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Klinik für Gastroenterologie und Hepatologie
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Klinik für Gastroenterologie und Hepatologie
• Duodenal ulcerations 27%
• Gastric ulcerations 24%
• Varices 19%• Gastroduodenal erosions 13%
• Reflux esophagitis 10%
• Mallory-Weiss lesions 7%
• Tumores 3%
• Angiodysplasia 1%
• not identifiable 6%
Ell, DMW 1995
Etiologies of Upper GI Bleeding
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Klinik für Gastroenterologie und Hepatologie
Risk of development in liver cirrhosis:
30-40% with compensated cirrhosis
60 % with decompensated cirrhosis
New onset of esophageal varices in liver cirrhosis 5-10%/year
Esophageal Varices- Epidemiology -
1°: collaps on insufflation 2°: 1/3 of luminaldiameter
3°: >50% of luminaldiameter
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Klinik für Gastroenterologie und Hepatologie
Total bleeding risk of esophageal varices 25-50%
Factors determining risk of hemorrhage
Mortality after hemorrhage (up to 50% in 6 weeks)
70% re-bleeding within first year without secondary prophylaxis
Esophageal Varices- Epidemiology -
García-Pagán, Sem Respir Crit Care Med 2012
HPVG >12mmHg Large varices Child-Pugh stage MELD score Alcohol consumption
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Klinik für Gastroenterologie und Hepatologie
• Primary prevention
• Acute variceal bleeding
• Prevention of recurrent bleeding
Esophageal Varices- Therapeutic Scenarios -
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Klinik für Gastroenterologie und Hepatologie
Use hepatic venous pressure gradient (HPVG) for estimation of
indication/prognosis (if available)
De Franchis, J Hepatol. 2010 (Baveno V Consensus Workshop)
Variceal Bleeding- Primary Prevention-
Non-selective betablockers Band ligation
Small varices without riskfactors
± no
Small varices with redspots or CHILD C
yes no
Medium or large varices Either betablockers or band ligation
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Klinik für Gastroenterologie und Hepatologie
Esophageal Variceal Bleeding- Preendoscopic therapy -
- Venous access (multiple large catheters)
- Volume resuscitation
- ICU treatment, stabilization
- Blood transfusions (hemoglobin cut-off 7g/dl)
- Pharmacotherapy: terlipressin (on suspicion of variceal bleeding)
Terlipressin Placebo
Active VB (endoscopy) 17% 28%
Recurent bleeding (12h) 12% 26%
Mortality (20d) 20% 42%
Levacher, Lancet 1995
De Franchis, Dig Liver Dis. 2004
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Klinik für Gastroenterologie und Hepatologie
Band ligation superior to sclerotherapy(early and long term results)
Villanueva, J Hepatol 2006
Therapy(+pharmacoth.)
Primary failure
Early recurrence
Complications
Band ligation 4% 5% 14%
Sclerotherapy 15% 9% 28%
Esophageal Variceal Bleeding- Endoscopic standard therapy -
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Klinik für Gastroenterologie und Hepatologie
Esophageal Variceal Bleeding- Endoscopic standard therapy -
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Klinik für Gastroenterologie und Hepatologie
Esophageal Variceal Bleeding- Endoscopic standard therapy -
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Klinik für Gastroenterologie und Hepatologie
Esophageal Variceal Bleeding- TIPS -
Hepatic vein
Portal vein
TIPS
Transiugular Intrahepatic Portosystemic Shunt
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Klinik für Gastroenterologie und Hepatologie
TIPS in high-risk patients after EBL
High risk: Child B + active bleedingChild C (all pts)
Early TIPS: Failure of therapy Recurrent bleeding 1year mortality
Garcia-Pagan, N Engl J Med. 2010
Problem:TIPS in salvage situation – death in >50%
Esophageal Variceal Bleeding- TIPS -
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Klinik für Gastroenterologie und Hepatologie
Survey 01
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Klinik für Gastroenterologie und Hepatologie
Failure to control bleeding
Esophageal Variceal Bleeding- Treatment Failure -
Baveno IV- Time frame 120 hours- Fresh hematemesis ≥2 hours after treatment
/ endoscopic intervention- >3g/dl drop in hemoglobin (no transfusions)- Death- Adjusted blood transfusion requirement index (ABRI)≥0.75
Baveno V- Time frame 120 hours- Fresh hematemesis / NG tube aspiration
≥2 hours after treatment / endoscopic intervention- >3g/dl drop in hemoglobin (no transfusions)- Hypovolemic shock or death
De Franchis, J Hepatol 2005De Franchis, J Hepatol. 2010
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Klinik für Gastroenterologie und Hepatologie
Balloon tamponade
Esophageal Variceal Bleeding- Treatment Failure -
Sengstaken – Blakemore - Tube
Limited time frame (<24 hours, if possible)Frequent decompression necessary to avoid esophageal necrosisHigh complication rate – aspiration / regurgitation / perforation
Panes, Dig Dis Sci 1988
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Klinik für Gastroenterologie und Hepatologie
Self-expanding metal stent (SEMS)SX Ella Stent DANIS
Esophageal Variceal Bleeding- Treatment Failure -
Work principle: - distension of esophageal wall
- compression of esophageal varices
- termination of hemorrhage
Device properties: - fully covered metal stent
- flares on both ends
- retrieval lassos on both ends
- delivery system with positioning balloon
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- System Demonstration -
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Recommendations for Placement -
SEMS placement possible without endoscopic guidance
Confirm esophageal bleeding source whenever possible
Use a guidewire (guide wire included) when possible
Adhere strictly to implantation manual
Endoscopic and/or radiographic guidance during stent
deployment possible
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Follow-up care -
Confirm proper stent placement by endoscopy as soon as possible
Check stent position after 24h (by X-ray or endoscopy) or in
signs of bleeding
After stent placement, stabilize pt. and evaluate TIPS indication
Remove stent after a week, longer indwelling time often possible
Remove stent urgently on suspicion of airway compression
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Klinik für Gastroenterologie und Hepatologie
Survey 02
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Extraction -
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Clinical Case -
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Klinik für Gastroenterologie und Hepatologie
Pilot study
11/02-05/05 143 episodes of esophageal variceal bleeding
15 refractory bleedings
+ 3 pts. with balloon compression
+ 2 pts. without primary endoscopic therapy
Three stent designs (diameter 18-25mm, length 95-140mm)
Stent indwelling time 1 – 14d
SX Ella Stent Danis- Published Data-
Hubmann, Endoscopy 2006
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Klinik für Gastroenterologie und Hepatologie
Complementarytreatment
n 60-day-mortality
TIPS 5 (28%) n = 0
Surgical shunt 5 (28%) n = 0
Band ligation 5 (28%) n = 1
Medical 2 (11%) n = 1
SX Ella Stent Danis- Published Data-
Immediate hemostasis in all patients
Stent removal in 18/20 pts (n=2 fatal liver failure)
No primary complications with explant
Hubmann, Endoscopy 2006
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Klinik für Gastroenterologie und Hepatologie
Extended cohort (2008)
01/03-08/06 34 SEMS in eosphageal variceal bleeding (all SX-Ella)
Implantation without complications, n=7 distal dislocations (partial)
Stent indwelling time1 – 14d, median 5d
Complementarytreatment
n
TIPS 8 (24%)
Surgical shunt 5 (15%)
Band ligation 11 (32%)
Medical ?
No recurrent bleeding with indwelling stent
No recurrent bleeding 30d after SEMS removal
60-day mortality n=10 (29%)
SX Ella Stent Danis- Published Data-
Zehetner, Surg Endoscopy 2006
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Klinik für Gastroenterologie und Hepatologie
2010
10 SEMS in esophageal variceal hemorrhage (all SX-Ella)
n=5 failure of primary endoscopic treatment
n=3 unsuccessful balloon compression
n=2 eophageal perforation on balloon compression
9/10 successful implantation (1/10: dysfunction of positioning balloon)
7/9 immediate hemostasis (2/9: bleeding source distally to esophagus)
SX Ella Stent Danis- Published Data-
Wright, Gastrointest Endoscopy 2010
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Klinik für Gastroenterologie und Hepatologie
Follow up:
42d-survival 50%
4/10 sustained hemostasis (>60d), 2xTIPS
1/10 early recurrence (30d), successful EBL+TIPS
2/10 death by exsanguination (distal bleeding)
1/10 death by multi-organ failure with indwelling stent
2/10 death by multi-organ failure after stent removal
SX Ella Stent Danis- Published Data-
Wright, Gastrointest Endoscopy 2010
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Klinik für Gastroenterologie und Hepatologie
8 pts. with esophageal variceal hemorrhage (08/07-08/09)
5 male, 3 female, median age 62 years (1 pt. treated twice with SEMS)
Acute bleeding episodes, refractory to pharmacological treatment and EVL
SX Ella Stent Danis- Published Data from Essen, Germany-
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Published Data from Essen, Germany-
9/9: EV-hemorrhage
and SEMS implant
3/9 Intervention directed at
lowering portal pressure
6/9 only pharmacologic treatmentto lower portal pressure
3/3 Stent removal after10 ± 1,5 d (8-11d)
5/6 SEMS removal after10 ± 3,6 d (6-12)
1/6 Death after 5d
4/5 SEMS removal after stabilization
1/5 Emergency SEMS removal(bronchus compression)
3/3 SEMS removalafter intervention and stabilization
No recurrent bleeding withindwelling SEMS
9/9: immediate hemostasis
Death 13 days after SEMS removalwithout further bleedingDechêne, Digestion 2012
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Published Data from Essen, Germany-
n=3Intervention (PPG )
prior to SEMS removal
n=4Pharmacological therapy of
portal pressure beforeSEMS removal
3/3 free of hemorrhage>3 months
3/4 recurrent bleeding within 10 days
1/3 EVLDeath after 57 days
2/3 death fromrefractory bleeding
1/4 free of hemorrhage> 3months
2/3 death after 14 days
Dechêne, Digestion 2012
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Published Data from Essen, Germany-
Patient #. 4
5d after SEMS placement: criticalimpairment of mechanical ventilation
Compression of right main bronchusby the SEMS
Emergency SEMS removal
Dechene Endoscopy. 2009
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent Danis- Published Data-
Fierz, Case Rep Gastroenterol 2013
9 SEMS in 7 patients, 3/9 without prior endoscopic treatment attempt
Hemostasis in 8/9, SEMS removal 12h – 5 days after stent placement
4/7 patients surviving >5 days, TIPS (3/4) or EBL (1/4)
Holster I, Endoscopy 2013
5 SEMS in 5 patients, failed attempts at EBL in all patients
Hemostasis in 5/5, SEMS removal in only 2/5 (after TIPS or liver transplantation)
1/5 patients deceased 214 days after intervention with indwelling stent
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Klinik für Gastroenterologie und Hepatologie
Survey 03
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Klinik für Gastroenterologie und Hepatologie
De Franchis. J Hep 2010
Rosolowski M, PrzGastroenterol 2014
„Another highly effective emergencyprocedure is endoscopic placement ofremovable, self-expanding metal stents(SX-Ella Danis stent).“
„Uncontrolled data suggest that self-expandingcovered esophageal metal stents may be an option in refractory esophageal varicelbleeding...“
SX-Ella Stent DanisSociety Statements
„Baveno V“
„Danis-Stent when endoscopy is not available or ineffective“
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent DanisClinical Case
57 y female, alcoholic liver cirrhosis
First episode of esophageal variceal bleeding treated successfully with EBL
Three months later: second variceal hemorrhage, refractory EBL + ethanol injection
Balloon compression (Senkstaken-Blakemore tube), referral to Essen University Hospital
Transjugular Intrahepatic Portosystemic Stent-ShuntSklerosing ulcers
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent DanisClinical Case
57 y female, alcoholic liver cirrhosis
152 days after TIPS implantation: recurrent variceal bleeding, refractory to EBL
Immediate hemostasis after implantation of SX-Ella Stent Danis
Esophagus with SX-Ella Stent Danis
After implant (d1) Before removal (d7) After removal (d7)
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent DanisClinical Case
57 y female, alcoholic liver cirrhosis
152 days after TIPS implantation: recurrent variceal bleeding, refractory to EBL
Immediate hemostasis after implantation of SX-Ella Stent Danis
TIPS dilation and retrograde embolization of gastric veins
Before TIPS-Dilatation Arrows: Gastric veins After Dilation/Embolization Arrow: Coil in gastric vein
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Klinik für Gastroenterologie und Hepatologie
SX Ella Stent DanisClinical Case
57 y female, alcoholic liver cirrhosis
341 days after TIPS implantation: recurrent variceal bleeding, refractory to EBL
Repeat deployment of SX-Ella Stent Danis with complete hemostasis
Surgical implantation of PTFE-covered splenorenal shunt
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Klinik für Gastroenterologie und Hepatologie
Conclusions
Esophageal Variceal Bleeding
Primary and secondary prophylaxis regimes are well defined
Treatment of hemorrhage and secondary prophylaxis by endoscopic means
In refractory bleeding, self-expanding metal stents (SEMS) very effective
Low complication rate of SEMS treatment
Removal of stents via dedicated extraction device
Combination with complementary methods of decreasing portal pressuremandatory
Stepwise repetition of therapeutic measures often necessary and successful
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Klinik für Gastroenterologie und Hepatologie
Time for your questions