An Expert Statement on Critical Limb Ischemia
Key findings
- Questions persist over defining high-quality, cost-effective outcomes for critical limb ischemia (CLI), the most advanced form of peripheral artery disease (PAD) with high potential for amputation, depression and death
- CLI is often undiagnosed and requires amputation, placing the patient at risk of subsequent amputation on the contralateral leg
- Despite advances in minimally invasive approaches, open surgery, regenerative and adjunct therapies, CLI care remains uneven across medical specialties, demographics and geographic regions
- Revascularization is the cornerstone of PAD treatment. Specialized PAD centers are indicated if local wound care expertise is not available or able to address underlying vascular disease
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An estimated 1-3% of patients diagnosed with peripheral artery disease (PAD) present with critical limb ischemia (CLI). This population is expected to increase due to the rise of obesity, sedentary lifestyle and diabetes.
Challenges in CLI Evaluation and Care
CLI patients face multiple challenges that typically require a multidisciplinary care team that includes psycho-social expertise. These challenges include:
- Failure to receive timely and adequate medical care. Many CLI patients undergoing major amputation do not have a vascular evaluation in the year before their amputation. Regular care would produce early interventions likely to reduce the disease’s impact
- Incomplete or unreliable assessments. Recent publications highlight limits of the ankle–brachial index (ABI) and toe pressure in accurately diagnosing CLI. Approximately 30% of patients with CLI have a near-normal or normal ABI. Patients would benefit from continued research on a personalized wound classification system that includes perfusion assessment
- Multifactorial etiology of foot ulcer formation. Ulcers develop from pressure, trauma, venous insufficiency, congestive heart failure and/or poor hygiene. Impaired biomechanics, joint mobility and sensory changes also can contribute to ulcer formation and must be addressed to minimize risk. A comprehensive patient evaluation with access to multiple specialists is needed to address all potential ulcer-forming factors
Assessments and Angiosomes
Improved perfusion assessment technology for detection of limb ischemia and wound healing are a welcome advance. The ideal technology is easy to use, reliably reproducible and cost-effective and provides a capillary and angiosome perfusion assessment.
The angiosome concept is a flow framework developed 30 years ago that delineates the body into 3-dimensional blocks of tissue fed by specific arterial and venous sources and termed “angiosomes.” Angiosomes are connected by collateral vessels or choke vessels that are able to supply indirect flow to a vascular territory in the absence of direct flow.
Expanding Options
In the face of progress and expanding options—from refinements to endovascular and open surgeries, to regenerative approaches such as stem cells, to angiogenic recombinant proteins, to stand-alone adjunctive therapies such as hyperbaric oxygen—guidance is still needed to clarify appropriate, affordable treatment and follow-up for CLI patients.
Many ongoing initiatives, including the National Institutes of Health-sponsored BEST-CLI, with Mass General as a Clinical Coordinating Center, and the European BASIL II and BASIL III are expected to provide this guidance.
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