by Caroline Chen | ProPublica
When a ringing phone woke Bob Naedele on his 64th birthday, the caller offered the best gift imaginable: Newark Beth Israel Medical Center had a heart for him. A heart attack had left Naedele, a former police detective, with grave cardiac damage, and he had spent the last 2 1/2 years on the transplant waiting list.
Naedele’s family usually celebrated birthdays with dinner and a cake. But on that day in May of 2018, Bob and his wife of 43 years, Cheryl, instead started calling their children to let them know that they were heading to the hospital. The cake would have to wait.
He went into surgery and received his new heart shortly after midnight.
At first, Bob Naedele’s recovery seemed to go well, according to his wife. He returned home after three weeks and initially had more energy than before. It seemed as though their longtime dream of traveling across the country in an RV to visit national parks might be within reach.
But nine weeks after his transplant, Naedele got a fever, and his hands began shaking with tremors. He returned to Newark Beth Israel. Doctors ran test after test but were unable to find the cause.
After he spent more than a month in the hospital, doctors discharged him, but he continued to decline. “He fell, and I had to get my neighbor’s help to get him back to bed,” Cheryl Naedele recalled. “I had to put him in a wheelchair to get him to the bathroom.” Bob Naedele deteriorated so quickly that his wife had to call for an ambulance. This time he went to Yale New Haven Hospital, which was closer to their home in Connecticut. By the next day, doctors in Yale’s intensive care unit found the culprit: The heart Naedele had received had been infected with a parasite that causes Chagas disease.
“He was basically filled with parasites,” recalled Dr. Tariq Ahmad, chief of heart failure at Yale cardiology. The organisms had multiplied in his heart and invaded his nervous system and brain.
For 12 long weeks, the doctors at Yale tried to purge the parasites, but this was difficult with a patient who needed to be on immunosuppressants to prevent his body from rejecting the new heart.
Damage to Bob Naedele’s nervous system made him hypersensitive, Cheryl Naedele recalled. Doctors intubated him after he developed pneumonia, and every time the nurses suctioned his tube to clear secretions, his wife walked out of the room so she wouldn’t have to hear her husband screaming. Finally, Bob told her that he couldn’t bear the pain any more, so they discontinued treatment. Her high school sweetheart passed away seven months after that hopeful call about the heart that was waiting for him.
His death could have been prevented if the donor had been screened for Chagas.
Chagas disease is caused by a parasite called T. cruzi, which is transmitted via insects and found mainly in rural areas of Central America, South America and Mexico. Though cases of Chagas in the United States are rare, the parasite has been a known risk for transplant recipients for decades. Since at least 2001, case studies have detailed how U.S. patients have died after receiving infected organs.
For years, experts have recommended that transplant networks screen donors who were born in countries where the parasite is endemic. A 2011 working group of transplant infectious diseases specialists and representatives from the U.S. Centers for Disease Control and Prevention said these donors should be tested, and so did the American Society of Transplantation in 2019. Infected patients can appear healthy for years, and some never develop symptoms, so it’s not obvious they harbor the parasites.
Yet, despite expert recommendations, the U.S. does not require at-risk organ donors to be screened for Chagas.
Some American transplant networks screen for the disease anyway, but New Jersey’s organ procurement organization, the NJ Sharing Network, did not — even though the donor whose heart Bob Naedele received was an immigrant from Mexico.
Cheryl Naedele filed a medical malpractice lawsuit against the NJ Sharing Network, Newark Beth Israel and members of the medical team involved in her husband’s care. NJ Sharing Network and Newark Beth Israel declined to comment on ongoing litigation. In court filings, both organizations denied the allegations of medical malpractice.
On Monday, the board of directors of the Organ Procurement and Transplantation Network, which governs transplant policies in the U.S., will meet to consider a proposal that would require screening of donors born in Mexico or 20 countries in Central and South America.
The proposal has divided transplant professionals. Some state and regional organ procurement organizations argue that screening for Chagas would be too cumbersome and could potentially delay organs from reaching patients in need. Others argue that there are ways to speed the process and it’s time to finally implement the screening that experts have recommended for years to prevent deaths like Bob Naedele’s.
To Cheryl Naedele, the choice is obvious. “With heart transplants, you’re supposed to be giving patients a second life, but then you’ve killed them” if you provide a diseased heart, she said. “How much should it cost to prevent this suffering?”
Though Chagas isn’t common in the U.S., the risk is serious enough that blood donations have been screened routinely for antibodies to the parasitic disease since 2007.
Studies estimate that about 300,000 infected people are currently living in the U.S., mostly immigrants. The risk of donor-derived infection is increasing, the Organ Procurement and Transplantation Network said, due to migration patterns and increased organ distribution.
The biggest concern about screening for Chagas is timing. Organs are typically transplanted within a few days after becoming available, in order to maintain their health after a donor dies. Organs are scarce, and nobody wants to lose one while waiting for a test result.
Current regulations require that organ donors be screened for a slew of infectious diseases, including HIV, hepatitis B and C, cytomegalovirus, Epstein-Barr virus and syphilis. Those tests can typically be completed within 12 hours, according to Colleen McCarthy, the president for the Association of Organ Procurement Organizations.
For more than 15 years, Donor Network of Arizona has tested every organ donor for Chagas, according to PJ Geraghty, the network’s vice president of clinical services. They haven’t had a positive donor yet but continue to screen because so many donors in the state come from endemic areas. A partnership with a lab in Tempe has allowed the group to test for Chagas in the same time frame as other mandatory tests, Geraghty said.
But McCarthy said that it’s “optimistic to think that the lab community could respond” quickly to a new requirement. “Some labs may have more ability to adjust to a new regulation,” while others may not, she said, potentially leaving some organ procurement organizations unable to comply.
Responding to this concern, a committee of the Organ Procurement and Transplantation Network added a workaround to its proposal. The committee recommended screening for at-risk donors but said that a transplant can proceed even if the Chagas test results are not back yet.
That means that a patient could learn after their transplant that they had received an infected heart, but knowing about the infection would allow doctors to treat it early. Currently, organs are not ruled out if they are infected with other viruses, but the patient is typically informed of any positive results so they can decide, along with their medical team, whether it is worth the additional risk and need for treatment. The fact that some patients choose to accept HIV-positive organs “highlights the incredible need” for organs, said McCarthy.
Anne Paschke, a spokesperson for the Organ Procurement and Transplantation Network, said the group was trying to “balance patient safety with the risk of negatively impacting organ utilization.”
Transplant experts, infectious disease specialists and the American Society of Transplantation have said that hearts from donors with Chagas should not be transplanted. While there is a treatment for Chagas, past case studies have found that hearts have a much higher risk of transferring the infection to the recipient compared with other organs.
Dr. Saima Aslam, the director of solid organ transplant infectious diseases at UC San Diego Health, said that though testing should be done prior to transplant, that doesn’t necessarily mean that an infected heart can’t be used. “Knowledge is power,” she said. “If we know a patient has a 90% chance of dying, we could take the organ and put them on treatment from the get-go with the patient or family’s buy-in, understanding the risk.”Treatment prognosis depends on the condition of both the patient and the heart, she said. Ultimately, she said, the industry should evolve to support faster testing, what Aslam called a “surmountable obstacle.”
The NJ Sharing Network, which obtained the heart that was offered to Bob Naedele, wrote in a public comment that it opposes the proposal for Chagas testing, saying that it will “increase the financial burden, process, and time” needed to evaluate donors.
Kasper Statz, director of systems integration at OurLegacy, an organ procurement organization in Florida, said that additional costs for testing shouldn’t be a major concern. “In the world of the things we pay for, testing is not that expensive,” especially compared to the cost of treating a patient who receives an infected organ, he said. OurLegacy, which covers Orlando and parts of central Florida, already screens for Chagas based on the donor’s history and risk profile. (So far, OurLegacy hasn’t found any positive donors.)
Donor Network of Arizona said the Chagas test costs it less than $100, with extra fees for expedited results. “We continue to test because the cost of the test — both financial and operational — is relatively low in Arizona compared to the risk that an inadvertent transmission of Chagas disease could pose to an organ recipient,” said Geraghty, the network’s vice president of clinical services.
Cheryl Naedele said she wants the Organ Procurement and Transplantation Network to mandate that Chagas screenings be completed before any transplants. “Knowing what I know now, I would never take a Chagas-infected heart,” she said. “If I found out after the fact, I’d be furious.”
In the case of Bob Naedele’s transplant, the donor was on life support, so Cheryl thinks there would have been time to run the test.
Gary Mignone, a spokesperson for the NJ Sharing Network, said, “It is the practice of New Jersey Sharing Network to follow all applicable guidelines and regulatory requirements with regard to organ donation, and we work closely with members of the transplant community to save lives.”
The fact that some organ procurement organizations screen for Chagas and some don’t may be a source of confusion for medical teams treating transplant patients.
Dr. Eliahu Bishburg, an infectious disease specialist at Newark Beth Israel who was part of Naedele’s medical team, said in a deposition that he had not considered Chagas as a possible cause of Naedele’s fevers, because he had thought that donor organs were already screened for it. He had read the 2011 expert working group’s report and thought that its recommendations had become policy.
Bishburg, a defendant in Cheryl Naedele’s suit, denied the malpractice allegations in a court filing. He did not respond to emails or a call requesting comment.
Newark Beth Israel’s pathology department also missed the parasite. When Bob Naedele was admitted with a fever, a doctor ordered a blood smear, in which a sample of blood is spread on a glass slide and examined under a microscope. This method can be used to detect parasites.
A lab worker, Annie Varughese, wrote in a statement that the slide looked a “little suspicious,” according to a court filing. Her statement said that she asked a colleague to review the slide, and her colleague gave the slide to pathologist Dr. Xinlai Sun to review. “Dr. Sun brought the slide back and said it was negative,” Varughese wrote. “So I entered the result as [negative] for parasites (reviewed by Dr. Sun).”
Varughese and Sun are both defendants in the malpractice case. In court filings both denied the allegations of medical malpractice. Varughese did not respond to a call seeking comment. Neither she nor Sun responded to messages left with their attorneys.
Sun said in a court filing that he “does not recall looking at the sample formally, as typically negative slides are not reviewed by the pathologist, only the technicians. However, it is possible he was asked by the technician to informally look or consult with respect to certain field(s) on the slide.”
At the Yale medical team’s urging, members of Newark Beth Israel’s pathology department looked again at the samples they had collected from Naedele during his July admission, according to a court filing. Upon reexamination, “the parasite(s) were found,” Sun said in a court filing.
Linda Kamateh, a spokesperson for Newark Beth Israel, said the hospital’s transplant team is monitoring the proposal to require Chagas screening for at-risk donors. “Should this proposal be adopted, the additional screenings would be immediately incorporated,” she said. “As always, our guiding principle is to provide our patients with the highest quality care possible.”
In 2019, a year after Naedele’s transplant, Newark Beth Israel’s program was the subject of a ProPublica investigation that revealed the heart transplant team at Newark Beth Israel kept a brain-damaged, unresponsive patient on life support to boost its lagging survival rate. A subsequent investigation by the federal Centers for Medicare and Medicaid Services found that the transplant program placed patients in “immediate jeopardy,” and the federal regulator required the hospital to implement corrective plans. Newark Beth Israel did not agree with all of the regulator’s findings, and in a statement at the time said its own review found that its post-transplant care was not unethical, was not compromised by concerns about survival rates and did not deviate from the standard of care expected of medical professionals.
Cheryl Naedele still remembers the hope and promise on Bob’s birthday in 2018, when they sped to Newark Beth Israel for his new heart. They had imagined it would bring him many more years to spend with his family; Bob had loved making cookies on Christmas and soda bread on St. Patrick’s Day with his grandchildren.
As for his treasured dream of visiting national parks, Cheryl recalls that even while her husband’s body was faltering at Yale’s hospital, he whispered to her in a lucid moment: “When I get out of here, can we still get the RV?”
Now she’s planning to take the trip with a friend. She’ll bring along the container of Bob’s ashes. It’s far from the original plan, but it’s all she can do now.
“I’m taking him to see all the national parks,” she said.