1. Recent advance in management of esophageal variceal bleeding Joint Hospital Surgical Grand Round 25 January, Tse Pui Ying Nicole (TMH)
EV bleeding: commonly encountered emergency in daily practice
Introduce a new device

2. M/58 We put in a metal stent for rupture esophagus
HBV carrier, child’s B cirrhosis
Admitted x Upper GI Bleeding
OGD: bleeding esophageal varices, banding performed
Rebleeding 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 esophagus
Patient has no more bleeding
? Metal stent can stop variceal bleeding?
Why failed endoscopic mean? Profuse bleeding, friable mucosa,

3. Recent advance in management of esophageal variceal bleeding Self-Expanding Metal Stents (SEMS)
Refractory bleeding: 10% (ongoing bleeding despite pharmacological and endoscopic treatment)
[4]

4. Current management Haemetemesis/Melena Resuscitation Endoscopy (OGD)
Confirm esophageal variceal bleeding
Variceal ligation (Banding) / Sclerotherapy
Failure
Success
Balloon Temponade:
- Sengstaken-Blakemore tube
Prevent rebleeding:
Vasoconstrictor

5. Current management SEMS Haemetemesis/Melena Resuscitation
Endoscopy (OGD)
Confirm esophageal variceal bleeding
Variceal ligation (Banding) / Sclerotherapy
Failure
Success
Balloon Temponade:
- Sengstaken-Blakemore tube
Prevent rebleeding:
Vasoconstrictor
SEMS

6. SEMS SX-Ella DANIS stent [10] Removable, covered, self- expanding
Control variceal bleeding by tamponade effect
Placed at most 2 weeks
Gold markers: loops at both end (for repositioning and stent removal)
Radiopaque markers: at both ends and midpoint
Ella-CS, Hradec Kralove, Czech Republic
Conform to esophageal peristalsis  reduce risk of stent migration
Protective pressure valve that does not allow gastric balloon to inflate against resistance

7. SEMS
Stent insertion
Mean duration of procedure: 10 (+/- 6 minutes) [7]
Balloon port
Gastric balloon
Guidewire
White lock
Blue lock
Stent
Endoscopy also confirm whether bleeding stopped
Distal portion of stent delivery system withdrawn to allow inflation of gastric balloon
Wire port
[14]

8. Guidewire delivered into stomach
Stent delivery device advanced over the guidewire
Gastric balloon inflated with 100ml of air
Withdraw whole system until resistance felt (i.e. balloon impacted at cardia)
Thus anchoring the distal end of stent during deployment
Gastric balloon deflated and stent delivery system withdrawn
Endoscopy or X-ray to confirm positioning
[14]

9. Stent Removal
Also can look for any immediate re-bleeding?
Through endoscopic procedure and a foreign body retractor
Grasp the proximal loop of the stent
Blunt ended plastic sheath advanced over the wire  constrain the stents  without exerting shear force
[5]

10. SEMS VS Sengstaken tube - Advantages
Can be left in situ as long as 2 weeks
Cannot be removed by an agitated patient
Allow detailed and repeated endoscopic examination
Less risk of pulmonary aspiration
Definite treatment: TIPS, lap azygoportal disconnection, band ligation, interventional radiography-guided coiling, transplant
Maximum 2 weeks: minimize risk of migration and wall injury or reaction [9]
SEMS: Standardized expansion power and pressure to esophageal wall

11. SEMS Limitation Complication Gastric varices cannot be controlled [9]
Do not exert a lasting effect
Complication
Stent migration into stomach
Esophageal ulcer
Esophageal tear
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
SEMS

12. Recent studies on SEMS
Control of acute bleeding (Time frame: 120 hours (5 days)), failed if [12]
Death
Fresh hematemesis / >=100ml fresh blood aspirated
Hypovolaemic shock
Hb drop >3g/dL within any 24 hour
Success of stent placement
Duration of placement
Stent migration
Complication
Mortality
Recurrent bleeding: i.e. secondary prophylaxis
Definition according to Baveno criteria

13. Success in stent placement Control of bleeding duration
No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
6.7% esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
2.9% esophageal tear
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
10% esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0%
12.5%
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
6.25% esophageal ulcer
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

14. Case series, not controlled trial Small sample size
No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
1 esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
1 esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0% 1
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
Case series, not controlled trial
Small sample size
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

15. Failure (delivery system error) gastric balloon rupture
No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
1 esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
1 esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0% 1
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
Failure (delivery system error)
gastric balloon rupture
failed inflation
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

16. c.f. Balloon tamponade: 80% Failure: GV bleeding
No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
1 esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
1 esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0% 1
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
c.f. Balloon tamponade: 80%
Failure:
GV bleeding
failed stent deployment
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

17. How to decide?? No. of patient Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
1 esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
1 esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0% 1
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
How to decide??
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

18. Immediate repositioning
No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
1 esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
1 esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0% 1
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
Immediate repositioning
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

19. Esophageal tear Esophageal ulcer No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
6.7% esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
2.9% esophageal tear
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
10% esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0%
12.5%
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
6.25% esophageal ulcer
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
77% (42 days)
Esophageal tear
Esophageal ulcer
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

20. c.f. Usual 6 week mortality rate: 15-20%
No. of patient
Success in stent placement
Control of bleeding
duration
Stent migration
Local complication
mortality
Hubmann et al [3] 15
100%
5 days (1-14)
25%
1 esophageal tear
20% (60 days)
Zehetner et al [4] 34
97%
18%
29% (60 days)
Wright et al [5] 10
90%
70%
9 days (6-14)
N/A
1 esophageal ulcer
50% (42 days)
Dechene et al [6] 8
88%
11 days (7-14) 0% 1
compression of left main bronchus
75% (60 Days)
Zakaria et al 2013 [7] 16
93.75%
87.5%
2-4 days
37.5%
25% (42 days)
Febienne et al 2013 [8] 9
89%
1-5 days
22%
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
All are case series
Location of study: Austria, UK, Egypt, Swiss,
Stent migration: reposition
Overlap between first 2 studies
+ further management, child grading, cause, etc

21. Discussion – practical aspect
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
Most study: either inserted with radiographic or endoscopic guidance
Some study: daily CXR for stent position, bleeding control by clinical, blood test
Further management after stent removal? TIPS, EVL, surgical shunt, etc
Pressure 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?

22. SEMS Limitation of study Future study
Limited number of study available
Not a controlled study
Small sample size
Only short term follow up (up to 60 days)
Future study
Need randomized trial
Larger sample size
Long term follow up
Treatment for EV bleeding with esophageal tear
Applicability of data to other currently available fully covered SEMS
As initial first line treatment (in emergency room)
As definitive therapy

23. Conclusion
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 data
low complication rate
Satisfactory rate of bleeding control & stent deployment
need further study
Practical aspect: duration, monitoring, expertise

24. Reference
Garcia-Tsao G, Sanyal AJ, Grace ND, et al. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology 2007; 46:
Gin-Ho Lo. Management of acute esophageal variceal hemorrhage. Kaohsiung J Med Sci 2010; 26:
Hubmann R, Bodlaj G, Czompo M, et al. The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy 2006; 38: 896–901.
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; 22:2149–2152.
Wright G, Lewis H, Hogan B, et al. Self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc 2010;71:71–78.
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;85:185–191.
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:
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:
Fuad Maufa and Firas H. Al-Kawas. Role of Self-Expandable Metal Stents in Acute Variceal Bleeding. Internalional Journal of Hepatology 2012;
Angels Escorsell and Jaime Bosch. Self-Expandable Metal Stents in the Treatment of Acute Esophageal Variceal Bleeding. Gastroenterology Research and Practice 2011;
Vivek Kumbhari, Payal Saxena, Mouen A, et al. Self-Expandable Metallic Stents for Bleeding Esophageal Varices. The Saudi J of Gastroenterology 2013; 1434
Roberto 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:
National Institute for Health and Clinical Excellence. Stent insertion for bleeding oesophageal varices. 2011; April László Benk M.D. New minimal invasive therapeutic options in the management of acute and recurrent esophageal bleeding, 2007

25. Thank You

26. [13]

28. Should we use it? Weak evidence 1st stage 2nd stage SEMS SEMS Failure
Failed EVL/EIS: profuse bleeding, prevoius intervention
SEMS
Failure
SEMS

29. 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

30. [9]

31. Management
Pre-primary prophylaxis (Prevention of formation of varices)
Non-selective beta-blockers: no evidence to prevent formation of varices
OGD: Should be screened for varices at diagnosis
Primary prophylaxis (prevention of first variceal hemorrhage)
Non-selective beta blocker: Recommended
OGD: Esophageal variceal ligation (EVL) recommended
Repeated every 1-2 weeks till complete obliteration
Secondary prophylaxis (prevention of rebleeding)
Combination of nonselective beta blockers + EVL
TIPS: recurrent variceal haemorrhage
Transplant
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

32. Contraindication of stent
When remove stent
Bind time to let pharmcological therapy to work
When elective procedure a/v or expertise a/v
Convert emergency procedure to elective
Contraindication of stent
Stricture
Esophageal tumor
Previous radiation
Body weight <40kg
Risk of stent complication like esophageal rupture
Protective pressure valve  does not allow gastric balloon to inflate against resistance
if gastric balloon inflate wrongly in esophagus  safety balloon at tip of delivery system is inflated

33. Migration Pressure it exert Monitoring Covered stent Uncovered stent
Wait for 3 minutes for full expansion
Optimal integration with esophageal wall
Uncovered stent
Metal wire to dense: impringe on varices with pin point pressure
Metal wire not close: varices may squeeze out between wire and can’t exert temponade effect
Pressure it exert
Not specific mentioned
Radial pressure
Evaluate in animal model and clinical experience to be sufficient and safe
Monitoring
CXR daily
OGD alt day

34. Treat the symptom, not underlying cause (liver failure)
Treat esophageal varices
Physical: banding, sengstaken, SEMS
Chemical: sclerosant, superglue (cyanoarcylate monomer)
Treat underlying disease
Best medical treatment
Further treatment
Late stage
Further treatment has its own risk and complication, e.g. TIPS (seldom do)
Nutrition, lactulose, antibiotic, avoid hepatotoxic drug, medication, etc
In our study: EVL, TIPS, shunt surgery, transplant