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July 2017 v1.8 Review date: 2020 Page 1 of 6 British Society for Dermatological Surgery (BSDS) & British Heart Rhythm Society (BHRS) Guidance on Implanted Devices & Dermatological Surgery Contents Page 1. Introduction 2. Summary & PPM 3. ICD & ILR 4. Cardiac physiology reports & bookings 5. References & Table: Types of electrosurgery with relevance to commonly used Dermatological equipment 6. Flowchart Glossary: Permanent Pacemakers (PPM), Implantable Cardiac Defibrillators (ICD), Implantable Loop Recorders (ILR), Electromagnetic Interference (EMI) Introduction: At present there is no specific national safety guidance available for clinicians who perform cutaneous surgery on patients with cardiac rhythm devices. The lower risk of skin surgery procedures and the electrosurgical devices that are typically used means some of the generic guidance is not so applicable to local anaesthetic skin surgery and may have significant resource implications. This guidance has therefore been developed to complement and clarify the detailed advice published by the BHRS 1 and MHRA 2 that was devised primarily for the general theatre and endoscopy setting, rather than the outpatient procedure room or clinic setting in which skin surgery is often performed. Skin surgery procedures are some of the commonest performed in the UK. A typical Dermatology department conducts well over 2000 procedures per year, and found 2% of these patients had implanted cardiac devices. 3 Therefore any advice can have significant ramifications for patient pathways and appropriate use of resources, as well as safety. We reviewed the published literature, contacted the Medicines & Healthcare products Regulatory Agency (MHRA), and conducted a national survey of members of the BSDS to determine if electromagnetic interference had been reported in practice in the context of skin surgery. We found no reported or published instances of any adverse events. Nevertheless definite risks still exist. It is possible that adverse events have occurred but either not been noticed immediately or not been reported. Precautions must still be taken.

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Page 1: British Society for Dermatological Surgery (BSDS) & … BHRS Implante… ·  · 2017-10-20British Society for Dermatological Surgery ... & British Heart Rhythm Society (BHRS) Guidance

July2017v1.8Reviewdate:2020

Page1of6

British Society for Dermatological Surgery (BSDS) & British Heart

Rhythm Society (BHRS) Guidance on Implanted Devices &

DermatologicalSurgery

Contents

Page

1. Introduction

2. Summary&PPM

3. ICD&ILR

4. Cardiacphysiologyreports&bookings

5. References & Table: Types of electrosurgery with relevance to commonly used

Dermatologicalequipment

6. Flowchart

Glossary: Permanent Pacemakers (PPM), Implantable Cardiac Defibrillators (ICD),

ImplantableLoopRecorders(ILR),ElectromagneticInterference(EMI)

Introduction:

Atpresentthereisnospecificnationalsafetyguidanceavailableforclinicianswhoperform

cutaneoussurgeryonpatientswithcardiac rhythmdevices.The lowerriskofskinsurgery

proceduresandtheelectrosurgicaldevicesthataretypicallyusedmeanssomeofthegeneric

guidance is not so applicable to local anaesthetic skin surgery and may have significant

resourceimplications.Thisguidancehasthereforebeendevelopedtocomplementandclarify

thedetailedadvicepublishedbytheBHRS1andMHRA2thatwasdevisedprimarily forthe

generaltheatreandendoscopysetting,ratherthantheoutpatientprocedureroomorclinic

settinginwhichskinsurgeryisoftenperformed.

Skin surgery procedures are some of the commonest performed in the UK. A typical

Dermatologydepartment conductswell over 2000proceduresper year, and found2%of

these patients had implanted cardiac devices.3 Therefore any advice can have significant

ramificationsforpatientpathwaysandappropriateuseofresources,aswellassafety.

We reviewed the published literature, contacted the Medicines & Healthcare products

RegulatoryAgency (MHRA), and conducted a national survey ofmembers of theBSDS to

determineifelectromagneticinterferencehadbeenreportedinpracticeinthecontextofskin

surgery.Wefoundnoreportedorpublishedinstancesofanyadverseevents.Nevertheless

definiterisksstillexist.Itispossiblethatadverseeventshaveoccurredbuteithernotbeen

noticedimmediatelyornotbeenreported.Precautionsmuststillbetaken.

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Disclaimer:

This isaguideonlyandclinical judgementshouldultimatelydeterminethedegreeofrisk,

particularlyforcomplexpatients.Advicefromamultidisciplinaryteammayalsobehelpful.

LimitationsofGuidance:

ThisdocumenthasbeenpreparedonbehalfoftheBSDSandisbasedonthemostrelevant

data and expert opinion available when the document was prepared. A full systematic

literaturereviewhasnotbeenconducted.Itisrecognisedthatundercertainconditionsitmay

benecessarytodeviatefromtheguidelinesandthattheresultsoffuturestudiesmayrequire

someoftherecommendationshereintobechanged.Failuretoadheretotheseguidelines

should not necessarily be considered negligent, nor should adherence to these

recommendationsconstituteadefenceagainstaclaimofnegligence.Limitingthereviewto

English language referenceswas apragmatic decisionbut the authors recognise thismay

excludesomeimportantinformationpublishedinotherlanguages.

Summaryofkeypoints(alsoseeflowchart)

1. Monitor thepatient clinically andwithpulseoximeterwhilstusingbipolarelectrosurgery in

shortbursts>5cmawayfromaPPM.

2. Inadditionto(1)switchoffanyICDimmediatelypre-opandbackonimmediatelypost-op.

3. Bookingclerkorcliniciantocontactcardiacphysiologypre-op:

a. torequestdevicereport(seebelow)

b. toarrangevisittotheatreimmediatelypre-andpost-opifICD

c. torequestcardiacphysiologyhavesomeoneonstandbyontheproceduredateifthesurgical

siteiswithin5cmofthepacemakerbox

d. toallowanopportunityforILRdatatobedownloadedpre-opifrequired.

4. IfaPPMisunderregularroutinereviewbycardiacphysiologythennoadditionalpre-orpost-

opchecksareusuallyrequired.

5. IfthepatienthasanILRrecordtheprocedureinthepatient’seventdiary

Background

Electrosurgery passes electricity through tissue to cause coagulation, damage, or cutting. It can

interferewiththeusualrunningofsomeimplanteddevicesbyEMI.Queriesaboutthesedevicesmay

causeconcern,ortheremaybearisktothesafetyofthepatientorstaff.

Pacemakers(PPM)

Allpacemakers

Pacemakersmayregulateheartrhythminavarietyofways,butofmostrelevanceiswhenthepatient

is‘pacemakerdependent’i.e.theyhavenonaturalpacemakeroftheirown,ortheirheartratewithout

thepacemakeristoolow(leadingtoanyof:lightheadedness,fainting,shortnessofbreath,chestpain,

weakness,fatigue,collapse).Insomecasesthedevicecouldmistaketheelectrosurgerycurrentfor

heart activity and stop pacing temporarily. This effect is unlikely if using bipolar electrosurgery,

particularly if away from thedevice. Also shortpulses canbeused tominimise theeffectof this

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problem even if it does occur, as the device should resume pacing immediately after the

electrosurgerypulsestops.Ifthepatient’spulseremainssteadythroughtheelectrosurgerypulse,it

isobviouslynothavingthiseffectinanycase.Althoughtheoreticallypossible,anyreprogrammingof

thedevicebyelectrosurgeryEMIisnotconsideredarealrisk.

Pacemakerswithin5cmofsurgicalsite

Ifthesurgicalsiteiswithin5cmofthepacemakerbox(althoughtheriskisstilllowwithbipolar)the

pacing team shouldbe informedof thedate that thepatient is coming in to have someoneon

standby.Intheunlikelycasethatthebipolardiathermydoesinhibitthepacemaker(i.e.ifthepatient

becomessymptomaticduringelectrosurgeryuseorifsomeinhibitionisnotedviapulseoximeter)the

teamwill comeand re-programme thedevice to an ‘asynchronous’mode for thedurationof the

procedure.

Defibrillators(ICD)

ICDoftenlookandfeelsimilartoapacemaker,andareusually inthesamesite.Thereisagreater

danger as these devices are constantly sensing for odd electrical activitywhichmight indicate an

imminentcardiacarrest.Theythenadministerashockdirectlytotheheartviainternalelectrodes.

Again thedevicecouldmistake theelectrosurgerycurrent forheartactivityandshock thepatient

inappropriately. These therefore need to be switched off immediately before, and back on

immediatelyafter,proceduresinvolvingelectrosurgery.Thecardiacphysiologytechnicianswilldothis

intheoperatingtheatrebypriorarrangement.Thedeviceshouldbeofffortheminimumtimepossible

i.e.onlytheperiodwhenelectrosurgeryisneeded,notduringLAinfiltration,orrecovery.Itiscritical

thattheWHOchecklistisfollowedtopreventdevicesfrominadvertentlybeingleftswitchedoff.

Whenbooking surgery it is important to ask thepatient, study the case-notes, and contact the

cardiacphysiologydepartmentthatlooksafterthedevice,toensurewhatyoumaypresumetobe

a pacemaker is not also a defibrillator. The booking team should also obtain from the cardiac

physiologyteamasummaryofeverydeviceandthereasonitwasimplanted.

LoopRecorders(ILR)

ThesearedevicesimplantedusuallyinasimilarsitetorecordaconstantrunningECGwhilstinplace,

when cardiac arrhythmias are suspected but have been difficult to prove (e.g. syncope, falls,

palpitations).Theyarenota risk topatientorstaffas theywillmerelyshowsomeextraelectrical

activityfromtheelectrosurgeryintheirrecordingdata,andneitherarethedevicesatparticularrisk

fromtheelectrosurgeryitself.Thepatientkeepsadiaryofanysymptomsthattheyfeelduringthe

time thedevice is implanted, so theyshouldmerelyaddanotesaying theyhadaprocedurewith

electrosurgeryatthattime,tohelpthetechnicianstointerpretthefindingscorrectly.Thefollow-up

centreshouldbeinformedthataprocedureisplanned,togivethemtheopportunitytodownload

thestoreddatafromtherecorderbeforehand.

Otherdevices

Otherimplantedpumpsandbrainstimulatorsetcmayalsobepresent.Bevigilantandseekadvice

fromtherelevantdepartmentiffound.

Intra-operativemonitoring

ContinuousECGusingacardiacmonitorhaspreviouslybeensuggested,butisnotusuallyhelpfulin

theout-patientskinsurgerysetting.ThemonitoritselfreadilypicksupEMIfromtheelectrosurgery

whichobscuresthepatient’sheartrhythmattheverymomentthesurgeonwishestoseetheeffect.

Alsowith the surgeon busy, no anaesthetist, and not always a scrub nurse, themonitormay not

actually be checked during the procedure, even if attached. Although it might be useful for the

resuscitationteamtoviewtheaberrantrhythmquicklyifanICDpatientsufferedcardiacarrestwhilst

theirdevicewasswitchedoff,thisisextremelyunlikelyiftheproperprecautionsaretaken.Alsomany

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out-patientordaycasesurgeryunitsmayhaveanAutomatedExternalDefibrillator(AED)onthecrash

trolley,theuseofwhichdoesnotrequireviewingtheheartrhythm(andthecardiacmonitorleads

mayactuallyget in theway).Thecardiacmonitor isalsoslowto fitandprone to leadconnection

problems,whichcandelaysurgery.Insteadapulseoximetercanbeusedforheartratemonitoring,

is quick and unobtrusive to fit, often can be monitored audibly by the surgeon themselves if

necessary,andisnotsusceptibletoEMIfromelectrosurgery.

Devicereportsfromcardiacphysiologyteam

Asummaryofeverydeviceandthereasonitwasimplantedisneeded:

• ToidentifyICD+PPMdevices

• Toensuredevicestatusandindicationknown(especiallyifpatientfromoutofareaormovedsince

implantation)

• Toensuredeviceisnotnearingendoflife/batterychange• Togivethecardiacphysiologyteamanopportunitytoarrangeadevicecheckpre-opifrequired

• Togivecliniciandefinitiveinformationontheindicationforthedevice(thiswillnotusuallyaffect

theirperi-operativemanagement,butgivesanawarenessoflevelofrisk)

Organisationofbookings

• Bookingcliniciantoaskpatient“whereareyounormallyseenforyourPPM/ICD?”whencompleting

the electronic surgical booking form (to help obtain accurate device/indication report -may be

anotherhospital)

• Booking admin team to contact cardiac physiology to obtain device/indication report prior to

dating,andgivetobookingclinicianforcomment

• 1weekminimum notice needed for cardiac physiology team for routine ICD patient bookings

(otherwisebyspecialarrangementifpossible)

• CallcardiacphysiologyteamatendofcasepriortoICDpatienttoallowtimetoattenddepartment

(andupdatethemduringsurgeryifproceduredurationchanges)

Authors

DrAdamBray,ConsultantDermatologist,Dermatological&MohsSurgeon.BSDSGuidance

[email protected]

MrGarethDavies,LeadCardiacDevicesPhysiologist,BristolHeartInstitute.

DrBethWright,SpecialityRegistrar,Dermatology.

UniversityHospitalsBristolNHSFoundationTrust.

Acknowledgements:ManythankstotheBritishHeartRhythmSociety(BHRS)Council, the

ExecutiveCommitteeofTheBritishSocietyforDermatologicalSurgery(BSDS),andMrSimon

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Holmes SeniorMedicalDeviceSpecialist DeviceSafetyandSurveillance MHRA, for their

contributionstothisguidance.

References:

1. British Heart Rhythm Society Guidelines for the management of patients with

cardiacimplantableelectronicdevices(CEIDs)aroundthetimeofsurgery.

ThomasH,TurleyA,PlummerC,onbehalfofBHRSCouncil–January2016

http://www.bhrs.com/guidelines-informationAccessedon:7thMay2017

2. Guidelines for the perioperative management of patients with implantable

pacemakers or implantable cardioverter defibrillators, where the use of surgical

diathermy/electrocauteryisanticipated.

Medicines&HealthcareproductsRegulatoryAgency(MHRA)2006

3. BristolDermatologyCentre.Personalcorrespondence.

TypesofelectrosurgerywithrelevancetocommonlyusedDermatologicalequipment

TypeofElectrosurgery Equipmentcomments Description

Monopolarsingleelectrode ConmedHyfrecatorwithnormalhandleprobeattachment

Current passes from probe to

patient and disperses through

thebody(possibleasitisonlya

small amount of current and

tableisinsulated)

Bipolar CoaCompMunit

ConmedHyfrecatorwithbipolar

forcepsattachment

Current passes from 1 side of

forceps to the other through a

smallareaofthepatient’stissue

Monopolarwithreturnplate Unusual in Dermatological

surgery, commoner in main

theatres

Current passes from probe

through patient to a separate

plate (earth electrode)

connectedtomachine

Electrocautery Largely replaced by other

electrosurgery machines but

some older units may still be

used or battery powered e.g.

Bovie

Using current to heat a metal

probe (like a soldering iron) to

causecoagulationordamageto

tissue