Patient Selection for the Treatment of Emphysema

Patient Selection Overview

The selection criteria are based on criteria established by the EMPROVE clinical trial2 and expert panel recommendations.3 The highlighted evaluation factors below are some of the most important inclusion 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.

1. Pulmonary and Exercise Evaluation

EMPROVE2

Expert Opinion3

FEV1

≤ 45% predicted

20–45% predicted

Residual Volume (RV)

> 150% predicted

> 175% predicted

Total Lung Capacity (TLC)

> 100% predicted

> 100% predicted

6MWD

> 140m

150–500m

 

 

 

 

 

 

 

 

2. HRCT Evaluation

Quantitative Analysis Strategies

Complete Fissures

The selected lobe must have an intact fissure
separation with ipsilateral lobe.2,3

Fissure may be visually estimated to be intact if it is > 85–90% complete after viewing the HRCT in three dimensions (sagittal, axial, and coronal).3,5

Automated methods to provide exact quantifications and support visual readings are recommended.3

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

Target lobe has ≥ 40% emphysema severity, assessed quantitatively with HRCT at -950 HU.2

High Heterogeneity

A high heterogeneity difference between
ipsilateral lobes may be useful to verify that
the nontarget lobes that will expand are healthier than the lobe targeted for treatment and volume reduction.1,2,3

Target lobe has emphysema involvement ≥ 15 percent greater than the healthier ipsilateral lobe, assessed quantitatively with HRCT.3

Perfusion Scintigraphy may also be conducted to confirm heterogeneity and very low perfusion of the target lobe region.1,3,4

 

 

SeleCT by VIDA

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 3,6
  • Heterogeneity (∆)
  • Fissure Integrity (%), as a marker of low collateral ventilation 3,6 

 

Advantages of quantitative measurements include:

  • More accurate and reproducible than visual CT analysis.6
  • Comparable accuracy to Chartis.6
  • Avoids an invasive procedure just to confirm collateral ventilation.6
  • Not dependent on anatomy, coughing, or mucus where direct bronchoscopic measure may be unreliable or not possible.6
  • Provides useful measures beyond complete fissures such as emphysema severity, heterogeneity and lobar volume that may improve the prediction of lung volume reduction.6

 

 

 

Step 1:

Step 2:

Step 3:

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.

HRCTs are uploaded through
a secure, web-based image
transfer system.

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.

  

 

 

Learn More

  • CLICK HERE to learn more about the state-of-the-art design of the Spiration 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. www.clinicaltrials.gov/ct2/show/NCT01812447.
  3. Herth. Respiration 2017; 93: 138–150.
  4. 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.
  5. 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.12253.
  6. 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):767-774; doi:10.1164/rccm.201407-1205OC.