Safety and efficacy of helium plasma for subdermal coagulation

Surgical and nonsurgical treatments or procedures are often combined to achieve desired aesthetic results. A novel helium‐based plasma device has recently been developed to briefly heat soft tissue which coagulates collagen and achieves additional tissue contraction through neocollagenesis and tissue remodeling. Two chart reviews were performed on patients who had undergone liposuction combined with helium plasma treatment.


| INTRODUCTION
The number of cosmetic procedures performed annually continues to grow, reaching 17.7 million in 2019, an increase of 163% since 2000. 1 Surgical procedures have a long history of aesthetic applications including skin rejuvenation 2,3 and an increasing number of pharmacologic agents, devices, and energy-based rejuvenation has become available. Many of these procedures are being combined to improve therapeutic outcomes 4,5 in different anatomical areas. 6,7 Treatment combinations include toxins and fillers, [8][9][10] fillers and energy-based therapies, [11][12][13] different energy-based therapies 14,15 and combining surgical procedures with skin resurfacing, intense pulsed light, and neuromodulators. 16 Consensus recommendations have been developed for many of these treatment combinations. 6,7 Liposuction is a surgical procedure intended to reduce and smooth the contours of the body and improve individual appearance.
Liposuction can dramatically improve contours but it does not tighten skin, relying on normal skin retraction. 17 Skin in certain areas of the body is prone to developing skin redundancy or laxity following liposuction. 18 A novel helium-based plasma device is a recent addition to aesthetic surgical procedures. Helium plasma achieves soft tissue contraction by briefly heating tissue to temperatures greater than 85°C. 19 The result of heating collagen is coagulation and immediate contraction of collagen fibers 20,21 by up to 38%. 22 The subsequent wound-healing response results in additional tissue contraction through neocollagenesis and tissue remodeling. [23][24][25] Although liposuction has become one of the most popular cosmetic procedures in the world, 1,26 little has been published about combining liposuction with other aesthetic procedures. 27 Two postmarketing chart reviews were performed on patients who had undergone liposuction combined with helium plasma treatment. The primary objective was to evaluate the safety of these combined treatments. Secondary objectives were to assess the extent of aesthetic improvements and overall subject satisfaction.

| Study subjects
Eligible subjects were male and female, 21 years of age or older who had received helium plasma for subdermal coagulation following a liposuction procedure, expressed their willingness to comply with all study requirements, and had pre-and posttreatment images available for evaluation. Reasons for exclusion from the study included diabetes or a bleeding disorder, use of immunosuppressant medications, an additional surgical procedure in the anatomical area to be treated with helium plasma subdermal coagulation, or an illness or condition that might put the subject at risk or jeopardize the objectives of the study.

| Procedure
Paper and electronic medical records for subjects meeting the eligibility requirements were reviewed. All procedures were performed on the arms, abdomen, or neck in a typical clinic setting. Blinded preand posttreatment images of the treatment area were obtained to assess the extent of tissue contraction. To be eligible for analysis, the Quantitative assessments of angle reduction and area measurements between before and after images were calculated and the percentage reduction was reported. Subject satisfaction surveys were completed by all study subjects following treatment. For abdominal measurements, the before and after images were analyzed using available markers identified on the body that do not change to align and create a reference point. The area was calculated as % of reduction = (Before − After)/(Before − Target) × 100.

| Chart Review #2
This retrospective study reviewed paper or electronic medical records for subjects meeting the eligibility requirements of being male or female, 21 years of age or older who had undergone a subdermal coagulation procedure with the helium plasma device following liposuction. Deidentified information was collected to perform descriptive statistics. Images were additionally mapped for quantitative measurements. The same site was isolated from the images obtained at both pre-and postprocedure. The procedure duration was longer than 2 h (n = 1), 2-4 h (n = 21), 4-7 h (n = 2), or unknown duration (n = 3). The amount of aspiration during the procedure was estimated to be lesser than or equal to 20 ml (n = 17), 30-50 ml (n = 9), 60-150 ml (n = 7), or an unknown quantity (n = 4). Subjects were followed for less than 1 month (25%), 1-5 months (44%), and 6-11 months (31%). There were no intra-or postprocedural complications.  The mean reduction in abdominal width was 82.1% (range, 52%-100%) and mean area reduction was 96.0% (range, 29.7%-66.2%). Figure 4 shows abdominal area measurement and a 29.7% reduction in area. Procedure information for this subject is: Ultrasound-assisted liposuction with power settings of 70% to stomach, hips, thighs, neck and arms, aspiration unknown, and helium plasma to abdomen, flanks, and arms with an unknown number of passes at 80% power, 3 LPM. Thighs were treated with helium plasma at 40% power, 3 LPM.
Most subjects (75.7%) reported aesthetic improvement (Improved, 21.6%, Much Improved, 13.5%, and Very Much Improved, 40.5%) following their procedure (Tables 1) and (67.6%, n = 25) were happy with their results, would recommend to a friend, and would consider having their procedure done again. Overall satisfaction was achieved by 74% (n = 27) of subjects by a scale from 1 to 10 (1 is the worst, 10 is the best), with scores 6 or more counted as satisfied (Table 2). On the basis of the Subject Global Aesthetic Improvement Scale (S-GAIS) scores, subjects rated the change in their appearance as Very Much Improved (40.5%), Much Improved (13.5%), Improved  An AE of upper buttocks redness resolved after 12 days, an AE of seroma left sacrum area resolved after 9 days, and an AE of swelling resolved after 64 days. These latter three events were not considered helium plasma device-related. All AEs were determined to be mild in severity.

| Chart Review #2
The   The larger group of 148 subjects from Chart Review #2 was treated with combined procedures over a broad range of anatomical areas. Few reported adverse events were considered definitely or probably related. Two serious adverse events were reported; however, both subjects were treated with ultrasound-assisted liposuction and helium plasma making it unclear which device or if the combined use of devices was responsible. Although the adverse events of seroma were commonly reported, it is a known complication associated with ultrasound-assisted liposuction. 28 The subjects in Group 2 were treated on 454 anatomical areas with 34 reported adverse events, an event rate of 7.8%. This compares favorably with similar reports. In one report, the incidence of minor complications associated with radiofrequency-assisted liposuction across all treatment areas was 8.3% and major complications was 6.25%. 29 There is little information available regarding liposuction in combination with other aesthetic procedures. A prospective cohort of patients who underwent liposuction between 2008 and 2013 was identified by researchers from the CosmetAssure database. Published results indicate that among subjects undergoing liposuction alone procedures (N = 31,010), the overall complication rate was 0.7%. 27 The complication rate increased significantly when liposuction was combined with other aesthetic procedures; however, these were largely surgical procedures such as abdominoplasty and breast augmentation. 27 When liposuction was combined with facial procedures such as rhinoplasty and facelift, the rate of adverse events was less than those when those facial procedures were performed alone (0%-1.5% vs. 0.4%-3.0%).
Helium plasma technology represents a novel method to safely and effectively improve the appearance of lax skin in several anatomical areas. Treated subjects expressed high levels of satisfaction.
The results of this study suggest helium plasma is a safe and effective adjunct therapy when used in combination with liposuction. Limitations of this study included the retrospective study design, a small number of eligible subjects, and missing data for a few subjects. A clinical trial with subjects randomized to undergo liposuction with or without helium plasma would help define the contribution made by this adjunct treatment. More data will become available as the use of helium plasma becomes more widely utilized.
The primary limitation to this study is the retrospective nature of a chart review and the lack of control groups.

| CONCLUSION
Two retrospective studies were completed of patients who underwent a procedure where a helium driven plasma radiofrequency device was used as a tool for subdermal coagulation of tissue. The results of these retrospective studies suggest helium plasma is safe and may be an effective adjunct therapy when used in combination with liposuction. Further research is warranted and underway (ClinicalTrials.gov Identifier: NCT04146467).