A patient in Alberta is suffering from a rare infection caused by faulty equipment used in open-heart surgery and the province is warning hundreds more could be at risk and that the machines are still in use.
Alberta Health Services (AHS) has confirmed a case of Mycobacterium chimaera infection, a distant cousin to tuberculosis, in an adult who had open-heart surgery about a year before symptoms appeared.
The individual is taking drugs for the infection and "doing well," Mark Joffe, senior medical director of infection prevention and control at AHS, told reporters on Tuesday. The likelihood of developing the infection after open-heart surgery with the device is between one in 100 and one in 1,000, Dr. Joffe said.
"It is a very serious infection," he said. "Individuals who have had heart surgery obviously have underlying health issues … and this can complicate their underlying heart issues and it can lead to death."
The federal government in February instructed hospitals to stop using the devices that cause the infection or try to limit risk. Dr. Joffe said Alberta is still using the machines, which warm and cool blood during surgery, because a "global shortage" of the devices is preventing the province from replacing its old ones.
"This is not an Alberta problem," he said. "This is a world-wide problem."
Britain's LivaNova PLC manufactured the defective heater-cooler units, Dr. Joffe said, and dominated the global market. Ottawa, in a statement in February, said only LivaNova's heater-coolers produced before 2014 have been tied to M. chimaera in cardiac patients around the world. Bacteria can leak from the water reservoir into the operating room's air, endangering patients, Dr. Joffe said. Alberta is trying to reduce risks by placing the machines far from patients, examining ventilation systems in operating rooms, and other methods, he said.
LivaNova said in a statement it is addressing the global problem by retrofitting units with an internal sealing and vacuum system, an effort that will soon start in Europe; offering a no-charge deep disinfection service; and lending new heater-cooler devices to users.
About 3,000 people have open-heart surgery in Alberta every year. AHS sent about 11,500 letters warning former patients they may have been exposed to the bacteria that causes the infection. Patients who had open-heart surgery in Edmonton after Jan. 1, 2012, or after Jan. 1, 2013, in Calgary are at risk. Dr. Joffe believes two or three cases of the infection have surfaced in Quebec.
Symptoms include profuse night sweats; unexpected weight loss; fatigue; aches and pains; and redness, heat or pus at the surgical incision site. The symptoms begin gradually, but are persistent. The incubation period is 18 months to three years after exposure and there is no screening test. M. chimaera cannot spread from person-to-person. It is curable with multiple antibiotics taken over a long period of time and, in some cases, further surgery, Dr. Joffe said.
The benefits of open-heart surgery outweigh the risk of contracting M. chimaera and other complications, he said.
"Heart surgery is never zero-risk."