Over 600,000 Open-heart Surgeries Since 2012 at Risk for Deadly Infection

If you or a loved one has had open-heart surgery since 2012, federal officials have a warning you don’t want to ignore. More than 600,000 patients in the United States who’ve undergone open-heart surgery since 2012 may be at increased risk for developing a rare, deadly bacterial infection transmitted by a medical device used during surgery.

The slow-growing bacterial infection caused by exposure to non-tuberculous mycobacterium chimaera, also known as NTM, is rare and difficult to detect. The infection is difficult to diagnose because the symptoms are very general, and may be attributable to other illnesses, thereby delaying accurate diagnosis. There is no test to determine whether you’ve been exposed to NTM. Diagnosis can be made through a laboratory culture although it may take up to two months to confirm the presence of infection because of the slow-growing nature of the bacteria.

Patients with weakened immune systems, or those who’ve had invasive procedures, are at greater risk for developing the infection if exposed to the NTM bacteria.

The FDA and CDC (Centers for Disease Control and Prevention) have traced the contamination back to Stockert 3T heater-cooler devices manufactured by German-based LivaNova PLC. The heater-cooler unit is used to warm and cool patients’ blood and organs during cardiopulmonary bypass surgery. Federal officials believe NTM bacteria contaminated the devices during the manufacturing process. The FDA estimates there are approximately 2000 of these heater-cooler devices currently in use in the U. S., which have been available since 2006.

There are more than 250,000 open-heart procedures performed each year in the United States, and with LivaNova heater-cooler devices occupying nearly 60% of the U. S. market share, federal officials fear thousands of patients may have been exposed to the potentially deadly bacteria since 2012.

The CDC recommends patients who have had open-heart surgery since 2012 should be aware of the signs of NTM bacterial infection. Because of the slow-growing nature of the bacteria, patients may not develop symptoms for months or years after open-heart surgery. If you develop any of these symptoms, please contact your doctor immediately.

Symptoms of NTM infection include:

  • Night sweats
  • Muscle aches
  • Weight loss
  • Fatigue
  • Unexplained fever

There are 28 confirmed cases of NTM infection following open-heart surgery, including 4 deaths, since 2015. Hospitals in Iowa, Michigan and Pennsylvania have reported cluster infections. NTM infections have also been reported in Europe.

Federal officials caution that the risk of infection is very low, between 1 in 100 to 1 in 1000. Patients with implanted valves or prosthetics have a higher risk of infection.

The CDC also recommends hospitals critically examine their heater-cooler devices, and stop using the devices if there is any evidence or suggestion of bacterial contamination. In addition to bacterial contamination during the manufacturing process, CDC officials believe design flaws in the device make cleaning and sterilization between patients difficult, even though the manufacturer updated cleaning methods in 2015. The CDC recommends hospitals strictly adhere to cleaning and sterilization procedure.

The good news is NTM bacterial infection is not always a deadly diagnosis. If caught early, the infection can be treated with a course of a specific combination of antibiotics, although it may take a year or longer to cure.