Health and financial security

A medical device may make heart surgery even riskier

Written by Diane Archer

Every year, more than half a million Americans have heart bypass surgery to get blood flowing to the heart. As we all know, heart surgery can be risky. What most of us don’t know is that a new infection associated with a medical device used in heart surgery may make heart surgery even riskier. While the Centers for Disease Control (CDC) is alerting hospitals to this risk and asking them to alert patients, neither the FDA nor the CDC has required hospitals to warn heart bypass patients about the risk nor does either have the authority to do so.

Consumer Reports writes about a patient who died after experiencing chest pain and fever post heart bypass surgery. He had been discharged from the hospital and then rehospitalized. The doctors found that his wound had opened and was oozing pus. He had non-tuberculosis mycobacteria (NTM), a rare microbial infection that can be deadly in the chest cavity or prosthetic heart valve but is otherwise generally harmless. While the infection can be treated in healthy patients, the patient was not healthy enough to tolerate the drug cocktail treatment and the hospital could do nothing to save him.

As it turns out, several other patients who have had heart surgery have also developed NTM infections, sometimes many months after surgery. In the past six years, at least 45 patients have been infected during surgery and at least nine have died. We do not know how many more cases have gone undiagnosed or unreported.

It appears that heater-cooler devices (HCDs), which regulate patients’ body temperatures during surgery are likely to be responsible. Hospitals use these HCDs in about 250,000 heart bypass surgeries each year. Many think that the HCDs spray the NTM bacteria into patients’ bodies during surgery through their exhaust fans. In most instances where infections were reported, the hospitals used a particular HCD, the Sorin Stockert 3T Heating-Cooling System, manufactured by the European company LivaNova.

The FDA and CDC have sent notices to hospitals warning them about the HCD risks for heart surgery patients, asking them to clean the HCDs in a particular way and recommending they turn the HCD exhaust fans away from the operating tables. But, believe it or not, it is up to individual state health departments to require hospitals to notify patients about the risks.

Some hospitals have addressed the possible problem by moving the HCDs outside the operating room in a way that allows them to regulate patients’ body temperature but keeps their exhaust vents away. But, many hospitals have not, and many hospitals do not have the ability to adopt this solution.

If you or someone you love is getting heart bypass surgery, Consumer Reports recommends you ask whether the hospital is using an HCD, whether it has been tested for NTM and other bacteria and whether any of their heart bypass patients have gotten NTM or other infections.

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