Category: Transplants

$16 Million Payout to BioJoint Knee Surgery Plaintiffs

The University of Missouri has settled claims over ‘BioJoint’  knee surgeries for $16.2 million, in what appears to be one of its largest public payouts in recent years.

The surgeries in question used the BioJoint system, a “biological joint restoration” which involves replacing parts of the knee with bones or cartilage from cadavers to treat arthritis or joint damage. This technology was pioneered by James Stannard, MD, and veterinarian James Cook, DVM.
The 22 plaintiffs, some of whom were minors, allege that they were not informed about the highly experimental nature of the BioJoint knee surgeries, with a failure rate of as high as 86%. This often required patients to have additional corrective surgeries or knee replacements. Some plaintiffs said that the surgery was pitched to them as a way to avoid a total knee joint replacement. They also allege that Dr Stannard negligently allowed Dr Cook—a veterinarian surgeon—to perform parts of the surgery without supervision.

The University denied wrongdoing, and settled without admission of liability or wrongdoing after claims against the defendants, Dr Stannard, Cook and another employee were dismissed. 

“It’s not uncommon to have vets as part of your research team, but it would be uncommon to have them as part of your clinical patient care team,” said Patrick McCulloch, MD, vice chairman of Houston Methodist’s orthopaedic surgery department.

“You have to be licensed as a physician to perform surgery on a human being,” added Jeff Howell, executive vice president of the Missouri State Medical Association.

A key part of the plaintiff’s case involved false advertising, including local airing at the Super Bowl and at Chicago’s O’Hare International Airport, and which they claim led them to the procedure. It was speculated that the false advertising claim made the settlement amount larger than the medical malpractice suit alone.

Source: St. Louis Post-Dispatch

COVID Vaccination in Immunosuppressed Patients Produces Weak Response

An article by Dorry Segev, MD, PhD for MedPage Today reveals poor results for COVID vaccination in immunosuppressed patients, with concerning implications. 

Dr Segev professor of surgery and epidemiology and associate vice chair of surgery at Johns Hopkins University School of Medicine and Bloomberg School of Public Health.

Dr Segev and colleagues launched a national study of vaccine immune responses in immunosuppressed solid organ transplant recipients. Among 436 COVID-naïve participants who received their first mRNA vaccine dose, only 17% of them mounted detectable antibodies to SARS-CoV-2.  The researchers also found that those taking anti-metabolites (eg, mycophenolate or azathioprine) were less likely to develop antibody responses, with 8.75% with detectable antibody found in those taking anti-metabolites versus 41.4% in those not taking them.

“Naturally, we were disappointed to see these findings, as we were hoping to be able to tell our immunosuppressed patients that the vaccines seemed to work well for them. Given this observation, the CDC should update their new guidelines for vaccinated individuals to warn immunosuppressed people that they still may be susceptible to COVID-19 after vaccination,
Dr Segev wrote. 

The current CDC guidelines are worded in a way that suggests vaccination translates into immunity, Dr Segev pointed out, but the study demonstrates that for most transplant recipients, as well as other immunosuppressed patients that the vaccine does not automatically confer immunity. This could also be a concern for the some 37.9 million people around the world living with HIV, although the effects of achieving viral suppression with antiretroviral therapy have so far not been well investigated in relation to COVID. Vaccine trials so far have not had sufficient numbers of participants living with HIV to draw any conclusions.

Notably, their previous research did show that rates of COVID infection and mortality were not greater for immunosuppressed transplant patients. 
Dr Segev noted that there are some implications for immunosuppressed patients; firstly, that they should at the very least receive the second dose of their vaccination (the current research is only on the effects of the first dose), and secondly, immunosuppressed patients should be aware that they may not necessarily be immunised after receiving a vaccination. They should speak to their provider about an antibody test to determine if the immunisation has been achieved.

The researchers are continuing to investigate other aspects of immune response besides antibodies, such as T and B cells, and are also looking at other vulnerable populations.

Source: MedPage Today

Teen Embraces Chance to ‘Live Well’ With Kidney Disease

Thanks to a young organ donor, Bronwen Fredericks has a new kidney that she and her mother Bridget are deeply thankful for.
The 15-year-old was one of two patients at Red Cross War Memorial Children’s Hospital who received their new kidneys last month. With a new chance at their childhoods, they have a chance to embrace the spirit of “Living Well with Kidney Disease”, the 2021 theme for World Kidney Day tomorrow. 

Bronwen said: “I’m really grateful to my donor and excited for my new life. I’m really looking forward to being able to dance again.”

According to her mother, a blood pressure test had alerted them to the problem.

“I would like to encourage everyone, especially parents, to do a regular general check-up with their children at a clinic or GP. A simple blood pressure test could show us that there was a serious problem and we were able to take action that saved my daughter,” she said.

“Irrespective of age, being diagnosed with kidney disease can pose a huge challenge for the patient and their family. It remains draining on those involved, be it emotional, financial, physical or a combination of these – but imagine the impact on a young child,” the Red Cross War Memorial Children’s Hospital said in a statement on Wednesday.  The hospital conducts around 10 to 12 kidney transplants a year.

The Red Cross Hospital said it is aiming to reduce stress factors through education, empowerment and by building a partnership with patients and their families.

“The diagnosis and management, particularly in the advanced stages of kidney disease, impacts severely upon the lives of our young patients by reducing their ability to participate in everyday activities like attending school, participating in extra-curricular activities and socialising, whilst the whole family’s ability to travel and parents ability to work is also affected,” said Dr Deveshni Reddy, ‎paediatric nephrologist at the hospital.

Current management includes dialysis to take the strain off of kidneys, and in more extreme cases, donor transplants.
Professor Mignon McCulloch, the hospital’s head of paediatric nephrology and solid organ transplantation, said: “While we always try our best to treat chronic kidney disease and other kidney disorders through medical intervention, sometimes a surgical intervention, or dialysis and resultant kidney transplant, is the only option.

“The Red Cross War Memorial Children’s Hospital conducts around 10-12 kidney transplants per year, making it one of the most active paediatric transplant services in South Africa, which is only possible due to the close collaboration with the multi-disciplinary role-players from Groote Schuur Hospital and Red Cross.”

Source: IOL News

Novel Transplant Technique Yields More Donor Hearts for Children

Two hospitals in the UK have reported great success in a new heart transplant technique, resulting in a record number of children receiving heart transplants in 2020.

Royal Papworth Hospital in Cambridge and Great Ormond Street Hospital (GOSH) have collaborated on a new procedure which has enabled a much larger supply of donor hearts for children, who have had to wait two and a half times as long as adults for a donation.

Royal Papworth Hospital was the first in Europe to harvest non-beating hearts from adult patients whose life support had been withdrawn, and then been restarted for transplantation, instead of waiting for brain death with a still-beating heart.

By using a special device called the organ care system, surgeons can effectively restart the heart and keep it healthy until transplantation. The first non-beating heart transplant was performed in Australia in 2014. Since February last year, the two hospitals have been offering the service to children.

The use of non-beating hearts had previously been ruled out for transplantation until recently, due to tissue damage from lack of oxygen. The new organ care system, which supplies the heart with oxygenated blood and nutrients, can be used to keep the heart alive and pumping outside the body for up to 12 hours. This is long enough for checks to be performed prior to the transplant procedure, or even transferred to another hospital.

GOSH and Freeman Hospital are the only two centres in the UK with paediatric heart transplant units. In the past five years, 39 children died while waiting for donors.

“Some patients will just not survive the wait,” said Jacob Simmonds, a transplant surgeon at GOSH. “There is also a risk that while waiting they could damage other organs, particularly the lungs.” 

Last year, six paediatric heart transplants were carried out in the UK using the new procedure, and only four elsewhere in the world. The organs came from adult donors, as the organ care system is designed to accommodate hearts from people weighing over 50kg. Development is being carried out on a system which could allow harvesting organs from children. This would increase the available transplants for infants and babies, who have a critical lack of donors.

Source: BBC News

First Successful Face and Double Hand Transplant

Doctors in New York have performed the world’s first successful face and double hand transplant.

The patient, 22 year-old Joe DiMeo, had suffered burns over 80% of his body in a 2018 crash, resulting in his fingers being amputated. His eyelids and lips were also amputated. He had been driving home from a night shift when he fell asleep at the wheel and his car crashed, bursting into flames. He spent four months in a burns unit, much of it in an induced coma. After 20 reconstructive surgeries, he still had only limited use of his hands and face.

In a 23-hour operation, doctors attached the donor’s face and hands. He then spent 45 days in ICU, then a further two months in hospital. Mr DiMeo learned to open his new eyelids and move his hands, and is now spending up to five hours a day in rehab.

Eduardo Rodriguez, director of the Face Transplant Program, said: “We wanted to give him not only an operation that made him look better, but it ultimately had to work ideally, especially with the hands.” He added that Mr DiMeo is the most motivated patient he had met.

The doctors waited to ensure that the transplant had taken before calling it successful. While a face and double hand transplants had been performed before, one patient died from complications and the other had to have their hands amputated when they failed to thrive.

Hand transplants have progressed a great deal since the first successful one in 1998. Enormous strides have been made in immunosuppression since then, requiring fewer drugs with less resultant toxicity and side effects. There is also a protocol for using donor bone marrow and stem cells to modulate the immune system in place of typical immunosuppression.

Mr Dimeo says that he can now exercise and make breakfast unaided.

“This is a once-in-a-lifetime gift, and I hope the family can take some comfort knowing that part of the donor lives on with me,” Mr Dimeo said. “My parents and I are very grateful that I’ve been given this second chance.”

Source: BBC News