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More Evidence Links Heart Surgery Device to Infections

Nancy Crotti

November 15, 2016

5 Min Read
More Evidence Links Heart Surgery Device to Infections

Heater-coolers made by LivaNova are seen as the source.

Nancy Crotti

Updated November 16, 2016

Sorin Heater Cooler

LivaNova's 3T heater-cooler system 

A study by Swiss researchers has confirmed suspicions of a link between heater-cooler devices (HCDs) and stubborn mycobacterial infections.

The study, published in the journal Infection Control & Hospital Epidemiology, linked the devices used during cardiac surgery in most hospitals worldwide to the invasive, slow-growing Mycobacterium chimaera. FDA confirmed at least 12 reported patient deaths.

"It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world," said Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland, the lead author of the study.

"Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk," Sommerstein said in a statement.

HCDs are stand-alone devices needed for heat exchange in heart-lung machines used in some 250,000 surgeries annually in the U.S., according to the Centers for Disease Control and Prevention. In response to an increasing number of infections, investigators looked into hospital water sources and found M. chimaera in HCD water circuits--specifically, in the LivaNova 3T HCD used in most hospitals around the world. They also found the bacteria in air samples during surgeries with LivaNova HCDs, suggesting transmission through air particles.

In an October alert, CDC said the 3T heater-cooler devices made by LivaNova might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections. Recently completed laboratory tests by CDC and National Jewish Health show bacteria from the 3T heater-cooler devices match bacteria found in patients in several states. These results build on previous evidence from Europe that suggests the bacteria contaminated these devices during manufacturing in Germany.

LivaNova noted in a statement shared with Qmed that heater-cooler devices provide a critical role regulating patients' blood temperature during cardiac surgery, and that there are no reasonable alternatives to heater-cooler devices. "Without these devices, hospitals would be unable to perform many of the hundreds of thousands of heart surgeries needed by patients each year," the company said. "We are working with regulators, clinicians, and all relevant parties to resolve this important industry-wide issue."

FDA recently finalized its updated device reporting requirements for manufacturers. According to the guidance, manufacturers must submit three types of reports, each within a mandatory time frame from the day the manufacturer becomes aware of a device-related death or serious injury, or of a reportable malfunction.

Device-related deaths or serious injuries must be reported within 30 days, according to a report by the Regulatory Affairs Professional Society. Events that necessitate remedial action to prevent an "unreasonable risk of substantial harm to public health" or one that prompted an FDA written request must be submitted within five days.

The lack of timely tracking of infections echoes problems outlined in duodenoscope litigation. Medtronic also failed to report to FDA more than 1000 adverse events related to its Infuse bone graft device between 2006 and 2008, according to an April 2016 report in the Star Tribune of Minneapolis.

A hospital in York, PA, reported last year that four of the eight patients who were infected with the nontuberculous mycobacterium strain during heart surgeries that occurred between October 1, 2011 to July 24, 2015 died.

An FDA spokeswoman said in an email that the agency had received 339 reports related to infections and contaminations associated with heater-coolers from January 2010 and August 2016. Of those, 298 were were associated with LivaNova's 3T heater-cooler. Multiple reports may be submitted for the same event, making it difficult to determine actual numbers of events.

The agency also said that in that same time period, it had received reports of at least 79 patient infections worldwide associated with the LivaNova devices, including reports of 12 deaths. Again, reports may be duplicated or may refer to clusters of patients.

Symptoms of M. chimaera infection can take months to develop, making timely reporting even more problematic.

A class action lawsuit filed earlier this year against LivaNova claims that thousands of patients were exposed to a potentially fatal infection through an open-heart surgery device.

The researchers made the following recommendations for hospitals, health systems, and public health authorities:

  • Ensure strict separation of contaminated HCDs from air of critical medical areas;

  • Educate clinicians on the risks for and dangers associated with M. chimaera;

  • Screen patients who have had open heart surgery, heart transplantation or those who were exposed to ventricular assist devices and demonstrate prolonged and unexplained fevers.

"The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas," Sommerstein said. "That is the only way to ensure that patients are protected from this infection moving forward."

Nancy Crotti is a contributor to Qmed.

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About the Author(s)

Nancy Crotti

Nancy Crotti is a frequent contributor to MD+DI. Reach her at [email protected].

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