Defending the Rest Basics on Lung Cancer, Other Cancers and Asbestosis: Review of the B-Read and Pulmonary Function Testing

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1 Defending the Rest Basics on Lung Cancer, Other Cancers and Asbestosis: Review of the B-Read and Pulmonary Function Testing ASBESTOSIS November 2013 Bruce T. Bishop Lucy L. Brandon Willcox & Savage 440 Monticello Avenue, Suite 2200 Norfolk, VA

2 Asbestosis Diffuse pulmonary fibrosis caused by the inhalation of excessive amount of asbestos fibers. Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 2

3 Role of Experts - Pathologist - Pulmonologist/Radiologist - Toxicologist 3

4 Roles of Experts: Pathologist 4

5 Roles of Experts: Pathologist - Teach the jury about asbestos 5

6 Different Types of Asbestos Amosite Crocidolite Chrysotile Amphiboles Serpentine long, thin fibers straight, rigid fibers curvy, wavy, flexible readily break down released from lung 6

7 Roles of Experts: Pathologist - Teach the jury about asbestos - Differentiate between asbestos-related diseases - Large Exposures 7

8 Roles of Experts: Pathologist - Teach the jury about asbestos - Differentiate between asbestos-related diseases - Large Exposures - Rarity given nature of exposures in the last 35 years 8

9 Diagnosis of Asbestosis Clinical asbestosis can be induced by cumulative asbestos exposure amounting to an estimated 25 fibers/ ml yrs p. 468 Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 9

10 Roles of Experts: Pathologist - Teach the jury about asbestos - Differentiate between asbestos-related diseases - Large Exposures - Detectable on Radiology - Rarity given nature of exposures in the last 35 years - Review of Pathology Gold Standard 10

11 Pathology of Asbestosis An Update of the Diagnostic Criteria Asbestosis Committee of the College of American Pathologists and Pulmonary Pathology Society Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 11

12 Microscopic Findings Requires both: (1) an appropriate pattern of interstitial fibrosis; and (2) the finding of asbestos bodies. Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 12

13 Figure 13A - Roggli, V.L., et al., "Pathology of Asbestosis-An Update of the Diagnostic Criteria: Report of the Asbestosis Committee of the College of American Pathologists and Pulmonary Pathology Society" Arch Pathol Lab Med. 134(3), p. 470,

14 Figure 20 - Roggli, V.L., et al., "Pathology of Asbestosis-An Update of the Diagnostic Criteria: Report of the Asbestosis Committee of the College of American Pathologists and Pulmonary Pathology Society" Arch Pathol Lab Med. 134(3), p. 470,

15 Roles of Experts: Pulmonologist 15

16 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis 16

17 ATS Criteria for Diagnosis of Non-Malignant Lung Disease Related to Asbestos 1986 Guidelines 2004 Guidelines CHEST X-RAY Evidence of small irregular opacities 1/1 or greater RESTRICTIVE IMPAIRMENT Forced vital capacity below the lower limit of normal with a restrictive pattern of lung impairment DIFFUSING CAPACITY STRUCTURAL CHANGE - Imagining; and/or - Histology (College of American Pathologists) RESTRICTIVE PLAUSIBLE CAUSATION IMPAIRMENT - Occupational & Environmental History of Exposure + Latency; or - Markers of Exposure; or - Recovery of Asbestos Bodies Below the lower limit of normal SOUNDS Bilateral inspiratory crackles (rales) not cleared by cough EXPOSURE Reliable history of adequate exposure and sufficient latency period EXCLUSION OF ALTERNATIVE DIAGNOSES FUNCTIONAL IMPAIRMENT - Signs and Symptoms (including crackles) - Change in Ventilatory Function - Impaired Gas Exchange - Inflammation - Exercise Testing Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 17

18 American Thoracic Society Diagnostic Criteria - Structural pathology consistent with asbestosrelated disease documented by imaging or histology - Causation by asbestos documented by the occupational and environmental history, markers of exposure, asbestos bodies or other means - Exclusion of alternative plausible causes Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 18

19 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Chest X-ray - CT Scans (including HRCT) 19

20 ATS Criteria for Diagnosis of Non-Malignant Lung Disease Related to Asbestos 1986 Guidelines 2004 Guidelines CHEST X-RAY Evidence of small irregular opacities 1/1 or greater RESTRICTIVE IMPAIRMENT Forced vital capacity below the lower limit of normal with a restrictive pattern of lung impairment DIFFUSING CAPACITY STRUCTURAL CHANGE - Imaging; and/or - Histology (College of American Pathologists) RESTRICTIVE PLAUSIBLE CAUSATION IMPAIRMENT - Occupational & Environmental History of Exposure + Latency; or - Markers of Exposure; or - Recovery of Asbestos Bodies Below the lower limit of normal SOUNDS Bilateral inspiratory crackles (rales) not cleared by cough EXPOSURE Reliable history of adequate exposure and sufficient latency period EXCLUSION OF ALTERNATIVE DIAGNOSES FUNCTIONAL IMPAIRMENT - Signs and Symptoms (including crackles) - Change in Ventilatory Function - Impaired Gas Exchange - Inflammation - Exercise Testing Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 20

21 Pneumoconiosis Surveillance Evaluation - ATS uses the ILO classification system - Inter-Observer Variability - Intra-Reader Variability - Film Quality 21

22 Chest Radiology Asbestosis typically presents with small, irregular opacities at the lung bases. Figure 1 Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 22

23 Chest Radiography As the disease progresses, these opacities coalesce and become coarser, leading to a honeycomb pattern of small cysts. p. 468 Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 23

24 HRCT - Computed Tomography - Isolated dotlike structures in the periphery of the lower lung - Pleural-based intralobular and interlobular lines - Ground-glass attenuation - Honeycombing Roggli, V.L., et al., Pathology of Asbestosis An Update of the Diagnostic Criteria, Arch Pathol Lab Med, 134: (2010). 24

25 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Physical Examination 25

26 ATS Criteria for Diagnosis of Non-Malignant Lung Disease Related to Asbestos 1986 Guidelines 2004 Guidelines CHEST X-RAY Evidence of small irregular opacities 1/1 or greater RESTRICTIVE IMPAIRMENT Forced vital capacity below the lower limit of normal with a restrictive pattern of lung impairment DIFFUSING CAPACITY STRUCTURAL CHANGE - Imagining; and/or - Histology (College of American Pathologists) RESTRICTIVE PLAUSIBLE CAUSATION IMPAIRMENT - Occupational & Environmental History of Exposure + Latency; or - Markers of Exposure; or - Recovery of Asbestos Bodies Below the lower limit of normal SOUNDS Bilateral inspiratory crackles (rales) not cleared by cough EXPOSURE Reliable history of adequate exposure and sufficient latency period EXCLUSION OF ALTERNATIVE DIAGNOSES FUNCTIONAL IMPAIRMENT - Signs and Symptoms (including crackles) - Change in Ventilatory Function - Impaired Gas Exchange - Inflammation - Exercise Testing Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 26

27 Physical Findings - Breathlessness - Clubbing - Cough - Crackles 27

28 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Physical Examination - Medical History 28

29 ATS Criteria for Diagnosis of Non-Malignant Lung Disease Related to Asbestos 1986 Guidelines 2004 Guidelines CHEST X-RAY Evidence of small irregular opacities 1/1 or greater RESTRICTIVE IMPAIRMENT Forced vital capacity below the lower limit of normal with a restrictive pattern of lung impairment DIFFUSING CAPACITY STRUCTURAL CHANGE - Imagining; and/or - Histology (College of American Pathologists) RESTRICTIVE PLAUSIBLE CAUSATION IMPAIRMENT - Occupational & Environmental History of Exposure + Latency; or - Markers of Exposure; or - Recovery of Asbestos Bodies Below the lower limit of normal SOUNDS Bilateral inspiratory crackles (rales) not cleared by cough EXPOSURE Reliable history of adequate exposure and sufficient latency period EXCLUSION OF ALTERNATIVE DIAGNOSES FUNCTIONAL IMPAIRMENT - Signs and Symptoms (including crackles) - Change in Ventilatory Function - Impaired Gas Exchange - Inflammation - Exercise Testing Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 29

30 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Chest X-ray - HRCT - Physical Examination - Medical History - Pulmonary Function Testing 30

31 Spirometry - Forced Vital Capacity (FVC) - Measures how much air comes out after a full breath - If < 80% of predicted Possible Restrictive Disease, such as Asbestosis - Forced Expired Volume in One Second (FEV 1 ) - Measures how fast the air comes out - Good indicator of obstruction is the ratio of FEV 1 to FVC - If < 70-75% of predicted COPD 31

32 American Medical Association, Guidelines to the Evaluation of Permanent Impairment, Fourth Edition,

33 Residual Volume Lung Volumes - Tests the measure of air remaining in the lung at the end of a forced exhalation - Total lung capacity is calculated by adding vital capacity and the residual capacity 33

34 Diffusing Capacity (DLCO) Evaluates the overall gas exchange function - Non-Specific - Smokers have significantly lower diffusing capacities than non-smokers - Persons with interstitial lung disease like asbestosis can have reduced DLCO as well 34

35 PFT RESULTS 35

36 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Chest X-ray - HRCT - Physical Examination - Medical History - Pulmonary Function Testing - Reliable & adequate history of exposure 36

37 ATS Criteria for Diagnosis of Non-Malignant Lung Disease Related to Asbestos 1986 Guidelines 2004 Guidelines CHEST X-RAY Evidence of small irregular opacities 1/1 or greater RESTRICTIVE IMPAIRMENT Forced vital capacity below the lower limit of normal with a restrictive pattern of lung impairment DIFFUSING CAPACITY STRUCTURAL CHANGE - Imagining; and/or - Histology (College of American Pathologists) RESTRICTIVE PLAUSIBLE CAUSATION IMPAIRMENT - Occupational & Environmental History of Exposure + Latency; or - Markers of Exposure; or - Recovery of Asbestos Bodies Below the lower limit of normal SOUNDS Bilateral inspiratory crackles (rales) not cleared by cough EXPOSURE Reliable history of adequate exposure and sufficient latency period EXCLUSION OF ALTERNATIVE DIAGNOSES FUNCTIONAL IMPAIRMENT - Signs and Symptoms (including crackles) - Change in Ventilatory Function - Impaired Gas Exchange - Inflammation - Exercise Testing Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 37

38 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Chest X-ray - HRCT - Physical Examination - Medical History - Pulmonary Function Test - Reliable & adequate history of exposure - Progression 38

39 Roles of Experts: Pulmonologist - Utilize the American Thoracic Society 1986 and 2004 Criteria for diagnosing asbestosis - Radiology - Chest X-ray - HRCT - Physical Examination - Medical History - Pulmonary Function Test - Progression - Epidemiology 39

40 Recently some studies have suggested that progression is not inevitable. * * * This study confirmed our impression that asbestosis is a disappearing disease. Gaensler, et al., Radiographic Progression of Asbestosis with and without Continued Exposure, 7th International Pneumoconiosis Conference, Pittsburgh, PA (1990). 40

41 Roles of Experts: Toxicologist 41

42 Roles of Experts: Toxicologist - Thresholds of Exposure 42

43 Alternative Diagnoses Clinical features of asbestosis are not unique - BUT the characteristic signs of the disease are highly suggestive when they occur together - Presence of pleural plaques provides a useful marker of asbestos exposure Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 43

44 Alternative Diagnoses Groups of Patients Most Likely with Diagnostic Uncertainty include: - Heavy Cigarette Smokers - Patients with Emphysema Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 44

45 Alternative Diagnoses - Idiopathic Pulmonary Fibrosis (IPF) - Hypersensitivity Pneumonitis - Sarcoidosis - Other Pneumoconiosises Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 45

46 Idiopathic Pulmonary Fibrosis - Rapid Progression - Visible year-to-year increase in symptoms - Progression of radiographic findings - Loss of pulmonary function - No pleural plaques - Absence of long, intense asbestos exposure SUGGESTS IPF rather than Asbestosis Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos, Am J Respir Crit Care Med, 170: (2004). 46

47 The course of Plaintiff s Lung Disease Was Not Consistent with Asbestosis Idiopathic pulmonary fibrosis (IPF) is increasingly recognised as a well-known clinical and highly complex entity with a poor prognosis and a median survival of 3-5 years after the diagnosis is made. Raghu, G, Idiopathic pulmonary fibrosis: guidelines for diagnosis and clinical management have advanced from consensus-based in 2000 to evidence-based in 2011, Eur Respir J, 37: (2011)

48 Mr. Tetrick s Smoking Put Him at Risk for IPF Cigarette Smoking. Smoking is strongly associated with IPF, particularly for individuals with a smoking history of more than 20 pack years. at 791 Raghu, G et al., An official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management, Am J Respir Crit Care Med, 183: (2011).

49 Pleural Plaques - Can be a marker of asbestos exposure, particularly when bilateral - Not a disease - Not asbestosis - Usually cause no symptoms - Not a precursor to cancer - Can occur with low levels of exposure 49

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