An off-the-shelf software product can be used to detect ICD malfunction trends more quickly than conventional post-market surveillance, researchers concluded March 6.

A retrospective analysis showed that a software analytics tool would have started to spot fracture issues with Medtronic Inc.’sSprint Fidelis defibrillator lead in 2005, and would likely have prompted a recall much earlier than October 2007, when the product was finally withdrawn from the market, according to researchers from Minneapolis and Boston.

Next, the team plans to apply the software tool in a prospective analysis of St. Jude Medical’s Durata ICD lead.

They published their results with Fidelis March 6 in the journal Circulation: Cardiovascular Quality and Outcomes. The study examined the Delta system, developed by Massachusetts-based Coping Systems specifically for mining medical information to spot adverse event trends. Delta employs complex statistical methods, including Bayesian analysis, to track outcomes and determine whether particular types of events are occurring more than expected.

FDA has said it is closely watching experiments with the software tool to inform its evolving approach to device post-market surveillance.

A Harvard team in 2010 applied the tool to a statewide Massachusetts coronary intervention registry, pinpointing previously undocumented safety signals for a stent and a vascular closure device. (See Also see "Automated Device Safety Surveillance Gets Proof Of Principle" - Medtech Insight, 15 November, 2010..) FDA has said it is closely watching experiments with the software tool to inform its evolving approach to device post-market surveillance. (See Also see "Harvard Device Safety Surveillance Project Could Inform FDA Efforts" - Medtech Insight, 17 May, 2010..)

The Fidelis study, led by Minneapolis Heart Institute Foundation electrophysiologist Robert Hauser, is the first to test the surveillance system to see if it could have detected the need for a device recall, according to the team.

They tasked the system with retrospectively analyzing lead failure rates based on information collected in an ICD patient database by three centers.

The software tracked outcomes on simulated monthly intervals beginning with information originally entered in the database in January 2005, four months after the first Fidelis lead had been implanted at one of the centers and four years after the first of Medtronic’s more established Quattro Secure ICD leads had been placed. The software compared Fidelis and Quattro failure rates.

The system triggered its first safety alert for Fidelis based on information that was in the database by October 2005, and that alert was sustained at all subsequent monthly checks. The first alert, according to the research team, could have prompted further analysis of the data, initiating steps that they estimate would have lead to complete market withdrawal or at least infrequent use of Fidelis by early 2007.

“The software works,” said Hauser, who was central to alerting FDA to elevated Fidelis fracture levels using more conventional analysis. (See Also see "Fracture Data Spurs Medtronic To Suspend Sales Of Fidelis ICD Lead" - Medtech Insight, 22 October, 2007..)

“Looking at ICD patients implanted years ago, we showed that the automated program detects medical device problems faster than current approaches,” he explained. “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 acknowledge that the tool needs to be validated in prospective studies with active databases such as the National Cardiovascular Data Registry or device remote monitoring databases. They plan to pursue this next step with surveillance of St. Jude’s currently marketed Durata lead, Hauser confirmed in an email. Hauser in particular has publicly urged caution with Durata in the wake of St. Jude’s 2011 recall of its Riata and Riata ST leads.

If the software is eventually employed for active device surveillance, it should be used cautiously, the researchers suggest.

“An initial alert should not precipitate an immediate regulatory action or recall or even a change in practice while confirmatory studies and analyses are underway,” they write.

The researchers also point out that the appropriate thresholds for system alerts will need to be considered separately for each surveillance effort.

ICD Lead Recall Could Have Come Sooner With Novel Surveillance Tool – Study

More from Regulation

More from Policy & Regulation