17/06/2018. None. Author/s: Andrea Taylor Date of issue: 17 June 2015

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1 Clinical Guideline Norfolk and Norwich University Hospitals (including the For Use in: Pacing and ICD satellite service at the James Paget Hospital) For use by Doctors, Nurses and other health care By: professionals within the NNUH All patients with implanted devices for the management of cardiac conditions including pacemakers, Implantable For: Cardioverter Defibrillators (ICD) and Cardiac Resynchronisation Therapy (CRT) devices including Implantable Loop Recorders (ILR). Division responsible for Medical / Surgical document: Pacemaker, ICD, CRT, ILR, Biventricular, Defibrillator, Key words: Radiotherapy Name of document author: Andrea Taylor Job title of document author: Lead Physiologist - Cardiac Rhythm Management Name of document author s Charles Graham Line Manager: Job title of author s Line Head of Technical Cardiology Manager: Charles Graham Head of Technical Cardiology Supported by: Dr Ian Williams, Lead Consultant Cardiologist for Devices Assessed and approved by the: Date of approval: 17/06/2015 Ratified by or reported as approved to (if applicable): To be reviewed before: This document remains current after this date but will be under review To be reviewed by: Reference and / or Trust Docs ID No: 7870 Version No: 2 Description of changes: Compliance links: (is there any NICE related to guidance) If Yes - does the strategy/policy deviate from the recommendations of NICE? If so why? Clinical Guidelines Assessment Panel (CGAP) Professional Protocols, Policies & Guidelines Committee (PPPG) 17/06/2015 Clinical Standards Group and Effectiveness Sub-board 17/06/2018 Andrea Taylor Lead Physiologist Amendments to the user of the document None Copy of complete document available from: Trust Intranet Page 1 of 15

2 Quick Reference Guideline/s Patients with all Implanted Cardiac Devices covering Implantable Cardioverter Defibrillators (ICDs), Cardiac Resynchronisation Therapy (CRT), Cardiac Pacemakers and Implanted Loop Recorders (ILR). Objective/s Patients admitted acutely to the NNUH with Implanted Cardiac Devices. Contact on-call cardiac physiologist for advice (out of hours) or the Pacemaker/ICD service (in hours) when patients with the above devices present with cardiac symptoms or in a clinical setting which may lead to consideration that the complex device would need analysis by a cardiac physiologist. For use by Doctors, Nurses and other health care professionals within the NNUH. Conflict with front sheet This guideline is to facilitate timely and appropriate clinical assessment, decisions and therapy for patients with implanted cardiac devices within NNUH, in line with ongoing advances in device therapy and practice. Rationale ICDs, CRTs, ILRs and Pacemakers are complex devices and need detailed management. They are implanted in patients following careful assessment by teams led by Consultant Cardiologists and require continued regular monitoring and follow up in the outpatient setting. This extends to the out-of-hours situation in patients requiring more urgent assessment and/or reprogramming as appropriate. Some medical or surgical interventions may impact on device function, and useful information can sometimes be obtained from devices to guide clinical management. Broad Recommendations When these patients present acutely to the hospital it is important that the cardiac physiologist is contacted in an appropriately timely manner for device assessment (if deemed appropriate by a Cardiologist (or one of his / her medical team)). Copy of complete document available from: Trust Intranet Page 2 of 15

3 The Implanting Centre Implantable Cardioverter Defibrillators (ICD) / Cardiac Resynchronisation Therapy (CRT) centres must have access to Echocardiography for accurate ejection fraction and dyssynchrony measurements Angiography Electrophysiology studies Revascularisation services such as Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Revascularisation (PCR) service. Anaesthetic support for sedation and general anaesthesia Cardiac CT and/or MRI Arrangements for 24-hour cover should be in place for all device patients. Where possible, the on-call service should not be used to cover elective radiotherapy and surgical procedures. Follow-up must be performed at nationally accepted intervals (within 2 months of implantation) and then 6-12 monthly for bradycardia pacing and 3-6 monthly for CRT and ICD therapy). Implanting centres are expected to develop the role of cardiac arrhythmia nurses as part of the Cardiac Rhythm Management (CRM) team at an appropriate (and sustainable) level as recommended in National Service Framework on Coronary Heart Disease, Chapter 8 focusing on Arrhythmias and Sudden Cardiac Death. There is currently not an inpatient follow up service at the James Paget Hospital. Copy of complete document available from: Trust Intranet Page 3 of 15

4 Implant Procedure Bradycardia device implants can be performed by any suitably experienced cardiac physiologist (after a minimum number of implants have been completed) either under the direct supervision of the operating physician alone, and/or a Band 7 physiologist (staff description and qualifications can be found in Appendix A) who may be remote to the lab, but onsite and immediately available. Trainee physiologists can perform bradycardia implants under direct supervision from a cardiac physiologist within the lab itself. This extends to and includes the implantation of CRT-P devices. ICD Implants should be performed by a Band 7 cardiac physiologist although this does not exclude the observation of, and participation by, junior cardiac physiologists and trainee cardiac physiologists. In the absence of a Band 7 cardiac physiologist, then a suitably experienced qualified cardiac physiologist may undertake an ICD implantation with company technical support, under the guidance of the implanting physician. Generator Change Procedure Listing a patient for generator change requires the signature of two qualified pacing physiologists. Forms not signed by two physiologists should be returned by the waiting list team. For patients who are listed for a generator change who are prescribed anticoagulation therapy, these patients should be discussed at the weekly MDT meeting. This is to ascertain whether this is required to be stopped and for how long. Out of Hours on-call Service A 24 hours/day, 7days/week cardiac physiologist cover is provided to cover all provisions of out of hours emergencies relating to patients with implanted cardiac devices. The On-call physiologist should not be called unless deemed necessary by one of the cardiology physicians in order to minimise inappropriate use of the on-call service. The on-call cardiac physiologist does not cover the James Paget Hospital and cannot be called directly by their consultants. Copy of complete document available from: Trust Intranet Page 4 of 15

5 Implanted Devices Follow-up Clinic Objectives: There is a clearly defined protocol documenting the lines of communication and support between the Lead Cardiac Physiologist for the ICD and CRT follow-up service and the Consultant Cardiologist responsible for the onsite service to ensure that clinical governance requirements are met. Identification of the device and leads from the patient records. To monitor the device implant site and manage any risk of infection. A wound inspection should take place at every clinic visit. Initial interrogation of the device and recording of any relevant information. Recorded patient rhythm data at the beginning and throughout the follow up. Device checks battery, lead impedance, pacing thresholds and sensitivity values must be obtained in line with BHRS guidelines. If relevant, clear documentation as to why data is not collected must be made in the notes. Assessment of device battery status and comparison with previous records. To assess battery status to predict end of life (EOL) of the pulse generator in order to permit timely elective generator replacement. Safe testing of device and lead status including thresholds for sensing and capture as well as impedance measurements. Non-collection of data must be documented and a reason clearly stated. Obtain all sensitivity measurements (including the use of VVI 30bpm if required). Pacing thresholds should be performed at heart rates suitably above baseline to ensure pacing, not fusion or competitive rhythm, using a mode suited to the implanted rhythm. Assessment of diagnostics, events and appropriate counters/histograms for rate assessment and appropriate function. Appropriate reprogramming of the device to ensure that optimal settings for clinical outcomes are provided for the patient. To optimise the pacing system to the individual patient needs whilst maximising generator life. Safety must be paramount whilst manufacturer, MHRA and BHRS recommendations should be complied with. To identify any abnormalities in the pacemaker system and complications of the therapy in order to ensure prompt treatment. Staff leading the clinic must be able to recognise problems and complications and make the appropriate changes or recommendations. To be aware of the need to identify clinical problems and refer patients for immediate or deferred medical care appropriately in line with local policy. To provide accurate and complete communication about patient-device interaction. Ensuring that device registration has been undertaken and that all patients have their registration/id cards and all appropriate information To provide patient and family support and education. Copy of complete document available from: Trust Intranet Page 5 of 15

6 Management of Implantable Cardiac Devices Including Pacemakers, ICDs, Checking final settings and ensuring that any changes have been fully and appropriately documented and checked to ensure patient safety. Appropriate scheduling of the next appointment or referral Respond to any special request e.g. physician request for specific data, such as arrhythmia burden. To then appropriately report such information to the requester. Communication with cardiologists, heart failure team and general practitioners as indicated. Data recording in a form which can be transferred to another centre and submitted to NICOR (CCAD) (where appropriate). To maximise clinical safety and efficiency in line with clinical governance requirements. To notify the MHRA and manufacturer of any problems arising with devices or leads. Access to specialised services for CRT optimisation when required. Access to specialised electrophysiology services for management of atrial and ventricular arrhythmias when required. Reports 1 A report is generated by cardiac physiologists in charge of the follow-up clinic and all parameters and clinical details are documented in department s database and/or the patient's pacemaker notes. 2 3 A copy of the report or a letter is sent to the patient s general practitioner (GP) and the referring hospital where appropriate. Copy of complete document available from: Trust Intranet Page 6 of 15

7 Perioperative Management Surgical patients with implanted devices do not always require a routine pre and post op pacemaker check. For elective surgery, if a pacemaker / ICD check is indicated, the Cardiac Rhythm Management team require at least 48 hrs notice. For areas who pre-assess their patients on the day of their procedure, there is a high possibly that a procedure would need to be postponed as insufficient notice has been given. There may not be a member of staff available to perform device check/deactivation. Prior to surgery the anaesthetist and surgeon involved should discuss the implications of the patient having an implanted pacemaker/icd. Where surgical diathermy/electrocautery cannot be avoided, the surgical team should contact the patient s cardiac follow-up centre for advice. Wards and theatres should be advised that elective cases should occur as early on the theatre list as possible, so as to stay within the normal working day. An elective complex case should not start at a time where the end is estimated to exceed 17:00hrs. The on-call device service should not be used to cover elective cases, and is for emergencies only. Where elective surgery is taking place in a different non-implanting centre remote to the pacemaker/icd follow up centre, advice should be gained in advance of patient admission to that hospital, and not on the day of procedure. If this is in a centre remote from the Norfolk and Norwich University NHS Trust, then the admitting centre must consult their on-call Cardiologist, in the absence of a Pacemaker or ICD Service. There is no ICD management service at the James Paget Hospital or Cromer Hospital. The patient s follow-up clinic should be contacted to advise to what extent support may be required from a cardiac pacing/icd physiologist before, during and/or after the surgical procedure to: Confirm the correct functioning of the pacemaker/icd and to check the condition of the battery and leads etc. prior to surgery. Advise if adjustments to sensing/pacing parameters are required (the majority of devices will not require changes prior to or after surgery). Programme an ICD prior to surgery to a monitor only mode to prevent inappropriate therapy/shock delivery. Programme a pacemaker to avoid or minimise inappropriate inhibition, or high rate pacing through the tracking of electrical interference, where there is a degree of pacemaker dependency. Copy of complete document available from: Trust Intranet Page 7 of 15

8 Consider programming rate response function to off in those devices that use minute ventilation sensors, if artificial ventilation will be used i.e. during general anaesthesia. Where the use of monopolar diathermy/electrocautery is unavoidable limit its use to short bursts. Ensure that the return electrode is anatomically positioned so that the current vector pathway between the diathermy electrode and return electrode is away from the pacemaker/defibrillator (and leads). ICD patients DO need the device deactivated in procedures using diathermy but do not need complete formal checks pre and post op, or deactivation in procedures not producing electrical noise. Copy of complete document available from: Trust Intranet Page 8 of 15

9 Radiotherapy Management Depending on the intended length of treatment, the frequency of checks will vary. A device check is required prior to the course of therapy, as it is following the completion of therapy. Checks are also required throughout the treatment, although the frequency of this is subjective and must be assessed by a cardiac physiologist who meets the lead cardiac physiologist role as outlined in appendix A. For example, patients who are pacing dependent (100% Paced rhythm) may require a check after each therapy. They do not require a check before each therapy. For non-pacing dependent patients, a device check post alternate therapies is sufficient. In situations where the radiotherapy target site is in very close proximity to the device, pre and post checks should be performed on each therapy. Close proximity is defined as the radiation source being less than 15cm from the pacemaker site. Therapeutic radiotherapy doses must not exceed 2Gy/minute as this level of dosing is more likely to cause device failure (total dose should not exceed 100Gy). Copy of complete document available from: Trust Intranet Page 9 of 15

10 Deactivation of ICDs at End of Life Guidelines on End of Life Issues Surrounding Deactivation of Implantable Cardioverter Defibrillators (ICDs) Appropriate discussion with patients and families regarding implications of disabling defibrillation therapies at end of life should take place as early as possible. It may be possible to include this in the initial consent process, and can be raised at patient support and education groups. The indicators described below should be used as a trigger for such discussions and decisions with the patient. It must be emphasized that disabling therapies in itself will not accelerate any deterioration in health, and is not an irreversible decision should the clinical picture change. Normal bradycardia pacing functions will not be affected by device deactivation. Information regarding the patient s device (type and model) should in all circumstances be communicated to their GP at time of implant by the centre that inserted the device. The centre that the patient attends for routine device follow-up will hold the responsibility for deactivating or arranging for deactivation of the device. Under usual circumstances, this will be the implanting centre, even if the follow-up clinic is a local satellite clinic. If the patient is geographically closer to another hospital with an active ICD follow-up service, it will still remain the responsibility of the follow-up centre to arrange for deactivation themselves or by direct communication with that hospital. For patients who have recently moved into an area, the service providing their follow-up is responsible for referring them onto their new local centre. Patients who have a preferred place of care (PPC) document should have all relevant device details clearly recorded within the document. This provides a valuable communication tool between the patient and all health care professionals involved in their care. In instances of deactivation, the request form (Appendix B) should be completed by the clinician in charge and accompany the patient in order for deactivation to be carried out. Where deactivation occurs in hospital, the request and rationale should be documented in the hospital record by the consultant currently responsible for the patient s care. Communication is essential between all relevant health care professionals managing a patient s care, so all are informed of decisions made regarding the deactivation of the ICD. Training and resources should be implemented to provide effective management of patients who are nearing end of life and require deactivation of their ICD. It must be documented if Cardiac Physiologists are required to attend a patient s home for deactivation. Copy of complete document available from: Trust Intranet Page 10 of 15

11 Indications for the deactivation of an ICD 1. DNAR order in place 2. Patient death is expected 3. Continued activation of ICD is futile in management of intractable ventricular arrhythmias 4. Withdrawal of anti-arrhythmic medications, (within the context of a patient nearing the end of life where such treatment is now deemed inappropriate) 5. Use of ICD is inconsistent with planned patient care 6. Diagnosis of a terminal malignancy where only palliative therapy is planned Communication between all health care professionals managing a patient s care is paramount and should ensure all are informed of decisions made regarding the deactivation of their ICD. Planned deactivation Patients should be expected to have a planned deactivation procedure carried out in their centre on a day case basis. This planned pathway should be followed for the majority of patients requiring deactivation. If a patient is unable to travel, arrangements can be made to have a device deactivated in their place of residence or Preferred Place of Care (PPC). Please see Appendix B Copy of complete document available from: Trust Intranet Page 11 of 15

12 Audit and Clinical Governance Device therapy is subject to immediate and long-term complications therefore there are advisories and safety notices from manufacturers and MHRA which necessitate timely action. The lead physiologist should be notified by either the MHRA either directly, or through the NHS Trusts nominated representative. All implanting centres must collect data on their patients, devices and follow-up which is immediately available to facilitate audit. All implanting centres must contribute accurate and timely implant data electronically to the National Pacemaker & ICD Database. This is a national quality requirement and is audited by the Care Quality Commission. Data from all local centres on indications for implantation, early and late complications should be presented annually at Network arrhythmia group meetings. The department will hold audit and clinical review meetings a minimum of four times annually. This will allow the continuous assessment and promote consistencies in follow up practices between the departments. This will be led by the lead cardiac physiologist or a nominated physiologist in their absence. Consultation Process All senior cardiac physiologists, the principle cardiac physiologist and lead consultant cardiologist were all asked for their opinions and comments on this protocol, all of which were considered and integrated into this document where possible. Dr Ian Williams, consultant cardiologist and the lead consultant for device therapy was consulted, and changes/recommendations made following his input accordingly. Jenny Tomes, the Head of Radiotherapy, senior therapeutic radiographers and medical physics department were consultant for their advice on the radiotherapy management section. Copy of complete document available from: Trust Intranet Page 12 of 15

13 Appendix A Staffing: Qualifications and Training Appendix The clinic should be manned with two staff, one of who meets the lead role competencies outlined below. The Second staff member can be either another qualified cardiac physiologist or be undergoing training in cardiac physiology. The associate practitioner must not be considered the 2 nd person in clinic with any physiologist graded lower than Band 7 unless the Band 6 physiologist has BHRS/IBHRE accreditation. They may assist in clinic with preparing the patient for a check and the documentation Lead Cardiac Physiologist A qualified Cardiac Physiologist (BSc Clinical Physiology or equivalent). Evidence of post-graduate training in CRM techniques, e.g. holds appropriate Certification of Accreditation HRUK or IBHRE. Hold current ILS or ALS accreditation. Evidence of Continual Professional Development (CPD) in CRM. Perform minimum of 100 bradycardia pacemaker system follow-up review procedures per year. Attend local implant centre regularly and not less than twice per annum to remain familiar with evolving technology (CP s leading Follow-Up Clinic at non implant hospitals). Demonstrate high level of understanding and knowledge of the full range of diagnostic cardiac investigations. Cardiac Physiologist A qualified Cardiac Physiologist (BSc Clinical Physiology or equivalent). Performs a minimum of 35 new implant/year this number includes both brady and complex implants inclusively. Holds current ILS accreditation. Has a proven understanding of bradycardia pacemaker implant procedures. Has a proven knowledge of bradycardia pacemaker technology. Has current CPD by attending relevant recognised training study days. Copy of complete document available from: Trust Intranet Page 13 of 15

14 Appendix B Request for deactivation of Implantable Cardioverter Defibrillator Patient s name:... Date of birth (dd/mm/yyyy):... Address : Telephone number:... GP name:... GP address: GP telephone:... DNAR completed:... Reason for request: Signature of GP or lead Consultant:... Print name:. Signature of patient or legal next of kin:... Print name: Signature of health care professional deactivating the device:... Print name:. Date and time of deactivation:... Detail of settings left active on the ICD: Copies should be sent to GP, key healthcare professionals and follow-up centre Appendix C Copy of complete document available from: Trust Intranet Page 14 of 15

15 Introduction End of life care continues to be a priority for the Government, evidenced by commitments in the White Paper, Our Health, Our Care, Our Say and the recently published A Framework for Action by Healthcare for London. The British Heart Foundation have also recently published a discussion document for health care professionals which provides further support of these guidelines and their importance in end of life care. When implementing these guidelines it will be essential to communicate and link with all key stakeholders involved in the patients care surrounding the deactivation of their ICD. These will include: GP s, cardiac physiologists, heart failure teams, A&E staff, out of Hours services, Ambulance Service, community matrons and district nurses, palliative care teams. As patients with ICDs are approaching the end of their life, it is important that sensitive discussions are had with them and their family/carers around the deactivation of the device. These conversations are often best carried out by the health care professional best known to them; this may not necessarily be the GP or Cardiologist. These discussions frequently do not occur at the time the device is implanted as this is often considered an inappropriate time when the therapy is being instituted with the goal of lengthening life. However, many clinicians currently support the need for early discussions to be had. When any device is inserted the patients GP should be informed of the type and functionality of the device. The patient should also be provided with this information for future reference. It should be remembered by all involved and explained fully to the patient and family/carers that in most instances the disabling of the device will not change the time and course of the illness or alter the ultimate outcome. The patient and carers should be informed that turning off the ICD will be painless and not result in immediate death. Do Not Attempt Resuscitation (DNAR) documentation needs to be fully completed and kept with the patient at all times to ensure no inappropriate treatment is initiated out of hours once deactivation is carried out. With patients suffering from intrinsic cardiac disease or dying of another unrelated disease having had a device implanted, the appropriateness of continuing the device as a defibrillator may not be appropriate. Ethically and legally if a therapy is deemed inappropriate for a patient and will not provide them with any long-term benefit it should be discontinued to enhance their quality of life. It is also a patient s right to request the withdrawal of life sustaining intervention. It is not euthanasia and should not be associated with this. Ethical Issues Some clinicians may have concerns regarding deactivation of ICDs when capacity to consent is compromised and the following information may be useful: When caring for a patient who lacks capacity clinicians have a duty to act in the patient s best interests and where the determination relates to life-sustaining treatment (the Copy of complete document available from: Trust Intranet Page 15 of 15

16 clinician) must not, in considering whether the treatment is in the best interests of the person concerned, be motivated by a desire to bring about his death. (Mental Capacity Act MCA ) Deactivation of the defibrillator mode of an ICD does not deactivate the pacing mode and in itself does not end a patient s life but will allow for a natural death without the risk of unnecessary shocks. The continued activation of an ICD when a patient is dying can deliver shocks to the patient which can be distressing to patients, relatives and carers. Therefore consideration of deactivation at this time can be seen as in the best interests of the patient, and not contrary to the MCA. The GMC Guidance Withholding and withdrawing life- prolonging treatments: Good practice in decision making (GMC 2006) states that: where it has been decided that a treatment is not in the best interests of a patient, there is no ethical or legal obligation to provide it and therefore no need to make a distinction between not starting the treatment and withdrawing it. Emergency deactivation Where the preferred or current place of care is hospital, and if that is the follow up centre, then the local cardiac physiologist should be asked, following appropriate consultation, urgently to deactivate the device. Where that expertise exists, but the hospital is not the follow up centre for the patient, such deactivation should be in liaison with the follow up centre. Where local expertise does not exist, a temporary measure, in particular the use of a Device Ring Magnet may be appropriate, again, in liaison with the follow-up centre. The preferred place of care staff should be made explicitly aware about the presence of the defibrillator and the plan with regards deactivation. The use of Device Ring Magnets to deactivate implantable defibrillators is fraught with difficulties. Not all devices respond in the same way, in the sense that some may be deactivated for a limited time, and others remain deactivated the whole time whilst the magnet is applied. Some devices require magnet de-activation to be programmed on in their software. All will require that the magnet remains in close proximity to the device (i.e. taped to the skin over the device) to deactivate it. Deactivating a device acutely whilst it is delivering technically appropriate, but medically and humanitarianly inappropriate therapy, may lead to the end of life at that point. Where end of life is clearly close and the patient is receiving shocks, whether technically appropriate or not, the decision regarding temporarily deactivating the device may be straightforward. However in many situations it will not be and may be beyond the training or level of responsibility of attending clinician, in which case its use as a method of deactivating an ICD may be inappropriate. The use of a magnet to deactivate an ICD should therefore not be seen as an option in planned end of life management, and resorting to it should be considered a failure of this process. If a sudden or unexpected deterioration in a patient s health leads to a situation where a magnet could be used then: Copy of complete document available from: Trust Intranet Page 16 of 15

17 1) This should only be done by an individual who, in terms of knowledge of the patient, relevant understanding of ICDs and appropriate training, feels competent to do so. 2) It should be seen as a temporary measure until the responsible follow up centre can manage definitive deactivation of the device 3) It is likely that, in these circumstances, such a service from the follow-up centre will need to be provided at the patients preferred place of care Training The training/resource implications associated with sustaining end of life care in the community have a large impact on the management of patients requiring deactivation of their ICDs. It is the responsibility of each organisation to provide sufficient education for staff and should provide: cardiac physiologists domiciliary visits; specialist input required for discussions regarding disablement of therapies; education of primary care, community heart failure nurses and hospice staff regarding device functions. Copy of complete document available from: Trust Intranet Page 17 of 15