Heater-Cooler Advisory: Update

Following the FDA safety communication regarding possible Mycobacterium chimaera infections associated with 3T Heater-Cooler Systems, PHSA is notifying potentially exposed patients and health care providers. The information below is also available on the PHSA website:

Cardiac Services BC and BC’s cardiac centres are notifying potentially exposed patients and all health care providers of a rare infection associated with heater-cooler units used during cardiothoracic surgery with cardiopulmonary bypass.

Patients are being encouraged to discuss any symptoms with their primary care physician or to call HealthLink BC (8-1-1) with any questions they may have.

Physicians caring for patients who have undergone cardiothoracic surgery should be familiar with the signs and symptoms of infection associated with the heater-cooler unit alerts. If you need to investigate a patient for possible infection, please consult a medical microbiologist or infectious diseases physician prior to submitting samples.

About the advisory

The infection is caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). While any of the NTMs and other bacteria may be associated with heater-cooler unit infections, M. chimaera has specifically been identified in some of the heater-cooler units.

This notification is based on recent alerts from the Health Canada, the US Centers for Disease Control and Prevention, and the US Food and Drug Administration. Health Canada is investigating all heater-cooler units licensed for use in Canada.

Letters to patients are being issued by Cardiac Services BC and BC’s cardiac centres – Vancouver General Hospital, St. Paul’s Hospital, Royal Columbian Hospital, Kelowna General Hospital, Royal Jubilee Hospital and BC Children’s Hospital.

Potentially exposed patients would have had surgery requiring the use of a heater-cooler unit after January 1, 2011. For these patients, the chance of infection with an NTM is very low. At this time, there have only been two confirmed cases in Canada, both in Quebec.

NTMs exist naturally in water and soil, and may cause opportunistic infections amongst immunosuppressed individuals, including those that require cardiothoracic surgeries, regardless of exposure to a heater-cooler unit. However, disease can be severe for those infected despite appropriate treatment, even in immunocompetent hosts.

Cardiac Services BC and the BC Centre for Disease Control (BCCDC) have reviewed their databases, and to date, no confirmed cases have been identified in BCCDC is investigating further to determine if any patients in BC have had this infection as a result of exposure to a heater-cooler unit. Physicians will be notified if one of their patients is identified as affected through ongoing surveillance.

In the meantime, physicians caring for patients who have undergone cardiothoracic surgery should be familiar with the signs and symptoms of NTM infections that have been associated with the heater-cooler unit alerts.

This includes patients who have undergone:

• Valve replacement, or annuloplasty
• Cardiac or thoracic aortic graft/prosthetic material
• Left ventricular assist device (LVAD)
• Heart transplants and lung transplants
• Coronary artery bypass graft (CABG)

Please refer to the Q&A for more detailed information, clinical signs and symptoms of infections, as well as a recommended approach to diagnosis.