Disclosures. Endoscopic Management of Variceal Bleeding

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1 Endoscopic Management of Variceal Bleeding Disclosures I have no relevant financial disclosures with respect to the content of this talk I will discuss the off-label use of cyanoacrylate glue Janak N. Shah, MD Section Head of Advanced Endoscopy Department of Gastroenterology and Hepatology Ochsner Medical Center New Orleans January 2016 Esophageal Varices (EV): the scope of the problem EV presence 50% of cirrhotics often correlates with severity of cirrhosis present in 40% with Child A vs. 85% with Child C EV progression (from none to small, small to large) 8%/year Risk factors ETOH and decompensated cirrhosis EV hemorrhage 5-15%/year Predictors large EV size, decompensated cirrhosis, presence of red wale marks AASLD Practice Guideline 2007 Esophageal Varices recommendations for screening EGD and primary prophylaxis with endoscopic variceal ligation (EVL) Screening EGD Recommendation evidence (1-4) Prophylactic EVL Recommendation Screen in all cirrhotics 4 Large EV; EVL if b-blocker contraindicated or intolerable Compensated cirrhosis: 2-3 yr if no EV 1-2 yr if small EV Yearly in ETOH or decomp cirrhosis if no EV Yearly if small EV with hi-risk stigmata 4 B-blocker or EVL for large EV with hi-risk stigmata or Child B/C cirrhosis 4 EVL at 1-8 wk intervals till eradicated 4 EGD 1-3 months after eradication; then 6-12 months From ASGE Practice Guideline 2014: The role of endoscopy in management of variceal hemorrhage Evidence (1-4)

2 Endoscopic and periprocedural therapy for EV hemorrhage and secondary prophylaxis Recommendations Evidence (1-4) Antibiotics (1-week course) 4 Octreotide (3-5 days post EGD) 3 Urgent EGD (within 12 hours admission) 3 Endotherapy: EVL preferred; sclerotherapy reserved for tech difficult EVL TIPS for failed endo/pharmocotherapy 3 Repeat EVL at 1-8 weeks till eradication 2-3 EGD surveillance at 3-6 month intervals after eradication 3 From ASGE Practice Guideline 2014: The role of endoscopy in management of variceal hemorrhage 3 Endoscopic techniques for variceal hemorrhage Band ligation vs sclerotherapy Similar / better initial hemostasis > 90% Decreased complications Esophageal strictures / ulcers infections Lo, Hepatol 1997; 25:1101 Laine, Ann Int Med 1993; 119:1 Stiegmann, NEJM 1992; 326: 1527 Decreased mortality? 19% vs. 35% Lo, Hepatol 1997; 25: % vs. 45% Stiegmann, NEJM 1992;326:1527 From Rockey, NEJM 2001; 345:669 Gastric Variceal (GV) bleeding GV the scope of the problem GV present in 5-33% with portal HTN ~ 30% cirrhotics develop variceal bleeding à ~10-20% related to GV Generally more severe with higher morbidity, transfusion requirements, and mortality than esophageal varices Incidence of bleeding in cirrhotic pts with GV 16% at 1 yr 36% at 3 yr 44% at 5 yr Risk factors for bleeding: Size- large (>10mm) > medium (5-10mm) > small (<5mm) Child class- C > B > A Endoscopic presence of red spots AASLD Practice Guideline 2007; Caldwell SH. Semin Intervent Radiol 2011; Kim T. Hepatol 1997.

3 GV Sarin classification and treatment Fundal GV treatment GOV-1 treatment similar to EV Splenectomy for IGV-1 due to SV thrombosis Most studies on endoscopic GV therapy focus on GOV-2 and IGV-1 Acute Primary prophylaxis Secondary prophylaxis Stabilization + pharmacologic tx Intragastric balloon tamponade (bridge) Endoscopic: sclerosants, banding, glue IR: TIPS +/- GV embol; balloon-occluded retrograde transvenous obliteration (BRTO) Insufficient data to recommend per guidelines Glue better than Beta-Bl or no tx in RCT (13% vs. 28% vs. 45% rebleed at 2 yrs) with survival benefit for glue compared to no tx* Insufficient data to recommend per guidelines Glue better than Beta-Bl in RCT (15% vs. 55% rebleeding at 2 yrs) + lower mortality ** If initial endoscopic tx successful, may consider additional endo tx for GV obliteration From ASGE Guideline 2005; AASLD Guideline 2007; * Mishra SR. J Hepatol 2011; ** Mishra SR. Gut GV treatment AASLD Practice Guideline (reviewed 2009) Endoscopic therapies for acute GV bleeding Technique Efficacy Comments Sclerosant 60-70% acute control Rebleed~ 20-50% Widely available - Familiar technique Less effective than glue for acute control and rebleeding Banding Thrombin 45-90% acute control Rebleed~ 50% >90% acute control Rebleed ~ 20-25% Widely available - Familiar technique Less effective than glue for acute control and rebleeding Difficult in acute bleeding (poor visualization) Risk of massive bleeding with premature dislodgement Only a few case series (largest series involving 52 pts) Cyanoacrylate (CYA) glue >90% hemostasis Rebleeding <30% Better than sclerotherapy/banding for acute and rebleeding Large published experience (mainly non-us) Sarin SK. GIE 1997; Sarin SK AJG 2002; Lo GH. Hepatol 2001; Tan PC. Hepatol 2006; Przemioslo RT. Dig Dis Sci 1999; Yang WL. AJG 2002; Cameron R. GIE 2013

4 RCTs of cyanoacrylate (CYA) vs. other endotherapies in GV Bleeding Study Tech Outcomes Sarin SK. AJG 2002 CYA (n=20) vs. sclerosant (n=17) Acute control: 89% vs. 62% (p=ns) GV obliteration: 100% vs 44% (p<0.05) Tan PC. Hepatol 2006 CYA (n=49) vs. banding (n=48) Acute control: 93% for both Rebleeding: 22% vs. 44% (p=0.044) Lo GH. Hepatol 2001 CYA (n=31) vs. banding (n=29) Acute control: 87 vs. 47% (p=0.03) Session needed for GV obliteration: similar Rebleeding: 31% vs. 54% (p=0.0005) Endoscopic glue injection 1st report: Soehendra et al., Endoscopy 1986 CYA preferred endoscopic therapy, when available Cyanoacrylate (CYA) glue: Cyanoacrylate glue plug Video courtesy of Dr. Ken Binmoeller Class of synthetic glues applied as monomers; Polymerize on contact with a weak base (e.g. blood, water) From Soehendra et al. Endoscopy 1986.

5 Cyanoacrylate (CYA) glues available in the US: all are off-label for treatment of GV Endoscopic glue injection Glue Trade names (company) Properties N-butyl-2- CYA Indermil (Covidien) Histoacryl (B. Braun Medical) Rapid polymerization (4-5 sec)- mixing with lipiodol increases polymerization time (and allows fluoro visualization) 2-octyl CYA Dermabond (Johnson & Johnson) Longer polymerization (15-30 sec) even longer if mixed with lipiodol (not recommended) Cameron R, Binmoeller KF. Cyanoacrylate applications in the GI tract. GIE 2013 ASGE Technology Report. Tissue Adhesives. GIE 2013 Complications among 753 patients treated with CYA for GV bleeding Endoscopic CYA- Difficult to visualize and control in active bleeding Complication Early onset (<3mo) rebleeding sepsis % (n) 4.4% (n=33) 1.3% (n=10) Distant embolism (symptomatic) 0.7% (n=5; pulm-1; brain-1; splenic-3) Gastric ulcer Hemoperitoneum / peritonitis 0.1% (n=1) 0.1% (n=1) Overall Complications 6.8% (n=51) Complication related mortality 0.5% (n=4; sepsis-3; rebleeding-1) Cheng LF et al. Clin Gastroenterol Hepatol 2010

6 New development in glue injection: EUS to the rescue? EUS-guided glue injection for gastric varices Possible advantages of EUS-guided interventions Direct intra-vessel targeting / injection Color Doppler to identify vessel / confirm vessel obliteration and lack of flow post intervention Eliminate need for endoscopic visualization may be useful in active bleeding Ability to target deeper vessels (perforators) leading to bleeding site New developments: EUS-guided coil +/- glue for gastric varices Technique: EUS puncture and embolization coil with or without CYA Coil itself may obliterate varix Decrease risk of embolization? Coil alone- no risk of glue embolization * Coil + glue: less volume glue? Coil as scaffold to retain glue? ** * Romero-Castro R et al. GIE 2013 ** Binmoeller KF, et al. GIE 2011 GIE pts; 2-yr period Technique: coil 1st, then glue Mean vol CYA=1.4mL (mean vol in studies with glue alone ~3-4mL) Tech success=100%; GV obliteration=96% No complications; no embolization

7 Multicenter retrospective analysis of EUS-CYA (n=19) vs. EUS-coil (n=11) coil favored when possible CYA technique: 1mL at each session; 1-wk interval procedures till obliteration GIE Nov 2013 Coil technique: multiple coils at each session; repeat EUS at 1-wk with additional therapy as needed CYA (n=19) Coil (n=11) P-value (if given) GV obliteration overall 95% 91% GV obliteration in 1 session 53% 82% # sessions / pt Glue vol / coil # per patient Recurrent GV (at least 6 mo f/u) mL (1-3) (2-13) 0 0 complications 11 (58%) Fever 1 Chest pain 1 Asymptomatic PE (on CT) 9 1 (9%) Bleeding from GV - 1 <0.01 Mean cost ~$ ~$ GIE Nov 2013 Endoscopic management of variceal bleeding take home points Thank you Esophageal Varices The Problem: 50% of cirrhotics 8% per year progression 5-15% bleed per year Treatment: Primary prophylaxis- EVL is an option for large EV with stigmata; large EV with decompensated ESLD; large EV with beta-blocker contraindicated Treat till eradicated (for primary or secondary prophylaxis) EVL preferred to sclerotherapy Gastric Varices The Problem: 10-20% of all variceal bleeding incidence of bleeding ~ 25% at 2 yrs Treatment: CYA (where available) IR therapies (e.g. TIPS; BRTO) No recs for primary or secondary prophylaxis Future directions: EUS-guided coils +/- glue

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