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Keywords:

  • Composite tissue allotransplantation;
  • cost;
  • face;
  • financial issues;
  • risk-benefits;
  • transplantation

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

For the first time, this study analyzes the cost of multiple conventional reconstructions and face transplantation in a single patient. This patient is a 46-year-old female victim of a shotgun blast resulting in loss of multiple functional and aesthetic subunits. For over 5 years, she underwent multiple conventional reconstructions with suboptimal results. In December 2008, she became the recipient of the first U.S. face transplant. This has provided the unique opportunity to present the cost of 23 separate conventional reconstructive procedures and the first face transplant in the United States. The combined cost of conventional reconstructive procedures and the first U.S. face transplant was calculated to be $353 480 and $349 959, respectively. The combined cost posttransplant totaled $115 463. The direct cost pretransplant was $206 646, $232 893 peritransplant and $74 236 posttransplant. The two largest areas of cost utilization were surgical ($79 625; 38.5%) and nursing ($55 860; 27%), followed by anesthesia ($24 808; 12%) and pharmacy ($16 581; 8%). This study demonstrates that the cost of the first U.S. face transplant is similar to multiple conventional reconstructions. Although the cost of facial transplantation is considerable, the alleviation of psychological and physiological suffering, exceptional functional recovery and fulfillment of long-lasting hope for social reintegration may be priceless.


Abbreviations: 
ATG

anti-thymocyte immunoglobulin

CMV

cytomegalovirus

CPT

current procedural terminology

CTA

composite tissue allotransplantation

ESRD

end-stage renale disease

G-CSF

granulocyte colony stimulating factor

MMF

mycophenolate mofetil

PCP

Pneumocystis carinii jerovici

PCV

pneumococcal vaccine

PTSD

posttraumatic stress disorder

Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

There has been a significant explosion in the field of facial transplantation with 11 occurring within the past 5 years (1–6). Thus, the issues regarding facial transplantation have shifted from successfully performing the procedure to posttransplant implications. While the technical and ethical concerns have been discussed at length, the financial cost has yet to be addressed (7–9). Most of the financial data and experience we have regarding transplants is with respect to solid organs and while hand transplantation may offer an acceptable comparison, it too is in its incipient stages with the longest follow-up limited to 10–12 years in only 10 patients (6). Many of the issues regarding Composite Tissue allotransplantation (CTA) will continue to be debated including: transplantation of a nonlife-saving organ, life-long immunosuppression, psychological implications and societal acceptance (10). However, it may be that the largest impediment to facial transplantation will not be ethical or medical issues, but financial restrictions (11).

There have been no reports thus far describing the actual cost of such a procedure, nor detailing the cost of traditional reconstructive alternatives. Undoubtedly, the questions regarding face transplantation will turn to ‘who is responsible for paying and how?’ These questions are quite relevant considering recent global concern and debate over the cost of health care. For example, Medicare spends an average of $71 000 annually for each individual who is on dialysis compared to a kidney transplant which costs Medicare $106 000 the first year and $17 000 for each additional year. However, Medicare only covers the first 3 years of immunosuppression despite the overwhelming benefit to society and the individual that this service provides. Similarly, it is absolutely necessary to begin comparing the costs and potential benefits of face transplantation as a competitive alternative to conventional reconstructive procedures if it is to become a wide-spread practice. Our experience with the first U.S. face transplant patient provides a unique opportunity to present the cost of conventional reconstructions and face transplantation in a single patient and discuss potential areas of concern.

Materials and Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

Study patient

The patient is a 46-year-old Caucasian female who suffered significant facial trauma following a shotgun blast in September 2004. The Cleveland Clinic IRB had already approved a protocol for composite facial allograft transplantation, but it mandated that only patients who had exhausted all conventional means of reconstruction could be considered as potential candidates as determined by the surgeons and other team members (e.g. ethicists, psychologist, psychiatrist, patient advocate, etc.). This was thought to be necessary to mitigate the trade-off between other viable alternatives and the ethical concerns of life-long immunosuppression for a nonlife threatening condition. Therefore, between 2004 and 2008, the patient underwent 23 separate, traditional reconstructive operations to restore the tri-dimensional anatomical defect and functional deficits (Table 1). Despite exceptional surgical expertise, these attempts resulted in suboptimal aesthetic and functional outcomes (Figure 1A–H). In August of 2008, after 4 years and all conventional surgical alternatives had been exhausted, the patient requested to be considered as a candidate for face transplantation as an alternative reconstructive option with the understanding that it is an experimental procedure. Following a 22-h surgery, the successful face transplant of a gender and age matched brain-dead donor was completed on December 8, 2008 (Figure 1I) (5). The patient has had marked improvement in aesthetics, self-esteem, psychological well-being, pain and function (4,5,12,13).

Table 1.  Timeline of conventional reconstructive procedures before face transplantation
DateProcedure
December 13, 2004Debridement skin, subcutaneous tissue, muscle and bone including entire nonviable maxilla
Right temporalis muscle flap to oral defect
Split calvaria bone grafts for reconstruction of bilateral orbits and nasal bones
Repair comminuted left zygoma fracture
Repair bilateral medial canthal tendon avulsions
Placement of right Medpor temporal fossa implant
Cranioplasty with bone source-defect size 42 cm2
Removal of mandibular area arch bars
Mid facial and maxillary reconstruction using free fibular osteal, septal and cutaneous free tissue transfer with vein
January 10, 2005Left eye tarsorrhaphy
Wound debridement on the open wound of the radix of the nose
Closure of the wound with right paramedian forehead flap
January 14, 2005Left medial canthoplasty, left lateral tarsorrhaphy
February 14, 2005Division and insetting of forehead flap, as well as excision of 5 cm benign cicatrix and closure
Sepetember 12, 2005Facial augmentation of the malar and cheek area with tissue and Alloderm
Correction of bilateral orbital hypoglobus and enopthalmos with titanium Medpor implants
Correction of orbital dystopia as well as mid face augmentation with tissue Alloderm
September 12, 2005Facial augmentation of the malar and cheek area with tissue and Alloderm
Correction of bilateral orbital hypoglobus and enopthalmos with titanium Medpor implants
Correction of orbital dystopia as well as mid face augmentation with tissue Alloderm
November 11, 2005Left upper eyelid gold weight, 1.0 g and Placement of tarsorrhaphy sutures in the left eyelid
April 14, 2006Left full-thickness excision and repair greater than one-quarter.
Left conjunctivoplasty with extensive rearrangement.
Left ear auricular cartilage harvest and placement to left lower lid
Left myocutaneous flap
May 19, 2006Free fibular graft repair
May 22, 2006Left anterolateral thigh free flap to right face as part of a staged reconstructive procedure and placement of dental implant
June 14, 2006Right face wound debridement with closure with 15 cm2 of local tissue rearrangement
January 22, 2007Flap local tissue rearrangement 20 cm2 on the right face to improve the temporal hollowing on the right face
Right facial contouring with suction-assisted lipectomy and thinning of the ALT flap
May 1, 2007Left lower eyelid cryotherapy
December 18, 2007Left orbitotomy with lysis of adhesions, left conj-unctivoplasty with extensive rearrangement.
Left lower eyelid entropion repair, wheeler-type blepharotomy left lower eyelid, auricular cartilage graft.
May 23,2008Left lower eyelid cryotherapy
July 7, 2008Percutaneous endoscopic gastrostomy tube and esophagogastroduodenoscopy
Complex left radial forearm free flap to the face with a complex inset
Exploration of the internal and external carotid artery and jugular vein on the right
Translocated saphenous vein bypass from the external carotid artery to the radial artery via transposed free flap
Local tissue rearrangement of approximately 25 cm2 and these were complicated secondary to multiple previous
microvascular flaps and scar condition secondary to gunshot wound
Partial rhinectomy
Maxilla reconstructions and stabilizations with reconstruction plates and screws
Integra applications to the left forearm donor site
Vacuum dressing placement in the Operating Room
Full-thickness skin graft 4 × 15 equals 60cm2 to the midface
July 23, 2008Application of split-thickness autograft skin measuring 16 × 9 cm to the left forearm
Application of VAC wound drainage system to the left forearm
Incision and drainage of necrotic flap at the mouth with excision of skin and subcutaneous tissue at the upper lip and oral
Application of approximately 30 cm2 of split thickness allograft skin to the upper lip and cheek area
August 1, 2008Closure of the defect at the upper lip and the mouth utilizing local tissue rearrangement techniques of approximately 30 sq.
Creation of moulage for face impression
Wound dressing changes on the left arm
Sepetember 26, 2008Left lower eyelid cryotherapy
image

Figure 1. Pretransplant reconstruction photographs. (A) November 18, 2004; (B) May 3, 2005; (C) November 17, 2005; (D) March 14, 2006; (E) August 24, 2006; (F) March 12, 2007; (G) September 13, 2007; (H) December 3, 2008; (I) 18 months posttransplant.

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Institution

The Cleveland Clinic Foundation is a large, non-for profit, academic quaternary referral center located in Cleveland, Ohio. Its reimbursement is a conglomeration of Medi-care, Medi-caid, private insurance and self-pay.

Data collection

All data was collected between November 18, 2004 and November 27, 2009 with respect to this patient's treatment before and after transplantation at the Cleveland Clinic. Financial data for conventional reconstruction was collected from November 8, 2004 to December 8, 2008 (1491 days), the date of face transplantation. Peritransplant costs included the operation and subsequent hospitalization from December 8, 2008 until discharge on February 5, 2009 (58 days). Posttransplant costs were recorded from the patient's discharge to November 27, 2009 (295 days). The cost incurred for the first U.S. face transplant was calculated using data collected by the Decision Support System, of the Cleveland Clinic.

Primary measures were the combined and direct costs of the patient's initial conventional reconstructions and face transplantation. Direct costs were based on technical and professional costs. Technical costs included supplies, operating room time, nursing care for the patient in the ICU and Transplant Unit, pharmacy costs, laboratory costs and pathology costs for performing the tests and other miscellaneous charges. Professional fees consisted of physician fees for the surgical procedure, laboratory, pathology and anesthesia. Combined costs were calculated by adding the indirect (e.g. overhead costs that include heating and cooling, electricity, security and maintenance) and direct costs. Secondary measures were based on the direct cost values and included inpatient versus outpatient costs, resource utilization by area including anesthesia, surgery, nursing and medication costs, specifically those related to immunosuppression, infection prophylaxis and analgesia. Maintenance immunosuppression cost was also calculated for the life-span of the patient, according to U.S. census data. All monetary values are presented in U.S. dollars ($).

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

Combined cost

The combined cost of multiple reconstructive procedures and face transplantation, for our patient, was calculated to be $353 480 and $349 959, respectively (Figure 2). The net difference in cost between pretransplant reconstruction and face transplantation was $3521, calculated as a 1% relative decrease. The combined cost posttransplant totaled $115 463.

image

Figure 2. Face transplant vs. conventional reconstruction direct and total costs.

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Direct cost

The direct cost pretransplant was $206 646, $232 893 peritransplant and $74 236 posttransplant (Figure 2). The net difference between conventional reconstruction and face transplantation direct costs was $26 247, a net increase of 12.7%. The combined cost of all transplant-related encounters, including peri- and posttransplant, was $307 129. These total costs are the basis for the categorical values recorded below.

In-patient cost

The combined technical and professional inpatient direct cost of all 23 operations, for our patient versus face transplantation was calculated to be $185 634 and $232 893, respectively (Figure 3A). The net difference in cost between pretransplant reconstruction and face transplantation was $47 259. This is a calculated 25.5% relative increase between face transplantation and conventional reconstructions. The direct in-patient posttransplant costs totaled $48 292 (Figure 3A). The patient was admitted pretransplant 9 times for a total of 115 days, once during the peritransplant period for a total of 58 days and eight times posttransplant for a total of 36 days (Figure 3B). The average length of stay pre- and posttransplant was 12.78 (1–46) and 4.5 (1–9) days, respectively (Figure 3B). The average hospitalization cost per day was $1614.21 pre-, $4015.40 peri- and $1341.44 posttransplantation. Indications for posttransplant admissions included: tracheostomy removal, G-tube removal, CMV infection (twice) and neutropenia (four admissions). The most expensive posttransplant admission was the surgical encounter ($9978) followed by concerns for CMV infection and neutropenia ($9035 and $7567, respectively).

image

Figure 3. (A) Direct inpatient and outpatient costs (B) number of admissions and length of stay (LOS).

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Outpatient costs

The patient was seen 77 times pretransplant (i.e. prior to consent) and a total of 73 times posttransplant. The direct pre- and posttransplantation outpatient costs were $21 012 and $25 944, respectively. The calculated average cost per visit pre- and posttransplant was $272.88 and $355.40.

Resource utilization by area

The highest areas of cost for conventional reconstruction were surgical ($79 625; 38.5%), nursing ($55 860; 27%), anesthesia ($24 808; 12%), pharmacy ($16 581; 8%), Pathology/Laboratory ($5826; 2.8%) and other areas. Similarly, surgery and surgical services ($97 811; 42%) and nursing ($45 870; 19.7%) were the highest areas utilized during face transplantation. However, the third highest resource utilized was pharmacy at $38 574 (16.6%) in contrast to $16 581 (8%) during conventional reconstruction. The cost utilization posttransplant was predominantly the pathology/laboratory services (24 892; 35.5%) followed by nursing ($14 742; 19.9%) and pharmacy ($12 256; 16.5%). The direct cost utilization by area and percent of the total direct cost can be found in Figure 4.

image

Figure 4. (A) Direct cost utilization by area, (B) percent of total direct cost by area.

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Medication costs

The total direct cost for immunosuppression was $21 506, with $14 184 being incurred peritransplant and the remaining $7322 accrued posttransplant. The most expensive therapy was antithymocyte immunoglobulin at $8757 (40.7%) followed by granulocyte stimulating factor ($5282; 24.6%), tacrolimus ($5127; 23.8%), mycophenolate mofetil ($2153; 10%) and steroids ($187; 0.9%). The direct cost for infectious prophylaxis was $27 for the pneumococcal (PCV) and influenza vaccines pretransplant, $10 453 peritransplant and $3909 posttransplant for a total of $14 389. The most expensive infection prophylaxis therapy was Voriconazole ($7793), followed by Ganciclovir ($3431) and CMV-Immunoglobulin ($2471). The combined cost of immunosuppression and infectious prophylaxis was $27 pre-, $24 637 peri- and $11 195 posttransplant. The cost of opiate analgesia (including Vicodin, Fentanyl, Dilaudid, Morphine, Oxycodone and Percocet) pretransplant was $1823, peritransplant $740 and $252 posttransplant for a total of $2808 (Figure 5).

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Figure 5. Direct cost of opiate analgesia.

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Acute rejection costs

Within the reported posttransplant period, there was one acute rejection episode on day 47, diagnosed on routine mucosal biopsy demonstrating Banff grade III rejection that resolved within 72 h after a single bolus of 500 mg methylprednisolone (14). The direct cost of this episode including pharmacy and pathology/laboratory services was $1186.50. As the patient was still hospitalized at that time, this cost does not include the hospital stay.

CMV-related costs

Our patient was a CMV sero-negative recipient while the donor was CMV+, thus mandating viral prophylaxis. In addition, there were three episodes representative of CMV infection requiring hospitalization. The first occurred on POD 294 and lasted 2 days, resulting in a direct and total cost of $4849 and $6095, respectively. The second hospitalization occurred on POD 305, and the direct and combined costs totaled $9035 and $14 161, respectively, over 9 days. The direct and combined costs for all CMV-related hospitalizations were $13 884 and $20 526, respectively.

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

We have demonstrated that the initial operative costs incurred from our patient's face transplantation are similar to her previous conventional reconstructions. Surgery and nursing services comprised the bulk of resource utilization by area for our patient's pre- and peritransplant costs. However, as would be expected, pharmacy was a larger contributor to the cost of face transplantation when compared to traditional reconstruction, at more than double (17% vs. 8% of the total cost). While the net direct cost for pharmacological services decreased by $26 318 in the posttransplant period, the percentage of the peri- and posttransplant costs was constant at 16–17% of the total cost. These figures also do not encompass the life-long pharmacological cost. Using data published on kidney and hand transplantation, the average cost per year of immunosuppression can range from $10 000 to $14 000 and $20 000, respectively (10). Therefore, the overall cost for our patient's life-long immunosuppression can be projected to be between $370 000 and $518 000 based on US census data. However, this estimate does not take into account the toll of a massive facial injury, multiple surgeries, or the side effects of immunosuppression and therefore these costs may be overinflated. The combination of increased cost and possible detriment to life expectancy caused by immunosuppression highlights the need for continued investigation into alternative therapies (15). In addition, in our patient, CMV-related costs including prophylaxis, treatment and hospitalizations were significant. Therefore, it may prompt future transplant surgeons to avoid a CMV donor–recipient mismatch, if possible.

However, the cost of face transplantation is not limited to financial dollars and cents but includes risks inherent to operative procedures and immunosuppression. Specific to face transplantation are risks associated with societal acceptance and aesthetic outcome. Given the external location of the graft, patients are more prone to loss of anonymity, health information confidentiality and potential exploitation for financial gain. In addition, graft failure is one of the potential risks of any transplant, but has yet to be described in the literature following face transplantation. Although organs such as the hand and kidney can be removed and the patient temporized until retransplant, the consequences of facial graft loss are unknown, including possible morbidity, mortality and reconstructive options.

Our delineation of the potential cost of face transplantation covers only one arm of the cost-benefit paradigm. Studies have already documented increased quality of life in end-stage renal disease patients following kidney (16,17) and hand transplantation (18,19). Given the face's external location and role in societal acceptance, it is impossible to truly quantify the value of this procedure using monetary means as it has immensely improved our patient's overall quality of life, thus leading to significant reductions in both psychological and physiological anguish.

Another unique aspect specific to face transplantation is that conventional reconstructive techniques require composite, autogenous tissue and therefore have inherent donor-site morbidity (20). It mandates the question of whether these techniques and their attendant morbidity should be the standard choice for the severely disfigured patient. In addition, the time required to complete this process may exceed 3–4 years. During this time the patient is subject to the additional risk of multiple surgeries as well as the psychological impact of a delayed reconstruction. If future studies find that the cost of face transplantation is comparable to conventional methods, the prolonged, reconstructive course and its associated morbidity may make face transplantation the first-line choice in a select group of severely disfigured patients.

Our study is not without limitations due mostly to the lack of available patient data that has been published. We are only privy to our experience with facial transplantation, but this information should be disseminated to allow for an informed debate to begin. A serious concern that will likely come to the forefront of discussion hereafter will center on our decision to perform face transplantation following conventional reconstruction. While it was the aim of our protocol to protect the patient from undue harm, the fact that the transplantation resulted in such superior outcomes and at a comparable cost to conventional reconstruction will undoubtedly call into question this approach. However, when one can justifiably make the decision of foregoing conventional reconstruction for face transplantation is still unknown. Based on our experience, future studies may want to address this issue utilizing an ‘intention to treat’ method into their design given that a large randomized control trial would be very difficult to perform and probably unethical. Also, since our data is based on a single patient with limited follow-up, the life-long cost of facial transplantation cannot be estimated at this point. However, given the extent of transplanted components in our patient during one surgical procedure, it most likely represents the upper end of complexity, resources and cost. In addition, due to the fact that the surgeons were aware of the face protocol, we cannot rule out an unintentional bias against conventional reconstruction methods.

Finally, our experience may not be germane to other patients, countries and institutions, since the cost of health care and quality of life will differ worldwide and will be governed by local traditions, economics and social conditions. Also, since this report describes experience within a single patient, formal statistical cost comparisons cannot be performed. Given these numerous limitations, it is not possible to make objective cost comparisons between conventional reconstruction and face transplantation and any conclusions derived from this study are only speculative.

Conclusion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

To the best of our knowledge this is the first report describing the cost of multiple conventional reconstructions and face transplantation in the same patient. Although many questions remain unanswered regarding the long-term financial and ethical costs, it is imperative to begin addressing these issues. As face transplantation moves further away from the questions of ‘can we?’ or ‘should we?’, the question of fiscal responsibility will soon move into the forefront and may likely become the central issue of the face transplant debate. While we have focused on the financial issues regarding facial transplantation, the alleviation of psychological and physiological suffering, the potential for functional recovery and the renewed hope given to our patient may be considered priceless.

Acknowledgments

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

We would like to sincerely thank Tracy Folger and Cheryl Smith for their continued support and assistance in preparing this manuscript for publication.

Disclosure

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference

The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

Reference

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. Disclosure
  10. Reference