Automated safety surveillance software programs might identify problematic implantable cardioverter defibrillator (ICD) leads earlier than current post-market surveillance methods, according to a study published in the journal Circulation: Cardiovascular Quality and Outcomes.
For the study, researchers used Data Extraction and Longitudinal Trend Analysis, or DELTA -- an automated safety surveillance tool -- to analyze data on patients who had received ICD leads.
Patients in the study received the leads between November 2001 and December 2008 at Beth Israel Deaconess Medical Center, the Mayo Clinic or the Minneapolis Heart Institute.
Overall, 1,035 patients included in the study received a Sprint Fidelis lead, a device that later was recalled, and 1,675 patients received a Quattro lead, which was not recalled.
During the study period, 84 of the Fidelis leads and 23 of the Quattro leads failed.
According to the study, a simulated analysis using DELTA "triggered a sustained alert for Fidelis leads beginning 13 months after the first implant and two years before Fidelis leads were removed from the market."
DELTA also found that the Fidelis problem was associated with certain patient characteristics, including age, gender and history of heart disease. Researchers found that none of the variables associated with failing Fidelis leads were associated with Quattro lead failures.
The study authors wrote that the findings suggest that automated surveillance software can identify cardiovascular device problems "substantially sooner than was achieved through existing postmarket surveillance methods."
They note that an earlier alert of the Fidelis problems "could have spared thousands of patients the consequences of receiving a device prone to failure, including the risks and costs of lead replacement."
SOURCE: iHealthBeat