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GENERAL COMMENTS FOR PRESENTERS

GENERAL COMMENTS FOR PRESENTERS. It is not intended for the presenter to use all of the slide deck as the audience will dictate the messages you want to convey

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GENERAL COMMENTS FOR PRESENTERS

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  1. GENERAL COMMENTS FOR PRESENTERS • It is not intended for the presenter to use all of the slide deck as the audience will dictate the messages you want to convey • At times the slides on CPR may not be necessary or you may want to combine the info into a few key concepts, emphasizing Epinephrine use

  2. RADIOCONTRAST MEDIA: ADVERSE REACTIONS American College of Asthma, Allergy, and Immunology Drug and Anaphylaxis Committee 2009

  3. Authors & Reviewers • Dana Wallace, MD • David Khan, MD • Paul Dowling, MD • Phil Lieberman, MD • David Lang, MD • Jay Portnoy, MD

  4. Disclosures(abbreviations below) • Dana Wallace, MD: A, SA,M,SEP, SP, SCI • David Khan, MD: None • Paul Dowling, MD: None • Phil Lieberman, MD: A, D, E, G, IS, IN,N, P, SA, SP • David Lang, MD: GSK, G, N, AZ,SA,SP,M, MI • Jay Portnoy, MD: GSK, SCI, Ph Alcon= A, Astra-Zeneca= AZ, D=Dey, E=Endo, G=Genetech, GSK, IN= Intelliject, IS+ Ista, MEDA, M=Merck, MI= Medimmune, N=Novartis, P=Pfizer, PH=Phadia, SA= Sanofi-Aventis, SP= Schering/Plough, SCI=Sciele, SEP= Sepracor

  5. Radiocontrast Media (RCM): • TYPES AND CHARACTERISTICS OF REACTIONS • RISK FACTORS FOR REACTIONS • DIAGNOSIS OF REACTIONS • TREATMENT OF REACTIONS • PREVENTION OF REACTIONS

  6. Incidence of RCM Reactions • 11-12% for ionic, 5-12% high osmolar • 3.13% for non-ionic contrast, 1-4% low osmolar • Severe reactions 0.04% (lower osmolar) 0.22% (ionic, high osmolar) • Fatality 1-2:100,000 exams (ionic % non-ionic) • 50-60 Million exams/year worldwide Canter, L. Allergy Asthma Proc. 2005;26:199-203. Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519. Katayama H. Radiology 1990, 175 (3): 621-268. Delaney A.BMC Medical Imaging 2006, 6:2. Kahn D et al. The Diagnosis and Management of Anaphylaxis Practice Parameter: 2008 update. Annals, in press. Tramer. BMJ 2006;333:675.

  7. Adverse Reactions to RCM • Immediate reactions • Anaphylactoid • 94% <20 minutes • 40% fatalities= respiratory decompensation • Chemotoxic: systemic and local • Delayed reactions • Hypersensitivity • Other, e.g. Iodine mumps • Vasovagal reaction • Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519.

  8. RCM ADVERSE REACTIONS:IMMEDIATE IN ONSET

  9. Anaphylactoid vs.. Chemotactic Reactions • Anaphylactoid (aka non-immunologic anaphylaxis) • Idiosyncratic • Does not require prior sensitization • Independent of infusion rate • Chemotoxic (cardio-, neuro-, or nephrotoxic) • Related to the chemical properties of the RCM • Dose & concentration dependent • Occur more frequently in medically unstable/debilitated patients Solensky R. Drug Allergy Practice Parameter. Annals, in press.

  10. Anaphylactoid RCM Reactions:Mechanism of action • It is not IgE mediated • Exact cause is unknown but possibly due to: • Histamine release • Complement activation • Recruitment of various mediators • Direct mast cell degranulation Lieberman PL. Clin Rev Allergy Immunol. 1999;17:469-496.

  11. Risk Factors for Anaphylactoid Reactions • Female gender (up to 20x)1 • History of previous reactions to radiocontrast media(5x)2 • Increased incidence 20-50 yrs. of age2 • Atopy (2-3x)2 and Asthma (10x)2 (not all articles agree as may just increase the severity of the reaction)4 • Lang, DM.JACI. 1995; 95:813-817. 2. Hagan. JB. Immuno Allergy Clin North Am • 2004; 24:507-519. 3. Tramer MR. BMJ 2006; 333: 675. 4. Brockow, K. Allergy, 2005. • 60(2): p. 150-8.

  12. Risk Factors for More Severe Anaphylactoid Reactions • Cardiovascular disease 1,2, 3 • Beta-blockers 1 (may also complicate Tx of reaction)2 • Debilitated, unstable, or elderly2 • Brockow, K. Allergy, 2005. 60(2): p. 150-8. 2. Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519. 3. Tramer MR. BMJ 2006; 333: 675.

  13. Possible Risk Factors for RCM • Non-immediate cutaneous • Interleukin-2 Tx (Non-immediate cutaneous)1,2 • Serum Creatinine >2.0 mg/dl2 • History of drug and contact allergy • Aspirin/NSAIDS 1 1. Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519. 2. Brockow, K. Allergy, 2005. 60(2): p. 150-8.

  14. Risk Factors for Non-anaphylactoid Reactions: • Cardiovascular Dx • Dehydration • Hematologic conditions, e.g. sickle cell anemia • Thrombotic tendencies • Renal disease • Anxiety and apprehension (?? No data) Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519.

  15. Seafood Allergy is NOT a risk factor: Possible origin of the myth! • In 1975 Shehadi et. al noted the following regarding patients with RCM reactions: • 15% of patients gave an unconfirmed history of shellfish allergy • They surmised iodine in shellfish was responsible for the allergy. [FALSE] • They surmised iodine in shellfish cross-reacted to iodine in RC. [FALSE] [Note: The allergens in shellfish is due to the protein components] Shehadi WH. Am J Roentgenol. 1975; 124: 145-152. Beaty AD. American Journal of Medicine. 2008; 121 (2): 158e.

  16. Slight  Risk of RCM Reactionfor an allergic (atopic patient) • Up to 46% population are atopic1 • Epidemiologic studies imply that atopic individuals are at risk of RCM reactions2 • Prospective analyses confirm  risk3 • Atopics may have a more severe Reaction4 • Basophils in atopic individuals may be more sensitive to the degranulation effect of RCM agents 1) Shibbald, B. Br J Gen Pract. 1990 Aug; 40(337):338-40. 2) Enright T et al. Ann Allergy 1989;62(4):302– 5. 3) Lieberman P. et al. Clin Rev in Aller and Immun. 1999; 17(4): 469-496. 4) Brockow,K. Allergy, 2005.

  17. NOT JUST SHELLFISH! 46% population are atopic !

  18. Facts on Shellfish Allergy and RCM Reactions • Shellfish allergy is caused by the protein allergen (e.g. tropomyosin), not iodine • Having shellfish &/or RCM reactions are unrelated and coincidental (except for indicating atopy) • Iodine and iodide are small molecules that do not cause anaphylactic or anaphylactoid reactions • Povidone-iodine contact dermatitis (e.g. Betadine solution or mouthwash) does not increase risk of RCM reactions Solensky R. The Diagnosis and Management of Anaphylaxis Practice Parameter:2009 update. Annals, in press.

  19. The Myth Lives On • 2007 survey of 231 academic centers • 61% inquire about seafood allergy before RCM administration • 37% withhold RCM or recommend premedication when a patient has a history of seafood allergy • 2005 survey of patients with seafood allergy • 65% had been informed to avoid RCM • 92% thought iodine caused their seafood allergy Beaty AD. American Journal of Medicine. 2008; 121 (2): 158e.

  20. Help to Dispel the Myth! • Identify “false” risk factors such as shellfish/iodine allergy in patient or other family member as these may: • May delay or prevent a necessary procedure • May increase risk from side effects of unnecessary pre-medications • Instruct all staff to refrain from asking the patient if they have seafood or iodine allergy

  21. Help to Dispel the Myth! • Remove any reference to seafood allergy and iodine allergy from all consent forms and questionnaires • Hold inservice education session for all employees • Provide patient education about this myth, e.g. brochure or informative handout

  22. SYMPTOMS OF ANAPHYLACTOID REACTIONS

  23. Common Symptoms of RCM Anaphylactoid Reactions • Flushing • Pruritus • Urticaria • Angioedema • Bronchospasm and wheezing • Laryngospasm/stridor • Hypotension • Shock/Loss of consciousness (rare)

  24. Symptoms of Grade 1:“Mild reactions” RCM Reactions • Limited nausea and vomiting • Limited urticaria • Pruritus • diaphoresis Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519.

  25. Symptoms of Grade 2:“moderate reactions” to RCM • Faintness • Severe vomiting • Profound urticaria • Facial and laryngeal edema • Mild bronchospasm Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519.

  26. Symptoms of Grade 3:“Severe reactions” to RCM • Hypotensive shock • Pulmonary edema • Respiratory arrest • Cardiac arrest • Convulsions Hagan. JB. Immuno Allergy Clin North Am 2004; 24:507-519.

  27. Clinical Criteria for Anaphylaxis (any agent) Anaphylaxis = Anaphylactoid (non-immune Anaphylaxis) Acute onset (min to hrs) Skin/mucosal symptoms AND Airway compromise OR ↓ BP or Associated symptoms Exposure to known allergen+ at least 2 items below within min to hrs History of severe reaction Skin/mucosal symptoms Airway compromise ↓ BP or Associated symptoms GI symptoms with food allergy Anaphylaxis is likely if 1 or 3 set of criteria are fulfilled: 1 2 Hypotension within min. to hrs. after exposure to known allergen 3 Sampson HA, et al. J Allergy Clin Immunol. 2005;115:584-591.

  28. ANAPHYLAXIS orANAPHYLACTOID REACTION • “SIMPLE DEFINITION” • An acute allergic-type reaction for which it is known that there is potential for fatality • Regardless of the severity of the presenting symptoms • For which immediate treatment has been shown to prevent progression of the disease process

  29. RCM ADVERSE REACTIONS:DELAYED

  30. Delayed RCM Reactions • Occur in 2% of patients1 • Occur between 1 hour and 1 week after RCM administration1 • Usually mild, cutaneous, self-limited1 • Serious reactions 0.004-0.008%1 • No association with anaphylactoid reactions • Controversial as reactions following CT with and without contrast may be equal.2 1. Lerch, M. Current Opinion in Allergy and Clinical Immunology: October 2004 - Volume 4 - Issue 5 - pp 411-419 2. Yasuda, R.Invest Radiol, 1998. 33(1): p. 1-5. .

  31. Delayed RCM Reactions: Risk Factors • Female • Pt being treated with IL-2 • Frequency of previous reaction (possible) but recurrence is not consistent • More frequent with non-ionic dimers • Equal frequency with ionic & non-ionic monomers Current Opinion in Allergy and Clinical Immunology: October 2004 - Volume 4 - Issue 5 - pp 411-419

  32. Delayed RCM Reactions • May be T-cell mediated • The majority are maculopapular, pruritic rashes with fever • Desquamation is frequent • Predilection for palms • Organ involvement. e.g. liver, kidneys, not uncommon • Often patient has multiple drug sensitivities Current Opinion in Allergy and Clinical Immunology: October 2004 - Volume 4 - Issue 5 - pp 411-419

  33. Delayed RCM Reactions:Biopsy findings • Lymphocyte rich perivascular infiltrate • Spongiosis • CD4+ memory cells • Negative for eosinophils, complement, and antibodies • Consistent with delayed hypersensitivity Current Opinion in Allergy and Clinical Immunology: October 2004 - Volume 4 - Issue 5 - pp 411-419

  34. Delayed RCM Reactions: Infrequent • Cutaneous vasculitis • Erythema multiforme • Stevens Johnson syndrome • Toxic Epidermal Necrolysis (TEN) • Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Current Opinion in Allergy and Clinical Immunology: October 2004 - Volume 4 - Issue 5 - pp 411-419

  35. DIAGNOSTIC STUDIES FORRCM ADVERSE REACTIONS

  36. RCM Diagnostic Studies • Immediate Reactions • Skin testing of no value • No blood tests are advised • Delayed Reactions • Skin testing: prick, intradermal, patch • Positive and negative • No relationship between type of reaction or agent used • Frequent cross-reactivity of agents • Testing is not recommended Kanny, G. J Allergy Immunol 2005; 115 (1): 179-184.

  37. TREATMENT OF RADIOCONTRAST MEDIA ADVERSE REACTIONS

  38. The Treatment of Anaphylaxis and Anaphylactoid Reactions is the same

  39. Have a TX Plan Available

  40. Enhancing Pediatric Safety during RCM Reaction • Resuscitation training results • Shortened the time to call code (98 vs. 140 seconds) • Shortened the time for requesting Epi (121 vs. 163 sec) and O2 (40 vs. 89) • Simulation training for radiology residents is valuable Gaca AM. Radiology, 2007. 245 (1):236-244.

  41. Broselow-Luten pediatric emergency tape: Consider using Gaca AM. Radiology, 2007. 245 (1):236-244.

  42. Sample Information sheet Gaca AM. Radiology, 2007. 245 (1):236-244.

  43. Anaphylaxis Treatment • Epinephrine • Position Supine • Oxygen • H1 and H2 Antihistamines • IV Fluids • Steroids (?)

  44. Anaphylaxis Treatment • Assess signs and symptom of Anaphylaxis • Review Airway, Breathing, Circulation, Defibrillator, and mental status • If severe anaphylaxis, staff to administer first dose of epinephrine using standing order

  45. CPR • Establish that the patient does not respond • Adult: Activate EMS immediately • Child: Give 5 cycles CPR then activate EMS • Head-tilt-chin lift • Look, listen, feel : 5-10 seconds • Give 2 breaths • Check carotid pulse and rate: 5-10 seconds

  46. CPR • Start compressions • Center of breastbone between nipples • 1 ½-2 inches depth in adults • Adult: 30:2 • Child: • 1-rescurer ratio is 30:2 • 2-rescurer ratio is 15:2

  47. # 1 DRUG F0R ANAPHYLAXIS EPINEPHRINE (.01 mg/kg to max of .5 mg) IM in Lateral thigh (or SC upper arm) Repeat q 5 minutes PRN

  48. IM vs. SQ Epinephrine 8 2minutes + SHORTEST ONSET OF ACTION - 34 14 (5 – 120)minutes p < 0.05 + - Time to Cmax after injection (minutes) Simons: J Allergy Clin Immunol 113:838, 2004

  49. # 2 DRUG OXYGEN • Any patient with Hypotension • Any patient with 02 sat <95% • Any patient requiring more than one Epi injection • Face mask recommended over nasal prongs. • Start with 6-8 Liter/minute

  50. Position Patient Supine • Sitting upright has been associated with • Empty ventricle syndrome • Pulseless Electrical Activity • Increased Death • 4/10 pre-hospital deaths associated with assuming upright or sitting position Pumphrey, R. J allergy Clin Immunol:2003, 112:451-452.

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