DENVER, May 14, 2010 – The Heart Rhythm Society (HRS) has released the first consensus statement for the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting device deactivation. The HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy was written in collaboration with representatives from the American College of Cardiology (ACC), the American Geriatrics Society (AGS), the American Academy of Hospice and Palliative Medicine (AAHPM), the American Heart Association (AHA) and the European Heart Rhythm Association (EHRA).
For decades, CIEDs —pacemakers, implantable cardioverter-defibrillators (ICDs), and more recently cardiac resynchronization therapy (CRT) devices — have proven to save lives in various populations at risk of serious heart rhythm disorders. As indications for device therapy continues to expand, the population of patients with these devices continues to grow. The new consensus statement is the first to offer clinicians and industry guidance on the management of CIEDs in those patients at the end of their lives or requesting withdrawal of device therapy.
“The overall understanding of device deactivation varies, and addressing device management with patients nearing the end of their lives can be very uncomfortable for many clinicians,” stated lead author of the statement, Rachel Lampert, MD, FHRS, Yale University School of Medicine in New Haven, CT. “The goal of this document is to provide clinicians with an understanding of the ethical and legal principles underlying device deactivation as well as guidance on communication about device deactivation with patients.”
The Heart Rhythm Society brought together a diverse panel of experts to comprehensively address the legal, ethical and religious principles supporting device deactivation in patients who have made this decision. To address the topic, a multidisciplinary group was convened and consisted of electrophysiologists, patients and representatives from the fields of geriatrics, palliative care, psychiatry, nursing, law, ethics and divinity.
The consensus statement outlines common ethical and legal concerns related to withdrawing CIED therapies (device deactivation), a decision-making algorithm for withdrawing CIED therapies, how CIED-related ethical conflicts can be prevented, and the rights and responsibilities of the clinician whose personal beliefs preclude his/her participation in device deactivation.
The new consensus statement presents several key points:
- A patient with decision-making capacity has the legal right to refuse or request the withdrawal of any medical treatment or intervention, regardless of whether he or she is terminally ill, and regardless of whether the treatment prolongs life and its withdrawal results in death.
- Legally and ethically, carrying out a request to withdraw life-sustaining treatment is neither physician-assisted suicide nor euthanasia.
- The right to refuse or request the withdrawal of a treatment is a personal right of the patient and does not depend on the characteristics of the particular treatment involved (i.e. CIEDs).
- A clinician cannot be compelled to carry out an ethically- and legally-permissible procedure (i.e. CIED deactivation) that he or she personally views as in conflict with his/her personal values. In these circumstances, the clinician cannot abandon the patient but should involve a colleague who is willing to carry out the procedure.
- Communication about CIEDs should be a part of a larger conversation about patients’ goals of care. The role of the clinician is to help patients determine how the benefits and burdens of device therapy align with their desired outcomes for their health care.
- Communication about CIED deactivation is an ongoing process that starts prior to implant and continues over time as patient's health status changes.
- Any physician or center that implants CIEDs should have a clearly defined process to withdraw therapies at such a time that becomes appropriate.
- The deactivation process should include anticipation of symptoms and appropriate palliative care planning tailored to individual patients’ needs, as well as the needs of family members when appropriate.
“Most clinicians who care for patients with cardiac devices regard the therapies delivered by those devices to be life-sustaining and for that reason device deactivation is a challenging practice for many clinicians to execute,” stated co-lead author of the statement, David Hayes, MD, FHRS, Mayo Clinic in Rochester, MN. “It is extremely important for clinicians to have a point of reference and this document provides guidance for device deactivation in patients with CIEDs.”
The complete guidance will be published in the July edition of HeartRhythm , the official journal of the Heart Rhythm Society.