Ethical Considerations of Implantable Devices in Patients with

Ethical Considerations of Implantable Devices in Patients with Advanced Disease Joan Berkley Bioethics Symposium April 10, 2013

Objectives • To review the concept of futility • To review the dilemma of patient autonomy vs. physician judgment • To examine the concept of “reverse futility” in the context of implantable cardiac devices • Examine the impact on patients

I would like to acknowledge the significant assistance in this presentation by: Arthur R. Derse, MD, JD Director Center for the Bioethics & Medical Humanities Julia and David Uihlein Professor of Medical Humanities, and Professor of Bioethics and Emergency Medicine Institute for Health and Society Medical College of Wisconsin

Futile – Useless, Ineffectual • From Latin – futilis = leaky, that easily pours out • The gods condemned daughters of Danaus to carry water in leaky buckets, never achieving their goal

Futility definitions (Translated) 1. “It won’t work (or won’t achieve the goals of the patient)” [quantitative] • General support by medical society ethics codes 2. “It may work, but if it does, it’s only going to work for a while, and will prolong the dying process [quantitative/qualitative] • Less consensus 3. “It’s not worth it (because of cost of quality of life)” [qualitative] • Most controversial

Conversations at the Crossroads Lee A. Biblo, MD Chief Medical Officer, Froedert Hospital, Associate Dean, Professor, Medical College of Wisconsin “The Ethics of Implantable Devices in Patients with Advanced Disease” Center for Practical Bioethics April 10, 2013 Kansas City, MO

Futility – the Dilemma (i. e. - Patient wants a therapy, physician doesn’t) • Patient autonomy – Many beliefs may be non-rational. • Physician judgment – A judgment, should be based on scientific expertise (but sometimes is masked as scientific expertise)

Teeter Totter of Physician Judgment ↑ Scientific Evidence Personal Values Physician Judgment ↓

Physician-Patient Relationship • To offer and perform a medical treatment or procedure in a given clinical situation is a professional medical determination. • Patient (or surrogate) may choose whether to accept or refuse that offer. • Patient expectations (driven by medical marketing? ) – Froedtert Hospital – "While others try to do what they can, we try to do everything possible. " – Children’s Hospital of Wisconsin – “part of the Children’s Miracle Network”

Froedtert Hospital & Futility Policy (1997 - updated 2002) • Recommendation after a number of difficult cases - by the palliative care service • Input from physicians, nurses, ethics committee, palliative care committee • Ratification by Froedtert Medical Executive Committee

Froedtert Hospital Futility Policy • A life-sustaining medical treatment is futile if it cannot: – restore or maintain vital organ function – achieve the expressed goals of the patient when decisional • Life sustaining medical treatment can include: – CPR – mechanical ventilation – artificial nutrition and hydration – blood products – renal dialysis – antibiotics or other medications – any other treatment that prolongs dying

Froedtert Hospital Futility Policy 1. Somewhat controversial - still. 2. Rarely invoked (several times each year). 3. Recently underwent scrutiny at Froedtert by CMS after a patient complaint.

Futility – the Dilemma (i. e. - Patient wants a therapy, physician doesn’t) • Patient autonomy – Many beliefs may be non-rational. • Physician judgment – A judgment should be based on scientific expertise (but sometimes is masked as scientific expertise)

“Reverse Futility” – the Dilemma (i. e. - Patient doesn’t want a therapy, physician does) • Patient autonomy – A judgment is made that has scientific merit. • Physician judgment – The patient’s judgment is not concordant with the physician’s value system.

Implantable Cardioverter Defibrillators (ICD’s) and Pacemakers ICD’s serve 2 functions • • Pace the heart when the native pacemaker fails (heart rhythm is too slow – often constant need) Shock the heart when an arrhythmia occurs(heart rhythm is too fast – always episodic need) Pacemakers serve a single function • Pace the heart when the native pacemaker fails(heart rhythm is too slow – often constant need)

Implantable Cardioverter Defibrillators (ICD’s) and Pacemakers 1. Enormously complex devices 2. Numerous advancements • Accelerometers – mimic normal heart rate response • Numerous ways to terminate arrhythmias • Can actually improve heart function with special placement of leads in certain patients 3. Numerous subtleties • EMI interference (like electro-cautery) can falsely trigger an inappropriate shock • Shocking function (not pacing function) can be disabled by magnetic fields – magnets are placed over the device in surgical procedures that use electro-cautery to prevent inappropriate shocks but maintain pacing

Mrs. Alexis Smith (72 y. o. executive with pancreatic cancer) 1. Six years earlier had an ICD placed after several heart attacks left her heart rate too slow and vulnerable to life threatening arrhythmias 2. Heart rate has been dependent on the ICD for the past 4 years and she has never had a shock from the device. 3. Underwent an extensive abdominal surgery, magnet used to avoid inappropriate shocks. Surgery was not successful in eliminating the cancer. 4. She is now requiring high dose narcotics to control her pain and is not able to function in a “respectable” fashion. 5. She remains alert and is able to care for herself. 6. She has requested that her ICD shock and pacemaker functions both be disabled.

“Reverse Futility” – the Dilemma (i. e. - Patient doesn’t want a therapy, physician does) • Patient autonomy – A judgment is made that has scientific merit. – (The pacemaker may be prolonging my suffering. ) • Physician judgment – The patient’s judgment is not concordant with the physician’s value system. – (Turning off the pacemaker is physician assisted suicide. )

Deactivating permanent pacemakers in patients with terminal illness: Patient Autonomy Is Paramount. Richard A. Zellner, Mark P. Aulisio and William R. Lewis Arrhythmia and Electrophysiology 2009 (published by the AHA) Mainstream biomedical ethics and professional practice standards recognize the propriety of withdrawal of life sustaining treatments. Whether the life-sustaining treatment is medication, food, water, or ICD or pacemaker therapy is itself not morally relevant; nor is whether the device is internal or external. For competent adults, patient autonomy or control over one’s body is the overriding principle associated with medical therapy. Thus, an informed patient or surrogate, with capacity to make medical decisions, has a right to refuse any and all medical treatment, including continued pacemaker therapy.

Kay and Bittner Circ Arrhythmia Electrophysiol June 2009 (in response to Zellner et al. ) In keeping with the principle of autonomy, patients have the right to request withdrawal of medically futile treatments. Why, then, do physicians feel uncomfortable about deactivating a pacemaker in a pacemakerdependent person, but not when deactivating an implantable cardioverter defibrillator? For pacemaker-dependent patients, the progression of their underlying disease will eventually result in failure of pacing stimuli to capture the heart, and death will occur naturally. In contrast, to intentionally interrupt pacing in such a patient probably will result in their nearly instantaneous death, regardless of their underlying medical illnesses (if any). To stop pacing in such a patient is a deliberate act that is intended to hasten death. As such, the ethical “bright line differentiating the patient’s natural death from illicit killing and physician assisted suicide” would indeed seem to have been crossed. .

Patient Attitudes toward ICD Deactivation Goldstein et. al. J Gen Int Med 2007 Many have touted the solution as – “Discuss the scenario of deactivation at implantation or while the patient is still healthy. ” Goldstein spoke with numerous ICD patients – qualitative conclusions: 1. ICD’s are different than most otherapies - implanted when patient is functional - viewed as a “security blanket” – “EMS following you around” 2. Patient’s (and their PCP’s) don’t seem to understand the nuances of ICD’s 3. Implanting physicians (electrophysiologists) are focused on life saving interventions, different “DNA” than PCP’s. 4. Patients have a complex psychological relationship with their ICD - “trusted companion” - “I can always depend on my ICD unlike my ………. …. . ”

Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: A quantitative assessment Kramer et al, Heart Rhythm 2010

Kirkpatrick et al. (ACC abstract 2013) 1. 73% of electrophysiology providers felt withdrawing the shocking function was morally similar to withholding CPR. 2. 83% of electrophysiology providers felt disabling pacemaker function was morally different than withholding CPR. 3. Most electrophysiology providers felt that shocking and pacemaker therapies of ICD’s were not comparable to other EOL discussions like intubation/ventilation or feeding tube insertion. 4. Kirkpatrick states “Based on these findings we need to further explore ways to help clinicians address end of life management of ICD’s. ”

Implantable Cardioverter-Defibrillator Recipient Attitudes towards Device Deactivation: How Much do Patients Want to Know? CLAIRE E. RAPHAEL, M. A. , MICHAEL KOA-WING, PH. D. , NOLAN STAIN, M. SC. , IAN WRIGHT, B. SC. , DARREL P. FRANCIS, M. D. , and PRAPA KANAGARATNAM, PH. D. Should the decision to switch off the ICD be discussed with patients? Yes 84% No 16% When should this discussion take place? Before implantation 52% Less than a year after implantation 11% At least a year after implantation 5% At least 5 years after implantation 2% Only if they are really ill 24% Don’t know 6% Have you ever considered switching off the device? Never 87% Once 7% Sometimes 2% Often 4%

Patient’s understanding of the device was poor 1. “Like an EMS squad following me 24/7”. 2. “My lifeline”. 3. “Keeps me alive”. 4. Patients were not clear as to how (and often why) the device functioned.

Situations where you would consider deactivating the device

Factors you would consider in your decision to deactivate your device

Implantable Cardioverter-Defibrillator Recipient Attitudes towards Device Deactivation: How Much do Patients Want to Know? CLAIRE E. RAPHAEL, M. A. , MICHAEL KOA-WING, PH. D. , NOLAN STAIN, M. SC. , IAN WRIGHT, B. SC. , DARREL P. FRANCIS, M. D. , and PRAPA KANAGARATNAM, PH. D. Conclusions of their study: 1. Patient understanding of their devices was anecdotal. 2. Most patients wanted to keep their device active. 3. Despite that, patients did want to have a discussion of deactivation in advance of end of life circumstance, a majority before implantation.

Mrs. Alexis Smith (72 y. o. executive with pancreatic cancer) 1. Six years earlier had an ICD placed after several heart attacks left her heart rate too slow and vulnerable to life threatening arrhythmias 2. Heart rate has been dependent on the ICD for the past 4 years and she has never had a shock from the device. 3. Underwent an extensive abdominal surgery, magnet used to avoid inappropriate shocks. Surgery was not successful in eliminating the cancer. 4. She is now requiring high dose narcotics to control her pain and is not able to function in a “respectable” fashion. 5. She remains alert and is able to care for herself. 6. She has requested that her ICD shock and pacemaker functions both be disabled.

Mrs. Alexis Smith 1. An extensive conversation ensued with her clinicians regarding the difference between the shocking and pacing function of the device. 2. After the discussion the shocking function was disabled in the clinic. The patient was told that “next time we will discuss the pacemaker issue”. 3. One week later the patient attended a family party for her 73 rd birthday. 4. The next day she was found dead in bed by her daughter with an empty bottle of pills by her bedside and a magnet taped to her chest.

Conclusions 1. Science, values, religion, and stewardship intersect at the end of life. 2. Patients don’t understand the nuances of ICD’s (as in my patient , Mrs. S. – the magnet had no effect on the pacing function). 3. End of life decisions should occur well before the end of life circumstances. 4. Futility and “reverse futility’ dilemmas may be best avoided by patientprovider preparation/multiple discussions/education/transparency. 5. Physician discomfort with disabling device function is significant.

References • Goldstein, N. E. , Mehta, et al. (2008). "That's like an act of suicide" patients' attitudes toward deactivation of implantable defibrillators. Journal of General Internal Medicine, 23 Suppl 1, 7 -12. • Kramer, D. B. , Kesselheim, A. S. , et al. (2010). Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: A quantitative assessment. Heart Rhythm : The Official Journal of the Heart Rhythm Society, 7(11), 1537 -1542. • Lampert, R. , Hayes, D. L. , et al. (2010). 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 : The Official Journal of the Heart Rhythm Society, 7(7), 1008 -1026. • Lewis, W. R. , Luebke, D. L. , et al. (2006). Withdrawing implantable defibrillator shock therapy in terminally ill patients. The American Journal of Medicine, 119(10), 892 -896. • Matlock, D. D. , Nowels, C. T. , et al. (2011). Patient and cardiologist perceptions on decision making for implantable cardioverter-defibrillators: A qualitative study. Pacing and Clinical Electrophysiology : PACE, 34(12), 1634 -1644. • Raphael, C. E. , Koa-Wing, M. , Stain, et al. (2011). Implantable cardioverter-defibrillator recipient attitudes towards device deactivation: How much do patients want to know? Pacing and Clinical Electrophysiology : PACE, 34(12), 1628 -1633. • Zellner, R. A. , Aulisio, M. P. , & Lewis, W. R. (2009). 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, 2(3), 340 -4; discussion 340

Back up slides

HRS Expert Consensus Management of CIED’s in patients nearing end of life or requesting withdrawal of therapy (Heart Rhythm 2010) Basic Principles – (ethical and legal) 1. 2. 3. 4. A patient with decision making capacity has the right to refuse or withdraw any medical treatment or intervention. Ethically and legally, there are no differences between refusing ICD therapy or withdrawing ICD therapy. Legally carrying out a request to withdraw a life sustaining therapy is neither physician assisted suicide or euthanasia. A clinician cannot be compelled to carry out a legally permissible procedure that s/he views as in conflict with his/her personal values.

HRS Expert Consensus Management of CIED’s in patients nearing end of life or requesting withdrawal of therapy (Heart Rhythm 2010) Milestones for communication regarding de-activation 1. Prior to implantation. 2. After an episode of repeated shocks. 3. Progression of cardiac disease. 4. When a patient chooses a DNR order. 5. Patients at end of life. Religious tenets 1. The distinction between “letting go” and taking life is religiously important. 2. Perception of disproportionate burden caused by continuation of a life sustaining treatment is central to permissibility of “letting go”. 3. A clinician whose beliefs are not in line with their patient’s beliefs may not override a patient’s choice. *