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Supplemental Digital Content 1: Harvard Medical School Case

SEVERE UPPER GASTROINTESTINAL BLEEDING IN A MAN WITH KNOWN CORONARY ARTERY DISEASE AND A CARDIAC STENT

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Emily Hayden, MD, MHPE

Elan Guterman, BS

Suma Magge, MD

G. Avinash Ketwaroo MD, M.S.

Farouc Jaffer, MD, PhD

Helen Shields, MD

Harvard Medical School

Gilbert Program in Medical Simulation

|I. Title…………………………………………………….………………………. |2 |

|II. Target Audience………………………………………………… ….………… |2 |

|III. Learning and Assessment Objectives………………………………………... |2 |

|IV. Environment…………………………………………………………………. |3 |

|V. Actors…………………………………………………………………………. |3 |

|VI. Case Narrative……………………………………….………………….…… |4 |

|VII. Instructor Notes……………………………………………………………... |6 |

|VIII. Debriefing Plan…………………………………………………………….. |7 |

|IX. Pilot Testing and Revisions…………………………………….……………. |7 |

|X. Authors and their affiliations………………………………….……………… |8 |

|XI. References…………………………………………………..………………... |8 |

|XII. Appendix A: Lab Values…….…..……….…………….…………………… |9,10 |

|XIII. Appendix B: Diagnostic Studies.….………………………….……………. |11 |

|XIV. Appendix C: Teaching Materials….………………………….…………… |12 |

Title: Severe Upper Gastrointestinal Bleeding in a Man with Known Coronary Artery Disease and a Cardiac Stent

Target Audience

A. Medical Students—second year medical students in pathophysiology course

B. Residents

C. Physicians

D. Nurses

Learning and Assessment Objectives

Participants are expected to execute the optimal management path as defined below and through the critical actions checklist, or at least discuss the pathophysiologic reasoning behind a certain course of treatment. Participants should provide a presentation of the patient to each physician consult that is deemed proficient by the instructor. Debriefing sessions may be used to allow each participant to reflect upon the team dynamics and to identify future technical and behavioral goals.

1. Recognize the symptoms and signs of cardiac ischemia in the setting of ongoing GI bleeding.

2. List and prioritize the tests needed to rule out myocardial infarction.

3. Understand the significance of black, tarry stool.

4. Discuss the significance of the bright red blood found on the naso-gastric aspirate performed in the ER.

5. List the resuscitation plan to carry out in a patient with ischemic heart disease and a rapidly dropping Hematocrit.

6. Describe the variables to be considered in your approach to the patient with cardiac ischemia who needs emergent upper endoscopy.

7. Provide the differential diagnosis for an upper GI bleed.

8. Discuss the role of NSAIDs, aspirin and clopidogrel in this patient’s bleeding and what can be done to minimize this problem in the future.

9. Consider the long term prognosis for this patient’s cardiac and gastrointestinal problems.

10. Discuss professionalism and collegiality in the setting of multiple consultants.

Critical Actions Checklist:

DONE CRITICAL ACTION

������ Telemetry monitoring

������ Patient history

������ Physical examination with rectal examination and testing stool for occult blood

������ EKG and Chest X-ray

������ Aggressive IV fluid resuscitation

With 2 large bore iv’s

������ Type and cross

������ NG aspiration for blood

������ Upper endoscopy

������ Administer IV proton pump inhibitor

������ Send off cardiac enzymes, MB and Troponin levels

Environment

A. Simulation room set up: Emergency Department

B. Manikin set up:

1. High fidelity patient simulator

2. No moulage needed

3. Lines needed

C. Props:

1. IV line

2. Lab values

3. EKG official reading available by verbal report

4. Images including Chest X-ray and upper endoscopy photographs

5. White Board for Faculty to write on

D. Distracters: none

Actors

A. Nurse: facilitate scenario

B. Consultants:

1. Gastroenterologist: recommends endoscopy

2. Cardiologist evaluates for possible emergent upper endoscopy given chest pain, prior cardiac stent, anemia and father’s history of fatal myocardial infarction at an early age.

3. Primary Care Physician: highlights pertinent elements of patient history

III. Case Narrative

PATIENT: Greg Smith is a 54 year old construction worker

CC: Epigastric discomfort

HPI:

Mr. Smith complains of epigastric pain on and off for the past week. The pain is worsening, so he decided to come in to the Emergency Room. The patient was worried because he had recently been admitted to the hospital for chest pain one month ago and at that time, the lab work and his exercise treadmill stress test did not show any significant abnormalities. He had a cardiac stent placed five years previously after he noted chest pain climbing a steep hill near his apartment. The cardiac catheterization at that time showed a 90 % blockage of one of his arteries. He is confused as to what is causing the upper abdominal pain, and is worried that they did not catch that it was his ‘heart’ on his last admission. He also is puzzled by the increasing “gnawing” hunger-like pain in his upper abdomen. He has lost his appetite which is usually excellent and has mild nausea intermittently.

The pain in the past two days is associated with exertion in that it came on when he climbed the two flights of stairs to his apartment yesterday and this morning. He has no sweating, but was short of breath climbing the stairs for the first time today, which along with the chest pain, prompted him to come in again. He has no vomiting. He notes a very dark bowel movement today.

PMHx:

Recent admission for r/o MI

Normal exercise treadmill stress EKG at that time

Stent in left anterior descending artery placed five years previously

Hypertension

Hypercholesterolemia

Arthritis

|MEDICATIONS |ALLERGIES |

|Ibuprofen ~600 mg BID x 1 year (knee pain, bilaterally) |NKDA |

|HCTZ | |

|Simvastatin | |

|Metoprolol | |

|Aspirin 81 mg daily | |

|Clopidogrel 75 mg daily | |

SOCIAL Hx:

EtOH: History of heavy abuse. Quit 15 years ago.

Tobacco: Quit 2 years ago after heavy use of one pack per day for 35 years

Illicits: Denies using any.

Occupation: Construction worker

Additional: Divorced

FAMILY Hx: Father died at age 56 of massive heart attack. Mother has hypertension at age 73.

ROS:

(+) Chest pain

(-) Denies vomiting, headache, fevers/chills, constipation/diarrhea

PHYSICAL EXAM:

GENERAL: Pale, alert and oriented

HEENT: Pale conjunctiva

Chest: Clear to auscultation and percussion

CV: Tachycardia but regular rhythm. No murmur or gallops

ABD: Soft, mild mid-epigastric tenderness, Liver 10 cm in RMCL, no spleen tip

EXT: No edema

Rectal: Hemoccult positive, black, tarry stool

Naso-gastric aspirate: Bright red blood that does not clear with 200 cc of saline lavage

|HR |BP |Temperature |O2 Sats (RA) |RR |

|115 |145/90 |37.0 |99% |16 |

LABS: See Appendix A

|Amylase/Lipase Level |X |Comprehensive Metabolic Panel |X |

|Arterial Blood Gas | |Lactate/Cortisol Level |X |

|Basic Metabolic Panel | |Liver Function Test |X |

|Cardiac Markers |X |Thyroid Panel | |

|Coagulation Profile |X |Toxicology Screen | |

|Complete Blood Count (CBC) | |Urinalysis |X |

|CBC with differential |X |Urine HCG | |

Additional Labs: none

IMAGES: See Appendix B

|Angiogram | |EKG, report available; not shown |X |

|CT Scan, with contrast | |MRI | |

|CT Scan, without contrast | |X-Ray |X |

|Echocardiogram | |Ultrasound | |

Additional Images: Esophagogastroduodenoscopy with cautery of visible vessel in a large benign gastric ulcer

CONSULTS:

Gastroenterologist – Dr. Lawrence Borges for 2016

Cardiologist: Dr. Farouc Jaffer

Primary Care Physician – Suresh Venkatan, MBBS, Simulation Specialist

CLINICAL PROGRESSION:

History and physical performed. IV fluids, EKG and blood tests ordered, and vital signs monitored. Students are expected to recognize possible cardiac ischemia or infarction. In addition they should detect GI bleeding by testing the stool for occult blood and finding it 4+ positive,performing the naso-gastric aspirate which shows bright red blood, consulting GI, and determining the immediate need for blood products. They or the GI consultants need to consult cardiology about the risks of this patient with ischemia by history and EKG report going for an endoscopy because of red blood in the naso-gastric aspirate and a rapidly dropping HGB of 7.1 to 5.8, and HCT of 24 to 19 after several hours in the ER without blood being given yet. What is the risk versus benefit ratio? What must be accomplished before the patient can go for a therapeutic endoscopy? Where should the endoscopy be performed? Should the patient be transferred to a Cardiac Care Unit for expert monitoring? Students may administer intravenous acid suppressors (proton pump inhibitors). Once students consult the GI service, the GI service is likely to ask for a cardiology consult if the primary team in the ER have not already called for one., The Cardiology consultant will discuss the parameters that are used to determine if the patient is an acceptable risk for the endoscopy. Platelet inhibitors will be held for the present during the active bleeding. Students and cardiology consultant will discuss future management and therapy of his known cardiac disease with platelet inhibitors even though he has had a significant GI bleed. After this the GI consultants will describe possible bleeding sites in esophagus, stomach and duodenum with a slide set as well as view the images of this patient’s benign gastric ulcer with visible vessel treated by endoscopic cautery. Then the students will walk to the BIDMC where each student will have the opportunity to perform an endoscopy under the guidance of a gastroenterology fellow and attending. During this time, the diagnosis and management of upper GI Bleeding will be reviewed along with the pathophysiologic rationale for the drugs used.

***If the students give 1-2 liters of fluid or blood products within the first 10-15 minutes of the case:

|HR |BP |Temperature |O2 Sats (RA) |RR |

|110 |145/90 |37.0 |99% |16 |

***Failure to give fluids within 15 minutes of the start of the case OR failure to consider GI bleeding as part of differential diagnosis, vitals will worsen with blood pressure gradually dropping and a slight increase in heart rate.

- If deemed necessary: GI or PCP will call for guidance

|HR |BP |Temperature |O2 Sats (RA) |RR |

|130 |105/90, (decrease over 10 |37.0 |99% |16 |

| |minutes) | | | |

IV. Instructors’ Notes

A. Tips to keep scenario flowing

1. If students fail to consider GI pathologies after normal cardiac labs/images obtained, PCP can provide an unprompted consult and additional information. PCP will call and inform/remind students of heavy NSAID use in addition to the aspirin and clopidogrel as well as a current history of tobacco use and prior heavy alcohol use.

2. If IV fluids are not provided, patient becomes increasingly hypotensive as case progresses. Blood products must be administered given the Hct of 24 and the prior cardiac stent. This patient would be excluded from the restrictive guideline for transfusion given his coronary stent and current chest pain, as outlined by Villanueva et al., in NEJM 2013.

3. If students are unsure of imaging modality, gastroenterology will recommend upper endoscopy. Cardiology must decide if the patient is an acceptable risk and explain the risk to benefit ratio and whether it is acceptable to go to emergent endoscopy. The factors that go into making this decision will be clearly laid out by the cardiologist. In addition, the GI service must explain to the patient the pros and cons of the procedure after cardiology has completed the consult and agreed that the patient is a reasonable risk for the procedure.

B. Scenario programming

1. Optimal management path:

• O2/IV/monitor

• History and physical examination

• Aggressive fluid resuscitation

• Appropriate lab workup

o Include type and cross

o Include rule-out MI

• Order endoscopy

• Administer IV proton pump inhibitor

• Consider administering somatostatin, Vitamin K, FFP and /or platelets depending on the case history, liver enzymes, albumin and clotting studies.

• Consider portal hypertension given past heavy alcohol intake and treat appropriately.

• Consider need for antibiotic therapy for cardiac stent

• Consult specialist for definitive care/determine need for surgical intervention

• Transfer to OR for laparotomy, if required

2. Potential complications/errors path(s):

• Failure to do any of the following: administer fluids, check Hct, check stool for occult blood, perform a naso-gastric aspirate, order blood products, obtain the EKG, Troponin T, and consult cardiology and GI services,

• If pertinent, failure to recognize need for possible surgical intervention

3. Program debugging: N/A

Debriefing Plan

A. Method of debriefing: Group with multimedia teaching materials and endoscopy findings

B. Debriefing materials: See Appendix C

C. Debriefing topics

1. Team dynamics

a. Leadership

b. Collaboration

c. Communication

d. Professionalism between consultants: showing respect for the other consultant’s opinions and recommendations and willingness to see a another point of view.

2. Didactic material

a. Appropriate differential diagnosis

i. Discuss definitive way to determine origin of GI bleed

ii. Discuss why endoscopy and colonoscopy may both be warranted when searching for source of GI bleed

b. Pathophysiology

i. Discuss similarity of chest pain and esophageal pain

c. Presentation

i. Ulcer in stomach

ii. Difference between MALT and Adenocarcinoma

d. Etiology

i. NSAIDS, H Pylori, and acid contributes to ulcers

ii. Other contributors such as tobacco which impedes ulcer healing

e. H Pylori treatment options

Pilot Testing and Revisions

Expectations and management mistakes as described above relate to medical students and may be modified for participants with more or less medical experience. The appropriate number of participants should correspond with the level of student, ranging from 1-6 students.

Authors and their affiliations

Primary Authors:

Emily Hayden, M.D., MHPE

Associate Director for Curricular Integration

Gilbert Program in Medical Simulation

Harvard Medical School

Elan Guterman, B.S. Weill Cornell Medical College

Other Authors:

Farouc Jaffer, M.D., Ph. D., Interventional Cardiology, Massachusetts General Hospital

G. Avinash Ketwaroo, M.D., M.S. Fellow in Gastroenterology, Beth Israel Deaconess Medical Center

Suma Magge, M.D. Fellow in Gastroenterology, Beth Israel Deaconess Medical Center

Helen Shields, M.D. Gastroenterology Division, Brigham and Women’s Hospital

References

1. Nikolsky E, Stone GW, Kirtane AJ, et al. Gastrointestinal bleeding in patients with acute coronary syndromes: Incidence, predictors, and clinical implications. Analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial J Am Coll Cardiol 2009; 54: 1293-1302.

2. Bhala N, Taggar JS, Rajasekhar P, et al. Anticipating and managing bleeding complications in patients with coronary stents who are receiving dual antiplatelet treatment. BMJ 2011; 343: d4264doi: 10.1136/bmj.d4264.

3. Yasuda H, Yamada M, Sawada, et al. Upper gastrointestinal bleeding in patients receiving dual antiplatelet therapy after coronary stenting. Inter Med 2009; 48: 1725-1730.

4. Gupta N, Nayak R, Grisolano SW, et al. Defining patients at high risk for gastrointestinal hemorrhage after drug-eluting stent placement: A cost utility analysis J Interven Cardiol 2010; 23: 179-187.

5. Liberopoulos EN, Elisaf MS, Tselepis AD, et al. Upper gastrointestinal haemorrhage complicating antiplatelet treatment with aspirin and/or clopidogrel: Where we are now? Platelets: 2006; 17(1): 1-6.

6. Becker RC, Scheiman J, Dauerman HL, et al. Management of platelet-directed pharmacotherapy in patients with atherosclerotic coronary artery disease undergoing elective endoscopic gastrointestinal procedures. J Am Coll Card 2009; 54:2261-2276.

7. Bhatt DL, Cryer BL, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med 2010; 363: 1909-1917.

8. Banerjee S, Weideman RA, Weideman MW, et al. Effect of concomitant use of clopidogrel and proton pump inhibitors after percutaneous coronary intervention Am J Cardiol 2011; 107: 871-878.

9. Kwok CS, Kong Y. Effects of proton pump inhibitors on platelet function in patients receiving clopidogrel: A systematic review. Drug Safety 2012: 35: 127-139.

10. Baradarian R, Ramdhaney S, Chapalamadugu R, et al. Early intensive resuscitation of patients with upper gastrointestinal bleeding decreases mortality.Am J Gastroenterol 2004;96: 619-622.

11. Leontiadis, GL, Sharma VK, Howden CW. Proton pump inhibitor therapy for peptic ulcer bleeding: Cochrane collaboration meta-analysis of randomized controlled trials. Mayo Clin Proc. 2007;82: 286-296.

12. Sung JJY, Barkun A, Kuipers EJ, et al. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding. Ann Intern Med 2009; 150:455-464.

13. Villanueva C, Colomo A, Bosch A, et al. Transfusion strategies for acute upper gastrointestinal bleeding. NEJM 2013; 368:11-21.

14. Loscalzo J, From Clinical Observation to Mechanism-Heyde’s Syndrome. NEJM 2012 367: 1954-1956.

15. Grosser T, Fries S, Lawson J.A. et al. Drug resistance and pseudoresistance: An unintended consequence of enteric coating aspirin. Circulation 2013; 127: 377-385.

16. Schjerning Olsen A-M, Fosbol E L, Lindhardsen J, et al. Long-term cardiovascular risk of nonsteroidal anti-inflammatory drug use according to time passed after first-time myocardial infarction: A nationwide cohort study. Circulation 2012; 126: 1955-1963.

17. Bates E R. Lau W C, Angiolillo D J. Clopidogrel-drug interactions J Am Coll Cardiol 2011; 57: 1251-1263.

18. Carson J L. Grossman B J, Kleinman S, et al. Red Blood cell transfusion: A Clinical Practice Guideline from the AABB. Ann Intern Med 2012; 157: 49-58.

19. Anderson M L, Peterson E R, Brennan J M,. et al. Short-and long-term outcomes of coronary stenting in women versus men: Results from the National Cardiovascular Data Registry Centers for Medicare and Medicaid Services Cohort Circulation 2012; 126: 2190-2199.

20. Srygley, F D, Gerardo, C J, Tran T, et al. Does this patient have a severe upper gastrointestinal bleed? JAMA 2012; 307: 1072-1079.

Appendix A: Lab Values

|COMPREHENSIVE METABOLIC PANEL |Reference Range |

|Sodium |136 |135-147 mmol/L |

|Potassium |3.5 |3.5-5.2 mmol/L |

|Chloride |100 |95-107 mmol/L |

|CO2 |24 |22-30 mmol/L |

|Urea Nitrogen (BUN) |20 |7-20 mg/dL |

|Creatinine |1.2 |0.5-1.4 mg/dL |

|Glucose |100 |60-110 mg/dL |

Calcium 9.8 8.4-10.3 mg/dL

Magnesium 1.9 1.6-2.6 mg/dL

Phosphorus 2.8 2.7-4.5 mg/dL

Alkaline Phosphatase 88 35-105 mg/dL

AST 34 0-40 IU/L

ALT 38 0-40 IU/L

Bilirubin Total 1.2 0-1.5 mg/dL

Bilirubin Direct 0.2 0-0.2 mg/dL

Albumin 3.8 3.5-5.2 g/dL

Amylase 61 0-100 IU/L

Lipase 32 0-60 IU/L

Lactate 1.9 0.5-2.0 mmol/L

|CARDIAC MARKERS |Reference Range |

|Creatine Kinase-BB |0% |0% |

|Creatine Kinase-MB (cardiac) |0% |0 - 3.9% |

|Creatine Kinase-MM |100% |96 – 100% |

|Creatine phosphokinase (CPK) |85 |8 – 150 IU/L |

|Troponin T |0.02, repeat in 8 |< 0.03 ng/mL |

| |hours | |

|COAGULATION PROFILE |Reference Range |

|Partial thromboplastin time (PTT) |32 |30 – 45 sec |

|Prothrombin time (PT) |11 |10 – 12 sec |

|International Normalized Ratio (INR) |1.3 |1 - 2 |

|Fibrinogen |189 |170 – 420 mg/dL |

|COMPLETE BLOOD COUNT |Reference Range |

| |Male |Female |

|White Blood Cell (WBC) |10,000 |4,500 - 10,000 K/uL |

|Hemoglobin (HGB) | 7.1.on admission to|13.5 - 16.5 g/dL |12.0 - 15.0 g/dL |

| |ER,falling to 5.8 | | |

| |after 3 hours in ER | | |

|Hematocrit (HCT) |24.0 falling to 19 |41 – 50% |36 – 44% |

| |after 3 hours in ER | | |

|Platelet |150,000 |100,000 - 450,000 K/uL |

Differential Pending

Appendix B: Diagnostic Studies

ECG: Myocardial ischemia. Anterolateral, lateral. Also STE in aVR suggesting multivessel CAD or left main. Borderline LVH may reduce the specificity of ST segment depression for ischemia.

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Chest X-Ray: normal, male



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Upper Endoscopy Photographs:

See Slide Set

Appendix C: Teaching Materials

Dave Project Videos on Gastrointestinal Hemostasis (On Line)

a. O’Shea CN, Raju GS. Stomach-Ulcer Bleeding, Mechanical Hemostasis



b. Shaikh SN, Ryou M, Azagury DE, Thompson CC. New Techniques in Gastrointestinal Hemostasis



Supplemental Digital Content 2. Evaluation Form

Simulation Laboratory during Homeostasis 2 Course Evaluation Form

Society ___________________________

Please circle your responses.

1. Overall, how would you rate the Simulation Laboratory?

Excellent Very Good Good Fair Poor

1. 2 3 4 5

Comments:

2. Overall, how would you rate the GI Instructor for the Simulation Laboratory?

Excellent Very Good Good Fair Poor

1 2 3 4 5

Comments:

3. Overall, how would you rate the Cardiology Instructor for the Simulation Laboratory?

Excellent Very Good Good Fair Poor

1 2 3 4 5

Comments:

4. What did you like Best about today’s session?

5. Would you Change anything about today’s session?

Supplemental Digital Content 3: Overall Likert1 scale rating by number of student responses (n=125 total students)

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1Likert scale used where Excellent=1 and Poor=5.

Supplemental Digital Content 4: Likert1 scale rating of the gastroenterologists’ teaching by number of student responses (n=125 total students)

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1Likert scale used where Excellent=1 and Poor=5.

Supplemental Digital Content 5: Likert1 scale rating of the cardiologists’ teaching by number of student responses (n=125 total students)

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1Likert scale used where Excellent=1 and Poor=5.

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