Published on:

New Study Finds More Than 20% of Patients with Implantable Cardioverter-Defibrillators May Not Have Needed Them

When a doctor tells us that we need surgery, we usually don’t question his or her judgment, especially if the procedure involves a medical device that can help supplement the function of our heart. But a recent article on CNN Health recently reported that 20% of patients who received an implantable cardioverter-defibrillator, or ICD (a device that produces electrical impulses to regulate heartbeats and prevent life-threatening arrhythmias), were not good candidates to receive the device.

A study of more than 111,000 patients who received ICD implants between 2006 and 2009 was conducted by researchers at Duke University. It was discovered that more than 25,000 of those patients did not meet evidence-based criteria for receiving the ICD.

Physicians and surgeons often recommend ICDs for patients who are at high risk for a cardiac arrest or life-threatening arrhythmia, but have not yet suffered from these symptoms. But according to Dr. Robert Michler, chairman of Cardiovascular and Thoracic Surgery at Montefiore-Einstein Heart Center, “Doctors are well-intentioned, but not all doctors should be determining the use of what is a very sophisticated therapy.”

As a result, the Centers for Medicare and Medicaid Services (CMS) has issued a “decision memo” stating the criteria that should be used when a patient is being considered for an implant. For example, only patients with serious heart conditions or cardiac histories should be considered suitable candidates for ICDs. But because some patients may fall into a gray zone, Dr. Michler believes that electrophysiologists should make the final decisions in determining if a patient needs a device.

The study found that the risk of dying in the hospital was significantly higher for patients who received the ICD but did not meet the criteria for an ICD. Dr. Sana Al-Khatib, lead researcher of the study, found that many patients who were implanted with an ICD had recently experienced arrhythmias or cardiac arrests. She said, “The physicians haven’t had the time to optimize the patients’ medical therapy before subjecting them to this surgery.” This could have accounted for the increase in deaths among implant patients who did not meet CMS criteria. Another possible explanation could be whether the cardiologists who performed the implant were electrophysiologists. These specialists have additional training in the diagnosis and treatment of abnormal heart rhythms.

Even with the best of intentions, mistakes can happen. If it’s been recommended that you or a loved one undergo a procedure to implant an ICD and you have questions, don’t be afraid to make your doctor aware of your concerns. But if you or a loved one has been injured by an ICD, contact the attorneys at Michael J. O’Connor & Associates for a free review of your case.