Clinical investigators are for the first time examining the
retrograde tibiopedal interventional approach, an endovascular technique that
has the potential to reduce the rate of leg amputations by as much as 50
percent[1] in patients with critical limb ischemia (CLI), a manifestation of
peripheral arterial disease (PAD). Cook
Medical, a global pioneer in interventional medical device technologies, is
sponsoring the Tibiopedal Access for Crossing Infrainguinal Artery Occlusions
study.
With the retrograde tibiopedal approach, a physician gains
vascular access at the foot and advances wire guides and catheters up the leg
to reach and cross arterial blockages. Individuals[1] and single centers[2]
have reported initial success with the technique, which is often tried after a
traditional antegrade approach fails. This is the first prospective,
multicenter study to collect data on this technique.
“This endovascular approach developed by leading physicians
has the demonstrated potential to address life-limiting and
lower-limb-threatening occlusions,” said Rob Lyles, vice president and global
leader of Cook’s Peripheral Intervention business unit. “We are committed to
enhancing the delivery of quality patient care and look forward to the initial
study results in 2013.”
An estimated 27 million people in Europe and North America
suffer from PAD,[3] which can lead to CLI, a severe obstruction of the arteries
that decreases blood flow to the extremities, producing pain and skin ulcers or
sores. CLI, which affects up to 300,000 people a year in the U.S.[4] is the end
stage of lower-extremity PAD and poses a significant risk for limb loss.
Currently, 25 percent of CLI patients undergo amputation as a primary
treatment.[4] Within two years of treatment, 25 percent of these patients die
and another 30 percent experience additional lower-limb amputation.[4] The
mortality rate at five years following amputation can be as high as 68 percent.[5]
Twelve sites in the United States and Europe will
participate in the Tibiopedal Access for Crossing Infrainguinal Artery
Occlusions study led by global principal investigator, Craig Walker, M.D.,
founder, president and medical director of the Cardiovascular Institute of the South
in Louisiana. Up to 200 patients with a totally occluded lower-limb artery will
be enrolled, and physicians will assess the technical success rates of the new
procedure both for gaining vascular access via the foot and for crossing the
lesion. Patient follow-up will consist of a telephone interview approximately
30 days after the procedure. J.A. Mustapha, M.D., director of endovascular
intervention at Metro Health Hospital, has
enrolled and treated the first patients in this study. Drs. Walker and Mustapha
are compensated by Cook Medical for educational lectures they present to
physicians on the tibiopedal access procedure.
Presented at: TCT 2010; September 21-25, 2010; Washington, DC. [2] Montero-Baker M, Schmidt A, Bräunlich S, et al. Retrograde
approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther.
2008;15(5):594-604. [3] Belch JJ, Topol EJ, Agnelli G, et al. Critical issues in
peripheral arterial disease detection and management: a call to action. Arch
Intern Med. 2003;163(8):884-892. [4] Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society
consensus for the management of peripheral arterial disease (TASC II). Eur J
Vasc Endovasc Surg. 2007;33(suppl 1):S1-S75. [5] Reiber GE, Boyko EJ, Smith DG. Lower extremity foot
ulcers and amputations in diabetes. In: Harris MI, Cowie CC, Stern MP, et al.,
eds. Diabetes in America. 2nd ed. Washington, DC: National Institute of
Diabetes and Digestive and Kidney Diseases, 1995:409-428.