Consent discussions regarding the use of implantable cardioverter-defibrillators (ICDs) in elderly individuals rarely include the device's implications at the end of life, indicate US study results.
Rectifying this omission is "ethically and practically requisite," say the researchers, who explain that true informed consent requires an understanding of all risks and benefits of a treatment or procedure, whether they may occur in the short or long term.
ICDs "confer risk for delivery of unexpected painful shocks during the dying process, thus reducing the quality of palliative care at the end of life," explain Sally Rigler (University of Kansas School of Medicine, Kansas City) and colleagues.
Their review of data for 91 patients treated at a mid-Western academic medical center between 2006 and 2008 revealed only one patient chart that documented a discussion with the healthcare provider about the ICD's impact on future end-of-life care. Indeed, the conversation was initiated by the patient, whose concerns were focused on quality of life.
All study participants, aged a median of 72 years, signed a generic consent form before being fitted with an ICD that specified risks for bleeding and infection associated with implantation. Only one patient signed a form to which ICD-specific risks had been added, note Rigler et al.
However, despite not appearing on consent forms, discussions covering procedure risk were documented in 16 patients' medical charts, most frequently citing infection (100%), bleeding (100%), pneumothorax (75%), cardiac perforation (69%), and stroke (56%).
Some patients with ICDs may ultimately prefer high-quality end-of-life treatment and palliative care to life-saving or preserving care, note Rigel and co-investigators, adding that "it is important for them to understand that the option exists to deactivate or reprogramme the ICD… so that its function does not interfere with the natural dying process."
The team suggests that reasons why future deactivation may not be covered by the informed consent process include a lack of time, a feeling of an inadequate patient-physician relationship to discuss deactivation, discomfort with the conversation, and fear of taking away hope.
However, consent discussions could be improved by the presence of an ethics consultant, a social worker, or another colleague with ethics competence, note the authors, and regular follow-up appointments provide a forum in which patient education - including deactivation options - can be reinforced.
One potential remedy is to use pre-printed, procedure-specific consent forms that contain more detail about end-of-life implications for the use of ICDs, the team suggests.
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