Another Study Casts Doubt on St. Jude Riata Defibrillator Leads

Another study has essentially condemned the St. Jude Riata line of defibrillator leads, indicating they’re far more dangerous for patients than its competitor, the Medtronic Quattro leads.

According to a Dow Jones report this week, a “multicenter study” presented at this year’s conference of Heart Rhythm Society indicates the Riata, not Riata ST, leads performed far worse during the course of seven different studies than the Medtronic Quattro. At least 79,000 people in the U.S. still rely on the Riata leads to regulate their heart rhythm and although St. Jude ceased marketing of these devices in 2010, many heart surgeons still remain mystified over the best course of treatment for their patients with them still implanted.

Close monitoring of patients with the Riata and Riata ST leads is currently recommended, but in recent months, several studies suggest failures of these lead wires is only a matter of time and the impact could be fatal. The most commonly reported malfunction associated with the Riata and Riata ST leads is its ability to break free of the silicone housing located at the connective ends of the leads. This defect has been corrected with a better connective end covering the leads but tens of thousands are still required to function daily to maintain a recipient’s heart beat.

A study completed earlier this year associated this malfunction of the Riata and Riata ST leads with at least 20 deaths, far more than the Quattro leads. This study initially started a war of words between St. Jude, makers of the Riata, the author of the study, and the journal publishing the study.

Implanted cardiac defibrillator leads are responsible for synchronizing the rhythm of the heart and to provide necessary shocks to a heart to keep it beating. Leads of all types have been associated with a sketchy safety record and the failures of the Riata and Riata ST leads only represent a percentage of problems with the devices. Leads connect to an implanted defibrillator and the heart and send the electrical charges necessary to keep a heart’s rhythm regulated.

This most recent study presented at the conference this week in Boston combed data from seven previous studies on the devices. It was funded by Minneapolis Heart Institute Foundation and Abbott Northwestern Foundation.

Though it associated with the Riata, not the Riata ST, leads with a higher rate of failure and one that performed “significantly worse” than Medtronic’s Quattro leads over the course of the multiple studies. Follow-care was required much sooner with the Riata ST leads over the Riata, however, according to the report on the new study.

When these devices begin to fail, the connective ends break free of that protective housing. Though some leads continue working despite this defect, the study found that one-third of all leads that broke out of the silicone housing had failed and put patients at serious risk of injuries or death.

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