Assessment of pain relief after four botulinum toxin A injection cycles in patients with post-stroke lower limb spasticity: A prospective, observational study.

INTRODUCTION: Spasticity is common after a stroke and is an independent risk factor for developing pain. BotulinumtoxinA injection is the treatment of choice for focal spasticity. We examined the effect of intramuscular botulinumtoxinA on pain relief in patients in routine clinical practice who were experiencing pain as a primary complaint associated with post-stroke lower limb spasticity. METHODS: Prospective, multicentre, post-marketing observational study. The study period was 16 months. The primary effectiveness variable was the mean change from baseline on the pain 0-10 Numerical Rating Scale after four botulinumtoxinA injection cycles. Secondary endpoints included changes from baseline on the pain 0-100 Visual Analogue Scale, Goal Attainment Scale, modified Ashworth Scale, 10-Meter Walk Test, Penn Spasm Frequency Scale, and 36-item Short-Form Health Survey. RESULTS: Of 186 enrolled patients, 180 (96.8%) received botulinumtoxinA at least once. The mean (standard deviation) pain 0-10 Numerical Rating Scale score decreased significantly (p<0.0001) from 4.9 (2.2) at baseline to 2.5 (2.1) at study end, representing a 50% decrease in pain severity. Relief of pain due to spasticity was supported by improvement from baseline in all secondary variables except the 10-Meter Walk Test. Two adverse events (erysipelas and phlebitis) in one patient were considered likely to be related to botulinumtoxinA injection. CONCLUSION: BotulinumtoxinA appears to provide pain relief as an additional benefit of local treatment in patients with post-stroke lower limb spasticity for whom pain relief is a primary therapeutic goal (a Lay Abstract has been provided as Appendix A).

Comprehensive Assessment of the Time Course of Biomechanical, Electrophysiological and Neuro-Motor Effects after Botulinum Toxin Injections in Elbow Flexors of Chronic Stroke Survivors with Spastic Hemiplegia: A Cross Sectional Observation Study.

Botulinum neurotoxin (BoNT) is commonly used to manage focal spasticity in stroke survivors. This study aimed to a perform comprehensive assessment of the effects of BoNT injection. Twelve stroke subjects with spastic hemiplegia (age: 52.0 ± 10.1 year; 5 females) received 100 units of BoNT to the spastic biceps brachii muscles. Clinical, biomechanical, electrophysiological, and neuro-motor assessments were performed one week (wk) before (pre-injection), 3 weeks (wks) after, and 3 months (mons) after BoNT injection. BoNT injection significantly reduced spasticity, muscle strength, reflex torque, and compound muscle action potential (CMAP) amplitude of spastic elbow flexors (all p < 0.05) during the 3-wks visit, and these values return to the pre-injection level during the 3-mons visit. Furthermore, the degree of reflex torque change was negatively correlated to the amount of non-reflex component of elbow flexor resistance torque. However, voluntary force control and non-reflex resistance torque remained unchanged throughout. Our results revealed parallel changes in clinical, neurophysiological and biomechanical assessment after BoNT injection; BoNT injection would be more effective if hypertonia was mainly mediated by underlying neural mechanisms. BoNT did not affect voluntary force control of spastic muscles.

Botulinum Toxin Injection for the Treatment of Strabismus: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the available evidence comparing the effectiveness of extraocular muscle botulinum toxin type A (BTXA) injection with eye muscle surgery for restoring ocular alignment in children and adults with nonparalytic, nonrestrictive horizontal strabismus. METHODS: Literature searches in the PubMed Cochrane Library, and clinical trial databases with no date restrictions, but limited to articles published in English, were conducted last on January 10, 2021. The searches yielded 515 citations, 40 of which were reviewed in full text by the first author. Fourteen articles met the criteria for inclusion (randomized or nonrandomized comparative studies, or case series with a minimum 50 patients; evaluating extraocular muscle BTXA injection for initial or repeat treatment of horizontal, nonparalytic, nonrestrictive strabismus; with at least 6 months of follow-up) and were graded by a methodologist. RESULTS: The 14 included studies consisted of 2 randomized clinical trials, 3 nonrandomized comparative studies, and 9 case series. All 5 comparative studies were graded level II evidence, and the 9 case series were graded level III evidence. Successful motor outcomes after BTXA injection were relatively consistent across 4 of the 5 comparative studies at 60%, when adjustment was made for differential selection bias in 1 of the studies. In the 4 studies, successful motor outcomes after surgery ranged from 66% to 77% with a mean follow-up of 23 to 75 months, and the outcomes were not significantly different from those after BTXA injection. In the fifth level II study, success was significantly higher with BTXA injection than with surgery (94% vs. 72%). The level III BTXA case series demonstrated higher motor success rates of 87% to 89% when children were treated in 2 muscles at a time; rates were lower in adults treated with single-muscle BTXA injection. CONCLUSIONS: Extraocular muscle injection of BTXA achieves a high rate of successful motor alignment, comparable with that achieved after eye muscle surgery for nonparalytic, nonrestrictive horizontal strabismus. Good alignment may require multiple BTXA injections, and it is not yet clear whether sensory outcomes are equivalent for BTXA injections versus eye muscle surgery in young children.

Comparison of botulinum toxins for treatment of movement disorders: real-world utilization and cost analysis in a national Medicare population.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) is the single largest payer for health care in the United States and the largest payer by spending globally. Medicare Part B, with more than 50 million beneficiaries, currently has no broad mechanisms in place for promoting cost-effective care of injectable drugs. OBJECTIVE: To conduct a real-world utilization and cost analysis comparing botulinum toxins in movement disorders. METHODS: The 2017 Medicare Provider Utilization and Payment Data: Physician and Other Supplier dataset from CMS was used for this claims level analysis. Neurologists, ophthalmologists, or physiatrists who injected predominantly for movement disorders (defined as blepharospasm, cervical dystonia, sialorrhea, and/or spasticity) were included along with their patients. Botulinum toxins with FDA indications spanning these 3 specialties were included. RESULTS: A total of 891 physicians (406 ophthalmologists, 338 neurologists, and 147 physiatrists) along with their 29,954 botulinum toxin (27,441 onabotulinumtoxinA and 2,513 incobotulinumtoxinA) patients were included in the analysis. The average total drug cost per patient per year (PPPY) was significantly lower for incobotulinumtoxinA versus onabotulinumtoxinA ($2,099 vs. $3,115; P < 0.001), for an average savings of 32.6%. Annual average out-of-pocket costs were also significantly less expensive for incobotulinumtoxinA versus onabotulinumtoxinA ($486 vs. $719; P < 0.001), for an average savings of 32.4%. Across 74,346 total injection visits, there was no significant difference in dosing between the agents, with an average dosing ratio of 0.94 incobotulinumtoxinA to 1.0 onabotulinumtoxinA. Injections PPPY were 2.42 for onabotulinumtoxinA and 2.29 for incobotulinumtoxinA. Average reported wastage was 64% higher for onabotulinumtoxinA than it was for incobotulinumtoxinA. A budget impact analysis estimated that increasing incobotulinumtoxinA use in the movement disorder space to attain an overall 20% botulinum toxin market share would save Medicare $32.9 million over a 3-year period versus current use. CONCLUSIONS: IncobotulinumtoxinA was shown to be a less costly alternative than onabotulinumtoxinA with similar dosing in real-world practice in this large national Medicare population. Policies to increase use of agents that promote cost-effective evidence-based care should be further explored and implemented for this fundamental federal payer. DISCLOSURES: This research received no external funding. Kazerooni was an employee of Merz Pharmaceuticals at the time of the analysis. Watanabe received no compensation or funding for this research project. Watanabe is a member of the National Academies of Sciences, Engineering, and Medicine Forum on Drug, Discovery, Development, and Translation. This information, content, and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by the U.S. government or the National Academies of Sciences, Engineering.

Assessment of Botulinum Neurotoxin Injection for Dystonic Hand Tremor: A Randomized Clinical Trial.

Importance: There is an unmet need for safe and efficacious treatments for upper-extremity dystonic tremor (DT). To date, only uncontrolled retrospective case series have reported the effect of botulinum neurotoxin (BoNT) injections on upper-extremity DT. Objective: To assess the effect of BoNT injections on tremor in patients with upper-extremity DT. Design, Setting, and Participants: In this placebo-controlled, parallel-group randomized clinical trial, 30 adult patients with upper-extremity DT treated at a movement disorder clinic in a tertiary care university hospital were randomized in a 1:1 ratio to BoNT or saline injection, 0.9%, using a computer-generated randomization sequence. Randomization was masked using opaque envelopes. The participant, injector, outcome assessor, and statistician were blinded to the randomization. Participants were recruited between November 20, 2018, and December 12, 2019, and the last follow-up was completed in March 2020. Interventions: Participants received electromyographically guided intramuscular injections of BoNT or placebo into the tremulous muscles of the upper extremity. Injection patterns and doses were individualized according to tremor phenomenologic findings. Main Outcomes and Measures: The primary outcome was the total score on the Fahn-Tolosa-Marin Tremor Rating Scale 6 weeks after the intervention. Outcomes were assessed at baseline, 6 weeks, and 12 weeks. All patients were offered open-label BoNT injections after 12 weeks and reassessed 6 weeks later. Results: A total of 48 adult patients with a diagnosis of brachial dystonia with DT were screened. Fifteen were ineligible and 3 refused consent; therefore, 30 patients (mean [SD] age, 46.0 [18.6] years; 26 [86.7%] male) were recruited, with 15 randomized to receive BoNT and 15 to receive placebo. In the intention-to-treat group, the Fahn-Tolosa-Marin Tremor Rating Scale total score was significantly lower in the BoNT group at 6 weeks (adjusted mean difference, -10.9; 95% CI, -15.4 to -6.5; P < .001) and 12 weeks (adjusted mean difference, -5.7; 95% CI, -11.0 to -0.5; P = .03). More participants in the BoNT group reported global improvement on the Global Impression of Change (PGIC) assessment (PGIC 1, 2, and 3: BoNT: 4 [26.7%], 6 [40.0%], and 5 [33.3%]; placebo: 5 [33.3%], 10 [66.7%], and 0, respectively; P = .047). Subjective hand weakness (BoNT: 6 [40.0%]; placebo: 4 [28.6%], P = .52) and dynamometer-assessed grip strength (mean difference, -0.2 log10[kgf/m2]2/Hz-Hz; 95% CI, -0.9 to 0.4 log10[kgf/m2]2/Hz-Hz; P = .45) were similar in both groups. Conclusions and Relevance: In this randomized clinical trial, botulinum neurotoxin injections were superior to placebo in reducing tremor severity in upper-extremity DT. An individualized approach to muscle selection and dosing was beneficial without unacceptable adverse effects. Trial Registration: Clinical Trials Registry of India (http://ctri.nic.in) Identifier: CTRI/2018/02/011721.

Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial.

AIM: This study compared the cost-effectiveness of botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands as treatment for severe drooling after one treatment cycle. METHOD: The study was part of a larger, partly single-blinded, randomized clinical trial (trialregister.nl identifier NTR3537). Data were collected between 2012 and 2017. Evaluation was at 32 weeks after one treatment cycle. Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective, were randomized to treatment by BoNT-A or two-duct ligation. An incremental cost-effectiveness ratio (ICER) was calculated using the success rates as the measure of benefit. Treatment success was defined as a decrease ≥50% from baseline to 32 weeks in the subjective visual analogue scale for the severity of drooling or the objective drooling quotient. RESULTS: Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y). Average costs for one treatment cycle, which included one BoNT-A injection, were €1929 (standard error 62) for BoNT-A and €3155 (standard error 99) for two-duct ligation. Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3). The ICER was €34 per 1% gain in treatment success in favour of two-duct ligation versus BoNT-A. INTERPRETATION: The additional cost of two-duct ligation is to some extent offset by a larger treatment success rate compared with BoNT-A. WHAT THIS PAPER ADDS: Botulinum neurotoxin A (BoNT-A) is less expensive per percentage of success than two-duct ligation. The additional cost of two-duct ligation over BoNT-A is offset by greater treatment success.

Incidence of muscle relaxant use in relation to diagnosis of Parkinson's disease.

Background Parkinson's disease is the second most common neurodegenerative disorder. Motor and non-motor symptoms seem to precede the diagnosis of Parkinson's disease. Objective To evaluate the incidence of muscle relaxant use in community-dwelling persons with and without Parkinson's disease from 4 years before to 4 years after the diagnosis of Parkinson's disease. Method Nationwide register-based cohort included all community-dwelling Finnish persons who received reimbursement of Parkinson's disease drugs between 2000 and 2015 (N = 17,450) and comparison persons without Parkinson's disease who were matched for age, gender and region of residence (N = 122,694). Data on muscle relaxant use during 1995-2016 were collected from the Prescription Register. Results The incidence of muscle relaxant use was higher among persons with Parkinson's disease in comparison to persons without Parkinson's disease from 3 years before the diagnosis until 6 months after the diagnosis. The largest difference in incidence rates was observed at the time of the diagnosis (incidence rate ratio = 2.04, 95% confidence interval = 1.81-2.30). Tizanidine was the most frequently initiated muscle relaxant. Conclusions The incidence of muscle relaxant use starts increasing years before the diagnosis of Parkinson's disease but declines after that. It is important to identify the causes of muscle symptoms to avoid unnecessary muscle relaxant use and consequent adverse effects and events.

Long-term treatment of blepharospasm with botulinum toxin A: a service-based study over a 16-year follow-up in southern China.

OBJECTIVE: To elucidate the effect of long-term treatment with botulinum toxin A (BTX-A) for blepharospasm. Prevalence data and clinical features in southern China and influencing factors for selecting BTX-A treatment were explored. METHODS: We collected data retrospectively from 338 consecutive patients diagnosed with blepharospasm over 16 years to assess prevalence data and clinical features. Thereafter, all patients were classified into BTX-A (n = 135) or non-BTX-A (n = 203) treatment groups according to the patients' requests in order to explore the factors influencing whether BTX-A treatment was chosen. Furthermore, dynamic follow-up data were analyzed to evaluate the long-term efficacy in the BTX-A group. RESULTS: The prevalence was 23.3 per million, with an onset age of 50.3 ± 12.3 years and a female:male ratio of 2.4:1; the most common symptom was excessive blinking (91.2%). The symptom severity and psychological assessment scores were significantly decreased by treatment with BTX-A (p < 0.01), and there was no significant difference in response duration with the prolongation of BTX-A injections. Adverse events occurred 52 times (5.0%) among 1038 injections. The symptom severity and psychological assessment scores and the occurrence of eye-opening difficulty were higher, and medical expenses and the symptom tolerability rate were lower in the BTX-A group than in the non-BTX-A group (p < 0.05). CONCLUSION: The onset age was earlier than that in Western countries. However, starting BTX-A treatment early is justified, even though a higher dosage was needed to maintain reliable long-term efficacy. Additionally, symptom severity and medical expenses are the primary factors affecting whether patients select BTX-A treatment.

Amifampridine for the Management of Lambert-Eaton Myasthenic Syndrome: A New Take on an Old Drug.

Objective: The purpose of this article is to review the literature for both 3,4-diaminopyridine (3,4-DAP) and amifampridine for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). Amifampridine (Firdapse) is the salt form of 3,4-DAP and was approved by the Food and Drug Administration for the treatment of LEMS. Data Sources: PubMed, TRIP database, and EMBASE searches were conducted without a back date (current to June 2019) utilizing the following search terms: amifampridine, 3,4-diaminopyridine, and Lambert-Eaton myasthenic syndrome. Completed trials were also reviewed at clinicaltrials.gov. Study Selection and Data Extraction: Criteria for article inclusion consisted of human subjects, age ≥18 years, phase II or III clinical trials, and English language for both drugs. Observational and pharmacokinetic studies for amifampridine were also included. Data Synthesis: Prior to the approval of amifampridine, 3,4-DAP was first-line for the management of LEMS symptoms. Two phase III trials have evaluated amifampridine to confirm efficacy, both showing superiority over placebo in the management of LEMS symptoms, with minimal adverse effects. A significant improvement in both quantitative myasthenia gravis scores and Subjective Global Impression scores was established at days 4 and 14. Relevance to Patient Care and Clinical Practice: With an improved stability profile and decreased dose variability, amifampridine will likely assume the role of first-line management of LEMS. Conclusions: Amifampridine has been shown to improve symptoms of LEMS and is generally well tolerated.

Assessment of Skin Physiology Change and Safety After Intradermal Injections With Botulinum Toxin: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Pilot Study in Rosacea Patients With Facial Erythema.

BACKGROUND: Botulinum toxin (BTX) has been used cosmetically with good clinical efficacy and tolerable safety. OBJECTIVE: This randomized, double-blind, split-face clinical study aimed to investigate the efficacy and safety of intradermal BTX in patients with rosacea. MATERIALS AND METHODS: Twenty-four participants were enrolled and randomly given intradermal injections of BTX and normal saline in both cheeks. Clinician Erythema Assessment (CEA) score, Global Aesthetic Improvement Scale (GAIS) score, skin hydration, transepidermal water loss (TEWL), melanin content, erythema index, elasticity, and sebum secretions were evaluated at baseline and 2, 4, 8, and 12 weeks. RESULTS: On the BTX-treated side, the CEA score significantly decreased and the GAIS score significantly increased. The erythema index decreased at Weeks 4 and 8. Skin elasticity was improved at Weeks 2 and 4 and skin hydration, at Weeks 2, 4, and 8. However, TEWL and sebum secretion did not show significant differences. CONCLUSION: Intradermal BTX injections reduced erythema and rejuvenated the skin effectively and safely in patients with rosacea.

Repeated injections of botulinum toxin-A for epiphora in lacrimal drainage disorders: qualitative and quantitative assessment.

PURPOSE: To report the outcome of repeated botulinum toxin-A (BTA) injections in the lacrimal glands in patients with epiphora. METHODS: We performed retrospective chart review of patients who were injected with 2.5 units of BTA in the lacrimal gland. Epiphora and tear production were assessed by the Munk score and Schirmer-1 test, respectively, pre-injection and at 1 and 3 months post injection. Regarding repeated injections, the effects of the first were compared to those of the second and third injections. RESULTS: Forty-six eyes of 35 patients had an average of 2.3 injections per eye (range, 1-6). The mean Munk score significantly decreased from 3.72 to 1.87 at 1 month (p < 0.001) and 2.21 at 3 months (p < 0.001) after injection. The mean Schirmer-1 score also significantly decreased from 15.35 mm to 10.52 mm at 1 month (p < 0.001) and 12.48 mm at 3 months (p < 0.001) after injection. The mean reduction rates of Munk and Schirmer-1 scores after the second (66.1% and 29.8%, respectively) and the third injections (56.1% and 23.3%, respectively) were not significantly different from those after the first injection (63.3% and 26.1%, respectively) (p > 0.05 for each comparison). There was a significant correlation between the difficulty in exposing the lacrimal gland for injection and the risk of complication (p = 0.017). CONCLUSION: BTA injection in the lacrimal gland showed favourable outcomes; repeated injections did not compromise efficacy. BTA injection can be safely repeated for epiphora, especially in patients whose lacrimal gland can be easily exposed.

Value of Urinary Brain-Derived Neurotrophic Factor Levels on the Assessment of Botulinum Toxin Type A Treatment for Neurogenic Detrusor Overactivity in Children with Myelodysplasia.

PURPOSE: Urinary cytokines are proposed to predict urodynamic findings and outcome of intradetrusor botulinum neurotoxin type A injection in children with myelodysplasia. The relationship between urinary brain-derived neurotrophic factor and neurogenic and nonneurogenic detrusor overactivity has been shown as well. We prospectively investigated the effect of intradetrusor botulinum neurotoxin type A injection on urine brain-derived neurotrophic factor levels in children with nonneurogenic detrusor overactivity due to myelodysplasia. MATERIALS AND METHODS: Urine samples of 23 children with nonneurogenic detrusor overactivity due to myelodysplasia were collected and analyzed before and 1 and 3 months after intradetrusor botulinum neurotoxin type A injection, and urodynamics were performed before and 6 weeks after injection. Brain-derived neurotrophic factor levels and urodynamic findings were analyzed and statistical comparisons were done. RESULTS: Mean ± SD age was 100.0 ± 34.5 months. Ratio of girls to boys was 2.8. Brain-derived neurotrophic factor levels significantly decreased (p <0.006), and maximum cystometric capacity and maximum detrusor pressure improved significantly following intradetrusor botulinum neurotoxin type A injection compared to preoperatively (p <0.001). No statistical correlations were determined between brain-derived neurotrophic factor levels and urodynamics. Of all analyses only bladder compliance 5 ml/cm H2O or less vs greater than 5 ml/cm H2O at postoperative urodynamics was associated with statistically increased urine brain-derived neurotrophic factor levels, suggesting that increased urine brain-derived neurotrophic factor predicts treatment failure. CONCLUSIONS: The present study does not suggest that urine brain-derived neurotrophic factor is a reliable followup marker in children with nonneurogenic detrusor overactivity due to myelodysplasia. However, this factor may have a role in treatment planning, which needs to be established in future large prospective studies.

Quantitative assessment for flexed-elbow deformity during gait following botulinum toxin A treatment.

BACKGROUND: The effect of botulinum toxin A (BoNTA) injection on flexed-elbow deformity is usually evaluated using the Modified Ashworth Scale (MAS), but only with the muscle tone at rest. Some patients show the flexed-elbow deformity during gait despite low muscle tone at rest. OBJECTIVE: This study aimed to evaluate the effect of BoNTA injection on flexed-elbow deformity during gait using a three-dimensional motion analysis system. METHODS: Twenty stroke patients with spastic flexed-elbow deformity during gait received BoNTA injections into the upper limb muscles. The MAS score of the elbow flexors, passive elbow range of motion, comfortable overground gait velocity, and elbow flexion angle during treadmill gait were evaluated just before and 2, 6, and 12 weeks after the injection. Twenty-five healthy subjects were also recruited to provide a normal reference of the elbow flexion angle. RESULTS: The MAS scores at 2, 6 and 12 weeks after the injection were significantly lower than that before the injection. Some patients showed no spasticity at rest but an obviously flexed elbow during gait. The elbow flexion angles during gait at 2 and 6 weeks after the injection were significantly lower than that before the injection. CONCLUSIONS: BoNTA injections to the upper limb muscles reduced muscle tone at rest and flexed-elbow deformity during gait. However, the elbow flexion angle during gait returned to its pre-injection level sooner than the muscle tone at rest. We strongly recommend evaluating muscle tone during motion and at rest, preferably using three-dimensional motion analysis since it can objectively detect small changes.

Quantitative assessment of muscle stiffness with acoustic radiation force impulse elastography after botulinum toxin A injection in children with cerebral palsy.

PURPOSE: Our objective in this study was to assess the changes in medial gastrocnemius muscle (GCM) stiffness after botulinum toxin A (BTA) injection in children with cerebral palsy (CP) by using acoustic radiation force impulse (ARFI) elastography and to research the usability of this technique in clinical practice. MATERIALS AND METHODS: Twenty-four spastic lower extremities of 12 children with CP were assessed. BTA injection treatment was applied to the medial GCM. Muscle stiffness was measured with the ARFI technique before the procedure and a month after the procedure. The patients were assessed with the modified Ashworth scale (MAS) in the physiotherapy department at about the same time. Shear wave velocity (SWV) values and MAS scores before and after the treatment were compared. RESULTS: Mean SWV values were measured as 3.20 ± 0.14 m/s before BTA and as 2.45 ± 0.21 m/s after BTA, and the difference between them was found to be statistically significant (p < 0.001). Mean MAS score (2.33 ± 0.70) after BTA decreased significantly when compared to the score before BTA (2.96 ± 0.62) (p = 0.001). SWV values positively correlated with MAS scores (ρ = 0.578, p = 0.003). The interobserver agreement expressed as interclass correlation coefficient (ICC) was 0.65 (95% CI 0.33-0.84, p < 0.001). CONCLUSION: ARFI elastography for identifying structural changes that occur in the spastic muscle after BTA injection in children with CP can yield more valuable information with combined use of MAS.

The Role of Injectables in Aesthetic Surgery: Financial Implications.

Background: The plastic surgeon competes with both core and noncore physicians and surgeons for traditional cosmetic procedures. In 2007, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) joined efforts to form a Cosmetic Medicine Task Force to further analyze this trend. Objectives: Our objective is to document and quantify the patient capture and total collections generated in a single surgeon's practice exclusive from Botulinum Toxin A and filler injections over a 10-year period. We subsequently identified the effect and importance that fillers and Botulinum Toxin A have on an active cosmetic practice. Methods: A retrospective chart review of all male and female patients who received Botulinum Toxin A or soft tissue filler injections (noninvasive aesthetic treatment) in a single surgeons practice from January 2004 to December 2013 was undertaken. Only those patients new to the practice and who were exclusively seeking out Botulinum Toxin A or fillers were included in the study. Chart review then identified which of these selected patients ultimately underwent invasive aesthetic surgery during this 10-year period. Noninvasive and invasive aesthetic surgery total collections were calculated using billing records. Results: From January 2004 to December 2013, 375 patients entered the senior surgeon's practice specifically requesting and receiving noninvasive aesthetic treatments. Of these 375 patients, 59 patients (15.7%) subsequently underwent an aesthetic surgery procedure at an average of 19 months following initial noninvasive aesthetic treatment. Of these 375 patients, 369 were female and 6 were male. The most common initial invasive aesthetic procedure performed after injectable treatment included 22 facelifts (18.5%), 21 upper eyelid blepharoplasties (17.6%), and 15 endoscopic brow lifts (12.6%). Total collections from noninvasive aesthetic sessions and invasive surgery combined represented US$762,470 over this 10-year span. This represented US$524,771 and US$396,166 in total collections for injectables and surgery respectively. Conclusions: Noninvasive aesthetic surgery is a critical part of a plastic surgery practice. A measurable and significant number of patients who sought out a single plastic surgeon exclusively for noninvasive treatment ultimately underwent traditional invasive cosmetic surgical procedures.

Facial Assessment and Injection Guide for Botulinum Toxin and Injectable Hyaluronic Acid Fillers: Focus on the Midface.

This second article of a three-part series addresses techniques and recommendations for aesthetic treatment of the midface. Injectable fillers are important for rejuvenation of the midface by replacing lost volume and providing structural support; neuromodulators play a smaller role in this facial region. Fillers are used for volumization and contouring of the midface regions, including the upper cheek and lid-cheek junction and the submalar and preauricular areas. Also, treatment of the frontonasal angle, the dorsum, the nasolabial angle, and the columella may be used to shape and contour the nose. Neuromodulators may be used to treat bunny lines and for elevation of the nasal tip. The midface is considered an advanced area for treatment, and injectors are advised to obtain specific training, particularly when injecting fillers near the nose, because of the risk of serious complications, including blindness and necrosis. Injections made in the midcheek must be performed with caution to avoid the infraorbital artery.

An objective assessment of botulinum toxin type A injection in the treatment of post-facial palsy synkinesis and hyperkinesis using the synkinesis assessment questionnaire.

This study aimed to provide reliable and valid evidence that botulinum toxin type A (BTX-A) is a successful treatment for facial synkinesis in facial palsy by using the synkinesis assessment questionnaire (SAQ) tool. Fifty-one patients completed questionnaires pre- and post-BTX-A treatment over 103 cycles of treatment. Each patient was individually assessed and then treated according to their presenting symptoms with a dosage in each injection site of between 0.5 and 5 U of BTX-A. A two-tailed paired samples t-test was used to compare the scores for each question before and after treatment. A significant difference was found between all scores before and after treatment at the level of p < 0.05. There was not only an improvement in the mean score in the post-treatment group but also a smaller spread of scores in the post-treatment group than in the pre-treatment group. The study showed that SAQ scores decreased significantly for every question on the SAQ after treatment. This indicates that BTX-A is an effective treatment for synkinesis, adding further weight to current evidence. The study also indicated that BTX-A continues to be effective even after three rounds of treatment, with a significant decrease in overall scores after each treatment cycle.

Botulinum toxin A for palmar hyperhidrosis: assessment with sympathetic skin responses evoked by train of stimuli.

Objective assessment of the effect of botulinum toxin A (BT) treatment in primary palmar hyperhidrosis (PH) is attempted by different methods. We decided to use for this purpose sympathetic skin responses evoked by train of stimuli (TSSR). Twenty patients with severe PH (five female, median age 24, range 18-36) were examined regularly over 3 months after receiving 50 UI BT in each palm. TSSR were recorded from the palms after sensory stimulation by a train of three supramaximal electric pulses 3 millisecond apart. Results were compared to longitudinally studied TSSR of 20 healthy sex- and age-matched control subjects. All hyperhidrosis patients reported excellent improvement. TSSR amplitudes decreased at week 1 (mean 54% range 48%-67%) and over the following months in a clinically significant trend (slope R=-.82, P<.0001). TSSR in controls changed insignificantly (±13% from the baseline). The difference between patients and controls was highly significant at any time point (P<.001). This study suggests that TSSR may help in assessment of treatments in PH. It confirms objectively the efficacy of BT in PH.