More than 20% of patients who received an implantable cardioverter-defibrillator — a high-tech device that produces electrical impulses to regulate heartbeats and prevent life-threatening arrhythmias — in recent years were not good candidates to receive the device, a new study suggests.
Researchers at Duke University looked at more than 111,000 patients who received ICD implants between 2006 and 2009. More than 25,000 of those patients did not meet evidence-based criteria for receiving the device, according to the study.
The risk of dying in the hospital was significantly higher for patients who received the ICD but did not meet the criteria, and 1 out of 121 patients in this category experienced complications following the implant, the study found.
According to the study published Tuesday in the Journal of the American Medical Assocaition,, ICDs often are recommended as a primary prevention tactic for patients who are at high risk for a cardiac arrest or life-threatening arrhythmia, but who have not yet suffered from these symptoms.
However, the Centers for Medicare and Medicaid Services, CMS, in the U.S. Department of Health and Human Services, has issued a “decision memo” stating that only people having certain serious heart conditions or cardiac histories are suitable candidates for ICDs.
The memo further states that patients must meet numerous other qualifications relating to clinical trials and not have certain serious diseases or conditions that would lower the implant’s efficacy or the patient’s likelihood of long-term survival.
Dr. Ralph Brindis, president of the American College of Cardiology, said in a statement that the Duke University findings will have “major implications.”
Dr. Robert Michler, chairman of Cardiovascular and Thoracic Surgery at Montefiore-Einstein Heart Center, said the data should act as a “wake-up call” for physicians, surgeons and patients.
He says that in this case electophysiologists should be making the final determination if the patient needs the device.
These specialists have additional training in the diagnosis and treatment of abnormal heart rhythms and were less likely to implant an ICD in a patient who did not meet evidence-based criteria, the study found
The study’s authors reported that even with the current guidelines some patients may fall into a gray zone and that each physician needs to use clinical judgment to make recommendations.
According to the authors , deviating from the guideline are acceptable in various circumstances, but 20% is a significant amount of deviation.
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