SPIRATION VALVE SYSTEM Patient Selection for the Treatment of Emphysema Based on Clinical Literature.

Transcription

1 SPIRATION VALVE SYSTEM Patient Selection for the Treatment of Emphysema Based on Clinical Literature.

2 SPIRATION VALVE SYSTEM The Spiration Valve System is a device placed in the lung airway to treat severely diseased lung in patients with heterogeneous emphysema and complete fi ssures by limiting airfl ow to selected areas. Spiration Valve System treatment benefi ts may include 1 Reduction in hyperinfl ation Improvements in pulmonary function as indicated by an improvement in FEV 1 Improved exercise tolerance Improved quality of life as measured by SGRQ Patient Selection Overview The selection criteria are based on clinical experience gathered to date on bronchial valve therapy and on peer-reviewed studies with the Spiration Valve System 1 or the Zephyr Endobronchial Valve 2,7,8 in similar emphysematous patient populations. The highlighted evaluation factors below are some of the most important criteria for patient selection from the published literature. Physicians should evaluate these studies and the selection criteria on their own. These recommendations are not meant to replace patient-specifi c clinical judgment, and may evolve with the release of new clinical study fi ndings. A Patient evaluation Pulmonary Function Exercise Testing HRCT Scan Evaluate A B Identify Target Lobe Identifying whether the patient has a suitable lobe for treatment involves three parameters. SELECTION CRITERIA 1. Complete Fissures 2. Severe Emphysema Involvement 3. High Heterogeneity B Target

3 A PATIENT EVALUATION Pulmonary and Exercise Evaluation Clinically studied patients have had: FEV 1 45% predicted 2 Residual Volume (RV) > 150% predicted 1,2 Total Lung Capacity (TLC) > 100% predicted 1,2 6MWD 150 m 1,2 Hypercapnia with PaCO 2 50 mm Hg 1,2 PaO 2 > 45 mm Hg (6.0 kpa) on room air 1 HRCT Scanning HRCT Scanning Parameters: An HRCT scan is used to estimate the extent and distribution of emphysema and to identify whether there is a suitable treatment lobe that may respond favorably to Spiration Valve System treatment. A suitable scanning protocol will include: Image taken at full suspended inspiration mm contiguous slices 3, milliampere seconds (mas) 3,4 120 kvp 3,4 512 x 512 slice matrices 3 Perfusion Scanning Perfusion Scintigraphy may also be conducted to confirm heterogeneity and very low perfusion in the region of the target lobe selected for treatment. 1,6

4 B IDENTIFY TARGET LOBE Identifying a Suitable Lobe for Treatment Involves Three Key Parameters 1. Complete Fissures The selected lobe must have an intact fissure separation with the ipsilateral lobe. 2 The Spiration Valve System has been demonstrated to enable significant lobar reduction in select patients. 1,5 Lobar volume reduction is most pronounced and clinically beneficial in patients where the targeted lobe is isolated from collateral ventilation through complete fissures. 1,2,7,8 Quantitative Analysis Strategies: Fissures may be visually estimated to be intact if it is 90% complete after viewing the HRCT in three dimensions (sagittal, axial, and coronal). 2,7 Automated methods to provide exact quantifications and support visual readings may also be used. 7,8

5 2. Severe Emphysema The lobe with the greatest amount of emphysema involvement should be evaluated first. If that lobe does not meet subsequent criteria, consider the second most diseased lobe. 2 Quantitative Analysis Strategies: Target lobe has 50% emphysema severity, assessed quantitatively with HRCT at approximately 910 HU High Heterogeneity A high heterogeneity difference between ipsilateral lobes is useful to verify that the nontarget lobes that will expand are healthier than the lobe targeted for treatment and volume reduction. 1,2 Quantitative Analysis Strategies: Target lobe has emphysema involvement 15 percent greater than the healthier ipsilateral lobe, assessed quantitatively with HRCT. 2 Perfusion Scintigraphy may also be conducted to confirm heterogeneity and very low perfusion of the target lobe region. 1,3,6

6 by SeleCT by VIDA provides clinicians a method to submit High Resolution CTs (HRCTs) and receive quantitative measurements to support visual readings of lung parenchyma that may be suitable for bronchial valve treatment. Emphysema Severity Fissure Integrity Each quantitative report contains lung parenchymal measurements at -910, and -950 HU for each lobe, such as: Lobar Volume (cc) Low Attenuation Area (%), as a marker of emphysema severity 2,8 Heterogeneity ( ) Fissure Integrity (%), as a marker of low collateral ventilation Advantages of quantitative measurements include: More accurate and reproducible than visual CT analysis. 8 Comparable accuracy to Chartis. 8 Avoids an invasive procedure just to confi rm collateral ventilation. 8 Not dependent on anatomy, coughing, or mucus where direct bronchoscopic measure may be unreliable or not possible. 8 Provides useful measures beyond complete fi ssures such as emphysema severity, heterogeneity and lobar volume that may improve the prediction of lung volume reduction. 8

7 R P Report CT Scan Report CT Scan YOUR MEASURE OF LUNG HEALTH Image Transfer System (lifeimage) Radiological Service (VIDA Diagnostics, Inc.) Step 1: Clinicians select HRCTs to submit for quantitative CT analysis. For optimal results, acquisition protocols are closely followed to assure that the scans can be analyzed appropriately. It is the responsibility of the hospital to anonymize the CT scans and obtain patient consent where required under local laws and regulations. Step 2: HRCTs are uploaded through a secure, web-based image transfer system (lifeimage). lifeimage works in partnership with the Radiological Society of North America, and has been used to exchange more than 1 billion images from over 90 countries. Step 3: A Radiological Service (VIDA Diagnostics, Inc.) analyzes the HRCT and prepares a report with quantitative measurements. VIDA uses CE Marked software and ISO certified processes for validated, reproducible and consistent measurements. The report is delivered within four business days as an attachment through the secure image transfer system.

8 RESOURCES 1. Eberhardt R, Gompelmann D, Schuhmann M, et al. Complete unilateral versus partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest 2012; 142(4): ; doi: /chest Supplement to: Scuriba F, Ernst A, Herth FJF, et al. A randomized study of endobronchial valves for advanced emphysema. NEJM 2010; 363: Hoffman E, Simon B and McLennan G. A structural and functional assessment of the lung via multi-detector-row computer tomography. Proc Am Thorac Soc 2006; 3: DOI: /pats MS. 4. Heussel CP, Herth FJF, Kappes J, et al. Fully automatic quantitative assessment of emphysema in computed tomography: comparison with pulmonary function testing and normal values. Eur Radiol 2009; 19: ; doi /s z. 5. Springmeyer S, Bollinger C, Waddell T et al. Treatment of heterogenous emphysema using the Spiration IBV Valves. Thorac Surg Clin 2009; 19: Thurnheer R, Engel H, Weder W, et al. Role of lung perfusion scintigraphy in relation to chest computed tomography and pulmonary function in the evaluation of candidates for lung volume reduction surgery. Am J Respir Crit Care Med 1999;159(1): Gompelmann D, Eberhardt R, Slebos DJ, et al. Diagnostic performance comparison of the chartis system and high-resolution computerized tomography fissure analysis for planning endoscopic lung volume reduction. Respirology 2014; doi:10.111/resp Schuhmann M, Raffy P, Yi Y, et al. CT Predictors of Response to Endobronchial Valve Lung Reduction Treatment: Comparison with Chartis. Am J Respir Crit Care Med 2015; 191(7): ; doi: /rccm oc. OLIT RevAF E Zephyr is a registered trademark of Pulmonx, Inc. Copyright 2015 Spiration, Inc. d/b/a Olympus Respiratory America ARTG Identifiers: , , WAND Reference Nos: WAND-6BJ53E, WAND-6B1TDA, WAND-6B2O34 OLYMPUS RESPIRATORY AMERICA th Ave NE, Redmond, Washington USA OLYMPUS EUROPA SE & CO. KG Wendenstrasse 14-18, Hamburg, Germany KEYMED LTD. KeyMed House, Stock Road, Southend-on-Sea, Essex, SS2 5QH, UK OLYMPUS AUSTRALIA PTY. LTD. 3 Acacia Place, Notting Hill, VIC 3168 Australia