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Automated monitoring system allowed earlier detection of ICD problems
Hauser RG. Circ Cardiovasc Qual Outcomes. 2012;doi:10.1161/CIRCOUTCOMES.111.962621.
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Recent study results suggest that an automated safety surveillance system designed to track implantable cardioverter defibrillators can identify issues with the devices sooner than current postmarket surveillance methods.
“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,” study researcher Robert G. Hauser, MD, senior consulting cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, said in a press release. “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 conducted simulated prospective, monthly, full-cohort and propensity-matched comparative survival analyses on data from 1,035 patients implanted with recalled Sprint Fidelis ICD leads (Medtronic) and 1,675 patients implanted with Quattro Secure ICD leads (Medtronic) using the commercially available Data Extraction and Longitudinal Trend Analysis system (DELTA, Coping Systems Inc.). All patients underwent implantation between 2001 and 2008.
During the study, 8.1% of Fidelis and 1.4% of Quattro leads failed. In the simulated full-cohort analysis, the DELTA system detected problems with the Fidelis leads 13 months after the first implant and 2 years before their recall. Similarly, in the propensity-matched analysis, the automated surveillance tool triggered an alert 22 months after the first Fidelis implant and more than 1 year before they were removed from the market.
“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.”
The researchers said applying such a tool to clinical registries and databases could potentially limit the exposure of many patients to hazardous devices.
Disclosure: Dr. Hauser reports no relevant financial disclosures. Several other researchers report financial relationships with Aegis Medical, Bard EP, Biotronik, Boston Scientific, Hewlett-Packard, Medical Positioning, Medtronic, NeoChord, Pfizer, Pixel Velocity, St. Jude Medical and Sorin Medical.