Commentary: Optimal Revascularization for Critical Limb Ischemia

Critical limb ischemia (CLI) is the most severe manifestation of peripheral artery disease (PAD), affecting 1% to 2% of all PAD patients and significantly impacting quality of life and longevity, as well as health care costs.^1,2 It is a complex disease often afflicting those with numerous comorbidities, and outcomes are generally poor. Despite the broad scope of this condition, optimal treatment strategies to improve functional capacity, limb preservation, and survival are not well defined, and data are limited. Revascularization is the cornerstone of therapy and leads to increased limb preservation; unfortunately, it remains under-utilized, resulting in high rates of amputation. ³ Further complicating matters, the optimal initial approach to revascularization remains controversial. To date only one large prospective randomized trial has evaluated a surgical-first vs an endovascular-first strategy, which demonstrated similar amputation-free survival between groups with increased morbidity in the surgical arm. ⁴ Recently, the frequency of endovascular therapy has increased, yet there remains little randomized data to support many of our current treatments. ⁵ Ultimately, a personalized approach to CLI revascularization accounting for patient characteristics, availability of distal targets and conduits, life expectancy, and cost-effectiveness is likely the best option (Figure 1).^6–8

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Figure 1.

Critical limb ischemia treatment algorithm.

The current study by Katib et al ⁹ in this issue of the JEVT aims to further our understanding of an endovascular-first vs a surgical-first approach to revascularization in CLI. In this study, the authors compared outcomes of CLI patients who underwent endovascular, surgical, and no revascularization in a single tertiary care center. To do this, they compared outcomes of patients receiving initial endovascular and initial surgical treatment strategies while also analyzing outcomes of a time period when a surgical-first approach was preferred and comparing them with a more contemporary time period when a change in their institution led to an endovascular-first approach. They concluded that a shift to an endovascular-first approach in CLI patients was associated with fewer major amputations and a shorter hospital stay, which was seen in both analyses. These results are encouraging and consistent with current national trends of increasing rates of endovascular revascularization to treat CLI. ⁵ However, there are limitations to this study, and its conclusions should be viewed as supportive of an endovascular-first approach when deemed appropriate, but likely not in all cases. It is therefore important to maintain a dynamic and individualized approach when selecting the best revascularization strategy for CLI.

Critical limb ischemia is a complex disease that requires a multidisciplinary approach. While the authors credit the improvement in outcomes to an endovascular-first approach, it is conceivable that the latter group had more contemporary medical therapy and wound care, which may have contributed to their results. Furthermore, the changes in the staff physicians may have led to a more timely recognition and prompt revascularization in patients with CLI. Importantly, revascularization alone rarely results in complete wound healing without a comprehensive program that encompasses aggressive risk factor modification, wound care, and follow-up.

The authors suggested a greater proportion of the patients with CLI were considered candidates for intervention in the endovascular-first era. While this may have been related to more aggressive therapy offered by an endovascular approach, it could also reflect more referrals due to improvements in reputation and possibly better outcomes. More important, these data support the phenomenon of increased revascularization leading to improved limb salvage and highlights a disparity in CLI revascularization between two time periods at a single institution, which is also reflective of known variations of care seen among providers and institutions in the United States. ³

Although the current study has limitations, its findings highlight the importance of revascularization in CLI and suggest the potential for continued improvement in outcomes as endovascular therapies become more accessible and sophisticated. The BEST-CLI (Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia) trial, which is currently enrolling patients, will hopefully help to further our knowledge in outcomes of more contemporary endovascular therapies compared to surgical revascularization as initial therapy for CLI. ¹⁰ Although this trial is likely to be somewhat limited by heterogeneity of operators and patients considered, it will offer valuable randomized prospective data in this field where little currently exists.

There are many challenges at present to improving care in CLI. The condition is currently managed by a variety of specialties, including vascular surgery, interventional cardiology, interventional radiology, vascular medicine, and podiatry, likely contributing to lack of clear consensus regarding optimal management strategies. Furthermore, as evidenced by Katib et al, ⁹ there is major heterogeneity in surgical and endovascular experience and technique worldwide. Despite this variation, there remains no consensus as to the necessary clinical knowledge base or the technical skills required to treat this complex disease. In order to provide optimal care for these patients, providers must possess both extensive knowledge of this condition and refined technical skills. In addition to these challenges, current reimbursement fails to account for the long and complex procedures often required to optimize outcomes in CLI patients, which has potential to discourage physicians and institutions from providing the best possible care for these patients. Furthermore, work to improve awareness of the broad scope of this condition and the high morbidity and mortality it confers is needed as evidenced by the vast variation and underutilization of revascularization procedures prior to amputations for these patients. ³

As previously noted, CLI is a multifaceted disease process often requiring multispecialty care, including prompt hemodynamic evaluation, revascularization, aggressive and appropriate wound care, and management of cardiovascular risk factors and comorbid conditions.^6,11 In order to achieve optimal care for these patients, revascularization strategies should be personalized to each individual patient, taking into account lesion location and complexity, distal runoff and collateral formation, wound angiosome, availability of venous conduit, and accompanying patient comorbidities that may lead to elevated operative risk or decreased long-term survival (Figure 1). We advocate for a “CLI Team” approach where patients can be offered endovascular, surgical, or hybrid revascularization that best fits their needs along with attentive and aggressive wound care to prevent amputation and optimize patient outcomes.