Original Investigation

Subjective and Objective Measures in the Treatment of Hemifacial Spasm With OnabotulinumtoxinA Rao V. Chundury, M.D., M.B.A.*, Alexander S. D’Angelo, B.S.*, Steven M. Couch, M.D.†, and John B. Holds, M.D.*‡§ *Department of Ophthalmology, Saint Louis University; †Department of Ophthalmology and Visual Sciences, Washington University; ‡Ophthalmic Plastic and Cosmetic Surgery, Inc.; and §Department of Otolaryngology/Head and Neck Surgery, Saint Louis University, St. Louis, Missouri, U.S.A.

Purpose: To evaluate the Sunnybrook Facial Grading System (SFGS) and Facial Clinimetric Evaluation (FaCE) Scale Instrument outcomes when treating hemifacial spasm (HFS) with onabotulinumtoxinA. Methods: An Institutional Review Board–approved retrospective review of records of 66 HFS patients treated with onabotulinumtoxinA. SFGS and FaCE surveys were completed prior to onabotulinumtoxinA therapy and at 1 month follow up. Surveys were analyzed for differences using paired Student t tests, with statistical significance set at p < 0.05. Correlations were determined using Spearman correlation (rs), with coefficients of ≥0.40 or ≤−0.40 considered significant. Results: There were 22 complete data sets. SFGS composite score improved from mean, 56.9 (SD, 12.3) to 63.6 (SD, 12.3), p < 0.01. SFGS subdomain synkinesis score significantly improved (p < 0.01). The FaCE scale subdomain oral function significantly worsened (p = 0.05). The ∆ pre-/post-SFGS composite score did not correlate with the ∆ pre-/post-FaCE composite score (rs = 0.24). There was a significant positive correlation between SFGS composite score and FaCE social function score (rs = 0.462, p = 0.03) and between SFGS voluntary movement score and FaCE social function score (rs = 0.477, p = 0.03). Subgroup analysis of single FaCE questions demonstrated no statistical change in subjective dry eye (p = 0.30). Conclusions: There was an improvement in social functioning in treated HFS patients, which positively correlated with improvement in overall objective voluntary facial movement. There was no statistical difference in subjective dry eye symptoms. The overall SFGS composite score improved following treatment of HFS with botulinum toxin. This information can be used when counseling expected outcomes in HFS patients treated with onabotulinumtoxinA. (Ophthal Plast Reconstr Surg 2016;32:133–137)

H

emifacial spasm (HFS) is a peripherally induced movement disorder characterized by clonic and tonic contractions of the facial muscles innervated by the seventh cranial

Accepted for publication January 29, 2015. S.M.C. is a Heed Ophthalmic Fellow and J.B.H. is a Consultant to Allergan and Merz Pharmaceuticals. Remaining authors do not disclose any conflicts of interest. No external support was used for this study. This manuscript was presented as a podium presentation at the 2012 American Society of Ophthalmic Plastic and Reconstructive Surgery 43rd Annual Fall Scientific Symposium in Chicago, Illinois (November 9, 2012). Address correspondence and reprint requests to Rao V. Chundury, M.D., M.B.A., 1755 South Grand Blvd., Cleveland Clinic Cole Eye Institute, 9500 Euclid, MO 44195. E-mail: [email protected] DOI: 10.1097/IOP.0000000000000443

Ophthal Plast Reconstr Surg, Vol. 32, No. 2, 2016

nerve. Compression of the facial nerve at the root exit zone was first described by Campbell and Keedy1 in 1947 as an etiology for HFS. The existence of a dolichoectatic artery compressing the nerve likely serves as the chief etiology of HFS, as described by Jannetta in 1975.2 However, atherosclerosis,1 arteriovenous malformations, aneurysms,3 tumors,4 and peripheral facial injury or prior Bell’s palsy have also been shown to result in HFS.5 Colosimo et al.6 found that at initial presentation over 56% of those with HFS had involvement of the orbicularis oculi muscle. In the same study, it was found that 47% of those with HFS also had facial nerve synkinesis. Synkinesis is a well-known finding in HFS and is thought to be due to ephaptic conduction at the facial nerve compression site.7 Patients with HFS have also been noted to have significant impaired Health-Related Quality of Life scores when compared with controls.8 The treatment for HFS varies greatly from simple application of heating pad to microvascular surgery. Microvascular decompression surgery historically has been the treatment of choice for HFS; however, it carries with it numerous risks, including hearing loss, facial weakness, hydrocephalus, and intracranial hemorrhage.9–12 Therefore, treatment for HFS has now shifted away from microvascular surgery toward therapy with botulinum toxin-A, with onabotulinumtoxinA (BOTOX-Allergan, Irvine, CA, U.S.A.) being used most frequently.13 The ability to grade facial nerve function in HFS is valuable in communicating and documenting the results of any treatment. The Sunnybrook Facial Grading System (SFGS) was first introduced in 1994 by Ross et al.14 (Appendix A). Studies have reported that the SFGS is superior to other scales in sensitivity comprehensiveness, ease of use, and interobserver reliability.15 Kanerva et al.16 evaluated the repeatability (intrarater reliability) and agreement (inter-rater reliability) of SFGS and found that SFGS was as good in repeatability as the House-Brackmann Facial Grading system (HBFG) while having more reliable results in agreement between doctors. It has been noted that patients’ overall perceptions of their facial movements were generally not incorporated into many commonly used facial grading systems.17 In 2001, Kahn et al.17 developed and validated a new patient-graded instrument for facial nerve paralysis called the Facial Clinimetric Evaluation Scale (FaCE Scale). The FaCE scale (Appendix B) demonstrated high test-retest reliability and significant correlation with HBFG scores.17 This study evaluates the SFGS and FaCE Scale Instrument outcome measures pretreatment and 30 days post-treatment of HFS with onabotulinumtoxinA and attempts to correlate the 2 scales.

133

Ophthal Plast Reconstr Surg, Vol. 32, No. 2, 2016

R. V. Chundury et al.

METHODS This study is an Institutional Review Board–approved retrospective review of records of 66 patients diagnosed as having HFS, examined and treated at Ophthalmic Plastic and Cosmetic Surgery, Inc., St. Louis, MO, U.S.A., from May 1, 2010, to May 3, 2012. Medical records of all HFS patients in the authors’ database were carefully reviewed. The treatment protocol initiated in May 2009 at Ophthalmic Plastic and Cosmetic, Inc., involved a pre- and post-SFGS and FaCE survey instruments with any HFS patient being treated using onabotulinumtoxinA injections. At 1 month follow up (post-treatment), the surgeon completed the SFGS and the patient completed a post-treatment FACE questionnaire. Some patients who could not return for the SFGS mailed in the FaCE survey. Patients with myokymia, tardive dyskinesia, and other forms of facial or oromandibular dystonic movements were not routinely evaluated using a facial grading system and were excluded from this study. The demographic data, including sex, age, side of onset, number of treatments, and total treatment units, were documented. SFGS and FaCE scores were tabulated, and data are expressed as mean ± SD. SFGS and FaCE composite, subdomain scores, and selected FaCE questions were compared and correlated with one another. The preand post-treatment scores were analyzed for differences using paired Student t tests, with statistical significance set at p < 0.05. Correlations were determined using Spearman correlation, with coefficients of ≥0.40 or ≤−0.40 and p < 0.05 considered significant. Statistics were calculated using commercially available statistical software (Microsoft Excel; Microsoft Corporation, Seattle, Washington, U.S.A., and PASW Statistics 18; Release 18.0.0, Quarry Bay, Hong Kong).

RESULTS Sixty-six patients met the criteria as described in the Methods section with 120 SFGS surveys and 99 FaCE surveys documented. Of the 66 patients, 22 complete data sets were obtained where all Likert scale items were completed (33% completion rate), 11 (50%) were women and 11 (50%) were men. Sixteen patients were diagnosed with primary HFS, 3 with post-paralytic HFS, and 3 were post-acoustic neuroma resection. The average duration of the disease was 38.4 months (range, 3–168 months). The age of the 22 patients was 67.5 years (range, 42–87 years), the average number of total onabotulinumtoxinA treatments was 13.0 (range, 1–56), and average total cumulative dose was 286.3 units (range, 14–1970 units) as shown in Table 1. All patients received treatments to the upper and lower eyelid orbital and preseptal orbicularis muscle. Eighteen patients required additional treatments to the corrugator muscle, 6 patients to the zygomaticus major, 2 patients to the depressor labii inferioris, and 1 to the platysma. SFGS composite scores and subdomains were calculated, including resting symmetry, symmetry of voluntary movement, and

TABLE 1.  Demographic and clinical features of 22 hemifacial spasm patients treated with onabotulinumtoxinA* Demographic and clinical features Sex  Male  Female Affected side  Right  Left Average age, years Average number of BTX-A treatments Average total cumulative dose, units Average units/treatment

Value 11 11

9 13 67.5 ± 12.2 42–87 13.0 ± 13.5 1–56 286.3 ± 427.3 14–1970 18.9 ± 6.9 8.1–35.2

*Data given as mean ± SD unless otherwise indicated. BTX-A, botulinum toxin-A

134

Range

synkinesis. A statistically significant improvement in the synkinesis subdomain was noted going from a mean value of 8.2 to 2.7 (p < 0.01). SFGS composite score was also found to have improved from 56.9 to 63.6 (p < 0.01). Improvement in SFGS resting symmetry and voluntary movement were not statistically significant and are shown in Table 2. FaCE composite scores and subdomains were calculated, including facial movement (items 1 + 2 + 3), facial comfort (items 4 + 6 + 13), oral function (items 11 + 12), eye comfort (items 5 + 7), lacrimal control (items 8), social function (items 9 + 10 + 14 + 15), and total score (sum of all 15 items). FaCE subdomain oral function significantly decreased from 9.5 to 9.2 (p = 0.05). Subdomain eye comfort decreased but not significantly. FaCE composite score and subdomains facial movement, facial comfort, lacrimal control, and social function improved, but this was not statistically significant as shown in Table 3. Attempt was made to correlate either positively or negatively the SFGS composite/subdomains with the FaCE composite/subdomains. The ∆ pre-/post-SFGS composite score did not correlate with the ∆ pre-/post-FaCE composite score (rs = 0.235). Subdomain analysis demonstrated significant positive correlation between ∆ pre-/post-SFGS composite score and ∆ pre-/post-FaCE social function score (rs = 0.462, p = 0.03) as well between ∆ pre-/post-SFGS voluntary movement score and ∆ pre-/post-FaCE social function score (rs = 0.477, p = 0.03). No other correlations were observed (Table 4). Subgroup analysis was completed on select questions of the FaCE scale which were deemed specific to HFS population subset, including questions 4, 5, 6, 9, 10, 13, and 14 (Appendix B). These questions specifically inquire about facial tightness, dry eye, tension, perception of facial problem, and willingness to participate in social activities. Facial tightness, question 4, statistically improved from 3.2 to 3.7 (p < 0.01) and facial tension, question 13, from 3.0 to 3.5 (p = 0.04). Questions 5, 6, 9, 10, and 14 were not found to be statistically significant, with question 5 inquiring about dry eye. There was no correlation when comparing ∆ pre-/post-SFGS subdomains with ∆ pre-/ post-individual FaCE questions.

DISCUSSION SFGS analysis demonstrates that HFS patients treated with onabotulinumtoxinA had a large and significant improvement in the amount of synkinesis they experienced. Synkinesis improvement contributed largely to the overall improvement in the SFGS composite score. In patients with hemifacial spasm, synkinesis is a well-known clinical sign and is considered to be secondary to ephaptic conduction at the facial nerve compression site.7 Synkinesis can be seen in up to 93% of HFS individuals as detected by electromyography7 and up to 46.7% by physical examination.6 It can be one of the most distressing consequences of hemifacial spasm.18 Previous studies have shown that botulinum toxin is effective in specifically treating postparetic ocular synkinesis.19,20 This study demonstrates the effectiveness of onabotulinumtoxinA therapy for HFS via significant reduction in synkinesis while consequently improving the overall SFGS composite score. The FaCE scale is composed of 15 items evaluating 6 different domains. A positive correlation was expected between the SFGS scale and the FaCE scale; however, the data demonstrated differently. Significant change was only seen in oral function with a resultant decrease in function. Given the action of onabotulinumtoxinA, this was not a completely unexpected result. However, it is noted that there was not an associated significant decrease in the subdomain “facial movement.” The authors suspect that although patients filled the FaCE scale at the time of Botox treatment, there was difficulty in interpreting the questions as it applied to them when completing the posttreatment FaCE scale. Many of the questions in the FaCE scale

© 2015 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.

Ophthal Plast Reconstr Surg, Vol. 32, No. 2, 2016

Subjective Objective Hemifacial Spasm

TABLE 2.  Comparison of SGFS Composite and Subdomain Scores After OnabotulinumtoxinA Treatment in Patients With Hemifacial Spasm* Categories

Pretreatment score Post-treatment score

Resting symmetry Voluntary movement Synkinesis Composite

13.9 ± 2.1 78.9 ± 10.1 8.2 ± 3.0 56.9 ± 12.3

13.0 ± 3.7 79.0 ± 9.6 2.7 ± 2.0 63.6 ± 12.3

p† 0.21 0.81

Subjective and Objective Measures in the Treatment of Hemifacial Spasm With OnabotulinumtoxinA.

To evaluate the Sunnybrook Facial Grading System (SFGS) and Facial Clinimetric Evaluation (FaCE) Scale Instrument outcomes when treating hemifacial sp...
694KB Sizes 5 Downloads 12 Views