TY - JOUR
T1 - Influence of Contrast Media Dose and Osmolality on the Diagnostic Performance of Contrast Fractional Flow Reserve
AU - Nishi, Takeshi
AU - Johnson, Nils P.
AU - De Bruyne, Bernard
AU - Berry, Colin
AU - Lance Gould, K.
AU - Jeremias, Allen
AU - Oldroyd, Keith G.
AU - Kobayashi, Yuhei
AU - Choi, Dong Hyun
AU - Pijls, Nico H.J.
AU - Fearon, William F.
N1 - Funding Information:
Dr Johnson received internal funding from the Weatherhead PET Center for Preventing and Reversing Atherosclerosis and significant institutional research support from St. Jude Medical (for this study, NCT02184117) and Volcano/Philips Corporation (for NCT02328820), makers of intracoronary pressure and flow sensors. Dr Berry received institutional research grant support and serves as a consultant for St. Jude Medical. Dr De Bruyne received institutional consultancy fees and research support from St. Jude Medical. Dr Gould received internal funding from the Weatherhead PET Center for Preventing and Reversing Atherosclerosis; and is the 510(k) applicant for CFR Quant (K113754) and HeartSee (K143664), software packages for cardiac positron emission tomography image processing and analysis, including absolute flow quantification. Dr Jeremias serves as a consultant and member of the Speakers’ Bureau for Volcano/ Philips Corporation. Dr Oldroyd received speakers’ fees from St. Jude Medical, AstraZeneca, and Volcano Corporation. Dr Kobayashi received institutional fellowship grant from Boston Scientific. Dr Pijls received institutional grant support from St. Jude Medical; serves as a consultant for St. Jude Medical, Boston Scientific, and Opsens; and possesses equity in Philips, GE, ASML, and Heartflow. Dr Fearon received institutional research support from St. Jude Medical and Medtronic and has received honoraria from Medtronic and served as a consultant to HeartFlow Inc and Cathworks.
Publisher Copyright:
© 2017 American Heart Association, Inc.
PY - 2017/10/1
Y1 - 2017/10/1
N2 - Background-Contrast fractional flow reserve (cFFR) is a method for assessing functional significance of coronary stenoses, which is more accurate than resting indices and does not require adenosine. However, contrast media volume and osmolality may affect the degree of hyperemia and therefore diagnostic performance. Methods and Results-cFFR, instantaneous wave-free ratio, distal pressure/aortic pressure at rest, and FFR were measured in 763 patients from 12 centers. We compared the diagnostic performance of cFFR between patients receiving low or iso-osmolality contrast (n=574 versus 189) and low or high contrast volume (n=341 versus 422) using FFR≤0.80 as a reference standard. The sensitivity, specificity, and overall accuracy of cFFR for the low versus iso-osmolality groups were 73%, 93%, and 85% versus 87%, 90%, and 89%, and for the low versus high contrast volume groups were 69%, 99%, and 83% versus 82%, 93%, and 88%. By receiver operating characteristics (ROC) analysis, cFFR provided better diagnostic performance than resting indices regardless of contrast osmolality and volume (P<0.001 for all groups). There was no significant difference between the area under the curve of cFFR in the low-And iso-osmolality groups (0.938 versus 0.957; P=0.40) and in the low-And high-volume groups (0.939 versus 0.949; P=0.61). Multivariable logistic regression analysis showed that neither contrast osmolality nor volume affected the overall accuracy of cFFR; however, both affected the sensitivity and specificity. Conclusions-The overall accuracy of cFFR is greater than instantaneous wave-free ratio and distal pressure/aortic pressure and not significantly affected by contrast volume and osmolality. However, contrast volume and osmolality do affect the sensitivity and specificity of cFFR. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT02184117.
AB - Background-Contrast fractional flow reserve (cFFR) is a method for assessing functional significance of coronary stenoses, which is more accurate than resting indices and does not require adenosine. However, contrast media volume and osmolality may affect the degree of hyperemia and therefore diagnostic performance. Methods and Results-cFFR, instantaneous wave-free ratio, distal pressure/aortic pressure at rest, and FFR were measured in 763 patients from 12 centers. We compared the diagnostic performance of cFFR between patients receiving low or iso-osmolality contrast (n=574 versus 189) and low or high contrast volume (n=341 versus 422) using FFR≤0.80 as a reference standard. The sensitivity, specificity, and overall accuracy of cFFR for the low versus iso-osmolality groups were 73%, 93%, and 85% versus 87%, 90%, and 89%, and for the low versus high contrast volume groups were 69%, 99%, and 83% versus 82%, 93%, and 88%. By receiver operating characteristics (ROC) analysis, cFFR provided better diagnostic performance than resting indices regardless of contrast osmolality and volume (P<0.001 for all groups). There was no significant difference between the area under the curve of cFFR in the low-And iso-osmolality groups (0.938 versus 0.957; P=0.40) and in the low-And high-volume groups (0.939 versus 0.949; P=0.61). Multivariable logistic regression analysis showed that neither contrast osmolality nor volume affected the overall accuracy of cFFR; however, both affected the sensitivity and specificity. Conclusions-The overall accuracy of cFFR is greater than instantaneous wave-free ratio and distal pressure/aortic pressure and not significantly affected by contrast volume and osmolality. However, contrast volume and osmolality do affect the sensitivity and specificity of cFFR. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT02184117.
KW - adenosine
KW - contrast fractional flow reserve
KW - coronary stenosis
KW - fractional flow reserve
KW - hyperemia
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U2 - 10.1161/CIRCINTERVENTIONS.117.004985
DO - 10.1161/CIRCINTERVENTIONS.117.004985
M3 - Article
C2 - 29042397
AN - SCOPUS:85040785119
SN - 1941-7640
VL - 10
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 10
M1 - e004985
ER -