O c t o b e r 2 0 1 1 | G L O B A L E D I T I O N

A d v a n c e s i n I n t e r v e n t i o n a l E n d o s c o p y

Clinical Updates• DevicesUsedDuringEMR–page 1

• Expect™NeedleforEUSFNA–pages 2-3

• SpyGlass®DirectVisualizationSystem–pages 4-5

• WallFlex®FamilyofStents–pages 6-7

International News• ClinicalResearchUpdates–page 8

• InternationalNews–page 9

What’s New• EndoscopyChannel LaunchedonYouTube

–back cover

A W O R D F R O M T H E P R E S I D E N T

Dave PierceSenior Vice President, Boston ScientificPresident, Endoscopy Division

Technology Innovation, Yes. But Our Value Goes Far Beyond.Recently,ForbesmagazinenamedBostonScientifictoitsannuallistofthe“World’sMostInnovativeCompanies.”Inhealthcare,innovationistrulymeaningfulwhenfocusedondeliveringvaluetopatientsandhealthcareprovidersalike.That’swhatwestriveforeverydayatBostonScientificEndoscopy.

Westartwithaclinicalexcellencemindsetanddatadiscipline.Overthepastfiveyearsalone,BostonScientificEndoscopyconductedclinicaltrialsin21countriesat110medicalcenterswithenrollmentofnearly1,400patients.Thesestudiesvigorouslytestedtheperformance,safety,andeffectivenessofourproductsinstandardpracticeorinnovelprocedures,pavingthewayforexpandedindications.Wealsosupportphysiciansgloballywithdataneededfortheirscientificstudies,presentations,andpublications.TofurtheradvanceEndoscopyprocedureefficienciesandknowledgeofthelatestpatienttreatmentoptions,webecamethefirstcorporatesponsoroftheAmericanSocietyforGastrointestinal Endoscopy’s (ASGE) planned global Institute for Training and Technology, a state-of-the-artversionofitscurrentfacility.

We furtheraddvalue throughcontinuingeducationonhealthcareeconomics. In theU.S., ourpresentationsoncodingandreimbursementpackconferenceroomswithhealthcareadministratorsand labmanagerssuchasattheannual meetingof theSociety ofGastroenterologyNursesand Associates. Year round, our reimbursementsupportteamisindemandattertiarycentersaswellasincommunityhospitals.Duringarecentspeakingtourofuniversity-affiliated institutions,GI reimbursement trendsandhospitalbenchmarkingdatawerehot topics.Onehealthprogramoperationsspecialistintheaudiencecommented,“Ican’tbelieveBostonScientifichasadedicatedteamthatspecializesinreimbursementandcoding.I’llbecontactingthemdirectlywithquestions.I’mplanningonpullingallmydatatounderstandournumbersbetter.”

Atthisyear’sDigestiveDiseaseWeek,weintroducedtheBoston Scientific Endoscopy Channel (BSCEC)onYouTube®featuring physician practices. This alternative learning environment is already having an impact on practicesworldwidewhilesavinghealthcareorganizationsandphysicianstraveltimeandmoney.Soonafterthechannel’sdebut,aU.S.biliarystentcasepresentedonBSCECprovidedreal-timedecisionsupporttoagastroenterologistatLilavatiHospitalinBandra,India.AstrongareaofinterestamongtopGIsocietiessuchastheASGEandtheUnitedEuropeanGastroenterologyFederation,e-communicationsispavingthewayforbothimprovedpatientcareandoperationalefficiencies.

Wehopeyou’llfindthecasesinthispublicationvaluableandlookforwardtoconnectingwithmanyofyouinpersonthisfallatGIcongressesworldwide.

uTuneintotheBoston Scientific Endoscopy Channelatwww.youtube.com/bostonscientificendo.

uLearnmoreabouthealthcareeconomicsandreimbursementsupportintheU.S.,call800-876-9960,extension 4145.

u SeeBostonScientific’slistinginForbes’“World’sMostInnovativeCompanies”athttp://www.forbes.com/ special-features/innovative-companies-list.html

PaTIeNT HIsTOrY

Thispatientisa71-year-oldfemalewhoinitiallysoughtconsultationwithageneralsurgeonforrectalprolapse.Hercomplaintwascomplicatedbysignificantconstipationandstrainingwithbowelmovements.Acolonoscopywasperformedbythesurgeonatanoutlyingfacility.A4.5cmpolypoidmasswithabroadbasewasdescribedintherectumapproximately5cmfromtheanalverge.Multiplebiopsieswereobtained,however themasswas leftin-situ.Thepathologyreportfromthebiopsiesdiagnosedavillousadenoma.Onfollowup,thesurgeonrecommendedatrans-analresectionofthelesionintheoperatingroomundergeneralanesthesia.

Thepatientpresentedtomeforasecondopinionconsultationregardingthemanagementofthemass.Arepeatcolonoscopywasrecommended.

PrOCedUre

Astandardcolonoscopywasundertakenandthececumwasintubatedwithoutdifficulty.Alongtheanteriorrectalwall,a4.5cmpolypoidmasswasencountered.Themasshadamoderatesizedbase.Therewerenosurfaceulcerationsordepressionstosuggestdysplastictransformation.ACaptivatorIISnarewasusedtograspthelesion,and it was removed en-bloc with one pass of electrocautery. Using the TWISTER® Rotatable Polyp RetrievalDevicethepolypspecimenwasretrievedanddeliveredtoaformalinjarforpathologicanalysis.Thepolypectomydefectwasthenre-approximatedwithclips.

POsT PrOCedUre

Pathologicaldiagnosisofthepolyprevealeda largevillousadenomawithouthigh-gradedysplasia.Onemonthpostprocedure,thepatientwasdoingwell.Hercomplaintsofrectalprolapse,constipation,andstrainingwithbowelmovementshaveresolved.Arepeatsurveillancecolonoscopyisplannedinoneyear.

dIsCUssION

Rectalprolapseoccurswhenpartorallofthewalloftherectumslidesoutofplace,sometimesprotrudingoutoftheanus.Avarietyofriskfactorsforprolapseexist,includingweakeningofthepelvicfloormuscleswithadvancedage,chronicconstipationandstraining.Rectalpolypsareanuncommoncauseofprolapse,servingasaleadpointforrectalmucosalintussusception.

This case demonstrates the importance of skilled endoscopists with cutting edge support equipment in themanagementoflargepolyps.TheCaptivator®IISnarewaspivotalinthiscase.Thesnare’slargediameterapertureallowedforcompleteen-blocresectionofthepolypwithonepass.Thestiffbraidedmetalfilamentachievedaclean-cutmucosalresectionwithouttheneedforexcesscautery.TheTWISTER®RotatablePolypRetrievalDevice,withitslargeapertureandcapacity,allowedforeasyretrievalofalargeintactpolypspecimenfromtherectumwithminimalmanipulation.Althoughthepost-EMRdefectwasnotactivelybleeding,itismypracticetoemploytheprincipleofimprovedwoundhealingwithprimaryclosureoverthatofsecondaryintent.TheclipofchoiceistheResolution®Clip,capableofopening,closing,andrepositioning.Thedeploymentapparatusisalsolesspronetotechnicianerrorandfaileddeploymentsthanotherclipsonthemarket.Arepeatcolonoscopysparedthepatienttheexpenseandrisksofsurgicalresection,whileachievingcompleteresolutionofhercomplaints.

Case presented by: david a. Florez, MdElms Digestive Disease SpecialistsCharleston, South Carolina, USA www.elmsdigestivesc.com

devices Used during endoscopic Mucosal resection (eMr)

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eXPeCTTM eNdOsCOPIC UlTrasOUNd asPIraTION Needle

Case presented by:Professor atsushi Irisawa, Md, Phd

(pictured) and associate Professor

Goro shibukawa, Md, Phd

DepartmentofGastroenterology

FukushimaMedicalUniversityAizuMedicalCenter

Aizuwakamatsu,Fukushima,JAPAN

A 54-year-old woman presented with nausea and abdominal distention. She had noparticularpasthistory.Bloodlaboratoryrevealeddiabetesmellitus;therefore,anabdominalultrasoundwasdoneforscreeningthepancreas,showingasmallmass15mmindiameteron thepancreaticbody.UponEndoscopicUltrasound (EUS)examination, themasswasvisualizedashypoechoicwithunclearborderfromthenormalpancreaticparenchyma.Themassledtodilationofthepancreaticductinthetail(Figure 1).Tomakeadiagnosis,EUSFineNeedleAspiration(FNA)wasdonewiththetransgastricapproach.

A22gaugeExpect™Needlewasdeployed.EventhoughthestrongangulationofthetipoftheEUSscopewasmanipulated,theneedletippuncturedthegastricwallandenteredthesmall pancreaticmasseasily.After threepasses,anadequateamountofmaterialwasobtainedfordiagnosis.Next,weusedthe25gaugeExpectNeedletopuncturepreciselythelocationofthepancreaticductobstructionduetothemass.The25gaugeneedleeasilyandpreciselyenteredintothesmallmassandtargetpoint (Figure 2).

TheExpectNeedlewasveryimpressivewithhighoperabilityandvisibilityoftheneedletip.Inparticular,the22gaugeExpectNeedlehandledasifitwerea25gaugeneedledevice.Therefore,a22gaugeneedlemaybeusedforawidevarietyoflesions.

eUs-FNa for a small Pancreatic Mass; High Manipulation Performance with expect Needle

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Case presented by:ryan Ponnudurai

Md, FasGeConsultant

GastroenterologistDirectorofEndoscopy

PrinceCourtMedicalCentre

KualaLumpur,MALAYSIA

A75-year-oldmalepresentedwithtwomonthsofjaundice,weightloss,andintermittentfevers.ACTscan (Figure 1) showedmultipleperi-pancreaticandceliacnodes,withalargeheterogenouspancreaticheadmassmeasuringto7x8cm.Thepatientwasnotacandidateforsurgery;anEndoscopicUltrasound-FineAspirationNeedle(EUS-FNA)wasplanned,tobefollowedbyERCPandbiliarymetalstentingforpalliation.

EUS showed a large cystic solid mass arising from the head of the pancreas withinvolvement of the portal vein and surrounding vascular structures, and multiple largeperipancreatic,perihepaticandceliacnodes.Asthepatient’sINRwas1.6,Itargetedthelymphnodesusinga22gaugeExpectNeedle.Adequatetissuewasacquiredafterthreepasses.Specimensweresentforhistopathologyandcytologyanalysis.AnERCPwasthenperformedandcholangiogram(Figure 2)revealedalongdistalstricturewithproximalbileductdilation.A10mmx6 cmWallFlex®BiliaryRXMetalStentwasplaced.TheFNAshowedabnormal lymphocyteaggregates,whichonfurtherstainingwithBcellmarker(Figures 3 and 4),wasstronglysupportiveofB-celllymphoma.

Thiscasefurthersupports thealgorithmfortissuesampling inunresectablepancreaticmasses as the patient can now receive the appropriate palliative chemotherapy. TheExpectNeedleshowedgoodvisibilitybyultrasoundatalltimes,anditwaseasytoremoveandreplacethestyletonallthreepasses.Itwasalsoencouragingthatusinga22gaugeneedle,adequatetissuewasobtained,makingthediagnosisof lymphomabyusingtheappropriatestains.

eUs-FNa efficacy in acquiring Tissue samples from solid Unresectable Pancreatic Mass

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eXPeCTTM eNdOsCOPIC UlTrasOUNd asPIraTION Needle

Case presented by:Krishnavel V.

Chathadi, MdTherapeuticEndoscopist

BJCMedicalGroupMissouriBaptist

MedicalCenterSt.Louis,Missouri,USA

An 84-year-old male was referred for an evaluation for possible lymphoma. A CT scandemonstrated mediastinal, retroperitoneal and mesenteric lymph adenopathy. EndoscopicUltrasound (EUS) revealed a malignant-appearing sub-carinal lymph node measuring2.0x1.5cm, inaddition toseveralabnormal lymphnodes in theceliac,peripancreaticandportahepatisregion.A19gaugeExpectNeedlewasusedtomakeonepass(Figure 1)intothesub-carinal lymphnode togeta largersampleafter twopriorpasseswitha22gaugeneedle.Thesamplewasalsosentforflowcytometryinadditiontocytologyreview.Cytologywasconsistentwithanonsmall-cellcarcinomaandflowcytometryidentifiedamonoclonalB-cell population consistent with involvement by B-cell non-Hodgkin’s lymphoma, favoringchronic lymphocytic leukemia. The patient tolerated the procedure well without anycomplications. The 19 gauge Expect Needle entered the lesion easily and its tip andtractwaswellvisualizedduringthepass.

eUs FNa of a Mediastinal lymph Node: 19 Gauge expect Needle Procures a larger sample to diagnose lymphoma

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Case presented by:Prof. Claudio

de angelis, Md, (pictured),

r. Francesco Brizzi, Md,

luca Molinaro*, MdGastroHepatology

Department,MolinetteHospital,

*DepartmentofPathology,Molinette

Hospital,UniversityofTurin,ITALY

INTrOdUCTION A 61-year-old female patient with a history of kidney stones underwent an abdominalultrasound,showinganew-onsetsolidmassnearthebodyofthepancreas.ACTscanshowedasolidmassofabout3cmneartheaorta, justabovethefourthportionof theduodenum,whilethepancreaticparenchymawasdeemednormal.

PrOCedUre EndoscopicUltrasound(EUS)wasperformed,whichconfirmedthemass.ItwasnotpossibletofindthelesionwithEUSscanningfromtheduodenum,butthemasswasclearlyvisiblefromthestomach, roughlyovalhypoechoic,withhighvascularity,mostprobablyoriginatingfromtheduodenalwall(Figure 1).ThisEUSfindingledtothediagnostichypothesisofaGastrointestinalStromalTumor(GIST)ofthefourthportionoftheduodenum.FineNeedleAspiration(FNA)wasperformedwiththe22gaugeand25gaugeExpect™Needles(Figure 2),with3and2passesrespectively in the lesion, through thestomachwall.Cytopathologicalexamination showedspindle cells, with positive reactions with vimentine and anti-CD117 antibodies (Figure 3),supportingthediagnosisofGIST.FNAsampleswereofgoodcellularitysothatwecouldalsohaveinformationaboutthecellularproliferationindexofthelesion:immunostainingwithKi67antibodieswas<1%.Suchdiagnosiswaseventuallyconfirmedaftersurgicalresectionofthelesion, with total agreement between FNA cytopathology and histology on the surgicalspecimen(Figure 4).

CONClUsIONTrans-gastricFNAofabdominallesionscanbechallenging,duetotheextrememobilityofthegastricwall:Sometimesitcanbehardtocarryoutwideneedlemovementswithinthelesioninordertoobtainsampleswithgoodcellularity(Figure 5).InthiscasewebelievethatthesharpnessoftheExpectNeedlewashelpful ineasilypenetratingthegastricwallandmovingwithinthehardstructureofthestromaltumor.TheexcellentagreementbetweencytologyonFNAsamplesandhistologyonsurgicalspecimensuggeststhatsamplesobtainedbytheExpectNeedlehaveoptimalcellularityandallowustoobtaininformationofprognosticvaluebeforesurgery.

a Challenging diagnosis of duodenal GIsT by Transgastric eUs-FNa Confirmed after surgical resection

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sPYGlass® dIreCT VIsUalIZaTION sYsTeM

Tubercular Biliary stricture Visualized with the spyGlass system

Case presented by: randhir sud, Md ChairmanInstitute of Digestive & Hepatobiliary Sciences Medanta, The MedicityGurgaon, New Delhi, INDIA

PaTIeNT HIsTOrY

A35-year-oldwomanpresentedwithcentralabdominalpainradiatingtotheback,andweightlossoccurringforone month. She developed cholestatic jaundice twoweekspriortopresentation.Labparametersuggestedextrahepaticbiliaryobstruction.

A contrast-enhanced computed tomography of theabdomenrevealedamassinrelationtothepancreaticbody with a common bile duct obstruction. Anendoscopic ultrasound (EUS) examination showed aheteroechoicmasslesionintheretropancreaticarea—pushing the pancreatic parenchyma up and causingnarrowingofthecommonbileduct(CBD)inthemiddlepart, with upstream dilatation. Fine needle aspiration(FNA) from the mass was done and cytopathologyconfirmedagranulomatouslesionthatstainedpositiveforanAFBsmear. Inviewofobstructive jaundice, theplanwastoproceedforCBDstentingandevaluatethestricturewiththeSpyGlass®DirectVisualizationSystem.

PrOCedUre

Wire-guidedCBDcannulationwasachieved,revealinga smooth stricture in the distal third of the CBD. Acholangioscopy using the SpyGlass System wasperformed after a papillotomy, which revealed anextrinsic bulge (Figure 1) with inflamed-appearingmucosa,causingluminalstenosisinthemidCBDfor1.5cm.TheproximalCBD,commonhepaticduct(CHD)andintrahepaticbileductwerenormal.Astraight10French,10cmplasticstentwaspassedacrossthestricturetoalleviate jaundice (Figure 2). In view of AFB +vegranulomasonEUSFNA,thepatientwasputonanti-tuberculosis treatment simultaneously. A diagnosis oftubercular peripancreatic lymphadenitis with biliarystricturecausingjaundicewasmade.

CONClUsION

TheSpyGlassSystemisausefulmodalityforimagingthebiliarytree,andtoknowthenatureofanobstruction.TheSpyGlassSystemhasdefinitelyaddedvaluetomypractice.

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I N M E M O R I A M

PeTer dUNsMOre sTeVeNs, MdDirector of Endoscopy, New York Presbyterian HospitalAssociate Professor of Clinical Medicine, Columbia University, New York, New York

November 1, 1961 – August 13, 2011

For years, many of us at Boston Scientific had the privilege to know and work with Dr. Peter D.Stevens, a gifted physician with a passion for patient care. Dr. Stevens demonstrated a deepcommitment to clinical research and advancing the field of interventional endoscopy. He wasrecognized and respected throughout the worldwide GI community for his vision, leadership anddedicationasateacherandmentorwhoneverlosthisownloveoflearning.

Dr.Stevenswasa leader indevelopingminimally invasive techniques for treatingpancreatic andbiliarydiseaseincludinghispioneeringworkwithsingleoperatorcholangioscopytogainitsacceptanceasastandardofcare.Dr.Stevenstouchedthelivesofsomanyandwemournthelossofthisbelovedphysicianandextraordinaryman.

sPYGlass® dIreCT VIsUalIZaTION sYsTeM

Biliary duct Varices diagnosed by Peroral Cholangioscopy with the spyGlass system

Case presented by: raffaele Manta, Md; angelo Caruso, Md; Helga Bertani, Md; Mauro Manno, Md; emanuele dabizzi, Md and rita Conigliaro, Md Gastroenterology and Digestive Endoscopy UnitNew Civil S. Agostino-Estense Hospital Baggiovara (Modena), ITAlY

PaTIeNT HIsTOrY

A58-year-oldmanwaswaitingfor“urgent”orthotopiclivertransplantation(OLT),duetoalcoholiclivercirrhosis(MELD:26)complicatedbyesophagealvarices(F2)andsplenomegalia.Becauseofincreasingjaundice,thepatientunderwentbloodtestsshowinghighlevelsofcholestaticliverenzymes(AST:149U/L;ALT:90U/L;totalbilirubin:12.6mg/dl;directbilirubin:4.8mg/dl),Ca19-9:230U/Landanemia(Hb:8.1gr/dl).Abdominalultrasound(US)diagnosedamildleftintra-hepaticbiliaryductdilatationwithnormalcommonbileduct(CBD)and incomplete portal vein thrombosis; a CT scan confirmed the US diagnosis and showed the absence of focal lesions in the liverparenchyma.Cholangio-magnetic resonanceimaging (MRI)underlinedthedilatationof left intrahepaticductswithoutstenosisoftheCBD;amildstenosisoftherightintrahepaticbiliaryductathilumbifurcationwithnocontrastmediumsignalinthehomolateralbiliarytract2cmabovethestenosisthatwassuspectedformalignancy (Figure 1).

PrOCedUre

The patient’s surgeons strongly required biopsy specimens bybiliarybrushingfromthestenotictractduringERCP.

ContrastmediumselectivecholangiographyobtainedduringERCPconfirmedthedilatationofleftintra-hepaticductswithoutlesionsintotheextrahepaticductslumenandshowedarightintrahepaticbiliary duct substenosis at the hilar bifurcation with stenosisestimatedintheleftbiliarytract,2cmabovethehilum(Figure 2).

On suspicion of malignancy at previous ERCP, and because ofanamnestic portal hypertension signs secondary to incompleteportal thrombosis,weperformedperoralcholangioscopywith theSpyGlass®Systemtodirectlyvisualizethelumenofthebiliaryducts.The SpyGlass System revealed four choledocal veins-ectasia/variceswithredmucosalspotslocalizedatmediumpartofCBD(notknownatpreviousERCP)andasubstenosisoftherightintra-hepaticductathilarbifurcationwithoutwalllesions.

Undercholangioscopicview,aJagwire®Guidewirewas insertedinto the right intra-hepatic duct; the direct visualization of thelumenwiththeSpyGlassSystemwasachieved.Twocmabovethehepatichilumshowedthestenotictractsecondarytobiliaryvarixthatdidnotallowtheguidewiretogothrough.

CONClUsION

TheSpyGlassSystemplaysafundamentalroleinthedifferentialdiagnosis between benign and malignant biliary stenosis notperformedbyeithercontrastmediumcholangiographyatpreviousERCP and/or others nor invasive radiological imaging techniques.The SpyGlass System provided direct visualization of the biliarylumen,allowedthecorrectdiagnosisofbiliarydisease,avoidedtheinvasive and dangerous endoscopic procedures (biliary brushing)with high risk of adverse events and it heavily changed thetherapeuticapproachandclinicaloutcomeofthepatient.

TwodayslaterthepatientsuccessfullyunderwentanOLT;noOLTrelatedcomplicationswerefoundatsixmonthsclinicalfollowup.

COMMeNT

Biliary ducts varices are a rare complication secondary to portalhypertensionanditisverydifficulttodistinguishthemfromotherbiliary tract diseases. Common non-invasive imaging techniques(US,CT,MRI)andendoscopicultrasonography(EUS)arethefirstdiagnostic tools to study the portal flow system. The SpyGlassDirectVisualizationSystemisthemostaccuratetooltodiagnosebiliarycomplicationssecondarytoportalhypertension.

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PaTIeNT HIsTOrY

A43-year-oldmalewithacquiredimmunedeficiencysyndrome(AIDS)withbiopsy-proveninvasivesquamouscellcarcinoma of the distal esophagus was admitted for recurrent aspiration pneumonia. A CT scan of the chestdemonstratedthatthedistalesophagealmasshaderodedintothelowerlobeoftherightlung.Bariumswallowconfirmedthepresenceofalargeesophagobronchialfistula(Figure 1).

PrOCedUre

Theprocedurewasperformedusingastandardupperendoscopeandrevealedalarge,circumferential,partiallyobstructing, fungatingandulceratingmassintheloweresophagusextendingtothelevelofthegastriccardiameasuring16cminlength.Alargeovalopeningmeasuringapproximately3cmwasnotedinthemidesophagus(Figure 2)consistentwiththeopeningofanesophagobronchialfistula.A0.035inchJagwire®Guidewirewasplacedintothestomachanda23mmby150mmWallFlexEsophagealPartiallyCoveredStentwasplacedunderendoscopicvisualizationensuringthatthecoveredportionofthestentclearlyoverlappedtheareaoffistulization(Figure 3).

POsT PrOCedUre

The patient did well following the procedure. A barium swallow was repeated on the following day, whichdemonstratednoextravasationofcontrastthroughthefistula(Figure 4).Thepatienttoleratedasoftdietandwasdischargedhomewithpalliativecare.

dIsCUssION

Malignantesophagorespiratoryfistulaedevelopduetoinfiltrationofesophagealcarcinomaintotherespiratorytract(tracheaorbronchi);aconditionassociatedwithhighmorbidityandmortalityrates.Caseseriesusingself-expandingmetalstents(SEMS)foresophagorespiratoryfistulaehavereportedocclusionratesof70-100%andcomplicationratesof10-30%.AcoveredorpartiallycoveredSEMSisusedtoachieveocclusionofthefistula;thelatterallowsproximalanddistalendstoembedintothetumorwhilethecoveredportionallowsocclusionofthefistula. Endoscopic placement of SEMS is now the treatment of choice for definitive palliative treatment ofesophagorespiratoryfistulaecausedbyadvancedesophagealcancer.

REFERENCES:1.SharmaP,KozarekRandthePracticeParametersCommitteeoftheAmericanCollegeof

Gastroenterology.AmJGastroenterol2010;105:258-273.2.ShinJH,SongHY,KoGY,etal.Esophagorespiratoryfistula:longtermresultsofpalliative

treatmentwithcoveredexpandablemetallicstentsin61patients.Radiology2004:232:252-9.

esophageal stenting in a Patient With a large esophagobronchial Fistula

sachin Wani, MdClinical Instructor in MedicineWashington University at St. louisSt. louis, Missouri, USA

daniel Mullady, MdAssistant ProfessorWashington University at St. louisSt. louis, Missouri, USA

WallFleX® esOPHaGael ParTIallY COVered sTeNT

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Case presented by:

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Note: Use of the WallFlex Biliary RX Fully Covered Stent for the treatment of benign strictures or stenoses have not been cleared for use in the United States.

PaTIeNT HIsTOrY

A42-year-oldmalewasadmittedforrecurrentrightupperquadrantabdominalpainformorethantwentyyears.Cholecystectomywasperformedtenyearsago,diagnosedas“gallstones”atalocalhospital.Thesymptomswererecurrentafterhischolecystectomy.Hewassubsequentlydiagnosedwithahilarandcommonbileduct (CBD)stenosis(Figure 1)threeyearsago.HeunderwentplasticstentexchangeduringERCPeighttimes;however,thesymptomsdidnotpalliateuntilacoveredmetalstentwasplacedduringERCP.Therewasnosymptomrecurrenceafterasix-monthfollowup.

PrOCedUre

ThefirstERCPshowedthebottomstenosiswithmoderateexpansionof theCBD,hilarbileductstenosiswithintrahepaticbiliarydilatation;plasticstentswerethenplacedintotheleftandrighthepaticducts.SixERCPswereperformedforstentreplacementevery4-6months,butthesymptomscontinuedtorecuruntila10mmx6mmWallFlex®BiliaryRXFullyCoveredStent(Figure 2)wasplaced.Thestricturewassignificantlyimproved(Figure 3),thestentwasremovedusingtheintegratedretrievalloopandanother10mmx6mmWallFlexBiliaryRXFullyCoveredStentwasplaced.

OUTCOMe

ERCPshowedstenosisof inferiorCBDwithmoderateexpansion.AWallFlexBiliaryRXFullyCoveredStentwasplacedinthebileductstrictureduringanERCP.ThestricturewassignificantlyimprovedafterbeingtreatedwithaWallFlexBiliaryRXFullyCoveredStent.

WallFleX® BIlIarY rX FUllY COVered sTeNT

Treatment of Malignant stenoses with the WallFlex Biliary rX Fully Covered stent

Case presented by: Xiaofeng Zhang, MdDepartment of GastroenterologyHangzhou No.1 People’s HospitalHangzhou, CHINA

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Clinical research Updates

WallFleX sTUdY COMPleTes eNrOllMeNT

Enrollment was completed in a clinical trial evaluating theWallFlex® Biliary rX Fully Covered stentforthetreatmentofbenignbileductstrictures.Onehundredandeighty-seven(187)patientswereenrolledat13centersincluding7inEurope,3inCanada,and1eachinIndia,AustraliaandChile.Thetrialwillevaluateremovabilityofthesestentsfollowingtemporaryindwell(5-11months)aswellastheeffectivenessoftemporarystenting for long-term stricture resolution assessed to fiveyears after stent removal. The trial is sponsored by BostonScientificandguidedbyProfessor Guido Costamagna (Rome,Italy)andProfessor Jacques deviere(Brussels,Belgium).

Peer-reVIeWed MedICal JOUrNals TO PUBlIsH sTUdY resUlTs

Finalresultsfromfourpost-marketclinicalregistriessponsoredbyBostonScientificwereacceptedforpublicationandwillbeinprintshortly.

soren Meisneretal.willpublishinGastrointestinal Endoscopy thecombinedresultsoftworegistriesdocumentingperformanceoftheWallFlex Colonic stentconductedat39centersin13countries.Thearticleentitled,“Self-expandingmetallicstentforrelieving malignant colorectal obstruction: Short term safetyandefficacywithin30daysofstentprocedurein447patients”representsthelargestmulti-centerprospectivestudytodateof colonic self expanding metal stents (SEMS) placement inpalliative care or bridge-to-surgery settings. The authorsconcludethatcolonic(SEMS)aresafeandhighlyeffectiveforthe treatment of malignant colorectal obstruction, allowingmost curable patients to have a one-step resection withoutstomaandprovidingmostincurablepatientsminimallyinvasivepalliation instead of surgery. They also conclude that risk ofcomplications,includingperforation,waslow.

Javier Jimenez-Perez et al. will publish in the American Journal of Gastroenterology the complete follow up of 182patients treated with the WallFlex Colonic stent as abridge-to-surgery in the same two registries. Theauthorsofthearticleentitled,“Colonicstentingasabridge-to-surgeryinmalignantlargebowelobstruction—areportfromtwolargemulti-nationalregistries”concludethatcolonicSEMSprovidean effective bridge-to-surgery treatment with an acceptablecomplication rate in patients with acute malignant colonicobstruction, restoring luminal patency and allowing electivesurgerywithprimaryanastomosisinmostpatients.

Guido Costamagnaetal.willpublish inDigestive and Liver Disease thecompleteresultsofaWallFlex duodenal stentregistry conducted at 12 centers in 10 countries. The articleentitled “Treatmentofmalignantgastroduodenalobstructionwith a Nitinol self-expanding metal stent: An internationalprospectivemulticentreregistry”reportson202patients.Theauthors conclude that safety and effectiveness of duodenalstentingforpalliationofmalignantgastroduodenalobstructionwasconfirmedinthe largest internationalprospectiveseriestodate.

Yang Chen† et al. will publish in Gastrointestinal Endoscopy thecomplete results froma15-center,297patientstudy, thelargest to date prospective series on peroral cholangioscopy.The article is entitled “Single-operator cholangioscopy inpatientsrequiringevaluationofbileductdiseaseortherapyofbiliarystones”.Theauthorsconcludethatevaluationofbileductdiseaseandbiliarystonetherapycanbesafelyperformedwithahighsuccessratebyusingthesingle-operatorcholangioscopy(SpyGlass®)System.

“Overthepastfiveyears,wehaveinvestedmillionsofdollarsinclinicalresearchconductingtrialsinmorethan110centersin21countries,andenrollingnearly1,400patients,”saidJoycePeetermans,PhD,DirectorofClinicalPrograms,BostonScientific.

“We are honored to partner with worldwide experts ingastrointestinal endoscopy to design and conduct trials withhighethical standards, inclusiveof complete transparencyofresultsandacommitmenttopublishingallstudyfindings.Wefocusonresearchthathasthepotentialtoexpandtreatmentoptionsandpositivelyimpactpatientcare,withintegrityeverystepoftheway.”

A C C E S S U P D A T E S

Joyce Peetersman, PhdDirector of Clinical Programs Boston Scientific, Endoscopy

8 a c c e s s

†deceased

WallFlex® Biliary rX Fully Covered stent approved in Canada for Use in Treating Benign Biliary strictures

Health Canada has approved the WallFlex® Biliary RX FullyCovered Stent for the treatment of benign biliary strictures,which supplements its current indication for management ofmalignantbiliarystrictures.

“Benign biliary strictures related to an injury, anastomosis orchronicpancreatitismaybechallengingtoresolve,”saidAndréRoy,M.D.,FRCSC,DirectoroftheLiverTransplantationProgramat Hôpital Saint-Luc du Centre Hospitalier de l’Université deMontréal. “The WallFlex Stent incorporates the latestinnovationsinself-expandingmetalstenttechnologyandmayprovide significant benefits as a less-invasive alternative tosurgeryinthesepatients.”

“Current management of benign biliary strictures typicallyincludes repeated dilation with balloons and plastic stents.However, this new approval allows me to offer a one-stepalternative,whichmayhelptoreducethenumberofproceduresmypatientsmustundergo,whileproviding thebestpossiblecare and containing costs,” said Paul Kortan, M.D.,GastroenterologistatSt.MichaelsHospitalinToronto.

TheWallFlexBiliaryRXFullyCoveredStent is constructedofbraided, Platinol™ (platinum-cored Nitinol) wire and featuresthreekeyattributes:radialforcetohelpmaintainductpatencyandresistmigration,flexibilitytoaidinconformingtotortuous

anatomies and full-lengthradiopacity to enhance stentvisibilityunderfluoroscopy.TheWallFlex Biliary RX family ofstents is available in fullycovered, partially covered anduncovered versions. Thecovered stents have a siliconepolymerPermalume®coatingdesignedtoreducethepotentialfortumor/tissueingrowth,andan integrated retrieval loop for removingor repositioning thestent in the event of incorrect placement during the initialprocedure or for removal up to 12 months following initialplacementinbenignstrictures.

ThecompletelineofWallFlexBiliaryRXStentshaspreviouslyreceivedHealthCanada,CEMarkandFDAclearance for thepalliativetreatmentofmalignantbiliarystrictures.TheWallFlexStentisthemostfrequentlyimplantedbiliarymetalstentintheU.S.,CanadaandEurope.

IntheU.S., theWallFlexBiliaryRXFullyCoveredStent isnotapproved for the treatment of benign biliary strictures. Thesafety and effectiveness of the WallFlex Biliary RX StentSystemforuseinthevascularsystemhavenotbeenestablished.

Cre Wireguided Balloon dilatation Catheter

The CRE™ Wireguided Balloon Dilatation Catheter has been CE Marked for endoscopic dilatation ofstricturesofthebiliarytreeandtheSphincterofOddifollowingsphincterotomy.

The CRE Wireguided Balloon Dilator is constructed of Pebax® material and uses a Three-in-OneTechnology, designed for successive, gradual dilation of strictures, helping to eliminate the need formultipleballoonstoemploymulti-sizedilationtherapy.TheroundedshoulderdesignisengineeredtohelpfacilitateBalloonEndoscopyandtoprovidevisualizationduringdilation.Thepreloadedguidewireisdesignedtofacilitateplacementwithintightstricturesandtortuousanatomy.

The CRE Wireguided Dilatation Balloon is pending 510(k) clearance in the United States for “endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi following Sphincterotomy,” it is not available for sale in the United States for this indication.

I n t e r n a t I o n a l n e w s

NOW CE MARKED

FOR THE

a c c e s s 9

educational Videos Now available to Physicians Worldwide

TheBostonScientificEndoscopyChannelonYouTube®,launchedduringDigestiveDiseaseWeek(Chicago,Ill.)earlierthisyear,hasreceivedover16,000visitorsfrom101countries.Withmorethan70videosandasteadystreamofnewarrivals,thesitefeaturesselectphysicianpresentations,animations,andcasestudiesonERCP,endoscopicultrasound-fineneedleaspiration,cholangioscopy/pancreatoscopy,stricturemanagement,tissueacquisition,andmoreusingBostonScientifictechnologiestotreatavarietyofdigestiveandpulmonaryconditions.

A global platform for peer-to-peer physician best practices,this web-based program is intended to support learning ondemand.“BostonScientifichasbeenalong-standingindustryleader in providing hands-on clinical training and educationprogramsforphysiciansandhospitalstaff,”saidArtButcher,GlobalVicePresidentofMarketing,BostonScientificEndoscopy.

“The Endoscopy Channel offers an efficient and effectivecomplement for physicians and nurses to keep current onemergingpracticesfromaroundtheworldanytime,anywhere.”

Warning: The safety and effectiveness of biliary metal stents for use in the vascular system has not been established.

The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.ACCESS Magazine was produced in cooperation with several physicians. The procedures discussed in this document are those of the physicians and do not necessarily reflect the opinion, policies or recommendations of Boston Scientific Corporation or any of its employees.CRE, Captivator, Expect, Jagwire, Resolution, SpyGlass, and WallFlex are unregistered or registered trademarks of Boston Scientific Corporation and its affiliates. TWISTER is a trademark of Horizons International Corporation. All other trademarks are the property of their respective owners.

© 2011 by Boston Scientific Corporation or its affiliates. All rights reserved.

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Boston scientific endoscopy launches YouTube Channel

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www.YouTube.com/Bostonscientificendo.

Cholangioscopy/ Pancreatoscopy4hoursagomoreinfo

enteral access 2hoursagomoreinfo

erCP 2hoursagomoreinfo

eUs 5hoursagomoreinfo

Hemostasis 6hoursagomoreinfo

Pulmonary 3hoursagomoreinfo

stricture Management 1houragomoreinfo