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Published on: September 22, 2020
Development of a standard definition of 'no-option' and 'poor-option' for revascularization in chronic
Mario Alejandro Fabiani1,2, Jos C van den Berg3,4, Oscar A De la Torre1
1Tecnologico de Monterrey, School of Medicine and Health Sciences, Monterrey, Nuevo Leon, Mexico.
Insights
A consensus definition for "no option" or "poor option" chronic limb-threatening ischemia (CLTI) patients was developed. This framework aids clinical assessment and reporting for patients unsuitable for revascularization.
Area of Science:
- Vascular Surgery
- Clinical Definitions
- Patient Stratification
Background:
- Chronic limb-threatening ischemia (CLTI) poses a significant risk of limb loss.
- Revascularization is not feasible or carries high risk for many CLTI patients.
- A standardized definition for patients with 'no option' (NO) or 'poor option' (PO) CLTI is lacking.
Purpose of the Study:
- To develop a consensus-based, multidomain definition for NO/PO CLTI.
- To improve clinical assessment and reporting for CLTI patients unsuitable for revascularization.
Main Methods:
- Modified Delphi process involving 164 international vascular specialists.
- Two iterative survey rounds to achieve consensus (≥70% agreement).
Main Results:
- A multidomain framework (arterial disease anatomy, biology, risk, function, context - ABRFC) achieved 83% consensus.
- Defined 'desert foot' (81.6% agreement) and inadequate autogenous bypass conduit (85% agreement).
- Established criteria for NO (e.g., 'desert foot', prohibitive risk) and PO (e.g., infection, lack of vein) revascularization patients.
Conclusions:
- A structured, expert-validated definition for NO/PO revascularization in CLTI was established.
- The ABRFC framework supports standardized clinical assessment and trial design.
- This definition will aid future guideline development for CLTI management.
Introduction:
Revascularization to prevent limb loss is not feasible or represents a very high risk in a significant proportion of patients with chronic limb-threatening ischaemia (CLTI). No standard definition currently exists to define this population of patients. The aim of this study was to develop a consensus-based, multidomain definition to improve clinical assessment and reporting of studies in people with 'no option' (NO) or 'poor option' (PO) CLTI.
Methods:
A modified Delphi process was conducted with 164 specialists from 30 countries. Two iterative survey rounds were used to reach consensus, defined as ≥70% agreement with a score of ≥7 on a nine-point scale.
Results:
Some 164 international vascular specialists participated in the study, averaging 19 years of experience. A multidomain framework including arterial disease anatomy, biology, risk, function, and context (ABRFC) achieved 83% consensus. A 'desert foot' was defined as the absence of distal arterial revascularization targets on advanced non-invasive imaging, invasive digital subtraction angiography, and at least one failed endovascular revascularization attempt (81.6% agreement). Inadequate autogenous bypass conduit was defined as the lack of usable autologous vein across all four limbs (85% agreement). Patients were classified as NO for revascularization if they present with 'desert foot', prohibitive medical risk, a non-functional limb, or in those patients who refused arterial revascularization. PO revascularization patients combined factors such as severe infection, lack of autologous vein, or treatment non-compliance (72.1% agreement).
Conclusion:
This consensus study established a structured, expert-validated definition of no option or poor option for revascularisation of patients with CLTI. The multidomain ABRFC framework provides a foundation for standardized clinical assessment, trial design, and future guideline development.
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