Author + information
- Received July 8, 2019
- Revision received October 15, 2019
- Accepted October 22, 2019
- Published online January 29, 2020.
- Guy Witberg, MDa,∗ (, )@GuyWitberg,
- Bernard De Bruyne, MD, PhDb,
- William F. Fearon, MDc,
- Stephan Achenbach, MD, PhDd,
- Thomas Engstrom, MD, PhDe,
- Hitoshi Matsuo, MDf and
- Ran Kornowski, MDa
- aDepartment of Cardiology, Rabin Medical Center, Petach Tikva, Israel
- bDepartment of Cardiology, Cardiovascular Center Aalst OLV Hospital, Aalst, Belgium
- cDivision of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California
- dDepartment of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany
- eHeart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- fGifu Heart Center, Gifu, Japan
- ↵∗Address for correspondence:
Dr. Guy Witberg, Rabin Medical Center, Department of Cardiology, 39 Jabotinsky Road, Petach Tikva, 4941492, Israel.
Objectives The study sought to assess the diagnostic performance of FFRangio (CathWorks, Kfar Saba, Israel), an angiogram-derived fractional flow reserve (FFR) technology.
Background 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 in daily practice.
Methods The study performed an analysis of pooled patient- and lesion-level data from 5 prospective cohort studies that examined the diagnostic performance of FFRangio compared with the reference standard wire-based FFR.
Results A total of 700 lesions from 588 patients were analyzed. 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 were in the 0.75 to 0.85 range, respectively. When using a binary cutoff FFR value of 0.80, 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 < 0.001). The C-statistic for FFRangio was 0.95 (p < 0.001). The accuracy of FFRangio was consistent across all subgroups examined.
Conclusions In the largest reported cohort examining the performance of angiogram-derived FFR technology, FFRangio showed excellent diagnostic performance, which was robust and consistent across all patient and lesion subgroups. Additional studies are needed allow FFRangio and fulfill its potential expand the implementation of functional assessment of coronary lesions in routine clinical practice.
All of the studies whose data were used for this pooled analysis were funded by CathWorks. No specific funding was required for this study Dr. De Bruyne has received institutional grant support from Abbott, Boston Scientific, Biotronik AG, and St Jude Medical; has received consulting fees from St. Jude Medical, Opsens, and Boston Scientific, outside of the submitted work; and is a shareholder for Siemens, GE, Bayer, Philips, HeartFlow, Edwards Lifesciences, and Ceyliad. Dr. Fearon has received institutional research support from Abbott, Medtronic, and CathWorks; and owns minor stock options with HeartFlow. Dr. Achenbach has received institutional research support from CathWorks. Dr. Kornowski is co-founder of, owns intellectual property in, and is a shareholder of CathWorks. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 8, 2019.
- Revision received October 15, 2019.
- Accepted October 22, 2019.
- 2020 American College of Cardiology Foundation
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