A study published by the Centers for Disease Control and Prevention warned health care providers about existing risk to heart surgery patients that are exposed to certain machines manufactured by LivaNova PLC.
The machines are heater-cooler devices, and some were exposed to bacteria during production so that the devices could have been contaminated. If this bacteria is exposed to patients during surgery, the infection could be fatal. Another issue is that there are no specific tests to detect the level of exposure of the patient to the organism. To detect the presence of the bacteria laboratory cultures are needed.
Risk at the surgery room
According to the CDC, “Mycobacterium chimera is an emerging pathogen causing disastrous infections of heart valve prostheses, vascular grafts, and disseminated infections after open-heart surgery.”
This bacteria can reach patients quickly, and invasive infections have been reported internationally. Allegedly, aerosols generated by contaminated machines used with extracorporeal circulation during surgery have been spreading the bacteria and producing severe damage to patients exposed to it.
Despite intensified cleaning and disinfection of the heater-cooler units, some grew the bacteria after a period of 174 days. Affected devices include surveillance samples from factory-new units acquired during 2014.
The study identified infection in 6 patients in Zurich, Switzerland. The hospital involved performs around 700 open-heart surgeries each year, and there is constant use of extracorporeal circulation. The problem was detected when investigators examined the components of the water from the cardioplegia and took airflow samples from running heater-cooler units for months. While some machines were treated to eradicate the presence of the bacteria, most efforts ended in failure. The health care center decided to buy new devices that eventually proved to be infected as well.
In the United States, almost 30 cases of confirmed infections were reported, all in heart surgery patients. The Food and Drug Administration released a statement claiming that 12 patients from different countries died as the result of this infected machines.
Those patients with valve implants or prosthetic product implants are at higher risk due to the conditions of their systems. This profile includes almost 600,000 patients that have been exposed to the infection in the past four years, during open-heart surgeries.
“In hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly. Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them,” added the CDC.
All units infected were produced by LivaNova, a company based in England that dedicates to design and provide some medical devices and machines that are used all over the world. Among the main products manufactured by the company, there are cardiac surgery tools, neuromodulation devices, and cardiac rhythm management products that are the three LivaNova’s specialties.
The devices and systems produced by LivaNova to cardiac surgery are used in more than 50% of open-heart surgery procedures worldwide.
Early this year, a lawsuit was filed against the company in Pennsylvania. Patients from the Penn State Milton Medical Center and the WellSpan York Hospital that underwent open-heart surgeries were affected with the bacteria present in the machines.
So far, the company has not released any official statement about the confirmed cases of infection nor the lawsuits and complaints filed against them.