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JACC CARDIOVASCULAR INTERVENTIONS VOL 9 NO 19 2016 Tu et al 2025. OCTOBER 10 2016 2024 35 The FAVOR Pilot Study, D iagnostic coronary angiography is the promising initial results FFR computation is ABBREVIATIONS. established standard for identi cation of still to be improved to increase the feasibility AND ACRONYMS. coronary artery disease However angio for use in routine clinical practice. aQFR adenosine ow, graphic images frequently fail to describe the func A novel approach enabling rapid computa quantitative ow ratio. tional signi cance of a stenosis which can lead to tion of FFR pullbacks from 3 dimensional. AUC area under the receiver, unnecessary revascularizations or deferral of neces quantitative coronary angiography 3D QCA operating characteristic curve. sary interventions 1 2 Fractional ow reserve was recently developed 15 The computa CI con dence interval. FFR is a precise index that reveals the speci c tional FFR denoted as quantitative ow ratio cQFR contrast ow. ischemic potential of coronary obstructions QFR can be obtained using 3 different ow quantitative ow ratio. Numerous studies have documented favorable clin models 1 a xed empiric hyperemic ow DS percent diameter. ical outcomes for FFR guided coronary interventions velocity HFV derived from previous FFR stenosis. in patients with stable coronary artery disease 3 7 studies 12 xed ow QFR fQFR 2 FFR fractional ow reserve. modelled HFV derived from coronary angi fQFR xed ow quantitative. SEE PAGE 2036, ography without pharmacologically induced ow ratio. Despite the clear advantages the clinical adoption hyperemia contrast ow QFR cQFR that HFV hyperemic ow velocity. of FFR has been variable and slow 8 A survey re is the contrast ow was converted into the QCA quantitative coronary. angiography, ported in 2014 showed that of 495 interventional virtual hyperemic ow based on data derived.
cardiologists evaluating the same 12 intermediate from previous studies 12 and cQFR was QFR quantitative ow ratio. stenoses 27 would not apply FFR at all despite the computed as if adenosine was actually used and 3. fact that all cases met the European Society of Car measured HFV derived from coronary angiography. diology Class I recommendations for FFR measure during adenosine induced maximum hyperemia. ment 9 A tool that allows calculating FFR without adenosine ow QFR aQFR It is unknown which of. the use of costly pressure wires and the administra these computational models is most precise There. tion of adenosine could increase the adoption of FFR fore we performed a prospective multicenter study to. With recent advances in computational sciences compare the diagnostic performance of these QFR. computational uid dynamics has been applied to computational models as compared with pressure. noninvasive imaging modalities such as multislice wire derived FFR. computed tomography for the computation of FFR, showing good diagnostic performances 10 11 Inva METHODS. sive quantitative coronary angiography QCA based, computational FFR by various methods was also STUDY DESIGN The prospective observational. reported with promising results 12 14 Despite multicenter FAVOR Functional Assessment by. From the aBiomedical Instrument Institute School of Biomedical Engineering Shanghai Jiao Tong University Shanghai China. Department of Cardiology Aarhus University Hospital Skejby Denmark cDepartment of Cardiology Guangdong General Hos. pital Guangzhou China dDepartment of Cardiology Thoraxcentrum Twente Medisch Spectrum Twente and Health Technology. and Services Research MIRA Institute University of Twente Enschede the Netherlands eCardiovascular Research Centre OLV. Hospital Aalst Belgium fDepartment of Advanced Biomedical Sciences University of Naples Federico II Naples Italy. Department of Cardiology and Angiology University of Giessen Giessen Germany hCardiovascular Institute Azienda Ospe. daliero Universitaria di Ferrara Ferrara Italy iDepartment of Cardiology Clinical Research Center Kyushu Medical Center. Fukuoka Japan jSection of Cardiovascular Medicine Yale University School of Medicine New Haven Connecticut kDepartment. of Radiology Leiden University Medical Center Leiden the Netherlands and lThe Lambe Institute for Translational Medicine and. Curam National University of Ireland Galway and Saolta University Healthcare Group Galway Ireland Dr Tu has received a. research grant from Medis Medical Imaging Systems BV Dr von Birgelen has been a consultant to Boston Scienti c and Med. tronic received lecture fees from AstraZeneca and his institution has received research grants from AstraZeneca Biotronik. Boston Scienti c and Medtronic Dr Reiber is the CEO of Medis and has a part time appointment at Leiden University Medical. Center as Prof of Medical Imaging Dr Holm has received speaker fees from St Jude Medical Biotronik and Terumo and. institutional research grants from St Jude Medical Terumo Boston Scienti c Medtronic Biotronic Medis medical imaging and. Cordis Cardiovascular Research Center Aalst receives institutional grant support and consultancy fees on behalf of Drs Wijns. and Barbato from St Jude Medical and other device and pharmaceutical companies Expenses associated with study enrollment. and procedures are covered by the participating centers The 3D angiographic reconstruction and computation of FFR at ClinFact. the Netherlands and the FFR core lab readings at Aarhus University Denmark are performed at their own expenses In addition. Shanghai Jiao Tong University received a research grant on behalf of Dr Tu from Medis Medical Imaging Systems and 2 research. grants from the Natural Science Foundation of China Grant Number 31500797 and 81570456 that supported the development of. the methods for coronary angiographic reconstruction and computation of FFR All other authors have reported that they have no. relationships relevant to the contents of this paper to disclose This is an investigator initiated study. Manuscript received April 22 2016 revised manuscript received June 25 2016 accepted June 30 2016. 2026 Tu et al JACC CARDIOVASCULAR INTERVENTIONS VOL 9 NO 19 2016. The FAVOR Pilot Study OCTOBER 10 2016 2024 35, Various Flow Reconstructions pilot study investi 1 coronary pressure remains constant through. gated of ine computation of QFR as compared with normal epicardial coronary arteries 17 2 the. conventional pressure wire based FFR as the stan amount of pressure drop is determined by the ste. dard reference The study was conducted at 8 sites in nosis geometry and the ow moving through the. 7 countries on 3 continents Europe Belgium Italy stenosis described by the uid dynamic equations. n 2 the Netherlands Germany Asia China 18 3 the stenosis geometry can be characterized by. Japan and North America the United States the deviation of the diseased lumen sizing with. Participating centers are listed in Online Appendix I respect to the reference sizing i e the healthy lumen. The study complied with the Declaration of Helsinki as if there was no stenosis by 3D QCA 12 and 4. for investigation in human beings The study protocol Coronary ow velocity is preserved distally relative to. was approved by the institutional review boards of proximal ow velocity 19 and the mass ow rate in. the individual centers and as appropriate by local the main coronary arteries decreases with the. and or national medical ethical committees All pa tapering of the arteries due to the presence of side. tients provided written informed consent before branches Hence the mass ow rate at each location. study enrolment along the interrogated vessel can be determined by. the mean ow velocity and the reference sizing from. STUDY POPULATION Patients 18 years of age with, 3D QCA Details of the computational methods are. stable angina pectoris and indication for invasive. described in Online Appendix II, coronary angiography and FFR assessment were.
The following 3 QFR computations were per, included if able to provide written informed consent. formed based on the different mean hyperemic ow, Exclusion criteria were contraindications to adeno. velocities, sine or adenosine triphosphate administration. Angiographic inclusion criteria were 1 1 lesion with 1 The fQFR pullback a xed empiric HFV of 0 35 m s. 30 to 80 diameter stenosis DS by visual esti that was derived from previous FFR studies 12. mation and 2 FFR measurement deemed feasible by was used for computation and then a compari. the operator Exclusion criteria were 1 ostial left son with the pressure wire based FFR was. main or ostial right coronary artery lesion and 2 performed. prior coronary artery bypass grafting of the interro 2 The cQFR pullback frame count analysis was per. gated vessels formed separately on the 2 diagnostic angiographic. projections without pharmacologically induced, STUDY PROCEDURE Invasive coronary angiography. hyperemia and the modelled HFVs were derived, was performed according to best local practice If FFR.
by which the software computed 2 new QFR pull, measurement was indicated the stenosis was assessed. backs The analyst chose the QFR pullback based, by pressure wire using the following strategies. on best image quality most well de ned contrast, Figure 1 1 pressure wire baseline distal coronary. ow in the frame count analysis as the cQFR, pressure to aortic pressure ratio then 2 FFR by intra. pullback to compare with the pressure wire based, venous adenosine adenosine triphosphate infusion.
Two angiographic projections were acquired during, each measurement Subsequent clinical decision The following quadratic function was applied. making was based on clinical guidelines at the oper to quantify the relation between the baseline. ator s discretion and was not study related Detailed ow velocity with injection of contrast medium. study procedures are described in Online Appendix II contrast ow velocity CFV and the HFV. COMPUTATION OF QFR Computation of QFR was HFV a0 a1 CFV a2 CFV2. performed of ine using a prototype software pack, Where a0 a1 and a2 are parameters that charac. age QAngio XA 3D prototype Medis Medical Imaging, terize the best tting curve that minimized the. System Leiden the Netherlands In the rst step 2, mean distance from all sample points in the training. diagnostic angiographic projections at least 25 apart. datasets to the tting curve The datasets from a, were selected and 3D reconstruction of the interro.
previous study 12 were used as the training data, gated vessel without its side branches was performed. sets and the optimal values were obtained at a0, as previously described 16 and 3D QCA data were. 0 10 a1 1 55 and a2 0 93 with an R 2 of 0 34, readily available Then the software computed. within a minute the following 3 QFR pullbacks based 3 The aQFR pullback frame count analysis was per. on a recently published method 15 The QFR formed separately on the 2 angiographic pro. computation was based on the underlying principles jections that were acquired during hyperemia. JACC CARDIOVASCULAR INTERVENTIONS VOL 9 NO 19 2016 Tu et al 2027. OCTOBER 10 2016 2024 35 The FAVOR Pilot Study, F I G U R E 1 Schematic Presentation of Study Procedures Showing the 2 Main Acquisition Steps. First the assessment of nonhyperemia distal coronary pressure to aortic pressure ratio and the corresponding angiographic runs for. computation of fQFR and cQFR Second assessment of FFR and acquisition of angiographic runs during intravenous adenosine infusion. for computation of aQFR aQFR adenosine ow QFR cQFR contrast ow QFR FFR fractional ow reserve fQFR xed ow QFR. QFR quantitative ow ratio, induced by intravenous administration of adeno during maximal stable hyperemia induced by intra.
sine or adenosine triphosphate The real HFVs venous adenosine adenosine triphosphate infusion. were derived and the software calculated 2 new core laboratory reading is used as the reference. QFR pullbacks The analyst chose the QFR pullback standard from which the diagnostic accuracy of QFR. based on best image quality in the frame count was derived. analysis as the aQFR pullback to compare with the, STATISTICS Descriptive statistics are reported as. pressure wire based FFR, mean SD median interquartile range IQR or. The QFR value at the position that matched the frequencies as appropriate Data were analyzed. location of the pressure transducer on the pressure on a per patient basis for clinical characteristics and. wire was used for comparison with the FFR value on a per vessel basis for the remaining calculations. measured by the pressure wire Normal distribution was tested with the Shapiro Wilk. Of note the ow velocity was derived by dividing test Correlation between QFR and FFR was deter. the arterial segment length from 3D QCA and the cor mined by Pearson s correlation coef cient r Pair. responding dye ow time from frame count analysis wise comparisons were made with Student t test or. The software allowed for selection of a subsegment Mann Whitney U tests as appropriate Sensitivity. of the reconstructed artery with good visualization speci city positive predictive value negative pre. of the dye ow for calculation of ow velocity dictive value positive likelihood ratio negative like. lihood ratio and diagnostic accuracy were de ned, DATA MANAGEMENT AND ANALYSIS Source data. from the calculated receiver operator characteristic. were collected on line using dedicated worksheets, curves The 95 con dence interval CI was added as. these computational models is most precise There fore we performed a prospective multicenter study to compare the diagnostic performance of these QFR computational models as compared with pressure wire derived FFR METHODS STUDY DESIGN The prospective observational multicenter FAVOR Functional Assessment by SEE PAGE 2036 ABBREVIATIONS AND

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