Philly heart patient claims contaminated device caused stroke

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Schematic drawing of heater-cooler units, which have been linked to infections in patients undergoing heart surgery in Pennsylvania and elsewhere. Blue arrows indicate cold water flow, and red arrows indicate hot water flow and patient blood flow.

Surgeons at Penn Presbyterian Medical Center cut into Kenneth Piechowski's chest in December 2014 to replace a faulty aortic valve, and all seemed fine afterward.

But a few months later, he began to feel weak and lethargic. Suddenly, in May, his right knee buckled, and he couldn't move the leg.

Piechowski had suffered a stroke, which he says was caused by slow-growing bacteria that he had picked up from a device used during his surgery months earlier. He is now suing the hospital and the device-maker in Common Pleas Court in Philadelphia.

Nationwide, dozens of infections such as his have led to growing concern among health officials about the devices, called heater-coolers.

The type of device used in Piechowski's surgery, the Stöckert 3T, may have been contaminated in the German factory that made it, according to a study published last week by scientists from the U.S. Centers for Disease Control and Prevention.

Other researchers published similar findings in April, and some area health systems that owned that model of heater-cooler, including Penn Medicine, Temple University Hospital, and Cooper University Health Care, have replaced it. Thomas Jefferson University Hospital and Children's Hospital of Philadelphia are doing so, while others are stepping up their disinfection procedures.

The CDC says that a recall of the machines, which are needed to maintain the blood temperature of patients on a heart-lung bypass machine, is not warranted and that the risk of infection is low. But the exact scope of the problem is elusive, and some experts warn that it may be more widespread than it seems.

The type of microbe found in the machines, called nontuberculous mycobacteria, can take months or even years to cause symptoms of infection, so it can be difficult to link illnesses to the devices.

The U.S. Food and Drug Administration says it was notified of 79 infections worldwide in patients who were on a 3T machine between January 2010 and August 2016. Twelve of those patients died, though the infections were not necessarily the cause.

At least 20 Pennsylvania patients have contracted infections after heater-cooler use, including 12 at WellSpan York Hospital, five at Penn State Hershey Medical Center, and three at Penn Presbyterian. A fourth patient at Penn Presbyterian tested positive for the bacteria but did not develop symptoms, the hospital has said. New Jersey health officials have said no confirmed cases have been reported there.

Piechowski, of Gibbstown, was taken to Inspira Medical Center in Woodbury, where he was found to have suffered a stroke. Scans revealed what looked like blood clots around his new heart valve, according to the lawsuit, filed on his behalf by his attorney, James P. Goslee.

He suffered several more strokes during the following months, and was found to have endocarditis — an inflammatory reaction that necessitated another valve replacement. In March 2016, a Penn physician told Piechowski his infection likely came from the heater-cooler, the lawsuit states.

Heater-coolers are used in 250,000 U.S. operations each year, and the 3T devices represent 60 percent of the market, according to the FDA. The machines were made by a company called Sorin, which has since merged into a larger corporation, LivaNova, based in London.

The bacteria in the devices can be found in tap water, but they were not thought to pose any risk because the water circulates inside the machine and does not come into contact with the patient.

But researchers have found that the bacteria could become airborne through a vent in the device and land in the chest cavity of someone undergoing surgery. In a timeline that the manufacturer sent to its customers, the company said it first learned of infections in January 2014. After launching an investigation, the company notified all customers in July of that year about the infections, months before Piechowski's surgery, though it said it had not confirmed they were caused by the machines.

Susan E. Phillips, a senior vice president at Penn Medicine, said the health system could not comment on any litigation, but she said it had taken precautions to address any risks.

"The devices in question were removed from our hospitals to address the concerns raised," she said. "And consistent with our commitment to patient safety, we have sent letters to patients as well as their physicians to ensure that they are informed of this low, but possible, risk."

The manufacturer also said it could not comment on litigation, but said it was taking steps to address the broader issue, given the key role that the devices play in life-saving surgery.

"We take this matter very seriously and are committed to working with regulators, clinicians, and other key parties to address it," LivaNova said in a statement.

Other area hospitals with 3T heater-coolers include Einstein Medical Center Philadelphia, Crozer-Chester Medical Center, Deborah Heart and Lung Center, Mercy Fitzgerald Hospital, and St. Mary Medical Center. None has identified any mycobacteria infections, and all said they were following strict disinfection steps as recommended by federal and state officials. Deborah and Crozer said their devices were purchased outside the period when the CDC suspects factory contamination may have occurred.

The various precautions taken are not enough, said Lawrence Muscarella, an infection-control consultant based in Montgomeryville.

The slow-growing bacteria are found in municipal water, and thus can contaminate heater-coolers at hospitals, not just at the manufacturing site, he said. And as for hospitals that have replaced their 3T devices, infections also have been reported in connection with devices made by other manufacturers, he said.

"I think it reduces the risk, but it doesn't eliminate the risk," Muscarella said of the replacements. "The contamination could also be happening on-site."

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