Overview and comparison of contemporary Society for Vascular Surgery, American Heart Association/American College of Cardiology, and European Society for Vascular Surgery guidelines for the management of patients with intermittent claudication.

Intermittent claudication (IC) is a phenotype of peripheral artery disease that is characterized by pain in the lower extremity muscles during activity that is relieved by rest. Medical management, risk factor control, smoking cessation, and exercise therapy have historically been the mainstays of treatment for IC, but advances in endovascular technology have led to increasing use of peripheral vascular interventions in this patient population. There are meaningful differences in published society guidelines and appropriate use criteria relevant to the management of IC, especially regarding indications for peripheral vascular interventions. The current review aims to highlight similarities and differences between major society recommendations for the management of IC, and to discuss practice trends, disparities, and evidence gaps in the use of peripheral vascular interventions for IC in the context of existing guidelines.

Skeletal muscle desmin alterations following revascularization in peripheral artery disease claudicants.

Peripheral artery disease (PAD) is characterized by varying severity of arterial stenosis, exercise induced claudication, malperfused tissue precluding normal healing and skeletal muscle dysfunction. Revascularization interventions improve circulation, but post-reperfusion changes within the skeletal muscle are not well characterized. This study investigates if revascularization enhanced hemodynamics increases walking performance with concurrent improvement of mitochondrial function and reverses abnormal skeletal muscle morphological features that develop with PAD. Fifty-eight patients completed walking performance testing and muscle biopsy before and 6 months after revascularization procedures. Muscle fiber morphology, desmin structure, and mitochondria respiration assessments before and after the revascularization were evaluated. Revascularization improved limb hemodynamics, walking function, and muscle morphology. Qualitatively not all participants recovered normal structural architecture of desmin in the myopathic myofibers after revascularization. Heterogenous responses in the recovery of desmin structure following revascularization may be caused by other underlying factors not reversed with hemodynamic improvements. Revascularization interventions clinically improve patient walking ability and can reverse the multiple subcellular functional and structural abnormalities in muscle cells. Further study is needed to characterize desmin structural remodeling with improvements in skeletal muscle morphology and function.

Co-Morbidity Differences Associated With Long-Term Amputation and Repeat Revascularization Rates After Femoropopliteal Artery Intervention for Intermittent Claudication by Sex, Race, and Ethnicity.

Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by sex, race, and ethnicity. This study aimed to examine amputation and revascularization rates up to 4 years after femoropopliteal (FP) PVI for IC by sex, race, and ethnicity. Patients who underwent FP PVI for IC between 2016 and 2020 from the PINC AI Healthcare Database were analyzed. The primary outcome was any index limb amputation, assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HRs) were estimated using Cox proportional hazard regression models. This study included 19,324 patients with IC who underwent FP PVI, with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs 47.8%, p = 0.0003); Black patients were more likely than White patients to receive atherectomy (50.7% vs 44.9%, p <0.001), and Hispanic patients were less likely than non-Hispanic patients to receive atherectomy (41% vs 47%, p = 0.0004). Unadjusted rates of any amputation were similar in men and women (6.4% for each group, log-rank p = 0.842), higher in Black patients than in White patients (7.8% vs 6.1%, log-rank p = 0.007), and higher in Hispanic patients than in non-Hispanic patients (8.8% vs 6.3%, log-rank p = 0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR 1.13, 95% confidence interval 1.04 to 1.22) and any FP revascularization (adjusted HR 1.10, 95% confidence interval 1.01 to 1.20). No statistical difference in amputation rate was observed among comparison groups. Women and men with IC had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than did White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences among different populations.

Staged bilateral release of the popliteus muscle using a posterior surgical approach to the popliteal fossa to treat type 4 popliteal artery entrapment.

Popliteal artery entrapment syndrome (PAES) is a rare cause of intermittent claudication in the young. Aberrant embryological development results in entrapment of the popliteal artery by myofascial structures of the popliteal fossa. Type 4 PAES is due to aberrant development of the popliteus muscle superficial to the popliteal artery. We present a case of bilateral type 4 PAES, along with intraoperative photography highlighting the anatomical cause for this pathology. Both limbs in this patient were treated successfully with surgical release of the entrapping popliteus muscle via a posterior surgical approach to the popliteal fossa. This report emphasises the importance of determining popliteal artery integrity and entrapment subtype to guide the management of this condition.

Intraoperative Transit-Time Flow as a Predictor of Failure after Infrainguinal Revascularization with Heparin-Bonded Expanded Polytetrafluoroethylene Graft.

BACKGROUND: The heparin-bonded expanded polytetrafluoroethylene (He-ePTFE) conduit is an option for patients requiring infrainguinal revascularization (iIR), but the risk of failure may be unpredictable, especially in cases with poor run-off. Intraoperative transit-time flow (TTF) provides an automated and quantitative analysis of flow and may serve as an adjunct evaluation during surgical revascularization. The aim of this study was to assess TTF in patients undergoing iIR with He-PTFE at 3 referral hospitals and to establish a predictive flow threshold for graft occlusion. METHODS: A prospective registry initiated in 2020 enrolled patients undergoing iIR using He-PTFE for critical limb ischemia or severe claudication, and TTF measurement was analyzed. Preoperative assessments of anatomical and clinical characteristics were available for all patients. The HT353 Optima Meter (Transonic Systems Inc., Ithaca, NY, USA) was used in all procedures according to a standardized protocol. The institutional ethics committee approved the study. A predictive model using receiver operating characteristic curve analysis was utilized to establish the threshold of flow, and variables were compared. Anatomical and clinical evaluation were reported according to Rutherford grade, Global Limb Anatomic System and Wound, Ischemia, and foot Infection classification. The main outcome considered was the correlation between TTF and graft occlusion. Secondary outcomes included survival, other predictors of graft occlusion, freedom from major adverse cardiovascular events, and freedom from major amputation. RESULTS: Among 68 patients, 55.8% had Rutherford 5-6, 45.6% had Global Limb Anatomic System 3 and 73.5% had Wound, Ischemia, and foot Infection 3-4. Distal anastomosis was at tibial level in 23.5% and mean diameter of conduit was 6.4 mm. Basal and postoperative TTF were 27.8 ± 15.6 ml/min and 109.0 ± 53.0 ml/min, respectively. After a mean follow-up of 18 ± 13 months, 7 (10.9%) patients presented graft occlusion and 5 (7.8%) required major amputation. TTF threshold = 80 ml/min revealed a sensitivity and specificity of 81.8% (95% confidence interval 48.2-97.7) and 80.7% (95% confidence interval 68.1-90.0) respectively, and it was selected as cut-off for graft occlusion. Freedom from graft occlusion in patients with TTF >80 ml/min vs. TTF ≤80 ml/min at 6, 12, and 24 months was 95.7% (standard error (SE) = 0.030) vs. 65.5% (SE = 0.115), 95.7% (SE = 0.030) vs. 58.9% (SE = 0.120) and 90.9% (SE = 0.054) vs. 51.6% (SE = 0.126), P = 0.0003. No statistical difference in primary patency, secondary patency and limb salvage was observed. At multivariate analysis, distal anastomosis at tibial vessel (odds ratio 8.50) and TTF ≤80 ml/min (odds ratio 9.39) were independent predictors of graft occlusion. CONCLUSIONS: These results suggest that TTF may serve as a valuable tool in the management of iIR. A TTF measurement of ≤80 ml/min should be regarded as a predictor of graft occlusion, prompting consideration of additional intraoperative maneuvers to enhance arterial flow. Caution should be exercised in patients requiring direct tibial artery revascularization, as it represents a predictor of failure independent of TTF levels. Larger cohorts of patients and longer follow-up periods are necessary to confirm these findings.

Cystic adventitial disease of the common femoral artery: a case report and overview of the literature.

INTRODUCTION: Cystic adventitial disease (CAD) is an uncommon condition that affects arteries and veins. It can cause a rare type of non-atherosclerotic peripheral vessel disease. The most common vessel affected is the popliteal artery. The number of case reports on CAD of the femoral artery is growing. We present a case of a 62-year-old female presented with claudication of the left leg diagnosed with CAD of the left common femoral artery. The patient was treated surgically with cyst excision and vessel reconstruction with saphenous vein autograft patch plasty. After 8-months the cyste relapsed and she had new claudication complains. We decided to perform new surgery. Surgical treatment consisted of cyst resection by excision of the femoral bifurcation and saphenous vein autograft interposition reconstruction of the bifurcation. We also provide an update on the latest literature of surgical treatment of CAD of the ilio-femoral artery region. METHODS: Medline and EMBASE were used to collect articles on CAD of ilio-femoral artery. We included English written or translated case reports or series between 1987 and 2023. RESULTS: Twenty-nine patients out of 28 case reports were included. Most patients were male (59%). Claudication is the most common symptom (76%). Treatment consisted of cyst resection, cyst decompression, Endarterectomy, patch angioplasty and interposition graft using PTFE, Dacron, Great saphenous vein (GSV) or femoral vein autograft. Recurrence appeared in 4 cases (14%). CONCLUSION: In accordance to the literature and our experience we recommend complete vessel excision and saphenous vein (or PTFE) interposition bypass as treatment.

Long-term outcomes in the smoking claudicant after peripheral vascular interventions.

OBJECTIVE: Emphasis on tobacco cessation, given the urgent and emergent nature of vascular surgery, is less prevalent than standard elective cases such as hernia repairs, cosmetic surgery, and bariatric procedures. The goal of this study is to determine the effect of active smoking on claudicating individuals undergoing peripheral vascular interventions (PVIs). Our goal is to determine if a greater emphasis on education should be placed on smoking cessation in nonurgent cases scheduled through clinic visits and not the Emergency Department. METHODS: This study was performed using the multi-institution de-identified Vascular Quality Initiative/Medicare-linked database (Vascular Implant Surveillance and Interventional Outcomes Network [VISION]). Claudicants who underwent PVI for peripheral arterial occlusive disease between 2004 and 2019 were included in our study. Our final sample consisted of a total of 18,726 patients: 3617 nonsmokers (19.3%) (NSs), 9975 former smokers (53.3%) (FSs), and 5134 current smokers (27.4%) (CSs). We performed propensity score matching on 29 variables (age, gender, race, ethnicity, treatment setting [outpatient or inpatient], obesity, insurance, hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, previous coronary artery bypass graft, carotid endarterectomy, major amputation, inflow treatment, prior bypass or PVI, preoperative medications, level of treatment, concomitant endarterectomy, and treatment type [atherectomy, angioplasty, stent]) between NS vs FS and FS vs CS. Outcomes were long-term (5-year) overall survival (OS), limb salvage (LS), freedom from reintervention (FR), and amputation-free survival (AFS). RESULTS: Propensity score matching resulted in 3160 well-matched pairs of NS and FS and 3750 well-matched pairs of FS and CS. There was no difference between FS and NS in terms of OS (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.82-1.09; P = .43), FR (HR, 0.96; 95% CI, 0.89-1.04; P = .35), or AFS (HR, 0.90; 95% CI, 0.79-1.03; P = .12). However, when compared with CS, we found FS to have a higher OS (HR, 1.18; 95% CI, 1.04-1.33; P = .01), less FR (HR, 0.89; 95% CI, 0.83-0.96; P = .003), and greater AFS (HR, 1.16; 95% CI, 1.03-1.31; P = .01). CONCLUSIONS: This multi-institutional Medicare-linked study looking at elective PVI cases in patients with peripheral artery disease presenting with claudication found that FSs have similar 5-year outcomes in comparison to NSs in terms of OS, FR, and AFS. Additionally, CSs have lower OS and AFS when compared with FSs. Overall, this suggests that smoking claudicants should be highly encouraged and referred to structured smoking cessation programs or even required to stop smoking prior to elective PVI due to the perceived 5-year benefit.

Trends in Lower Extremity Artery Disease Repair Incidence, Comorbidity, and Mortality: A Danish Nationwide Cohort Study, 1996-2018.

Background: The prevalence of occlusive lower extremity artery disease (LEAD) is rising worldwide while European epidemiology data are scarce. We report incidence and mortality of LEAD repair in Denmark from 1996 through 2018, stratified on open aorto-iliac, open peripheral, and endovascular repair. Methods: A nationwide cohort study of prospective data from population-based Danish registers covering 1996 to 2018. Comorbidity was assessed by Charlson's Comorbidity Index (CCI). Incidence rate (IR) ratios and mortality rate ratios (MRR) were estimated by multivariable Poisson and Cox regression, respectively. Results: We identified 41,438 unique patients undergoing 46,236 incident first-time LEAD repairs by either aorto-iliac- (n=5213), peripheral surgery (n=18,665) or percutaneous transluminal angioplasty (PTA, n=22,358). From 1996 to 2018, the age- and sex-standardized IR for primary revascularization declined from 71.8 to 50.2 per 100,000 person-years (IRR, 0.70; 95% CI, 0.66-0.75). Following a 2.5-fold IR increase of PTA from 1996 to 2010, all three repair techniques showed a declining trend after 2010. The declining IR was driven by decreasing LEAD repair due to claudication, and by persons aged below 80 years, while the IR increased in persons aged above 80 years (p interaction<0.001). LEAD repair was more frequent in men (IRRfemale vs male, 0.78; 95% CI, 0.77-0.80), which was consistent over calendar time (p interaction=0.41). Crude mortality decreased following open/surgical repair, and increased following PTA, but all three techniques trended towards lower adjusted mortality comparing the start and the end of the study period (MRRaorto-iliac, 0.71; 95% CI, 0.54-0.93 vs MRRperipheral, 0.76; 95% CI, 0.69-0.83 vs MRRPTA, 0.96; 95% CI, 0.86-1.07). Increasing age and CCI, male sex, smoking, and care dependency associated with increased mortality. Conclusion: The incidence rate of LEAD repair decreased in Denmark from 1996 to 2018, especially in persons younger than 80 years, and primarily due to reduced revascularization for claudication. Adjusted mortality rates decreased following open surgery, but seemed unaltered following PTA.

Morbidity and mortality of common femoral endarterectomy.

OBJECTIVE: Common femoral endarterectomy (CFE) comprises the current standard-of-care for symptomatic common femoral artery occlusive disease. Although it provides effective inflow revascularization via a single incision, it remains an invasive procedure in an often-frail patient population. The purpose of this retrospective clinical study was to assess the morbidity and mortality of CFE in a contemporary cohort. METHODS: Consecutive CFEs performed at a large, urban hospital were reviewed. Six-month mortality, local complications (hematoma, lymphatic leak, pseudoaneurysm, wound infection, and/or dehiscence), and systemic complications were analyzed using univariate and multivariate analyses. RESULTS: A total of 129 isolated CFEs were performed over 7 years for claudication (36%), rest pain (16%), tissue loss (29%), or acute on chronic limb ischemia (21%). Mean age was 75 ± 9 years, and 68% of patients were male. Comorbidities were prevalent, including coronary artery disease (54%), diabetes (41%), chronic pulmonary disease (25%), and congestive heart failure (22%). The majority of CFEs were performed under general anesthesia (98%) with patch angioplasty using bovine pericardium (73% vs 27% Dacron). Twenty-two patients (17%) sustained local complications following the procedure; their occurrence was significantly associated with obesity (P = .002) but no technical or operative factors. Nineteen patients (15%) sustained serious systemic complications; their occurrence was significantly associated with chronic limb-threatening ischemia (P < .001), and a high American Society of Anesthesiologists (ASA) class (P = .002). By 6 months, 17 patients (13%) had died. Being on dialysis, presenting with chronic limb-threatening ischemia, and being in a high ASA class at the time of operation were all associated with 6-month mortality; a high ASA class at the time of operation was independently predictive of mortality (odds ratio, 3.08; 95% confidence interval, 1.03-9.24; P = .044). CONCLUSIONS: Although commonly performed, CFE is not a benign vascular procedure. Disease presentation, anesthetic risk, and expected longevity play an important role in clinical outcomes. Evolving endovascular approaches to the common femoral artery could serve to reduce morbidity and mortality in the future.

Artificial Intelligence to Predict Quality-of-Life Outcomes for Vascular Intervention of the Leg.

BACKGROUND: Artificial intelligence (AI) tools created to enhance decision-making may have a significant impact on treatment algorithms for peripheral arterial disease (PAD). A Markov-based AI model was developed to predict optimal therapy based on maximization of calculated quality of life (cQoL), a patient-centered system of assessment designed to report outcomes directly linked to health-related quality of life. STUDY DESIGN: The AI model was prospectively interrogated immediately after individual interventions for PAD over a 12-year period to test predictive performance. Patient cQoL was determined at each patient follow-up visit. RESULTS: A total of 1,143 consecutive patients were evaluated, with a median follow-up of 18 months. Observed mean annualized cQoL was higher than predicted by the model (0.85 ± 0.38 vs 0.79 ± 0.18, p < 0.0001). Of 5 potential clinical outcomes, the AI model correctly predicted final status in 71.3% of patients, with insignificant model performance deterioration over time (-0.15% per month, r = -0.49, p = 0.063). The chance of having the condition predicted by the model was 0.57 ± 0.32, compared with a theoretical maximum of 0.70 ± 0.19 (p < 0.0001, mean ratio 0.79). The AI model performed better in patients with claudication than limb-threatening ischemia (75.5% vs 63.6%, p = 0.014) but equally well for open or endovascular intervention (69.8% vs 70.5%, p = 0.70). Graft or artery patency and amputation-free survival were better for patients with claudication and those treated with endovascular techniques. CONCLUSIONS: AI can successfully predict treatment for PAD that maximizes patient quality of life in most cases. Future application of AI incorporating better estimates of patient anatomic and physiological risk factors and refinement of model structure should further enhance performance.

Revascularization for claudication: Changing the natural history of a benign disease!

OBJECTIVE: The benign natural history of intermittent claudication was first documented in 1960 and has been reconfirmed in several subsequent studies. Excellent outcomes in patients with intermittent claudication can be achieved with exercise therapy and optimal medical management. Professional society guidelines have clearly stated that revascularization procedures should be performed only in patients with incapacitating claudication who have failed conservative therapy. Despite these guidelines, revascularization procedures, primarily percutaneous interventions, have been increasingly utilized in patients with claudication. Many of these patients are not even offered an attempt at medical therapy, and those who are often do not undergo a full course of treatment. Many studies document significant reintervention rates following revascularization, which are associated with increased rates of acute and chronic limb ischemia that may result in significant rates of amputation. The objectives of this study were to compare outcomes of conservative therapy to those seen in patients undergoing revascularization procedures and to determine the impact of revascularization on the natural history of claudication. METHODS: Google Scholar and PubMed were searched for manuscripts on the conservative management of claudication and for those reporting outcomes following revascularization for claudication. RESULTS: Despite early improvement in claudication symptoms following revascularization, multiple studies have demonstrated that long-term outcomes following revascularization are often no better than those obtained with conservative therapy. High reintervention rates (up to 43% for tibial atherectomies) result in high rates of both acute and chronic limb ischemia as compared with those patients undergoing medical therapy. In addition, amputation rates as high as 11% on long-term follow-up are seen in patients undergoing early revascularization. These patients also have a higher incidence of adverse cardiovascular events such as myocardial infarctions compared with patients treated medically. CONCLUSIONS: Revascularization procedures negatively impact the natural history of claudication often resulting in multiple interventions, an increase in the incidence of acute and chronic limb ischemia, and an increased risk of amputation. Accordingly, informed consent requires that all patients undergoing early revascularization must be appraised of the potential negative impact of revascularization on the natural history of claudication.

Comparison of endovascular therapies for chronic limb-threatening ischemia and claudication.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Determination of Treatment Efficacy after Revascularization of Intermittent Claudication Patients by Physical Function Assessment.

PURPOSE: There have been few reports examining changes in physical activity (PA) after revascularization of lower extremities from the perspective of physical function at discharge. The purpose of this study was to clarify the effects of physical function before discharge on the amount of PA after discharge in patients who underwent revascularization. METHODS: The subjects were 34 Fontaine class II patients admitted for elective surgical revascularization or endovascular treatment at two hospitals from September 2017 to October 2019. Triaxial accelerometers were used to measure changes in sedentary behavior (SB) before admission and 1 month after discharge. Multiple regression analysis was performed on the 6-min walking distance (6MWD) at the time of discharge and the change in SB 1 month after discharge; the cutoff value was calculated from the receiver operating characteristic (ROC) curve. RESULTS: SB 1 month after discharge significantly decreased in the decreased SB group compared to the increased SB group (575.5 [400-745.2] vs. 649.5 [453.8-809.2], p <0.01). ROC curve was plotted with SB increase/decrease as the dependent variable and 6MWD at discharge as the independent variable; the cutoff value was 357.5 m. CONCLUSION: 6MWD measurement at discharge may help predict changes in SB after discharge.

Outcomes of lower extremity revascularization in octogenarians and nonagenarians for intermittent claudication.

OBJECTIVE: Revascularization for intermittent claudication (IC) due to infrainguinal peripheral arterial disease (PAD) is dependent on durability and expected benefit. We aimed to assess outcomes for IC interventions in octogenarians and nonagenarians (age ≥80 years) and those younger than 80 years (age <80 years). METHODS: The Vascular Quality Initiative was queried (2010-2020) for peripheral vascular interventions (PVIs) and infrainguinal bypasses (IIBs) performed to treat IC. Baseline characteristics, procedural details, and outcomes were analyzed (comparing age ≥80 years and age <80 years). RESULTS: There were 84,210 PVIs (12.1% age ≥80 years and 87.9% age <80 years) and 10,980 IIBs (7.4% age ≥80 years and 92.6% age <80 years) for IC. For PVI, patients aged ≥80 years more often underwent femoropopliteal (70.7% vs 58.1%) and infrapopliteal (19% vs 9.3%) interventions, and less often iliac interventions (32.1% vs 48%) (P < .001 for all). Patients aged ≥80 years had more perioperative hematomas (3.5% vs 2.4%) and 30-day mortality (0.9% vs 0.4%) (P < .001). At 1-year post-intervention, the age ≥80 years cohort had fewer independently ambulatory patients (80% vs 91.5%; P < .001). Kaplan-Meier analysis showed patients aged ≥80 years had lower reintervention/amputation-free survival (81.4% vs 86.8%), amputation-free survival (87.1% vs 94.1%), and survival (92.3% vs 96.8%) (P < .001) at 1-year after PVI. Risk adjusted analysis showed that age ≥80 years was associated with higher reintervention/amputation/death (hazard ratio [HR], 1.22; 95% confidence interval [CI], 1.1-1.35), amputation/death (HR, 1.85; 95% CI, 1.61-2.13), and mortality (HR, 1.92; 95% CI, 1.66-2.23) (P < .001 for all) for PVI. For IIB, patients aged ≥80 years more often had an infrapopliteal target (28.4% vs 19.4%) and had higher 30-day mortality (1.3% vs 0.5%), renal failure (4.1% vs 2.2%), and cardiac complications (5.4% vs 3.1%) (P < .001). At 1 year, the age ≥80 years group had fewer independently ambulatory patients (81.7% vs 88.8%; P = .02). Kaplan-Meier analysis showed that the age ≥80 years cohort had lower reintervention/amputation-free survival (75.7% vs 81.5%), amputation-free survival (86.9% vs 93.9%), and survival (90.4% vs 96.5%) (P < .001 for all). Risk-adjusted analysis showed age ≥80 years was associated with higher amputation/death (HR, 1.68; 95% CI, 1.1-2.54; P = .015) and mortality (HR, 1.85; 95% CI, 1.16-2.93; P = .009), but not reintervention/amputation/death (HR, 1.1; 95% CI, 0.85-1.44; P = .47) after IIB. CONCLUSIONS: Octogenarians and nonagenarians have greater perioperative morbidity and long-term ambulatory impairment, limb loss, and mortality after PVI and IIB for claudication. Risks of intervention on elderly patients with claudication should be carefully weighed against the perceived benefits of revascularization. Medical and exercise therapy efforts should be maximized in this population.

Enhancing Functional Efficiency and Quality of Life through Revascularization Surgery in Peripheral Arterial Disease: A Comparative Analysis of Objective and Subjective Indicators.

BACKGROUND This study aimed to compare the ankle-brachial index (ABI), maximal claudication distance (MCD), pain-free walking distance (PFWD), claudication pain, and quality of life (intermittent claudication questionnaire [ICQ]) before and 3 months after revascularization surgery in 98 patients diagnosed with peripheral arterial disease (PAD) at a single center in Poland. MATERIAL AND METHODS Ninety-eight patients were examined (77% men, 23% women, 65.65±7.27 years old), diagnosed with PAD, and qualified for revascularization. The diagnosis of PAD was made on the basis of ABI ≤0.9 and medical records. The patients underwent a noninvasive examination, including measurement of ABI (by Doppler with the EZ8 probe), assessment of the quality of life by ICQ, distance of intermittent claudication on a treadmill using the Gardner-Skinner protocol (including PFWD and MCD), and pain intensity during walking (numeric rating scale [NRS11]). The assessment was carried out twice: 1 to 5 days before surgery and 3 months after surgery. RESULTS There was an increase of ABI (0.4 vs 0.62, P<0.001), PFWD (26.64 vs 80.21, P<0.001), MCD (60.08 vs 181.85, P<0.001), and ICQ (79.92 vs 60.23, P<0.001) and reduction of PFWD pain (7.26 vs 6.05, P<0.001) and MCD pain (9.24 vs 8.11, P<0.001). CONCLUSIONS Revascularization surgery improved the ABI and patients functional efficiency expressed in the improvement of subjective indicators PFWD, MCD, NRS11, and ICQ. Patients who had a longer duration of disease had worse outcomes after revascularization. More attention should be paid to increasing access to preventive examinations aimed at early detection of PAD and the possibility of implementing conservative treatment.

Duplex ultrasound for surveillance of lower limb revascularisation.

BACKGROUND: Lower extremity atherosclerotic disease (LEAD) - also known as peripheral arterial disease - refers to the obstruction or narrowing of the large arteries of the lower limbs, most commonly caused by atheromatous plaque. Although in many cases of less severe disease patients can be asymptomatic, the major clinical manifestations of LEAD are intermittent claudication (IC) and critical limb ischaemia, also known as chronic limb-threatening ischaemia (CLTI). Revascularisation procedures including angioplasty, stenting, and bypass grafting may be required for those in whom the disease is severe or does not improve with non-surgical interventions. Maintaining vessel patency after revascularisation remains a challenge for vascular surgeons, since approximately 30% of vein grafts may present with restenosis in the first year due to myointimal hyperplasia. Restenosis can also occur after angioplasty and stenting. Restenosis and occlusions that occur more than two years after the procedure are generally related to progression of the atherosclerosis. Surveillance programmes with duplex ultrasound (DUS) scanning as part of postoperative care may facilitate early diagnosis of restenosis and help avoid amputation in people who have undergone revascularisation. OBJECTIVES: To assess the effects of DUS versus pulse palpation, arterial pressure index, angiography, or any combination of these, for surveillance of lower limb revascularisation in people with LEAD. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 February 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared DUS surveillance after lower limb revascularisation versus clinical surveillance characterised by medical examination with pulse palpation, with or without any other objective test, such as arterial pressure index measures (e.g. ankle-brachial index (ABI) or toe brachial index (TBI)). Our primary outcomes were limb salvage rate, vessel or graft secondary patency, and adverse events resulting from DUS surveillance. Secondary outcomes were all-cause mortality, functional walking ability assessed by walking distance, clinical severity scales, quality of life (QoL), re-intervention rates, and functional walking ability assessed by any validated walking impairment questionnaire. We presented the outcomes at two time points: two years or less after the original revascularisation (short term) and more than two years after the original revascularisation (long term). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We used the Cochrane RoB 1 tool to assess the risk of bias for RCTs and GRADE to assess the certainty of evidence. We performed meta-analysis when appropriate. MAIN RESULTS: We included three studies (1092 participants) that compared DUS plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation and arterial pressure index (ABI or TBI) for surveillance of lower limb revascularisation with bypass. One study each was conducted in Sweden and Finland, and the third study was conducted in the UK and Europe. The studies did not report adverse events resulting from DUS surveillance, functional walking ability, or clinical severity scales. No study assessed surveillance with DUS scanning after angioplasty or stenting, or both. We downgraded the certainty of evidence for risk of bias and imprecision. Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (short-term time point) In the short term, DUS surveillance may lead to little or no difference in limb salvage rate (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.49 to 1.45; I² = 93%; 2 studies, 936 participants; low-certainty evidence) and vein graft secondary patency (RR 0.92, 95% CI 0.67 to 1.26; I² = 57%; 3 studies, 1092 participants; low-certainty evidence). DUS may lead to little or no difference in all-cause mortality (RR 1.11, 95% CI 0.70 to 1.74; 1 study, 594 participants; low-certainty evidence). There was no clear difference in QoL as assessed by the 36-item Short Form Health Survey (SF-36) physical score (mean difference (MD) 2 higher, 95% CI 2.59 lower to 6.59 higher; 1 study, 594 participants; low-certainty evidence); the SF-36 mental score (MD 3 higher, 95% CI 0.38 lower to 6.38 higher; 1 study, 594 participants; low-certainty evidence); or the EQ-5D utility score (MD 0.02 higher, 95% CI 0.03 lower to 0.07 higher; 1 study, 594 participants; low-certainty evidence). DUS may increase re-intervention rates when considered any therapeutic intervention (RR 1.38, 95% CI 1.05 to 1.81; 3 studies, 1092 participants; low-certainty evidence) or angiogram procedures (RR 1.53, 95% CI 1.12 to 2.08; 3 studies, 1092 participants; low-certainty evidence). Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (long-term time point) One study reported data after two years, but provided only vessel or graft secondary patency data. DUS may lead to little or no difference in vessel or graft secondary patency (RR 0.83, 95% CI 0.19 to 3.51; 1 study, 156 participants; low-certainty evidence). Other outcomes of interest were not reported at the long-term time point. AUTHORS' CONCLUSIONS: Based on low certainty evidence, we found no clear difference between DUS and standard surveillance in preventing limb amputation, morbidity, and mortality after lower limb revascularisation. We found no studies on DUS surveillance after angioplasty or stenting (or both), only studies on bypass grafting. High-quality RCTs should be performed to better inform the best medical surveillance of lower limb revascularisation that may reduce the burden of peripheral arterial disease.

Long-Term Patient Outcomes After Femoropopliteal Peripheral Vascular Intervention in Patients With Intermittent Claudication.

BACKGROUND: In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates. OBJECTIVES: The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC. METHODS: From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression. RESULTS: The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only. CONCLUSIONS: IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation.

Patient Related Outcomes After Receiving a Person Centred Nurse Led Follow Up Programme Among Patients Undergoing Revascularisation for Intermittent Claudication: A Secondary Analysis of a Randomised Clinical Trial.

OBJECTIVE: The aim was to evaluate the effect of a person centred nurse led follow up programme on health related quality of life (HRQoL), health literacy, and general self efficacy compared with standard care for patients undergoing revascularisation for intermittent claudication (IC), and to describe factors associated with HRQoL one year after revascularisation. METHODS: This was a secondary analysis of a randomised controlled trial. Patients with IC scheduled for revascularisation at two vascular surgery centres in Sweden between 2016 and 2018 were randomised to intervention or control. During the first year after surgery, the intervention group received a person centred follow up programme with three visits and two telephone calls with a vascular nurse, while the control group received standard follow up with two visits to a vascular surgeon or vascular nurse. Outcomes were HRQoL measured by VascuQol-6, health literacy, and general self efficacy measured by validated questionnaires. RESULTS: Overall, 214 patients were included in the trial; this secondary analysis comprised 183 patients who completed the questionnaires. One year after revascularisation, HRQoL had improved with a mean increase in VascuQol-6 of 7.0 scale steps (95% CI 5.9 - 8.0) for the intervention and 6.0 scale steps (95% CI 4.9 - 7.0) for the control group; the difference between the groups was not significant (p = .18). In an adjusted regression analysis, the intervention was associated with higher VascuQoL-6 (2.0 scale steps, 95% CI 0.08 - 3.93). There was no significant difference between the groups regarding health literacy or general self efficacy. The prevalence of insufficient health literacy among all participants was 38.7% (46/119) at baseline and 43.2% (51/118) at one year. CONCLUSION: In this study, a person centred, nurse led follow up programme had no significant impact on HRQoL, health literacy, or general self efficacy among patients undergoing revascularisation for IC. The prevalence of insufficient health literacy was high and should be addressed by healthcare givers and researchers.

Long-term outcomes after lower extremity bypass in the actively smoking claudicant.

OBJECTIVE: Smoking is known to increase complications, including poor wound healing, coagulation abnormalities, and cardiac and pulmonary ramifications. Across specialties, elective surgical procedures are commonly denied to active smokers. Given the base population of active smokers with vascular disease, smoking cessation is encouraged but is not required the way it is for elective general surgery procedures. We aim to study the outcomes of elective lower extremity bypass (LEB) in actively smoking claudicants. METHODS: We queried the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network LEB database from 2003 to 2019. In this database we found 609 (10.0%) never smokers (NS), 3388 (55.3%) former smokers (FS), and 2123 (34.7%) current smokers (CS) who underwent LEB for claudication. We performed two separate propensity score matches without replacement on 36 clinical variables (age, gender, race, ethnicity, obesity, insurance, hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, previous coronary artery bypass graft, carotid endarterectomy, major amputation, inflow treatment, preoperative medications and treatment type), one of FS to NS and a second analysis of CS to FS. Primary outcomes included 5-year overall survival (OS), limb salvage (LS), freedom from reintervention (FR), and amputation-free survival (AFS). RESULTS: Propensity score matches resulted in 497 well-matched pairs of NS and FS. In this analysis we found no difference in terms of OS (HR, 0.93; 95% CI, 0.70-1.24; P = .61), LS (HR, 1.07; 95% CI, 0.63-1.82; P = .80), FR (HR, 0.9; 95% CI,0.71-1.21; P = .59), or AFS (HR, 0.93; 95% CI,0.71-1.22; P = .62). In the second analysis, we had 1451 well-matched pairs of CS and FS. There was no difference in LS (HR, 1.36; 95% CI,0.94-1.97; P = .11) or FR (HR, 1.02; 95% CI,0.88-1.19; P = .76). However, we did find a significant increase in OS (HR, 1.37; 95% CI,1.15-1.64, P <.001) and AFS (HR, 1.38; 95% CI,1.18-1.62; P < .001) in FS compared with CS. CONCLUSIONS: Claudicants represent a unique nonemergent vascular patient population that may require LEB. Our study found that FS have better OS and AFS when compared with CS. Additionally, FS mimic nonsmokers at 5-year outcomes for OS, LS, FR, and AFS. Therefore, structured smoking cessation should be a more prominent part of vascular office visits before elective LEB procedures in claudicants.