OBJECTIVE:Peripheral artery disease (PAD) imposes significant clinical and economic burdens. Current fee-for-service models incentivize volume rather than outcomes, highlighting the need for value-based medicine (VBM) approaches. This review evaluates contemporary strategies for integrating VBM into PAD management, focusing on enhancing patient outcomes, optimizing resource use, and reducing health care expenditures. METHODS:We undertook a narrative review of the English-language literature by searching PubMed, Google Scholar, and professional society websites through April 2025 with the terms peripheral artery disease, value-based medicine, cost-effectiveness, and payment model. Contemporary guidelines, randomized or prospective comparative studies, cost-effectiveness analyses, and national policy documents were included; editorials, small case series, and non-English papers were excluded. Relevant gray literature (eg, Centers for Medicare and Medicaid Services payment-model frameworks, American College of Surgeons/Society for Vascular Surgery Vascular Verification Program manual) was also consulted. RESULTS:For intermittent claudication, primary objectives include decreasing cardiovascular morbidity and mortality, improving functional performance and quality of life via supervised exercise therapy, lifestyle modification, and optimal pharmacological management. Advanced imaging modalities, such as duplex ultrasound examination, computed tomography angiography, and magnetic resonance angiography, are cost effective primarily for preprocedural planning. Conversely, simple and accessible tests, like the ankle-brachial index and toe pressures with pulse volume recordings, offer cost-effective initial screening and surveillance. Optimal timing of interventions balances preventing progression to chronic limb-threatening ischemia with avoiding unnecessary and costly early interventions. Recent landmark trials inform decision-making around surgical and endovascular interventions, emphasizing patient-specific strategies that balance clinical outcomes and costs. CONCLUSIONS:Effective PAD management requires transitioning from volume-driven care to value-based paradigms, emphasizing evidence-based preventive measures, appropriate diagnostic tools, judicious timing of interventions, and multidisciplinary teamwork. Adopting VBM principles promises improved patient outcomes, cost efficiency, and sustainable care delivery in PAD populations.

Background Transcarotid artery revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi consensus document was to attempt to provide some guidance on these topics. Methods A 3-round Delphi consensus process was performed, including 29 experts. The aim of round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During round 3, the participants had the opportunity to finalize their vote. Results Most participants agreed that TCAR can or can probably or possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hr. It was felt that TCAR cannot or should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can or can probably be used for the treatment of restenosis following CEA or TFCAS. Finally, there is a need for a randomized controlled trial (RCT) to provide better evidence for the unresolved issues. Conclusions This Delphi consensus document attempted to assist the decision-making of physicians or interventionalists or vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and RCTs should provide more evidence to address the unanswered questions regarding TCAR.

Background The BEST‐CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) trial tested the optimal initial revascularization strategy in patients with chronic limb‐threatening ischemia. Little is known about the prognostic relevance of Lp(a) (lipoprotein[a]) and its modification by renal function in patients with chronic limb‐threatening ischemia. We investigated the relationship between Lp(a) and prespecified cardiovascular outcomes. Methods A subgroup of patients from the BEST‐CLI trial (as part of the TIDE [The Impact of Diabetes on Revascularization] study) underwent blinded, core‐laboratory assessment of Lp(a) levels and were included in this analysis. The primary end point was major adverse limb events or death from any cause. Secondary end points were the components of the primary end point, major amputation, major reintervention, and major adverse cardiac events (myocardial infarction, ischemic stroke, or death from any cause). The association of Lp(a) with end points was assessed using Cox proportional hazard models adjusting for traditional risk factors and then also for renal function and statin use, which increase Lp(a) levels. Results A total of 189 patients (median [interquartile range] age 67.3 [61.6–74.1] years) were included and followed for a median of 2.1 (1.2–2.9) years. Median Lp(a) for the total study population was 27.3 (10.4–65.8) mg/dL, and 62 (32.8%) patients had elevated values (≥50 mg/dL). The 1‐year event rate of the primary outcome was 33.3 (95% CI, 23.7–42.8) per 100 person‐years. There was no association between Lp(a) and the primary outcome (hazard ratio [HR], 1.00 [95% CI, 0.99–1.00]; P=0.186). In secondary analyses controlling for renal function, elevated Lp(a) was associated with increased risk for all‐cause death (HR, 1.03 [95% CI, 1.01–1.05]; P=0.009). Results were similar regardless of peripheral revascularization strategy. Conclusions Elevated Lp(a) level was not associated with major adverse limb events or death but was associated with all‐cause death after controlling for renal function. Lp(a) may be an important therapeutic target in the patient population with high‐risk chronic limb‐threatening ischemia. Registration https://clinicaltrials.gov/study/NCT03085524; Unique identifier: NCT03085524.

BACKGROUND:Patients with chronic limb-threatening ischemia (CLTI) who are ineligible for conventional revascularization ("no-option") face a 1-year major amputation rate of up to 67%. Transcatheter arterialization of deep veins (TADV) has shown promising outcomes, but comparative data with standard-of-care (SoC) treatments are lacking. METHODS:This evidence summary reviews current data for the only Food and Drug Administration-approved, Conformité Européenne-marked TADV procedure vs SoC treatments. The TADV cohort consisted of studies of Food and Drug Administration-approved TADV procedures, yielded from a systematic search of PubMed and Embase (2015-2025) in no-option CLTI patients with Rutherford class 5 or 6 disease and inadequate conventional revascularization options. The SoC cohort consisted of the natural progression of high-risk chronic limb-threatening ischemia natural history study of 180 no-option CLTI patients treated with conventional strategies. RESULTS:Four TADV studies (n = 197) were compared with the natural progression of high-risk chronic limb-threatening ischemia registry (n = 180). The primary end point of limb salvage rates was significantly higher in the TADV cohort: 79.6% [95% confidence interval: 67.6%, 93.9%] vs 55.1% in the SoC cohort (P < .001) at 12 months. Amputation-free survival was superior in TADV patients: 71.0% [56.9%, 88.6%] vs 37.3% in SoC (P < .001). The technical success rate was 97.6% [93.8%, 99.1%] across TADV studies. CONCLUSIONS:TADV demonstrates substantially superior limb salvage, amputation-free survival, and wound healing compared with SoC in no-option CLTI patients, representing a transformative advancement for this challenging population.

BACKGROUND:Up to 20% of patients with chronic limb-threatening ischemia (CLTI) are ineligible or have exhausted conventional options of lower extremity revascularization ("no-option") and face high rates of major amputation and death. OBJECTIVES:The authors present the 1-year outcomes of the pivotal PROMISE II trial and a patient-level pooled analysis combined with PROMISE I and PROMISE UK, comprising the largest cohort of prospectively studied patients following transcatheter arterialization of the deep veins (TADV) with the LimFlow System. METHODS:The single-arm, multicenter prospective PROMISE II study included patients with Rutherford class 5/6 CLTI and independently assessed no-option status. Amputation-free survival (AFS), limb salvage, and survival were assessed through 1 year. Clinical outcomes included Rutherford classification, pain scores, and wound healing. RESULTS:In PROMISE II, 105 enrolled patients had a median age of 70 years, 68.6% (72/105) were men, and the prevalence of comorbidities was high, including 77.1% (81/105) with diabetes. At 1 year, AFS was 54.2% (95% CI: 45.2-65.1%), limb salvage was 68.7% (95% CI: 59.8-78.9%), and survival was 79.0% (95% CI: 70.2-88.8%). The pooled analysis included 137 patients from PROMISE I, II, and UK and showed 1-year AFS of 66.1% (95% CI: 58.4-74.9%), limb salvage of 74.4% (95% CI: 67.1-82.5%), and survival of 88.9% (95% CI: 82.9-95.2%). Clinical symptoms and wound status showed improvement through 1 year. CONCLUSIONS:1-year outcomes following TADV with the LimFlow System demonstrated durable AFS and limb salvage rates, and improvement in clinical symptoms in no-option CLTI patients who often face major amputation or palliative care.

The incidence of chronic limb-threatening ischemia, the most severe form of peripheral artery disease, is increasing. A considerable portion are deemed "no-option" patients and have high rates of limb loss and death, with even worse outcomes in underrepresented populations. This study aimed to delineate real-world, contemporary outcomes in an observational study of no-option chronic limb-threatening ischemia patients. The composite primary end point was amputation-free survival (defined as freedom from death and above-ankle amputation) at 1 year. A total of 180 patients with no-option chronic limb-threatening ischemia were included from 22 centers across the US. The median age was 70 years (IQR, 61-78 years), 33% were women, 39% were Black, and 11% were Hispanic/Latino. Comorbidities included 76% with diabetes, 33% with heart failure, and 25% with end-stage renal disease. At 1 year, the amputation-free survival rate was 37%, 45% had major amputation, and 33% died. Additionally, two-thirds of the remaining patients had persistent non-healing ulcers, 44% had minor amputation, and 83% required ambulatory assistance. In this severely diseased population, approximately half of patients underwent major amputation and one-third died within a year, highlighting the pressing need for innovative interventions for limb salvage.

BACKGROUND:Patients with peripheral artery disease experience walking impairment that is incompletely explained by large-artery atherosclerotic occlusive disease and abnormal ankle-brachial index (ABI). Microvascular dysfunction is associated with adverse outcomes, including amputation, but its effect on ambulation is unknown. We tested the hypothesis that skeletal muscle microvascular function directly associates with walking distance, is a more sensitive indicator of walking distance than conduit artery blood inflow, and correlates with ambulatory improvement following peripheral artery disease interventions. METHODS:Sixty-eight participants, including 50 with peripheral artery disease (ABI ≤0.85) and 18 healthy controls, underwent vascular function assessment after sphygmomanometer cuff-induced calf ischemia using magnetic resonance imaging measures of blood oxygenation level-dependent reactivity and arterial spin labeling perfusion reactivity. Functional status was assessed using the 6-minute walk test. A subgroup of patients with peripheral artery disease underwent repeat testing after supervised exercise therapy (n=14) or revascularization (n=14). Multivariable linear regression models were used to assess the association of macrovascular reactive hyperemic blood inflow within the conduit arteries, skeletal muscle microvascular blood oxygenation level-dependent reactivity, and walking distance. RESULTS:Resting large-artery pressure by ABI (R=0.74; P<0.001), macrovascular blood inflow (R=0.40; P<0.001), and skeletal muscle microvascular blood oxygenation level-dependent reactivity (R=0.66; P<0.001) significantly correlated with the 6-minute walk test distance in univariable vascular testing. In multivariable analysis of each vascular parameter, however, calf skeletal muscle microvascular reactivity was most strongly associated with the 6-minute walk test (β=825.3; P=0.023). In those with repeat testing after intervention, the change in microvascular reactivity, but not ABI or macrovascular blood inflow, significantly correlated with the change in the 6-minute walk test distance (R=0.46; P=0.014). CONCLUSIONS:Microvascular reactivity after ischemia directly associates with walking distance and was a stronger predictor of walking distance than macrovascular blood inflow and ABI. After supervised exercise therapy or revascularization, improvements in microvascular function, but not macrovascular inflow or ABI, correlate with improvement in walking distance. Further study of microvascular dysfunction as a mechanistic driver of ambulatory function is warranted. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03490968.

OBJECTIVE:The optimal management of patients with asymptomatic carotid stenosis (AsxCS) and symptomatic carotid stenosis (SxCS) is controversial and includes intensive medical management (ie, best medical therapy [BMT]) with or without an additional carotid revascularization procedure (ie, carotid endarterectomy [CEA], transfemoral carotid artery stenting [TFCAS] or transcarotid artery revascularization [TCAR]). The aim of this international, expert-based, multispecialty Delphi consensus document was to reconcile the conflicting views regarding the optimal management of AsxCS and SxCS patients. METHODS:A three-round Delphi consensus process was performed including 63 experts from Europe (n = 37) and the United States (n = 26). A total of six different clinical scenarios were identified involving patients with either AsxCS or SxCS. For each scenario, five treatment options were available: (i) BMT alone, (ii) BMT plus CEA, (iii) BMT plus TFCAS, (iv) BMT plus TCAR, and (v) BMT plus CEA/TFCAS/TCAR. Differences in treatment preferences between US and European participants were assessed using Fisher's exact test, and odds ratios were used to quantify the magnitude and direction of association. Consensus was achieved when >70% of the Delphi consensus participants agreed on a therapeutic approach. RESULTS:Most participants concurred that BMT alone is not adequate for the management of a 70-year-old fit male or female patient with 80% to 99% AsxCS (52/63 [82.5%] and 45/63 [71.5%], respectively). In contrast, most panelists would opt for BMT alone for an 80-year-old male AsxCS patient with several comorbidities (48/63 [76.2%]). The majority of participants would opt for BMT plus a carotid revascularization procedure for an 80-year-old male SxCS patient with a recent ipsilateral cerebrovascular event, an ipsilateral 70% to 99% SxCS, and a 5-year predicted risk of ipsilateral ischemic event of 10% (54/63 [85.7%]), 15% (59/63 [93.6%]), or 20% (63/63 [100%]). The opinion of US-based participants varied from that of Europe-based respondents in some scenarios. CONCLUSIONS:The panel agreed that BMT alone is insufficient for most patients with SxCS, and that select subgroups of AsxCS patients may also benefit from revascularization, especially when high-risk features are present. Patients should be stratified according to their predicted stroke risk, as well as their individual clinical, anatomical, and imaging features and should be treated accordingly.

Background: Patients with peripheral artery disease (PAD) experience walking impairment that is incompletely explained by conduit artery atherosclerotic occlusive disease and ankle-brachial index (ABI). Microvascular dysfunction is associated with adverse outcomes including amputation but its effect on ambulation is unknown. We tested whether calf skeletal muscle microvascular function independently associates with walking distance and with ambulatory improvement following exercise therapy or revascularization. Hypothesis: Calf skeletal muscle microvascular function predicts walking distance after adjusting for conduit artery function and ABI. Methods: Sixty-eight participants, including 50 with PAD (ABI < 0.85) and 18 controls underwent vascular function assessment after sphygmomanometer cuff-induced calf ischemia using magnetic resonance imaging (MRI) measures of blood-oxygenation-level-dependent (BOLD) perfusion-dependent reactivity and arterial-spin labeling-based perfusion reactivity. Functional status was assessed using 6-minute walk testing (6MWT). A subgroup of PAD patients underwent repeat testing after exercise therapy (n=14) or revascularization (n=14). Multivariable regression models were used to assess the association of microvascular function with 6MWT distance controlling for age, sex, diabetes, ABI, and macrovascular function. Results: Resting conduit artery pressure by ABI (R=0.74, p<0.001), BOLD macrovascular reactive hyperemic blood flow (R=0.40, p<0.001), and skeletal muscle microvascular BOLD maximal reactivity (R=0.66; p<0.001) significantly correlated with 6MWT distance in univariable vascular testing (Figure 1A-C). In multivariable analysis of each vascular parameter, calf skeletal muscle microvascular reactivity most strongly associated with 6MWT (b=825.3, p=0.023). In those with repeat testing after intervention, the change in microvascular BOLD reactivity, but not ABI or macrovascular BOLD blood flow, significantly correlated with change in 6MWT distance (R=0.46, p=0.014, Figure 1D-F). Conclusions: Skeletal muscle microvascular function directly associates with walking distance independent of conduit artery blood flow and correlates with ambulatory improvement following PAD interventions.

BACKGROUND:Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS:We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS:We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS:We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).

OBJECTIVE:As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics. METHODS:A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS:Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS:This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas.

Critical limb-threatening ischemia is the most advanced stage of peripheral arterial disease, and patients with this problem represent a group at very high risk of limb loss. Until recently, patients with severe disease in the foot that was unreconstructable through the arterial system were relegated to treatment with wound care, pain management, and ultimately often faced major amputation. In recent investigations into the use of a percutaneous approach to venous arterialization, transcatheter arterialization of the deep veins has been evaluated as a mechanism to improve oxygen delivery to the foot in patients faced with the prospect of limb loss. Identifying patients who would benefit from this approach and a critical evaluation of the technique are provided along with expected outcomes. While the procedure remains in its infancy, early outcomes are promising, and continued advancement and improvement will further enhance options for these patients.