Systematic Review of Decision Tools and their Suitability for Patient-Centered Decisionmaking regarding Electronic Cardiac Devices

CMS evidence review | evidence_type=Technology Assessment | record_type=technology_assessment | document_id=88 | year=2012

Over the past three decades, electronic cardiac devices (ECDs) have been used to electronically stimulate the heart in order to regulate heart function. ECDs include implantable cardioverter-defibrillators (ICDs; with or without cardiac resynchronization therapy [CRT] function), pacemakers, and ventricular assist devices (VADs). Patients with ECDs may develop terminal illnesses due to worsening of their underlying heart condition or other chronic disease. Terminally-ill patients are at greater risk for developing tachyarrhythmias and other arrhythmias, thereby increasing the frequency of ICD shocks. ICD discharges may be so painful and frequent that the harms derived from an ICD can outweigh the benefits. 1 This is challenging however because of the complexity of decisionmaking, particularly in relation to end-of-life issues which are charged with multiple uncertainties around the effects of deactivation, prognosis, and possible frequency of shocks. Therefore, it is reasonable to consider deactivating the shock function of the ICD to neutralize harm from the device as a patient nears the end of life. High-quality decisionmaking, with associated aspects such as informed consent, effective communication, and patient involvement, has emerged as an important area for the insertion and deactivation of ECDs. Recently, the Health Rhythm Society in the United States has addressed important ethical and legal concerns regarding deactivating ICDs and published guidelines on how to promote effective and ethical decisionmaking. These and other recent European guidelines view deactivation of devices as being similar in ethical and legal terms as the withdrawal of any other form of health care or medical treatment. Current opinion is that deactivation of ICDs cannot be considered legally or ethically synonymous with any form of assisted suicide, euthanasia, or cardiopulmonary resuscitation. For practice to be ethical, informed consent must guide decisionmaking on the withdrawal of devices. Specific recommendations exist for ICDs, with current guidelines stating that deactivation issues should be discussed prior to insertion. Further, decisions should be made wherever possible by patients following extensive dialogue with appropriate physician(s) and should be based on personalized, balanced, and comprehensive information of choices. Sufficient time should be provided for patients to make decisions and when possible, discussions should occur prior to the end-of-life stages of the underlying disease. However, over the past five years, evidence has consistently shown that health care practices around decisionmaking in the United States and elsewhere remain concerning and frequently risk compromising informed consent, particularly in relation to ICDs. Decisionmaking aids have been found to be effective in promoting shared and effective decisionmaking in various populations and health decisions. We then examine here the possible effectiveness of these aids in relation to the insertion, continuation, or cessation of ICDs.

Issue: Over the past three decades, electronic cardiac devices (ECDs) have been used to electronically stimulate the heart in order to regulate heart function. ECDs include implantable cardioverter-defibrillators (ICDs; with or without cardiac resynchronization therapy [CRT] function), pacemakers, and ventricular assist devices (VADs). Patients with ECDs may develop terminal illnesses due to worsening of their underlying heart condition or other chronic disease. Terminally-ill patients are at greater risk for developing tachyarrhythmias and other arrhythmias, thereby increasing the frequency of ICD shocks. ICD discharges may be so painful and frequent that the harms derived from an ICD can outweigh the benefits. 1 This is challenging however because of the complexity of decisionmaking, particularly in relation to end-of-life issues which are charged with multiple uncertainties around the effects of deactivation, prognosis, and possible frequency of shocks. Therefore, it is reasonable to consider deactivating the shock function of the ICD to neutralize harm from the device as a patient nears the end of life. High-quality decisionmaking, with associated aspects such as informed consent, effective communication, and patient involvement, has emerged as an important area for the insertion and deactivation of ECDs. Recently, the Health Rhythm Society in the United States has addressed important ethical and legal concerns regarding deactivating ICDs and published guidelines on how to promote effective and ethical decisionmaking. These and other recent European guidelines view deactivation of devices as being similar in ethical and legal terms as the withdrawal of any other form of health care or medical treatment. Current opinion is that deactivation of ICDs cannot be considered legally or ethically synonymous with any form of assisted suicide, euthanasia, or cardiopulmonary resuscitation. For practice to be ethical, informed consent must guide decisionmaking on the withdrawal of devices. Specific recommendations exist for ICDs, with current guidelines stating that deactivation issues should be discussed prior to insertion. Further, decisions should be made wherever possible by patients following extensive dialogue with appropriate physician(s) and should be based on personalized, balanced, and comprehensive information of choices. Sufficient time should be provided for patients to make decisions and when possible, discussions should occur prior to the end-of-life stages of the underlying disease. However, over the past five years, evidence has consistently shown that health care practices around decisionmaking in the United States and elsewhere remain concerning and frequently risk compromising informed consent, particularly in relation to ICDs. Decisionmaking aids have been found to be effective in promoting shared and effective decisionmaking in various populations and health decisions. We then examine here the possible effectiveness of these aids in relation to the insertion, continuation, or cessation of ICDs. Other Material: Other Material 1 Questions: Questions Technology Assessment: Download technology assessment [PDF, 839KB]