

60%

80%

100%

All Cases Stable /Acute

CCS Non Inva

Of Stable, CCS 0/1, no non invasive testing

93

2435

144

0%

20%

40%

60%

80%

100%

IVUS /

FFR

IVUS/FFR

Remainder

UnK

2008 data: Ludman

Appropriateness

40117

Unk

33309

0%

20%

40%

60%

80%

100%

All Cases Stable /Acute

CCS Non Inva

Of Stable, CCS 0/1, no non invasive testing

93

2435

144

0%

20%

40%

60%

80%

100%

IVUS /

FFR

IVUS/FFR

Remainder

UnK

2008 data: Ludman

Appropriateness

73426

40117

Unk

33309

0%

20%

40%

60%

80%

100%

AllCases

Stable /Acute

CCS Non Inv Invas

2008 data: Ludman

Number %

? Inappropriate 2435 3.3 %

Unknown 6587 8.8 %

• Stable• CCS 0/1• no non invasive testing• no invasive testing for ischaemia

Audit Potential

• Structure

• Appropriateness

• Process

• Outcome

Admitted fromthe community

Direct admissionto PCI centre

Transferto PCI centre

Admission toNon-PCI centre

Primary PCI

device

D1

D2

Primary PCIDirect and IHT: Call to Balloon times < 150 min

Number of Cases

% C

TB

< 1

50

min

2009 data: Ludman

75.3%

3 SD3 SD2 SD2 SD

Audit Potential

• Structure

• Appropriateness

• Process

• Outcome

All as % No. SuccessPartial

success

Fail no

compRe-PCI QMI

Em CABG

CVADeath

In hosp

Death

30/7 ONS

NSTEMI / UA no shock

26,555 92.9 2.3 4.0 0.3 0.2 0.09 0.07 0.56 1.3

All STEMI

no shock14,485 92.0 2.0 3.5 0.6 0.11 0.21 2.3 3.8

*Primary PCI 13,189 89.8 2.1 3.7 0.6 0.11 0.18 4.3 6.2

*Rescue PCI 1,695 92.0 1.6 2.4 0.9 0.12 0.7 4.0 5.8

Shock 1416 66.2 2.5 4.0 0.9 0.14 0.43 26.6 34.0

Outcome 20092009 data: Ludman

*all PPCI (includes shock / ventilation etc)

Primary PCI (includes shock/vent)

30 day ONS tracked Mortality 2009 data: Ludman

Number of PPCI procedures

% M

orta

lity

at 3

0 da

ys

6.2%

Shock andventilation INCLUDED

+3 σ+2 σ

-2 σ-3 σ

Observed MACCE

Predicted MACCE

NWQIP Model 2009 data: Ludman

Feedback to units

• Live view in Lotus Notes

• emailed reports

• Annual reports

National

PCI Unit

QEB

National

0.9%

2.0%

60% 35%

66% 55%

Delays ReportsMonthly

Cumulative FunnelsQuarterly

Audit Research

Audit Research

RegistryRCT

Randomised Control Trials

• Strengths– Randomisation– Ability to test hypotheses– Cause and effect conclusions– Precise and robust analysis

• Weakness– Focused entry criteria– costs limit patient number and FU duration

ESC STEMI Guidelines

13% based on RCTs

(Tricoci P JAMA 2009;301:831)

Euro Heart Survey

up to 89% wld be excluded from RCTs

(Hordijk_Trion M EHJ 2006;27:671)

Registry

• Strengths– Generalised entry

• full spectrum including high risk patients included– Population outcomes– Long follow up– Large numbers of patient assessed– Suited to Risk Modelling

• Weaknesses– Non randomised– Observational– Hypothesis generating (cause v effect uncertain)

SCAAR scare

? 32% Mortality

James S. EuroInt 2009;5:501

SCAAR scareJames S. EuroInt 2009;5:501

BCIS-CCADResearch Strategy

• NICOR– National Institute for Outcomes Research– Within the Institute of Cardiovascular Science at UCL– Links with Cardiovascular prevention unit– Newly appointed analyst

• UK research groups– Data governance framework– Data applications review group– 6 projects about to start, 2 await approval

Research: BCIS-CCAD

• Exploratory analyses

0 30/7 6/12 1 yrMortality: PCI Success 0.4% 0.9% 1.8%

Number at risk 2344 2331 2314 2292

Mortality: PCI failed 0.7% 2.1% 3.7%

Number at risk 1101 1089 1072 1054

Chronic Total Occlusions2008 Data with ONS track to May 2010

2009 data: Ludman

PCI Success

PCI Failure

0.6

0.9

0.5

0.97

0.43

1.1

0

0.2

0.4

0.6

0.8

1

1.2

Femoral Radial

% of all cases200720082009

2009 data: Ludman

Complication by Access routeComplications to hospital Dx:False aneurysmHaemorrhage (retroperitoneal, delay Dx, surgery)Art occlusion / dissectionAny need for surgery

0.09

0.06

0.1

0.06

0

0.05

0.1

0.15

0.2

Femoral Radial

% Cases with CVA

2008

2009

2009 data: Ludman

Complication by Access routeCVA

• Diabetes

44.642.7 44.4

16.1 14.9 15.6 15.8

45.5

0

5

10

15

20

25

30

35

40

45

50

2005 2006 2007 2008

Asian

European

Diabetes by Ethnicity2008 data: Ludman

27.1 27.9

0

5

10

15

20

25

30

BMI

AsianEuropean

• BMI

BMI by Ethnicity2008

2008 data: Ludman

• Diabetes

44.642.7 44.4

16.1 14.9 15.6 15.8

45.5

0

5

10

15

20

25

30

35

40

45

50

2005 2006 2007 2008

Asian

European

Diabetes by Ethnicity2008 data: Ludman

Outcomes from PCI in South Asians?

Risk Models

• Large unselected population• Validated mortality• Potential to cross link datasets

– MINAP: ACS / re-MI– SCTS: CABG– HES: re-admission

BUT ….

OutcomeData for 2007, 2008 and 2009 2009 data: Ludman

Risk Adjusted MACCE

Number of PCI procedures

% M

AC

CE

OutcomeData for 2007, 2008 and 2009 2009 data: Ludman

Risk Adjusted MACCE

Number of PCI procedures

% M

AC

CE

MOU

OutcomeData for 2007, 2008 and 2009 2009 data: Ludman

Risk Adjusted MACCE

Number of PCI procedures

% M

AC

CE

• Model out of date• Over report procedural risk• Under report adverse outcome

Cardiogenic Shock% Cases with shock by PCI unit

2009 data: Ludman Shock in 1.8% of cases (1416 of 77,660)

Cardiogenic Shock% Cases with shock by PCI unit

2009 data: Ludman Shock in 1.8% of cases (1416 of 77,660)

• Model out of dateRecalibrateNew model

• Over report procedural riskAvoid subjective measuresPeer review

• Under report adverse outcomeMortality only

Research:Current potential projects

• Outcomes– in South Asians– by access route– after CTO intervention

• HES v BCIS for revalidation• Variation in outcomes by unit

– Unit features (volume / organisation…)– Patient presentation and demographics

• Models for mortality after PCI

Conclusions

• Audit potential– Valuable contribution– Evolving analyses and feedback systems

• Research potential– Dataset quantity and quality improving– Huge potential for registry based investigation– Strategy

• NICOR• UK Research groups

The End