11,500 Alberta open-heart surgery patients potentially exposed to bacteria

Approximately 11,500 former open-heart surgery patients may have been exposed to bacteria during their procedure, according to Alberta Health Services.

AHS is notifying former patients after the Federal Drug Administration, Center for Disease Control and Health Canada reported a potential risk for Mycobacterium chimaera infection with certain heater-cooler units.

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Notifications are being mailed to Alberta physicians and former adult and pediatric open-heart surgery patients who had their procedures done at the Foothills Medical Centre in Calgary, Edmonton’s Mazankowski Alberta Health Institute or the Stollery Children’s Hospital in Edmonton. Potentially affected patients in Edmonton would have had their surgery between January 2012 to present while potentially affected patients in Calgary would have had their surgery between January 2013 and present, according to AHS.

Watch below: AHS said open-heart procedures are not possible without this piece of medical equipment. As such, AHS said it will do everything it can to minimize the risk until the companies who make the equipment come up with a fix.

Dr. Mark Joffe, AHS senior medical director in infection, prevention and control, said the hospital was first alerted by Health Canada about five weeks ago.

When asked why there was a delay in reporting it to the public, Joffe said the procedure for doing that is complex.

“AHS began to review our own situation. We need to be able to support patients, guardians and parents of children who may have had surgery. We need to make sure everything is in place before we put out this notification,” he said.

The risk comes as a result of heater-cooler units that are critical for cardiac surgery. The units are used to warm and cool blood during adult and pediatric open-heart surgery.

“The device has a reservoir that contains water. At the same time, [it] has to maintain its own temperature so it has an exhaust system to keep the machine from overheating,” Joffe said.

“There is a very small potential for water, a very small amount of water, to leak into the exhaust system of the heater-cooler unit and then that is exhausted into the airflow within the operating room.”

Joffe said the circumstances for this potential type of exposure are unique.

“Where there happens to be the growth of this particular bacteria, within that water reservoir, if enough of it happens to leak into the exhaust system of the heater-cooler unit, if it’s directed in the right way into the airflow within the operating room – it could land inside the surgical site, in an individual who’s having a surgical procedure.”

Watch below: AHS says infection is very slow to develop

The machines are only used in three facilities in the province: at the Foothills Medical Centre in Calgary and the Mazankowski Alberta Health Institute and Stollery Children’s Hospital in Edmonton.

Joffe said there is no exact number on how many patients are in Edmonton or Calgary, though the Edmonton program is larger so more patients from the Capital Region may be impacted.

He said there is also no exact number for how many patients are adult and how many are pediatric. He said about 10 per cent of open-heart surgery patients in general in the province are children.

Joffe said there is an extremely low risk of infection to those who may have been exposed, adding it is less than one in 1,000. He said no infections have been identified to date. M. chimaera infections grow slowly and may take months or years to develop.

“On average it develops approximately 18 months after surgery. It could start earlier, [after] a few months. It can even go out to five years after the surgery,” Joffe said, adding it can be fatal.

“This would be the type of infection that will begin slowly, will gradually get worse. An individual with that kind of infection would find their health deteriorating, declines over a period of time.”

Symptoms include fever, persistent and profuse night sweats, unintentional weight loss, muscle aches, fatigue and red, heat or pus at the surgical incision site. Joffe said it cannot be spread by person-to-person contact but it can be treated with antibiotics.

At this point, Joffe said open-heart surgeries are critical and there have always been risks involved with the procedure. AHS will continue using the heater-cooler units and advise patients of the risk involved.

“At this point Health Canada has issued some recommendations that we are following. Primarily, that involves ensuring we are following manufacturer instruction for disinfection, cleaning, maintenance of the equipment. There is a risk mitigation strategy whereby we try to ensure that the machines, these heater-cooler units are positioned in the operating room and the exhaust is directed away from the patient instead of potentially towards the patient,” Joffe said.

He adds manufacturers are expected to come up with a fix for the issue, such as a better filtration system, which is expected in the next few months.

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