CCAD Training Manual Cardiac Rhythm Management (CRM) Version 1.0 A D Cunningham 19/3/2008 Introduction This manual is intended to assist users of the Notes Client version of the CCAD Cardiac Rhythm Management database. It is not intended to address issues relating to the web-based version of CRM. For further information on the web-based application, please contact CCAD at helpdesk@ccad.org.uk or 0846 300 6016 option 2. Contents Introduction..................................................................................................................................... 1 Contents......................................................................................................................................... 1 Getting Started ............................................................................................................................... 2 The Opening Splash Screen ............................................................................................................. 2 The Main CRM Screen...................................................................................................................... 2 Adding a New Patient ...........................................................................................................................3 Accessing Existing Patient Data.................................................................................................... 3 Devices: Pacemaker, ICD and CRT ................................................................................................ 4 Adding a new procedure.................................................................................................................. 4 Patient Details ........................................................................................................................................5 Procedure Details ...................................................................................................................................6 Indications for Implant .................................................................................................................... 9 CRT and ICD Devices....................................................................................................................... 9 Implant Procedure......................................................................................................................... 11 Generator Details........................................................................................................................... 12 Other Generator Fields for CRT and ICD Devices....................................................................14 Lead Details .........................................................................................................................................16 In Hospital ...........................................................................................................................................17 Editing procedure data ...................................................................................................................... 18 Device Follow-Up..........................................................................................................................19 Device or Lead Explant ...................................................................................................................... 21 File Closure / Death...................................................................................................................................22 Reports and Letters......................................................................................................................23 Available device reports ............................................................................................................23 Available device letters .............................................................................................................24 EPS/Ablation Procedures .................................................................................................................. 27 Patient Details ......................................................................................................................................27 Procedure Details .................................................................................................................................27 Indication for Intervention ........................................................................................................29 Procedure.................................................................................................................................29 Outcome (in hospital) .................................................................................................................... 30 Outcome (late) .....................................................................................................................................30 System Reports.............................................................................................................................31 PM/ICD Procedure Reports ............................................................................................................ 31 EPS/Ablation Reports..................................................................................................................... 34 -1- Training Manual Cardiac Rhythm Management (CRM) Getting Started TheOpeningSplashScreen This is important – PLEASE READ IT ! You MUST NOT disclose your password/PIN to any other users. If you do so, CCAD may suspend your access to the database without further warning! TheMainCRMScreen When you have logged in and cleared the splash screen, you will see patients in the right window, and a menu in the left window. Training Manual Cardiac Rhythm Management (CRM) Adding a New Patient In the main CRM view, click on _________ . A blank patient document will appear, and you can enter the patient details. Some fields are mandatory, e.g. Hospital Number. Some fields are desirable, and a prompt will ask you to try to enter this field. Please make every effort to get the data, but it is recognised that some data cannot be found, e.g. NHS Numbers and Postcodes1 for Overseas patients. You will still be able to save the record without these fields. Accessing Existing Patient Data You can double-click on a patient to reveal their demographic data: Click on the task bar (Edit Document) above the document if you want to edit the details: 1 The NHS provides pseudo-postcodes (beginning with ZZ99) for all overseas patients – if you do not know the correct one for the native country of the patient, use ZZ99 9ZZ as a general indicator that the patient is of overseas origin. -3- Training ManualCardiac Rhythm Management (CRM) Devices: Pacemaker, ICD and CRT Addinganewprocedure Select a patient record. Then click on and this menu will appear: Select Pacemaker/ICD if you want to enter a device record. This screen will appear: This screen has 3 sections: 1. Patient Details (top left section) 2. Procedure Details (top right section) 3. Procedure specific data (lower section, which has 3 tabbed sections) -4- Training Manual Cardiac Rhythm Management (CRM) PatientDetails The top left section, Patient Details, is completed automatically from the Demographics form, with the exception of two fields. Patient Status This field has possible values: 'Amenity' means a patient being treated in a private hospital but paid for by the NHS. The other options are self-explanatory. Consultant Responsible This field should be completed with the Consultant looking after the patient on this admission. This can be typed in free text or selected from a list of local staff members which is maintained in the Local Staff Database. -5- Training ManualCardiac Rhythm Management (CRM) ProcedureDetails The next (top right) section contains Procedure Details. Date The procedure date defaults to today's date, but it can be altered either by typing the date in or selecting from the Date Picker by clicking on the icon then selecting the date you require. Implanted at This field will automatically take the value of the hospital registering the implant. If the implant was carried out elsewhere, please enter that different hospital's name in this field. -6- Training Manual Cardiac Rhythm Management (CRM) Intervention The intervention type is usually either a new system (GN+LD) or a box change (GN). Please select the intervention being carried out from the dropdown list. Pacing mode Pacing mode is selected from the dropdown list. NB: Please record the final (intended or actual) programmed mode at discharge, not any temporary mode at the end of the procedure, which can sometimes be different. Operator 1 Like the Consultant field, this can be typed in or selected from the dropdown list. Operator 2 Like the Consultant field, this can be typed in or selected from the dropdown list. ICD Option If the device has high voltage defibrillation capability, click on on PLEASE DO NOT LEAVE THIS FIELD BLANK! Biventricular pacing option If the device can deliver cardiac resynchronisation therapy (CRT), click on otherwise click on PLEASE DO NOT LEAVE THIS FIELD BLANK! -7- otherwise click Training ManualCardiac Rhythm Management (CRM) The lower section of the form contains three tabbed sheets called: 1. Indications for Implant 2. Implant Procedure (detailed information on the implant) 3. In hospital (complications and discharge) -8- Training Manual Cardiac Rhythm Management (CRM) IndicationsforImplant You will be asked to fill in the following four fields: Date of first implant The Date of First Implant is very important – it tells us whether this is a new system or not. Please enter this field carefully. Symptom, ECG and Aetiology Please select the required value from the dropdown list. CRTandICDDevices If you select BiV pacing = Yes, then you must be registering either a CRT-P or CRT-D device. A further three fields will appear if you select this option: -9- - 10 - Baseline QRS duration Please enter the QRS duration in milliseconds. LV Function Please select from these options: NYHA Score The New York Heart Association dyspnoea score is a measure of how badly the patient is disabled by heart failure; the correct option must, if possible, be ascertained and entered. Indication for ICD If ICD Function = Yes, a further field will appear. This field is designed to record whether the implant follows NICE guidelines for Primary or Secondary prevention of sudden cardiac death, or is implanted for another indication. - 11 - Training Training Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) ImplantProcedure The Implant Procedure form opens at the generator page. It is also possible to enter details of up to four leads – two atrial2 leads and two ventricular3 leads. 2 3 Bi-atrial pacing is occasionally used to control atrial fibrillation. Bi-ventricular pacing is frequently used to improve ventricular synchronization, often for patients in heart failure. The LV lead is not actually located in the left ventricle, it is placed in the distal coronary sinus and the electric stimulation field effectively paces the left ventricle. - 12 - GeneratorDetails For a pacemaker4, the generator form looks like this: Manufacturer CCAD provides a list of current generator manufacturers. Select from this dropdown list. Model CCAD maintains a library of generator models, but it is impossible to keep this completely up to date. If the model you need is not in the list, you can enter it manually. The list only shows you devices for your chosen manufacturer and your selection of ICD and BiV options – so if you select Medtronic and you have selected a CRT-D device, the list will look like this: 4 If a CRT or ICD device is selected, further generator options will appear – see later pages. - 13 - Training Training Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) Serial Number For many models a standard serial number format is stored. If you enter a serial number with a different format you will be prompted to check that your data entry is correct. ‘A’ stands for ‘alphanumeric’, i.e. a letter. ‘N’ stands for a number. Site The generator site will usually be Pectoral Subcutaneous. Bradycardia Pacing On? Usually bradycardia pacing will be switched on at the end of the procedure. Pacing Mode This field records the INTENDED pacing mode at discharge, not any temporary mode at the end of the procedure. Low Rate The fallback pacing rate (in beats per minute [bpm]) for the device. Antitachycardia pacing On? If the device has antitachycardia (ATP) capability, record here whether it is switched on. - 14 - Lead Extraction Performed? Usually this will not be the case. Procedure Comments Free text comments. These will appear in the Procedure Report (see below). OtherGeneratorFieldsforCRTandICDDevices If ICD and/or BiV functionality is selected, more fields will appear: VT shock on? Will the device deliver a cardioverting shock when VT is sensed? Defib therapy on? Will the device deliver a defibrillating shock? Biventricular pacing on? Is resynchronization pacing enabled? AV delay (sensed) Delay between a sensed atrial event and a ventricular pacing stimulus. - 15 - Training ManualCardiac Rhythm Management (CRM) Training Manual Cardiac Rhythm Management (CRM) AV delay (paced) Delay between an atrial pacing stimulus and a ventricular pacing stimulus. Which ventricle paced first? Left, right or simultaneous? V-V delay If not simultaneous, what is the delay between the ventricles being paced? - 16 - LeadDetails The four lead detail forms are functionally identical. The RV lead form looks like this: Ventricular Lead Manufacturer Again select from the list of current manufacturers. Ventricular Lead Model Models for that manufacturer can be selected from the list. Ventricular Lead Serial Number Lead serial number will be compared to a known format if available, to assist in entering the serial number in the correct format. Ventricular Lead Site/Access This field specifies the vascular access and the endocardial or epicardial location of the lead tip. Ventricular Threshold Enter the ventricular pacing threshold (in Volts) and the pulse width (in ms) at which it was measured. - 17 - Training Training Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) R Wave Enter the R-wave amplitude (P-wave for atrial leads) in milli-Volts. Impedance Enter the lead impedance in Ohms. InHospital The post-procedure complications form looks like this: Procedure Complications Multiple in-hospital complications can be recorded by clicking the appropriate option. Additional Comments Additional comments can be entered as free text. - 18 - Editing procedure data In the main CRM view, click on the icon (to the left of a patient record). The associated procedure records will appear: In the example above, patient # 1088447 has two procedures – a first implant in 1998 and a generator replacement in 2005. Double-click on a procedure record to view the procedure. The record will open in lockdown (read-only) mode. Ifyouareauthorisedtodoso, you can click on the button and you can then edit the details. - 19 - Training Training Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) Device Follow-Up Select and open an implant record. Click on Follow Up: This screen will open: Previous follow-up records are shown in a list: Actions available are: - 20 - Enter New Follow-Up The follow-up form appears, and the date defaults to today’s date – but can be changed if you wish. Enter as much information as you wish in this form then click OK to save. Edit Last Follow-Up The most recent follow=up record will be displayed, and you can edit it and save your changes. Remove Last Follow-Up Click on this and you will be prompted to confirm that you wish to delete the most recent follow-up record. This cannot be undone so please ensure you really want to delete the record. - 21 - Training Training Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) Device or Lead Explant Select and open an implant record. Click on Explant: This screen will appear: Select which component you want to record as explanted (usually the generator), and enter the Date and Reason for Explant. Finally, save the record. In future CCAD will implement automatic prompting of explants when a new implant is registered; this facility is not yet ready. - 22 - File Closure / Death The patient’s file is closed for one of three reasons: Death Transfer to another hospital Lost to follow-up To record a file closure, select and open a patient record. Date Click on . This screen will open: Enter the date of file closure (the date of the event, such as the date the patent died, not the date you were informed of the event). Reason This drop down list allows you to specify whether the patient died, was transferred or was lost to follow-up. CAUTION: the entry B2. Death related to pacemaker implies that a device or lead malfunction directly contributed to the patient’s death. Only use this code if you are CERTAINthis is the case, as it may trigger an enquiry. - 23 - Training Manual Cardiac Rhythm Management (CRM) Reports and Letters The device database has a number of Reports and Letters available. When viewing an implant record, at the top of the record is a menu bar: Availabledevicereports The Reports menu looks like this: PM - Patient Passport This report creates the traditional format of registration document that the patient should carry with them at all times. PM – Patient Passport Credit Card (etc...) A new format of much smaller registration card which can be folded (where the red dotted line is shown) and inserted into a miniature self-laminating pouch 5. This is a very convenient size for patients. 5 Suitable self-laminating pouches (credit card size: 86x54mm) can be ordered from a number of suppliers, including bindingbazaar.com (product code 15C30010, 100 for £6.95 + VAT). If you wish to try some out, contact NPDB on 01505 612829 and we can send you a few samples. - 24 - Training Manual Cardiac Rhythm Management (CRM) PM Manufacturer Warranty This version of the report suppresses patient identifiers and is suitable for sending to the manufacturer(s) for warranty purposes. Availabledeviceletters The device letter menu shows two options: Letter Defaults These default values will determine what is printed on the letterhead. - 25 - Training ManualCardiac Rhythm Management (CRM) Pacing Implant Letter A dialog box will open to allow you to specify to whom the letter will be sent and from whom it will be written: Referrer Select GP or Consultant. A drop down list will appear from which you can select a value, or you can type in a Referrer Name. Signatory Select from the dropdown list or type in a value. - 26 - Training Training Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) The finished letter looks something like this, but can be customised/edited as it is an embedded Word document. - 27 - EPS/Ablation Procedures The CRM database can also store procedure information on Electrophysiology Studies6 (EPS) and Ablation Procedures 7. PatientDetails These are entered in the same way as for device implant patients (see page 3). ProcedureDetails Select a patient record. Then click on 6 7 and this menu will appear: Electrophysiology Studies (EPS) investigate the underlying cause of a patient’s heart rhythm disturbance – usually (but not always) a rapid heart rhythm (tachycardia). If a patent’s rhythm abnormality is amenable to catheter-delivered therapy, then Catheter Ablation may be performed. - 28 - Training ManualCardiac Rhythm Management (CRM) Training Manual Cardiac Rhythm Management (CRM) Select EPS Ablation. This screen will appear: Follow the instructions on page 5 to complete the Admin Status and Consultant Responsible field. The remaining sections relate to the specific procedure. They are: Indication for Intervention Procedure Outcome (in hospital) Outcome (late) There is also a facility to define and use User Defined Fields. Please contact the CCAD Helpdesk for more assistance with this feature. - 29 - IndicationforIntervention All fields are completed from drop down lists, apart from Baseline QRS duration, which should be entered in milliseconds. Indication for Intervention is a mandatory field. Procedure The procedure form contains the key detail for an ablation procedure. Crucial fields include Ablation Procedure(s) and Ablation Energy Source(s). The second part of the procedure form is shown below. - 30 - Training ManualCardiac Rhythm Management (CRM) Training Manual Cardiac Rhythm Management (CRM) Ablation Procedure Success must be entered for every procedure. Outcome(inhospital) Early complications are entered in this form: Outcome(late) Late events are entered here, if known: - 31 - System Reports PM/ICDProcedureReports In the left window are the standard reports. For PM/ICD these are shown to the right. The intention of these reports is self-explanatory. The Report section is open to user input. If any reports can be improved, or new reports could be added, please contact the CCAD Helpdesk. Some of the reports are described below. Data Completeness This view shows how good your hospital is at completing the most important data fields. UCL’s 2007 data shows generally good data completeness, but poor for BiV function (0% vs. 94% nationally) and Presenting ECG (69% vs. 93% nationally). - 32 - Training Training ManualCardiac Manual Rhythm Management (CRM) Cardiac Rhythm Management (CRM) Indications Indications for pacing can be viewed by Aetiology, Presenting ECG or Presenting Symptom. The Aetiology view is shown here. There if, of course, a huge difference in the aetiology of pacing (ICD=No) and ICD patients. ICD patients have predominantly ischaemic or myopathic aetiologies. For pacemaker patients the most common aetiology remains Conduction Tissue Fibrosis Procedure Types This view shows a breakdown of the type of procedures performed nationally by year. Pacing Mode The declining use of VVI mode and the increase of dual chamber pacing can be clearly seen. - 33 - Outcomes These views are still under development. - 34 - TrainingTraining Manual ManualCardiac Rhythm Management (CRM) Cardiac Rhythm Management (CRM) EPS/AblationReports Reports can be selected from the menu: Data Completeness This view shows how good your hospital is at completing the most important data fields. The upper section shows the national data. The lower section shows the data for your hospital. In this case UCL have data for 2007 and 2008. The national data covers 2002-2008. You can see, for instance, that UCL is better than average at recording NHS Number and Complications, but not as good at recording the patient’s arrhythmia or the procedure type. - 35 - Indications This view shows the national pattern of indications for EPS/ablation. Below is shown the 2007 aetiology for patients who were ablated. Most patients had apparently normal hearts. - 36 - Training Manual Cardiac Rhythm Management (CRM) Procedures by year (all) This view shows all procedures - their type, duration and success rate by year. For 2007, the most common procedure was AV nodal slow pathway ablation, with 92% success rate and average procedure time 81 minutes. Atrial flutter ablation had a 90% success rate and procedure time 107 minutes. Atrial fibrillation ablation has a lower success rate and a longer procedure time. - 37 -