Heart Surgery Device Linked to Deadly Infection

An infection risk from medical devices used during open-heart surgery to warm or cool a patient has prompted the Centers for Disease Control and Prevention to issue a warning about the units.

Patients who experience symptoms of infection—unexplained fever, fatigue, or weight loss; night sweats; or muscle aches—after undergoing heart surgery should contact their health care provider immediately.

Those bacterial infections can be serious and sometimes deadly. At this time, it appears patients with heart valve replacements or other prosthetic implants are at the highest risk for infection. Symptoms may take months to develop, delaying diagnosis—sometimes for years—and making treatment more difficult.

According to the CDC, certain devices that keep circulating blood and organs at specific temperatures during heart bypass surgery may have been contaminated with bacteria (nontuberculous mycobacterium, or NTM) when they were manufactured in Germany. The Stockert 3-T heater-cooler devices are made by LivaNova PLC (formerly Sorin Group Deutschland GmbH). NTM organisms are commonly found in the environment, from sources such as water and soil. They are typically not harmful to persons exposed to them, according to the U.S. Food and Drug Administration, but in rare cases, the organisms may cause infections in very ill patients, including those with compromised immune systems, and chronic diseases or health conditions.

“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, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion, in a statement. “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.”

Heater-cooler devices are used in more than 250,000 heart bypass procedures each year in the United States. Of these surgeries, approximately 60 percent involve devices that may have been contaminated. The CDC estimates that in hospitals with at least one confirmed bacterial infection from this contamination, the risk for further infections is between 1 in 100 and 1 in 1,000.

The CDC, along with the U.S. Food and Drug Administration, first published information and alerts about this possible contamination in 2015. The CDC also released a Health Alert Network advisory to help hospitals and health care providers identify and inform at-risk patients.