Richard R. Heuser, MD; Kerry Zang, DPM; Arthur Mollen, MD
Every 30 seconds a limb is lost to diabetes mellitus. If a patient has an amputation, the family as well as the patient can look forward to a 40% mortality in the first year and a 80% mortality in 5 years. Diabetic foot ulcers affect over 1.5 million people annually at a cost of $6-$10 billion (1-3). In this month’s Journal of Invasive Cardiology, we describe the case of a 75-year-old diabetic lady who presented with critical limb ischemia, but fortunately because of a quick thinking primary care physician as well as podiatrist, she had not yet suffered an ulcer. When the angiogram reveals a popliteal occlusion, this presents a challenge to the interventionist; however, success rates approach 85% in these patients and no matter how you open the vessel — whether with ballooning, laser, atherectomy or stents — the recanalization success will most likely prevent an amputation. To cross a 100% occlusion, we have been impressed by the Prodigy catheter and its ability to keep the wire lumen in the true channel of the vessel when passing the wire with the Prodigy balloon inflated (4).
Until we developed the CrossLock catheter, we were not able to keep a support catheter close to a peripheral total occlusion, particularly when we wanted to pass balloons, lasers, atherectomy devices, or stents. The advantage of the CrossLock is that it is only 6 Fr compatible, making the antegrade approach as well as retrograde approach an acceptable risk to the patient.
Interventionists need new devices to aid in limb salvage. The CrossLock, with its centering balloon and super support, is unique and is intuitively obvious for the operator. Whether this will be a device of choice for the peripheral interventionist requires more operators to utilize the device, experience with SFA-CTO, as well as experience with retrograde and antegrade approaches. We do think this is a unique device and have been very happy with our results at this stage.
Limb salvage requires a multidisciplinary team. The total team effort is important because diabetes and vascular disease affect every system in the body.
- American Diabetes Assocation Standards of Medical Care in Diabetes – 2009. Diabetes Care. 2009;32(Suppl 1):S13-S61.
- Boulton AJ, Kirsner RS, Vileikyte L. Clinical practice. Neuropathic diabetic foot ulcers. N Engl J Med. 2004;351(1):48-55.
- Diabetic Foot Pnline. Diabetic foot: facts and figures. http://diabeticfootonline.com/diabetic-foot-acts-and-figures/.
- Moualla S, Khan S, Heuser RR: Anchoring improved: Introduction of a new over-the-wire support balloon. J Invasive Cardiol. 2014; (9):130-132.