March 7th, 2012

Software Tool Could Provide Early Warning of ICD Lead Failure

In recent years, defects in ICD leads have caused recalls and provoked broad concerns among healthcare professionals and patients alike about the safety and reliability of ICDs and other implanted cardiac devices. Now a key player in these events proposes that a computer software program can better monitor ICD leads and provide earlier warnings of possible malfunctions.

In a paper published in Circulation: Cardiovascular Quality and Outcomes, Robert Hauser and colleagues report on their evaluation of DELTA (Data Extraction and Longitudinal Trend Analysis), a commercially available automated surveillance tool, in simulated analyses of lead survival in a population of 1035 patients with the recalled Sprint Fidelis lead and 1675 patients with the Quattro Secure lead. Lead failures occurred in 8.1% of the Fidelis leads and 1.4% of the Quattro leads during the study.

A simulated analysis of the entire cohort “triggered a sustained alert” for the Fidelis lead 13 months after device approval and a full 2 years before the leads were pulled from the market. A second, propensity-matched analysis triggered an alert 22 months after approval and more than 1 year before withdrawal from the market.

“The results of this multicenter study suggest that an active automated surveillance system could have identified this cardiovascular device problem substantially sooner than was achieved through existing postmarket surveillance methods,” the authors conclude. An earlier alert of the Fidelis problem, the add, “could have spared thousands of patients the consequences of receiving a device prone to failure, including the risks and costs of lead replacement.”

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