(HealthDay News) – A software monitoring program that tracks implantable cardioverter-defibrillator lead function could detect problems with the devices earlier than current monitoring processes.
Robert G. Hauser, MD, 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%) were successfully matched to Quattro patients for a propensity-matched analysis.
The researchers found that, during the study, 8.1% of the 1,035 Fidelis and 1.4% 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.