Mitsuaki Matsumura1, Nils P Johnson2, William F Fearon3, Gary S Mintz1, Gregg W Stone4, Keith G Oldroyd5, Bernard De Bruyne6, Nico H J Pijls7, Akiko Maehara4, Allen Jeremias8. 1. Cardiovascular Research Foundation, New York, New York. 2. McGovern Medical School at UT Health and Memorial Hermann Hospital, Houston, Texas. 3. Stanford University Medical Center, Stanford, California. 4. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York. 5. West of Scotland Heart and Lung Centre, Golden Jubilee Hospital, Clydebank, United Kingdom. 6. Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium. 7. Catharina Hospital, Eindhoven, the Netherlands; Eindhoven University of Technology, Eindhoven, the Netherlands. 8. Cardiovascular Research Foundation, New York, New York; St. Francis Hospital, Roslyn, New York. Electronic address: allen.jeremias@chsli.org.
Abstract
OBJECTIVES: The aim of this study was to compare site-reported measurements of fractional flow reserve (FFR) with FFR analysis by an independent core laboratory (CL). BACKGROUND: FFR is an index of coronary stenosis severity that has been validated in multiple trials and is widely used in clinical practice. However, the incidence of suboptimal FFR measurements is unknown. METHODS: Patients undergoing FFR assessment within the CONTRAST (Can Contrast Injection Better Approximate FFR Compared to Pure Resting Physiology) study had paired, repeated measurements of multiple physiological metrics per local practice. An independent central physiology CL analyzed blinded pressure tracings off-line in a standardized fashion for comparison. RESULTS: A total of 763 patients were included in the study; 4,946 distal coronary artery pressure/aortic pressure (nonhyperemic) and FFR tracings were analyzed by the CL (mean 6.5 tracings per patient). Pull-back data were available for 616 patients (80.7%), of whom 108 (17.5%) had signal drift, defined as distal coronary artery pressure/aortic pressure (nonhyperemic) <0.97 or >1.03. Among the remaining 4,217 tracings without evidence of signal drift, 222 (5.3%) were noted to have ventricularization of the aortic waveform, and 168 (4.0%) had aortic waveform distortion. Excluding cases with signal drift and waveform distortion, there was excellent agreement between CL-calculated and site-reported FFR, with a mean difference of 0.003 ± 0.02. Predictors of distorted waveforms were smaller guiding catheter size (odds ratio: 6.30; 95% confidence interval: 3.22 to 12.32; p < 0.001) and intracoronary adenosine use (odds ratio: 0.13; 95% confidence interval: 0.05 to 0.33; p < 0.001). CONCLUSIONS: This FFR CL analysis showed that almost 10% of tracings demonstrated waveform artifacts, and an additional 17.5% had signal drift. Among adequate tracings, there was a close correlation between site-reported and CL-analyzed FFR values. Attention to detail is critical for FFR studies to ensure adequate technique and optimal results.
OBJECTIVES: The aim of this study was to compare site-reported measurements of fractional flow reserve (FFR) with FFR analysis by an independent core laboratory (CL). BACKGROUND: FFR is an index of coronary stenosis severity that has been validated in multiple trials and is widely used in clinical practice. However, the incidence of suboptimal FFR measurements is unknown. METHODS:Patients undergoing FFR assessment within the CONTRAST (Can Contrast Injection Better Approximate FFR Compared to Pure Resting Physiology) study had paired, repeated measurements of multiple physiological metrics per local practice. An independent central physiology CL analyzed blinded pressure tracings off-line in a standardized fashion for comparison. RESULTS: A total of 763 patients were included in the study; 4,946 distal coronary artery pressure/aortic pressure (nonhyperemic) and FFR tracings were analyzed by the CL (mean 6.5 tracings per patient). Pull-back data were available for 616 patients (80.7%), of whom 108 (17.5%) had signal drift, defined as distal coronary artery pressure/aortic pressure (nonhyperemic) <0.97 or >1.03. Among the remaining 4,217 tracings without evidence of signal drift, 222 (5.3%) were noted to have ventricularization of the aortic waveform, and 168 (4.0%) had aortic waveform distortion. Excluding cases with signal drift and waveform distortion, there was excellent agreement between CL-calculated and site-reported FFR, with a mean difference of 0.003 ± 0.02. Predictors of distorted waveforms were smaller guiding catheter size (odds ratio: 6.30; 95% confidence interval: 3.22 to 12.32; p < 0.001) and intracoronary adenosine use (odds ratio: 0.13; 95% confidence interval: 0.05 to 0.33; p < 0.001). CONCLUSIONS: This FFR CL analysis showed that almost 10% of tracings demonstrated waveform artifacts, and an additional 17.5% had signal drift. Among adequate tracings, there was a close correlation between site-reported and CL-analyzed FFR values. Attention to detail is critical for FFR studies to ensure adequate technique and optimal results.
Authors: Nils P Johnson; Wenguang Li; Xi Chen; Barry Hennigan; Stuart Watkins; Colin Berry; William F Fearon; Keith G Oldroyd Journal: Eur Heart J Date: 2019-08-14 Impact factor: 29.983
Authors: Daixin Ding; Junqing Yang; Jelmer Westra; Yundai Chen; Yunxiao Chang; Martin Sejr-Hansen; Su Zhang; Evald H Christiansen; Niels R Holm; Bo Xu; Shengxian Tu Journal: Cardiovasc Diagn Ther Date: 2019-10
Authors: K Masdjedi; L J C van Zandvoort; T Neleman; I Kardys; J Ligthart; W K Den Dekker; R Diletti; F Zijlstra; N M Van Mieghem; J Daemen Journal: Neth Heart J Date: 2022-04-07 Impact factor: 2.854
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