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Facial animation with gracilis muscle transplant reinnervated via cross-face graft: Does it change patients' quality of life?
Accepted Manuscript Facial animation with gracilis muscle transplant reinnervated via cross-face graft: Does it change patients’ quality of life? Bernardo Bianchi, MD, Andrea Ferri, MD, Valentina Poddi, MD, Andrea Varazzani, MD, Giuseppe Pedrazzi, Silvano Ferrari, MD, Enrico Sesenna, MD PII:
S1010-5182(16)30060-9
DOI:
10.1016/j.jcms.2016.05.009
Reference:
YJCMS 2367
To appear in:
Journal of Cranio-Maxillo-Facial Surgery
Received Date: 2 April 2016 Revised Date:
7 April 2016
Accepted Date: 9 May 2016
Please cite this article as: Bianchi B, Ferri A, Poddi V, Varazzani A, Pedrazzi G, Ferrari S, Sesenna E, Facial animation with gracilis muscle transplant reinnervated via cross-face graft: Does it change patients’ quality of life?, Journal of Cranio-Maxillofacial Surgery (2016), doi: 10.1016/j.jcms.2016.05.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Facial animation with gracilis muscle transplant reinnervated via cross-face graft: Does it change patients’ quality of life?
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Bernardo Bianchi, MD; Andrea Ferri, MD; Valentina Poddi, MD; Andrea Varazzani, MD; Silvano Ferrari, MD, Enrico Sesenna, MD: Maxillo-Facial Surgery Division, Head and Neck Department, University Hospital of Parma, Parma, Italy
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Giuseppe Pedrazzi: Department of Neuroscience, University of Parma, Parma, Italy
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Corresponding author: Andrea Ferri, via Gramsci 14; 43100 Parma; Italia. Telphone: +390521703107; +390521703109. Fax: +390521703761.
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e-mail: [email protected]
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Running title: Cross Graft QOL
ACCEPTED MANUSCRIPT Summary
Purpose: Gracilis muscle reinnervated by the contralateral facial nerve via cross-graft technique is nowadays considered to be a first-line procedure for facial animation in
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unilateral palsies. Despite the wide number of papers published analyzing technical
aspects, refinements, functional results, and cosmetic outcomes, only a few authors have focused their publications on the patient’s perspective and impact on QOL of these
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procedures.
Material and Methods: Changes in quality of life in 42 patients treated with gracilis
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muscle transplant reinnervated via cross-face graft were analyzed through a comparison of preoperative and postoperative items on the Facial Disability Index questionnaire. Statistical evaluation with a paired t-test was performed concerning overall results and specific items modifications.
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Results: Overall improvement of QOL was found to be highly significant (p = 0.001). Mouth and eye functions were the most improved (p = 0.001), whereas isolation (p = 0.004) and feeling calm and peaceful (p = 0.001) were the most improved among the
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social functions.
Conclusions: Facial animation with gracilis neuromuscular transplantation reinnervated
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with contralateral healthy facial nerve via a cross-graft procedure has been demonstrated to be a safe and reliable procedure in the treatment of congenital or established facial palsies. Our results on quality of life impact support that these operations are not only reliable and safe but also of primary relevance to patients’ every-day lives.
Key Words: cross-graft; facial animation; facial palsy; quality of life
ACCEPTED MANUSCRIPT INTRODUCTION
Facial palsy is a severe disabling condition that leads to functional and psychological
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impairments that deeply affect patients’ quality of life (QOL). Functionally, incomplete mouth closure and commissural asymmetry cause oral incompetence and difficulties in speaking, while incomplete eye closure results in paralytic lagophtalmos, eye
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discomfort, and sometimes ocular complications. Psychologically, facial disfigurement causes difficulties in social interactions, reduction of self-esteem, and depression.
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In the last 20 years, several efforts have been made by surgeons to treat this condition, and many surgical procedures have been proposed in the international literature for both recent and established or congenital palsies, having as goals the restoration of a spontaneous smile and of facial symmetry and the improvement of functional and
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psychological impairments (Bianchi et al., 2012).
When established (conventionally defined as lasting for more than 18 months) and congenital palsies are approached, neuromuscular transplantations are nowadays
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considered as the gold-standard procedures, and gracilis muscle transplant is the most commonly used technique worldwide (Bhama and Hadlock, 2014). The key point, and
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most debated topic of the procedure, is the selection of the donor nerve for reinnervation of the transplant: contralateral facial nerve via cross-graft technique, masseteric nerve, and combined techniques are the procedures usually performed by the largest majority of authors (Faria et al., 2007). When unilateral forms are treated, in order to achieve a spontaneous activation of the transplanted muscle, the use of contralateral healthy facial nerve via a cross-graft procedure is worldwide considered as the best option in the majority of patients, whereas the masseteric nerve use is usually
ACCEPTED MANUSCRIPT reserved for selected cases including elderly patients, salvage surgeries after previous cross-graft failures, incomplete bilateral palsies when contralateral facial nerve is not completely healthy, or in combination with a cross-graft to provide a dual innervation to
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the transplant (Bianchi et al., 2014). When gracilis muscle re-innervated by the contralateral facial nerve via cross-graft
technique is chosen, results are usually satisfactory, and in our experience this is the
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first-line procedure for facial animation in unilateral palsies.
Despite the wide number of papers published analyzing technical aspects, refinements,
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functional results, and cosmetic outcomes, only a few authors have focused their publications on the patient’s perspective and impact on QOL of these procedures. The aim of the present study is to evaluate the impact on QOL of facial animation with gracilis muscle transplant re-innervated by contralateral healthy facial nerve via cross-
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graft procedure in patients affected by unilateral established or congenital facial palsy, through the administration of QOL Facial Disability Index (FDI) questionnaires
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(Appendix 1).
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MATERIAL AND METHODS
Patients treated for established or congenital unilateral facial palsy with gracilis muscle transplant re-innervated with a cross-graft by the contralateral facial nerve between January 1, 2004, and January 1, 2016 at the Facial Nerve Center (Maxillo-Facial Surgery Division) of the University Hospital of Parma were retrospectively considered. Patients with transplant contraction lasting less than 6 months were considered not yet significant for assessing QOL changes and were therefore excluded from the study. Two
ACCEPTED MANUSCRIPT patients did not complete the postoperative questionnaire and were also excluded. One case of failure in re-innervation of the transplant, later salvaged with a masseter cooptation of the same gracilis, was excluded as well.
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Due to the retrospective nature of the study, institutional review board approval was not required by our institution. The study was conducted written in accordance with the principles of the Declaration of Helsinki.
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The study population consisted of 42 patients, 20 male and 22 female, aging from 6 to 61 years in age (mean age, 33.5 years). Children were assisted by their parents in filling
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out the questionnaire according to methods previously described in the literature for such evaluation in these patients (Lindsay et al., 2014). Of the 42 patients, 23 were affected by congenital unilateral facial palsy (Figures 1 and 2), whereas the remaining 19 had acquired established palsies (Figures 3 and 4). Among the latter, 6 palsies
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developed after acoustic neuroma resection, 6 from Bell’s palsy, 4 from skull base tumor removal, and the remaining 3 consequent to parotid malignancy resections. At the first visit, clinical examination included a specific facial palsy evaluation and FDI QOL
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questionnaire administration.
All of the patients underwent cross-face graft operation followed by gracilis muscle
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transplantation. The cross-graft procedure consisted of isolation of the zygomaticbuccal branch of the healthy facial nerve (through a pre-auricular incision) and the transfer of a sural nerve graft sutured to the selected branch and placed in the upper oral vestibulum (Zuker et al., 2000). Time elapsed between the two procedures ranged from 12 to 18 months (mean 15 months). Evaluation of cross-graft reliability was performed in 40 cases using the Tinel test, whereas in the other 2 cases, when the Tinel result was not clear, a neural biopsy under local anesthesia was performed before gracilis
ACCEPTED MANUSCRIPT transplantation. A second surgical procedure consisted of a gracilis muscle neuromuscular transplant according to the smile surgery procedure described by Harii et al. in 1976 (Harii et al., 1976). After flap insetting and revascularization, the obturatory
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nerve of the flap was sutured to the sural graft placed during the first surgical procedure. Activation of the transplanted muscle was observed after a time ranging between 4 and 11 months (mean 7.5 months). In all cases, activation was spontaneous and synchronous
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with the contralateral healthy side. Of the 42 patients, 31 were also treated for periocular complex rehabilitation with platinum eyelid loading and inferior palpebral
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suspension; 8 underwent minor revision surgery consisting of muscle repositioning (3 cases), adherence removal (3 cases), and fat injection procedures (2 cases). All patient were routinely treated with botulinum toxin injections to improve facial symmetry, with the depressor labii and forehead being the most common target areas.
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Follow-up ranged between 6 and 18 months (mean 12 months), and the QOL FDI questionnaires were administered at the last follow-up clinical examination.
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RESULTS
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Results of preoperative and postoperative questionnaires were compared to assess modifications of patient’s perception of QOL (Table 1). Statistical analysis was performed comparing preoperative and postoperative results normalized using the FDI formula using paired t-test in a statistical database (SPSS 20.0, IBM Inc., Armonk, NY, USA), considering p < 0.05 as statistically significant and p < 0.01 as statistically highly significant. Comparisons were made on overall outcomes and on specific items of the questionnaire, to assess the most and the less modified items.
ACCEPTED MANUSCRIPT Preoperative overall results of 42 QOL questionnaires ranged between scores 19 and 45 with a mean of 29.0. After surgery, scores ranged between 22 and 49, with a mean of 36.55, resulting in a statistically significant improvement (p = 0.001).
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Among the 10 items composing the questionnaire, regarding the first part of the questionnaire (physical function), the most improved was the number 2 (“How much
difficulty did you have drinking from a cup?”), which moved from a mean score of 3.12
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to a mean score of 4.31, resulting in a p value of 0.001 (considered statistically highly significant), and the number 4 (“How much difficulty did you have with your eye
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tearing excessively or becoming dry?”), which moved from a mean score of 2.76 to a mean score of 3.90, resulting in a p value of 0.001. In the second part (social/well-being function), the two parameters that improved the most were number 7 (“How much of the time did you isolate yourself from people around you?”) and number 6 (How much
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time have you felt calm and peaceful?”), with a mean score that moved respectively from 2.31 to 2.86 (p = 0.004) and from 2.86 to 3.48 (p = 0.001). The least improved was item number 9 (“How often did you wake up early or wake up several times during your
DISCUSSION
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nighttime sleep?”) with a p value of 0.017 and mean scores changing from 2.67 to 3.02.
Neuromuscular transplants have drastically changed the perspectives of patients affected by facial palsies: the possibility to restore even a partial function of the inferior third of the face coming back to smile again, improving their appearance at rest, and restoring oral competence, obviously has a great impact on the life of these patients (Ueda et al., 1998). However, as mentioned above, only a few papers in the
ACCEPTED MANUSCRIPT international literature have focused on patient outcomes in terms of improvement of QOL (Ho et al., 2012). On the other hand, because this surgery is quite difficult and is mainly performed in a few highly specialized centers, the majority of previous efforts
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have been focused on consolidation and validation of reliable surgical techniques and evaluation of such results as flap success rates, quantification of movements in degrees, complication rates, and number of procedures performed (Zuker, 2015). Nowadays,
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thanks to these papers, we can consider neuromuscular transplants as safe and reliable procedures if performed in dedicated centers, and we are allowed to move our attention
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to patient perspectives. Therefore, the success of transplantations and good cosmetic results should not still be considered as the main goal of our procedure, which should instead have as a final objective the achievement of a complete social and functional rehabilitation, which must be evaluated not only in our clinics but also based on
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patients’ daily life experiences (Jowett and Hadlock, 2015). This concept is even more relevant, since we deal with patients who are often psychologically frail: those affected by congenital palsies pay the fee of a life with facial impairment, as those affected by
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acquired palsies have to deal with issues related to critical changes in their functions and appearance. For all of these reasons, it seems quite plausible that restoration of
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spontaneous movement of the inferior third of the face will lead to an overall improvement of patients’ QOL, as our p values demonstrate when global preoperative and postoperative scores are compared. At the same time, we found that a complete rehabilitation of these patients that also takes into account ancillary procedures for such neglected areas as the depressor labii, forehead, eyelid (which we usually manage with platinum weights), and peri-orbital complex is mandatory to obtain a high satisfaction rate (Bianchi et al., 2014a; Benichou et al., 2015).
ACCEPTED MANUSCRIPT Another primary consideration is that the possibility of a simultaneous smile with the healthy side and especially under emotional control is really essential for these patients, who could benefit from fast and easy rehabilitation. For this reason, we think that the
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use of contralateral healthy facial nerve as donor nerve for the transplant should be considered as the best option in unilateral palsies, thus avoiding the longer and less
reliable rehabilitation protocols that usually required when other nerves (i.e., masseteric
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nerve) are used (Bhama et al., 2014).
Concerning the first part of the questionnaire (physical function), our results show what
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we expected in relying on clinical examinations: Many of the patients go through a dramatic improvement in their global facial function. Particularly, eating and drinking functions are improved (p < 0.001), thanks to the success of surgery and speech therapy in functional rehabilitation of the lower third of the face with great improvement of oral
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competence. Similarly, eye discomfort, which represents a great part in our patients’ care and is a focus for our ancillary procedures (Bianchi et al., 2014b), is no longer an issue after surgery (p < 0.001), with reduction or even cessation of the use of eye drops
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and eye ointments. This further underlines the importance of complete facial rehabilitation with ancillary procedures, especially those having as their target those
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areas that are not treated with the muscle transplant, such the eye and the peri-ocular complex.
In the second part of the questionnaire (social/well-being function), our analysis shows that restored facial function is also reflected in patients’ social life: They become more confident with both known and unknown individuals, and their feelings about themselves are more favourable (p < 0.001). The acquired ability to express their emotions by smiling spontaneously and to control facial movements allows them to face
ACCEPTED MANUSCRIPT social situations (e.g., eating in restaurants, attending parties, etc.) that were previously thought not to be possible. Question number 9 was shown to be the least improved: Even though the result is statistically significant in the pre- to postoperative
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comparison, this item tends to be scored lower, probably because it is affected by numerous factors that are not necessarily dependent on the paralysis and are therefore less modified after the surgical procedure.
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The major difficulty encountered in this study was the method used to evaluate QOL. In 2004 we started to use the FDI questionnaire in each patient treated for facial palsy in
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our center, because it was one of the first proposed questionnaires in the international literature (Van Swearingen and Brach, 1996; Pavese et al., 2014), and only later did we add the FACE evaluation scale (not considered in this study), as other authors suggest doing today (Kahn et al., 2001; Kleiss et al., 2015). We think that among the
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internationally validated questionnaires, the FDI is the most patient-centered and takes into account only QOL aspects that do not include surgical or clinical evaluations that could bias the patient’s perspective on the value of the final output. However, the
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retrospective design of this study limits some possible further evaluation, such as the observation of the modification of QOL over time, and poses the bias of differences in
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the time elapsed between activation of the muscle and administration of the questionnaire in different patients. On the other hand, because of the relatively small number of patients who needs this surgery, unicentric studies could not expect to overcome these bias completely. It seems important, therefore, to underline that many other studies (ideally with prospective multicentric design) should be performed to assess the real impact of these procedures also in other cultural environments (as our
ACCEPTED MANUSCRIPT series is composed mainly of Italian patients) and to evaluate additional aspects of QOL.
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CONCLUSIONS
Facial animation with gracilis neuromuscular transplantation reinnervated with
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contralateral healthy facial nerve via a cross-graft procedure has been demonstrate to be a safe and reliable procedure in the treatment of congenital or established facial palsies.
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Our results regarding the impact on patient quality of life support that these operations
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are not only reliable and safe but also of primary relevance for patients’ everyday lives.
ACCEPTED MANUSCRIPT Conflict of interest None of the authors have any conflict of interest with this work, including any financial
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interest in any of the products, devices, or drugs mentioned in this manuscript.
ACCEPTED MANUSCRIPT REFERENCES 1. Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA: Clinician-graded electronic facial paralysis assessment: the eFACE. Plast Reconstr Surg
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136:223e-230e, 2015. 2. Benichou L, Labbe D, Le Louarn C, Guerreschi P: Facial palsy sequel and botulinum toxin. Ann Chir Plast Esthet 60:377-92, 2015.
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3. Bhama PK, Hadlock TA: Contemporary facial reanimation. Facial Plast Surg 30:145-51, 2014.
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4. Bhama PK, Weinberg JS, Lindsay RW, Hohman MH, Cheney ML, Hadlock TA: Objective outcomes analysis following microvascular gracilis transfer for facial reanimation: a review of 10 years' experience. JAMA Facial Plast Surg 16:85-92, 2014.
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5. Bianchi B, Ferri A, Sesenna E: Facial animation after nerve sacrifice in the treatment of head and neck cancers. Curr Opin Otolaryngol Head Neck Surg 20:114-9, 2012.
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6. Bianchi B, Copelli C, Ferrari S, Ferri A, Sesenna E: Facial animation in Moebius and Moebius like patients. Int J Oral Maxillofac Surg 39:1066-1073,
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2010.
7. Bianchi B, Ferri A, Ferrari S, Copelli C, Salvagni L, Sesenna E: The masseteric nerve: a versatile power source in facial animation techniques. Br J Oral
Maxillofac Surg 52:264-269, 2014.
8. Bianchi B, Ferri A, Ferrari S, Leporati M, Ferri T, Sesenna E: Ancillary procedures in facial animation surgery. J Oral Maxillofac Surg 72:2582-90, 2014a.
ACCEPTED MANUSCRIPT 9. Bianchi B, Ferri A, Leporati M, Ferrari S, Lanfranco D, Ferri T, Sesenna E: Upper eyelid platinum chain placement for treating paralytic lagophthalmos. J Craniomaxillofac Surg 42:2045-2048, 2014b.
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10. Faria JC, Scopel GP, Busnardo FF, Ferreira MC: Nerve sources for facial reanimation with muscle transplant in patients with unilateral facial palsy: clinical analysis of 3 techniques. Ann Plast Surg 59:87-91, 2007.
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11. Hadlock TA, Malo JS, Cheney ML, Henstrom DK: Free gracilis transfer for smile in children: the Massachusetts Eye and Ear Infirmary Experience in
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excursion and quality-of-life changes. Arch Facial Plast Surg 13:190-4, 2011. 12. Harii K, Ohmori K, Torii S: Free gracilis muscle transplantation, with microneurovascular anastomoses for the treatment of facial paralysis. A preliminary report. Plast Reconstr Surg 57:133-43, 1976.
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13. Ho AL, Scott AM, Klassen AF, Cano SJ, Pusic AL, Van Laeken N: Measuring quality of life and patient satisfaction in facial paralysis patients: a systematic review of patient-reported outcome measures. Plast Reconstr Surg 130:91-9,
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2012.
14. Jowett N, Hadlock TA: A contemporary approach to facial reanimation. JAMA
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Facial Plast Surg 17:293-300, 2015. 15. Kahn JB, Gliklich RE, Boyev KP, Stewart MG, Metson RB, McKenna MJ: Validation of a patient-graded instrument for facial nerve paralysis: the FaCE scale. Laryngoscope 111:387-98, 2001.
16. Kleiss IJ, Hohman MH, Susarla SM, Marres HA, Hadlock TA: Health-related quality of life in 794 patients with a peripheral facial palsy using the FaCE Scale: a retrospective cohort study. Clin Otolaryngol 40:651-6, 2015.
ACCEPTED MANUSCRIPT 17. Lindsay RW, Bhama P, Hadlock TA: Quality-of-life improvement after free gracilis muscle transfer for smile restoration in patients with facial paralysis. JAMA Facial Plast Surg 16:419-24, 2014.
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18. Pavese C, Cecini M, Camerino N, De Silvestri A, Tinelli C, Bejor M, Dalla Toffola E: Functional and social limitations after facial palsy: expanded and
independent validation of the Italian version of the facial disability index. Phys
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Ther 94:1327-36, 2014.
19. Ueda K., Harii K., Asato H., Yamada A. Neurovascular free muscle transfer
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combined with cross-face nerve grafting for the treatment of facial paralysis in children. Plast Reconstr Surg. 1998; 101:1765e-1773e.
20. Van Swearingen J, Brach J: The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular
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system. Phys Ther 76:1288-98; discussion 1298-300, 1996. 21. Zuker RM, Goldberg CS, Manktelow RT: Facial animation in children with Moebius syndrome after segmental gracilis muscle transplant. Plast Reconstr
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Surg 106:1-8; discussion 9, 2000.
22. Zuker RM: Facial paralysis and the role of free muscle transplantation. Ann Chir
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Plast Esthet 60:420-9, 2015.
ACCEPTED MANUSCRIPT Table 1. Statistical evaluation of the results
Paired Differences
Difference
Pair
n
SD
SEM
Lower
Upper
t
df
p
-
.795
.123
-1.295
-.800
-
41
.001
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Mea
41
.001
41
.001
41
.001
41
.001
41
.001
41
.004
41
.002
41
.017
#1.1–#2.1 1.048
Pair
–
8.541
.833
#1.2–#2.2 2
1.190
Pair
–.976 .749 #1.3–#2.3
3 – #1.4–#2.4
.814
4
1.143
Pair
–.667 .721
Pair
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#1.5–#2.5 5
.116
.126
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Pair
.129
–.619 .909
–1.450
–.931
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1
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95% CI of
.111
.140
–1.209
–1.396
–.743
–.889
–
9.258 – 8.451 – 9.103
–.891
–.442
– 5.990
–.902
–.336
–
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#1.6–#2.6 6
Pair
–.548 1.173
4.412 .181
–.913
–.182
–
#1.7–#2.7
7
Pair
–.548 1.087
3.026 .168
–.886
–.209
–
#1.8–#2.8 8 Pair
3.266 #1.9–#2.9
–.357 .932
.144
–.648
–.067
–
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2.482
Pair
#1.10–
–.452 1.131
10
#2.10
Pair
TOT 1–
–
11
TOT 2
7.548
.174
–.805
–.100
–
41
.013
41
.001
2.593 –9.182
–5.913
–
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.809
9.324
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5.246
Abbreviations: df, degrees of freedom; CI, confidence interval; p, p value; SD, standard
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deviation; SEM, standard error of the mean; t, t-test.
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“Pair” refers to items on the Facial Disability Index (FDI) questionnaire.
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Figure 1. Preoperative picture of a 7-year-old patient with congenital unilateral right
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facial palsy at rest (a) and smiling (b).
Figure 2. Postoperative results after gracilis transplant reinnervated via cross-graft in
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patient at rest (a) and smiling (b).
Figure 3. Preoperative picture of a 38-year-old patient with unilateral left facial palsy
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acquired after acoustic neuroma resection at rest (a) and smiling (b).
Figure 4. Postoperative results after gracilis transplant reinnervated via cross-graft at
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rest (a) and smiling (b).
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Appendix 1. Facial Disability Index (FDI).
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S1010-5182(16)30060-9
DOI:
10.1016/j.jcms.2016.05.009
Reference:
YJCMS 2367
To appear in:
Journal of Cranio-Maxillo-Facial Surgery
Received Date: 2 April 2016 Revised Date:
7 April 2016
Accepted Date: 9 May 2016
Please cite this article as: Bianchi B, Ferri A, Poddi V, Varazzani A, Pedrazzi G, Ferrari S, Sesenna E, Facial animation with gracilis muscle transplant reinnervated via cross-face graft: Does it change patients’ quality of life?, Journal of Cranio-Maxillofacial Surgery (2016), doi: 10.1016/j.jcms.2016.05.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Facial animation with gracilis muscle transplant reinnervated via cross-face graft: Does it change patients’ quality of life?
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Bernardo Bianchi, MD; Andrea Ferri, MD; Valentina Poddi, MD; Andrea Varazzani, MD; Silvano Ferrari, MD, Enrico Sesenna, MD: Maxillo-Facial Surgery Division, Head and Neck Department, University Hospital of Parma, Parma, Italy
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Giuseppe Pedrazzi: Department of Neuroscience, University of Parma, Parma, Italy
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Corresponding author: Andrea Ferri, via Gramsci 14; 43100 Parma; Italia. Telphone: +390521703107; +390521703109. Fax: +390521703761.
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e-mail: [email protected]
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Running title: Cross Graft QOL
ACCEPTED MANUSCRIPT Summary
Purpose: Gracilis muscle reinnervated by the contralateral facial nerve via cross-graft technique is nowadays considered to be a first-line procedure for facial animation in
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unilateral palsies. Despite the wide number of papers published analyzing technical
aspects, refinements, functional results, and cosmetic outcomes, only a few authors have focused their publications on the patient’s perspective and impact on QOL of these
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procedures.
Material and Methods: Changes in quality of life in 42 patients treated with gracilis
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muscle transplant reinnervated via cross-face graft were analyzed through a comparison of preoperative and postoperative items on the Facial Disability Index questionnaire. Statistical evaluation with a paired t-test was performed concerning overall results and specific items modifications.
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Results: Overall improvement of QOL was found to be highly significant (p = 0.001). Mouth and eye functions were the most improved (p = 0.001), whereas isolation (p = 0.004) and feeling calm and peaceful (p = 0.001) were the most improved among the
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social functions.
Conclusions: Facial animation with gracilis neuromuscular transplantation reinnervated
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with contralateral healthy facial nerve via a cross-graft procedure has been demonstrated to be a safe and reliable procedure in the treatment of congenital or established facial palsies. Our results on quality of life impact support that these operations are not only reliable and safe but also of primary relevance to patients’ every-day lives.
Key Words: cross-graft; facial animation; facial palsy; quality of life
ACCEPTED MANUSCRIPT INTRODUCTION
Facial palsy is a severe disabling condition that leads to functional and psychological
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impairments that deeply affect patients’ quality of life (QOL). Functionally, incomplete mouth closure and commissural asymmetry cause oral incompetence and difficulties in speaking, while incomplete eye closure results in paralytic lagophtalmos, eye
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discomfort, and sometimes ocular complications. Psychologically, facial disfigurement causes difficulties in social interactions, reduction of self-esteem, and depression.
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In the last 20 years, several efforts have been made by surgeons to treat this condition, and many surgical procedures have been proposed in the international literature for both recent and established or congenital palsies, having as goals the restoration of a spontaneous smile and of facial symmetry and the improvement of functional and
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psychological impairments (Bianchi et al., 2012).
When established (conventionally defined as lasting for more than 18 months) and congenital palsies are approached, neuromuscular transplantations are nowadays
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considered as the gold-standard procedures, and gracilis muscle transplant is the most commonly used technique worldwide (Bhama and Hadlock, 2014). The key point, and
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most debated topic of the procedure, is the selection of the donor nerve for reinnervation of the transplant: contralateral facial nerve via cross-graft technique, masseteric nerve, and combined techniques are the procedures usually performed by the largest majority of authors (Faria et al., 2007). When unilateral forms are treated, in order to achieve a spontaneous activation of the transplanted muscle, the use of contralateral healthy facial nerve via a cross-graft procedure is worldwide considered as the best option in the majority of patients, whereas the masseteric nerve use is usually
ACCEPTED MANUSCRIPT reserved for selected cases including elderly patients, salvage surgeries after previous cross-graft failures, incomplete bilateral palsies when contralateral facial nerve is not completely healthy, or in combination with a cross-graft to provide a dual innervation to
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the transplant (Bianchi et al., 2014). When gracilis muscle re-innervated by the contralateral facial nerve via cross-graft
technique is chosen, results are usually satisfactory, and in our experience this is the
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first-line procedure for facial animation in unilateral palsies.
Despite the wide number of papers published analyzing technical aspects, refinements,
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functional results, and cosmetic outcomes, only a few authors have focused their publications on the patient’s perspective and impact on QOL of these procedures. The aim of the present study is to evaluate the impact on QOL of facial animation with gracilis muscle transplant re-innervated by contralateral healthy facial nerve via cross-
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graft procedure in patients affected by unilateral established or congenital facial palsy, through the administration of QOL Facial Disability Index (FDI) questionnaires
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(Appendix 1).
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MATERIAL AND METHODS
Patients treated for established or congenital unilateral facial palsy with gracilis muscle transplant re-innervated with a cross-graft by the contralateral facial nerve between January 1, 2004, and January 1, 2016 at the Facial Nerve Center (Maxillo-Facial Surgery Division) of the University Hospital of Parma were retrospectively considered. Patients with transplant contraction lasting less than 6 months were considered not yet significant for assessing QOL changes and were therefore excluded from the study. Two
ACCEPTED MANUSCRIPT patients did not complete the postoperative questionnaire and were also excluded. One case of failure in re-innervation of the transplant, later salvaged with a masseter cooptation of the same gracilis, was excluded as well.
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Due to the retrospective nature of the study, institutional review board approval was not required by our institution. The study was conducted written in accordance with the principles of the Declaration of Helsinki.
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The study population consisted of 42 patients, 20 male and 22 female, aging from 6 to 61 years in age (mean age, 33.5 years). Children were assisted by their parents in filling
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out the questionnaire according to methods previously described in the literature for such evaluation in these patients (Lindsay et al., 2014). Of the 42 patients, 23 were affected by congenital unilateral facial palsy (Figures 1 and 2), whereas the remaining 19 had acquired established palsies (Figures 3 and 4). Among the latter, 6 palsies
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developed after acoustic neuroma resection, 6 from Bell’s palsy, 4 from skull base tumor removal, and the remaining 3 consequent to parotid malignancy resections. At the first visit, clinical examination included a specific facial palsy evaluation and FDI QOL
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questionnaire administration.
All of the patients underwent cross-face graft operation followed by gracilis muscle
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transplantation. The cross-graft procedure consisted of isolation of the zygomaticbuccal branch of the healthy facial nerve (through a pre-auricular incision) and the transfer of a sural nerve graft sutured to the selected branch and placed in the upper oral vestibulum (Zuker et al., 2000). Time elapsed between the two procedures ranged from 12 to 18 months (mean 15 months). Evaluation of cross-graft reliability was performed in 40 cases using the Tinel test, whereas in the other 2 cases, when the Tinel result was not clear, a neural biopsy under local anesthesia was performed before gracilis
ACCEPTED MANUSCRIPT transplantation. A second surgical procedure consisted of a gracilis muscle neuromuscular transplant according to the smile surgery procedure described by Harii et al. in 1976 (Harii et al., 1976). After flap insetting and revascularization, the obturatory
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nerve of the flap was sutured to the sural graft placed during the first surgical procedure. Activation of the transplanted muscle was observed after a time ranging between 4 and 11 months (mean 7.5 months). In all cases, activation was spontaneous and synchronous
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with the contralateral healthy side. Of the 42 patients, 31 were also treated for periocular complex rehabilitation with platinum eyelid loading and inferior palpebral
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suspension; 8 underwent minor revision surgery consisting of muscle repositioning (3 cases), adherence removal (3 cases), and fat injection procedures (2 cases). All patient were routinely treated with botulinum toxin injections to improve facial symmetry, with the depressor labii and forehead being the most common target areas.
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Follow-up ranged between 6 and 18 months (mean 12 months), and the QOL FDI questionnaires were administered at the last follow-up clinical examination.
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RESULTS
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Results of preoperative and postoperative questionnaires were compared to assess modifications of patient’s perception of QOL (Table 1). Statistical analysis was performed comparing preoperative and postoperative results normalized using the FDI formula using paired t-test in a statistical database (SPSS 20.0, IBM Inc., Armonk, NY, USA), considering p < 0.05 as statistically significant and p < 0.01 as statistically highly significant. Comparisons were made on overall outcomes and on specific items of the questionnaire, to assess the most and the less modified items.
ACCEPTED MANUSCRIPT Preoperative overall results of 42 QOL questionnaires ranged between scores 19 and 45 with a mean of 29.0. After surgery, scores ranged between 22 and 49, with a mean of 36.55, resulting in a statistically significant improvement (p = 0.001).
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Among the 10 items composing the questionnaire, regarding the first part of the questionnaire (physical function), the most improved was the number 2 (“How much
difficulty did you have drinking from a cup?”), which moved from a mean score of 3.12
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to a mean score of 4.31, resulting in a p value of 0.001 (considered statistically highly significant), and the number 4 (“How much difficulty did you have with your eye
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tearing excessively or becoming dry?”), which moved from a mean score of 2.76 to a mean score of 3.90, resulting in a p value of 0.001. In the second part (social/well-being function), the two parameters that improved the most were number 7 (“How much of the time did you isolate yourself from people around you?”) and number 6 (How much
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time have you felt calm and peaceful?”), with a mean score that moved respectively from 2.31 to 2.86 (p = 0.004) and from 2.86 to 3.48 (p = 0.001). The least improved was item number 9 (“How often did you wake up early or wake up several times during your
DISCUSSION
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nighttime sleep?”) with a p value of 0.017 and mean scores changing from 2.67 to 3.02.
Neuromuscular transplants have drastically changed the perspectives of patients affected by facial palsies: the possibility to restore even a partial function of the inferior third of the face coming back to smile again, improving their appearance at rest, and restoring oral competence, obviously has a great impact on the life of these patients (Ueda et al., 1998). However, as mentioned above, only a few papers in the
ACCEPTED MANUSCRIPT international literature have focused on patient outcomes in terms of improvement of QOL (Ho et al., 2012). On the other hand, because this surgery is quite difficult and is mainly performed in a few highly specialized centers, the majority of previous efforts
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have been focused on consolidation and validation of reliable surgical techniques and evaluation of such results as flap success rates, quantification of movements in degrees, complication rates, and number of procedures performed (Zuker, 2015). Nowadays,
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thanks to these papers, we can consider neuromuscular transplants as safe and reliable procedures if performed in dedicated centers, and we are allowed to move our attention
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to patient perspectives. Therefore, the success of transplantations and good cosmetic results should not still be considered as the main goal of our procedure, which should instead have as a final objective the achievement of a complete social and functional rehabilitation, which must be evaluated not only in our clinics but also based on
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patients’ daily life experiences (Jowett and Hadlock, 2015). This concept is even more relevant, since we deal with patients who are often psychologically frail: those affected by congenital palsies pay the fee of a life with facial impairment, as those affected by
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acquired palsies have to deal with issues related to critical changes in their functions and appearance. For all of these reasons, it seems quite plausible that restoration of
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spontaneous movement of the inferior third of the face will lead to an overall improvement of patients’ QOL, as our p values demonstrate when global preoperative and postoperative scores are compared. At the same time, we found that a complete rehabilitation of these patients that also takes into account ancillary procedures for such neglected areas as the depressor labii, forehead, eyelid (which we usually manage with platinum weights), and peri-orbital complex is mandatory to obtain a high satisfaction rate (Bianchi et al., 2014a; Benichou et al., 2015).
ACCEPTED MANUSCRIPT Another primary consideration is that the possibility of a simultaneous smile with the healthy side and especially under emotional control is really essential for these patients, who could benefit from fast and easy rehabilitation. For this reason, we think that the
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use of contralateral healthy facial nerve as donor nerve for the transplant should be considered as the best option in unilateral palsies, thus avoiding the longer and less
reliable rehabilitation protocols that usually required when other nerves (i.e., masseteric
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nerve) are used (Bhama et al., 2014).
Concerning the first part of the questionnaire (physical function), our results show what
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we expected in relying on clinical examinations: Many of the patients go through a dramatic improvement in their global facial function. Particularly, eating and drinking functions are improved (p < 0.001), thanks to the success of surgery and speech therapy in functional rehabilitation of the lower third of the face with great improvement of oral
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competence. Similarly, eye discomfort, which represents a great part in our patients’ care and is a focus for our ancillary procedures (Bianchi et al., 2014b), is no longer an issue after surgery (p < 0.001), with reduction or even cessation of the use of eye drops
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and eye ointments. This further underlines the importance of complete facial rehabilitation with ancillary procedures, especially those having as their target those
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areas that are not treated with the muscle transplant, such the eye and the peri-ocular complex.
In the second part of the questionnaire (social/well-being function), our analysis shows that restored facial function is also reflected in patients’ social life: They become more confident with both known and unknown individuals, and their feelings about themselves are more favourable (p < 0.001). The acquired ability to express their emotions by smiling spontaneously and to control facial movements allows them to face
ACCEPTED MANUSCRIPT social situations (e.g., eating in restaurants, attending parties, etc.) that were previously thought not to be possible. Question number 9 was shown to be the least improved: Even though the result is statistically significant in the pre- to postoperative
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comparison, this item tends to be scored lower, probably because it is affected by numerous factors that are not necessarily dependent on the paralysis and are therefore less modified after the surgical procedure.
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The major difficulty encountered in this study was the method used to evaluate QOL. In 2004 we started to use the FDI questionnaire in each patient treated for facial palsy in
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our center, because it was one of the first proposed questionnaires in the international literature (Van Swearingen and Brach, 1996; Pavese et al., 2014), and only later did we add the FACE evaluation scale (not considered in this study), as other authors suggest doing today (Kahn et al., 2001; Kleiss et al., 2015). We think that among the
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internationally validated questionnaires, the FDI is the most patient-centered and takes into account only QOL aspects that do not include surgical or clinical evaluations that could bias the patient’s perspective on the value of the final output. However, the
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retrospective design of this study limits some possible further evaluation, such as the observation of the modification of QOL over time, and poses the bias of differences in
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the time elapsed between activation of the muscle and administration of the questionnaire in different patients. On the other hand, because of the relatively small number of patients who needs this surgery, unicentric studies could not expect to overcome these bias completely. It seems important, therefore, to underline that many other studies (ideally with prospective multicentric design) should be performed to assess the real impact of these procedures also in other cultural environments (as our
ACCEPTED MANUSCRIPT series is composed mainly of Italian patients) and to evaluate additional aspects of QOL.
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CONCLUSIONS
Facial animation with gracilis neuromuscular transplantation reinnervated with
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contralateral healthy facial nerve via a cross-graft procedure has been demonstrate to be a safe and reliable procedure in the treatment of congenital or established facial palsies.
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Our results regarding the impact on patient quality of life support that these operations
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are not only reliable and safe but also of primary relevance for patients’ everyday lives.
ACCEPTED MANUSCRIPT Conflict of interest None of the authors have any conflict of interest with this work, including any financial
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interest in any of the products, devices, or drugs mentioned in this manuscript.
ACCEPTED MANUSCRIPT REFERENCES 1. Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA: Clinician-graded electronic facial paralysis assessment: the eFACE. Plast Reconstr Surg
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136:223e-230e, 2015. 2. Benichou L, Labbe D, Le Louarn C, Guerreschi P: Facial palsy sequel and botulinum toxin. Ann Chir Plast Esthet 60:377-92, 2015.
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3. Bhama PK, Hadlock TA: Contemporary facial reanimation. Facial Plast Surg 30:145-51, 2014.
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4. Bhama PK, Weinberg JS, Lindsay RW, Hohman MH, Cheney ML, Hadlock TA: Objective outcomes analysis following microvascular gracilis transfer for facial reanimation: a review of 10 years' experience. JAMA Facial Plast Surg 16:85-92, 2014.
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5. Bianchi B, Ferri A, Sesenna E: Facial animation after nerve sacrifice in the treatment of head and neck cancers. Curr Opin Otolaryngol Head Neck Surg 20:114-9, 2012.
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6. Bianchi B, Copelli C, Ferrari S, Ferri A, Sesenna E: Facial animation in Moebius and Moebius like patients. Int J Oral Maxillofac Surg 39:1066-1073,
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2010.
7. Bianchi B, Ferri A, Ferrari S, Copelli C, Salvagni L, Sesenna E: The masseteric nerve: a versatile power source in facial animation techniques. Br J Oral
Maxillofac Surg 52:264-269, 2014.
8. Bianchi B, Ferri A, Ferrari S, Leporati M, Ferri T, Sesenna E: Ancillary procedures in facial animation surgery. J Oral Maxillofac Surg 72:2582-90, 2014a.
ACCEPTED MANUSCRIPT 9. Bianchi B, Ferri A, Leporati M, Ferrari S, Lanfranco D, Ferri T, Sesenna E: Upper eyelid platinum chain placement for treating paralytic lagophthalmos. J Craniomaxillofac Surg 42:2045-2048, 2014b.
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10. Faria JC, Scopel GP, Busnardo FF, Ferreira MC: Nerve sources for facial reanimation with muscle transplant in patients with unilateral facial palsy: clinical analysis of 3 techniques. Ann Plast Surg 59:87-91, 2007.
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11. Hadlock TA, Malo JS, Cheney ML, Henstrom DK: Free gracilis transfer for smile in children: the Massachusetts Eye and Ear Infirmary Experience in
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excursion and quality-of-life changes. Arch Facial Plast Surg 13:190-4, 2011. 12. Harii K, Ohmori K, Torii S: Free gracilis muscle transplantation, with microneurovascular anastomoses for the treatment of facial paralysis. A preliminary report. Plast Reconstr Surg 57:133-43, 1976.
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13. Ho AL, Scott AM, Klassen AF, Cano SJ, Pusic AL, Van Laeken N: Measuring quality of life and patient satisfaction in facial paralysis patients: a systematic review of patient-reported outcome measures. Plast Reconstr Surg 130:91-9,
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2012.
14. Jowett N, Hadlock TA: A contemporary approach to facial reanimation. JAMA
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Facial Plast Surg 17:293-300, 2015. 15. Kahn JB, Gliklich RE, Boyev KP, Stewart MG, Metson RB, McKenna MJ: Validation of a patient-graded instrument for facial nerve paralysis: the FaCE scale. Laryngoscope 111:387-98, 2001.
16. Kleiss IJ, Hohman MH, Susarla SM, Marres HA, Hadlock TA: Health-related quality of life in 794 patients with a peripheral facial palsy using the FaCE Scale: a retrospective cohort study. Clin Otolaryngol 40:651-6, 2015.
ACCEPTED MANUSCRIPT 17. Lindsay RW, Bhama P, Hadlock TA: Quality-of-life improvement after free gracilis muscle transfer for smile restoration in patients with facial paralysis. JAMA Facial Plast Surg 16:419-24, 2014.
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18. Pavese C, Cecini M, Camerino N, De Silvestri A, Tinelli C, Bejor M, Dalla Toffola E: Functional and social limitations after facial palsy: expanded and
independent validation of the Italian version of the facial disability index. Phys
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Ther 94:1327-36, 2014.
19. Ueda K., Harii K., Asato H., Yamada A. Neurovascular free muscle transfer
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combined with cross-face nerve grafting for the treatment of facial paralysis in children. Plast Reconstr Surg. 1998; 101:1765e-1773e.
20. Van Swearingen J, Brach J: The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular
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system. Phys Ther 76:1288-98; discussion 1298-300, 1996. 21. Zuker RM, Goldberg CS, Manktelow RT: Facial animation in children with Moebius syndrome after segmental gracilis muscle transplant. Plast Reconstr
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Surg 106:1-8; discussion 9, 2000.
22. Zuker RM: Facial paralysis and the role of free muscle transplantation. Ann Chir
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Plast Esthet 60:420-9, 2015.
ACCEPTED MANUSCRIPT Table 1. Statistical evaluation of the results
Paired Differences
Difference
Pair
n
SD
SEM
Lower
Upper
t
df
p
-
.795
.123
-1.295
-.800
-
41
.001
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Mea
41
.001
41
.001
41
.001
41
.001
41
.001
41
.004
41
.002
41
.017
#1.1–#2.1 1.048
Pair
–
8.541
.833
#1.2–#2.2 2
1.190
Pair
–.976 .749 #1.3–#2.3
3 – #1.4–#2.4
.814
4
1.143
Pair
–.667 .721
Pair
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#1.5–#2.5 5
.116
.126
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Pair
.129
–.619 .909
–1.450
–.931
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1
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95% CI of
.111
.140
–1.209
–1.396
–.743
–.889
–
9.258 – 8.451 – 9.103
–.891
–.442
– 5.990
–.902
–.336
–
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#1.6–#2.6 6
Pair
–.548 1.173
4.412 .181
–.913
–.182
–
#1.7–#2.7
7
Pair
–.548 1.087
3.026 .168
–.886
–.209
–
#1.8–#2.8 8 Pair
3.266 #1.9–#2.9
–.357 .932
.144
–.648
–.067
–
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2.482
Pair
#1.10–
–.452 1.131
10
#2.10
Pair
TOT 1–
–
11
TOT 2
7.548
.174
–.805
–.100
–
41
.013
41
.001
2.593 –9.182
–5.913
–
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.809
9.324
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5.246
Abbreviations: df, degrees of freedom; CI, confidence interval; p, p value; SD, standard
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deviation; SEM, standard error of the mean; t, t-test.
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“Pair” refers to items on the Facial Disability Index (FDI) questionnaire.
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Figure 1. Preoperative picture of a 7-year-old patient with congenital unilateral right
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facial palsy at rest (a) and smiling (b).
Figure 2. Postoperative results after gracilis transplant reinnervated via cross-graft in
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patient at rest (a) and smiling (b).
Figure 3. Preoperative picture of a 38-year-old patient with unilateral left facial palsy
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acquired after acoustic neuroma resection at rest (a) and smiling (b).
Figure 4. Postoperative results after gracilis transplant reinnervated via cross-graft at
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rest (a) and smiling (b).
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Appendix 1. Facial Disability Index (FDI).
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