Application of the RF Energy to the Soft Tissues.
The RFAL device parameters are set with a cutoff temperature of 38–40°C and a power output of 35 W. The depth wheel is set to 3 or 4 cm depending on the thickness of the tissue treated. Bacitracin ointment is used to minimize friction and protect the access incisions. Sterile ultrasound gel is applied liberally over the treated area to decrease impedance between the 2 electrodes. The RFAL device is typically placed first through the elbow region entry ports and gently moved back and forth while avoiding overtreatment in any one area. The treatment strokes are identical to SAL, and the suction is set to 15 mm Hg. This lower setting allows for gentle extraction of the oils and fluids that are released by the RF energy without significantly changing the contour. This minimizes isolated areas of hardness possibly seen in the first 3 months postoperatively.
As the temperature approaches 35°C, the distance between the 2 electrodes is narrowed to 2 cm and the more superficial layers are treated to a temperature of 38°C. Once 38–40°C is reached, the area is treated for 1 minute at that goal temperature with the endpoint of uniform heating. In addition, we used an infrared camera to independently corroborate the reading of the external electrode and found it to be within 1°C.
Two safety features of the device are controlled energy delivery and the previously mentioned external temperature sensor and cutoff.8,10 Real-time temperature monitoring shuts off the RF energy delivery at the temperature maximum. The majority of the energy is directed to the proximal one-third of the arm that corresponds to the area of greatest laxity in most patients. Once the target temperature is reached and the heat is uniformly applied, the RF portion of the operation is concluded. Standard power-assisted liposuction (Microaire, Charlottesville, VA) or SAL is then used for contouring and residual fat removal with 2.7-, 3-, and 4-mm-diameter blunt Mercedes tip cannulas. The incisions are closed with 5-0 nylon sutures removed 1 week post-op. A compression arm garment is then worn for 4 weeks.
Follow-up appointments were made in the office at 1, 4, 12, 26, and 52 weeks. Patients were asked to complete an online survey following their procedure to describe the factors in choosing RFAL, the level of discomfort with the procedure, and their level of satisfaction and time to return to work (Table 1). Also, 3 independent plastic surgeons evaluated photographs of the 6- and 12-month results of the first 20 completed cases. They were asked to grade the improvement in body contouring and the degree of skin tightening using a 4-point scale: 1 = poor, 2 = moderate, 3 = good, and 4 = excellent.
Forty patients underwent RFAL under local anesthesia without any major complications or mortalities. The average age was 40 years and the average body mass index was 31. Average tumescent infiltration volume was 2232 cm3 and average aspirate volume was 1072 cm3 (average fat aspirate volume, 568 cm3). The mean amount of energy applied to both arms was 39.0 kJ delivered at an average setting of 37 W with an average temperature maximum of 39°C. Average operating time was 127 minutes. The average lidocaine load was 18.6 mg/kg body weight.
Minor complications occurred in 2 patients (5.4%). A full-thickness burn occurred near the elbow in a 48-year-old woman, which healed with local wound care. One seroma occurred unilaterally in a 50-year-old woman and was treated successfully with aspiration. No deaths, hospitalizations, or infections occurred and no revisions were performed.
Twenty-seven out of forty patients responded to the questionnaire (67.8%). Regarding the factors in choosing RFAL, 65% cited the ability to have the procedure under local anesthesia, 55% the ability to return to work quickly, and 47% considered the degree of skin tightening important. Forty-five percent of respondents felt no pain on infiltration of the local anesthetic, 35% minimal discomfort, and 15% moderate discomfort, but 5% felt significant discomfort. Regarding discomfort during the application of heat, 39% felt no discomfort, 41% minimal discomfort, 18% moderate discomfort, and 2% significant discomfort. During fat aspiration, 55% felt no discomfort, 32% minimal discomfort, 13% moderate discomfort, and none had significant discomfort.
At 6 months postoperatively, 38% of respondents were extremely satisfied, 19% were very satisfied, 30% were satisfied, and 13% were not satisfied with arm contouring. At 6 months post-op, 9% were extremely satisfied, 37% were very satisfied, 39% were satisfied, and 15% were not satisfied with the degree of skin tightening. Eighty-one percent of respondents returned to work within 1–3 days, 17% within 4–6 days, and 2% by 7–9 days. Seventy-three percent said that they would definitely recommend, 19% probably would recommend, and 8% would not likely recommend the procedure.
The 3 independent plastic surgeons’ evaluations of the preoperative and postoperative photographs indicated that the improvement in arm contouring was found to be 8% excellent, 72% good, 18% moderate, and 2% poor. They determined the degree of skin tightening to be 11% excellent, 46% good, 38% moderate, and 5% poor.
Patients are often told that they require a brachioplasty for aesthetic improvement of their arms or are not candidates for traditional liposuction. Concerns about the length and appearance of a brachioplasty scar often lead patients to seek other alternatives. RFAL may present an alternative, nonexcisional procedure for patients with mild to moderate skin laxity. It has been reported that loose skin can be improved through the effect of the RF energy tightening the connection of the skin/fat layer to the underlying fascia and the overlying dermis.10 It is important to point out that the degree of skin contracture, in our experience, is variable depending on the patient’s Fitzpatrick skin type. In general, patients with a thicker dermis respond better to SAL regardless of energy application. All patients included in this study were counseled that there was a possibility that they may require a form of a brachioplasty in the future.
We believe that arm contouring under local anesthesia is a viable alternative to traditional forms of anesthesia with several advantages in appropriately selected patients. In the patient surveys, 81% returned to work within 1–3 days of the procedure and 55% factored the short recovery time in deciding on the procedure. The ability to perform the operation awake was cited in nearly two-thirds (65%) of those surveyed. Regarding the procedure, the majority of patients had either minimal or no pain in the tumescent phase (80%), the application of heat phase (80%), or fat aspiration phase (87%) of the operation. From the surgeon’s standpoint, there was no difference in the technique of energy application or fat removal in this series of local anesthesia patients and patients who had RFAL under traditional anesthesia
We utilized a third-party plastic surgeon survey to assess subjective changes in arm contouring following RFAL at 1 year post-op as compared to the preoperative images. Regarding improvement in arm contour, 98% of the surgeons stated moderate, good, or excellent improvement. Ninety-five percent stated that the skin tightening aspect was moderate, good, or excellent.
We realize that a major limitation of the study besides the subjective nature of the surveys is the lack of a control where there was no RF energy component to the arm contouring operation. Both arms were treated with the identical procedure. Future studies where a comparison can be made with and without RF energy are warranted to determine its efficacy. The focus of this study is to demonstrate a technique under local anesthesia utilizing RF energy and to establish the safety parameters.
Caution needs to be exercised to avoid thermal injury and over resection. Sterile ice may be necessary to cool areas of erythema on the skin (“hot spots”) that can result in blistering and full-thickness burns. Knowing the exact position of the internal electrode and keeping the tip deep is integral to avoiding “end hits.” Regarding the possibility of port site burns and end hits, the development of a Teflon sheath over the probe and the tip of the catheter has decreased the risk of burn. With careful consideration of the anatomy with accurate markings and attention to uniform heating of the tissues, these risks are mitigated. Further, these potential complications are reduced with temperature monitoring, experience, and modifications to the equipment such as the Teflon-coated tip. The cases complicated with a burn and seroma, respectively, were successfully treated with local care.
Arm contouring in patients with excess fat and skin laxity has traditionally been achieved with brachioplasty and the resulting extensive incision and scar. Techniques such as aggressive subdermal liposuction4 and energy-assisted liposuction modalities have been reported to result in better skin retraction following SAL and an improvement in the arm aesthetic.2,6,10 RFAL represents a novel technique utilizing electromagnetic radiation to cause contraction of the soft tissue matrix.6,10 For patients who are candidates for RFAL (Fig. 12), the operation may be performed under local anesthesia with a focused approach to minimize complications.8 Technical considerations include identifying the DFP, TMM, and anatomic zones of the triceps in the operative plan to obtain reproducible results. Future studies where an objective assessment or comparison can be made between RFAL treated areas and traditional SAL would ideally provide quantitative and qualitative data to support or refute use of energy-assisted modalities in body contouring.
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© 2013 American Society of Plastic Surgeons
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