1.5 Critical limb ischemia
1.5.1 Controversy: Critical limb ischemia. Endo or open first?
Endo is the first choice strategy.
K. Deloose
Surgical bypass has been the gold standard for revascularization in the critical limb ischemic (CLI) patient for years now. In fact, it allows a 5-year limb salvage rate >80%. However, it has a 5% mortality rate, 10% to 20% incision wound complications. In 20% to 80% of successful patent bypasses, there is a recurrent or persistent ulcer or wound at one year. It has also been shown that bypass surgery induces a 12% decline in deambulation and a 15% loss in independent living post procedure. Additionally, distal bypass surgery only allows one vessel to be revascularized and cannot be performed in infected distal areas. Moreover, many times, there are no suitable veins and these patients typically have numerous comorbidities (the “old fragile no-vein men” concept). The progress in minimally invasive, endovascular techniques and technologies, combined with the improving skills among interventionalists, is starting to shift from bypass-surgery toward using an endovascular approach first.
The BASIL trial (Bypass versus Angioplasty in Severe Ischaemia of the Leg) is the only randomized trial to compare bypass with an endovascular approach (Bradbury AW et al; BASIL trial Participants. J Vasc Surg. 2010;51:18S-31S). This study showed a similar amputation-free survival as well as quality of life between the two groups. However, the BASIL trial has several issues: (i) inclusion of patients with severe limb ischemia instead of CLI (inclusion ankle pressure ≥50 mm Hg); (ii) exclusion of end-stage renal disease patients; (iii) almost no below the knee lesions included; (iv) high primary procedural failure rate (20%); (v) failed angioplasties are logically doing worse; (vi) limited range of endovascular strategies (balloon angioplasty only); (vii) post hoc long-term 24-month analysis with low patient numbers (high mortality rate in the patient cohorts); and (viii) outdated because the devices and techniques for endovascular treatment have improved substantially over the past decade. In fact, results of several high-quality, well-controlled (randomized and nonrandomized) studies and registries, using modern endovascular techniques and technologies, reveal one-year primary patency and limb salvage comparable with surgical bypass results, but with tremendously lower morbidity and mortality rates. Moreover, the vascular community has followed the evolution and, between 1996 and 2006, the number of endovascular lower-extremity interventions in the Medicare population reportedly increased by 230%, whereas the number of bypass procedures decreased by 42%.
Last, but not least, endovascular intervention, as a first approach, is also the preferred personal choice of CLI patients. Now, people prefer minimally invasive approaches with short hospital stays to huge surgical incisions with long admissions in high-dependency units.
Surgery should be first line.
F. Mussa
The author started by saying that, according to the BASIL trial (Bypass versus Angioplasty in Severe Ischaemia of the Leg), critical limb ischemic (CLI) patients who would live more than 2 years and have a usable vein should undergo a bypass procedure. Then, he assumed that endovascular techniques have markedly evolved and showed the results from a study performed by his group reporting the fate of failed primary revascularization and their rescued approaches. In this study, a cohort of 302 patients with CLI was identified between March 2007 and December 2010. Endovascularfirst was selected if: (i) the patient had short (5 to 7 cm) occlusions or stenoses in crural vessels; (ii) the disease in the superficial femoral artery was limited to transatlantic inter-society consensus II class A, B, or C lesions (TASC II A, B, or C); and (iii) no impending limb loss. Failures were defined as recurrent clinical signs and symptoms. Criteria for reintervention were the same as for primary intervention. Regarding the results, endovascular-first was performed in 187 (62%) and open-first in 105 patients (35%). Secondary procedures (endo or open) were more common after open-first (68% vs 55%; P=0.029). Patients with above knee open-first interventions were less likely to undergo secondary interventions than those who underwent endo-first at the same location, 58% vs 40%, respectively (P=0.003). Patients treated with rest pain were more likely to undergo secondary interventions than those with ulcers, 29% vs 54%, respectively (P<0.0001). At five-years, mortality rates were higher among those without secondary interventions, 53% vs 39%, respectively (P=0.0096). However, amputation rates were higher in patients undergoing secondary interventions, 22% vs 5%, respectively (P=0.0016). There was no difference in amputation-free survival based on the need for secondary interventions, 49% vs 47%, respectively (P=0.165). Patients with an initial open intervention followed by endovascular reintervention had a trend toward the best outcome with a 70% five-year amputation-free survival. The study concluded that at 5 years, a selective revascularization strategy led to frequent reinterventions, higher in those treated with an open-first approach. While amputation rates were higher in those undergoing secondary interventions, mortality was higher among those without secondary interventions. Amputation-free survival was not different between the two cohorts and a trend toward improved outcomes was demonstrated in those undergoing an open-first followed by endovascular reintervention.
The author determined that an endovascular approach can be bad depending on the patient’s issues (unreliable, renal impairment, intolerance to antiplatelet medication), anatomy (difficult access, small vessels with multilevel disease, chronic total occlusions of the popliteal artery or its trifurcation), and system limitations (poor endovascular expertise or insurance issues). He also concluded that open surgery is better for long, calcified, multilevel disease, large tissue loss, distal target adequacy, and in cases of endovascular failure (technical, nonhealing, repeated intervention, mounting cost, etc). He finished his talk by stating that: (i) he is an endovascular believer and practitioner; (ii) there are negative consequences for nonselective use of the endovascular-first approach; (iii) there is a need to make choices individually based on the patient’s anatomical, wound, and functional status; (iv) patients should not be denied a highquality bypass because they are sick or the physician thinks it is a big operation.
