A nonimaging catheter for measurement of coronary artery lumen area: A first in man pilot study

James Hermiller, Jenny S. Choy, Mark Svendsen, Brian Bigelow, A. Fouts, Jack Hall, Kirk Parr, Michael Ball, Anjan Sinha, Deepak L. Bhatt, Ghassan S. Kassab

Research output: Contribution to journalArticle

15 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)202-210
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume78
Issue number2
DOIs
StatePublished - Aug 1 2011

Keywords

  • electrical conductance
  • IVUS
  • percutaneous coronary intervention
  • QCA
  • sizing

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

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    Hermiller, J., Choy, J. S., Svendsen, M., Bigelow, B., Fouts, A., Hall, J., Parr, K., Ball, M., Sinha, A., Bhatt, D. L., & Kassab, G. S. (2011). A nonimaging catheter for measurement of coronary artery lumen area: A first in man pilot study. Catheterization and Cardiovascular Interventions, 78(2), 202-210. https://doi.org/10.1002/ccd.22842