title: A novel system for the reconstruction of a coronary artery lumen profile in real time: a preclinical validation.
abstract: Accurate sizing of vessel diameter is important for understanding the physiology of blood vessels as well as the treatment of coronary and peripheral artery disease. The objective of this study was to validate a novel catheter-based system [the LumenRECON (LR) system] for the real-time reconstruction of lumen cross-sectional area (CSA) along the length of a vessel segment. A total of 22 swine (20 Yorkshire and 2 atherosclerotic Ossabaw swine) were used to evaluate the accuracy, reproducibility, and safety of the system compared with intravascular ultrasound (IVUS). The CSA of the right coronary artery, left anterior descending coronary artery, and left circumflex artery were determined by IVUS and the LR system over a 3- to 4-cm segment in 12 Yorkshire and 2 atherosclerotic Ossabaw swine and 2 postmortem atherosclerotic human hearts. In eight chronic animals, the effect of the LR catheter on the vessel wall was evaluated at 1 day and 2 wk (4 animals each) after the intervention. A Bland-Altman plot of the LR and IVUS data showed a mean difference between the two measurements of 0.055 mm in diameter, which was not statistically significant from zero, indicating a lack of bias in the comparison of the LR system with IVUS. The root mean square error of the two measurements was 10.2% of the mean IVUS diameter. The repeatability of the LR system was assessed using duplicate measurements. The mean of the difference between the two measurements was nearly zero, and the repeatability coefficient was within 4.5% of the mean of the two measurements. No injury or intimal hyperplasia was found acutely or chronically after the use of the LR system. This study establishes the accuracy, reproducibility, and safety of a nonimaging 2.7-Fr catheter for lumen sizing of coronary arteries. The system provides a continuous quantitative axial profile of the mean vessel lumen in real time and may have significant utility in vascular research and clinically in the catheterization laboratory.
authors.affiliation: Department of Biomedical Engineering, Indiana University-Purdue University Indianapolis (IUPUI), Indianapolis, IN 46202, USA. gkassab@iupui.edu
authors.forename: Ghassan S
authors.initials: GS
authors.lastname: Kassab
authors.forename: Jenny S
authors.initials: JS
authors.lastname: Choy
authors.forename: Mark
authors.initials: M
authors.lastname: Svendsen
authors.forename: Anjan K
authors.initials: AK
authors.lastname: Sinha
authors.forename: Mouhamad
authors.initials: M
authors.lastname: Alloosh
authors.forename: Mike
authors.initials: M
authors.lastname: Sturek
authors.forename: Yunlong
authors.initials: Y
authors.lastname: Huo
authors.forename: George E
authors.initials: GE
authors.lastname: Sandusky
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
mesh_terms: D000465:Algorithms; D000818:Animals; D050197:Atherosclerosis / Q000235:genetics / Q000473:pathology; D002404:Catheterization; D003331:Coronary Vessels / Q000033:anatomy & histology* / Q000473:pathology / Q000502:physiology*; D004562:Electrocardiography; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D007091:Image Processing, Computer-Assisted; D066298:In Vitro Techniques; D016018:Least-Squares Analysis; D008953:Models, Anatomic; D019047:Phantoms, Imaging; D015203:Reproducibility of Results; D013552:Swine