Ear, Nose and Throat (Otolaryngology) – Head and Neck Surgery

Tracheal Transplant Frequently Asked Questions

Mount Sinai has launched the world’s first Tracheal Transplant and Airway Reconstruction Program for candidates suffering from long segment tracheal defects and/or severe damage to the trachea. The purpose of this research study is to determine if tracheal transplantation from a deceased (dead) donor is a safe and effective treatment for extensive tracheal damage. This procedure has not been performed in humans as of 05/01/2017, and no benefits can be guaranteed. The research informed consent document provides the most complete and authoritative information about the trial; however, below are some of the most frequently asked questions.  If your question is not answered below, please email our tracheal transplant coordinator, Kara Bland, at kara.bland@mountsinai.org or call 212-241-0591 or the transplant research director, Brandy Haydel, at brandy.haydel@mountsinai.org or 212-241-0255.

Q: How does a tracheal transplant work?
A: Patients who suffer airway obstruction as a result of either trauma or scarring may have no choice but to live with an artificial airway, a tracheostomy. The tracheal transplant trial provides patients who are unable to undergo primary reconstruction with an opportunity to reconstruct the windpipe and proceed with normal life. The transplanted organ is procured from a deceased donor. Many of these donors may also donate their liver and/or kidneys to transplant recipients in need. The tracheal donor provides the tissue that can be used to reconstruct the recipient’s trachea.

Q: Why not use stem cells or a synthetic trachea?
A: In spite of extensive research focused on synthetic trachea and stem cell engineering, this approach has not proven effective for the clinical management of extensive airway defects. While research in this area continues, it does not appear that this approach will provide a solution in the immediate future.

Q: Who are appropriate candidates for the tracheal transplant trial?
A: Candidates for the tracheal transplant trial are patients over the age of 18 years who have extensive airway defects, not due to cancer, that have not responded to  the current treatments available. Many of these patients suffer recurrent airway obstruction, difficulty breathing, and significant limitation in their activities of normal daily living.

Q: What are the exclusion criteria of the trial?
A: Exclusion criteria for the tracheal transplant trial include the following:

  • Patients under the age of 18 years
  • Tracheal defect due to cancer
  • Severe disease that is poorly controlled or at end stage including unstable angina, symptomatic COPD, symptomatic CHF, and/or active hepatorenal failure
  • Current, untreated, active infection
  • Active substance abuse
  • Severe cardiovascular, peripheral vascular or cerebrovascular disease
  • Irreversible brain damage or neurological dysfunction
  • Psychiatric or physical illness that may interfere with the ability to participate in the study

Q: How will you seek the right donor for each recipient?
A: Deceased donors are carefully screened by the medical team to ensure that the recipient is an appropriate match and the transplant can be accomplished safely.

Q: What medical tests are required to determine transplant candidacy?
A: All patients who are considering candidacy for transplantation will be evaluated by our multidisciplinary team.  In addition to a medical evaluation, patients will undergo a psychiatric evaluation to ensure that they are informed of the risks and benefits of this program.

Q: What are the risks of this surgery?
A: The risks include but are not limited to, infection, bleeding, airway obstruction,  rejection of the graft and graft failure. In most cases, in the event of airway obstruction or failure of the tracheal graft, a tracheostomy would be safely placed to provide a safe airway.  There is also a lifelong need for anti-rejection medications which may lead to adverse side effects including increased risk of infection or other cancers.

Q: How does one recognize if he or she is undergoing a rejection of the transplant?
A: Transplant recipients are evaluated routinely by endoscopic bronchoscopy to assess for graft rejection.  Some signs of rejection may include fever or flu like symptoms or pain in the area of the tracheal graft.  The only way to confirm rejection is by doing a biopsy.

Q: How do I enroll on the list? Do you work with UNOS?
A: If you believe that you would be an appropriate candidate for the tracheal transplant trial, contact the tracheal transplant coordinator, Kara Bland, to schedule an interview.  A multidisciplinary team will evaluate you and a review committee will decide if you meet criteria for placement on the United Network for Organ Sharing (UNOS) waiting list.

Q: What is the expected recovery?
A: Patients should expect a 5 to 7 day stay in the hospital before being discharged home. Complete healing should take place within three weeks.

Q: Will I fully regain my voice?
A: It is important to know that you may not get any benefit from taking part in this research.  However, if tracheal transplantation is determined to be safe and effective it may increase survival and improve the quality of life in patients with extensive tracheal damage.

Q: Will insurance cover the surgery?
A:  As part of the evaluation, all potential candidates will meet with a financial coordinator who will determine insurance coverage available and provide financial counseling.

Q: Will I need to take medications for life following the transplant?
A: Following the transplantation, patients will be required to maintain immunosuppression. Immunosuppression is achieved with oral medications taken twice daily. The level of immunosuppression will be checked routinely to ensure the appropriate drug levels to prevent rejection of the new trachea.

Q: What are the other possible options to consider?
A: You may decide not to take part in this research study.  Instead of being in this research study, your choices may include undergoing surgical resection of your trachea or seeking other research studies.  Surgical options may be life-saving in approximately half (50%) of the patients treated.

For patients with moderate damage to the trachea (< 4 cm in length) surgical reconstruction is currently the only available option

For patients with severe damage to the trachea (> 4.0 cm in length or approximately half of the total trachea length) there are currently no long term options available.  For those patients with life-threatening injuries, an alloplastic stent (a plastic tube) may be used as a temporary treatment

Very severe damage (> 6.0 cm) is not compatible with life and there are currently no treatment options available.