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.

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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.

4 Comments

  • jennyMarch 3, 2011 at 10:18 pm

    my ejection fraction was 15% thats why it was implanted

  • JAJanuary 25, 2011 at 2:12 am

    I used to work for an electrophysiologist in a different state and we ALWAYS played by the rules. The group I work with now breaks the rules ALL THE TIME . . . . I have been waiting for this investigation! The reality is that many MD's forget that they are still human and that they need to follow rules. Bob, defibrillators are only considered treatment for CHF if that person also has dys-synchr[Show More]I used to work for an electrophysiologist in a different state and we ALWAYS played by the rules. The group I work with now breaks the rules ALL THE TIME . . . . I have been waiting for this investigation! The reality is that many MD's forget that they are still human and that they need to follow rules. Bob, defibrillators are only considered treatment for CHF if that person also has dys-synchrony (LBBB) otherwise it is simply for prevention of death from VF or VT. Jenny, the question to ask you doc is "have I ever had VT or VF?" If you have, keep the ICD. If you never have had a "malignant arrhythmia" and your EF is now normal . . . Have it explanted and move on. I am sorry this happened to you. The right thing to do (when you were diagnosed) was to treat you with medications, protect you with a WEARABLE defibrillator, and re-evaluate your heart function in 3 months . . . if still low at that time, then it is appropriate to implant. Sounds like they wanted the $100,000 that they get for a device implantation. Good Luck

  • jennyJanuary 15, 2011 at 11:57 am

    i was 23 when i went to the ER with what i thought was a chest cold ,i was admitted and tests were taken,i was retaining water they said it was heart failure and that i need to have an icd if i did not go for the surgery i would not survive.being a mother of 2 young children i thought that was my only option to live as you are supposed to be able to trust a dr?i had the surgery about 1 yr passed[Show More]i was 23 when i went to the ER with what i thought was a chest cold ,i was admitted and tests were taken,i was retaining water they said it was heart failure and that i need to have an icd if i did not go for the surgery i would not survive.being a mother of 2 young children i thought that was my only option to live as you are supposed to be able to trust a dr?i had the surgery about 1 yr passed i had my first shock i was feeling fine doing laundry i reached up and was shocked.the next time i go for a device check and the nurse changed the settings and as i was leaving the office i was shocked 10 times one right after the other as i struggled back into the office they did not know what to do after about 5 more shocks they finally disabled it with a magnet changed the setting .and had someone from guidant come change the settings a few months later.just a few days ago i went for a app. to see my cardiologist i she said my heart has returned to normal and that i should get a second opinion from a cardiologist that specializes in the device and thier opinion on just turning it off? i feel every one is missing the point in this it has nothing to do with the care of the patient or heart failure but JUST THE COMMISSION EACH IMPLANT PUTS IN THE DOCTORS POCKET !!!now 29 what can be done ?i have 2 children that i want to see grow can i trust another local dr !??????????

  • bobJanuary 5, 2011 at 3:26 pm

    The study missed an important point. That new bypass and heart attack patients can have congestive heart failure. Only lawyers would argue the device shouldn't have been implanted. The reality is that the congestive heart failure is the reason for the implant.

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