National CRM Database Future Directions. Francis Murgatroyd King s College Hospital, London
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1 National CRM Database Future Directions Francis Murgatroyd King s College Hospital, London
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? How will data be reported?
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? How will data be reported?
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 Audit Adult Cardiac Interventions Adult Cardiac Surgery Cardiac Rhythm Management Congenital Heart Disease Heart Failure MINAP Lead Specialist Society British Cardiovascular Intervention Society Society for Cardiothoracic Surgery Heart Rhythm UK British Congenital Cardiac Association British Society for Heart Failure British Cardiovascular Society TAVI British Cardiovascular Intervention Society Society for Cardiothoracic Surgery Provides coordinated IT support, analysis, and structures for governance, research, data handling Databases remain property of individual societies...
5 Daily Mail
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? How will data be reported?
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 Outcomes
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? How will data be reported?
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% 6%
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) Late complications (discharge to 1 year)
12 How are the Databases Changing? Example: Intervention Intervention 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 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 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 RA Lead 1, LV Lead 1, etc
13 How are the Databases Changing? Device Dataset Flow Demographics Baseline Data Aetiology, indication, LV function etc Procedure Date/time, Operators, Intervention etc Generator Procedure, Hardware. etc RV Lead 1 Procedure, Hardware. etc RA Lead 1 Procedure, Hardware. etc LV Lead 1 Procedure, Hardware. etc DF Lead 1 Procedure, Hardware. etc RV Lead 2 RA Lead 2 LV Lead 2 DF Lead 2 Lead Extraction Early Complications Late Complications File Closure
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 Demographics Baseline Data Aetiology, indication, LV function etc Procedure Date/time, Operators Intervention Mapping & Steering techniques AF Ablation extras LA size Current AF status Past & Current Drugs Type of AF ablation, etc Early Complications Outcomes at FU PROMS
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? How will data be reported?
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? How will data be reported?
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 Assume that all data will be public one day
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? How will data be reported?
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 Q Operator registry, FAQs 1/4/14 new dataset mandatory FY procedure numbers (by centre, then by operator) FY start to report outcomes Self-reported complications etc Correlation with death reporting Correlation with repeat interventions (home and away) Correlation with HES data
22 How will Data be Reported? Quarterly Report to Operator Operator Quarterly Report 1/4/15 Dr Q Seuss, GMC No Apr - Jun 2014 Jul - Sep 2014 Oct - Dec 2014 Jan - Mar 2015 UNITED MEGAHOSPITALS NHS TRUST Pacemaker procedures First implant Scrubbed Responsible Other Scrubbed Responsible ICD procedures First implant Scrubbed Responsible Other Scrubbed Responsible CRT procedures First implant Scrubbed Responsible Other Scrubbed Responsible NETHER WALLOP GENERAL HOSPITAL NHS TRUST Pacemaker procedures First implant Scrubbed Responsible Other Scrubbed Responsible ICD procedures First implant Scrubbed Responsible Other Scrubbed Responsible CRT procedures First implant Scrubbed Responsible Other Scrubbed Responsible
23 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? Qus How will data be reported? QUESTIONS?
CCAD Training Manual. Cardiac Rhythm Management (CRM)
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