Clinical Papers

Background:
Contouring of the arms that does not involve skin excision remains a difficult challenge due to the dependent nature and quality of the skin. Although brachioplasty remains effective, it requires lengthy incision. Radiofrequency-assisted liposuction (RFAL) may improve skin retraction with a satisfactory aesthetic result without skin resection and the resultant scar. The purpose of this study is to present our experience of RFAL arm contouring under local anesthesia, detailing safety guidelines, the marking technique, operative technique, complications, third party surgeon appraisal, and patient satisfaction survey

Methods:
Forty patients underwent RFAL under local tumescent anesthesia for aesthetic arm contouring. Postoperative patient satisfaction surveys were conducted and independent third-party surgeons were surveyed to assess improvements in contour and skin quality with preoperative and postoperative photographs

Conclusion:
In appropriately selected patients, RFAL arm contouring under local anesthesia represents and alternative procedure with acceptably low morbidity and high patient satisfaction. To achieve consistent results while minimizing complication, consideration to anatomic details, infiltration of the local anesthetic, and application of the radiofrequency energy must be given.

Background: Male gynecomastia is a commonly occurring aesthetic concern. Traditional liposuction, laser and ultrasound-assisted liposuction have many limitations, and excisional gynecomastia procedures can leave undesirable scars in the treatment of the enlarged male breast.

Methods: In this study, the authors report the use of radiofrequency-assisted liposuction (RFAL) in the treatmentof male gynecomastia. A total of 59 males had their gynecomastia treated by RFAL technology, 47/59 by closed RFAL alone, and an additional 12 patients with RFAL combined with our personal technique of trans-mammillary glandular reduction. The RFAL device afforded strong RF current and thermal energy for glandular and adipose coagulation and liquefaction, together with strong soft tissue contraction forces.

Results: All patients were followed for more than 12 months, and all reported good to excellent breast contour results. There was one seroma and over 90 % of patients report being very happy with their contour, and no secondary surgical procedures were necessary. The authors report RFAL as new and potentially powerful option in the treatment of male gynecomastia, having the advantages of strong coagulation, liquefaction and aspiration of glandular tissue, simultaneous coagulation and aspiration with constant thermal monitoring, and very strong soft tissue contraction, eliminating the need for skin resection in the majority of cases. In minority of cases where there may be remnant glandular structures following RFAL, a simple, minimally intrusive trans-mammillary glandular extraction technique can be deployed that leaves minimal scarring.

Conclusions: The mixed technique presented in this study appears to be safe and effective. The RFAL mixed technique has proven to be superior to ultrasonic and power-assisted liposuction due to the skin contraction, having no limitation dependent on the quality of the patient’s skin.

Introduction:

The increased prevalence of obesity worldwide has grown the body contouring market, as patients demand more solutions. One of the most popular body contouring methods is liposuction. Pioneered in Europe in the early 1980’s as a simple fat aspirating technique, liposuction has quickly expanded its breadth to incorporate a variety of energy sources and modus operandi.

Many types of energies have been combined with standard liposuction techniques in an attempt to improve and optimize treatment outcomes. The current chapter is dedicated to the authors’ experience with the most recent addition to the liposuction family, Radio-Frequency Assisted Liposuction (RFAL). RFAL delivers RF energy for a thermal effect to the adipose tissue, skin and sub-dermal matrix in a minimally invasive manner. Enhancing the standard lipoplasty experience with a safe and consistent thermal influence provides the following key benefits:

• Blood vessel coagulation to reduce patient downtime through less bleeding and bruising.
• Tissue tightening to expand the range of patients to now include individuals who are obese and/or have compromised skin conditions (lax skin).
• Increased patient comfort and safety will increase consumer acceptance.
• Reduced procedure time and ease of treatment will increase physician acceptance.

Excerpt:
“Linear contraction observed at 3 months follow-up were much more significant than reported with any other technology and varied from 12.7% up to 47% depending on patient and treatment variables.”

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 modelling 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.

Conclusion: 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.

WHAT IS MAINTENANCE OF CERTIFICATE?

Developed by the ABMS and the Member Boards, including the American Board of Plastic Surgery, the Maintenance of Certification® requirement is a response to the rapid pace of research and technological changes in the medical field and the drive toward improving the overall care and safety of patients. Maintenance of Certification® in Plastic Surgery (MOC-PS®) involves continuous professional development to measure a physician’s continued competency in his or her certified specialty and/or subspecialty.

About Plastic and Reconstructive Surgery Journal:

For more than 70 years Plastic and Reconstructive Surgery® has been the one consistently excellent reference for every specialist who uses plastic surgery techniques or works in conjunction with a plastic surgeon. Plastic and Reconstructive Surgery® , the official journal of the American Society of Plastic Surgeons, is a benefit of Society membership, and is also available on a subscription basis.

The purpose of the Journal serves in cooperation with the overall mission of the American Society of Plastic Surgeons,® which is to support its members in their efforts to provide the highest quality patient care and maintain professional and ethical standards through education, research and advocacy of socioeconomic and other professional activities.
Official Journal of the American Society of Plastic Surgeons, Inc.

Excerpt of Article:

Using the BodyTite (Invasix Ltd., Yokneam, Israel) device in an industry-sponsored in vivo study, linear contraction observed at 6-month follow-up was much more significant than reported with any other technology and varied from 12.7 percent up to 47 percent, depending on patient and treatment variables.

Abstract:
Background Aging can lead to changes in facial expressions, transforming the positive youth expression of happiness to negative expressions as sadness, tiredness, and disgust. Local skin distension is another consequence of aging, which can be difficult to treat with rejuvenation procedures. The “face expressive lifting” (FEL) is an original concept in facial rejuvenation surgery. On the one hand, FEL integrates established convergent surgical techniques aiming to correct the agerelated negative facial expressions. On the other hand, FEL incorporates novel bipolar RF technology aiming to correct local skin distension. Methods One hundred twenty-six patients underwent FEL procedure. Facial expression and local skin distension were assessed with 2 years follow-up. Results There was a correction of negative facial expression for 96 patients (76 %) and a tightening of local skin distension in 100 % of cases. Conclusions FEL is an effective procedure taking into account and able to correct both age-related negative changes in facial expression and local skin distension using radiofrequency. Level of Evidence: Level IV, therapeutic study.

Introduction:
The recent years have seen a better understanding of the physiopathogenesis and manifestations of facial aging such as sagging due to gravity, fat loss and redistribution, and loss of bone volume [1–5]. However, aging can also lead to changes in facial expressions, transforming the positive youth expressions (happiness) to negative expressions (sadness, tiredness, and disgust) overtime [6, 7]. These projected “negative emotions” can impact other’s views of us and social interaction. This might explain that a high number of patients ask not only for cosmetic improvement but also for improvement of unattractive facial expression. Almost no studies have clearly analyzed and shown how to correct the age-related changes on facial expression. The FEL concept was developed upon the convergence of effects of rejuvenation surgical procedures on different levels of the face with priority given to the re-establishment of “vitality” in both the eyes and the smile, which are the key of emotions expressions. The present study aimed to address the question of wether the FEL could correct negative facial expressions of the aging face. Secondly, the skin of the face loses its tonicity over time. Although a lift can eliminate remaining folds after musculocutaneous tightening, simple redraping is not always sufficient in cases of local distension. The application of bipolar radiofrequency (RF), using FaceTite™ (Invasix Ltd., Yokneam, Israel) makes it possible to obtain stable quantitative and qualitative effects on the skin over time through the regeneration of the deep dermis and superficial subdermal septo-fascial fat [12]. The second question addressed was whether we could correct local skin distension on zones of weak facial skin (malar crescent, labio-jugal, and submental) using radiofrequency.

Introduction:
Western civilization is experiencing a “boom in boomers,” an aging population, with population
decline. The aging population in Western Europe, North America, and Asia has disposable income
and the mantra of “youth and vitality” has this generation increasingly presenting for aesthetic treatments, specifically noninvasive or nonexcisional procedures. The neck aesthetic subunit often ages early and more noticeably than other head and neck regions and is one of the most common motivations for patients to present to aesthetic physicians for rejuvenation options. The neck undergoes extrinsic and intrinsic aging changes in all anatomic layers and the aesthetic physician must be well equipped to deal with aging cervical concerns, both surgically and nonsurgically. For the surgeon, being skilled in nonsurgical cervical rejuvenation is critical, as many patients may opt or nonexcisional cervical enhancements, alone, or in combination with other facial cosmetic surgical procedures. For the cervical surgeon, a familiarity and expertise with nonsurgical management of the neck, as “stand-alone” therapy or as postoperative “protect your investment” treatments, may help extend and prolong the achievements achieved surgically.

A youthful neck is most often characterized by an acute cervicomental angle and a firm, well-defined jawline (Fig. 1). The skin in a youthful neck is smooth and devoid of horizontal or vertical neck lines; has no platysmal bands; no visible submandibular glands; small, nonhypertrophic masseter muscles; and skin that is bright and even in color, with minimal melanin or vascular lesions. For the nonexcisional cervical physician, aesthetic rejuvenation of the neck with a multimodal, nonexcisional, minimally invasive approach will be a very common and popular component of the facial aesthetic practice. For all aesthetic physicians, familiarity with the aging tissue changes of the neck, its anatomy and the possible minimally invasive, nonexcisional interventions, including laser, light, radio frequency, high-intensity focused ultrasound (HIFU) energy-based therapy, both transepidermal and subdermal approaches, injectable soft tissue fillers, neuromodulators, and ablative and nonablative technologies for skin rejuvenation, as well as suture-based suspensory techniques, all used alone or in combination, will be a valuable asset to the global aesthetic head and neck cosmetic physician.

This article brings together the “tried-and-true” nonexcisional neck rejuvenation methodologies, which have had long-term, peer-reviewed success in the literature, together with procedures and technologies that have emerged in the past few years that have proven to be successful and complementary. It is my hope that this information assists aesthetic physicians in enhancing their global approach to nonexcisional rejuvenation of the neck.

Background: The purpose of this study is to report our experience using radio-frequency-assisted liposuction (RFAL) for neck and face contouring. This article details the operative technique, selection, complications, third-party surgeon appraisal, and patient satisfaction survey.

Methods: From November 2009 to November 2013, 55 patients who underwent RFAL treatment were enrolled in the study. Postoperative patient satisfaction surveys were conducted, and 2 independent plastic surgeons evaluated contour and skin quality with randomized preoperative and postoperative photographs at 6 months post operatively. The different parameters recorded involved age, sex, weight, body mass index, operative time, amount of fat aspirated and energy delivered, complications, and aesthetic outcome in 1 and 4 weeks and 3 and 6 months. Our longest follow-up was 4 years. Patients were asked 6 months post operatively to grade their satisfaction as poor, no change, moderate, good, and excellent.

Results: The mean age was 51 years (range, 35–61 years), and the mean amount of fat aspirated was 30 mL (range, 10–200 mL). Five out of 55 patients (9.1%) developed tissue hardness that resolved with massage. All patients were followed up for a minimum of 6 months. Eighty-five percent of patients were satisfied with their contouring result and degree of skin tightening (48/55 patients). Two independent plastic surgeons considered the improvement in contouring and degree of skin tightening good to excellent in 52 of 55 cases.

Conclusions: In appropriately selected patients, RFAL neck and face contouring represent a safe procedure to achieve significant improvement of the skin laxity and fat deposits of the cervicomental zone and jowls.

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

Background:
Liposuction of the arms alone may be inadequate for aesthet- ic improvement because of skin laxity. Radiofrequency-assisted liposuction (RFAL) and aggressive super cial liposuction (SupL) have been described to stimulate soft tissue retraction to improve results. We compare the tech- niques and describe a classi cation scheme that factors skin laxity, skin quality, and Fitzpatrick type to provide treatment recommendations.

Methods:
Ten consecutive female patients underwent RFAL of 1 arm and SupL on the contralateral arm. All patients had Fitzpatrick skin types of III, IV, or V with an average body mass index of 26.0. Using uorescent tattooing, key points on the arm skin were measured preoperatively and postoperatively to indicate changes in surface area.

Results:
There were no complications in the group, and all patients re- ported satisfaction with the aesthetic results. All patients showed reduc- tion of measured skin surface areas and skin distances postoperatively. At 1 year, the measured surface area reductions on the anterior arms averaged 15.0% for RFAL and 10.9% for SupL on the anterior arm skin. Posteriorly, RFAL showed 13.1% reduction and SupL 8.1% reduction in the surface areas at 1 year. Linear reduction for RFAL averaged 22.6% and 17.8% for SupL 1 year postoperatively anteriorly.

Conclusion:
Both RFAL and SupL of the arms showed quanti able and sustained reductions in skin surface. Good contour and soft tissue contrac- tion were achieved with both techniques but RFAL with its safety features presents an alternative to SupL, which has a higher complication rate, risk for contour deformities, and steeper learning curve.

Background: Brachioplasty is frequently recommended for patients with more skin laxity than subcutaneous fat. However, many patients are reluctant to accept a visible scar that will affect the activity of the upper arm or clothing choices. Traditional liposuction is effective when minimal skin laxity is present, but the dual problems of postoperative residual skin laxity and unsatisfactory contour irregularities are common when upper arm skin laxity is the chief complaint.

Objectives: The author investigates the degree of skin contraction resulting from treatment with radiofrequency-assisted liposuction (RFAL) and attempts to determine whether, after long-term follow-up, the classification of upper arm deformities and their corresponding treatment protocols can be refined to offer patients with prominent skin laxity an alternative to traditional brachioplasty.

Results: One year after treatment with RFAL, the mean surface area reduction in the volar upper arm region was 33.5% bilaterally. The mean degree of pendulous vertical “hang” shortening was 50%bilaterally. Statistical analysis showed a P value of >.001 for both measurements.

Conclusion: Treatment with RFAL achieved statistically significant skin contraction in the upper arm region. Patients in categories 2b and 4 were successfully treated with RFAL instead of traditional brachioplasty (which is recommended by the current classification system). Category 3 patients, however, did require a short-scar brachioplasty procedure to obtain satisfactory results.

Abstract:

42 patients with broad age and ethnic demographics where treated with a novel, non-excisional, minimally invasive device to coagulate a very thin layer of sub-dermal septo-fascial fat, denature the deep reticular dermis and tighten the skin and sub-dermal matrix of connective tissue. The detailed treatment protocol and results are presented. Patients were observed for up to 6 month following the procedure. No major side effects were observed. The aesthetic outcome of this non-excisional procedure includes improvement of the position and shape of the cheek, lower lid-cheek junction, jawline and neck. The overall aesthetic results deliver a noticeable and impressive tightening of the soft-tissue and may be compared with a conservative, small excisional procedure. The authors propose this versatile device and treatment as a non-excisional, moderate facial rejuvenation procedure on its own, or as an adjunct to open procedures performed simultaneously, or as a simplified treatment for secondary skin laxity in combination with a lift procedure.

Excerpt:
“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.”

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.

Excerpt:
“Body contour improvement was observed postoperatively in all patients and there were no severe systemic or local complications, although postoperative pain was minimal in all patients. Weight and circumference reductions were significant at both 6-week and 3-month follow-up. Skin tightening was judged optimal by the surgeon in all patients. “

Abstract:

Background: The feasibility, safety, and efficacy of a novel radiofrequency device for radiofrequency-assisted liposuction were evaluated in various body areas.

Methods: From July to December of 2008, 23 subjects underwent radiofrequency-assisted liposuction using the BodyTite system. Information regarding aesthetic results and local and systemic complications was collected immediately after the procedure and at 6- and 12-week follow-up.

Results: The mean age of the patients was 38.8 ± 12.4 years, and 87 percent were women. Radiofrequency-assisted liposuction was performed successfully in all cases; volume aspirated per patient was 2404 ± 1290 ml, whereas operative time was 158 ± 44 minutes. All patients underwent liposuction at the hip and low abdominal areas, laterally. Body contour improvement was observed postoperatively in all patients and there were no severe systemic or local complications, although postoperative pain was minimal in all
patients. Weight and circumference reductions were significant at both 6-week and 3-month follow-up. Skin tightening was judged optimal by the surgeon in all patients.

Conclusions: The authors’ study suggests that the removal of moderate volumes of fat with concurrent subdermal tissue contraction can be performed safely and effectively with radiofrequency-assisted liposuction. Additional benefits of this technique are excellent patient tolerance and fast recovery time. Nonetheless, a larger sample is required to confirm the authors’ results and guarantee the efficacy and safety of the procedure. Direct comparison with traditional liposuction or energy-assisted liposuction techniques may provide some insights to tailor future indications of this novel technique.

Introduction
Die Liposuktion ist derzeit die meist angewandte Technik zur Entfernung ?bersch?ssiger und dysmorpher Fettdepots. Aufgrund ihrer derzeitigen Sicherheit und der relativ leichten Durchf?hrbarkeit wird sie weltweit eingesetzt. Im Lauf der Jahre wurden durch verschiedene Innovationen verbesserte Ergebnisse erzielt. Anf?nglich gab es lediglich die trockene Fettabsaugungstechnik [2] mit all ihren Komplikationen, welche durch die Einf?hrung der Tumeszenz-Fettabsaugung abgel?st wurde, die deutlich weniger Komplikationen zur Folge hatte und bessere ?sthetische Ergebnisse erzielte. Neuere Methoden wie der Gebrauch von Vibrationskan?len [5] oder die ultraschallassistierte Fettabsaugung [6, 7, 8] haben zwar Verbesserungen in der Prozedur gebracht, zeigten jedoch keine wesentlichen Ergebnisse in der Straffung der Haut. Auch durch die laserassistierte Fettabsaugung wurden gelegentlich gute Straffungsergebnisse [10, 11, 18, 19] erzielt. Diese Methode ist jedoch sehr zeitaufwendig und eine pr?zise Anwendung hinsichtlich W?rmeentwicklung und Bindegewebsspezifit?t ist nicht m?glich. In letzter Zeit haben nicht-invasive Radiofrequenztechniken Hautstraffungsergebnisse im Rahmen der w?rmeinduzierten Hautbehandlung gezeigt [11, 12]. Die Anwendung von au?en erbrachte jedoch nur moderate Straffungsergebnisse. Das Body-Tite™-System (Invasix Ltd.) ist bis dato die einzige bipolare Anwendung, die genug Radiofrequenzenergie w?hrend der Fettabsaugung erzeugt, um kontrollierte Energie von innen an die Haut und das subdermale Bindegewebe abzugeben und zwar in pr?ziser Tiefe, wobei sowohl eine Lipolyse als auch eine Gef??koagulation stattfindet und zugleich auch eine Straffung der Haut erzielt wird. Die Pilotstudie diente dem Zweck, die Anwendungsm?glichkeit und Sicherheit dieser radiofrequenzassistierten Fettabsaugungstechnik zu pr?fen.

Abstract:

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.

Introduction:

Recently, LAL, specifically Smartlipo™ has gained a great deal of attention based on expectations of a skin tightening caused by laser thermal effect on collagen and connective tissue. LAL is based on manual scanning of the adipose tissue treatment volume with a cannula delivering laser radiation through a very small fiber with a 600 microns diameter. Due to the manual delivery during LAL and the relatively small size of the laser radiation source questions are raised about treatment uniformity. Hot spots in the treatment area may lead to adermal injury while undertreated areas reduce uniformity of the treatment, potentially compromising the overall result including soft tissue contraction. The development of a Radiofrequency Assisted Liposuction system(Bodytite™,InvasixLtd.), which delivers high power radiofrequency to adipose and connective tissue while continuously monitoring all parameters including temperature allowed an opportunity to compare RFAL heating characteristics with LAL.

Abstract:

Background: A novel Radiofrequency-Assisted Liposuction (RFAL) technology was evaluated clinically. Parallel original histological studies were conducted to substantiate the technology’s efficacy in skin tightening, and cellulite improvement.

Methods: BodyTiteTM system, utilizing the RFAL technology, was used for treating patients on abdomen, hips, flanks and arms. Clinical results were measured on 53 patients up to 6 months follow-up. Histological and biochemical studies were conducted on 10 donors by using a unique GREDECO model of skin fragments cultured under survival conditions. Fragments from RFAL treated and control areas were examined immediately and after 10 days in culture, representing long-term results. Skin fragments from patients with cellulite were also examined.

Results: Gradual improvement in circumference reduction (3.9 – 4.9 cm) and linear contraction (8% – 38%) was observed until the third month. These results stabilized at 6 months. No adverse events were recorded. Results were graded as excellent by most patients, including the satisfaction from minimal pain, bleeding, and downtime. Histological analysis of skin fragments immediately following RFAL treatment showed hypodermal coagulation of fat and blood vessels, and structural changes in dermal fibers. After 20 days in culture, fibroblast fibers metabolism was stimulated. Histological changes following cellulite treatment were also noted.

Conclusions: The novel RFAL technology offers immediate skin tightening effect that is stable over time. The histological results correlated with the clinical observations of circumference reduction and skin tightening, as expressed by tissue fibers modulation. Moreover, RFAL offers an effective treatment for cellulite by formation of a thick collagen band at the dermal-hypodermal junction.