Abstract
Background
Communication about deactivation of ICDs in patients near the end of life is rare.
Objectives
To determine if hospices are admitting ICD patients, if hospice patients are receiving shocks, and how hospices manage ICDs.
Design
Cross-sectional survey.
Setting
Randomly selected hospice facilities
Participants
900 hospices were surveyed. A total of 414 hospices responded.
Measurements
Frequency of admission of ICD patients, frequency of patients receiving shocks, existence of deactivation policies, and frequency of deactivation.
Results
97% of hospices admit patients with ICDs. 58% reported that in the last year a patient had been shocked. Only 10% of hospices had a policy which addressed deactivation. On average, 42% (SE 2.9) of patients with ICDs have the shocking function deactivated. A sample deactivation policy is available as a web-only appendix.
Limitations
The study relied on the knowledge of hospice administrators.
Conclusions
Hospices are admitting patients with ICDs, and patients are being shocked at the end of life. Assuring that hospices have policies in place to address deactivation may improve the care for patients with these devices.
Introduction
There has recently been significant expansions in the indications for Implantable Cardioverter Defibrillators (ICDs).(1, 2) Because shocks from an ICD are painful and anxiety provoking, (3, 4) at the end of life some patients may choose to have the shocking function deactivated. Deactivation conversations are complicated and rare (5, 6) and patients may not understand the role the device plays in their end-of-life care.(7)
Hospices have long been a leader in caring for patients with advanced disease. Patients admitted to hospice must have a prognosis of six months or less and agree to forego life-prolonging treatment. As such, a discussion about defibrillator management is appropriate for hospice patients with an ICD. However, there has been no systematic examination of the management of ICDs for patients on hospice.
The objectives of this study were to determine the frequency with which hospices are admitting ICD patients, the frequency with which hospice patients are receiving shocks, and the processes hospices use to care for ICD patients.
Methods
We received a list of 3750 hospices from the National Hospice and Palliative Care Organization, whose membership includes over 80% of U.S. hospices.(8) From this list, we generated a stratified random sample of 100 hospices from each of the 9 US Census regions. To account for the unequal probability of hospice selection by region, we included a sampling weight proportional to the inverse of the probability of a hospice being chosen using SAS/STAT® Version 9.1.3 (9).
Based on our previous work, (6, 7) we created a novel survey instrument. The survey asked how many patients with active ICDs had been admitted, and respondents were given a range of choices. The survey then asked if any of the patients had been shocked (yes/no) and if any had ever received multiple shocks (yes/no). The survey prompted for the time period of these responses to be “in the last year.” Next, the survey asked if there was an item on the hospice intake forms to identify ICD patients (yes/no), if the hospice had a formal deactivation policy (yes/no), what percent of patients had their device deactivated while on hospice (open-ended), and if there was a strong magnet on hand for emergency deactivation (yes/no). (It was clearly stated that questions about device deactivation referred only to the shocking function.) Hospices with formal policies were asked to submit a copy.
We then sent the survey to the Scientific Advisory Committee of the Population-based Palliative Care Research Network.(10) The Advisory Committee provided feedback on survey readability, ease of use, and validity. The survey was next pilot tested with several clinicians. Since the study did not collect patient data, it was exempt from review according to Mount Sinai's Institutional Review Board.
We mailed the survey to all selected hospices, and respondents could either fax back the paper version or complete an identical version online. We used a series of incentives, including a pen and a $2 bill. Non-responding hospices were called to encourage participation.
Results relating to response rate and analysis of deactivation policies are presented as actual (unweighted) numbers. All other results are reported as weighted percentages. Chi-square and t-test were used for bivariate analyses. When hospices answered “don't know” to a yes/no question, we performed a sensitivity analysis where we assigned all of the “don't know” responses as both “no” and then “yes” to determine the potential range of responses that might be possible.
We (NG, MC) reviewed the submitted ICD policies (inter-rater reliability was 96%) for the following generally accepted necessary criteria (11, 12): 1) prompt to identify patients with ICDs; 2) discussion of the benefits/burdens of the device as they relate to the patient's illness; and 3) instructions as to how to have the device re-programmed. In addition, we examined the policies to determine if they discussed the ethical basis for deactivation, what to do if a patient could not travel, and a process outlining the use of a magnet in an emergency setting. These last criteria have been identified as being important (although not essential) elements of a deactivation policy.(12)
Results
After accounting for those hospices for which we had incorrect contact information (n=41) or which no longer operated as a hospice (n=24), the denominator was reduced to 835. The 62 hospices who told us they have not admitted ICD patients but declined to provide any further information were treated as refusals, as has been previously described.(13) We received completed surveys from 414 hospices, a 50% response rate. Response rates did not differ by census regions (χ2=11.2; P=0.20). The table shows the hospices’ characteristics.
Table.
Characteristics of Hospices and Management Practices Relating to Implantable Defibrillators.1
| Ownership Type (%) | |
| For Profit | 25% |
| Not-for-Profit | 72% |
| Other | 2% |
| Unknown | 1% |
| Daily Census Mean (SE) | 116.5 (10.6) |
| Length of Stay in Days Mean (SE) | 62.3 (2.0) |
| Percent of Patients with Admitting Diagnosis of heart Disease Mean (SE) | 15.3 (0.6) |
| Facilities that will Admit Patients with Active ICDs2 | 97% (96, 99) [89-97%] |
| Number of Patients Hospice Admitted with an Active ICD in the Last Year | |
| 0 | 15% |
| 1-10 | 76% |
| 11-25 | 6% |
| 26-50 | 2% |
| 51-100 | 1% |
| >100 | 0% |
| Facilities with Question on Intake Form Asking if Patient Has ICD2 | 20% (16, 24) [19-21%] |
| Hospices with Written Policy for Deactivating ICDs2 | 10% (7, 13) [10-12%] |
| At Least One Patient at Hospice was Shocked2 | 58% (53, 64) [45-68%] |
| At Least One Patient at Hospice was Shocked Multiple Times2 | 40% (34, 47) [25-59%] |
| How are ICDs Deactivated?3 | |
| Patient Sent to Clinic | 34% |
| Member of hospice team turns off device | 14% |
| Non-Hospice health care provider comes to hospice/home to deactivate device. | 31% |
| Representative from device manufacturing company come to hospice/home to deactivate device. | 47% |
| Hospice has magnet on hand to deactivate ICD.2 | 25% (20, 29) [24-28%] |
| Of hospices with magnet, special training is provided to staff in its use.2 | 64% (53, 76) [60-66%] |
Weighted data.
Percentages shown in the parenthesis represent the 95% confidence interval for the data. Percentages shown in brackets represent a sensitivity analysis to determine the range of potential responses for those facilities that answered “don't know” to the question. The range was determined by assigning either all “no” or all “yes” answers to those hospices that answered “don't know” to the question.
Hospices could choose more than one response.
Almost all hospices (97%) would admit patients with active ICDs. In the last year, 76% of hospices admitted between 1-10 patients with an active ICD. 58% of hospices reported that at least one person was shocked in the last year, and 40% of those reported that at least one patient had received multiple shocks during a single episode.
20% of hospices had a question on their intake forms to identify patients with ICDs, and 10% of hospices had a deactivation policy. Hospices with a question on their intake forms were more likely to have a deactivation policy (odds ratio 4.6, 95% confidence interval 2.3-9.2). 25% of hospices had a strong magnet available to deactivate an ICD, and of those 64% provided training in its use.
Of patients with active devices, on average 42% (SD = 2.9) have the shocking function turned off while on hospice. Hospices which have a policy are more likely to have a higher mean percentage of patients have their devices deactivated compared to those without a policy (73% vs. 38%, P<0.001).
Fifteen hospices provided copies of their deactivation policies. In a content analysis, 11 had a section prompting device identification, 15 discussed “informed consent” in relation to deactivation, and 14 outlined the steps to reprogram the device. In addition, 9 discuss the ethical basis for deactivation, 9 addressed what should be done if the patient cannot travel, and 7 addressed the emergency use of a magnet. No policy required deactivation. The authors synthesized elements of submitted policies to create a sample policy that contains all of the essential elements (web-only appendix).
Discussion
We found that hospices were admitting patients with active ICDs and patients with these devices were being shocked near the end of life. Less than half of patients had their devices deactivated during their time on hospice, and having a policy addressing deactivation was associated with a higher percentage of device deactivation.
Improvements in models of care for ICD patients with advanced disease are needed. The strong relationship between having a question on the hospice intake form and having a deactivation policy demonstrates that the two go hand-in-hand, but most facilities have neither. A causal relationship between having a policy and a greater number of devices deactivated cannot be established, but the relationship is intriguing and further study is needed. By writing the sample policy we hope to facilitate quality improvement for hospices. Our objective in providing this sample policy is that hospices will adapt it to their own circumstances to improve the quality of care for patients and their families.
The sample policy proposed is a combination of the “best elements” of the policies the investigators received. It must be remembered that ICDs are complex devices, and in many cases may be multi-functional. A clear understanding of these devices is important to assure the highest quality conversations with patients and their families. Hospices must create relationships with local electrophysiologists and representatives from device manufacturing companies to assure that patients – especially those who cannot leave their place of residence – are able to have their devices re-programmed. Willingness of non-hospice clinicians or manufacturer representatives to do “home visits” may vary, thus the implications of device deactivation are not only important for hospices – but also for any clinician who deals with a patient with an ICD.
This is the first nationwide study examining the management of ICDs in hospice patients. There are limitations that must be considered. First, this study relied on the knowledge of hospice administrators so data provided by the hospices cannot be directly verified; we did, however, ask the recipient to work collaboratively with other team members when responding. Second, our response rate was low, but it is similar to or better than other studies examining practices of end-of-life care, (14-16) and there was no regional variation in response rates. Finally, the survey was conducted at the level of the hospice, so no information about individual patients was collected. Future work will need to determine how patient level factors relate to ICD deactivation practices.
In conclusion, hospices enroll patients with active ICDs, and patients are shocked near the end of life. These data show an association between having a deactivation policy and a higher percentage of patients with deactivated ICDs. We hope that by providing a sample policy, hospices are encouraged to engage in quality improvement activities that will improve outcomes for patients with ICDs and their families.
Supplementary Material
WEB-ONLY APPENDIX. Sample ICD Deactivation Policy. This policy is a synthesis of actual policies submitted by responding hospices. It provides the core elements that should be included in a policy addressing the management of these devices for patients on hospice. It has not been pilot tested, and should be adapted by hospices once they have identified community partners who will assist with re-programming of patients’ devices.
Ethical Rationale for Deactivation:
Implantable Cardioverter Defibrillators (ICDs) are often multi-functional devices that are programmed to meet an individual patient's cardiac needs. These devices are designed to terminate potentially life-threatening arrhythmias in patients, and one way that they do this is to deliver electrical shocks to the heart. Unlike other treatments these devices may deliver to correct arrhythmias, the patient may experience pain or discomfort when the ICD discharges. That an ICD is present does not automatically mean that it will fire as death approaches. Deactivation of the shocking function is not a requirement for admission to hospice, but may be in line with the goals of hospice care to preserve quality of life during the dying process. Defibrillators are medical treatments subject to the same ethical and clinical considerations as any other treatment. ICDs are subject to an analysis of potential benefits and burdens and patients/surrogates have the right to accept or refuse its interventions just like any other treatment. These should not be isolated decisions but instead made in the context of the patient's larger goals of care.
Identification of Device
At the time of evaluation and admission to hospice (regardless of setting in which care is delivered), all patients/families will be queried about the presence of a pacemaker and/or ICD. On physical examination, the chest wall of each patient should be checked for the presence of a cardiac device. (Devices are usually placed underneath the clavicle and may be visible and/or palpable.) If a device is identified, the patient/family should be asked if they have the card that was provided at the time of implantation to aid in determining the nature of the device. If the card cannot be located, the hospice nurse should contact the patient's primary care physician or cardiologist to determine the nature of the device.
Informed Consent Discussion about Device Deactivation
After an ICD has been identified, the hospice nurse should engage in an informed consent discussion with the patient/family/surrogate about the potential benefits and burdens of the device at this point in the patient's illness. In order to make a truly informed choice about whether or not to deactivate the shocking function, the following points should be emphasized during the discussion.
Leaving the defibrillation function on could potentially cause the patient to experience pain if the device delivers shocks near the end of life.
Turning off the shocking function means the device will not be able to provide all of the available methods of life-saving therapy in the event of a potentially fatal heart rhythm. Leaving the shocking function active does not guarantee, however, that in the event of an arrhythmia the heart will return to a normal pattern of beating.
Turning off the ICD will not cause death.
Turning off the ICD will not be painful, nor will a patient's death be more painful if it is turned off.
Decisions about deactivating a pacemaker are often made separately from the decision to turn off a defibrillator, and depend on the indication for the pacemaker and the patient's underlying intrinsic cardiac rhythm. Both are justifiable, however, on ethical grounds depending on the patient's overall goals of care. Deactivating a pacemaker may result in changes in a patient's symptoms. Consultation before deactivation with a cardiologist and/or electrophysiologist is often advisable to assure that appropriate treatments are readily available if the pacemaker is deactivated.
Process for Re-Programming the ICD
If a decision has been made to deactivate the shocking function of the ICD, the hospice nurse will inform the medical director to let him/her know the decision has been made to re-program the device so it will no longer deliver shocks. Note: Re-programming an ICD in this manner will stop it from ever delivering shocks. Placing a magnet over the ICD will stop it from sensing the rhythm and delivering a shock, but only while the magnet is physically present over the device.
If the patient is ambulatory, the nurse will contact the patient's cardiologist or electrophysiologist to arrange for the patient to come to the office to have the device re-programmed so the shocking function can be deactivated.
If the patient is not able to leave his/her place of residence, then the hospice nurse will develop a plan with the attending physician for the re-programming of the patient's ICD, which may include one of the following processes:
The patient's cardiologist/electrophysiologist or a member of the team will be contacted to come to the patient's place of residence to re-program the device.
A member of the hospice team with special training in the deactivation of ICDs will arrange to borrow the equipment (similar to a small laptop computer) from the cardiologist/electrophysiologist and bring it to the patient's place of residence to re-program the device. Equipment may be manufacturer specific, so this member of the team must know which manufacturer made the patient's ICD.
A representative from the device manufacturing company, after appropriate consultation with the hospice medical director and/or the patient's cardiologist/electrophysiologist will come to the patient's place of residence to re-program the ICD.
In any situation where the patient is not ambulatory, the hospice nurse will be present in the place of residence during the re-programming process to provide emotional support to the patient/family/surrogate.
Process for Deactivation of an ICD in an Emergent Scenario
If there is a decision for the shocking function of the ICD to remain active, a magnet designed for cardiac devices should be left in the patient's place of residence in the event of an emergent scenario where the patient is being repeatedly shocked. It should be explained to the family that if a patient is receiving repeated shocks from the ICD, then placing the magnet over the device will stop it from sensing the cardiac arrhythmia. The magnet will need to be taped in place, as it only stops the ICD from sensing. (An ICD which does not sense will not deliver treatments.) Once the magnet is removed the ICD will begin sensing again and may again deliver shocks.* The magnet is heavy and may not be comfortable if left in place for an extended period of time. If the family is not comfortable performing this procedure themselves, the magnet should still be left in the place of residence so in an emergent situation a hospice nurse who arrives will have the tools necessary to suspend the shocking function of the device.
Post-Mortem Care
After a patient has died, the ICD will not deliver a shock. If a magnet has been taped to the chest, it can be removed as soon as a nurse has verified the patient no longer has cardiac function. If the body is to be cremated, the funeral director should be notified of the presence of an ICD, as incinerating the battery can lead to its explosion.
* Note: At the time this protocol was written, there was one ICD on the market which, when placed in the presences of a magnet for a brief period of time, would be permanently re-programmed to completely deactivate the shocking function. If one is not sure of the exact specifications of a patient's ICD the best practice is to keep the magnet in place.
Acknowledgments
The authors would like to thank the hospices that participated in our survey for sharing their information and policies. They also thank the National Hospice and Palliative Care Organization for sharing the list of hospices, and the Population-based Palliative Care Research Network for their assistance with the survey design. The findings and interpretation reported in this manuscript do not reflect the opinions of either the National Hospice and Palliative Care Organization or the Population-based Palliative Care Research Network. Portions of this study were presented at the 2009 Assembly of the American Academy of Hospice and Palliative Medicine. The authors have no conflicts of interest to disclose.
Sources of Funding:
Dr. Goldstein is supported by a Mentored Patient-Oriented Research Career Development Award for the National Institute of Aging (K23 AG025933). Dr. Carlson is supported by a NINR Career Development Award (1K99NR010495-01). Dr. Kutner is supported by an Academic Career Leadership Award from the NIA (K07AG030337-01A2). The funders had no role in the study design, data collection, or manuscript preparation, and the results do not represent the opinions of the funding organizations. Dr. Goldstein had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Footnotes
Publisher's Disclaimer: This is the prepublication, author-produced version of a manuscript accepted for publication in Annals of Internal Medicine. This version does not include post-acceptance editing and formatting. The American College of Physicians, the publisher of Annals of Internal Medicine, is not responsible for the content or presentation of the author-produced accepted version of the manuscript or any version that a third party derives from it. Readers who wish to access the definitive published version of this manuscript and any ancillary material related to this manuscript (e.g., correspondence, corrections, editorials, linked articles) should go to www.annals.org or to the print issue in which the article appears. Those who cite this manuscript should cite the published version, as it is the official version of record.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
WEB-ONLY APPENDIX. Sample ICD Deactivation Policy. This policy is a synthesis of actual policies submitted by responding hospices. It provides the core elements that should be included in a policy addressing the management of these devices for patients on hospice. It has not been pilot tested, and should be adapted by hospices once they have identified community partners who will assist with re-programming of patients’ devices.
Ethical Rationale for Deactivation:
Implantable Cardioverter Defibrillators (ICDs) are often multi-functional devices that are programmed to meet an individual patient's cardiac needs. These devices are designed to terminate potentially life-threatening arrhythmias in patients, and one way that they do this is to deliver electrical shocks to the heart. Unlike other treatments these devices may deliver to correct arrhythmias, the patient may experience pain or discomfort when the ICD discharges. That an ICD is present does not automatically mean that it will fire as death approaches. Deactivation of the shocking function is not a requirement for admission to hospice, but may be in line with the goals of hospice care to preserve quality of life during the dying process. Defibrillators are medical treatments subject to the same ethical and clinical considerations as any other treatment. ICDs are subject to an analysis of potential benefits and burdens and patients/surrogates have the right to accept or refuse its interventions just like any other treatment. These should not be isolated decisions but instead made in the context of the patient's larger goals of care.
Identification of Device
At the time of evaluation and admission to hospice (regardless of setting in which care is delivered), all patients/families will be queried about the presence of a pacemaker and/or ICD. On physical examination, the chest wall of each patient should be checked for the presence of a cardiac device. (Devices are usually placed underneath the clavicle and may be visible and/or palpable.) If a device is identified, the patient/family should be asked if they have the card that was provided at the time of implantation to aid in determining the nature of the device. If the card cannot be located, the hospice nurse should contact the patient's primary care physician or cardiologist to determine the nature of the device.
Informed Consent Discussion about Device Deactivation
After an ICD has been identified, the hospice nurse should engage in an informed consent discussion with the patient/family/surrogate about the potential benefits and burdens of the device at this point in the patient's illness. In order to make a truly informed choice about whether or not to deactivate the shocking function, the following points should be emphasized during the discussion.
Leaving the defibrillation function on could potentially cause the patient to experience pain if the device delivers shocks near the end of life.
Turning off the shocking function means the device will not be able to provide all of the available methods of life-saving therapy in the event of a potentially fatal heart rhythm. Leaving the shocking function active does not guarantee, however, that in the event of an arrhythmia the heart will return to a normal pattern of beating.
Turning off the ICD will not cause death.
Turning off the ICD will not be painful, nor will a patient's death be more painful if it is turned off.
Decisions about deactivating a pacemaker are often made separately from the decision to turn off a defibrillator, and depend on the indication for the pacemaker and the patient's underlying intrinsic cardiac rhythm. Both are justifiable, however, on ethical grounds depending on the patient's overall goals of care. Deactivating a pacemaker may result in changes in a patient's symptoms. Consultation before deactivation with a cardiologist and/or electrophysiologist is often advisable to assure that appropriate treatments are readily available if the pacemaker is deactivated.
Process for Re-Programming the ICD
If a decision has been made to deactivate the shocking function of the ICD, the hospice nurse will inform the medical director to let him/her know the decision has been made to re-program the device so it will no longer deliver shocks. Note: Re-programming an ICD in this manner will stop it from ever delivering shocks. Placing a magnet over the ICD will stop it from sensing the rhythm and delivering a shock, but only while the magnet is physically present over the device.
If the patient is ambulatory, the nurse will contact the patient's cardiologist or electrophysiologist to arrange for the patient to come to the office to have the device re-programmed so the shocking function can be deactivated.
If the patient is not able to leave his/her place of residence, then the hospice nurse will develop a plan with the attending physician for the re-programming of the patient's ICD, which may include one of the following processes:
The patient's cardiologist/electrophysiologist or a member of the team will be contacted to come to the patient's place of residence to re-program the device.
A member of the hospice team with special training in the deactivation of ICDs will arrange to borrow the equipment (similar to a small laptop computer) from the cardiologist/electrophysiologist and bring it to the patient's place of residence to re-program the device. Equipment may be manufacturer specific, so this member of the team must know which manufacturer made the patient's ICD.
A representative from the device manufacturing company, after appropriate consultation with the hospice medical director and/or the patient's cardiologist/electrophysiologist will come to the patient's place of residence to re-program the ICD.
In any situation where the patient is not ambulatory, the hospice nurse will be present in the place of residence during the re-programming process to provide emotional support to the patient/family/surrogate.
Process for Deactivation of an ICD in an Emergent Scenario
If there is a decision for the shocking function of the ICD to remain active, a magnet designed for cardiac devices should be left in the patient's place of residence in the event of an emergent scenario where the patient is being repeatedly shocked. It should be explained to the family that if a patient is receiving repeated shocks from the ICD, then placing the magnet over the device will stop it from sensing the cardiac arrhythmia. The magnet will need to be taped in place, as it only stops the ICD from sensing. (An ICD which does not sense will not deliver treatments.) Once the magnet is removed the ICD will begin sensing again and may again deliver shocks.* The magnet is heavy and may not be comfortable if left in place for an extended period of time. If the family is not comfortable performing this procedure themselves, the magnet should still be left in the place of residence so in an emergent situation a hospice nurse who arrives will have the tools necessary to suspend the shocking function of the device.
Post-Mortem Care
After a patient has died, the ICD will not deliver a shock. If a magnet has been taped to the chest, it can be removed as soon as a nurse has verified the patient no longer has cardiac function. If the body is to be cremated, the funeral director should be notified of the presence of an ICD, as incinerating the battery can lead to its explosion.
* Note: At the time this protocol was written, there was one ICD on the market which, when placed in the presences of a magnet for a brief period of time, would be permanently re-programmed to completely deactivate the shocking function. If one is not sure of the exact specifications of a patient's ICD the best practice is to keep the magnet in place.