The Cleveland Experience

Maria Siemionow, Cleveland Clinic Foundation, Cleveland, OH, USA.

Evidence of Experience and IRB Approval:Cleveland Clinic was the first institution in the world to get approval for facial transplantation in humans, on October 15, 2004. This happened following one year of presentation of evidence by our experts to the Cleveland Clinic Institutional Review Board. Once all technical, ethical, and social issues were addressed, the Board approved the protocol.

Organ Procurement Organizations: The organ procurement organization approval was a challenging process. Following IRB approval, it took two years to obtain approval from some of the OPOs in Ohio, Michigan, and Pennsylvania and an additional two years after that, to receive approval from our local organ procurement organization, LifeBanc. In July 2008, the patient was listed as a transplant candidate and then, finally, in December 2008, the transplant was performed.

Patient Selection Process:The protocol of inviting potential candidates included requests for the medical history, history of the accident/injury, history of all previous surgeries, as well as series of photos showing different views which were most representative of the disfigurement of the face. This served as a screening process for the evaluation of potential candidates before inviting them for the formal screening by all experts of the multi-disciplinary team.

Our patient had undergone 23 reconstructive procedures which all failed to restore normal function and, for this reason, the patient requested evaluation as a potential face transplant candidate.

The Team:The face transplantation team was comprised of over 35 experts in different specialties including plastic surgery, transplant surgery, psychiatry, psychology, immunology, infectious disease, anesthesia, intensive care, neurology, ethics, dentistry and prosthetics. Media were also included in the multi-disciplinary team which was ready for evaluation of potential candidates.

Cost:It was clear that the cost of the first face transplant patient within our institution, and in the United States, would be in the vicinity of $500,000 or more, based on the cost of reported hand transplantations. Cleveland Clinic management supported the program of face transplantation and approved coverage of the entire cost of the first patient.

Transplant Surgery:Transplantation surgery took 23 hours, 8 reconstructive surgeons, and over 30 supporting staff who participated in 2 operating rooms. The transplant was, at that time, in December 2008, the most complex transplant performed worldwide and included over 80% of the entire face including bones, maxillary sinuses, zygomas, entire nose, lower eyelids, upper lip, palate, hard palate, and alveolus.

Outcome: The patient’s outcome was satisfactory, and the patient had one episode of rejection, at day 47 post transplant, and a second episode of rejection at day 459 post transplant, both of which were treated with a bolus of steroids, after which the rejection reversed from grade 3 to grade 0, at 3 days. The patient has returned good function of breathing through the nose, smelling, eating solid foods, tasting, and drinking from a cup. There was no occurrence of post-traumatic stress disorder. The patient regained self confidence and self esteem. There was also reduction of pain after surgery. The patient’s therapy included induction with thymoglobulin triple therapy for the first 6 months with Prednisone, MMF, and FK506, and after 6 months, MMF was withdrawn and the patient was on the two-drug therapy of Prednisone and FK506. The reconstruction of the skeletal, as well as soft tissue features of the patient, was excellent. There was return of sensory recovery starting at 3 months post transplant and normal sensation of light touch, temperature, cold and heat. Colometric studies showed normal sensation at 6 months.

The functional outcome of the patient being able to pucker, smile, and say vowel sounds was excellent, and facial nerve recovery took about a year.

The aesthetic outcome, up to one year, was satisfactory; however, there was redundant skin on the jaws which required additional surgical removal. After this reconstructive procedure of extra skin removal and tightening of the soft tissues, there has been a very pleasing aesthetic outcome. The patient is also psychologically stable, socially re-integrated, and a very happy person.

Objectives:

1. This lecture will outline the basic science research and immunology related to face transplantation.
2. This lecture will outline the pre-clinical cadaver studies for defining the anatomy of the facial allografts.
3. This lecture will outline the preparation for clinical face transplantation, including the institutional review board (IRB) approval process, organ procurement organization (OPO) approval, and the patient selection process.
4. This lecture will present the outcome of the first U.S. near-total face transplant surgery, which was performed in December 2008.

References:

1. Siemionow M, Papay F, Alam D, Bernard S, Djohan R, Gordon C, Hendrickson M, Lohman R, Eghtesad B, Coffman K, Kodish E, Paradis C, Avery R, Fung J: Near-total Human Face Transplantation for a Severely Disfigured Patient in the USA. Lancet, 374(9685): 203-209, July 18, 2009.
2. Siemionow M, Papay F, Djohan R. Bernard S, Gordon CR, Alam D, Hendrickson M, Lohman R, Eghtesad B, Fung J: First U.S. Near-total Human Face Transplantation – a Paradigm Shift for Massive Complex Injuries. Plast. Reconstr. Surg., 125(1): 111-22, Jan. 2010.
3. Siemionow M, Gatherwright J, Djohan R, Papay F: Cost Analysis of Conventional Facial Reconstruction Procedures Followed by Face Transplantation. American Journal Transplantation, 11(2): 379-385, February 2011.