M. chimaera Patient Information

Following CDC and FDA recommendations, we have been actively working to identify and alert those patients who may have been exposed to M. chimaera at ChristianaCare. Our Infection Prevention team has been actively monitoring this situation. The team has analyzed lab results for suspect infection diagnoses, such as mycobacterial cultures and sarcoidosis, and then compared them to the records of patients who underwent open-heart surgery at ChristianaCare during the time period of January 1, 2012 to September 30, 2016, in which these heater-cooler devices were used.

We have identified several patient cases with  M. chimaera, which were probably linked to the heater-cooler devices used during their surgeries. These patients presented with several weeks of symptoms and were found to have heart-valve infections. Their blood cultures grew M. chimaera. Since identifying the first case, we have worked with the Delaware Division of Public Health and the CDC on the appropriate response, and reported the cases to the FDA. In addition, our clinical engineering team made significant improvements to the surgical devices to reduce the risk of aerosolization and protect the safety of our patients, until new devices could be obtained. As of February 2017, the new heater-cooler devices (from a different manufacturer) are in place.

We are providing ongoing information and updates to our entire Medical Dental staff.  We have also begun to alert all providers whenever a patient who underwent cardiac surgery between January 2012 and September 2016 enters the health system, to remind them to screen patients for symptoms and order appropriate testing, if needed.

Throughout this situation we have responded to new information as it became available.  In summer/fall of 2015 it was first identified that heater-cooler units could spread infection in this way, but it was initially believed that contamination of the devices occurred at individual hospitals.  “It was not reported until spring of 2016 that these devices may have become contaminated at the Sorin factory in Germany. It was not until fall of 2016 that we confirmed two cases as having M. chimaera, at which point we immediately began the process of notifying all patients who had been exposed to these devices.

In cases that have been described who had >1 culture obtained, if 1 was positive they were all positive.  So we believe that obtaining 1 mycobacterial culture will allow us to evaluate whether or not you have disease.  Repeated testing may be necessary if symptoms continue.  Of course, if your symptoms change or worsen at any time, you should be re-evaluated, not only for M. chimaera but for other problems as well.

We can arrange for direct billing for those patients who would prefer to see their own PCP or another provider.

Symptoms include the following:

• night sweats
• muscle aches
• weight loss
• fatigue
• fever
• joint pains

These symptoms are not specific for M. chimaera and can be due to many other causes, but M. chimaera should be considered if you had possible exposure from open-heart surgery, and have any of the above symptoms without another known cause.  In addition, other physical findings or laboratory abnormalities, such as low blood counts, liver abnormalities, kidney problems, enlarged spleen, enlarged lymph nodes, or wound infections may be seen.

Mycobacteria are slow-growing and infections may take months to develop. Cases associated with this device have been diagnosed within months and up to several years after an open-heart surgery involving heater-cooler unit exposure.

According to the CDC, the risk of infection is very low, but if you did happen to be infected, there are effective antibiotic treatments available. These infections typically require months of treatment.

No. This bacterium cannot be spread by person-to-person contact.

Of the initial cases that have been described, about half have died.   However, this is partly due to the fact that there was a delay in their diagnosis and treatment.  This is not a typical bacterium that would be found doing routine testing.  Now that we are notifying patients, know to look for M. chimaera, and identifying the infection earlier, patients’ outcomes should be much better.

Because the risk of infection is low, in most cases we would not recommend starting antibiotics without knowing for certain that you have the infection.  While the antibiotics are generally safe, the risk of side effects is greater than the possible benefit, if we don’t know that you actually have the infection.  If we are highly suspicious of mycobacterial infection based on your initial evaluation, we may refer you to see an Infectious Diseases doctor for evaluation, before your blood culture results are complete.

Treatment for mycobacterial disease is effective but requires at least 12 months of 2-3 different antibiotics.  Depending on the location of the infection (such as on a heart valve), some patients have required repeat surgery to clear the infection.  Most however only require antibiotics.