CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

August 16th, 2012

FDA Calls for Imaging of Implantable Cardiac Devices with Riata Leads

The FDA is recommending imaging studies for patients whose implantable cardioverter/defibrillator or cardiac resynchronization therapy defibrillator has Riata or Riata ST leads.

The studies are to check for abnormalities in the leads’ insulation, which can cause the devices to deliver inappropriate or no shock therapy. The abnormalities may be detected with two-view chest X-ray or fluoroscopy. The leads are manufactured by St. Jude Medical, which reported that there are some 79,000 Riata leads implanted in the U.S.

The agency recommends close monitoring of affected patients, who should be notified of the risk. Patients who’ve not had a recent evaluation should get one, and their devices should be checked for electrical abnormalities. The FDA also advises that clinicians consider remote monitoring of patients.

Categories: Cardiac Imaging, Electrophysiology


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