Heart Defibrillators Often Implanted in Inappropriate Patients: Study

More than one out of every five heart defibrillators implanted in the United States may be unnecessary, or were implanted without their doctor following the appropriate guidelines for when the devices should or should not be used, according to new research.

The study, published this week in the Journal of the American Medical Association (JAMA), suggests that as many as 22,000 patients each year could undergo $35,000 worth of heart surgery that they do not need, which may expose them to a risk of unnecessary harm.

Researchers looked at data on 111,707 cases from a national registry over nearly four years, and found that about 22.5% of patients who received ICDs did not meet the criteria for receiving them. They also found that those patients faced a higher risk of death or complications.

According to the researchers, many doctors do not make evidence-based decisions on giving patients the implants according to accepted implantable cardioverter defibrillator (ICD) guidelines.

Current medical standards for implanting the devices recommend that they not be given to patients who have recently had a heart attack or bypass surgery. They also recommend that doctors do not give them to people who have recently been diagnosed with heart failure or who have a terminal illness. Despite the recommendations for restraint, about 100,000 patients each year receive the implants.

In addition to the health risks that may be involved with a perfectly operable implanted heart defibrillator, patients also face a potential risk of defective ICDs, which could lead to serious injury or death.

Last February, the Justice Department filed criminal charges against Guidant, a division of Boston Scientific, for attempting to cover up catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs. The company tried to reach a $296 million plea deal to settle the charges but a federal judge rejected the plea, saying that it failed to properly punish the company, whose defective ICDs were responsible for at least six deaths.

A Medtronic Sprint Fidelis lead recall was issued on October 15, 2007, after it was confirmed that the small wires that connect defibrillators to the heart were prone to fracture or break. The leads were already implanted in about 268,000 people at the time they were recalled from the market, and if the defibrillator lead fails, it could result in a massive electrical shock or cause a patient’s cardiac defibrillator not to work when it is needed to deliver a life-saving jolt.

Although initial studies indicated that the leads had a failure rate of only about 3%, a UBS analysis predicted that rate could rise as high as 30% in patients over the next three years. The analysis also suggests that it appears that the leads are more likely to fail in healthier patients.