A new and effective computer software program helps track implantable cardioverter-defibrillator (ICD) function sooner, according to a recent research published in Circulation: Cardiovascular Quality and Outcomes. ICDs monitor heart rhythms and deliver electric shocks to restore normal rhythm when life-threatening, irregular heartbeats occur.
But the surgically implanted devices can malfunction, particularly in the leads, or wires, that connect them to the heart, causing injury or death. Device manufacturers track repeated malfunctions and issue recalls if they're widespread. However, often by the time of the recall, thousands of the devices have been implanted in patients worldwide. "Current monitoring approaches aimed at reducing harm from malfunctioning medical devices rely largely on voluntary reporting of adverse events by manufacturers, possibly leading to missed warning signs and delayed responses to the problems, such as late recalls," said Robert G. Hauser, M.D., lead study author and senior consulting cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minn.
"We looked at whether using an automated software program to monitor large databases of ICD patients might help us detect potential device-related problems earlier."Hauser and colleagues used a commercially available software surveillance program to compare data from about 1,000 patients with recalled leads to about 1,600 patients implanted with ICD leads still on the market. Patients in both databases had their ICDs implanted between 2001 and 2008.