International consensus recommendations on face transplantation: A 2-step Delphi study.

Face transplantation is a viable reconstructive approach for severe craniofacial defects. Despite the evolution witnessed in the field, ethical aspects, clinical and psychosocial implications, public perception, and economic sustainability remain the subject of debate and unanswered questions. Furthermore, poor data reporting and sharing, the absence of standardized metrics for outcome evaluation, and the lack of consensus definitions of success and failure have hampered the development of a "transplantation culture" on a global scale. We completed a 2-round online modified Delphi process with 35 international face transplant stakeholders, including surgeons, clinicians, psychologists, psychiatrists, ethicists, policymakers, and researchers, with a representation of 10 of the 19 face transplant teams that had already performed the procedure and 73% of face transplants. Themes addressed included patient assessment and selection, indications, social support networks, clinical framework, surgical considerations, data on patient progress and outcomes, definitions of success and failure, public image and perception, and financial sustainability. The presented recommendations are the product of a shared commitment of face transplant teams to foster the development of face transplantation and are aimed at providing a gold standard of practice and policy.

Enhanced recovery after surgery (ERAS) protocol improves patient outcomes in free flap surgery for head and neck cancer.

BACKGROUND: In recent years, enhanced recovery after surgery (ERAS) guidelines have been developed to optimize pre-, intra-, and postoperative care of surgical oncology patients. The aim of this study was to compare management outcome of patients undergoing head and neck cancer (HNC) surgery with free flap reconstruction at our institution before and after the implementation of the ERAS guidelines. METHODS: This retrospective study comprised 283 patients undergoing HNC surgery with free flap reconstruction between 2013 and 2020. Patients operated before and after the implementation of the ERAS protocol in October 2017 formed the pre-ERAS group (n = 169), and ERAS group (n = 114), respectively. RESULTS: In the pre-ERAS group the mean length of stay (LOS) and intensive care unit length of the stay (ICU-LOS) were 20 days (range 7-79) and 6 days (range 1-32), and in the ERAS group 13 days (range 3-70) and 5 days (range 1-24), respectively. Both LOS (p < 0.001) and ICU-LOS (p = 0.042) were significantly reduced in the ERAS group compared to the pre-ERAS group. There were significantly fewer medical complications in the ERAS group (p < 0.003). No difference was found between the study groups in the surgical complication rate or in the 30-day or 6-month mortality rate after surgery. CONCLUSIONS: We found reduced LOS, ICU-LOS, and medical complication rate, but no effect on the surgical complication rate after implementation of the ERAS guidelines, which supports their use in major HNC surgery.

Costs of oropharyngeal squamous cell cancer treatment in Finland.

BACKGROUND: Oropharyngeal squamous cell carcinoma (OPSCC) can be treated with definitive (chemo)radiotherapy ((C)RT) or primary surgical treatment (PST) with or without postoperative oncologic treatment. The prognosis of OPSCC does not essentially depend on the treatment modality, which allows to consider secondary decision-making aspects such as treatment costs when recommending an individual treatment modality. We attempted to analyze the costs associated with definitive (C)RT and PST in the treatment of OPSCC in Finland. MATERIALS AND METHODS: We included 73 patients diagnosed with OPSCC at the Helsinki University Hospital (HUS) (Helsinki, Finland) in 2019 and 2020. Treatment costs were defined as the costs incurred in the specialized medical care during the first 12 months after the diagnosis was established. RESULTS: Definitive RT and definitive CRT were on a 1-year horizon associated with median costs of approximately 10 700€ and 13 300€, respectively; while, the median costs of PST equaled about 40 600€. The costs of definitive (C)RT mostly consisted of the costs of (chemo)radiotherapy sessions; while, the operating room costs and the costs of intensive care and stay on a ward drove the costs of PST. CONCLUSIONS: PST is associated with 2-3 times higher median costs than definitive (C)RT in Finland. The finding differs from the results previously reported in North America, which is related, e.g., to differences in the treatment practices as well as in the regulation of the health care systems.

Comprehensive outcome analysis in two composite face transplants in Helsinki: Have we succeeded?

INTRODUCTION: There is a need to define what is success after face transplantation (FT). We have previously created a four-component criteria tool to define indications for FT. In this study, we used the same criteria to evaluate the overall outcome of our first two patients after FT. PATIENTS AND METHODS: Preoperative analysis of our two bimaxillary FT patients was compared to the results at four and six years post-transplantation. The facial deficiency impact was divided into four categories: (1) anatomical regions, (2) facial functions (mimic muscles, sensation, oral functions, speech, breathing, periorbital functions), (3) esthetics, and (4) impact on health-related quality of life (HRQoL). Immunological status and complications were also evaluated. RESULTS: For both patients, near-normal anatomical restoration of almost all the facial regions (except the periorbital and intraoral regions) was achieved. The majority of the facial function parameters improved in both patients (patient 2 to a near-normal level). The esthetic score improved from severely disfigured to impaired (patient 1) and to near to normal (patient 2). Quality of life was severely lowered prior to FT and improved after FT but was still affected. Neither patient has experienced acute rejection episodes during follow-up. CONCLUSIONS: We conclude that our patients have benefitted from FT, and we have succeeded. Time will reveal whether we have achieved long-term success.

Facial Expression after Face Transplant: An International Face Transplant Cohort Comparison.

BACKGROUND: Assessment of motor function restoration following face transplant (FT) is difficult, as standardized, bilateral tests are lacking. This study aims to bolster support for software-based analysis through international collaboration. METHODS: FaceReader (Noldus, Wageningen, The Netherlands), a facial expression analysis software, was used to analyze posttransplant videos of eight FT patients from Boston, Massachusetts (range, 1 to 9 years after transplant), two FT patients from Helsinki, Finland (range, 3 to 4 years after transplant), and three FT patients from Antalya, Turkey (range, 6.5 to 8.5 years after transplant). Age-matched healthy controls from respective countries had no history of prior facial procedures. Videos contained patients and controls performing facial expressions evaluated by software analysis using the Facial Action Coding System. Facial movements were assigned intensity score values between 0 (absent) and 1 (fully present). Maximum values were compared with respective healthy controls to calculate percentage restoration. RESULTS: Of 13 FT patients, eight patients were full FT, five patients were partial FT, and two patients were female patients. Compared with healthy controls, the median restoration of motor function was 36.9% (interquartile range, 28.8% to 52.9%) for all patients with FT ( P = 0.151). The median restoration of smile was 37.2% (interquartile range, 31.5% to 52.7%) for all patients with FT ( P = 0.065). When facial nerve coaptation was performed at the distal branch level, average motor function restoration was 42.7% ± 3.61% compared with 27.9% ± 6.71% at the proximal trunk coaptation level ( P = 0.032). Use of interpositional nerve grafts had no influence on motor outcomes. CONCLUSIONS: Software-based analysis is suitable to assess motor function after FT. International collaboration strengthens outcome data for FT. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Risk factors for evaluating early mortality after microvascular reconstruction of head and neck cancers.

BACKGROUND: Free tissue transfer reconstruction carries significant complication rates in surgical head and neck oncology. A registry-based approach offers a possibility to investigate the factors affecting increased morbidity and early mortality, that is, death within 6 months of treatment. METHODS: A retrospective registry review was conducted on a series of 317 consecutive microvascular free tissue transfers in head and neck cancer patients performed during 2013-2017 at the Helsinki University Hospital (Helsinki, Finland). All surviving patients had a minimum follow-up of 2 years (range 24-84 months). RESULTS: Overall, 36 (11.4%) early deaths occurred in this series. In multivariable logistic regression analysis, patients aged 75 years and older (p = 0.019), Adult Comorbidity Evaluation-27 (ACE-27) score of 3 (p = 0.048), tumor class T3 (p = 0.005), lymph node class N2 (p = 0.014), or thrombocyte count of 360 (× 109 L) or more (p = 0.001) were more likely to die within 6 months of surgery. Of these 36 patients, 27 (75%) had a complication warranting hospital care and most (n = 22, 61%) had several complications. CONCLUSIONS: Early postoperative mortality most frequently affects patients aged 75 years and above, with a high ACE-27 score, advanced tumor stage, or high thrombocyte count. Therefore, preoperative assessment and patient selection should have a crucial role in this patient population.

Carotid interposition in patients with head and neck tumors: clinical experience of 13 cases reconstructed with a great saphenous vein autograft.

BACKGROUND: Carotid interposition graft (CIG) surgery in the setting of head & neck cancer (HNC) is a rare procedure with a limited number of cases described in the literature. AIMS/OBJECTIVES: To assess the outcomes of the surgery at Helsinki University Hospital. MATERIALS AND METHODS: Patients who underwent CIG in a head and neck tumor surgery were retrospectively analyzed over 15 years. Overall-survival (OS) was calculated until 1 May 2020. The primary-outcome was to measure the 30-day OS, postoperative stroke rate, and other complications. The secondary-outcome was to measure 1-, 2-, and 5-year OS. RESULTS: Thirteen patients were identified, 11 with HNC and two with Shamblin III Carotid Body Tumors. The great saphenous vein was used for all vascular reconstructions, and shunting was routinely performed. The 30-day stroke incidence was nil. Two graft-blowouts were encountered, one of which lead to death and the other was successfully managed. For HNC patients, the locoregional recurrence-rate was 36%. The 5-year OS was 46.2%. CONCLUSION AND SIGNIFICANCE: CIG in HNC setting can achieve oncologic-control with an acceptable rate of complications. Routine shunting, heparinization, and elevating blood-pressure during closure seem to be safe protocols to maintain cerebral-circulation perioperatively. A moderate graft-blowout risk should be considered.

Cytomegalovirus-related Complications and Management in Facial Vascularized Composite Allotransplantation: An International Multicenter Retrospective Cohort Study.

BACKGROUND: There is a paucity of data on the impact of cytomegalovirus (CMV) serostatus and CMV infection on outcomes in facial vascularized composite allotransplantation. METHODS: This international, multicenter, retrospective cohort study presents data on CMV and basic transplant-related demographics, including pretransplant viral D/R serostatus, and duration of antiviral prophylaxis. CMV-related complications (viremia, disease), allograft-related complications (rejection episodes, loss), and mortality were analyzed. RESULTS: We included 19 patients, 4 of whom received CMV high-risk transplants (D+/R-). CMV viremia was noted in 6 patients (all 4 D+/R- patients and 2 D-/R+), mostly within the first-year posttransplant, shortly after discontinuation of antiviral prophylaxis (median 2 mo). CMV disease occurred in 2 D+/R- patients. The high-risk group experienced relatively more rejection episodes per month follow-up. None of D+/R- patients suffered allograft loss due to rejection (longest follow-up: 121 mo). CONCLUSIONS: D+/R- patients were at increased risk of CMV-related complications. Although a higher number of rejections was noted in this group, none of the D+/R- patients lost their allograft or died because of CMV or rejection. Thus, CMV D+/R- face transplantation can likely be safely performed with prophylaxis, active surveillance, and prompt treatment.

Validation of the Finnish FACE-Q for use in patients undergoing surgery for functional problems or malignancy.

The aim of this study was to produce a Finnish version of the FACE-Q scales Satisfaction with Forehead and Eyebrows, Adverse effects: Forehead, Eyebrows and Scalp, and Adverse effects: Cheeks, Lower face and Neck, and assess the performance of these scales and the Satisfaction with Facial Appearance, Satisfaction with Outcome and Appearance-related Psychosocial Distress in patients who had undergone surgery for functional problems or malignancy affecting the forehead or cheeks. The general health-related outcomes instrument 15 D was used as a reference. Patients who had undergone a frontal lift, a direct brow lift, a facelift or an excision of a facial tumor in Helsinki University Hospital plastic surgery department in 2009-2019 were identified. A postal survey study was conducted with 305 patients, of whom 135 (44%) responded. Diagnoses included facial nerve dysfunction (53%), brow ptosis (21%) and skin, mucosal or salivary gland tumor (20%). The FACE-Q scales displayed high internal consistency (Cronbach's alphas ≥0.80) and good reliability on repeat administration. The exploratory factor analysis revealed unifactorial influences for all scales except the Adverse effects: Forehead, Eyebrows and Scalp. Weak correlations with 15 D dimensions were detected. The FACE-Q scales evaluated here are suitable for use in patients with functional problems or malignancy.

The four category systematic approach for selecting patients for face transplantation.

There is a need for a systematic approach to evaluate patients for potential face transplantation (FT). Ten patients with severe facial defects treated between 1995 and 2017 formed the study group. Data was collected from patient charts and clinical, radiological and laboratory examinations. Facial deficiencies were subdivided into four different categories: anatomical region (10 facial subunits), facial function, aesthetic defect (range 0-9-worst), and impact on health-related quality of life (HRQoL) (15D questionnaire, range 0-1). Immunological status and possible contraindications were also evaluated. Defect aetiology consisted of burns (4), ballistic injury (3), blunt injury (1), blast injury (1), and neurofibromatosis type I (1). All patients had central facial deficiencies and 6 patients had 8 to 10 injured facial subunits. All patients had at least partial loss of facial function. The mean aesthetic disfigurement score was 6.4. The median lowering of 15D score was -0.107. None were significantly sensitized although four patients had relative contraindications and one patient had an absolute contraindication for FT. Three patients with a severe overall facial deficiency were considered as potential FT candidates. We herein propose a comprehensive and systematic tool to evaluate potential candidates for FT. This approach includes assessment of 4 key categories: anatomical regions affected, facial function, aesthetics, and HRQoL.

The Second Helsinki Face Transplantation and the World Experience of Revision Surgery During the First Posttransplantation Year.

INTRODUCTION: We conducted a review of all surgical interventions performed during the first postoperative year in published face transplantation (FT) cases. In addition, we herein present our second FT patient, a full-face composite FT with an emphasis on surgical revisions after transplantation. MATERIALS AND METHODS: A literature review was conducted and resulted in 376 publications of which 33 included reference to surgical interventions during the first post-FT year. For our second FT patient, a thorough review of all medical records was performed. RESULTS: Among the first 41 FTs, 32 FT patients had reports with reference to corrective surgery during the first year (22 composite and 10 soft-tissue FTs). Soft-tissue FTs had a median of 2 procedures (range, 1-8 procedures), and composite FTs, 3 procedures per patient (range, 1-9 procedures). Nearly all early interventions (<1 month) were performed in composite FT patients (anastomotic occlusion, hematoma, sialocele, palatinal dehiscence). The most common late interventions were scar corrections, tissue suspensions, periorbital corrections, osseal and dental procedures, and interventions for palatinal dehiscence and sialocele. Our second FT patient has recovered well and has undergone 3 surgical interventions during the first year. CONCLUSIONS: Surgical interventions are very common during the first postoperative year after FT, and composite FTs are more prone to complications necessitating surgical intervention than soft-tissue FTs. There is a wide variety of complications reflecting the heterogeneity of FT allografts. Corrective surgery in FT patients appears safe with only a few reported complications.

Virtual 3D planning and prediction accuracy in two bimaxillary face transplantations in Helsinki.

BACKGROUND: The aim of this study was to describe the 3D planning process used in our two composite face transplantations and to analyze the accuracy of a virtual transplantation in predicting the end-result of face transplantation. METHODS: The study material consists of two bimaxillary composite face transplantations performed in the Helsinki University Hospital in 2016 and 2018. Computed tomography (CT) scans of the recipient and donor were used to define the osteotomy lines and perform the virtual face transplantation and to 3D print customized osteotomy guides for recipient and donor. Differences between cephalometric linear and angular measurements of the virtually simulated and the actual postoperative face transplantation were calculated. RESULTS: No changes to the planned osteotomy lines were needed during surgery. The differences in skeletal linear and angular measurements of the virtually simulated predictions and the actual postoperative face transplantations of the two patients varied between 0.1-5.6 mm and 0.7°-4°. The postoperative skeletal relationship between maxilla and mandible in both patients were almost identical in comparison to the predictions. CONCLUSIONS: 3D planning is feasible and provides close to accurate bone reconstruction in face transplantation. Preoperative virtual transplantation assists planning and improves the outcome in bimaxillary face transplantation.

Speech Characteristics and Oromyofunctional Outcomes in Two Bimaxillary Face Transplantation Patients in Helsinki.

OBJECTIVES/HYPOTHESIS: Facial functional restoration is one of the main goals in face transplantation. We report the oromyofacial function outcomes of two bimaxillary face transplantation (FT) patients in Helsinki. STUDY DESIGN: Outcome Study. METHODS: Two male patients, aged 34 and 59, had severe functional facial disabilities following self-inflicted gunshot injuries sustained to their mid and lower faces several years earlier. Both underwent tooth-bearing maxillomandibular face transplantation in 2016 and 2018. We collected data regarding speech, swallowing, sensory recovery, motor recovery, and olfaction prior to transplantation. Patient charts were reviewed from the follow-up period of 4 and 2 years, respectively. RESULTS: Speech intelligibility, acceptability, and articulation continued to improve during follow-up for both patients. Voice quality and resonance were mainly normal at last follow-up. Swallowing improved once lip occlusion was regained, with only minor aspiration evident on videofluorography. Both patients had significant improvement in facial mimic muscle function after FT. The first patient who only had buccal sensory nerves connected has only recovered protective facial sensation, whereas our second patient with buccal, infraorbital, and alveolar nerves connected has almost complete facial two-point discrimination. CONCLUSION: Both patients have regained satisfactory facial sensory and motor function. Sensory recovery seems to be faster and more precise if multiple sensory nerve coaptations are performed. Swallowing and speech have continued to improve over time although not reaching the level of the normal population. We demonstrate how speech-corrective surgery can safely be performed in a FT patient and can improve speech recovery. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2643-E2649, 2021.

Application of the FACE-Q rhinoplasty module in a mixed reconstructive and corrective rhinoplasty population in Finland.

The FACE-Q Rhinoplasty module is a patient-reported outcome instrument developed for the assessment of primarily aesthetic outcomes of rhinoplasty. The aim of our study was to produce a Finnish version of the instrument and validate it for use in patients undergoing nasal reconstruction as well as those treated with a rhinoplasty. Finnish versions of the FACE-Q scales Satisfaction with Nose, Satisfaction with Nostrils and Adverse Effects: Nose, were translated following established guidelines. Patients undergoing nasal resection, reconstruction or rhinoplasty in Helsinki University Hospital plastic surgery department in 2009-2019 were identified using theatre records. A total of 240 Finnish-speaking patients 18-85 years old were approached with a postal survey questionnaire. The questionnaire included the translated FACE-Q modules and those for Satisfaction with Facial Appearance, Appearance-Related Psychosocial Distress and Satisfaction with Outcome, as well as the general health-related quality of life instrument 15 D. The FACE-Q scales translated readily to Finnish. Eighty-three patients (35%) responded to the survey. Most FACE-Q scales performed well with high internal consistency (Cronbach's alphas 0.87-0.92) and repeatability. Only the Adverse Effects: Nose scale displayed poor consistency and a floor effect with 18% of the patients reporting no adverse outcomes. Answers to the Appearance-Related Psychosocial Distress scale were skewed towards no experienced stress. Answers to the other scales were normally distributed with weak correlation with 15 D dimensions. The Finnish translations of the FACE-Q Rhinoplasty scales perform well at assessing a diverse group of patients including those undergoing nasal reconstruction as well as those undergoing rhinoplasty.

Oral findings and treatment of patients with face transplants in Helsinki.

OBJECTIVES: Oral health and balanced occlusion are important aspects of a well-functioning face transplant. This study describes the oral and dental status, dental management, and sialoendoscopy of the first 2 patients in Helsinki who underwent face transplantations. STUDY DESIGN: Two patients received near-full face transplantations in 2016 and 2018, respectively. The transplanted tissues included a Le Fort type II maxilla, angle-to-angle mandible, all oral mucosa, ventral tongue tissue, and the muscles of the floor of the mouth. Comprehensive oral examinations and all required dental treatment, including follow-up examinations, were performed for both patients after the transplantations. RESULTS: Both patients rehabilitated well, and their quality of life improved. Stable, functioning dentition and occlusion were achieved for both patients. Hyposalivation and dental caries were issues for both patients. Patient 1 also experienced infections in the jaws. Implants were placed in the transplanted jaws of patient 2 with successful osseointegration. CONCLUSIONS: We report successful tooth-bearing face transplantations in 2 patients. Patient selection, particularly regarding oral health, is crucial in avoiding posttransplantation complications. Moreover, the oral and dental status of the donor should be examined by a dentist before transplantation, and regular follow-up dental examinations should be performed after transplantation.

Finnish translation and validation of the FACE-Q Eye module.

BACKGROUND AND OBJECTIVE: The aim of this study was to first produce and cross-culturally validate a Finnish version of the FACE-Q Eye module, a patient-reported outcome measure designed for patients undergoing eyelid surgery for esthetic reasons, and second assess the suitability of this instrument for use in a university hospital setting. METHODS: The FACE-Q Eye module and the general FACE-Q components Satisfaction with Facial Appearance, Appearance-Related Psychosocial Distress, and Satisfaction with Outcome were translated according to established guidelines. A postal survey study was conducted with the translated instrument and the generic health-related quality of life instrument 15D on 245 patients operated in the Helsinki University Hospital between 2009 and 2019. Cronbach's alpha, floor and ceiling effects, measurement reliability with repeat administration, and convergence with 15D dimensions were analyzed. RESULTS: The FACE-Q Eye module and general components translated readily into Finnish. Eighty-one patients (33%) responded to the survey, most of whom (78%) had undergone blepharoplasty. Most subscales demonstrated acceptable internal consistency with Cronbach's alphas 0.79-0.96. A ceiling effect was observed for four of the seven subscales evaluated. Intra-class correlation coefficients were high (0.82-0.91) indicating good reliability. Results of the FACE-Q subscales correlated at best moderately with the 15D dimensions. CONCLUSIONS: The Finnish versions of the FACE-Q Eye module and the FACE-Q components Satisfaction with Facial Appearance, Appearance-Related Psychosocial Distress, and Satisfaction with Outcome perform well when assessing outcomes relevant to patients after eyelid surgery. However, when used in patients operated on for mainly functional reasons, subtle variations may be missed.