NEJM: Time to give ICD replacement protocol a jolt
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“ICD replacement has not received enough attention, and untold numbers of patients will continue to receive devices whose implantation they might reasonably elect to defer if the system were more rationally designed to support decision making,” wrote Daniel B. Kramer, MD, and colleagues, all from Beth Israel Deaconess Medical Center and Harvard Medical School in Boston.
They pointed out that every year, 100,000 ICDs are implanted in patients in the U.S., with a quarter of those procedures due to drained batteries requiring replacement of the generator. While these patients are evaluated before receiving their initial ICDs, no such process is required for replacing an ICD. Given the high cost and 5 percent risk of major complications from ICD replacement, Kramer and colleagues said equally rigorous scrutiny should be considered beforehand.
They recommended physicians:
- Perform a medical exam and re-evaluate clinical data. As written in guidelines for an initial ICD, the patient should have a reasonable expectation of surviving at least one year. Conversely, the examination may find the patient no longer needs an ICD.
- Recognize that the patient may prefer to forgo replacement, either because of experienced complications or concerns about risks.
- Consider the patient’s wishes about life-sustaining technologies.
Patients, especially complex patients, may have many specialists as well as a primary care physician caring for them. “Such fragmentation may mean that no one physician holds responsibility for identifying reasons to avoid a potentially unnecessary and costly procedure,” they wrote.
A fee-for-service healthcare system, fears of litigation and concerns that not replacing ICDs is viewed as withholding care exacerbate the problem. To overcome these barriers, they recommended that the physicians who implant ICDs step up by educating other physicians and patients about the appropriateness of ICD replacements. They suggested broaching the topic of a replacement before the initial ICD implantation.
They also called for professional societies and patient advocates to push for prospective studies on outcomes and the cost effectiveness of ICD replacements to build evidence for guidelines. Those changes ultimately will lead to better, cost-effective patient care, they argued.
“From both patient and societal perspectives, the expense and uncertainty of ICD therapy argue for a more considered and nuanced approach to generator replacement,” they concluded. “It is time for a change in our approach to this common, costly and complex clinical decision.”