Our five patients could be divided into two groups: noncomplicated FT and complicated FT. The noncomplicated FT group consisted of cases 1, 4, and 5. They had no major complications, relatively short intensive care unit (ICU) stays and overall costs from (20AC)102,227 to (20AC)105,805. The complicated FT group consisted of cases 3 and 4. They had longer ICU stays due to respiratory or infective problems, respectively, and had consequently higher overall costs of (20AC)170,071 and (20AC)167,207, respectively.
For the different cost groupings, the mean costs were (20AC)14,540 ((20AC)12,541–(20AC)15,323) for the preoperative investigations, (20AC)68,437 ((20AC)41,851–(20AC)99,812) for the operation itself, (20AC)15,060 ((20AC)7,464–(20AC)25,950) for the ICU stay, and (20AC)31,761 ((20AC)23,665–(20AC)40,371) for hospitalization.
For all the cost groups except “preoperative investigations,” we separated the personnel, material, and transport costs. Figure 2 shows the cumulative personnel costs versus the corresponding costs of material and transport, if used. Personnel and material each account for approximately 50% of the total cost of FT.
Comparing the costs of FTs performed in different countries is difficult due to their specific reimbursement systems. We, therefore, compared costs of FTs performed in our hospital to those of heart, liver, and kidney transplantations performed in the same hospital. This should allow other teams to be able to estimate the costs of FT in their institution relative to the costs of established solid organ transplantations performed within their unit.
Our cost analysis focused on FT as a treatment. Pre- and posttransplant operations, such as canthopexy or restoration of the dentition, were not included.
Constant Cost Factors
The constant cost factors for all patients included the preoperative studies and all the aspects of treating the donor, such as the personnel and material costs of facial harvest and the cost of the resin mask. Operation times did not differ much, and the procedure included a predictable number of donor examinations and treatments to be carried out. As expected, the highest donor cost was for the third patient (Table 1 and Fig. 3), in whom an upper face, scalp, and double hand transplantation was performed. If the graft harvesting was performed in an outside hospital (i.e., cases 2 and 5), the transportation cost alone (if done by air) more than doubled the total harvesting cost.
Variable Cost Factors
Differences among the five cases are mainly due to graft-recipient operation costs, which rose sharply as the length and complications of the procedure increased. Our first case, in which the FT contained soft tissue, only, had the lowest recipient operation cost, the shortest operation time, and the lowest overall FT cost.
All the four subsequent patients had more demanding interventions than case 1. Two of them received composite grafts that included osseous parts of the facial skeleton, one received an upper face and bilateral hands, and one received a total face (soft tissues) (Table 1). Thus, all these patients had higher recipient operation costs.
Case 3 had the highest recipient operation cost. Because of the simultaneous transplantation of the face and both hands, the hands and face were harvested by two teams and were subsequently transplanted by the same two subteams. The operation time for case 3 was not exceedingly long, but more personnel were involved and more materials were consumed.
Intensive Care Unit
The duration of an ICU stay depended mainly on the complications involved. Case 5 had the shortest ICU stay and no complications and consequently had the lowest ICU cost. Case 1 also had an uneventful ICU stay and the second lowest ICU cost. Case 4 had an ICU stay of about the same duration as case 1, but it was twice as costly. In case 4, a return to theater on day 3 due to a technical problem led to a longer ICU stay. The cost of this return to theater was included in the ICU cost of case 4. The ICU stay of case 2 was nearly twice as long as that of case 1, and this led to a remarkably higher cost. This patient had postoperative pulmonary infection that required a short interruption of the immunosuppressive treatment, which may explain the higher cost.
Case 3 had the most complex intervention and the longest ICU stay. This patient suffered the most severe complications due to a multidrug-resistant Pseudomonas aeruginosa infection that led to graft necrosis. This patient died after numerous radical surgical debridements including left hand amputation. During the procedure, he suffered an anoxic cardiac arrest. Predictably, his ICU cost was the highest of the five FT patients.
Hospitalization costs depended mainly on duration. Once the patient was on the ward, they were in a stabilized situation that was comparable for all FT patients. The lowest hospitalization cost was for case 3, who stayed mainly in the ICU due to his complications and had a short hospitalization. The highest hospitalization cost was for case 2, who had the longest hospitalization. Case 2 was a non-French national and was referred to our hospital because there was no team performing FT in his country. Because of the European Union convention and Formula E112, the patient was included in our protocol. This patient had the longest stay on the ward because most of his follow-up was to take place in his own country.
Comparison With Other Teams
Compared with a cost analysis reported by a team in Cleveland, Ohio (the United States) (10), we report a slightly lower mean cost ((20AC)129,798), as their inpatient cost amounted to $232,893 (approximately (20AC)163,548). Nevertheless, the most important cost factors in both of these analyses were the hospitalization and nursing and costs of the operation.
Our analysis found that the costs of FT are lower than the costs of hand transplantation reported by a group in Louisville, Kentucky (the United States) (9). This difference might be due to differences in the respective health care systems of the United States and France and to the fact that the additional therapies required in hand transplantation follow-up, such as intensive physiotherapy, are extremely costly.
Comparison With Solid Organ Transplantation
To compare the costs of FT with the costs of other types of transplantation, we analyzed the mean costs of the heart, liver, and kidney transplantations performed in our hospital and subdivided these costs into the same groups used in our FT cost analysis (Fig. 4). The costs of all these procedures were lower than those for FT. Heart transplantation, with a mean cost of (20AC)85,518, was closest to the mean cost of our five FTs ((20AC)129,798). The mean cost of liver transplantation was (20AC)64,247 and approximately half that of FT. This comparison might help other teams planning to establish a FT program to estimate FT costs based on their own solid organ transplantation costs.
The costs of HMH solid organ transplants are comparable with those reported for other European countries. The cost of a liver transplant in the United Kingdom (£56,323) was similar to that of a transplant performed in our institute, but our cost for a heart transplant was higher than that reported for a heart transplant in the United Kingdom (£55,825) (11). HMH liver transplantation costs were slightly lower than those reported for Italy in 2003 ((20AC)77,475 in 2000) (12). A cost analysis from the Division of Cardiothoracic Surgery of Columbia University, New York, reported a cost for heart transplantation ($124,830, approximately (20AC)87,662) (13) that was similar to the one from the HMH.
The mean FT cost for this cohort of five patients was (20AC)129,798 and included the preoperative investigations, the operation itself, and the immediate postoperative period spent in hospital. The cost of FT was currently higher than the costs of solid organ transplantations. Within the same hospital, its cost was most comparable with that of heart transplantation and was double that of liver transplantation. This may be explained by the fact that FT was a relatively new treatment and was currently performed in a research setting only. Intensive care and the duration of the overall hospital stay may diminish as a team gains experience by performing FTs on a regular basis. Thus, we propose that cost should not be a limitation that prevents FT from being continued.
MATERIALS AND METHODS
The FT research project at HMH was initiated in 2002 with a request to the French National Ethics Advisory Committee for Life Sciences and Health for advice on facial repair using CTA (14). In 2004, the committee allowed this kind of procedure as an experimental project for severely disfigured patients. The surgical technique had already been optimized on preclinical anatomical studies (15–17). Thus, a clinical research protocol was designed to assess the immunological, psychological, and functional aspects of FT (14). This protocol was designed as a preliminary trial on five patients, with an intermediate assessment planned after the first patient before proceeding with subsequent cases. This design was approved in 2005 by the French Agency for the Sanitary Safety of Health Care Products, which guarantees the efficacy, quality, and appropriate use of all human health care products, including human organs, in France. In 2005, the national ethics committee approved the final research protocol. Each indication of FT required validation by an independent committee of experts. Financial support was received through a grant of (20AC)450,000 from the French ministry of health care for five patients and was recently renewed.
An FT is a CTA of skin, muscles of facial expression, nerves, and blood vessels with or without bony components in the region between the anterior hairline and the submental area. It was laterally limited to the temporal area, with or without external ears, and downwardly rejoins the submental area. The nose with its bones and septal complex was always included.
In total and lower FT, the anterior vestibulum of the oral cavity was included, but the tongue and the floor of the mouth were not. In total or upper FT, the eyelids including the levator muscles and part of the conjunctiva were included, but no components of the globes were included.
According to our protocol, the extent of the graft was adapted to the recipient’s defect, which determines whether upper, lower, or total FT was required and whether the inclusion of bony (mandible or midface) elements was necessary.
As illustrated in Figure 5, patients 1, 2, and 4 had lower face transplants without ears, in which the highest point of each FT was the upper anatomical margin of the frontonasal suture, which included the nose, horizontally below the lower eyelid. The FTs of patients 2 and 4 included bony elements. In patient 2, the bony elements were limited to the premaxilla and chin. In patient 4, the premaxilla and the mandible from angle to angle were included. Patient 3 had an upper face transplant, in which the lower margin was below the nose to the nasolabial sulcus. It included the upper half of the cheek, ears, and scalp without bony elements. Patient 5 had a total face transplant with ears and without bony elements.
At the HMH, the FT team included a variety of specialists. The team was leaded by a plastic surgeon (L.L.), and the surgical team includes five plastic surgeons, one maxillofacial surgeon, and five residents. The nonsurgical members of the medical team included a psychiatrist, a nephrologist (transplant immunology), anesthesiologists, and a pathologist. The paramedical team included scrub nurses, ward nurses, and a speech therapist.
Pursuant to the French health care system, there was a constant rotation among the medical staff. Fellows and junior consultants in plastic surgery generally stay for 2 years, whereas residents rotate every 6 months. This practice requires ongoing education of the medical team members on the basis of FT, such as cadaver dissections and the basic aspects of immunology. For each case, the surgical team was split into two different teams: one team harvested the facial graft and one team prepared the recipient site. The senior surgeons performed the transplant insets.
Currently, a total of nine patients have been included in our open study. Seven have undergone FT, and one was combined with bilateral hand transplantation. The FTs of two patients were too recent to be included in this study.
Two patients were withdrawn from the waiting list. One patient had a severely disfigured face, skull, and amputated right upper arm after accidental severe burns and was deemed unsuitable for FT due to immunological problems. The second patient, disfigured by severe xeroderma pigmentosum, had to be withdrawn due to the development of malignant melanoma.
The five transplanted patients analyzed in this study were aged between 26 and 37 years. Their facial disfigurements were due to the genetic disorder of neurofibromatosis type 1 (two patients), ballistic trauma (two patients), or severe burns (one patient). All the patients had difficulties in speaking and eating and had social seclusion due to their appearance. All patients had no other relevant medical comorbidities.
Each patient received a thorough general medical examination and a focused facial assessment that evaluated scar tissue, superficial veins, and the motor and sensory function of the face. The facial musculature was also evaluated using electromyography. Immunological investigations included blood group and human leukocyte antigen analyses and a screen for infections. Preoperative planning included performing a computed tomography (CT) angiogram and creating a stereolithographic model of the skull and its bony structures based on the CT data. Photographs of the face (front, profile, and half-side view) were taken, and the patient’s speech was video recorded. Patients underwent a psychiatric investigation and an assessment of their social situation.
Once a suitable donor was found, specific medical investigations were carried out on the donor to plan the facial harvest. These included an evaluation of the phototype, photographs, and a CT angiogram. The donor’s general health state was determined, and their immunological suitability was verified.
The clinical and technical details of these FTs were published previously (1, 7, 15–18). For all five FTs, the harvesting team and the team preparing the recipient worked simultaneously during the first part of the procedure to limit the ischemic time of the facial graft. Simultaneously, a painted resin mask was prepared during the operation to restore the defect on the donor after the face was harvested. Graft procurements required between 6 and 10 hours, and total transplantation time varied between 16 and 25 hr, depending on the extent of the procedure. Operation times were longer when bony elements or the scalp was included.
Early Postoperative Period
After the transplantation, patients stayed in the ICU for at least 5 days, followed by another 8 weeks on the plastic surgery ward. Various medical and paramedical professionals accompanied the patient during this phase. Hospitalization ended when the healing transplant, the patient’s immunologic response, and their medication were stabilized. Follow-up plans were established for medical and laboratory surveillance in an outside hospital near the patient’s home and for outpatient speech training.
FT is currently an experimental treatment, and the costs of the procedure and hospitalization are reimbursed by our research fund. In France, follow-up costs are reimbursed by the national social security, even for an experimental treatment.
This study analyzed the cost of the first five FTs, specifically the costs of the procedure and hospitalization (Table 1). We obtained detailed cost evaluations for these five patients from the financial department of the hospital (Table 1). These were similar to those provided by the hospital for solid organ transplantation. The specific cost groups included the costs of preoperative investigations; the operations on the donor and recipient; the ICU stay; and hospitalization. The costs of each cost group (excluding preoperative investigations) were further subdivided into personnel costs and material costs. The costs of solid organ transplantation (heart, lung, or kidney) were analyzed in the same manner to allow them to be compared with the costs of FT. Preoperative investigation costs included the costs of laboratory and radiologic investigations, and consultation expenses.
The overall operation costs included all the expenses of facial harvest, recipient preparation, and transplantation. These were subdivided into donor and recipient operation costs. The costs of the resin mask (episthesis) and for transport (if the donor was in another hospital) were also included in the operation costs.
“Hospitalization” costs included the cost of the stay on the ward. “Administration” costs included those for hospital administration, cleaning, furniture, electricity, and heating.
The authors thank Isabelle Castellotti and Dylan Augé from the Henri Mondor Hospital Financial Department for the detailed hospitalization bills for our five transplantations, and the Clinical Research Program of Public Health Care in Paris for a grant for the face transplantation program.
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Keywords:© 2012 Lippincott Williams & Wilkins, Inc.
Face transplantation; Composite tissue allotransplantation; Cost analysis; Financial aspects; Economic outcome