Premium
A nonimaging catheter for measurement of coronary artery lumen area
Author(s) -
Hermiller James,
Choy Jenny S.,
Svendsen Mark,
Bigelow Brian,
Fouts Andrew M.,
Hall Jack,
Parr Kirk,
Ball Michael,
Sinha Anjan,
Bhatt Deepak L.,
Kassab Ghassan S.
Publication year - 2011
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.22842
Subject(s) - medicine , intravascular ultrasound , percutaneous coronary intervention , repeatability , coronary artery disease , lumen (anatomy) , reproducibility , conventional pci , coronary angiography , catheter , nuclear medicine , mace , radiology , cardiology , biomedical engineering , mathematics , myocardial infarction , statistics
Objectives: The objective of this human pilot study was to determine the safety and the level of agreement between a novel nonimaging 2.7 Fr. catheter‐based system (LumenRECON, LR) that uses electrical conductance for measurement of lumen cross‐sectional area (CSA) with intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA). Based on previous animal studies, we hypothesized the level of agreement between LR and IVUS to be 13%. Background: Accurate and reproducible vessel sizing is essential for optimal percutaneous coronary intervention (PCI). Methods: A total of 12 patients were studied to evaluate the safety, accuracy, and reproducibility of the system in comparison with IVUS and QCA. The CSA of coronary arteries was determined by IVUS, QCA, and LR in the distal, proximal, and center of a lesion during standard PCI. Results: A Bland‐Altman plot of the LR versus IVUS and QCA show a nonsignificant mean difference between the two measurements of 0.04 and 0.07 mm in diameter, respectively. The root mean square error of LR versus IVUS and QCA was 14.3 and 25.8% of the mean IVUS or QCA diameter, respectively. The mean of the difference between two LR duplicate measurements was nearly zero (0.03 mm) and the repeatability coefficient was within 8.7% of the mean of the two measurements. There were no procedural complications nor were any device‐related MACE reported within 30 days of the procedure. Conclusions: This proof of concept pilot study establishes the safety and accuracy of the conductance technology for a pivotal trial of coronary sizing. © 2011 Wiley‐Liss, Inc.