Patients don’t always fully understand the lifestyle limitations imposed by cardiac implantable electronic devices. Informed consent conversations should:
- be tailored to the specific device;
- describe strategies to mitigate burdens;
- address different stages of the patient’s life.
Patients may view cardiac implantable electronic devices (CIEDs) as a lifesaver — without fully understanding quality of life issues.
“The informed consent conversation must be tailored to the specific device,” says Cynthiane J. Morgenweck, MD, MA, a clinical ethicist at the Center for Bioethics and Medical Humanities at Medical College of Wisconsin in Milwaukee.
The three most common implantable cardiac devices are pacemakers, automatic implantable cardioverter defibrillators (AICD) and ventricular assist devices (VADs). Each comes with a different set of benefits and burdens for the patient.1
“Automatic implantable cardiac devices may or may not be intrusive, depending on the patient’s perceptions of the shocks that are delivered,” says Morgenweck. “The perceptions range from hardly noticed to the proverbial ‘sledgehammer to the chest.’”
Morgenweck says VADs require significant buy-in from the patient after placement: “Intrusiveness of the device in the patient’s life should be described by the provider, as well as strategies to mitigate the burdens of the device.”
The utility of the device for the patient at different stages of the patient’s life also should be discussed before the implantation.
For example, an AICD prevents sudden cardiac arrest. “But when the patient receives a life-limiting diagnosis such as Alzheimer’s, the patient may prefer a sudden cardiac arrest over a long, slow decline with its attendant burdens,” says Morgenweck.
After a VAD is placed, patients might conclude that the lifestyle limitations are more burdensome than anticipated. Some ask for the device to be deactivated.
“Providers must decide for themselves whether or not they would be willing to honor such a request,” says Morgenweck. “This decision ought to be conveyed to the patient before the implantation.” She recommends that providers:
- briefly introduce patients to the possibility of deactivation before any device is implanted;
- remind the patient about deactivation at routine assessment visits, at battery change visits, and at the time of new life-limiting diagnoses;
- encourage patients to fill out a new advance directive outlining under what circumstances, if any, the device should be deactivated.
Thomas S. Huddle, MD, an ethics instructor at UAB’s Center for Clinical and Translational Science and professor of medicine at UAB’s School of Medicine, says clinicians should clearly state what they’d be willing to do in specific scenarios.
“We, as clinicians, need to be upfront with our patients about all aspects of their future care at the time of CIED implantation,” says Huddle. Despite the Heart Rhythm Society’s 2010 consensus statement, says Huddle, “the issue of the ethical status of CIED deactivation is not settled either in the ethics literature or in the clinical community.”2
Some clinicians take the position that deactivating life-sustaining pacemakers is intentionally hastening death and, hence, not morally permissible.3 “Those clinicians are not going to deactivate non-burdensome life-sustaining CIEDs, even if patients request it,” says Huddle.
Trajectories of the patient’s life after deactivation also should be covered during informed consent conversations. Morgenweck would like to see an easily accessible registry of device deactivation protocols and stories: “All providers would be able to more clearly understand the patient’s health after deactivation.”
- Morgenweck CJ. End-of-life issues: Management of cardiac implantable electronic devices. Jericho BG, editor, Ethical Issues in Anesthesiology and Surgery, Springer Publishing, 2015; 171-184.
- Lampert R, Hayes DL, Annas GJ, et al. JRS expert consensus statement on the management of cardiovascular implantable electronic devices (CIEDs) in patients nearing the end of life or requesting withdrawal of therapy. Heart Rhyth 2010; 7(7):1008-1026.
- Kay GN, Pelosi F. An ethical analysis of withdrawal of therapy in patients with implantable cardiac electronic devices: Application of a novel decision algorithm. Linacre Quarterly 2013; 80(4):308-316.
- Thomas S. Huddle, MD, Professor, UAB School of Medicine, Birmingham, AL. Phone: (205) 934-9638. Email: firstname.lastname@example.org.
- Cynthiane J. Morgenweck, MD, MA, Clinical Ethicist, Center for Bioethics and Medical Humanities, Medical College of Wisconsin, Milwaukee. Phone: (414) 955-8498. Email: email@example.com.