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Patient Guidance Regarding Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices

Frequent Questions and Answers – Sorin/ Stöckert® 3T Heater Cooler Notice

What has happened?

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating reports that a device used to heat and cool the body temperature during cardiac surgery -- the Sorin/ Stöckert® 3T heater-cooler-- has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). For patients who have had one of these surgeries, the chances of getting this infection are very low. CDC estimates the risk to be less than 1 percent.

AtlantiCare has not identified any patients who have had this infection.

Like many hospitals in the United States and Europe, AtlantiCare used the Sorin/ Stöckert® 3T heater-cooler. Though the risk of infection is low, our priority is the health and safety of our patients. We are alerting patients who had cardiac surgery when the Sorin/ Stöckert® 3T heater-cooler was used.

We have developed the following questions and answers to help you learn more about this national/international issue.

What is NTM?

Nontuberculosis mycobacterium (NTM) are slow-growing bacteria that are found in surface water, tap water, and soil. Although NTM typically is not harmful, it can – in rare cases – cause infections in patients after their surgery, especially in people with weakened immune systems.

How do I know if I have the NTM infection?

NTM is a very slow growing and difficult to diagnose bacterium. It is possible to develop symptoms years after surgery, so it is important to know the symptoms. Discuss any symptoms or questions you might have with your primary care provider or your cardiologist. Symptoms include:

  • night sweats
  • muscle aches
  • weight loss
  • fatigue
  • unexplained fever
  • heat, pain, redness, or discharge around a surgical incision

What are the surgeries in which the Sorin/ Stöckert® 3T was used?

  • Valve replacements
  • Bypass surgery
  • TAVR
  • Complex aortic valve repairs
  • Complex aortic valve repairs for aneurysm or dissection

Do all of these surgeries at AtlantiCare involve the Sorin/ Stöckert® 3T?

No. We have notified patients who had surgery at AtlantiCare when the Sorin/ Stöckert® 3T was used.

If I was exposed to this device during surgery, should I receive antibiotics just in case?

No. There is no antibiotic treatment to prevent infection. The risk that patients will develop an infection following exposure to a contaminated heater-cooler unit is very low. If you are experiencing symptoms, speak with your primary care provider or cardiac surgeon to let him or her know that you recently had open heart surgery with a heater-cooler the CDC and FDA have noted posed a risk for NTM. There is no test to determine whether a person has been exposed to NTM. A test can identify infection once symptoms begin, but testing results can take up to two months to confirm. Symptoms include:

  • night sweats
  • muscle aches
  • weight loss
  • fatigue
  • unexplained fever
  • heat, pain, redness, or discharge around a surgical incision

What do I do if I am diagnosed with this infection?

If your primary care provider, cardiologist or other specialist diagnoses you with an NTM infection, he or she will discuss antibiotic treatment with you.

Can I be tested somewhere for this infection?

Testing for NTM should only be done once there are symptoms. Tests do not detect NTM unless symptoms are present.

What does testing of the bacteria entail?

Testing for NTM is done by submitting blood cultures and/or tissue-biopsy specimens to be sent for culture. Growth of the bacteria can take up to two months.

Will AtlantiCare provide testing and treatment if I need it?

Yes, however, tests do not detect NTM unless symptoms are present. There is no test for exposure, but there is a test for symptoms. AtlantiCare will provide follow-up care and testing to patients whom we’ve notified as being at increased risk of NTM after surgery, free of charge.

Do you have a hotline if I have questions?

Patients and their families can call AtlantiCare’s 24-hour information hotline number - 609-652-3500 – for additional information or assistance.

If I’ve been exposed to NTM, what are the chances that I have, or will get, this infection?

The CDC advises the chances of getting this infection are less than 1 percent.  

The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) 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 surgery can develop general and nonspecific symptoms that can often take months to develop. As a result, 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 the bacteria. Infections can be diagnosed by detecting the bacteria by laboratory culture; the slow growing nature of the bacteria can require up to two months to rule out infection.

Individuals who develop an NTM infection after being exposed are typically those with weakened immune systems. Examples would include those with severe diabetes or heart failure, or who have recently had cancer treatment, or high dose steroid treatment.

Is this infection treatable?

The infection can usually be treated successfully once it is identified. Because the bacterium grows slowly, it can take up to several months for it to develop into an infection and years before the infection is diagnosed. Your primary care provider, cardiologist or other specialist would discuss treatment options with you. It is treated by using three to four antibiotics over an extended period of time.

What are the signs and symptoms of an NTM infection?

According to the CDC, symptoms of this NTM infection might include

  • night sweats
  • muscle aches
  • weight loss
  • fatigue
  • unexplained fever
  • heat, pain, redness, or discharge around a surgical incision

Can a person who develops an NTM infection spread it to others?

NTM is not spread person-to-person. It is common in soil and water, but rarely makes healthy people sick.

Where can I learn more about this heater-cooler issue or NTM?

The following websites include more information:

 

 

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