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U.S. face transplant successful with decades of design

Article-U.S. face transplant successful with decades of design

Editor’s Note: This month’s issue of Cosmetic Surgery Times is devoted to current trends in facelift techniques and technologies, but we thought it important to also pay tribute to the amazing advancements taking place in reconstructive surgery, particularly with regard to facial reconstruction. This article discusses the experiences of Maria Siemionow, M.D., Ph.D., D.Sc., and her team as they prepared for the first U.S. face transplant that took place at The Cleveland Clinic in December 2008.

The path to performing the first U.S. face transplant began in the laboratory 20 years ago and reached the operating room based on the findings from a series of studies conducted to develop surgical techniques, evaluate graft rejection and immunosuppression protocols and gather evidence to achieve IRB, institutional and organ procurement organization approval, says Maria Siemionow, M.D., Ph.D., D.Sc.

Dr. Siemionow, professor of surgery, director of plastic surgery research, and head of microsurgical training, Cleveland Clinic, Cleveland, spoke about her experiences with this research at the 26th annual scientific meeting of the American Academy of Cosmetic Surgery (AACS). Dr. Siemionow led the team that performed the first U.S. face transplant in December 2008. As the featured speaker at the AACS meeting, she outlined the systematic approach taken to prepare for this landmark procedure.

“Face transplantation is not really about the incision. Rather it is about the decision to develop the program by conducting the necessary experimental studies and obtaining the organizational approvals needed to operate,” Dr. Siemionow says. “Over 20 years, we faced multiple challenges, and more lie ahead, many of which are beyond our control. However, we need only look at how happy our patient is today to conclude it was worth all of our effort. Working with a great team, we’ve done great work not just transplanting a face but restoring a life. After all, a person needs a face to face the world.”

Laying the groundwork

The first experimental models of face transplantation were conducted in the laboratory using a rat model. The first publication from this research appeared in 2002 and described face transplantation involving a fully mismatched donor and recipient.

“Rejection was an important issue to understand. We needed to find out what is happening to the transplanted skin, how to identify signs of rejection and if we could develop protocols for minimal immunosuppression,” Dr. Siemionow explains.

Between 2000 and 2009, more than 1,000 composite face transplants were performed in five different experimental models mimicking various possible clinical scenarios. After beginning with a full face and scalp transplantation in the rat, which involved a 7-hour procedure, Dr. Siemionow and her team scaled back to a smaller, hemifacial model. Subsequent models included vascularized calvarial bone in anticipation of patients who’d suffered skeletal trauma.

“This was an important model because we also learned that progenitor cells carried in the calvarium promoted engraftment and longterm survival,” Dr. Siemionow says.

Yet another model included maxilla transplantation, which had application for the human face transplant that was to be performed 10 years later. Anticipating the needs of patients with head and neck cancers, a composite hemiface-mandible-tongue model was also undertaken.

“This was one of our most challenging protocols, but we knew this type of surgery would be important for certain cancer resection patients,” Dr. Siemionow says.

Progressing from the rat to the cadaver lab, more than 40 studies were performed to establish the feasibility of preserving vascular territories without leakage; develop optimal methods for harvesting facial nerves; and gain insight into coordination between the donor harvesting and transplant teams, the duration of the procurement procedure and the surface area of skin needed for transplantation.

“Since we had never before looked at this procedure from a 3-D perspective, we were surprised to find that up to 1,200 cm2 of intact, well-vascularized skin was needed to transplant the entire face and scalp, while almost 700 cm2 was needed excluding the scalp. Ten years later, we found these early studies accurately predicted the amount of skin needed for our first patient,” Dr. Siemionow says.

In addition, a model of cadaver dissection was created using a 3-D CT scan of the recipient in order to determine the minimal amount of skin and bony structures that needed to be harvested. For the actual surgery, that value is adjusted upward to allow for edema and serial biopsies taken to monitor for rejection.

Securing permissions

While these laboratory studies were ongoing, obtaining necessary approvals from the IRB committee, institution and organ procurement organization became a full-time job in itself, and evidence from laboratory studies was also needed to support these efforts, Dr. Siemionow explains.

“For example, we needed to prove to the IRB committee that a free flap harvested from the patient would not be sufficient to resurface the face. In the cadaver lab, we found that even taking the entire bipedicled scapular and parascapular flap from the back would cover less than half of the 3-D face,” she says.

The first IRB approval for face transplantation in humans was obtained in October 2004, thanks also to the efforts of a multidisciplinary team including psychologists, psychiatrists, media relations representatives and surgeons representing numerous subspecialties.

It was also necessary to prove that face transplantation did not result in identity transfer — this too was established in a cadaver study — and to establish that the face is an organ, not a tissue. While the latter eliminated a requirement for FDA regulation, it became necessary to gain approval from an organ procurement organization, which proved to be the most challenging.

Success in the OR

In December 2008, Dr. Siemionow and her team performed the first U.S. near-total face transplantation on Connie Culp, a 44-year-old woman whose midface, including bone, had been obliterated by a gunshot injury. The team included 12 surgeons, four anesthesiologists and more than 30 nurses and other staff who labored more than 22 hours.

Thirteen months later, Culp is said to have sensory recovery, functional return of breathing, smell, drinking, eating and oral motions, and her psychological outcome is good as well. She experienced only one rejection episode at 47 days post-transplant that was successfully reversed with steroids, and she is now on low-dose prednisone plus FK506.

“We think these results are excellent and encouraging,” Dr. Siemionow says.

The facial transplantation research conducted by Dr. Siemionow and colleagues has been the subject for 65 publications. These papers appeared in bioethics and transplantation journals as well as in the plastic and reconstructive surgery literature. Dr. Siemionow notes that she was particularly proud that two of these papers, published in 2004 and 2007, respectively, received the James Barrett Brown Award.

“This award is presented to the best plastic surgery-related paper published during the previous year based on voting by the entire membership of the American Association of Plastic Surgeons. Receiving this recognition was particularly meaningful to us because it showed our colleagues considered our research an important addition to the field of reconstructive surgery,” she says.

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