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According to the findings of a new study, many patients who received a recalled St. Jude Riata defibrillator lead may have the small wires fail, potentially causing them not to provide life-saving electrical stimulation to the heart if needed.
Researchers presented the new data at a meeting of the Heart Rhythm Society in Boston last week, representing the first large study to provide some guidance for physicians about the rate at which St. Jude Riata defibrillator leads are failing.
Out of 712 devices identified in a seven-hospital study, at least 67 had failed by the end of December. When x-ray images were reviewed for 110 patients, researchers found that the small lead wires had pierced through the insulation in about 25% of the cases
The findings come just months after the St. Jude Riata and Riata ST implantable cardioverter-defibrillators (ICDs) were recalled and there has been an ongoing debate over how dangerous the Riata leads are for patients.
Researchers suggested that the trend in data indicates that the Riata ICD problems are progressively worsening over time.
The St. Jude Riatta leads were recalled because the externalized conductors could poke through the leads insulation, posing an electrical hazard or potentially causing the defibrillators to fail when needed.
The internal defibrillators are designed to be implanted near a patient’s heart, monitor the heart rhythms and give life-saving electrical shocks if necessary. The defibrillator leads, which deliver the electrical charge, are supposed to remain covered by insulation once implanted. However, in some cases it appears that the leads have penetrated the insulation and parts of those leads are bare and uncovered inside patients’ bodies.
The recalled leads pose a serious health concern, as it is largely impractical for patients to have the ICD leads removed, leaving patients with more frequent medical follow ups and the need to hope that they do not experience any of the problems associated with the small wires that connect their implanted defibrillator to their heart.