Author + information
- Received November 6, 2016
- Revision received March 15, 2017
- Accepted March 23, 2017
- Published online July 17, 2017.
- Mitsuaki Matsumura, BSa,
- Nils P. Johnson, MDb,
- William F. Fearon, MDc,
- Gary S. Mintz, MDa,
- Gregg W. Stone, MDa,d,
- Keith G. Oldroyd, MDe,
- Bernard De Bruyne, MDf,
- Nico H.J. Pijls, MD, PhDg,h,
- Akiko Maehara, MDa,d and
- Allen Jeremias, MD, MSca,i,∗ ()
- aCardiovascular Research Foundation, New York, New York
- bMcGovern Medical School at UT Health and Memorial Hermann Hospital, Houston, Texas
- cStanford University Medical Center, Stanford, California
- dColumbia University Medical Center, New York, New York
- eWest of Scotland Heart and Lung Centre, Golden Jubilee Hospital, Clydebank, United Kingdom
- fCardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
- gCatharina Hospital, Eindhoven, the Netherlands
- hEindhoven University of Technology, Eindhoven, the Netherlands
- iSt. Francis Hospital, Roslyn, New York
- ↵∗Address for correspondence:
Dr. Allen Jeremias, St. Francis Hospital, Department of Cardiology, 100 Port Washington Boulevard, #105, Roslyn, New York 11576.
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.
This study was an investigator-initiated study and supported financially by St. Jude Medical. Dr. Johnson has 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. Fearon has received institutional research support from St. Jude Medical and Medtronic; has received honoraria from Medtronic; and has served as a consultant to HeartFlow. Dr. Mintz has received honoraria from Boston Scientific and ACIST Medical; and fellowship or grant support from Boston Scientific and St. Jude. Dr. Oldroyd has received speaking fees from St. Jude Medical, AstraZeneca, and Volcano Corporation. Dr. De Bruyne has received institutional consultancy fees and research support from St. Jude Medical. Dr. Pijls has 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, General Electric, and HeartFlow. Dr. Maehara has received research grants from and is consultant for Boston Scientific; and speaking fees from St. Jude Medical. Dr. Jeremias has served as a consultant and member of the Speakers Bureau for Volcano/Philips Corporation and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 6, 2016.
- Revision received March 15, 2017.
- Accepted March 23, 2017.
- 2017 American College of Cardiology Foundation