Enright, Kaitlyn M.

AbstractBackgroundThe growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.AimsThe inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.MethodsThe STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon.ResultsThe establishment of a global database for tracking filler‐related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non‐medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field.ConclusionsThe STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.

Background: Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G’) for strong structural support with minimal integration propensity. Methods: A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3–6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. Results: A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. Conclusion: Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. Level of Evidence: Level III: Evidence obtained from well-designed cohort study.

AbstractBackgroundSeveral studies have started investigating the safety of temporal rejuvenation using soft tissue fillers. However, as the temporal region is highly vascularized, adverse events due to intravascular injection are of primary concern. The scarcity of treatment guidelines to date have focused primarily on avoiding the superficial and middle temporal arteries. The aim of the present anatomical study was to describe the topography of the deep temporal arteries (DTAs) with reference to superficial landmarks, to aid clinicians who perform temporal injections.MethodsThe tissue layers of eight fresh‐frozen cephalic cadavers were dissected and assessed, bilaterally in the temporal region (N = 16). Distance (D) of the anterior (D1 and D3) and posterior (D2 and D4) arteries was measured from (i) the zygomaticofrontal suture line at the lateral orbital rim (D1 and D2) and (ii) the junction of the superior border of the zygomatic arch and lateral orbital rim (D3 and D4). The distance between the anterior and posterior DTAs was also recorded, at the two regions (D5).ResultsBifurcations of the DTAs were observed in 18.75% (3/16) and 12.5% (2/16) of cases, for the anterior and posterior branches, respectively. On average [mean (standard deviation)], D1 (anterior DTA to the zygomaticofrontal suture line at the lateral orbital rim) = 1.56 cm (0.59); D2 (posterior DTA to the zygomaticofrontal suture line at the lateral orbital rim) = 2.98 cm (0.70); D3 (anterior DTA to the junction of the superior border of the zygomatic arch and lateral orbital rim) = 1.14 cm (0.63); D4 (posterior DTA to the junction of the superior border of the zygomatic arch and lateral orbital rim) = 2.37 cm (0.62); and D5 (distance between the anterior and posterior DTAs) = 1.54 cm (0.68).ConclusionTo help avoid vascular adverse events while performing temporal injections, aesthetic clinicians should be conscientious of safety implications related to the anatomical location of the DTAs and their ramifications.

AbstractBackgroundInjections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small‐ and large‐particle HA (SP‐HA; LP‐HA).AimTo assess and compare the safety and efficacy of SP‐HA and LP‐HA for the correction of nasolabial folds (NLFs).MethodsA prospective, split‐face, triple‐blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2, and a follow‐up visit at Week 4. At weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3‐dimensional imagery and ultrasonography of patients’ NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries.ResultsThe GAIS response rate, defined as ≥ “improved” from baseline, was between 90 (2 weeks) and 100% (1 month) for SP‐HA and was 100% for LP‐HA, at both visits. Paired‐samples t tests revealed significant differences in the change in WSRS scores between groups, at both visits (P < .01). Differences in the clinical effect and lifting capacity of both products were observed in 3‐dimensional imagery and ultrasonography. Treatment volumes varied, with 61.32% more SP‐HA being required than LP‐HA for achieving a ≥ one‐grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device.ConclusionsLP‐HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region.

AbstractBackgroundTreating the lower face with neuromodulators and targeting the masseter muscle can reduce masseteric hypertrophy but can also change the facial shape. A novel observation after the treatment of the masseter muscle with incobotulinumtoxin Type A was the increase in temporal volume.AimObjectively assess temporal volume increase following treatment of masseteric hypertrophy using incobotulinumtoxin Type A.MethodsNine female patients with a mean age of 35.11 years ± 9.1 [Asian (11.1%) and Caucasian (88.9%)] were treated with incobotulinumtoxin Type A for masseteric hypertrophy. Masseteric prominence and temporal volume were assessed by two independent raters, and temporal fossa volume was measured via 3‐dimensional volumetric imaging.ResultsIndependent of the neuromodulator injection technique (ie, single‐injection versus multi‐injection), a reduction in masseteric hypertrophy occurred represented by a decrease in the masseter prominence scale. In addition, the treatment resulted in a significant improvement of the temporal volume scale and an increase in the measured volume of the temporal fossa. None of the presented measurements were statistically significantly different between the two utilized injection techniques.ConclusionsThis study supports using a full‐face approach when performing aesthetic treatments. Anatomical concepts can help to guide treatments: the compensatory increase in temporalis function after masseter muscle treatment resulted in an increased in temporal fossa volume. The findings presented herein should not be considered as a new concept for treating the temporal fossa but rather as an additional possibility for increasing the temporal volume.