Each year, about 250,000 heart bypass surgeries are performed in the U.S. The majority of cardiac and cardiopulmonary surgeries in the U.S. have been performed while using a heater-cooler unit (HCU), which regulates the patient’s body temperature during the procedure.
In 2010, the FDA and/or CDC began receiving reports of bacterial infections after cardiac surgeries in the U.S. These government agencies later identified how the bacteria spread. During use of HCUs, the bacteria would become airborne, thus potentially invading the patient’s tissues.
The infections were caused by a specific bacteria, Mycobacterium chimaera, which is a species of nontuberculous mycobacterium (NTM). Mycobacterium chimaera is a relatively rare bacteria. It is present in water and soil and historically seen in immunocompromised patients or those with lung disease.
In 2015, Mycobacterium chimaera infections after open heart surgery were identified and studied in Europe. This triggered increased awareness at the CDC and FDA the same year. By late 2015, the CDC and the FDA began issuing warnings about problematic bacterial infections after cardiac surgery. They involved a specific HCU, the Sorin or Stockert 3T Heater-Cooler, which was recalled by the manufacturer in 2015. Learn about Sorin/Stockert 3T Heater-Cooler lawsuits, which are currently being filed against the manufacturer.
Diagnosis of Mycobacterium chimaera bacterial infections after cardiac surgery can take months if not years. In some cases, diagnosis might not occur until up to 4 to 6 years after the surgery. Diagnosis tends to be difficult for multiple reasons:
Localized signs or diagnoses include prosthetic valve endocarditis, prosthetic vascular graft infection, sternotomy wound infection, mediastinitis or deep organ space infection. Non-localized signs include bacteremia, splenomegaly, arthritis, osteomyelitis, chorioretinitis, cerebral vasculitis, myocarditis, hepatitis, and nephritis.
Patients in rural areas of the country face a greater risk for delayed diagnosis of a bacterial infection after heart surgery. The surgeon or hospital where the surgery was performed may be too far for post-op visits and treatment. Patients in these situations often follow up with their local doctors, who simply may not be aware of the risk of the Mycobacterium chimaera infections after surgery.
A Mycobacterium chimaera bacterial infection after heart surgery often manifests as prosthetic valve endocarditis or vascular graft infection. The infection may be diagnosed or misdiagnosed as endocarditis, blood infections/septicemia, etc. If bone marrow is involved, cytopenia and/or splenomegaly may be involved. Oftentimes patients exhibit fever, unspecified pain, fatigue and weight loss.
Once identified, treatment of a bacterial infection after heart surgery often requires a tough protocol of powerful antibiotics and toxic drugs. In many cases, a subsequent surgery to remove the implant will be necessary. Unfortunately, the mortality rate tends to be high for these infections, potentially 50%.
In one case, a 60 year old male underwent two heart procedures within a 3 year span and died shortly after the second procedure. Analysis of the patient’s medical case revealed that he had a Mycobacterium infection.
About 2 years after the first surgery (aortic, mitral reconstruction with implant), the patient reported symptoms of fever, weight loss and respiratory problems. Prosthetic vale endocarditis was ruled out with negative blood cultures; even subsequent testing produced negative results. Sarcoidosis was diagnosed, and the patient was started on immunosuppressive therapy, including a steroid (prednisone). The patient’s condition deteriorated over the course of the following year.
He was admitted to the hospital with respiratory distress. An echocardiogram showed mitral and aortic valve insufficiency, so he was referred for additional valve surgery. During the surgery, acute necrotizing mycobacterial endocarditis was discovered. Further testing revealed the presence of two kinds of bacteria, Mycobacterium avium and Mycobacterium chimaera, in the patient’s heart tissue and implant. He was started on a strong, toxic trio of drugs: rifabutin, ethambutol and clarithromycin/azithromycin (the current standard for treating Mycobacterium infections). Unfortunately, the patient died of heart failure two weeks later.
If you or a loved one suffered a serious or long-term complication after heart or chest surgery, contact our firm. Our drug and medical device lawyers are accepting Sorin, Stockert 3T Heater-Cooler System lawsuits across the country.
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