The Centers for Disease Control and Prevention (CDC) has warned healthcare providers and patients about the potential risk of infection with Mycobacterium chimaera during open heart bypass surgery that employed a heater-cooler device during heart/lung bypass. Approximately 60 percent of heart bypass procedures performed in the United States utilize these devices. In particular, CDC issued an alert stating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices might have been contaminated with Mycobacterium chimaera during manufacturing. CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between 1 in 100 and 1 in 1,000. Patients who had valves or prosthetic devices implanted are at higher risk of infection.
Mycobacterium chimaera, is a species of nontuberculous mycobacterium found in soil and water, that rarely causes disease healthy people.M. chimaera are slow-growing and patients may not experience symptoms for months or even years after surgery. CDC is recommending that clinicians consider mycobacterial infection as a potential cause of unexplained chronic illness in cardiac surgery patients. Symptoms of a mycobacterial infection may include:
- night sweats
- muscle aches
- weight loss
- unexplained fever
Patients have presented with a variety of clinical manifestations, including endocarditis, surgical site infection, abscess formation and bacteremia. Other presentations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.
There is no test to determine whether a person has been exposed to the mycobacteria. Infections can be diagnosed by submitting specimens for mycobacterial culture. Acceptable specimens are blood collected in a SPS tube, tissue, or other sterilely collected specimens such as fluid, pus, or drainage. The slow growing nature of the bacteria can require up to six weeks to rule out infection.
Contaminated Devices Putting Open-Heart Surgery Patients at Risk, CDC Press Release, October 13, 2016. https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html