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Management of Implantable Cardioverter Defibrillators in End-of-Life Care

Nathan E. Goldstein, MD; Rachel Lampert, MD; Elizabeth Bradley, PhD; Joanne Lynn, MD, MA, MS; and Harlan M. Krumholz, MD
[+] Article and Author Information

From the Robert Wood Johnson Clinical Scholars Program, Yale University School of Medicine, New Haven, Connecticut; and the Washington Home Center for Palliative Care Studies, Washington, DC.


Acknowledgments: The authors thank Barbara Mendes and Joanne McGloin at the Program on Aging, Yale University, for their assistance with data collection. The After-Death Bereaved Family Interview of the Toolkit of Instruments to Measure End-of-Life Care is used with permission of Joan Teno, MD, MS, Center for Gerontology and Health Care Research, Brown Medical School, Providence, Rhode Island.

Grant Support: Dr. Goldstein was a Robert Wood Johnson Clinical Scholar funded by the Department of Veterans Affairs during the course of this study. Dr. Lampert is supported by American Heart Association grant #0030190N. Dr. Bradley is supported by the Patrick and Catherine Weldon Donaghue Medical Research Foundation (Donaghue Investigator Award grant #02-102) and the Claude D. Pepper Older Americans Independence Center at Yale University (#P30AG21342). Dr. Lynn is supported by The Washington Home Center for Palliative Care Studies.

Potential Financial Conflicts of Interest:Expert testimony: J. Lynn (Medicare Coverage Advisory Committee).

Requests for Single Reprints: Nathan E. Goldstein, MD, Department of Geriatrics, Mount Sinai Medical Center, Box 1070, One Gustave L. Levy Place, New York, NY 10029; e-mail, nathan.goldstein@mssm.edu.

Current Author Addresses: Dr. Goldstein: Brookdale Department of Geriatrics, Box 1070, Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10029.

Dr. Lampert: Section of Cardiovascular Medicine, Yale University School of Medicine, 333 Cedar Street, PO Box 208017, New Haven, CT 06510.

Dr. Bradley: Yale School of Public Health, 60 College Street, PO Box 208034, New Haven, CT 06520.

Dr. Lynn: The Washington Home Center for Palliative Care Studies, 3720 Upton Street, NW, Washington, DC 20016.

Dr. Krumholz: Clinical Scholars Program, Yale University School of Medicine, 333 Cedar Street, PO Box 208025, New Haven, CT 06520-8025.

Author Contributions: Conception and design: N.E. Goldstein, R. Lampert, J. Lynn, H.M. Krumholz.

Analysis and interpretation of the data: N.E. Goldstein, R. Lampert, E. Bradley, J. Lynn, H.M. Krumholz.

Drafting of the article: N.E. Goldstein.

Critical revision of the article for important intellectual content: N.E. Goldstein, R. Lampert, E. Bradley, J. Lynn, H.M. Krumholz.

Final approval of the article: N.E. Goldstein, R. Lampert, E. Bradley, J. Lynn, H.M. Krumholz.

Provision of study materials or patients: R. Lampert.

Statistical expertise: N.E. Goldstein.

Obtaining of funding: H.M. Krumholz.

Administrative, technical, or logistic support: N.E. Goldstein.

Collection and assembly of data: N.E. Goldstein.


Ann Intern Med. 2004;141(11):835-838. doi:10.7326/0003-4819-141-11-200412070-00006
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Patients had a median age of 76 years, and most patients (n = 83) were men (Table 1). Our interviews with the next of kin occurred at a median of 2.3 years after the patient died. The average length of time between death and timing of interview for those patients who did and did not have a discussion about deactivating the ICD was 2.1 and 2.6 years, respectively (P > 0.05). The respondents were younger than the patients (median age, 67 years), and most were the spouses of the deceased patients. Patients' ICDs had been in place for a median of 2.3 years. Patients often had a history of several comorbid conditions: 81 patients had heart failure, 22 had stroke, and 6 had metastatic cancer.

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Comments

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ICD Use and Biased Care
Posted on December 16, 2004
Jeffrey T. Berger
Winthrop University Hospital
Conflict of Interest: None Declared

Goldstein et al (1) in their important study on communication and ICD use may have uncovered yet another cardiac sevice biased against female and ethnic minority patients.(2-4)83% of recipients were male and 96% were white. Athough gender based and ethnically associated variations in treatment is highly complex and multifactorial, we must be vigilantly monitor for unfair use of implantable defibrillators as its use rapidly becomes widespread.

References 1. Goldstein NA, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of Implantable Cardioverter Defibrillators in End-of-Life Care. Ann Intern Med. 2004;141:835-838.

2.Raine RA, Black NA, Bowker TJ, Wood DA. Gender differences in the management and outcome of patients with acute coronary artery disease. J Epidemiol Community Health. 2002 Oct;56(10):791-7.

3.Beery TA. Gender bias in the diagnosis and treatment of coronary artery disease. Heart Lung. 1995 Nov-Dec;24(6):427-35

4.Ibrahim SA, Whittle J, Bean-Mayberry B, Kelley ME, Good C, Conigliaro J. Racial/ethnic variations in physician recommendations for cardiac revascularization. Am J Public Health. 2003 Oct;93(10):1689-93

Conflict of Interest:

None declared

"Management of Implantable Cardioverter Defibrillators in End-of-Life Care", a Reply
Posted on December 16, 2004
Katrina A. Bramstedt
Cleveland Clinic Foundation
Conflict of Interest: None Declared

Goldstein et al recently reported that the next of kin of dying patients with implantable cardioverter defibrillators (ICDs) recalled that physicians rarely discussed ICD deactivation (1). We agree with the authors that the rates of discussions about ICD deactivation in these patients are not only "strikingly low," but also unacceptable.

The authors speculate that the discussions about ICD deactivation may have been limited because such conversations "may seem out of context to both clinicians and patients." However, other factors may account for the low rates. First, data was collected from only one center whose culture may not view ICD defibrillations as heroic measures in dying patients (even in the presence of a do-not-resuscitate order) and, hence, do not talk to patients about it. Second, dying patients may not be aware of the option of ICD deactivation. Third, even after discussing ICD deactivation with a physician, some dying patients or surrogates may chose to keep the ICD activated or "on". Fourth, physicians may be uncomfortable with discussing ICD deactivation with dying patients. Finally, physicians, patients and families may regard ICD deactivation as a form of physician- assisted death or euthanasia and avoid discussing deactivation altogether. Indeed, we have encountered this situation on several occasions and only after a series of formal ethics consultations did a number of physicians recognize the ethical permissibility of device deactivation (2).

The clinical status of a given patient is dynamic, and over time, the patient's healthcare preferences may change, especially at the end-of-life (3). Beneficent physicians aim to minimize discomfort in dying patients. Allowing dying patients with ICDs to experience uncomfortable defibrillations when they may not want them violates this aim. The only way for physicians to discern the preferences of dying patients is to engage in discussions with them. Notably, a substantial number of patients in the Goldstein et al study elected to have their ICDs deactivated after discussions with their physicians took place.

We agree with Goldstein et al that professional groups should develop guidelines related to ICD deactivation in dying patients. This measure alone, however, may be insufficient. Discussions regarding device management should begin before implantation and should occur whenever a patient's clinical status changes. Physicians, patients and surrogates should fully understand their options regarding device management and the ethical permissibility of device deactivation. Finally, patients should be encouraged to incorporate their preferences regarding device management in their advance directives (3).

Katrina A. Bramstedt, PhD Cleveland Clinic Foundation bioethics@go.com

Paul S. Mueller, MD Mayo Clinic mueller.pauls@mayo.edu

References: 1. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life care. Ann Intern Med. 2004;141:835-838. 2. Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of pacemaker or implantable cardioverter-defibrillator support at the end of life. Mayo Clin Proc. 2003; 78:959-63. 3. Bramstedt KA. The use of advance directives and do not resuscitate orders when considering the inactivation of implantable cardioverter- defibrillators in terminal patients. Cardiovasc Rev Rep. 2001; 22:175- 76.

Conflict of Interest:

None declared

Limitations with Next of Kin responses and DNR implications for ICDs
Posted on December 20, 2004
Laura J. Morrison
Baylor College of Medicine
Conflict of Interest: None Declared

In their article, Management of Implantable Cardioverter Defibrillators in End-of-Life Care, Goldstein et al (1) report low rates of discussion of ICD deactivation and of ICD shocks in the last month of life based on next-of-kin interviews. Though these data largely support our perception, more attention should be paid to the limitations of the methods employed. The challenge of study design is well recognized for those studying quality of care at the end of life and quality of death and dying. Since few small studies have been performed in the area, validity and reliability of bereaved next-of-kin responses in retrospective studies are still a concern and areas of needed research (2). Efforts to complement next-of-kin responses by using chart review, diagnostic codes, or other databases could have better defined the contexts of individual dying patients and added significantly to validity and reliability. Certainly, we can conclude little about whether ICD shocks were appropriate, inappropriate or accurately perceived by the bereaved next-of -kin. In the future, society will benefit from ongoing prospective studies following the course of patients with ICDs and the context of their eventual deaths, thus avoiding the issues surrounding recall of the bereaved.

The authors also raise the issue of what a do-not-resuscitate (DNR) order means for a patient with an ICD. They report that although patients with DNR orders were statistically more likely to have a discussion about ICD deactivation, discussions were still reported in less than 50% of cases. Does a DNR order imply that a patient's ICD should be deactivated? We both participated in a 2004 American Academy of Hospice and Palliative Medicine conference session (3) where this question generated intense debate. Some clinicians believe that internal and external defibrillations are equivalent and some do not. Differences in invasiveness, efficacy, and burden of suffering between ICD shocks and cardiopulmonary resuscitation are important considerations. Clearly, this is an area in need of more investigation and consensus. For the time being, however, we advocate that any patient with an ICD and a DNR order must have a discussion exploring potential deactivation of their device. Such discussions and relevant education should be part of routine care and should be incorporated into pre-implantation consent for ICDs. Indeed, this is an ideal opportunity to discuss advance care planning and plant seeds for easier discussions down the road.

Laura J. Morrison, MD Baylor College of Medicine Houston, TX 77030 lmorriso@bcm.tmc.edu

Christian T. Sinclair, MD Kansas City Hospice Kansas City, MO 64114 csinclair@kchospice.org

References

1. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz H. Management of Implantable Cardioverter Defibrillators in End-of-Life Care. Ann of Intern Med 2004;141:835-838.

2. Teno J. Measuring Outcomes Retrospectively. In: National Institutes of Health State-of-the-Science Conference on Improving End-of- Life Care Program and Abstract Book; 2004 Dec 6-8. p. 35-37. Available from: http://consensus.nih.gov/ta/024/024EndOfLifepostconfINTRO.htm/.

3. Morrison LJ, Storey, CP. Is It Time to Turn Off the Defibrillator? Palliation vs. Causing Harm vs. Usual Care. Concurrent Session at the Annual Assembly of the American Academy of Hospice and Palliative Medicine and Hospice and Palliative Nurses Association, Phoenix, AZ. January 22, 2004. J of Pall Med 2004 Jan 7;1:151.

Conflict of Interest:

None declared

Implantable Defibrillators Could Improve End-Of-Life Care
Posted on January 27, 2005
David T Martin
Lahey Medical Center
Conflict of Interest: None Declared

The recent paper by Goldstein and colleagues (1) is certainly consonant with my own experience as a practicing electrophysiologist. It is important for us to remind ourselves and our patients that these devices treat sudden cardiac death but do not create immortality. Patients may experience a lingering and potentially unpleasant death made worse by the potential for defibrillator discharges long after the device has outlived its life-prolonging potential.

I have suggested elsewhere (2) that there is a paradoxical potential benefit from pacemakers and defibrillators in that they contain within them enough memory to support an implantable advance directive which could be securely coded within the pulse generator at the time of implant (or later) in such a way that this information would be readily available to all care providers in the future by using a simple and widely available hand-held telemetry device. The ability to store health care proxy data and other information regarding the patient's preferences for end-of-life care would potentially provide great peace of mind to patients who are often appropriately anxious that their expressed and notarized wishes may not be available (and therefore not complied with) when needed.

For this technological solution to be successful it is important that these difficult issues are addressed early enough in the course of a patient's illness such that when the time comes, death may be dignified and humane.

References 1. Goldstein NA, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of Implantable Cardioverter Defibrillators in End-of-Life Care. Ann Intern Med. 2004;141:835-838.

2. Martin D. Using implantable devices to improve end-of-life care. Am J Cardiology. 2003; 91:583-584

Conflict of Interest:

None declared

In Response
Posted on February 1, 2005
Nathan E Goldstein
Mount Sinai School of Medicine
Conflict of Interest: None Declared

To the editor:

We agree with Morrison and Sinclair that bereaved next-of-kin may well report inaccurately as to experiences of the deceased patient. Nevertheless, the perspectives of survivors are important as a first estimate of the experience of patients and as evidence of the impact on family, which is important in its own right. Prospective interviews or observation may well evidence other insights, but chart review suffers from substantial limitations of the completeness of the data and after- death review of the defibrillator's memory is uncommon.

As for the issue of what a do-not-resuscitate (DNR) order means for a patient, our finding of a low rate of discussions about deactivating ICDs in patients with a DNR order(1) is not meant to imply that ICDs "should" be deactivated when a patient or family agrees to a DNR order. Our results call into question instead why the issue of ICD deactivation was never discussed. We agree with Morrison and Sinclair that conversations about ICDs in patients near the end of life should take place within the much larger context of advance care planning in an effort to help patients weigh the benefits and burdens of various treatments to make sure they live out the end of their lives in accordance with their wishes.

Nathan E. Goldstein, MD The Mount Sinai School of Medicine New York, NY

Rachel Lampert, MD Yale University School of Medicine New Haven, CT

Harlan M. Krumholz, MD Yale University School of Medicine New Haven, CT

References 1. Goldstein NE, Lampert R, Bradley EH, Lynn J, Krumholz HM. Management of Implantable Cardioverter-Defibrillators in End-of-Life Care. Annals of Internal Medicine. 2004;141(11):835-838.

Conflict of Interest:

None declared

Submit a Comment

Summary for Patients

Implantable Cardioverter Defibrillators and End-of-Life Care

The summary below is from the full report titled “Management of Implantable Cardioverter Defibrillators in End-of-Life Care.” It is in the 7 December 2004 issue of Annals of Internal Medicine (volume 141, pages 835-838). The authors are N.E. Goldstein, R. Lampert, E. Bradley, J. Lynn, H.M. Krumholz.

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