First complete tracheal transplant in the world performed in New York-

Thirty years of research, attempts and false starts. Of scandals, too, in the last ten years. Now, however, trachea transplantation seems to have taken an encouraging path: a team led by Eric M. Genden, head of the Department of Otolaryngology Surgery and Professor of Neurosurgery and Immunology at the hospital, at the Icahn School of Medicine, at Mount Sinai Hospital in New York has carried out, for the moment it seems successfully, a complete trachea transplant, on a patient whose organ was damaged six years ago after a series of intubations. The intervention which took place on January 13th, e the patient, Sonia Sein, 56 years old, currently in good health. At the moment I have no scientific data, but whether the transplant was performed and was successful definitely a step forward, he comments Michele Colledan, director of the Department of organ failure and transplantation of the Giovanni XXIII hospital in Bergamo. Before talking about a breakthrough it must be said that a certain number is made and most of them are fine.

Problems with vascularity

The trachea, il tube that connects the larynx to the lungs, has always been considered very difficult to transplant due to the complexity of the blood vessels that run through it. The transplanted one was taken from the donor and reconstructed in the recipient, and they were connected the different small blood vessels that carry oxygen to the organ, meanwhile using a portion of the esophagus and thyroid to supply blood to the tissue being rebuilt. For the first time we can offer a therapeutic option to patients with severe tracheal defects – says Eric Genden -. Our reliable, reproducible and technically advanced transplant and revascularization protocol. An achievement that has the potential to save the lives of thousands of patients around the world they have birth defects of the trachea, untreatable airway diseases, burns, tumors or severe damage to the trachea by intubation, including those who have been hospitalized with Covid-19 and placed under ventilatory support.

Attempts from the past

In the past decades there have been several attempts to intervene on the trachea. The Italian surgeon Paolo Macchiarini he tried the path of organ reconstruction with stem cells, but his line of research was strongly contested by the Karolinska Institut in Stockholm, where he operated, and never caught on. In 2018 in France instead, a donor’s aorta was used, stabilized by an artificial structure and transformed into a trachea. The historical procedure of Mount Sinai, which lasted 18 hours and which required a team of over 50 specialists among surgeons, nurses, anesthetists, the result of 30 years of research largely focused on how to revascularize or supply blood flow to the trachea. The aspect to be considered, still to be written, is the immunological one. These composite organs are also subject to rejection. We need to see how the patient behaves from this point of view. As one of the complications can occur with rejection vascular damage, being small vessels the real riskadds Colledan.

The procedure followed in the USA

Let’s see what state the procedure followed by the Mount Sinai surgical team . First, the trachea and associated blood vessels were removed from the donor. So, the surgeons they rebuilt the trachea in the recipient, from the lungs to the larynx, and have performed a series of anastomosi microvascolari, connecting the small blood vessels that feed the donor’s windpipe with the recipient’s blood vessels. The surgeons they used part of the esophagus and thyroid gland to help provide blood supply to the trachea, which led to a revascularization judged successful by US experts. Ultimately, this procedure allowed the recipient’s tracheostomy to be removed, giving her the opportunity to breathe through her mouth for the first time in six years.

The patient’s condition

The patient has so far had no complications or signs of organ rejection and doctors are monitoring her closely to assess her progress and response to anti-rejection therapy. He’ll be celebrating his 57th birthday next month and, in an interview with the New York Times, he says he feels he has had a chance to be alive once again. The observations made by Professor Genden’s team during the complex intervention will serve to develop the Tracheal Transplant Program of Mount Sinai, which gained approval in 2016 for a clinical trial to perform the first long segment tracheal transplant using a deceased donor’s trachea. The goal of this program offer patients who have sustained extensive damage to the trachea a lasting alternative to current treatments, including tracheostomy. Existing treatments are effective in only about half of all surgeries performed, may only be temporary, and are often associated with complications, such as scarring or airway obstruction. Donor tracheal transplantation offers new hope for candidates, in particular to those who have suffered: trauma / accidents to the trachea; damage from intubation; airway tumors or congenital tracheal defects. This protocol can be read on the Mount Sinai website it does not concern the “tissue” or “synthetic bioengineered” trachea; rather just the donor’s trachea. The protocol uses precisely a segment of the trachea with the thyroid gland and its associated vessels. Research suggests that this approach can provide patients with a unique opportunity to breathe and speak normally. In addition, the procurement of donor tissue allows surgeons to research the graft and improve our reliability for patients and their families.

The eligibility criteria

The transplant just performed cannot be proposed for all patients. As mentioned, the ongoing trial designed to provide hope for patients with long segment tracheal defects. Many of these patients are unable to speak or breathe without the aid of a tracheostomy, the Mount Sinai Program specifies. Defects longer than 4-5 cm are often not manageable with surgical reconstruction. Consequently, tracheal transplantation represents a viable solution. The criteria for potential trachea transplant candidates are: male or female aged between 18 and 75 years; circumferential tracheal defect> 4 cm including suprasternal, cervical and upper thoracic sites, due to prolonged intubation, idiopathic scar, autoimmune disorder or trauma; able to provide written informed consent; with the availability and ability to complete all pre-transplant examination and evaluation procedures.

April 7, 2021 (change April 7, 2021 | 17:02)

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