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.

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.

Effect of four sessions of aerobic exercise with abdominal radiofrequency in adipose tissue in healthy women: Randomized control trial.

BACKGROUND: Abdominal adiposity is a cardiovascular risk factor; it is assumed that the combination of radiofrequency and physical exercise may decrease this excess of adipose tissue. PURPOSE: To analyze the effect of four intervention sessions on abdominal adipose tissue. METHODOLOGY: The study analyzes the effect of four sessions of aerobic exercise combined with radiofrequency. Participants were 28 healthy female volunteers, aged 18-28 years, randomly assigned to an experimental group and a placebo group. They were characterized by a sociodemographic questionnaire, the International Physical Activity Questionnaire and the Food Frequency Questionnaire. The groups performed four sessions of abdominal radiofrequency followed by moderate aerobic exercise, assessing body mass, body mass index, fat mass, waist circumference, waist/height ratio, subcutaneous adipose thickness, and horizontal abdominal adipose fold at the first and fourth sessions. In the experimental group, a percentage of potency was used that allowed to maintain the temperature between 40°C and 42°C to the epidermis. In the placebo group, the power of the radiofrequency was 0 W. To compare results, Student's t test was used for a significance level of 0.05. RESULTS: There was a statistically significant decrease in waist circumference, abdominal subcutaneous adipose thickness, and horizontal abdominal fold in the experimental group compared to the placebo group (P < 0.05). CONCLUSION: Combined exercise intervention with radiofrequency has been shown to be effective in reducing abdominal adiposity.

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.