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Clinical Operating Procedure ICD Consent at Implantation and ... · 10) Deactivation Decision Tree...

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  • Clinical Operating Procedure

    Procedure Ref No: COP 511

    Expiry date: April 2019

    Version Number: V2

    Summary statement / scope of the procedure:

    Implantable Cardiovertor Defibrillator (ICD) Guidance including: consent at implantation, and deactivation, with a focus on considerations towards end of life

    Definitions

    Implantable Cardiovertor Defibrillator (ICD)

    Recommendations for procedure content: Clinical operating procedures should detail clear and explicit recommendations for practice and in addition to providing general guidance should clearly detail behaviour specific instruction; what, who, when, where and how. This will increase the likelihood of adoption of the procedure.

    Procedure Title: ICD Consent at Implantation and Deactivation at the End of Life

  • 2

    Coventry & Warwickshire Cardiovascular Network

    Network Guideline Document

    Implantable Cardiovertor Defibrillator (ICD) Guidance including: consent at implantation, and deactivation, with a focus on considerations towards end of life.

    Approved by the

    Cardiology QIPPs March 2015

    Date March 2017

    Review March 2019

    This document links to the Alert clinical reporting system at University Hospital Coventry &

    Warwickshire. The patients whom the document links to are only those who have been seen in the

    Department of Cardiac investigations at UHCW. Patients who have ICD’s implanted and are

    followed up at other centres may present at UHCW but will not have the alert link until they are

    seen in the department of cardiac investigations.

  • 3

    Review Schedule

    This document should be reviewed annually to ensure accuracy of contacts and reflect developments in cardiology.

    Review number

    Date of review Date revised policy published

    1 March 2012

    2 March 2015

    3

    4

    5

    Table of contents Page

    1: Introduction 3

    2: Discussion and information at the time of consent 4

    3.Transfer of Information 5

    4. Management of ICD shock/s

    & Use of Magnet to prevent ICD shocks 6

    5.Psychological Support of ICD patients 7

    6. Staff who see patients with ICD’s 7

    7. Medical management of ICD patients 7

    8. Surgery / Radiotherapy in ICD patients 7

    9) Deactivating an ICD when a patient is nearing death 8

    10) Deactivation Decision Tree 10

    11) Deactivation for patients in hospital 11

    12) Deactivation for patients in the community 11

    13) Independent Mental Capacity Advocates and Trust Legal Services 13

    14) Record of Decision and consent to Withdraw ICD therapy 14

    15) Death certification for ICD’s & removal of ICD post mortem 15

    16) Deactivation of ICD’s for inpatients at George Eliot Hospital 16

    17)References 17

    18) Members of the original working group & contributors to the document thereafter 18

  • 4

    1) Introduction The Department of Health continues to expand the group of patients who fit the eligibility criteria for the implantation of an Implantable Cardioverter Defibrillator (ICD)1. The majority of this patient group are heart failure patients. Devices for cardiac patients include:

    ICD (implantable cardiovertor defibrillator)

    cardiac-resynchronization therapy pacemaker (CRT-P) which does not include a defibrillator function in the device

    cardiac-resynchronization therapy and defibrillator (CRT-D). Also known as the biventricular pacemaker, CRT restores synchrony to the failing heart by pacing both ventricles, in synchrony, on a continuous basis. Depending on the indications, a patient can have an ICD on its own or as a combined device (Cardiac Resynchronisation Therapy & Defibrillator (CRT-D). In 2012 there were approximately 110 CRT implants and 44 ICD implants per million population ICD implants across the Arden, Hereford and Worcestershire region2. This is well below the national average. The number of implants is expected to grow as our rates of implantation across the area continue to grow and with NICE Guidance updated in 2014 which expands the indications for an ICD and CRT implant. Recent Audit data completed at UHCW showed there were a total of implants from 2015-16 :

    ICD implants 40

    CRT-P 45

    CRT-D. 43 - 31 (18) pulse generator change The ICD is implanted for either primary prevention in patients who are at high risk of sudden cardiac death or for secondary prevention in those who have survived cardiac arrest without a reversible cause. The ICD can terminate malignant arrhythmias through the delivery of anti-tachy pacing and/or delivering direct current to the heart through a shock. If the patient is conscious at the time an ICD shock is painful, often described as “being kicked in the chest by a horse” (8). The ICD has a specific and different function to a permanent pacemaker implanted for bradycardia (slow heart beats) and therefore the ICD should be specifically referred to as an ICD when discussing with patients, and documenting. Do not refer to an ICD as “pacemaker”. Although originally implanted to prevent sudden cardiac death shocking from the ICD, particularly multiple shocking can result in psychological distress and the presence of an ICD at the time of natural death can present problems.(2) Goldstein et al3 found in a group of next of kin contacted after the patient’s death that 8% of ICD patients received a shock in the last minutes of life and a further 19% received a shock in the last month. With only 27% of patients having had any discussion about deactivation the authors noted the difficulty for clinicians in having this discussion with patients especially at implantation when it would seem ‘out of context to both clinicians and patients’. Heart Rhythm Society

  • 5

    (5) and BHF (6) have recommended guidance on the management of ICD’s towards the end of life and how to approach conversations on ICD deactivation towards the end of life. With these issues in mind and the advent of the Mental Capacity Act (2005), the Coventry and Warwickshire Cardiovascular Network formed a multidisciplinary working group in 2010 to address the need for clear procedural guidance that could be adopted across all providers. The group’s remit was to produce a policy and guidelines surrounding consent at implantation, consent to deactivate, along with guidelines regarding the operational issues around deactivation outside of hospital in Coventry and Warwickshire. In 2014, we took the opportunity to update this document to include ICD guidance on the management of ICD shock/s and ICD’s at the time of surgery. The Coventry and Warwickshire Cardiovascular Network multidisciplinary working group acknowledge the work of the Kent Cardiac Network and their policy on which this document was initially based. This document has benefited from the advice of Julie Midgely UHCW Trust Solicitor. The British Heart Foundation has produced a useful discussion booklet for any health professional who is involved in caring for dying patients with an ICD 4.

    2) Discussion and information at the time of consent When counselling patients regarding their suitability for the insertion of an ICD, the potential benefits/limitations/risks of the treatment are discussed and documented. This ensures the patient is fully informed of the role of the device. It is appropriate to explain that the defibrillator function provides electrical therapy (anti-tachy pacing and/or shock therapy) to treat dangerous heart rhythms. A defibrillator function monitors the heart rhythm, acting as a safety net against life threatening arrhythmias. It is important that the patient/carer understands that the devices are not a cure for the underlying heart condition (in heart failure), and will not prevent heart attacks. The ICD protects against life-threatening arrhythmias. Comprehensive written/verbal information should be provided to patients and carers during the pre-implantation discussions and it is recommended that the following information be included:- a) Deactivation of the defibrillator function of the ICD The decision to implant the ICD is right treatment at this time in the patient’s life. Experiencing a brief painful shock will save a patient’s life whilst maintaining quality of life. However there are times when the ICD may be reprogrammed, and changes can be made to the settings, including deactivating or turning off the ICD function. Circumstances when the ICD needs deactivating include procedures such as angiogram, angioplasty, surgery, radiotherapy and at the end of natural life. Deactivating is done painlessly, takes a few minutes using the portable programmer. The ICD can be reactivated appropriately, for example following surgery. At the end of natural life, it should be made clear to the patient that deactivating the ICD is not a surgical procedure. If the patient has CRT pacing and a defibrillator, then the CRT pacing can be maintained whilst deactivating the ICD.

  • 6

    This reassures heart failure patients who have benefited from CRT. This can be done without discomfort or pain. Deactivating the ICD allows comfort at the end of natural life. Deactivation does not mean the patient will imminently die as the ICD is deactivated but, should a dangerous rhythm occur, the ICD will not treat this. HRS (Lampert et al 2010) recommend a “helpful phrase” health professionals can use around the time of implant : “It seems clear at this point that this device is in your best interest, but you should know at some

    point if you become very ill from your heart disease or another process you develop in the future,

    the burden of this device may outweigh its benefit. While that point is hopefully a long way off, you

    should know that turning off your defibrillator is an option.”

    All devices will deactivate when an appropriate magnet is secured over them.

    b) ‘Advance Care Planning’ (ACP) should be offered to the patient. ACP is the process by which the Clinician for the patient offers the opportunity to plan for future care. The Clinician explains the likely path their clinical condition will take; what potential treatments may be offered to the patient, under what circumstances. The patient may then be in a position to decide whether or not they would choose to accept or decline such treatments. The patient may then feel empowered and document their wishes, with the Clinician’s support, via an ‘Advance Statement’ or ‘Advance Decision’ (as part of the ‘Advance Care Planning’ process). If there are treatments they wish to decline this can be achieved via a more formal ‘Advance Decision to Refuse Treatment’ (previously known as an Advance Directive).

    Staff involved with discussions around ACP and end of life care need to have the appropriate competences and/or training in ACP.

    The member of staff obtaining consent for the insertion of the ICD needs to ensure there is a written record of issues discussed and the agreed plan and file a copy in the patient’s notes.

    3) Transfer of Information Staff should ensure a clear information pathway between the acute hospital, GP and ‘out of hours’ staff. . Knowledge about whether or not deactivation was discussed at implant and more importantly when deactivation has been carried out should be clearly communicated. Copies of relevant letters

    at implant discussion around deactivating at end of natural life

    following deactivation of an ICD should be sent to the GP and the patient’s local hospital (should this be different from the implant hospital or where deactivation has occurred). A copy of the relevant deactivation consent (recommended sample at end of document) of an ICD should be sent to Morticians at the local hospital. Each area should ensure that a clear information pathway is known to all staff involved.

  • 7

    4) Management of ICD Shock/s

    • Patient reports of number of shock does not determine if there has been a shock or how many shocks.

    Patient Advice following an ICD shock

    •Contact Clinic 7 (DCI) on 024 7696 6416

    •Arrangement will be made for patient to come into clinic when a qualified cardiac physiologist is in clinic (usually within 24 hours)

    1 shock & feeling well

    • Attend A&E > than 1 shock in 24 hours or feeling unwell dial 999.

    Advice for staff caring for patient

    receiving shock from ICD

    Patient receiving

    multiple shocking/

    distressed from shocks

    Must be in monitored bed on

    CCU or cardiology ward

    Consider temporarily

    deactivate ICD by taping

    magnet over ICD (available

    on CCU & ward 10)

    ICD only deactivated whilst

    magnet is taped over the

    ICD

    Patient

    Stable

    Contact DCI extension x26417 to

    interrogate ICD Mon-Fri 8:30-4:30

    Do not advise patient to self-present

    at DCI (only specific CP’s can

    interrogate ICD)

    Patient not to be sent home

    without ICD interrogation

    unless D/W Cardiology first

    Out of Hours:

    patient stable

    contact DCI during

    working hours

    Contact Cardiology

    Registrar on-call

    If patient looses

    consciousness from VT/VF

    remove magnet from over

    ICD – allow ICD to shock.

    Have crash trolley to hand:

    patient can be defibrillated

    with ICD insitu if

    necessary.

    Interrogation determines if a shock

    & how many have been delivered

    (not the patient reported experience):

    Appropriate Shock/s: check U&E,

    magnesium, review anti-arrhythmic

    drugs, ? precipitating cause ie:

    ischaemic event, ? reprogramming

    issues

    Reducing/ stopping anti-arrhythmic

    drugs (ie:amiodarone & beta-

    blockers) significantly increases risk

    of painful ICD shocks

    Causes of inappropriate shock/s:

    Supraventricular tachy arrhythmia

    (ie: Atrial Fibrillation), lead fracture

    (some ICD’s leads have advisory’s).

  • 8

    5. Psychological support for ICD patients Having an ICD implanted often follows a very serious event. This event and the implant itself can cause anxiety or fears in some people or their carers. If the ICD shocks, then it is normal for this to cause distress to the patient and carer (witnessing an ICD shock can be particularly distressing) (3). If the distress causes significant problems such as avoidance behaviours, loss of sleep or anxiety patients should be referred for expert help (3).

    The specialist nurse who has experience of counselling patients and carers with ICDs is available for support. Issues may be raised with the GP or the cardiac physiologist who will be able to offer advice and/or direct patients to other appropriate services which may be available.

    Having access to psychological support is essential. The psychologist is able to address issues in depth. Importantly, at the end of natural life the psychologist is invaluable for addressing unmet psychological needs of the patient and family/carers regarding the ICD. This includes issues around deactivation and coming to terms with their prognosis.

    Staff who see patients with ICDs. . When a patient returns to hospital for a technical check of their ICD, this time may also be used to discuss non-technical issues relating to the device. Staff must be aware of the potential problems associated with ICDs. Managers are responsible for ensuring staff have the necessary skills to recognise potential problems and to respond appropriately. Staff should be able to identify worries or associated psychological problems, be able to provide limited support and have enough knowledge to identify when onward referral to more advanced counselling services is appropriate.

    7. Medical management of ICD patients The ICD is implanted to prevent sudden cardiac death. However as an ICD shock can often be

    distressing, minimising the chance of the ICD shocking is in the patients best interests. Anti-arrhythmic drugs, particularly beta-blockers and amiodarone minimise ICD shocks. Do not reduce or stop these drugs without first discussing with a cardiologist.

    8. Surgery / Radiotherapy in ICD patients. Patients having surgery (particularly using bipolar diathermy) and radiotherapy will need their ICD deactivating prior to surgery and reactivating afterwards. The department can be contacted on 024 7696 6419 (extension 26419) to discuss and plan all request.

  • 9

    9) Deactivating an ICD when a patient is nearing death When caring for patients ‘approaching the end of their life...you must treat patients and those close to them with dignity, respect and compassion, especially when they are facing difficult decisions about care’, section 7, GMC Guidance July 2010: “Treatment and Care towards the End of Life”.

    ‘Following established ethical and legal (including human rights) principles, decisions concerning potentially life-prolonging treatment must not be motivated by a desire to bring about a patient’s death, and must start from a presumption in favour of prolonging life. This presumption will normally require you to take all reasonable steps to prolong a patient’s life. However, there is no absolute obligation to prolong life irrespective of the consequences for the patient, and irrespective of the patient’s views if they are known or can be found out’, section 10, GMC Guidance “Treatment and Care towards the End of Life”, July 2010.

    ‘In order to ensure a peaceful death for a patient with an ICD who is reaching the end of their natural life the doctor caring for the patient should consider deactivating the defibrillator function of the ICD when they judge it to be no longer clinically indicated. Where the patient has capacity this should be done after discussion with the patient and the doctor explaining their reasons to the patient‘.

    For further details see section 14, GMC Guidance “Treatment and Care towards the End of Life”, July 2010:

    Some clinicians may have concerns regarding deactivation of ICDs when capacity to consent is compromised. The following GMC Guidance may be useful for doctors in such circumstances:

    GMC Guidance “Treatment and Care towards the End of Life” July 2010, Section 15:

    ‘If you assess that a patient lacks capacity to make a decision you must:

    a) Be clear what decisions about treatment and care have to be made b) Check the patient’s medical record for any information suggesting that they have made

    a potentially legally binding advance decision or directive refusing treatment c) Take enquiries as to whether someone else holds legal authority to decide which

    option would provide overall benefit for the patient (an attorney or other ‘legal proxy’)’ as long as that proxy has the appropriate legal powers to make health-related decisions on behalf of that patient

    d) ‘Take responsibility for deciding which treatment will provide overall benefit to the patient, when no legal proxy exists, and you are the doctor with responsibility for the patient’s care. You must consult those close to the patient and members of the healthcare team to help you make your decisions.

    ‘In England and Wales, if there is no legal proxy, close relative or other person who is willing or able to support or represent the patient and the decision involves serious medical treatment (see MCA Code of Practice) the doctor must approach their employing ...organisation about appointing an Independent Mental Capacity Advocate (IMCA) as required by the Mental Capacity Act 2005 (MCA). The IMCA will have authority to make enquiries about the patient and contribute to the decision by representing the patient’s interests but cannot make a decision on behalf of the patient.’ GMC Guidance July 2010: “Treatment and Care towards the End of Life”, Section 16

  • 10

    If a patient (or legal proxy or other person involved in the decision making) asks for a treatment that the doctor considers would not be clinically appropriate or of overall benefit to the patient the ‘doctor should explain the basis for this view and explore the reasons for the request. If after discussion the doctor still considers that the treatment would not be clinically appropriate and of overall benefit, they are not obliged to provide it. However, as well as explaining the reasons for their decision, the doctor should explain to the person asking for the treatment the options available to them. These include the option of seeking a second opinion...’ GMC Guidance: “Treatment and Care towards the End of Life” July 2010, Section 16

    The term ‘overall benefit’ is used to ‘describe the ethical basis on which decisions are made about treatment and care for adult patients who lack capacity to decide’. GMC Guidance: “Treatment and Care towards the End of Life” July 2010, Section 5 ‘The benefits of a treatment that may prolong life, improve a patient’s condition or manage their symptoms must be weighed against the burdens and risks for that patient’ [in order] ‘to reach a view about its overall benefit’. The benefits, burdens and risks associated with a treatment are not always limited to clinical considerations’ [there may be] ‘other factors relevant to the circumstances of each patient’. GMC Guidance: “Treatment and Care towards the End of Life” July 2010, Section 40-41 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 will be included in the end of life care planning documentation. The GMC Guidance “Treatment and Care towards the End of Life” July 2010 ‘Some members of the healthcare team or people close to the patient may find it more difficult to contemplate withdrawing a life-prolonging treatment than to decide not to start the treatment in the first place...You should not allow these anxieties to override your clinical judgement and lead you either not to start treatment that may be of some overall benefit to the patient, or to continue treatment that is of no overall benefit’...’You should also explain...that the patient’s condition will be monitored and managed to ensure that they are comfortable and as far as possible free of pain and distressing symptoms.’

  • 11

    10.Decision Tree for Withdrawal of ICD Therapy in an Adult Patient at End of Life

    Where patient lacks capacity to make this decision and there is no person whom it is practicable or appropriate to consult, and has previously indicated wishes in an advance decision or has appointed a personal welfare attorney with lasting powers

    Where patient lacks capacity to make decision and it is practicable and appropriate to consult those close to patient.

    Failure to reach consensus on ‘best interests’/ ‘overall benefit’ to the patient; further discussions and offer 2

    nd Opinion

    Clinicians may wish to seek legal advice. If so local details can be found on Page 11

    The patient is counselled regarding ICD use and consented for implantation of an ICD. The patient and those close to the patient are given information (oral and written) on the appropriate use and withdrawal of ICD therapy including when

    nearing the end of life. This should be documented.

    The patient is nearing the end of life and/or has a Do Not Attempt Resuscitation order active

    (Refer to local hospital/community DNAR policy

    Assessment of patient’s condition, likely prognosis and treatment options – which might include Palliative Care – is undertaken by the doctor in charge of the patient’s care in consultation with the whole Integrated Cardiology-Palliative Care

    Multidisciplinary Team with relevant health professionals over the telephone or at the Monthly Palliative Care-Heart Failure MDT Meeting.

    Where patient is competent, treatment options including the anticipated benefit and burden of continuing ICD therapy are discussed with him/her.

    Deactivation of the ICD is deemed to be of greater overall benefit for the patient (ie the burdens/risks of continuing activation of the of ICD outweigh the benefits of the use of ICD)

    a) Patient wishes ICD therapy to be withdrawn b) OR lacking capacity there is a written valid and applicable

    Advance Decision indicating the patient’s wishes for ICD therapy to be withdrawn in these specific circumstances

    c) OR Doctor in charge decides ICD therapy should be withdrawn in the patient’s ‘best interests’ for a patient who lacks capacity: o When consent is given by an Attorney appointed under an

    LPA or by a Deputy appointed by the Court of Protection o OR Taking account of information from those close to the

    patient regarding what they feel patient would have wanted under these circumstances.

    Decision to withdraw ICD therapy recorded in writing by doctor. Sample form is on page 12

    Decision reviewed at appropriate intervals. Advance Care Plan reassessed to ensure treatment goals remain appropriate for the

    patient. Patient consulted throughout and second opinion obtained if patient’s condition does not progress as expected.

    Local cardiac physiologist contacted to arrange deactivation of ICD (cardiac physiologist will only do so on receipt of signed form)

    PCT/Trust has a duty to provide the patient with access to an Independent Mental Capacity Advocate. See contact details on Page 11

    Where patient lacks capacity to make decision and there is no person whom it is practicable or appropriate to consult.

    Assessment of the patient’s capacity regarding the decision about deactivation of the ICD

    Decision communicated throughout the patient’s care team using local Advance Care Planning tools to communicate between Primary, Secondary Care and Ambulance Service. Personal support given to both patient and those close to

    them.

  • 12

    11. Deactivation for patients in hospital

    Hospital cardio respiratory departments will ensure that all departments in their hospital know how to arrange for ICD deactivation during the working day. Out of hours, staff are required to contact CCU for a magnet. Devices need to be considered within hospitals’ local “Do Not Attempt Cardio-Pulmonary Resuscitation” policies.

    12) Deactivation for patients in the community

    GPs will have increasing contact with ICD patients towards the end of their life as they should be placed on the practice Supportive and Palliative Care register. Placing a patient on the register will prompt the discussion of “Do Not Attempt Cardio Pulmonary Resuscitation” and ICD deactivation.

    Patients who are not in hospital at the time of the decision to deactivate should have equal access to deactivation facilities. This decision should ideally be undertaken when the patient has the mental capacity to do so. Therefore, the procedure can be planned and carried out in a timely fashion. Cardio respiratory departments should be able to accommodate these requests within a short timescale i.e. 1-3 days, maximum 72 hours. Under exceptional circumstances where a patient is deemed to be imminently dying and not fit to be moved temporary deactivation with a magnet may be considered. When using a magnet, this must be securely placed over the ICD.

    If the magnet is removed/falls off this will reactivate the ICD.

  • 13

    The pathway below sets out the options for deactivation for patients in the community:-

    The decision to deactivate made by the doctor currently caring for the patient needs to be recorded e.g. Record of Decision form is completed – which needs to be made available to the cardiac physiologist prior to undertaking the deactivation.

    De-activation in the community is best facilitated by a heart failure nurse specialist, an arrhythmia nurse specialist or community matron in conjunction with the patient’s GP or deputising GP.

    DECISION TO DEACTIVATE

    (as in decision tree on page 8)

    Patient able to

    attend cardio-respiratory department

    Patient unable to

    attend cardio-

    respiratory

    department

    * Planned

    deactivation in the community by cardio-respiratory staff

    Patient dying with active

    ICD in situ and no previous arrangements made for de-activation. (This should NOT be the norm)

    * Prognosis >72 hours and within normal office hours: Call to local cardio-respiratory department to attend within 72 hours to deactivate

    Deactivation for patients in the community (including Hospices)

    Call to local cardio-respiratory department to attend within 72 hours to deactivate

    * Prognosis

  • 14

    13) Mental Capacity Advocates

    Independent Mental Capacity Advocate If the person lacks the mental capacity** to make decisions for themselves and does not have support from family and friends, a statutory advocate will be required to ensure the individuals best interest are being met. Contact details for the statutory advocacy provider is: http://www.pohwer.net/about_us/contact_us.html ** NB: The person’s responsible clinician must assess and record in the clinical case notes that the individual lacks the mental capacity to make informed decisions about their care and treatment before an advocate can be appointed. Margaret Greer is the named nurse for Safeguarding Adults at UHCW and will also provide advice relating to Mental Capacity issues: [email protected] The following have overseen these guidelines: University Hospitals Coventry & Warwickshire Solicitor: Julie Midgley George Eliot Hospital Legal Service Lead: Alex Palethorpe Contact via board Secretary 024 76865211.

    http://www.pohwer.net/about_us/contact_us.htmlmailto:[email protected]%20NHS%20Trust.nhs.uk

  • 15

    14) SAMPLE FORM TO BE USED Record of Decision and Consent to Withdraw Implantable Cardioverter Defibrillator (ICD) Therapy in an Adult Patient

    NB: THE CARDIAC PHYSIOLOGIST REQUIRES THIS FORM TO BE COMPLETED BEFORE DEACTIVATING AN ICD

    Information provided to patient: __

    ___________________________________________________________________ The wording of this document has been overseen by Julie Midgeley – Director of Legal Services at University Hospitals Coventry & Warwickshire

    As the doctor currently caring for Patient Name ……………………………………………NHS number ……………….. Address ……………………………………...............................………………………… DOB …………………. Tick all relevant statements:- I am satisfied that

    □ The patient wishes the ICD to be deactivated □ As a member of the Multidisciplinary Team caring for this patient we have consulted all relevant information in order to reach the decision that Deactivation of this patient’s ICD is the most appropriate clinical decision to be of overall benefit for the patient. (Senior clinician (preferably consultant) decision □ I have the consent of the patient’s Attorney

    (Named …………………………….........) to withdraw ICD therapy. The Lasting Power of Attorney appointing him/her is registered and authorises him/her to make decisions on life sustaining treatment.

    □ I have the consent of the deputy appointed by the Court of Protection (Named …………………………………….) to withdraw ICD therapy.

    □ I am satisfied that a written advance refusal of ICD therapy exists, which is valid and applicable to current circumstances and I have the patient’s authority to withdraw ICD therapy. □ I am satisfied that the patient lacks capacity to consent to withdrawal of treatment and confirm that I believe it is in the patient’s best interests that ICD therapy should be withdrawn. The Multidisciplinary Team and I have attempted to establish/completed the necessary steps to ascertain any relevant views/wishes of the patient prior to becoming incapacitated and have taken account of the views offered by those close to the patient (where available), the IMCA, where applicable, and the views of the multidisciplinary team.

    Doctor Name Position Signature Date

  • 16

    15) Removal of ICD post mortem If the body is to be cremated the ICD must be removed to avoid damage to the furnace. Removal of an active ICD has a high risk of shock injury to the mortician involved and the MDA (Medical Devises Agency ) SN2002(35) states: ‘Do not remove an ICD from a cadaver without first disabling all high voltage shock therapies’ Acute trusts should ensure that they are able to advise morticians regarding what devices patients may have and support their deactivation before removal.

    Doctors signing a death certificate must ensure they have thoroughly checked the clinical reporting systems and letters regarding the type of device the patient has in. The ICD is not to be referred to as a pacemaker. If in doubt the doctor should contact the department of cardiac investigations on 024 7696 6419 during working hours.

  • 17

    DECISION TO DEACTIVATE ICD

    (as in decision tree on page 8)

    Patient able to attend cardio-

    respiratory department

    Patient unable to attend cardio-respiratory

    department

    Planned deactivation. Consultant looking

    after the patient to fill in deactivation form at the back of

    the policy. Two copies of the

    form to be placed into the patient notes.

    Call to cardio-respiratory staff

    department to attend within 72 hours to deactivate

    Tel. 024 76865128

    Patient dying with active ICD in situ and no

    previous arrangements made for de-activation. (This should NOT be

    the norm)

    Within normal office hours:

    Call consultant looking after

    the patient to sign deactivation

    forms. Two copies of the signed form to

    be placed into the patient’s notes.

    Call to cardio-respiratory

    department to attend urgently within 72 hours

    to deactivate Tel. 024 7686

    5128

    16. Deactivation of ICD’s for inpatients at George Eliot Hospital

    Out of normal office hours:

    Call consultant overseeing the

    patient to inform & sign deactivation

    form within 24 hours. Two copies of the

    signed form to be placed into the patient’s

    notes. Call CCU

    (Tel. 5294), to attend urgently to suspend ICD

    therapy temporarily, with a magnet.

    Contact the Cardio-Respiratory

    Dept at the earliest opportunity to

    deactivate. Tel. 5128

    Patient attends cardio-

    respiratory department for planned de-

    activation (relevant parties notified)

    Contact The Cardio-respiratory dept for further information and advice Tel 024 7686 5128

  • 18

    17) References

    1. NICE Implantable cardioverter defibrillators for arrhythmias Technology (review of TA 95), June 2014

    2. National Audit of Cardiac Rhythm Management Devices NICOR BHRS 2014 3. .Dunbar SB, Dougherty CM, Sears SF, et al; on behalf of the American Heart

    Association Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Cardiovascular Disease in the Young (2012) Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families: a scientific statement from the American Heart Association. Circulation 126:2146–72

    4. Goldstein N E, Lampert R, Bradley E, Lynn J, and Krumholz H M Management of Implantable Cardioverter Defibrillators in End of Life Care Ann of Internal Medicine 2004 ; 141: 835-8

    5. Lampert R, Hayes D, Annas G et al (2010) HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm 7:1008-26

    6. BHF Implantable cardioverter defibrillators in patients who are reaching the end of life, (Beattie 2013)

    7. DoH Mental Capacity Act , April 2005

    8. Wath MS., DeGroot, P., Sweeney, M., Stark, A., Otterness, M., Adkisson, W., Canby, R., Khalighi, K. Machado, C., Rubenstin, D., Volosin, K. (2004) Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) Trial Results published as “Prospective Randomized Multicenter Trial of Empirical Antitachycardia Pacing Versus Shocks for Spontaneous Rapid Ventricular Tachycardia in Patients With Implantable Cardioverter-Defibrillators” Circulation 110:2591-2596

  • 19

    Appendix Members of the working group (July 2010)

    Dr Prithwish Banerjee

    Consultant Cardiologist Heart Failure UHCW

    Dr Rosie Bronnert Palliative Medicine Registrar Coventry Myton Hospice

    Dr Nigel Clarke

    Consultant Cardiologist SWFT

    Shirley Murray Lead Cardiac Physiologist – Devices UHCW

    Sr Helen Eftekhari Arrhythmia Nurse Specialist UHCW

    Ben Knight Associate Director Coventry & Warwickshire Cardiovascular Network

    Dr Sarah MacLaran Consultant in Palliative Medicine UHCW /

    The Myton Hospices

    Dr Dan Munday Consultant in Palliative Medicine Coventry Community / The Myton Hospices

    Lynn Gardner Head of Cardiac Investigations UHCW

    Dr Faizel Osman Consultant Cardiologist/Electrophysiologist UHCW

    Dr Jo Poultney Consultant in Palliative Medicine The Myton Hospices/ Rugby Community

    Dr Steph Seeley

    GP, Rugby

    Lillian Smith-Vincent Heart Failure Nurse South Warwickshire

    Sr Kath Warwick CCU Nurse SWFT

    Subsequent amendments accepted by Sally Prychart & Dr Venketarama (GEH) 2012

    If the Reviewer and Author is the same person please tick box If the Reviewer and Author is not the same person please provide the Reviewer details below

    Reviewer Name: Helen Eftekhari

    Reviewer Job Title: Arrhythmia Nurse

    Reviewer email address: [email protected]

    Approved by:

    Date Approved:

    Author Name: Dr Osman

    Author Job Title: Consultant Cardiologist

    Author email address: To Be Completed

    mailto:[email protected]

  • 20

    Specialty Folder 1: Cardiology

    Specialty Folder 2: To be allocated by Quality & Effectiveness Department upon receipt

    Other Specialty folders: To be allocated by Quality & Effectiveness Department upon receipt

    Are there any UHCW documents related to this topic area To Be Completed Yes No

    If yes please provide Title See above

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Clinical Operating Procedure Procedure Ref No: COP 511 Expiry date: April 2019 Version Number: V2 Summary statement / scope of the procedure: Implantable Cardiovertor Defibrillator (ICD) Guidance including: consent at implantation, and deactivation, with a focus on considerations towards end of life Definitions Implantable Cardiovertor Defibrillator (ICD) Recommendations for procedure content: Clinical operating procedures should detail clear and explicit recommendations for practice and in addition to providing general guidance should clearly detail behaviour specific instruction; what, who, when, where and how. This will increase the likelihood of adoption of the procedure. Procedure Title: ICD Consent at Implantation and Deactivation at the End of Life
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