February 17, 2020
Pooled Analysis Supports Diagnostic Performance of CathWorks' Angiogram-Derived Fractional Flow Reserve
February 17, 2020—A pooled analysis of five prospective cohort studies sought to assess the diagnostic performance of FFRangio (CathWorks), an angiogram-derived fractional flow reserve (FFR) technology. The investigators performed an analysis of pooled patient- and lesion-level data from these five studies that examined the diagnostic performance of FFRangio compared with the reference standard wire-based FFR.
Guy Witberg, MD, et al published the findings online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2020;13:488–497). In December 2018, CathWorks announced FDA 510(k) clearance for the FFRangio system. The company stated that the FFRangio system is designed to deliver quick and precise FFR guidance to help optimize decision-making during percutaneous coronary intervention therapy.
Despite practice guidelines recommendations, the use of coronary physiologic assessment in daily practice remains low for patients undergoing coronary angiography. Angiogram-derived FFR technologies have the potential to promote the integration of physiologic assessment into daily practice.
As summarized in JACC: Cardiovascular Interventions, the analysis was composed of a total of 700 lesions from 588 patients. The investigators stated that this is the largest reported cohort examining the performance of angiogram-derived FFR technology. Mean age was 65 years, 71% were men, and 40% presented with acute coronary syndromes. Mean FFR and FFRangio were 0.81 ± 0.12 and 0.81 ± 0.11, with 31.6% and 31.4% of lesions in the 0.75 to 0.85 range, respectively.
When using a binary cutoff FFR value of 0.80, the investigators found that FFRangio showed a sensitivity of 91%, a specificity of 94%, and a diagnostic accuracy of 93%. The mean difference between FFR and FFRangio was 0.00 ± 0.12. The correlation coefficient between FFR and FFRangio was 0.83 (P < .001). The C-statistic for FFRangio was 0.95 (P < .001). The accuracy of FFRangio was consistent across all subgroups examined.
The investigators concluded. "FFRangio showed excellent diagnostic performance, which was robust and consistent across all patient and lesion subgroups." Additional studies are needed to allow FFRangio to fulfill its potential to expand the implementation of functional assessment of coronary lesions in routine clinical practice, advised the investigators in JACC: Cardiovascular Interventions.