One in five patients who receive the heart-shocking, life-saving devices known as implantable cardioverter-defibrillators, or ICDs, may be getting them unnecessarily, according to a study published in the Journal of the American Medical Association Tuesday.
The study, which looked at more than 100,000 patients, also found that those who did not meet the guidelines for use of the product but received the devices anyway had a significantly higher risk of in-hospital death than patients who met the criteria.
Using data from the National Cardiovascular Data Registry's on ICD use , researchers at Duke University found that more than 20 percent of patients who receive an ICD fall outside the recommended eligibility guidelines for the procedure.
Clinical trials have demonstrated the effectiveness of ICDs when used in patients with certain forms of heart failure, but the research fails to support a benefit for the device in people still recovering from a heart attack, coronary artery bypass surgery or those with a recent diagnosis of heart failure.
The study concluded that a substantial proportion of the devices end up in patients who fall into one of the categories. What's more, the risk of in-hospital complications was significantly higher in the patients given ICDs outside of the recommendations.
Study authors argued that this extra risk of complications is unacceptable considering the lack of evidence for benefit in patients who fail to meet the guideline criteria.
"[T]hese complications could have significant effects on patients' quality of life and health care use, including length of hospital stay and costs," the authors wrote. "Importantly, these complications resulted from procedures that were not clearly indicated in the first place. While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has no demonstrated benefit."
But cardiac experts were split on whether the "off-label" use of ICDs was an acceptable exception to make for certain patients. While some doctors argue that the study should be seen as an impetus for stricter compliance with the evidence-based recommendations, others said they believe that the use of the ICD in certain non-evidence-based circumstances is up to the discretion and expertise of the physician.
"If 'appropriate' is practicing medicine by following the guidelines, then this is clearly not appropriate," said Dr. Brian Olshansky, a cardiac electrophysiologist at University of Iowa Hospitals. "On the other hand, if physicians implanted device due to the fact that they're concerned about the long-term outcome of the patient and weigh the risks and benefits and then decide to implant the device in lieu of the guidelines, this may be appropriate."
Unlike a pacemaker, which delivers smalls amounts of electricity to regulate heartbeat, an ICD delivers larger jolts of electricity in order to prevent the onset of sudden cardiac death.
The guidelines concerning when such a device is appropriate may be overruled in certain circumstances, said lead author on the study and researcher for the Duke Clinical Research Institute, Dr. Sana Al-Khatib. But the recommendations are based on multi-centered randomized clinical trials showing that the device does not help under certain conditions.