Simulated prospective study identified danger two years before devices were removed from market
TUESDAY, March 6 (HealthDay News) -- A software monitoring program that tracks implantable cardioverter-defibrillator lead function could detect problems with the devices earlier than current monitoring processes, according to a study published online March 6 in Circulation: Cardiovascular Quality and Outcomes.
Robert G. Hauser, M.D., from the Minneapolis Heart Institute Foundation, and colleagues simulated prospective monthly full-cohort and propensity-matched comparative survival analyses using databases from three centers on Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads. The researchers used a commercially available automated surveillance tool that was set to trigger an alert if the log rank probability value was <0.05. Of the 1,035 patients who had Fidelis leads, up to 969 (93.6 percent) were successfully matched to Quattro patients for a propensity-matched analysis.
The researchers found that, during the study, 8.1 percent of the 1,035 Fidelis and 1.4 percent of the 1,675 Quattro leads failed. Thirteen months after the first Fidelis implant the simulated full-cohort analysis triggered a sustained alert for Fidelis leads, which was two years before the leads were removed from the market. Based on the propensity-matched analysis, the alert triggered 22 months after the first Fidelis implant, which was more than a year before the leads were recalled.
"An active automated safety surveillance system could have identified this implantable cardiovascular device problem substantially sooner than was achieved through existing post-market surveillance methods," the authors write.
Several authors disclosed financial ties to medical device companies, including Medtronic, the manufacturers of Sprint Fidelis and Quattro Secure defibrillator leads.
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