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Zingaretti, Nicola; Albanese, Roberta; Pisano, Gaetano; Isola, Miriam; Giusti, Alessandra; De Martino, Maria; De Francesco, Francesco; Riccio, Michele; Parodi, Pier Camillo
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad203pmid: 37378563
BackgroundLiposuction is a safe, simple, and effective method of body contouring. Pain, ecchymosis, and edema are often local complications at the removal site, especially in the first weeks after surgery. Several studies have shown that kinesiology (kinesio) taping improves blood and lymphatic flow, removing congestions of lymphatic fluid and alleviating hemorrhage. However, there are limited data on the effect of kinesio taping in mitigating local complications at fat grafting donor sites.ObjectivesThe aim of this pilot study was to evaluate the impact of kinesio taping in reducing postoperative edema, pain, and ecchymosis in the liposuction area.MethodsOver a period of 18 months (January 2021-June 2022), 52 patients underwent liposuction of both flanks with subsequent breast fat grafting. Immediately after the surgery, kinesio taping was used on the right abdomen flank in all patients. Degree of edema as well as ecchymosis and pain were quantified at 7, 14, and 21 days after surgery.ResultsThere were statistically significant differences in the taping area for ecchymosis at 7 days after surgery, edema at 14 and 21 days after surgery, and in pain, rated on a visual analog scale, at 7, 14 and 21 days after surgery.ConclusionsKinesio taping, as used in this study, is beneficial in the reduction of edema and pain and the resolution of ecchymosis after liposuction.Level of Evidence: 3
Cai, Siyuan; Sheng, Yang; Lin, Liheng; Cui, Wei; Jiang, Zhiyuan; Zhang, Liyuan; Li, Qingqing; Cai, Zhen; Chen, Zaihong
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad118pmid: 37083130
BackgroundFor patients with a congenitally defective type of earlobe cleft, repair techniques similar to those utilized for earlobe lacerations are not suitable due to the presence of certain tissue defects. However, traditional earlobe reconstruction techniques imply the need to form complex flaps with adjacent normal tissues, which may lead to many complications.ObjectivesIn this study, we developed a technique to repair the earlobe with residual lobular tissue based on the characteristics of congenitally defective earlobe clefts.MethodsWe designed a triangular random flap out of the remnant lobular tissue, rotated and embedded into the edge of the remnant earlobe to repair the earlobe.ResultsIn the past 3 years, this technique was applied to 15 patients with congenitally defective earlobe clefts. With this technique, the new earlobe achieved the desired aesthetic results, such as smooth edges and fullness of form, without complicated and unnecessary incisions. It also solved the aesthetic problem of residual lobular tissue on the face.ConclusionsBased on the characteristics of the congenitally defective type of earlobe cleft, we innovatively proposed the utilization of residual lobular tissues for earlobe repair, and the feasibility and multiple advantages of this technique have been demonstrated in practice.Level of Evidence: 4
Jabbari, Kayvon; Gehring, Michael B; Iorio, Matthew L; Mathes, David W; Kaoutzanis, Christodoulos
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad107pmid: 37071801
BackgroundMacromastia is associated with increased opioid consumption, which could potentially be the initial exposure for patients with an opioid use disorder amid an escalating opioid crisis in the United States.ObjectivesThe purpose of this study was to evaluate outpatient cost of care and opioid consumption in patients with macromastia and compare those who underwent reduction mammaplasty vs those who did not have surgery.MethodsPearlDiver, a database encompassing a national cohort of private payers with 153 million unique patients, was queried. The study cohort included patients diagnosed with macromastia who did or did not undergo reduction mammaplasty utilizing both ICD-9 and ICD-10 and CPT codes. Outpatient cost of care and morphine milligram equivalents (MME) were calculated up to 5 years postoperatively for both cohorts.ResultsAt 1 to 3 years postoperatively, there was no statistically significant difference in outpatient cost of care between cohorts. At every follow-up thereafter, outpatient cost of care was higher among macromastia patients who did not undergo reduction mammaplasty, with cohort differences of US$240.68 and US$349.90 at 4 years and 5 years, respectively (P < .05). MME consumption was greater in patients who underwent reduction mammaplasty up to 30 days postoperatively (P < .01). Beyond that, there was no significant difference in MME consumption between cohorts. However, patients who did not undergo surgery had opioid consumption levels above 50 MME/day until 3 years after diagnosis of macromastia.ConclusionsPatients with macromastia who undergo reduction mammaplasty have lower outpatient care costs than patients who do not undergo reduction mammaplasty, with safer long-term opioid consumption in alignment with current Centers for Disease Control and Prevention guidelines.
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad099pmid: 37042719
BackgroundThere is some controversy regarding whether the nipple-areola complex (NAC) is elevated, remains stable, or is lowered in breast augmentation. There is a general belief that one can modulate its position depending on the implant chosen. In addition, many preoperative markings include elevating the arms to predict the final position of the NAC.ObjectivesThe aim of this study was to investigate changes in the position of the NAC and determine whether the postoperative position of the NAC can be predicted preoperatively by elevating the arms.MethodsThe study included 45 patients. A 3-dimensional scan was performed to take basal (preoperative) and 12-month measurements with the patient's arms in abduction and elevated over the head. The distances measured were the sternal notch-nipple (SN-Ni), nipple-nipple (Ni-Ni), and nipple-inframammary fold (Ni-IMF) distances.ResultsWith arms abducted, the SN-Ni distance increased by 6% when measured linearly, 8.5% when measured on the skin surface, and 1% to 2% when measured on the sternal line. The Ni-Ni distance increased by 9% (linear) and 15% (over the surface). The Ni-IMF increased by 44%. With arms adducted, the SN-Ni distance increased by 9% (linear), 12% (on the skin surface), and 0.5% at the sternal midline projection. The Ni-Ni distance increased 11% (linear) and 19% (on the surface). The Ni-IMF distance increased by 53%. The postoperative position of the NAC with the arms abducted increased by 17% compared with the preoperative position in adduction.ConclusionsImplants do not elevate the NAC; its position remains nearly unaltered. The SN-Ni distance was increased in 90% of the patients. Lifting the arms for preoperative markings does not help to predict the postoperative position of the NAC.Level of Evidence: 4
Shridharani, Sachin M; Dayan, Steven; Biesman, Brian; Cohen, Joel; Downie, Jeanine; Jones, Derek; Shamban, Ava; Fabi, Sabrina; Yoelin, Steve; Fagien, Steven; Ablon, Glynis; Gold, Michael; Gueta, Racheli; Walker, Patricia
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad195pmid: 37348516
BackgroundTapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume.ObjectivesThe goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction.MethodsPatients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment.ResultsThe proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs).ConclusionsA single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.Level of Evidence: 1
Anderson, Lexy; Nguyen, Clara Do Tran; Trinh, Kathleen; Dorfman, Robert; Tandon, Vickram; Do, Nicholas; Lambros, Val; Grotting, James; Song, David; Delong, Michael
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad196pmid: 37350541
Fat grafting can restore facial volume for reconstructive and cosmetic indications. Common practice often involves extracting lipoaspirate from the most abundant anatomic location. However, grafted fat retains the phenotypic characteristics of its original location and can undergo exaggerated hypertrophy with patient weight fluctuations. The aim of this study was to systematically assess the literature to summarize the reported effects of postoperative weight gain on facial hypertrophy in patients after facial fat grafting and to determine potentially avoidable factors. A search through PubMed/MEDLINE was conducted on October 4, 2022, to identify relevant articles with appropriate search terms. No lower date limit was applied and all eligible nonanimal clinical articles in English were included for review. Reports were summarized and presented as descriptive statistics. The search generated 714 articles. After abstract and full-text review of the initial set of articles, 6 were included in our analysis. All articles described poor cosmetic outcomes resulting from nonanatomic hypertrophy of the grafted fat. None of the articles reported a thorough methodology for selecting the donor site to minimize fat hypertrophy with potential future weight fluctuations. Grafted facial fat is susceptible to exaggerated hypertrophy as a result of changes in patient weight. Specifically, harvesting lipoaspirate from maximally abundant areas of the body may increase this risk. Individualizing the area of fat donation may attenuate unwanted fat growth and further contribute to increased patient quality of life.Level of Evidence: 4
Asaad, Malke; Hassan, Abbas M; Morris, Natalie; Kumar, Saloni; Liu, Jun; Butler, Charles E; Selber, Jesse C
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad175pmid: 37265099
BackgroundThe impact of obesity on outcomes of prepectoral vs subpectoral implant–based reconstruction (IBR) is not well-established.ObjectivesThe goal of this study was to assess the surgical and patient-reported outcomes of prepectoral vs subpectoral IBR. The authors hypothesized that obese patients would have similar outcomes regardless of device plane.MethodsWe conducted a retrospective review of obese patients who underwent 2-stage IBR from January 2017 to December 2019. The primary endpoint was the occurrence of any breast-related complication; the secondary endpoint was device explantation.ResultsThe authors identified a total of 284 reconstructions (184 prepectoral, 100 subpectoral) in 209 patients. Subpectoral reconstruction demonstrated higher rates of overall complications (50% vs 37%, P = .047) and device explantation (25% vs 12.5%, P = .008) than prepectoral reconstruction. In multivariable regression, subpectoral reconstruction was associated with higher risk of infection (hazard ratio [HR], 1.65; P = .022) and device explantation (HR, 1.97; P = .034). Subgroup analyses demonstrated significantly higher rates of complications and explantation in the subpectoral group in those with a body mass index (BMI) ≥ 35 and BMI ≥40. The authors found no significant differences in mean scores for satisfaction with the breast (41.57 ± 13.19 vs 45.50 ± 11.91, P = .469), psychosocial well-being (39.43 ± 11.23 vs 39.30 ± 12.49, P = .915), and sexual well-being (17.17 ± 7.83 vs 17.0 ± 9.03, P = .931) between subpectoral and prepectoral reconstruction.ConclusionsPrepectoral reconstruction was associated with significantly decreased overall complications, infections, and device explantation in obese patients compared with subpectoral reconstruction. Prepectoral reconstruction provides superior outcomes to subpectoral reconstruction with comparable patient-reported outcomes.Level of Evidence: 4
Aguilera, Shino Bay; McCarthy, Alec; Khalifian, Saami; Lorenc, Z Paul; Goldie, Kate; Chernoff, W Gregory
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad173pmid: 37635437
For decades, a wide variety of natural and synthetic materials have been used to augment human tissue to improve aesthetic outcomes. Dermal fillers are some of the most widely used aesthetic treatments throughout the body. Initially, the primary function of dermal fillers was to restore depleted volume. As biomaterial research has advanced, however, a variety of biostimulatory fillers have become staples in aesthetic medicine. Such fillers often contain a carrying vehicle and a biostimulatory material that induces de novo synthesis of major structural components of the extracellular matrix. One such filler, Radiesse (Merz Aesthetics, Raleigh, NC), is composed of calcium hydroxylapatite microspheres suspended in a carboxymethylcellulose gel. In addition to immediate volumization, Radiesse treatment results in increases of collagen, elastin, vasculature, proteoglycans, and fibroblast populations via a cell-biomaterial–mediated interaction. When injected, Radiesse acts as a cell scaffold and clinically manifests as immediate restoration of depleted volume, improvements in skin quality and appearance, and regeneration of endogenous extracellular matrices. This narrative review contextualizes Radiesse as a regenerative aesthetic treatment, summarizes its unique use cases, reviews its rheological, material, and regenerative properties, and hypothesizes future combination treatments in the age of regenerative aesthetics.Level of Evidence: 5
Minelli, Lennert; Wilson, Jeremy L; Bravo, Francisco G; Hodgkinson, Darryl J; O’Daniel, T Gerald; van der Lei, Berend; Mendelson, Bryan C
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad148pmid: 37186556
BackgroundDespite the central role of the platysma in face and neck rejuvenation, much confusion exists regarding its surgical anatomy.ObjectivesThis study was undertaken to clarify the regional anatomy of the platysma and its innervation pattern and to explain clinical phenomena, such as the origin of platysmal bands and their recurrence, and the etiology of lower lip dysfunction after neck lift procedures.MethodsFifty-five cadaver heads were studied (16 embalmed, 39 fresh, mean age 75 years). Following preliminary dissections and macro-sectioning, a series of standardized layered dissections were performed, complemented by histology and sheet plastination.ResultsIn addition to its origin and insertion, the platysma is attached to the skin and deep fascia across its entire superficial and deep surfaces. This composite system explains the age-related formation of static platysmal bands, recurrent platysmal bands after complete platysma transection, and recurrent anterior neck laxity after no-release lifting. The facial part of the platysma is primarily innervated by the marginal mandibular branch of the facial nerve, whereas the submandibular platysma is innervated by the “first” cervical branches, which terminate at the mandibular origin of the depressor labii inferioris. This pattern has implications for postoperative dysfunction of the lower lip, including pseudoparalysis, and potential targeted surgical denervation.ConclusionsThis anatomical study, comprised of layered dissections, large histology, and sheet plastination, fully describes the anatomy of the platysma including its bony, fascial, and dermal attachments, as well as its segmental innervation including its nerve danger zones. It provides a sound anatomical basis for the further development of surgical techniques to rejuvenate the neck with prevention of recurrent platysmal banding.
Janssen, Tim J; Maheshwari, Kavish; Sivadasan, Anand; Waterhouse, Norman
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad097pmid: 37040449
BackgroundThe hemostatic net has been promoted as a safe and effective method to prevent hematoma formation following facelift procedures. To date there is little published evidence to validate the replicability and effectiveness of the technique.ObjectivesThis study presents 2 cohorts of facelift patients from a single surgeon's practice to assess the impact of the hemostatic net on hematoma formation.MethodsThe records of 304 patients were reviewed on whom the hemostatic net was placed following a facelift between July 2017 and October 2022. Data were collected and assessed for complications and compared with a control group of 359 patients who underwent a facelift procedure without placement of a hemostatic net by the same surgeon between 1999 and 2004.ResultsA total of 663 patients were included. In this retrospective cohort study, analysis of available data showed a significantly reduced hematoma rate of 0.6% in the intervention group compared with 3.9% in the control group (P = .006722).ConclusionsThe use of the hemostatic net is a safe, reproducible, and effective technique in reducing the risk of hematoma in facelift surgery.Level of Evidence: 4
Fan, Wanlin; Rokohl, Alexander C; Maus, Julia; Guo, Yongwei; Ju, Xiaojun; Li, Xueting; Wawer Matos, Philomena A; Heindl, Ludwig M
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad136pmid: 37157856
BackgroundAlthough a portable 3-dimensional (3D) imaging system has been used for periocular measurement analysis, this system has yet to be tested and validated for periocular area and volume measurements.ObjectivesThe aim of this study was to define the upper eyelid and upper eyelid fold region through a modified landmark strategy and validate a portable 3D imaging system for area and volume measurements in this periocular region.MethodsEighty-one healthy adult Caucasians underwent 3D facial imaging with the VECTRA M3 (static) and VECTRA H2 (portable) 3D imaging systems (Canfield Scientific, Inc., Parsippany, NJ). Subsequently, the upper eyelid and upper eyelid fold regions were selected according to a modified landmark localization strategy. Direct measurements of area and volume were performed to assess intrarater, interrater, intramethod, and intermethod reliability, and to compare the agreement between the 2 devices.ResultsThe VECTRA M3 and H2 showed high reliability on upper eyelid area measurements. Excellent intra-, inter-, and intramethod reliability agreements were observed in intraclass correlation coefficient; very good agreement in intrarater reliability was observed in the relative error of measurement (REM) and relative technical error of measurement (rTEM); and good inter- and intramethod reliability were observed in the REM and rTEM. For area measurement of the upper eyelid fold, the intrarater, interrater, and intramethod reliability of the M3 was lower than that of the H2. Both systems had poor intrarater, interrater, and intramethod reliability for volume measurements in the upper eyelid and upper eyelid fold region.ConclusionsThis new portable 3D imaging system achieved excellent or very good reliability values for standardized direct measurements of the upper eyelid and upper eyelid fold region, although volume measurements seem less reliable.
Seth, Ishith; Cox, Aram; Xie, Yi; Bulloch, Gabriella; Hunter-Smith, David J; Rozen, Warren M; Ross, Richard J
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad140pmid: 37158147
BackgroundThe integration of artificial intelligence (AI) and machine learning (ML) technologies into healthcare is transforming patient-practitioner interaction and could offer an additional platform for patient education and support.ObjectivesThis study investigated whether ChatGPT-4 could provide safe and up-to-date medical information about breast augmentation that is comparable to other patient information sources.MethodsChatGPT-4 was asked to generate 6 commonly asked questions regarding breast augmentation and respond to them. Its responses were qualitatively evaluated by a panel of specialist plastic and reconstructive surgeons and reconciled with a literature search of 2 large medical databases for accuracy, informativeness, and accessibility.ResultsChatGPT-4 provided well-structured, grammatically accurate, and comprehensive responses to the questions posed; however, it was limited in providing personalized advice and sometimes generated inappropriate or outdated references. ChatGPT consistently encouraged engagement with a specialist for specific information.ConclusionsAlthough ChatGPT-4 showed promise as an adjunct tool in patient education regarding breast augmentation, there are areas requiring improvement. Additional advancements and software engineering are needed to enhance the reliability and applicability of AI-driven chatbots in patient education and support systems.
Miller, Jonathan E; Raman, Shreya; Chishom, Taylor A; Mountziaris, Paschalia M
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad094pmid: 37032513
BackgroundPostoperative surgical site infection (SSI) is a devastating complication of implant-based breast reconstruction. Its occurrence may require additional hospitalization and ultimately necessitate prosthesis removal. The effect of foot traffic in the operating room has not yet been investigated within plastic surgery.ObjectivesThis study analyzed the influence of scrubbed and unscrubbed personnel on postoperative SSI in immediate implant-based breast reconstruction.MethodsThis was a retrospective review of 223 consecutive patients who underwent immediate implant-based reconstruction from 2015 to 2021 at the authors’ institution. Patient demographics, comorbidities, smoking status, laterality, number of personnel, use of drains, and length of surgery were collected. The primary outcome assessed was surgical site infection with secondary outcomes of delayed wound healing, skin necrosis, hematoma, seroma, and reoperation within 90 days.ResultsPatients who had a postoperative SSI had a mean number of 8.7 scrubbed individuals, whereas those who did not have a postoperative SSI had a mean number of 7.9 individuals scrubbed (P < .05). Univariate analysis demonstrated that increasing number of scrubbed individuals was predictive of SSI (odds ratio [OR]: 1.239, CI: 1.064-1.444, P < .05). A multivariate logistic regression demonstrated increased likelihood of SSI with increasing number of individuals scrubbed (OR: 1.232, CI: 1.027-1.478, P < .05).ConclusionsThis study demonstrates an increased risk of SSI in immediate, implant-based breast reconstruction with an increased number of personnel in the operative field. The findings highlight the importance of reducing foot traffic in the operating room when feasible to reduce risk of postoperative SSI and its associated morbidity.
Harutyunyan, Robert; Gilardino, Mirko S; Papanastasiou, Vasilios W; Jeffries, Sean D; Hemmerling, Thomas M
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad121pmid: 37099036
BackgroundFat manipulation procedures such as liposuction contain a degree of subjectivity primarily guided by the surgeon's visual or tactile perception of the underlying fat. Currently, there is no cost-effective, direct method to objectively measure fat depth and volume in real time.ObjectivesUtilizing innovative ultrasound-based software, the authors aimed to validate fat tissue volume and distribution measurements in the preoperative setting.MethodsEighteen participants were recruited to evaluate the accuracy of the new software. Recruited participants underwent ultrasound scans within the preoperative markings of the study area before surgery. Ultrasound-estimated fat profiles were generated with the in-house software and compared directly with the intraoperative aspirated fat recorded after gravity separation.ResultsParticipants’ mean age and BMI were 47.6 (11.3) years and 25.6 (2.3) kg/m2, respectively. Evaluation of trial data showed promising results following the use of a Bland Altman agreement analysis. For the 18 patients and 44 volumes estimated, 43 of 44 measurements fell within a confidence interval of 95% when compared with the clinical lipoaspirate (dry) volumes collected postsurgery. The bias was estimated at 9.15 mL with a standard deviation of 17.08 mL and 95% confidence interval between −24.34 mL and 42.63 mL.ConclusionsPreoperative fat assessment measurements agreed significantly with intraoperative lipoaspirate volumes. The pilot study demonstrates, for the first time, a novel companion tool with the prospect of supporting surgeons in surgical planning, measuring, and executing the transfer of adipose tissues.Level of Evidence: 4
Alavi-Arjas, Fatemeh; Goodman, Michael P; Simbar, Masoumeh; Majd, Hamid Alavi; Sharp, Gemma; Nahidi, Fatemeh
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad109pmid: 37078824
Performance of female genital cosmetic and reconstructive procedures (FGCRP) has been increasing over past decades. Appearance and functional concerns are the most common reasons for seeking FGCRP. Poor body and genital self-image may contribute to the increase in demand for surgery. The aim of this systematic review is to explore outcomes of FGCRP in the domains of body and genital self-image. A systematic literature review of PubMed, Web of Science, Scopus, PsycINFO, Embase, and the Cochrane Library was conducted to identify articles that measured body and genital self-image in females after FGCRP. The authors identified 5 articles for a systematic review of body image and 8 studies for a systematic review of genital self-image. The most common procedure performed was labia minora labiaplasty. Instruments for body image evaluation were the Yale–Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder and the Body Image Quality of Life Inventory. Genital image was assessed with the Female Genital Self-Image Scale and Genital Appearance Satisfaction (GAS) scale. Most of the studies indicated that FGCRP can improve both body image and genital self-image; meta-analysis revealed that FGCRP improved GAS scores by 17.96 (range: 0-33; P < .001). It appears that FGCRP leads to improvements in females’ body and genital self-image. Inconsistencies in study design and measures, however, limit this conclusion. Future research should involve more rigorous study designs (for example randomized clinical trials with large sample sizes) for a more accurate assessment of FGCRP's consequences.Level of Evidence: 4
Ruff, Paul G; Bharti, Gaurav; Hunstad, Joseph; Kortesis, Bill; DiBernardo, Barry; Gentile, Richard; Cohen, Steven; Martinez, Allison; Shridharani, Sachin M
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad055pmid: 36883611
BackgroundMinimally invasive procedures that deliver thermal energy to subcutaneous tissue offer a solution when deciding between excisional and noninvasive options to address face and neck aging-related changes. A minimally invasive helium plasma device, Renuvion, was first utilized for subdermal tissue heating to reduce skin laxity under an FDA general clearance for cutting, coagulation, and ablation of soft tissue.ObjectivesThe purpose of this study was to demonstrate the safety and effectiveness of the helium plasma device for improving the appearance of loose skin in the neck and submental region.MethodsPatients undergoing the procedure with the helium plasma device in the neck and submentum were studied. They were seen for 6 months following the procedure. The primary effectiveness endpoint for improvement in lax skin in the treatment area was determined by 2 of 3 blinded photographic reviewers. The primary safety endpoint was the level of pain after treatment.ResultsThe primary effectiveness endpoint was met; 82.5% demonstrated improvement at Day 180. The primary safety endpoint was met; 96.9% of patients experienced no pain to moderate pain to Day 7. There were no serious adverse events reported related to the study device or procedure.ConclusionsThe data demonstrate benefit to patients by improvement of the appearance of lax skin in the neck and submental region. Outcomes resulted in US Food and Drug Administration 510(k) clearance in July 2022, expanding indications for the device to include subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and submental region.
Humphrey, Shannon; Dover, Jeffrey S; Bowsher, Ronald R; Clancy, Amanda; Liu, Yan; Prawdzik, Gregg; Gallagher, Conor J
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad101pmid: 37051886
DaxibotulinumtoxinA-lanm for injection (DAXI), a novel botulinum toxin type A formulation, contains a purified 150-kD core neurotoxin (daxibotulinumtoxinA) and proprietary stabilizing peptide (RTP004), and is approved for glabellar line treatment. As with any biologic product, DAXI may potentially be immunogenic and elicit unwanted antibody formation, possibly resulting in partial or complete treatment failure. The immunogenicity of DAXI was assessed in 2 double-blind, placebo-controlled, single-dose studies and an open-label safety study of up to 3 repeat treatments. Of the 2737 evaluable patients, none developed neutralizing antibodies to daxibotulinumtoxinA and 0.8% developed treatment-related nonneutralizing anti–daxibotulinumtoxinA-binding antibodies. Of evaluable patients exposed to RTP004 with either DAXI or placebo, 1.3% developed treatment-related anti–RTP004-binding antibodies, which were mostly transient. No patient developed binding antibodies to both daxibotulinumtoxinA and RTP004. All patients with treatment-related binding antibodies to daxibotulinumtoxinA or RTP004 achieved a clinical response (none or mild glabellar line severity) at Week 4 following each DAXI treatment cycle. The duration of clinical response was not different between treatment cycles when antibodies were detected vs when they were absent. Although the analysis population was small compared to the number of patients likely to receive repeated treatment in clinical practice, these results suggest that DAXI administration at the approved glabellar lines dose has low immunogenic potential and that nonneutralizing antibodies to daxibotulinumtoxinA or RTP004 occur infrequently and often transiently, and have no impact on clinical efficacy, safety, or duration of action. Real-world data encompassing larger numbers of patients is needed to substantiate these results.Level of Evidence: 3
Glicksman, Caroline; McGuire, Patricia; Kadin, Marshall; Barnes, Kirsten; Wixtrom, Roger; Lawrence, Marisa; Haws, Melinda; Ferenz, Sarah; Sung, C James; Hamilton, Robert G; Faasse, Kate
2023 Aesthetic Surgery Journal
doi: 10.1093/asj/sjad098pmid: 37040435
BackgroundBreast Implant Illness (BII) describes a variety of symptoms reported by patients with breast implants. Biospecimens data revealed minimal statistical differences between BII and non-BII cohorts. Baseline analysis of PROMIS data demonstrated significant differences between the BII cohort and the 2 control cohorts.ObjectivesThis study was designed to determine if patients in the BII cohort obtained any symptom improvement after explantation, whether symptom improvement was related to the type of capsulectomy, and which symptoms improved.MethodsA prospective blinded study enrolled 150 consecutive patients divided equally into 3 cohorts. Baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, were obtained at baseline, 3 to 6 weeks, 6 months, and 1 year.ResultsA total of 150 patients were enrolled between 2019 and 2021. Follow-up at 1 year included 94% of the BII cohort and 77% of non-BII and mastopexy cohorts. At 1 year, 88% of patients showed at least partial symptom improvement, with a reduction of 2 to 20 symptoms. The PROMIS score in the BII cohort decreased at 1 year for anxiety, sleep disturbances, and fatigue. Systemic symptom improvement was noted out to 1 year in the BII cohort regardless of the type of capsulectomy performed.ConclusionsParts 1–3 in this series concluded that there were no consistent differences in biospecimen results between the cohorts. Unlike the data observed in the biospecimen analysis, BII patients had heightened symptoms and poorer PROMIS scores at baseline compared to the control cohorts. The reduction of negative expectations and a potential nocebo effect could contribute to this improvement.Level of Evidence: 4