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Journal of Cosmetic and Laser Therapy

ISSN: 1476-4172 (Print) 1476-4180 (Online) Journal homepage: http://www.tandfonline.com/loi/ijcl20

Use of a controlled subdermal radio frequencythermistor for treating the aging neck: Consensusrecommendations

Brian M. Kinney, Anneke Andriessen, Barry E. DiBernardo, Jason Bloom,Dennis F. Branson, Richard D. Gentile, David J. Goldberg, Paul Z. Lorenc,Mark Nestor & Douglas Wu

To cite this article: Brian M. Kinney, Anneke Andriessen, Barry E. DiBernardo, Jason Bloom,Dennis F. Branson, Richard D. Gentile, David J. Goldberg, Paul Z. Lorenc, Mark Nestor & DouglasWu (2017) Use of a controlled subdermal radio frequency thermistor for treating the aging neck:Consensus recommendations, Journal of Cosmetic and Laser Therapy, 19:8, 444-450, DOI:10.1080/14764172.2017.1343952

To link to this article: http://dx.doi.org/10.1080/14764172.2017.1343952

Accepted author version posted online: 30Jun 2017.Published online: 30 Jun 2017.

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Use of a controlled subdermal radio frequency thermistor for treating the agingneck: Consensus recommendationsBrian M. Kinneya*, Anneke Andriessenb,c, Barry E. DiBernardod, Jason Bloome, Dennis F. Bransonf, Richard D. Gentileg,David J. Goldbergh, Paul Z. Lorenci,j, Mark Nestork,l, and Douglas Wum

aDepartment of Plastic Surgery, USC School of Medicine, Beverly Hills, CA, USA; bRadboudumc, Radboud Academie, Nijmegen, Netherlands;cAndriessen Consultanta, Malden, Netherlands; dSurgery, Plastic Surgery Division, University of Medicine & Dentistry of New Jersey, Montclair, NJ,USA; eMain Line for Laser Surgery, Ardmore, OK, USA; fAesthetic, Plastic and Reconstructive Surgery, Fayetteville, NY, USA; gFacial Plastic & AestheticLaser Center & The MIA Center, Boardman, OH, USA; hSkin Laser & Surgery Specialists, Westwood, CA, USA; iLorenc Aesthetic Plastic Surgery Center,New York, USA; jLenox Hill Hospital, New York, NY, USA; kSchool of Medicine, Dermatology and Cutaneous Surgery, University of Miami, Miami, FL,USA; lCenter for Cosmetic Enhancement and Center of Cosmetic Research, Aventura, FL, USA; mCosmetic Laser Dermatology, San Diego, CA, USA

ABSTRACTIntroduction: A new temperature-controlled device has been used as a percutaneous radio frequencyprobe to treat lax submental and other facial areas. It has significant advantages over other estheticdevices as it provides the dual benefit of fat lipolysis and skin tightening. Our goal here is to presentconsensus recommendations for treating the aging neck. Methods: A panel of 11 expert physiciansconvened in Dallas, Texas, on October 15, 2016 to arrive at a consensus on the best current practice forsubmental skin tightening and contour improvement. Prior to the meeting, a comprehensive review ofthe literature was performed and a survey was sent to esthetic dermatologists and plastic surgeons whowere queried about various aspects of neck rejuvenation. Results: The literature search revealed 10different technologies for neck rejuvenation evaluated in double-blind (n = 2) and single-blind (n = 1)clinical trials and other clinical evaluations (n = 21). The survey was sent via an email to 1248 individualsand was completed by 92 respondents. Review of the data and discussion by meeting attendeesgenerated eight consensus recommendations. Discussion: Subdermal monopolar radio frequencyrepresents an effective means for disrupting fat volume and skin tightening of the face, neck, andjawline. For suitable patients, this treatment can be used to achieve significant esthetic improvements.

ARTICLE HISTORYReceived 26 March 2017Accepted 14 June 2017

KEYWORDSEsthetic dermatology;consensusrecommendations; neckrejuvenation; subdermalradio frequency thermistor;submental skin tightening;temperature-controlled

Introduction

Facial aging is the result of intrinsic factors including hormonalchanges and free radical-induced damage, and extrinsic factorssuch as the effects of gravity, sun exposure, and smoking (1).Common features of the aging neck include increased submen-tal fat, platysmal banding, and redundant dyspigmented skin(2). Since the contour of the neck is a significant aspect in facialesthetics, creating a more acute cervicomental angle, distinctmandibular border, mobile, supple and tight muscle, and fibro-septal subcutaneous tissues, homogeneous skin tone, andsmoother texture are important factors for achieving a moreyouthful appearance. Historically, these unwanted changes inneck appearance were treated using surgery and liposuction (3–7); however, numerous non- and minimally invasive proce-dures have been developed to provide non-surgical approachesfor cervicomental rejuvenation and fatty recontouring.

As the combination of different intrinsic and extrinsicfactors can result in a wide range of clinical presentations(2), esthetic treatments need to be customized accordingly.Selecting the right procedure for appropriate patients that willeffectively meet the esthetic goals and expectations of each

patient is the core of successful neck rejuvenation. In additionto tightening lax submental skin, these procedures involve inthe removal of unwanted submental fat, requiring a thoroughunderstanding of neck anatomy. Supraplatysmal fat is founddeep in the skin and superficial to the platysma muscle, anddistributed between suprahyoid and infrahyoid compartments(8). Subplatysmal fat is found in three compartments, central,medial, and lateral, which border one another to form thesubplatysmal fat layer (9). It is also important to know thelocation of nerves and to perform nerve mapping prior toperforming esthetic procedures to avoid injuries (10,11).

Among the various minimally invasive therapies whichare now available for treating the aging neck, a novel tem-perature-controlled device uses a percutaneous radio fre-quency probe to achieve submental skin tightening(THERMItight®; Thermi™, Irving, TX) (12,13). This deviceappears to have significant advantages over other estheticdevices used to improve submental areas as it provides thedual benefit of fat lipolysis and foreshortening of the pla-tysma, fascia, and skin, which lifts the area. The objective ofthis paper is to gain a better understanding of the available

CONTACT Brian M. Kinney brian@briankinneymd.com Department of Plastic and Reconstructive Surgery, USC School of Medicine, 120 South Spalding Drive,Suite 330, Beverly Hills, CA 90212, USA.

*Dr. Brian M. Kinney is the Medical Director of ThermiAesthetics.Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/ijcl.

JOURNAL OF COSMETIC AND LASER THERAPY2017, VOL. 19, NO. 8, 444–450https://doi.org/10.1080/14764172.2017.1343952

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procedures used for skin tightening and contour improve-ment of the submental area.

Literature search

A systematic literature search was performed on August 1–3,2016 (PubMed.gov; US National Library of Medicine,National Institutes of Health). Searches were prospectivelylimited to English language articles published betweenJanuary, 2005 and August, 2016. Review articles wereexcluded. Medical subject heading terms used in variouscombinations included tissue tightening, skin tightening,skin laxity, neck tightening, neck, submental, contourimprovement, under-chin, jowls, radio frequency, dermalheating, radio frequency, ultrasound, deoxycholic acid, laser,infrared, cryolipolysis, and non-ablative.

Identified publications that met the selection criteria werereviewed based on clinical relevance and level of evidenceusing a consensus process and pre-established criteria. The qual-ity of evidence used for clinical recommendations was gradedusing a three-point scale (14): (I) good-quality patient-orientedevidence, (II) limited-quality patient-oriented evidence, and (III)other evidence including consensus guidelines, opinion, casestudies, or disease-oriented evidence. Clinical recommendations(14) were based on (A) consistent and good-quality patient-oriented evidence, (B) inconsistent or limited-quality patient-oriented evidence, and (C) consensus, opinion, case studies, ordisease-oriented evidence. A summary of the literature searchresults is provided in Table 1 and an overview of treatmentoptions and available devices is provided in Table 2.

For all the reviewed treatments, there was only limited-quality patient-oriented evidence (Level II-B) available, exceptfor deoxycholic acid injections which were supported withtwo randomized double-blind, placebo-controlled studies(Evidence Level I-A) (15,16); however, this type of treatmentshowed moderate adverse events at the injection site andmarginal mandibular nerve paresis which was resolved with-out sequelae (16).

Temperature-controlled subdermal skin tightening treat-ment efficacy and safety was supported by two small studies(12,13). Subdermal monopolar radio frequency skin tighteningefficacy and safety was supported by three single-treatmentstudies, one study using six treatments and two open-labelstudies using two radio frequency treatments (17–21). Theuse of bipolar radio frequency was supported by one smallopen-label study (22), which reported mild adverse events.Super-pulsed radio frequency was tested in a cohort study (N= 100) with a six-month follow-up. Most subjects in this study(94%) showed a marked improvement with this safe treatment(23). An open-label study on safety and efficacy of pulsed 1440-nm Nd:YAG wavelength and side-firing fiber for subcutaneousfat and skin laxity of the neck in 24 subjects showed a sig-nificant improvement in the cervicomental angle and physicianglobal esthetic improvement scores (24). Four small studiesusing infrared light (1100–1800 nm) demonstrated facial con-tour and neck improvements in most treated subjects with onlymild or no adverse events reported (25–28). Micro-focusedultrasound treatment efficacy and safety on the submental,submandibular, lower neck, and platysmal areas was evaluated

in six studies (29–34). Although most treated subjects demon-strated improvements, moderate adverse events such as pro-longed erythema and mild scabbing were reported.Cryolipolysis was evaluated in a pivotal investigational deviceexemption study (N = 60) (35). A single-treatment cycle wasdelivered at −10°C for 60 minutes and an optional secondtreatment was delivered at six weeks. Independent photoreview and ultrasound data indicated marked improvementsin the cervicomental angle.

Pre-meeting survey

A pre-meeting survey was conducted to gain an under-standing of the procedures being used for subdermal skintightening and contour improvement of the under-chinand jowl areas in medical esthetic practice, and theirassociated challenges and benefits. An additional goal ofthe survey was to establish the clinical positioning oftreatment using the temperature-controlled device (12,13)based on the experience of current users with respect to itsefficacy, optimal dose, frequency of administration, andother procedural details. Other clinical considerationswere specific factors that could influence clinical out-comes, contraindications, adverse events, and optimalrisk–benefit ratio.

The survey questionnaire was sent via an email to 1248physicians on August 27, 2016 of whom 415 who opened theemail and 92 who completed the questionnaire were includedin the analysis. The survey respondents described themselvesas primarily plastic surgeons (39.13%) and esthetic plasticsurgeons (21.74%) working in private practice (71.74%)(Figure 1). Among patients seeking treatment, most(52.17%) were between 45 and 55 years and the majority(59.9%) were considered suitable candidates for treatmentwith the temperature-controlled device. When physicianswere asked to indicate the type of radio frequency technologyused for the treatment of fat reduction and skin laxity of thesubmentum (and jowls) in their practice, the majority (85.9%)used the temperature-controlled subdermal monopolar radiofrequency device (Figure 2). Before treatment, surveyed phy-sicians gathered the following patient information: patient age(89–96.7%), degree of skin laxity (96.7%), previous treatment(93.5%), full medical history (88.0%), physical exam (80.4%),history of smoking (79.4%), ethnicity (45.7%), body massindex (41.3%), and other information (13.0%).

Although the respondents had mixed opinions regardingcontraindications (Table 3), probe temperature (Table 4), andclinical endpoints, they were generally in agreement thattreatment with monopolar temperature-controlled devicecan safely and effectively achieve skin tightening and fatreduction of submental tissue and jowls (89.1%) and glidingplanes (78.3%). The lack of downtime makes this procedurevery interesting for esthetic surgeons (83.70%). Temperature-controlled treatment delivers comprehensive skin tightening,which takes place over time and involves submuscular ape-neurotic system (SMAS), dermal and hypodermal collagenremodeling (95.65%), and skin tightening, which continuesto be evident six months after a single treatment (85.87%).

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Table1.

Summaryof

theliteraturesearch

results.

Treatm

ent/device

Stud

ydesign

Subjects

(N)

Results

Adverseevents

Thermistor-controlledsubd

ermal

skin

tightening

Retrospectivereview

ofsubjects

undergoing

thermistor-

controlledsubd

ermalskin

tighteningviapercutaneous

radio

frequency(13).

18Tw

oinfrared

thermom

etersrecorded

meantemperaturesof

43.6

and38.2°C

supp

ortin

gits

useforskin

tightening.

Non

e

Retrospectivestud

yon

thedevice

used

forsubm

entalskin

tighteningof

under-chin

andjowls(12).The

thermistor

prob

ewas

used

totreat3.0cm

2every2minutes.The

clinical

endp

oint

was

anepidermal

temperature

of42°C.

35Using

a4.0-po

intskin

laxity

scale,thecombinedmeanchange

inbaselineskin

laxity

scores

was

−0.78

(p<0.0001).

Non

e

Subsurface

mon

opolar

radio

frequency(SMRF)skin

tightening

Retrospectivestudyassessed

theoverallefficacy

andsatisfaction

ofsubjectswho

underwenta

singleSM

RFtreatm

enttotheface,

neck,jaw

line,aloneor

incombination(17).

35At

180days

post-treatment,77%

ofthesubjects

repo

rted

improvem

ent,and64%

repo

rted

satisfaction.

Non

e

Coho

rtstud

ytreatin

gmild-to-mod

eratecheek(n

=30)or

neck

laxity

(n=20)with

oneSM

RFtreatm

ent(18).

50Sign

ificant

improvem

entin

cheekandneck

skin

laxity

was

observed

inmostpatients.

Mild

erythema,edem

aand

dysesthesia.

Evaluatio

nof

sixradiofrequencytreatm

ents

every15

days,

everymon

th,and

everytwomon

ths,allfor

twoconsecutive

sessions

(19).

17At

four

weeks

post-treatment,patient-reportedmean

improvem

entof

25–30%

was

notedandpriorto

thelast

treatm

ent,themeanimprovem

entwas

48–50%

,decreasingto

46and30%

atsixmon

thsafterthefin

altreatm

ent.

Mild

Openlabelstudy

ontworadiofrequencytreatm

ents

tothe

face

andneck

onemon

thapart(20).

49Noted

improvem

ents:o

verall,74%

ofthesubjects;skin

cond

ition

,85%

;skinlaxity,8

1%.

Non

e

Evaluatio

nof

multip

lepass,low

fluence

treatm

entalgo

rithm

forlower

face

laxity

(21).

66At

sixmon

ths,improvem

entin

overallapp

earancewas

notedin

92%

ofthesubjects

usingtheLeal

Laxity

Classificationsystem

and84%

with

independ

entph

otog

raph

icassessment.

Non

e

Bipo

larradiofrequency

Openlabelstudy.Sub

jectsun

derwentaseriesof

four

tosix

weeklytreatm

ents

(22).

14At

sixweeks,7

1%no

tedimprovem

entand29%

show

edmild

improvem

ent.

Mild

Super-pu

lsed

radiofrequency

Coho

rtstud

yface

andneck

laxity

(23).

100

Atsixmon

ths,improvem

entwas

notedin

94%

ofthesubjects.

Mild

1440-nm

Nd:YA

Gdevice

Openlabelstudy

onsafety

andefficacyof

pulsed

1440-nm

Nd:YA

Gwavelengthandside-firing

fiber

forsubcutaneous

fat

andskin

laxity

oftheneck

insubjects

40–65yearsold(24).

24At

sixmon

thspo

st-treatment,79%of

thesubjectshadsign

ificant

improvem

entin

theCervicom

entalA

ngle

Score(p

<0.001)

and

79%

demon

stratedan

improvem

enton

theGAIS.

Mild

Infrared

light

Prospectivestud

yon

threetreatm

ents

with

incoherent

infrared

(1100–1800

nm)light

attwo-

tofour-weekintervals,

evaluatin

gsafety,efficacy,and

tolerabilityfortreatin

gfacial

andneck

skin

laxity

(25).

22Afteramean(SD)of

2.1(0.9)treatm

entsandmeanfollow-up

intervalof

1.9(1)mon

ths,themeanbaselinelaxity

gradeof

2.9

(0.5)decreasedto

2.5(0.6)(p

<0.0001).

Non

e

Evaluatio

non

efficacyof

1100–1800nm

infrared

givenas

twotreatm

ents

onemon

thapartforfacialandcervicalskin

tightening(26).

10Afterthreemon

ths,ph

ysicians

noted10%

improvem

entand

patient

repo

rted

32%

improvem

entforthecheeks

and20%

for

theneck.

Non

e

Prospective,split-face,single-blindedstudyon

safetyandefficacy

usingthedevice

forskintightening(27).The

untreatedsid

eserved

asacontrol.Treatm

entw

asperfo

rmed

twicewith

afour-

weekintervalbetweenthetreatm

ents.

13Subjectsrepo

rted

mild

(23%

),mod

erate(15%

),andsign

ificant

(54%

)improvem

entsat

threemon

ths.By

objectiveassessment,

41%

ofthesubjects

hadsomedegree

ofimprovem

entof

the

treatedside.

Blisterin

g(n

=1)

Prospective,open-labelstudy

assessed

theclinicalefficacyand

safetyof

threetreatm

entsessions

four

weeks

apart(28).

21At

sixmon

ths,57%show

edmarketimprovem

entsand28%mild.

Mild

pain

andedem

a,episod

esof

blisterin

g(n

=7)

Micro-focused

ultrasou

ndEvaluationof

treatm

entattwofocaldepthson

thesubm

ental,

subm

andibular,lower

neck,and

platysmalareas(29).

71At

sixmon

ths,allp

atientsshow

edimprovem

ents.

Non

e

Prospective,op

en-labelp

ilotusingadu

aldepthtreatm

ent

with

avectored

pattern(30).

20Evaluationat90

days,180

days,and

oneyear(GAIS)show

edthat

90–100%ofthesubjectshadimprovem

entsat90

and180days

and

95%atoneyear.

Retrospectiveclinicalevaluatio

n(31).

45Evaluatio

n(GAIS)

at90

and180days

show

edthat

81.3

and

77.8%

ofthesubjects

achieved

improvem

ents,respectively.

Mild

Prospective,no

n-rand

omized

clinicaltrial(32)

103

Blindedreview

ersob

served

improvem

entin

skin

laxity

in58.1%

ofthesubjects

andoverallimprovem

entin

skin

laxity

in63.6%.

Mod

eratepain

Open-label,no

n-rand

omized

trialo

nsafety

(33).

52Threemod

eratelysevere

prolon

gedcasesof

erythemawith

mild

scabbing

(n=1)

resolved

after90

days

with

outsequ

elae.

Mild-m

oderateerythema

Open-labelstudy

treatin

gface

andneck

with

two

transducerswith

focald

epthsof

3.0and4.5mm

(34).

12At

90days,80%

ofthe10

evaluablesubjectsshow

edimprovem

ents.

Non

e

(Con

tinued)

446 B. M. KINNEY ET AL.

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Expert panel composition

A consensus panel of 11 physicians who are experts inesthetic medicine was convened in Dallas, Texas, onOctober 15, 2016. This evidence-based approach (14)included a review of the researched literature and theresults of the pre-meeting survey on submental skin tigh-tening and contour improvement of the aging neck.Consensus of the panel on best current practice and clinicalrecommendations for rejuvenating the appearance of theaging neck was defined as two-thirds of the majority,obtained via a blinded Delphi process. The recommenda-tions and their clinical interpretation were outlined in aclinical treatment algorithm for the temperature-controlleddevice.

Clinical treatment algorithm

A review of available literature, survey responses, and groupdiscussions reaching consensus resulted in a clinical algo-rithm for the use of temperature-controlled subdermalmonopolar radio frequency treatment for skin laxity andfat reduction of the face, neck, and jawline (Figure 3). Thesubdermal monopolar radio frequency device is a preciseand controlled subdermal skin- and connective-tissue-tigh-tening device that uses a percutaneous radio frequency treat-ment probe (12,13). When treating fat, lipolysis may occurwhen specific temperatures are achieved. Similarly, whentreating lax skin, and the fibro-septal network, the deliveryof thermal energy causes denaturation and contraction ofcollagen within seconds with subsequent de novo regenera-tion of collagen and tissue remodeling over weeks to months.Thus, subdermal monopolar radio frequency represents aneffective modality for disrupting fat volume and achievingskin tightening of the face, neck, and jawline. It improvescontours by tightening the skin, fibro-septal network, andfascia and treating unwanted fat accumulation in the neckand jowl. The mean treatment time with the device is 19minutes (range: 8–38 minutes) for the submentum and thebilateral neck anterior to the sternocleidomastoid. Treatmenttimes for 25–38 minutes yield optimal results. Survey resultssuggest that there is an energy delivery threshold, abovewhich a higher percentage of subjects report satisfaction.Adverse events may include pain during or after treatment,edema, bruising, burns, numbness, nerve impairment,nodules or induration and scarring. Burns usually resolvewithout sequelae.

Limitations

Limitations of this work include a small number of ran-domized, controlled studies of non- and minimally inva-sive techniques for the treatment of lax submental areasupon which comparisons were made. In addition, theremay have been a bias among the survey respondentstoward those physicians using the temperature-controlledsubdermal monopolar radio frequency device.Ta

ble1.

(Con

tinued).

Treatm

ent/device

Stud

ydesign

Subjects

(N)

Results

Adverseevents

Deoxycholicacid

injections

Phase3,

rand

omized,p

lacebo

-con

trolledstud

yon

efficacy

andsafety

formod

erate-to-severesubm

entalfat

redu

ction

(15).

Stud

ytreatm

ent

(n=258),p

lacebo

(n=258)

Atweek12,o

neor

moregrades

ofimprovem

entwereachieved

by66.5%

stud

ygrou

psubjectsvs.22.2%

intheplacebogrou

p(p

<0.001).

Mod

erateat

theinjectionsite

inbo

thgrou

ps

Phase3,rand

omized,d

ouble-blind,

placebo-controlledstud

yassessed

theefficacyandsafety

formod

erateor

severe

subm

entalfat

treatm

ent(16).

Stud

ytreatm

ent

(n=256),p

lacebo

(n=250).

Atweek12,o

neor

moregrades

ofimprovem

entwereachieved

by70%

stud

ygrou

psubjectsvs.18.6%

intheplacebogrou

p(p

<0.001).

Mod

erateat

theinjectionsite

inbo

thgrou

ps.M

arginal

mandibu

larnerveparesis

(4.3%).Allresolvedwith

out

sequ

elae.

Posthocstud

yassessed

theefficacyandsafetyof

deoxycho

licacid

forsubm

entalfat

redu

ctionby

apo

oled

analysisof

two

largeph

ase3stud

ies(36).

–Clinician-repo

rted

≥1-po

intimprovem

entinSM

F:58.8and63.8%

ofthepatientswho

received

deoxycho

licacid,and

28.6%

ofthe

placeborecipients

(p<0.001).

Mod

erateat

theinjectionsite

inbo

thgrou

ps

Cryolipolysis

Pivotalinvestig

ationald

eviceexem

ptionstud

y.Asing

letreatm

entcyclewas

delivered

at−10°C

for60

minutes.A

nop

tionalsecon

dtreatm

entwas

delivered

atsixweeks

(35).

60Independ

entph

otoreview

from

threeblindedph

ysicians

identified91%

ofthebaselineph

otog

raph

s.Ultrasou

nddata

indicatedmeanfatlayerredu

ctionof

2.0mm.

Non

e

GAIS,glob

alaesthetic

improvem

entscale.

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Table 2. Treatment of the aging neck.

Technology Treatment

Thermistor-controlled subdermal skin tightening viapercutaneous radio frequency (THERMItight®)

One session. The thermistor probe was used to treat 3.0 cm2 every 2 minutes. The clinicalendpoint was an epidermal temperature of 42°C.

Subsurface monopolar radio frequency skin tightening(Thermage®/ThermaCool®)

One session as a stand alone or in combination with other treatments.

Monopolar radio frequency for skin tightening (Pellevé®) Six radio frequency treatments administered every 15 days for two consecutive sessions, everymonth for two consecutive sessions, and every two months for two consecutive sessions.

Bipolar radio frequency for skin tightening (Aluma™) Series of four to six weekly treatments.Super-pulsed radio frequency for skin tightening (Dermalift®) Non-ablative super-pulsed radio frequency in one session.1440nm Nd:YAG device with the side-firing fiber (Cellulaze™) Laser lipolysis of the submental and anterior cervical areas using a mean of 1205 J per 5 × 5 cm2

area with a maximum internal temperature setting of 47°C.Infrared light for skin tightening (Titan®) One to three treatments with incoherent infrared (1100–1800 nm) light at two- to four-week intervals.Micro-focused ultrasound for skin tightening (Ulthera®) Micro-focused ultrasound at two focal depths.Deoxycholic acid for submental fat reduction (Kybella®) One session of injections.Cryolipolysis for reduction of submental fat (CoolSculpting® System) A single treatment cycle was delivered at −10°C for 60 minutes.

0

5

10

15

20

25

30

35

40

percentage respondents

Medical specialty of the respondents

plastic surgery

aesthetic plast. surg

aesthetic physician

aesthetic derm.

medical aesthetic derm.

other

Figure 1. Medical specialty of survey respondents.

0

10

20

30

40

50

60

70

80

90

percentage used

Type of RF used for fat reduction and skin laxity

of the submentum and jowls

temperature-controlled

monopolar RF

microfocused ultrasound

bipolar RF

fractional RF

IF ultrasound

IR light

combined IR/BRF

Figure 2. Type of radio frequency used by survey respondents. Radio frequency (RF); intense focused ultrasound (IF ultrasound); infrared light (IR); bipolar radiofrequency (BRF).

Table 3. Survey results: contraindications.

Contraindications Strongly disagree Disagree Neutral Agree Strongly agree

Pregnancy 4 (4.4) 6 (6.5) 13 (14.1) 37 (40.2) 32 (34.8)External or internal pacemakers 1 (1.1) 9 (9.8) 14 (15.2) 29 (31.5) 39 (42.4)Implantable defibrillators 1 (1.1) 7 (7.6) 10 (10.9) 33 (35.9) 41 (44.6)Cochlear implants 1 (1.1) 7 (7.6) 33 (29.4) 27 (29.4) 24 (26.1)

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Conclusion

The use of subdermal monopolar radio frequency hasemerged as a safe and effective means for treating theaging neck. It has significant advantages over other esthetic

devices as it provides the triad benefit of disrupting fatvolume and SMAS, and skin tightening of the face, neck,and jawline. For suitable patients, this treatment can be usedto achieve significant esthetic improvements of the agingneck.

Table 4. Survey results: probe, epidermis, and fat layer temperatures.

Probe temperature in thesuperficial skin layer is

Epidermis temperature iskept between

The temperature to treat the fat layerin a deeper plane is between

°C n (%) °C n (%) °C n (%)30–40 1 (1.1) 40–41 5 (5.4) 30–40 040–45 12 (13.0) 42–43 29 (31.5) 40–45 2 (2.2)45–50 6 (6.5) 43–44 35 (38.0) 45–50 10 (10.9)50–60 31 (33.7) 45–46 18 19.6) 70–75 52 (56.5)60–65 27 (29.4) >45 5 (5.4) >75 065–70 8 (8.7) 0 0 Other 28 (30.4)70–75 0 0 0 0 0>75 0 0 0 0 0Other 7 (7.6) 0 0 0 0

Candidate for thermistor controlled SMRF:

Mild-to-moderate skin laxity and fat reduction of the submentum,

lateral neck, mandibular border and jowl lateral to the nasolabial fold.

Exclude patients:

• With risk factors

• Who may not benefit from

the procedure1

Assess :

• Type and severity: skin laxity, skin excess, facial volume, and volume distribution.

• Comorbid conditions that could make the patient unsuitable for the procedure.

• Take photographs of the area to be treated.

Preparation:

• Cleansing of the insertion area:

4% Chlorhexidine gluconate solution

or betadine.

• Anesthesia: Diluted lidocaine solution is

administered via subdermal cannula

using a double Klein Solution,

i.e. 0.2% concentration.

• Map marginal mandibular nerve: Use a

peripheral nerve stimulator to map

nerves in the area of treatment, e.g.

Stimpod.

Procedure:

• Divide the neck into three zones, perimedian,

right and left lateral.

• Insert the electrode fully.

• Avoid skin contact with the hub.

• Wait for the actual temperature to reach the set

temperature. Subsurface temperature target

is set between 55-65° C and epidermal

temperature is not to exceed 46° C.

• Monitor the epidermal temperature with an

external infrared camera (e.g. FLiR)

throughout the procedure.

• Slowly withdraw electrode approximately

0.5 to 1 cm per second.

• Keep the actual temperature within

3-5 degrees of set temperature.

• Repeat linear stroke in a fanning manner until

the area has been treated, reaching the clinical

endpoints with each stroke.

Clinical endpoint:

• The skin temperature should reach between

42-46° C over the entire area treated

• The entire area must be a uniform color (yellow –

white color on the infrared monitor). Use FLiR

default color scheme.

• The actual temperature and set temperature

remained within 3 degrees of each other for the

entire procedure.

Avoid complications:

Avoid tenting the skin, catching the dermis

with the cannula, and end-hitting distal skin

with the tip of the cannula. Monitor skin

temperature and cool with saline-soaked

swabs for skin >46°C.

To prevent nerve injuries:

• Cutaneously map and mark with ink the

path of the marginal mandibular nerve.

• Infuse infiltrate over and around the

nerve area to create a physical distance

between the heat source and the nerve.

• In patients with thinner tissue, consider

using lower temperatures (e.g. 55°C)

• Consider staying >5 mm away from the

mapped nerve.

Figure 3. Algorithm for temperature-controlled subdermal monopolar radio frequency. Subsurface monopolar radio frequency (SMRF). 1Women during pregnancy,collagen vascular diseases, autoimmune diseases, acute infections, patients with cochlear and neurostimulator implants, and patients with morbid conditions thatcould make them unsuitable for the procedure. For patients with an external pacemaker, implantable defibrillator, or monitoring equipment, the attendingcardiologist should be consulted prior to the procedure. All implanted devices should be evaluated for contraindications from the manufacturer. When indicated,consult primary care physician. 2Higher temperatures may be targeted in individual circumstances.

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Acknowledgments

The authors acknowledge the guidance of RBC Consulting, Miami Beach,FL, during the research and preparation of this consensus document.

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Nerve 85° C

Lipolysis, Sculpting 65-70 ° C

Septal tightening 55-65 ° C

Collagen remodeling 42-46 ° C

Figure 4. Temperature and treatment effect on various tissue types.

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