Have Endovascular Advances Reinvented Limb Salvage Expectations?
Should We Reevaluate Our Criteria For Limb Salvage Success?
Despite the effort invested in diabetic foot revascularization, how much of the foot do surgeons save? Clinical studies have limb salvage as a primary goal while foot amputations are only a collateral observation.
In revascularization studies on diabetic arterial disease, should we really be talking about CLI? We all have seen that a patient with diabetes may lose only a toe in the presence of repeated sequential arterial lesions or lose a whole limb with good pedal pulses. In light of this, should we propose a different clinical classification for diabetic peripheral vascular disease with respect to the current classification, which includes all patient populations?
In the diabetic population, should the efficacy criteria of revascularization therapy be limb salvage? Given the current technology, which currently allows us to perform lower risk interventions to distal vessels in patients whose arterial disease is less than critical, why not aim for foot salvage?
Does foot salvage mean salvage of the functional foot? If everyone agrees that foot ulcer prevention is a must in patients with diabetes and if vascular specialists can successfully treat single tibial vessel occlusion in the presence of signs of trophic lesions in the diabetic foot, we propose a more preemptive action. Functional foot salvage should be the primary endpoint by which one should measure the effectiveness of any proposed therapy in these clinical studies.
To this end, we need the multidisciplinary foot salvage team to work together with podiatrists in the lead to define the edge of the functional foot. This would be the threshold where the loss of tissue begins to compromise foot action. With this new concept in mind, we should propose a new classification for diabetic peripheral vascular disease and consequently use a new paradigm for clinical observation. The brief table, “A New Classification For Saving The Diabetic Foot” (see above), can start an open discussion of these issues.
Once we take the aforementioned actions, we can truly begin to measure the effectiveness of newer revascularization strategies and techniques (such as single tibial treatment, specially dedicated tibial devices, high tech angioplasty balloons, smart stents, lasers and gene therapy) that are being proposed in preemptive stages of the arterial disease.
In this way, we do not persist to measure limb salvage in clinical settings where limbs were never threatened. We also will not keep referring to minor foot amputations as successes when tissue loss of the foot is what we are trying to avoid.
We need to build up evidence-based data to support the exciting new technology that is opening up to us to save the foot.
Dr. Serino is the Chief of the Endovascular Surgery Program, Diabetic Foot Team at the Istituto Dermopatico Dell’Immacolata, Istituto di Ricovero e Cura a Carattere Scientifico (IDI IRCCS) in Rome, Italy.
Dr. Cao also practices at the aforementioned institution in Rome, Italy.
Dr. Steinberg is an Assistant Professor in the Department of Plastic Surgery at the Georgetown University School of Medicine in Washington, D.C. Dr. Steinberg is a Fellow of the American College of Foot and Ankle Surgeons.