(RxWiki News) For patients with life-threatening heart arrhythmias, an implantable cardioverter-defibrillator (ICD) may be a necessity. New software designed to detect potential problems with the devices sooner could make them safer.
The software could help detect problems years before widespread problems or recalls occur, and may detect dangers before large-scale introductions of the devices.
"See a doctor immediately if you suspect a problem with an ICD."
ICDs deliver electric shocks when an abnormal heart rhythm is detected. Though the device can save the lives of patients with potentially deadly arrhythmias, the devices can malfunction, causing injury or even death.
Dr. Robert G. Hauser, lead study author and senior consulting cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, noted that current monitoring practices involve relying largely on patients and doctors to voluntarily report adverse events, which can lead to late recalls.
During the study researchers utilized a commercially available software surveillance program to compare data from about 1,000 patients with recalled ICD leads, or wires, to about 1,600 patients implanted with ICD leads still on the market. In both groups the devices were implanted between 2001 and 2008.
Investigators used the software to simulate previous years. They found the software was able to detect problems with the recalled leads at least a year before they were recalled.
“The software works,” said Dr. Hauser. “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.”
Dr. Hauser plans to use data from large populations of recently implanted patients, which could mean they receive warnings about future problems or recalls much earlier.
The research, funded by the Minneapolis Heart Institute Foundation and the Abbott Northwestern Hospital Foundation, was recently published in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.
