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.