Conductance sizing balloon for measurement of peripheral artery minimal stent area

• Published in: Journal of vascular surgery 2014-09, Vol.60 (3), p.759-766
• Main Authors: Svendsen, Mark C., PhD, Akingba, A. George, MD, Sinha, Anjan K., MD, Chattin, Brooke, BS, Turner, Amelia, BS, Brass, Margaret, BS, Bhatt, Deepak L., MD, MPH, Kassab, Ghassan S., PhD
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon - instrumentation; Animals; Carotid Arteries - diagnostic imaging; Electric Conductivity; Humans; Iliac Artery - diagnostic imaging; Male; Models, Animal; Peripheral Arterial Disease - diagnosis; Peripheral Arterial Disease - therapy; Predictive Value of Tests; Pressure; Prosthesis Design; Radiography; Reproducibility of Results; Stents; Surgery; Swine; Ultrasonography, Interventional; Vascular Access Devices
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2013.06.095

Background Because stent underdeployment occurs frequently, accurate minimal stent area (MSA) measurement during postdilatation is necessary. This study investigated the accuracy and repeatability for MSA determination using a novel conductance balloon (CB) catheter for peripheral vessels. Methods The CB catheter is a standard balloon catheter that measures electrical conductance (ratio of current/voltage drop) in real-time during inflation, which directly relates to the balloon cross-sectional area through Ohm's law. CB measurements were made in 4- to 10-mm phantoms on the bench, ex vivo in stents fully deployed in diseased human peripheral arteries, and in vivo in stents fully deployed in peripheral vessels in six swine. CB measurement accuracy and repeatability were calculated and compared with the known dimension (bench phantoms) or with intravascular ultrasound (IVUS) measurement after stent deployment (ex vivo and in vivo). Results CB measurements were highly accurate (error: 1.8% bench, 5% ex vivo, and 5% in vivo) and repeatable (error: 0.9% bench, 1.8% ex vivo, and 1.3% in vivo), with virtually no bias (average difference in measurements: −0.05 mm bench CB vs known phantom diameters, −0.06 mm ex vivo CB vs IVUS, and −0.11 mm in vivo CB vs IVUS). Conclusions The CB sizing capability can be integrated within a standard balloon catheter (two-in-one function) to provide accurate, real-time assessment of MSA to ensure full stent apposition rather than the use of pressure as a surrogate for size.