Performance Assessment of a Radiofrequency Powered Guidewire
for Crossing Peripheral Arterial Occlusions Based on Lesion Morphology
M
OHAMMAD
A. T
AVALLAEI
,
1,5
J
AMES
J. Z
HOU
,
2,3
T
RISHA
L. R
OY
,
4
and G
RAHAM
A. W
RIGHT
1
1
Department of Medical Biophysics, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada;
2
Sunnybrook Health Sciences Centre, Toronto, ON, Canada;
3
University of Waterloo, Waterloo, ON, Canada;
4
Division of
Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada; and
5
Sunnybrook Health
Sciences Centre, 2075 Bayview Ave., Room M7 508, Toronto, ON M4N 3M5, Canada
(Received 5 February 2018; accepted 30 March 2018; published online 3 April 2018)
Associate Editor Umberto Morbiducci oversaw the review of this article.
Abstract—Endovascular wires and devices for peripheral
arterial disease therapy have evolved greatly, yet failure rates
of these procedures remain high. Information on lesion
composition may inform device selection to improve the
success rates of these procedures. This paper, presents an
approach for informed guidewire selection. The objective of
this study is to quantitatively assess the performance of a
radiofrequency powered guidewire in the crossing of various
morphology types of peripheral chronic total occlusions.
Samples taken from amputated patient limbs are character-
ized by magnetic resonance imaging. Using a customized
catheter test station, the performance of a radiofrequency
powered guidewire in puncturing these lesions is compared to
a conventional guidewire, and to itself when not powered.
The analysis includes quantitative and statistical compar-
isons of the puncture forces experienced by the different
guidewires in ‘‘hard’’ vs. ‘‘soft’’ lesions as well as qualitative
assessment of deflections, buckling and puncture success of
the wires. Results indicate that the use of radiofrequency
ablation significantly reduces the required puncture force,
reduced events of buckling and deflection, and resulted in a
significantly higher puncture success rate.
Keywords—Endovascular interventions, Guidewires, Mag-
netic resonance imaging, Chronic total occlusions, Radio
frequency ablation, Peripheral arterial disease.
INTRODUCTION
Peripheral arterial disease (PAD) is a common cir-
culatory disease in which the narrowing of blood ves-
sels limits blood flow to limbs. It is estimated that more
than 10 million people are affected by this disease in
North America alone.
7
If left untreated, PAD can lead
to critical limb ischemia and these patients are at a very
high risk of major amputation. In general, PAD is
associated with significant morbidity and mortality.
9
Revascularization strategies for the treatment of
occlusive PADs have transitioned from open surgery
methods to percutaneous endovascular procedures and
an ‘‘endovascular-first’’ approach is now widely
adopted.
11,12,27
Various endovascular techniques, utilizing different
devices, are used for the treatment of occlusive PADs.
These procedures involve either the removal of plaque
(atherectomy) or angioplasty, with and without stent
placement. All endovascular procedures must first use
a guidewire to cross through the occlusion; the device
is then passed over the guidewire to perform the
therapy (angioplasty or stenting). Chronic total
occlusions (CTOs) are complete obstructions of the
artery for a duration of more than three months. CTOs
account for a significant portion of lesions encountered
by endovascular interventionalists.
14
However, failure
rates for crossing CTOs in PADs remain above 20%;
the most common mode of endovascular failure is the
inability to cross the lesion
2,13,15
and guidewire selec-
tion is pivotal to the success of the procedure. Con-
ventional passing devices are passive guidewires—with
various tip shapes, materials, and mechanical proper-
ties—that are used to penetrate the vessel by applying
mechanical pressure. Various alternative solutions ex-
ist that incorporate a broad range of approaches to
achieve crossing of the lesion including: directional,
rotational, orbital and laser atherectomy; high fre-
quency vibration; rotational and micro dissection;
ultrasound stimulated microbubbles; miniature end-
effector manipulation; drug injection; and radiofre-
Address correspondence to Mohammad A. Tavallaei, Sunny-
brook Health Sciences Centre, 2075 Bayview Ave., Room M7 508,
Toronto, ON M4N 3M5, Canada. Electronic mails: atavallaei@
gmail.com, tavallaei@sri.utoronto.ca
Annals of Biomedical Engineering, Vol. 46, No. 7, July 2018 (
Ó
2018) pp. 940–946
https://doi.org/10.1007/s10439-018-2021-y
0090-6964/18/0700-0940/0
Ó
2018 Biomedical Engineering Society
940
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