klinik für gastroenterologie und hepatologie · klinik für gastroenterologie und hepatologie...

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


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


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


• Primary prevention

• Acute variceal bleeding

• Prevention of recurrent bleeding

Esophageal Varices- Therapeutic Scenarios -


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


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


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 -


Esophageal Variceal Bleeding- Endoscopic standard therapy -


Esophageal Variceal Bleeding- TIPS -

Hepatic vein

Portal vein

TIPS

Transiugular Intrahepatic Portosystemic Shunt


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 -


Survey 01


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


Balloon tamponade


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


Self-expanding metal stent (SEMS)SX Ella Stent DANIS


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


SX Ella Stent Danis- System Demonstration -


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


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


Survey 02


SX Ella Stent Danis- Extraction -


SX Ella Stent Danis- Clinical Case -


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


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


Immediate hemostasis in all patients

Stent removal in 18/20 pts (n=2 fatal liver failure)

No primary complications with explant

Hubmann, Endoscopy 2006


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%)


Zehetner, Surg Endoscopy 2006


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)


Wright, Gastrointest Endoscopy 2010


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


Wright, Gastrointest Endoscopy 2010


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-



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



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



Patient #. 4

5d after SEMS placement: criticalimpairment of mechanical ventilation

Compression of right main bronchusby the SEMS

Emergency SEMS removal

Dechene Endoscopy. 2009



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


Survey 03


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“


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




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)





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





Repeat deployment of SX-Ella Stent Danis with complete hemostasis

Surgical implantation of PTFE-covered splenorenal shunt


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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