Premium
A lumen sizing workhorse guidewire for peripheral vasculature: Two functions in one device
Author(s) -
Svendsen Mark C.,
Choy Jenny S.,
Ebner Adrian,
Bigelow Brian,
Sinha Anjan,
Moussa Issam,
Akingba A. George,
Combs Bill,
Kassab Ghassan S.
Publication year - 2013
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.24950
Subject(s) - imaging phantom , medicine , biomedical engineering , sizing , repeatability , radiology , art , chemistry , chromatography , visual arts
Objectives Ideally, guidewires used during peripheral vasculature (PV) interventions could serve both as a therapy delivery platform and a diagnostic tool for real‐time vessel sizing (2‐in‐1 function). Background Vascular imaging modalities, like intravascular ultrasound (IVUS), used during lower PV interventions, can improve outcomes versus angiographic assessment alone, but are rarely used due to added time, cost, and required clinical training/interpretation. Methods A 0.035″ bodied 0.035″ conductance guidewire (CGW) is described here as a vascular navigation and diagnostic real‐time PV sizing tool. When attached to a console, the CGW creates a safe, electric field to determine vascular size through simultaneous voltage measurements. Results The CGW showed functionality as a workhorse guidewire on the bench (torqueability and trackability equivalent to a Wholey guidewire) and in vivo (over‐the‐wire stent deployment in domestic swine and first‐in‐man study with no major adverse events). Validation of CGW sizing versus the true diameter and IVUS was completed in 4–10 mm diameter phantoms on the bench and in swine and showed virtually no bias with excellent repeatability and accuracy (i.e., CGW repeatability: swine phantom bias = 0.03 ± 0.09 mm (1.3% error). CGW vs. true diameter: in vivo bias = 0.14 ± 0.15 mm (2.7% error). IVUS vs. true diameter: swine phantom bias = 0.01 ± 0.36 mm (4.7% error). CCW vs. IVUS: swine phantom bias = 0.13 ± 0.26mm (3.8% error)). Conclusions Real‐time, accurate, and safe PV dimension assessment and therapy‐delivery (2‐in‐1 function) is possible using a novel workhorse 0.035″ bodied CGW. © 2013 Wiley Periodicals, Inc.