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CLINICAL STATEMENTS AND GUIDELINES

June 11, 2024 Circulation. 2024;149:e1313–e1410. DOI: 10.1161/CIR.0000000000001251 e1366

compression may be useful in patients with nooption CLTI to reduce ischemic pain, improve wound healing, and increase amputation-free survival but does not appear to reduce rate of major amputation. Further research is warranted. 3.	 Venous arterialization is a novel approach to the no-

option patient that involves connecting a proximal artery to a distal vein (deep or superficial), then disrupting the valves of the vein and allowing arterial blood to enter the foot through the venous system. These procedures have been performed via open, percutaneous deep vein arterialization (pDVA) and hybrid techniques.8,9 A systemic review of 15 studies (768 patients) reported a pooled limb salvage rate of 75% at 12 months in an analysis of 9 studies of pDVA and 6 studies of superficial techniques.8 A 2019 review of all 3 techniques reported limb salvage rates for open (25%-100%) in 184 cases, percutaneous (60%-71%) in 22 cases, and hybrid (46%-69%) venous arterialization in 62 cases.10 Midterm results from the ALPS (Alkmaar, Leipzig, Paris, Singapore) Multicenter Study of 32 patients having undergone pDVA reported a 24-month limb salvage rate of 78% and 73% complete wound healing.9 An interim report of the PROMISE I trial evaluated a pDVA technique (LimFlow) in a single-arm prospective study of 10 patients and showed a 6-month 100% amputationfree and 30% complete wound-healing result.11,12 Subsequent publication of the PROMISE I trial reported on 31 patients with a procedural success rate of 75% and amputation-free survival rates at 6 and 12 months of 74% and 70%, respectively.12

10.3.4 Amputation for CLTI

Recommendations for Amputation for CLTI Referenced studies that support the recommendations are summarized in the Online Data Supplement. COR LOE Recommendations

1 B-NR 1.	 In patients with CLTI who require amputation,

evaluation should be performed by a multispecialty care team (Table 15) to assess for the most distal level of amputation that facilitates healing and provides maximal functional ability.1–6

1 C-EO 2 In patients with CLTI, primary amputation is indicated

when life over limb is the prevailing consideration and clinical factors suggest the threatened limb to be the cause of the patient’s instability (eg, ischemia, metabolic derangement, or advanced infection).

1 C-EO 3 In patients with CLTI, a patient-centered approach

using objective classification of the threatened limb, patient risk, and anatomic pattern of disease combined with patient and family goals is recommended to identify those patients in whom primary amputation or palliative management is appropriate.

1 C-EO 4 In patients with CLTI undergoing minor amputation

(ie, inframalleolar level), a customized program of follow-up care that can include local wound care, pressure offloading, serial evaluation of foot biomechanics, and use of therapeutic footwear is recommended to prevent wound recurrence. 2a C-EO 5 For patients with CLTI, retrospective assessment of

institutional outcomes (including amputation) with objective limb threat classification tools can be useful for quality improvement.

Synopsis CLTI is associated with poor health-related QOL regardless of treatment approach.7,8 Preservation of a functional limb with a shoeable foot is the primary goal for the patient presenting with CLTI in whom ambulation is anticipated after the intervention. The use of a prosthetic and resumption of walking are the 2 outcomes with the greatest impact on QOL among amputees.9–12 Additional factors associated with QOL among patients who have undergone amputation are shown in Table 19. When superficial ulceration without infection is present, timely revascularization with restoration of adequate perfusion may permit healing of the soft-tissue envelope. However, when more extensive tissue loss or infection is present, with involvement of bone or soft tissues, then debridement with bone amputation and primary or delayed coverage may be necessary to facilitate healing and function. A multispecialty care team facilitates collaboration necessary to achieve this resource-intensive goal (Table 15). Although it is clear that preservation of maximal tissue of the limb is the goal, no evidence from RCTs is available to guide the selection process for the optimal level of amputation that is likely to heal in the face of chronic ischemia. This void of evidence represents an opportunity for future research.7 At a population level, prevention of limb loss is an important public health goal, and a 20% reduction in nontraumatic amputation by the year 2030 has been proposed by the AHA.8

Recommendation-Specific Supportive Text

1 Multispecialty care team collaboration (Table 15)

is essential to meet the broad needs of the patient with CLTI (see Section 10.1, “Team-Based Care for CLTI”). When amputation is required, clinical factors including the presence of infection and the degree of ischemia and tissue loss ultimately impact the level of amputation necessary to achieve the goal of a healed wound with a functional limb. Evidence exists to support the use and effectiveness of this team evaluation paradigm both before amputation and in the postoperative, long-term phase.1–6 For clinical circumstances in which these services are unavailable, consideration should be given to transferring the patient’s care to such a facility, except in instances of life-threatening sepsis due to foot infection when immediate amputation is warranted (see Recommendation 2). When clinically

Recommendations for Amputation for CLTI (Continued) COR LOE Recommendations

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