24-Carat Gold, 14-Carat Gold, or Platinum Standards in the Treatment of Critical Limb Ischemia:

Abstract

Critical limb ischemia (CLI) remains a poorly understood, rarely reported, and inconsistently treated major global healthcare epidemic. The incidence in the US is estimated at 1% of the population aged 50 years and older and at approximately double that rate in the over-70 age group. These frequencies are expected to increase significantly with the aging population and the expected increase in diabetes. Within 1 year of being diagnosed with CLI, 40% to 50% of the now 20 million US diabetics will experience an amputation, and 20% to 25% will die. The estimate for treating CLI in the US alone is $10 to $20 billion per year, but just a 25% reduction in amputations could save $2.9 to $3.0 billion annually. Infrainguinal bypass surgery (IBS) utilizing autogenous saphenous vein has been considered the "24-carat gold standard" treatment for CLI, but over the last decade, endovascular therapy has emerged to seriously challenge IBS, which has created considerable controversy. Despite an overall lack of "hard" level I data, many interventionists are questioning the role of IBS as a first-line CLI therapy or are at least now considering IBS a "tainted" gold standard ("14-carat"). This review will examine the available evidence, but there should be no doubt regarding the huge global clinical and economic impact of CLI and amputations.

Below the Knee Techniques: Now and Then

“…However, revascularization when compared with amputation have an overall lower perioperative mortality and enhanced long-term survival (Brosi et al, 2007;Varu et al, 2010). However, CLI is associated with multisegmental complex arterial lesions and consequently with high rates of revascularization failure (Allie et al, 2009). Specific features of the tibial vessels, such as the small caliber, the remote location, the slow flow of the distal bed, and the need of preserving runoff capacity, make this vascular territory particularly challenging for endovascular treatment (Blevins and Schneider, 2010).…”

“…Meanwhile, continued technical improvements and very encouraging results have changed the paradigm of CLI therapy, until recently based on vein graft bypass. As so, the endovascular approach is, nowadays, the first-line modality for limb-threatening ischemia for a majority of authors (Allie et al, 2009;DeRubertis et al, 2007). it is expected that the incidence of CLI would rise significantly with the current aging population and the expected increase in inactivity, obesity and consequently in diabetes (Allie et al, 2009;van Dieren et al, 2010).…”

“…As so, the endovascular approach is, nowadays, the first-line modality for limb-threatening ischemia for a majority of authors (Allie et al, 2009;DeRubertis et al, 2007). it is expected that the incidence of CLI would rise significantly with the current aging population and the expected increase in inactivity, obesity and consequently in diabetes (Allie et al, 2009;van Dieren et al, 2010). As a result and despite advances in medical therapies, the number of patients needing lower limb revascularization for severe limb ischemia will probably increase in the near future (Adam et al, 2005).…”

“…Moreover, the diagnosis of CLI remains a predictor of poor survival and outcomes (Varu et al, 2010): the overall mortality in these patients approaches 50% at 5 years and 70% at 10 years (Varu et al, 2010). Within one year of being diagnosed with CLI, 20% to 25% will die and 40% to 50% of the diabetics will experience an amputation (Allie et al, 2009;Kroger et al, 2006). The economic impact of CLI is considerable.…”

“…The economic impact of CLI is considerable. It has been assessed that the total cost of treating CLI in the US is $10 to $20 billion per year (Allie et al, 2009). The cost of follow-up, longterm care, and treatment for an amputee who remains at home has been estimated at $49,000 per year compared to only $600 to $800 per year after limb salvage (Allie et al, 2009).…”