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January 5, 2011

A new study released today says 22.5% of implantable cardioverter-defibrillators (ICDs) are surgically implanted in patients who do not meet medical guidelines for these devices.

An implantable cardioverter-defibrillator (ICD) is a medical device about the size of a cookie implanted in the chest that detects an irregular heartbeat, an arrhythmia, and sends electrical shock to the heart to restore a normal rhythm.

Researchers studied 111,707 cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009 and found that 25,145 patients, or 22.5%, given an ICD were non-evidence-based ICD patients, meaning they failed to meet medical criteria indicating use of an ICD.

While ICDs are effective in preventing sudden cardiac death in patients with advanced heart failure, they are not recommended in patients recovering from coronary artery bypass surgery or heart attack, or those recently diagnosed with heart failure.

Non-evidence-based ICD patients were more likely to be older, with diseases such as heart failure, atrial fibrillation or flutter, ischemic heart disease, cerebrovascular disease, chronic lung disease, diabetes and end-stage renal disease. They required a hospital stay three times longer and suffered a significantly increased risk of dying in the hospital than patients who did meet ICD guidelines.

The study called Non–Evidence-Based ICD Implantations in the United States appears in the January 5 issue of The Journal of the American Medical Association (JAMA).

“Clearly there is a lack of knowledge and a lack of awareness of the guidelines, and some patients were harmed,” said Sana Al-Khatib, lead researcher from the Duke Clinical Research Institute told “More education is needed. Hopefully physicians will look at our results and reflect on their practices.”

ICD implant sales in the U.S. are 6.6 billion dollars a year, reports Bloomberg. An ICD implant procedure can cost more than $50,000.

One Comment

  1. Gravatar for ICDer

    From my experience of having an ICD, six more factors need to be studied about where and who implants defibrillators. The fist three questions regard the percentage of defibrillators that are: 1)Implanted after entering through an Emergency Room; 2)Implanted person had no heart disease; 3)Defibrillator implanted person was taking no prescriptions or not under medical care. An additional three research questions are the role and presence of the following; 1) Defibrillator manufacturer reps at the hospital; 2)Implant Eletrophysiologists versus Cardiologists; 3)Internal Medicine MDs and the drugs prescribed after the implant. An example is Newport Beach's Hoag Hospital, Boston Scientific, Newport Heart Medical Group, and Pacific Hospitalist Associates.

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