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The role and clinical benefits of high intensity focused electromagnetic devices for non-invasive lipolysis and beyond: A narrative review and position paper
Abstract
Background:
In 2018, the first device to use high intensity focused electromagnetic (HIFEM) technology to non-invasively build muscle was brought to market. Even more recently, the first HIFEM + radiofrequency combination device designed to both build muscle and eliminate fat cells came into use (HIFEM+). In view of the increase in recently published original data pertaining to HIFEM, an advisory board recently convened to discuss the group's clinical experiences with this technology.
Aim:
Communicate an advisory group's recommendations for the current use of HIFEM+ technology for aesthetic indications.
Methods:
An advisory board meeting to discuss challenges and opportunities for HIFEM devices in aesthetic medicine took place in November 2020, via remote conference. The expert advisory board consisted of a group of senior aesthetic physicians regularly treating patients with non-invasive body contouring devices. A narrative review of the literature, and key recommendations from the meeting are presented herein.
Results:
To date, the combined results of several clinical studies (including over 500 patients and 30 investigators) support that patients treated with HIFEM+ experience on average, 30% less fat, 25% more muscle, 19% reduction in abdominal separation and up to 5.9cm reduction in waist circumference. Moreover, HIFEM+ induces a 30% increase in satellite cell content, which is similar to the 36% increase observed following twelve weeks of exercise.
Conclusions:
The advisory board unanimously agreed on several messages related to HIFEM technology, including that the pairing of HIFEM + radiofrequency enables a higher intensity of muscle stimulation and lipolysis, compared to HIFEM alone.
... 7 Electromagnetic treatments were cleared by the US Food and Drug Administration (FDA) in 2017 for strengthening, firming, and toning the abdomen, buttocks, thighs, arms, and calves. 8 In 2019, the Emsculpt device (BTL Industries, Boston, Mass) received 510(k) clearance for noninvasive lipolysis of the abdomen. 9 A circular magnetic coil positioned over the body produces rapidly alternating magnetic fields that induce an electric current in the underlying tissue. ...
... [10][11][12][13] Unlike radiofrequency, the energy does not cause thermal effects. 8 This electric current stimulates motor neurons to cause involuntary "supramaximal" muscle contractions. 5,8,[11][12][13][14] Almost 20,000 pulses are delivered in a 30-minute treatment session. ...
... 8 This electric current stimulates motor neurons to cause involuntary "supramaximal" muscle contractions. 5,8,[11][12][13][14] Almost 20,000 pulses are delivered in a 30-minute treatment session. [15][16][17] The rectus abdominis, internal oblique, and external oblique muscles are targeted. ...
Background:
Energy-based treatments include ultrasound, lasers, cryolipolysis, and radiofrequency. The most recent energy treatment for noninvasive body contouring is electromagnetic treatments-a hot topic in plastic surgery today. A systematic review to assess efficacy and safety has not been published.
Methods:
An electronic search was performed using PubMed to identify the literature describing electromagnetic treatments. Measurements from imaging studies were tabulated and compared.
Results:
Fourteen clinical studies were evaluated. Two studies included simultaneous radiofrequency treatments. In 11 studies, the Emsculpt device was used; in 2 studies, the Emsculpt-Neo device was used. One study included a sham group of patients. The usual protocol was 4 treatments given over a 2-week period. No complications were reported. Eight studies included abdominal measurement data obtained using magnetic resonance imaging, computed tomography, or ultrasound. Photographic results were typically modest. Photographs showing more dramatic results also showed unexplained reductions in untreated areas.Measurement variances were high. The mean reduction in fat thickness was 5.5 mm. The mean increment in muscle thickness was 2.2 mm. The mean decrease in muscle separation was 2.9 mm (P = 0.19). Early posttreatment ultrasound images in 1 study showed an echolucent muscle layer, compared with a more echodense layer at the baseline, consistent with tissue swelling after exercise. Almost all studies were authored by medical advisors for the device manufacturer.
Discussion:
Measurement data show small reductions in fat thickness, occurring almost immediately after the treatments. Adipocyte removal without tissue swelling would be unique among energy-based treatments. Similarly, muscle hypertrophy is not known to occur acutely after exercise; muscle swelling likely accounts for an early increment in muscle thickness. Any improvement in the diastasis recti is likely fictitious.
Conclusions:
Electromagnetic treatments, either administered alone or in combination with radiofrequency, are safe. However, the evidence for efficacy is tenuous. Measured treatment effects are very small (<5 mm). Conflict of interest and publication bias are major factors in studies evaluating energy-based alternatives. The evidence-based physician may not be satisfied that an equivocal treatment benefit justifies the time and expense for patients.
... The available devices deliver pulses in a frequency that produces supramaximal contractions not achievable voluntarily. Electromagnetic stimulation acts directly on motor neurons, inducing involuntary contraction, while the surrounding tissue does not absorb the energy, and no thermal effects have been reported [17]. Muscle tissue is constricted to adapt to supramaximal contractions and responds with an intense remodeling of its internal structure, increasing muscle density and volume, thus leading to better muscle definition and tone. ...
... In addition, the body is subjected to a stressful condition, with the need for more energy to supply the contractions obtained through intensive lipolysis and the degradation of lipids into free fatty acids stored within adipocytes. Therefore, a secondary effect of HI-FEM includes subcutaneous tissue remodeling by lipolysis of adipocytes [16][17][18]. ...
... Previous studies demonstrated the role of HI-FEM in body shaping [16][17][18][19]. In work by Jacob et al. [16] on 41 patients, a median 5.87 ± 3.64 cm waist circumference reduction was reported after HI-FEM treatment, with increased muscle mass and fat thickness reduction. ...
Background:
A healthy lifestyle is not always able to improve the abdomen's appearance, especially in those patients who have undergone sudden weight changes.
Objective:
We aimed at evaluating the efficacy of combined microwaves and flat magnetic stimulation (FMS) to treat abdominal localized adiposity and laxity.
Methods:
Twenty-five patients were subjected to two treatment sessions per month on the abdominal area with microwaves. FMS was also performed twice per week, with a minimum of two days between each session for two months. The technology uses three types of different protocols: massage, muscle definition (shaping), and muscular strengthening. Measurements, including body mass index (BMI) and waist, and abdominal ultrasound were performed at baseline and three months after the last treatment session. Blood examinations were performed, and a 5-Likert scale questionnaire was used to assess patient satisfaction.
Results:
At follow-up, three months after the last treatment, the mean waist circumference (WC) was significantly reduced, and skin laxity improved in all patients (p < 0.001). A significant improvement in abdominal muscle tissue thickness was also shown in all abdominal areas, and the thickness of the adipose tissue evaluated by ultrasound was reduced.
Conclusions:
This study proves that the combination of microwaves and FMS treatment is secure and efficient for treating abdominal subcutaneous fat and skin laxity.
... 2,3 High-intensity focused electromagnetic field treatments (HIFEM) use low-frequency electromagnetic waves to induce supramaximal muscle contractions in the targeted areas, causing muscle strengthening and growth and lipolysis, thus reducing the thickness of the subcutaneous fat. 4,5 These therapeutic effects act upon different causes of cellulite lesions and improve the overall appearance of the gluteal region. 6,7 Given that HIFEM improves muscle tone, reduces subcutaneous fat, and improves the overall aspect of the buttocks, it may be an effective cellulite treatment. ...
... The effects of the HIFEM treatment in increasing muscle mass and decreasing subcutaneous fat by lipolysis, although discrete, are well-documented. 4,6,7,13 Theoretically, this therapy can improve cellulite by reducing the thickness of the fat projections that cause the cellulite raised lesions by improving the buttocks' muscle tone. ...
Introduction: High-intensity focused electromagnetic field treatment (HIFEM) uses low-frequency electromagnetic waves to induce supramaximal muscle contractions, causing muscle hypertrophy and reducing fat.
Objective: To evaluate the effects of a HIFEM treatment for the improvement of cellulite on the buttocks.
Methods: Thirty patients were divided into two groups that received eight or 12 HIFEM sessions on the buttocks for six weeks. We assessed the improvement in cellulite and the buttocks' global appearance through the Cellulite Severity Scale (CSS), the Global Aesthetic Improvement Scale (GAIS), and a satisfaction questionnaire. Changes in body composition were evaluated through bioimpedance and hip circumference measurements.
Results: Patients from both groups improved the global appearance of their buttocks. Cellulite lesions of some patients improved, but for most patients, the improvement wasn’t great enough to change the grade on the Cellulite Severity Scale. Patient satisfaction was high and adverse events were few, minor, and transitory.
Conclusion: The effects of HIFEM on cellulite are subtle, as this treatment modality cannot address the fibrous septa that cause the depressed lesions of cellulite. Nevertheless, HIFEM procedures can improve the buttocks’ global appearance, enhancing the patients’ subjective perception of their cellulite.
... 2 This technique is among the top trends that may safely provide favorable outcomes with high satisfaction and no downtime, rivaling traditional and modern methods. [3][4][5][6][7][8][9] The combined application of HIFEM+RF is effective for simultaneous muscle toning and fat reduction. [10][11][12][13] HIFEM generates an electromagnetic field that activates neuromuscular tissue by induced electric current, leading to supramaximal muscle contractions, which create a significant energy demand causing muscles to utilize the energy stored in the adipocytes in free fatty acid form. ...
... [10][11][12][13] HIFEM generates an electromagnetic field that activates neuromuscular tissue by induced electric current, leading to supramaximal muscle contractions, which create a significant energy demand causing muscles to utilize the energy stored in the adipocytes in free fatty acid form. 4,14,15 This leads to a reduction in size and, under the extreme muscle load, decreased number of adipocytes. In addition, the synchronized RF generates adjustable heat that predominantly accumulates in the fat tissue, leading to selective heating of adipocytes within 42-45°C, inducing adipocyte apoptosis. ...
Background:
Inevitable signs of aging are especially noticeable in middle to elder age when stretch marks, loose skin, cellulite, and body-contour changes naturally appear.
Aims:
To verify efficacy of high-intensity focused electromagnetic field (HIFEM), radiofrequency (RF), and Targeted Pressure Energy (TPE) combination treatment to address unfavorable changes in skin, fat, and muscle tissue.
Methods:
The device simultaneously emitting monopolar RF and TPE energies was consecutively combined with simultaneous HIFEM+RF procedure in 32 subjects (21-64 years, 17.4-33.5 kg/m2 ) for treatment of thighs (N = 15; back, inner, or front), buttocks/saddlebags (N = 7), abdomen (N = 8), and upper arms (N = 2). All patients underwent four weekly, combined treatments of 30-min HIFEM+RF procedure followed by 15-30 min RF+TPE, depending on treatment area. Circumferential measurements, digital photographs, subject satisfaction, and comfort questionnaires were assessed up to 3-months post-treatment.
Results:
Majority of participants found treatments comfortable, no adverse events occurred. Subjects showed substantial improvement in all treated areas from 1-month follow-up. Combination of HIFEM+RF, monopolar RF, and TPE resulted in significant circumference decrease. Generally, more pronounced results were seen at 3 months when subjects showed -5.2 cm on abdomen, -3.0 cm on thighs, and -5.5 cm on saddlebags, respectively. Ninety-four percent of subjects were satisfied with treatment results, most noticed improvement in cellulite, skin laxity, and muscle definition.
Conclusions:
Results showed high patient satisfaction and efficacy in improving body contour and skin quality. Combining simultaneous HIFEM+RF procedure with simultaneous monopolar RF+TPE treatments considerably enhanced body contour and skin tissue. The procedure proved versatile and may effectively treat multiple body parts.
... Synchronized RF generates electromagnetic energy that can be regulated to concentrate mostly in the adipose tissue, leading to the selective heating of adipocytes in the temperature range of 42 • C to 45 • C, inducing apoptosis. Patients treated with HIFEM+ show an average of 30% less body fat, and 25% more muscle [41,44]. ...
Adipocytes accumulate triacylglycerols as an energy store, thereby causing an increase in the adipose tissue volume. Weight gain can be prevented through damage to the adipocyte structure or an increase in the body’s metabolic rate. Commonly used methods to disintegrate the cell membrane of adipocytes include injection lipolysis, cryolipolysis, ultrasonic lipolysis, radiofrequency lipolysis, laser lipolysis, carboxytherapy, and lipolysis using an electromagnetic field. The names of these methods suggest which substances are being used, and their main advantages are a very low invasiveness, as well as effectiveness. However, new discoveries in medicine, along with individuals’ desire to improve their appearance, have resulted in numerous studies on more ways of reducing body fat. Great potential is seen in beige adipocytes, which can be transformed, i.e., “recruited” from white adipocytes, or synthesized de novo; they also show thermogenic properties. One of the stimuli inducing the formation of beige adipocytes is cold and B3-adrenergic stimulation. Based on these findings, the researchers created, for example, cooling clothing. Additionally, curcumin and natural anthocyanins have proven to be helpful in the treatment of obesity and diabetes, by stimulating the secretion of glucagon-like peptide-1, and inducing the formation of beige adipocytes. Another study showed that the conversion of white adipose tissue is indirectly influenced by interleukin-6 secreted by the muscles, the expression of which is increased in people actively exercising. Moreover, there is potential in adenosine analogs, fenoldopam, rhubarb, the herbal extract Ephedra sinica Stapf, electroacupuncture simulation, and the drug CBL-514. Despite knowledge and experience, the ideal method for a quick and noticeable, but safe and non-invasive reduction of body fat has not been found yet. The research conducted nowadays may bring us closer to the development of a universal method, and turn out to be a breakthrough in the fight against overweight and obesity.
... An advisory board meeting of senior aesthetic physicians was conducted in November 2020, via a virtual mode, to discuss various aspects related to use of HIFEM devices in the field of aesthetic medicine. 67 From the analysis of cumulative data related to 500 cases and derived from multiple studies from 30 investigators, it was found that HIFEM+ results in 30% reduction in fat, 25% increase in muscle mass, 19% reduction in abdominal layer separation and up to 5.9 cm decrease in waist circumference. Moreover, HIFEM+ leads to a 30% enhancement in satellite cell content, which is the almost the same as achieved after 3 months of exercise. ...
Non-invasive body contouring modalities optimize the cosmesisof the human body safely and effectively and represent a fast-expanding domain of cosmetic dermatology. There are currently five approved modalities including cryolipolysis, radiofrequency, high-intensity focused ultrasound, laser therapy and high-intensity focused electromagnetic field. This article provides a brief overview of these modalities in the light of the recent literature.Key wordsObesity; Body contouring; Lipolysis; Laser; Radiofrequency; High frequency focusedultrasound; High-intensity focused electromagnetic field.
Background:
Unwanted lateral fat most prominently affects the female population and may cause self-esteem issues.
Objective:
To investigate the effectiveness and safety of synchronized high-intensity focused electromagnetic (HIFEM) + radiofrequency (RF) for the treatment of lateral thigh adipose tissue.
Materials and methods:
Ninety-three subjects (21-70 year old) received 4, 30-minute HIFEM + RF treatments of the lateral thighs. Magnetic resonance imaging (MRI) of the treated area was obtained at baseline, 1, 3, and 6 months post-treatment to document the changes in fat layer thickness. Furthermore, digital photographs, circumference measurements of the lateral thighs, subjects' satisfaction questionnaires, and therapy safety and comfort were documented.
Results:
Magnetic resonance imaging revealed a significant reduction of fat tissue in the saddlebag region peaking at 3 months (-18 ± 5.5 mm; N = 51). The thigh circumference measured at 3 predefined levels decreased on average by 2.3 cm, with the greatest change at the level of 10 cm below the infragluteal fold (-3.5 cm, 3-month follow-up). Results were maintained at 6 months. No adverse events were recorded. The therapy was found comfortable with a high satisfaction rate.
Conclusion:
High-intensity focused electromagnetic + RF treatment to the lateral thigh area demonstrated effectiveness in long-term fat thickness reduction by MRI imaging. Secondary endpoint showed simultaneous effectiveness and safety.
Background:
Aesthetic muscle stimulation (AMS) using high-intensity electromagnetic field (HIFEM) targets skeletal muscle neurons, causing muscle hypertrophy and loss of adipose tissue, thereby cultivating a sculpted physique. Many studies have evaluated AMS for noninvasive body contouring; however, the efficacy, safety, and long-term data remain unclear.
Objective:
To critically evaluate the current literature on the use of electromagnetic muscle stimulation for body contouring and provide a consensus on patient selection and long-term efficacy of AMS.
Materials and methods:
PubMed and Embase were searched using the terms: "HIFEM," "Electromagnetic therapy," and "muscle" or "Electrical stimulation muscle treatments" and "aesthetics." Studies involving the use of muscle stimulation for nonaesthetic/dermatologic, in vitro studies or studies involving animals were excluded.
Results:
Twenty studies in total were included [9 moderate-quality, 8 low-quality, and 3 very low‒quality studies] based on the Grading of Recommendations, Assessment, Development, and Evaluation scale, representing 521 patients. Body sites evaluated included the abdomen (378 patients), buttock (156 patients), arms (22 patients), and calves (15 patients).
Conclusion:
Electromagnetic muscle stimulation represents an effective therapeutic intervention for abdominal contouring that yields increased muscle thickness, and reduced abdominal fat thickness, for up to 1 year after treatment. Larger, controlled studies are needed to determine the efficacy of electromagnetic muscle stimulation alone for contouring of buttocks, thighs, arms, and calves.
With improvements in living standards and advancements in medical technology, the demand for fat reduction and body shaping is increasing. Non-invasive fat reduction and body shaping therapy has gradually become a research hotspot in plastic surgery. High-intensity electromagnetic technology, a non-invasive treatment that can reduce subcutaneous fat and strengthen muscle, has been increasingly applied in clinics in recent years. This article reviews the fat reduction and body shaping mechanism and clinical effects of this equipment and provides a reference for its clinical application.
Background:
Radiofrequency (RF) is commonly recognized treatment option for fat reduction, utilizing heat-induced adipocyte deletion. HIFEM treatment has been proven to be an effective tool for body shaping.
Objectives:
To document the structural changes in human subcutaneous tissue induced by the combination of RF treatment with the HIFEM procedure.
Methods:
Four subjects (51.50±6.35 years, 22.59±3.21 kg/m2 ) received three 30-minute abdominal treatments consisting of RF therapy and HIFEM. One subject (57 years, 23.60 kg/m2 ) served as a control. Punch biopsies were collected at baseline, 1-week and 1-month post-treatment. Samples were sliced and stained with H&E. Waist circumference, digital photographs, satisfaction and therapy comfort were assessed. Subjects were monitored for any adverse event, and fat temperatures were measured.
Results:
Baseline samples showed a healthy appearance of adipocytes, composed of round-shaped unilocular cells of uniform size. At follow-up, treated adipocytes demonstrated nuclear and shape changes with consequent fat reduction. Adipocytes were found to be flattened/shrunken and of smaller size (-33.5% at 1 week; -31.7% at 1-month) along with occasional ruptures of the cytoplasmic membrane. In contrast to baseline, pyknotic nuclei with condensed nuclear chromatin were seen at 1-week and 1-month post-treatment. The control samples showed no treatment-related changes. Waist circumference decreased by an average of 2.20 cm in the treated patients. No adverse events were observed. The fat temperature reached 42-45°C, during treatment; the therapy was comfortable with high patient satisfaction.
Conclusions:
Results suggest the efficacy and safety of the therapy combining RF and HIFEM. The adipocyte deletion and shrinkage resulted in overall reduction of fat tissue.
Background
Several studies investigating high-intensity focused electromagnetic (HIFEM) treatments have been recently published. However, long-term data are due to the novelty of the procedure still missing.
Objective
The aim of this study is to evaluate changes in abdominal tissues on average one year after a series of HIFEM treatments, to determine the long-term durability of patients’ original body responses.
Methods
MRI or CT scanning was performed on 21 patients on average 332.6 ± 88.5 days after their original HIFEM treatment series. The scans were evaluated by blinded radiologist for abdominal muscle thickness, subcutaneous fat changes, and abdominal separation. The results were compared to the MRI/CT assisted measurements taken at the baseline and 6-week follow-up. Correlations between collected data sets were calculated and tested. The incidence of any adverse events related to earlier treatments was monitored.
Results
When comparing the 1-year follow-up measurements with the baseline, the MRI/CT-assisted calculations revealed on average 14.63% (2.97 ± 2.11 mm) reduction in fat, 19.05% (1.89 ± 0.88 mm) muscle thickening, and 10.46% (1.96 ± 1.71 mm) diastasis recti reduction. All changes were significant (p<0.05) and not related to weight fluctuations (p>0.05). The baseline width of diastasis positively correlated with the degree of improvement at follow-up. No adverse events were reported.
Conclusion
The HIFEM-induced muscle hypertrophy, fat reduction, and reduction in abdominal separation were maintained 1-year post-treatment. This suggests long-term durability of the original bodily response, which needs to be verified by continuing follow-up of this group and by further studies.
Background:
Cryolipolysis, a preferred method for minimally invasive body contouring, involves the noninvasive cooling of adipocytes to induce lipolysis without damaging other tissues. This study aimed to evaluate the safety and efficacy of cryolipolysis for the treatment of excessive fat tissue.
Methods:
Between May 2014 and December 2017, 231 patients with 448 areas of interest were enrolled and their records were retrospectively reviewed. We used five different vacuum applicators, and the best-fitting applicator was used for each area. One cycle of cryolipolysis was applied at a cooling intensity factor of 41.6. The efficacy was evaluated 12 weeks after treatment via review of clinical photographs, the pinch test, and ultrasonographic measurements of fat thickness. The occurrence of any complications was also assessed.
Results:
The volume was reduced in all of the areas to which cryolipolysis was applied. The rate of reduction of the fat layer as measured via the pinch test was 19.2%, and the rate of the decrease in fat layer thickness as measured via ultrasonography was 22.8%. Fat reduction of the upper arm differed significantly from that of the abdomen and flank, but no significant difference was found between sexes. The side effects were limited to erythema, edema, bruising, and numbness at the treatment site and resolved without treatment.
Conclusions:
Cryolipolysis, with new and better-fitting applicators, is safe, fast, and effective for the reduction of excessive fat tissue on the abdomen, back, flank, and extremities. It is a good option for treating excess adipose tissue in Asian patients.
Background
High-intensity focused electromagnetic (HIFEM) field technology has been reported to increase muscle thickness and hypertrophy. However, this process has not yet been confirmed on a histologic level.
Objectives
The aim of this study was to evaluate in-vivo structural changes in striated porcine muscle tissue following HIFEM treatment.
Methods
Three Yorkshire pigs received four 30-minute HIFEM treatments applied to the biceps femoris muscle on 1 side only. The fourth pig served as a control subject. At baseline and 2 weeks after the last treatment, biopsy specimens of the muscle tissue were collected from the treatment site. The control pig underwent muscle biopsy from a similar but untreated site. Twenty-five histology slides were evaluated from each pig. A certified histopathologist analyzed sliced biopsy samples for structural changes in the tissue.
Results
Histologic analysis showed hypertrophic changes 2 weeks posttreatment. The muscle mass density increased by 20.56% (to a mean of 17,053.4 [5617.9] µm2) compared with baseline. Similarly, muscle fiber density (hyperplasia) increased: the average change in the number of fibers in a slice area of 136,533.3 µm2 was +8.0%. The mean size of an individual muscle fiber increased by 12.15% (to 332.23 [280.2] µm2) 2 weeks posttreatment. Control samples did not show any significant change in fiber density or hyperplasia.
Conclusions
Histopathologic quantification showed significant structural muscle changes through a combination of fiber hypertrophy and hyperplasia. Control biopsies showed a lack of similar changes. The data correlate with findings of other HIFEM research and suggest that HIFEM could be used for noninvasive induction of muscle growth.
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. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.
Background: Cryolipolysis is a contemporary method of reducing fat by controlled extraction of heat from adipocytes.
Objectives: The authors recorded temperature profiles during a single cryolipolysis treatment/recovery cycle (with and without massage) and report on the clinical safety and efficacy of this procedure.
Methods: In the pilot study group (PSG), the abdomens of 6 patients were treated with cryolipolysis and subdermal temperatures were recorded. In the clinical treatment group (CTG), 112 patients were treated without temperature recordings and results were evaluated through matched comparison of standardized photographs, caliper measurements, ultrasound imaging, and global assessments.
Results: Thirty minutes into the cooling phase, subdermal temperatures of patients in the PSG declined precipitously from pretreatment levels and remained low until the end of treatment. During recovery, subdermal temperatures of the only subject who received massage returned faster and to higher levels than the temperatures of subjects who did not receive massage. Patients in the CTG who were available for follow-up measurements at 6 months (n = 85) demonstrated an average fat reduction of 21.5% by caliper measurements; 6 random patients from this group also showed an average of 19.6% fat reduction by ultrasound imaging at 6 months. Global assessments were highest for the abdomen, hip, and brassiere rolls. Minimal side effects were observed, and patients experienced no significant downtime.
Conclusions: Noninvasive cryolipolysis results in a predictable and noticeable fat reduction within 6 months and does not cause skin damage. Profiling of subdermal temperatures may provide additional insights for improving clinical effectiveness and safety.
Level of Evidence: 3
Cryolipolysis procedures have been shown to safely and effectively reduce the thickness of fat in a treated region. This study was conducted to determine whether the addition of post-treatment manual massage would improve efficacy while maintaining the safety profile of the original cryolipolysis treatment protocol.
The study population consisted of an efficacy group (n = 10) and a safety group (n = 7). Study subjects were treated on each side of the lower abdomen with a Cooling Intensity Factor of 42 (-72.9 mW/cm(2) ) for 60 minutes. One side of the abdomen was massaged post-treatment and the other side served as the control. Immediately post-treatment, the massage side was treated for 1 minute using a vigorous kneading motion followed by 1 minute of circular massage using the pads of the fingers. For the efficacy group, photos and ultrasound measurements were taken at baseline, 2 months, and 4 months post-treatment. For the safety group, histological analysis was completed at 0, 3, 8, 14, 30, 60, and 120 days post-treatment to examine the effects of massage on subcutaneous tissue over time.
Post-treatment manual massage resulted in a consistent and discernible increase in efficacy over the non-massaged side. At 2 months post-treatment, mean fat layer reduction was 68% greater in the massage side than in the non-massage side as measured by ultrasound. By 4 months, mean fat layer reduction was 44% greater in the massage side. Histological results showed no evidence of necrosis or fibrosis resulting from the massage.
Post-treatment manual massage is a safe and effective technique to enhance the clinical outcome from a cryolipolysis procedure. Lasers Surg. Med. © 2013 Wiley Periodicals, Inc.
Objective: High-intensity focused electromagnetic (HIFEM) technology offers an alternative to surgical procedures in terms of correction of altered body shape. In this pilot study, we investigated whether HIFEM technology can positively affect abdominal appearance in postpartum women. Methods: Ten women (3-36 months postpartum; average age: 37.7 years) received four 30-minute abdominal HIFEM treatments. Magnetic resonance imaging (MRI) examination of abdominal fat thickness, rectus abdominis thickness, and the width of abdominal separation was performed and evaluated at baseline, one month, three months, and six months post-treatment. Additionally, weight was recorded, standardized photographs were taken, and patient comfort levels with the procedures were assessed, using a 7-point scale, at these same time points. The paired t-test was used to statistically analyze the mean differences between the baseline and post-treatment data. Results: Results obtained from MRI images showed an average abdominal fat reduction of 17.0 percent at the one-month follow-up visit, while at the three-month follow-up, it was 20.2 percent. The average muscle thickness increase at the one-month follow-up was 20.5 percent, and at the three-month follow-up, it was 21.3 percent. The distance between the rectus abdominis muscles was reduced by 16.7 percent at the first follow-up visit and by 22.7 percent at three-month follow-up visit. The nine subjects who attended the six-month visit showed, on average, a 17.6-percent fat reduction, 21.7-percent increase in muscle, and a 23.2-percent reduction of abdominal separation. Weight did not change significantly. Conclusion: HIFEM treatments appeared to reduce the fat layer and width of abdominal separation, while increasing the thickness of abdominal muscle thickness in postpartum women. The observed results at one month post-procedure were improved at three months post-procedure and remained stable at the six-month follow-up visit. Future studies that include a control or sham group are needed to identify and reduce the risk of bias.
Background:
High-intensity focused electromagnetic (HIFEM) field procedure induces changes in the gluteal muscles and improves the aesthetic appearance of the buttocks.
Objective:
This study aims to objectively assess the hypertrophic response of the gluteal muscles after HIFEM treatments.
Materials and methods:
Seven subjects (40.00 ± 6.68 years) received 4, 30-minute HIFEM treatments of the buttocks. Magnetic resonance imaging of the pelvic region was obtained at baseline, 1-month, and 3-month follow-up to reconstruct 3D volumes of musculus gluteus maximus, medius, and minimus. Volumetric changes were calculated and statistically analyzed. Standardized photographs, weight measurements, patient satisfaction, treatment comfort, and adverse events were also documented.
Results:
Volumetric analysis revealed a significant increase (p = .001) in the size of the examined muscles at 1-month (+10.81 ± 1.60%) and 3-month (+13.23 ± 0.91%) follow-up. A more profound hypertrophic effect was seen in the upper buttock region. This translated into a visible buttock lifting, also captured by patient photography. Gluteal adipose tissue was insignificantly affected. Patients were satisfied, and they found the treatments comfortable. No adverse events were observed.
Conclusion:
Simultaneous enhancement of gluteal muscles was documented. This represents the first objective evaluation of the HIFEM-induced structural changes in the gluteal muscles and physiologic documentation of the aesthetic improvement previously reported by other authors.
Introduction
Cold-induced adipocyte injury or “cryolipolysis” is a noninvasive means of subcutaneous fat reduction. We review a series of 192 cryolipolysis treatments in 59 patients.
Materials and Methods
Ultrasound measurements were used to determine the change in subcutaneous thickness before treatment and 2 months after treatment.
Results
An average thickness reduction of 25.2% was seen after a single treatment.
Conclusions
We conclude that cryolipolysis is an effective method of noninvasive body contouring.
Cryolipolysis is a noninvasive and well-tolerated treatment for reduction of localized subcutaneous fat. Although several studies demonstrate the safety and efficacy of this procedure, volumetric fat reduction from this treatment has not been quantified. This prospective study investigated the change in volume of fat after cryolipolysis treatment using three-dimensional (3D) photography.
A prospective study of subjects treated with cryolipolysis on the flank (love handle) was performed at Massachusetts General Hospital. Volume measurements were performed with a Canfield Scientific Vectra three-dimensional camera and software to evaluate the amount of post procedure volume change. Clinical outcomes were assessed with caliper measurements, subject surveys, and blinded physician assessment of photographs.
Eleven subjects were enrolled in this study. Each subject underwent a single cycle of cryolipolysis to one flank. The untreated flank served as an internal control. The follow-up time after treatment was 2 months. The mean amount of calculated absolute fat volume loss using 3D photography from baseline to 2 months follow-up visit was 56.2 ± 25.6 from the treatment site and 16.6 ± 17.6 cc from the control (P < 0.0001). A mean absolute difference of 39.6 cc between the treated and untreated sides was calculated at 2 months post-treatment. Comparison of caliper measurements from baseline to 2 months post-treatment demonstrated significant reduction of the treated flank from 45.6 ± 5.8 mm at baseline to 38.6 ± 4.6 mm at 2 months post-treatment (P < 0.001). The untreated flank did not show significant reduction with caliper measurements demonstrating 45.3 ± 5.0 mm at baseline and 44.6 ± 5.1 mm at 2 months post-treatment (P = 0.360). No unexpected side effects or adverse events were reported. Post-treatment satisfaction surveys demonstrated 82% of subjects were satisfied with the results.
Cryolipolysis is a safe, well-tolerated, and effective noninvasive fat removal methodology that on average leads to 39.6 cc of fat loss of the treated flank at 2 months after a single treatment cycle. Lasers Surg. Med. 46:75-80, 2014. © 2013 Wiley Periodicals, Inc.
Background:
Comprehensive assessment of safety, tolerance, and patient satisfaction has not been established from noninvasive body contouring techniques, such as low-level laser therapy, ultrasound, radiofrequency, and infrared light, for reduction of subcutaneous fat.
Objective:
This multicenter study investigated the clinical outcomes of noninvasive cryolipolysis in European subjects.
Methods:
A retrospective study was performed at clinical sites in Belgium and France. Safety was assessed according to reports of side effects. Tolerance was evaluated according to pain scores and patient perception of treatment duration. Clinical outcomes were assessed according to patient surveys, caliper measurements, and assessment of photographs.
Results:
The investigators treated 518 patients. No significant side effects or adverse events were reported. The procedure was well-tolerated, with 89% of respondents reporting a positive perception of treatment duration and 96% reporting minimal to tolerable discomfort. Survey results demonstrated 73% patient satisfaction and that 82% of patients would recommend the cryolipolysis procedure to a friend. Caliper measurements demonstrated 23% reduction in fat layer thickness at 3 months. Abdomen, back, and flank treatment sites were most effective, with 86% of subjects showing improvement per investigator assessment.
Conclusions:
With proper patient selection, cryolipolysis is a safe, well-tolerated, and effective treatment method for reduction of subcutaneous fat.
The objective of the study is to determine the clinical efficacy and patient satisfaction of a novel cryolipolysis device (Zeltiq®) for body contouring in Chinese after a single treatment and after 2 treatments at a commercial setting.
Two groups of patients were recruited for this procedure at their own cost. Group A, 21 subjects, received a single treatment and group B, 12 subjects, received 2 treatments, average 3 months apart using the Zeltiq Breeze System®. The thickness of fat at the treatment site was measured by a caliper and the data were collected at baseline and 2 months post-treatment. Standardized clinical photos were also taken at baseline and follow-up visits. Subjective assessment was carried out in the form of a questionnaire. Any adverse effects were documented. Statistical analyses were performed on the data to compare the efficacy after a single treatment and after 2 treatments.
The first group of subjects, received a single treatment, showed that there was a significant improvement (P < 0.0001). The second group of subjects showed that the improvement was significant after 1 and 2 treatments when compared to the baseline. The extent of improvement after the second treatment however, was not as dramatic as the first treatment.
Non-invasive cryolipolysis is effective for body contouring in Chinese. It is shown to have a further improvement with subsequent treatment sessions but of a lesser extent. The second treatment was statistically significant for abdomen, though not for love handles.
The main objective of the present study is to demonstrate the feasibility of utilizing a novel non-invasive radiofrequency (RF) device to induce lethal thermal damage to subcutaneous adipose tissue only by establishing a controlled electric field that heats up fat preferentially.
Adipocyte cells in six-well plates were subjected to hyperthermic conditions: 45, 50, 55, 60, and 65 degrees C during 1, 2, and 3 minutes. Cell viability was assessed 72 hours after exposure. Two groups of abdominoplasty patients were treated with the RF device during and days before their surgical procedure. Temperatures of cutaneous and subcutaneous tissues were measured during treatment (3 minutes) of the first group. The immediate tissue response to heating was assessed by acute histology. The delayed tissue response was assessed by histology analysis of the second group, 4, 9, 10, 17, and 24 days after treatment (22 minutes). A mathematical model was used to estimate treatment temperatures of the second group. The model uses patient-based diagnostic measurements as input and was validated with in vivo clinical temperature measurements.
Cell viability dropped from 89% to 20% when temperature increased from 45 to 50 degrees C during 1 minute exposures. Three minutes at 45 degrees C resulted in 40% viability. In vivo, the temperature of adipose tissue at 7-12 mm depth from the surface increased to 50 degrees C while the temperature of cutaneous tissues was <30 degrees C during RF exposure. Acute and longitudinal histology evaluations show normal epidermal and dermal layers. Subcutaneous tissues were also normal acutely. Subcutaneous vascular alterations, starting at day 4, and fat necrosis, starting at day 9, were consistently observed within 4.5-19 mm depth from the skin surface. Subcutaneous tissue temperatures were estimated to be 43-45 degrees C for 15 minutes.
A controlled internal electric field perpendicular to the skin-fat interface is selective in heating up fat and, consequently, has the ability to induce lethal thermal damage to subcutaneous adipose tissues while sparing overlying and underlying tissues. In vitro adipocyte cells are heat sensitive to thermal exposures of 50 and 45 degrees C on the order of minutes, 1 and 3 minutes, respectively. In vivo, 15 minutes thermal exposures to 43-45 degrees C result in a delayed adipocyte cellular death response-in this study, 9 days. The novel RF device presented herein effectively delivers therapeutic thermal exposures to subcutaneous adipose tissues while protecting epidermal and dermal layers.
Incubation of ECV304 cells with 7-ketocholesterol, a lipid component of oxidized low-density lipoproteins, caused a concentration- and time-dependent decrease in the number of viable cells. Other cholesterol oxides, 7 beta-hydroxycholesterol and 25-hydroxycholesterol, but not cholesterol, were only weakly cytotoxic. No evidence for activation of caspase-3 and -8, DNA laddering, or release of cytochrome c from mitochondria into the cytoplasm was obtained in 7-ketocholesterol-treated cells, indicating that cell death was not due to apoptosis. As a positive control for apoptosis, ECV304 cells were treated with staurosporine, which indeed caused significant activation of caspase-3 activity, DNA laddering, and cytochrome c release. Cellular morphology and actin cytoskeletal organization were distinctly different after exposure to the two drugs. Furthermore, staurosporine caused intracellular acidification, whereas 7-ketocholesterol induced a significant alkalinization, which was abolished by 4,4'-diisothiocyanatodihydrostilbene-2,2'-disulfonic acid. In conclusion, in ECV304 cells 7-ketocholesterol induces some typical hallmarks of necrotic cell death but not of apoptosis.
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