Patient Selection for the Treatment of Emphysema with the IBV Valve System

The selection criteria are based on clinical experience gathered to date on bronchial valve therapy and two peer-reviewed studies, including two similar emphysematous patient populations. The first study was sponsored by a grant from Olympus using the IBV Valve System1, and the second sponsored by Pulmonx using the Zephyr® Endobronchial Valve.2  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-specific clinical judgment, and may evolve with the release of new clinical study findings.

Patient Evaluation

Clinically studied patients have had:

  • FEV1 ≤ 45% predicted2
  • Residual Volume (RV) > 150% predicted1,2
  • Total Lung Capacity (TLC) > 100% predicted1,2
  • 6MWD ≥ 150 m1,2
  • Hypercapnia with PaCO2 ≤ 50 mm Hg1,2
  • PaO2 > 45 mm Hg (6.0 kPa) on room air1


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 IBV Valve treatment.  A suitable scanning protocol will include:

  • Image taken at full suspended inspiration3
  • 1-1.25mm contiguous slices3,4
  • 70-100 milliampere seconds (mAs)3,4
  • 120 kVp3,4
  • 512 x 512 slice matrices3

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

 

HRCT Analysis

1. Severe Emphysema

  • The lobe with the greatest amount of emphysema destruction 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 involvement, assessed quantitatively with HRCT at approximately –910 HU.2

2. High Heterogeneity

  • A high heterogeneity difference between ipsilateral lobes is important to verify that the non-target lobes that will expand are healthier than the lobe targeted for treatment and volume reduction. 1,2

Quantitative Analysis Strategies:

Target lobe has ≥ 15 point heterogeneity difference with 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

3. Complete Fissures

  • The selected lobe must have an intact fissure separation with the ipsilateral lobe.2

The IBV Valve 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

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

 

Learn More

  • CLICK HERE to learn more about the state-of-the-art design of the IBV Valve System
  • CLICK HERE to learn more about the minimally invasive procedure
  • CLICK HERE for information on the clinical studies supporting the use of bronchial valves for the treatment of emphsyema

FOOTNOTES

  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):900-908; doi: 10.1378/chest.11-2886
  2. Supplement to: Scuriba F, Ernst A, Herth FJF, et al. A Randomized Study of Endobronchial Valves for Advanced Emphysema. NEJM 2010; 363:1233-1244
  3. 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; 3:519-534. DOI: 10.1513/pats.200603-086MS
  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: 2391–2402; doi 10.1007/s00330-009-1437-z
  5. Springmeyer S, Bollinger C, Waddell T et al. Treatment of heterogenous emphysema using the Spiration IBV Valves. Thorac Surg Clin 2009; 19:247-253
  6. 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):301-10

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