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Nearly 80,000 heart patients may still have recalled St. Jude Riatta leads, which are used to connect implanted defibrillators to their hearts, and new research highlights how these defective wires can fail in multiple ways, posing a serious and potentially life-threatening risk for patients.
A St. Jude defibrillator lead recall was announced last year, but patients who already had the small wires implanted as part of a St. Jude Riata and Riata ST implantable cardioverter-defibrillator (ICD) were left with few options, since it is extremely risky to attempt to remove the faulty leads.
The St. Jude Riatta leads were recalled because the externalized conductors could poke through the leads insulation, causing an electrical hazard. However, according to a new study by the Minneapolis Heart Institute, the defibrillators could have multiple defects that may pose an injury risk for patients.
According to the report, presented Sunday at the American College of Cardiology meeting in Chicago, researchers looked at 105 reports of failed wires and found that two-thirds suffered from more than one problem. Not only did some of the wires poke through the insulation, but in some cases they produced static noise that could cause unnecessary shocks or drain power needed for life-saving heart stimulation.
Another study presented at the conference by Irish researchers revealed that the insulation problems appear to affect 19 percent of patients with the Riata ICD.
The St. Jude Riata lead recall came in the form of a Physician Advisory Letter sent out by St. Jude Medical, Inc. in late November, where the company warned doctors that there were problems with conductors poking through the leads’ insulation. The FDA reported at at that time that at least two patient deaths and one serious injury had been linked to the externalized conductor problem.
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.