by Arnold R. Eiser, MD MACP
Our healthcare system is failing our most senior citizens by assuming they want and need to receive maximal technological intervention despite modest or minimal benefit to them and the increasing of substantial discomfort to them. Every year in the United States about 140,000 automated implantable defibrillators (AICD) are implanted for primary and secondary prevention of sudden death (probably less in this COVID pandemic). Over 60% of AICDs are implanted in patients 65 years or older with 42% in people over 70 years of age. The National ICD registry demonstrates that of those 65 years and older receiving an AICD, over half are dead or in hospice 5 years after implantation.
The informed consent process for this device in the elderly patient is truly challenging giving its complexity and rarely fully informed. At the time of placement, elderly patients may be experiencing minimal cognitive impairment (MCI): An eight-year study of community dwelling seniors in their 70s found 53% show minor cognitive decline, 16% show major decline, and only 30% maintain normal cognition. Elderly patients are rarely informed of the complex choices, situations, and side effects that AICDs present to them. The consent process focuses on the immediate procedural risks but rarely mention the midterm or long-term risks that include inappropriate (and painful) shocks, device malfunction, recalls, the need for replacement in eight years, anxiety and depression engendered by the device, and the impact on the patient’s significant other. A study of patients with heart failure found that they overvalued sevenfold the value of an AICD. It does not confer any symptomatic benefit at any age, and for many patients in their 80s and 90s it does not confer survival advantage either. Moreover it is even rarer in the consent process to discuss the probable need for device deactivation especially if another illness such as advanced cancer develops. Less than half of AICD patients entering hospice care have their device deactivated and thus are more likely to experience a painful death when the AICD discharges.
How can the informed consent process be improved? There may be a role for an institutional ethics committee to help develop guidelines for the consent process in AICD placement, though it is hardly the only complex consent situation in medicine that needs more bioethical input. A nationwide survey of 540 diagnostic and therapeutic consent forms across specialties showed that only 25% of the forms provided a comprehensive descriptions of risks, benefits and alternative methods of therapy. But AICDs are a reasonable place for bioethicists to be involved with because the devices are expensive, provide some patients with minimal benefits and substantial burdens, and are extraordinarily complex in understanding all their features.
The ideal consent process should include more than one care provider including the Electrophysiology Cardiologist (EPC), the patient, the surrogate decisionmaker to help the patient understand this complex issue, and perhaps others in a collaborative process assisted by decision aids. Todays’ digital communication programs makes this possible to do so from remote locations and even asynchronously as needed. A truly informed consent process is enabled by these digital processes but still needs a driving moral force to be implemented. That force should be the individual’s right to fully informed consent and society’s right to use its resources in a fair, equitable, and effective manner. Greater involvement of bioethicists in this matter would likely be helpful.
Before the referral to the EPC, the goals of medical care need to be thoroughly discussed. That process may be better accomplished by including the patient’s next of kin or healthcare surrogate, the patient’s general cardiologist, and his/her primary care physician. The EPC nurse can also provide important information to help improve the decision-making process. Consultation with other services such as psychology, ethics, or palliative care services may be helpful too. Decision aids have been developed and they should be used to help patients and their surrogates understand the process, risks, benefits and alternative choices. All the cardiology societies including the Heart Rhythm Society call for patients to be informed of the realistic expectations of benefits of AICD placement but process for doing so is often lacking in the actual clinical situation.
Several other Western countries handle this medical situation with much less use of these devices in elderly patients without noticeable differences in mortality. Bioethicists’ involvement can help restore an appropriate balance in the care of older patients in this regard to the AICD device in the U.S. They may provide useful input to the development of their institution’s policy regarding AICDs.