PrintDownload PDFGet Adobe ReaderDownload to WordDownload as HTMLDownload as XMLCitation Manager
Save to Favorites
Guideline Summary
Guideline Title
HRS expert consensus statement on the management of cardiovascular implantable electronic devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy.
Bibliographic Source(s)
Lampert R, Hayes DL, Annas GJ, Farley MA, Goldstein NE, Hamilton RM, Kay GN, Kramer DB, Mueller PS, Padeletti L, Pozuelo L, Schoenfeld MH, Vardas PE, Wiegand DL, Zellner R, American College of Cardiology, American Geriatrics Society, American Academy of Hospice and Palliative Medicine, American Heart Association, European Heart Rhythm Association, Hospice and Palliative Nurses Association. 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. 2010 Jul;7(7):1008-26. [115 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Diseases and conditions, including bradycardia and heart failure, requiring cardiovascular implantable electronic devices (CIEDs)

Guideline Category
Counseling
Evaluation
Management
Clinical Specialty
Cardiology
Family Practice
Geriatrics
Internal Medicine
Nursing
Pediatrics
Psychiatry
Psychology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Nurses
Other
Patients
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Social Workers
Guideline Objective(s)
  • To make clinicians aware of the legal, ethical, and religious principles which underlie withdrawal of life sustaining therapies, including device deactivation, in patients who have made this decision
  • To highlight the importance of proactive communication by the clinician in order to minimize suffering as the end of life nears for patients with cardiovascular implantable electronic devices (CIEDs)
  • To provide a management scheme to guide the clinician in assisting a patient with a request to withdraw CIED therapy
Target Population
  • Adult and pediatric patients with cardiovascular implantable electronic devices (CIEDs) who are nearing end of life or who are considering CIED deactivation for other reasons
  • Family members of the above patients
Interventions and Practices Considered
  1. Consideration of ethical and legal principles and precedents
  2. Consideration of religious beliefs and principles
  3. Communication with patient and family members about the cardiovascular implantable electronic device (CIED) deactivation process
  4. Logistics of CIED deactivation, including discussion of alternatives
  5. Management of CIEDs in children nearing end of life or requesting withdrawal of treatment
Major Outcomes Considered
  • Mortality rates
  • Rate of painful implantable cardioverter-defibrillators (ICD) shocks
  • Quality of life
  • Patient and family distress

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Medline and PubMed databases were searched. All initial literature searches were performed at the time the document writing committee was initiated in March of 2009. Subsequent literature searches were performed as needed throughout document development and concluded in May of 2010. Because the document is more of a policy document than a scientifically based research article, no relevant information was excluded. Initial search terms of implantable device and palliative care, communication and ethics were used; each section author was responsible for adding search criteria relevant to their section.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

To address this topic, a multidisciplinary writing group was convened consisting of electrophysiologists, patients, and individuals with expertise in the fields of geriatrics, palliative care, psychiatry, pediatrics, nursing, law, ethics, and divinity. Input from industry and patient groups was also solicited and incorporated where relevant. Recommendations are based on consensus of the writing group and confirmed by the Heart Rhythm Society's established consensus process. Agreement was greater than 90% on all recommendations.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Not stated
Description of Method of Guideline Validation

Not applicable

Recommendations

Major Recommendations

Basic Principles

Ethical and Legal Principles and Precedents

  • A patient with decision-making capacity has the legal right to refuse or request the withdrawal of any medical treatment or intervention, regardless of whether s/he is terminally ill, and regardless of whether the treatment prolongs life and its withdrawal results in death.
  • When a patient lacks capacity, his/her legally-defined surrogate decision-maker has the same right to refuse or request the withdrawal of treatment as the patient would have if the patient had decision-making capacity.
  • The law presumes that all adults are competent, defined as the ability to understand the nature and consequences of one's decisions. Only a court can declare an adult patient incompetent. In most situations, however, clinicians can assess patients' decision-making capacity and act on these assessments without involvement of the courts.
  • Ethically and legally, there are no differences between refusing cardiovascular implantable electronic device (CIED) therapy and requesting withdrawal of CIED therapy.
  • Advance directives should be encouraged for all patients with CIEDs.
  • Legally, carrying out a request to withdraw life-sustaining treatment is neither physician-assisted suicide nor euthanasia.
  • Ethically, CIED deactivation is neither physician-assisted suicide nor euthanasia. When carrying out a patient's request for withdrawal of a life-sustaining treatment that a patient perceives as unwanted (including CIED therapies), the clinician's intent is to discontinue the unwanted treatment and allow the patient to die naturally of the underlying disease - not to terminate the patient's life.
  • The right to refuse or request the withdrawal of a treatment is a personal right of the patient and does not depend on the characteristics of the particular treatment involved (i.e., CIEDs). Therefore, no treatment, including CIED therapies, has unique ethical or legal status.
  • A clinician cannot be compelled to carry out an ethically- and legally-permissible procedure (i.e., CIED deactivation) that s/he personally views in conflict with his/her personal values. In these circumstances, the clinician cannot abandon the patient but should involve a colleague who is willing to carry out the procedure.

Basic Religious Principles

  • Legal and ethical rationales for respecting patients' rights to refuse medical treatment are supported by the tenets of major religious traditions in Western culture.
  • Depending on the significance (to the patient) of religious belief and its bearing on the decision to be made, it can be part of what motivates a patient to choose or refuse deactivation of CIED devices.
  • The distinction between letting life go (allowing to die) and taking life (intending to actively kill) is religiously important, especially for those who appeal to it as part of their religious understanding of justifiable choices regarding death.
  • Perception of disproportionate burden caused by continuation of life-sustaining treatment, as determined by the patient, is central to religious justifications of permissibility of letting life go.
  • A clinician whose own religious beliefs are not in line with the patient's may not override a patient's or surrogate's choice. The clinician may, however, appeal to his/her own right not to participate in deactivation—not abandoning the patient but by involving a colleague who is willing to carry out the procedure.
  • Patients should be provided the support they want and need in order to make decisions about deactivation of CIEDs that are coherent with their spiritual and moral beliefs.

Effectively Putting into Practice the Device Deactivation Process

Communication

  • Communication about CIEDs should be a part of a larger conversation about patients' goals of care. The role of the clinician is to help patients determine how the benefits and burdens of device therapy align with their desired outcomes for their health care.
  • Communication about CIED deactivation is an ongoing process that starts prior to implant and continues over time as patient's health status changes.
  • While the role of the clinician is to advise and assist the patient and family, the ultimate decision-making authority rests with the patient; or his/her surrogate, if the patient does not have capacity to make the decision.
  • Multiple options are available to the patient, family, and clinicians with regard to the extent of deactivation of CIED therapy and the modalities available, ranging from programming off only certain features such as shock therapy, to discontinuation of all therapy to not replacing a depleting device.

Logistics of CIED Deactivation

  • Any physician or center that implants CIEDs should have a clearly defined process to withdraw therapies at such a time that becomes appropriate.
  • Deactivation of CIED therapies requires an order from the responsible physician, preferably written, with appropriate documentation. In emergent situations, a verbal order should be followed by written documentation within 24 hours.
  • Documentation prior to deactivation must include the physician's determination that the patient has the capacity to make the decision or that the appropriate surrogate has been identified; that consequences to deactivation have been discussed; and that alternatives have been discussed if relevant.
  • A physician order for deactivation must include the specific therapies to be deactivated or re-programmed.
  • The deactivation process should include anticipation of symptoms and appropriate palliative care planning tailored to individual patients' needs, as well as the needs of family members when appropriate.
  • Deactivation of anti-tachycardia therapies may be achieved by re-programming or by magnet application.
  • Deactivation of pacing therapies may be achieved by reprogramming to specific modes or to sub-threshold outputs.
  • Any uncertainties about the specifics of deactivation should be clarified by the health care team, ideally in consultation with a physician with electrophysiology expertise.
  • The specific resources of acute care facilities, inpatient hospice, long-term care facilities, or patients at home require careful consideration when planning and carrying out a device deactivation.
  • All Industry Employed Allied Professionals (IEAP) must work under direct supervision of medical personnel (except in highly rare circumstances).
  • Each manufacturer has policies that apply to the deactivation of CIED therapies; it is the responsibility of the IEAP to ensure that they adhere to these policies.
  • Personnel including clinicians and IEAPs who do not wish to personally participate in deactivation should assist in locating qualified individuals who are willing to carry out this request.

Special Populations—Pediatrics

  • Management of CIEDs in children nearing end of life or requesting withdrawal of treatment requires an assessment of the child's decision-making capacity.
  • If a child does not have decision-making capacity, a parent or guardian should make decisions in the child's best interest.
  • Even when a child does not have decision-making capacity, communication of decisions should be provided to the child, recognizing their developmental level and individual preferences.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of evidence supporting each recommendation is not specifically stated.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Improved evaluation, communication and management (including device deactivation) of patients with cardiovascular implantable electronic devices (CIEDs) nearing end of life

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements

When using or considering the guidance given in this document, it is important to remember that there are no absolutes with regard to many clinical situations. The ultimate judgment regarding care of a particular patient must be made by the health care provider and the patient in light of all the circumstances presented by that patient.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
End of Life Care
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Lampert R, Hayes DL, Annas GJ, Farley MA, Goldstein NE, Hamilton RM, Kay GN, Kramer DB, Mueller PS, Padeletti L, Pozuelo L, Schoenfeld MH, Vardas PE, Wiegand DL, Zellner R, American College of Cardiology, American Geriatrics Society, American Academy of Hospice and Palliative Medicine, American Heart Association, European Heart Rhythm Association, Hospice and Palliative Nurses Association. 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. 2010 Jul;7(7):1008-26. [115 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Jul
Guideline Developer(s)
Heart Rhythm Society - Professional Association
Source(s) of Funding

Heart Rhythm Society

Guideline Committee

Writing Group

Composition of Group That Authored the Guideline

Authors: Rachel Lampert, MD, FHRS, Yale University, School of Medicine, New Haven, CT; David L. Hayes, MD, FHRS, Mayo Clinic, Rochester, MN; George J. Annas, JD, MPH, Boston University, School of Public Health, Boston, MA; Margaret A. Farley, PhD, Yale University Divinity School, New Haven, CT; Nathan E. Goldstein, MD, Mount Sinai School of Medicine New York, NY, and the James J Peters VA Medical Center, Bronx, NY; Robert M. Hamilton, MD, The Hospital for Sick Children, Toronto, Canada; G. Neal Kay, MD, FHRS, The University of Alabama at Birmingham, Birmingham, AL; Daniel B. Kramer, MD, Beth Israel Deaconess Medical Center, Boston, MA; Paul S. Mueller, MD, MPH, Mayo Clinic, Rochester, MN; Luigi Padeletti, MD, University of Florence, Institute of Cardiology, Florence, Italy; Leo Pozuelo, MD, Cleveland Clinic, Cleveland, OH; Mark H. Schoenfeld, MD, FHRS, Yale University, School of Medicine, New Haven, CT; Panos E. Vardas, MD, PhD, Heraklion University Hospital, Crete, Greece; Debra L. Wiegand, PhD, RN, University of Maryland, School of Nursing, Baltimore, MD; Richard Zellner, JD, MA, Patient representative; Adjunct lecturer at Case Western Reserve University, Bioethics Department, Cleveland, OH

Financial Disclosures/Conflicts of Interest

See the Appendix in the original guideline document for author relationships with industry.

Guideline Endorser(s)
American Academy of Hospice and Palliative Medicine - Professional Association
American College of Cardiology Foundation - Medical Specialty Society
American Geriatrics Society - Medical Specialty Society
American Heart Association - Professional Association
European Heart Rhythm Association - Professional Association
Hospice and Palliative Nurses Association - Professional Association
Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Heart Rhythm Society (HRS) Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

  • The HRS policy for development and endorsement of clinical guidance documents from HRS and others. Washington (DC): Heart Rhythm Society (HRS); 2009 Sep. 6 p. Available from the Heart Rhythm Society Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on March 5, 2013.

Copyright Statement

This summary is based on the original guideline, which is subject to the guideline developer's restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Read full disclaimer...