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New CAP™ method for FibroScan®: CAPc (continuous CAP™)

 
Paper of the Month
New CAP™ method for FibroScan® : CAPc (continuous CAP™) 
# December 2021

Study reference

Audiere S., et al. Improved ultrasound attenuation measurement method for the
non-invasive evaluation of hepatic steatosis using FibroScan®. Ultrasound in
Medicine & Biology 2021.
>> Access to Pubmed abstract <<





Background and objectives

Controlled Attenuation Parameter (CAP™) was introduced by Echosens in 2010 on
the FibroScan® range of devices to measure ultrasound attenuation for
non-invasive assessment of liver steatosis. This “standard” CAP™ can be measured
using both M+ and XL+ probes, and the final result is the median of usually 10
manually triggered sequential measurements of ultrasound attenuation, associated
with its Interquartile Range (IQR).

In order to improve the precision and intra procedure variability, Echosens is
introducing a new method for CAP™ acquisition that uses ultrasound data
continuously acquired during the FibroScan® examination, and therefore named as
continuous CAP™, "CAPc".
CAPc can be measured using S+, M+ & XL+ probes. The CAPc final result is
displayed as the mean of at least 200 automatically qualified measurements of
ultrasound attenuation, associated with its standard deviation (SD).

 This technical study aimed to assess the performance of CAPc both ex vivo and
in vivo.



Methods
 
  Ex vivo
Seven reference tissue-mimicking phantoms.

  In vivo
Two cohorts of patients using MRI-PDFF as reference:
 * Cohort A: ROI was positioned by operators of respective device
 * Cohort B: MRI-PDFF ROI was placed as closely as possible to ROI of FibroScan®


  CAPc was evaluated a posteriori by reprocessing the raw data recorded in
standard CAP™ examination files.




Main Results
 
  Ex vivo
 * Precision (in terms of Standard Deviation) of CAPc was improved by 57% (M+
   probe)
   & 63% (XL+ probe)
 * Almost perfect agreement between standard CAP™ & CAPc with ICC of  0.996
   and 0.988 with M+ and XL+ probe, respectively.


  In vivo
 * Precision of CAPc was improved by 41% for M+ probe and 33% for XL+ probe
   (Cohort A)
   & 38% for M+ probe and 22% for XL+ probe (Cohort B) 
 * Excellent agreement between standard CAP™ & CAPc: 0.901 (Cohort A) & 0.940
   (Cohort B)
 * Diagnostic performance of CAPc was at least equal or superior, with AUROC of
   0.900
   vs 0.889 for Standard CAP™ (Cohort A) [cf. Figure 1]
   and of 0.873 vs 0.835 for Standard CAP™ to 0.873 (Cohort B) [cf. Figure 2].



Fig 1. Diagnostic performance of CAP™ & CAPc with MRI-PDFF as reference (cohort
A)
 

Fig 2. Diagnostic performance of CAP™ & CAPc with MRI-PDFF as reference (cohort
B)
 




Take home messages
 
 CAPc is a promising tool and a reliable alternative to the standard CAP™ method
for diagnosing and monitoring hepatic steatosis on patients with chronic liver
diseases.

 New CAPc method can significantly improve the precision of CAP™ measurements.

 New CAPc demonstrated equivalent performances in terms of hepatic steatosis
quantification when using MRI-PDFF as a reference; this suggests a diagnostic
performance at least as good as for the standard CAP™.

 ICC between the two CAP™ computation methods showed almost a perfect in vivo
agreement, which confirms that both methods measure the same ultrasound
attenuation parameter. 
 
 Cut-offs defined for standard CAP™ in the literature remain applicable to CAPc.
 

   New CAPc method has three major improvements   

1/ Higher number of ultrasound acquisitions versus Standard CAP™,
with a patient breathing normally during the examination.
 A larger volume of tissue is sampled.

2/ Ultrasound signals are automatically qualified
using a dedicated validity criteria.
 This helps improve precision by decreasing operator dependency.

3/ Examination measurement depths are adapted automatically
to the patient’s morphotype when using M+ & XL+ probes.
 This helps improve the applicability and performances of CAP™ in patients with
thick subcutaneous tissues and deeply located livers.
 
 

CAPc is now available on FibroScan®,
with the new Smart Exam software.

 Learn more on SmartExam
 

Should you have any further question, feel free to contact us !

All the best,

The Echosens Team
training@echosens.com







Copyright © 2021 Echosens, All rights reserved.


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