Experts say the achievement has the potential to save the lives of thousands of patients around the world who have tracheal birth defects, untreatable airway diseases, burns, tumors, or severe tracheal damage from intubation, including those who had been hospitalized with COVID-19 and placed on a ventilator.
Until now, no long-term treatments existed for these patients with long-segment tracheal damage, and thousands of adults and children have died each year as a result.
The trachea, also known as the windpipe, is an organ that is essential for speaking, breathing, and normal lung function. The trachea connects the larynx to the lungs and plays a critical role in normal lung function, the immune system, and breathing.
Surgeons have been unable to transplant the organ in large part because of the complexity of providing blood flow to the donor trachea, leaving patients with long-segment tracheal disease no option for treatment.
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Mount Sinai's historic procedure resulted from 30 years of research that focused on how to revascularize, or provide blood flow, to the trachea, and understanding the biology of the organ.
The 18-hour procedure took place on Wednesday, January 13, and was led by surgeon-scientist Dr. Eric Genden. The complex surgery involved a team of more than 50 specialists, including surgeons, nurses, anesthesiologists, airway specialists, and residents.
"For the first time, we are able to offer a viable treatment option to patients with life-compromising long-segment tracheal defects, and this development will change the standard of care," Dr. Genden said. "It is particularly timely, given the growing number of patients with extensive tracheal issues due to COVID-19 intubation. Because of both mechanical ventilation and the nature of the COVID-19-induced airway disease, tracheal airway disease is precipitously increasing, and now we have a treatment."
The trachea transplant recipient, Sonia Sein, is a 56-year-old social worker from New York City. She had severe tracheal damage due to repeated intubation after an asthma attack, and several failed surgical attempts to reconstruct her trachea led to even further damage.
"When they went in, they didn't expect it, but I was actually suffocating," she said. "He said if we would have waited, it would have been three months of my life."
She breathed through a tracheostomy, a surgically created hole in her neck, and was at high risk of suffocation and death because of the progression of her airway disease and likelihood of her trachea collapsing.
"After the transplant, I'm feeling better," she said. "I can breathe better. Actually, I'm talking a lot stronger."
The fear of going to sleep and never waking up was her main motivator to undergo the experimental procedure.
"She had become progressively more debilitated, where she wanted to enter herself into palliative care, end of life care," Dr. Genden said.
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During the procedure, the Mount Sinai surgical team removed the trachea and the associated blood vessels from the donor. Then, the surgeons reconstructed the trachea in the recipient from the lungs to the larynx and performed a series of microvascular anastomoses, connecting the small blood vessels that nourish the donor trachea with the recipient's blood vessels.
"For years, the medical and scientific consensus has been that trachea transplantation could not be done because the organ's complexity made revascularization impossible, and every previous attempt to perform in-human transplantation ended in failure," Dr. Genden said. "This surgical achievement is not only the culmination of 30 years of research that began when I was a medical student at Mount Sinai, but was also made possible by the spirit of collaboration that exists at Mount Sinai."
Surgeons used a portion of the esophagus and thyroid gland to help provide blood supply to the trachea, which led to successful revascularization.
Ultimately, the procedure allowed the removal of the recipient's tracheostomy, giving her an opportunity to breathe through her mouth for the first time in six years.
"Despite extensive research on the vascular supply to the organ using human and animal models, there is no real way to fully prepare for conducting a first-ever in-human transplantation such as this," Dr. Genden said. "For example, we had no guide for how well the graft would tolerate transplantation, so we worked very quickly. Eighteen hours later, it was clear we had accomplished what many said could not be done."
The patient has had no complications or signs of organ rejection, and doctors are monitoring her closely to assess her progress and reaction to antirejection therapy. Their observations will inform the development of Mount Sinai's Tracheal Transplant Program, enabling Dr. Genden to offer this therapeutic approach to patients nationwide and internationally.
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