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Heartbeats, Burdens, and Biofixtures

Published online by Cambridge University Press:  25 March 2021

KELSEY GIPE
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Abstract

This paper addresses a dichotomy in the attitudes of some clinicians and bioethicists regarding whether there is a moral difference between deactivating a cardiac pacemaker in a highly dependent patient at the end of life, as opposed to standard cases of withdrawal of treatment. Although many clinicians hold that there is a difference, some bioethicists maintain that the two sorts of cases are morally equivalent. The author explores one potential morally significant point of difference between pacemakers and certain other life-sustaining treatments: specifically, that the former are biofixtures, which become part of the patient in a way that the latter do not. The concept of the pacemaker as biofixture grants pacemakers a unique moral status that gives reason to treat a pacemaker the same as other parts of the patient that are necessary to sustain life. The author employs this biofixture analysis to affirm the intuition that deactivating a pacemaker in a highly dependent patient at the end of life is, in moral terms, more analogous to active euthanasia than it is to standard cases of withdrawal of treatment. The paper concludes with consideration of potential implications for further implantable medical technologies, such as ventricular assist devices and total artificial hearts.

Keywords

pacemakersend-of-lifeeuthanasiaimplantable medical technologiesventricular assist devicestotal artificial hearts
Type
Special Section: Decision Making and Leadership in Crises and Beyond
Information
Cambridge Quarterly of Healthcare Ethics , Volume 30 , Issue 2 , April 2021 , pp. 285 - 296
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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Footnotes

Acknowledgment: Special thanks to Dr. Robert Gipe, MD, PhD for medical advising on this project. His input on drafts has been invaluable.

References

Notes

1. See, for example, Zellner, RA, Aulisio, MP, Lewis, WR. Should implantable cardioverter-defibrillators and permanent pacemakers in patients with terminal illness be deactivated? Deactivating permanent pacemaker in patients with terminal illness. Patient autonomy is paramount. Circulation Arrhythmia and Electrophysiology 2009;2(3):340–4;CrossRefGoogle ScholarPubMed discussion 340.; Benjamin MM, Sorkness CA. Practical and ethical considerations in the management of pacemaker and implantable cardiac defibrillator devices in terminally ill patients. Baylor University Medical Center Proceedings 2017;30(2):157–60; discussion 158–9.; Rhymes JA, McCullough LB, Luchi RJ, Teasdale TA, Wilson N. Withdrawing very low-burden interventions in chronically ill patients. JAMA 2000;283(8):1061–3.; Ballentine, JM. Pacemaker and defibrillator deactivation in competent hospice patients: An ethical consideration. American Journal of Hospice & Palliative Medicine 2005;22(1):14–9; discussion 17–8.

2. Lampert, R, Hayes, DL, Annas, GJ, Farley, MA, Goldstein, NE, Hamilton, RM, et al. 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;7(7):1008–26.CrossRefGoogle ScholarPubMed

3. See, for example, Hester, M, Swota, A. Choosing to stop a heart: The ethical status of deactivating an implantable cardiac device. Cambridge Quarterly of Healthcare Ethics 2019;28:327–8; discussion 327CrossRefGoogle ScholarPubMed.; Kapa S, Mueller PS, Hayes DL, Asirvatham SJ. Perspectives on withdrawing pacemaker and implantable cardioverter-defibrillator therapies at end of life: Results of a survey of medical and legal professionals and patients. Mayo Clinic Proceedings 2010;85(11):981–90.; Mueller PS, Jenkins SM, Bramstedt KA, Hayes DL. Deactivating implanted cardiac devices in terminally ill patients: Practices and attitudes. Pacing and Clinical Electrophysiology 2008;31:560–8.; Whitlock SN, Goldberg IP, Singh JP. Is pacemaker deactivation at the end of life unique?: A case study and ethical analysis. Journal of Palliative Medicine 2011;14(10):1184–8.

4. “More than 4.5 million people worldwide live with an implanted pacemaker, including >3 million in the United States alone. Also, >0.8 million people in the United States have an implantable cardioverter defibrillator.” Benjamin MM, Sorkness CA. Practical and ethical considerations in the management of pacemaker and implantable cardiac defibrillator devices in terminally ill patients. Baylor University Medical Center Proceedings 2017;30(2):157–60; discussion 157.

5. See Pasalic, D, Tajouri, TH, Ottenberg, AL, Mueller, PS. The prevalence and contents of advance directives in patients with pacemakers. Pacing and Clinical Electrophysiology 2014;37(4):473–80CrossRefGoogle ScholarPubMed.; Buchhalter LC, Ottenberg AL, Webster TL, Swetz KM, Hayes DL, Mueller PS. Features and outcomes of patients who underwent cardiac device deactivation. JAMA Internal Medicine 2014;174(1):80–5.

6. See, for example, Daeschler, M, Verdino, RJ, Caplan, AL, Kirkpatrick, JN. Defibrillator deactivation against a patient’s wishes: Perspectives of electrophysiology practitioners. Pacing and Clinical Electrophysiology 2015;38(8):917–24.;CrossRefGoogle ScholarPubMed Strömberg A, Fluur C, Miller J, Chung ML, Moser D, Thyĺen I. ICD recipients’ understanding of ethical issues, ICD function, and practical consequences of withdrawing the ICD in the end-of-life. Pacing and Clinical Electrophysiology 2014;37(7):834–42.; Svanholm, JR, Nielsen JC, Mortensen P, Christensen CF, Birkelund R. Refusing implantable cardioverter defibrillator (ICD) replacement in elderly persons-The same as giving up life: A qualitative study. Pacing and Clinical Electrophysiology 2015;38(11):1275–86.

7. See note 2, Lampert et al. 2010, at 1008.

8. For an in-depth debate regarding the moral permissibility of deactivating CIEDS which focuses on the distinction between killing and allowing to die, see Hester, D, Swota, A, Huddle, TS, Sulmasy, DP, Courtois, MA. The great debates. Cambridge Quarterly of Healthcare Ethics 2019;28:327–60.CrossRefGoogle Scholar

9. I am here relying on the concept of “active euthanasia” as explicated by James Rachels in Rachels J. Active and passive Euthanasia. New England Journal of Medicine 1975;292:78–80.

10. Paola, F, Walker, R. Deactivating the implantable cardioverter-defibrillator: A biofixture analysis. Southern Medical Journal 2000;93(1):20–3.CrossRefGoogle ScholarPubMed

11. Sulmasy, DP. Within you/without you: Biotechnology, ontology, and ethics. Journal of General Internal Medicine 2008;23(Suppl 1):69–72.CrossRefGoogle ScholarPubMed

12. See note 11, Sulmasy 2008, at 70.

13. See note 11, Sulmasy 2008, at 70.

14. See note 11, Sulmasy 2008, at 71.

15. See note 11, Sulmasy 2008, at 71–2.

16. Sulmasy, DP, Courtois, MA. Unlike diamonds, defibrillators are not forever: Why it is sometimes ethical to deactivate cardiac implantable electrical devices. Cambridge Quarterly of Healthcare Ethics 2019;28:338–46; discussion 342.CrossRefGoogle Scholar

17. E.g., “A replacement therapy (e.g., kidney transplantation) literally becomes “part of the patient” and provides the lost function in the same fashion as the patient did when healthy. Replacement therapies also respond to physiologic changes in the host and are independent of external energy sources and control of an expert. Removing or withdrawing a replacement life-sustaining treatment has been characterized as euthanasia.” (See note 2, Lampert et al. 2010, at 1012).

18. For example, “[A] ‘replacement’ must be capable of growth and self-repair and must be independent from external energy sources and expertise. Pacemakers are not capable of growth or self-repair. They rely on batteries that deplete. Pacemakers are subject to malfunction, often need expert intervention, and are subject to recall. Thus, pacemakers are not ‘replacements’.” (Zellner RA, Aulisio MP, Lewis WR. Response to Kay and Bittner. Circulation Arrhythmia and Electrophysiology 2009;2:339).; See also Kay GN, Bittner GT. Should implantable cardioverter-defibrillators and permanent pacemakers in patients with terminal illness be deactivated? Deactivating permanent pacemaker in patients with terminal illness: An ethical distinction. Circulation Arrhythmia and Electrophysiology 2009;2:336–9.

19. Struber, M, Meyer, AL, Malehsa, D, Kugler, C, Simon, AR, Haverich, A. The current status of heart transplantation and the development of “artificial heart systems”. DeuDeutsches Arzteblatt International 2009;106(28–29):471–7.;Google ScholarPubMed Copeland JG, Smith RG, Arabia FA, Nolan PE, Sethi GK, Tsau PH, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. The New England Journal of Medicine 2004;2009;351(9):859–67.

20. See, for example, Ganz LI, Hayes DL. Cardiac implantable electronic devices: Patient follow-up. In Downey BC, ed. Up to Date; 2018; available at https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-patient-follow-up?csi=af56db72-f28d-4b5c-ba84-5220e038c3c0&source=contentShare (last accessed 9 Jun 2018).

21. See Enderby, C and Keller, CA. An overview of immunosuppression in solid organ transplantation. The Americal Journal of Managed Care 2015;21(1):S12–3.;Google ScholarPubMed van Sandwijk, MS, Bemelman FJ, Ten Berge IJM. Immunosuppressive drugs after solid organ transplantation. The Netherlands Journal of Medicine 2013;71(6):281–9.

22. For a thorough treatment of potential complications of pacemaker implantation, see Ellenbogen, KA, Kay, GN, Wilkoff, BL. Clinical Cardiac Pacing and Defibrillation, 2nd ed. Philadelphia, PA: Saunders; 2000; discussion 669–94.Google Scholar

23. One such risk, which is rare, is of the pacemaker eroding through thin skin and thus causing a situation where the pacemaker and leads must be removed and re-implanted. (See note 22, Ellenbogen et al. 2000, at 673–4, 676).

24. Ganz LI, Hayes DL. Cardiac implantable electronic devices: Patient follow-up. In Downey BC, ed. Up to Date; 2018; available at https://www.uptodate.com/contents/cardiac-implantable-electronic-devices-patient-follow-up?csi=af56db72-f28d-4b5c-ba84-5220e038c3c0&source=contentShare (last accessed 9 Jun 2018).

25. See Mangrum, JM and DiMarco, JP. The evaluation and management of Bradycardia. The New England Journal of Medicine 2000;342(10):703–9.CrossRefGoogle ScholarPubMed

26. For a thorough treatment of the current state of VAD technology, see Eisen, HJ. Left ventricular assist devices (LVADS): History, clinical application and complications. Korean Circulation Journal 2019;49(7):568–85.CrossRefGoogle ScholarPubMed

27. See Densford, F. Leviticus Cardio, Jarvik Heart unveil wireless LVAD. Mass Device; 2019 Feb 7; available at https://www.massdevice.com/leviticus-cardio-jarvik-heart-unveil-wireless-lvad/ (last accessed 24 Jun 2020).; Smart, F. Fully implantable LVAD nets FDA breakthrough device designation. Cardiology Today; 2019 Oct 31; available at https://www.healio.com/news/cardiology/20191031/fully-implantable-lvad-nets-fda-breakthrough-device-designation (last accessed 24 Jun 2020).; Rachal, M. Abbott wins breakthrough tag for fully implantable LVAD system, following Medtronic. MedTech Dive; 2020 Feb 4; available at https://www.medtechdive.com/news/abbott-wins-breakthrough-tag-for-fully-implantable-lvad-system-following-m/571670/ (last accessed 24 Jun 2020).; Kelly, S. Medtronic developing fully implanted LVAD with FDA breakthrough support. MedTech Dive; 2019 Oct 30; available at https://www.medtechdive.com/news/medtronic-developing-fully-implanted-lvad-with-fda-breakthrough-support/566131/ (last accessed 24 Jun 2020).

28. For a discussion of some of the moral issues around total artificial hearts and end-of-life care, see Finder, SG, Nurok, M. Death, devices, and double effect. HEC Forum 2019;31:63–73.CrossRefGoogle ScholarPubMed