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William F Fearon - One of the best experts on this subject based on the ideXlab platform.
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accuracy of fractional flow reserve measurements in clinical practice observations from a core laboratory analysis
Jacc-cardiovascular Interventions, 2017Co-Authors: Mitsuaki Matsumura, Akiko Maehara, Bernard De Bruyne, William F Fearon, Gregg W. Stone, Nils P Johnson, Gary S Mintz, K G Oldroyd, Nico H J Pijls, Allen JeremiasAbstract: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) 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 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.
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multicenter core laboratory comparison of the instantaneous wave free ratio and resting pd pa with fractional flow reserve the resolve study
Journal of the American College of Cardiology, 2014Co-Authors: Allen Jeremias, Akiko Maehara, Philippe Genereux, Kaleab N Asrress, Colin Berry, Bernard De Bruyne, Justin E Davies, Javier Escaned, William F FearonAbstract:Objectives This study sought to examine the diagnostic accuracy of the instantaneous wave-free ratio (iFR) and resting distal Coronary Artery Pressure/aortic Pressure (P d /P a ) with respect to hyperemic fractional flow reserve (FFR) in a core laboratory–based multicenter collaborative study. Background FFR is an index of the severity of Coronary stenosis that has been clinically validated in 3 prospective randomized trials. iFR and P d /P a are nonhyperemic Pressure-derived indices of the severity of stenosis with discordant reports regarding their accuracy with respect to FFR. Methods iFR, resting P d /P a , and FFR were measured in 1,768 patients from 15 clinical sites. An independent physiology core laboratory performed blinded off-line analysis of all raw data. The primary objectives were to determine specific iFR and P d /P a thresholds with ≥90% accuracy in predicting ischemic versus nonischemic FFR (on the basis of an FFR cut point of 0.80) and the proportion of patients falling beyond those thresholds. Results Of 1,974 submitted lesions, 381 (19.3%) were excluded because of suboptimal acquisition, leaving 1,593 for final analysis. On receiver-operating characteristic analysis, the optimal iFR cut point for FFR ≤0.80 was 0.90 (C statistic: 0.81 [95% confidence interval: 0.79 to 0.83]; overall accuracy: 80.4%) and for P d /P a was 0.92 (C statistic: 0.82 [95% confidence interval: 0.80 to 0.84]; overall accuracy: 81.5%), with no significant difference between these resting measures. iFR and P d /P a had ≥90% accuracy to predict a positive or negative FFR in 64.9% (62.6% to 67.3%) and 48.3% (45.6% to 50.5%) of lesions, respectively. Conclusions This comprehensive core laboratory analysis comparing iFR and P d /P a with FFR demonstrated an overall accuracy of ∼80% for both nonhyperemic indices, which can be improved to ≥90% in a subset of lesions. Clinical outcome studies are required to determine whether the use of iFR or P d /P a might obviate the need for hyperemia in selected patients.
Allen Jeremias - One of the best experts on this subject based on the ideXlab platform.
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accuracy of fractional flow reserve measurements in clinical practice observations from a core laboratory analysis
Jacc-cardiovascular Interventions, 2017Co-Authors: Mitsuaki Matsumura, Akiko Maehara, Bernard De Bruyne, William F Fearon, Gregg W. Stone, Nils P Johnson, Gary S Mintz, K G Oldroyd, Nico H J Pijls, Allen JeremiasAbstract: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) 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 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.
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multicenter core laboratory comparison of the instantaneous wave free ratio and resting pd pa with fractional flow reserve the resolve study
Journal of the American College of Cardiology, 2014Co-Authors: Allen Jeremias, Akiko Maehara, Philippe Genereux, Kaleab N Asrress, Colin Berry, Bernard De Bruyne, Justin E Davies, Javier Escaned, William F FearonAbstract:Objectives This study sought to examine the diagnostic accuracy of the instantaneous wave-free ratio (iFR) and resting distal Coronary Artery Pressure/aortic Pressure (P d /P a ) with respect to hyperemic fractional flow reserve (FFR) in a core laboratory–based multicenter collaborative study. Background FFR is an index of the severity of Coronary stenosis that has been clinically validated in 3 prospective randomized trials. iFR and P d /P a are nonhyperemic Pressure-derived indices of the severity of stenosis with discordant reports regarding their accuracy with respect to FFR. Methods iFR, resting P d /P a , and FFR were measured in 1,768 patients from 15 clinical sites. An independent physiology core laboratory performed blinded off-line analysis of all raw data. The primary objectives were to determine specific iFR and P d /P a thresholds with ≥90% accuracy in predicting ischemic versus nonischemic FFR (on the basis of an FFR cut point of 0.80) and the proportion of patients falling beyond those thresholds. Results Of 1,974 submitted lesions, 381 (19.3%) were excluded because of suboptimal acquisition, leaving 1,593 for final analysis. On receiver-operating characteristic analysis, the optimal iFR cut point for FFR ≤0.80 was 0.90 (C statistic: 0.81 [95% confidence interval: 0.79 to 0.83]; overall accuracy: 80.4%) and for P d /P a was 0.92 (C statistic: 0.82 [95% confidence interval: 0.80 to 0.84]; overall accuracy: 81.5%), with no significant difference between these resting measures. iFR and P d /P a had ≥90% accuracy to predict a positive or negative FFR in 64.9% (62.6% to 67.3%) and 48.3% (45.6% to 50.5%) of lesions, respectively. Conclusions This comprehensive core laboratory analysis comparing iFR and P d /P a with FFR demonstrated an overall accuracy of ∼80% for both nonhyperemic indices, which can be improved to ≥90% in a subset of lesions. Clinical outcome studies are required to determine whether the use of iFR or P d /P a might obviate the need for hyperemia in selected patients.
Felix Zijlstra - One of the best experts on this subject based on the ideXlab platform.
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validation of resting diastolic Pressure ratio calculated by a novel algorithm and its correlation with distal Coronary Artery Pressure to aortic Pressure instantaneous wave free ratio and fractional flow reserve
Circulation-cardiovascular Interventions, 2018Co-Authors: Jurgen Ligthart, Kaneshka Masdjedi, Karen Witberg, Frits Mastik, Laurens J C Van Zandvoort, Miguel E Lemmert, Jeroen Wilschut, Roberto Diletti, Peter De Jaegere, Felix ZijlstraAbstract:Background: Instantaneous wave–free ratio (iFR) offers a reliable non–hyperemic assessment of Coronary physiology but requires dedicated proprietary software with a fully automated algorithm. We hy...
Philippe Genereux - One of the best experts on this subject based on the ideXlab platform.
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multicenter core laboratory comparison of the instantaneous wave free ratio and resting pd pa with fractional flow reserve the resolve study
Journal of the American College of Cardiology, 2014Co-Authors: Allen Jeremias, Akiko Maehara, Philippe Genereux, Kaleab N Asrress, Colin Berry, Bernard De Bruyne, Justin E Davies, Javier Escaned, William F FearonAbstract:Objectives This study sought to examine the diagnostic accuracy of the instantaneous wave-free ratio (iFR) and resting distal Coronary Artery Pressure/aortic Pressure (P d /P a ) with respect to hyperemic fractional flow reserve (FFR) in a core laboratory–based multicenter collaborative study. Background FFR is an index of the severity of Coronary stenosis that has been clinically validated in 3 prospective randomized trials. iFR and P d /P a are nonhyperemic Pressure-derived indices of the severity of stenosis with discordant reports regarding their accuracy with respect to FFR. Methods iFR, resting P d /P a , and FFR were measured in 1,768 patients from 15 clinical sites. An independent physiology core laboratory performed blinded off-line analysis of all raw data. The primary objectives were to determine specific iFR and P d /P a thresholds with ≥90% accuracy in predicting ischemic versus nonischemic FFR (on the basis of an FFR cut point of 0.80) and the proportion of patients falling beyond those thresholds. Results Of 1,974 submitted lesions, 381 (19.3%) were excluded because of suboptimal acquisition, leaving 1,593 for final analysis. On receiver-operating characteristic analysis, the optimal iFR cut point for FFR ≤0.80 was 0.90 (C statistic: 0.81 [95% confidence interval: 0.79 to 0.83]; overall accuracy: 80.4%) and for P d /P a was 0.92 (C statistic: 0.82 [95% confidence interval: 0.80 to 0.84]; overall accuracy: 81.5%), with no significant difference between these resting measures. iFR and P d /P a had ≥90% accuracy to predict a positive or negative FFR in 64.9% (62.6% to 67.3%) and 48.3% (45.6% to 50.5%) of lesions, respectively. Conclusions This comprehensive core laboratory analysis comparing iFR and P d /P a with FFR demonstrated an overall accuracy of ∼80% for both nonhyperemic indices, which can be improved to ≥90% in a subset of lesions. Clinical outcome studies are required to determine whether the use of iFR or P d /P a might obviate the need for hyperemia in selected patients.
Bernard De Bruyne - One of the best experts on this subject based on the ideXlab platform.
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accuracy of fractional flow reserve measurements in clinical practice observations from a core laboratory analysis
Jacc-cardiovascular Interventions, 2017Co-Authors: Mitsuaki Matsumura, Akiko Maehara, Bernard De Bruyne, William F Fearon, Gregg W. Stone, Nils P Johnson, Gary S Mintz, K G Oldroyd, Nico H J Pijls, Allen JeremiasAbstract: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) 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 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.
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multicenter core laboratory comparison of the instantaneous wave free ratio and resting pd pa with fractional flow reserve the resolve study
Journal of the American College of Cardiology, 2014Co-Authors: Allen Jeremias, Akiko Maehara, Philippe Genereux, Kaleab N Asrress, Colin Berry, Bernard De Bruyne, Justin E Davies, Javier Escaned, William F FearonAbstract:Objectives This study sought to examine the diagnostic accuracy of the instantaneous wave-free ratio (iFR) and resting distal Coronary Artery Pressure/aortic Pressure (P d /P a ) with respect to hyperemic fractional flow reserve (FFR) in a core laboratory–based multicenter collaborative study. Background FFR is an index of the severity of Coronary stenosis that has been clinically validated in 3 prospective randomized trials. iFR and P d /P a are nonhyperemic Pressure-derived indices of the severity of stenosis with discordant reports regarding their accuracy with respect to FFR. Methods iFR, resting P d /P a , and FFR were measured in 1,768 patients from 15 clinical sites. An independent physiology core laboratory performed blinded off-line analysis of all raw data. The primary objectives were to determine specific iFR and P d /P a thresholds with ≥90% accuracy in predicting ischemic versus nonischemic FFR (on the basis of an FFR cut point of 0.80) and the proportion of patients falling beyond those thresholds. Results Of 1,974 submitted lesions, 381 (19.3%) were excluded because of suboptimal acquisition, leaving 1,593 for final analysis. On receiver-operating characteristic analysis, the optimal iFR cut point for FFR ≤0.80 was 0.90 (C statistic: 0.81 [95% confidence interval: 0.79 to 0.83]; overall accuracy: 80.4%) and for P d /P a was 0.92 (C statistic: 0.82 [95% confidence interval: 0.80 to 0.84]; overall accuracy: 81.5%), with no significant difference between these resting measures. iFR and P d /P a had ≥90% accuracy to predict a positive or negative FFR in 64.9% (62.6% to 67.3%) and 48.3% (45.6% to 50.5%) of lesions, respectively. Conclusions This comprehensive core laboratory analysis comparing iFR and P d /P a with FFR demonstrated an overall accuracy of ∼80% for both nonhyperemic indices, which can be improved to ≥90% in a subset of lesions. Clinical outcome studies are required to determine whether the use of iFR or P d /P a might obviate the need for hyperemia in selected patients.