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The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Background Accurate and convenient methods for assessing a patient's risk of postoperative morbidity and mortality comprise important tools in clinical decision-making. Whereas some aspects of the patient's fitness for surgery can be easily quantified, measurement of the patient's frailty is often difficult or time-consuming. Previous research in the context of multiple types of major surgical procedures has reported psoas-L4 vertebral index (PLVI) to be a useful predictor of postoperative morbidity and mortality. Methods This retrospective cohort study assessed the hypothesis that PLVI can predict amputation-free survival (AFS) in patients undergoing open or endovascular lower extremity revascularization. The records of all lower extremity revascularization patients with preoperative computed tomography arteriography before revascularization during a recent 6-year period were reviewed for demographic information and outcomes. With use of embedded computed tomography software, the cross-sectional area of the bilateral psoas muscles and vertebral body at the L4 level were measured and used to calculate the PLVI. Univariate, multivariate logistic regression, and Cox proportional hazards analyses were performed for the primary outcome of AFS. Results During a 6-year period, 188 patents had preoperative scanning, qualifying for inclusion in the study; 52% received open surgical bypass and 48% received a percutaneous endovascular procedure, with a median duration of follow-up of 12 months (interquartile range [IQR], 3-24 months). Median bilateral psoas cross-sectional area was 24.9 cm 2 (IQR, 20.5-29.7 cm 2 ), and mean PLVI was 1.74 (IQR, 1.39-2.05). Cox proportional hazards analysis identified age (hazard ratio [HR], 1.07; 95% confidence interval [CI], 1.01-1.14; P = .026), congestive heart failure (HR, 4.7; 95% CI, 1.29-16.9; P = .019), and dyslipidemia (HR, 0.34; 95% CI, 0.12-0.99; P = .049) as independent predictors of AFS loss, whereas PLVI was not (HR, 2.6; 95% CI, 0.83-8.39; P = .099). Kaplan-Meier life-table analysis demonstrated no significant differences in survival between the highest and lowest PLVI cohorts of patients. Hazard analysis showed concomitant congestive heart failure (HR, 15; 95% CI, 1.1-210; P = .042) and serum albumin concentration (HR, 0.16; 95% CI, 0.05-0.52; P = .0026) to be independent predictors of limb loss, whereas advanced age (HR, 1.20; 95% CI, 1.07-1.35; P = .0026), bypass procedure (HR, 4.6; 95% CI, 1.04-21; P = .045), non-African American race (HR, 9.09; 95% CI, 1.02-100; P = .048), and higher PLVI (HR, 10.9; 95% CI, 1.7-72; P = .013) predicted increased risk of mortality. Conclusions PLVI did not predict AFS after intervention for peripheral arterial occlusive disease. This is contrary to the ability of PLVI to predict perioperative and midterm survival after abdominal aortic aneurysm repair and other major abdominal surgery.

Improved survival is reported for patients with end-stage renal disease who are kidney transplant recipients (KTRs) compared with dialysis-dependent patients (DDPs). Whether amputation-free survival (AFS) and freedom from major adverse limb events (MALEs) after peripheral vascular intervention (PVI) or lower extremity bypass (LEB) are superior after renal transplantation remains incompletely defined.A retrospective cohort study was undertaken of KTRs and DDPs undergoing infrainguinal PVI or LEB for symptoms of limb-threatening ischemia recorded in the Vascular Quality Initiative from 2003 to 2017. Primary outcomes were AFS and freedom from MALEs along with their components of assisted primary patency, limb salvage, and patient survival. The χThere were 2707 PVI (351 KTRs and 2356 DDPs) and 1444 LEB (198 KTRs and 1246 DDPs) procedures performed for limb-threatening ischemia. Chronic obstructive pulmonary disease, congestive heart failure, female patients, and African Americans were more common among the DDP group, as were lower preoperative hemoglobin values and older age. After PVI, KTRs had better AFS than DDPs (42% vs 66% at 1 year, 15% vs 26% at 2 years; hazard ratio [HR], 1.91; 95% confidence interval [CI], 1.38-2.64; P .001) and fewer MALEs (53% vs 64% at 1 year, 35% vs 49% at 18 months; HR, 1.71; 95% CI, 1.25-2.34; P = .001). PVI outcomes, AFS, and freedom from MALEs were driven primarily by differences in limb salvage and patient survival but not assisted primary patency. After LEB, KTRs also displayed improved AFS compared with DDPs (44% vs 65% at 1 year, 10% vs 36% at 3 years; HR, 2.32; 95% CI, 1.41-3.81; P = .001), driven by patient survival but not limb salvage, whereas differences in freedom from MALEs did not attain statistical significance (67% vs 58%; P = .08).For patients with end-stage renal disease, subsequent kidney transplantation was associated with better AFS and freedom from MALEs after PVI but only improved AFS after LEB. Open or endovascular revascularization can be advocated in patients with limb-threatening ischemia who have received kidney transplantation to a greater degree than in those who remain dialysis dependent.

Acceptable complication rates after carotid endarterectomy (CEA) are drawn from decades-old data. The recent Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated improved stroke and mortality outcomes after CEA compared with carotid artery stenting, with 30-day periprocedural CEA stroke rates of 3.2% and 1.4% for symptomatic (SX) and asymptomatic (ASX) patients, respectively. It is unclear whether these target rates can be attained in "normal-risk" (NR) patients experienced outside of the trial. This study was done to determine the contemporary results of CEA from a broader selection of NR patients.The Society for Vascular Surgery (SVS) Vascular Registry was examined to determine in-hospital and 30-day event rates for NR, SX, and ASX patients undergoing CEA. NR was defined as patients without anatomic or physiologic risk factors as defined by SVS Carotid Practice Guidelines. Raw data and risk-adjusted rates of death, stroke, and myocardial infarction (MI) were compared between the ASX and SX cohorts.There were 3977 patients (1456 SX, 2521 ASX) available for comparison. The SX group consisted of more men (61.7% vs 57.0%; P = .0045) but reflected a lower proportion of white patients (91.3% vs 94.4%; P = .0002), with lower prevalence of coronary artery disease (P.0001), prior MI (P.0001), peripheral vascular disease (P = .0017), and hypertension (P = .029), although New York Heart Association grade3 congestive heart failure was equally present in both groups (P = .30). Baseline stenosis80% on duplex imaging was less prevalent among SX patients (54.2% vs 67.8%; P.0001). Perioperative stroke rates were higher for SX patients in the hospital (2.8% vs 0.8%; P.0001) and at 30 days (3.4% vs 1.0%; P.0001), which contributed to the higher composite death, stroke, and MI rates in the hospital (3.6% vs 1.8; P = .0003) and at 30 days (4.5% vs 2.2%; P.0001) observed in SX patients. After risk adjustment, the rate of stroke/death was greater among SX patients in the hospital (odds ratio, 2.05; 95% confidence interval, 1.18-3.58) although not at 30 days (odds ratio, 1.36; 95% confidence interval, 0.85-2.17). No in-hospital or 30-day differences were observed for death or MI by symptom status.The SVS Vascular Registry results for CEA in NR patients are similar by symptom status to those reported for CREST and may serve as a benchmark for comparing results of alternative therapies for treatment of carotid stenosis in NR patients outside of monitored clinical trials. The contemporary perioperative risk of stroke after CEA in NR patients continues to be higher for SX than for ASX patients.

Objective Although smoking cessation is a benchmark of medical management of intermittent claudication, many patients require further revascularization. Currently, revascularization among smokers is a controversial topic, and practice patterns differ institutionally, regionally, and nationally. Patients who smoke at the time of revascularization are thought to have a poor prognosis, but data on this topic are limited. The purpose of this study was to evaluate the impact of smoking on outcomes after infrainguinal bypass for claudication. Methods Data from the national Vascular Quality Initiative from 2004 to 2014 were used to identify infrainguinal bypasses performed for claudication. Patients were categorized as former smokers (quit >1 year before intervention) and current smokers (smoking within 1 year of intervention). Demographic and comorbid differences of categorical variables were assessed. Significant predictors were included in adjusted Cox proportional hazards models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) by smoking status for outcomes of major adverse limb event (MALE), amputation-free survival, limb loss, death, and MALE or death. Cumulative incidence curves were created using competing risks modeling. Results We identified 2913 patients (25% female, 9% black) undergoing incident infrainguinal bypass grafting for claudication. There were 1437 current smokers and 1476 former smokers in our study. Current smoking status was a significant predictor of MALE (HR, 1.27; 95% CI, 1.00-1.60; P = .048) and MALE or death (HR, 1.22; 95% CI, 1.03-1.44; P = .02). Other factors found to be independently associated with poor outcomes in adjusted models included black race, below-knee bypass grafting, use of prosthetic conduit, and dialysis dependence. Conclusions Current smokers undergoing an infrainguinal bypass procedure for claudication experienced more MALEs than former smokers did. Future studies with longer term follow-up should address limitations of this study by identifying a data source with long-term follow-up examining the relationship of smoking exposure (pack history and duration) with outcomes.

Objective The purpose of this study was to validate published Society for Vascular Surgery Vascular Quality Initiative (VQI) prediction models for patients with limb-threatening ischemia (LTI) undergoing open or endovascular revascularization for infrapopliteal occlusive disease. Methods We sought to validate our prior VQI LTI models for major adverse limb events (MALEs) and amputation-free survival (AFS) in a VQI new cohort undergoing open or percutaneous interventions from September 2014 through August 2016. Receiver operating characteristic curves were generated including the C statistic, and the predicted vs actual outcomes were correlated. The Hosmer-Lemeshow (HL) statistic was calculated to determine goodness of fit, and the Tjur R2 statistic was derived to demonstrate the degree to which the observed outcomes were accurately predicted by the models. Results Of 15,576 open infrainguinal and 34,679 percutaneous interventions collected in the VQI during the 24-month interval, 8852 and 17,124, respectively, were performed for LTI, among which 4410 and 5116 specifically targeted the infrapopliteal vessels. MALEs and AFS were identified for 400 of 927 (43.1%) and 576 of 982 (58.7%) open procedures and 197 of 855 (23.0%) and 658 of 1115 (59.0%) percutaneous procedures, respectively. For open operation, the predictive ability of the model was poor for MALEs (C = 0.59; HL = 107; R2 = 0.03) and only marginally better for AFS (C = 0.69; HL = 130; R2 = 0.10). Similarly, for endovascular intervention, the model performed poorly for MALEs (C = 0.62; HL = 183; R2 = 0.06) and slightly better for AFS (C = 0.68; HL = 68; R2 = 0.11). Breaking AFS into its component determinants, the predictive ability of the open operation model for patient survival (C = 0.77; HL = 70; R2 = 0.15) surpassed that for limb salvage (C = 0.64; HL = 54; R2 = 0.05). For endovascular interventions, the survival model (C = 0.71; HL = 94; R2 = 0.11) also outperformed the limb salvage model (C = 0.67; HL = 28; R2 = 0.07). For both types of intervention, the actual MALE rate was lower and AFS was higher than predicted by the models. Conclusions The ability of reported VQI-derived models to accurately predict major outcomes for infrapopliteal LTI is limited and cannot be advocated for clinical decision-making at this time. Further study would be necessary to determine whether this is due to intraoperative and postoperative variables not accounted for in our models, absence of pertinent data points from the registry, or incomplete follow-up.

Inferior survival outcomes have historically been reported for African Americans with cardiovascular disease, and poorer outcomes have been presumed for peripheral arterial disease (PAD) as well. The current study evaluates the effect of race and ethnicity on survival of patients undergoing open or endovascular interventions for lower extremity PAD.Data of patients from the Society for Vascular Surgery Vascular Quality Initiative database were obtained for patients undergoing open infrainguinal (INFRA) or suprainguinal (SUPRA) bypass, peripheral vascular intervention (PVI), and amputation (AMP). Patients were further stratified as suprainguinal (SupraPVI) if any of the first three interventions listed included the aorta or iliac vessels or infrainguinal (InfraPVI) if not. The primary outcome was the patient's death (overall mortality) as recorded in the database or determined by cross-reference with the Social Security Death Index (SSDI). The secondary outcome consisted of perioperative mortality during the index hospitalization. Generalized linear modeling provided multivariate analysis, with entry of variables dependent on results of univariate analysis.From January 2003 through September 2015, a total of 24,241 INFRA bypass, 8028 SUPRA bypass, 48,048 InfraPVI, 21,196 SupraPVI, and 3423 AMP patients met criteria for analysis, with a median follow-up of 18 (interquartile range, 8-33) months. Combining all procedures, overall mortality was lower among African Americans than among white Americans (12.4% vs 14.2%; P .0001) but not death in the periprocedural period (1.1% vs 1.2%; P = .26). To account for differences in length of follow-up, Cox proportional hazards analysis confirmed that the African American race was independently associated with a significantly lower occurrence of overall mortality after INFRA bypass (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.70-0.88; P .0009), InfraPVI (HR, 0.72; 95% CI, 0.67-0.78; P .0001), and SupraPVI (HR, 0.77; 95% CI, 0.66-0.90; P = .0009) interventions but not after SUPRA bypass or AMP. Similarly, by Cox proportional hazards, Hispanic/Latino ethnicity was also independently associated with lower overall mortality after INFRA bypass (HR, 0.75; 95% CI, 0.62-0.91; P = .0030), InfraPVI (HR, 0.69; 95% CI, 0.62-0.78; P .0001), and SupraPVI (HR, 0.68; 95% CI, 0.52-0.89; P = .0045) but not after SUPRA bypass or AMP.Contrary to the published data for other forms of cardiovascular disease, African American patients as well as patients identified with Hispanic/Latino ethnicity with PAD included in the Society for Vascular Surgery Vascular Quality Initiative undergoing INFRA revascularization for lower extremity PAD experienced better overall survival compared with white Americans.

Objective The outcomes of open surgical or endovascular intervention for limb-threatening ischemia (LTI) involving the infrapopliteal vessels are dependent on complex anatomic, demographic, and disease factors. To assist in decision-making, we used the Vascular Quality Initiative (VQI) to derive a model using only preoperatively available factors to predict important outcomes for open or endovascular revascularization. Methods National VQI data for the infrainguinal bypass and peripheral vascular intervention (PVI) modules were reviewed in a blinded fashion for patients who underwent intervention for LTI of the infrapopliteal vessels. Primary outcomes consisted of major adverse limb event (MALE) and amputation-free survival (AFS). Generalized linear modeling was used for the multivariate analyses, with entry of variables dependent on results of univariate analysis. Results From January 2003 through August 2014 a total of 19,053 infrainguinal open bypass and 48,739 PVI procedures were identified, among which 5264 and 5252, respectively, represented infrapopliteal (tibial-peroneal-pedal) revascularization for LTI. From these, 3036 infrapopliteal open bypass patients and 1319 infrapopliteal PVI patients had sufficient follow-up data for study inclusion. For open surgery, the reduced generalized linear model revealed that American Society of Anesthesiologists class 4 or 5, previous major amputation, living at home, and female sex had the greatest adverse effect on MALE, and dialysis dependence, low body mass index, and lack of great saphenous vein as a conduit had the greatest negative effect on AFS. For PVI, lesion length from 10 to 15 cm, treatment of three or more arteries, and classification other than A on the Trans-Atlantic Inter-Society Consensus demonstrated the largest adverse effects on MALE, and dialysis dependence, low body mass index, and congestive heart failure most negatively affected AFS. Conclusions This study on a cross-section of patients selected for intervention in academic and community hospitals offers a "real world" glimpse of factors predictive of outcome. The VQI can be used to derive models that predict the outcomes of open surgical bypass or PVI for LTI involving the infrapopliteal vessels.

Objective The eversion technique for carotid endarterectomy (eCEA) offers an alternative to longitudinal arteriotomy and patch closure (pCEA) for open carotid revascularization. In some reports, eCEA has been associated with a higher rate of >50% restenosis of the internal carotid when it is defined as peak systolic velocity (PSV) >125 cm/s by duplex imaging. Because the conformation of the carotid bifurcation may differ after eCEA compared with native carotid arteries, it was hypothesized that standard duplex criteria might not accurately reflect the presence of restenosis after eCEA. Methods In a case-control study, the outcomes of all patients undergoing carotid endarterectomy by one surgeon during the last 10 years were analyzed retrospectively, with a primary end point of PSV >125 cm/s. Duplex flow velocities were compared with luminal diameter measurements for any carotid computed tomography arteriography or magnetic resonance angiography study obtained within 2 months of duplex imaging, with the degree of stenosis calculated by the methodology used in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST) as well as cross-sectional area (CSA) reduction. Simulations were generated and analyzed by computational model simulations of the eCEA and pCEA arteries. Results Eversion and longitudinal arteriotomy with patch techniques were used in 118 and 177 carotid arteries, respectively. Duplex follow-up was available in 90 eCEA arteries at a median of 16 (range, 2-136) months and in 150 pCEA arteries at a median of 41 (range, 3-115) months postoperatively. PSV >125 cm/s was present at some time during follow-up in 31% of eCEA and pCEA carotid arteries, each, and in the most recent duplex examination in 7% after eCEA and 21% after pCEA ( P = .003), with no eCEA and two pCEA arteries occluding completely during follow-up ( P = .29). In 19 carotid arteries with PSV >125 cm/s after angle correction (median, 160 cm/s; interquartile range, 146-432 cm/s) after eCEA that were subsequently examined by axial imaging, the mean percentage stenosis was 8% ± 11% by NASCET, 11% ± 5% by ECST, and 20% ± 9% by CSA criteria. For eight pCEA arteries with PSV >125 cm/s (median velocity, 148 cm/s; interquartile range, 139-242 cm/s), the corresponding NASCET, ECST, and CSA stenoses were 8% ± 35%, 26% ± 32%, and 25% ± 33%, respectively. NASCET internal carotid diameter reduction of at least 50% was noted by axial imaging after two of the eight pCEAs, and the PSV exceeded 200 cm/s in each case. Conclusions The presence of hemodynamically significant carotid artery restenosis may be overestimated by standard duplex criteria after eCEA and perhaps after pCEA. Insufficient information currently exists to determine what PSV does correspond to hemodynamically significant restenosis.