HBV carrier, childs B cirrhosisAdmitted x Upper GI BleedingOGD: bleeding esophageal varices, banding performedRebleeding few hours later failed to stop bleeding with endoscopic method (banding and sclerotherapy)Put in Sengstaken tube complicated with esophageal tear

We put in a metal stent for rupture esophagusPatient has no more bleeding

? Metal stent can stop variceal bleeding?

[4]

Haemetemesis/MelenaResuscitationEndoscopy (OGD)Variceal ligation (Banding) / SclerotherapyConfirm esophageal variceal bleedingPrevent rebleeding:VasoconstrictorBalloon Temponade:- Sengstaken-Blakemore tubeSuccessFailure

Haemetemesis/MelenaResuscitationEndoscopy (OGD)Variceal ligation (Banding) / SclerotherapyConfirm esophageal variceal bleedingPrevent rebleeding:VasoconstrictorBalloon Temponade:- Sengstaken-Blakemore tubeSuccessFailureSEMS

SX-Ella DANIS stent [10]Removable, covered, self-expandingControl variceal bleeding by tamponade effectPlaced at most 2 weeks

Gold markers: loops at both end (for repositioning and stent removal)

Radiopaque markers: at both ends and midpoint

Stent insertion

Mean duration of procedure: 10 (+/- 6 minutes) [7]

[14]GuidewireGastric balloonStentBalloon portWire portBlue lockWhite lock

[14]

Stent Removal

[5]

Can be left in situ as long as 2 weeksCannot be removed by an agitated patientAllow detailed and repeated endoscopic examinationLess risk of pulmonary aspiration

LimitationGastric varices cannot be controlled [9]Do not exert a lasting effect

ComplicationStent migration into stomachEsophageal ulcerEsophageal tear

SEMS

Control of acute bleeding (Time frame: 120 hours (5 days)), failed if [12]DeathFresh hematemesis / >=100ml fresh blood aspirated Hypovolaemic shockHb drop >3g/dL within any 24 hour

Success of stent placementDuration of placementStent migrationComplicationMortality

Definition according to Baveno criteria

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%6.7% esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%2.9% esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A10% esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%12.5%compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%6.25% esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

Case series, not controlled trialSmall sample size

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%1 esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%1 esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A1 esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%1compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%1 esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

Failure (delivery system error) gastric balloon rupture failed inflation

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%1 esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%1 esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A1 esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%1compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%1 esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

c.f. Balloon tamponade: 80%

Failure: GV bleeding failed stent deployment

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%1 esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%1 esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A1 esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%1compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%1 esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

How to decide??

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%1 esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%1 esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A1 esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%1compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%1 esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

Immediate repositioning

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%1 esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%1 esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A1 esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%1compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%1 esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

Esophageal tear

Esophageal ulcer

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%6.7% esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%2.9% esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A10% esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%12.5%compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%6.25% esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

c.f. Usual 6 week mortality rate: 15-20%

Reason of death liver failure, multi-organ failure, uncontrolled bleeding

High mortality rate Selection bias (more severe underlying liver disease)

Further study to rule out ? Related to stent Delayed / Unrecognized complication

No. of patientSuccess in stent placementControl of bleedingdurationStent migrationLocal complicationmortalityHubmann et al. 2006 [3]15100%100%5 days (1-14)25%1 esophageal tear20% (60 days)Zehetner et al. 2008 [4]34100%97%5 days (1-14)18%1 esophageal tear29% (60 days)Wright et al. 2010 [5]1090%70%9 days (6-14)N/A1 esophageal ulcer50% (42 days)Dechene et al. 2012 [6]8100%88%11 days (7-14)0%1compression of left main bronchus75% (60 Days)Zakaria et al 2013 [7]1693.75%87.5%2-4 days37.5%1 esophageal ulcer25% (42 days)Febienne et al 2013 [8]989%89%1-5 days22%0%77% (42 days)

How to monitor any re-bleeding/complication after stent insertion ? Daily OGD/CXR

? One single size of stent fit for every patient

Need expertise for stent placement

Limitation of studyLimited number of study availableNot a controlled studySmall sample sizeOnly short term follow up (up to 60 days)

Future studyNeed randomized trialLarger sample sizeLong term follow up

SEMS is a recent advance in management of refractory esophageal variceal bleeding

Considered as a alternative to balloon temponade

safe and effective treatment in limited datalow complication rateSatisfactory rate of bleeding control & stent deployment

need further study

Practical aspect: duration, monitoring, expertise

Garcia-Tsao G, Sanyal AJ, Grace ND, et al. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology 2007; 46: 922-38.Gin-Ho Lo. Management of acute esophageal variceal hemorrhage. Kaohsiung J Med Sci 2010; 26: 55-67.Hubmann R, Bodlaj G, Czompo M, et al. The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy 2006; 38: 896901. Zehetner J, Shamiyeh A, Wayand W, et al. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc 2008; 22:21492152.Wright G, Lewis H, Hogan B, et al. Self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc 2010;71:7178.Dechene A, El Fouly AH, Bechmann LP, et al. Acute management of refractory variceal bleeding in liver cirrhosis by self-expanding metal stents. Digestion 2012;85:185191.Zakaria MS, Hamza IM, Mohey MA, et al. The fist Egyptian experience using new self-expandable metal stents in acute esophageal variceal bleeding: Pilot study. Saudi J Gastroenterol 2013; 45: 485-8.Fabienne C. Fierz, Walter Kistler, Volker Stenz, et al. Treatment of esophageal variceal hemorrhage with self-expanding metal stents as a rescue maneuver in a swiss multicentric cohort. Case Rep Gastroenterol 2013; 7: 97-105.Fuad Maufa and Firas H. Al-Kawas. Role of Self-Expandable Metal Stents in Acute Variceal Bleeding. Internalional Journal of Hepatology 2012; 418369.Angels Escorsell and Jaime Bosch. Self-Expandable Metal Stents in the Treatment of Acute Esophageal Variceal Bleeding. Gastroenterology Research and Practice 2011; 910986.Vivek Kumbhari, Payal Saxena, Mouen A, et al. Self-Expandable Metallic Stents for Bleeding Esophageal Varices. The Saudi J of Gastroenterology 2013; 1434Roberto de Franchis, on behalf of the Baveno V Faculty, Revising consensus in portal hypertension: Report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension, Journal of Hepatology 2010; 53: 762-768National Institute for Health and Clinical Excellence. Stent insertion for bleeding oesophageal varices. 2011; April Lszl Benk M.D. New minimal invasive therapeutic options in the management of acute and recurrent esophageal bleeding, 2007

[13]

Weak evidence

SEMSFailureSEMS1st stage2nd stage

The Danis stent is larger in diameter and the expansion force has been adjusted to work efficiently against bleeding varices, but not to harm the esophageal tissue.

The larger diameter is sufficient to fit every patient.

The pressure exerted by the stent has been evaluated in animal model and later with clinical experience to be sufficient and safe

[9]

Pre-primary prophylaxis (Prevention of formation of varices)Non-selective beta-blockers: no evidence to prevent formation of varicesOGD: Should be screened for varices at diagnosis

Primary prophylaxis (prevention of first variceal hemorrhage)Non-selective beta blocker: Recommended OGD: Esophageal variceal ligation (EVL) recommendedRepeated every 1-2 weeks till complete obliteration

Secondary prophylaxis (prevention of rebleeding)Combination of nonselective beta blockers + EVLTIPS: recurrent variceal haemorrhageTransplant

When remove stentBind time to let pharmcological therapy to workWhen elective procedure a/v or expertise a/vConvert emergency procedure to elective

Contraindication of stentStrictureEsophageal tumorPrevious radiationBody weight

MigrationCovered stentWait for 3 minutes for full expansionOptimal integration with esophageal wallUncovered stentMetal wire to dense: impringe on varices with pin point pressureMetal wire not close: varices may squeeze out between wire and cant exert temponade effect

Pressure it exertNot specific mentionedRadial pressureEvaluate in animal model and clinical experience to be sufficient and safe

MonitoringCXR dailyOGD alt day

Treat the symptom, not underlying cause (liver failure)Treat esophageal varicesPhysical: banding, sengstaken, SEMSChemical: sclerosant, superglue (cyanoarcylate monomer)Treat underlying diseaseBest medical treatment

Further treatmentLate stageFurther treatment has its own risk and complication, e.g. TIPS (seldom do)Best medical treatmentNutrition, lactulose, antibiotic, avoid hepatotoxic drug, medication, etcIn our study: EVL, TIPS, shunt surgery, transplant

EV bleeding: commonly encountered emergency in daily practice

Introduce a new device*Why failed endoscopic mean? Profuse bleeding, friable mucosa, *Refractory bleeding: 10% (ongoing bleeding despite pharmacological and endoscopic treatment)*Ella-CS, Hradec Kralove, Czech RepublicConform to esophageal peristalsis reduce risk of stent migrationProtective pressure valve that does not allow gastric balloon to inflate against resistance

*Endoscopy also confirm whether bleeding stoppedDistal portion of stent delivery system withdrawn to allow inflation of gastric balloon

*Guidewire delivered into stomachStent delivery device advanced over the guidewireGastric balloon inflated with 100ml of airWithdraw whole system until resistance felt (i.e. balloon impacted at cardia)Thus anchoring the distal end of stent during deploymentGastric balloon deflated and stent delivery system withdrawnEndoscopy or X-ray to confirm positioning

*Also can look for any immediate re-bleeding?

Through endoscopic procedure and a foreign body retractorGrasp the proximal loop of the stent Blunt ended plastic sheath advanced over the wire constrain the stents without exerting shear force

*Definite treatment: TIPS, lap azygoportal disconnection, band ligation, interventional radiography-guided coiling, transplantMaximum 2 weeks: minimize risk of migration and wall injury or reaction [9]SEMS: Standardized expansion power and pressure to esophageal wall

*Prevent migration of stent into stomach: (minimize by delayed the second endoscopy for 3 mins (give time for full stent expansion and optimal integration with esophageal wall)Definitve therapy: e.g. EVL, TIPS, transplant*Recurrent bleeding: i.e. secondary prophylaxis

*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*Location of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*All are case seriesLocation of study: Austria, UK, Egypt, Swiss, Stent migration: repositionOverlap between first 2 studies+ further management, child grading, cause, etc*Most study: either inserted with radiographic or endoscopic guidanceSome study: daily CXR for stent position, bleeding control by clinical, blood testFurther management after stent removal? TIPS, EVL, surgical shunt, etcPressure that it can exert?Theorectically how much pressure to arrest EV bleeding?How is it different from commonly used stents in malignant stricture

Attempted in HK?

*Treatment for EV bleeding with esophageal tearApplicability of data to other currently available fully covered SEMSAs initial first line treatment (in emergency room)As definitive therapy

*Failed EVL/EIS: profuse bleeding, prevoius intervention*Non-endoscopic method in predict varices: plt count, fibroteest, spleen size, PV diameter, transient elastography(point prevalence of medium/large varices: 15-25%)Rebleeding rate in untreated individual: 60% within 1-2 years need secondary prophylaxis*