Argon Plasma CoagulationThe preferred choice for interventional endoscopy

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1.0 TECHNOLOGY 04

1.1 Argon Plasma Coagulation (APC™) 4

1.2 APC™ Modes 4

1.2.1 FORCED APC™ 4

1.2.2 PULSED APC® 5

1.2.3 PRECISE APC® 5

1.3 Description of the Units 6

1.4 APC™ Instruments 7

1.4.1 APC™ Probes 7

2.0 PRACTICAL APPLICATION 05

2.1 Tissue Effects 8

2.2 Recommendations for Applications 8

2.2.1FactorsInfluencingtheTissueEffect 8

2.2.2DurationofActivation 8

2.2.3Power(“max.watts”)Settingor“Effect” SettingifUsingthePRECISEAPC® Mode 9

2.2.4 Probe Distance 9

2.2.5 Static and Dynamic Applications 9

2.2.6DifferentTissueSensitivities 9

2.2.7WhichAPC™ModeShouldbeUsedfor Which Areas? 10

2.3 Important Clinical Aspects for the Application of APC™ 11

2.4 Gastrointestinal Tract 12

2.4.1 Ablation 12

2.4.2Hemostasis/Coagulation 13

2.4.3TumorAblation 14

2.4.4 APC™ and Stents 15

2.5 Tracheobronchial Tract 15

2.5.1 Recanalization 15

2.5.2 Hemostasis 16

2.5.3StentIngrowthandOvergrowth 16

3.0 ADVERSE CONDITIONS AND AVOIDING COMPLICATIONS 17

4.0 LITERATURE 18

TABLE OF CONTENTS

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Important note

Erbe Elektromedizin GmbH has taken the greatest possible care when compiling these recommendations. Nevertheless, it is impossible to exclude the possibility that errors may be contained herein. The information and recommendations given herein may not be construed as constituting any basis for any claims against Erbe Elektromedizin GmbH. Should legal regulations stipulate liability, such liability shall be lim-ited to intentional misconduct or gross negligence. The data in respect to areas of application, application duration, or the use of instruments is based on clinical experience; it is important to remember that individual centers and physi-cians may favor techniques which differ from the informa-tion contained within this document.

© on all drawings & illustrations: Erbe Elektromedizin GmbH (with the exception of photographs of applications)

▻U

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1.0 Technology

Return electrode

TissueIHF IHF IHF IHF

Ar Ar

Ar Ar

HF Electrode

HF

Argon Plasma Beam

U HF d

IHF

Argon (Ar)

Fig. 1: Transfer of energy from the APC probe to the tissue using ionized argon gas (argon plasma). HF = electrosurgical unit. IHF = high frequency/electrosurgical current, UHF = high frequency voltage, d = distance between electrode and target

tissue, Ar = argon, NE = return electrode.

Fig. 2: En face and tangential APC. Light blue: argon gas, yellow-black: argon plasma energy.

01 02

APC™ is amonopolar electrosurgical procedure inwhich electrical energy istransferredtothetargettissueusingionizedand,thus,conductiveargongas(argonplasma),withouttheelectrodecomingintodirectcontactwiththetis-sue(Fig.1).Incontrasttolasertechnologyprocedures,thetransferofenergybetweentheelectrodeandthetissueoccursinaccordancewithelectrophysicallaws(electricalfield),andnotthelawsofoptics.Theargonplasmafollowsthepathofleastelectricalresistance,regardlessofwhetherthetissueliesdirectlyinfrontoftheelectrodeorlateraltoit,andregardlessofthedirectionoftheflowoftheargongas.Forthetransferofenergy,itisimportanttoensurethegreatestpossibleconcentrationofgasbetween the tipof theprobeand thetargettissue.

1.1 Argon Plasma Coagulation (APC™)

Thisphenomenonoffersparticularadvantagesforendoscopicapplicationsasitpermitstheargonplasmatobeappliedbothenfaceandtangentially(Fig.2),allowingthepotentialforlessaccessibleregionstobetreated.

Properties of Argon GasArgon(Ar)isacolorless,odorlessandtastelessnoblegaswhichispresentinairatapercentageof0.93Vol%.Itischemicallyinertand,therefore,non-toxic.

5

FORCED APC™

4

2

120

UHF [kVp]

[watts]6030 90

continuous

[P]

[t]

Fig. 3: FORCED APC™: Increased voltage (green curve) depending on the selected highfrequency output. Continuous energy output over time (small illustration).

03

TheAPCmodes,describedinmoredetailbelow,arecurrentwaveformsusedforcoagulationinmonopolarapplications.TheAPCmodes:FORCEDAPC™,PULSEDAPC® Effect 1 and Effect 2 as well as PRECISE APC®havedifferentcoagulation/ablationpropertiesthataremoresuitableforvariousclinicalrequirements(SeeChapter2,“PRACTICALAPPLICATION”).

1.2.1 FORCED APC™

TheFORCEDAPC™modeintheVIO®APC/ESUSystemisverysimilartothefirstgenerationErbesystem(i.e.,APCModel300®/ESU ICC®Model)mode,whichwasintroducedgloballyin1992(USA1996).

Characteristics☑ High-frequencyvoltageincreaseswhentheoutputsetting

(i.e.,wattage)isincreased(Fig.3)☑ High-frequencyoutputcanbeadjustedtoamaximumof120watts☑ Consistentfiringat30wattsorabovewithanapplicationdistanceofupto

5 mm☑ Continuousapplicationofenergy(Fig.3)☑ ImprovedefficiencyduetothetechnologyoftheVIO®Systems:Tissue

effectaround50%higherthanICCSystemtechnologywhenusingthesameoutputsettings

☑ Plasmainitiationandsupportduringactivationisaccomplishedvia proprietaryalgorithms

Fig. 4: The voltage for the modes PULSED APC® Effect 1 (4a) and PULSED APC® Effect 2 (4b) remains constant (green line). The energy is applied with automatic

intervals to the tissue in individual pulses (PULSED APC® Effect 1) or with a higher number of pulses (PULSED APC® Effect 2).

04

a

b

1.2.2 PULSED APC®

TheapplicationofenergywiththePULSEDAPC® Effect 1 and Effect 2 is discon-tinuous(i.e.,pulsed)usingtwodifferentfrequencies(Fig.4).Theaverageenergyoutputovertimeisthesameforbothmodes.

Characteristics☑ PULSED APC®Effect1:Higherenergyoutputperpulsewithalonger

intervalbetweenpulses(approx.1pulse/second)☑ PULSED APC®Effect2:Greaternumberofpulses(16pulses/second)with

alowerenergyoutputperpulse☑ ComparedtoFORCEDAPC™:Constanthigh-frequencyvoltageoverthe

wholesettingrange☑ Consistentfiringfrom10wattswithapplicationdistancesofupto7mm

(distancebetweentheprobeandthetissue).Thisislimitedduetoholloworganintervention.

[watts]

UHF [kVp]

PULSED APC®, Effect 2

4

2

20 12040 60

pulsed

80 100

16 pulses/sec.

[P]

[t]

UHF [kVp]

PULSED APC®, Effect 1approx. 1 pulse/sec.

4

2

20 120 [watts]

single pulse

40 1008060

[P]

[t]

1.2 APC™ Modes

6

effect8642

spar

king

inte

nsity

Fig. 5: With the PRECISE APC® mode, the intensity of the plasma increases when the effect setting is increased.

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1.2.3 PRECISE APC®

The PRECISE APC®modehasanautomaticadjustmentcontrolwhichadjuststheargonplasmaregardlessofthe impedanceoftheoverallsystem(plasmaregulation).

Characteristics☑ Continuousapplicationofenergy☑ TheintensityoftheionizedplasmaincreaseswhentheEffectsettingis

increased(Fig.5)☑ Thetissueeffectismoreorlessindependentofthedistance(upto5mm)

betweentheprobeandthetissue(SeeFig.14onpg.9)☑ Plasmaintensityautomaticallyself-regulatesbasedupondistancefrom

targettissue

1.3 Description of the UnitsThe following is a depiction (Fig. 6a) of a complete VIO®

ESU/APC System for endoscopic applications, including:

01

02

0403

Fig. 6a: VIO® workstation

06a

☑ a VIO® Electrosurgery Unit (ESU) [ 01 Model VIO® 300 D]☑ the associated Argon Plasma Coagulator ( 02 Model APC™ 2)☑ the Irrigation Pump ( 03 Model EIP™ 2)☑ integrated on the VIO® Cart ( 04 )

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USERINTERFACE

AllAPCmodesarecoagulationmodesandaredisplayedonthemonitororuserinterfaceinthebluefield(Figs.6band6c).FortheFORCEDandPULSEDAPC® modes, the intensity of the thermal effect can be adjusted using the power(“max.watts”)setting,whileforthePRECISEAPC®mode,adjustmentsaremadeusingthe“Effect”setting(Figs.6band6c).ThegasflowcanalsobeadjustedwithincertaindefinedlimitsdependingupontheAPCinstrument(i.e.,applicatororprobe)beingused(Fig.6d).

Thefillleveloftheargongastankisindicatedinthesubmenu“SelectGasFlow.”Ifthelevelinthetankfallsbelowaspecificfilllevel,thiswillbeindicatedac-cordinglyonthescreen–bothwhennotinuseandduringuse.(Fig.6d).

Figs. 6b-6d: User interface of the VIO® system. Adjustment parameters for the FORCED APCTM mode (6b), and the PRECISE APC®

mode (6c); submenu “Gas Flow” (6d).

06

b

c

d

Fig. 7a+b: Purge button (red arrow) on the APC™ 2.

APC™PURGEBUTTON

TohaveattachedAPCinstrumentsreadyforimmediateactivation,theins-trumentsshouldbefilledwithargongaspriortothefirstapplication.Thiscanbecarriedoutmanuallybyusingthepurgebutton(Fig.7).

07b →

07a

8

Fig. 8b: Plasma and tissue effects of A, S and C probes.

08b

A S C

1.4.1 APC™PROBES

The term “APC™ Probe” is used below to describe flexible APC instrumentswhicharetypicallyused inendoscopic interventionalprocedures. Inprinciple,APCprobesdifferaccordingtotheir:

☑ diameter☑ (working) length☑ tip design (e.g., circumferential)

ThelengthoftheendoscopeandthesizeofaworkingchannelbeingusedwilldictatethediameteroftheAPCprobebeingemployed.Thedistaltipdesignwilldeterminethedirectionoftheargongasflowand,forthemostpart,theplasmadirection(Fig.8a)whichwillcreatevariousplasmaandtissueeffects(Fig.8b).ThereisachoiceofAxial(A)StraightFireprobes(axialprobetip),SideFire(S)probes(lateralprobetip),andCircumferential(C)probes(circular/360°radius,probe tip).

Probe Tip Design

Blackringsarevisibleinintervalsof10mmatthedistaltipoftheprobe.Topre-ventanyflashoveroftheargonplasmatotheendoscope(i.e.,tokeepthebeamfromdamagingtheendofthescope),thedistaltipoftheAPCprobeshouldbeextendedatleast10mmoutsidetheendoscope.Clearanceisachievedoncethefirstblackringofthedistaltipisvisiblethroughtheendoscope.

ErbeAPCprobeshavebeendesignedwithinstrumentrecognition.Typically,theVIO® ESU/APC System is programmedwith default (starting) settings (Note:SomeprobeswillneedanAPChose).Settingscanbealtered,butonlywithindefinedlimits.Allsettingsshouldbeconfirmedpriortoactivation.

Probe Opening

Axial (Straight Fire) A Side Fire S Circumferential C

→↓

↗

↘

Fig. 8a: Direction of the argon gas flow (arrows) depending on the positionof the probe tip design or probe tip;

1.4 APC™ Instruments

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2.0 Practical application

Fig. 10b: Histological cross-section (H&E staining) of a (porcine) esoph-agus; radial spread of the coagulation zone (yellow dotted line) after APC

application (PRECISE APC® Effect 1, 1 second).

10b

2.1 Tissue Effects

The tissue effect of APC™ is created by endogenous heating of the target tissue during application of electrical current and/or voltage. Temperature rise can be a determinant of thermal insult (Fig. 10a):

1. Hyperthermia2. Devitalization3. Dessication4. Carbonization5. Vaporization

While the insult associate of 1, 2, 3 and5maybewhat is desired clinically,carbonization(orcharring)shouldbekepttoaminimum.Argongasdisplacesoxygen,therebyminimizingcarbonizationandpreventinganoxidationreaction.TheartofAPCapplicationistolimitthedepthofthermal“insult”tothetargetedtissue(Fig.10b).

above approx.

1 Hyperthemia 40°C

2 Devitalization 60°C

3 Dessication 100°C

4 Carbonization 150°C

5 Vaporization 300°C

10a

Fig. 10a: Temperature dependent tissue effects. The arrows marked as “i” indicate the flow of current

1 2 3 45

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Fig. 11: Some factors influencing the tissue effect. Fig. 12: Depth effect depending on the duration of activation with the APC modes in a bovine liver. Testing was performed with an ESU (VIO® 300 D Model)/APC (APC 2 Model) System along with an A-type (Straight Fire) APC probe, O.D. 2.3 mm.

Also, the application was vertical and the probe distance was 5 mm.

2.2.1FACTORSINFLUENCINGTHETISSUEEFFECT

TheextentofthethermalinsultofAPContissuedependsonseveralfactors.Thethreemostimportantfactorsinfluencingcoagulationdeptharelistedinorderofdecreasingimportance(Fig.11):

1. The duration of the application, in particular in static applications (i.e., when the probe is stationary)

2. The power (i.e., “max. watts”) setting or “Effect” setting if using the PRECISE APC® mode

3. The distance of the probe to target tissue (operative distance)*

* Note: If using the PRECISE APC® mode with a probe distance less than 5 mm from the target tissue, the thermal impact is relatively constant.

2.2.2DURATIONOFACTIVATION

Whenthedurationofactivation,orapplicationtimeoverthesameareaisin-creased, thedepthof the tissuebeingaffectedwill increase (Fig.12;cf.also2.2.5).Therefore,thephysicianshouldtreatwithanactivationtimethatcorres-pondswiththedesiredthermaleffect.Nonetheless,theclinicianshouldalwaysusethelowestpossibleapplicationdurationatthebeginningofanapplicati-onandthen,whilevisuallymonitoringthetreatedarea,graduallyincreasethedurationuntilthedesiredclinicaloutcomeisachieved.Thisappliesinparticularwhentreating“difficult”anatomy(e.g.,thin-walledareas).

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2.2 Recommendations for Applications

111. DURATION OF ACTIVATION

2. POWER SETTING

3. PROBE DISTANCE

HIGH INFLUENCE

Factors influencing the tissue effect

LESS INFLUENCE

00 1 2 3 54

0,5

1,0

1,5

2,0

2,5

3,0

Activation time/sec.

● PULSED/E1/25 W● PULSED/E2/25 W● PRECISE/E2

Coagulationdepthmax.[mm]

Activation time/coagulation depth

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Fig. 13a: Depth of penetration on bovine liver depending on the power setting when using PULSED APC® mode with an A-type (Straight Fire) APC™ probe, O.D. 2.3 mm.

Fig. 13b: Depth of penetration on bovine liver depending on the Effect setting when using PRECISE APC® with an A-type (Straight Fire) APC probe, O.D. 1.5 mm. Testing was performed

with an ESU (VIO® 300 D Model)/APC (APC™ 2 Model) System. Also, the application was vertical, the probe distance was 5 mm, and the application duration was 3 seconds.

Fig. 14: Depth of effect depending on the distance of the probe to the bovine liver, using an ESU (VIO® 300 D Model)/APC (APC™ 2 Model)

System with an A-type (Straight Fire) APC probe, O.D. 2.3 mm. Also, the application was vertical, and the application duration was 3 seconds.

2.2.3POWER(“MAX.WATTS”)SETTINGOR“EFFECT”SETTINGIFUSINGPRECISEAPC® MODE

Theoutputsetting[i.e.,power(“max.watts”)or“Effect”forthePRECISEAPC® mode]dependsonthelocationandthesize(diameter,depth,elevation)oftheareabeingtreated.Figs.13aand13bshowtheincreaseindepthofpenetrationdependinguponthepowerorEffectsettingwiththePULSEDAPC® and PRECISE APC®modes.Generally,outputsettingguidelinesareasfollows:

☑ Loweroutputsettingsaresuitableforthetreatmentofverysuperficialsmallareas,inapplicationswithverythin-walledtissuestructures

☑ Mid-rangeoutputsettingsareusedinflexibleendoscopyforawiderangeofapplicationswherehemostasis,ablationand/orreductionofundesirab-legrowthisdesired

2.2.4PROBEDISTANCE

WhenusingthemodesFORCEDAPC™,PULSEDAPC® Effect 1 and PULSED APC® Effect2,thefollowingapplies:Asthedistanceofthedistaltipoftheprobetothetissueincreases,thetissueeffectbecomesmoresuperficial,andthepene-trationdepthdecreases.WhenusingthePRECISEAPC®mode,thetissueeffectremainsmoreorlessconstantuptoadistanceof5mm.However,duetoplasmaregulationwiththePRECISEAPC®mode,anincreaseinpenetrationdepthmayoccurwithprobedistancesgreaterthan5mmfromthetargettissue(Fig.14).

14

13

13

a

b

Probe distance/coagulation depth

Power/coagulation depth

Effect settings/coagulation depth

00 2 31 4 5 6 7 8

0,5

1,0

1,5

2,0

2,5

3,0

distanceprobe/tissue[mm]

Coagulationdepthmax.[mm]

● PULSED/E1/25 W● PULSED/E2/25 W● PRECISE/E2

00 10 20 30 40 50 60 70

0,5

1,0

1,5

2,0

2,5

3,0

powersetting[watts]

Coagulationdepthmax.[mm]

● PULSED/E1/25 W● PULSED/E2/25 W

00 1 2 3 4 5 6 7 8 9

0,5

1,0

1,5

2,0

effectsettings

Coagulationdepthmax.[mm]

● PRECISE

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Fig. 16: Initial ex vivo bench testing. In vivo clinical results will vary.Fig. 15: Thermal tissue sensitivity.

2.2.5STATICANDDYNAMICAPPLICATIONS

WhenAPC™isappliedstatically(i.e.,theprobeisfocusedonlyonasinglearea),thethermalpenetrationdepthwillincreaseovertime.Ifappliedforlongperi-odsinthesamearea,carbonizationorvaporizationcanoccur,whichmayleadto over-treatment and adverse events.Therefore,when carrying out a staticapplicationforasuperficialtreatment,shortactivationtimesof1to2secondsare recommended.

WhenusingAPCdynamically,movetheinstrumentwithpaintbrush-likestrokesoverthetargetareawhileobservingthetargettissueeffect.

2.2.6DIFFERENTTISSUESENSITIVITIES

WhencarryingoutAPCinthegastrointestinaltract,itisimportanttotakeintoaccountthedifferentthermalsensitivitiesofwallstructures(Fig.15).

Thermal sensitivitymaybe increased if the lumenwallhasbeenexcessivelydistendedbytheinsufflationofair.

2.2.7WHICHAPC™MODESHOULDBEUSEDFORWHICHAREAS?

DifferentAPC™modesaresuitablefordifferentapplications,dependingonthelocationofthetargettissuerequiringtreatment,andtheintendeddesiredcli-nicaloutcome.

FORCED APCTM

Erbe’sVIO®ModelESUisapproximately50%greaterinefficiencyinregardstotissueeffect,comparedtothetechnologyofouroldergenerationICCModels.Thatsaid,theFORCEDAPC®modeinaVIO®ESU/APCSystemisusedparticular-lyforhemostasisofsmalldiffuseareasofbleeding,aswellasthedevitalizationand reductionof target tissue.The characteristic featureof thismode is theconstant ionizedplasmainaneverchangingenvironmentofresistancevaria-bles.Figure16showstheresultingeffect(depthofthermalinsultandrelativediameterofcoagulationvolume)ofFORCEDAPC™atvarioussettingsinanexvivomodel.TheexvivobenchtestingofFORCEDAPC™isindicativeofitspoten-tialtorapidlyablatetargettissueandforhemostaticpurposes.

Areas of Application:☑ Rapidablationoftargettissueandforhemostaticpurposes☑ Acutebleeding☑ Ablationandreductionofundesirablelesions

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15

Thermal tissue sensitivity

less sensitive very sensitive

Stomach Rectum Esophagus Transverse colon,

left colon

Duodenum,small

intestine

Rightcolon

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Fig. 17: Initial ex vivo bench testing. In vivo clinical results will vary. Fig. 18: Initial ex vivo bench testing. In vivo clinical results will vary.

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PULSED APC® Effect 1 and Effect 2The PULSED APC®modes–Effect1andEffect2–areusedforthehemostasisofdiffuseareasofbleeding,aswellasfortheablationandreductionoftargettissuewhencontrolledpoweroutputispreferred(e.g.,inthermosensitiveareasand/orinthin-walledstructures).

SincethisAPCmodeispulsedandnotcontinuous,itsionizedplasmaismoredispersive,withlessoutputenergybeingdelivered(Fig.17PULSEDAPC® Effect 2exvivobenchtesting)relativetoFORCEDAPCTMmodes.Asaresult,theeffectontissueiscontrolledandmoresuperficial.Therefore,withvisualmonitoring,thereisgenerallylesscarbonizationandlesscomplicatedtargettissueappli-cationinvivo.Whilemoresuperficialinnature,longactivationscancausesig-nificantanddeepablationoftissue.

Areas of Application:☑ Hemostasisofdiffusebleedingoverlargerareas☑ PULSEDAPC®Effect1(shortindividualpulses):Morefocused(lessdiffuse)

ionizedplasmaforstaticapplicationsinthetreatmentofsmaller,moresu-perficialareas,aswellasthermosensitiveand/orthin-walledstructures

☑ PULSEDAPC®Effect2(higherfrequencyofpulses):Forthetreatmentofdiffuse, superficial anatomy for ablation and reduction of target tissueusingstaticapplicationsforlongerperiodsoftime

PRECISE APC®

The PRECISE APC® mode creates a superficial coagulation effect using alow-energyoutputperunitoftime.Itisthereforesuitableintemperature-sen-sitiveareasand/orwithinthin-walledstructures.Forthemostpart,thetissueeffect is independentof thedistancebetween theprobeand the tissue,andonlyasuperficial thermaleffect iscreated.Thefactthattheeffectcreated isindependentofthedistancebetweentheprobeandthetissue(uptoadistanceof5mm)isanadvantagewhenexternalcircumstancesmakeitdifficultorim-possibletomaintainaspecificdistancebetweentheprobeandtissue.

Areas of Application:☑ Hemostasisinwhichthebleedingissuperficial☑ Inthermosensitiveareasand/orwithinthin-walledstructures☑ Ablationandreductionofundesirablelesions/remnantsthataresuperficial

innature☑ Insituationswhereitishardtomaintainaspecificprobedistancefromthe

tissue(e.g.,enteroscopicintervention)

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Fig. 19: Endoscopic tangential view of the tissue and the APC probe: 1) Probe tip Fig. 20a: The probe is too close to the tissue, which may result in an undesirable thermal effect and/or submucosal emphysema;

Fig. 20b: The distance of the probe is sufficient, leading to a more even distribution of current.

1. Greater efficiency with the VIO® ESU/APC SystemAs compared to Erbe’s first generation ESU ICC/APC 300®Models, the VIO® ESU/APCSystems’outputefficiency isapproximately50%greater—that is,thepower(“max.watts”)settingsoftheVIO® ESU/APC System are approxima-telyone-halfofthesettingsthatwouldbeemployedwithICCESU/APCSystems.

2. The APC probe must always remain in the clinician’s field of visionDuringnon-staticapplications,itisimportant(whenpossible)tomovetheen-doscopebackwards/forwardsandside-to-sidewiththeAPCprobeandnevermovetheprobebyitselfexceptwhentechniqueoranatomydictates(e.g.,re-troflexed).

3. Activate only when the tissue being treated is within the field-of-view

4. Use the lowest possible settings to achieve the desired thermal tissue effect

Thelowestpossibleoutputsetting[i.e.,power(max.watts)and“Effect”whenusingPRECISEAPC®]andactivationtimesshouldbeusedwithAPCtreatment.Aspreviouslystated, thepenetrationdepthof thethermaleffectscreatedbyAPCdependsonvariousfactors.Itisparticularlyimportanttohavelow-energyoutputsandactivationtimesinthermosensitiveareasand/orwithinthin-wal-ledstructures.

5. Do not activate the Straight Fire APC probe when en face and touching target tissueAPCisanon-contactmodality.TheStraightFireprobecanlightlytouchtissueadjacent to targetedmucosawhenworking tangentially, suchas in the rightcolon or cecum.This tangential approach (Fig. 19) maintains the non-cont-actprincipleofionizedplasmaapplication.Theoutershelloftheprobeisnot“electrified.” If theStraight Fireprobe is activatedwhile touchingmucosaenface (Fig.20aonpg.12), itmaybecomeacontactmonopolarelectrode,anddeepernecrosisislikely.Also,theflowoftheargongasmaycauseasubmuco-salemphysema,orcollectionofgas,whichusuallyresolvesspontaneously,butperforationcannotberuledoutinthiscase.

Circumferentialprobeswereaddedtothesystemtoallowlighttamponadeenface,ortangentialapplicationindifficultanatomy, inordertomaintainprobeposition prior to activation.

Amechanicalperforationcanoccur if theendoscopeorAPCprobe ispushedinto a wall.

To reiterate: It is particularly important whenworking en facewith the APCStraightFireprobetomaintainasufficientdistance(>1mm)fromtissuewhentreatingthin-walledstructures(Fig.20bonpg.12).

19 20

2.3 Important Clinical Aspects for the Application of APC™

Important clinical aspects for applying the new technology in Erbe’s VIO® ESU/APC™ System,

or when using APC™, are summarized as follows:

ba

suboptimal optimal

15

Fig. 21: Unintended direct coupling of electric arcing from the APC probe to a metal clip.

6. Avoid APC™ activation in close proximity of metal objectsDonotactivateanAPC™probeifthedistaltipisclosetoametalobject(e.g.,metalclips,metalstents,etc.)unlesstheintentistoworkontheobject(e.g.,“trimming”ofametalstent).Directcouplingcouldoccurwiththeelectricarcsandcreateanunintendedcoagulation(Fig.21).

Furthermore,withmetalbeingagoodconductorofelectricalcurrent,ametalobjectmaybedamaged,ortissueincontactwiththeobjectmaybeunintenti-onallyburned.Finally,thisissueisexaggeratedwhenusingthePRECISEAPC® mode,duetoplasmaregulation.

7. The use of argon gas in the gastrointestinal tract may cause over-dis-tentionIfAPCisbeingusedinthegastrointestinaltract,over-distentioncanoccur,duetotheintroductionoftheargongas.Therefore,theabdomenshouldbeconti-nuouslymonitoredforsignsofbecomingoverlydistended.Briefandrepeatedaspirationofgasshouldbeperformedthroughouttheprocedure.

8. Avoid using APC in an environment in which combustible gases are presentPriortoactivation,makesuretherearenoendogenouscombustiblegasespre-sent(i.e.,makesurehydrogen,methane,etc.,areremovedfromthebowelpriortoworkinginthetract).Also,aspartoftheprocedure,oxygenandotherga-ses(e.g.,hydrogen)maybeintroducedandconcentratedinanorgan.Inthesesituations,thegasesshouldbeevacuatedviaachannelofthescopepriortoactivation.Finally,combustiblegaseousby-productsofelectrosurgerymaybuildup.Therefore,gasesshouldberemovedroutinelyfromtheclinicalsiteduringtheprocedure.

9. Do not activate APC in an oxygen-rich environmentWhencarryingoutAPCapplicationsinthepresenceofoxygen,theoxygencon-centrationshouldbeaslowaspossible(i.e.,below40%,FiO2<0.4)inordertoreducethepossiblyofanyexplosionorburning.

NOTE: Indications for use is as follows: The Erbe VIO® APC with accessories is intended to deliver argon gas for argon plasma coagulation of tissue, when used in conjunction with a compatible Erbe VIO® Electrosurgical Generator (ESU) and applicators or probes. The clinical applications in in the gastrointestinal tract and in the tracheobronchial tract outlined in this educational brochure are com-monly found in published literature. The information with the applications is being provided for guidance purposes only (i.e., clinical education per the pu-blished literature) and is not intended to endorse or infer specific indications.

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Fig. 22: APC-treated residual adenoma in the colon after endoscopicmucosal resection (EMR).

Fig. 23a: Barrett’s metaplasia before and Fig. 23b: after ablation with APC™.

2.4.1 Ablation

AblationwithAPC™leadstothermaldamageandreductionoftargettissue.

2.4.1.1ABLATIONOFADENOMAREMNANTS (AFTERPOLYPECTOMYOREMRPROCEDURES)

Afterpolypectomyorendoscopicmucosalresection(EMR)ofadenomatousle-sions,theremayremainsometissueremnantsalongtheedgeoftheresectedarea, particularly after a piecemeal EMR procedure. APC™has been used totreatsuchsmallresidualtissueremnants,eitherduringthesameendoscopicsessionorduringafollow-upexamination,topreventordelayanyrecurrences(Fig.22).5,20,34,52,54

2.4.1.2BARRETT’SESOPHAGUS

ThermoablativeproceduresfortheremovalofprecancerousBarrett’sesopha-gushavenotbeensufficientlyvalidatedandarecurrentlythesubjectoffurtherclinicalstudies.However,APChasbeen foundtoplaya role in the removalofnonneoplasticresidualBarrett’smucosaafterendoscopicremovalofintestinalmetaplasia(Fig.23).APChasalsobeenreportedlyusedinsuchlesionsforablationoftumorswhich cannot be removed by repeat endoscopic resection23,26,40,41 and for the ablationofsmalltumorremnantsalongtheresectionedmarginsafterendos-copic resection.

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23

ba

2.4 Gastrointestinal TractSome Examples see Insert A: “Gastroenterology Uses found in Clinical Literature”

17

Fig. 25a: Bleeding over a larger surface area due to radiation proctitis and Fig. 25b: after hemostasis with APC.

2.4.2 Hemostasis/Coagulation

Thermalhemostasisisachievedwithrelativelylow-energyoutputsbymakinguseofthefollowingeffects:

1. Denaturation of small vascular lesions (thermal coagulation)2. Activation of the endogenous clotting cascade3. Retraction of coagulated vessels4. Compression of vessels due to the tissue shrinkage contingent upon

desiccation

APC™is frequentlyusedtotreatchronicandactivelybleeding lesionsof thegastrointestinal tract. Especially diffuse venous and arterial bleeding can becontrolledverywellbyAPC(Fig.25).TheuseofAPCtotreatactivelyspurtingbleedingaspartofacombinedtherapyiscurrentlybeingstudied.

To treatdiffusebleedingof largesurfaces,suchas radiation inducedprocto-pathy(radiationproctitis),itisnecessarytocarryoutcoagulationoveralargersurface,whilelimitingthepenetrationdepth.Insuchcases,itisrecommendedtomovetheAPCprobeoverthetissueusingpaintbrush-likestrokes(“nonstaticapplications”).

Forthehemostasisofstronger,locallylimitedbleeding,adeepercoagulationorocclusionoftheinjuredvesselisnecessary.Insuchcases,thethermalenergyshouldbedeliveredtothetissueviamorestaticapplication.

2.4.2.1RADIATIONPROCTITIS

Radiationproctitiscantaketheformofteleangiectasiasandhemorrhagicmu-cosalchangesintheareaoftherectum(Fig.25a).TheuseofAPCtotreatradiationproctitismayleadtoanimprovementofsym-ptomsandbleedingepisodesafteranaverageoftwosessionscarriedoutatanintervalof3–4weeks.6,21,30,43,47,48,51,52

25

ba

18

Fig. 28a: GAVE syndrome before, and Fig. 28b: after treatment.

Fig 27a: Angiodysplasia located in the colon before, andFig 27b: after treatment with APC.

Fig. 26a: Angiodysplasia located in the gastric antrum before, andFig. 26b: after treatment with APC™.

2.4.2.2VASCULARMALFORMATIONS

[Gastric antral vascular ectasia (GAVE syndrome), angiodysplasias, arte-rio-venous malformations (AVM), portal hypertensive gastropathy, teleangiec-tasias] Manydifferentvascularmalformations,inallareasofthegastrointestinaltract,havebeentreatedwithAPC™,andhavebeenusedtopreventtherecurrenceof bleeding.Depending on the indication, APC is applied in conjunctionwithproton-pumpinhibitortherapy(GAVEsyndrome)orothermedications.20,22,30,38,39,52,53

Usuallyanapplicationusinga low-energyoutput issufficient tostaunchthebleeding.Theuseoflow-energyoutputsalsohelpstominimizetheriskofper-forationinthin-walledareas(e.g.,thesmallintestineortherightcolon),whereangiodysplasiasoftenoccur.

Endoscopicprocedures,suchasdouble-balloonendoscopy,haveprovedusefulforthetreatmentofvascularmalformationsinthesmall intestine,ashastheuseofacaptolimittheareaundertreatment,tocreateanoptimalargongasatmosphereandhelpmaintaintheproperdistance.Figs.26and27onpg.14showhemostasisofangiodysplasiasinthestomachandcolon.Fig.28showsthetherapeutictreatmentofGAVEsyndrome.

2.4.2.3BLEEDINGULCER

Currentongoingclinicalstudieshave indicated thatwhile theuseofAPC forthehemostasisofbleedingpepticulcersisnotyetcommonlyused,ithasbeenshownusefulinlimitedreports.7,9,24,43

ThetherapyisparticularlyusefulforthetreatmentofForrestIb-IIbbleedingaspartofamultimodaltherapeuticapproachandiscurrentlybeingevaluatedinclinicalstudies.

2.4.2.4VARICEALBLEEDING

APCisnotastandardtherapyforthetreatmentofvaricealbleeding.Upuntilnow,APCwasonlyused in investigational cases–aspartof a combinationtherapy,notasamonotherapy.Itsuseiscurrentlybeingevaluatedincontrolledstudies.APCmaybeusefulforthetreatmentofresidualvaricesand/orulcera-tedvarices.Duetothelimiteddataavailable,itisnotyetpossibletoofferanyfurtherdiscussion.9,15,28

2827

26

bb

b

aa

a

19

Fig. 29a: Large duodenal adenoma before, and Fig. 29b: after ablation using APC.

Fig. 29a: Large duodenal adenoma before, and Fig. 29b: after ablation using APC.

2.4.3 Tumor Ablation

Thepreferredformoftissueablationoflargetumormasses(debulking)usingAPC™isbymeansofvaporization/coagulationusingveryhigh-energyoutputs.Inadditiontothetumormasseswhicharedirectlyexcised,inthedaysfollowingtheintervention,thermallynecrotizedtissuewillalsosloughoff.Therewillalsobetissueshrinkagecreatedbydesiccationofthetissue,furtherreducingtheexophytictissue.

Incertaincases, itmaybehelpful toperformAPC incombinationwithotherendoscopicprocedures(i.e.,asbougienage)inordertoensurethefreepassageofnourishment(e.g.,intheesophagus).

Figs.29and30showtheablationofaduodenaladenomausingAPC.

2.4.3.1STENOSES(RECANALIZATION)

While endoscopic laser ablation is the most common method used for therecanalizationofobstructivelesionsinthegastrointestinaltract,APCisanef-fective and often simpler alternative.1,12,14,19,25,37,52Inmanycases,APChasal-readyreplacedthelaserineverydayclinicaluse.

Stenoticsectionsmayundergomechanicaldilatationpriortotheproceduretopreventanybuild-upofpotentiallyexplosivegases;suchobstructedsectionsshouldnotbeprimarilyopenedupbyAPC.

3029

bb aa

20

2.4.4 APC™ and Stents

The APC™ applications described below (with the exception of section 2.4.4.1) referprimarilytoitsreportedusewithmetalstentsinthegastrointestinaltract.

2.4.4.1PREPARATIONSFORSTENTIMPLANTATION

Priortotheimplantationofastent,itisoftennecessarytoopenuporwidenthelumen.WithAPC,itispossibletocarryoutextensiverecanalizationofastenosis,makingsubsequentplacementofthestenteasier.

2.4.4.2STENTINGROWTHANDOVERGROWTH

Proliferationoftumortissuethroughthemeshofthestentoftenoccurswhenusingnon-coatedmetalstents(Fig.31).APChasbeenshowntobeeffectiveinremovingsuchingrowthsandovergrowths.14

2.4.4.3EXTRACTIONOFMETALSTENTS

Whenremovingametalstent,itispossibletoperformanextensiveAPCablationoftissueingrowthsinthemetalmeshbeforeremovingthestent;thiswillmakeit easier to remove the stent with forceps.

2.4.4.4STENTSHORTENING(“TRIMMING”)

Self-expandingmetalstentsareoftenplacedinpatientswithobstructivedisea-sesofthegastrointestinaltract.Overtime,suchstentsmaybecomedisplacedor,iftheinitialplacementisinaccurate,thestentmaypresentariskofbleedingorulceration.Inordertoavoidremovingtheentirestent,theprojectingendsofthestenthavebeenshortened (“trimmed”)usingAPC,8,11,17,48 as reported in theliterature.

Insuchacase,thedistaltipoftheprobeisplacedclosetothewirerequiringseparationwithinthestent.WhentheAPCisactivated,theionizedplasmaflowstothewireclosesttotheprobetip,resultinginrapidheatingandmeltingofthewire.Thisprocedureiscontinuedaroundtheentirecircumferenceofthestentuntiltheprojectingendisseparated.

TheshorteningofstentswiththehelpofAPCiscurrentlybeinginvestigatedinclinicalresearch.However,cautionshouldbetakenwithplasticcoatedstents,asliteraturehasdiscussedplastic(silicone)couldcausecombustion.

Fig. 31: Tissue overgrowth of a metal stent.

31

21

Fig. 32: a) Stenosing tumorb) Recanalization using APC

c) Reopened bronchus

APC™isusedintherapeuticbronchoscopyinterventionsforthehemostasisofbleeding(localanddiffusehemoptysis),forthepartialorcompleterecanaliza-tionofsymptomatictrachealandbronchialstenoses,andtoremovemalignantandbenigntumorgrowths.10,35,36,45

AnadvantageofAPC,comparedtonon-thermaltherapeuticprocedures(e.g.,cryotherapy,brachytherapy),isimmediateeffecttotargettissue.

Whenusingthermalproceduresinthetracheobronchialtract,itisimportanttoensurethattheconcentrationofoxygenintheairislow(≤40%,FiO2<0.4)inordertoreducetheriskofanycomplicationsduringapplication.

2.5.1 Recanalization

As in the treatment of stenoses in thegastrointestinal tract, theuseofAPCtotreatmalignantstenoses intherespiratorytractcanresult inanobjectiveimprovementofthestenosisanditssymptoms(Fig.32)andoffersbenefitsforsubsequenttherapy,whichmayconsistofradio-and/orchemotherapy,stentimplantation or an operation.10,35

A combinedapproachusingAPCand subsequentmechanical tumorablation(e.g.,usingforceps)canbeusedtoeffectivelytreatpatientswithlargetumorsandlife-threateningstenoses.10,35,36

32

c

a

b

2.5 Tracheobronchial TractSee Insert B: “Pulmonary Uses found in Clinical Literature”

22

Fig. 33: Hemostasis with APC:a) Beforeb) During

c) After APC therapy

Fig. 34: Stent ingrowth and overgrowth:a) Initial state

b) Treatment with APCc) Postoperative appearance

2.5.2 Hemostasis

Due to the hemostatic properties of APC™ (previously described in section2.4.2),spontaneousbleeding–includingbleedingcausedbytumors, localordiffusebleeding,andbleedingafterbiopsiestakeninthetracheobronchialtract–canbestaunchedeffectively(Fig.33).35

2.5.3 Stent Ingrowth and Overgrowth

Asinthegastrointestinaltract(Seesection2.4.4.2),stentingrowthsandover-growthsinthetracheobronchialtractcanberemovedusingAPC(Fig.34).37

3433

cc bb

aa

23

3.0 Adverse conditions and avoiding complications

Gastrointestinal Tract

PAIN

DuetothelackofinnervationinmostoftheGastrointestinalTract(GIT),painisnotdirectlyexperiencedduringAPC™application.However,inthedistalpartoftheanalcanal(atthelevelofthedentateline,orinindividualcasesupto1.5cmabovethisline),patientsmayexperiencepain.Thispainusuallyabatesveryquicklywhentreatedconservativelywithanalgesicsand/oranti-inflammatorymedications.

Otherindirecttriggersofpainduringtheproceduremaybecausedbyexcessivedilatation, due togasor over-manipulationof theendoscope. Similarly, afterAPCapplications,indirectpainmaybeexperiencedinthevicinityofthedentateline,duetomuscularspasmscausedbyextremecontractionsoftheexternalanal sphincter.6,25,29,33,49,51

Finally,aftertheapplicationofAPCintheesophagus,postinterventionalodyno-phagia(painfulswallowing)andretrosternalpainhasbeenreported.

GASEMPHYSEMA

Argongasemphysemaisareversiblecollectionofargongasintheareaofthetargettissueand/orinthetissueinitsimmediatevicinityand,asarule,hasnopathological importance.16,49Clinically, itpresents itselfasasoft,submucosalblebcreatedbydirect contactof the tissuewith theprobe.Nonetheless, theclinicianshouldtrytokeeptheAPCprobefromcomingintocontactwiththetissuewhenusingtheStraightFireprobeenface.

NEUROMUSCULARSTIMULATION(NMS)

Aknownriskofelectrosurgeryistheunintentionalelectricalstimulationofthepatient’snervesandmuscles.Suchstimulationmaybecausedbylow-frequencyelectricalcurrents,whichareproducedeitherbylow-frequencypowersourcesorelectricarcsbetweentheactiveelectrodeandthepatient’stissue.Thiscanresultinstrongspasmsormusclecontractions.

Normal/ESUalternatingcurrentwithafrequencyabove300kHzcannotstimu-latenervesandmuscles.Ifnerveormusclestimulationisobserved,theinstru-mentsandwireconnectionsshouldbecheckedforintegrity(Note:Demodula-tioncanbecausedbylooseconnections,incompleteinsulation,etc.anywherealongthecircuitincludingareasthatmaynotbevisible.).Ifthesituationisnotremedied,a changeof cord, instrument,and/orof theModemay rectify thesituation.

GASEXPLOSION/COMBUSTION

WhenapplyingAPCandotherenergysourcesintheGIT,adeflagrationofpoten-tiallypresent,flammablegasesintheintestinecanoccuriftheintestinewasnotcleanedproperlyprevioustotheintervention;intheworstcase,thiscanresultinagasexplosion.2-4,31,32,44Followaproperpreparatoryproceduretoreducetherisksofbowelexplosion.

PERFORATION

Despite its physically limited depth effect, perforation can occurwhen usingAPC.13,18Thefollowingpreventivemeasuresarethereforerecommended:

☑ Activationinstaticapplicationsshouldbeshort(1-2sec)☑ Outputsettingsandapplicationdurationsmusttakeintoaccounttheindi-

cationandlocationofthelesion(thicknessofthewall)☑ Thedistancebetweenprobeandtissueshouldbe1-5mm(dependingon

theAPCmodeused), especiallywhenworkingen facewithStraightFireprobes

☑ Avoidphysicalstressestotheintestinalwall(over-insufflation,mechanicalmanipulation)

☑ Particular caremust be takenwhen treating previously damaged tissue,(e.g.,infiltrated,ulceratedorscarredtumortissue,ulcersormuscularismu-cosae exposed after endoscopic resection)

24

Tracheobronchial Tract

GASEMBOLISM

When applying APC™, a combination of unfavorable conditions, such as lar-ge,openvenousvesselsandanintraluminalpressurewhichishigherthanthevenouspressure,can result ina transferofgas fromtheAPCprobe into theopenvessel,with subsequent creation of a gas embolism.This phenomenonhasbeendescribedinisolatedcasesinwhichtheinterventiontookplaceundergeneralconditionsofexcesspositivepressure;thus,itismoreofaproblemwithlaparoscopicthanendoscopicinterventions(e.g.,bronchoscopy).

Thefollowingmeasurescanhelptopreventtheoccurrenceofagasembolism:

☑ Reducetheargonflowtotheminimumlevelrequiredtoachievethedesiredtissueeffect

☑ AvoidholdingtheAPCprobesuchthatitisperpendiculartothetissue,andavoidanycontactbetweentheprobeandthetissue

☑ Donotaimtheprobedirectlyatlarge,openvessels☑ Maintaingoodfield-of-view

PERFORATION

Despite its physically limited depth effect, perforation can occurwhen usingAPC.Thefollowingpreventivemeasuresarethereforerecommended:

☑ Activationinstaticapplicationsshouldbeshort(1-2sec)☑ Outputsettingsandapplicationdurationsmusttakeintoaccounttheindi-

cationandlocationofthelesion(thicknessofthewall)☑ Thedistancebetweenprobeandtissueshouldbe1-5mm(dependingon

theAPCmode used) especiallywhenworking en facewith Straight Fireprobes

COMBUSTION

ThepresenceofcombustiblegasesshouldbeavoidedwhenperformingAPCprocedureswithinthetracheobronchialtree.WhencarryingoutAPCinthetra-cheobronchialsystem,oxygenconcentrationshouldbeaslowaspossible(i.e.,below40%,FiO2<0.4)inordertoreducethepossibilityofcombustionifsuchgasesarepresent.

25

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Educational books

ClassenMetal.GastroenterologischeEndoskopie.2004,GeorgThiemeVerlag.

GinsbergGetal.ClinicalGastrointestinalEndoscopy.2005,Elsevier,Inc.

WayeDJetal.ColonoscopyPrinciplesandPractice.2003,BlackwellPublishingLtd.

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