Clinical papers

Background and Objective
A novel, noninvasive technology, utilizing suction-coupled radiofrequency (RF) heating and ultra-short pulse duration, high-voltage electrical pulses was studied for its efficacy and safety on adipose tissue reduction.

Method
Twenty-one subjects underwent treatment of their abdominal fat once weekly for 6 weeks. Clinical outcomes including abdominal circumference, adipose tissue thickness (measured by ultrasound), adipose tissue weight, body weight, and clinical photographs were obtained at visits 1 and 3 months after last treatment. Adverse events were recorded. Three subjects, who were undergoing a future elective abdominoplasty, were treated with the same protocol, but on only one side of the abdomen before abdominoplasty. Biopsies from the RF-treated and untreated sides were harvested during abdominoplasty and cultured; measurements of adipocyte size and shape, rate of apoptosis, collagen production, and dermal thickness were determined.

Results
Significant clinical improvements (P  < 0.05) were observed for the reduction of abdominal circumference (113.4–110.7 cm). Within the adipose tissue of the treated areas, increased levels of adipocyte apoptosis were observed immediately following the treatment series, with approximately 20% of all adipocyte cells staining positive for APAF-1, a validated marker of apoptosis. In contrast, the control untreated skin only rarely had adipocytes undergoing apoptosis, with less than 1% of adipocytes staining positive for APAF-1. At day 14 of culture, fat cell apoptosis had further increased (30% of adipocytes staining positive for APAF-1) within the RF-treated adipose tissue. Additionally, a significant increase in collagen synthesis (neocollagenesis) representing an average increase of 13.7% was observed after treatment by the RF device, with a mean collagen level of 57.6 mg/mg in the treated zone versus 49.7 mg/mg in the non-treated zone, as determined by the spectrocolorimetric method. Only minor, transient side effects were reported.

Conclusions
This novel, noninvasive RF device was effective for improving subcutaneous fat, reducing abdominal circumference and reducing subcutaneous fat layer thickness. Histologically, these improvements appear to be partly related to increased adipocyte apoptosis.

Noninvasive fat reduction is claimed by many device manufacturers, but proof of efficacy has been difficult to established. This prospective study was designed to measure the reduction of fat thickness and actual volume reduction in 20 female patients treated with an external radiofrequency (RF) device. This device combines RF heat, suction coupled vacuum, and oscillating electrical pulses that induce adipocyte death over time. Patients underwent pre-and-post-treatment and intercurrent measurements of weight, body mass index, ultrasonic transcutaneous fat thickness, and 2D and 3D Vectra photography with independent calculation of circumferential and volumetric change. Mean transcutaneous ultrasound thickness at reproducible points was 2.78 cm; at 1-month post treatment, the mean fat thickness was 1.71 cm. At 3-month post-treatment, the mean fat thickness reduction was 39.6%. Vectra circumference measurements were taken at 10-mm intervals, with pastureland breathing cycle control. Independent analysis of serial measurements from +60 to – 70mm showed mean abdominal circumference measurement of 2.3 cm. Mean abdominal volume loss was 202.4 and 428.5 cc at 1- and 3-month post-treatment, respectively. Scanning electron microscopy confirmed that permanent cell destruction was caused by irreversible electroporation. Proptosis appears to be the mechanism of action.