Computer software monitoring detects implantable cardioverter-defibrillator malfunctions sooner

A software monitoring program that tracks implantable cardioverter-defibrillator (ICD) function could detect problems with the devices earlier than current monitoring processes, according to new research in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.

ICDs monitor 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 by manufacturers, possibly leading to missed and delayed responses to the problems, such as late recalls," said Robert G. Hauser, M.D., lead study author and senior consulting at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minn. "We looked at whether using an automated 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.

Using the , researchers simulated what occurred years earlier. The software detected problems with the recalled leads at least a year before the company had recalled them.

"The software works," Hauser said. "Looking at ICD patients implanted years ago, we showed that the automated program detects medical device problems faster than current approaches. Pinpointing the malfunction a year earlier in this case could have spared thousands of patients the health risks, costs and inconvenience of receiving a device prone to failure."

Monitoring newly approved devices could help identify potential problems before the ICDs are introduced on a large scale, he said.

The next step, according to Hauser, is to apply the software to large populations of newly implanted ICD patients, in order to reduce gaps in warning sign detection and action.

add to favorites email to friend print save as pdf

Related Stories

Recalled ICD leads fail in women, youths most often

Jan 31, 2011

The recalled Sprint Fidelis implantable cardioverter-defibrillator (ICD) leads (Medtronic) failed more often in younger patients, women, and individuals with hereditary heart disease, according to a multicenter study published ...

Are ICDs up to par with patients living longer?

Apr 04, 2011

Most patients with ischemic cardiomyopathy (ICM) and dilated cardiomyopathy (DCM) who have an implantable cardioverter-defibrillator (ICD) now live more than seven years and those ICD patients with hereditary heart disease ...

Largest study to date finds benefits of ICDs in children

May 01, 2008

More and more children with congenital heart disease are receiving implantable cardioverter-defibrillators (ICDs) to maintain proper heart rhythm. ICDs were first introduced for adults in the 1980s, but little is known about ...

Recommended for you

Towards renal artery stenosis treatment

22 hours ago

Renal artery stenting to open blockages in the kidney arteries may benefit patients who have historically been excluded from modern clinical trials, according to new recommendations for renal artery stenosis e-published in ...

New technologies help people with heart disease

Aug 22, 2014

People taking part in cardiac rehabilitation exercise programmes are likely to maintain healthy behaviours for longer with text message and web-based support, according to recent research from the University of Auckland.

A novel pathway for prevention of heart attack and stroke

Aug 21, 2014

A recent Finnish study could pave the way for preventing brain and cardiac ischemia induced by atherosclerosis. Finnish researchers have found that the low-expression variant of fatty acid-binding protein 4 (FABP4), which ...

User comments