The Centers for Disease Control and Prevention (CDC) is warning health care providers and patients about the potential risk of infection from certain devices used during open-heart (open-chest) surgery. New information indicates that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year, according to the CDC. Heater-cooler units are an essential part of these surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60% of heart bypass procedures performed in the U.S. use the devices that have been associated with these infections.
The CDC also released a Health Alert Network advisory to help hospitals and health care providers identify and inform patients who might have been put at risk.
“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Michael Bell, MD, Deputy Director of the CDC’s Division of Healthcare Quality Promotion. “Hospitals should check to see which type of heater-coolers are in use; ensure that they’re maintained according to the latest manufacturer instructions; and alert affected patients and the clinicians who care for them.”
The CDC and the FDA initially published information and alerts about these potentially contaminated heater-cooler devices in 2015. The current issue of the CDC’s Morbidity and Mortality Weekly Report details recently completed laboratory tests by the CDC and National Jewish Health, which showed that bacteria from the 3T heater-cooler devices matched bacteria found in patients in several states. These results build on previous evidence from Europe that suggests the bacteria contaminated these devices during manufacturing in Germany.
The bacterium—Mycobacterium chimaera—is a species of nontuberculous mycobacterium often found in soil and water. In the environment, M. chimaera rarely makes healthy people sick. Patients who have been exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that often take months to develop. As a result, a diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. There is no test to determine whether a person has been exposed to M. chimaera. Infections can be diagnosed by detecting the bacteria in laboratory culture; the slow-growing nature of the bacteria can require up to two months to rule out infection.
Source: CDC; October 13, 2016.