A retrospective chart review of subdermal neck coagulation using helium plasma technology

A helium‐based plasma technology has recently been cleared by the Food and Drug Administration for cutting, coagulation, and ablation of soft tissue (Renuvion® System; Apyx™ Medical Corporation). As the safety of helium plasma for treating lax and sagging skin in the neck area has not been previously reported, the objectives of this study were to obtain safety results from helium plasma used for neck rejuvenation, to summarize subject and procedure variables, and to assess treatment outcomes for the development of future treatment protocols.

handpiece (Figure 1), an electrosurgical unit (Figure 2), and a supply of helium gas ( Figure 2). The device handpiece delivers RF energy percutaneously in a controlled fashion that results in soft tissue coagulation and contraction within the fibroseptal network. The system consists of an electrosurgical generator unit, a handpiece, and a supply of helium gas. RF energy is delivered to the handpiece by the generator to energize an electrode. 3 When helium gas passes over the energized electrode, a stream of helium plasma is generated which allows heat to be applied to tissue in two different and distinct ways. First, the heat generated by the plasma beam itself through ionization and rapid neutralization of helium atoms. As plasma is a very good conductor of electricity, a portion of the RF energy used to energize the electrode is also transferred to the tissue where heat is created due to electrical resistance by a process known as Joule heating. 4 These two novel heat sources make the helium plasma device a useful surgical tool for heating, coagulating, and contracting soft tissue. 5,6 This is achieved by the almost instant heating of soft tissue to over 85°C for 0.040 to 0.080 s. 5 As a result, there is a less unwanted transfer of heat to adjacent tissue compared with other heat-based devices. In a preclinical study, surface skin temperature reached a maximum of 41°C, an increase of less than 4°C. 5 Advantages of helium plasma include 3,7 : • Unfettered power delivery regardless of tissue impedance due to the unique power output from the electrosurgical generator • Focused delivery of energy immediately heats the fibro-septal network of the dermis resulting in immediate soft tissue contraction without heating the full thickness of the dermis • Low-current RF energy causes the minimal depth of thermal effect and prevents overtreating tissue when performing multiple passes As the safety of helium plasma for treating lax and sagging skin in the neck area has not been previously documented by clinical studies, two retrospective chart reviews were performed using data from patients who had undergone procedures in the neck area using a helium plasma procedure. The primary objective was to obtain information on the safety and treatment data F I G U R E 1 Apyx™ Plasma/Radiofrequency handpiece F I G U R E 2 Electrosurgical unit and helium tank from helium plasma used for neck rejuvenation. Secondary objectives were to summarize subject and procedure variables and assess treatment effects. This will provide some necessary parameters to conduct a formal, prospective, larger randomized clinical trial of the use of helium plasma alone or with concomitant facial procedures.

| METHODS
Paper or electronic medical records at the investigational sites were reviewed. Eligible participants were adult male and female subjects who had undergone a helium plasma neck procedure. All patients that underwent subdermal coagulation in the neck from the time period from December 2017 to August 2018 were considered eligible for analysis. The group of eligible patients represented a broad spectrum of patients seeking the esthetic face and body improvements, included both men and women over the age of 21, with body mass index (BMI) ranging from normal to obese. Table 1 Table 1). Tumescent fluid volumes were not quantified separately between the neck and body in the charts.
The mean generator settings were 70% power (range, 60%-85%) and 2 (range, 1.5 -4) LPM helium with a mean of five passes (range, 3-6; Table 2). The only adverse event reported in this study was previously described in the results of Study 1.
All subject image sets met the image review criteria. Shadowing in the images did not impact the identification of skin borders that was used to calculate differences in the angle of measurement or area reduced in the submentum. The six medical advisory board (MAB) members correctly identified 80% of pre-and posttreatment images (range, 69%-87%; Table 3) and all subject images (100%)  Table 5  Before After Before After

| DISCUSSION
The outward signs of aging can be very evident in the neck. Changes affecting the appearance of the neck can include an increase or decrease of subcutaneous fat, platysmal banding, jowling, and skin laxity.
Depending on the severity, a range of treatment options is available for use alone or in combination for treating the aging neck. 8 As an ongoing series of retrospective analyses, the authors are demonstrating the adequacy of measured variables, methodologic omissions, and data abstraction methods in an attempt to establish clinical protocols for widespread adoption and clarify the safety and effect of this radiofrequency powered helium plasma technology. We have previously published a retrospective chart review in which helium plasma technology was safely used for skin contraction with and without concomitant tumescent liposuction and had a limited side effect protocol. 9 Subsequently, looking across multiple investigator sites, we were able to present similar findings of few device-related adverse events occurring in patients treated intraoperatively with the same helium plasma subdermal coagulation technology immediately following  quantitative results suggest this method of measuring tissue contraction resulting from a treatment with helium plasma technology will be effective in future studies and that there is good consistency between subjective and quantitative assessments.
Although limited by small sample size and retrospective study design, the results of the present studies indicate helium plasma technology provides a safe and well-tolerated method for rejuvenating the appearance of an aging neck.

| CONCLUSION
Two retrospective reviews of 15 and 13 patients who underwent a neck procedure with a device based on helium plasma technology revealed a low incidence of mild adverse events after a mean follow-up of 4 months. Helium plasma technology appears to be a safe and well-tolerated treatment for lax tissue in the neck with skin contraction changes visually apparent by subjective and quantitative analyses of before and after photographs.

ACKNOWLEDGMENT
This study was sponsored by Apyx™ Medical Corporation, Clearwater, FL.

CONFLICT OF INTERESTS
No blinded physician reviewer received direct financial compensation for their participation. Each blinded physician reviewer is a member of the MAB, a consultant for Apyx™ Medical Corporation, and has stock options in Apyx™ Medical Corporation. Vaishali Doolabh, MD was an investigator on this study and is a paid Consultant for Apyx™ Medical Corporation.

ETHICS STATEMENT
All patients in this study consented to photographs and the use of those photographs in educational content and scientific journals.