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In the treatment of chronic limb-threatening ischemia (CLTI), complete wound healing is an important goal. Although foot perfusion status seems to be important for wound healing, the Global Limb Anatomic Staging System (GLASS) of the Global Vascular Guidelines does not include pedal artery status for the staging process due to the lack of sufficient evidence of its importance. This study aimed to clarify the importance of pedal perfusion status after bypass surgery. Among the 153 CLTI cases that underwent bypass distal to popliteal arteries from 2014 to 2018, 117 CLTI limbs with wounds and with sufficient pedal angiographic data were enrolled. They were classified into two groups, based on the wound status 6 months postoperatively; early wound healing group (EWG; n = 78), which achieved complete wound healing within 6 months postoperatively, and prolonged healing or unhealed wounds group (PWG; n = 39), which failed to achieve wound healing within 6 months. Various factors associated with wound healing, including the wound, ischemia, and foot infection (WIfI) classification, intraoperative graft flow, and pedal angiographic data, were analyzed. Regarding pedal angiographic data, in addition to the GLASS inframalleolar/pedal disease descriptor (IPD), newly formed classification system of the pedal circulation status in association with the location of wounds was included: pedal circulation status was classified into two groups as visualized arterial perfusion towards wounds (visualized perfusion) and non-visualized arterial perfusion towards wounds (non-visualized perfusion). Univariate analysis showed preoperative albumin (Odds ratio [OR], 0.47; 95% confidence interval [CI], 0.24-0.94; P =.027), higher WIfI clinical stage (OR, 3.88; 95% CI, 1.74-10.1; P =.0005), higher IPD (OR, 2.16; 95% CI, 1.16-4.02; P =.012), and non-visualized perfusion to wounds (OR, 5.74: 95% CI, 2.45-14.0; P <.0001) as significant for prolonged wound healing. Multivariate analysis showed higher WIfI stage (OR, 5.04; 95% CI, 1.74-14.6; P =.0029) and non-visualized perfusion to wounds (OR, 4.34; 95% CI, 1.71-11.0; P =.0021) as significant, whereas IPD was not detected as significant. Regarding blood supply to the foot, although graft flow was significantly lower in IPD-P2 than IPD-P0/P1, graft flow was similar regardless of the status of angiographic circulation to wounds, suggesting that distribution of blood supply to the wound would be more important than total amount of blood supply to the foot for wound healing. WIfI clinical stage and pedal circulatory environment were important factors for wound healing after bypass surgery. Pedal anatomical classification system including perfusion status would be important for decision making in CLTI treatment. [ABSTRACT FROM AUTHOR]

Prior studies have described risk factors associated with amputation in patients with concomitant diabetes and peripheral arterial disease (DM/PAD). However, the association between the severity and extent of tissue loss type and amputation risk remains less well-described. We aimed to quantify the role of different tissue loss types in amputation risk among patients with DM/PAD, in the context of demographic, preventive, and socioeconomic factors. Applying International Classification of Diseases (ICD)-9 and ICD-10 codes to Medicare claims data (2007-2019), we identified all patients with continuous fee-for-service Medicare coverage diagnosed with DM/PAD. Eight tissue loss categories were established using ICD-9 and ICD-10 diagnosis codes, ranging from lymphadenitis (least severe) to gangrene (most severe). We created a Cox proportional hazards model to quantify associations between tissue loss type and 1- and 5-year amputation risk, adjusting for age, race/ethnicity, sex, rurality, income, comorbidities, and preventive factors. Regional variation in DM/PAD rates and risk-adjusted amputation rates was examined at the hospital referral region level. We identified 12,257,174 patients with DM/PAD (48% male, 76% White, 10% prior myocardial infarction, 30% chronic kidney disease). Although 2.2 million patients (18%) had some form of tissue loss, 10.0 million patients (82%) did not. The 1-year crude amputation rate (major and minor) was 6.4% in patients with tissue loss, and 0.4% in patients without tissue loss. Among patients with tissue loss, the 1-year any amputation rate varied from 0.89% for patients with lymphadenitis to 26% for patients with gangrene. The 1-year amputation risk varied from two-fold for patients with lymphadenitis (adjusted hazard ratio, 1.96; 95% confidence interval, 1.43-2.69) to 29-fold for patients with gangrene (adjusted hazard ratio, 28.7; 95% confidence interval, 28.1-29.3), compared with patients without tissue loss. No other demographic variable including age, sex, race, or region incurred a hazard ratio for 1- or 5-year amputation risk higher than the least severe tissue loss category. Results were similar across minor and major amputation, and 1- and 5-year amputation outcomes. At a regional level, higher DM/PAD rates were inversely correlated with risk-adjusted 5-year amputation rates (R2 = 0.43). Among 12 million patients with DM/PAD, the most significant predictor of amputation was the presence and extent of tissue loss, with an association greater in effect size than any other factor studied. Tissue loss could be used in awareness campaigns as a simple marker of high-risk patients. Patients with any type of tissue loss require expedited wound care, revascularization as appropriate, and infection management to avoid amputation. Establishing systems of care to provide these interventions in regions with high amputation rates may prove beneficial for these populations. [ABSTRACT FROM AUTHOR]

Occlusive disease of the common femoral artery can generate profound lower extremity ischemia as the normal collateral pathways from the profunda to the superficial femoral artery cannot adequately develop. In patients with lifestyle-limiting claudication, isolated common femoral endarterectomy (CFE) is highly effective. Because CFE does not provide direct, in-line flow to the plantar arch, it has been felt to provide inadequate revascularization to patients with chronic limb-threatening ischemia (CLTI). The purpose of this retrospective clinical study was to report and assess the natural history of selected patients with CLTI treated with isolated CFE (without concomitant infrainguinal revascularization). Consecutive CFEs performed in a large, urban hospital for CLTI between 2014 and 2021 were reviewed. Patient characteristics, limb, and anatomical stages using the Wound, Ischemia, foot Infection (WIfI) and Global Limb Anatomic Staging System were tabulated. Limb-specific and survival-related end points were analyzed. Fifty-eight patients presenting with CLTI underwent isolated CFE (mean age, 74 ± 10 years; 62% male, 90% current or prior smoker). Comorbidities included diabetes (52%), coronary artery disease (55%), congestive heart failure (22%), and end-stage renal failure on hemodialysis (5%). Patients presented with either rest pain (36%) or tissue loss (64%); the latter group exhibited advanced limb threat (68% in WIfI stage 3 or 4). The majority of patients had associated severe infrainguinal disease (50% Global Limb Anatomic Staging Systems 3). After a median follow-up of 17 months (range, 10-29 months), vascular reintervention was required in 7 patients (12%). One patient (2%) required major limb amputation after presentation in WIfI stage 4 (W3I3fI0). Indeed, WIfI stage 4 was a significant univariate predictor of the need for subsequent infrainguinal bypass (P =.034). Isolated CFE as primary therapy in highly selected patients with CLTI was safe and effective. Index limb stage is predictive of the need for associated infrainguinal revascularization in this complex population. [ABSTRACT FROM AUTHOR]

The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P =.0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P =.94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P <.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P =.0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P =.30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P =.0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P =.93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P =.12). Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes. [ABSTRACT FROM AUTHOR]

The Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system aims to risk stratify patients with chronic limb-threatening ischemia (CLTI), predicting both amputation rates and the need for revascularization. However, real-world use of the system and whether it predicts outcomes accurately after open revascularization and peripheral interventions is unclear. Therefore, we sought to determine the adoption of the WIfI classification system within a contemporary statewide collaborative as well as the impact of patient factor, and WIfI risk assessment on short- and long-term outcomes. Using data from a large statewide collaborative, we identified patients with CLTI undergoing open surgical revascularization or peripheral vascular intervention (PVI) between 2016 and 2022. The primary exposure was preoperative clinical WIfI stage. Patients were categorized according to the SVS Lower Extremity Threatened Limb Classification System into clinical WIfI stages 1, 2, 3, or 4. The primary outcomes were 30-day and 1-year amputation and mortality rates. Multivariable logistic regression was performed to estimate the association of WIfI stage on postrevascularization outcomes. In the cohort of 17,417 patients, 83.4% (n = 14,529) had WIfI stage documented. PVIs were performed on 57.6% of patients, and 42.4% underwent an open surgical revascularization. Of the patients, 49.5% were classified as stage 1, 19.3% stage 2, 12.8% stage 3, and 18.3% of patients met stage 4 criteria. Stage 3 and 4 patients had higher rates of diabetes, congestive heart failure, and renal failure, and were less likely to be current or former smokers. One-half of stage 3 patients underwent open surgical revascularization, whereas stage 1 patients were most likely to have received a PVI (64%). As WIfI stage increased from 1 to 4, 1-year mortality increased from 12% to 21% (P <.001), 30-day amputation rates increased from 5% to 38% (P <.001), and 1-year amputation rates increased from 15% to 55% (P <.001). Finally, patients who did not have WIfI scores classified had significantly higher 30-day and 1-year mortality rates, as well as higher 30-day and 1-year amputation rates. The SVS WIfI clinical stage is significantly associated with 1-year amputation rates in patients with CLTI after lower extremity revascularization. Because nearly 55% of stage 4 patients require a major amputation within 1 year of intervention, this finding study supports use of the WIfI classification system in clinical decision-making for patients with CLTI. [ABSTRACT FROM AUTHOR]

The recent Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) study showed that bypass was superior to endovascular therapy (ET) in patients with chronic limb-threatening ischemia (CLTI) deemed suitable for either approach who had an available single-segment great saphenous vein (GSV). However, the superiority of bypass among those lacking GSV was not established. We aimed to examine comparative treatment outcomes from a real-world CLTI population using the Vascular Quality Initiative-Medicare-linked database. We queried the Vascular Quality Initiative-Medicare-linked database for patients with CLTI who underwent first-time lower extremity revascularization (2010-2019). We performed two one-to-one propensity score matchings (PSMs): ET vs bypass with GSV (BWGSV) and ET vs bypass with a prosthetic graft (BWPG). The primary outcome was amputation-free survival. Secondary outcomes were freedom from amputation and overall survival (OS). Three cohorts were queried: BWGSV (N = 5279, 14.7%), BWPG (N = 2778, 7.7%), and ET (N = 27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4705 pairs of ET vs BWGSV and 2583 pairs of ET vs BWPG. In the matched cohorts of ET vs BWGSV, ET was associated with greater hazards of death (hazard ratio [HR] = 1.34, 95% confidence interval [CI], 1.25-1.43; P <.001), amputation (HR = 1.30, 95% CI, 1.17-1.44; P <.001), and amputation/death (HR = 1.32, 95% CI, 1.24-1.40; P <.001) up to 4 years. In the matched cohorts of ET vs BWPG, ET was associated with greater hazards of death up to 2 years (HR = 1.11, 95% CI, 1.00-1.22; P =.042) but not amputation or amputation/death. In this real-world multi-institutional Medicare-linked PSM analysis, we found that BWGSV is superior to ET in terms of OS, freedom from amputation, and amputation-free survival up to 4 years. Moreover, BWPG was superior to ET in terms of OS up to 2 years. Our study confirms the superiority of BWGSV to ET as observed in the BEST-CLI trial. [ABSTRACT FROM AUTHOR]

Aortic endarterectomy (AE), once a treatment of choice for aortoiliac occlusive disease, is now rarely performed in favor of endovascular procedures or open aortobifemoral bypass. However, in select patients with paravisceral or aortoiliac occlusive disease, AE remains a viable alternative for revascularization, either as a primary procedure or after prior interventions have failed. Here, we evaluated outcomes for an extended series of patients undergoing paravisceral or aortoiliac endarterectomy, demonstrating that these procedures can be an excellent alternative with acceptable morbidity and mortality in properly selected patients. A single institution retrospective review of 20 patients who underwent AE from 2017 to 2023 was performed. Five patients (25%) underwent paravisceral endarterectomy and 15 (75%) underwent aortoiliac endarterectomy. There were no perioperative mortalities. One paravisceral patient died 3 months postoperatively from complications of pneumonia. Three patients in the paravisceral group required reinterventions; one acutely due to thrombosis of the superior mesenteric artery (SMA) requiring extension of the endarterectomy and patch angioplasty on postoperative day 0, one due to stenosis at the distal edge of the endarterectomy 1 month postoperatively, successfully treated with SMA stenting, and one at 10-month follow-up due to SMA stenosis at the distal aspect of the endarterectomy, also successfully treated with SMA stenting. With these reinterventions, the 1-year primary patency in the paravisceral group was 40%, primary-assisted patency was 80%, and secondary patency was 100%. In the aortoiliac group, 1-year primary, primary-assisted, and secondary patency were 91%, 91%, and 100%, respectively. One patient developed iliac thrombosis 10 days postoperatively owing to an intimal flap distal to the endarterectomy site. She and one other patient, a young man with an undefined hypercoagulable disorder, ultimately required neoaortoiliac reconstructions at 18 and 32 months postoperatively, respectively (the latter in the setting of stopping anticoagulation). The remaining 13 patients experienced no complications. All patients had rapid resolution of clinical symptoms, and median postoperative ankle-brachial indexes of 1.06 on the right and 1.00 on the left, representing a median improvement from preoperative ankle-brachial indexes of +0.59 on the right and +0.56 on the left (P <.01 and P <.01). In this series of 20 patients undergoing paravisceral and infrarenal aortoiliac endarterectomy, AE was associated with no perioperative mortality, relatively low and manageable morbidity, and excellent clinical outcomes in patients with both paravisceral and aortoiliac occlusive disease. SMA-related early reintervention was not uncommon in the paravisceral group, and attention should be given particularly to the distal endarterectomy site. AE remains a viable treatment for severe multivessel paravisceral or aortoiliac occlusive disease isolated to the aorta and common iliac arteries in select patients. [ABSTRACT FROM AUTHOR]

Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for the measurement of clinical effectiveness and cost effectiveness and for shared decision-making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, and other PROMs exist for patients with pain, and still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps that need to be addressed to develop a unifying PROM instrument for CLTI.

The pedal medial arterial calcification (MAC) score has been associated with risk of major limb amputation in patients with chronic limb-threatening ischemia. This study aimed to validate the pedal MAC scoring system in a multi-institutional analysis to validate its usefulness in limb amputation risk prediction. A multi-institution, retrospective study of patients who underwent endovascular or open surgical infrainguinal revascularization for chronic limb-threatening ischemia was performed. MAC scores of 0 to 5 were assigned based on visible calcified arteries on foot X ray then trichotomized (0-1, 2-4, 5) for analysis. The primary outcome was major limb amputation at 6 months. Adjusted Kaplan-Meier models were used to analyze time-to-major amputation across groups. There were 176 patients with 184 affected limbs (mean age, 66 years; 61% male; 60% White), of whom 97% presented with a wound. The MAC score was 0 in 41%, 1 in 9%, 2 in 13%, 3 in 11%, 4 in 13%, and 5 in 13% of the limbs. There were 26 major amputations (14%) and 16 deaths (8.7%) within 6 months. Patients with MAC 5 had a significantly higher risk of major limb amputation than both the 0 to 1 and 2 to 4 groups (P =.001 and P =.044, respectively), and lower overall amputation-free survival (log-rank P =.008). Pedal MAC score is a reproducible and generalizable measure of inframalleolar arterial disease that can be used with Wound, Ischemia, and foot Infection staging to predict major limb amputation in patients with chronic limb-threatening ischemia. [ABSTRACT FROM AUTHOR]

Estimates of chronic limb-threatening ischemia (CLTI) based on diagnosis codes of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) suggest a prevalence of 0.23%-0.32% and incidence of 0.20%-0.26% among Medicare patients. ICD-10-CM includes 144 CLTI diagnosis codes, allowing improved specificity in identifying affected patients. We sought to use ICD-10-CM diagnosis codes to determine the prevalence of CLTI among Medicare patients and describe the patient cohort affected by this condition. Using two years of data from Centers for Medicare and Medicaid Services, we identified all patients that had at least one CLTI diagnosis code to determine prevalence and incidence rates. Sensitivity analyses were performed to compare our methodology to prior publications and quantify the extent of missed diagnoses. The number and type of vascular procedures that occurred after diagnosis were tabulated. A cohort of patients with two or more CLTI diagnosis codes were then identified for further descriptive analysis. Associations between patient demographics and survival were analyzed using Cox proportional hazards models. Over 65 million patients were enrolled in Medicare in 2017 to 2018. Of these, 480,227 had diagnosis of CLTI, with a corresponding to a 1-year incidence of 0.33% and a 2-year prevalence of 0.74%. Patients underwent an average of 43.6 vascular procedures per 100 person-years. Sensitivity analyses identified 89,805 additional patients that had a diagnosis code of peripheral arterial disease who underwent revascularization or amputation. Patients with CLTI were predominantly male (56.2%), white (76.4%), and qualified for Medicare due to age (64.0%). Thirty-seven percent were dual-eligible. One-year survival was 77.7%, significantly lower than estimated actuarial survival adjusted for age, sex, and race (95.1%; P <.001). Cox proportional hazards models demonstrate significantly increased mortality for men vs women (hazard ratio, 1.07; 95% confidence interval, 1.04-1.10; P <.001), but no association between race and overall survival (hazard ratio, 0.99; 95% confidence interval, 0.98-1.01; P =.83). Using ICD-10-CM diagnosis codes, we demonstrated slightly higher incidence and prevalence of CLTI than in published literature, reflecting our more complete methodology. Sensitivity analyses suggest that increased complexity of the highly specific ICD-10-CM coding may diminish capture of CLTI. Inclusion of patients with non-CLTI peripheral arterial disease diagnoses produces moderate increases in incidence and prevalence at the cost of decreased specificity in identifying patients with CLTI. Medicare patients with CLTI are older, and more commonly male, black, and dual eligible compared with the general Medicare population. Observed mid-term survival for patients with CLTI is significantly lower than actuarial estimates, confirming the importance of focused efforts on identifying and aligning goals of care in this complex patient population. [ABSTRACT FROM AUTHOR]

Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P <.001), primary patency (80.3% vs 76.9%; P <.001), and freedom from MALE (72.6% vs 67.9%; P <.001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P <.001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P <.001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P <.001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P =.07), but significant in the de-novo treated patients (73.9% vs 70.7%; P =.02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P =.02). FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome. [ABSTRACT FROM AUTHOR]

Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

In the present study, we evaluated the effects of inframalleolar (IM) disease on the occurrence of major adverse limb events (MALE) in patients undergoing endovascular revascularization for chronic limb-threatening ischemia (CLTI). Patients who had undergone endovascular revascularization for CLTI between January 2015 and December 2019 at two university-affiliated hospitals were reviewed retrospectively. Patients with severe IM disease (pedal score of 2) were compared with those with mild to moderate IM disease (score of 0 or 1) using the Global Vascular Guidelines. The primary outcome was MALE (open revascularization, acute leg ischemia, major amputation). The secondary outcomes were mortality, reintervention, major adverse cardiac events, and perioperative complications ≤30 days after endovascular revascularization, primary limb-based patency, and the occurrence of any limb event (defined as any amputation, acute leg ischemia, or open revascularization). Kaplan-Meier estimates were used to compare the primary outcome, and the Cox proportion hazard model was used to assess the effects of IM disease. The study included 167 limbs in 149 patients (36% female; mean age, 74 ± 12 years). Severe IM disease was identified in 71 limbs (43%). No differences were found in the baseline characteristics, except for a higher prevalence of dyslipidemia in the patients with severe IM disease (66% vs 43%; P =.003). Most patients in both groups had had a WIfI (Wound, Ischemia, foot Infection) score of 4 (severe IM disease, 64%; vs mild to moderate IM disease, 57%; P =.462) and GLASS (global limb anatomic severity scale) III anatomy (severe IM disease, 54%; vs mild to moderate IM disease, 48%; P =.752). The Kaplan-Meier estimates showed that severe IM disease was associated with lower freedom from MALE (69% vs 82%; P =.026). The Cox proportion hazard regression model showed that severe IM disease was an independent predictor of increased MALE and amputation risk (hazard ratio, 1.715; 95% confidence interval, 1.015-2.896; P =.044) after adjusting for covariates. During follow-up, patients with severe IM disease had had mortality (27% vs 31%; P =.567) and reintervention (42% vs 38%; P =.608) similar to those for patients with mild to moderate IM disease. Primary limb-based patency was also similar (79% vs 84%; P =.593) at a mean follow-up of 3.8 ± 0.8 years. Severe IM disease was prevalent in 43% of limbs that had undergone endovascular revascularization for CLTI and was associated with lower freedom from MALE. Severe IM disease also independently increased the hazard of adverse limb outcomes and amputations in patients with CLTI by >70%, highlighting its importance as a measure of foot perfusion. [ABSTRACT FROM AUTHOR]

Patients with chronic limb-threatening ischemia (CLTI), the end stage of peripheral artery disease, often present with comorbid depression and anxiety disorders. The prevalence of these comorbidities in the inpatient context over time, and their association with outcomes after revascularization and resource usage is unknown. Using the 2011 to 2017 National Inpatient Sample, two cohorts were created—CLTI hospitalizations with endovascular revascularization and CLTI hospitalizations with surgical revascularization. Within each cohort, the annual prevalence of depression and anxiety disorder diagnoses was determined, and temporal trends were evaluated using the Cochran-Mantel-Haenszel test. Hierarchical multivariable logistic and linear regression analyses were used to examine the association of depression and anxiety disorder diagnoses with inpatient major amputation, mortality, length of stay (LOS), and cost, adjusting for illness severity, comorbidities, and potential bias in the documentation of depression and anxiety disorder diagnoses stratified by patient sociodemographic data. Across the study period were a total of 245,507 CLTI-related hospitalizations with endovascular revascularization and 138,922 with surgical revascularization. Hospitalizations with a depression or anxiety disorder diagnosis increased from 10.8% in 2011 to 15.3% in 2017 in the endovascular revascularization cohort and from 11.7% in 2011 to 14.4% in 2017 in the surgical revascularization cohort (P trend <.001). In the endovascular revascularization cohort, depression was associated with higher odds of major amputation (odds ratio, 1.15; 95% confidence interval, 1.03-1.30). In addition, depression (9 vs 8 days [ P <.001]; $105,754 vs $102,481 [ P =.018]) and anxiety disorder (9 vs 8 days [ P <.001]; $109,496 vs $102,324 [ P <.001]) diagnoses were associated with a longer median LOS and higher median costs. In the surgical revascularization cohort, depression was associated with a higher odds of major amputation (odds ratio, 1.33; 95% confidence interval, 1.13-1.58) and a longer LOS (median, 9 vs 9 days; P =.004). Depression and anxiety disorder diagnoses have become increasingly prevalent among CLTI hospitalizations including revascularizations. When present, these psychiatric comorbidities are associated with an increased risk of amputation and greater resource usage. [ABSTRACT FROM AUTHOR]

We evaluated limb salvage (LS), amputation-free survival (AFS), and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and atherectomy for treatment of infrapopliteal disease (IPD) with chronic limb-threatening ischemia (CLTI). All index peripheral vascular interventions for IPD and CLTI were identified from the Vascular Quality Initiative registry. Of the multilevel procedures, the peripheral vascular intervention type was indexed to the infrapopliteal segment. Propensity score matching was used to control for baseline differences between groups. Kaplan-Meier and Cox regression were used to calculate and compare LS and AFS. The 3-year LS for stenting vs POBA was 87.6% vs 81.9% (P =.006) but was not significant on Cox regression analysis (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.56-0.76; P =.08). AFS was superior for stenting vs POBA (78.1% vs 69.5%; P =.001; HR, 0.73; 95% CI, 0.60-0.90; P =.003). LS was similar for POBA and atherectomy (81.9% vs 84.8%; P =.11) and for stenting and atherectomy (87.6% vs 84.8%; P =.23). The LS rate after propensity score matching for POBA vs stenting was 83.4% vs 88.2% (P =.07; HR, 0.71; 95% CI, 0.50-1.017; P =.062). The AFS rate for stenting vs POBA was 78.8% vs 69.4% (P =.005; HR, 0.69; 95% CI, 0.54-0.89; P =.005). No significant differences were found between stenting and atherectomy (P =.21 for atherectomy; and P =.34 for POBA). The need for TER did not differ across the groups but the interval to TER was significantly longer for stenting than for POBA or atherectomy (stenting vs POBA, 12.8 months vs 7.7 months; P =.001; stenting vs atherectomy, 13.5 months vs 6.8 months; P <.001). Stenting and atherectomy had comparable LS and AFS for patients with IPD and CLTI. However, stenting conferred significant benefits for AFS compared with POBA but atherectomy did not. Furthermore, the interval to TER was nearly double for stenting compared with POBA or atherectomy. These factors should be considered when determining the treatment strategy for this challenging anatomic segment. [ABSTRACT FROM AUTHOR]

The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass. Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency's Expanded Access Program. Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P =.059), coronary artery disease (71% vs 43%; P =.007), and prior coronary artery bypass grafting (38% vs 14%; P =.003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P =.018) and with previous index leg revascularizations (97% vs 53%; P <.001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P =.693) and Global Anatomic Staging System stage III (91% vs 96%; P =.346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P <.001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P <.001). At a median of 12 months, major amputation-free survival (73% vs 81%; P =.55) and overall survival (84% vs 88%; P =.20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P =.044), primary-assisted patency (45% vs 72%; P =.002), and secondary patency (64% vs 72%; P =.003) compared with group 2. Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months. [ABSTRACT FROM AUTHOR]

Length of stay (LOS) is a major driver of cost and resource utilization following lower extremity bypass (LEB). However, the variable comorbidity burden and mobility status of LEB patients makes implementing enhanced recovery after surgery pathways challenging. The aim of this study was to use a large national database to identify patient factors associated with ultrashort LOS among patients undergoing LEB for peripheral artery disease. All patients undergoing LEB for peripheral artery disease in the National Surgical Quality Improvement Project database from 2011 to 2018 were included. Patients were divided into two groups based on the postoperative length of stay : ultrashort (≤2 days) and standard (>2 days). Thirty-day outcomes were compared using descriptive statistics, and multivariable logistic regression was used to identify patient factors associated with ultrashort LOS. Overall, 17,510 patients were identified who underwent LEB, of which 2678 patients (15.3%) had an ultrashort postoperative LOS (mean, 1.8 days) and 14,832 (84.7%) patients had a standard LOS (mean, 7.1 days). When compared to patients with a standard LOS, patients with an ultrashort LOS were more likely to be admitted from home (95.9% vs 88.0%; P <.001), undergo elective surgery (86.1% vs 59.1%; P <.001), and be active smokers (52.1% vs 40.4%; P <.001). Patients with an ultrashort LOS were also more likely to have claudication as the indication for LEB (53.1% vs 22.5%; P <.001), have a popliteal revascularization target rather than a tibial/pedal target (76.7% vs 55.3%; P <.001), and have a prosthetic conduit (40.0% vs 29.9%; P <.001). There was no significant difference in mortality between the two groups (1.4% vs 1.8%; P =.21); however, patients with an ultrashort LOS had a lower frequency of unplanned readmission (10.7% vs 18.8%; P <.001) and need for major reintervention (1.9% vs 5.6%; P <.001). On multivariable analysis, elective status (odds ratio , 2.66; 95% confidence interval [CI], 2.33-3.04), active smoking (OR, 1.18; 95% CI, 1.07-1.30), and lack of vein harvest (OR, 1.55; 95% CI, 1.41-1.70) were associated with ultrashort LOS. Presence of rest pain (OR, 0.57; 95% CI, 0.51-0.63), tissue loss (OR, 0.30; 95% CI, 0.27-0.34), and totally dependent functional status (OR, 0.54; 95% CI, 0.35-0.84) were associated negatively with an ultrashort LOS. When examining the subgroup of patients who underwent vein harvest, totally dependent (OR, 0.38; 95% CI, 0.19-0.75) and partially dependent (OR, 0.53; 95% CI, 0.32-0.88) functional status were persistently negatively associated with ultrashort LOS. Ultrashort LOS (≤2 days) after LEB is uncommon but feasible in select patients. Preoperative functional status and mobility are important factors to consider when identifying LEB patients who may be candidates for early discharge. [ABSTRACT FROM AUTHOR]

Clinical guidelines recommend shared decision-making for treatment of peripheral artery disease (PAD), which requires understanding of patient perspectives and preferences. We conducted a focus group study of patients with symptomatic PAD to identify factors important and relevant to treatment choices, and to characterize aspects of the health care process that contribute to positive vs negative experiences apart from the specific treatment(s) received. Participants were recruited from an academic medical center over 2 years using a purposeful sampling approach based on a clinical diagnosis of symptomatic PAD (either claudication or chronic limb-threatening ischemia [CLTI]) confirmed by the abnormal ankle or toe brachial index. Focus groups were led by a nonphysician moderator, consisted of 5 to 12 participants, and were conducted separately for patients with CLTI and claudication. Audio recordings converted to verbatim transcripts were used for qualitative analysis. A total of 51 patients (26 with CLTI and 25 with claudication) were enrolled and participated in focus groups. Major themes identified related to treatment preferences and decisions included specific interventions under consideration, the chance of technical success versus failure, anticipated degree of symptom improvement, outcome durability, and risk. Major themes related to the process of care included decision-making input, provider communication and trust, the timeline from diagnosis to definitive treatment, and compartmentalized care (including different venues of care). The results provide insights into patient preferences, perspectives, and experiences related to PAD treatment. These observations can be used to inform patient-centered approaches to shared decision-making, communication, and assessment of PAD treatment outcomes. [ABSTRACT FROM AUTHOR]

Objective: Chronic limb-threatening ischemia (CLTI) due to isolated tibial occlusive disease is treated by either popliteal-distal bypass (PDB) or tibial angioplasty (TA), although there is limited data directly comparing efficacy and outcomes between these two treatment modalities. This study compares 30-day mortality and major adverse limb events following infrapopliteal bypass and TA in patients with CLTI., Methods: Patients who underwent PDB for CLTI were extracted from American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity open database, whereas patient with CLTI who underwent isolated TA were identified in the targeted lower extremity endovascular database. Any case with more proximal angioplasty such as femoral/popliteal/iliac was excluded. The time interval was 2011 through 2022. The two groups were comparable in demographics, and preoperative comorbidities were obtained using propensity matching. Mortality, systemic complications, and major adverse limb events were measured. Multivariable logistic regression was used for data analysis. To obtain granular data on the angiographic characteristics of patients undergoing PDB or TA, The George Washington University institutional data from 2014 to 2019 was used as a supplement to the database., Results: There were 1947 and 3423 cases identified in the bypass and endovascular groups, respectively. After propensity matching for all preoperative variables, 1747 cases remained in each group. Although bypass was associated with higher major adverse cardiovascular events, pulmonary, renal, and wound complications, bypass had significantly better 30-day limb salvage when compared with TA (major amputation rate, 3.32% vs 6.12%; P < .01). Institutional data identified 69 patients with CLTI due to isolated tibial occlusive disease; 25 (36.2%) underwent PDB and 44 (63.8%) underwent TA. Review of angiographic details revealed patients who underwent PDB had better pedal targets (inframalleolar/pedal score of P0 [24.0% vs 15.9%] or P1 [68.0% vs 61.3%]) than TA patients (inframalleolar/pedal score of P2 [22.7% vs 8.0%])., Conclusions: PDB was associated with higher morbidity but better limb salvage than endovascular interventions. However, this could be explained by the association with better pedal targets in patients who underwent popliteal-tibial bypass. Prospective studies should be done comparing PDB and TA in cases with similar pedal targets., Competing Interests: Disclosures None., (Published by Elsevier Inc.)

Objective: This study compares chronic limb-threatening ischemia disease characteristics and endovascular revascularization outcomes in a multi-ethnic Asian cohort vs their North American counterparts., Methods: The Society for Vascular Surgery Vascular Quality Initiative (VQI) registry database from the first and currently the only VQI center in Asia was reviewed to identify patients with chronic limb-threatening ischemia who underwent endovascular revascularization between July 2019 and April 2024. Standardized VQI reporting variables were compared against benchmarks derived from all participating centers in North America., Results: A total of 2862 endovascular revascularization procedures from our center were benchmarked against 129,347 procedures from 406 North American centers. Our cohort had a higher burden of comorbidities (diabetes mellitus, end-stage renal disease, cardiac disease) and presented with more advanced Wound, Ischemia, and foot Infection stages. Our patients had more heavily calcified and longer (14.8 cm vs 6.0 cm) diseased vessels with higher prevalence of multi-level (87% vs 54.6%), infrapopliteal (52.6% vs 38.9%), and inframalleolar (9.6% vs 2.4%) disease. Rates of technical success (92.7% vs 93%) and symptom improvement (39.1% vs 40.4%) were comparable between cohorts. However, 1-year mortality rates (28.9% vs 25.1%) and major amputation rates (13.3% vs 7.8%) were significantly higher., Conclusions: Short-term outcomes of technical success and symptom relief in our center were comparable to benchmarked North American outcomes despite having a cohort with more diseased vessels, higher Wound, Ischemia, and foot Infection stages, and more comorbidities. However, this cohort fared worse in longer term outcomes of 1-year mortality and major amputation rates. Further studies are required to elucidate the causes to improve these outcomes., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Inframalleolar disease is present in most diabetic patients presenting with tissue loss. Inframalleolar (pedal) artery disease and pedal medial arterial calcification (pMAC) are associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). This study aimed to examine the impact of pMAC on the outcomes after isolated inframalleolar (pedal artery) interventions. A database of lower extremity endovascular intervention for patients with tissue loss between 2007 and 2022 was retrospectively queried. Patients with CLTI were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries and who had foot x-rays were identified. X-rays were assessed blindly for pMAC and scored on a scale of 0 to 5. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention to treat analysis by the patient was performed. Amputation-free survival (survival without major amputation) was evaluated. A total of 223 patients (51% female; 87% Hispanic; average age, 66 years; 323 vessels) underwent isolated infra-malleolar intervention for tissue loss. All patients had diabetes, 96% had hypertension, 79% had hyperlipidemia, and 63% had chronic renal insufficiency (55% of these were on hemodialysis). Most of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease and had various stages of pMAC: severe (score = 5) in 48%, moderate (score = 2-4) in 31%, and mild (score = 0-1) in 21% of the patients. Technical success was 94%, with a median of one vessel treated per patient. All failures were in severe pMAC. Overall, major adverse cardiovascular events was 0.9% at 90 days after the procedure. Following the intervention, most patients underwent a planned forefoot amputation (single digit, multiple digits, ray amputation, or trans-metatarsal amputation). WIfI ischemic grade was improved by 51%. Wound healing at 3 months was 69%. Those not healing underwent below-knee amputations. The overall 5-year amputation-free survival rate was 35% ± 9%. The severity of pMAC was associated with decreased AFS. Increasing severity of pMAC influences the technical and long-term outcomes of infra-malleolar intervention in diabetes. Severe pMAC is associated with amputation and should be considered as a variable in the shared decision-making of diabetic patients with CLTI. [ABSTRACT FROM AUTHOR]

Vascular complications (VCs) associated with extracorporeal membrane oxygenation (ECMO) during index hospitalization are prevalent and associated with increased mortality. Few studies have evaluated late VCs following ECMO; this study aims to assess occurrence and management practices of late VCs following discharge. A retrospective single-institution review was performed of all patients surviving initial hospitalization after being cannulated for central or peripheral veno-venous (VV) or veno-arterial (VA) ECMO between January 1, 2019, and December 31, 2020. Primary outcomes were to categorize and determine the rate of late VCs. Late VCs were defined as any cannulated vessel injury resulting from ECMO cannulation presenting after discharge from index hospitalization. Analysis was conducted by cannulated vessel and stratified by VV or VA ECMO configurations. A total of 229 patients were identified, of which 50.6% (n = 116) survived until discharge. Late VCs occurred in 7.8% of the surviving cohort (n = 9/116); with a median time until presentation of 150 days (interquartile range, 83-251 days). The most common late VC was infection (n = 5; 55.6%) followed by progression to limb-threatening ischemia (n = 4; 44.4%). Urgent procedures were required in 55.6% of patients (n = 5), whereas 44.4% (n = 4) were elective interventions. Interventions performed for management of late VCs included lower extremity arterial revascularization (n = 6; 66.7%), major (n = 1; 11.1%) or minor amputation (n = 1; 11.1%), and wound debridement (n = 1; 11.1%). The majority of patients presenting with late VCs had initially been cannulated for peripheral VA ECMO (n = 8; 88.9%), and one patient (11.1%) was cannulated for peripheral VV ECMO. VCs during index hospitalization were seen in 77.8% of patients (n = 7) returning with late VCs. Odds for late VCs were significantly increased in patients that had been cannulated for ECMO as part of extracorporeal cardiopulmonary resuscitation (odds ratio, 8.4; P =.016) and in cases where patients had experienced an index VC during index hospitalization (odds ratio, 19.3; P =.001). Late vascular complications after peripheral ECMO cannulation are not rare, particularly after arterial cannulation. Patients should be followed closely early after surviving ECMO with wound evaluation and formal assessment of perfusion with ankle-branchial indices in the cannulated limb. [ABSTRACT FROM AUTHOR]

Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P =.78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P =.04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P <.001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P =.67). CKD status did not modify these results. Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery. [ABSTRACT FROM AUTHOR]

Several reports have shown that ethnic and racial minority patients with chronic limb-threatening ischemia (CLTI) are more likely to undergo major amputation. Whether this disparity is driven by limited access to care, statistical discrimination, or biologic factors has remained a matter of debate. We studied the effects of race and ethnicity on the short- and long-term outcomes of limb-salvage procedures among patients with new-onset CLTI. We identified all patients who had undergone first time (open or endovascular) revascularization for CLTI between January 2010 and December 2016 in the Vascular Quality Initiative–Medicare-linked database. These patients were divided into two groups: non-Hispanic White (NHW) and racial and ethnic minority (REM). The early end points included length of stay and operative mortality. The 2-year outcomes included major amputation, freedom from subsequent revascularization, number of limb salvage reinterventions, and all-cause mortality. Subanalyses comparing NHW and Hispanic patients and NHW and Black patients were also performed. Of 16,249 patients presenting with CLTI, 73.9% were NHW. The REM patients were younger (mean age, 69.9 ± 11.3 years vs 74.2 ± 10.5 years; P <.001) and more likely to be women (45.9% vs 37.7%; P <.001). Other baseline differences included a higher rate of smoking history, coronary artery disease, chronic obstructive pulmonary disease, and chronic kidney disease for the NHW group. In contrast, the REM patients were more likely to have diabetes and hypertension and were more likely to present with tissue loss (78% vs 76.6%; P =.04). The preoperative ankle brachial index and procedure type (endovascular vs open) were similar between the two groups. On multivariable analysis, the NHW group had had a 13% increase in the length of stay and a 25% decrease in operative mortality. Of the 2-year outcomes, the limb salvage estimate was 86% for the NHW group and 77.1% for the REM group (P <.001). A comparison between the two groups showed similar rates of freedom from subsequent revascularization (67.9% vs 67.1%; P =.2). The REM patients had had higher rates of overall survival (70.3% vs 68.4%; P =.01) compared with their NHW counterparts. The patients in the REM group were also more likely to have undergone more than two limb salvage reinterventions during follow-up (14.2% vs 8.6%; P <.001). After adjusting for potential confounders, the REM patients had significantly greater odds of major amputation at 2 years (adjusted hazard ratio, 1.49; 95% confidence interval, 1.36-1.63; P <.001). The results from the present Vascular Quality Initiative–Medicare-matched study have shown that REM patients continue to face a higher major amputation risk despite equivalent attempts at limb salvage. Further studies to identify the risk factors and evaluate intervention strategies that might be more effective in preventing amputation in this particular population are warranted. [ABSTRACT FROM AUTHOR]

Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P <.001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P <.001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P <.001, Kruskal-Wallis). Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis. [ABSTRACT FROM AUTHOR]

Objective: Several observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial., Methods: Baseline characteristics were compared between patients with and without DM in the BEST-CLI trial. Cox regression was used to determine the association between DM and major outcomes of major adverse limb events (MALE), reintervention, above-ankle amputation, and all-cause death., Results: Among 1777 patients who underwent LER, 69.2% had DM. Compared with patients without DM, those with DM were significantly younger, less likely to be White, and more likely to be Hispanic. Patients with DM were more likely to have hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, and renal disease and be on optimal medical therapy (antiplatelets and statins), whereas patients without DM were significantly more likely to be smokers and have chronic obstructive pulmonary disease. Patients with DM were significantly more likely to present with late Wound Ischemia foot Infection (WIfI) stages (3-4) (73.7% vs 45.9%; P < .001) that were driven predominantly by differences in wound and infection grade. Conversely, patients without DM had significantly lower ankle pressures and toe pressures and were significantly more likely to have WIfI ischemia grade 3 compared with patients with DM (60% vs 52.5%; P = .016). At 3 years, patients with DM exhibited higher rates of above-ankle amputation and all-cause death compared with patients without DM. Kaplan-Meier analysis demonstrated significantly higher MALE or all-cause death compared with patients without DM (3-year estimate: 53.5% vs 46.4%; P < .001). After adjusting for potential confounders, regression analysis demonstrated that DM was independently associated with increased above-ankle amputation (1.75 [1.22-2.51]), all-cause death (1.63 [1.31-2.03]), and MALE or all-cause death (1.24 [1.04-1.47])., Conclusions: Patients with DM undergoing LER for chronic limb-threatening ischemia experienced a greater incidence of MALE or all-cause death compared with patients without DM. The impact of DM seems to be mediated by more severe wounds and infections at the time of presentation, and a higher prevalence of cardiac and renal disease., Competing Interests: Disclosures J.S. reports education grants provided by Becton, Dickinson and Company and W. L. Gore & Associates; funds were paid to Boston University. A.F. reports consultant to LeMaitre, Sanifit, and BiogenCell, and is on the advisory board of iThera and DilaysisX. C.I.O.C. reports consultant for Envveno. Patent: U.S.S.N. 10,524,891 B1 “Inferior vena cava filter retrieval device and method of retrieving same.”, (Copyright © 2024. Published by Elsevier Inc.)

Background: In the Heart Outcomes Prevention Evaluation study, investigators found that ramipril was associated with improved survival as well as decreased MI and stroke rates in patients with peripheral arterial disease. Nonetheless, their effect on chronic limb-threatening ischemia (CLTI)-specific outcomes is unclear. We aim to assess the effect of ACEIs/ARBs on amputation-free survival in patients with CLTI undergoing peripheral vascular intervention (PVI) in a Medicare-linked database., Methods: Patients undergoing PVI in the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database were included. Primary outcomes included amputation-free survival. Kaplan-Meier survival and multivariable Cox regression analyses were used to assess 1-year outcomes., Results: A total of 34,284 patients were included, 46.3% of whom were discharged on ACEIs/ARBs. Patients discharged on ACEIs/ARBs were more likely to be smokers, have diabetes, and have hypertension. They were also more likely to present with rest pain. The overall 1-year survival rate for patients on ACEIs/ARBs vs those who are not was (79.1% vs 69.4%; P < .001). Freedom from amputation was 87.8% for patients on ACEIs/ARBs vs 84.2% for those who were not (P < .001). Amputation-free survival was 70.5% vs 59.5% for ACEIs/ARBs vs no ACEIs/ARBs (P < .001). After adjusting for potential confounders, ACEIs/ARBs use was associated with lower 1-year mortality (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.7-0.8; P < .001), amputation (HR, 0.89; 95% CI, 0.8-0.9; P < .001), and amputation or death (HR, 0.79; 95% CI, 0.76-0.8; P < .001)., Conclusions: ACEIs/ARBs were associated independently with lower amputation, improved survival, and amputation-free rates survival at 1 year in patients with CLTI undergoing PVI. The fact that more than one-half the patients were not discharged on these medications presents an area for potential quality improvement., Competing Interests: Disclosures None., (Published by Elsevier Inc.)

Objective: Poor glycemic control in the perioperative period has been reported to be associated with early and late major adverse limb events (MALEs). However, these studies were mostly from large databases or lacked long-term outcomes. We examined the long-term effects of high hemoglobin A1c (HbA1c) level on patency, MALE, limb salvage (LS) and survival after lower extremity revascularization procedures in patients with diabetes., Methods: Patients with diabetes who underwent revascularization for Rutherford class 3 to 6 ischemia between May 2002 and December 2018 were identified. Patients with an HbA1c of ≤7% were compared with those with an HbA1c of >7% for patency, MALE, survival, LS, and amputation-free survival., Results: Of 706 patients, 699 had HbA1c data (775 limbs), with 311 (357 limbs) in the HbA1c ≤7% and 388 (418 limbs) in the HbA1c >7% groups. Patients with an HbA1c of >7% were younger (69.9 ± 10.2 years vs 71.7 ± 9.5 years; P = .011), had higher lipid levels, insulin use (70% vs 49%; P < .01), American Society of Anesthesiologists classification of 4, and had a lower prevalence of chronic kidney disease (32% v s41%; P = .023). Patients with an HbA1c of >7% were more likely to present with chronic limb-threatening ischemia (CLTI) (79% vs 72%; P = .019) and undergo infrapopliteal interventions (49% vs 42%; P = .005), with no difference in anatomical complexity (TransAtlantic Inter Society Consensus class C/D, 75% vs 77%; P = .72) or type of revascularization (24% vs 18% open, 66% vs 70% endovascular, 10% vs 12% hybrid; P = .236). Patency and freedom from MALE were significantly lower in patients with an HbA1c of >7% for infrainguinal revascularizations, whereas amputation-free survival and overall survival were similar. In patients with chronic limb-threatening ischemia, LS rates at 5 years were significantly lower in patients undergoing open revascularization (HbA1c > 7%: 64% ± 6% vs HbA1c < 7%:86% ± 5%; P = .020), whereas it was similar after endovascular interventions (HbA1c > 7%:79% ± 4% vs HbA1c < 7%:77% ± 3%; P = .631). Seventy patients with an HbA1c of >7% lost limbs vs 38 patients with an HbA1c of ≤7% (P = .007). In multivariate analysis, HbA1c was associated significantly with primary patency. HbA1c, insulin use, level of intervention, and angiotensin-converting enzyme inhibitor use were associated with MALE., Conclusions: A perioperative HbA1c of >7% is associated with poorer patency rates and increased MALE, especially at the infrainguinal level revascularization in patients with diabetes, with no significant impact on survival. LS is impacted after open, but not after endovascular revascularization., Competing Interests: Disclosures None., (Copyright © 2024. Published by Elsevier Inc.)

Since the turn of the millennium, there has been a worldwide trend towards an endovascular-first strategy where possible revascularization strategy for chronic limb-threatening ischemia. There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoropopliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMSs), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA ± BMS in the United Kingdom National Institute of Health Research Health Technology Assessment-funded Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-1 [B1]) trial (treated 1999-2004). Baseline and clinical outcome data (amputation-free survival [AFS], overall survival [OS], limb salvage, freedom from reintervention, and freedom from major adverse limb events) were obtained from prospectively gathered hospital data and B1 trial case record forms. There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years; P =.0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2; P <.0001) before they reached their primary endpoint (AFS). Immediate technical success was nonsignificantly higher in the CS patients (87% vs 83%; P =.2). BMS were used in 20 CS (8%) and 2 B1 (1%) patients (P =.0002). AFS (hazard ratio, 0.64; 95% confidence interval, 0.49-0.82; P =.0005) and OS (hazard ratio, 0.58; 95% confidence interval, 0.44-0.76; P =.0001) were significantly worse in the CS cohort. There was no significant difference in limb salvage, freedom from reintervention, or freedom from major adverse limb events. Patients with chronic limb-threatening ischemia managed in our unit (2009-2014) by means of a FP-PBA ± BMS first (where possible) revascularization strategy experienced significantly worse AFS and OS than patients treated with FP-PBA ± BMS in the B1 trial 10 years earlier (1999-2004). [ABSTRACT FROM AUTHOR]

We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System. Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months. Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. The wound healing status of fully healed or healing was 67% at 6 months, and 75% at 12 months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first 3 months. The majority of reinterventions (n = 12; 75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention. The LimFlow pDVA System was utilized in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System that supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population. [ABSTRACT FROM AUTHOR]

We sought to determine the benefit of performing multiple tibial artery revascularization compared with single vessel revascularization for patients with chronic limb-threatening ischemia (CLTI). We performed a single-center, retrospective cohort study of all patients with CLTI treated with below-the-knee endovascular intervention from 2012 to 2019. Group 1 included patients who had undergone single tibial artery revascularization. Group 2 included patients who had undergone multiple (two or more) tibial artery revascularization. More proximal disease, if present, was treated, in addition to the tibial disease. The primary endpoint was freedom from amputation. The secondary endpoints included the reintervention rates and all-cause mortality. A total of 527 limbs in 470 patients with CLTI (nonhealing ulcers, 62%; gangrene, 33%; and ischemic rest pain, 5%) were included in the present study. Of the 527 limbs, 245 (46%) had undergone single vessel revascularization and 282 (54%) had undergone multiple vessel revascularization. The mean follow-up was 19 ± 18 months. No difference was found in freedom from amputation between the two groups (68% vs 63%; P =.109). On multivariable analysis, the factors associated with amputation included dialysis (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.16-2.45), dyslipidemia (OR, 1.37; 95% CI, 0.96-1.94), and gangrene (OR, 2.08; 95% CI, 1.50-2.98). No differences were found in the reintervention rates between the two groups (21.2% vs 16.7%; P =.13). The overall survival rate was 73% in both study groups. The results from the present large, single-center study have demonstrated that multiple below-the-knee vessel revascularization is not associated with improved limb salvage compared with single vessel revascularization. [ABSTRACT FROM AUTHOR]

Major adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized trial. The BEST-CLI trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting. This is a single-center retrospective study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis). Among 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P =.008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot. In this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass. [ABSTRACT FROM AUTHOR]

Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints. In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models. In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P <.001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P <.001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P <.001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P =.007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P =.04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P <.001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P <.001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P <.001 and MR, 0.66; 95% CI, 0.55-0.79; P <.001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial. Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions. [ABSTRACT FROM AUTHOR]

Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P =.04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P =.02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P <.01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P =.12). In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS. [ABSTRACT FROM AUTHOR]

The role of direct oral anticoagulants (DOACs) in chronic limb-threatening ischemia after revascularization is unknown. Current evidence-based guidelines do not provide clear guidance on the role of anticoagulation or the selection of anticoagulant. Current practice is highly varied and based on provider and patient preference. The purpose of this study was to measure the impact of different anticoagulants on the incidence of major adverse limb events (MALEs) after revascularization for chronic limb-threatening ischemia, major adverse cardiovascular events (MACEs), all-cause mortality, and hospitalization for major bleeding events. This was a single-center, observational, retrospective cohort study. Subjects were eligible if they were 18 years or older; underwent endovascular or open revascularization for chronic limb-threatening ischemia, rest pain, or tissue loss; and were subsequently prescribed apixaban, rivaroxaban, or warfarin. The primary end point was the incidence of MALEs, including above-ankle amputation or major index-limb reintervention, within 1 year of index event. Secondary end points included the rate of all-cause mortality, MACEs, and incidence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding. From January 1, 2017, to September 20, 2022, 141 patients met the inclusion and exclusion criteria and were reviewed. The median age was 67 years, with 92 patients prescribed apixaban or rivaroxaban and 49 patients prescribed warfarin. Of these, 42 patients were prescribed triple antithrombotic therapy, 88 dual antithrombotic therapy, and 13 anticoagulant monotherapy. The primary outcome of 1-year MALEs occurred in 36.7% of the warfarin group and 33.7% of the DOAC group (relative risk [RR], 1.09; 95% CI, 0.53-2.25; P =.72). Secondary outcomes of 1-year MACEs (10.2% vs 4.3%; RR, 2.35; 95% CI, 0.60-9.18; P =.18) and 1-year all-cause mortality (26.5% vs 16.3%; RR, 1.63; 95% CI, 0.70-3.78; P =.15) did not differ between the groups. The secondary safety outcome of 1-year ISTH major bleeding occurred in 16.3% of the warfarin group and 4.3% of the DOAC group (RR, 3.76; 95% CI, 1.07-13.19; P =.015). In patients with chronic limb-threatening ischemia who were revascularized and prescribed anticoagulation with apixaban, rivaroxaban, or warfarin on discharge, no difference in MALEs, MACEs, or all-cause mortality was found. However, 1-year admissions for ISTH major bleeding were significantly higher among patients prescribed warfarin. A randomized trial may confirm these findings. [ABSTRACT FROM AUTHOR]

Analysis of regional data from the Vascular Quality Initiative (VQI) suggested improved survival for patients undergoing stent placement compared with balloon angioplasty and atherectomy. Using national data from the VQI linked to Medicare claims data through the Vascular Implant Surveillance and Interventional Outcomes Network program, this study aimed to compare the rates of mortality, reintervention, and amputation after endovascular interventions (atherectomy, stenting, and balloon angioplasty) for two separate cohorts: patients with chronic limb-threatening ischemia (CLTI) and patients with claudication. This was a secondary data analysis of Society for Vascular Surgery National VQI data linked to Medicare claims, between October 2016 and December 2019. Patients aged ≥65 years with symptoms of claudication or CLTI and a diagnosis of occlusive disease were included. Urgent or emergent interventions or those with concurrent procedures (endarterectomy, bypass, or bilateral intervention) were excluded. Interventions were grouped into (1) balloon angioplasty only; (2) stent (with or without balloon angioplasty); or (3) atherectomy (alone, with or without stent, with or without balloon angioplasty). Propensity score-matched cohorts were constructed to conduct pairwise intervention comparisons of mortality, reintervention, and amputation rates. Multivariable logistic regression was used to derive propensity scores for each patient. Kaplan-Meier estimates and Cox proportional hazards ratios (HRs) (95% confidence interval [CI]) analyses were performed. A total of 9785 (2665 claudication, 7120 CLTI) eligible patients were identified. After propensity score matching for the CLTI group, 2826, 3608, and 2796 pairs of cases were used to compare balloon angioplasty vs atherectomy, balloon angioplasty vs stent, and stent vs atherectomy, respectively. No statistically significant difference in mortality was observed among all interventions. However, atherectomy was associated with a significant increase in reintervention rate compared with balloon angioplasty (HR, 1.22; 95% CI, 1.06-1.39; P =.01) and compared with stenting (HR, 1.27; 95% CI, 1.10-1.46; P <.01) within the first year after the index procedure. Of note, both atherectomy (HR, 0.82; 95% CI, 0.68-0.98; P <.05) and stenting (HR, 0.76; 95% CI, 0.64-0.90; P <.01) showed lower rates of major amputation when compared with balloon angioplasty within 1 year after the index procedure. In the claudication group, there were no significant differences observed among interventions for peripheral arterial disease for mortality, reintervention, or amputation rates. Further studies are needed to identify appropriate indications for atherectomy, because there may be a subset of patients with CLTI who benefit from this therapy with respect to amputation rates. Until then, caution should be exercised when using atherectomy because it is also associated with higher reintervention rates. [ABSTRACT FROM AUTHOR]

Intravascular ultrasound (IVUS) is an important adjunctive tool for patients with lower extremity peripheral arterial disease (PAD) undergoing endovascular therapy (EVT). The evidence regarding the advantages of IVUS use is evolving, and recent studies have reported conflicting results. We aimed to perform a meta-analysis to evaluate the efficacy of IVUS during angiography-guided EVT for patients with PAD. MEDLINE and EMBASE were searched through April 2023 to identify studies that investigated the outcomes of IVUS with angiography-guided EVT vs angiography-alone-guided EVT. The primary outcome was restenosis/occlusion rate; secondary outcomes were target lesion revascularization, major amputation, and mortality. One randomized controlled trial and 14 observational studies, largely of moderate quality, were included, yielding a total of 708,808 patients with 709,189 lesions that were treated with IVUS-guided EVT (n = 101,405) vs angiography-alone (n = 607,784). Compared with angiography alone, IVUS-guided EVT was associated with a non-significant trend towards decreased restenosis/occlusion (relative risk [RR], 0.74; 95% confidence interval [CI], 0.54-1.00; I2 = 60%). Although the risk of target lesion revascularization and mortality were comparable (RR, 0.85; 95% CI, 0.65-1.10; I2 = 70%; RR, 1.01; 95% CI, 0.79-1.28; I2 = 43%, respectively), the use of IVUS was also associated with significantly lower risk of major amputation (RR, 0.74; 95% CI, 0.67-0.82; I2 = 47%). Subgroup analysis focusing on femoropopliteal disease demonstrated significantly higher patency (RR, 0.72; 95% CI, 0.52-0.98; I2 = 73%). However, superiority with major amputation was not observed. IVUS-guided EVT for PAD may possibly be associated with a lower major amputation rate compared with angiography alone-guided EVT, although the difference in patency remained an insignificant trend in favor of IVUS-guided EVT. Adjunctive use of IVUS during EVT may be beneficial, and further prospective studies are warranted to delineate this relationship and the applicability of this technology in routine practice. [ABSTRACT FROM AUTHOR]

Objectives: There has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb-threatening ischemia (CLTI). We aimed to assess treatment preferences of Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) investigators prior to and following the trial., Methods: An electronic 60-question survey was sent to 1180 BEST-CLI investigators in 2022, after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon (VS) surgical and ENDO preferences were compared with a 2010 survey administered to prospective investigators before trial funding., Results: For the 2022 survey, the response rate was 20.2% and was comprised of VSs (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for >20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between ENDO and OPEN procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and ENDO interventions (86%). A minority reported always or usually using the wound, ischemia, and foot infection (WIfI) criteria (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than one-half (52.9%) agreed that the statement "no bridges are burned with an ENDO-first approach" was false. Intervention choice was influenced by availability of the operating room or ENDO suite, personal schedule, and personal skill set in 30.1%, 18.0%, and 45.9% of respondents, respectively. Most respondents reported routinely using paclitaxel-coated balloons (88.1%) and stents (67.5%); however, 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing >10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing >10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI teams improved care; however, only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by VSs to the 2010 survey, there were no changes in preferred treatment based on Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification or conduit preference. In 2022, OPEN surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except a decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs 30.8%) (P < .05)., Conclusions: There is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced OPEN and ENDO techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial, there was overall similar equipoise among VSs., Competing Interests: Disclosures A.F. has received a grant from the Novo Nordisk Foundation; is a consultant for Sanifit, LeMaitre, and BioGenCell; and is on the advisory board of Dialysis-X and iThera Medical. M.M. is an advisor for Janssen. K.G. is an advisory board member for Boston Scientific. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular; Althea Medical; Angiodynamics; Auxetics; Becton-Dickinson; Boston Scientific; Contego; Crossliner; Innova Vascular; Inspire MD; Janssen/Johnson and Johnson; Magneto; Mayo Clinic; MedAlliance; Medtronic; Neptune Medical; Penumbra; Philips; Surmodics; Terumo; Thrombolex; Truvic; Vasorum; Vumedi. KR owns equity or stock options in the following entities: Access Vascular; Aerami; Althea Medical; Auxetics; Contego; Crossliner; Cruzar Systems; Endospan; Imperative Care/Truvic; Innova Vascular; InspireMD; JanaCare; Magneto; MedAlliance; Neptune Medical; Orchestra; Prosomnus; Shockwave; Skydance; Summa Therapeutics; Thrombolex; Vasorum; Vumedi. K.R. or his institution (on my behalf) receive research grants from the following entities: NIH; Abiomed; Boston Scientific; Novo Nordisk Foundation; Penumbra; Gettinge-Atrium. K.R. serves as a member of the Board of Directors of the following organization: The National PERT ConsortiumTM., (Copyright © 2024. Published by Elsevier Inc.)

The optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study, we investigated outcomes after open and endovascular revascularization in the femoropopliteal segment for CLTI. Between March 2011 and January 2015, there were 190 patients presenting with CLTI with the principal target lesion in the superficial femoral or popliteal segment who underwent endovascular intervention (n = 117) or bypass surgery (n = 73) and were observed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were observed for 2 years. The primary end point was amputation-free survival (AFS) assessed with Kaplan-Meier estimates; secondary end points included CLTI symptom alleviation rates and reintervention rates. A Cox proportional hazards regression model was used to investigate risk factors for amputation and death. AFS at 2 years was 59% in the endovascular group and 76% in the bypass group (P =.020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis, the observed difference in AFS between the groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (hazard ratio, 2.38; 95% confidence interval, 1.14-4.96). At 2 years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% vs 45%; P =.009). The proportions of patients who underwent reintervention within 2 years were similar in the two groups (38% vs 39%; P =.90), but repeated reinterventions were more frequent in the bypass group. At 2 years, bypass surgery was associated with higher AFS than endovascular intervention, a finding that could not be explained only by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both 1 year and 2 years after revascularization. Reinterventions to maintain patency were equally common after bypass and endovascular intervention. [ABSTRACT FROM AUTHOR]

The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System has been developed to stratify amputation risk on the basis of extent of the wound, level of ischemia, and severity of foot infection (WIfI). However, there are no currently validated metrics to assess, grade, and consider functional status, especially ambulatory status, as a major consideration during limb salvage efforts. Therefore, we propose an adjunct to the current WIfI system to include the patient's ambulatory functional status after initial assessment of limb threat. We propose a functional ambulatory score divided into grade 0, ambulation outside the home with or without an assistive device; grade 1, ambulation within the home with or without an assistive device; grade 2, minimal ambulation, limbs used for transfers; and grade 3, a person who is bed-bound. Adding ambulatory function as a supplementary assessment tool can guide clinical decision making to achieve optimal future functional ambulatory outcome, a patient-centered goal as critical as limb preservation. This adjunct may aid limb preservation teams in rapid, effective communication and clinical decision making after initial WIfI assessment. It may also improve efforts toward patient-centered care and functional ambulatory outcome as a primary objective. We suggest a score of functional ambulatory status should be included in future trials of patients with chronic limb-threatening ischemia. [ABSTRACT FROM AUTHOR]

Objective: There is no established consensus or guidelines for wound management after revascularization for patients with chronic limb-threatening ischemia (CLTI) without severe infection. This study is designed to evaluate the clinical effect of the wound management strategy on toe wounds after revascularization for CLTI., Methods: This retrospective cohort study was performed at eight institutions affiliated with Keio University School of Medicine in Japan and included 261 patients who underwent revascularization for CLTI between April 2019 and July 2021. We identified 132 patients with toe wounds from the database who had restored in-line blood flow to the foot. Patients were divided into two groups by the timing of toe resection after revascularization, which dictated the wound management policy. Group A (62 patients) underwent early toe amputation for suspected osteomyelitis, whereas group B (70 patients) underwent watchful waiting. The primary outcome was wound healing after revascularization; the secondary outcome was major amputation. We compared outcomes between groups A and B after propensity score matching., Results: Using propensity score matching, each patient in group A (33 patients) was matched with a patient in group B (33 patients). Wound healing in matched group A was significantly better than that in matched group B (respectively: 1-year wound healing rate: 90.0% vs 68.2%, P < .001; median wound healing time: 65 days vs 258 days, P < .01). Although five major amputations were necessary in matched group B, none were required in matched group A (P = .05). The high rate of major amputations in group B was attributed to the sudden exacerbation of infection. Limb salvage rate in matched group A exceeded matched group B (100.0% vs 90.5%: 1-year limb salvage rate, P = .02)., Conclusions: Early toe amputation for highly suspected osteomyelitis in patients with CLTI with toe wounds may expedite wound healing compared with watchful waiting, potentially avoiding unnecessary major amputation. Considering the wound management strategy is crucial when evaluating wound healing outcomes in patients with CLTI with revascularization., Competing Interests: Disclosures N.F. has served as a consultant for Japan Lifeline and Cook Medical. S.O. served as a consultant for Medico’s Hirata. H.O. received educational grant from Cardinal Health, Japan Blood Products Organization, JMS, Taiho Pharmaceutical, Teijin Pharma Limited, MSD, Kaken Pharmaceutical, Sanofi, Dainippon Sumitomo Pharma, Mitsubishi Tanabe Pharma Corporation, Nihon Pharmaceutical, Japan Lifeline, Limfix, Medtronic Japan, Otsuka Pharmaceutical Factory, Daiichi Sankyo Company, Johnson & Johnson, Otsuka Pharmaceutical, Kowa, and W. L. Gore & Associates. Y.K. received lecture fees from Chugai Pharmaceutical, Taiho Pharmaceutical, Asahi Kasei Pharma Corporation, Otsuka Pharmaceutical Factory, Ono Pharmaceutical, Shionogi, AstraZeneca, Ethicon, Bristol-Myers Squibb, Olympus Corporation, Cardinal Health, MSD, Smith & Nephew, Kaken Pharmaceutical, Aska Pharmaceutical, Miyarisan Pharmaceutical, Toray Industries, Daiichi Sankyo Company, Chugai Foundation for Innovative Drug Discovery Science, Nippon Kayaku, EA Pharma, Intuitive Surgical, Takeda Pharmaceutical Company Limited, Sysmex Corporation, and Tsumura; and received educational grant from Chugai Pharmaceutical, Taiho Pharmaceutical, Yakult Honsha, Asahi Kasei Pharma, Otsuka Pharmaceutical, Ono Pharmaceutical, Tsumura, Kaken Pharmaceutical, Dainippon Sumitomo Pharma, EA Pharma, Eisai, Otsuka Pharmaceutical Factory, Kyowa Kirin, Takeda Pharmaceutical, Teijin Pharma, Nippon Covidien, Cardinal Health, and Kowa. All other authors declare that they have no relevant conflicts of interest., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Suprainguinal bypass for peripheral artery disease (PAD) carries important surgical risks; however, outcome prediction tools remain limited. We developed machine learning (ML) algorithms that predict outcomes following suprainguinal bypass., Methods: The Vascular Quality Initiative database was used to identify patients who underwent suprainguinal bypass for PAD between 2003 and 2023. We identified 100 potential predictor variables from the index hospitalization (68 preoperative [demographic/clinical], 13 intraoperative [procedural], and 19 postoperative [in-hospital course/complications]). The primary outcomes were major adverse limb events (MALE; composite of untreated loss of patency, thrombectomy/thrombolysis, surgical revision, or major amputation) or death at 1 year following suprainguinal bypass. Our data were split into training (70%) and test (30%) sets. Using 10-fold cross-validation, we trained six ML models using preoperative features (Extreme Gradient Boosting [XGBoost], random forest, Naïve Bayes classifier, support vector machine, artificial neural network, and logistic regression). The primary model evaluation metric was area under the receiver operating characteristic curve (AUROC). The best performing algorithm was further trained using intra- and postoperative data. Model robustness was evaluated using calibration plots and Brier scores. Performance was assessed on subgroups based on age, sex, race, ethnicity, rurality, median Area Deprivation Index, symptom status, procedure type, prior intervention for PAD, concurrent interventions, and urgency., Results: Overall, 16,832 patients underwent suprainguinal bypass, and 3136 (18.6%) developed 1-year MALE or death. Patients with 1-year MALE or death were older (mean age, 64.9 vs 63.5 years; P < .001) with more comorbidities, had poorer functional status (65.7% vs 80.9% independent at baseline; P < .001), and were more likely to have chronic limb-threatening ischemia (67.4% vs 47.6%; P < .001) than those without an outcome. Despite being at higher cardiovascular risk, they were less likely to receive acetylsalicylic acid or statins preoperatively and at discharge. Our best performing prediction model at the preoperative stage was XGBoost, achieving an AUROC of 0.92 (95% confidence interval [CI], 0.91-0.93). In comparison, logistic regression had an AUROC of 0.67 (95% CI, 0.65-0.69). Our XGBoost model maintained excellent performance at the intra- and postoperative stages, with AUROCs of 0.93 (95% CI, 0.92-0.94) and 0.98 (95% CI, 0.97-0.99), respectively. Calibration plots showed good agreement between predicted and observed event probabilities with Brier scores of 0.12 (preoperative), 0.11 (intraoperative), and 0.10 (postoperative). Of the top 10 predictors, nine were preoperative features including chronic limb-threatening ischemia, previous procedures, comorbidities, and functional status. Model performance remained robust on all subgroup analyses., Conclusions: We developed ML models that accurately predict outcomes following suprainguinal bypass, performing better than logistic regression. Our algorithms have potential for important utility in guiding perioperative risk mitigation strategies to prevent adverse outcomes following suprainguinal bypass., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To examine limb salvage (LS) and wound healing in dialysis-dependent and -independent patients with chronic limb-threatening ischemia (CLTI) after infrainguinal bypass surgery or endovascular therapy (EVT)., Methods: We retrospectively analyzed the multi-center data of patients who underwent infrainguinal revascularization for CLTI with Wound, Ischemia, and foot Infection (WIfI) stage 2 to 4 between 2015 and 2020. The primary endpoint was LS. The secondary endpoint included wound healing, amputation-free survival (AFS), periprocedural complications, and 2-year survival. Comparison of these outcomes were made after propensity score matching., Results: We analyzed 252 dialysis-dependent (318 limbs) and 305 dialysis-independent (354 limbs) patients. Propensity score matching extracted 202 pairs with no significant differences in characteristics. The LS rate in bypass surgery was better than that in EVT in dialysis-dependent patients (P < .001). There was no significant difference in the LS rates between bypass surgery and EVT in dialysis-independent patients (P = .168). The wound healing rate of bypass surgery was better than that of EVT both dialysis-dependent and -independent patients with CLTI. The AFS rate of bypass surgery was better than that of EVT in dialysis-dependent patients (P < .001). There was no significant difference in the AFS rates between bypass surgery and EVT in dialysis-independent patients (P = .099). There was no significant difference in the occurrence of Clavien-Dindo ≥ IV and V between bypass surgery and EVT in dialysis-dependent and -independent patients. Age ≥75 years, serum albumin levels <3.5 g/dL, and non-ambulatory status were risk factors for 2-year mortality in dialysis-dependent patients. The 2-year survival rates in dialysis-dependent patients with risk factors of 0, 1, 2, and 3 were 82.5%, 67.1%, 49.5%, and 10.2%, respectively (P < .001)., Conclusions: For LS and wound healing, bypass surgery was preferred for revascularization in dialysis-dependent patients with WIfI stage 2 to 4. Although dialysis dependency was one of the risk factors for 2-year mortality, dialysis-dependent patients, who have 0 to 1 risk factors, may benefit from bypass surgery, as 2-year survival of >50% is expected., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Patients with chronic limb-threatening ischemia (CLTI) and no great saphenous vein to use as a conduit for arterial bypass have a high risk for amputation despite advances in medical and endovascular therapies. This report presents findings from a U.S. Food and Drug Administration (FDA) supported study of the Human Acellular Vessel (HAV) (Humacyte Inc.) used as a conduit for arterial bypass in patients with CLTI and inadequate or absent autologous conduit., Methods: The HAV is a 6-mm, 40-cm vessel created from human vascular smooth muscle cells seeded onto a polyglycolic acid scaffold pulsed in a bioreactor for 8 weeks as cells proliferate and the scaffold dissolves. The resultant vessel is decellularized, creating a nonimmunogenic conduit composed of collagen, elastin, and extracellular matrix. The FDA issued an Investigational New Drug for an intermediate-sized, single-center study of the HAV under the agency's Expanded Access Program in patients with advanced CLTI and inadequate or absent autologous conduit. Technical results and clinical outcomes were analyzed and reported., Results: Between March 2021 and July 2023, 29 patients (20 males; mean age, 71 ± 11 years) underwent limb salvage operation using the HAV as a bypass conduit. Most patients had advanced CLTI (Rutherford class 5/6 in 72%; wound, ischemia, and foot infection stage 3/4 in 83%), and 97% had previously failed revascularization(s) of the extremity. Two HAVs were sewn together to attain the needed bypass length in 24 patients (83%). Bypasses were to tibial arteries in 23 patients (79%) and to the popliteal artery in 6 (21%). Technical success was 100%, and the 30-day mortality rate was 7% (2 patients). With 100% follow-up (median, 9.3 months), the limb salvage rate was 86% (25/29 patients). There were 16 reinterventions to restore secondary patency, of which 15 (94%) were successful. Primary and secondary patency of the HAV at 9 months were 59% and 71%, respectively., Conclusions: The HAV has demonstrated short- to intermediate-term safety and efficacy as an arterial bypass conduit in a complex cohort of patients with limb-threatening ischemia and no autologous options. This experience using the FDA's Expanded Access Program provides real-world data to inform regulatory deliberations and future trials of the HAV, including the study of the vessel as a first-line bypass conduit in less severe cases of chronic limb ischemia., Competing Interests: Disclosures T.E.R. has served in a clinical advisory role for Humacyte, Inc., the funds for which are paid to the Mayo Clinic; Humacyte provides funding to support the performance of this IND study to Mayo Clinic. The other authors have no competing interests., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: There is increasing evidence that depression is a risk factor for worse outcomes in patients with peripheral artery disease. The association of depression in patients with chronic limb-threatening ischemia (CLTI) is not well described, nor is the impact of medical treatment for depression in this patient population. The objective of this study was to investigate the prevalence of depression in patients with CLTI, its association on major amputation and all-cause mortality, and whether medical antidepressant treatment is associated with improvement in these outcomes in patients with depression., Methods: A retrospective review of all adult patients (≥18 years old) diagnosed with CLTI from January 1, 2007, to December 31, 2018, at a single academic medical center was performed. Collected data included patient demographics, comorbidities, and diagnosis of depression within 6 months of initial CLTI diagnosis. We also collected data on use of antidepressant medications. Outcomes evaluated were need for major lower extremity amputation and all-cause mortality. Multivariable logistic regression models estimated the adjusted effects of comorbid depression and antidepressant medication use on major amputation and all-cause mortality. Kaplan-Meier survival curves illustrated the probabilities of survival and limb salvage over time, stratified by diagnosis of comorbid depression. Multivariable Cox proportional hazards models estimated the adjusted effects of comorbid depression on time to major amputation and all-cause mortality, and the adjusted effect of antidepressant treatment on time to all-cause mortality., Results: A total of 2987 patients with CLTI were identified. Mean age was 68.6 years (standard deviation, 12.9 years); 56.5% were male, and 43.5% were female. Comorbid depression within 6 months of CLTI diagnosis was present in 7.1% of the cohort (212 patients). In multivariable analysis, comorbid depression was associated with a 68% increase in the odds of major amputation (adjusted odds ratio [aOR], 1.68; 95% confidence interval [CI], 1.19-2.37; P < .01), a 164% increase in the odds of all-cause mortality among patients not taking antidepressants (aOR, 2.64; 95% CI, 1.31-5.32; P = .03), and only a 6% increase in the odds of all-cause mortality among patients taking antidepressants (aOR, 1.06; 95% CI, 0.72-1.55; P = .99). The effect of comorbid depression on mortality varied significantly by whether or not the patient was taking an antidepressant medication (P = .02)., Conclusions: Comorbid depression in the patient population with CLTI is associated with a worse prognosis for major lower extremity amputation overall, and a worse prognosis for all-cause mortality among patients not taking an antidepressant. Furthermore, antidepressant treatment in the presence of comorbid depression in this patient population is associated with an improvement in the odds of all-cause mortality, illustrating the potential importance of medical management of depression., Competing Interests: Disclosures None., (Published by Elsevier Inc.)

Objective: Many patients with chronic limb-threatening ischemia (CLTI) have additional comorbidities requiring systemic immunosuppression. Few studies have analyzed whether these medications may inhibit graft integration and effectiveness, or conversely, whether they may prevent inflammation and/or restenosis. Therefore, our study aim was to examine the effect of systemic immunosuppression vs no immunosuppression on outcomes after any first-time lower extremity revascularization for CLTI., Methods: We identified all patients undergoing first-time infrainguinal bypass graft (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution between 2005 and 2014. Patients were stratified by procedure type and immunosuppression status, defined as ≥6 weeks of any systemic immunosuppression therapy ongoing at the time of intervention. Immunosuppression vs nonimmunosuppression were the primary comparison groups in our analyses. Primary outcomes included perioperative complications, reintervention, primary patency, and limb salvage, with Kaplan-Meier and Cox proportional hazard models used for univariate and multivariate analyses, respectively., Results: Among 1312 patients, 667 (51%) underwent BPG and 651 (49%) underwent PTA/S, of whom 65 (10%) and 95 (15%) were on systemic immunosuppression therapy, respectively. Whether assessing BPG or PTA/S patients, there were no differences noted in perioperative outcomes, including perioperative mortality, myocardial infarction, stroke, hematoma, or surgical site infection (P > .05). For BPG patients, Kaplan-Meier analysis and log-rank testing demonstrated no significant difference in three-year reintervention (37% vs 33% [control]; P = .75), major amputation (27% vs 15%; P = .64), or primary patency (72% vs 66%; P = .35) rates. Multivariate analysis via Cox regression confirmed these findings (immunosuppression hazard ratio [HR] for reintervention, 0.95; 95% CI, 0.56-1.60; P = .85; for major amputation, HR, 1.44; 95% CI, 0.70-2.96; P = .32; and for primary patency. HR, 0.97; 95% CI, 0.69-1.38; P = .88). For PTA/S patients, univariate analysis revealed similar rates of reintervention (37% vs 39% [control]; P = .57) and primary patency (59% vs 63%; P = .21); however, immunosuppressed patients had higher rates of major amputation (23% vs 12%; P = .01). After using Cox regression to adjust for baseline demographics, as well as operative and anatomic characteristics, immunosuppression was not associated with any differences in reintervention (HR, 0.75; 95% CI, 0.49-1.16; P = .20), major amputation (HR, 1.46; 95% CI, 0.81-2.62; P = .20), or primary patency (HR, 0.84; 95% CI, 0.59-1.19; P = .32). Sensitivity analyses for the differences in makeup of immunosuppression regimens (steroids vs other classes) did not alter the interpretation of any findings in either BPG or PTA/S cohorts., Conclusions: Our findings demonstrate that patients with chronic systemic immunosuppression, as compared with those who are not immunosuppressed, does not have a significant effect on late outcomes after lower extremity revascularization, as measured by primary patency, reintervention, or major amputation., Competing Interests: Disclosures M.S. is a consultant for Medtronic, Endologix, Cook, and Abbot., (Published by Elsevier Inc.)

Objective: The aim of this study was to assess the association between the proximity to the tertiary care hospital and the severity of peripheral arterial disease (PAD) at the time of lower extremity bypass (LEB) in a rural-urban mix region., Methods: Patients undergoing LEB from 2010 to 2020 at Penn State Milton S. Hershey Medical Center were reviewed and stratified into two study groups based on a median distance from hospital (ie, Group I: ≥34 miles and Group II: <34 miles). Patients' demographic features, preoperative data including comorbidities, and medications were analyzed. A univariate analysis for the patient characteristics between the two study groups, along with evaluation of postoperative outcomes, and a multivariate predictive modeling to study the PAD stage as the indication of LEB was performed. A P-value of < .05 was set as a significant difference between the groups for all the analyses., Results: There were 175 patients (49.9%) in Group I and 176 patients (50.1%) in Group II with a mean age of 65 ± 11.92 years (median, 64.61 years). No significant difference was observed in gender (P = .530), age (P = .906), and functional status (P = .830) between study groups. It was observed that patients in Group I were more likely to be overweight or obese (71.3% vs 57%; P = .007) and had a prior history of myocardial infarction (24.3% vs 15.3%; P = .036) in comparison to Group II. No postoperative outcomes were found to be statistically different between the study groups. The multivariate analyses based on various confounders displayed that patients in Group I had 56% higher likelihood of LEB for chronic limb-threatening ischemia (adjusted odds ratio, 1.56; 95% confidence interval, 0.92-2.62; P = .042). Group I patients also had five times higher odds of LEB for acute limb ischemia (adjusted odds ratio, 5.07; 95% confidence interval, 1.42-18.13; P = .012) as compared with those in the Group II., Conclusions: Patients' proximity to a major tertiary hospital may have implications on the disease progression for patients with PAD and could also be related to inadequate vascular services in primary and secondary hospitals. Lack of preventive care and disease management in regions afar from a tertiary hospital could be other implicating factors and highlights the need for outreach programs, along with distribution of vascular specialists, to reduce geographical disparities and ensure equity in access to care., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Superficial femoral artery (SFA) stenting is a common treatment for peripheral artery disease. It is effective in the short term; however, in-stent restenosis (ISR) limits long-term success. Surveillance with duplex ultrasound (DUS) can identify patients who develop ISR leading to early reintervention, but data to support this practice is sparce. The purpose of this study was to evaluate whether surveillance and subsequent reintervention improves outcomes in patients with SFA stents., Methods: A single-center, retrospective study was performed with patients undergoing SFA stenting between 2005 and 2020 who had a follow-up with DUS. Five groups were identified based on the presence of ISR on DUS (ISR vs no ISR [NISR]), recurrence of symptoms (symptomatic [SX] vs asymptomatic [ASX]), and if any reintervention was performed (reintervention [R] vs no reintervention [NR]): (1) ISR+SX+R; (2) ISR+SX+NR; (3) ISR+ASX+R; (4) ISR+ASX+NR; and (5) NISR+NR. The primary endpoint was amputation-free survival, and the secondary endpoint was patency. Predictors of mortality and surveillance were identified by multivariable logistic regressions and Cox multivariate regression models. Survival curves were presented as Kaplan-Meier plots using log-rank test for subgroup comparison., Results: Two hundred fifty-seven patients were included in the analysis. The indication for intervention was claudication in 28% and chronic limb-threatening ischemia in 72%. A total of 161 patients (63%) underwent reintervention for ISR. Of patients who had restenosis on DUS, those who were symptomatic and did not undergo reintervention (ISR+SX+NR) did the worst, with 50% amputation rate. In contrast, those who were asymptomatic but did undergo reintervention (ISR+ASX+R) had the lowest amputation rate of 13%. Active smoking was a predictor of both loss of patency and amputation (1.72; 95% confidence interval [CI], 1.00-2.98; P = .050; 3.55; 95% CI, 1.53-8.25; P = .003). Post procedure dual antiplatelet therapy had a positive association with limb salvage (hazard ratio [HR], 0.23; 95% CI, 0.09-0.58; P = .001), whereas diabetes (HR, 2.61; 95% CI, 1.21-6.01; P = .019), stent occlusion (HR, 17.0; 95% CI, 5.93-63.1; P < .001), and chronic limb-threatening ischemia presentations (HR, 4.31; 95% CI, 1.86-11.7; P=.002) were negatively associated with limb salvage., Conclusions: Routine surveillance DUS and subsequent reintervention on ISR after SFA stenting is associated with improved patency and amputation-free survival. Surveillance DUS should be routine for patients after stenting, with reintervention strongly considered if ISR is identified for both symptomatic and asymptomatic., Competing Interests: Disclosures C.T. has been a consultant for and received research support from Cook Medical, Inc, W.L. Gore & Associates, and Philips Healthcare. M.K. is a consultant for W.L. Gore & Associates., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)