EXECUTIVE SUMMARY

Addressing implantable cardiac devices in hospital policies on withdrawal of life-sustaining interventions can support clinicians and prevent arbitrary decision-making. Bioethicists can do the following:

  • Educate providers on the ethical consensus that pacemaker deactivation is not considered euthanasia.
  • Work hard to resolve concerns of resistant clinicians.
  • Explicitly include pacemakers, implantable cardioverter-defibrillators, and left ventricular assist devices.

Recently, a letter from the family of a man who died of lung cancer was presented to University of Michigan Health System in Ann Arbor’s ethics committee. “It spurred the development of an organizationwide policy for deactivation of implanted cardiac devices,” says Adam D. Marks, MD, MPH, a clinical ethicist and associate director of the university’s Hospice and Palliative Medicine Fellowship.

The clinical team had transitioned the man to comfort measures to allow a natural death, but he entered into a prolonged dying phase. For the next several days, he was unconscious and unresponsive.

“This was dragging on longer than the physician or family anticipated,” recalls Marks. “They asked if we were doing anything that was prolonging the dying process.”

The family asked if the pacemaker could be deactivated. Clinicians declined to do so because they viewed it as euthanasia. “The family found it extremely distressing,” says Marks.

Nurses brought the question to the ethics committee, which reviewed the case and the literature. “We found broad consensus that pacemaker deactivation is not considered euthanasia, and is an appropriate practice,” says Marks. “The family had the right to request its removal.”

Not all clinicians agreed. “Some felt strongly it was unethical to deactivate pacemakers,” says Marks. “Others did not feel supported by existing policies.”

The institution’s longstanding policy stated that competent adults had the right to request withdrawal of life-sustaining therapies. However, some clinicians didn’t feel this covered pacemakers.

The ethics committee responded by creating a specific policy on implantable cardiac devices. “Some 1.2 million Americans are living with these devices currently,” says Marks. “We can expect more conflicts like this to occur.”

Some policies omit devices

Even if hospitals have policies in place regarding withdrawal of life-sustaining interventions, these don’t always include implantable cardiac devices.

“Ethics committees may wish to undertake this issue in order to avoid arbitrary decision-making at the bedside,” suggests Leslie M. Whetstine, PhD, an associate professor of philosophy at Walsh University in North Canton, OH.

Withdrawal of implantable cardiac devices has been a primary focus of Paul S. Mueller’s research for the past 15 years. “My interest in the topic started with a dying patient from whom life-sustaining treatments were being withdrawn, and whose family requested device deactivation,” says Mueller, MD, MPH, a professor of biomedical ethics at Mayo Clinic in Rochester, MN.

Multiple ethics consults centered around this scenario. “We have not had too many in recent years, as the matter is largely resolved,” says Mueller. Clinicians utilize end-of-life care order sets that specifically address management of cardiac devices in dying patients.

In Mueller’s view, the same ethical considerations apply as with other life-sustaining treatments such as ventilators or dialysis. “Once started, a patient is not mandated to continue with a treatment,” says Mueller. “The treatment should not be the master of the patient.”

Patients or surrogates might request device deactivation because the device no longer serves their healthcare-related goals and values. A dying patient with an implantable cardioverter-defibrillator (ICD) may wish to avoid uncomfortable shocks at the end of life. A patient with a pacemaker may perceive the device as a barrier to a natural death.

“The intent of device deactivation is not patient death,” says Mueller. “The intent is removal of a treatment that is perceived by the patient as burdensome.”

Implantable devices are life-sustaining treatments that can be withheld or withdrawn for the same reasons that clinicians withhold or withdraw other therapies, says Daniel P. Sulmasy, MD, PhD, MACP, associate director at the University of Chicago’s MacLean Center for Clinical Medical Ethics. The devices may no longer be doing for the patient what they were implemented to do, or the patient or family judges them more burdensome than beneficial.

“Psychologically, it can seem more uncomfortable to deactivate an ICD,” says Sulmasy. “But the mere fact that it is located inside the patient does not mark a moral difference.” The device is not part of the patient the way a heart transplant would be, says Sulmasy, as it’s controlled by the medical team, gets its energy from an external source, and does not grow or interact with the rest of the patient’s body.

Sulmasy says bioethicists can help in the following ways:

Educate staff on the ethical consensus that the devices are life-sustaining treatments, and that deactivation is a form of allowing to the patient to die a natural death.

“Hospital bioethicists could do this through grand rounds presentations or in-service educational programs,” Sulmasy suggests.

Assist in updating policies on discontinuation of life-sustaining treatments to explicitly include pacemakers, ICDs, and left ventricular assist devices (LVADs).

Sulmasy advises against writing separate policies to cover such devices. “It is better to develop an understanding that they belong under the umbrella of forgoing life-sustaining treatments,” he says.

Joanne Lynn, MD, director of the Center for Elder Care and Advanced Illness at Washington, DC-based Altarum Institute, says patients who are offered an ICD are owed honest information.

“As it is being monitored, discontinuation should always be an option,” says Lynn. “And in every setting — including home care — it must be possible to discontinue it quickly.” A strong magnet can be taped over the device to block its function until more definitive discontinuation can be arranged, for instance.

Lynn says ethicists should ensure that ICD implementation forms are honest about the merits of the devices. Equally important is for clinicians to know how to get a device deactivated and be comfortable with the process.

“Patients and family members sometimes think that deactivating an ICD is tantamount to suicide,” says Lynn. “But they need information to better understand this device.”

Some cardiologists object

Mayo Clinic’s cardiologists sometimes object to device deactivation, especially in pacemaker-dependent patients. “We don’t force them to carry out the deactivations,” says Mueller. Instead, a process was implemented allowing the patient’s care to be transferred to an alternative provider.

Some clinicians view discontinuation of an LVAD as ethically problematic. They view the device as an artificial organ that becomes part of the patient.

“They argue that if a clinician would not remove a transplanted organ after the fact, then one could not legitimately stop an LVAD,” says Whetstine. Thus, they conclude that stopping an LVAD is tantamount to physician-assisted death or even euthanasia.

“Others reject this position, asserting that what matters is the right of patients or surrogates to determine their medical care in light of their values,” says Whetstine. According to this perspective, the clinician has not killed the patient, but the patient dies of his underlying condition of heart failure. “This distinction between killing a patient and allowing a patient to die is supported in both ethics and the law,” says Whetstine.

Whetstine says bioethicists can serve as a unique voice in support of the clinical team by raising ethical questions for consideration early, before therapy has been initiated. Ongoing consultation with a palliative care team “is paramount,” adds Whetstine. “It helps ensure that the patient, family, and clinician understand the debate surrounding this issue and their available options.”

When a University of Michigan committee was developing a policy on deactivation of implantable cardiac devices, it encountered stiff resistance. Certain members of the electrophysiology division were uncomfortable with the language of the policy. “http://adamarks@med.umich.eduIt took us a good year to iron all that out,” reports Marks.

Ethicists worked very hard to continue the dialogue with individuals who expressed concerns. “We met with them time and time again. Eventually, we got to a point of shared understanding,” says Marks.

Ethicists attended meetings in the cardiology division and invited cardiologists to ethics meetings. Some cardiologists asked for specific language about the informed consent process and conscientious objectors, which was added.

Hospital administrators wanted to know if other institutions had similar policies in place. Ethicists pointed to a consensus statement and a Mayo Clinic study on the topic.1,2

“With that information, they were comfortable moving forward,” says Marks. The policy states that it is ethically appropriate and reasonable to deactivate implantable cardiac devices after an informed consent process is performed with the patient and family.

“Previously, some clinicians believed it was ethically appropriate to withdraw the devices but were concerned about the legal implications,” says Marks. They now have a document to refer to that has been vetted by ethicists and the legal department.

“It’s not just you shooting from the hip,” says Marks. “Even in the face of resistance, clinicians know they are acting with the full support of the institution behind them.”

REFERENCES

  1. Lampert R, Hayes DL, Annas GJ, 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):1008-1026.
  2. Kapa S, Mueller PS, Hayes DL, et al. 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):981-990.

SOURCES

  • Joanne Lynn, MD, Director, Center for Elder Care and Advanced Illness, Altarum Institute, Washington, DC. Phone: (202) 776-5109. Email: Joanne.Lynn@altarum.org.
  • Adam D. Marks, MD MPH, Associate Director, Hospice and Palliative Medicine Fellowship, University of Michigan, Ann Arbor. Phone: (734) 764-6831. Fax: (734) 647-8535. Email: adamarks@med.umich.edu.
  • Paul S. Mueller, MD, MPH, Consultant and Chair, Division of General Internal Medicine/Professor of Biomedical Ethics, College of Medicine, Mayo Clinic, Rochester, MN. Phone: (507) 538-6341. Fax: 507-284-4959. Email: mueller.pauls@mayo.edu.
  • Daniel P. Sulmasy, MD, PhD, MACP, Associate Director, MacLean Center for Clinical Medical Ethics, The University of Chicago. Phone: (773) 702-0912. Fax: (773) 702-0090. Email: dsulmasy@uchicago.edu.
  • Leslie M. Whetstine, PhD, Associate Professor, Philosophy, Walsh University, North Canton, OH. Phone: (330) 244-4697. Email: lwhetstine@walsh.edu.