Erez Dayan, MD
Paolo Rovatti, MD
Sherell Aston, MD
Christopher T. Chia, MD
Rod Rohrich, MD
Spero Theodorou, MD

Background: Nonexcisional facial skin tightening has long been an elusive goal in  aesthetic surgery. The “treatment gap” includes cases who are not “severe” enough  for excisions surgery but not “mild” enough for most traditional noninvasive aes thetic modalities. In this retrospective review, we present the largest evaluation to  date of radiofrequency (RF) skin tightening technology combination including  bipolar RF (FaceTite; InMode) and fractional bipolar RF (Fractora modified to  Morpheus8; InMode).

Methods: A multicenter retrospective study was conducted between January 2013  and December 2018 using a combination of bipolar RF and fractional bipolar RF  for the treatment of facial aging. Data collection included demographic informa tion, Baker Face/Neck Classification, amount of energy used, adverse events, and  patient satisfaction. Four cadaver dissections were also conducted to correlate the  underlying neuromuscular anatomy with RF treatment of the lower face and neck. Results: Two hundred forty-seven patients (234 women and 13 men) were included in  the study. Average age was 55.1 years (SD, ±8), body mass index was 24.3 (±2.4), and  9% (23/247) of patients were active smokers at the time of treatment. Patients had  an average Baker Face/Neck Classification score of 3.1 (SD, ±1.4). The procedure  was performed under local anesthesia in 240/247 cases  (97.2%). Patients objectively  improved their Baker Face/Neck Classification score by 1.4 points (SD, ±1.1). Ninety three percent of patients indicated that they were pleased with their results and would  undergo the procedure again. Complications recorded for our cohort included pro longed swelling >6 weeks (4.8%, 12/247), hardened area >12 weeks (3.2%, 8/247),  and marginal mandibular neuropraxia (1.2%, 3/247), which all resolved without  further intervention. When considering possible control variables, age seems to be  a significant factor. That is, older patients were more likely to benefit from a larger  magnitude of the treatment effect (as demonstrated by a decrease in the Baker rating  from pre- to posttreatment) when compared with younger patients. However, both  groups did demonstrate significant improvements across time.

Conclusion: While this combination RF treatment (FaceTite bipolar RF and  fractional bipolar RF) does not aim to replace a facelift/necklift in appropriate  candidates, it does broaden the plastic surgeons’ armamentarium to potentially  fill a treatment gap. (Plast Reconstr Surg Glob Open 2020;8:e2862; doi: 10.1097/ GOX.0000000000002862; Published online 26 August 2020.)

From *Plastic and Reconstructive Surgery, Avance Plastic Surgery

Institute, Reno/Tahoe, Nev.; †Studio Dott. Rovatti, Verona, Italy;

Plastic and Reconstructive Surgery, Manhattan Eye, Ear & Throat  Hospital, New York, N.Y.; §Plastic and Reconstructive Surgery,  BodySculpt, New York, N.Y.; and Plastic and Reconstructive  Surgery, Dallas Plastic Surgery Institute, Dallas, Tex.

Received for publication November 4, 2019; accepted March 25,  2020.

Copyright © 2020 The Authors. Published by Wolters Kluwer Health,  Inc. on behalf of The American Society of Plastic Surgeons. This  is an open-access article distributed under the terms of the Creative  Commons Attribution-Non Commercial-No Derivatives License 4.0  (CCBY-NC-ND), where it is permissible to download and share the  work provided it is properly cited. The work cannot be changed in  any way or used commercially without permission from the journal.

DOI: 10.1097/GOX.0000000000002862

Disclosure: Dr. Dayan is consultant at InMode; he  receives book royalties from Thieme & Elsevier and is a  co-investigator of Allergan, Galderma, and MTF. Dr.  Rovatti is consultant at InMode. Dr. Aston is consultant  at InMode. Dr. Chia is consultant at InMode. Dr. Rohrich  receives book royalties from Thieme and instrument roy alties from Micrins. He is a co-investigator of Allergan,  Galderma, MTF, and InMode. Dr. Theodorou is consul tant at InMode.

Related Digital Media are available in the full-text  version of the article on www.PRSGlobalOpen.com.

INTRODUCTION 

Nonexcisional correction of facial soft tissue lax ity has long been an elusive goal in aesthetic surgery.  Improvements in skin texture, dyschromias, and defla tion are achievable with chemical peels, lasers, micronee dling, and fillers. Areas of neck adiposity may be treated  using liposuction, deoxycholic acid (Kybella; Allergan,  Dublin, Ireland), and cryolipolysis (CoolSculpting;  Allergan), with limited improvements in properly selected  patients. However, even in cases where these treatments  appear successful, skin and soft tissue laxity often remain  uncorrected.

There are 3 groups of patients with facial skin laxity  that we characterize as part of a “treatment gap”: (1) young  patients whose skin redundancy is not “severe” enough to  justify a traditional excision procedure (ie, facelift/neck lift), but also not “mild” enough to treat with liposuction  or noninvasive procedures alone; (2) patients who have  already undergone a facelift or necklift, who present with  recurrent laxity, and (3) patients who may benefit from  traditional face/necklift but want to avoid surgery and are  willing to accept a more modest improvement.

Energy-assisted skin tightening procedures have rapidly  evolved over the past decade. Multiple technologies includ ing laser, high-intensity focused ultrasound, and radiofre quency (RF) have been developed in an attempt to meet  this rising demand.1–8 RF technology has steadily gained  popularity since the early 2000s, with consecutive increases  annually of 10% or more.9,10 These gains encompass aes thetic surgery and numerous nonaesthetic applications  (tissue electrodissection, cardiac catheter ablation, oph thalmic surgery, etc).7 Through impedance of electromag netic current, RF waves lead to differential heating across  distinct tissue types, consistent with Ohm’s law (energy =  current2 × impedance × time). For example, adipose tis sue is less conductive than water (higher impedance) and  leads to generation of temperatures higher than those  generated by muscles. Once soft tissue temperatures reach  50°C and those of the skin surface reach 40°C–42°C, there  is a trigger to induce neocollagenesis, angiogenesis, and  elastogenesis. Through different applications of RF energy  (ie, monopolar, bipolar, multipolar, microneedling), sub dermal adipose remodeling and long-term soft tissue con traction can be safely and consistently achieved.

An increasingly popular soft tissue tightening tech nique of the lower face and neck has been a combi nation procedure (Embrace Protocol; InMode, Lake  Forest, Calif.) using bipolar RF (FaceTite; InMode) and  fractional bipolar RF (Fractora modified to Morpheus8;  InMode Aesthetics, Lake Forest, Calif.).11 The purpose of  this study was to evaluate this combination therapy in the  largest study to date.

METHODS 

A multicenter retrospective study was conducted eval uating treatments from January 2013 to December 2018  (New York, N.Y.; Dallas, Tex.; and Verona, Italy) using a  combination of bipolar RF (FaceTite; InMode Aesthetics)  and RF microneedling (Fractora modified to Morpheus8;

InMode Aesthetics) for the treatment of facial aging.  Procedures were performed by all the authors of this study  (E.D., S.T., P.R., R.J.R., C.T.C, S.A.).

All the patients voluntarily presented to respective  plastic surgery practices with a desire to improve facial aes thetics. Patients included in the study were deemed to fit  into 1 of the 3 aforementioned treatment gaps. Exclusion  criteria included active infection, collagen disorders,  immunocompromised state, medications that mitigate  inflammatory response, and propensity for keloids/hyper trophic scaring. Valcyclovir was given to patients with a his tory of herpes simplex. All Fitzpatrick types were included  in this study.

Patients were all marked in a standardized manner,  identifying first the mandibular border and jowls bilat erally. The jowls were subdivided into zone 1 (above the  mandibular border) and zone 2 (below the mandibular  border). Areas of localized adiposity in the lower face and  neck region were marked. Nontreatment zones were iden tified by carrying a line inferiorly perpendicular to the  lip commissures (ie, marionette lines). The area medial  to these lines was avoided to preserve marginal mandibu lar innervation to the depressor anguli oris, mentalis, and  depressor labii inferioris. Five access points were identi fied: (1) the submental midline, (2) 1–2cm inferior to the  mandibular parasymphysial/body junction, (3) postauric ular (two of the access points were bilateral). (See Video 1  [online], which displays bipolar RF markings.)

Depending on clinical circumstances and patient  desires, cases were performed either under general  or under local anesthesia. In cases of local anesthesia,  patients were premedicated with oxycodone (5mg) and  benzodiazepam (5mg) or both. Access sites were each  injected with 2–4ml of 2% lidocaine with epinephrine. A  14-gauge needle was used to make access ports that were  slightly dilated with Stevens scissors. A spinal needle was  used to slowly infiltrate tumescent solution (1g lidocaine  per liter of lactate Ringer’s solution) from deep to superfi cial, starting in the pre-platysmal plane and moving to the  subdermal plane (approximately 100–150ml of tumescent  total). At the conclusion of tumescent infiltration, the can nula was passed through the subdermal plane to confirm  adequate analgesia.

In all cases, bipolar RF was performed first. The RF  settings included an internal temperature cutoff of 68°C  and external cutoff temperature of 38°C. The RF cannula  was used to pretunnel treatment areas for ease of treat ment. The predetermined treatment areas were systemati cally heated to avoid heat loss when treating wide areas.  RF application was performed on retrograde movement  of the cannula and stopped within 1cm of the access port  to prevent overheating this area. Audible and visual cues  from the RF console were used to assess temperature of  tissues, and treatment was stopped after 1 minute of reach ing target internal and external temperatures. (See Video  2 [online], which displays the bipolar RF technique.) Fractional bipoar RF (Fractora modified to Morpheus8;  InMode Aesthetics) was subsequently used at a depth of  2mm and energy of 30 with 50% overlap. The handpiece  was applied firmly and perpendicular to the treatment area before delivery of RF energy pulses. (See Video 3 [online],  which displays fractional RF technique.) In patients with  thinner skin or darker Fitzpatrick types, energy settings  were reduced by 20%. Patients were seen at 1-week and at  1, 3, and 6-month intervals.

Data evaluated included demographic information,  prior procedural history, anesthesia, medications, Baker  Face/Neck Classification, amount of energy used, and  adverse events. The primary outcome evaluated was pre and post-procedure Baker Face/Neck Classification.  Three independent plastic surgeons graded the pre- and  postprocedure photographs, and subsequently a t test was  used to determine statistical significance. Repeated mea sured analysis of variance test was used to determine any  impact of control variables.

Additionally, 4 cadaver dissections were conducted  to correlate the underlying neurovascular anatomy to  access points and application of RF energy. These cadaver  specimens were treated with the combination procedure  mentioned previously, and dissections were subsequently  performed to identify proximity and the potential impact  on underlying specific neurovascular structures (ie, mar ginal mandibular nerve, facial vessels, etc).

RESULTS 

Two hundred forty-seven patients (234 women and 13  men) were included in the study. Average age was 55.1 years  (SD, ±8), body mass index was 24.3 (±2.4), 9% (23/247)  of patients were active smokers at the time of treatment,  2% (5/247) of patients had prior neck liposuction, and  8.5% (21/247) of patients had prior facelift/necklift.  Patients had an average Baker Face/Neck Classification  score of 3.1 (SD, ±1.4). The procedure was performed  under local anesthesia in 240/247 cases  (97.2%) (50ml  2% lidocaine, 1.5mg epinephrine, 1.5ml bicarbonate, in  1L or lactated Ringer’s solution), and 2.8% (7/247) of  patients underwent the procedure under general anesthe sia or intravenous sedation. Average procedure time was  58 minutes (SD, ±23). All patients were given Valium and  cephalosporin antibiotics before the procedure.

Average energy used per jowl was 3.2 kJ (SD, 1.1).  Patients objectively improved their Baker Face/Neck  Classification score by 1.4 points (SD, ±1.1). Ninety-three  percent of the patients indicated they were pleased with  their results and would undergo the procedure again.  Average follow-up time was 2.1 years (SD, ±1.1).

To test the efficacy of the treatment, a 1-way, repeated  measure t test was conducted. A decrease in the mean val ues of pretest to posttest Baker Face/Neck Classification  rating would indicate a positive effect of the treatment.  Indeed, the t test demonstrated a favorable effect of the  treatment in all the 247 patients. The pretest mean value  was 2.66 (SD = 0.72), and the posttest mean value was 1.86  (SD = 0.64). This mean difference (μ = 0.81, SD = 0.46) was  statistically significant: t(237) = 27.34, P < 0.001, and the  effect size was large (D = 1.76). In other words, the mean  values of the patients’ Baker Face/Neck Classification  decreased as a result of the treatment. (See supplemental  figure 1, Supplemental Digital Content 1, which displays  pre- and posttreatment Baker Face/Neck Classification  scores, http://links.lww.com/PRSGO/B410.) However, it is also possible that several control variables  may have had an unhypothesized effect on the relation ship. Thus, a 1-way, repeated measures analysis of variance  test was conducted, inclusive of control variables. These  control variables were (1) gender, (2) smoking habit, (3)  liposuction history, (4) weight, (5) age (dichotomized  at the median value, 55), (6) body mass index, (7) right  jowl energy (in kJ), (8) left jowl energy (in kJ), and (9)  neck energy (in kJ). Although 247 valid cases were pres ent, complete data were available for only 238 patients;  thus, data from 9 patients were excluded in these analyses.  The following table presents the mean values or percent ages of the control variables in the overall fitted model.  (See table, Supplemental Digital Content 2, which displays  the descriptive statistics, http://links.lww.com/PRSGO/B411.)

When considering the overall model, it is clear from  the analysis that the treatment was effective in reducing  the Baker Face/Neck Classification rating: pretreatment  Baker classification μ = 2.62 (SE = 0.03), pretreatment  Baker classification μ = 1.84 (SE = 0.03); F(1, 208) = 11.36,  P = 0.001. None of the control variables was statistically  significant, except for age. A significant treatment by  age interaction effect was present: F(1, 208) = 17.53, P < 0.001. This simply indicates that the Baker Face/Neck  Classification pre- and posttreatment ratings are different  at different age groups. The mean values demonstrates  that while older patients seem to benefit from the treat ment more than younger patients by a larger magni tude, both age groups still show marked and significant  improvements in their Baker Face/Neck Classification  scores from pretreatment to posttreatment, as evidenced  by Supplemental Digital Content 3. (See supplemental  figure 2, Supplemental Digital Content 3, which displays  Baker Face/Neck Classification scores by treatment age,  http://links.lww.com/PRSGO/B412.)

Complications recorded for our cohort included pro longed swelling >6 weeks (4.8%, 12/247), hardened area  >12 weeks (3.2%, 8/247), and marginal mandibular neu ropraxia (1.2% 3/247), which all resolved without further  intervention. There were no repeat treatments or cases  requiring operative interventions following RF treatment.

DISCUSSION 

While this combination RF treatment (FaceTite bipo lar RF and fractional bipolar RF) does not aim to replace  a facelift/necklift in appropriate candidates, it does  broaden the plastic surgeons’ armamentarium to poten tially fill a treatment gap. Also, it provides patients with an  option to improve facial soft tissue laxity without a tradi tional surgery.

In recent years, RF has emerged as an effective treat ment to achieve nonablative skin tightening.6,7,10,12,13 Heating the dermal tissue to 42°C has been shown to trig ger a healing cascade that leads to stimulation of new col lagen and elastin formation.9,14–16 In animal studies, after  10 minutes of exposure to temperatures of 39°C–43°C, the amount of collagen increased from an average of 9%  before therapy to 25.9% after a 3-month follow-up period  compared with no change in the untreated areas.4,17 Clinical studies on RF-assisted liposuction have shown up  to 25% area contraction at 6 months and 35%–40% area  contraction achieved at 1 year.10,18–20 Other studies have  similarly shown through electron microscopy that collagen  fibrils had a greater diameter after RF treatment. In addi tion, Northern blot analysis has confirmed microinflam mmatory stimulation of fibroblasts and other substances  that enhance dermal structure.21 RF has not only been  proved effective for skin tightening, but it has also been  studied and proved effective in diminishing adipocytes.14 A number of RF applications are available to apply  this energy in different ways (monopolar, bipolar, mul tipolar, and microneedling). The 2 RF delivery meth ods (bipolar RF and fractional bipolar RF) used in this  study help achieve different treatment goals. The bipolar  RF applicator uses a small 1.8-mm diameter, 13-cm long,  silicone-coated RF-emitting probe. This directs electrical  current flow from the internal to the external electrodes  connected by the handpiece. As current is applied, the  heat coagulates subcutaneous fat in close proximity to the  internal probe and denatures the reticular dermis but pre serves the papillary dermis. The controlled heating allows  for immediate tightening of the collagen triple helix via  breakdown of hydrogen bonds in the collagen, causing  shrinkage of the normal collagen structure, as well as  induction of the healing cascade, leading to neocollagen esis, elastin remodeling, and angiogenesis over the follow ing 3–4 months.9 In addition, using a parachute analogy,  the application of heat tightens the overlying fibroseptal  networks (strings) and serves to uniformly contract the  overlying skin (parachute). Complications are minimized  by internal and external temperature, and impedance  probes to rapidly detect (10×/ms) the soft tissue environ ment and automatically turns off RF energy if beyond the  preset safety parameters (Figs. 1, 2).

In bipolar RF, the penetration depth is half of the dis tance between the electrodes, meaning the energy does  not reach beyond the epidermis. Many attempt to circum vent this limitation by combining RF with other technolo gies to penetrate deeper, such as application of a vacuum  to thin skin, infrared light pretreatment to change imped ance, or cooling procedures to increase the penetration  depth.4 In this study, the effect of bipolar RF treatment  was augmented by performing fractional bipolar RF in the  same session. Fractional bipolar RF (Fractora modified  to Morpheus8; InMode Aesthetics) deploys RF-emitting  needles at variable programmable depths and energies  depending on the region being treated. Unlike fractional  CO2 or erbium, the fractional bipolar RF resurfacing can  induce 3 types of effects—minimal superficial ablation  for dyschromias and rhytids, controlled dermal coagula tion for tissue renewal, and overall volumetric heating for  collagen stimulation.4 Fractional photothermolysis creates  thermal injury that tapers as it descends deeper. In con trast, fractional bipolar RF creates zones of dermal injury  narrowest at the epidermis with conical enlargement as the  microneedles descend.10 When the RF needles penetrate  deep into the dermis, there is a “molding” component of  the subdermal adipose tissue which we term “subdermal  adipose remodeling.” Hruza et al16 reported that 90% of  patients with skin types II–IV showed an improvement  in smoothness and rhytids, and 87% had improved in  skin tightness. Seo et al13 compared facial soft tissue lax ity improvement with RF versus surgical facelift using  blinded grading of photographs. They demonstrated a  49% improvement in skin laxity relative to baseline for  the surgical facelift compared with 16% for the fractional

bipolar RF. Further, the mean laxity improvement from  a single fractional bipolar RF treatment was 37% of the  surgical facelift.13 Peterson et al22 also studied objective  measurements of mechanical skin properties and demon strated a statistically significant improvement (5%–12%  decrease in Young’s modulus and 10%–16% decrease in  retraction time), as well as 1.42 grade improvement on the  Fitzpatrick scale for wrinkles, and 0.66 on the Alexiades  scale for skin laxity, increasing to 1.57 and 0.70 improve ment at 6 months. Patient satisfaction was noted to be  “very high” for >90% of patients.22 A clinical study of the  microneedle fractional bipolar RF handpiece (Intensif  handpiece; EndyMed, Caesarea, Israel) demonstrated a  significant improvement after 2 sessions and after 4 and  12 weeks of follow-up.6 A similar system (Scarlet, Korea)  was studied in 3 consecutive sessions 4 weeks apart.  Immunohistochemical staining (fibrillin-1) showed a sig nificant increase in dermal collagen content at 4 weeks  after 3 sessions when compared with the baseline, as well  as a significant increase in fibrillin-1 density from the  dermal–epidermal junction to the deep dermis compared  with the baseline.23

Other studies have demonstrated the efficacy of com bined multimodal RF application for facial aesthetic pur poses. Kaplan et al used 3 RF delivery methods together  (nonablative skin tightening, RF fractional skin resur facing, and microneedling RF) on 14 subjects, showing  improvements (>50%) in skin texture, laxity, and rhytids  in 43% of the cohort without adverse effects or a signifi cant downtime.24 Previous studies have shown the efficacy  of nonablative multisource RF as a single modality for  face/body contouring.15,20,25 Other studies have shown the  efficacy of RF microneedling as a single modality26 and the  efficacy of a combination of nonablative RF and fractional  skin resurfacing.27 Similarly to our findings, Mulholland in  Hruza et al. identified the benefit of combining bipolar RF  and fractional RF, stating that combining these applica tions allows for thermal stimulation for an “inside-outside  dermal stimulation,” which can induce both an ablative  rejuvenation of dyschromia, fine lines, and rhytides and a  nonablative deeper dermal tightening.16 Our study find ings were consistent with Mulholland’s conclusion that  combination therapy can deliver safe and consistent soft  tissue rejuvenation.

The anatomic dissections performed as part of this  study demonstrated the important surgical anatomy rel evant to this procedure. Specifically, the marginal man dibular nerve was found to be always above the inferior  border of the mandible while anterior to the facial artery.  The position was more variable posterior to the facial  artery, in which case it was above the inferior border of  the mandible in majority of cases. Importantly, consistent  with prior anatomic studies, at approximately 2cm from  the oral commissure, the marginal mandibular nerve  divides and subdivides to enter the lip depressors. At this  anatomic location, the skin and underlying muscle planes  are closely adherent. It is for this anatomic reason that  we elect to not treat areas medial to the marionette lines.  Using this anatomic knowledge and aforementioned  access ports, we found no nerve injuries (ie, transection,  neuropraxia) and no extension of the device heat sig nature in proximity to the marginal mandibular nerve,  consistent with the relatively low complication rate in the  clinical arm of the study.

CONCLUSIONS 

Combination therapy of bipolar RF and fractional RF  had a positive effect on reducing the Baker Face/Neck  Classification rating. When considering possible control  variables, older patients were more likely to benefit from a  larger magnitude of the treatment effect (as demonstrated  by a decrease in the Baker rating from pre- to posttreat ment) compared to younger patients. However, both groups  did demonstrate significant improvements across time.

Erez Dayan, MD 

Avance Plastic Surgery Institute

5570 Longley Lane, Suite A

Reno, NV

E-mail: drdayan@avanceinstitute.com

PATIENT CONSENT 

Patients provided written consent for the use of their images.

REFERENCES 

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