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.

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.

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.

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.

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.

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.

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.

Market competition influences practice patterns in management of patients with intermittent claudication in the vascular quality initiative.

OBJECTIVE: The Society for Vascular Surgery (SVS) clinical practice guidelines recommend best medical therapy (BMT) as first-line therapy before offering revascularization to patients with intermittent claudication (IC). Notably, atherectomy and tibial-level interventions are generally discouraged for management of IC; however, high regional market competition may incentivize physicians to treat patients outside the scope of guideline-directed therapy. Therefore, we sought to determine the association between regional market competition and endovascular treatment of patients with IC. METHODS: We examined patients with IC undergoing index endovascular peripheral vascular interventions (PVI) in the SVS Vascular Quality Initiative from 2010 to 2022. We assigned the Herfindahl-Hirschman Index as a measure of regional market competition and stratified centers into very high competition (VHC), high competition, moderate competition, and low competition cohorts. We defined BMT as preoperative documentation of being on antiplatelet medication, statin, nonsmoking status, and a recorded ankle-brachial index. We used logistic regression to evaluate the association of market competition with patient and procedural characteristics. A sensitivity analysis was performed in patients with isolated femoropopliteal disease matched by the TransAtlantic InterSociety classification of disease severity. RESULTS: There were 24,669 PVIs that met the inclusion criteria. Patients with IC undergoing PVI were more likely to be on BMT when treated in higher market competition centers (odds ratio [OR], 1.07 per increase in competition quartile; 95% confidence interval [CI], 1.04-1.11; P < .0001). The probability of undergoing aortoiliac interventions decreased with increasing competition (OR, 0.84; 95% CI, 0.81-0.87; P < .0001), but there were higher odds of receiving tibial (OR, 1.40; 95% CI, 1.30-1.50; P < .0001) and multilevel interventions in VHC vs low competition centers (femoral + tibial OR, 1.10; 95% CI, 1.03-1.14; P = .001). Stenting decreased as competition increased (OR, 0.89; 95% CI, 0.87-0.92; P < .0001), whereas exposure to atherectomy increased with higher market competition (OR, 1.15; 95% CI, 1.11-1.19; P < .0001). When assessing patients undergoing single-artery femoropopliteal intervention for TransAtlantic InterSociety A or B lesions to account for disease severity, the odds of undergoing either balloon angioplasty (OR, 0.72; 95% CI, 0.625-0.840; P < .0001) or stenting only (OR, 0.84; 95% CI, 0.727-0.966; P < .0001) were lower in VHC centers. Similarly, the likelihood of receiving atherectomy remained significantly higher in VHC centers (OR, 1.6; 95% CI, 1.36-1.84; P < .0001). CONCLUSIONS: High market competition was associated with more procedures among patients with claudication that are not consistent with guideline-directed therapy per the SVS clinical practice guidelines, including atherectomy and tibial-level interventions. This analysis demonstrates the susceptibility of care delivery to regional market competition and signifies a novel and undefined driver of PVI variation among patients with claudication.

Short- and long-term outcomes after endarterectomy with autologous patching in endurance athletes with iliac artery endofibrosis.

OBJECTIVE: Endurance athletes such as cyclists may develop intermittent claudication owing to iliac artery endofibrosis after long-lasting extreme hemodynamic challenges. This study investigated short-term (<1.5 years) and long-term (>5 years) satisfaction and safety after a surgical endarterectomy and autologous patching. METHODS: Data of endurance athletes who underwent an endarterectomy for flow limitation of the iliac artery owing to endofibrosis between 1997 and 2015 in one center were studied. Maximal cycling exercise tests, ankle-brachial index with flexed hips, echo-Doppler examination (peak systolic velocity), and contrast-enhanced magnetic resonance angiography were performed before and 6 to 18 months after surgery. Short-term and long-term satisfaction were evaluated using questionnaires. Potential patch dilatation was assessed using echo-Doppler. RESULTS: Analysis of 68 patients (79 legs; 55.7% males, median age at the time of surgery, 34 years; interquartile range, 26-41 years) demonstrated that cycling workload at symptom onset improved from 226 ± 97 to 333 ± 101 (P < .001) Watts. Peak workload increased from 326 ± 111 to 352 ± 93 Watts (P < .001). Ankle-brachial index with flexed hips increased from 0.34 (interquartile range [IQR], 0.00-0.47) to 0.59 (IQR, 0.51-0.69; P < .001). Peak systolic velocity with extended and flexed hip decreased from 2.04 m·sec-1 (IQR, 1.52-2.56 m·3sec-1) to 1.25 m·sec-1 (IQR, 0.92-1.62 m·sec-1; P < .001) and 2.40 m·sec-1 (IQR, 1.81-2.81 m·sec-1) to 1.15 m·sec-1 (IQR, 0.97-1.60 m·sec-1; P < .001), respectively. Thirty-day major complication rate was 5.1% (hematoma requiring evacuation nLegs = 2, septic bleeding from deep infection nLegs = 1, and iliac occlusion requiring thrombectomy nLegs = 1). In the short term, 91.2% of patients reported symptom reduction with a 93.7% overall satisfaction rate. After a median of 11.1 years (IQR, 7.8-17.6 years), the overall satisfaction was 91.7%; 94.5% of patients reported persistent symptom reduction. Patch dilatation of >20 mm was observed in two patients. Linear mixed model analysis revealed no alarming patch dilatation in the long term. CONCLUSIONS: Endarterectomy with an autologous patch for intermittent claudication owing to iliac artery endofibrosis in endurance athletes shows high rates of patient satisfaction and symptom reduction in both the short and long term. The risk of surgical complications or patch dilatation is mild. A surgical intervention for flow limitation of the iliac artery owing to endofibrosis is safe and successful.

Indications for a "Surgery-First" Approach for the Treatment of Lower Extremity Arterial Disease.

BACKGROUND: In recent years, there has been a tendency toward an "endovascular-first" approach for the treatment for femoropopliteal arterial disease. The purpose of this study is to determine if there are patients that are better served with an initial femoropopliteal bypass (FPB) rather than an endovascular attempt at revascularization. METHODS: A retrospective analysis of all patients undergoing FPB between June 2006 - December 2014 was performed. Our primary endpoint was primary graft patency, defined as patent using ultrasound or angiography without secondary intervention. Patients with <1-year follow-up were excluded. Univariate analysis of factors significant for 5-year patency was performed using χ2 tests for binary variables. A binary logistic regression analysis incorporating all factors identified as significant by univariate analysis was used to identify independent risk factors for 5-year patency. Event-free graft survival was evaluated using Kaplan-Meier models. RESULTS: We identified 241 patients undergoing FPB on 272 limbs. FPB indication was disabling claudication in 95 limbs, chronic limb-threatening ischemia (CLTI) in 148, and popliteal aneurysm in 29. In total, 134 FPB were saphenous vein grafts (SVG), 126 were prosthetic grafts, 8 were arm vein grafts, and 4 were cadaveric/xenografts. There were 97 bypasses with primary patency at 5 or more years of follow-up. Grafts patent at 5 years by Kaplan-Meier analysis were more likely to have been performed for claudication or popliteal aneurysm (63% 5-year patency) as compared with CLTI (38%, P < 0.001). Statistically significant predictors (using log rank test) of patency over time were use of SVG (P = 0.015), surgical indication of claudication or popliteal aneurysm (P < 0.001), Caucasian race (P = 0.019) and no history of COPD (P = 0.026). Multivariable regression analysis confirmed these 4 factors as significant independent predictors of 5-year patency. Of note, there was no statistical correlation between FPB configuration (above or below knee anastomosis, in-situ versus reversed saphenous vein) and 5-year patency. There were 40 FPBs in Caucasian patients without a history of COPD receiving SVG for claudication or popliteal aneurysm that had a 92% estimated 5-year patency by Kaplan-Meier survival analysis. CONCLUSIONS: Long-term primary patency that was substantial enough to consider open surgery as a first intervention was demonstrated in Caucasian patients without COPD, having good quality saphenous vein, and who underwent FPB for claudication or popliteal artery aneurysm.

Long-Term Outcomes of Exercise Therapy Versus Revascularization in Patients With Intermittent Claudication.

OBJECTIVE: The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC). BACKGROUND: Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and noninvasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831). RESULTS: A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2-8) per 1000 person-years] and noninvasive treatment [6 (3-10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35-1.69; P =0.51, I2 =0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54-5.26; P =0.36, I2 =0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91-1.74; P =0.16, I2 =0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80-6.16; P <0.00001, I2 =83%). The results were not changed by fixed effect or random-effects models, nor by sensitivity analysis. CONCLUSIONS: Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared with noninvasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of noninvasive treatment for first-line IC therapy is supported.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication.

OBJECTIVE: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. METHODS: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. RESULTS: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain "Role Physical" (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. CONCLUSION: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

Impact of neighborhood social disadvantage on the presentation and management of peripheral artery disease.

OBJECTIVE: Studies examining the relationship between socioeconomic disparities and peripheral artery disease (PAD) often focus on individual social health determinants and fail to account for the complex interplay between factors that ultimately impact disease severity and outcomes. Area deprivation index (ADI), a validated measure of neighborhood adversity, provides a more comprehensive assessment of social disadvantage. Therefore, we examined the impact of ADI on PAD severity and its management. METHODS: We identified all patients who underwent infrainguinal revascularization (open or endovascular) or amputation for symptomatic PAD in the Vascular Quality Initiative registry between 2003 and 2020. An ADI score of 1 to 100 was assigned to each patient based on their residential zip code, with higher ADI scores corresponding with increasing adversity. Patients were categorized by ADI quintiles (Q1-Q5). The outcomes of interest included indication for procedure (claudication, rest pain, or tissue loss) and rates of revascularization (vs primary amputation). Multinomial logistic regression was used to evaluate for an independent association between ADI quintile and these outcomes. RESULTS: Among the 79,973 patients identified, 9604 (12%) were in the lowest ADI quintile (Q1), 14,961 (18.7%) in Q2, 19,800 (24.8%) in Q3, 21,735 (27.2%) in Q4, and 13,873 (17.4%) in Q5. There were significant trends toward lower rates of claudication (Q1: 39% vs Q5: 34%, P < .001), higher rates of rest pain (Q1: 12.4% vs Q5: 17.8%, P < .001) as the indication for intervention, and lower rates of revascularization (Q1: 80% vs Q5: 69%, P < .001) with increasing ADI quintiles. In adjusted analyses, there was a progressively higher likelihood of presenting with rest pain vs claudication, with patients in Q5 having the highest probability when compared with those in Q1 (relative risk: 2.0; 95% confidence interval: 1.8-2.2; P < .001). Patients in Q5, when compared with those in Q1, also had a higher likelihood of presenting with tissue loss vs claudication (relative risk: 1.4; 95% confidence interval: 1.3-1.6; P < .001). Compared with patients in Q1, patients in Q2-Q5 had a lower likelihood of undergoing any revascularization procedure. CONCLUSIONS: Among patients who underwent infrainguinal revascularization or amputation in the Vascular Quality Initiative, those with higher neighborhood adversity had more advanced disease at presentation and lower rates of revascularization. Further work is needed to better understand neighborhood factors that are contributing to these disparities in order to identify community-level targets for improvement.