Nonsurgical Treatment of Postpartum Lower Abdominal Skin and Soft-Tissue Laxity Using Microfocused Ultrasound With Visualization.

BACKGROUND: Microfocused ultrasound with visualization (MFU-V) is a well-established treatment modality for skin tightening. There is a paucity of evidence for its use in body treatments, such as the lower abdomen. OBJECTIVE: To investigate the effectiveness and safety of MFU-V in treating lower abdominal skin and soft-tissue laxity in postpartum women. METHODS: The lower abdomen of 20 female patients between 6 and 24 months postpartum are treated with MFU-V using 1.5-, 3.0-, and 4.5-mm transducers. Data are prospectively collected and analyzed at 3 and 6 months using subject-reported and investigator-reported outcome measures. One additional patient underwent planned abdominoplasty 6 weeks after MFU-V treatment with tissue assessed intraoperatively and histologically. RESULTS: There was a mean improvement of 1.0 and 1.3 grades at 6 months using the investigator-reported and patient-reported skin laxity scale, respectively (p < .001). Patient-reported outcomes and satisfaction survey showed consistent improvement at 6 months. Histological examination of pretreated tissue showed increased total collagen, increased number and thickness of fibrous septae, and no change in fat cells within pretreated tissue compared with the control. No significant adverse events were recorded. CONCLUSION: MFU-V is an effective and safe treatment modality for lower abdominal skin laxity in postpartum patients.

High-Intensity Focused Ultrasound Ablation Combined with Electrical Passive Exercise for Fast Removal of Body Fat.

BACKGROUND: High-intensity focused ultrasound (HIFU) lipolysis still lacks treatment efficacy. The authors hypothesized that electrical stimulation of muscular groups can enhance the metabolism of free lipids released from HIFU-ablated adipocytes. METHODS: Five-month-old, male Landrace swine, with an average initial weight of 95 kg, were divided randomly into sham, HIFU only, HIFU plus electrical stimulation I, and HIFU plus electrical stimulation II groups. Subcutaneous adipose tissue of the porcine abdomen was treated once by HIFU on days 1 of weeks 1, 3, and 5, and electrical stimulation of the quadriceps was performed once on the day 1 of weeks 1 through 6. The numbers of ultrasonic sonications were 70 per treatment for the HIFU-only and HIFU plus electrical stimulation I groups and 400 for the HIFU plus electrical stimulation II group. The measured data are expressed as medians (ranges). RESULTS: The body weights of all pigs increased gradually with time. The waist circumferences below the sheath decreased from 97.7 ± 6.0 cm in week 1 and 97.9 ± 5.3 cm in week 3 to 96.4 ± 10.0 cm in week 6, and from 105.3 ± 5.1 cm and 101.2 ± 7.4 cm to 100.5 ± 6.1 cm for the HIFU plus electrical stimulation I and II groups, respectively, whereas they increased for the sham and HIFU-only groups. The reductions in the adipose tissue thickness were 0.59, 1.46, and 2.18 mm for the HIFU-only, HIFU plus electrical stimulation I, and HIFU plus electrical stimulation II groups, respectively, when the sham group increased by 1.42 mm. Follow-up blood analyses demonstrated no significant changes in lipid panel parameters from baseline values. CONCLUSION: HIFU plus electrical stimulation can induce a substantial reduction in the waist circumference of pigs.

A randomized double-blind trial evaluating the efficacy and tolerability of topical body treatment with TriHex Technology® combined with abdomen cryolipolysis or radiofrequency procedures.

BACKGROUND: Nonsurgical fat reduction procedures using cryolipolysis and radiofrequency are among the most popular noninvasive aesthetic procedures. In a previous study, TransFORM Body Treatment (TFB) with TriHex Technology® (ALASTIN® Skincare) improved the contour and reduced skin laxity following cryolipolysis of the arms. This product is formulated using a combination of peptides and other active ingredients designed to stimulate the autophagic breakdown of lipid droplets and expedite the apoptotic process after fat reduction procedures. AIMS: To assess the changes in abdominal volume after application of TFB for 12 weeks following cryolipolysis and radiofrequency procedures. METHODS: Following abdominal cryolipolysis or radiofrequency therapy, the subjects (N = 15) received TFB product and placebo and were randomly assigned to apply to the right or left sides of the abdomen for 12 weeks. Using 3-dimensional digital imaging analysis, subjects were evaluated at 4, 8, and 12 weeks posttreatment. RESULTS: Topical TFB resulted in increased volume loss, which was greater than that for placebo at weeks 4 (P = .0511), 8 (P = .0238), and 12 (P = .0078), respectively, and statistically significant at weeks 8 and 12. There were no reported adverse events. CONCLUSION: In this study, Topical application of TFB significantly increased adipose volume loss and improved clinical outcomes of nonsurgical fat reduction procedures.

Efficacy and Safety of High-Intensity Focused Ultrasound for Noninvasive Abdominal Subcutaneous Fat Reduction.

BACKGROUND: Demand for noninvasive body contouring has increased. OBJECTIVE: We evaluated the efficacy and safety of a thermal high-intensity focused ultrasound (HIFU) device for abdominal body shaping. PATIENTS AND METHODS: Adults with a body mass index ≤30 kg/m and an abdominal subcutaneous fat tissue thickness ≥2.5 cm were enrolled for HIFU treatment at energy levels of 150 J/cm (first session) and 135 J/cm (second session). The primary end point was a change from baseline waist circumference at post-treatment Week 8. Secondary efficacy end points were: changes in body weight, waist/hip ratio, and fat thickness assessed by ultrasound, caliper, and a fat CT scan. The Global Aesthetic Improvement Scale was evaluated by both investigators and subjects. RESULTS: The primary assessment achieved statistical significance, showing a reduction of 3.43 cm in mean waist circumference. The treatment effect was cumulative, with a steady decrease in waist circumference and fat thickness. The mean pain scores immediately after treatment were 4.45 ± 2.74 on a scale of 1 to 10 with 10 being the most painful, which decreased to 1.10 ± 1.33 after 1 week. CONCLUSION: High-intensity focused ultrasound is an effective and safe treatment modality for reducing waist circumference in nonobese individuals with focal fat accumulation.

Paradoxical adipose hyperplasia after noninvasive radiofrequency treatment: A novel report and review.

The past decade has experienced a surge in the frequency of nonsurgical procedures, including injectables, skin rejuvenation, and nonsurgical fat reduction. Nonsurgical fat reduction methods include cryolipolysis (Coolsculpting), ultrasound (Vaser Shape), laser (Liposonix), and radiofrequency (Vanquish). These methods generally produce good results, with cryolipolysis gaining much popularity over the past few years. Multiple reports of paradoxical adipose hyperplasia have been reported with Coolsculpting, with an incidence of 0.025% to 1%. This entity has never been reported with other methods of nonsurgical fat reduction, including noninvasive radiofrequency (Vanquish). We present a case of paradoxical adipose hyperplasia in a 57-year-old male following treatment with noninvasive radiofrequency (Vanquish) to the abdomen. He was treated with power-assisted liposuction to the abdomen and flanks. This is the first case in the literature of paradoxical adipose hyperplasia in a patient treated with this form of noninvasive fat reduction.

Numerical Study of Hyper-Thermic Laser Lipolysis With 1,064 nm Nd:YAG Laser in Human Subjects.

BACKGROUND AND OBJECTIVES: The aim of this study was to develop a numerical model for hyperthermic laser lipolysis in human subjects to improve understanding of the procedure and find optimal therapeutic parameters. STUDY DESIGN/MATERIALS AND METHODS: A numerical model of hyperthermic laser lipolysis (HTLL) on human subjects was developed that is based on light and heat transport, including the effects of blood perfusion and forced air cooling. Tissue damage was evaluated using the Arrhenius model. Three irradiation scenarios were considered: single skin area irradiation without and with forced air cooling, and sequential heating of four adjacent skin areas in a cyclical manner. An evaluation of the numerical model was made by comparing the recorded skin surface temperature evolution during an experimental HTLL procedure performed on the abdomen of ten human volunteers using a 1,064 nm Nd:YAG laser irradiation. RESULTS: A good agreement was obtained between the simulated skin surface temperatures and that as measured during the HTLL procedure. The temperature difference between the simulations and experiments was in the range of 0.2-0.4°C. The model parameters, which were fitted to the experiment were the perfusion parameter (0.36-0.79 and 0.18-0.49 kg/m 3 ·s for dermis and subcutis) and the subcutaneous tissue absorption coefficient (0.17-0.21 cm -1 ). By using the developed HTLL model and the determined parameters, temperature depth distributions and the resulting thermal injury to adipocytes were simulated under different treatment conditions. Optimal ranges of the HTTL treatment parameters were determined for different skin types, damaging adipocytes while preserving skin cells. The target subcutaneous temperatures were in the range of 43-47°C, which has been found to lead to programmed adipocyte death. The optimal treatment parameters were further used to define a range of recommended protocols for safe and effective multiarea cycled HTLL treatment of large body surfaces. Specifically, for the set of chosen optimal treatment parameters (4-5 treatment cycles, 1.2 W/cm 2 radiant exposure, and 60-130 W/cm 2 forced air heat-transfer coefficient) the threshold surface temperature during irradiation was found to be in the range of 31-38°C, depending on the skin type and heat-transfer coefficient. CONCLUSIONS: The developed numerical model allows for the calculation of the temperature distribution and the resulting injury to adipocyte cells within deeper lying fatty tissues under different clinical treatment conditions. It is demonstrated that by measuring the temporal evolution of the skin surface temperature and by stopping the laser irradiation at predefined skin surface threshold temperatures, it may be possible to monitor and control the effects of the HTLL procedure deeper within the tissue. As such, the model provides a better insight into the HTLL, and may become a tool for defining the range of safe and effective HTLL treatment protocols for patients with different skin types. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Ultrasound Assessment of Subcutaneous Abdominal Fat Thickness After Treatments With a High-Intensity Focused Electromagnetic Field Device: A Multicenter Study.

BACKGROUND: High-intensity focused electromagnetic (HIFEM) technology is intended for muscle toning, firming, and strengthening. OBJECTIVE: The goal of this study is to quantify the effect of HIFEM treatments on subcutaneous fat. MATERIALS AND METHODS: A total of 33 patients participated in the study. Each subject underwent 4 treatments on the abdomen with the HIFEM device. Ultrasound images were obtained measuring the thickness of the subcutaneous fat from 4 standardized measurement points. Ultrasound images were taken before treatment and at 1-month and 3-month follow-up visits. Photographs were captured using both 2D and 3D cameras. Weight measurements were taken, as well as surveys assessing both patient comfort, satisfaction, and adverse events. RESULTS: A significant reduction in the subcutaneous fat thickness across the abdomen was observed, averaging 19.0%/4.47 ± 3.23 mm (p < .01) at 1 month after treatment and 23.3%/5.78 ± 4.07 mm 3 months after treatment. At 1 month, the most significant reduction in subcutaneous fat was measured subumbilically (26.6%/6.25 ± 4.70 mm; p < .01) and epiumbilically (21.6%/5.08 ± 3.69 mm; p < .01). No discomfort was reported, and 91% of study participants were satisfied with their result. CONCLUSION: Based on the ultrasonographic and photographic observations, the authors conclude that the application of an HIFEM field is an effective option for the noninvasive treatment of subcutaneous fat.

High intensity focused electromagnetic therapy evaluated by magnetic resonance imaging: Safety and efficacy study of a dual tissue effect based non-invasive abdominal body shaping.

OBJECTIVES: This study introduces an initial evaluation of a novel High-Intensity Focused Electromagnetic (HIFEM) technology. The primary goal is to quantify any effects the treatments may have on abdominal tissues, as well as to establish hypotheses for future research of this technology. METHODS: Twenty-two patients received four abdominal treatments using the EMSCULPT device (BTL Industries Inc., Boston, MA). Anthropometric evaluations were recorded and digital photographs were taken at baseline, at 2 months, and at 6 months post-treatments. The MRI without contrast determined by vertertebras T12 and S1 (FIESTA and FSPRG sequences) was used to measure dimensions in coronal cross-sectional images of abdominal muscle and fatty tissues, in order to assess any anatomical changes induced by the application. RESULTS: Analysis of the same MRI slices verified by tissue artefacts showed a statistically significant (all P < 0.0001) average 18.6% reduction of adipose tissue thickness, 15.4% increase in rectus abdominis muscle thickness, and 10.4% reduction in rectus abdominus separation (diastasis recti) as measured from the medial border of the muscle 2 months post-treatment. More significant improvements were observed in patients with BMI 18.5-24.9 (classified as "normal"). MRI data from 6-month follow-up suggest the changes can be preserved in longer term. Tape measurements showed on average 3.8 cm subumbilical circumference reduction. The weight of the subjects did not change significantly (average -0.5 lb; P > 0.05). No adverse events were reported. CONCLUSIONS: MRI, considered as a highly precise diagnostic method, revealed simultaneous muscle growth, fat reduction and reduced abdominal separation at 2 months and at 6 months post treatments, unrelated with dieting. Further research should investigate the exact physiological processes which stand behind the tissue changes observed in this study. Lasers Surg. Med. 51:40-46, 2019. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Treating multiple body parts for skin laxity and fat deposits using a novel focused radiofrequency device with an ultrasound component: Safety and efficacy study.

BACKGROUND AND OBJECTIVES: Growing demand for noninvasive skin tightening and reduction in fat results in an increasing pressure for devices with good clinical efficacy, consistency of results, and high patient comfort. The objective was to validate clinical efficacy and versatility of a novel device, which combines radiofrequency (RF) and ultrasound for treating skin laxity and fat deposits. METHODS: We treated 34 subjects with facial skin laxity and/or abundant body or arm fat deposits. Subjects were divided based on their indications. Ten subjects received treatments to the face, 7 subjects to arms, 8 subjects to thighs, and 9 subjects on abdomen. All patients received 4 treatments on a weekly basis. Photographs of patients were assessed by blinded evaluators to recognize the baseline images from the 3-month follow-up images. Patient comfort and satisfaction were evaluated using a 5-point Likert scale questionnaire. Any adverse events were recorded. RESULTS: Patient images were correctly recognized in >90% of cases in all study groups. Patient questionnaires showed overall satisfaction with the therapy course and results. On a scale of 1 to 5, the patients agreed (4.1) that they are satisfied with the results that the treatment is comfortable (4.1) and that they are satisfied with the treatment time (4.1). No adverse events were reported. CONCLUSIONS: Consistent clinical efficacy was confirmed across all the treated areas, together with high patient comfort and satisfaction. We conclude the device is a highly versatile solution that can deliver results across body parts and different indications.

Megasessions: Efficacy of Fewer, Longer Treatment Sessions for Fat Reduction in Noninvasive Body Contouring Using a Radiofrequency Based Device.

While the field of noninvasive body contouring is booming, many patients still note a lesser result than they might achieve with a single session of liposuction or dermolipectomy. The duration of a noninvasive fat reduction treatment series can be daunting. Patients have questioned the worth of these procedures when the expected benefit is modest and the time they devote to the project is significant. An eight-patient mini-study was performed to see if two or three "megasessions" could be substituted for eight weekly sessions of bipolar radiofrequency based fat reduction treatments. Patients were randomized into a two session or three session group by drawing straws. The device used was the BodyFX bipolar RF device by InMode. This device employs a suction coupled vacuum that heats a section of skin and soft tissue in the treatment region and delivers a high voltage pulse. Each patient was treated for 2 hours per session, using the Body FX, more superficial Mini FX, and the Deep FX device in an effort to treat on a multilevel basis. Preoperative 2D and 3D Vectra photos were taken, and were repeated at 1 month and 3 months post-treatment. Volumetric analysis and patient assessment showed similar results with a two or three treatment "megasession" protocol when compared with the traditional protocol of eight weekly sessions. While the cohort number was not statistically significant, the photographs and measurements are compelling enough to warrant further investigation into this treatment protocol.

J Drugs Dermatol. 2017;16(5):478-480.

Use of a novel combined radiofrequency and ultrasound device for lipolysis, skin tightening and cellulite treatment.

INTRODUCTION: Skin laxity and excessive subcutaneous fat are growing cosmetic concerns. The objective of this study is to evaluate the efficacy and safety of a novel radiofrequency and ultrasound workstation for lipolysis, circumference reduction, treatment of skin laxity and cellulite. MATERIALS AND METHODS: Two hundred seventy-five (235 women and 40 men) patients were enrolled into the study. Each patient received 3 treatment sessions, each session comprising Ultrasound and Radiofrequency treatments, at two-week intervals. Some received treatment for the abdomen, some for the thighs and some for both. Efficacy was assessed accordingly by measuring changes in abdominal circumference, thigh circumference and appearance of cellulite. Any adverse effect was noted. RESULT: Paired t-test between measurements at baseline and 4 weeks after 3rd session was significant amongst all the groups, showing that most patients showed improvement in abdominal and/or thigh circumferences. No significant adverse effects were noted during or after the treatment. CONCLUSION: A combination of alternating hot and cold module Ultrasound and Radiofrequency technologies is a safe and effective modality for lipolysis and to treat skin laxity and cellulite.

Safety and efficacy of a non-contact radiofrequency device for body contouring in Asians.

BACKGROUND: The non-invasive reduction of subcutaneous abdominal fat became popular. Radiofrequency, non-contact, selective-field device Vanquish® has been developed to selectively induce deep fat tissue heating to reduce waist circumference. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of clinical, radiological results of the radiofrequency, non-contact, selective-field device treatment. METHODS: Twelve healthy individuals with no underlying medical problem were treated with five sessions of radiofrequency treatment to reduce abdominal subcutaneous fat. 45-minute sessions were performed with an 1-week interval. For efficacy evaluation, patient's abdominal circumferences and body weight were measured, and photographs were taken at baseline and each follow-up visit for 12 weeks. One subject was examined with computed tomography (CT) before the first session and six weeks after the first CT scan, and we measured the volume of subcutaneous fat layer. Any adverse effect was assessed during the entire study period. RESULTS: Reduction in abdominal circumferences was noted in most participants (10 of 12 patients). No serious adverse effect was reported. Volume reduction of abdominal subcutaneous fat layer was confirmed in a subject who took CT scan. CONCLUSIONS: Our study shows that the selective-field radiofrequency treatment seems to be safe and efficient for reduction of abdominal subcutaneous fat.

Low-level laser therapy (LLLT) does not reduce subcutaneous adipose tissue by local adipocyte injury but rather by modulation of systemic lipid metabolism.

Low-level laser (light) therapy (LLLT) has been applied recently to body contouring. However the mechanism of LLLT-induced reduction of subcutaneous adipose tissue thickness has not been elucidated and proposed hypotheses are highly controversial. Non-obese volunteers were subject to 650nm LLLT therapy. Each patient received 6 treatments 2-3 days apart to one side of the abdomen. The contralateral side was left untreated and served as control. Subjects' abdominal adipose tissue thickness was measured by ultrasound imaging at baseline and 2 weeks post-treatment. Our study is to the best of our knowledge, the largest split-abdomen study employing subcutaneous abdominal fat imaging. We could not show a statistically significant reduction of abdominal subcutaneous adipose tissue by LLLT therapy. Paradoxically when the measurements of the loss of fat thickness on treated side was corrected for change in thickness on non treated side, we have observed that in 8 out of 17 patients LLLT increased adipose tissue thickness. In two patients severe side effect occurred as a result of treatment: one patient developed ulceration within appendectomy scar, the other over the posterior superior iliac spine. The paradoxical net increase in subcutaneous fat thickness observed in some of our patients is a rationale against liquefactive and transitory pore models of LLLT-induced adipose tissue reduction. LLLT devices with laser diode panels applied directly on the skin are not as safe as devices with treatment panels separated from the patient's skin.

Quantification of adipose volume reduction with a prospective study analyzing the application of external radiofrequency energy and high voltage ultrashort pulse duration electrical fields.

To date, there have been no objective measurements of subcutaneous volume loss following treatments with a noninvasive radiofrequency (RF)-based device. Twenty female patients were treated with a suction-coupled bipolar RF device using external RF energy combined with pulsed electromagnetic RF energy for subcutaneous fat reduction. Parameters followed included weight, Vectra measurements of abdominal circumference and torso volume, and high-definition ultrasound measurements of fat thickness. Measurements were taken before treatment and three times following treatment. Analysis of the measured parameters showed that mean circumference reduction of 2.30 cm was noted at three months post-treatment. Independent volumetric analysis showed a mean subcutaneous volume reduction of 428 cc three months following RF treatment. High-resolution ultrasound fat thickness was reduced by a mean of 39.6% three months following the final BodyFX treatment. Independent and paired-sample t-tests showed a p value of < 0.05. Repeated measures of analysis of covariance (ANCOVA) adjusted for differences in age, as well as height and weight (proxy for body mass index) to minimize individual differences and control for extraneous variables that may affect the pre- and post-treatment results were analyzed. No confounding variables were found. All analyses were conducted using IBM SPSS 21.0.

Cryolipolysis versus laser lipolysis on adolescent abdominal adiposity.

BACKGROUND: Noninvasive body contouring is one of the fastest growing segments of the cosmetic aesthetic industry. There is increased public demand for procedures with fewer side effects and shorter recovery times. Cryolipolysis and Laser lipolysis have been used as treatments for localized body contouring. OBJECTIVE: To compare the effect of Cryolipolysis versus Laser lipolysis on adolescent's abdominal adiposity. DESIGN: Randomized, controlled trial. SUBJECTS: Forty-five obese adolescents of both sexes ranged in age from 13 to 16 years participated in this study were to be categorized into three groups of equal number (each group 15 subjects) randomly selected from population. METHODS: Participants were randomly assigned to three groups. Group A was received (Cryolipolysis and diet), Group B was received (Laser lipolysis and diet), Group C was received (only diet) all groups were observed for 8 weeks. Weight and height scale for (change in weight), tape measurement for (waist-hip ratio), skinfold caliper, and MRI. RESULTS: There was no significant difference between three groups post-treatment in BMI and body weight P-value were (0.2, 0.42, 0.67), respectively. There was a significant improvement for Cryolipolysis group in waist-hip ratio, Suprailiac skin fold, and subcutaneous adipose tissue than other groups P-value (0.001). CONCLUSIONS: Cryolipolysis has a favorable effect than Laser lipolysis in the reduction of waist-hip ratio, skin folds at Suprailiac level and subcutaneous adipose tissue (SAT), there is no significant difference between them in the reduction of BMI and body weight. All groups did not have an effect on VAT.

A Clinical Evaluation of a Next Generation, Non-Invasive, Selective Radiofrequency, Hands-Free, Body-Shaping Device.

OBJECTIVE: The aim of this study was to compare clinical outcomes of a noninvasive selective radiofrequency (RF) eld device (BTL Vanquish METM, BTL Industries Inc., Boston MA) with its predecessor (VanquishTM, BTL Industries Inc., Boston MA). The BTL Vanquish METM system has been thoroughly redesigned for more efficient, predictable and homogenous energy delivery to the targeted tissue. MATERIALS AND METHODS: In this multi-center study, 36 subjects with BMIs under 30 were randomly assigned to be treated in Group A (BTL Vanquish METM) or Group B (VanquishTM) in order to obtain a side by side comparison of the devices' ef cacies. Each subject re- ceived 4 weekly 45-minute treatments with the device determined by their group assignments. Measurements of subject's abdominal fat were taken prior to the first treatment and again four weeks after finishing the final treatment. RESULTS: The primary outcome was abdominal fat thickness reduction as measured by ultrasound one month following each subject's final treatment. Thirty four subjects completed the study. Two patients did not complete their treatments due to the reasons unrelated to the study (one from each group). Subjects in Group A treated with BTL Vanquish METM had an abdominal fat thickness reduction of 4.17 mm, or 29.46%, while subjects in Group B treated with VanquishTM had an abdominal fat thickness reduction of only 2.72 mm, or 15.21%. The 4 weekly treatments with BTL Vanquish METM in Group A produced a 53% higher reduction (4.17 mm vs 2.72 mm) of abdominal fat layer thickness than those in Group B. The standard deviation of ultrasound measurements in Groups A and B were 1.42mm and 2.21mm, respectively. Assuming a homogenous response across the entire treatment area, the volume of fat reduced was calculated by multiplying the average measured reduction in fat layer by the surface area of the treatment applicator (2100 cm2; 325.5 square inches). It was calculated that Group A patients lost an average of 0.876 liter (0.23 liquid gallon) of fat, while Group B patients lost 0.571 liter (0.15 liquid gallon) of fat. DISCUSSIONS AND CONCLUSIONS: The mean difference between the tested groups was statistically significant proving better outcomes in the Vanquish METM than its predecessor. Furthermore, the reduction in standard deviation of fat reduction measurements in Group A vs Group B is evidence that the Vanquish METM provides more consistent performance. J Drugs Dermatol. 2016;15(12):1557-1561.

Multi-gradient echo MR thermometry for monitoring of the near-field area during MR-guided high intensity focused ultrasound heating.

The multi-gradient echo MR thermometry (MGE MRT) method is proposed to use at the interface of the muscle and fat layers found in the abdominal wall, to monitor MR-HIFU heating. As MGE MRT uses fat as a reference, it is field-drift corrected. Relative temperature maps were reconstructed by subtracting absolute temperature maps. Because the absolute temperature maps are reconstructed of individual scans, MGE MRT provides the flexibility of interleaved mapping of temperature changes between two arbitrary time points. The method's performance was assessed in an ex vivo water bath experiment. An ex vivo HIFU experiment was performed to show the method's ability to monitor heating of consecutive HIFU sonications and to estimate cooling time constants, in the presence of field drift. The interleaved use between scans of a clinical protocol was demonstrated in vivo in a patient during a clinical uterine fibroid treatment. The relative temperature measurements were accurate (mean absolute error 0.3 °C) and provided excellent visualization of the heating of consecutive HIFU sonications. Maps were reconstructed of estimated cooling time constants and mean ROI values could be well explained by the applied heating pattern. Heating upon HIFU sonication and subsequent cooling could be observed in the in vivo demonstration.

Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy.

BACKGROUND AND OBJECTIVE: Currently there are many non-invasive radiofrequency (RF) devices on the market that are utilized in the field of aesthetic medicine. At this time, there is only one FDA cleared device on the market that emits RF energy using a non-contact delivery system for circumferential reduction by means of adipocyte disruption. Innovation of treatment protocols is an integral part of aesthetic device development. However, when protocol modifications are made it is important to look at the safety as well as the potential for improved efficacy before initiating change. The purpose of this study was to evaluate the safety and efficacy of a newly designed extended treatment protocol using an operator independent selective non-contact RF device for the improvement in the contour and circumferential reduction of the abdomen and flanks (love handles). METHODS: Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits. RESULTS: Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment photographs to determine which photo was the after photo. The evaluators were able to correctly identify the post treatment photos with an 88% accuracy rate. Treatments were well tolerated by all subjects. No study related adverse events were reported. CONCLUSION: This study found that an extended treatment protocol using a selective RF device is a safe and effective method for the reduction of circumference and improved contouring of the abdomen and love handles.

Selective radiofrequency therapy as a non-invasive approach for contactless body contouring and circumferential reduction.

In this study, the efficacy of non-contact, selective radiofrequency (RF) were evaluated for body contouring as non-invasive fat and circumferential reduction of the abdomen. 40 healthy (36 female, 4 male) subjects showing significant volume of subcutaneous fat tissue on the abdomen and waistline were included. Once a week for 30 minutes, 4 sessions were performed. The applicator was placed on a supplied spacer covering the treatment area. Maximum power was 200W, which induced heat in the fat and connective tissue layer. The homogeneity of heat distribution and temperature of the skin surface were controlled. The circumferential reduction was measured at the baseline and after the last treatment. The photographs and adverse effects were recorded. Participants completed the self-evaluation questionnaires and rated their level of satisfaction. All subjects tolerated the treatments well. The only side effect was mild to moderate erythema. 35 subjects finished the protocol as planned and 5 subjects dropped off due to events not related to the study. 32 subjects had a 1-13 cm decrease in abdominal circumference and 3 subjects did not show significant response (0-1 cm). Most likely, a very thin fat layer was the reason for lack of response (the non-responding group was the thinnest patient group). No significant differences were found between men and women. The average decrease of 4.93 cm was calculated as a result of circumferential reduction statistical evidence. This study demonstrates that the selective RF system designed for contactless deep tissue heating is a painless, safe, and effective treatment for non-surgical body contouring and circumferential fat reduction.

Efficacy of low-level laser therapy for body contouring and spot fat reduction.

BACKGROUND: Low-level laser therapy (LLLT) is commonly used in medical applications, but scientific studies of its efficacy and the mechanism by which it causes loss of fat from fat cells for body contouring are lacking. This study examined the effectiveness and mechanism by which 635­680 nm LLLT acts as a non-invasive body contouring intervention method. METHODS: Forty healthy men and women ages 18­65 years with a BMI <30 kg/m2 were randomized 1:1 to laser or control treatment. Subject's waistlines were treated 30 min twice a week for 4 weeks. Standardized waist circumference measurements and photographs were taken before and after treatments 1, 3, and 8. Subjects were asked not to change their diet or exercise habits. In vitro assays were conducted to determine cell lysis, glycerol, and triglyceride release. RESULTS: Data were analyzed for those with body weight fluctuations within 1.5 kg during 4 weeks of the study. Each treatment gave a 0.4­0.5 cm loss in waist girth.Cumulative girth loss after 4 weeks was −2.15 cm (−0.78 ± 2.82 vs. 1.35 ± 2.64 cm for the control group,p < 0.05). A blinded evaluation of standardized pictures showed statistically significant cosmetic improvement after 4 weeks of laser treatment. In vitro studies suggested that laser treatment increases fat loss from adipocytes by release of triglycerides, without inducing lipolysis or cell lysis. CONCLUSIONS: LLLT achieved safe and significant girth loss sustained over repeated treatments and cumulative over 4 weeks of eight treatments. The girth loss from the waist gave clinically and statistically significant cosmetic improvement.