Consulted With Post/Committee/Group Date Dr Dhillon Cardiology Consultant April Professionally Approved By 2. Clinical Effectiveness

Transcription

1 Implantable Cardioverter Defibrillator (ICD) Deactivation End of Life Type: Clinical Guidance Register No: Status: Public on ratification Developed in response to: Best Practice Contributes to CQC Outcome number: 9, 12 Consulted With Post/Committee/Group Date Dr Dhillon Cardiology Consultant April Professionally Approved By 2. Clinical Effectiveness Dr Gerald Clesham Dr Kath Rowe 07/04/2017 June 2017 Version Number 1.1 Issuing Directorate Medical Ratified by: DRAG Chairmans Action Ratified on: 7 th July 2017 Executive Management Board Sign Off July/August 2017 Date Implementation Date 18 July 2017 Next Review Date June 2020 Author/Contact for Information Michelle Colton - Goff/Rebecca Teesdale Policy to be followed by (target staff) Clinical Staff Distribution Method Intranet/Website Related Trust Policies (to be read in Resuscitation Policy conjunction with) Adult Do Not Attempt Resuscitation Trigger Response Team Op Policy Caring for Adult Patients with a Learning Disability on the Acute Hospital Setting Carers Policy Mental Capacity Act Policy Safeguarding Vulnerable Adults Policy Document Review History Version Number Authored/Reviewed by Active Date 1.0 Michelle Colton - Goff/Rebecca Teesdale 18 th July Amended Title Rebecca Teesdale 23 rd October

2 Content 1. Purpose 2. Equality and Diversity 3. Scope 4. Staffing and training 5. Infection control 6. Introduction 7. Clinical instruction Planned ICD Deactivation 8. Clinical Instruction Emergency Out of Hours ICD Deactivation 9. Breach reporting 10. Audit 11. References Appendix 1 - Consent and request for permanent ICD deactivation as part of End of Life care Appendix 2 - Equality Impact Assessment (EIA) Appendix 3 ICD Deactivation Summary 2

3 1. Purpose 1.1 To provide guidance to medical professionals for planning or considering ICD deactivation for patients as part of end of life care. 1.2 To clarify what to do and who to contact when a decision has been made to deactivate an ICD. 2. Introduction 2.1 An ICD is a small device usually fitted in the chest, or abdomen, which connects to the heart. They are used to treat life threatening heart rhythms such as Ventricular Tachycardia and Ventricular Fibrillation, and are fitted in cardiac patients who have experienced or are at high risk of developing these abnormal rhythms. 2.2 An ICD continuously monitors the heart rhythm and if an abnormal rhythm is detected, the device sends an electrical impulse or shock to the heart to return the heart rhythm back to normal (defibrillation). 2.3 However, patients fitted with such devices may suffer from progressive diseases that may reach a stage where it is no longer appropriate for the device to provide this type of therapy. This could be for several reasons (see section 6) but particularly as dying patients are at risk of receiving ineffective and painful electric shocks from the ICD if they develop abnormal rhythms in their terminal phase of illness. This can be distressing for the patient, family, friends and carers. 3. Scope 3.1 This clinical guidance applies to any patient fitted with an Implantable Cardioverter Defibrillator, who is considered to be at end of life and requires device deactivation. 4. Staffing and training 4.1 Medical Staff are responsible for: Being aware of and complying with this clinical guidance Deciding which patients may be appropriate for device deactivation (consulting multi-disciplinary clinical device team where appropriate) Liaising with Cardiac Physiologists regarding patients who require device deactivation. Ensuring that patients and family members are given adequate information and that consent is gained from patient. Ensure plan of care is well documented including prescribed deactivation settings if not standard. The consultant holds ultimate responsibility for ensuring medical staff follow this document. 4.2 Cardiac Physiologists deemed competent in ICD deactivation are required to: Be aware and comply with this clinical guidance. Ensure they have signed documents prior to performing deactivation. Ensure they have information about the device manufacturer and mode and that the appropriate programmer is available. 3

4 Ensure patient and relatives understand the deactivation procedure. Record deactivation appropriately on Cardiology Reporting (TOMCAT) system. 5. Infection Prevention 5.1 All infection prevention methods should be adhered to at all times i.e. hand washing and gloves and aprons where indicated. 6. Equality and Diversity 6.1 The Trust is committed to the provision of a service that is fair, accessible and meets the needs of all individuals. 6.2 An Equality Impact Assessment form is attached as Appendix Clinical Instruction Planned ICD deactivation 7.1 When ICD deactivation could be considered: Patient request Death is expected in the near future, no further interventions are planned and delivery of shock therapy from the ICD would be inappropriate as the person approaches the end of life When transfer to a hospice or home for end of life care is being planned or referral to palliative care team is being considered If withdrawal of anti-arrhythmic drugs is required An active Not For Resuscitation order is in force or being considered 7.2 Considerations prior to Deactivation Discussion about deactivating an ICD should take place as early as appropriate to avoid unnecessary distress; to enable a planned ICD deactivation so the patient and their family are informed on what to expect and to aid the end of life care plan The option of deactivating the ICD needs to be considered by the MDT in conjunction with the patient/family as appropriate Responsibility for the final decision to deactivate lies with one of the following; Cardiology Consultant, Palliative Care Consultant, other hospital Medical Consultant or the patient General Practitioner Patients and relatives should be fully aware of the reasons for deciding to deactivate the ICD and the consequences It is the responsibility of the Consultant and their team to explain fully the consequences of Device deactivation, this being: o Deactivation will not in itself cause death o The device will still provide basic pacemaker therapy to prevent slow heart rhythms (bradycardia). o The device will no longer provide shock therapy for life threatening heart rhythms o Deactivation will not be painful o The decision is reversible the ICD can be reactivated if the situation changes 7.3 Requesting an ICD deactivation Medical professionals are required to complete the ICD deactivation request form and gain consent from patient or next of kin (if patient does not have capacity) see appendix 1. 4

5 Once the consent/request form is completed, the Cardiac Department should be informed of the decision to deactivate and the completed form returned to the Cardiac Centre (A210 ext 4185) or sent via nhs.net to the generic ICD/Pacing address Planned deactivation is achieved by use of specialist equipment, therefore can only be carried out in a hospital setting. For circumstances where this is not possible, please see section 8 for advice about emergency ICD deactivation. 7.4 Deactivation: Cardiac Physiologists deemed competent in follow-up management of ICDs are responsible for: Ensuring they have appropriate, completed ICD deactivation form and the appropriate programmer is available. Ensuring patients and relatives understand the deactivation procedure. Carrying out the deactivation procedure. Informing Medical staff of deactivation, and ensuring the procedure is documented in patient notes. Ensure appropriate follow-up arrangements are in place for continued pacemaker function of device. Completing documentation on Cardiology Reporting system (TOMCAT) and file completed deactivation form and reports in the Cardiac Department. 7.5 Non-deactivated devices in a dying patient: In some circumstances, patients with ICDs will die prior to device deactivation having been instigated. In the majority of these cases, shock therapy will not occur due to the nature of a typical heart rhythm in a dying patient. In the event that shock therapy is triggered during the late stages of dying, the number of shocks delivered will typically be limited to no more than six (dependent on device model and programmed settings). 7.6 When a patient dies with an active ICD, the Cardiac Physiology team should be notified at the earliest convenience, as the device may need permanent deactivation prior to removal by mortuary staff, autopsy or cremation NB. All devices must be explanted before a body is cremated 8. Clinical Instruction - Emergency out of hours ICD Deactivation 8.1 There are situations where emergency ICD deactivation is required outside of normal working hours (9-5pm Monday to Friday) or in a community setting. If deactivation by a Cardiac Physiologist is not available then a magnet can be used in these situations. Medical staff should obtain verbal consent following communication to the patient/family the reasons and consequences for magnet use: Shock therapies will be temporarily disabled (for duration of application) It is safe to apply a magnet to an ICD when it is actively shocking. 8.2 For transvenous devices, the magnet should be taped securely on the skin directly over the device (see below diagram). If any concerns or further advice is required out of ours then cardiology advice is available by contacting the Cardiology Registrar at Essex Cardiothoracic Centre (tel bleep 9010). 5

6 8.3 Subcutaneous Implantable Cardioverter Defibrillators (S-ICD) are usually implanted in a lateral position below the patients armpit. Diagram 3: Illustration of Comparison between Transvenous ICD and S-ICD S-ICD s do not have a standard bradycardia pacing function as with traditional transvenous systems, however will deliver limited back up outputs post shock therapy delivery 8.4 In the event of an emergency deactivation being required for an S-ICD, a magnet should be placed and taped securely on the skin as shown in Diagram 4. Diagram 4: Magnet Placement for S-ICD Deactivation 6

7 8.5 Magnets can be obtained from the following locations: Cardiac Centre Theatres Terling Ward (A305) Bed Office Palliative Care Nurses 8.6 Some devices are only inhibited by a magnet for 8 hours, so the magnet should be removed for 30 seconds and then reapplied every 7 hours. 8.7 When a magnet has been used in an emergency situation, arrangements should be made for a Cardiac Physiologist to permanently deactivate the ICD as soon as possible. 9. Breach Reporting 9.1 In the event that this guidance is not followed, a risk event (DATIX) form should be completed. 10. Audit 10.1 This document will be reviewed annually and when new clinical guidance is issued. ICD deactivation request procedure compliance will be monitored to ensure that guidance is being adhered to, and any significant concerns will be raised via DATIX reporting Incidences and complaints will be reviewed every 3 months by a Senior Cardiac Physiologist and results will be reported to the Principal Physiologist. 11. References Standards of implantations and follow up of cardiac rhythm management devices. February 2013 BHRS StandardsStandards%20for%20Implantation%20and%20Follow%20Up%20of%20CR M%20Devices.pdf Treatment and care towards the end of life: good practice in decision making. General Medical Council. Mat Implantable Cardioverter defibrillators (ICDs) in dying patients. The Arrhythmia Alliance

8 Appendix 1 ICD Deactivation Form Consent and request for permanent ICD deactivation as part of End of Life care Patient details Surname: Forename: DOB: MEHT Hospital Number: NHS Number: GP Details GP Name: GP Address: Date & Time of Request: Name of Requester: Designation: Contact Number/Extension/Bleep number: Reason for Deactivation: Is the patient an Inpatient? Yes/No If Yes, name of ward: Device Follow-up Centre: Device Manufacturer/Model: Does the patient lack capacity to consent to withdrawal of treatment? Yes/No If yes, I confirm a Mental Capacity Assessment form has been competed in accordance with the Mental Capacity Act 2005.* I confirm that the following has been discussed with the patient and/or family: The device will no longer provide life-saving therapy in the event of a ventricular tachyarrhythmia. Deactivating the device will not cause instantaneous death. Deactivating the device will not be painful. The device will continue to provide slow heart rhythm support if needed (basic pacemaker function). Signature of authorising Consultant/Physician: Print name: Date: Patient Consent: I confirm that I understand the reasons for and consequences of deactivating my device and hereby give my consent for ICD deactivation. Signature of patient: *Print name if signed by Next of Kin Date: Please return completed form to Cardiac Centre A210 or to mie-tr.mehtpacingicd@nhs.net 8

9 Appendix 2 - Equality Impact Assessment (EIA) Title of document being impact-assessed: Implantable Cardioverter Defibrillator (ICD) Deactivation End of Life Equality or human rights concern Gender Race and ethnicity Disability Religion, faith and belief Does this item have any differential impact on the equality groups listed? Brief description of impact. All identified patients requiring ICD Deactivation will be treated the same irrespective of their gender. All identified patients requiring ICD Deactivation will be treated the same irrespective of their race and ethnicity. It is acknowledged that some patients requiring ICD Deactivation may have/live with physical disabilities, learning disabilities, autism or other mental health issues. All identified patients requiring ICD Deactivation will be treated the same irrespective of their beliefs. How is this impact being addressed? Staff communication is encouraged to support all patients. Staff will ensure that dignity for all patients is maintained regardless of gender. All complaints will be fully investigated and responded to. The Trust operates within the requirements of The Race Equality Act Language may be a barrier; however staff should plan in advance for an interpreter to be present during the procedure or use relative/carers to assist with translation if necessary, wherever possible. Patient information should always be accessible and up to date. All areas have disabled access such as wheelchairs, lifts and toilets. In patients with sensory impairment or sensitivities extra care will be taken to explain every step of the procedure to the patient including the use of different materials that may touch their skin to avoid distress. There is access to the multi faith chaplaincy team who offer advice and support for patients, relatives, carers and staff. 9

10 Appendix 3 ICD Deactivation Summary 10