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1/9/2018
Endoscopic Evaluation &
Management of Pancreatic Cancer
Nathan Landesman, D.O.
Flint Gastroenterology Associates
January 10, 2018
Disclosures
• Paid consultant for Olympus America
Emerging Role of Endoscopy
in Pancreatic Cancer
• Therapeutic
– Fiducial Placement
– Fine Needle Injection (FNI)
• Palliative
– Celiac Plexus Neurolysis (CPN)
– Relief of Obstruction
• Gastroduodenal
• Biliary
• Shifting emphasis from ERCP-based
approach to EUS-guided modalities
1
1/9/2018
Therapeutic Endoscopic
Interventions
• Fiducial Placement
– Delineates extent of malignancy
– Quantifies respiratory-associated tumor motion
Therapeutic Endoscopic
Interventions
• Fiducial Placement Technique
– 19 or 22 gauge delivery system
– Loaded retrograde after stylet withdrawal
– Needle tip sealed with sterile bone wax
– Lesion accessed and fiducial deployed by stylet
or sterile water injection
Therapeutic Endoscopic
Interventions
• Fiducial Placement Technique
– 19 or 22 gauge delivery system
2
1/9/2018
Therapeutic Endoscopic
Interventions
• Fiducial Placement Technique
– Placement of at least 3 markers is preferred to
“triangulate” the malignancy
– > 4 markers to “box-in” the lesion is ideal
Therapeutic Endoscopic
Interventions
• Fiducial Placement Safety/Efficacy
– Prior studies reported technical failure with 19
gauge delivery system in the pancreatic head
and/or altered anatomy
– Newer trials report 88-97% success with only
minor complications
• Equipment malfunction
• Pain (Pancreatitis)
• Bleeding/Infection
• Migration
Therapeutic Endoscopic
Interventions
• Fiducial Placement Safety/Efficacy
– < 7% migration rate is likely overstated
• Decompression of gastroduodenal obstruction
• Decompression of biliary obstruction
3
1/9/2018
Therapeutic Endoscopic
Interventions
• Fine Needle Injection (FNI)
– Activated lymphocytes
– Oncolytic viruses
– Viral vectors (“Gene Therapy”)
– Ink marking of small lesions
Celiac Plexus Neurolysis (CPN)
• Bupivacaine and absolute alcohol
• 74-88% effective
– Head lesions may respond more favorably
– Single/Multiple sites +/- fenestrated needles
• Side Effects:
– Bleeding/Infection
– Diarrhea
– Pain
– Hypotension
– Paralysis
Celiac Plexus Neurolysis (CPN)
4
1/9/2018
Gastroduodenal Obstruction
in Pancreatic Cancer
• Surgical bypass
• Uncovered metal prosthesis
of varying lengths
Gastroduodenal Obstruction
in Pancreatic Cancer
Biliary Obstruction
in Pancreatic Cancer
• Role of pre-operative biliary decompression
in resectable pancreatic head tumors
– van der Gaag NEJM 1/14/10 reported “serious
complication” rate of 39% and 74% in 2 arms
from biliary intervention
• Pancreatitis
• Bleeding
• Biliary contamination
• Pancreatic fistula/leak
– Post-op complication rates did not differ
significantly
5
1/9/2018
Biliary Obstruction
in Pancreatic Cancer
• Is plastic stenting for pancreatic cancer still
relevant? GIE review (Wang)
– Plastic stents 15-40x cheaper than metal
– Historically, there was believed to be a cost
advantage in using plastic stents if:
• Diagnosis of malignancy not established
• Patients expected to live < 3-6 months
• Patients undergoing resection < 3 months
Biliary Obstruction
in Pancreatic Cancer
• Is plastic stenting for pancreatic cancer still
relevant?
– Patency of 10 French plastic biliary stents
becomes an issue after 8 weeks with larger
caliber stents failing to increase patency
duration
– Plastic stents > 7 cm length associated with
higher occlusion (and migration) rates
Biliary Obstruction
in Pancreatic Cancer
• Multiple studies have demonstrated superior
patency of metal stents, which overrides
cost savings of plastic stenting
– Fewer ERCPs
– Less hospitalizations for occluded stents
– Avoid sequelae of migrated plastic stents
6
1/9/2018
Biliary Obstruction
in Pancreatic Cancer
• 2014 NCCN Guidelines on Pancreatic
Adenocarcinoma
– Short metal stent should be considered effective
first-line therapy for palliation (uncovered) or
bridge to surgery (covered) in borderline
resectable, non-metastatic patients assigned to
neoadjuvant therapy.
Biliary Obstruction
in Pancreatic Cancer
• Covered vs Uncovered metal biliary stents
– Comparable patency
– Higher migration risk of covered stents
– Higher cholecystitis/sludge risk of covered
stents
– Fragmentation risk with covered stent removal
Patient-to-Procedure Matching for
Biliary Obstruction
• CA diagnosis not established
– Fully covered metal stent versus plastic
• CA diagnosis established and resectable
– No stent (versus plastic or fully covered metal)
• CA diagnosis established & borderline resectable
– Fully covered metal stent
• CA diagnosis established and unresectable
– Uncovered metal stent
7
1/9/2018
Biliary Obstruction
in Pancreatic Cancer
• EUS-guided biliary drainage
– Transgastric
• Intrahepatic
• Gallbladder
– Transduodenal
• Transbulbar
• Rendezvous
–IR assistance
References
• Available upon request
8
1/9/2018
Quality Preventative Care in IBD:
What Every Provider Should Know
Jami Kinnucan, MD
Assistant Professor of Medicine
University of Michigan Health Systems
Division of Gastroenterology
Disclosers
Advisory board member
Abbvie
Janssen Biotech
Crohn’s and Colitis Foundation
Patient education committee member
AGA IBD Quality Care Pathway Working Group, Co-Chair
Audience Poll
Which best describes you?
A. Medical student
B. Resident/Fellow
C. Gastroenterology provider
D. Primary care provider
E. Surgeon
F. Other
11/9/2018
Audience Poll
Which team do you root for?
A. University of Michigan
B. Michigan State University
C. Ohio State University
D. Depends on the day
Outline
1. Brief overview of inflammatory bowel disease (IBD) basics
2. Case-based review addressing key quality measures in
patients with IBD
-Focus on outpatient quality processes/measures
-Will review inpatient quality processes/measures
3. Summary including practical clinical implementation of
quality preventative care in IBD
Overview: IBD Basics
• Affects 1.6 million (0.6%) • What causes IBD?
people in the United states
• Prevalence 200/100,000
• Women=men
• Caucasian predominance
• IBD classification
• Ulcerative colitis (UC)
• Crohn’s disease (CD)
• Indeterminate colitis (IC) OR
IBD-unspecified (IBD-U)
Image adapted from Crohn’s and Colitis Foundation
21/9/2018
Overview: IBD Basics
Ulcerative Colitis Crohn’s disease
• Limited to the colon • Can extend throughout entire GI tract
• Superficial inflammation • Transmural inflammation
• Continuous inflammation • “Patchy” inflammation
• Rectal involvement • Rectal sparing
• Various extents – Perianal involvement
• Extraintestinal Manifestations
• Extraintestinal Manifestations
Overview: IBD Medical Management
Mesalamine (5ASA) Steroids Immunomodulator Biologics
Oral: Prednisone (10mg) Imuran (azathioprine) Anti-TNF:
Sulfasalazine Hydrocortisone (40mg) 6-mercaptopurine (6MP) Remicade (infliximab)- IV
Pentasa Methylprednisolone (8mg) Methotrexate Humira (adalimumab)- SQ
Lialda Entocort (budesonide) Cellcept (MMF) Cimzia (certolizumab- pegol)- SQ
Apriso Uceris (budesonide-MMX) Cyclosporine Simponi (golimumab)- SQ
Asacol HD Tacrolimus
Delzicol Topical: Anti-integrin:
Colazal (balsalazide) Anusol HC (hydrocortisone) Tysabri (natalizumab)- IV
Cortenema Entyvio (vedolizumab)- IV
Topical: Cortifoam
Rowasa (enema) Proctifoam Anti-IL12/23:
Canasa (suppository) Budeonside foam Stelara (ustekimab)- IV/SQ
Ulcerative Colitis Crohn’s disease Combination
Mesalamine- ASCEND Infiliximab- ACCENT SONIC (IFX/AZA)
Infliximab- ACT Adalimumab- CLASSIC UC-SUCCESS (IFX/AZA)
Adalimumab- ULTRA Certilizumab-peg- PRECiSE COMITT (IFX/MTX)
Golimumab- PURSUIT Natalizumab- ENACT/ENCORE CHARM (ADA/IMM)
Vedolizumab- GEMINI Vedolizumab- GEMINI
Tofacitinib- OCTAVE Ustekinumab- CERTIFI
Audience Poll
In the last 6 months, how many IBD patients
have you seen either inpatient or outpatient?
A. None
B. 1-5
C. 6-10
D. 10+
31/9/2018
Why is quality IBD care important?
• Common sense would tell us that of course higher
quality care is better than lower quality care
• But what defines higher quality care?
• Higher quality care can mean more expense on the
health system
• We have to show that “doing more” actually
changes outcomes in patients
• Medicare/Medicaid reimbursements can depend on
meeting quality measures
• This is true for any chronic illness (HTN, DM…)
Define Quality
• Institute of Medicine (IOM)- 1990
• The degree to which health services for individuals and
populations increase the likelihood of desired health
outcomes and are consistent with professional knowledge
Measurable outpatient and inpatient, best in chronic illness
Processes of medical care
Process
Easy and quick to measure (checkbox)
Measures
Developed by AGA and Crohn’s and Colitis Foundation
Recognized by Medicaid/Medicare
Harder to measure
Outcomes Processes often linked to outcome
Measures Developed by Crohn’s and Colitis Foundation
This is what patients care most about
AGA IBD Quality Measures
AGA IBD performance measures set 2011.
41/9/2018
Crohn’s and Colitis Foundation:
“Top Ten” Measures
Processes Outcome
Steroid sparing therapy (if steroids >4m) Steroid-free clinical remission
Pre-treatment: Testing for TB Days lost from work/school
Pre-treatment: TPMT before thiopurine Days hospitalized
Education for vaccinations ED visits
Smoking cessation in Crohn’s disease Malnutrition
LGD: Colectomy OR close surveillance Anemia
Testing for C. difficile in active flare Narcotic use
Flex sig for CMV evaluation in steroid Fecal incontinence
refractory hospitalized patients Normal health-related QOL
Nocturnal symptoms
Melmed G IBD 2013.
ACG Preventative Health
Recommendations (2017)
1a: Annual influenza vaccination (C) 9: Vaccination to Tdap, HAV, HBV, HPV
2: Pneumonia vaccination in patients on per ACIP guidelines (C)
immunosuppression (C) 10: IBD women on immunosuppression
3: Adults >50yo vaccination against should undergo annual pap smear (C)
Herpes Zoster (S) 11: Screening for anxiety and depression
4: Adults should be assess for prior is recommended (C)
exposure to varicella (C) 12a: IBD patients should undergo
5: Travel to endemic areas of yellow screening for melanoma, independent
fever should consult travel spec (C) of biologic treatment (S)
6: Adolescents should receive 12b: Immunomodulator use in IBD pts
meningococcal vaccination (C) should have screening for NMSC (S)
7:Household members of IS patients can 13: Patients with risk factors should
received LIVE vaccination (C) undergo BMD evaluation at dx (C)
8: Adults should receive age-appropriate 14: CD patients who smoke should be
vaccinations (C) counselled to quit (S)
C= conditional recommendations S= STRONG recommendation Farraye FA et al. Am J Gastro 2017.
Case: Disease evaluation
50 year old female with ulcerative pancolitis who is failing outpatient
management with mesalamine therapy and currently prednisone
dependent x 2 months with ongoing active symptoms and elevated
fecal calprotectin. Recommend escalation of therapy to anti-TNF
therapy in combination with azathioprine. What should be
documented in medical record?
51/9/2018
Disease documentation
• All patients should have disease documentation
assessed during outpatient clinic visit
• In practice what does this look like?
• Disease type Ulcerative colitis
• Disease location Pancolitis
• Disease activity Clinical and biochemical activity
• Steroid sparing therapy Initiate steroid sparing tx
AGA Quality Measures: #1, #2
Case: Bone Health Assessment
50 year old female with ulcerative pancolitis who is failing
outpatient management with mesalamine therapy and
currently prednisone dependent x 2 months (cumulative
lifetime exposure >6m steroids). Given her steroid exposure
what is indicated for evaluation?
A. Nothing currently
B. Vitamin D level and supplementation
C. Dual-energy x-ray (DEXA)
D. Both B + C
Preventative Health: Bone Health
• IBD patients higher risk for developing bone disease1-3
• Crohn’s disease > ulcerative colitis
• Higher risk with cumulative exposure to steroids
• Risk for lower Vitamin D levels which is linked to bone disease
• Indications of dual-energy x-ray (DEXA)
• Prednisone >7.5 mg/day x 3 m • Post-menopausal women
• >60 years old • History of fracture
*Assessment of 25-OH Vitamin D levels in all IBD patients
*Replacement with goal Vitamin D > 30 ng/ml4
*DEXA when indicated (as above)
*Referral to endocrinology when indicated
1. Shirazi KM et al. Saudi J Gastro 2012. 2. Farraye FA et al. Am J Gastro 2017 (guidelines)
AGA Quality Measures: #3 3. Driscoll RH et al. Gastroenterology 1982. 4. Ananthakrishnan AN IBD 2013.
61/9/2018
Case: Pre-treatment evaluation
50 year old female with ulcerative pancolitis who is failing outpatient
management with mesalamine therapy and currently prednisone
dependent x 2 months with ongoing active symptoms and elevated
fecal calprotectin. Recommend escalation of therapy to anti-TNF
therapy in combination with azathioprine. Based on quality
measures what pre-treatment labs we should we check?
A. Nothing, she can start therapy now
B. Hepatitis B screening
C. TB screening
D. Hepatitis C screening
E. Hepatitis B + TB screening
F. Hepatitis B + Hepatitis C + TB screening
Prevention of infection:
Pre-immunosuppression assessment
• Prior to starting medical therapy (any immunosuppression)
• Hepatitis B
• Hepatitis B surface antigen (Hep Bs Ag)
• Hepatitis B surface antibody (Hep Bs Ab)
• Hepatitis B core antibody (Hep Bc Ab)
• TB assessment
• PPD skin testing
• QuantiFERON-TB Gold
• TPMT (if considering azathioprine or 6MP)
AGA Quality Measures: #6, #7
CCF Recommendation
Prevention of infection:
Assessment and Vaccination
• If non-immune to Hepatitis B ACG Recommendation #8
• Independent of prior vaccination status
Standard Vaccination Accelerated Vaccination
Hepatitis B vaccination* Hepatitis B vaccination
Dose 1: Day 0 Dose 1: Day 0
Dose 2: 3 months Dose 2: Day 7
Dose 3: 6 months Dose 3: Day 21 or 30
Hep Bs Ab: 1-2m later Booster: 12 months
Hep Bs Ab: 1-2m later
*Assessment of Hepatitis B and TB is important before starting
immunosuppression therapy
*It is important to vaccinate those patient who are non-immune
*Assess immunity 1-2 months after vaccination
*can substitute Engerix-B, Recombivax HB (Hep B) with Adult recommended vaccination Schedule. CDC. 2017
Twinrix (HepA+B) ACIP Guidelines
71/9/2018
Case: Pre-treatment evaluation
50 year old female with ulcerative colitis who is steroid dependent
who underwent pre-treatment evaluation:
QuantiFERON-TB Gold: negative
Hepatitis Bs Ab: non-reactive
TPMT: normal
Patient received accelerated Hepatitis B vaccination schedule.
Will check immunity in 4-6 weeks (after 12m booster). She had a
reactive Hep Bs Ab.
Initiated anti-TNF therapy and azathioprine 1 week after initial labs
*Don’t delay adequate therapy for IBD for vaccination series
Case: Vaccination
Same 50 year old patient presents now for her 3 month follow-up
after initiation of anti-TNF therapy with azathioprine. She inquires
about what vaccinations she needs. What vaccinations are
indicated in this patient?
A. No additional vaccinations
B. Influenza
C. Pneumonia vaccination
D. Influenza + pneumonia
E. Herpes Zoster (Zostavax)
F. All of the above
AGA Quality Measures: #3, #4
Prevention of infection:
Influenza and pneumonia vaccinations
• Annual influenza vaccination in recommended in
ALL patients with IBD
• LIVE vaccination contraindicated in patients on IS*
• Pneumonia vaccination is indicated in patients > 65
years old, or patients on immunosuppression
therapy
Vaccine naive PCV13 PPSV23 2m-12m later
*ideal is 2m (8 weeks)
PCV13- Prevnar
PPSV23 prior PCV13 given 1 year after PPSV23 PPSV23- Pneumovax
PCV13 + Up to date, PPSV23 should be given 5
PPSV23 years from the last PPSV23
*LIVE vaccination was less effective, no longer available ACIP MMWR 2013.
81/9/2018
Avoid LIVE vaccines in
immunosuppressed patients
• Indicated in patients who are on
immunosuppression based therapy Live Vaccines
MMR (measles, mumps, rubella)
• CDC has clear recommendations Shingles (Zostavax)
about timing for how long to wait Chicken pox (varicella)
Rotavirus (oral)
Immunomodulators Biologic Medications
Yellow fever
Azathioprine (Imuran) Remicade (infliximab) BCG vaccination
6-mercaptopurine (6-MP) Humira (adalimumab) Polio vaccination (oral)
Methotrexate Cimzia (certolizumab) Smallpox vaccination
Cellcept (mycophenolate) Simponi (golimumab)
Adenovirus vaccine
Typhoid (live)
Tacrolimus Stelara (ustekinumab)
Cyclosporin Prednisone
Adult recommended vaccination Schedule. CDC. 2017.
Prevention of infection: Shingles
• Zostavax is a LIVE vaccination
• Single dose vaccination
• Recommended in all adults age 60 and older
• Okay on patients on low dose immunosuppression: low dose
Prednisone, MTX, 6MP, azathioprine
• Patients starting biologic therapy need to wait 4 weeks
• Shingrix is NON-LIVE, recombinant subunit vaccination
• Approved by FDA 10/2017
• 2-dose vaccination series (0 2-6m)
• Recommended in all adults age 50 and older
• Even if they have previously received Zostavax
ACG Recommendation #3
Adult recommended vaccination Schedule. CDC. 2017.
Case: Tobacco Assessment
30 year old female smoker with ileal Crohn’s disease with
history of ileocecal resection on 6-MP since surgery with
evidence of clinical and biochemical (normal fecal calprotectin)
remission (healing) presents for follow-up. She is currently
smoking ½ PPD. What should she be counseled regarding
her tobacco use?
A. Nothing- she is in remission
B. Education about tobacco use risks in Crohn’s disease
C. Referral to primary care for smoking cessation
D. Both B + C
91/9/2018
Tobacco Use Assessment
• All patients: assessment and documentation of tobacco use
• Crohn’s disease: documentation of tobacco use and
counseling of smoking cessation (each visit)
• Active tobacco use is associated with worse disease
outcomes1-3
• Higher risk for development of Crohn’s disease
• Increased risk for disease relapse
• Increased risk for post-surgical recurrence and resection
1. Calkins BM et al. Meta-analysis. Dig Dis Sci 1989.
AGA Quality Measures: #10 2. Duffy LC et al. Am Rev Prev Med 1990.
3. Sutherland LR et al. Gastroenterology 1990.
Case: Preventative Health
40 year old female with Crohn’s disease on infliximab with
azathioprine (5 years) currently in clinical remission presents
for routine follow-up exam. Recent MRI shows no signs of
active disease. Focus this visit is on preventative health for this
patient. What are important preventative health measures
are recommended on thiopurines?
A. Nothing- she is in remission
B. Cervical cancer screening- annual
C. Skin cancer education and screening- annual
D. Both B+C
Preventative Health:
Cervical Cancer Screening
• IBD patients have an increased risk of cervical dysplasia and
neoplasia
• Women with IBD are increased risk for abnormal pap smear
• IBD patients have lower compliance for screening programs
• Highest risk associated with thiopurine therapy
• Data also show that corticosteroid and 5-ASA use are also associated with
increased risk for abnormal pap
*HPV vaccination is available and safe in IBD patients (9-26yo)
*Annual pap smear for those on thiopurines, general population
screening guidelines for other female patients
ACG Recommendations #8,10
1. Kane S et al. Am J Gastro 2008. 2. Allegretti JR et al. IBD 2015.
101/9/2018
Preventative Health:
Skin Cancer Screening
• IBD patients (independent of therapy) are at an increased
risk for skin cancer1-4
• Melanoma: studies suggest increased risk over general pop, several
studies show anti-TNF therapy possibly doubles risk
• NMSC: increased risk in patients on thiopurine therapy, not clear if
goes to baseline risk after discontinuation
*Educate ALL IBD patients about risk and sun avoidance and
use of sunscreen and protective clothing, SPF > 30
*NMSC: Patients on thiopurines require annual evaluation
*Melanoma: ALL IBD patients should have screening evaluation
ACG Recommendations #12 NMSC= non-melanomatous skin cancer
1. Singh S et al. Meta-analysis. CGH 2014. 2. Long M et al. CGH 2011. 3.. Farraye FA et al. Am J Gastro 2017
4. Kimmel et al. J Skin Cancer 2016. 5. Van Assche G et al. ECCO Guidelines. J Crohns Colitis 2013 5. Torres et al. IBD 2013.
Case: Colon Cancer Screening
30 year old male with ulcerative pancolitis since age 22
currently in remission on mesalamine therapy. Last
colonoscopy was 3 years ago showing deep remission. He
would like to know when he should undergo colon cancer
screening? What do you recommend?
A. General population risk, age 50
B. Now, after 8 years of disease
C. In the next few years
ASGE Guidelines: Dysplasia and Colon
Cancer Screening in IBD
Indication Screening Surveillance Recommendations Comments
UC: left-sided Starting at Every 1-3y based Techniques: *PSC starting
or extensive duration 8y* on risk factors** -4-quadrant biopsies every 10 at diagnosis
cm limited to greatest extent of and then
CD: >1/3 colon prior involvement (minimum 33 annually
involvement biopsies)
-Chromoendoscopy with
pancolonic dye spray and
targeted biopsies
**Risk factors: Active inflammation, anatomic abnormality (stricture, multiple pseudopolyps),
history of dysplasia, family history of CRC (FDR), primary sclerosing cholangitis (PSC)
*Starting 8 years after disease in at risk patients, they should
begin colon cancer screening program.
CCF Recommendation
ASGE Guideline Based
ASGE Guidelines. GIE 2015.
111/9/2018
Inpatient Quality Measures: Case
25 year old patient with ulcerative colitis presents with low
grade fever, abdominal pain, watery diarrhea (12+ bm/day)
and rectal bleeding. HgB 8 (baseline 10).
True or False? It is important to assess for infection including
C. difficile in this patient and any patient hospitalized with IBD
and diarrhea.
A. True
B. False
Inpatient Quality Measure:
Clostridium difficile evaluation
• IBD patients are up to 8x more likely to have
C. diff than non-IBD patients1
• Prevalence is increasing 2.4% 3.9%2
• Risk higher in ulcerative colitis > Crohn’s disease
• Study in Rhode Island showed only assessed in
50% of hospitalized IBD patients
*Patients with increasing symptoms (clinical relapse) of
inflammatory bowel disease should be tested for C. diff
*Treatment for C. diff in patients with IBD should include
Vancomycin over metronidazole
AGA Quality Measure: #8 1. Nguyen GC. Am J Gastroenterol. 2008 3. Khanna CGH 2017.
2. Ananthakrishnan AN. Gut 2008..
Inpatient Quality Measures: Case
25 year old patient with ulcerative colitis presents with low
grade fever, abdominal pain, watery diarrhea (12+ bm/day)
and rectal bleeding. HgB 8 (baseline 10). Hemodynamically
the patient is stable.
True or False? Given the patients anemia and ongoing
bleeding it is contraindicated to start this patient on DVT
prophylaxis.
A. True
B. False
121/9/2018
Inpatient Quality Measure:
Venous Thromboembolism Prevention
• Hospitalized IBD patient are 2-3x more likely to
have VTE than general population
• Study in Boston only 7% received adequate prevention
despite no contraindications
• Blood clots are PREVENTABLE
• Rectal bleeding is not an absolute contraindication to
VTE prophylaxis
*Clinical guidelines recommend that all hospitalized IBD
patients receive pharmacologic prophylaxis (unless a clear
contraindication)
AGA Quality Measure: #9 1. Yuhara Aliment Pharmacol Ther 2013.
2. Pleet Aliment Pharmacol Ther 2014
Quality IBD Care: Clinical Checklist
Disease assessment DEXA (if >3m steroids)
Disease location Vitamin D level, supplement
Clinical disease activity CD: Smoking cessation
Objective disease assessment Colon cancer screening
Steroid sparing therapy >8y disease, every 1-3y
Therapy related drug monitoring
Pre-treatment testing IM: Labs every 4 months
TB testing Biologic: Labs every 6 months
HBV testing Mesalamine: Annual Cr
Vaccination if non-immune Skin cancer education (all pts) and
TPMT level melanoma screening advised
Vaccinations Thiopurine preventative health
Pneumonia Skin cancer screening
Cervical cancer screening
Influenza (annual)
Hep B: if non-immune Mental health screening
No LIVE vaccination (on IS) Family planning (if appropriate)
*based on my current clinical practice
Quality IBD Care: Cornerstones
Health IBD Checklist
Adapted from cornerstoneshealth.org
131/9/2018
Summary
• Following quality measures in the management of
IBD patients is associated with better outcomes
• It can also be tied to reimbursement
• Educate your patients about quality measures,
and use clinical checklists available to aid in
implementation
• The management of IBD patients requires a
multidisciplinary approach across all specialties,
communication is key between ALL providers
University of Michigan Crohn’s
Questions? and Colitis Inpatient Unit
141/9/2018
Gastroesophageal Reflux Disease
Review
Mark Minaudo, DO
Flint Gastroenterology
Jan 10th 2018
Outline of GERD Presentation
• GERD background
• Evidenced based diagnosis of GERD
• Evidenced based initial management of GERD
• Brief review of PPI side effects, risks and complications
• Evidenced based approach to PPI refractory GERD
• GERD related complications
GERD Epidemiology
• Very common
• 10‐20% of western world
• Troublesome GERD in 6%
• Most common symptoms are heartburn and
regurgitation.
• Troublesome:
• Mild‐ > 2x per wk.
• Moderate to severe‐ >1 x weekly.
• Nocturnal GERD worse the daytime GERD.
• Increase work time off and decrease productivity (QOL).
• Symptom frequency does NOT change with age.
• Aging increases prevalence of erosive disease.
• Barrett’s more frequent in men (>50 y/o).
11/9/2018
Definition of GERD
• GERD should be defined as symptoms or complications resulting
from the reflux of gastric contents into esophagus or beyond, into the
oral cavity (including larynx) or lung
• Classified as the presence of symptoms:
• Non‐erosive reflux disease or NERD.
• Erosive reflux disease or ERD.
Pathogenesis of GERD
• Transient lower esophageal sphincter relaxations (TLESRs), which
are physiologic, are part of the main mechanism leading to acid
reflux
• Gastric distension (food or gas)
• TLSESRs are the decline in pressure and position of the LES.
• Occurs about 3‐6 times per hour (> 10 seconds)
• Allows for venting of gas from the stomach
• Most reflux occurs during the TLESRs (60‐70%)
Pathogenesis
21/9/2018
Other Key Players
• Hiatal hernia
• Hypotensive lower esophageal sphincter
• Obesity
• Acid pocket position
• Body position
• Gastric emptying
• Dilated intercellular spaces
• Visceral sensitivity
• Esophageal acid clearance related to saliva and peristalsis
• Genetics
Hiatal Hernia
Others
31/9/2018
GERD Symptoms
• Typical: Heartburn, regurgitation, chest pain, dysphagia.
• Atypical: Dyspepsia, epigastric pain, early satiety, nausea, globus,
bloating and belching.
• Extra‐esophageal symptoms: Cough, asthma and laryngitis.
Natural History
Gender Differences
• Men are more likely to have erosive disease, while women NERD.
• Barrett’s esophagus is more frequent in men.
• Gender ratio for esophageal adenocarcinoma is estimated to be 8:1 male to female.
41/9/2018
Diagnosis
• Symptom presentation
• Anti‐secretory responsiveness
• Endoscopy
• Ambulatory reflux monitoring
Diagnosis: GERD Symptoms
• Heartburn and Regurgitation: Most reliable.
• Sensitivity for erosive esophagitis 30‐76%.
• Specificity from 62‐96%.
• Empiric PPI Trial: Responsiveness to PPI therapy.
• Sensitivity of 78%.
• Specificity of 54%.
Initial Diagnostic Recommendation
•A presumptive diagnosis of GERD can be
established in the setting of typical symptoms.
Empiric medical therapy with a PPI is
recommended in this setting (Strong
recommendation, moderate level of evidence).
•Patients may require further evaluation:
• Alarm features.
• Risk factors for Barrett’s esophagus.
• Abnormal GI imaging.
51/9/2018
Non‐Cardiac Chest Pain
• Esophagus is one of the most common causes of NCCP; GERD is by
far the most common esophageal cause.
• A meta‐analysis found a high probability that non‐cardiac chest pain
responds to aggressive acid suppression.
• PPI trial (PPI twice daily in variable doses)
GERD Related Chest Pain
• A cardiac cause should be excluded in patients with chest pain before
the commencement of a gastrointestinal evaluation (Strong
recommendation, low level of evidence)
• Patients with non‐cardiac chest pain suspected due to GERD should
have a diagnostic evaluation before institution of therapy.
(Conditional recommendation, moderate level of evidence)
Extra‐Esophageal Symptoms
• Other symptoms: globus, chronic cough, hoarseness, wheezing, and
nausea.
• May be seen in the setting of GERD.
• Not sufficient to make clinical diagnosis in the absence of heartburn or
regurgitation.
• Other disorders need to be excluded.
61/9/2018
Four Conditions to do Endoscopy in GERD
• (1) Alarm symptoms especially dysphagia
• See next slide.
• (2) Non‐cardiac chest pain
• (3) Screening high risk patients for Barrett’s
• (4) Patients that are unresponsive to PPI
The vast majority of patients with regurgitation and heartburn will
have a negative EGD—70%.
Alarm Features
• New onset of dyspepsia in pt >60 y/o
• Evidence of GI bleeding
• Iron deficiency anemia
• Anorexia
• Unexplained weight loss
• Dysphagia
– Odynophagia
• Persistent vomiting
• GI cancer in 1st degree relative.
GERD and Endoscopy
•Findings on Endoscopy:
•(1) Erosive esophagitis
•(2) Strictures
•(3) Barrett’s esophagus
•(4) Adenocarcinoma
•How often do we find ERD in the diagnostic
phase of GERD?
71/9/2018
LA GERD Classification
(validated good interobserver variability)
• Grade A: One or more mucosal breaks < 5 mm in maximal length
• Grade B: One or more mucosal breaks > 5mm, but without
continuity across mucosal folds
• Grade C: Mucosal breaks continuous between > 2 mucosal folds,
but involving less than 75% of the esophageal circumference
• Grade D: Mucosal breaks involving more than 75% of esophageal
circumference
Endoscopy
81/9/2018
Management of GERD
• Lifestyles changes
• Medical Therapy
• Surgical Therapy
GERD Treatment
• Do lifestyles changes really help?
• If so, which are supported with the strongest level of evidence?
Supported Lifestyle Recommendations
• (1) Weight loss (conditional recommendation, moderate level of
evidence)
• (2) Head of bed elevation and avoidance of meals 2‐3 hours before
bedtime for patients with nocturnal GERD (conditional
recommendation, low level of evidence)
91/9/2018
Wedge Pillow
Dietary Modifications
• Routine GLOBAL elimination of foods that can trigger reflux is NOT
recommended in the treatment of GERD (conditional
recommendation, low level of evidence)
Culprits: fatty foods, caffeine, chocolate, ETOH, spicy foods, carbonated
beverages, peppermints
Other Modifications
• Avoidance of tight‐fitting garments:
• Prevent INC in intra‐gastric pressure and GERD gradient.
• Promotion of salivation:
• Gum/oral lozenges
• Neutralizes refluxed acid and INC esophageal clearance.
• Avoidance of tobacco and alcohol:
• Reduces LES pressure.
• Abdominal breathing exercise (diaphragmatic):
• Strengthens LES pressure.
101/9/2018 Diaphragmatic Breathing Medical Management • Antacids • Surface agents and alginates • Histamine (H2) Receptor Inhibitors (H2RA) • Proton Pump Inhibitors (PPI) Antacids • Role for mild GERD symptoms
1/9/2018
Surface Agents/Alginates
•1. Sucralfate: (aluminum sucrose sulfate)
•Mechanism:
• Adheres to mucosal surface, promotes healing, and
protects from peptic injury.
• Short duration of action.
• Side effects: Al retention and low phosphate.
•2. Sodium Alginate: (Gaviscon)
• Polysaccharide from sea weed.
• Forms viscous gum that floats—reduces post‐
prandial acid pocket.
• No side effects reported.
Histamine 2 Receptor Antagonists
•Mechanism:
• Decrease acid secretion—inhibits H2 receptor on
gastric parietal cell.
• Works in 30min‐2.5 hrs, Lasts 4‐10 hrs.
• Tachyphylaxis develops within 2‐4 wks.
• Limits use as maintenance therapy.
• Healing rate—mild erosive disease (10‐24%)
• Maintenance for non‐erosive esophagitis.
• Especially nocturnal symptoms.
• Ineffective for severe esophagitis.
• Side effects rare.
Proton Pump Inhibitors
• Mechanism:
– Irreversibly binds to and inhibits H‐K ATPase on the parietal cell.
• Should take 30‐60 minutes before 1st meal of day.
– Used for step‐down therapy for erosive esophagitis or frequent symptoms
(>2x/wk).
• Standard dose PPI daily for 8 weeks.
121/9/2018
The Superiority of PPIs in ERD
• PPI therapy:
• Superior healing rates and decreased relapse rates.
• PPI> H2RAs>placebo.
• The mean ( ± s.d.) overall healing proportion was highest with PPIs (84% ±
11%) vs H2RAs (52% ± 17%), sucralfate (39% ± 22%), or placebo (28% ± 16%).
The Superiority of PPIs in ERD
• PPIs showed a significantly faster healing rate (12%/week) vs. H2RAs
(6%/week) and placebo (3%/week).
• PPIs provided faster, more complete heartburn symptoms relief
(11.5%/week) vs. H2RAs (6.4%/week).
PPI Summary in ERD
• Faster relief of symptoms and erosions and more complete healing.
131/9/2018
PPIs in ERD vs NERD
• PPIs are associated with a greater rate of symptom relief in patients
with ERD (~70–80%) compared to patients with NERD (where the
symptom relief approximates 50–60%).
Relapse Rates off PPI for NERD and ERD
• In patients found to have PPI responsive NERD, two‐third of the
patients will demonstrate symptomatic relapse off of PPIs over time.
• For patients found to have LA grade C‐D esophagitis, nearly 100% will
relapse off PPIs by 6 months.
Duration of Therapy for ERD Healing
• An 8‐week course of PPIs is the therapy of choice for symptom relief
and healing of ERD . There are no major differences in efficacy
between the different PPIs. (Strong recommendation, high level of
evidence)
141/9/2018
Maintenance Therapy
• Maintenance PPI therapy should be administered for
GERD patients who continue to have symptoms after
PPI is discontinued and in patients with complications
including erosive esophagitis and Barrett’s esophagus.
(Strong recommendation, moderate level of
evidence).
• Long‐term PPI therapy should be administered in the
lowest effective dose, including on demand or
intermittent therapy. (Conditional recommendation,
low level of evidence)
GERD in Pregnancy
• GERD is very common in pregnancy and presents as heartburn and
may begin in any trimester
• 22% had GERD in 1st ; 39% in 2nd ; and 72% in 3rd.
• The only widely accepted indication for Sucralfate in GERD is for
pregnancy because of its poor absorption.
• PPIs are safe in pregnant patients if clinically indicated; category B
(Conditional recommendation, moderate level of evidence)
PPI Side Effects
Freedman. Gastroenterology. 2017 Mar;152(4):706‐715.
151/9/2018
PPI Risk in Specific Populations
Proposed Risk Plausibility Absolute Risk Take Home
Chronic Kidney Low/Moderate 0.1‐.03% ‐Low Quality of
Disease evidence
‐Not sufficient to
change
management
Acute CVA Low No association in ‐Same
RCT
Alzheimer’s Disease Low 0.07‐1.5% ‐Same
Yadlapati, R. ANMS 2017
PPI Risk in Specific Populations
Proposed side Plausibility Absolute Excess Take Home
effect Risk
C. difficile infection Moderate 0‐0.9% ‐Low quality of
evidence.
‐Emphasizes need
for valid PPI
indication.
SIBO High Unable to calculate ‐Likely an INC risk.
‐Treatable &
Reversible.
Community Low No association in ‐Low quality and
acquired PNA recent study conflicting
evidence.
Yadlapati, R. ANMS 2017
PPI Risk in Specific Populations
Proposed Plausibility Risk Estimate Take Home
Micronutrient
Deficiency
Magnesium High OR 2.0 ‐Emphasizes need
for valid PPI
indication.
B12 High OR 1.83 ‐Likely INC risk for
sub‐populations.
‐Treatable and
reversible.
Iron High OR 2.49 ‐Inconsistent data.
‐Treatable and
reversible.
Calcium/Bone Moderate ‐ ‐Inconsistent data.
fracture ‐Practice standard
bone health recs.
Yadlapati, R. ANMS 2017
161/9/2018
Summary of Take Home
• Long‐term PPI use INC some risks (SIBO, B12 deficiency,
hypomagnesemia).
• These are exceedingly rare, idiosyncratic, or are treatable and reversible.
• Data supporting the risks of CV events, dementia, CKD, C dif,
calcium/iron deficiency is of low quality and/or conflicting and should
not alter current PPI management.
Yadlapati, R. ANMS 2017
Refractory GERD
• Definition is controversial.
• Partial or lack of response to PPI PO BID.
• Treatment failure.
• Occurs in 10‐40% of GERD patients.
• Non‐responders have either NERD or functional heartburn.
• NERD response (~40%)
• Erosive esophagitis (~60%)
Etiology
• Insufficient acid suppression.
• Medication timing and adherence‐1/9/2018
Refractory GERD
• Once compliance or appropriate dosing are assured.
• Consider trial of a different PPI or the PPI can be increased to twice daily;
• Either strategy resulted in symptomatic improvement in roughly 20% of patients.
Algorithm for Refractory PPI
1. Step 1: PPI optimization.
2. Step 2: EGD to rule out other causes: EOE, infectious esophagitis, etc
(weak recommendation, low quality of evidence)
3. Step 3: Ambulatory pH testing: to determine phenotype of non‐
responder
On or OFF PPI Ambulatory pH Testing?
• Low probability of GERD off PPI, ambulatory pH testing; those with
suspected functional disease
• High probability of GERD on PPI, ambulatory pH testing WITH
impedance
181/9/2018
Ambulatory pH Monitoring
Findings on Ambulatory pH Testing
• (1) Those with residual acid reflux: pathologic acid exposure and/or
strong positive symptom‐acid reflux association
– ~10% of refractory GERD.
• (2) Those with non‐acid reflux: normal acid exposure with positive
symptom‐ reflux association
– ~30% of refractory GERD.
• (3) Those with functional disease: normal acid exposure and negative
symptom‐reflux association
Residual Acid Reflux
•Refractory heartburn with acid reflux on pH
testing while on PPI PO BID.
•Alternative treatment:
• 1. Alginates
• 2. H2RA– add at bedtime.
• 3. Reflux inhibitors:
• Baclofen—shown to reduce #, length of reflux episodes, and
TLESR relaxations.
• 5‐10 mg PO BID– up to 20 mg PO TID.
• Side effects: CNS—confusion, dizziness, weakness, etc.
• Crosses blood‐brain barrier.
191/9/2018
Non‐Acid Reflux
• Refractory GERD who demonstrate symptoms associated with non‐
acid reflux.
• Reflux of gastric contents—pH >4.0.
• Adjunct therapy:
• Reinforce lifestyle and dietary modification.
• Baclofen
• Surgical evaluation
Functional Heartburn
• Pain Modulators:
• Nortriptyline 25 mg
• Citalpram 20 mg
• Fluoxetine 20 mg
• Medications have delayed onset—INC dose after 2‐4 weeks.
• Stop medication in 12 weeks if no improvement.
• Behavioral therapy
• Acupuncture
What About Adding Prokinetics to PPI?
• Benefit of metoclopramide to PPI therapy has not been adequately
studied.
• Metoclopramide has been shown to increase LESP, enhance esophageal
peristalsis and augment gastric emptying.
• Domperidone is a safer alternative to metoclopramide but hasn’t
been studied adequately in GERD.
201/9/2018
Surgical Treatment for GERD
• Potential surgical options:
• 1. Laparoscopic fundoplication
• 2. Bariatric surgery –Roux en y
• 2. LINX prosthesis
When to Refer for Surgery
(1) Desire to discontinue medical therapy
(2) Medication non‐compliance
(3) Side‐effects associated with medical therapy
(4) Presence of a large hiatal hernia
(5) Esophagitis refractory to medical therapy
(6) Persistent symptoms documented to be caused by refractory
GERD.
Surgery in GERD
• “Highest quality evidence on the efficacy of anti‐reflux surgery exists
only for esophagitis and/or excessive distal acid exposure”
Kahrilas PJ, Shaheen NJ, Vaezi MF, et al AGA Medical Position Statement
on GERD 2008. Gastroenterology 2008; 135(4):1383‐91
211/9/2018
Surgery is as effective in GERD in carefully
selected patients
• Surgical therapy is generally not recommended in patients who do
not respond to PPI therapy. (Strong recommendation, high level of
evidence)
• Preoperative ambulatory pH monitoring is mandatory in patients
without evidence of erosive esophagitis;
• All patients should undergo preoperative manometry to rule out
achalasia or scleroderma‐like esophagus. (Strong recommendation,
moderate level of evidence)
Nissen Fundoplication
Bariatric Surgery
• Obese patients contemplating surgical therapy for GERD should be
considered for bariatric surgery‐‐ Gastric bypass.
– Preferred operation in obese patients. (conditional recommendation,
moderate evidence)
221/9/2018
Roux‐en‐Y
LINX Prosthesis
• Augments LES with a ring made up of earth magnets.
• INC LES closure pressure, but permits food passage.
• Indications: GERD symptoms, abnormal pH study, partial response to
PPI, absence of large hiatal hernia or severe esophagitis.
• Results:
– Significantly fewer reported moderate‐severe GERD (12 vs 89%),
regurgitation (1 vs 57%), gas‐bloat (8 vs 52%), and daily PPI use (15 vs 100%).
LINX Prosthesis
231/9/2018
GERD Related Complications
• (1) Erosive esophagitis
• (2) Strictures
• (3) Barrett’s esophagus
• (4) Adenocarcinoma
Barrett’s Esophagus
• Metaplastic columnar epithelium that predisposes to cancer
development.
• Develops as a consequence of chronic GERD.
• Mean age 55 years.
• Prevalence ranges from 0.4‐20% general population.
• Male to female 2:1.
• Mainly white males.
• Clinical features: None.
Guideline
• AGA Guideline—Recommend screening patients with multiple risk
factors.
• ACP: Screen for Barrett’s esophagus in men >50 y/o with GERD
symptoms for more then 5 years and the additional risk factors.
241/9/2018
Barrett’s Esophagus
•Risk factors:
• Duration of GERD of at least 5‐10 years
• Age >50 years
• Male sex
• White race
• Hiatal hernia
• Obesity
• Nocturnal reflux
• Tobacco use (past or current)
• First‐degree relative with Barrett’s and/or esophageal
cancer.
Barrett’s Esophagus
Barrett’s Treatment
• All patients with Barrett’s esophagus should be treated with
indefinite PPI therapy.
• May prevent cancer by reducing chronic inflammation.
• PPI once daily.
• Only INC dose to eliminate GERD.
• PPI can lead to Barrett’s regression.
• PPI>H2RA
251/9/2018
Key Points
•Heartburn and regurgitation are the most
sensitive symptoms of GERD.
•Empiric PPI trial is reasonable 1st line approach.
• Monitor for alarm features.
•PPI are still considered to be relatively safe.
• Lowest effective dosage.
•Evaluate indication.
•Patients with multiple risk factors for Barrett’s
and esophageal cancer should under screening
EGD even without significant GERD.
References
• Katz K, Gerson L, Vela M et al. GERD practice guideline review. Am J
Gastroenterol 2013.
• Up to Date
261/9/2018
Antithrombotic
Management PRIOR TO
Endoscopy:
GI Perspective
J U S T I N MILLE R, D O FA CO I
F L I N T G A ST RO E N TE RO LO GY ASSO C I AT ES
JA N UA RY 1 0 , 2 0 1 8
Disclosures
None
EDUCATIONAL OBJECTIVES
Understand risks of holding antithrombotics before and after GI endoscopy
Understand safety of maintaining antithrombotics during GI endoscopy
Understand variable risks of GI procedures as they relate to antithrombotic decision‐making
11/9/2018
Antithrombotic Management for
Endoscopy
Decisions in patients on these agents during the periendoscopy period depend on 4 factors
◦ Procedure risk
◦ Low bleeding risk
◦ High bleeding risk
◦ Cardiovascular risk factors: risk of an event while off antithrombotic agent
◦ Atrial fibrillation
◦ Coronary artery disease (CAD)
◦ History of venous thromboembolism (VTE) and/or valve replacement
◦ Drugs: the effect of the medication on the bleeding risk
◦ Antiplatelet agents (APA)
◦ Anticoagulants
◦ The urgency of the procedure
Procedure Risk
Low‐risk procedures
◦ Diagnostic EGD, colonoscopy, sigmoid with mucosal biopsy
◦ ERCP without sphincterotomy
◦ Biliary stent placement
◦ Push or balloon‐assisted enteroscopy
◦ EUS without FNA
◦ Argon plasma coagulation
Procedure Risk
High‐risk procedures
◦ Polypectomy (risk depends on size, technique, morphology)
◦ Sphincterotomy
◦ Treatment of varices
◦ PEG placement (low risk if on ASA or clopidogrel)
◦ EUS with FNA (low risk if ASA/NSAIDS and solid mass)
◦ Pneumatic or bougie dilation
◦ Endoscopic hemostasis
◦ Endoscopic mucosal resection
◦ Ampullary resection
◦ Therapeutic balloon‐assisted enteroscopy (other than APC)
21/9/2018
Procedure Risk
Post‐Polypectomy bleeding
◦ 0.3 – 10% risk
◦ Polyp size
◦ Location
◦ Morphology
◦ Resection technique
◦ Type of cautery used
Procedure Risk
Condition Risks
Risk of thromboembolic event depends on
◦ Indication for antithrombotic therapy
◦ Individual patient characteristics
31/9/2018
Cardiovascular Risk Factors – Non‐rheumatic
Atrial Fibrillation
Cardiovascular Risk Factors – Atrial Fibrillation
Cardiovascular Risk Factors – CAD
High Coronary Thrombosis Risk
◦ Drug‐eluting stent (DES) within last 12 months
◦ Bare metal stent (BMS) within last 1 month
◦ BMS within last year with acute coronary syndrome (ACS)
41/9/2018
Cardiovascular Risk Factors – CAD
Consider other clinical risk factors predisposing to higher rate of stent thrombosis beyond one
year after stent placement and modify approach to APA therapy accordingly
◦ 1/5 patients suffering 1st stent thrombosis will experience 2nd stent occlusion at a rate of 0.6% per year
over the next 3 years with a cumulative risk of cardiac death of 27.9%
◦ History of stent occlusion, ACS or ST elevation myocardial infarction, multi‐vessel percutaneous
coronary intervention, diabetes, renal failure, or diffuse CAD are at higher risk of stent occlusion or ACS
with alteration of APA therapy
History of venous thromboembolism
(VTE) and/or valve replacement
VTE risk factors
◦ Time from initial VTE
◦ History of recurrent VTE with antithrombotic interruption
◦ Presence of thrombophilia
Mechanical valves risk factors
◦ Type
◦ Number
◦ Location
◦ Presence or absence of HF or AF
◦ Bioprosthetic valves are considered low risk
Low, medium and high risk categories
History of VTE or valve replacement
51/9/2018
Antithrombotic Management for
Endoscopy
Antiplatelet agents (APA): Decrease platelet aggregation, preventing thrombus formation
◦ Aspirin
◦ NSAIDs
◦ Dipyridamole (Persantine)
◦ Cilostazol (Pletal)
◦ Thienopyridines
◦ Clopidogrel (Plavix)
◦ Prasugrel (Effient)
◦ Ticlopidine (Ticlid)
◦ Ticagrelor (Brilinta)
Antithrombotic Management for
Endoscopy
Antiplatelet agents (APA) – cont’d
◦ GPIIb/IIIa Inhibitors
◦ Tirofiban (Aggrastat)
◦ Abciximab (ReoPro)
◦ Eptifibatide (Integrilin)
◦ PAR‐1 Inhibitor
◦ Vorapaxar (Zontivity)
Antiplatelet Agents (APA)
61/9/2018
CAD with Dual Antiplatelet Therapy
(DAPT)
Antithrombotic Management for
Endoscopy
Anticoagulants: Prevent blood from clotting by interfering with the clotting cascade
◦ Warfarin (Coumadin)
◦ Unfractionated Heparin (UFH)
◦ Low Molecular Weight Heparin (LMWH)
◦ Enoxaparin (Lovenox)
◦ Dalteparin (Fragmin)
◦ Fondaparinux (Arixtra)
◦ Direct Factor Xa Inhibitor (NOACs)
◦ Rivaroxaban (Xarelto)
◦ Apixaban (Eliquis)
◦ Edoxaban (Savaysa)
Antithrombotic Management for
Endoscopy
Anticoagulants – cont’d
◦ Direct Thrombin Inhibitors (NOACs)
◦ Dabigatran (Pradaxa)
◦ Desirudin (Iprivask)
71/9/2018
Anticoagulants
Periendoscopic period considerations
◦ Time to maximum effect
◦ Half‐life
◦ Excretion
Drugs should be stopped for at least 2 half‐lives before high risk procedures
Adjust dosing in setting of renal impairment
Anticoagulants
Xarelto Considerations
81/9/2018
Eliquis Considerations
Savaysa Considerations
Pradaxa Considerations
91/9/2018
Endoscopy considerations
If antithrombotic therapy is required for short period of time, hold elective procedure until
therapy is no longer required
Factoring In All Variables
101/9/2018
Reinitiation of antithrombotic agents
Antithrombotic therapy should be resumed upon completion of the procedure
◦ Must consider risk of bleeding, time to onset of medication
2014 AHA/ACC guideline
◦ Low‐risk for TE: Restart warfarin within 24 hours of procedure in pts with valvular HD and
◦ High risk for TE: UFH or LMWH as soon as bleeding stability allows and continued until INR is
therapeutic
No data for NOACs
Endoscopy in the Acutely Bleeding
Patient on Antithrombotic Therapy
Safe
Indicated
Anticoagulants in Acute Bleed
Correction of INR to 1.5‐2.5 allowed successful diagnosis and treatment in comparable numbers
to those not on anticoagulation
INR level prior to endoscopy was not a predictor of rebleeding
Studies have indicated that normalizing the INR delays time to endoscopy and is not necessarily
associated with risk of rebleeding
ASGE guidelines recommend that INR be corrected to < 2.5
111/9/2018
Anticoagulants in Acute Bleed
ACCP recommendations (2012) for warfarin in acute GIB
◦ Hold warfarin
◦ Rapid reversal with 4‐factor prothrombin complex (PCC) [Kcentra] over FFP in patients with vitamin K
antagonist‐associated bleeding
◦ Vitamin K (5‐10 mg IV)
AHA/ACC guidelines (2014) for those with mechanical valves
◦ FFP
◦ PCC
◦ No high dose vitamin K
Anticoagulants in Acute Bleed
Dabigatran (Pradaxa)
◦ Hemodialysis
Rivaroxaban (Xarelto), edoxaban (Savaysa), apixaban (Eliquis)
◦ No HD due to fact that they are protein bound and have minimal renal excretion
◦ Use of factor VIIa and 4‐factor PCC is unclear
APA in Acute Bleed
Stop agent
Administer platelets
Restart APA as soon as hemostasis is achieved
ASA resumption is imperative
◦ No increased risk in rebleeding
◦ Increased risk in 30‐day mortality in cardiac patients where ASA was not restarted
◦ Use concomitant PPI if ASA induced ulcer
121/9/2018
Recommendation Summary: Elective
Procedure on Anticoagulation
Hold elective endoscopy until short‐term anticoagulation therapy is completed
Discontinue anticoagulation for the appropriate interval based on the drug used (not a one size
fits all approach) if the patient is to undergo high risk procedure with low risk for TE event
Bridge patients undergoing high‐risk procedures who are at high risk for TE events
Restart warfarin on same day as procedure in all patients who do not have ongoing bleeding
Restart NOACs after high‐risk procedure when hemostasis in ensured. Consider bridge if unable
to restart for 12‐24 hours after procedure
Recommendation Summary: Elective Procedure
on APA therapy
Continue low‐dose ASA and NSAIDs for elective procedures
Continue thienopyridines for low‐risk procedures
Hold thienopyridines for 5‐7 days before HR procedure or switch to ASA monotherapy
Hold thienopyridines for at least 5‐7 days (3‐5 days for ticagrelor) for HR endoscopy and
continue ASA for those on dual therapy
Hold elective endoscopy in patients with recent stents or ACS until they have received the drug
from the minimum recommended duration
endoscopy on anticoagulant
Hold anticoagulants in patient with active bleeding
4‐factor PCC and vitamin K or FFP for life‐threatening GI bleeding in patients on warfarin
Do not delay endoscopy in active bleeding if INR < 2.5
UFH in patients who require anticoagulation after successful endoscopic hemostasis for high‐risk
stigmata
131/9/2018
Recommendation Summary: Urgent/emergent
endoscopy on APA therapy
Consult cardiology in patients on APA with active bleeding if
◦ DES within past 12 months
◦ Bare metal stent in past 30 days
◦ ACS within past 90 days
Risk of cardiac event exceeds benefit of decreasing postendoscopic bleeding
Hold APAs with life‐threatening or serious GI bleeding after discussion with cardiology
Resources
Baron, et al. Management of antithrombotic therapy in patients undergoing invasive procedures.
NEJM 2013
Douketis et al. Perioperative management of antithrombotic therapy and prevention of thrombosis.
ACCP Evidence‐Based Clinical Practice Guidelines 2012
January, et al. AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation. Journal
of the American College of Cardiology 2014
Nishimura, et al. AHA/ACC guideline for the management of patients with valvular heart disease.
Circulation 2014
Ruben, et al. The Management of Antithrombotic Agents for Patients Undergoing GI Endoscopy.
ASGE Standards of Practice Committee. Gastrointestinal Endoscopy 2016
Zullo, et al. Gastrointestinal Endoscopy in Patients on Anticoagulant Therapy and Antiplatelet Agents.
Annals of Gastroenterology 2017
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