Implantable cardioverter-defibrillators (ICDs) are true lifesavers, but like all devices, their components potentially can malfunction. The natural life of a well-performing ICD lead, for instance, is about 10 years or so; however, several models of leads have higher rates of failure and a few have been subject to recall. Properly managing a patient with a failing lead or a recalled lead is a clinical challenge, due to a host of factors that must be balanced when determining the best interests of the patient.
Recently, electrophysiologist David B. DeLurgio, MD, of Emory University Crawford Long Hospital in Atlanta, had a difficult conversation with a patient in whom he had implanted an ICD in 2005. The ICD had been operating properly and twice had delivered appropriate shocks to the patient. But the patient had a recalled lead implanted. Like all recipients with this same lead in DeLurgio’s practice, the patient has regular fluoroscopic examinations, and the most recent one showed extrusion of several segments of the lead.
|New vs. Known|
New models of ICD leads continue to enter the market, each accompanied by a marketing effort that trumpets its innovations and superiority over existing models. But Raed Abdelhadi, MD, of the Minneapolis Heart Institute, points out that new leads may not include substantial information about how that lead will perform over time.
This is a key point for both physicians and patients, as understanding the typical mechanism of failure of each model is crucial for optimum patient monitoring and management. Yet this information is not typically available until long after a new product is introduced to the market, and that can make managing the patient more challenging.
"There are no strict reporting requirements, and many of us have the sense that failures are under-reported," he says. "If post-marketing data were collected and disseminated in a more systematic way, we would have a better understanding, sooner, of the risks to watch for and could try to prevent them."
To that end, Abdelhadi encourages physicians to report all lead dysfunction to the manufacturers and to the FDA. He also suggests returning all damaged, extracted leads to the manufacturers. In this way, practicing physicians can contribute to the body of evidence about the specific performance of the devices their patients are receiving, add to the knowledge base and, ultimately, provide a better experience for the patients who depend on these life-saving devices.
The patient was due for a generator replacement, and DeLurgio counseled him that the lead should be replaced as well as the battery—a more difficult and involved procedure. “There was no electrical malfunction, but there was clearly structural malfunction that may be a harbinger of eventual electrical malfunction,” DeLurgio says. “And in a patient like this one, who is likely to need a life-saving shock again, we want to replace that lead.”
With this patient, the decision proved relatively easy, but that is not always the case. Many questions arise when managing ICD patients with suspect, faulty or recalled leads: When is it prudent to replace the lead, or when is close monitoring the better choice? Is it better to extract the old lead, or is extraction too risky for this patient? How best to discuss these issues with the patient, to ensure informed, shared decision-making? There are no hard and fast answers, but after years of experience, there are some emerging schools of thought.
Facing the inevitable
Approximately 400,000 patients receive ICDs every year in the U.S., and more than 3 million patients in the U.S. currently have ICDs (Circulation 2011;123:e378-380). Even if a particular lead model has no documented performance problems, leads have a finite life expectancy. When a patient receives an ICD prior to age 60, it is likely that lead replacement will be necessary at some point. Younger patients and patients who receive leads that do not perform properly may undergo several lead replacements.
“Even well-performing leads have a failure rate of about 0.3 percent per year,” says Jason C. Rubenstein, MD, an electrophysiologist with the Medical College of Wisconsin in Milwaukee. “And leads that have performance problems can have failure rates as high as 1 or 2 percent per year.” According to a 2011 study modeling costs of ICD lead management in the U.S., Medicare will spend approximately $287 million over five years on the management of high-failure leads (Heart