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RECOMMENDEDREFERENCESAND READINGS
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patientswithanalincontinence.DisColonRectum2000;43(6):813–20.
LamblinG,BouvierP,DamonH,etal.Long-termoutcomeafteroverlappinganterioranal
sphincterrepairforfecalincontinence.IntJColorectalDis2014;29(11):1377–83.
LehtoK,HyotyM,CollinP,HuhtalaH,AitolaP.Seven-yearfollow-upafteranteriorsphincter
reconstructionforfaecalincontinence.IntJColorectalDis2013;28(5):653–8.
MahonyR,BehanM,O’HerlihyC,O’ConnellPR.Randomized,clinicaltrialofbowelconfinement
vs.laxativeuseafterprimaryrepairofathird-degreeobstetricanalsphinctertear.DisColon Rectum2004;47(1):12–7.
MaloufAJ,NortonCS,EngelAF,NichollsRJ,KammMA.Long-termresultsofoverlapping
anterioranal-sphincterrepairforobstetrictrauma.Lancet2000;355(9200):260–5.
MarklandAD,BurgioKL,WhiteheadWE,etal.Loperamideversuspsylliumfiberfortreatmentof
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NessimA,WexnerSD,AgachanF,etal.Isbowelconfinementnecessaryafteranorectal
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Chapter16
MagneticAnalSphincter
PaulA.LehurandMiaKim

INDICATIONS/CONTRAINDICATIONS

Magneticanalsphincter(MAS)augmentationisanewtreatmentoption forpatientswithfecalincontinence(FI),whofailtoimprovewithother availabletreatmentoptions.TheMASdevice(FENIX;ToraxMedical, Inc,Shoreview,MN)isaringofmagneticbeadsthatissurgically implantedaroundtheanalcanal.Itisdesignedtoreinforceweakened analsphinctermuscles.ItreceivedEuropeanCommissionapprovalin 2011andwasapprovedbytheFoodandDrugAdministration(FDA)asa humanitarianusedeviceinDecember2015.Thedevicewasacquiredby JohnsonandJohnson(Somerville,NJ)fromToraxMedicalInc, Shoreview,MN)in2017afterwhichitwaspromptlywithdrawnfromthe market.
MASisindicatedatthepresenttimeforpatientswithsevereFI(oneor morefecalleakperweek),whofailtoachievesatisfactorysymptomatic reliefwithconservativetreatmentoptions(Table16-1).MASisa promisinginnovationastheimplantationisaless-invasiveandsimpler procedurecomparedwiththeonerequiredforimplantationofthe artificialbowelsphincter(ABS)thatisnolongeravailable.Although beinganartificialimplantaroundtheanalcanal,theMASsignificantly differsfromtheABSinitsconceptandinitsindications.
TABLE16-1 IndicationsandContraindications(asProposedinthe
MASReportedStudiesandOn-goingClinicalTrialsComparing SacralNerveStimulationandMAS)
INDICATIONS
Adultpatient
Lifeexpectancy≥3y
DocumentedFIforatleast6mo
SevereFI(average≥1FIepisodesperweekovera3-wkbaselineboweldiary)
CONTRAINDICATIONS
Historyofsignificantchronicdefecatorymotilitydisorder
UnderlyingsystemdiseaseasasourceofFI(neurologicdisorder,scleroderma, chronicdiarrhea,inflammatoryboweldisease,orirritablebowelsyndrome)
Previousanorectalposteriorcompartmentsurgery
Rectalresection
Overtrectalorvaginalprolapse
Complexanalorrectovaginalfistulas
Activepelvicinfection
Historyofpelvicradiation
Historyofanal,rectal,orcoloncancerwithin2y
Anelectricormetallicimplantwithin10cmofproposedareaofdeviceplacement
Pregnancy,nursing,orplanningtobecomepregnant
DEVICEDESCRIPTION
MASisadynamiccircularimplant,placedaroundtheanorectaljunction, designedtoreinforcethenativeanalsphinctermechanismwithmagnetic attraction:wideningwhilestrainingduringdefecationandmagnetically self-retractingthereafter.TheconceptofMASdevicehasoriginatedfrom asimilardevicededicatedtothetreatmentofgastroesophagealreflux disease,theFDA-approvedLINXRefluxManagementSystem.The rationaleforthedesignofthesedevices(LinxandFenix,Johnsonand Johnson,Somerville,NJ)isbasedontheconceptof“reversestenting”: thedevicesimplydeliversalow-levelpressurearoundthetubethatit encirclestorestorefunction;themagneticbondcanbetemporarily brokentoallowtheintentionalpassageofcontents(food—stool)and restoredimmediatelythereafter.
p.117
p.118
TheMASimplantconsistsofaseriesoftitaniumbeadswithmagnetic coresthatarelinkedtogetherwithindependenttitaniumwirestoforman annularshape(Fig.16-1AandB).Thedeviceismanufacturedindifferent lengthsbasedonthenumberofbeads(from14to20beads)to accommodatethevariationinanalcanalcircumferencesindifferent individuals.
FIGURE16-1Magneticanalsphincterreinforcement
device(MAS).A.MASclosed.B.MASopen.Thetitaniumwires connecteachbeadtotheotherindependentlytoforma flexibleringthatrestsaroundtheupperanalcanalina circularfashion.
Thedeviceisfunctionalimmediatelyaftertheimplantation.To defecate,thepatientstrainsinanormalwayandtheforcegenerated separatesthebeadstoopenuptheanalcanal.Thisactionallowsthe stoolstopassthroughtheanalcanalreinforcedbytheMASdevice.The separationforcerequiredtoopentheadjacentbeadsisapproximately 100g.
PREOPERATIVEPLANNING
NofullbowelpreparationisrequiredforMASimplantationasitis desirabletohavethepatientresumingbowelmovementsassoonas possibleafterthesurgerytofacilitatetheactuationofthemagneticbeads. Onlythelowerbowelisclearedwithtwosmallenemasthedaypriorto thesurgeryorintheearlymorning.Normaldietisencouraged preoperatively.Usuallynodepilationisrequired.Ifneeded,ithastobe limitedanddoneon-table.
Althoughsubjecttovariationsaccordingtoenvironmentalbacterial pressureand/orgeneralrecommendationsininstitutionsorcountries, onlyonedoseofintravenousprophylacticantibioticsisrecommendedat theinductionofanesthesia.RecommendeddrugsincludeCephazolin2g slowIV,incaseofallergy:Vancomycin15mg/kg/60minuteor Clindamycin600mgslowIV+Metronidazole1gIV.
Generalorspinalanesthesiascheduledforaprocedureoflessthanan hour—Lithotomypositionforaperinealaccessonly.
Nobladdercatheterisroutinelyrequired.
Oncethepatientispositionedontable,firstthecleanlinessofthe vaginaandoftherectalampullaisassessed.Ifneeded,completethe rectalwashoutbeforestartingthedraping.
Introductionofapovidone-iodine-soakedspongeorpackisanoption toavoidleakingoffecalmaterialduringtheprocedurewhentherectum isnotperfectlyclean.
Therearenospecificrequirementsforinstrumentsexceptaspecific passingtoolandasizingtooltomeasurethenumberofbeadsrequired. Standardinstrumentsincludeelectrocautery,suction,andfluoroscopy.

SURGERY

InSummary
TheMASisimplantedundergeneralanesthesiabymakingananterior perianalincision.TheMASisfittedaroundtheanalcanalinclose contact,thesizeoftheimplantbeingadaptedtothediameterofthe perianaltissuewiththehelpofasizingtool.AfinalX-rayiscarriedoutto confirmthatthecorrectimplanthasbeenchoseneffectively.Theringis closedbymeansofanonabsorbabledoubleligaturethreadedthrough twoeyeletsattheendsoftheMAS.
SurgicalTechnique
Itisimperativethatmeticuloussteriletechniquebemaintainedduring thisprocedure,includingchangingglovesseveraltimes.Generoususeof 10%povidoneiodine(Betadine)isrecommended.Theoperatingroom teammustunderstandthechallengeofperfectasepsisforthesuccessof theprocedure,whichdiffersfromthatinotheranorectaloperations.The numberofpersonnelintheroomshouldbelimited.
PositionandPreparethePatient
Whileanesthetized,thepatientisplacedinthelithotomypositionwith thebuttockspositionedslightlyovertheedgeofthetabletofacilitate accesstotheanalarea.Theperinealareaisgenerouslyscrubbedwiththe iodinesolution.Carefullydrapethelegsandtheperinealareaofthe patient,spreadingandtapingthebuttocksifnecessary.
CreatethePerianalTunnel
Ahorizontalperinealincision6–7cminlengthismadehalfwaybetween thevaginalintroitusandtheanalverge.Itisimportanttomakethis incisionfairlywideforaneasypassageoftheMASintroducertool(Fig.
16-2A).Thetunnelingcanbegindownwardperipheraltotheanalcanal,
aimingtothetipofthecoccyxthroughthefatoftheischioanalspaces.
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