Surgeon shares the transplant experience

"The surgery and patient's progress have exceeded our expectations," says David Lott, M.D., lead surgeon and chair of the Department of Otolaryngology (ENT) - Head and Neck Surgery/Audiology at Mayo Clinic in Arizona. "This is a tremendous accomplishment in launching what we believe is the future for laryngeal transplantation."

A paper by Dr. Lott on the case was published July 9 in the peer-reviewed medical journal Mayo Clinic Proceedings. The larynx, located in the throat, is commonly known as the voice box. Larynx transplantation is a rare and complex procedure, performed only a handful of times in the world. Even more notably, Mayo Clinic's surgical team successfully performed the larynx transplant on a patient with active cancer, making it one of the first cases of its kind globally.

Six surgeons at Mayo Clinic conducted the 21-hour transplant, which included the larynx, pharynx, upper trachea, upper esophagus, thyroid and parathyroid glands, blood vessels, and nerves.

The transplant was performed on a Massachusetts man, Marty Kedian, who was diagnosed with a rare form of laryngeal cancer called chondrosarcoma. For 10 years, Kedian underwent dozens of surgeries, which eventually robbed him of his voice and his ability to swallow and breathe normally. Several years ago, Kedian had to undergo a tracheostomy that allowed him to breathe through a hole in his neck. He says the tracheostomy, combined with the loss of his voice, significantly diminished his quality of life. "I was alive, but I wasn't living," says Kedian. "I love to talk to people everywhere I go, and I just couldn't. I felt strange, and I wouldn't go out anywhere."

After years of surgeries, doctors told Kedian his only remaining option was to get a laryngectomy and have his larynx completely removed. He declined. "I didn't want a laryngectomy. I wanted to find a way to get my quality of life back," he says.

Kedian found what he was looking for at Mayo Clinic's Larynx and Trachea Transplant Program, where Dr. Lott was leading the first known clinical trial on laryngeal transplantation in the U.S. After being accepted as a patient for the clinical trial, Kedian and his wife, Gina, moved to a temporary home in Phoenix. On Feb. 29, Kedian became Mayo Clinic's first patient to undergo a total larynx transplant. "I wanted this so I could talk and breathe normally with my new granddaughter. I want to read her bedtime stories with my own voice," says Kedian.

Clinical trial advances next steps

Because it was conducted as part of a clinical trial, Mayo's case is considered a significant pivotal step in making the rare procedure available to a wider population. "Until now, laryngeal transplants have been done as one-offs," says Dr. Lott. "This clinical trial allows us to conduct a true scientific investigation aimed at thoroughly researching the safety and efficacy of laryngeal transplantation as a trusted option for patients." The program is approved to perform additional larynx transplants in the coming years.

The American Cancer Society estimates there will be 12,650 new cases of laryngeal cancer in the U.S. this year. Until now, many of these patients had little hope of laryngeal transplantation as a possible option in the future due to the risk associated with the use of immunosuppressive therapy. Transplant patients are given immunosuppressive therapy to lower the body's immune response, which reduces the risk of organ rejection. However, immunosuppressive drugs also increase the risk of the cancer spreading.

Kedian's case was unique. He was already on immunosuppressive therapy from a previous kidney transplant. "Having a patient with an active cancer who already had his own immune suppression allowed us to do the transplant safely without introducing additional risk in a way that has rarely, if ever, been done before," says Girish Mour, M.B.B.S., medical director of the program. Dr. Lott adds, "Being able to perform this transplant in the setting of active cancer in a patient already on immunosuppressive therapy, under the rigor and oversight of a clinical trial, enabled us to take that vital step toward better understanding the safety for cancer patients and potentially making larynx transplant a standard option."

Removing the cancer was the surgical team's main priority. "First, we removed Mr. Kedian's cancerous larynx," explains Dr. Lott. "Then, with the confidence of our team that the cancer was gone, we focused on the transplant."

Living life after surgery

Four months after surgery, Kedian can speak with his new voice, swallow and breathe on his own, which Dr. Lott calls remarkable. "Mr. Kedian has already regained about 60 percent of his voice, which I wouldn't have thought would happen for at least a year. He still speaks with the same voice and Boston accent he had prior to the cancer," says Dr. Lott. "He can also eat hamburgers, macaroni and cheese, almost anything, and swallow with no problem. His breathing also continues to steadily improve." Doctors plan to remove the tracheostomy tube when Kedian regains full ability to breathe on his own.

"The team at Mayo has given me my life back," says Kedian. "I'm so grateful. I have the deepest gratitude for Dr. Lott's team and especially the generosity of my organ donor and donor family. I hope one day I get the chance to tell them, 'Thank you.'"

"This case signifies a monumental breakthrough. It represents the future of laryngeal transplantation, where every patient needing a total laryngectomy will have the option of a reconstruction that allows them to maintain their quality of life," says Marshall Strome, M.D., who made medical history by performing the world's first total laryngeal transplant in 1998. "With the clinical trial underway, Dr. Lott and his team are positioned to advance the field in ways no other program can currently achieve. The Mayo team has discovered the holy grail for managing laryngeal cancer, which I believe will come to fruition by the end of this decade."

Dr. Lott calls Kedian's case the capstone of his two decades of research. In addition to the clinical trial, Dr. Lott's research team is investigating ways to restore laryngeal function through improving transplantation techniques and pioneering regenerative medicine technologies. "I set my path on becoming a laryngeal surgeon and researcher to build a program that is pushing the boundaries of science forward," says Dr. Lott. "Our dedication is to the thousands of individuals who suffer from laryngeal dysfunction and to find trusted options that preserve their health and their quality of life. That's what this clinical trial is all about."

Kedian returns to Massachusetts next week. He is excited to be back with family and friends and to read bedtime stories to his granddaughter. Kedian also plans to use his own story to inspire others and be a voice for hope. "Mayo and Dr. Lott have helped me regain my quality of life," says Kedian. "My job now is to get better. My next job will be to show others they can do it too."