Excimer Laser-Assisted Angioplasty in Severe Infrapopliteal Disease and CLI: The CIS "LACI Equivalent" Experience
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Critical limb ischemia (CLI) has only recently been characterized in the clinical literature; therefore knowledge of the clinical impact of CLI is still rudimentary at best. The TransAtlantic Inter-Societal Consensus (TASC) committee and document on the management of peripheral arterial occlusive disease (PAOD) have recently attempted to unify and clarify CLI with the following recommendations:1
1. Recommendation 73: Clinical definition of critical limb ischemia:
The term critical limb ischemia should be used for all patients with chronic ischemic rest pain, ulcers, or gangrene attributable to objectively proven arterial occlusive disease. The term critical limb ischemia implies chronicity and is to be distinguished from acute limb ischemia.
2. Recommendation 74: Trials and reporting standards definition of critical limb ischemia:
A relatively inclusive entry criterion is favored, the aim being to ensure that the ulceration, gangrene, or rest pain is indeed caused by peripheral arterial disease and that most would be expected to require a major amputation within the next 6-months to a year in the absence of a significant hemodynamic improvement. To achieve this, it is suggested to use absolute pressures of either ankle pressure < 50-70 mm Hg or reduced toe pressure (< 30-50 mm Hg) or reduced TCPO2 (< 30-50 mm Hg).
Wolfe et al classically described the natural history of CLI in a collation of 20 publications on 6118 patients by stratifying them into a low-risk cohort of 4089 patients (rest pain only and ankle pressure > 40mmHg) and a high-risk cohort of 2029 patients (rest pain and tissue loss with or without ankle pressure < 40mmHg).2 At 1 year, 95% of the high-risk group and 73% of the low-risk group required a major amputation without revascularization. A 75% limb salvage rate was achieved at 1 year in the high-risk group with revascularization. The cumulative probability of survival for the entire group was 74% at 1 year, 58% at 2 years, 56% at 3 years, 48% at 4 years, and 44% at 5 years.
It is estimated that between 150,000 – 200,000 major and minor lower extremity amputations are performed in the United States (US) and Europe yearly for CLI.3-4 In the US, the amputation rate has increased from 19 to 30 per 100,000 persons over the last two decades primarily due to an increase in diabetes and an advancing age population.5-6 Despite advances in cardiovascular treatment and revascularization technology, in patients over 85 years of age, an amputation rate of 140 per 100,000 persons/year has been reported, with a primary amputation (PA) still carrying an excessively high mortality rate of 13-17%.6-8 Successful rehabilitation after below-knee amputation (BKA) is achieved in less than two-thirds of patients and in less than one half of patients after above-the-knee amputations (AKA).9-11
Multiple reports have repeatedly documented the poor overall prognosis for the CLI patient, but recent reports by Panayiotopoulos et al and Kalra et al have shown significantly improved long-term survival after revascularization and limb salvage as compared to CLI patients following revascularization failure and amputation.6,12 Kalra et al reported the long-term survival after infrainguinal bypass surgery (IBS) (pedal bypass) in 256 CLI patients. Amputation and ESRD predicted higher mortality (p = 0.014, p = 0.0001, respectively) and overall 5-year survival rates were 60%.6 The 5-year survival rate after an amputation was 26%, therefore documenting significantly worse long-term survival for patients suffering an amputation versus those CLI patients achieving limb salvage.6
Clearly, the clinical costs to the CLI patient are extremely high, underscoring the need for a better understanding of the entire scope of this major problem as well as the development of new technologies involved in treating this CLI patient population in which the incidence is expected to increase yearly. Therefore, any treatment strategy aimed at decreasing amputations would have a significant impact on both short- and long-term clinical outcomes. Laird et al in 2003 reported the encouraging results of the Laser Angioplasty for Critical Ischemia (LACI) phase II pivotal trial results. 13 This prompted a retrospective analysis of our group’s (the Cardiovascular Institute of the South [CIS]) 24-month excimer laser atherectomy (ELA) experience in a similar patient population; therefore, we report our CIS “LACI Equivalent” results.
LACI Pivotal Trial
The LACI pivotal multi-center trial (15 US and German sites) enrolled 145 CLI patients with 155 ischemic limbs with Rutherford Class 4-6 (rest pain and early tissue loss-ulceration) who were poor or nonsurgical bypass candidates. These patients were considered very fragile with significant cardiopulmonary comorbidities and at high-risk for major amputation. ELA was delivered in 96% of the cases, including 8% who had failed guidewire crossing and required the “step-by-step” technique developed and championed by Professor Giancarlo Biamino. This technique utilizes methodical laser advancements through chronic total occlusions (CTO) uncrossable by traditional guidewire techniques. Of the 423 lesions treated, 41% were superficial femoral artery (SFA), 15% were popliteal artery (PA), and 41% were infrapopliteal arteries (IA). Forty-five percent of the overall lesions treated with ELA required a stent with 61% in the SFA, 38% in the PA, and 16% in the IA.13
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