“Determining the effect of an intermediate lesion on coronary blood flow is critical to making a treatment decision,” said Shai Levanon, president and CEO, Rcadia. “Currently, the standard technique for evaluating the haemodynamic significance of coronary lesions is by measuring fractional flow reserve (FFR) through invasive coronary catheterisation. Our initial study shows a good correlation to FFR, highlighting the potential of our technology to enhance the diagnostic utility of cCTA and reduce the number of invasive, costly diagnostic cardiac catheterisation produces.”
Levanon noted that Rcadia’s approach builds on its FDA cleared COR Analyzer System, which performs fully automatic detection of coronary stenosis from cCTA studies. “A capability for assessing haemodynamic significance has potential to provide a powerful complement to the COR Analyzer’s ability to identify significant stenosis in suspected patients with coronary artery disease.”
To assess the diagnostic performance of the method, Rcadia conducted a retrospective study based on 44 patients who underwent both cCTA and diagnostic coronary catheterisation with FFR measurements. Assessments using Rcadia’s proprietary technique were performed for 49 of 51 lesions with FFR measurements present in those studies. Two lesions were not evaluated due to poor image quality.
The Rcadia method correctly identified all 11 haemodynamically significant lesions (FFR <=0.8) and 33 of 38 haemodynamically insignificant lesions (FFR>0.8), yielding the sensitivity of 100% and specificity of 87%.