Facial Plast Surg. 2005 Feb;21(1):65-73.

Current concepts in nonablative radiofrequency rejuvenation of the lower face and neck.

Abraham MT, Vic Ross E. With the multitude of treatment options and emerging technology available for rejuvenation of the lower face and neck, it is often difficult to determine which specific treatment would benefit an individual patient. Monopolarradiofrequency (MRF) nonablative skin rejuvenation is a promising new procedure that is utilized to tighten and contour nonsurgically mild to moderate laxity of the

skin of the lower face and neck in patients without significant underlying structural ptosis. In these selected patients and others who wish to avoid surgical treatment modalities, MRF treatment offers a noninvasive method of tightening skin and soft tissue, causing softening of the nasolabial lines, tightening of the jowl, and improving the definition of the cervicomental angle, all without significant recovery time or complications. Further development of MRF technology and refinement of treatment protocols may allow even greater tightening of the skin and more dramatic

modulation of underlying deeper structures, making the treatment more universally applicable for patients desiring facial rejuvenation. Lasers Surg Med. 2006 Mar;38(3):211-7. Effect of monopolar radiofrequency treatment over soft-tissue fillers in an animal model:

part 2. Shumaker PR, England LJ, Dover JS, Ross EV, Harford R, Derienzo D, Bogle M, Uebelhoer

N, Jacoby M, Pope K. BACKGROUND AND OBJECTIVE: Monopolar radiofrequency (RF) treatment is used by physicians to heat skin and promote tissue tightening and contouring. Cosmetic fillers are used to soften deep facial lines and wrinkles. Patients who have had dermal fillers implanted may also benefit from or are candidates for monopolar RF skin tightening. This study examined the effect of RF treatment on various dermal

filler substances. This is the second part of a two-part study. STUDY DESIGN/MATERIALS AND METHODS: A juvenile farm pig was injected with dermal fillers including cross-linked human collagen (Cosmoplast), polylactic acid (PLA) (Sculptra), liquid injectable silicone (Silikon 1000), calcium hydroxylapatite (CaHA) (Radiesse), and hyaluronic acid (Restylane). Skin injected with dermal fillers was RF-treated using a 1.5-cm2 treatment tip and treatment levels typically used in the

clinical setting. Fillers were examined histologically 5 days, 2 weeks, or 1 month after treatment. Histological specimens were scored for inflammatory response, foreign body response, and fibrosis

in order to assess the effect of treatment on early filler processes, such as inflammation and encapsulation. RESULTS: Each filler substance produced a characteristic inflammatory response. No immediate thermal effect of RF treatment was observed histologically. RF treatment resulted in statistically significant

increases in the inflammatory, foreign body, and fibrotic responses associated with the filler substances. CONCLUSIONS: Monopolar RF treatment levels that are typically used in the clinical setting were employed in this animal study. RF treatment resulted in measurable and statistically significant histological changes associated with the various filler materials. Additional clinical and histological studies are required to determine the optimal timing of monopolar RF treatment and filler placement for maximal

potential aesthetic outcome. Dermatol Ther. 2008 Mar-Apr;21(2):118-30. Esthetic and cosmetic dermatology.

Wollina U, Goldman A, Berger U, Abdel-Naser MB.

The field of esthetic and cosmetic dermatology has gained remarkable interest all over the world. The major advantage of recent years is the high scientific levels of the most significant new developments in techniques and pharmacotherapy and other nonsurgical approaches. The present paper reviews selected fields of interest under this view. Sexual hormones are involved in the aging process of men and women. Skin function, in particular the epidermal barrier, is affected by a loss of endocrine activity. Hormone replacement therapy has only recently been introduced in treatment

of aging males. This is an area of gender-medicine in dermatology with a strong well-aging attempt. Botulinum toxin therapy for hyperfunctional lines has become not only well-established but evidence-based medicine on its highest level. Recent advantages were gained in objective

evaluation and monitoring the effect. Digital imaging techniques with various facets have been

introduced to assess the achievements of treatment in the most objective way. This may become

an example for other techniques as peeling, laser therapy, or radiofrequency in esthetic and cosmetic dermatology. Botulinum toxin has become a valuable tool for brow lifts. Details of the technique are discussed. Cellulite is a strongly female gender-related condition. During the past decades numerous treatments had been recommended but only recently a more critical scientific approach led to improvements in therapy of this common and disfiguring condition. Three major approaches are developed: (a) skin loosing with techniques such as subcision, (b) skin tightening

with radiofrequency and other approaches, and (c) improving circulation in blood and lymphatic microvasculature using both physical treatments and pharmacotherapy. The last two chapters are devoted to body sculpturing by lipotransfer and lipolysis. Lipotransfer for facial or body sculpturing has a history of about 100 years. Nevertheless, recently the role of adult stem cells in adipose tissue has gained much interest. By optimizing the harvesting, storage, and transplantation of adipose tissue, remarkable long-standing results have been obtained. Here the present authors will

focus on midface contouring, where lipotransfer competes with dermal fillers. Lipolysis is another effective tool in body sculpturing. The present authors will focus on recent advances in laser-assisted lipolysis for delicate body sculpturing in the submental region but also for gynecomastia abdominal region, flanks, and hips. In conclusion, esthetic and cosmetic dermatology has become a scientific-based subspeciality of dermatology with evidence-based treatments and a great variety of

high-tech approaches to provide more effective, more selective, and safer therapeutic options.

Dermatol Ther. 2008 Mar-Apr;21(2):118-30. Esthetic and cosmetic dermatology. Wollina U, Goldman A, Berger U, Abdel-Naser MB. The field of esthetic and cosmetic dermatology has gained remarkable interest all over the world. The major advantage of recent years is the high scientific levels of the most significant new

developments in techniques and pharmacotherapy and other nonsurgical approaches. The present paper reviews selected fields of interest under this view. Sexual hormones are involved in the aging process of men and women. Skin function, in particular the epidermal barrier, is affected by a loss of endocrine activity. Hormone replacement therapy has only recently been introduced in treatment of aging males. This is an area of gender-medicine in dermatology with a strong well-aging attempt. Botulinum toxin therapy for hyperfunctional lines has become not only well-established

but evidence-based medicine on its highest level. Recent advantages were gained in objective evaluation and monitoring the effect. Digital imaging techniques with various facets have been

introduced to assess the achievements of treatment in the most objective way. This may become an example for other techniques as peeling, laser therapy, or radiofrequency in esthetic and cosmetic dermatology. Botulinum toxin has become a valuable tool for brow lifts. Details of the technique are discussed. Cellulite is a strongly female gender-related condition. During the past decades numerous treatments had been recommended but only recently a more critical scientific

approach led to improvements in therapy of this common and disfiguring condition. Three major approaches are developed: (a) skin loosing with techniques such as subcision, (b) skin tightening withradiofrequency and other approaches, and (c) improving circulation in blood and lymphatic microvasculature using both physical treatments and pharmacotherapy. The last two chapters are devoted to body sculpturing by lipotransfer and lipolysis. Lipotransfer for facial or body sculpturing has a history of about 100 years. Nevertheless, recently the role of adult stem cells in adipose tissue has gained much interest. By optimizing the harvesting, storage, and transplantation of

adipose tissue, remarkable long-standing results have been obtained. Here the present authors will focus on midface contouring, where lipotransfer competes with dermal fillers.Lipolysis is another effective tool in body sculpturing. The present authors will focus on recent advances in laser-assisted lipolysis for delicate body sculpturing in the submental region but also for gynecomastia abdominal region, flanks, and hips. In conclusion, esthetic and cosmetic dermatology has become a

scientific-based subspeciality of dermatology with evidence-based treatments and a great variety of

high-tech approaches to provide more effective, more selective, and safer therapeutic options.

m J Clin Dermatol. 2009;10(3):153-68. doi: 10.2165/00128071-200910030-00002.

The Asian dermatologic patient: review of common pigmentary disorders and cutaneous

diseases. Ho SG, Chan HH. The Asian patient with Fitzpatrick skin types III-V is rarely highlighted in publications on cutaneous disorders or cutaneous laser surgery. However, with changing demographics, Asians will become an increasingly important group in this context. Although high melanin content confers better

photoprotection, photodamage in the form of pigmentary disorders is common. Melasma, freckles, and lentigines are the epidermal disorders commonly seen, whilst nevus of Ota and acquired bilateral nevus of Ota-like macules are common dermal pigmentary disorders. Post-inflammatory hyperpigmentation (PIH) occurring after cutaneous injury remains a hallmark of skin of color. With increasing use of lasers and light sources in Asians, prevention and management of PIH is of great research interest. Bleaching agents, chemical peels, intense pulsed light (IPL) treatments, and

fractional skin resurfacing have all been used with some success for the management of melasma. Q-switched (QS) lasers are effective for the management of epidermal pigmentation but are associated with a high risk of PIH. Long-pulsed neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers and IPL sources pose less of a PIH risk but require a greater number of treatment sessions. Dermal pigmentary disorders are better targeted by QS ruby, QS alexandrite, and QS

1064-nm Nd:YAG lasers, but hyper- and hypopigmentation may occur. Non-ablative skin rejuvenation using a combination approach with different lasers and light sources in conjunction

with cooling devices allows different skin chromophores to be targeted and optimal results to be achieved, even in skin of color. Deep-tissue heating using radiofrequency and infra-red light sources affects the deep dermis and achieves enhanced skin tightening, resulting in eyebrow elevation, rhytide reduction, and contouring of the lower face and jawline. For management of severe degrees of photoaging, fractional resurfacing is useful for wrinkle and pigment reduction, as well as acne scarring. Acne, which is common in Asians, can be treated with topical and oral antibacterials, hormonal treatments, and isotretinoin. Infra-red diode lasers used with a low-

fluence, multiple-pass approach have also been shown to be effective with few complications. Fractional skin resurfacing is very useful for improving the appearance of acne scarring. Hypertrophic and keloid scarring, another common condition seen in Asians, can be treated with the combined used of intralesional triamcinolone and fluorouracil, followed by pulsed-dye laser. Esthetic enhancement procedures such as botulinum toxin type A and fillers are becoming increasingly popular. These are effective for rhytide improvement and facial or body contouring.

We highlight the differences between Asian skin and other skin types and review conditions common in skin of color together with treatment strategies.

Aesthetic Plast Surg. 2009 Sep;33(5):687-94. A New Approach for Adipose Tissue Treatment and Body Contouring Using Radiofrequency-Assisted Liposuction

Malcolm Paul and Robert Stephen Mulholland

Abstract A new liposuction technology for adipocyte lipolysis and uniform three-dimensional tissue heating and contraction is presented. The technology is based on bipolar radiofrequency energy applied to the subcutaneous adipose tissue and subdermal skin surface. Preliminary clinical results, thermal

monitoring, and histologic biopsies of the treated tissue demonstrate rapid preaspiration liquefaction of adipose tissue, coagulation of subcutaneous blood vessels, and uniform sustained heating of tissue. We live in a culture preoccupied with both weight and body contour. North America also is a society in which obesity is an epidemic. It is no surprise then that liposuction continues to be the most commonly performed aesthetic procedure in the world. In 2007, 450,000 liposuction procedures

were performed in the United States alone by board-certified plastic surgeons, and another

150,000 by nonplastic surgeon physicians, for a total 600,000 lipocontouring procedures, accounting for approximately 5% of all elective surgeries in the United States. It is estimated that the number of liposuction procedures will more than double over the next 5 years. Coincident with the dramatic rise in liposuction procedures, the aging “baby boomer” population, with decreasing skin tone and advanced laxity, are seeking body contour procedures. A technology that effectively allows the physician to remove and contour adipose tissue with less bruising,

swelling, and pain while simultaneously providing for significant soft tissue contraction would enjoy popular appeal. Traditional tumescent, small-cannula, suction-assisted liposuction (SAL) is based on mechanical disruption of adipose tissue by a suction cannula moved manually through the subcutaneous space

aspirating small fat clusters of adipose tissue through the openings in the cannula

[4, 9, 11, 12, 21]. This traditional liposuction procedure of avulsing fat through a mechanically

induced negative pressure requires a degree of effort on the part of the physician and can be quite traumatic for the patient. Traditional SAL is less effective in secondary liposuction procedures and in fibrous areas, which do not enjoy significant skin contraction [13, 14]. The evolution of smaller vented cannulas, wetting solutions, and syringe aspiration techniques has refined the art of liposuction [5–7, 13, 14, 16–18, 22]. In an attempt to improve the postoperative patient recovery profile of pain, swelling, and

bruising, and to enhance skin contraction, physician effort, and effectiveness in secondary and fibrous cases, newer generations of energy-assisted liposuction technologies have been developed. The technique of ultrasound-assisted liposuction, in which cavitational ultrasound energy is delivered through a probe to adipose tissue specifically cavitated and liquified, is shown to be less traumatic than SAL and may result in more skin contraction [2, 15, 20, 23, 24]. Power-assisted liposuction (PAL) is a commonly used technology that uses a variable-speed motor to provide

reciprocating motion to the cannula, which in combination with the reciprocating action of the surgeon’s arm, facilitates removal of adipose tissue [3]. The principal advantage of PAL is treatment speed and economy of motion. Most recently, laser-assisted lipolysis (LAL) has been popularized [1, 8, 10, 19]. With the LAL technique, small fiberoptic probes deliver thermal and micromechanical lipolysis to adipose tissue,

reducing the need for traumatic adipose aspiration forces and pressures and leading to an improved recovery profile for the patient. One of the purported LAL benefits is enhanced skin

contraction after application of the small fiber to the subdermal space and warming of the skin to a temperature of 40°C [1, 8, 10, 19]. Although LAL became popular because of a strong campaign directly to consumers highlighting diminished recovery pain and risk as well as the potential ability to tighten the skin through subdermal heating, its use remains limited by relatively slow treatment speed, poor control of heating uniformity, and risk of tissue burns. The radiofrequency-assisted liposuction (RFAL) technique described in this report offers

Faster treatment

Reduced tissue trauma

Improved safety

Uniform heating of the skin and the subcutaneous layer

Potential skin contraction. Go to: Materials and Methods

The RFAL procedure was performed for 20 patients and 40 lipoplasty zones. The average age of the 18 women and 2 men was 43.9 years (range, 17–56 years). All RFAL areas underwent tumescent anesthesia before application of the radiofrequency (RF) energy. All aspiration was performed using a standard blunt-nose Mercedes cannula (Grahams Medical Corp, Costa Mesa, CA) (2.4–3.7 mm). The body areas treated included hips (n = 16), abdomen (n = 14), outer (n = 2) and inner (n = 4)

thighs, arms (n = 1), love handles (n = 2), and male breasts (n = 2) (Table 1).

Table 1 Treated areas

The RFAL body contour procedure was performed using the BodyTite system (Invasix Ltd, Yokneam, Israel). The BodyTite system’s bipolar RF handpiece is inserted into the subcutaneous

tissue, as shown in Fig. Fig.1.1. The internal electrode is inserted into the adipose tissue at the

desired depth for adipose and blood vessel coagulation. This insulated internal electrode probe

emits the RF current through a small conductive tip. The external electrode has a larger contact area and is applied to the skin surface, creating lower power density in the skin than in the adipose tissue. Up to 50 W of RF power is applied between the two electrodes. The RF power distribution between the electrodes is shown schematically in Fig. 2. The RF current creates heat and coagulates the adipose, vascular, and fibrous tissue in the operative area.

Fig. 1

Bipolar radiofrequency handpiece inserted into the body

Fig. 2

Power distribution between electrodes

In this study, electrode size and applied power were adjusted to provide adipose tissue liquefaction in the tissue between the internal and external electrodes and subnecrotic heating in the skin. Online, continuous skin temperature measurements with a negative feedback loop control of power were conducted by a temperature sensor embedded in the external electrode and confirmed by thermal camera FLIR A320 (FLIR Systems, Sausalito, CA). Continuous online tissue impedance and power output between electrodes were monitored. During treatment, the parameters of the BodyTite device were set so that the system would reach 40°C

and maintain that target temperature for 1 to 2 min. The typical RF energy introduced into the treated area was 100 J/cm2. Uniformity of temperature distribution was analyzed using thermal images and Researcher 2.9 of Flir Systems software. In addition, two patients underwent RFAL to their lower abdominal tissue immediately before excision of this tissue through an abdominoplasty procedure. Several 6-mm excisional biopsies were taken at the end of the treatment to analyze the RFAL treatment effect on fat and skin. A

control biopsy was taken from an immediately adjacent untreated area. The objective of the study was to establish the range of optimal treatment parameters and the RFAL treatment technique for different anatomic zones and thicknesses of the fat layer. The main

success indicators were

Safe treatment

Fast treatment

Easy technique

Uniform temperature distribution (±2°C)

Ability to maintain desired contraction temperatures for a consistent duration of time

Coagulation and liquefaction of adipose tissue

Blood vessel coagulation in the adipose layer.

The areas to be contoured were divided into distinct thermal zones of 10 × 15 cm. The discrete thermal zones corresponded to the length of the internal electrode and were selected to ensure a quick uniform adipose and vascular coagulation and a rise in temperature. Zones were selected and marked on the patient’s body. The cutoff temperature was set as high as 42°C. When measured skin temperature reached this thermal target point, the device automatically cut off the power and

restored power only when the temperature fell below the preset value. The power used for treatment in each zone was set initially to 20 W and increased gradually up to 50 W if no warning signs such as temperature spikes, erythema, or intradermal vesicles were observed. After determination of the maximal safety power level, the zone was treated with RFAL until the

temperature-controlled power cutoff limit was reached, which then was maintained at this level for 1 to 2 min to ensure uniform heating. Typical treatment power was 40 to 45 W. Two depth settings were used for the treatment. The depth of 30 to 45 mm was used for treatment

of deep fat. The end point for deep fat was reduction of mechanical tissue resistance. The superficial layer then was treated using a depth preset at 10 to 25 mm. A uniform desired tissue temperature elevation was the indication of successful treatment. After the RF treatment, aspiration of the coagulated adipose tissue was performed using a standard vented microcannula. Aspiration and contouring of the zone was completed when the “pinch and roll” test indicated symmetric, even, and uniform fat reduction. Fat thickness, treated area, and

total applied energy were documented to determine the volumetric RF dose required to perform the

treatment according to the aforementioned criteria.

Go to: Results

We compared the thermal effect created using RFAL BodyTite technology with the effect of LAL (SmartLipo MPX, Cynosure, Westford, MA) as the standards for thermal and nonthermal lipolysis

and lipoplasty. For the speed of treatment, the gold standard remains PAL (Microaire Surgical Instruments, Charlottesville, VA). Treatment Speed The initial temperature of the treatment sites varied from 26 to 29°C. At a power output of 45 W, it took approximately 8 to 12 min to heat up a typical zone with a thermal zone of 15 × 10 cm and a thickness of 25 mm. This treatment speed of uniform heating is much faster than that of the available LAL devices. We believe that the high speed of treatment is achieved not only by the

higher power of the device, but also from the more efficient use of applied power, which is not scattered from the treatment tip in all directions but concentrated in the treated zone between the two electrodes. The high speed of tissue heating facilitates the treatment of patients with large or multiple anatomic zones. In the current study, the treatment speed was comparable with that of ultrasound-assisted liposuction devices, but we believe that combination RFAL handpieces with simultaneous aspiration will make the treatment speed comparable with that of PAL.

Volumetric analysis of applied energy and treated volume showed that approximately 50 J/cm3 is required to reach the needed thermal effect in a lipoplasty zone of standard size. At an RF power of 40 to 50 W, the speed of volumetric treatment is in the range of 1 to 1.2 s/cm3. Ease of Use For a thermal sensor embedded in the external electrode, anticarbonization protection of the internal electrode and treatment depth control makes treatment safe, effective, and easy. Uniformity of Temperature Distribution

Figure 3 shows the typical temperature distribution for an LAL treatment zone (5 × 5 cm) when an external infrared thermometer (Raytek Corporation, Santa Cruz, CA) indicates the required target temperature of 40°C. It can be seen that the LAL temperature distribution is not completely uniform and is concentrated in “hot spots.” Although the hot spots reach temperatures of 47°C, a significant part of the thermal zone is still cold and exhibits temperatures of below 35°C. Application of additional LAL energy creates a high risk of a burn in the “hot spots,” but ceasing treatment may lead to lack of uniform heating, poor skin contraction, and inconsistency of the

results.

Fig. 3 Typical thermal image of the zone treated with laser-assisted lipolysis (LAL)

Using the temperature, impedance, and power control of the BodyTite device, we developed a new technique in which treatment is sustained at the target temperature for the treatment period at subnecrotic thermal levels to optimize soft tissue contraction. Closed-loop temperature and impedance control prevent thermal injury and facilitate longer treatment times at critical target temperatures, allowing all soft tissue in the treatment zone to reach a uniform temperature distribution. Figure 4 shows the uniformity of the temperature distribution after a BodyTite RFAL treatment.

Fig. 4 Typical thermal image of the zone treated with radiofrequency-assisted liposuction (RFAL) The histogram in Fig. 5 obtained using Researcher 2.9 software for analysis of all thermal images

shows uniformity of the treatment. It can be seen that the temperature distribution in the treatment zone after RFAL treatment exhibits twice the uniformity achieved during LAL.

Fig. 5

Temperature distribution in the thermal zone after treatment

Fat Necrosis Histologic samples taken from the treated area show extensive destruction and coagulation of the adipocytes and adipose tissue. Figure 6 shows histologic images of fat from control biopsy (Fig. 6a) and posttreatment zones. Trichrome staining of the samples shows disruption and coagulation of adipocyte membranes and adipose tissue after the RFAL treatment (Fig. 6c).

Fig. 6

Adipose tissue from the control biopsy (a), after PAL (b), and after radiofrequency-assisted liposuction (RFAL) (c) It can be seen that PAL creates channels in the adipose tissue with strong bleeding (Fig. 6b). Erythrocytes fill most of the space between fat cells. After RF-assisted treatment, the channel is free of blood, and strong fat cell membrane defragmentation is observed.

Blood Vessel Coagulation

Observation of post–RFAL-treated tissue after abdominoplasty shows no bleeding in the adipose fatty tissue to a 5- to 30-mm depth, whereas bleeding is observed from blood vessels in the subdermal area, as shown in Fig. 7. Histologic analysis of blood vessels in the RFAL-treated zone shows coagulation of small and medium-sized blood vessels, whereas the subdermal plexus vessels are not damaged (Fig. 8).

Fig. 7 Cross-section of treated adipose tissue

Fig. 8 Blood vessel from the radiofrequency-assisted liposuction (RFAL)-treated subcutaneous layer Collagen Tissue and Skin Contraction Histologic observation of connective tissue in the treatment area shows significant change in its structure, with coagulation of deep, reticular dermal collagen (Fig. 9). Early RFAL-induced soft tissue contraction appears very favorable and is better characterized and quantified with a long-term follow-up evaluation of 6 months. It appears that a powerful contraction and retraction of the

entire subcutaneous fibrous and dermal matrix occurs after the RFAL thermal stimulation that can lead to impressive three-dimensional soft tissue contraction and contours (Figs. 10, ,11,11, ,12).12). We believe the necessary physiologic thresholds and criteria for soft tissue contraction, specifically maintenance of a critical temperature for a critical duration in the fibrous tissue of the adipose and subdermal regions, are optimized with the advanced BodyTite feedback controls.

Fig. 9 Collagen appearance. Control condition (a) and immediately after the treatment (b)

Fig. 10 Body shape appearance of a female patient before (left) and 6 months after treatment (right)

Fig. 11

Body shape appearance of a female patient before (left) and 6 months after treatment (right)

Fig. 12 Body shape appearance of a female patient before (left) and 6 months after treatment (right)

Treatment Safety No complications or any long-lasting negative side effects were observed for any patients. All the patients experienced minimal pain, swelling, and ecchymosis. It is postulated that the reduced bruising observed was due to blood vessel coagulation in the treated zone before aspiration. The feedback control in the BodyTite handpiece allowed for the necessary sustained tissue heating to 40 to 42°C without thermal injury. Go to:

Discussion

Radiofrequency-assisted liposuction is a promising technology for body contouring with the following apparent advantages:

Ability to heat a significant volume of tissue quickly and uniformly

Ability to control tissue heating through direct monitoring of temperature and tissue

impedance.

Defragmentation of fat cells and coagulation of blood vessels in the treated zone, reducing

bleeding and bruising

Obvious collagen denaturation after RFAL treatment

Significant contraction and retraction of adipose and dermal tissue after treatment. The correlation between tissue-heating temperature, time, and body tightening requires further investigation but appears to offer an exciting new vista in nonexcisional body contouring.

Go to: Acknowledgment

We thank Invasix Ltd for assistance in thermal measurements, and we appreciate Patricia Ganas for her assistance with preparing this report for publication. The chief of medical advisory board was compensated for fees and options by Invasix Ltd.

Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. Go to: Contributor Information

Malcolm Paul, Email: moc.liamtoh@dmluapm. Robert Stephen Mulholland, Phone: +416-922-3743, Fax: +416-922-2351, Email:moc.acidemaps@dmdnallohlum. Go to: References

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J Cosmet Laser Ther. 2009 Dec;11(4):229-35. Post-pregnancy body contouring using a combined radiofrequency, infrared light and tissue manipulation device. Winter ML. BACKGROUND: Non-invasive body contouring is an increasingly popular aesthetic application. Previous data

support the efficacy of combined radiofrequency, infrared and skin manipulation for cellulite

treatment. OBJECTIVE: To evaluate the performance of a high-power device (50 W as opposed to 25 W) combining these energies for reshaping and improvement of skin texture/laxity in postpartum women. METHODS: Twenty women received five weekly treatments to the abdomen, buttocks and thighs with the

VelaShape system. We followed up each patient's weight and nutritional habits. Outcome was assessed using reproducible circumference measurements, digital photography, the physician's scores of cellulite and improvement as well as patient satisfaction. Safety was evaluated by recording subjects' comfort and tolerance. RESULTS: The overall mean circumferences reduction was 5.4 +/- 0.7 cm (p < 0.001). Significant (p < 0.02) improvement in skin laxity and tightening was noted by both the physician and patients.

Treatments were well tolerated with no major safety concerns (one purpura, one mild burn). CONCLUSIONS: The enhanced capabilities of the evaluated system enabled significant results in fewer and shorter

sessions without compromising patients' safety or comfort. These data suggest that postpartum reshaping via circumferential reduction and skin laxity improvement can be effectively and safely achieved using a high-energy combination of radiofrequency, infrared and mechanical manipulation.

Lasers Surg Med. 2009 Dec;41(10):791-8. doi: 10.1002/lsm.20872.

Improvement in arm and post-partum abdominal and flank subcutaneous fat deposits

and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device. Brightman L, Weiss E, Chapas AM, Karen J, Hale E, Bernstein L, Geronemus RG. BACKGROUND AND OBJECTIVES: Skin laxity of the body is a growing cosmetic concern. Laxity can result from chronological or

photoaging and changes in body dimensions during pregnancy or weight loss. The end result is loose, sagging skin, and localized fat deposits. Liposuction and abdominoplasty or brachioplasty are established approaches to these issues. Patient desire for alternatives to surgical correction has spawned the development of non-invasive body contouring devices. The combination of infrared light (IR), bipolar radiofrequency(RF), vacuum and mechanical massage (Velashape, Syneron Medical Ltd, Israel) has demonstrated efficacy in improving skin appearance and circumference of

the thighs [Goldberg et al., Derm Surg 2008; 34:204-209; Fisher et al., Derm Surg 2005; 31:1237-1241; Arnoczky and Aksan, J Am Acad Orthop Surg 2000; 8:305-313; Alster and Tanzi, J Cosmetic Laser Therapy 2005; 7:81-85; Wanitphakdeedecha and Manuskiatti, J Cosmet Dermatol 2006; 5:284-288; Nootheti et al., Lasers Surg Med 2006; 38: 908-912], but only anecdotal evidence has supported its use on other anatomic locations. This study was designed to evaluate

the efficacy and safety of Velashape on additional body sites and more rigorously examine the technology's impact on upper arm as well as abdominal and flank circumference.

STUDY DESIGN AND METHODS: Subjects were 28-70 years old, skin types I-V. Nineteen subjects underwent 5 weekly treatments of the upper arms, and 10 subjects underwent 4 weekly treatments of the abdomen and flanks. Treatments were performed using Velashape. Circumference measurements, photographs, and subject weights were performed prior to treatment and at 1- and 3-month follow-ups. Subjects were asked to record their treatment satisfaction level. RESULTS:

Change in arm circumference, at the 5th treatment was statistically significant with a mean loss of 0.625 cm. At 1- and 3-month follow-ups, mean loss was 0.71 and 0.597 cm respectively. Reduction of abdominal circumference at 3rd treatment was statistically significant with a 1.25 cm mean loss. At 1- and 3-month follow-ups, average loss was 1.43 and 1.82 cm respectively. CONCLUSIONS: This study demonstrates with statistical significance, sustainable reduction in circumference and

improvement in appearance of arms and abdomen following treatment with Velashape.

Eur J Dermatol. 2010 May-Jun;20(3):367-72. Clinical and histopathological study of the TriPollar home-use device for bodytreatments. Boisnic S, Branchet MC, Birnstiel O, Beilin G.

Professional non invasive treatments for body contouring based on radiofrequency (RF) became popular in aesthetic clinics due to proven efficacy and safety. A new home-use RF device for body treatments has been developed based on TriPollar technology. Our objective was to evaluate the TriPollar home-use device for circumference reduction, cellulite improvement and skin tightening using objective and subjective methods. An ex-vivo human skin model was used for histological and biochemical evaluations of the TriPollar clinical effect. Additionally, twenty four subjects used the new device on the abdomen and thigh areas and the circumference reduction

was measured. Ex-vivo models indicated a significant increase of 82% in hypodermal glycerol release. Histology revealed a 34% alteration in adipocyte appearance. Collagen synthesis increased by 31% following TriPollar treatment. A significant average reduction of 2.4 cm was measured on the treated thighs. On the control thighs a lesser, non-significant reduction was found. Average abdominal laxity was reduced from 1.4 at baseline to 0.8 following treatments. A certain reduction

was measured in the abdomen circumferences, although it was not significant. The reported results

demonstrate the safety and efficacy of the new TriPollar home-use device forbody contouring and skin tightening. Treatment may lead to discrete circumference reduction and moderate laxity improvement.

Eur J Dermatol. 2010 Sep-Oct;20(5):615-9.

Clinical experience with a TriPollar radiofrequency system for facial and bodyaesthetic

treatments. Levenberg A. Non-invasive aesthetic treatments aiming at circumference reduction and facial wrinkle improvement are becoming increasingly popular. TriPollar treatments for the purpose of body contouring and skin tightening procedures have recently gained interest. Our aim was to

evaluate the safety and efficacy of the Apollo device for non invasive treatment of localized excess fat and facial tightening. 37 female patients were treated for wrinkles, laxity and circumference reduction on different facial and body areas. Facial results were objectively analyzed with the Primos 3D imaging system. Body results were evaluated using photographs and circumferential measurements. Five volunteer patients underwent blood tests to assess changes in liver function and lipid profile following treatment. Significant reductions in body circumferences were measured.

The average circumference reduction in main body areas (abdomen, buttocks, thighs), was 3.6 +/- 2.4 cm with a maximum reduction of up to 10.5 cm in the abdomen. An improvement of perioral and periorbital wrinkles was achieved and analyzed. No significant changes were found in any of the liver function and lipid profile indicators. Findings confirm safety and efficacy of the new treatment modality for localized fat reduction and for body and face contouring.

G Ital Dermatol Venereol. 2010 Oct;145(5):583-96. What's new in skin resurfacing and rejuvenation? Kirkland EB, Gladstone HB, Hantash BM. Skin resurfacing and rejuvenation techniques have experienced significant advances in the last few decades, and new devices are continuously being introduced into the marketplace. The large

number of available modalities such as fractional lasers, radiofrequency systems, microdermabrasion, laser-assistedlipolysis, and ultrasound provides practitioners with a wide array of choices to address the needs of cosmetic patients. Many of the newer technologies, such as devices that integrate a fractional delivery system, provide excellent results with few adverse side effects. However, proper perioperative management is essential to achieving the desired effects. Furthermore, practitioners must be fluent with the operation and expected complications of these

new technologies. While there are many overlapping treatment indications for each of the devices mentioned above, some modalities offer distinct advantages making proper patient selection

essential. In certain cases, utilizing various combinations of mechanical, optic, acoustic, and electrical energies may be necessary to achieve the desired outcomes. This review discusses the application of new and existing skin rejuvenation techniques to clinical practice. A particular emphasis is placed on the use of fractional, radiofrequency, microdermabrasion, laser-assisted lipolysis, and ultrasound devices.

Aesthetic Plast Surg. 2011 Feb;35(1):87-95. Three-Dimensional Radiofrequency Tissue Tightening: A Proposed Mechanism and Applications for Body Contouring Malcolm Paul, G. Blugerman, M. Kreindel, and R. S. Mulholland

Abstract The use of radiofrequency energy to produce collagen matrix contraction is presented. Controlling the depth of energy delivery, the power applied, the target skin temperature, and the duration of application of energy at various soft tissue levels produces soft tissue contraction, which is measurable. This technology allows precise soft tissue modeling at multiple levels to enhance the

result achieved over traditional suction-assisted lipectomy as well as other forms of energy such as

ultrasonic and laser-generated lipolysis. Introduction

Radiofrequency (RF) thermal-induced contraction of collagen is well known in medicine and is used in ophthalmology, orthopedic applications, and treatment of varicose veins. Each type of collagen

has an optimal contraction temperature that does not cause thermal destruction of connective tissue but induces a restructuring effect in collagen fibers. The reported range of temperatures causing collagen shrinkage varies from 60 to 80°C [1–7]. At this temperature tissue contraction occurs immediately after tissue reaches the threshold temperature. The shrinkage of tissue is

dramatic and can reach tens of percent of the heated tissue volume. This type of contraction is well

studied in cornea [1], joints [2], cartilage [4, 7], and vascular tissue [5] but its application for skin,

subdermal tissue, and subcutaneous tissue tightening has not been studied. Noninvasive RF and lasers have been used for skin-tightening effects since the mid-1990s [6, 8–12]. Because of superficial thermal safety concerns, the skin surface temperature is maintained below 45°C. To increase the temperature in the deep dermis the skin is heated with RF or laser energy penetrating into the tissues deeper than 1.5 mm, with simultaneous skin surface cooling. This sophisticated method of transepidermal, noninvasive RF thermal delivery provides a variable

and controversial tightening effect, which is not usually apparent, if at all, until dermal remodeling occurs a few months after the treatment. Noninvasive tissue tightening treatments have an inherent safety limitation because energy is delivered through the skin surface and the threshold epidermal burn temperature is significantly lower than the optimal temperature for the collagen contraction. Studies indicate that deeper penetrating energy provides better skin contraction and RF energy, by penetrating deeper than laser radiation, is a superior method, not only for treatment

of facial rhytides and laxity, but also for body tightening [6, 9, 12]. It is the physical and biological characteristics of RF that explain its superior three-dimensional mechanism of skin tightening. Recently, the use of thermal-induced tissue tightening was expanded to minimally invasive treatments [13–16]. Using laser-assisted liposuction (LAL) or radiofrequency-assisted liposuction (RFAL), physicians have attempted to achieve reduction of subcutaneous tissue with simultaneous

tissue contraction [13, 16]. DiBernardo [13] reported 17% skin surface shrinkage measured at 3 months follow-up after LAL treatment. RFAL technology provides much higher power and more

efficient energy transfer than laser energy systems and thus allows the treatment of larger volumes of subcutaneous tissue with optimal thermal profiles, facilitating the significant tightening of the tissue. Paul and Mulholland [16] introduced a RFAL and soft tissue contraction technology that showed tremendous promise for thermal contouring. Invasive thermal treatments are superior because the RF conduit (RFAL emitting cannula) targets the whole volume of treated tissue with critical thermal energy, not only the superficial subdermal layer, and the invasive RF treatments can heat deep adipose and subcutaneous tissue to much higher temperatures without

compromising skin safety. When considering skin contraction we have to differentiate two-dimensional horizontal x-axis tightening of the skin surface from three-dimensional x-y-z tissue tightening of the subcutaneous tissue, where the skin is also more firmly connected and adjacent to the deeper anatomical structures. If two-dimensional contraction is a function of collagen structure changes in the dermis, the three-dimensional tissue-tightening changes involve contraction of different types of

collagenous tissue. We can separate the following types of collagen tissue in the subcutaneous space:

Dermis: papillary and reticular

Fascia: relatively thick layer of connective tissue located between muscles and skin

Septal connective tissue: thin layers of connective tissue separating lobules of fat and connecting dermis with fascia

Reticular fibers: framework of single collagen fibers encasing fat cells One of the main objectives of this study was to evaluate the possibility of immediate thermal-induced subcutaneous tissue contraction and to estimate the thermal threshold of the effect. In this study we compare the threshold temperature and contraction level of different types of ex vivo

collagenous tissue samples and the clinical results based on RFAL results for body contouring. Materials and Methods

Ex Vivo Experiment Setup An ex-vivo study was conducted to measure subcutaneous collagenous tissue contraction with

simultaneous monitoring of local tissue temperature to determine the threshold temperature of the collagen shrinkage. Three types of collagenous tissue were studied for thermal-induced contraction: (1) adipose tissue with septal and reticular connective tissue, (2) dermis, and (3) fascia.

Samples of ex vivo human tissue were taken from an abdominoplasty surgery and were tested within 10 min of excision. Immediate thermal testing was performed to minimize changes in tissue related to long storage and temperature variation or change of liquid content, including blood and

lymphatic content. The tissue samples were placed between the two BodyTite™ (Invasix Ltd., Israel) RF electrodes, where the small-area, internal RF-active electrodes (cannula) were placed in contact with the studied tissue and the other large-area electrode was applied to the opposite side, or epidermal side, of the sample. Large samples of subcutaneous tissue were used, allowing observation of any contraction behavior in the tissue’s native environment in connection with its entire matrix structure. Two marks were placed 1 cm from the active internal electrode to visualize tissue displacement. The experiment design setup is shown in Fig. 1.

Fig. 1

Ex vivo experimental setup RF energy was delivered by the BodyTite device. The delivered power was 70 W at 1 MHz, and energy was delivered until evaporation of water from the adipocytes was observed. Video and thermal cameras (FLIR A-320) were used to monitor tissue displacement and temperature change during the treatment. The start of tissue displacement was correlated with tissue temperature to determine the contraction thermal threshold. Each experiment was repeated three times for each type of tissue to sample tissue averages and avoid measurements of random events.

In Vivo Evaluation with Radiofrequency-Assisted Liposuction (RFAL) Twenty-four consecutive patients, 22 female and 2 male, underwent RFAL to the abdomen and hips. The average age was 39.7 years (range = 19-52 years). The average preoperative weight was 71 kg. The selected patients were typical patients indicated for a liposuction procedure. All patients were healthy anesthetic risks and active with no significant medical diseases. Fifteen of 24 patients had a normal BMI (<25), while 9/24 patients were moderately overweight (BMI = 25–30)

and 3 patients were obese (30 < BMI < 32).

RFAL was performed using the BodyTite device. The BodyTite device deploys a handpiece to deliver radiofrequency energy to the adipose tissue and skin. The internal cannula is coated with dielectric material and has a conductive tip that emits RF energy into the adipose tissue toward the skin surface. RF energy flows between the tip of the internal cannula and external electrode creating a localized, confined thermal effect between them. The internal cannula is inserted into the pretumesced fat to be contoured and is moved gently back and forth at various predetermined and

controlled depths for uniform heating of the treated volume. There is also an external electrode that moves along the surface of the skin in tandem vertical alignment with the tip of the internal cannula (Fig. 2). The subcutaneous tissue and skin between the electrodes experience a significant thermal effect which is maximal near the tip of the internal cannula and decreases in intensity toward the skin electrode The operator controls the depth of the internal cannula within a predetermined range of 5–50 mm and moves the handpiece back and forth through the desired fat volume to be contoured. The RF energy coagulates the adipose, connective, and vascular tissues in

the vicinity of the internal cannula tip and gently heats the dermis below the external electrode. The internal electrode also serves as an asynchronous internal suction cannula, aspirating the coagulated adipose, vascular, and fibrous tissues.

Fig. 2 Schematic drawing of RF handpiece inserted into the body The RF power, in the range of 40–70 W, was used for uniform heating throughout a thick

subcutaneous flap. The average total energy of about 72 kJ was delivered to the abdominal area. The temperature around the tip of the cannula reached 70-80°C. This internal temperature was observed using thermography on tissue cross section for preabdominoplasty patients treated with RFAL when the skin surface temperature reached 38–42°C (see Fig. 3, cross section of lower abdominal tissue showing the thermal image of the skin surface and tissue incision allowing visualization of the thermal profile of the internal subcutaneous temperature). The target skin temperature was monitored and controlled with a thermal sensor built into the external electrode.

The sensor provides continuous real-time epidermal temperature monitoring and feedback loop control of RF power. The system was set to a target temperature of 38–42°C, which was maintained for 1–3 min. The strong and sustained tissue heating during the procedure results in thermal stimulation of the subdermal layer, the entire matrix of adipose tissue, and the vertical and oblique fibrous septa, eliciting a powerful three-dimensional retraction and contraction of the entire soft tissue envelope.

Fig. 3

Temperature profile inside adipose tissue during the RFAL treatment The distance between the internal and external electrodes was controlled with an eccentric spring-loaded mechanism that keeps the external electrode on the surface of the skin at all times. The device also controls vaporization and prevents carbonization around the tip of the cannula. When evaporation around the internal cannula occurs, the tissue impedance rises and exceeds the online monitored high impedance and the device shuts off the RF energy.

All patients had their treatment area infiltrated with tumescent anesthesia prior to the RFAL

procedure. Tumescent anesthesia is critical in the technique as the RF current travels through

tissue most efficiently in a salinated environment. The objective of this in vivo portion of the study was to optimize treatment parameters and correlate treatment soft tissue contraction results with procedure and patient variables, including amount of deposed RF energy, body mass index (BMI) of the patients, and amount of aspirated fat. A zone measuring as large as 15 × 10 cm (150 cm2) may be heated to critical target temperature within 3–8 min depending on the thickness of the treated fat layer and then uniform volumetric

heating can be safely performed to reach uniform temperature distribution over the entire treated volume. All patients from the study were followed up at 6, 12, and 24 weeks. To measure linear contraction, the distance between two fixed points was measured preoperatively and then at the 24-week postoperative visit. Distances between incision ports and natural “fixed” anatomical registration points, such as moles or the umbilicus, were measured before the treatment, after the

treatment, and at 3- and 6-month follow-up visits. The linear contraction was measured as relative change of distance between two points over the curved surface of the body. Distances were measured using a flexible ruler applied over the skin surface. For the abdominal area, at least three measurements were taken between three different points and average linear contraction was calculated (Fig. 4).

Fig. 4 Before and after RFAL and intraoperative two-point linear contraction registration points from pubic RFAL incision point to the lower pole of the umbilicus Pre- and postoperative photography, weights, and circumferential reduction data were obtained on all patients. One RFAL study patient had a biopsy of the thermally treated skin 12 months after the

procedure during which epidermal skin temperatures of 40°C had been attained and there was an area contraction of 43% at 6 months. Results and Discussion

Ex Vivo Tissue Contraction Experiments

The adipose tissue with septal and reticular collagen behavior is shown in Fig. 5. The experiments showed that the marker movement (contraction) started within 2 s after the start of RF energy delivery. Tissue contraction was not symmetrical as the displacement from one side was 8 mm and from the other side the average displacement was 3 mm. Adipose fibrous septal tissue coagulation

and vaporization started to be observed at 13 s after the initiation of RF energy. Nonsymmetrical behavior can be explained by the nonuniform structure of connective tissue and the nonsymmetrical geometry of the studied tissue sample. The average marker migration and tissue

contraction for the three experiments with adipose tissue was 6.5 mm.

Fig. 5 Adipose-septal tissue behavior during RF energy delivery at different time points

Figure 6 shows thermal images of the same sample taken before the treatment, at the beginning of tissue displacement, and at the end of the treatment showing the rise in thermal profile with time and onset of contraction. For fascial tissue, contraction started when the maximal adipose tissue temperature near the active internal electrode reached 69.4°C. Adipose fibrous septal tissue coagulation and vaporization started when tissue temperature reached 90-100°C and is most probably associated with boiling of adipocyte water content.

Fig. 6 Adipose-fibrous septal tissue thermal behavior during RF energy delivery at different time points Fascia contraction is demonstrated in Fig. 7. The displacement of the markers and tissue contraction in fascia were significantly less than in adipose tissue. The average movement was

2.75 mm or approximately 2.5 times less than the mark migration and tissue contraction observed in adipose tissue. The marker migration and medial contraction started after 3.5 s and maximal temperature near the active electrode at this moment was 61.5°C.

Fig. 7

Fascia contraction behavior during RF energy delivery at different time points

Skin behavior is presented in Fig. 8. The migration of markers and medial displacement and tissue contraction on the skin were similar to the fascia. The average movement was 2.0 mm or approximately 3 times less than the marker migration and contraction observed in adipose tissue. The medial marker movement started after 2.5 s and the maximal temperature near the active electrode during this contraction was 81.9°C.

Fig. 8

Skin contraction behavior during RF energy delivery at different time points Table 1 summarizes the results on subcutaneous tissue contraction. From the results one can see that the strongest contraction response was observed in adipose tissue containing septal connective tissue and reticular collagen fibers encasing fat cells. The contraction temperature threshold was the highest for dermis. It is clear that the immediate contraction of dermal collagen is not possible to achieve without a skin burn, which happened when the epidermal temperature

exceeded 45°C [13]. Fascia and septa can be heated to these high, optimal contraction temperatures, but it can be done only in a minimally invasive transcutaneous manner that deposits

the thermal RF energy directly into the adipose tissue and subdermal space, thus avoiding heating the epidermal surfaces.

Table 1 Average displacement and contraction threshold The contraction temperatures of collagen in our ex vivo study were in the same range reported for

other collagenous tissues. We observed tissue contraction in the area with a diameter of 2 cm, which corresponds to a spherical contraction volume of 4.2 cm3. Knowing the tissue volume and deposited energy before the start of contraction, we can estimate the energy density required for each cubic centimeter of treated tissue to reach tissue contraction effects. We can calculate that for 1 L of adipose tissue up to 48.3 kJ is required to start to see immediate and significant collagen contraction. These calculations of tissue energy needed to initiate adipose contraction are consistent with empirical data obtained with LAL treatment where energy from 50 up to 100 kJ is

recommended for treatment of the abdominal area. In vivo clinical monitoring of temperature in the adipose tissue and on the epidermal surface should allow the physician to predict more accurately the thermal treatment times and reduce the risk of thermal injuries. In Vivo Clinical RFAL Results The skin biopsies taken from an RFAL study patient at 12 months show normal dermal architecture

with healthy collagen (Fig. 9) and elastin fibers (Fig. 10) in the deep reticular dermis and no evidence of scar tissue or abnormal collagen fibers. All RFAL patients demonstrated some level of contraction. From 8 to 15% linear tightening was observed at the end of the surgery on the operating table. It then increased dramatically during the first week when most of the swelling was reduced. The linear and area contraction process continued for weeks and maximum contraction was noted at the last follow-up visit 24 weeks after the treatment.

Fig. 9 Normal skin histology 12 months following optimal RFAL thermal end point

Fig. 10

Same RFAL patient with 43% contraction and normal elastic fiber content

Linear contraction observed at 6 months follow-up was much more significant than reported with

any other technology and varied from 12.7 up to 47% depending on patient and treatment variables. It is important to note that soft tissue area contraction can be calculated as the square of the linear contraction and represents much higher numbers. The measured linear contraction was then correlated with three parameters: (1) aspirated volume that ranged from 0.5 to 3.4 L, with an average volume of 2.0 L, (2) BMI that varied from 20.8 to 31.7, with an average index of 25.7, and (3) deposed RF energy that varied from 60 to 96 kJ per abdominal area, with an average RF

energy of 72 kJ. For statistical analysis of the correlation between the measured variables and linear contraction, the Pearson product moment correlation coefficients were calculated. The closer the coefficient is to 1, the higher the linear correlation between the measured variable and tissue contraction. Analysis shows no or very weak correlation between aspirated volume and linear skin contraction. The Pearson coefficient is about 0.22. Figure 11 shows the correlation between these values and has a

random distribution. The Pearson coefficient for correlation between contraction and patient BMI is much higher and equal to 0.64. Figure 12demonstrates a much stronger connection between these parameters and it is easy to understand that a patient with a larger volume of adipose tissue would have more tissue available to undergo contraction.

Fig. 11 Correlation between aspirated volume and linear contraction

Fig. 12

Correlation between BMI and linear contraction The highest correlation (0.86) was obtained between deposed RF energy and skin contraction. Figure 13shows measurement results that have an almost linear function between these two parameters. The more energy deposited, the more linear contraction that was observed. In spite of improved contraction obtained at higher energies, the amount of energy used during treatment can

and should be measured and controlled to avoid side effects such as seroma and skin burn and still achieve optimal linear and area contraction.

Fig. 13 Correlation between total energy and linear contraction Features of an ideal liposuction procedure would include reduced ecchymosis, pain, and edema from preaspiration coagulation of adipose and vascular tissue, followed by less forceful and traumatic extraction forces, as well as significant soft tissue contraction when host tissue elasticity is compromised. Thermal-based lipoplasty appears to hold this potential.

In the present study based on volumetric heating, we reached an average local linear contraction of 31% that is statistically significantly higher than that reported with other energy-emitting liposuction technologies. Overall area contraction was much higher than linear contraction. We believe that these in vivo results confirm our proposed mechanism of RF-based tissue tightening and recruitment of the vertical and oblique fibrous adipose matrix. Our biopsy at 7 months

suggests that the papillary and reticular dermis is populated with normal collagen and elastin that have been stimulated and remodeled by subnecrotic subdermal RFAL temperatures.

About 30% of patients noted minor weight loss but it is premature to correlate it with the treatment procedure. The in vitro experiments produced different degrees of contraction for septal and dermal tissues which emphasizes the balance between these processes for optimal aesthetic results. Lower two-dimensional contraction of the skin and significant three-dimensional contraction of subdermal adipose connective tissue may cause wrinkling of the skin surface in high-volume liposuction patients.

During this study we had one case of a seroma that was treated with closed serial aspiration.

Seroma is not a rare side effect for energy-assisted liposuction, especially for high-volume

treatment and may necessitate a lower threshold for closed drainage systems in selected patients. Conclusions

We believe the study results confirm the hypothesis of Kenkel [17], i.e., skin tightening and

elasticity changes following thermal lipoplasty are mostly a result of subdermal tissue contraction but not dermal, which experiences lower heating during the treatment. It is clear that 40–42°C on the skin surface cannot result in an immediate contraction effect. Deep dermal remodeling may account for some horizontal contraction over time. It is possible that the dermal-fat junction experiences higher temperatures, but this process requires future investigation. We believe that the mechanism of subcutaneous collagen contraction during RF-assisted liposuction is similar to that witnessed in other types of collagen in that the contraction process has thermal contraction

thresholds in the range of 60–70°C. It is likely more accurate to talk about tissue contraction rather than skin tightening because significant area contraction is a result of the strong contribution of deeper adipose fascial layers. Further studies with accurate 3D area measurements will tell us more about the RF-mediated area contraction in this RFAL technology. This RFAL thermal process and contraction can be effectively applied during a liposuction treatment in selected cases, improving patient satisfaction and

extending liposuction procedures to higher-weight patients and patients with compromised skin conditions. Disclosures

Dr. Paul serves as consultant to and chairman of the board of the medical advisory board for

Invasix, Ltd., and received consultation fees and stock options. He also serves as consultant to and chairman of the scientific advisory board for Angiotech/Surgical Specialties and receives consultant fees. Dr. Mulholland received consulting fees and technology from Invasix. Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

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Aesthetic Plast Surg. 2011 Oct;35(5):901-12. Noninvasive body sculpting technologies with an emphasis on high-intensity focused

ultrasound. Jewell ML, Solish NJ, Desilets CS. BACKGROUND: Body-sculpting procedures are becoming increasingly popular in the United States. Although surgical lipoplasty remains the most common body sculpting procedure, a demand exists for noninvasive alternatives capable of reducing focal adiposity without the risks of adverse events

(AEs) associated with invasive excisional body-sculpting procedures. METHODS: This report describes the mechanism of action, efficacy, safety, and tolerability of cryolipolysis,radiofrequency ablation, low-level external laser therapy, injection lipolysis, low-intensity nonthermal ultrasound, and high-intensity focused ultrasound (HIFU), with an emphasis on thermal HIFU. The articles cited were identified via a PubMed search, with additional article citations identified by manual searching of the reference lists of articles identified through the

literature search.

RESULTS: Each of the noninvasive treatments reviewed can be administered on an outpatient basis. These treatments generally have fewer complications than lipoplasty and require little or no anesthesia or analgesia. However, HIFU is the only treatment that can produce significant results in a single treatment, and only radiofrequency, low-level laser therapy, and cryolipolysis have been approved

for use in the United States. Early clinical data on HIFU support its efficacy and safety for body sculpting. In contrast,radiofrequency, laser therapy, and injection lipolysis have been associated with significant AEs. CONCLUSIONS: The published literature suggests that noninvasive body-sculpting techniques such asradiofrequency ablation, cryolipolysis, external low-level lasers, laser ablation, nonthermal ultrasound, and HIFU may be appropriate options for nonobese patients requiring modest reduction

of adipose tissue.

Clin Plast Surg. 2011 Jul;38(3):503-20. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy.

Mulholland RS1, Paul MD, Chalfoun C.

Noninvasive body contouring is perhaps one of the most alluring areas of esthetic surgery today. This article discusses current noninvasive body-contouring modalities, including suction massage devices,radiofrequency energy, high-frequency focused ultrasound, cryolipolysis, and low-level light laser therapy devices. It also discusses imminent technologies awaiting approval by the Food and Drug Administration, reviews the basic science and clinical effects behind each of these existing and emerging technologies, addresses patient selection and clinical applications of each modality,

and discusses the applicability and economics of providing noninvasive lipolysis services in office.

J Plast Surg Hand Surg. 2011 Dec;45(6):286-93. Body-contouring with radiofrequency-assisted liposuction. Ion L, Raveendran SS, Fu B.

Liposculpturing is the most frequently performed procedure in the aesthetic clinical practice. The techniques have evolved into significant modification during the past few decades with introduction of several new devices, leading to superior outcome. Radiofrequency-assisted liposuction (RFAL) have revolutionised body contouring techniques by providing simultaneous fat liquefaction, coagulation of blood vessels, and skin tightening in the tissues. In this study we discuss our

preliminary experience with RFAL in treating patients for aesthetic body contouring and patients with HIV-related lipohypertrophy. Forty-two patients were treated with RFAL for cosmetic concerns, and eight were treated for HIV-related lipohypertrophy after unsuccessful outcome with other techniques. Significant reduction of adipose tissue with marked tightening of the skin was noted in all the patients. Clinical results were impressive in terms of pain, recovery, and patient satisfaction. Remarkable improvement was observed in patients with HIV-related cervical lipohypertrophy and

gynaecomastia with fibrous fatty tissue. Two patients suffered superficial burns and were managed conservatively. Our experience suggests that controlled application of radiofrequency power for liposculpturing may open up a new horizon of non-excisional lipectomy in the future. Adv Ther. 2012 Mar;29(3):249-66. Exploring channeling optimized radiofrequency energy: a review

of radiofrequencyhistory and applications in esthetic fields. Belenky I, Margulis A, Elman M, Bar-Yosef U, Paun SD. INTRODUCTION: Because of its high efficiency and safety, radiofrequency (RF) energy is widely used in the dermatological field for heating biological tissue in various esthetic applications, including skin tightening, skin lifting, body contouring, and cellulite reduction. This paper reviews the literature on

the use of nonablative RF energy in the esthetic field and its scientific background. The purpose of this article is to describe in detail the extensive use of medical devices based on RF technology, the development of these medical devices over the years, and recent developments and trends in RF

technology. METHODS: The authors conducted a systematic search of publications that address safety and efficacy issues,

technical system specifications, and clinical techniques. Finally, the authors focused on their own clinical experiences with the use of patented Channeling Optimized RF Energy technique and mechanical massage. An in-vivo study was conducted in domestic pigs, with a thermal video camera. Twenty-seven female patients participated in a cellulite and body shaping study. The treatments were conducted according to a three-phase protocol. An additional 16 females participated in a skin tightening case study. All of the patients underwent three treatment sessions at 3-week intervals, each according to a protocol specific to the area being treated.

RESULTS: The review of the literature on RF-based systems revealed that these systems are safe, with low risks for potential side effects, and effective for cellulite, body contouring, and skin tightening procedures. The in-vivo measurements confirmed the theory that the penetration depth of RF is an inverse function of its frequency, and using a vacuum mechanism makes an additional contribution to the RF energy penetration. The heating effect of RF was also found to increase blood circulation and to induce collagen remodeling. The results from the cellulite and body shaping treatments

showed an overall average improvement of 55% in the appearance of cellulite, with an average circumferential reduction of 3.31 cm in the buttocks, 2.94 cm in the thighs, and 2.14 cm in the abdomen. The results from the skin tightening procedure showed moderate improvement of skin appearance in 50% and significant improvement in 31%. At the follow-up visits the results were found to be sustained without any significant side effects. CONCLUSION:

Of all tissue heating techniques, RF-based technologies appear to be the most established and clinically proven. The design and specifications of the described vacuumassisted bipolar RF device fall within the range of the specifications currently prescribed for esthetic, nonablative RF systems.

J Dermatol Sci. 2012 Feb;65(2):95-101. doi: 10.1016/j.jdermsci.2011.10.011. Epub 2011 Nov 11. Visualizing radiofrequency-skin interaction using multiphoton microscopy in vivo. Tsai TH, Lin SJ, Lee WR, Wang CC, Hsu CT, Chu T, Dong CY.

BACKGROUND: Redundant skin laxity is a major feature of aging. Recently, radiofrequency has been introduced for nonablative tissue tightening by volumetric heating of the deep dermis. Despite the wide range of application based on this therapy, the effect of this technique on tissue and the subsequent tissue remodeling have not been investigated in detail. OBJECTIVE:

Our objective is to evaluate the potential of non-linear optics, including multiphoton autofluorescence and second harmonic generation (SHG) microscopy, as a non-invasive imaging modality for the real-time study ofradiofrequency-tissue interaction. METHODS: Electro-optical synergy device (ELOS) was used as the radiofrequency source in this study. The

back skin of nude mouse was irradiated with radiofrequency at different passes. We evaluated the effect on skin immediately and 1 month after treatment with multiphoton microscopy.

RESULTS: Corresponding histology was performed for comparison. We found that SHG is negatively correlated to radiofrequency passes, which means that collagen structural disruption happens immediately after thermal damage. After 1 month of collagen remodeling, SHG signals increased above baseline, indicating that collagen regeneration has occurred. Our findings may explain mechanism of nonablative skin tightening and were supported by histological examinations. CONCLUSIONS:

Our work showed that monitoring the dermal heating status of RF and following up the detailed process of tissue reaction can be imaged and quantified with multiphoton microscopy non-invasively in vivo. Aesthetic Plast Surg. 2012 Aug;36(4):767-79.

Radiofrequency-assisted liposuction device for body contouring: 97 patients under local anesthesia.

Theodorou SJ, Paresi RJ, Chia CT. BACKGROUND: Radiofrequency-assisted liposuction involves the delivery of a controlled amount of energy to treated tissue resulting in fat liquefaction, accompanying hemostasis, and skin tightening. The

purpose of this study is to report experience with a larger sample size using the BodyTite™ radiofrequency-assisted liposuction (RFAL) platform, and its first use with local tumescent anesthesia. The Bodytite™ device is currently awaiting FDA approval. METHODS: We prospectively included 97 patients who underwent radiofrequency-assisted liposuction under local anesthesia under IRB approval. We treated 144 anatomical areas in 132 operations and collected the following data: age, sex, height, weight, body mass index (BMI), anatomical area of

treatment, operative time, amount of tumescent solution used, amount of fat aspirated, amount of kilojoules (kJ) delivered, and the incidence of infections, seromas, adverse effects from medications, and thermal injuries. Patients were asked to complete an online survey assessing the aesthetic outcome and quality of life after treatment with RFAL-assisted liposuction. Three independent plastic surgeons were asked to evaluate photographs of our 6-month postoperative

results in comparison to the preoperative photos.

RESULTS: The average age and BMI of our study population was 37.6 years and 28.2 kg/m2, respectively. The study population was 88% female. The mean amount of lidocaine given per treatment session was 32.7 mg/kg (range=3.8-83.3 mg/kg). The mean amount of tumescent fluid given per anatomical treatment area was 1,575 cc. The average amount of total aspirate across all anatomical treatment areas was 1,050 cc, with an average total aspirate of 1,146 cc per treatment date. The overall incidence of major complications was 6.25% and the incidence of minor

complications was 8.3%. Overall patient satisfaction was 82% for the degree of skin tightening and 85% for the body-contouring result with the BodyTite™ device. Three independent plastic surgeons

graded the improvement in body contour as good to excellent in 74.5% of patients and the

improvement in skin tightening as good to excellent in 58.5% of patients.

CONCLUSIONS: The BodyTite™ RFAL platform is a safe and effective device for use as an energy-based liposuction technique under local tumescent anesthesia in the awake patient. Aesthet Surg J. 2013 Nov 1;33(8):1154-66.

Nonexcisional tissue tightening: creating skin surface area reduction during abdominal liposuction by adding radiofrequency heating. Irvine Duncan D. BACKGROUND: Recent publications show that heat-mediated tissue tightening is a promising treatment for the lax

abdomen and may provide better long-term outcomes than traditional suction-assisted liposuction (SAL). OBJECTIVES: The author evaluates the degree and duration of skin surface area contraction, as well as the influence of anatomic location of the treatment region on the degree of tissue tightening, in a study

comparing SAL alone vs SAL plus radiofrequency-assisted liposuction (RFAL). METHODS:

In this prospective, randomized, split abdominal study, 12 consecutive patients were treated with SAL alone on 1 side and with SAL plus RFAL on the other side. Each patient had 4 (3 × 3-cm) squares-2 per treatment type-tattooed in the lower abdominal region (2 on the right and 2 on the left). The surface area of these squares was measured with the Vectra computerized measurement system (Canfield, Inc, Fairfield, New Jersey) at pretreatment, at 6 weeks post treatment, and at 1 year posttreatment. All measurements were subjected to statistical analysis using predictive analytic software and were evaluated for statistical significance.

RESULTS: In regions treated with SAL alone, there was a 10.4% mean skin surface area contraction at 6 weeks and 8.3% at 1 year posttreatment. The mean skin surface area reduction was 25.8% in regions treated withradiofrequency plus SAL at 6 weeks and at 1 year. The anatomic location of each square (medial vs lateral) did not statistically correlate with more or less tissue tightening. CONCLUSIONS:

Radiofrequency-assisted tissue tightening, when applied in conjunction with SAL, is effective in achieving greater skin surface area reduction.

J Drugs Dermatol. 2014 Mar;13(3):291-6. Selective radiofrequency therapy as a non-invasive approach for contactless bodycontouring and circumferential reduction.

Fajkošová K, Machovcová A, Onder M, Fritz K. 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 bodycontouring and circumferential fat reduction.

Lasers Med Sci. 2014 Sep;29(5):1627-31.

Reduction in adipose tissue volume using a new high-power radiofrequencytechnology

combined with infrared light and mechanical manipulation for bodycontouring.

Adatto MA, Adatto-Neilson RM, Morren G. A growing patient demand for a youthful skin appearance with a favorable body shape has led to the recent development of new noninvasive body contouring techniques. We have previously demonstrated that the combination of bipolar radiofrequency (RF) and optical energies with tissue manipulation is an efficient reshaping modality. Here, we investigated the efficacy and safety of a

new high-power version of this combined technology, in terms of adipose tissue reduction and skin tightening. Thirty-five patients received one treatment per week over 6 weeks to their abdomen/flank, buttock, or thigh areas and were followed up to 3 months post completion of the treatment protocol. This new device has an increased power in the bipolar RF, as this parameter appears to be the most important energy modality for volume reduction. Patient circumferences were measured and comparisons of baseline and post treatment outcomes were made. Diagnostic

ultrasound (US) measurements were performed in 12 patients to evaluate the reduction in adipose tissue volume, and a cutometer device was used to assess improvements in skin tightening. We observed a gradual decline in patient circumferences from baseline to post six treatments. The overall body shaping effect was accompanied with improvement in skin tightening and was clearly noticeable in the comparison of the before and after treatment clinical photographs. These findings

correlated with measurements of adipose tissue volume and skin firmness/elasticity using diagnostic US and cutometer, respectively. The thickness of the fat layer showed on average a

29% reduction between baseline and the 1-month follow up. The average reduction in the circumference of the abdomen/flanks, buttocks, and thighs from baseline to the 3-month follow-up was 1.4, 0.5, and 1.2 cm, respectively, and 93% of study participants demonstrated a 1-60% change in fat layer thickness. Patients subjectively described comfort and satisfaction from treatment, and 97% of them were satisfied with the results at the follow-up visit. The application of high-power RF energy combined with infrared (IR), mechanical massage, and vacuum appears to be an effective modality for the reduction in circumferences of the abdomen/flank, buttock and

thigh regions, and the improvement of skin appearance. The present study performed with a new device suggests that the underlying mechanism of action is reduction in the subcutaneous adipose tissue volume and intensification of dermal matrix density.

Introduction

Localized subcutaneous fat deposits and tissue laxity are of growing concern among

cosmetic patients, the contributing factors of which include chronological aging, photoaging, as well

as changes in body dimensions due to pregnancy and significant weight loss. The most popular body contouring approaches used to improve the cosmesis of subcutaneous fat deposits and skin laxity are surgical and include liposuction, abdominoplasty, and thigh lifts, among other procedures. However, in tandem with cosmetic patients’ desire for a favorable body shape is their increasing demand for noninvasive treatment approaches that are painless, safe, and require little to no downtime. This increasing demand has led to the rapid growth and development of

noninvasive, nonsurgical treatment techniques. Although surgical techniques can result in the most pronounced outcomes in respect to improved body contouring results, they are also associated with inherent risks as well as prolonged recovery times. These factors, in combination with today’s cosmetic patients’ active lifestyles and coupled with their desire for noninvasive treatment options have further popularized noninvasive, nonsurgical treatment approaches.

The first most common and available noninvasive treatments for body contouring were based on nonthermal mechanical rollers and suction systems that were thought to cause

vasodilatory effects, which enhance lymphatic drainage in fat deposits and improve microcirculation. Over the past couple of years, however, the technology has moved towards the use of thermal-based suction devices which combine radiofrequency (RF) with or without infrared energies and mechanical massage. The application of energy to the skin’s surface produces heat in

the dermis and subcutaneous tissues with subsequent induction of collagen denaturation and neocollagenesis, resulting in tissue tightening [1–4]. The RF technology delivers a thermal stimulus

to the skin and superficial adipose tissue causing a thickening of the dermis and enhancement of fat cell metabolism, resulting in a reduction in skin laxity and adipocyte volume [1–5].

The VelaShape device (Syneron Medical Ltd. Yokneam, Israel) incorporates four treatment modalities including pulsed vacuum and mechanical massage, bipolar RF energy, and IR light, the latter of which preheats the targeted tissue, mitigating impedance, and thereby allowing greater attraction of the RF current and deeper penetration of RF energy into the targeted tissues [1–6]. This study evaluated the efficacy and safety of the VelaShape II device (Syneron Medical Ltd.,

Yokneam, Israel), a new high-power version of its predecessor the VelaShape, in terms of adipose

tissue reduction and skin tightening.

Materials and methods

In this prospective, two-center clinical trial conducted at Skinpulse Dermatology and Laser Centre, Geneva, Switzerland, and Dr. Morren’s private practice, Leuven, Belgium, treatment was

performed using the VelaShape II system, a device that combines four different technologies including broadband IR (infrared), bipolar RF-pulsed vacuum and massage rollers. The broadband IR light spectrum is 700–2,000 nm with a high pass filter, at up to 35 W. The RF frequency is 1 MHz and up to 60 W. Pulsed vacuum was set up at 200 mbar of negative pressure.

The combination of the IR and pulsed vacuum coupled RF technologies causes a deep heating of the connective tissue including the fibrous septae. This in turn promotes an increase in collagen deposition and cellular metabolism resulting in a localized reduction in skin laxity and

volume [1–4]. The additional mechanical tissue manipulation by the vacuum and massage rollers, causes an immediate increase in the local circulation and enhances lymphatic drainage, both effects of which are considered to be essential components for healthy skin structure. The VelaShape II system has two applicators, namely the Vsmooth with a 40 mm × 40 mm spot size and the Vcontour with a 30 mm × 30 mm spot size. The applicators are fitted with a replaceable cap that has a treatment chamber, into which the targeted skin is repeatedly drawn during

treatment via mechanical manipulation and is exposed to IR and RF energies. The user can individualize treatment by adjusting the energies and vacuum levels according to the patient and anatomical site treated.

The study included 35 healthy adult female patients who were between 21 and 58 years of age (mean age 43) with clinically appreciable skin laxity and localized subcutaneous fat deposits on the abdomen/flanks, buttocks or thigh regions, and Fitzpatrick skin types I to III. Patient inclusion criteria were the presence of at least 20 mm of subcutaneous fat (assessed by ultrasound) and the

presence of lax skin and cellulite. Study exclusion criteria were mainly pregnancy, lactation, and any kind of previous cosmetic treatment in these areas for the last 12 months. Every patient signed the informed consent prior to the study. Study participants were treated for circumferential reduction on the abdomen/flanks (n = 32), buttocks (n = 14), and thighs (n = 16) and received a total of six treatments performed once or twice a week. All of the treatments in this study were performed with the Vsmooth large spot applicator using RF energy of 60 W and IR energy of up to 35 W. Each procedure was performed using the established and standardized treatment protocol of

the VelaShape II system, which at the time of this study was a new device with increased power. The pulsed vacuum was typically set at level 2 (200 mbar of negative pressure). Treatment sessions typically lasted from 35 to 45 min, in which the goal was to treat the area until the target

tissue temperature of between 39–41 °C has been reached and maintain it for at least 5 min per 10 × 10 cm2 zone (per the VelaShape II user manual). The temperature maintained was measured at skin level using an external thermometer. It has been shown that in the temperature range 37–

44 C, skin blood perfusion increases 10 times, muscle about nine times, and fat only two times [13]. The skin cools much faster than the fat because of the increased blood flow, thus the temperature is maintained much longer in the fat layer than what we measure on the skin.

Patients did not gain or lose weight significantly during the course of the study, as they were weighed at each visit. Various clinical evaluations were performed by an independent observer at baseline, after the fourth treatment, immediately after the last treatment, and 1 and 3 months after the last treatment. Objective clinical assessments included changes in the fat layer

thickness and skin firmness/elasticity, which were performed using an external ultrasound probe (Echoblaster 128, Telemed Ltd., Vilnius, Lithuania) and a cutometer, respectively. Both the ultrasound and cutometer technologies used to ascertain the objective clinical changes achieved in this study are FDA-approved modalities. Measurements were taken in three consecutive repetitions, and the average score (in mm) was recorded. Improvement evaluation was performed by the physician using the following percentile categories: 0, 1–24, 25–49, 50–74, and 75–100 %. All clinical photographs were taken with a medical standardized system (Profect Full Body System,

Profect Medical Technologies LLC, Pound Ridge, NY, USA). Patients evaluated treatment outcome satisfaction based on the following satisfaction scale: not satisfied, slightly satisfied, satisfied, very satisfied, and extremely satisfied. Safety and patients’ report of treatment-associated sensation was monitored throughout the study.

Results

All of the patients met the inclusion/exclusion criteria of the study and signed an informed consent for US and cutometer measurements prior to its initiation. Results showed that all of the 35 healthy adult women (aged 21 to 58 years, mean 43 years) completed the clinical trial. The Fitzpatrick skin type allocation was 9 % type I, 85 % type II, and 6 % type III. The 35 patients included in the study received VelaShape II treatment to one or more anatomical sites including

the abdomen/flanks (n = 32), buttocks (n = 14), and thighs (n = 16). The average reduction in the

circumference of the abdomen/flanks, buttocks, and thighs from baseline to the 3-month follow-up

was 1.4, 0.5, and 1.2 cm, respectively, while the SD was 2, 0.7, and 3.3 cm, respectively. P value (Wilcoxon signed rank test for single group median) was 0.0004, 0.0446, and 0.1503, respectively (Table 1).

Table 1 Circumference 3 months after end of treatments The thickness of the fat layer as per the comparative ultrasound measurements taken

showed on average a 29 % reduction between baseline and the 1-month follow-up, and 93 % of

study participants demonstrated a 1–60 % change in fat layer thickness (Fig. 3).

Fig. 3 Four treatment results, reduction of fat thickness is visible and stable at 1 and 3 months FU The physician’s evaluation measurements revealed that almost all patients had some level

of overall improvement in adipose tissue reduction and skin tightening in the treated areas, with

60 % of patients showing a 1–24 % improvement, 27 % showing a 25–49 % improvement, and 5 % showing a 50–74 % improvement, while only 8 % of patients showed no improvement in the treated anatomical sites (Fig. 1). At the final follow-up visit, 97 % of patients expressed an overall satisfaction with the treatment outcomes, including 3 % being extremely satisfied, 32 % very satisfied, 52 % satisfied, and 10 % slightly satisfied. The overwhelming majority of patients tolerated the treatments well, with 69 % of patients subjectively rating the treatment as very

comfortable, 21 % comfortable, 6 % somewhat comfortable, and 3 % somewhat uncomfortable,

while only 3 % perceived the treatment as very uncomfortable. Side effects of treatment included transient erythema and edema in all patients and two patients with bruising at the treated site. Adverse events included a burn to the abdomen in one patient, which could be treated with remedial therapy.

Fig. 1 Fat thickness change at FU visit Go to: Discussion

This study supports the safety and efficacy of the VelaShape II system for the improvement in circumferential reduction and skin laxity in the abdomen/flanks, buttocks, and thigh regions (Fig. 2). The safety and efficacy of an older version of the device (VelaSmooth, Syneron Medical

Ltd., Yokneam, Israel) has already been demonstrated in previous clinical trials in terms of circumference reduction and cellulite improvement, mainly in thighs and buttocks [6–11]. The VelaShape (immediate predecessor to the VelaShape II) was the first device to achieve an FDA

indication for circumferential reduction in 2007, following clinical trials performed on thighs [1, 6, 9–14].

Fig. 2

Overall satisfaction—FU

The clinical effect seen with VelaShape treatment is thought to occur as follows: the pulsed vacuum combined with the action of massage rollers causes a vasodilation as well as an increased local circulation and lymphatic drainage in the treated area. The subsequent increase in available oxygen can facilitate an increase in the localized fat metabolism. In addition, the heat generated from the application of IR and RF energies theoretically increases the available oxygen, further enhancing fat metabolism and causes the adipocytes to shrink as they break down the fat. The

mechanical massage also enhances the flow of these breakdown products to the lymphatic system and stretches the fibrous septae. The collagen fibers in the dermis and fibrous septae shrink, resulting in smaller fat chambers and skin tightening. The heat energy also causes collagen shrinkage and stimulates the fibroblasts to produce new collagen fibers. Taken together, these combined actions result in circumferential reduction and improvements in skin laxity and the appearance of cellulite (Fig. 3).

Among other changes, one of the pivotal upgrades made to the VelaShape II device from its immediate predecessor is an increase in power in the bipolar RF energy by 20 % to 60 W. The increased power in the bipolar RF energy appears to be the most important energy modality that can impact and enhance volume reduction. The 40 mm × 40 mm Vsmooth large spot applicator used in this study can emit RF energy of 60 W and IR of up to 35 W. The simultaneous application

of IR and RF heat energies is combined with mechanical tissue manipulation achieved with massage rollers and pulsed, the latter of which allows for a higher penetration depth for higher

peak heating of the subcutaneous tissue. The peak temperature reached in the tissues and the time over which that temperature is

maintained are two important factors that impact tissue tightening. Achieving and maintaining a peak temperature over a period of time result in a progressive skin tightening and subsequent measureable reductions in circumference [15]. It is widely known that clinical results are dependent on the maintenance of targeted tissue temperature over 40 °C [2, 14]. Therefore, one of the goals during treatment with the device in this study was to reach and maintain a target

tissue temperature between 40–41 °C for at least 5 min per 10 × 10 cm2 zone. Data has shown that at 10- and 15-mm tissue depths, the temperature elevates after VelaShape treatment and is maintained over 40 °C, long after completion of treatment enabling an enhanced thermal effect for a more effective clinical outcome [14]. It is thought that the synergy of the combined technologies of IR and RF energies (heating the tissue up to 3 and 15 mm, respectively), as well as vacuum and massage rollers can result in improved results that may last longer compared to previous versions

of the device. The 20 % higher bipolar RF energy of the VelaShape II device up to 60 W enables a deeper and more intense heating of the dermis and subcutaneous tissues, allowing for clinicians to

reach the target temperature quicker, resulting in a reduction of treatment times, particularly when compared to earlier versions of the device.

Limitations of this study include a relatively small patient cohort as well as the lack of extended follow-up evaluations and untreated control subjects. In addition, each abdomen measurement could ideally be taken at the same point in the respiratory cycle in order to better

address measurement bias. Moreover, the timing of measurements in respect to the patients’ menses (i.e., bloating) could potentially alter circumference measurements. One can also assume that large meals or volumes of fluid taken directly prior to circumference measurement can affect the measurement result [16]. Future clinical trials that can address these points could be part of the focus of future clinical trials, which may further support the clinical outcomes achieved here.

Go to: Conclusion

In conclusion, the combination of bipolar RF, IR light, and mechanical tissue manipulation with pulsed vacuum and massage rollers appears to be a safe and effective therapeutic modality for the reduction of adipose tissue volume and skin tightening. It is suggested that the 20 % higher bipolar RF energy available in the VelaShape II device may also result in a more intense heating of the targeted tissues, resulting in both faster treatment times as well as improved clinical outcomes.

Go to: References

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mechanical rollers with suction to improve skin surface irregularities (cellulite) in a limited treatment area. J Cosmet Laser Ther. 2006;8:185–190. doi:

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randomized, comparative prospective clinical study to determine the efficacy of the Velasmooth System versus the Triactive System for the treatment of cellulite.Lasers Surg Med. 2006;38(10):908–912. doi: 10.1002/lsm.20421. [PubMed][Cross Ref]

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Photomed Laser Surg. 2014 Oct;32(10):561-73 The biological effects of quadripolar radiofrequency sequential application: a humanexperimental study. Nicoletti G, Cornaglia AI, Faga A, Scevola S.

OBJECTIVE:

An experimental study was conducted to assess the effectiveness and safety of an innovative quadripolar variable electrode configuration radiofrequency device with objective measurements in an ex vivo and in vivo human experimental model. BACKGROUND DATA: Nonablative radiofrequency applications are well-established anti-ageing procedures for cosmetic skin tightening. METHODS:

The study was performed in two steps: ex vivo and in vivo assessments. In the ex vivo assessments the radiofrequency applications were performed on human full-thickness skin and subcutaneous tissue specimens harvested during surgery for body contouring. In the in vivo

assessments the applications were performed on two volunteer patients scheduled

for body contouring surgery at the end of the study. The assessment methods were: clinical

examination and medical photography, temperature measurement with thermal imaging scan, and light microscopy histological examination. RESULTS: The ex vivo assessments allowed for identification of the effective safety range for human application. The in vivo assessments allowed for demonstration of the biological effects of sequential radiofrequencyapplications. After a course of radiofrequency applications, the collagen

fibers underwent an immediate heat-induced rearrangement and were partially denaturated and progressively metabolized by the macrophages. An overall thickening and spatial rearrangement was appreciated both in the collagen and elastic fibers, the latter displaying a juvenile reticular pattern. A late onset in the macrophage activation after sequential radiofrequencyapplications was appreciated. CONCLUSIONS:

Our data confirm the effectiveness of sequential radiofrequency applications in obtaining attenuation of the skin wrinkles by an overall skin tightening. Introduction

OVER THE PAST DECADE, RADIOFREQUENCY(RF) has become an important and frequently used

technology in aesthetic medicine. The mechanism of action of RF is based on an oscillating electrical current (2,000,000–3,000,000 times/sec) forcing collisions between charged molecules and ions, which are then transformed into heat.1 A further contribution to the increase in the local temperature is provided by the radiation component of the RF field, with electromagnetic energy transfer to the water-rich dermal matrix. Noninvasive delivery of RF energy to collagen and subcutaneous tissues produces collagen remodelling, therefore, achieving noninvasive tightening of lax skin and body contouring.2,3 RF-

treated skin displays an immediate and temporary change in the helical structure of collagen, with fibrils showing a greater diameter than that of fibers pretreatment.4 It is also thought that RF thermal stimulation results in a microinflammatory stimulation of fibroblasts, which produces new collagen, new elastin, and other substances, to enhance dermal structure.1,5 The depth of penetration of RF energy is inversely proportional to the frequency. Consequently, lower frequencies of RF are able to penetrate more deeply. The currently available devices work

with frequencies within the 1 Hz to 40.68 MHz range. Two different forms of RF delivery have been developed so far: monopolar and bipolar. Monopolar systems deliver current through a single contact electrode with an accompanying grounding pad

that serves as a low resistance path for current flow to complete the electrical circuit; the active electrode concentrates most of the energy near the point of contact, and energy rapidly diminishes as the current flows through the body toward the grounding electrode. As a result, the tissue in the

treated area is heated rather deeply (usually up to 20 mm) and intensely.2 Bipolar devices pass electrical current between two electrodes closely positioned to the skin; no grounding pad is necessary with these systems because no current flows throughout the rest of the body. The depth of penetration is approximately half the distance between the two electrodes.3 As a result, the tissue in the treated area is heated less deeply (usually up to 2–4 mm in depth) and less intensely than with the monopolar RF devices.6 Despite its lesser absolute effectiveness, the bipolar technology is currently gaining an increasing

popularity, as it allows fair outcomes with significantly less invasive applications.7 Nowadays, patients asking for cosmetic medical treatments expect perfect results, with a minimum of work and social downtime. Therefore, such innovative noninvasive treatments have been progressively replacing the traditional and time-honored surgical procedures for skin tightening. The increasingly large number of technological innovations proposed on the global market require rigorous study protocols for the assessment of safety and effectiveness prior to authorization for human use. As a group of academic plastic surgeons actively involved in aesthetic surgery and

medicine research, we were commissioned to assess the effectiveness and safety of an innovative quadripolar variable electrode configuration RF device. Materials and Methods

The study was conducted at the Advanced Technologies for Regenerative Medicine and Inductive

Surgery Research Center of the University of Pavia, Italy, in cooperation with the Plastic and Reconstructive Surgery Unit of the Salvatore Maugeri Research and Care Institute, Pavia, Italy, and the Histology and Embryology Unit, Department of Public Health, Neuroscience, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.

The study was approved by the University of Pavia Ethical Committee. A formal informed written

consent was obtained from all of the patients and the study conformed to the Declaration of

Helsinki. A novel Class I RF generator, RADIO4™, produced by Novavision Group s.p.a., (Via dei Guasti 29, 20826 Misinto, Milan, Italy) was tested. RADIO4 is based on a four electrode system with software-controlled automatic dynamic configuration providing a 1 MHz RF current circulation. The variable electrode configuration allows for creation of custom-made electric fields promoting thermal energy transfer to the tissue from RF current circulation. The device allows three possible electrode

configurations within the four electrodes (Fig. 1):

• 1–3: one transmitter electrode and three receiver electrodes

• 2×2: two transmitter electrodes and two receiver electrodes in a cross fashion

• 2=2: two transmitter electrodes and two receiver electrodes in a parallel fashion

FIG. 1.

The three electrode configuration options in the tested device: (1) 1–3, one transmitter electrode and three receiver electrodes; (2) 2×2, two transmitter electrodes and two receiver electrodes in a cross fashion; (3) 2=2, two transmitter ...

The single electrode configuration is allowed to swap over at a time interval adjustable between 1 and 9 sec. The maximum device working power is 55 W adjustable within a 5–100% delivery range. The device is equipped with an original patented safety technology, Radiofrequency Safety System (RSS™), and has been developed for noninvasive treatment of skin wrinkles and cellulite and for skin tightening. The study was performed in two steps: ex vivo and in vivo assessments.

Ex vivo assessment The ex vivo assessment was conducted on eight human anatomical specimens, including full thickness skin and subcutaneous tissue harvested from four female patients during sessions of abdominoplasty. The specimens underwent the experimental process after surgical harvesting, and the average time delay between harvesting the tissue and starting the experiment was 10 min. The tests were conducted in a dedicated air conditioned room at a temperature of 23°C. A control biopsy, including full thickness skin and adipose tissue, was harvested from each specimen before

treatment. The effects of RFs on the specimens were assessed with the association of three different methods:

• Clinical full examination and medical photography

• Temperature measurement in the specimens before and after the treatments with

thermal imaging scan using the AVIO Thermal Video System TVS 500 camera with an uncooled infrared sensor with a 8–14 μm spectrum sensitivity, 320×240 pixel thermal image resolution, and 0.1°C thermal resolution (Nippon Avionics Co., Ltd. Gotanda Kowa Bldg., 1–5, Nishi-Gotanda 8-chome, Shinagawa-ku, Tokyo, 141-0031 Japan).

• Histological examination at light microscopy. Tissue samples were fixed in a 4% paraformaldehyde solution in phosphate buffer for 6 h, cryoprotected by immersion in sucrose saturated solution, frozen in liquid nitrogen, and finally cut in a cryostat. Finally, tissue sections were routinely stained using hematoxylin and eosin.

A water gel was applied on the skin surface in order to allow an optimal delivery of the RFs from the probe to the tissues (Fig. 2). The gel was stored at room temperature (23°C).

FIG. 2. Ex vivo radiofrequency application with the device's probe. The study was performed using the 1–3 electrode configuration modality, Radio Frequency System (RFS) 1–3, and the configuration swap over time (RFS time) was set at 5 sec. The eight specimens were divided into four groups of two and the RF was delivered to each group at the following percentages of the maximum device working power: 25% (13.75 W), 50% (27.50W), 75% (41.25 W), and 100% (55 W). The energy was delivered in continuous mode (duty cycle

100%, time on=1.000 msec, time off=0 msec). The scheduled maximum application time was 4

min. As the specimens treated with the maximum device working power displayed clinical evidence

of full thickness burn after few seconds, the applications in this group were discontinued at this

time. At the end of the application, a full thickness skin and subcutaneous tissue biopsy was harvested in each specimen from the site of maximum tissue warming, as displayed by the thermocamera scan. In vivo assessment The in vivo investigations were conducted on two volunteer female patients scheduled for abdominoplasty at the end of the experimental study (Fig. 3). The assessments were performed on

the lower abdominal skin area bounded above by the umbilicus, below by the pubis, and on each side by the anterior superior iliac spine. The applications were performed in the same dedicated air conditioned room at a temperature of 23°C, as in the ex vivo tests.

FIG. 3. Areas of abdominal fat that were investigated on the two patients scheduled for abdominoplasty.

A control biopsy, including full thickness skin and adipose tissue, was harvested before the treatment. Three sequential treatments were performed with 2 weeks' interval. A water gel was applied on the skin surface in order to allow an optimal RF energy delivery from the probe to the tissues.

The applied parameters were the same as in the ex vivo section of the study: RFS 1–3, duty cycle 100%, RFS time 5 sec. Three sequential treatments were scheduled with 2 weeks' interval. Each treatment lasted 20 min. The initial working power was 45% (24.75 W); however, following a patient's consistent subjectively perceived discomfort, the energy delivery power was reduced to 35–40% (19.25–22W) in all of the tests, and this level was comfortably tolerated. On occasion of the second

treatment in one patient, the energy delivery power had to be reduced to 20% (11 W) in the last 8min of application, because of severe subjective discomfort. The effects of the RF applications on the patient were assessed with the same methods used in the ex vivo assessment: clinical examination, thermocamera scan, and histological examination of treated tissue biopsies. Three punch full thickness skin and subcutaneous tissue biopsies were harvested from each treated area. The first biopsy was harvested 2 weeks after the first treatment, the second one 2 weeks after the second treatment, and the third one 10 weeks after the last

treatment. Results

Ex vivo assessment (Figs. 4–21) Clinical examination

At the end of the application, the specimen treated with 25% of the maximum working power did not display any macroscopic skin surface alterations, although the subcutaneous tissue was softer at palpation and displayed some degree of shrinkage. The specimen treated with 50% of the maximum working power showed a significant wizening of the subcutaneous tissue after 90 sec, whereas the skin showed a remarkable retraction and separation from the subcutaneous tissue in 3 min; after 4 min, the overall appearance was as a deep skin and subcutaneous tissue burn.

The specimen treated with 75% of the maximum working power displayed a total skin retraction and separation from the subcutaneous tissue after 90 sec, with coagulative necrosis of the subcutaneous fat. The specimen treated with full working power displayed a full thickness burn appearance in a few seconds. Temperature report

The energy application was followed by an increase of the specimen temperature proportional to the application power and time, with a gradient decreasing from the surface to the subcutaneous adipose tissue (Table 1).

T pre

T post 4’25%

T post 4’ 50%

T post 4’ 75%

T post 45” 100%

Skin surface 25.8° 37°Δ+11.2° 47.7°Δ+21.9° 55 Δ+29.2° 60 Δ+34.2°

Subcutaneous adipose tissue

27.5° 28.8°Δ+1.3° 27.5°Δ 0 27.2 Δ−0.3° 27 Δ−0.5°

T, temperature in degrees Celsius; Δ, average temperature delta between pre- and post-

treatment; ’, minutes; ”, seconds.

TABLE 1. AVERAGE EX VIVO SPECIMEN TEMPERATURE VALUES MEASURED AT DIFFERENT WORKING POWER APPLICATIONS Histological examination All of the specimens displayed scattering of the collagen bundles that was appreciated from the

papillary dermis up to 1.5 cm in depth. Such an alteration was proportional to both time and energy power application. The epithelial superficial lining appeared intact up to the application of 50% of the maximum working power. The subcutaneous tissue, the nerves, and the skin glands appeared intact up to the application of 75% of the maximum working power. In vivo assessment Clinical examination

The treatments were well tolerated, and the patients occasionally referred to tolerable local heat sensation, burning pain, and electric shock sensation. At the end of the treatments, no skin lesions were appreciated. After two applications, the patients referred to improved local skin softness and smoothness. Temperature report

The energy application was constantly followed by an increase of the skin surface temperature (Table 2, Fig. 22).

FIG. 22. Thermal imaging scan of the lower abdominal region after the in vivo treatment.

T pre T post Δ

Skin surface 29.6° 38.2° +8.6°

T, temperature in degrees Celsius; Δ, average temperature delta between pre- and post-treatment. TABLE 2. AVERAGE SKIN SURFACE TEMPERATURE VALUES MEASURED AT THE END OF THE IN VIVO TREATMENT

Histological examination (Figs. 23–29) The in vivo findings 2 weeks after the first treatment closely resemble those in the ex vivo specimens: the collagen bundles appeared diffusely scattered whereas the epithelial superficial lining, the subcutaneous tissue, the nerves, and the skin glands appeared intact. Two weeks after the second application, the collagen bundles appeared coagulated in small grumes in the papillary dermis and in larger grumes in the underlying reticular dermis. The epidermis

appeared normal. The overall connective cell count and general pattern did not differ from the control areas. A remarkable thickening in the elastic fibers with a regular reticular pattern and a definite orientation perpendicular to the basal membrane in the papillary dermis was appreciated in the treated areas versus the controls. Ten weeks after the third application, the macrophages had moved from the perivascular niche and displayed a slight increase in their count, thus suggesting some sort of functional activation. Such a

finding suggests the presence of coagulated collagen fragments and/or other tissue debris. Go to: Discussion

The device used in our study is one of the innovative multipolar developments of the bipolar

technology.8

As any technical innovation should undergo a rigorous assessment of both safety and effectiveness prior to clinical use, our study provided a prudent design with two different and sequential steps. The ex vivo experimental assessments allowed for identification of the effective safety range for human application, which was established between 11 and 22 W. We deliberately opted for a random choice of only one electrode configuration out of three potentially available in the device setting, as the rigorous compliance requirements substantially limited the number of patients recruited for the study.

As expected, the biological effects of RF application were related to the thermal energy transfer to the tissues, and were proportional to both local temperature and exposure time.9 All of the possible

typical macro- and microscopic tissue burn features were observed in the ex vivo samples in

relation to the different levels of applied energy. However, these effects were mainly appreciated in

the dermis and subcutaneous tissue, with involvement of the overlying epidermis only for the highest applied energy levels. Such a figure is a peculiar advantage of RF technology that allows selective heat transfer to the dermis and subcutaneous tissue, yielding a controlled collagen alteration. After accurate definition of the effective safety range of RF applications on human tissues, the trial proceeded with the in vivo assessments.

These tests allowed for demonstration of the biological effects of the device under study at different time intervals. The temperature changes reported in the ex vivo samples were partially compensated in vivo by the active thermoregulation and the local temperature increase was proportional to the application time. A selective effect was appreciated in the more dense and compact tissues, as the dermis and the

connective septa of the adipose tissue. The temperature reports and the histological examinations, both ex vivo and in vivo, consistently demonstrated selective scattering of the collagen bundles in the dermis. The small grumes observed in the reticular dermis of the in vivo samples 2 weeks after the second application might have followed local increase of RF current density in sites of enhanced electric conductivity with eventual focal temperature rise.

It is demonstrated that collagen fibers begin to curve at 52–55°C10 and contract at 65°C,11 and the denaturation threshold falls between 60° and 70°C.12 According to the thermal imaging scan in

our ex vivo and in vivo samples, such a temperature threshold was unlikely to have been approached, although it may be theoretically supposed that it occurred in very small and circumscribed tissue spots. We can, therefore, suppose that the observed structural changes of the collagen fibers were not related exclusively to the temperature rise. The overall effects of the sequential in vivo RF applications observed on the connective fibers, both collagen and elastic, might suggest their spatial rearrangement in the absence of complete denaturation: actually, no signs of scarring were observed under the microscope in any of our

samples. As the collagen and elastic fibers are highly hydrophobic and are invested by a highly electric conductive water rich matrix, they obviously tend to gather when the temperature in the investing highly hydrophilic matrix rises. Some interesting changes were observed in the skin elastic fiber network after two sequential applications with 2 weeks' interval 1 month after the first treatment: the elastic fibers appeared thicker both in the papillary and the reticular dermis; however, although thick elastic fibers are a

typical feature of skin photo- and chrono-ageing, in our samples their regular network pattern was found more similar to the juvenile one.

Such an interesting figure might also be explained by the shrinkage of the highly hydrophobic elastic fibers with exclusive physical mechanism after increase of the energetic potential in the local water rich environment. These data are consistent with the literature,13 and are in favor of the bipolar technology, as the elastic fibers seem to significantly decrease after monopolar treatment. 2 The epidermis did not display any significant damage apart from a transient erythema

at the end of the in vivo treatments. Adipose tissue, endothelial cells, nerves, and skin adnexa appeared intact with power application up to 41.25 W (Figs. 10, ,14,14, and and18).18). Such an evidence was consistent with the peculiar temperature gradient figure between the skin surface and the underlying adipose tissue where relevant temperature changes in the dermis were not transmitted to the underlying fat. These data both confirmed the low thermal conductivity of the human skin and demonstrated the selective superficial distribution of the electromagnetic energy within the treated tissues.

The in vivo effects of the RF application included a slight macrophage activation after three sequential applications with 2 weeks' interval, and might suggest the presence of tissue debris and/or coagulated collagen still being metabolized. Nevertheless, no actual inflammatory cells or fibroblast response was appreciated. However, a significant cellular response might be expected after further sequential applications, as

suggested by the clinical protocols currently in use. The sequential application of RF for the

treatment of skin wrinkling would definitely appear as a far different philosophy from the traditional surgical face and body lifting, as it would rely on a progressively induced and gently modulated body biological response. RF might, therefore, be considered an effective alternative for mild cases of skin laxity, and a useful completion of traditional surgical techniques. Go to: Conclusions

The tested quadripolar variable electrode configuration RF equipment can provide selective and favorable changes in the dermal structure without side effects in the epidermis, vessels, and nerves when the energy delivery power ranges between 11 and 22 W.

After a course of RF application, the native collagen fibers underwent an immediate heat- induced

rearrangement, and were just partially denaturated and progressively metabolized by the

macrophages. Subsequently, an overall thickening and spatial rearrangement was appreciated both in the collagen and in the elastic fibers, the latter displaying a juvenile skin reticular pattern. Our data demonstrated a late onset in the macrophage activation after sequential RF applications. It might be supposed that such a recruitment might be followed by a fibroblastic response at a later stage,5 although such a hypothesis would suggest further investigations. All of our data confirm the effectiveness of the RF applications in obtaining attenuation of the skin

wrinkles by an overall skin tightening. Go to: Acknowledgments

The authors thank Floriana Cazzola and Gian Mario Pelizzoli for their technical support. This work was partially funded by Novavision Group s.p.a., Via dei Guasti 29, 20826 Misinto, Milan, Italy.

Go to: Author Disclosure Statement

No competing financial interests exist. Go to: References

1. Beasley K.L., and Weiss R.A. (2014). Radiofrequency in cosmetic dermatology.Dermatol.

Clin. 32, 79–90 [PubMed] 2. el-Domyati M., el-Ammawi T.S., Medhat W., Moawad O., Brennan D., Mahoney M.G., and Uitto J. (2011). Radiofrequency facial rejuvenation: evidence-based effect. J. Am. Acad. Dermatol. 64, 524–535 [PubMed]

3. Elsaie M.L. (2009). Cutaneous remodeling and photorejuvenation using radiofrequency devices. Indian J. Dermatol. 54, 201–205 [PMC free article][PubMed] 4. Zelickson B.D., Kist D., Bernstein E., Brown D.B., Ksenzenko S., Burns J., Kilmer S., Mehregan D., and Pope K. (2004). Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch. Dermatol. 140, 204–249 [PubMed]

5. Hantash B.M., Ubeid A.A., Chang H., Kafi R., and Renton B. (2009). Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis.Lasers Surg. Med. 41, 1–9 [PubMed] 6. Alster R.S., and Lupton J.R. (2007). Nonablative cutaneous remodeling using radiofrequency devices. Clin. Dermatol. 25, 487–491 [PubMed] 7. Montesi G., Calvieri S., Balzani A., and Gold M.H. (2007). Bipolar radiofrequency in the treatment of dermatologic imperfections: clinicopathological and immunohistochemical aspects. J.

Drugs. Dermatol. 6, 890–896 [PubMed] 8. Lee Y.B., Eun Y.S., Lee J.H., Cheon M.S., Cho B.K., and Park H.J. (2014).Effects of multipolar radiofrequency and pulsed electromagnetic field treatment in Koreans: case series and survey study. J. Dermatolog. Treat. 25, 310–313[PubMed] 9. Moritz A.R., and Henriques F.C. (1947). Studies of thermal injury II. The relative importance of time and surface temperature in the causation of cutaneous burns. Am. J. Pathol. 23, 695–720 [PMC free article] [PubMed]

10. Lin S.J., Hsiao C.Y., Sun Y., Lo W., Lin W.C., Jan G.J., Jee S.H., and Dong C.Y. (2005). Monitoring the thermally induced structural transitions of collagen by use of second-harmonic generation microscopy. Opt. Lett. 3, 622–624 [PubMed] 11. Paul M., Blugerman G., Kreindel M., and Mulholland R.S. (2011). Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesthetic Plast. Surg. 35, 87–95[PMC free article] [PubMed]

12. Hayashi K., Thabit G., Massa K.L., Bogdanske J.J., Cooley A.J., Orwin J.F., Mark D., and Markel M.D. (1997). The effect of thermal heating on the length and histologic properties of the glenohumeral joint capsule. Am. J. Sports Med. 25, 107–112 [PubMed] 13. Willey A., Kilmer S., and Newman J. (2010). Elastometry and clinical results after bipolar

radifrequency of skin. Dermatol. Surg. 36, 877–884 [PubMed]

Histology of the human ex vivo specimen before treatment: the epidermis displays a regular multilayered structure, the dermis shows regular dermal papillae with thin collagen fibers and thick collagen bundles in the reticular dermis. Light microscopy, hematoxylin and eosin staining, bar 400 μm.

Histology of the human ex vivo specimen after treatment with 25% of the maximum device working power (13.75 W): complete sparing of the epidermis that displays normal structure; an early thickening of the collagen bundles is appreciated in the deep dermal layers. Light microscopy, hematoxylin and eosin staining, bar 400 μm (left). Histology of the human ex vivo specimen after treatment with 25% of the maximum device working power (13.75 W): the sweat glands and the nerves (asterisk) display a normal structure and a regular staining. Light microscopy, hematoxylin and eosin staining, bar 40 μm (right).

Histology of the human ex vivo specimen after treatment with 50% of the maximum device working power (27.50 W): the thickening of the collagen fibers in the papillary dermis is appreciated, whereas the blood vessels in the dermal papillae do not display any alteration (box). Light microscopy, hematoxylin and eosin staining, bar 400 μm (left). Histology of the human ex vivo specimen after treatment with 50% of the maximum device working power (27.50 W): the sweat glands and the nerves (asterisk) display a normal structure and a regular staining. Light microscopy, hematoxylin and eosin staining, bar 40 μm (right).

Histology of the human ex vivo specimen after treatment with 75% of the maximum device working power (41.25 W): the epidermis is necrotic, and the collagen bundles display a remarkable diffuse thickening in the whole dermis. Light microscopy, hematoxylin and eosin staining, bar 400 μm.

Histology of the human ex vivo specimen after treatment with 75% of the maximum device working power (41.25 W): the subcutaneous tissue (A, bar 750 μm), the vascular wall with its endothelial lining (B, bar 120μm), the nerves (C, bar 120 μm), and the sweat glands (D, bar 120 μm) appear intact. Light microscopy, hematoxylin and eosin staining.

Histology of the human ex vivo specimen after treatment with 100% of the maximum device working power (55 W): a complete loss of the epidermal lining and a massive coagulative dermal necrosis are appreciated; the sweat glands display early signs of necrosis (arrows). Light microscopy, hematoxylin and eosin staining, bar 400 μm.

Histology of in vivo control biopsy: the collagen fibers appear thin and outstretched. Light microscopy, hematoxylin and eosin staining, bar 400 μm (left). Histology of in vivo sample harvested 2 weeks after the first treatment with 35–40% of the full device working power: early signs of coagulations are appreciated both in the papillary and in the reticular dermis. Light microscopy, hematoxylin and eosin staining, bar 400 μm (right).

Histology of in vivo sample harvested after two treatments with 35–40% of the full device working power, 1 month after the first treatment: the collagen fibers are coagulated in small grumes in the papillary dermis and in larger ones in the underlying layers; the epidermal lining is intact. Light microscopy, hematoxylin and eosin staining, bar 400 μm (left). Histology of in vivo sample harvested 10 weeks after the third treatment with 35–40% of the full device working power: the epidermis displays a normal differentiation and layer organization; a remarkable degree of collagen coagulation is appreciated in the papillary dermis, and the collagen bundles in the reticular dermis display a significant thickening as well. Light microscopy, hematoxylin and eosin staining, bar 400 μm (right).

Histology for macrophages of in vivo control biopsy: the arrows highlight the macrophages in quiescent status around the vessels. Light microscopy, toluidine blue staining, bar 25 μm (left). Histology for macrophages of in vivo biopsy harvested after three treatments with 35–40% of the full device working power: the arrows highlight the macrophages that have moved from the perivascular niche, and display a slight increase in their count, thus suggesting an active status. Light microscopy, toluidine blue staining, bar 25 μm (right).

Dermatol Surg. 2015 Jan;41(1):18-34. A review of the aesthetic treatment of abdominal subcutaneous adipose tissue:

background, implications, and therapeutic options. Friedmann DP.

BACKGROUND:

The demand for aesthetic body sculpting procedures has expanded precipitously in recent years. Subcutaneous adipose tissue (SAT) deposits of the central abdomen are especially common areas

of concern for both males and females. OBJECTIVE: To review the available literature regarding the underlying pathophysiology of subcutaneous fat accumulation in the abdominal area and available treatment options. METHODS: A MEDLINE and Google Scholar search was performed accordingly. RESULTS:

The preferential accumulation of SAT in the central abdomen is attributable to the reduced lipolytic sensitivity of its adipocytes. A number of therapeutic options are available for the treatment of central abdominal adiposity. Cryolipolysis, high-intensity focused ultrasound, nonthermal ultrasound, radiofrequency, and injection adipolysis lead to adipocyte destruction through multiple different mechanisms. Nonablative modalities such as injection lipolysis mobilize fat stores from viable adipocytes, although its effects may be curtailed in obese patients. Liposuction through tumescent technique, however, mechanically extricates SAT.

CONCLUSION:

Although tumescent liposuction remains the gold standard for SAT removal, less invasive ablative and nonablative options for targeting localized deposits of adipose tissue now permeate the aesthetic marketplace. Limited results associated with these modalities mandate multiple sessions or combination treatment paradigms.