title: First-In-Man application of a miniature self-contained intracoronary magnetic resonance probe. A multi-centre safety and feasibility trial.
abstract: OBJECTIVE
  To assess safety and feasibility of intracoronary Magnetic Resonance (MR) Spectroscopy in living patients, using a self-contained MR catheter.
  
  
  RESULTS
  Prospective, multi-centre study in patients with stable or unstable angina that were scheduled for percutaneous coronary diagnostic or therapeutic catheterization. We assessed the feasibility of an intravascular MR catheter, capable of analysing the arterial wall without external magnets or coils, by differentiating lipid rich, intermediate and fibrotic areas of the atherosclerotic plaque on the basis of differential water diffusion.Twenty-nine patients were included at 4 centres. The intracoronary MR-spectroscopy procedure was well tolerated; no MACE and no device related serious adverse event was observed. The MR catheter was successfully advanced into the lesion in 28 patients. Introduction of the MR catheter was not possible in one patient with a tortuous proximal right coronary artery. MR data were obtained in 22 patients. According to the predominant MR pattern, lesions were classified as fibrous plaque in 4 patients, as intermediate plaque in 4 patients and as lipid-rich plaque in 8 patients. Six patients were excluded from analysis because artifacts impeded the quality of the MR signal. Plaque type did not show a correlation with angina status (p=0.552; all groups) or angiographic parameters, such as minimal lumen diameter and diameter stenosis.
  
  
  CONCLUSIONS
  This prospective, multi-centre study demonstrates for the first time that coronary artery assessment of potentially vulnerable, non-flow limiting lesions using a dedicated intravascular MR catheter, free of external magnets or coils, is feasible in clinical practice. Assessment of the coronary wall may provide important data regarding the composition of the atherosclerotic lesion, which then could contribute to predicting the likelihood of eventual rupture and clinical instability.
authors.affiliation: Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Regar
authors.forename: B
authors.initials: B
authors.lastname: Hennen
authors.forename: E
authors.initials: E
authors.lastname: Grube
authors.forename: D
authors.initials: D
authors.lastname: Halon
authors.forename: R L
authors.initials: RL
authors.lastname: Wilensky
authors.forename: R
authors.initials: R
authors.lastname: Virmani
authors.forename: J
authors.initials: J
authors.lastname: Schneiderman
authors.forename: S
authors.initials: S
authors.lastname: Sax
authors.forename: H
authors.initials: H
authors.lastname: Friedmann
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: W
authors.initials: W
authors.lastname: Wijns