Tell us where things stand presently with treatment options for diabetics with critical limb ischemia (CLI).
The majority of diabetics with CLI have foot wounds which are very often complicated with infection. The target in these patients is to avoid major amputations (limb salvage). TASC II indicates revascularization as the first-choice treatment for CLI (recommendation no. 24). We know from direct experience and from the literature that endovascular treatment is actually considered the first choice and that this treatment should be part of a multidisciplinary approach. The new concept is to revascularize these legs in order to obtain a “walking function salvage” based on wound healing and aggressive surgical debridement with proper timing.
Where is lower extremity disease most severe in diabetics? How are these lesions best treated?
Diabetic arteriopathy is a multilevel disease primarily involving the superficial femoral artery (SFA), popliteal tract and, above all, below-the-knee and foot vessels. Long occlusions are more frequently encountered than are any kind of stenoses, and media-calcinosis is typical. When associated with dialysis, calcifications are very tough, diffuse and severe. Endovascular treatment with balloon angioplasty extended to all involved tracts to achieve the best in-flow and out-flow is currently considered the best treatment strategy.
What are some of the new techniques and devices available for diabetic patients with CLI?
Both subintimal and endoluminal coronary-type techniques can be used with multiple arterial accesses (antegrade, distal retrograde, transpedal or loop techniques) and wires. Most of the device companies in this field are launching dedicated products for below-the-knee procedures. These include 0.014 inch dedicated devices to treat peripheral chronic total occlusions and 0.014 inch over-the-wire very low-profile balloons, as well as complete dedicated systems including long sheaths and rapid-exchange balloons. New paclitaxel drug-eluting balloons appear to be very promising for the prevention of restenosis and in-stent reocclusion. Also, a new generation of atherectomy devices and bioabsorbable stents is now available.
What are the long-term outcomes for these patients?
Most of our patients are treated once every 18–24 months. Our limb salvage rate is 94%, and the walking function salvage rate is 87%. [Short-term] arterial patency is not what is important: we need these vessels to remain patent for the entire wound-healing period, which is 160 days on average.
How about quality-of-life improvement for CLI patients post treatment?
Avoidance of amputation and achievement of greater autonomy at home and outside the home for CLI patients constitute good results in terms of quality of life.
How do you see treatment strategies evolving in the coming years for diabetics with CLI?
I see a trend toward utilization of the multidisciplinary model for diabetic patients — the foot and ankle clinic — where diabetologists, orthopedic specialists, vascular surgeons, plastic surgeons, endovascular interventionists and podiatrists work together to treat the patient. This working model is the only one with proven positive results.
What do the data show regarding CLI therapies? Is there a trial currently under way?
The BASIL trial (Bypass versus Angioplasty in Severe Ischemia of the Leg) is no longer relevant in my opinion. What is needed is a new randomized, controlled trial for a selected and homogeneous population of CLI patients comparing different endovascular treatment options. Two or three randomized studies are being launched comparing drug-eluting balloon angioplasty to normal balloon angioplasty in CLI patients.
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