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AHN Notice on Heater-Cooler Devices Used in Open Chest Cardiac Procedures

Monday, March 20, 2017

PITTSBURGH, Pa. -- Allegheny General Hospital (AGH) and West Penn Hospital, part of Allegheny Health Network (AHN), have replaced a specific type of heater-cooler device used during open chest cardiac surgeries in response to an advisory issued by the Centers for Disease Control and Prevention (CDC) regarding a potential risk associated with the technology. The CDC determined that the Stöckert 3T heater-cooler devices manufactured by LivaNova PLC may put patients at risk for infection from a slow-growing bacterium known as non-tuberculous mycobacterium, or NTM. The risk is considered to be very low and less than 1 percent of patients worldwide who have had an open chest cardiac surgery that involved the Stöckert 3T device have been diagnosed with an NTM infection. Additionally, no cases of infection related to these devices have been identified at AGH or West Penn.
 
Since NTM are a slow-growing bacterium, it can take several months to several years for symptoms to develop.  Those symptoms include: fever lasting more than a week; pain, redness, heat or pus from your cardiac surgical incision; night sweats; or weight loss not explained by any other illness. While several of these symptoms also are associated with many other illnesses, if you had an open chest cardiac surgery at AGH or West Penn between August 29, 2012 and March 14, 2017 and are experiencing any of them, you should contact your physician to be evaluated.
 
Consistent with our strong commitment to patient safety, AHN has always adhered to manufacturer guidelines for disinfecting and maintaining its heater-cooler devices. After the CDC issued its advisory recommending more stringent disinfection practices for the Stöckert 3T heater-cooler devices, AGH and West Penn immediately implemented those recommendations.  Although the Stöckert 3T heater-cooler devices have not been recalled by the FDA, and many hospitals continue to use them, AHN subsequently decided to replace the devices altogether out of an overabundance of precaution. 

Despite the extremely low risk of developing an infection from the Stöckert 3T heater-cooler devices previously used at AGH and West Penn, AHN is reaching out to patients who underwent an open chest cardiac surgery at those two hospitals between August 29, 2012 and March 14, 2017 to make sure they are aware of the issue and provide direction to those who have questions or health concerns. 

The Network has established the following phone line to address those questions: 412-DOCTORS

Frequently Asked Questions for Patients

What is the situation?
The U.S. Centers for Disease Control and Prevention (CDC) has notified all hospitals of a potential exposure to NTM bacteria in patients who have undergone an open chest cardiac surgery that used the Stöckert 3T heater-cooler devices manufactured by LivaNova PLC. The bacteria have been linked to the Stöckert 3T heater-cooler devices used during these surgical procedures.

What type of bacteria is involved?
The bacterium is called Nontuberculous Mycobacteria, or NTM. It grows slowly and is commonly found in soil and water, including tap water. It is usually not harmful to humans, and typically only rarely has caused infections in patients with weakened immune systems. However, patients who have had open chest heart surgery with bypass may have become exposed to these bacteria during their procedure and could be at risk of infection.

What is a heater-cooler device and how might it be related to this problem?
A heater-cooler device is used during open heart surgeries to warm or cool a patient's blood as part of their usual surgical care. It is never in direct contact with the patient or the patient's blood. There is a water reservoir inside the device. NTM can grow in the water in heater-cooler devices. During use, some of the water evaporates and enters the air in the operating room. It is believed that the NTM bacteria may be put in to the air by the heater-cooler device, and can then possibly enter the patient's open chest during the procedure.

Why is AHN contacting patients?
Although the risk of developing an NTM infection after cardiac surgery is very low, we want to make sure that our open chest heart surgery patients are aware of this issue, and understand that we have resources available to our patients who may have questions or health concerns.

What types of surgeries place patients at risk for this infection?
Only open-chest heart surgeries that used the Stöckert 3T heater-cooler devices carry this very low risk. This includes coronary artery bypass graft (CABG) surgeries, valve surgeries, and surgical procedures involving the thoracic aorta. AGH and West Penn used the implicated heater-cooler device between August 29, 2012 and March 14, 2017, and AHN is therefore notifying patients who underwent these types of surgeries during this timeframe.

Has this happened at other hospitals?
Yes. There have been multiple cases documented in the United States and Europe. In the United States, federal health authorities, including the CDC and Food and Drug Administration (FDA), have issued health advisories to hospitals to help them prevent and detect these infections.

What action is being taken at Allegheny General Hospital and West Penn Hospital to protect patients?
We have always consistently followed manufacturer guidelines for disinfecting and maintaining heater-cooler devices across our health system. Although the FDA has not recalled the device, due to the recently recognized association of NTM infections with heater-cooler devices, and to address this potential risk, we replaced all of our heater-cooler devices that were the focus of the FDA's investigation. The new heater cooler devices are being maintained according to the most recent manufacturer's cleaning procedures and FDA guidelines. We are confident that the potential risk of exposure to NTM bacteria has been addressed effectively. In addition to notifying our patients, we have created a hotline (412-DOCTORS) to provide our patients with additional information, screening, and appointments, if needed.

What are my chances of having this infection?
The estimated risk of infection is less than 1%. To date, patients known to have developed an invasive NTM infection following open chest heart surgery at other U.S and European hospitals have undergone complex procedures like heart transplantation, heart valve reconstruction or surgeries involving the implanta¬tion of foreign material. This includes patients who have undergone surgeries for:
•    tissue or mechanical heart valves,
•    vascular grafts,
•    left ventricular assist devices (LVADs)
•    total artificial heart devices
To date, no cases of NTM infections have been identified among patients who have undergone an open chest cardiac procedure at AGH or West Penn. 

What if I had another type of heart surgery?
Patients who have had other, less invasive heart procedures, such as stents, pacemakers, defibrillators and ablations,  or minimally invasive cardiac surgery procedures, such as transcatheter aortic valve replacement (TAVR), are not at risk because the heater-cooler device is not used for these procedures.

What do I need to do now?
If you have any questions or concerns, call us at 412-DOCTORS.  Our call center will be open 8 AM — 4PM, Tuesday—Friday. We will ask you a few screening questions, answer your questions, and if necessary, we can arrange an appointment with a medical provider. You will not be charged for this appointment.

What are the symptoms of an NTN infection?
According to the Centers for Disease Control and Prevention (CDC), symptoms may include those associated with an unex¬plained infection, including the following:
•    night sweats
•    muscle aches
•    weight loss
•    fatigue
•    unexplained fever
These symptoms are not specific for NTM and can be due to many other causes, but NTM should be considered if you had possible exposure from open-heart surgery. NTM infection may take a long time to develop after potential exposure — from a few weeks up to four years. Therefore, those who may have been exposed to NTM should continue to look for symptoms and see their clinician for further evaluation if any develop.

Is this infection treatable?
Yes, there are effective antibiotic treatments available for this infection.

If I have been exposed or develop an NTM infection, is my family at risk of getting the infection? 
No. This bacterium cannot be spread by contact with those who have been exposed to this infection.

Can I find out whether I'm infected?
If you do not have symptoms, you do not require testing. Because the bacterium grows slowly, it can take several months or years for symptoms of infection to develop. If you have or develop symptoms, it is important for your physician to know in order to arrange testing.

Is there a test I can have done to let me know if I have the infection but just don’t have symptoms yet?
No. 

How long should I be closely monitoring for this infection? It did say years, but does that mean the rest of my life?
Most patients who have developed these complications do so in the first year or two.

What impact could this infection have on my surgical outcome?
Most patients present with either mediastinitis or endocarditis.