Management of Critical Limb Ischemia
Patients with critical limb ischemia require immediate revascularization when possible to minimize tissue loss and prevent amputation, with an interdisciplinary team evaluation that includes urgent arterial imaging and a decision between endovascular or surgical revascularization based on anatomy, available conduit, and life expectancy. 1
Immediate Assessment and Stabilization
Clinical Recognition
- Recognize CLI by nocturnal rest pain that awakens patients within 20 minutes of lying supine, relieved by leg dependency, and accompanied by dependent rubor (maximal vasodilation from tissue hypoxia) 2
- Assess for nonhealing ulcers, gangrene, or tissue loss in the foot 1
- Measure ankle-brachial index (ABI <0.4 in non-diabetics indicates CLI risk), though this may be falsely elevated in diabetics with calcified vessels 2
- Recognize that patients with diabetes, neuropathy, or chronic renal failure presenting with acute limb symptoms represent vascular emergencies requiring immediate assessment 2
Initial Medical Management
- Initiate antiplatelet therapy (aspirin or clopidogrel) and high-intensity statin therapy immediately while planning revascularization 2, 3
- Provide adequate analgesia for ischemic rest pain control 1, 4
- Start appropriate antibiotics if infection is present: oral antibiotics for localized infection, intravenous antibiotics for extensive infection with systemic signs 1
- Order X-ray or MRA if deep-seated infection is suspected to diagnose osteomyelitis, which requires prolonged antibiotic therapy adapted to tissue cultures 1
Arterial Imaging Strategy
Obtain urgent arterial imaging to define anatomy for revascularization planning before considering amputation. 1, 2
Acceptable imaging modalities include: 1
- Duplex ultrasound
- CT angiography (CTA)
- MR angiography (MRA)
- Catheter-based angiography
The choice depends on local expertise, renal function (contrast considerations), and urgency of intervention. 1
Interdisciplinary Team Evaluation
An interdisciplinary care team must evaluate all CLI patients before amputation to assess revascularization options. 1
The team should include at minimum: 1
- Vascular surgeon
- Interventional radiologist or cardiologist
- Vascular medicine physician
- Wound care specialist
- Infectious disease specialist (if infection present)
Revascularization Strategy
Primary Decision Algorithm
The goal is to establish in-line blood flow to the foot through at least one patent artery to decrease ischemic pain and allow wound healing. 1
For Patients with Life Expectancy ≤2 Years or No Suitable Vein:
- Endovascular revascularization is the preferred initial approach 1, 5
- Endovascular procedures are recommended to establish in-line blood flow in patients with nonhealing wounds or gangrene 1
- The BASIL trial demonstrated equivalent amputation-free survival between endovascular and surgical approaches at 2 years 1
For Patients with Life Expectancy >2 Years AND Available Autogenous Vein:
- Surgical bypass is reasonable as initial treatment 1
- The BEST-CLI trial showed lower rates of major adverse limb events or death with surgical revascularization when a single-segment great saphenous vein was available 1
- The BASIL trial showed surgery was associated with significantly reduced risk of amputation or death after 2 years of follow-up 1
Critical caveat: The BASIL-2 trial (most recent data) showed endovascular revascularization had better amputation-free survival than surgery for infra-popliteal disease, primarily due to fewer deaths in the endovascular group. 1 This suggests that for high-risk patients requiring tibial revascularization specifically, endovascular may be preferred regardless of vein availability.
Endovascular Approach Details
For patients with nonhealing wounds or gangrene, restore direct in-line flow to the foot in a single procedure. 1
- Perform revascularization on hemodynamically significant stenoses (>75% or 50-75% with abnormal pressure measurements across the lesion) 1
- For multilevel disease with ischemic rest pain alone (no tissue loss), address inflow lesions first, then reassess; outflow lesions can be staged if needed 1
- Angiosome-directed therapy may be reasonable for wound healing, though evidence quality is low and randomized data are lacking 1
- Use balloon angioplasty with or without stenting; drug-eluting stents and drug-coated balloons offer lower repeat revascularization rates 5
Surgical Approach Details
When surgery is performed for CLI, bypass to popliteal or infrapopliteal arteries must be constructed with autogenous vein (preferably great saphenous vein). 1
- Single-segment great saphenous vein of at least 3.5 mm diameter is optimal 5
- If endovascular revascularization has failed and suitable autogenous vein is unavailable, prosthetic material can be effective for bypass to below-knee popliteal and tibial arteries 1
- For multilevel disease, address inflow lesions first; if CLI symptoms persist after inflow revascularization, perform outflow revascularization 1
- Hybrid approaches (iliac stenting plus common femoral endarterectomy) can reduce operative risk 5
When Revascularization is Not Indicated
Do not attempt revascularization in nonviable limbs with: 1
- Significant necrosis of weight-bearing portions of the foot (in ambulatory patients)
- Uncorrectable flexion contracture
- Paresis of the extremity
- Sepsis with life-threatening infection
- Very limited life expectancy where procedural risk exceeds benefit
Wound Care and Infection Control
Implement aggressive offloading to allow wound healing after revascularization. 1
- Prohibit lower-limb exercise training until ulcers are healed 1
- Adapt antibiotics according to tissue cultures (preferred over empirical therapy) 1
- Consider individualized wound treatments: antimicrobial dressing, silver dressing, honey- or iodine-based dressings, platelet-rich plasma, collagen, or negative pressure therapy to accelerate healing 1
- Assess for venous component in ulcers and consider compression therapy after revascularization for mixed ulcers 1
- Coordinate wound care with revascularization efforts through the interdisciplinary team 1
Postoperative Care and Monitoring
Immediate Post-Revascularization
- Monitor for compartment syndrome and perform fasciotomy if indicated 6, 4
- Assess clinical and hemodynamic success of revascularization 6, 4
Anticoagulation Strategy
- Consider dual antiplatelet therapy (aspirin plus clopidogrel) or rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily after revascularization 6
- Continue single antiplatelet therapy long-term for cardiovascular risk reduction 3
Surveillance After Bypass Surgery
- For autogenous vein bypass: perform periodic evaluations for at least 2 years including symptom assessment, pulse examination, and duplex imaging of entire graft length with peak systolic velocities and velocity ratios 1
- For synthetic bypass: perform periodic evaluations for at least 2 years including symptom assessment, pulse examination, and ABIs at rest and after exercise 1
Adjunctive Therapies for Non-Revascularizable CLI
- Intermittent pneumatic compression (arterial pump) devices may be considered to augment wound healing or ameliorate severe ischemic rest pain 1, 6
- Prostanoids are NOT indicated (Class III recommendation) based on lack of efficacy 1
Amputation Considerations
Minor amputation (up to forefoot level) should be performed after revascularization to remove necrotic tissue and improve wound healing. 6
- When major amputation is necessary, infragenicular (below-knee) amputation is preferred over above-knee amputation to preserve knee joint function 6
- Primary major amputation should be considered only for non-viable limb, potentially life-threatening infection (gas gangrene or necrotizing fasciitis), or functionally useless limb 6
Prognostic Context
Without revascularization, CLI carries a 22% all-cause mortality rate and 22% major amputation rate at 12 months. 1 Patients with gangrene treated conservatively have a 95% amputation rate at 1 year. 6 These sobering statistics underscore the imperative for aggressive revascularization attempts when anatomically feasible.