Statement of Principles concerning PERICARDITIS (Reasonable Hypothesis) (No. 90 of 2023) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986. Dated 25 October 2023 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Terence Campbell AM Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Application 5 Definitions 6 Kind of injury, disease or death to which this Statement of Principles relates 7 Basis for determining the factors 8 Factors that must exist 9 Relationship to service 10 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning pericarditis (Reasonable Hypothesis) (No. 90 of 2023). 2 Commencement This instrument commences on 28 November 2023. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies. 5 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 6 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about pericarditis and death from pericarditis. Meaning of pericarditis (2) For the purposes of this Statement of Principles, pericarditis: (a) means an inflammation of the pericardium; and (b) includes: (i) acute pericarditis; (ii) chronic pericarditis; (iii) recurrent pericarditis; and (iv) constrictive pericarditis; and (c) excludes haemorrhage from pericardial injury not associated with pericardial inflammation. (3) While pericarditis attracts ICD‑10‑AM codes, I30, I31.0, I31.1, I01.0, and I09.2, in applying this Statement of Principles the meaning of pericarditis is that given in subsection (2). (4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4. Death from pericarditis (5) For the purposes of this Statement of Principles, pericarditis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's pericarditis. Note: terminal event is defined in the Schedule 1 – Dictionary. 7 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that pericarditis and death from pericarditis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary. 8 Factors that must exist At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting pericarditis or death from pericarditis with the circumstances of a person's relevant service: (1) having open heart surgery within the 20 years before the clinical onset or clinical worsening of pericarditis; (2) having a pacemaker, or defibrillator lead insertion within the 20 years before the clinical onset or clinical worsening of pericarditis; (3) having a cardiac ablation procedure to treat cardiac dysrhythmia within the 4 weeks before the clinical onset or clinical worsening of pericarditis; (4) having sclerosants such as talc, and tetracyclines directly introduced into the pericardial sac before the clinical onset or clinical worsening of pericarditis; (5) having penetrating or blunt trauma to the heart within the 20 years before the clinical onset or clinical worsening of pericarditis; (6) having electrical injury affecting the heart within the 20 years before the clinical onset or clinical worsening of pericarditis; (7) having a peptic ulcer that erodes the pericardium at the time of the clinical onset or clinical worsening of pericarditis; (8) undergoing a course of therapeutic radiation for cancer, where the heart was in the field of radiation, within the 20 years before the clinical onset or clinical worsening of pericarditis; (9) having a pericardial infection at the time of the clinical onset or clinical worsening of pericarditis; (10) having a systemic viral infection within the 4 weeks before the clinical onset or clinical worsening of pericarditis; (11) having tuberculosis before the clinical onset or clinical worsening of pericarditis; (12) having an infection of the structures contiguous with the pericardium at the time of the clinical onset or clinical worsening of pericarditis; Note: Infections reported to spread to the pericardium from anatomical sites contiguous with the pericardium include empyema, and amoebic liver abscess. (13) having myocarditis at the time of the clinical onset or clinical worsening of pericarditis; (14) having acute rheumatic fever at the time of the clinical onset or clinical worsening of pericarditis; (15) having one of the following vasculitides: (a) Behcet's disease; (b) eosinophilic granulomatosis with polyangiitis (Churg Straus syndrome); (c) giant cell (temporal) arteritis; (d) granulomatosis with polyangiitis (Wegener's granulomatosis); (e) microscopic polyangiitis; (f) polyarteritis nodosa; or (g) Takayasu's arteritis; at the time of the clinical onset or clinical worsening of pericarditis; (16) having one of the following systemic inflammatory diseases: (a) Addison disease with type 2 autoimmune polyglandular syndrome; (b) ankylosing spondylitis and seronegative spondyloarthropathies; (c) dermatomyositis; (d) IgG4-related disease; (e) inflammatory bowel disease; (f) mixed connective tissue disease; (g) polymyositis; (h) rheumatoid arthritis; (i) scleroderma (progressive systemic sclerosis); (j) Sjögren's syndrome; or (k) systemic lupus erythematosus; at the time of the clinical onset or clinical worsening of pericarditis; (17) having a heart transplant, lung transplant, kidney transplant or haematopoietic cell transplant before the clinical onset or clinical worsening of pericarditis; (18) having a myocardial infarction within the 4 weeks before the clinical onset or clinical worsening of pericarditis; (19) having a dissection of the ascending aorta at the time of the clinical onset or clinical worsening of pericarditis; (20) having a pulmonary infarction at the time of the clinical onset or clinical worsening of pericarditis; (21) having pancreatitis at the time of the clinical onset or clinical worsening of pericarditis; (22) having a benign or malignant cancer involving the pericardium at the time of the clinical onset or clinical worsening of pericarditis; (23) having a malignant neoplasm with a paraneoplastic pericarditis at the time of the clinical onset or clinical worsening of pericarditis; (24) having sarcoidosis or amyloidosis at the time of the clinical onset or clinical worsening of pericarditis; (25) having acute or chronic renal failure at the time of the clinical onset or clinical worsening of pericarditis; Note: Pericarditis can occur in patients who are undergoing haemodialysis or peritoneal dialysis. Chronic renal failure is equivalent to a stage 5 chronic kidney disease with a glomerular filtration rate <15 ml/min/1.73 m2. (26) having diabetic ketoacidosis at the time of the clinical onset or clinical worsening of pericarditis; (27) taking a drug from the specified list at the time of the clinical onset or clinical worsening of pericarditis; Note: drug from the specified list is defined in the Schedule1- Dictionary. (28) taking a drug which is associated in the individual with the development of pericarditis during drug therapy; and either: (a) the improvement of pericarditis within one month of discontinuing or tapering drug therapy; or (b) the redevelopment of pericarditis on rechallenge with the same drug; and where taking the drug continued for at least the 7 days before the clinical onset of pericarditis; (29) having a COVID-19 vaccine within the 4 weeks before the clinical onset or clinical worsening of pericarditis; (30) having smallpox vaccine within the 4 weeks before the clinical onset or clinical worsening of pericarditis; (31) having asbestosis or asbestos related pleural plaques before the clinical onset or clinical worsening of pericarditis; (32) inhaling respirable asbestos fibres in an enclosed space at the time material containing asbestos was being applied, removed, cut, drilled, dislodged or disturbed: (a) for a cumulative period of at least 1,000 hours before the clinical onset of pericarditis; and (b) where the first inhalation of asbestos fibres commenced at least 5 years before the clinical onset of pericarditis; Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an enclosed space may result in exposure to respirable asbestos fibres. (33) inhaling respirable asbestos fibres in an open environment at the time material containing asbestos was being applied, removed, cut, drilled, dislodged or disturbed: (a) for a cumulative period of at least 3,000 hours before the clinical onset of pericarditis; and (b) where the first inhalation of asbestos fibres commenced at least 5 years before the clinical onset of pericarditis; Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an open environment may result in exposure to respirable asbestos fibres. (34) inability to obtain appropriate clinical management for pericarditis before the clinical worsening of pericarditis. 9 Relationship to service (1) The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person. (2) The clinical worsening aspects of factors apply only to material contribution to, or aggravation of, pericarditis where the person's pericarditis was suffered or contracted before or during (but did not arise out of) the person's relevant service. 10 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 8 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 5 1 Definitions In this instrument: drug from the specified list means: (a) 5-fluorouracil; (b) amiodarone; (c) anthracyclines including doxorubicin, daunorubicin, idarubicin, epirubicin and mitoxantrone; (d) anticoagulants; (e) bromocriptine; (f) cabergoline; (g) clozapine; (h) cromolyn sodium; (i) cyclophosphamide; (j) cyclosporine; (k) cytarabine/cytosine arabinoside; (l) dantrolene; (m) GM-CSF/granulocyte macrophage colony stimulating factor; (n) hydantoins; (o) hydralazine; (p) immune checkpoint inhibitors including ipilimumab, nivolumab, pembrolizumab, atexolizumab, avelumab, dostarlimab, and durvalumab; (q) intravesicular BCG; (r) isoniazid; (s) mesalazine/mesalamine/5-aminosalicylic acid; (t) methyldopa; (u) methysergide; (v) minoxidil; (w) penicillins; (x) pergolide; (y) phenylbutazone; (z) phenytoin; (aa) practolol; (bb) procainamide; (cc) psicofuranine; (dd) reserpine; (ee) rifampicin; (ff) Streptokinase; (gg) streptomycin; (hh) sulfa drugs; (ii) thiazides; (jj) thrombolytic agents; (kk) tocainide; (ll) tryptophan; (mm) tumour necrosis alpha antagonists; or (nn) tyrosine kinase inhibitors. MRCA means the Military Rehabilitation and Compensation Act 2004. pericarditis—see subsection 6(2). relevant service means: (a) operational service under the VEA; (b) peacekeeping service under the VEA; (c) hazardous service under the VEA; (d) British nuclear test defence service under the VEA; (e) warlike service under the MRCA; or (f) non-warlike service under the MRCA. Note: MRCA and VEA are defined in the Schedule 1 - Dictionary. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.