Santa Clara, CAMany warnings, complaints and investigations linking the Stockert 3T heater-cooler system to nontuberculous mycobacteria (NTM) infections and other serious side effects seems to have cooled down. But NTM infections can take years to manifest, and many of the Stockert 3T systems used to regulate body temperature during cardiopulmonary surgeries have not been replaced.
A few months ago, Bob Marks, age 74, wondered if he had developed NTM after heart surgery at Allegheny General Hospital. While the emergency surgery saved his life, this type of infection is life-threatening. According to Pharma & Healthcare Monitor Worldwide
, Allegheny began notifying patients such as Marks of the potential problem in July. It had used the devices between August, 2012 and March, 2017. The letter said the chances for developing this infection are very low, and the CDC
estimates the risk to be less than one percent. It went on to say that, “While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.” The investigation is also unclear regarding how long patients were monitored after surgery.
“About 15 percent of the samples we tested were so heavily contaminated with bacterial or fungal overgrowth that they were uninterpretable.”
Experts, such as Cancer Therapy Advisor
and the CDC have shown the potential for problems from the slow-growing infection. NTM can take from several months to several years to develop. Given that 250,000 open-heart procedures are performed each year in the U.S., Stockert 3T infections can still pose a significant risk. A 2015 study in Switzerland triggered warnings across Europe, and the CDC -- about one year later -- alerted U.S. hospitals that used the Stockert 3T device to warn patients about the potential for NTM.
A study published last year was presented by John Rihs, a microbiologist and vice-president of laboratory services at Special Pathogens Laboratory to the annual conference of the Association for Professionals in Infection Control and Epidemiology. It analyzed 89 heater-cooler units in 23 hospitals in Canada and the U.S. between 2015 and 2016. A total of 33 units, or 37 per cent, tested positive for the bacteria M. chimaera, reported CTV National News
. And the Stockert device is used in about 60 percent of heart bypass procedures.
The lab, one of several in the U.S. that specializes in water-borne pathogens, also found four of the units colonized for Legionella, the bacteria associated with Legionnaire`s Disease. “I was shocked at the level of contamination we found. About 15 percent of the samples we tested were so heavily contaminated with bacterial or fungal overgrowth that they were uninterpretable,” Rihs told Trib Live
in August, 2017. He said the actual number of positive tests might have been higher, adding that NTM infections are so rare that many hospitals would never have tested for it. “That`s why it took so long for this to be worked out. It`s an unusual pathogen, and it's pretty amazing that the link was even made”, he said.
So, besides diagnosis being possibly delayed for years, it can also be missed altogether. For instance, a patient recovers from heart surgery performed in 2012. Now he is complaining, like Bob Marks, of fatigue, night sweats, pneumonia, influenza and shingles. Five years later, it is unlikely that linking the “rare” infection to a specific device such as the Stockert 3T will happen.
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If you are scheduled for an open-heart surgery, you might want to ask if the hospital uses the Stockert 3T heater-cooler device—you might have the option to find a facility that uses a different device. “These machines are scheduled to be replaced in the near future. Because our patients are at extremely low risk and since notification of patients has so far not demonstrated any benefit — but does have the potential to induce significant anxiety — we have decided that patient notification is not warranted at this time,” UPMC Heart and Vascular Institute (a national center for heart surgery) spokeswoman Wendy Zellner said in an email. When would patient notification be warranted?
Marks is considering legal action against the European manufacturer of the 3T heater-cooler units.