Split-face double-blind study comparing the onset of action of onabotulinumtoxinA and abobotulinumtoxinA.

OBJECTIVE: To report and discuss the outcome of a prospective, internally controlled, randomized, double-blind, split-face study comparing the onset of action of 2 commercially available botulinum neuromodulators. METHODS: Ninety individuals with moderate-to-severe lateral orbital rhytids were treated with onabotulinumtoxinA, 10 U, and abobotulinumtoxinA, 30 U, for the treatment of lateral orbital rhytids. Participants were assessed live with a validated 5-point photographic scale before treatment and on days 2, 4, and 6 after treatment. Photographs were taken at each encounter. Statistical analysis was applied to evaluate for any significant difference in onset of action between the 2 products. RESULTS: AbobotulinumtoxinA and onabotulinumtoxinA demonstrated statistically significant change from baseline at day 2 in the treatment of lateral orbital rhytids at maximal contraction and rest when evaluated independently by investigator and participant (P.001). Also at day 2, the improvement with abobotulinumtoxinA was better than that with onabotulinumtoxinA for the primary end point of maximal contraction graded by the investigator, although this did not reach statistical significance (P=.21); by day 4, the greater improvement achieved with abobotulinumtoxinA reached statistical significance (P=.02) and remained superior at day 6 (P=.02). The primary findings were strengthened by similar results in the secondary end points of patient self-grade at maximal contraction and at rest and of investigator grade at rest. CONCLUSIONS: In conclusion, both abobotulinumtoxinA and onabotulinumtoxinA achieved statistically significant onset of action at day 2. This improvement was seen in all end points, with abobotulinumtoxinA demonstrating a trend toward greater improvement than onabotulinumtoxinA at day 2 and a statistically significant greater improvement at days 4 and 6 when looking at maximal contraction.

An internally controlled, double-blind comparison of the efficacy of onabotulinumtoxinA and abobotulinumtoxinA.

OBJECTIVE: To compare 2 commercially available botulinum neuromodulators in a randomized, double-blind, split-face study. METHODS: Ninety patients were treated with 10 U of onabotulinumtoxinA and 30 U of abobotulinumtoxinA for the treatment of lateral orbital rhytids. Patients were assessed live with a validated 5-point photographic scale prior to treatment and at 30 days. Patients were also photographed at each visit. RESULTS: AbobotulinumtoxinA demonstrated a statistically significant advantage compared with onabotulinumtoxinA in the treatment of lateral orbital rhytids at maximal contraction, as evaluated independently by the investigator (P = .01) and patient (P = .03). AbobotulinumtoxinA was also favored by the patient over onabotulinumtoxinA 67% of the time. While abobotulinumtoxinA seemed to treat lateral orbital rhytids better at rest, as evidenced by the data and photographs, this difference was not statistically significant (P = .42). CONCLUSIONS: AbobotulinumtoxinA offers superior efficacy in the treatment of lateral orbital rhytids compared with onabotulinumtoxinA. Further studies are needed to compare the 2 products in different muscle groups and for other indications.

Maxillary removal and reinsertion: a favorable approach for extensive anterior cranial base tumors.

OBJECTIVE: To analyze the long-term results and the complications related to an expanded series of maxillary removal and reinsertion (MRRI) with 18-year surgical experience. STUDY DESIGN: Case series with chart review of the MRRI patients in the last 18 years. SETTING: The Ohio State University Comprehensive Cancer Center, James Cancer Hospital and Solove Research Institute. SUBJECTS AND METHODS: Seventy-eight patients who underwent MRRI from February 1990 through February 2007. The median age was 51 years (range 11-77 yrs). Sixty-two (80%) patients had malignant lesions. RESULTS: MRRI has been successfully completed in all 78 patients, with no intraoperative mortality. The most commonly encountered malignant neoplasm was squamous cell cancer (40.3%), followed by esthesioneuroblastoma (24.1%), adenoid cystic cancer (8%), and other neoplasms (27.4%). The most commonly encountered postoperative complication was diplopia, which has persisted in five (6.4%) patients in the short-term and in three (4%) patients in the long-term follow-up. Nasal asymmetry was the most common long-term complication (17.9%), followed by plate-associated problems (10.2%) and midface asymmetry (10.2%). Overall five-year survival for the patients with squamous cell carcinoma was 62 percent. CONCLUSION: MRRI is a favorable surgical technique for the treatment of anterior cranial base (ACB) tumors in adults and even in children. It improves operative morbidity by preserving both function and form of the maxillary region and gives excellent exposure to ACB.

Patterns of recurrence and survival of head and neck adenoid cystic carcinoma after definitive resection.

OBJECTIVES/HYPOTHESIS: To determine factors impacting recurrence and long-term survival of adenoid cystic carcinoma (ACC) of the head and neck after definitive resection. STUDY DESIGN: Retrospective cohort study at an academic tertiary care hospital. METHODS: Patients with ACC of the head and neck treated at our institution were reviewed. Those not receiving surgery, or with metastatic disease were excluded. Clinicopathological data on each patient was collected. RESULTS: Of 113 patients identified with ACC, 99 were studied. The overall median survival for the cohort was 71 months (mean +/- standard deviation, 94 +/- 79 months). American Joint Committee on Cancer (AJCC) tumor stage and N stage were independent predictors of survival on multivariate analysis. Mean overall survival (P = .001) and time to recurrence (P = .006) were lower for patients with cervical lymph node positive disease (N+). Tumors in major salivary glands were associated with longer survival (P = .027). The overall recurrence rate was 53%, with a mean time to recurrence of 63 +/- 64 months. The presence of lymphovascular invasion predicted recurrence on multivariate analysis (P = .002), with advanced tumor stage predicting early (

Pins and needles: minimally invasive office techniques for facial rejuvenation.

The desire for minimally invasive facial rejuvenation has continued to increase from the perspective of both the patients and injectors. For successful rejuvenation, it is important to understand the anatomic changes of the aging face as well as the properties of available neuromodulators and soft tissue fillers. The injector should be knowledgeable of the advantages and disadvantages of each product. Patient selection, perhaps, plays the largest role in success, choosing patients that would truly benefit from and have reasonable expectations for minimally invasive techniques. Unsatisfactory outcomes can be limited by meticulous injection technique and well thought out treatment plans.

Training otologic surgical skills through simulation-moving toward validation: a pilot study and lessons learned.

INTRODUCTION: Methods for surgical education and training have changed little over the years. Recent calls to improve surgical efficiency and safety impose additional pressures that have an impact on surgical education and training. USE OF SIMULATION: Integration of data from advanced imaging technologies and computer technologies are creating simulation environments of unprecedented realism. Surgical education and training are poised to exploit low-cost simulation technologies to mitigate these pressures that are having an adverse impact on curricula. To become effective, simulation needs to undergo rigorous validation studies. INTERVENTION: With funding from that National Institute on Deafness and Other Communicative Disorders, we have embarked on a research design project to develop, disseminate, and validate a surgical system for use in otologic resident training and assessment and present key steps from this process. DISCUSSION: We discuss limiting factors related to technology and conducting multi-institutional studies, along with current developments to integrate curricula, as well as training and assessment capabilities in surgical education using simulation.