In an editorial in the New England Medical Journal, three leading specialists in the management of cardiac rhythm disorders argue for a more “considered and nuanced” approach to replacing implantable cardioverter defibrillators (ICD).
Daniel Kramer, Alfred Buxton, and Peter Zimetbaum, from the Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA and Harvard Medical School, Boston, Massachusetts, USA, argue that although the initial placement of an ICD has been closely scrutinised, little consideration has been given to what happens when the ICD battery, or generator, requires replacement. They write: “We believe that patients and clinicians must move beyond the view of ICD therapy as a lifelong treatment, committing patients to obtaining replacement devices for years or decades after implantation.”
Kramer et al explain that there are several factors that should be considered before a generator is replaced, including whether ICD therapy is still appropriate. They state that by the time a replacement is needed, a patient’s health may have deteriorated to such an extent that their life expectancy is less than a year. They write: “Guidelines for initial ICD implantation state that patients should be expected to survive for at least one year with a reasonable quality of life, and the same assessment should be critical for making recommendations regarding replacement.”
They add that a patient’s health may have also improved to the extent that they are no longer at high risk of sudden death (and thus, may no longer need an ICD).
Other considerations, according to Kramer et al, to take into account include patients’ perceptions of the benefits and risks of having ICD therapy and how they may have changed in years since the initial implantation. They write: “For example, progressive heart failure or end-stage renal disease with multiple hospitalisations may change a patient’s perspective on sudden death in relation to other possibilities, such as death from end-state systolic function.”
However, Kramer et al also claim that there are several barriers to incorporating these considerations into the assessment of ICD replacement. One of these barriers is that either the physician or the patient (or both) may view not replacing an ICD as being the same as deactivating a currently functioning one. Thus, the physician or patient may refuse to not replace an ICD (or even discuss the subject of non-replacement) because of concerns about the morality and legality of not replacing it. Kramer et al write: “Indeed, some patients or physicians might consider non-replacement equivalent to either physician-assisted suicide or euthanasia, despite consensus statements that clearly reject this view.”
To move forward on the issue of ICD replacement, Kramer et al argue that physicians who implant ICDs should “take the lead” in engaging and educating other physicians involved in the management of patients with ICDs (including primary care physicians) about the appropriateness of ICD replacement in individual patients. They say: “At the very least, cases should be identified early–well before the need for replacement–in which significant co-existing conditions (eg, new cancers or progressive dementia) raise commonsense questions about procedures.”
They add that professional societies and patient groups must “push for studies” of outcomes of ICD replacement to inform the development of more evidence-based guidelines.