Guidelines for the Decision to Withdraw Implantable Cardioverter Defibrillator ( ICD ) Therapy

Publication: 20/07/2015  --
Last review: 08/04/2020  
Next review: 08/04/2023  
Clinical Guideline
CURRENT 
ID: 4267 
Approved By: Trust Clinical Guidelines Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2020  

 

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Guidelines for the Decision to Withdraw Implantable Cardioverter Defibrillator (ICD) Therapy

  1. Introduction
  2. Deactivation
  3. The process
  4. The decision
  5. Completion

1.0 Introduction

An ICD is implanted into two groups of patients:

  • Patients who have had a life threatening ventricular arrhythmia, or
  • Patients who have been identified as being at risk of developing a life-threatening ventricular arrhythmia.

The purpose of the ICD is to monitor the heart rhythm and respond to arrhythmias using several key functions:

  • Administration of defibrillation shocks to terminate ventricular fibrillation (VF) or ventricular tachycardia (VT).
  • Anti-tachycardia pacing (ATP) to terminate ventricular tachycardia.
  • Anti-bradycardia pacing to prevent the heart rate dropping below a specified value.

An ICD is sometimes combined with a Cardiac Resynchronisation Therapy device (CRT-D). CRT is used in patients who exhibit ventricular dyssynchrony and symptoms of heart failure. This device paces both ventricles in an attempt to resynchronise their activation. The CRT-D also provides the same key functions as the ICD described above.

As disease states advance or as the patient enters the last hours or days of life, it may be no longer appropriate for ICD therapy to be delivered. Deactivating the therapies may help to ensure a peaceful death for the patient reaching the end of their natural life.

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2.0 Deactivation

Pacemaker and ICD functions can be programmed independently of each other. 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 painful or distressing unnecessary shocks. In the event that the patient’s condition improves or changes their mind the ICD can be reactivated.

2.1 Deactivation for Patients in Hospital

All hospital wards and departments can request ICD deactivation by completing the attached pro-forma and contacting the Cardiac Devices clinic at Leeds General Infirmary on 0113 3926389 or bleep 80-2243.

The department will ensure the device is deactivated within 72 hours of initial request.

For patients in outlying hospitals and district generals it may be appropriate to organise for the patient to attend the ICD clinic for the deactivation.

2.2 Deactivation for Patients in the Community

Patients that are not in hospital at the time of the decision to deactivate should have equal access to deactivation facilities. GP's will have increasing contact with patients towards the end of their life as they are identified as being in the last months of life and have their care co-ordinated by an Electronic Palliative Care Co-ordination System (EPaCCS). This stage in a patients care should prompt the discussion of ICD deactivation.

GP’s and consultants within hospices can request ICD deactivation by completing the attached pro-forma and contacting the Cardiac Devices clinic on 0113 3926389.

The department will ensure the device is deactivated within 72 hours of initial request.

For patients at home or in a hospice it may be appropriate to organise for the patient to attend the Cardiac Devices clinic for a planned deactivation. If a patient is unable to attend the department for an outpatient visit the deactivation can be carried out in another environment which may include the patient’s home / hospice. In this case the patient’s doctor or healthcare professional caring for the patent should be present.
http://thehub.leedsth.nhs.uk/Documents/PoliciesandProcedure/Lone%20Worker%20Procedure.doc

2.3 Urgent Deactivation.

The decision to deactivate ICD therapy should be made early allowing the procedure to be planned and carried out within a timely fashion.

In very rare circumstances it may be necessary to arrange for urgent deactivation of an ICD if the patient is receiving inappropriate ICD shocks. Should this be the case it is still imperative that the deactivation pro-forma is completed and signed by the doctor in charge of the patient’s care.

Within ‘office hours’ deactivation can be arranged by contacting the Cardiac Devices clinic at Leeds General Infirmary on 0113 3926389 or bleep 80-2243. At other times an on-call Cardiac Physiologist can be contacted via Ward L20 at LGI on 0113 3927420 / 3927520.

Please be aware that in circumstances of urgent deactivation the Cardiac Physiologist will attempt to attend to the patient as soon as possible but may be delayed by other emergency work.

Urgent deactivation may be performed by taping a white/blue ring magnet so that it is positioned on the skin directly over the device. Magnets secured over Biotronik ICDs (only) must be removed for a few seconds and then reapplied every 7 hours as ICD therapies are only deactivated by the magnet for 8 hours with these specific devices. If urgent deactivation using this method has been carried out this must be recorded in the patient’s medical notes. Ring magnets are available on the coronary care unit, in the emergency department and on delivery suite or by contacting the Cardiac Physiologists on 0113 3926389 or 0113 3927420/3927520. Where emergency deactivation using this method is implemented arrangements for definitive deactivation with a programmer should be made with the Cardiac Devices Clinic as soon as possible.

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3.0 The Process

The patient should be aware that therapy deactivation is possible, as described in the pre-procedural consultation with an Arrhythmia Nurse Specialist / Consultant Cardiologist. The question of deactivation may be raised by the patient themselves, the family, or a member of the care team.

The decision to withdraw ICD therapy must be made by the doctor in charge of the patient’s care, such as the consultant overseeing the current patient care (Cardiology or other speciality) or the patient’s General Practitioner. The doctor in charge is responsible for assessing and monitoring the patient’s condition, likely prognosis and treatment options. It may be appropriate to consider the views and assessments of the multi-disciplinary team, and consider if a second opinion would be helpful in a particular case. Decisions regarding deactivation should be shared decisions involving the patient and healthcare team providing care for the patient.

The doctor in charge must record the key stages of the decision making process on the pro-forma (see attached). They should include sufficient detail to ensure that they can give a clear rationale for the decision if ever required in the future. Discussions with the patients, and all involved parties should be documented, along with any relevant clinical findings.

Once completed, the pro-forma should be filed in the patient notes with a copy sent to the Cardiac Devices clinic at Leeds General Infirmary. From there it will be acted upon by the ICD team of Cardiac Physiologists, and filed into the ICD clinic file. The decision must be communicated to the health care parties involved, thus, if the decision is made without the knowledge of the GP, the GP must be informed.

Once the decision has been made, and the ICD therapy deactivated, a review process should be put into place. It is suggested that a review date should be stipulated at which point the patient condition, clinical findings, and patient wishes should be taken into consideration. The ICD therapies can be reactivated in the event that a patient’s condition improves unexpectedly or the patient changes their mind, and if this decision is made the doctor in charge should communicate with the ICD team to arrange for this.

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4.0 The Decision

4.1 The Competent Patient

According to the Mental Capacity Act (2005) ‘A person must be assumed to have capacity unless it is established that he lacks capacity’. This along with other principles outlined in the act is designed to protect the patient against having decision making taken away from them. The adult patient has the right to decide about different treatment options and how much weight to attach to benefits, burdens, risks and overall acceptability of any treatment, even life-sustaining treatment.

If it is deemed that the patient is of the capacity to make a decision regarding their own treatment the doctor in charge of the care has a responsibility to discuss ICD therapy with them. The doctor should outline the prognosis of the patient’s condition and both the disadvantages and advantages of withdrawing ICD therapy and also those of continuing ICD therapy. At this point it is encouraged that family members that are close to the patient are involved in the discussions regarding future treatment, providing the patient consents to the contribution of the relatives.

With this information the patient has the right to decide whether or not they agree to withdrawal of ICD therapy.

4.2 Patients who may Lack Capacity

It may be deemed that a patient is not competent to make a decision regarding ICD therapy for themselves.

The Mental Capacity Act (2005) defines a patient who lacks capacity. “A person lacks capacity in relation to a matter, if at the material time he is unable to make a decision for himself in relation to the matter, because of an impairment of, or a disturbance in the function of the mind or brain.”

The act sets out a test for assessing whether a person lacks capacity. Detail on assessing capacity is covered in the Mental Capacity Act Code of Practice. This can be viewed online by clicking on the link (Click Here) or by visiting the web address below -
http://www.legislation.gov.uk/ukpga/2005/9/contents

Examples of conditions that may elicit one that lacks capacity include dementia, learning disabilities, mental health problems and stroke or head injuries.

In this situation there are a number of routes which the person in charge of care can follow with regards to coming to a decision on ICD therapy. They include an advance decision, an appointed attorney under Lasting Power of Attorney for health and welfare document, a consensus decision on the patient’s best interests, or the appointment of an Independent Mental Capacity Advocate (IMCA). The options are discussed in more detail below.

Under all of these circumstances it is important to consider the Mental Capacity Act (2005) and adhere to its code of practice.

Further information is available on the LTHT Intranet pages - Click Here

4.3 Advanced Care Planning

Advance Care Planning (ACP) is a process of discussion between an individual and their care provider irrespective of discipline. The process of ACP is to make clear a person’s wishes and will usually take place in the context of an anticipated deterioration of the individual’s condition. It is recommended that with the individual’s agreement this discussion is documented, regularly reviewed and communicated to key persons involved in their care.

As part of ACP a patient may have discussed and documented their wish to have ICD therapies withdrawn as their condition deteriorates. The wishes expressed during ACP are not legally binding but should be taken into account when professionals are required to make a decision on a person’s behalf.

Further Information is available on:

4.4 Advance Decision (to Refuse Treatment)

In some circumstances the patient may have made an advance decision. The advance decision should specify the treatment which is to be refused and may specify the circumstances in which the refusal applies. In this particular instance there should be written documentation of the wish to withdraw ICD therapy should an illness be determined as terminal. Should an advance decision have been made that is relevant and applicable to the current circumstances the doctor in charge of care should consider these wishes.

4.5 Lasting Power of Attorney

It is possible for a patient to have appointed an attorney(s) under the Lasting Power of Attorney for health and welfare document. This must have been completed and registered with the Office of the Public Guardian while the patient still had capacity. A registered Lasting Power of Attorney (LPA) form for Health and Welfare would usually consist of 12 pages (unless there are more than one attorney or replacement attorneys). It would bear the Office of the Public Guardian stamp on the front page, and would display the text ‘Validated – OPG’.

Should the patient have appointed an attorney for health and welfare, and the patient is deemed to lack capacity the decision regarding withdrawal of ICD therapy can be made by this attorney.

In this situation the doctor in charge of patient care may discuss the treatment options with the attorney, prognosis of the patient’s condition and both the disadvantages and advantages of withdrawing ICD therapy and also those of continuing ICD therapy.

4.6 Best Interests

It may well be the case that a patient that lacks capacity has not made an advance decision or appointed a Lasting Power of Attorney. If the doctor in charge of patient care decides that ICD therapy should be withdrawn, in this situation they may make a decision based on the best interests of the patient. When considering making a decision in the patient’s best interests they should consider section 1.4 of the Mental Capacity Act; ‘Best Interests’.

At this point it may or may not be appropriate to consider the views of the multidisciplinary team, those close to the patient or anyone engaged in caring for the patient or interested in their welfare. Should this be the case a consensus decision must be reached regarding the deactivation of ICD therapy.

4.7 Independent Mental Capacity Advocate (IMCA)

If a decision cannot be made on the patient’s best interests or if there is no-one close to the patient or properly interested in their welfare with whom it is practical and appropriate to consult, a referral must be made to an Independent Mental Capacity Advocate (IMCA). The Mental Capacity Act requires NHS bodies to instruct an IMCA in all cases where ‘serious medical treatment’ is proposed. The IMCA’s role is to be consulted about whether withdrawal of ICD therapy is in the patient’s best interests, and to represent the views of the patient.

On investigation of the medical notes, consideration of views of the multi-disciplinary team, and ascertaining what the patient’s feelings and wishes would likely be, the IMCA can make a recommendation on the direction of future treatment. The IMCA will usually provide a report with their conclusions.

It is the duty of the doctor in charge of care to consider the recommendations and conclusions of the IMCA but the doctor remains responsible for the final decision on withdrawal of ICD therapy.

If it is decided that an IMCA does need to be consulted, the relevant information can be found on the LTH Intranet pages (Click here)

Further information and support can be obtained from:

Adult Safeguarding Team -

4.8 Seeking Legal Advice

The decision to withdraw ICD therapy is the responsibility of the most senior doctor in charge of the patient’s care. If at any point during the decision making process the doctor in charge of care is in any doubt about the decisions he/she has to make they must seek legal advice through the usual channels within Leeds Teaching Hospitals NHS Trust. This would be done by contacting the Risk Management Department and speaking to the Associate Medical Director for Risk or the Trust Risk Manager.

Risk Management can be contacted on: (0113) 2066992 / 2066688. They are based within Trust Headquarters at St James’s University Hospital.

Further, should the doctor in charge disagree with decisions made by the patient, the patient’s attorney, or the IMCA, and consider these decisions to be unethical they should again endeavour to seek legal advice.

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5.0 Completion

Please complete, sign, and fax the attached pro-forma to the Cardiac Physiologists at Leeds General Infirmary on 0113 3923371. This must be accompanied by a telephone call to the department on 0113 3926389 to alert us of the fax.

See attached decision tree for further guidance in completing the pro-forma.

Provenance

Record: 4267
Objective:
  • To allow timely deactivation of ICD therapy prior to the death of a patient to promote high quality care for patients approaching end of life.
  • To ensure good documentation and communication with regards to discussions and decisions related to ICD deactivation.
Clinical condition:
Target patient group:
Target professional group(s): Secondary Care Doctors
Adapted from:

Evidence base

Not supplied

Approved By

Trust Clinical Guidelines Group

Document history

LHP version 2.0

Related information

Not supplied

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