Landmark trial to test implantable defibrillator in diabetic patients with history of heart attack

Loyola Medicine is enrolling patients in a landmark international trial to determine whether defibrillator devices can save lives when implanted in diabetic patients who have had prior heart attacks.

An implantable defibrillator can prevent sudden death from cardiac arrest by treating life-threatening arrhythmias (abnormal heart rhythms). The device continually monitors the patient's heart rhythm. If the heart begins to beat dangerously fast or chaotically, the device restores normal rhythm with an electric shock.

Diabetic patients who have had a heart attack may be at risk of dying suddenly from life-threatening arrhythmias. However, there currently is no official recommendation to implant defibrillators in these patients. The trial will investigate whether implanting a defibrillator in such cases will save lives. Patients will be selected to either receive an implantable defibrillator along with standard medical therapy or medical therapy alone.

Loyola is the only Illinois center participating in the trial, which is enrolling 1,800 patients from 100 centers in the United States, Europe and Israel.

To be eligible for the trial, a patient must:

• Be age 65 or older
• Have diabetes
• Have experienced at least one heart attack
• Have a left ventricular ejection fraction of 36 to 50 percent (meaning heart muscle pumping function is mildly or moderately reduced)

The device used in the trial is called a subcutaneous implantable cardioverter defibrillator (S-ICD). The battery and electronic circuitry of the S-ICD is implanted on the left side of the chest under the arm pit. A conductor wire from the device (called a lead) is implanted over the heart, just under the skin.