Taking on Critical Limb Ischemia
- Volume 7 - Issue 9 - September 2010
- Posted on: 9/3/10
- 1 Comments
- 8718 reads
J. A. Mustapha, MD, FACC, FSCAI
Revascularization catheters. The first-generation Pathway device is the Jetstream G3™ (Pathway Medical Technologies, Inc., Kirkland, Washington), which has a front-cutting blade that is able to create a channel between 2.5–2.75 mm. With its blades fully deployed, the Jetstream G3 can create a channel up to 4 mm. The second and recently released device is the Jetstream G3SF (small fixed), which is a more flexible catheter with a 1.85 mm front-end cutting tip. Both devices have the ability to aspirate while performing atherectomy.
Adjunctive balloon angioplasty is used with atherectomy and standalone scoring balloons with devices such as the AngioSculpt® (AngioScore, Inc., Fremont, California) and cutting balloons with longitudinal microsurgical blades such as the Flextone® (Boston Scientific Corp., Natick, Massachusetts). Both balloons are limited by their ≤ 2 cm length, which makes these devices impractical to treat long, diffusely diseased or long occlusions.
The Vascutract™ (Bard Peripheral Vascular, Inc., Tempe, Arizona) features a long, single 0.014 inch wire on the outer edge of a long balloon, which provides an acceptable alternative to scoring and cutting balloons in long, diffusely diseased vessels. The Vascutract is a unique balloon with a distal rapid-exchange exit port allowing a single wire on the outside of the balloon. When the balloon is inflated, the Vascutract wire and standalone guidewires are pushed against the plaque and the vessel wall. The wire trapped between the vessel wall and the balloon provides controlled dissection and changes the compliance of resistant plaque.
Long, tapered balloons provide a unique therapeutic option for long, tapered tibio-pedal vessels. The tapered balloons differ by a 0.5 mm outer diameter from the distal to proximal ends. Multiple balloons provide large variations in length and strength to accommodate the variation in the complexity of CLI.
The IN.PACT Amphirion™ paclitaxel-eluting PTA balloon (Invatec, Inc./Medtronic, Inc., Roncadelle, Italy) was recently launched in Europe. More data are needed to support the long-term benefits of drug-eluting balloons in the treatment of CLI.
Most bare-metal, balloon-expandable and self-expandable stents have not shown any long-term benefits, primarily due to the well-known phenomenon of intimal hyperplasia formation potentially leading to insufficient long-term patency rates.2,8
Treating below-the-knee with drug-eluting stents is an effective means of relieving symptoms and preventing major amputation. Procedural complications and limb revascularization rates have been low. Limb salvage and survival rates in patients treated with drug-eluting stents exceed those of historic controls.2,8
CLI is associated with significant morbidity and mortality. It is imperative that physicians maintain a high index of suspicion, which often requires a multidisciplinary approach including aggressive treatment of traditional risk factors, lifestyle modification and therapeutic intervention to restore antegrade blood flow. The availability of multiple interventional devices and techniques can offer patients options in diseased arterial territories, which have traditionally not been possible, particularly in tibial and pedal interventions. Endovascular therapy has emerged as a minimal morbidity and mortality procedure with significant improvement in distal extremity perfusion pressure. An understanding of the natural history of peripheral arterial disease, patient-related risk factors and lesion morphology and selection criteria, as well as an understanding and knowledge of various devices and techniques, are essential elements required to perform these procedures effectively and safely.
1. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): Multicentre, randomized controlled trial. Lancet 2005;366:1925–1934.
2. Feiring, AJ, Krahn, M, Nelson, L, et al. Preventing leg amputations in critical limb ischemia with below-the-knee drug-eluting stents: The PaRADISE (Preventing Amputations using Drug eluting StEnts) Trial. J Am Coll Cardiol 2010;55:1580–1589.
3. Schmieder FA, Comerota AJ. Intermittent claudication: Magnitude of the problem, patient evaluation, and therapeutic strategies. Am J Cardiol 2001;87:3D–13D.
4. Dormandy J, Verstraete M, Andreani D, et al. Second European consensus document on chronic critical leg ischemia. Circulation 1991;84(Suppl 4):1–26.
5. DeBakey ME, Crawford ES, Garrett E, et al. Occlusive disease of the lower extremities in patients 16 to 37 years of age. Ann Surg 1964;159:873–890.
6. Cohen D, Kassab E, Pupp G, et al. Peripheral arterial disease. Are we doing enough to diagnose and treat patients with PAD? Supplement to Endovascular Today. Summer 2008.
7. Faxon D, Creager MA, Smith SC, et al. Executive summary: Atherosclerotic vascular disease conference proceeding for healthcare professionals from a special writing group of the American Heart Association. Atherosclerotic Vascular Disease Conference. American Heart Association. Circulation 2004;109:2595–2604.
8. Romiti M, Albers M, Brochado-Neto FC, et al. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008;47:975–981.
From the Department of Research and Endovascular Interventions, Metro-Health Hospital, Wyoming, Michigan.
Disclosures: Dr. Mustapha has been a consultant for Bard, Cardiovascular Systems, Inc., Cordis Corp., and ev3, Inc.