Long-Term Efficacy and Tolerability of a Medium G' HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone.

Purpose: Injectable hyaluronic acid-based fillers are commonly used for the correction of skin contour irregularities and to smooth skin depressions formed by volume loss during the aging process. These fillers are particularly efficient to restore perioral skin depressions/wrinkles or to correct topographical anomalies. The European directives require a continuous evaluation of the performance of these medical devices, particularly for CE marked products. Methods: An 18-month prospective randomized single-blind study for the efficacy and safety of ART FILLER Universal (AFU) was performed on the lips, the nasolabial folds, and the marionettes lines. The evaluations were performed on 153 subjects enrolled in this study. The efficacy, the longevity, and the safety were evaluated for the injected areas via area specific clinical scoring after a single injection with the filler and with no re-touch. Results: We showed here that filler injection induced potent improvements of volume restoration after a single injection on all the treated areas. These beneficial properties of the filler were significant 3 weeks after injection and during the whole study period. Moreover, injections of the filler were well tolerated by the subjects. The recorded adverse events are routinely seen with HA fillers for face volume corrections, and most of these local reactions resolved within 14 days. Conclusion: AFU was well tolerated and showed a continuous efficacy for at least 18 months, in exploratory analyses.

Long-term efficacy and safety of a hyaluronic acid dermal filler based on Tri-Hyal technology on restoration of midface volume.

INTRODUCTION: Art Filler Volume (AFV) is a hyaluronic acid (HA)-based filler formulated with "Tri-Hyal" technology, a unique combination of three sizes of HA chains. This study assessed AFV efficacy and safety over 18 months when used to restore midface volume. METHODS: During this open-label study, a maximum of 1.8 mL AFV was injected into each cheek area on Day 0 (D0). Subjects were evaluated at D21, when, if necessary, a retouch could be performed (maximum 1.2 mL per cheek). Subjects were evaluated at seven follow-up visits through to D540. The primary assessment was based on the evolution of the Medicis Midface Volume Scale (MMVS) grade on D21. Secondary outcomes were local and general adverse events, investigator- and subject-assessed Global Aesthetic Improvement Scale scores and changes in self-esteem. RESULTS: Of the 79 healthy Caucasians enrolled (mean age 54.8 years), 25 required a second injection. In the intention-to-treat population, mean overall MMVS scores improved significantly from D0 (3.2 ± 0.4) to D21 (1.8 ± 0.6) and D42 (1.7 ± 0.6) (all p < 0.0001). MMVS scores for each cheek also improved significantly, irrespective of retouch on D21: 22% of injections showed a persistent benefit at D540 without retouch. The most common adverse events were pain on palpation (19%), erythema (15%) and edema (13%); most were mild or moderate and resolved within 2 weeks. CONCLUSION: AFV produces a sustained objective and subjective midface volume restoration in female and male subjects, often without retouching, and was well tolerated.

Comparative clinical study for the efficacy and safety of two different hyaluronic acid-based fillers with Tri-Hyal versus Vycross technology: A long-term prospective randomized clinical trial.

BACKGROUND: Hyaluronic acid-based fillers have an immediate volumizing effect for the treatment of dermal contour deformities and to smooth dermal depressions formed by the loss of volume. A previous study on 2016-2018 has shown the efficacy and safety of the HA-based filler ART FILLER® Volume on the midface only, but not in a comparative manner. METHODS: In this context, an 18 months prospective randomized single-blind study of the non-inferiority of ART FILLER® Volume versus the reference product Juvéderm Voluma® was performed on the midface, temple, and jawline, and non-comparative study on the chin. The efficacy and the longevity were evaluated for the selected face areas via dedicated clinical scoring systems after a single filler injection without any re-touch or re-injection. The short- and long-term adverse effects were also recorded. RESULTS: The observations confirmed the non-inferiority of ART FILLER® Volume versus the reference product on the different injected areas. For both fillers, the beneficial effects on volumes restoration were maintained 18 months post-injection; however, these effects were diminished among the time. Furthermore, injections of Art Filler® Volume were well tolerated by the subjects and showed less acute side effects compared with the reference product that may be explained by a lower induction of inflammation.

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.

BACKGROUND: Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers. AIMS: To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines. MATERIALS AND METHODS: This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS). RESULTS: In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up. CONCLUSIONS: The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.

Microfat and Nanofat Grafting in Genital Rejuvenation.

BACKGROUND: Genitourinary syndrome of menopause (GSM) is a major problem in many post- or perimenopausal women. Lipofilling has long been considered to be an effective technique for restoring volume, but the discovery of its trophic proprieties has made it the most widely utilized method in regenerative medicine. OBJECTIVES: The authors aimed to assess the safety and efficacy of microfat and nanofat grafting for vulvovaginal rejuvenation. METHODS: Women with GSM who met the inclusion criteria were enrolled. Women received microfat in the labia majora and nanofat in the vagina; follow-up was conducted 1, 3, 6, 12, and 18 months. The vaginal health index (VHI) and Female Sexual Distress (FSD) were utilized to assess improvement in vulvovaginal atrophy, orgasm, and sexual desire posttreatment. RESULTS: Fifty women were included; their average age was 53 years (range, 45-63 years). The VHI score significantly increased at 1 and 3 months after treatment (P < 0.0001). Moreover, the average FSD score showed a significant improvement at 1 and 3 months posttreatment. This score stabilized from 6 to 12 months but showed further improvement at 18 months. At 6 months posttreatment, for both scales, data pertaining to 80% of patients appeared normalized. There was a particular benefit noted for dryness and dyspareunia. At 18 months, the results remained stable for all of patients. No major side effects were observed. CONCLUSIONS: There are now many ways to rejuvenate the intimate sphere, but microfat and nanofat grafting seem to offer good results with an autologous procedure. Their utilization appears promising for genital rejuvenation.

Post-EVAR Thrombus Density on Late Non-Contrast CT Scans Predicts Successful Aneurysm Exclusion.

PURPOSE: The incidence of type II endoleaks (ELII) after endovascular aneurysm repair (EVAR) ranges from 10-44%. Aneurysm thrombus density after EVAR could predict successful aneurysm exclusion. MATERIALS AND METHODS: Twenty-seven patients with an abdominal aortic aneurysm (AAA) who had a CT scan within the first 45 days (early group) post-surgery or after 7 months (late group) were included. Thrombus density was analyzed on non-contrast enhanced CT scans. RESULTS: A total of 5/13 (38%) patients in the early group had an ELII and 9/14 (64.3%) in the late group had a persistent ELII since surgery. In the early group, thrombus density was similar in patients with or without an ELII (mean: 39.9 ± 4.8 vs. 41.9 ± 3.4, p = 0.7; median: 38.7 ± 4.8 vs. 39.7 ± 3.1, p = 0.8). In patients with an ELII, there was no difference in thrombus density at 45 days and after 7 months (mean: 39.9 ± 4.8 vs. 40.2 ± 2.1, p = 0.9; median: 38.7 ± 4.8 vs. 38 ± 2.6, p = 0.9). In patients without an ELII, thrombus density was significantly higher at 45 days than after 7 months (mean: 41.9 ± 3.44 vs. 25.7 ± 2.0, p = 0.005; median: 39.7 ± 3.11 vs. 24.4 ± 1.5, p = 0.004). In patients with an ELII, thrombus density was significantly higher after 7 months than in patients without an ELII (mean: 40.2 ± 2.1 vs. 25.7 ± 2.0. p = 0.001; median: 38 ± 2.6 vs. 24.4 ± 1.5, p = 0.003). CONCLUSION: Low thrombus density after EVAR on late unenhanced CT scans predicts aneurysm exclusion.

Early Postoperative Renal Dysfunction Predicts Long-Term Renal Function Degradation after Type IV Thoracoabdominal Aortic Aneurysm Surgical Repair.

BACKGROUND: Type IV thoracoabdominal aortic aneurysm surgical repair is often complicated by postoperative acute kidney injury. The aim was to evaluate early renal injury influence on long-term renal function. METHODS: All type IV thoracoabdominal surgical repair performed between January 2000 and January 2014 in our tertiary hospital were included in this retrospective observational study. All procedures were performed through a retroperitoneal approach with at least suprarenal aortic cross-clamping. Cold Ringer Lactate was used to perfuse the kidneys. Serum creatinine (Scr.) and glomerular filtration rate (GFR) were recorded preoperatively, daily until discharge and at least annually during follow-up. Postoperative renal dysfunction was classified using the RIFLE score. Predictors of long-term renal decline were identified by logistic regression and a Cox model. RESULTS: Of total, 80 patients were included. Aortic clamping level was suprarenal (10%), supramesenteric (37%) or supracoeliac (53%). Ischemic durations were 29 ± 9 min for the gastrointestinal tract and the right kidney, 54 ± 28 min for the left kidney. Three patients died postoperatively. At discharge, 31 (38.8%) patients did not have a postoperative renal impairment (RIFLE-), compared with 49 (61.2%) who had a renal dysfunction (RIFLE+). GFR was 89 ± 29 ml/min vs 68 ± 37 ml/min, respectively (P < 0.01). In the RIFLE + group, Scr. was increased by x1.5 (Risk) for 22 patients, x2 (Injury) for 19 patients, and ×3 (Failure) for 8 patients. Mean follow-up was 59 months. Eighteen patients died, and 2 patients started permanent dialysis at 46 and 118 months during follow-up. The only predictive factor of long-term GFR degradation was a postoperative GFR below 45 ml/min (OR: 16.5; 95%; P < 0.001). CONCLUSIONS: Postoperative renal dysfunction was a frequent complication, associated with long-term renal function degradation.

Objective 18-month Comparison of the Tolerability of 2 Dermal Fillers Formulated with Tri-Hyal Technology.

The first phase of this study showed that ART FILLER Universal filler (AFU; FILORGA Laboratories) and ART FILLER Fine lines (AFFL) were non-inferior to JUVÉDERM Ultra 3 (Allergan) and FIRST LINES PureSense (Teoxane), respectively. The clinical benefits of AFU and AFFL on nasolabial folds and crow's feet persisted until at least Day 180. This article reports results from an open-label extension phase that assessed the tolerability and efficacy of AFU and AFFL for up to 18 months based on clinical evaluation and ultrasound high-frequency imaging. METHODS: Eligible subjects were enrolled at D180 and assessed on D270, D360, and D540. The primary outcome measured was local tolerability. Secondary outcomes measured included: proportion of subjects in whom the severity of nasolabial folds and crow's feet remained at least 1 point below the baseline measurement (Lemperle scale); general safety; Global Aesthetic Improvement Scale scores by subjects and investigators; wrinkle volumes; and skin thickness by high-frequency ultrasound. RESULTS: Adverse events were consistent with the product information and the initial study. No serious adverse events were recorded. In exploratory analyses, wrinkle correction with AFU and AFFL is sustained for at least 18 months: 48.4% and 98.3% of subjects respectively still showed at least a 1-point decrease in the mean Lemperle score compared with the baseline. The benefits were sustained irrespective of whether subjects received additional injections. Modifications in wrinkle volume and skin thickness at D540 were statistically significant compared with the baseline. CONCLUSION: AFU and AFFL were well tolerated and, in exploratory analyses, showed a sustained efficacy for at least 18 months.

Labia Majora Augmentation Combined With Minimal Labia Minora Resection: A Safe and Global Approach to the External Female Genitalia.

BACKGROUND: All the labia minora reduction techniques fail to treat the other component of the abnormally increased labia minora to majora ratio: the labia majora atrophy. The purpose of this study is to describe a technique of female genitalia beautification, which combines labia majora augmentation and conservative labia minora reduction. METHODS: The hypertrophied labia minora were first treated by a conservative inferior wedge excision with a superior flap. The conservative excision was done to obtain labia minora that would still protrude beyond the labia majora because it will be masked by the augmentation of the labia majora. Labia majora augmentation was done by autologous fat transplantation. The newly augmented labia majora completely masked the conservatively reduced labia minora. RESULTS: Twenty-one patients underwent surgery for labia majora augmentation and labia minora reduction. One patient (4.7%) had a small separation of the labial edge postoperatively that resolved with no additional interventions. There was no flap necrosis or infections. No patient reported pain or sexual dysfunction. Seventeen patients (81%) were satisfied or very satisfied with their results. CONCLUSIONS: Labia majora augmentation combined with a conservative labia minora reduction is an appealing procedure because it enhances the global aspect of the female genitalia while reducing the labioplasty complications.

Prospective, Split-Face, Randomized, Long-Term Blinded Objective Comparison of the Performance and Tolerability of Two New Hyaluronic Acid Fillers.

BACKGROUND: There are requirements for long-term, objective comparisons of hyaluronic acid (HA) dermal fillers. OBJECTIVE: To compare efficacy and tolerability of ART FILLER Universal (AFU) and ART FILLER Fine lines (AFFL) with the existing HA fillers for the treatment of nasolabial folds and crow's feet. MATERIALS AND METHODS: Prospective, randomized, rater- and patient-blind, split-face comparison of AFU with JUVEDERM Ultra 3 (JUV) and AFFL with FIRST LINES PureSense (FLPS). The severity of nasolabial folds and crow's feet was assessed by independent blinded evaluators using the Lemperle scale at baseline, day (D) 30/D45, D90, and D180. Tolerability, Global Aesthetic Improvement Scale (GAIS), wrinkle volumes, and skin thickness and density were also measured at D30/D45, D90, and D180. RESULTS: At D30 and D180 respectively, 61 and 57 patients were assessed. Scores for nasolabial folds and crow's feet showed statistically significant improvements at D30, D90, and D180. AFU and AFFL were noninferior to JUV and FLPS, respectively. Most patients showed GAIS improvements, maintained until at least D180 and significant increases of collagen synthesis in crow's feet and nasolabial folds. Treatments were well tolerated. CONCLUSION: AFU and AFFL are noninferior to comparators. The methodology used represents a novel approach to augment existing clinical assessment of HA fillers.

Below-The-Knee Angioplasty for Critical Limb Ischemia: Results of a Series of 157 Procedures and Impact of the Angiosome Concept.

BACKGROUND: To evaluate the long-term clinical results of below-the-knee percutaneous transluminal angioplasty (BTK-PTA) with or without stenting, in patients with critical limb ischemia (CLI), and to determine factors affecting clinical results including the role of the angiosome concept. METHODS: All patients undergoing primary BTK-PTA from January 2007 to December 2011 were included. Primary patency, assisted patency, limb salvage, survival, and wound healing were assessed using the Kaplan-Meier method. Predictors of patency, limb salvage, survival, and wound healing, including the role of the angiosome theory, were determined using multivariate models. RESULTS: A total of 157 procedures were performed in 139 patients with CLI (Rutherford IV 10.8%; Rutherford V-VI 89.2%). Mean age was 74.2 years and 68.3% were men; 60% had diabetes and 31% renal insufficiency. PTA was confined to the infrapopliteal segment alone in 53.5% of cases. Technical success was 87.9%. Stents were placed in 42.6% of cases. The mean follow-up was 14.7 months (range, 1-67 months). Four-year primary and secondary patency were 51% and 61%, respectively. Limb salvage at 4 years was 68.8%. Complete wound healing was 52% at 4 years. Positive predictors of survival were the absence of renal insufficiency (P < 0.0001) and technical success (P = 0.029). Target vessel occlusion of >50% was a negative predictor of limb salvage (P = 0.0072). Positive predictors of wound healing were technical success (P = 0.0067), the absence of renal insufficiency (P < 0.0001) and continuity between a leg artery and a foot artery (P = 0.02). CONCLUSIONS: BTK-PTA can be performed with favorable long-term results in patients with limited longevity. Secondary interventions may be necessary to maintain target vessel patency. In our experience, the angiosome concept had no impact on clinical success.

Depression, anxiety and quality of life: outcome 9 months after facial cosmetic surgery.

OBJECTIVE: The request for cosmetic surgery is of a psychological nature. Very few studies have quantitatively assessed whether or not this psychological need was actually satisfied, and more precisely, which psychic components were satisfied. MATERIAL AND METHODS: This is a multicentric, prospective cohort study. One hundred and three patients scheduled for facial cosmetic surgery from three different hospitals were examined before and after surgery using four assessment scales validated using European populations. The Montgomery and Asberg depression rating scale (MADRS) measured the existence and intensity of depression, the self-assessment test of thoughts in social interaction (SISST) measured the positive or inhibitory thoughts in the context of social relationships, and the European quality of life 5 dimensions (EQ-5D) (generic test) measured the quality of life. In addition, a semi-directive interview was specially created by our team. For statistical analysis, ANOVA and Student's t test were applied. RESULTS: Twenty-four patients were lost to follow-up. Although the initial MADRS index was high (p<0.05), it did not change after surgery (p>0.1). SISST+ (positive thoughts): the social anxiety of the individual examined was significantly greater than that of the control group (p<0.005) and improved after surgery (p<0.01). The SISST- (inhibitory thoughts) did not change (p>0.1). The EQ-5D visual analogue scale (VAS) did not reveal any difference (p>0.1) while the descriptive EQ-5D demonstrated over-representation of anxiety/depression (p<0.01), and an improvement of this (p<0.05) postoperatively. The mean subjective satisfaction index was 8.1 (scale of 1-10) without sharing any influence of the complications suffered (65% of the patients made self-assessments). CONCLUSION: The best indications for facial cosmetic surgery seem to be a lack of self-confidence associated with a desire for social interaction, and a request focused on a specific physical feature. The results presented add documentary confirmation to the impression shared by the majority of cosmetic surgeons. However, it was also confirmed that cosmetic surgery is not limited to its technical components, but remains a medical act which must consider the overall effect on the whole patient.

Depression, anxiety and quality of life among scheduled cosmetic surgery patients: multicentre prospective study.

Objective: To measure cosmetic surgery patients' state of psychological vulnerability. Method: A multicentre prospective study was carried out in three hospital departments. One hundred and three patients scheduled for cosmetic surgery were examined using a structured interview and using three assessment scales: the MADRS (Montgomery and Asberg Depression Rating Scale), the SISST (Social Interaction Self Statement Test) and the EQ-5D (EuroQol) which measures quality of life. Results: The MADRS index was higher than that of the control group (p<0.01) with 20% depressive patients. SISST: the social anxiety was greater than that of the control group (p<0.001). The EQ-5D visual analogue scale average was 77.39% indicating that there was no significant difference when compared with the control group, but the descriptive EQ-5D revealed an over-representation of the anxiety/depression category (p<0.01); 50% had already taken psychotropic treatment of which 27% were an antidepressant. Conclusion: The cosmetic surgery population presents a significant state of psychological vulnerability. Copyright 2001 European Association for Cranio-Maxillofacial Surgery.