National CRM Database Future Directions. Francis Murgatroyd King s College Hospital, London

(1)

National CRM Database

Future Directions

Francis Murgatroyd

(2)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(3)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(4)

National Institute for Cardiovascular Outcomes Research

• Part of UCL

• Funded by government (but each audit has to apply via HQIP)

• Hosts all audits/registries of BCS affiliated groups

• Provides coordinated IT support, analysis, and structures for

governance, research, data handling

• Databases remain “property” of individual societies....

Audit

Lead Specialist Society

•Adult Cardiac Interventions

British Cardiovascular Intervention Society

•Adult Cardiac Surgery

Society for Cardiothoracic Surgery

•Cardiac Rhythm Management

Heart Rhythm UK

•Congenital Heart Disease

British Congenital Cardiac Association

•Heart Failure

British Society for Heart Failure

•MINAP

British Cardiovascular Society

• TAVI

British Cardiovascular Intervention Society

Society for Cardiothoracic Surgery

(5)

(6)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(7)

Why are the Databases Changing?

• Current Database is not Comprehensive

–

New and “new” devices: ILR, SQID

–

New and multiple leads

–

Complex device procedures (upgrades etc)

–

Surgical device procedures (not ablation)

–

Lead extraction

• Needs to be updated with futureproofing mechanism

–

PA monitor, leadless PM, ?neural stimulators

• Remove ambiguity & redundant data

• Improve audit aspects

–

Operators

(8)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(9)

How are the Databases Changing?

Example: “Intervention”

Old Dataset

• ALD. Atrial Lead Replacement

• APOS. Atrial Lead Repair/Reposition

• AREM. Atrial Lead Removal

• BiV. Upgrade to biventricular

• DREM. Dual Lead Removal

• DREP. Dual Lead Repair/Reposition

• GEXP. Generator Explant

• GN. Generator Replacement

• GNXLD. Upgrade From Single To Dual Chamber

• GN+LD. Generator + Lead

• ICD. Upgrade to ICD

• LD. Lead Replacement

• LOOP. Loop Recorder

• RPGEN. Generator Reposition

• SEXP. System Explant

• VLD. Ventricular Lead Replacement

• VPOS. Ventricular Lead Repair/Reposition

• VREM. Ventricular Lead Removal

• WREV. Wound Revision

New Dataset

• New pacemaker/ICD system - FIRST IMPLANT

• Generator change only

• New generator and lead revision/change

• Upgrade - increased functionality (to DDD, CRT, ICD)

• Downgrade - decreased functionality

• System explant

• Wound revision/generator resite/haematoma

• Lead intervention only

• Monitor procedure only

70%

20%

4%

(10)

How are the Databases Changing?

Example: “Pre Device Aetiology”

Old Dataset

A1. Unspecified B1. Unknown

B2. Conduction Tissue Fibrosis B3. Apparently Normal Heart C1. Ischaemic

C1A. Transient Ischaemia C2. Post Infarction C3. Post MI - 1 vessel CAD C4. Post MI - 2 vessel CAD C5. Post MI - 3 vessel CAD C6. Post MI

C7. Post multiple MI - 1 vessel CAD C8. Post multiple MI - 2 vessel CAD C9. Post multiple MI - 3 vessel CAD

C10. Post multiple MI - coronary anatomy unknown C11. No MI - 1 vessel CAD

C12. No MI - 2 vessel CAD C13. No MI - 3 vessel CAD C14. Ischaemic

D1. Congenital Unspecified

D1A. Congenital Conduction Defect Only D1B. Congenital Structural And Conduction Defect E1. Surgical Complication

E2. Surgical Therapeutic (Ablation) E3. Catheter Ablation - unspecified E3A. Catheter Ablation - complication E3B. Catheter Ablation - therapeutic E4. Drug Induced

F1. Carotid Sinus Syndrome F2. Vasovagal Syndrome F3. Orthostatic Hypotension G1. Cardiomyopathy - unspecified G1A. Cardiomyopathy - hypertrophic G1B. Cardiomyopathy - dilated G1C. Cardiomyopathy - RV dysplasia G2. Myocarditis

G3. Valvular heart disease G6. Endocarditis G7. Heart Transplant G8. Ionising Radiation H1. Idiopathic H2. Long QT syndrome H3. Other

H4. Hypertensive heart disease H5. Brugada syndrome

New Dataset

B3. Apparently normal heart C1. Ischaemic heart disease D1A. Congenital - conduction only D1B. Congenital - structural E1. Cardiac surgery E3. Catheter ablation

E4. Percutaneous structural cardiac intervention F1. Reflex - carotid sinus syndrome

F2. Reflex - vasovagal F4. Reflex - other

G1B. Cardiomyopathy - dilated G1A. Cardiomyopathy - hypertrophic

G1C. Cardiomyopathy - arrhythmogenic RV dysplasia G1D. Cardiomyopathy - amyloid

G1E. Cardiomyopathy - sarcoid

G1X. Cardiomyopathy - other (specify in comments) G6. Endocarditis

G2. Myocarditis

G3A. Valve disease - operated/intervened G3B. Valve disease - no intervention G7. Cardiac Transplant

H2. Channelopathy - long QT syndrome H5. Channelopathy - Brugada syndrome H9. Channelopathy - other (specify in comments) K1. Myotonic dystrophy

H3. Other (specify in comments) Z1. Unknown

(11)

How are the Databases Changing?

Changes to remove ambiguity, etc

Old Dataset

New Dataset

Pre device ECG

becomes

ECG indication for device

(added)

Atrial rhythm at implant

Generator pacing mode at discharge

AAI AAIR AAIR<=>DDDR AAIR>DDDR AAIsafeR AAI<=>DDD DDD DDDR DDI DDIR DDR DVI OOO VAT VDD VDDR VOO VVI VVIR

becomes

Maximum system capability

AAI(R) VVI(R) DDD(R) CRT-P ICD-VR ICD-DR CRT-D ICD-SQ

Monitor (passive device) None (e.g. lead only)

Why this generator eventually explanted

becomes

Reason for (current) generator change/removal

Why this lead eventually revised/changed,

removed

becomes

(Main) reason for lead revision/change/removal

Pacing procedure complications

Becomes

Acute complications (pre- or peri-discharge)

(12)

How are the Databases Changing?

Example: “Intervention”

Intervention

Procedure

for each component

Generator:

• New generator

• Replacement generator

• Additional generator

• Generator repositioned/revised/reconnected

• Generator unchanged

• Generator removed

• Monitor implant

• Monitor revision/resite

• Monitor explant

• No generator present

• New pacemaker/ICD system - FIRST IMPLANT

• Generator change only

• New generator and lead revision/change

• Upgrade - increased functionality (to DDD, CRT, ICD)

• Downgrade - decreased functionality

• System explant

• Wound revision/generator resite/haematoma

• Lead intervention only

• Monitor procedure only

RV Lead 1

• New RV lead

• Existing RV lead unaltered

• Additional RV lead

• RV lead replacement

• RV lead revision/reposition/reconnection

• RV lead removal

• No RV lead

(13)

How are the Databases Changing?

Device Dataset Flow

Lead Extraction

Demographics

Baseline Data

Aetiology, indication, LV function etc

Procedure

Date/time, Operators, Intervention etc

File Closure

Early

Complications

Late

Complications

RV Lead 1

Procedure,

Hardware. etc

Generator

Procedure,

Hardware. etc

DF Lead 1

Procedure,

Hardware. etc

RA Lead 1

Procedure,

Hardware. etc

LV Lead 1

Procedure,

Hardware. etc

(14)

EP/Ablation Dataset

• All EP procedures

–

Catheter-based diagnostic procedures

• EPS, VT stim, internal cardioversion

• not NIPS or CV via device

–

Catheter ablation

• Specific changes

–

Characterization of AF (twice)

–

Clarification of patient details (including ECG diagnosis)

–

Simplification of procedure details

–

Ablation sources updated

–

Mapping and steering technologies

• Separate section for AF ablation

• Outcomes

–

Early and ~ 3 months for all

–

PROMS for AF ablation

(15)

How are the Databases Changing?

EP Dataset Flow

Procedure

Date/time,

Operators

Intervention

Mapping & Steering techniques

Demographics

Baseline Data

Aetiology, indication, LV function etc

Early

Complications

Outcomes at

FU

PROMS

AF Ablation extras

LA size

Current AF status

Past & Current Drugs

Type of AF ablation, etc

(16)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(17)

What does my Centre Need to Do?

• _{Prepare for new dataset}

–

Direct entry (Lotus Notes)

• New online forms will be visible before 1/4/14

• Understand fields

• Establish GMC nos for all operators

–

Proprietary IT systems

• Put data manager to work urgently

–

3 rd

_{Part IT Providers}

• Should be aware of changes to dataset

• Discuss roadtesting & implementation

• Regular data monitoring meetings

• _{Ensure we have up to date contact details for data}

manager and clinical lead

(18)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(19)

What do I Need to Do?

• Understand the dataset

• Take responsibility for data entry for your

procedures

• Regular data monitoring meetings

• Register with BHRS if you want reports

(20)

Questions

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

(21)

How will Data be Reported?

• Reporting is not optional!

• BHRS must be proactive

–

Correct & meaningful data at the right time

• Centres given warning and feedback

–

What analyses will be done?

–

What have you submitted?

–

Data submission errors

• Responsibility of centres

• NICOR will not correct errors at request of individuals

• Timeline

–

1/9/13 Dataset finalized

–

Q4 2013 Operator registry, FAQs

–

1/4/14 new dataset mandatory

–

FY 14-15 procedure numbers (by centre, then by operator)

–

FY 15-16 start to report outcomes

• Self-reported complications etc

• Correlation with death reporting

• Correlation with repeat interventions (home and away)

(22)

How will Data be Reported?

Quarterly Report to Operator

Operator Quarterly Report 1/4/15

Dr Q Seuss, GMC No. 123456

Apr - Jun 2014

Jul - Sep 2014

Oct - Dec 2014

Jan - Mar 2015

UNITED MEGAHOSPITALS NHS TRUST

Pacemaker procedures

First implant

Scrubbed

2

3

0

0 Responsible

10

14

0

0 Other

Scrubbed

0

1

0

0 Responsible

6

5

0

0 ICD procedures

First implant

Scrubbed

4

3

0

0 Responsible

6

7

0

0 Other

Scrubbed

2

1

0

0 Responsible

2

0

0 CRT procedures

First implant

Scrubbed

6

7

0

0 Responsible

6

7

0

0 Other

Scrubbed

2

0

0 Responsible

2

3

0

0 NETHER WALLOP GENERAL HOSPITAL NHS TRUST

Pacemaker procedures First implant

Scrubbed

0

14

12 Responsible

0

14

12 Other

Scrubbed

0

4

5 Responsible

0

4

5 ICD procedures

First implant

Scrubbed

0

0 Responsible

0

0 Other

Scrubbed

0

0 Responsible

0

0 CRT procedures

First implant

Scrubbed

0

0 Responsible

0

0 Other

Scrubbed

0

(23)

Qus

CRM Dataset Changes

• What is NICOR, and what happened to CCAD?

• Why are the databases changing?

• What changes are being made?

• What does my centre need to do?

• What do I need to do?

• How will data be reported?