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Questions & Answers - Open Heart Surgery Heater Cooler

Questions and Answers

The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are investigating national and world-wide reports that during certain open-heart surgeries the device used to heat and cool the blood has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a species of bacteria known as nontuberculous mycobacterium (NTM). While this is exceedingly uncommon and to our knowledge no case has been identified at our hospitals, out of an abundance of caution, we are providing this background information.

 

Q. Are you notifying patients about possible limited exposure to the NTM bacteria during open-heart surgery?

A. Yes. Letters were sent to patients who potentially may have been exposed to this bacteria. The letter encourages those patients who believe they have chronic symptoms of unexplained fever, night sweats, muscle aches, weight loss, fatigue to consult their primary care providers.

 

Q. How many open-heart surgery patients at St. Francis or Good Samaritan Hospital have been identified with this infection?

A. No patients have been identified with this infection at either St. Francis or Good Samaritan Hospital.

 

Q. What specific open-heart surgery procedures were involved in these NTM infections and exposure?

A. There is limited risk of infection for patients who underwent open-heart surgery during the last four years. These procedures included surgery to treat an aortic or mitral valve defect and, in some cases, coronary bypass surgery. It is believed that patients who had these types of procedures during the mentioned time period were at low risk for these infections. This is because the heater-cooler device was used in these procedures.Please note: both St. Francis and Good Samaritan Hospital have been and continue to follow all FDA requirements related to proper maintenance and disinfection of this equipment to minimize any risk of infection and no cases have been identified at either hospital at this time.

 

Q. What are the chances of acquiring this infection for open-heart patients whose procedures occurred during the last four years?

A. The chances of acquiring this infection are extremely low. In hospitals where at least 1 infection has been identified, the risk of infection was between about 1 in 100 and 1 in 1,000 patients. Currently, no patient who had open-heart surgery at either St. Francis or Good Samaritan Hospitalhas been identified with this infection.

 

Q. Are St. Francis and Good Samaritan the only hospitals with this device?

A. No. Hospitals world-wide use this machine. Federal authorities have issued health advisories across the country to alert them of this issue and to prevent infections in patients.

 

Q. Are the patients who had non-invasive heart procedures—such as stents, pacemeakers, defribrillators and ablations—also at risk?

A. No. The heater-cooler device is not used for these procedures. Patients who had one of these non-invasive heart procedures are not considered to be at risk for this infection.

 

Q. What is the risk of infection?

A. Overall, the risk is thought to be very low. In hospitals where at least 1 infection has been identified, the risk of infection was between about 1 in 100 and 1 in 1,000 patients. Initial information suggests that patients who had prosthetic implants are at higher risk. It is possible that not all of the devices introduced these bacteria into the operating room or exposed patients, making it extremely low risk. Please note: both St. Francis and Good Samaritan Hospital have been and continue to follow all FDA requirements related to proper maintenance and disinfection of this equipment to minimize any risk of infection and no cases have been identified at either hospital at this time.

 

Q. How long does it usually take for these infections to show up?

A. NTM are slow-growing bacteria 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.

 

Q. Can a person who develops one of these NTM infections spread it to others, such as family members?

A. No, the bacteria cannot be spread to others from an infected patient. Also, it is important to keep in mind that NTM is common in soil and water but rarely makes healthy people sick.

 

Q. Q. How long does it take to find out if an infection is being caused by NTM?

A. M. chimaera is a slow-growing species of NTM that can take eight weeks and sometimes longer to grow on culture and allow final identification.

 

Q. Why are these infections so risky?

A. Symptoms of infection can take months to develop, and are often general and nonspecific. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. Clinicians may not immediately consider an NTM diagnosis. Delayed diagnosis can result in more widespread disease in a patient. This, combined with underlying health problems such as heart disease can make these infections difficult to treat.

 

Q. What are the symptoms of an NTM infection?

A. Symptoms of the infection may be very general. If a patient has had open-heart surgery within the past four years, and unexplained infection symptoms are present, this bacteria should be considered as a possible cause. According to the CDC, symptoms of the NTM (bacterial) infection “may include a combination of the following chronic conditions: fever; pain, redness, or pus around a surgical incision; night sweats; joint pain; muscles pain; and fatigue. Those who were exposed to NTM should continue to look for signs of unexplained infection and keep in touch with their clinicians for further evaluation and tracking.”

 

Q. What should I do if I think I have an infection?

A. If you have a health concern, please contact your primary care physician or call our hotline at St. Francis 516-562-6312 or Good Samaritan 631-376-3171. Your call will be answered by our Infection Control Directors and further guidance will be given. These non-specific symptoms can be confusing, particularly during flu season. This infection is very slow-growing and difficult to diagnose. It is possible to develop symptoms years after surgery, so it is imperative to know the symptoms (see above) to look for and to discuss any symptoms or questions you may have with your primary care doctor.

 

Q. What health issues can the bacteria cause?

A.  Although NTM typically poses no harm, it can—in very rare cases—cause infections in post-operative surgical patients, especially in people with weakened immune systems. These could include respiratory infections or more serious infections in patients with weakened immune systems.

 

Q. Is there testing for patients who have symptoms?

A. If a patient has symptoms and a source is suspected, then testing could occur. As with any infection, the area of the body where the infection exists is where the test should occur. Due to the slow-growing nature of the bacteria and the testing that is required, final test results may take as long as eight weeks.

 

Q. Is this infection treatable?

A. The infection can usually be treated successfully once it is identified. Unfortunately, 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 correctly diagnosed, unless patients and their clinicians are alert to the possibility of NTM infection.

 

Q. Is there a way to treat patients prophylactically with antibiotics, if a patient asks whether he/she can take medication to prevent infection?

A. Because the bacteria is already prevalent in the environment and the risk of clinical infection in surgically exposed patients is thought to be less than 1 percent, antibiotic prophylaxis is not recommended by the Centers for Disease Control or New York State Department of Health.

 

Q. What specific type of bacterium is involved in these infections?

A. The bacterium is called Non-tuberculous Mycobacterium (NTM), which is commonly found in the environment, such as in soil and water. While frequently not further identified beyond the NTM group, the specific bacteria indentified by the CDC was Mycobacterium Chimaera, which is part of the Mycobacterium Avium Complex (MAC). It is generally treated like any other MAC infection.

 

Q. What role does the heater-cooler device have in the infection?

A. Heater-cooler devices are used during cardiac surgeries to warm or cool a patient as part of their care. There is the potential for the bacteria to grow in a water reservoir in the heater-cooler units. It is important to note that the water in the heater-cooler unit never comes into contact with the patient’s blood or body fluids. When the water evaporates, the bacteria can escape the device with the water. Once it hits the open air, the bacteria then becomes aerosolized and can then make contact with a patient’s open wound during surgery. Please note: both St. Francis and Good Samaritan Hospital have been and continue to follow all FDA requirements related to proper maintenance and disinfection of this equipment to minimize any risk of infection and no cases have been identified at either hospital at this time.

 

Q. How do you think the devices got contaminated?

A. NTM is common in water and soil. Recent CDC findings are consistent with previous reports suggesting that the heater-cooler units were contaminated during production. Testing conducted by the manufacturer in August of 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.

 

Q. Have these devices ever been recalled? Why aren’t they being recalled now?

A. In 2015, the manufacturer recalled the instructions for use, but not the device itself. Information provided by the manufacturer reminded users that while water from the device itself is not intended to contact the patient directly, under certain circumstances, due to fluid leakage and/or aerosolization, NTM could reach a patient's surgical site. Heater-cooler devices are critical for life-saving surgery. A national recall could result in patients not getting life-saving surgeries that are needed now.