title: First-in-man evaluation of intravascular optical frequency domain imaging (OFDI) of Terumo: a comparison with intravascular ultrasound and quantitative coronary angiography.
abstract: OBJECTIVE
  The objective of this study is to evaluate the feasibility and safety of imaging human coronary arteries in vivo by optical frequency domain imaging (OFDI) in comparison to intravascular ultrasound (IVUS). OFDI has been recently developed to overcome the limitations of conventional time-domain optical coherence tomography (OCT), namely the need for proximal balloon occlusion. The Terumo-OFDI system is capable of acquiring images with high-speed automated pullback (up to 40 mm/sec) and requires only a short injection (3-4 sec) of small amount of x-ray contrast (9-16 ml).
  
  
  RESULTS
  Nineteen patients who underwent stent implantation were enrolled. IVUS/OFDI were performed before and after stenting. The incidences of any adverse event and angiographic adverse findings were recorded. Lumen area (LA) was measured by IVUS and OFDI at 1 mm intervals in the stented segments (n=19) as well as in the proximal, distal, and to-be-stented segments (n=40). In addition, lumen area in the stented segment was also measured by edge (E-) and video-densitometric (VD-) quantitative coronary angiography (QCA). The OFDI images were obtained without any adverse event related to imaging procedures. Post stenting (n=19), minimal LA (MLA) measured by OFDI (5.84 ± 1.89 mm2) was larger than that of E-QCA (4.16 ± 1.46 mm2, p<0.001) and VD-QCA (4.92 ± 1.55 mm2, p<0.05). It was smaller than IVUS-MLA (6.26 ± 2.01 mm2, N.S.) but the correlation between the two measurements was highly significant (R2=0.82, p<0.001).
  
  
  CONCLUSIONS
  The OFDI imaging is feasible both before and after stenting and has a promising safety profile. The OFDI provided clear high resolution images and robust lumen measurements.
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Okamura
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Héctor M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: Robert-Jan M
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.forename: Carl
authors.initials: C
authors.lastname: Schultz
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Jurgen
authors.initials: J
authors.lastname: Ligthart
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005583:Fourier Analysis; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015607:Stents; D041623:Tomography, Optical Coherence / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000009:adverse effects