title: Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound.
abstract: OBJECTIVE
  Previous studies have reported the safety and feasibility of both time-domain optical coherence tomography (TD-OCT) and Fourier-domain OCT (FD-OCT) in highly selected patients and clinical settings. However, the generalizability of these data is limited, and data in unselected patient populations reflecting a routine cathlab practice are lacking. We compared safety of intracoronary FD-OCT imaging to intravascular ultrasound (IVUS) imaging in a large real-world series of consecutive patients who underwent invasive imaging during coronary catheterization in our centre.
  
  
  RESULTS
  This is a prospective, single-centre registry of patients scheduled for coronary angiography or intervention undergoing intracoronary imaging with FD-OCT or IVUS between April 2008 and December 2013. Intra-procedural and major in-hospital adverse events that could be possibly related to invasive imaging were registered routinely by the operator as part of our clinical report and prospectively recorded in our database. These events were retrospectively individually adjudicated by an independent safety committee. Between April 2008 and December 2013, 13 418 diagnostic or interventional coronary catheterization procedures were performed. Of these, 1142 procedures used OCT and 2476 procedures used IVUS. Invasive imaging-related complications were rare, did not differ between the two imaging methods (OCT: n = 7, 0.6%; IVUS: n = 12, 0.5%; P = 0.6), and were self-limiting after retrieval of the imaging catheter or easily treatable in the catheterization laboratory. No major adverse events, prolongation of hospital stay, or permanent patient harm was observed.
  
  
  CONCLUSIONS
  FD-OCT is safe in an unselected and heterogeneous group of patients with varying clinical settings.
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Johannes N
authors.initials: JN
authors.lastname: van der Sijde
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Antonios
authors.initials: A
authors.lastname: Karanasos
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Nienke S
authors.initials: NS
authors.lastname: van Ditzhuijzen
authors.affiliation: Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Okamura
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Jurgen M R
authors.initials: JM
authors.lastname: Ligthart
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Karen T
authors.initials: KT
authors.lastname: Witberg
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Saskia
authors.initials: S
authors.lastname: Wemelsfelder
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.|National Heart Centre Singapore, Singapore.
authors.forename: Jiang Ming
authors.initials: JM
authors.lastname: Fam
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.|Department of Cardiology, The Affiliated Hospital of Xuzhou Medical College, Jiangsu, China.
authors.forename: BuChun
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Peter P
authors.initials: PP
authors.lastname: de Jaegere
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: van Mieghem
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Gijs
authors.initials: G
authors.lastname: van Soest
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Ron T
authors.initials: RT
authors.lastname: van Domburg
authors.affiliation: Thoraxcenter, Erasmus MC, Bd 585, 's-Gravendijkwal 230, 3015-CE Rotterdam, The Netherlands.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000601:surgery; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011237:Predictive Value of Tests; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D017751:Safety Management; D041623:Tomography, Optical Coherence / Q000009:adverse effects / Q000379:methods*; D018084:Ultrasonography, Interventional / Q000009:adverse effects / Q000379:methods*
keywords: Adverse events; Intravascular ultrasound; Optical coherence tomography; Safety