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Cotofana, Sebastian

0000-0001-7210-6566

Mayo Clinic

Department of Clinical Anatomy, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.

Citations 44

Deliberations of the Safety Task Force: Risk factors and treatment of adverse events associated with aesthetic injectables
Nikolis, Andreas , Cohen, Joel L. , Enright, Kaitlyn M. , Avelar, Luiz Eduardo Toledo , Beleznay, Katie, Biesman, Brian S. , Cartier, Hugues , Cotofana, Sebastian , Fabi, Sabrina G. , Parada, Meire Brasil, Rzany, Berthold, Wang, Hang, Bromée, Torun, Weiner, Steven C., Avelar, Luiz , Goodman, Greg , Schelke, Leonie , Cotofana, Sebastian , Fitzgerald, Rebecca, Lee, Won , Weiner, Steven

Journal of Cosmetic Dermatology | August 20, 2024 | Volume: 23 | Issue: 11 | Pages: 3551-3564

10.1111/jocd.16476 Get It

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.
A Prospective Clinical Trial Evaluating the Efficacy and Safety of Non-Animal Stabilized Hyaluronic Acid Injections for Non-Surgical Rhinoplasty
Nikolis, Andreas , Enright, Kaitlyn M. , Nguyen, Quynh Thuy , Sinno, Hani , Cotofana, Sebastian , Cotofana, Sebastian , Nguyen, Quynh

Plastic Surgery | July 12, 2023 | Volume: 33 | Issue: 1 | Pages: 97-106

10.1177/22925503231184263 Get It

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.
Histological effects of a combined collagen stimulation procedure consisting of microfocused ultrasound, soft tissue filler, and Ca‐HA injections
Casabona, Gabriela , Kaye, Kai , Cotofana, Sebastian , Davidović, Kristina , Alfertshofer, Michael , Freytag, Lysander, Cotofana, Sebastian , Alfertshofer, Michael

Journal of Cosmetic Dermatology | April 19, 2023 | Volume: 22 | Issue: 6 | Pages: 1724-1730

10.1111/jocd.15770 Get It

AbstractBackgroundAn increasing demand for in‐office aesthetic procedures aiming to improve collagen stimulation has been reported.ObjectiveTo analyze the effects of combinations of different aesthetic collagen stimulation procedures using histological analysis.MethodsHistological analysis was performed on skin samples of the excess skin of a 60‐year‐old patient after sub‐superficial musculo‐aponeurotic system facelift surgery. The excess skin before facelift surgery was divided into three areas per hemiface. Each area—with exception of area A as a control—received an isolated or combined treatment of microfocused ultrasound (MFU), injections of calcium‐hydroxylapatite/hyaluronic‐acid‐based soft tissue filler, and microneedling. The effect of the treatments was analyzed using histological analysis with H&E coloration and PAS staining.ResultsA threefold increase of epidermal and dermal thickness was achieved by treating the skin with the proposed combined treatment comprising MFU and injections of calcium‐hydroxylapatite‐ and hyaluronic‐acid‐based soft tissue fillers.ConclusionThe investigated treatments act synergistically in the production of collagen and combining these treatments allows for an increase in collagen production.
Introduction of the Lip Classification of Tubercles: A Novel Approach to Minimally Invasive Aesthetic Lip Treatments
Alfertshofer, Michael , Allen, Rory , Castellari, Fabrizio, Othoro, Don, Bran, Greg, Cotofana, Sebastian , Alfertshofer, Michael , Cotofana, Sebastian , Harris, Steven

Aesthetic Surgery Journal Open Forum | March 15, 2023 | Volume: 5 | Issue: No issue available | Pages: No page available

10.1093/asjof/ojad007 Get It

Abstract Background Lip enhancement procedures involving dermal fillers are one of the most sought after nonsurgical aesthetic treatments. However, current trends are associated with unnatural results and involve increased risks of complications and compromise to normal function. It appears that lips may be classified according to the presentation of their tubercles and this may be used to guide minimally invasive techniques which aim to preserve individual lip shapes and normal function. Objectives To test the reliability of a classification system based on lip tubercle morphology, named the Lip Classification of Tubercles (LCT). Methods To test the reliability of the LCT, a total of 214 high-definition photographs of patients’ lips with no previous histories of lip treatments were classified independently by 4 experienced aesthetic practitioners on 2 separate occasions 3 months apart; the second followed a more detailed explanation of the classification. Results When inter-rater reliability was calculated for the first attempt, the results were 36% and 43% for upper and lower lips, respectively. The second attempt following an education process resulted in 79% for both lips. When 1 practitioner was considered the standard, the average score for the remaining 3 showed some individual variation but improved significantly from 58% to 85%. Conclusions The LCT is a reliable way to classify lip types based on the morphology of tubercles. Level of Evidence: 3
Facial aesthetic minimally invasive procedure: More than just vanity, a social‐psychological approach
Elzen, Helga E. van den, Barends, Ard J. , Vugt, Mark van , Biesman, Brian S. , Alfertshofer, Michael , Cotofana, Sebastian , Cotofana, Sebastian , Alfertshofer, Michael , ELZEN, HELGA J. VAN DEN, Velthuis, Peter J.

Journal of Cosmetic Dermatology | March 5, 2023 | Volume: 22 | Issue: 7 | Pages: 2063-2070

10.1111/jocd.15678 Get It

AbstractBackgroundDue to the great importance of the face in social interaction, minimally invasive treatments can—besides their ability to rejuvenate and enhance beauty—also change the way facial impressions of a person are perceived. In recent literature, three main character traits (attractiveness, trustworthiness, and competence) and subdomains essential for facial perception were described.ObjectiveTo investigate whether minimally invasive procedures truly influence different character traits when evaluated by independent, objective observers.MethodsPhotographs of n = 34 female faces before and after treatment with injectable fillers and botulinum toxin were rated by 393 individuals without aesthetic background with regards to different character traits on a 7‐point Likert scale. Tests for dimensionality were performed, and composite scores of the impressions underlying each of the three dimensions were created and compared using within‐subjects t tests.ResultsTreatments statistically significantly improved the overarching character trait domains attractiveness, trustworthiness, and competence in posttreatment photographs compared with pretreatment. Posttreatment ratings of the respective subdomains also showed a statistically significant difference compared with pretreatment photographs, with the exception of the subdomain dominance which failed to reach statistical significance.ConclusionImpressions of facial attractiveness, trustworthiness, and competence can be improved by injectables while the naturalness of the face is left intact. An implication is that the improvement of traits highly relevant to social interaction will accommodate the patient's desires for beautification and rejuvenation.
Clinical validation of the upper face first principle—A clinical, prospective, interventional split‐face study
Hernandez, Claudia A, Zapata, David E. Uribe, Bermudez, Maria Paula, Frank, Konstantin , Alfertshofer, Michael , Davidović, Kristina , Cotofana, Sebastian , Alfertshofer, Michael , Cotofana, Sebastian , Zapata, David Uribe , Moellhoff, Nicholas , Gotkin, Robert H.

Journal of Cosmetic Dermatology | December 27, 2022 | Volume: 22 | Issue: 2 | Pages: 418-425

10.1111/jocd.15563 Get It

AbstractBackgroundPrevious clinical and anatomic investigations have identified the clinical relevance of facial biomechanics. Based on this new understanding, principles for facial aesthetic procedures were established: Lateral Face First, Deep Layers First, and Upper Face First.ObjectiveTo test the upper face first principle by showing that an injection sequence, starting in the upper face is superior to an injection sequence starting in the lower face.MethodsThis study was designed as an interventional split‐face study administering the same amount and type of soft tissue filler for the upper, middle, and lower face but in a different sequence: upper, middle, lower face versus lower, middle, and upper face. A total of 15 patients (5 males and 10 females) with a mean age of 39.4 years (9.6) and a mean BMI of 23.4 kg/m2 (1.7) were studied. Follow‐up at D0, D30, and D90 was conducted utilizing semiquantitative scores and objective 3D imaging.ResultsDespite not reaching statistical significance, midfacial volume and jawline contouring were rated better at every follow‐up visit (D0, D30, D90) when treated with the upper versus the lower face first injection algorithm. The global aesthetic improvement scale showed statistically significantly better values for the upper face first algorithm when compared to the lower face first algorithm at all evaluated time points with all p < 0.001.ConclusionApplying the upper face first injection algorithm seems to result in better aesthetic outcomes when directly compared to the lower face first algorithm. Semiquantitative and objective outcome measurements confirm its clinical effectiveness.
Aesthetic considerations when treating the Latin American patient: Thriving in diversity international roundtable series
Fabi, Sabrina G. , Hernandez, Claudia A, Montes, José Raúl , Cotofana, Sebastian , Dayan, Steve, Cotofana, Sebastian

Journal of Cosmetic Dermatology | December 5, 2022 | Volume: 22 | Issue: 2 | Pages: 593-602

10.1111/jocd.15516 Get It

AbstractBackgroundThe Hispanic/Latin American population is the fastest growing non‐Caucasian group in the United States. Within this group, demand for aesthetic procedures is on the rise. High ethnic variability among these patients influences treatment approaches and patient priorities. Understanding these ethnic differences is central to providing optimal care.AimsTo discuss similarities and differences in anatomy and treatment preferences of Hispanic/Latin American patients both within the United States and internationally and explore how these differences may influence or inform aesthetic practices.Patients/MethodsIn support of clinicians who wish to serve a diverse patient population, a 6‐part, international roundtable series focused on diversity in aesthetics was conducted from August 24, 2021 to May 16, 2022. In this roundtable, held in Medellin, Columbia, expert clinicians from across Latin America and the United States were invited to contribute and share best practices.ResultsThe results of the second roundtable in the series, the Latin American Patient, are described here. A special emphasis is placed on procedures that address the most commonly encountered concerns in these patients.ConclusionsHispanic and Latino patients represent a broad demographic with unique anatomical features, aesthetic preferences, and treatment priorities. Clinicians should consider these differences when treating this patient population.
Clinical outcomes after lip injection procedures—Comparison of two hyaluronic acid gel fillers with different product properties
Hilton, Said, Frank, Konstantin , Alfertshofer, Michael , Cotofana, Sebastian , Cotofana, Sebastian , Alfertshofer, Michael

Journal of Cosmetic Dermatology | December 2, 2022 | Volume: 22 | Issue: 1 | Pages: 119-127

10.1111/jocd.15548 Get It

Abstract Background Transient swelling is common after lip injections with hyaluronic acid (HA) based fillers. Swelling and other injection‐site reactions may relate to the injection procedure itself, or to gel properties, which differ between fillers due to differences in manufacturing methods. Objectives To evaluate safety and effectiveness of lip injections with two HA fillers manufactured using different gel technologies. Methods In a study sample of 40 subjects, treatment with two soft tissue filler product (HA RK or HA JUS ) was randomly assigned. Subjects were injected with 0.5 cc per upper and lower lip using a standardized injection procedure. Early‐onset adverse events (AEs) were assessed by evaluation up to Day 14. Aesthetic improvement, subject satisfaction, and AEs post‐Day 14 were assessed up to 24 weeks. Results In subjects treated with HA RK , the intensity of early onset swelling, erythema, and pain/tenderness was lower than in subjects treated with HA JUS . Aesthetic improvement was achieved in both groups, and most subjects were satisfied with the appearance of their lips. Treatment‐related AEs post‐Day 14 mostly related to the implant site; most were mild‐to‐moderate, and none were serious. Conclusions The intensity of early‐onset swelling, and other injection‐site reactions was lower in subjects treated with HA RK than in subjects treated with HA JUS . Since both the injection volume and injection procedure were standardized, the difference in local tolerability between the two HA fillers may relate to differences in gel properties. Aesthetic improvement, subject satisfaction, and AE profiles post‐Day 14, however, were similar between filler groups.
Precision of Soft-Tissue Filler Injections: An Ultrasound-Based Verification Study
Calomeni, Mariana, Bravo, Bruna S F, Velthuis, Peter J. , Schalet, Grant, Frank, Konstantin , Guertler, Anne , Alfertshofer, Michael , Cotofana, Sebastian , Elias, Mariana Calomeni , Frank, Konstantin , Frank, Konstantin , Alfertshofer, Michael , Cotofana, Sebastian , Schelke, Leonie , Moellhoff, Nicholas

Aesthetic Surgery Journal | October 25, 2022 | Volume: 43 | Issue: 3 | Pages: 353-361

10.1093/asj/sjac272 Get It

Abstract Background Uncontrolled product spread is an important issue to consider in facial filler injections. Lack of precision can result in reduced effectiveness and surface projection, as well as irregularities and product visibility. Objectives The authors sought to assess the precision of soft-tissue filler injections in the face by employing a cannula. Methods This single-center observational study investigated soft-tissue filler distribution utilizing real-time non-invasive ultrasound imaging. Outcome parameters included (1) the tissue plane of product distribution, (2) the extent of horizontal as well as vertical product spread at the injection site, and (3) the product surface area taking into account the multifactorial influence of several independent variables. Participants were followed up to 30 days post-injection. Results A total 100 facial injections were performed in 8 patients (2 males, 6 females) with a mean age of 37.20 (±6.34) years and a mean BMI of 22.21 (±1.39) kg/m.2. The plane of product distribution remained constant in approximately 90% of cases at day 0 (d0), d14, and d30. Mean horizontal product spread was higher compared with vertical spread, and both significantly decreased over all time points (P &lt; .001). Mean product surface area was 22.51 ± 16.34 mm2 at d0, 15.97 ± 11.28 mm2 at d14, and 12.9 ± 9.15 mm2 at d30. Analysis employing generalized linear models revealed that injection volume and injection depth significantly influenced product surface area. Conclusions Injection of soft-tissue filler employing a cannula allows precise application of the product within the intended tissue plane. Precision can be improved by injecting less product into deeper tissue layers. Level of Evidence: 5
Two New Phenomena Associated With Filler Injection
Cotofana, Sebastian , Velthuis, Peter J. , Cotofana, Sebastian , Frank, Konstantin , Schelke, Leonie

Aesthetic Surgery Journal | October 21, 2022 | Volume: 43 | Issue: 2 | Pages: NP134-NP135

10.1093/asj/sjac271 Get It