Faulty St. Jude Riata Defibrillator Leads Eyed for Link to Heart Infections

September 11, 2017, 6:00PM. By Anne Wallace

Washington, DC: Premature Insulation Failure in recalled St. Jude Medical Riata Defibrillator (ICD) Leads has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that causes inflammation of the heart lining, muscles and valves. The decayed insulation on the electrical leads that connect the pacemaker to a patient’s heart may be a fertile breeding ground for bacteria and fungi that can attack a patient’s heart.

Patients who still carry recalled St. Jude Defibrillators leads in their chests have many reasons to be wary. This is another one that needs to be watched. Left untreated, endocarditis is always fatal.

Patients suffering from the condition may experience:

• High fever;
• New or different heart murmur;
• Fatigue;
• Muscle pain;
• Small spots from broken blood vessels under the nails, on the whites of the eyes, on the chest, in the roof of the mouth and inside the cheeks;
• Chest pain, shortness of breath, coughing;
• Night sweats;
• Headache;
• Blood in the urine; or
• Unexpected weight loss.

Treatment commonly involves a course of antibiotics, such as penicillin and gentamycin, or surgery when a patient’s heart valves are more severely damaged.

In previous studies, endocarditis has been linked to intravenous drug abuse, dental infections and surgical procedures. Having had heart surgery, including a pacemaker implant has long been recognized as increasing a patient’s risk for the condition. The infectious agent in most of the occurrences is streptococcal or staphylococcal bacteria or fungi, but for the most part, infections may be traced to a single source.

The studies of endocarditis in patients with premature insulation failure in recalled St. Jude Medical Riata defibrillator (ICD) leads shows something different. Polymicrobial endocarditis arises from several infectious agents.

There is, for some reason, more variety in the flora (referred to in the scientific literature as “vegetations”) involved in these cases. The findings suggest that, somewhere in the patient’s body, there is a fertile place for bacteria and fungi to flourish. The inquiry has moved to the possibility that the faulty insulation and resulting exposure (or externalization) of St. Jude Medical Riata defibrillator leads may be the host.

The study  that advances this theory notes that, “The externalization of Riata lead may cause the malfunction but it could also promote bacterial colonies and vegetations. In conclusion, looking for early signs of infection is mandatory during Riata leads follow-up checks.”