Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication.

BACKGROUND: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.

Adherence and Persistence to Antiplatelet Therapy in Lower Extremity Peripheral Arterial Disease: A Danish Population Based Cohort Study.

OBJECTIVE: Adherence to antiplatelet therapy is recommended but unexplored in patients with symptomatic lower extremity peripheral arterial disease (PAD). Therefore, this study aimed to determine adherence and persistence to antiplatelet therapy in patients with PAD, defined as intermittent claudication and chronic limb threatening ischaemia. DESIGN: Population based nationwide cohort study. METHODS: This study included all Danish citizens aged ≥ 40 years with a first inpatient or outpatient diagnosis of symptomatic PAD between 2010 - 2017, and who had at least one prescription claim for aspirin and/or clopidogrel within 90 days after diagnosis. Adherence was determined by the proportion of days covered (PDC) during the first year after diagnosis. Persistence was defined as no treatment gap ≥ 30 days between prescription renewals over three year follow up. RESULTS: A total of 39 687 patients were eligible for inclusion, of whom 23 279 (58.7%) claimed a prescription for aspirin and/or clopidogrel within 90 days of diagnosis. Among these, 12 898 (55.4%) were prevalent users, while the remainder comprised new users who initiated the therapy after the index PAD diagnosis. The mean PDC was 74.5% (SD 35.0%) for prevalent users and 60.5% (SD 30.5%) for new users. Adherence increased with age and number of concomitant drugs. The overall one year cumulative incidence treatment discontinuation was 13.0% (95% CI 12.5 - 13.4%) overall, 17.2% (CI 16.6 - 17.9%) for prevalent users, and 7.9% (CI 7.4 - 8.4%) for new users. At three year follow up, the cumulative incidence of discontinuation was 31.5% (CI 30.9 - 32.2%) overall, 44.6% (CI 43.7 - 45.4%) for prevalent users, and 14.6% (CI 13.9 - 15.3) for new users. CONCLUSION: Less than 60% of patients with newly diagnosed symptomatic PAD claimed a prescription for antiplatelet therapy within 90 days of diagnosis, and both adherence and persistence were moderate during the first year after diagnosis. These findings underscore the importance of efforts to improve the initiation and continuation of antiplatelet therapy in patients with PAD.

In-patient characteristics of peripheral artery disease in Germany.

Background: Peripheral artery disease (PAD) frequently leads to hospital admission. Sex related differences in in-patient care are a current matter of debate. Patients and methods: Data were provided from the German national in-patient sample provided by the Federal Bureau of Statistics (DESTATIS). Trends on risk profiles, therapeutic procedures, and outcomes were evaluated from 2014 until 2019 stratified by sex and PAD severity. Results: Two-thirds of an annual >191,000 PAD in-patient cases applied to male sex. Chronic limb-threatening ischemia (CLTI) was recorded in 49.6% of male and 55.2% of female cases (2019). CLTI was as a major risk factor of in-hospital amputation (OR 229) and death (OR 10.5), whereas endovascular revascularisation (EVR) with drug-coated devices were associated with decreased risk of in-hospital amputation (OR 0.52; all p<0.001). EVR applied in 47% of CLTI cases compared to 71% in intermittent claudication (IC) irrespective of sex. In-hospital mortality was 4.3% in male vs. 4.8% in female CLTI cases, minor amputations 18.4% vs. 10.9%, and major amputation 7.5% vs. 6.0%, respectively (data 2019; all p<0.001). After adjustment, female sex was associated with lower risk of amputation (OR 0.63) and death (OR 0.96) during in-patient stay. Conclusions: Male PAD patients were twice as likely to be admitted for in-patient treatment despite equal PAD prevalence in the general population. Among in-patient cases, supply with invasive therapy did not relevantly differ by sex, however is strongly reduced in CLTI. CLTI is a major risk factor of adverse short-term outcomes, whereas female sex was associated with lower risk of in-patient amputation and/or death.

Relationship Between the Severity of Exercise Induced Ischaemia and the Prevalence of Exercise Induced Calf Symptoms During Treadmill Testing With Transcutaneous Oximetry.

OBJECTIVE: It was hypothesised that there is a linear relationship between the severity of exercise induced calf ischaemia and the prevalence of calf claudication on a treadmill until a plateau is reached. It was expected that no pain would be present in the absence of ischaemia and all severely ischaemic calves would be symptomatic. METHODS: This was a retrospective analysis of a cross sectional acquired database recording. Transcutaneous oxygen pressure (TcPO2) on the chest and on each calf was used to evaluate calf ischaemia during treadmill tests with simultaneous recording of calf pain in 7 884 subjects (15 768 calves). The minimum value of calf changes from rest minus chest changes from rest (DROPm) was calculated. Regression analyses were used to determine the correlation between the proportion of exercise induced symptoms present in the calves and each unit of DROPm values. Analysis was repeated after objective determination of the cutoff point between the linear increase and the plateau. RESULTS: A linear relationship was found between the degree of ischaemia and the proportion of symptomatic calves for DROPm values ranging from 0 mmHg to -28 mmHg (proportion = -0.014 × DROPm + 0.32, r = 0.961, p <.001). For DROPm values lower than -28 mmHg (severe ischaemia), on average one of three limbs remained asymptomatic. The biphasic relationship between DROPm and prevalence of symptoms persists after exclusion of patients with diabetes mellitus, exercise induced hypoxaemia, and no evidence of lower extremity arterial disease (LEAD). CONCLUSION: The relationship between exercise induced pain and ischaemia is biphasic with a linear increase in the proportion of symptomatic limbs with ischaemia severity, until a plateau is reached for the more severely ischaemic limbs. The presence of exercise related calf symptoms should not automatically be reported as indicating the presence of LEAD; and the absence of exercise induced symptoms is not proof that ischaemia does not occur during exercise.

Risk factors for failed back surgery syndrome following open posterior lumbar surgery for degenerative lumbar disease.

BACKGROUND: With the growing number of traditional posterior open surgery, the incidence of failed back surgery syndrome (FBSS) increases gradually. We aimed to investigate the incidence and risk factors for FBSS following open posterior lumbar surgery for degenerative lumbar disease (DLD). METHOD: A multivariable regression analysis was performed for 333 consecutive patients to identify potential risk factors for FBSS. Clinical outcomes were evaluated by the validated North American Spine Society (NASS) Questionnaire and numerical rating scale (NRS) for pain. Demographics, diagnostic characteristics, surgical data, radiographic parameters for each patient were analyzed. RESULT: 16.8% of the included patients were classified as FBSS. Univariate analysis showed that age, hypertension, symptom location, intermittent claudication, preoperative pain NRS-leg, HIZ, Modic changes (MCs), surgical strategy and postoperative rehabilitation were related to FBSS. Multivariable logistic regression analysis demonstrated that preoperative NRS-leg (OR:0.80, 95%CI:0.71-0.91, P = 0.001), hypertension (OR: 2.22, 95%CI: 1.10-4.51, P = 0.027), intermittent claudication with waking distance > 100 m (OR: 4.07, 95%CI: 1.75-9.47, P = 0.001) and waking distance ≤ 100 m (OR: 12.43, 95%CI: 5.54-27.92, P < 0.001), HIZ (OR: 8.26, 95%CI: 4.00-17.04, P < 0.001), MCs (OR: 3.41, 95%CI: 1.73-6.71, P < 0.001), postoperative rehabilitation (OR: 2.63, 95%CI: 1.13-6.12, P = 0.024) were risk factors for FBSS. CONCLUSION: Open posterior lumbar surgery is an effective treatment for DLD which provides pain reduction and lumbar curve improvement with a considerable satisfaction rate. Lower preoperative NRS-leg, hypertension, intermittent claudication, HIZ, MCs and postoperative rehabilitation are risk factors for FBSS, which can serve as a tool for clinicians to identify at-risk population and provide more effective management to mitigate the doctor-patient contradictions and further occupation of medical resources.

Poor patient awareness of peripheral arterial disease, it is time to optimize the clinical visit.

INTRODUCTION: Peripheral arterial disease (PAD) is a growing public health burden. The development and progression of PAD is influenced by vascular risk factor management and lifestyle changes. However, public awareness of PAD is low compared with other conditions such as heart disease and stroke, which have been the subject of widespread public health campaigns. This study aimed to determine current levels of PAD awareness among hospital patients. METHODS: This cross-sectional, tertiary hospital-based, descriptive study was conducted over 6 months in 2019. Two investigators administered the survey in face-to-face interviews to patients attending 3 different hospital-based settings including vascular clinics (VC), cardiology clinics (CVC), and Emergency Department (ED). RESULTS: A total of 150 patients were interviewed. Participants demonstrated low overall awareness of vascular disease (32% PAD and 21% AAA) compared to cardiovascular disease including stroke (71%) and myocardial infarction (63%). Awareness of PAD was higher in vascular patients (51%) compared to CVC and ED patients (p=<0.01). Of the total population, 77% and 71% identified the contributory role of smoking and limited exercise to the development of PAD respectively. VC patients were more informed of intermittent claudication (78%) and amputation (80%) (p < 0.01) compared to CVC and ED patients. CONCLUSION: In the global drive to reduce vascular morbidity, this study highlights the poor knowledge of PAD among the public. In addition, there is poor awareness about the incidence, risk factors and complications of PAD. These results highlight the need for accessible and easily understood information regarding PAD in both the clinic setting and public health campaigns.

Association between meeting daily step count goals with ambulatory function and quality of life in patients with claudication.

OBJECTIVE: To determine (a) whether patients with peripheral artery disease (PAD) who walked at least 7000 and 10,000 steps/day had better ambulatory function and health-related quality of life (HRQoL) than patients who walked less than 7000 steps/day, and (b) whether differences in ambulatory function and HRQoL in patients grouped according to these daily step count criteria persisted after adjusting for covariates. METHODS: Two hundred forty-eight patients were assessed on their daily ambulatory activity for 1 week with a step activity monitor, and were grouped according to daily step count targets. Patients who took fewer than 7000 steps/day were included in group 1 (n = 153), those who took 7000 to 9999 steps/day were included in group 2 (n = 57), and patients who took at least 10,000 steps/day were included in group 3 (n = 38). Primary outcomes were the 6-minute walk distance (6MWD) and Walking Impairment Questionnaire (WIQ) distance score, which is a disease-specific measurement of HRQoL. Patients were further characterized on demographic variables, comorbid conditions, and cardiovascular risk factors. RESULTS: The groups were significantly different on ankle-brachial index (P = .02), and on the prevalence of hypertension (P = .04), diabetes (P < .01), abdominal obesity (P < .01), arthritis (P = .04), and chronic obstructive pulmonary disease (P < .01). Thus, these variables served as covariates in adjusted analyses, along with age, weight, and sex. The 6MWD (mean ± standard deviation) was significantly different among the groups in unadjusted (P < .01) and adjusted (P < .01) analyses (group 1, 313 ± 90 m; group 2, 378 ± 84 m; and group 3, 414 ± 77 m), with groups 2 and 3 having a higher 6MWD than group 1 (P < .01). The WIQ distance score was significantly different among the groups in unadjusted (P < .01) and adjusted (P < .01) analyses (group 1, 30 ± 30%; group 2, 45 ± 35%; and group 3, 47 ± 34%), with groups 2 and 3 having higher WIQ distance scores than group 1 (P < .01). CONCLUSIONS: Patients with PAD who walked more than 7000 and 10,000 steps/day had greater ambulatory function and HRQoL than patients who walked fewer than 7000 steps/day. Second, the greater ambulatory function and HRQoL associated with walking 7000 and 10,000 steps/day persisted after adjusting for covariates. This study provides preliminary evidence that patients with PAD who walk more than 7000 steps/day have better ambulatory function and HRQoL than patients below this threshold.

A systematic review and meta-analysis of gender differences in long-term mortality and cardiovascular events in peripheral artery disease.

OBJECTIVE: Individual studies of peripheral artery disease (PAD) have indicated that gender discrepancies exist in the symptoms, functional status, and treatment usage. It remains uncertain whether these discrepancies result in different long-term outcomes. We examined the potential gender differences in mortality and major adverse cardiovascular events (MACE) in patients with symptomatic PAD. METHODS: The PubMed and Embase databases were searched for studies from 2000 to January 2019. After a review of 13,582 citations, 14 articles were analyzed. The reported age-adjusted hazard ratios (HRs) for gender differences in mortality and MACE were included in the meta-analysis. The mortality outcomes were stratified according to the clinical presentation and study context. RESULTS: Male gender was associated with a greater risk of all-cause mortality (HR, 1.13; 95% confidence interval [CI], 1.10-1.16; P < .001) and MACE (HR, 1.10; 95% CI, 1.06-1.14; P < .001). In a stratified analysis, male gender was associated with a higher mortality risk for patients presenting with either critical limb ischemia (HR, 1.08; 95% CI, 1.05-1.10; P < .001) or mixed clinical presentations (HR, 1.16; 95% CI, 1.11-1.21; P < .001) but not for those with intermittent claudication (HR, 1.13; 95% CI, 0.98-1.30; P = .09). Elevated mortality risk was evident after revascularization (HR, 1.11; 95% CI, 1.04-1.19; P = .003), hospitalization (HR, 1.15; 95% CI, 1.08-1.22; P < .001), and amputation (HR, 1.09; 95% CI, 1.08-1.10; P < .001), although not in outpatient clinics (HR, 1.13; 95% CI, 0.97-1.32; P = .13), in men compared with women. CONCLUSIONS: Greater mortality and MACE rates in men with PAD occurred despite other accepted gender disparities. The mechanisms underlying these gender differences in the outcomes for PAD patients require further investigation.

Association of state tobacco control policies with active smoking at the time of intervention for intermittent claudication.

OBJECTIVE: Active smoking among patients undergoing interventions for intermittent claudication (IC) is associated with poor outcomes. Notwithstanding, current levels of active smoking in these patients are high. State-level tobacco control policies have been shown to reduce smoking in the general US population. We evaluated whether state cigarette taxes and 100% smoke-free workplace legislation are associated with active smoking among patients undergoing interventions for IC. METHODS: We queried the Vascular Quality Initiative database for peripheral endovascular interventions, infrainguinal bypasses, and suprainguinal bypasses for IC. Active smoking at the time of intervention was defined as smoking within one month of intervention. We implemented difference-in-differences analysis to isolate changes in active smoking owing to cigarette taxes (adjusted for inflation) and implementation of smoke-free workplace legislation. The difference-in-differences models estimated the causal effects of tobacco policies by adjusting for concurrent temporal trends in active smoking unrelated to cigarette taxes or smoke-free workplace legislation. The models controlled for age, sex, race/ethnicity, insurance type, diabetes, chronic obstructive pulmonary disease, state, and year. We tested interactions of taxes with age and insurance. RESULTS: Data were available for 59,847 patients undergoing interventions for IC in 25 states from 2011 to 2019. Across the study period, active smoking at the time of intervention decreased from 48% to 40%. Every $1.00 cigarette tax increase was associated with a 6-percentage point decrease in active smoking (95% confidence interval, -10 to -1 percentage points; P = .02), representing an 11% decrease relative to the baseline proportion of patients actively smoking. The effect of cigarettes taxes was greater in older patients and those on Medicare. Among patients aged 60 to 69 and 70 to 79 years, every $1.00 tax increase resulted in 14% and 21% reductions in active smoking relative to baseline subgroup prevalences of 53% and 29%, respectively (P < .05 for both); however, younger age groups were not affected by tax increases. Among insurance groups, only patients on Medicare exhibited a significant change in active smoking with every $1.00 tax increase (an 18% decrease relative to a 33% baseline prevalence; P = .01). The number of states implementing smoke-free workplace legislation increased from 9 to 14 by 2019; however, this policy was not significantly associated with active smoking prevalence. At follow-up (median, 12.9 months), $1.00 tax increases were still associated with decreased smoking prevalence (a 25% decrease relative to a 33% baseline prevalence; P < .001). CONCLUSIONS: Cigarette tax increases seem to be an effective strategy to decrease active smoking among patients undergoing interventions for IC. Older patients and Medicare recipients are the most responsive to tax increases.

Trends and causes of readmission following peripheral vascular intervention in patients with peripheral vascular disease.

OBJECTIVES: To study the risk factors associated with 30-readmission postperipheral vascular intervention (PVI) in peripheral artery disease (PAD). BACKGROUND: There has been a paucity of data regarding the trend and predictors of PVI readmission. METHODS: We performed an observational cohort study of patients admitted with peripheral vascular disease for PVI using the NRD for the years 2010-2014. PVI was defined as angioplasty, atherectomy, and/or stenting of lower limb vessels. RESULTS: A total of 453,278 patients (30-day readmission n = 97,235). The mean age of study population was 68.6 ± 12.2 years and included 43.8% women. The 30-day readmission post-PVI was 21.5% (p = .034). Cardiovascular causes constitute 44% of readmission. Chronic limb ischemia and intermittent claudication were two most common cardiovascular causes constituting 11.7 and 4.9% cases of readmissions. Other cardiac causes of readmissions included heart failure (4.64%), dysrhythmias (1.4%), and acute myocardial infarction (1.7%). The high-risk factors for of all-cause 30-day readmission were hypertension, CLI, diabetes, renal failure, dyslipidemia, smoking, chronic pulmonary disease, and atrial fibrillation (p < .005). Length-of-stay was greater than 5 days for 56.2 and 75.4% paid by Medicare. CONCLUSIONS: Our study shows an average yearly readmission rate of 21.5% post-PVI. Chronic comorbidities and prolonged hospitalization were associated with higher risk of readmission.

Fibrosis and Inflammatory Markers and Long-Term Risk of Peripheral Artery Disease: The ARIC Study.

OBJECTIVE: Inflammatory markers, such as hs-CRP (high-sensitivity C-reactive protein), have been reported to be related to peripheral artery disease (PAD). Galectin-3, a biomarker of fibrosis, has been linked to vascular remodeling and atherogenesis. However, its prospective association with incident PAD is unknown; as is the influence of inflammation on the association between galectin-3 and PAD. Approach and Results: In 9851 Atherosclerosis Risk in Communities Study participants free of PAD at baseline (1996-1998), we quantified the association of galactin-3 and hs-CRP with incident PAD (hospitalizations with PAD diagnosis [International Classification of Diseases-Ninth Revision: 440.2-440.4] or leg revascularization [eg, International Classification of Diseases-Ninth Revision: 38.18]) as well as its severe form, critical limb ischemia (PAD cases with resting pain, ulcer, gangrene, or leg amputation) using Cox models. Over a median follow-up of 17.4 years, there were 316 cases of PAD including 119 critical limb ischemia cases. Log-transformed galectin-3 was associated with incident PAD (adjusted hazard ratio, 1.17 [1.05-1.31] per 1 SD increment) and critical limb ischemia (1.25 [1.05-1.49] per 1 SD increment). The association was slightly attenuated after further adjusting for hs-CRP (1.14 [1.02-1.27] and 1.22 [1.02-1.45], respectively). Log-transformed hs-CRP demonstrated robust associations with PAD and critical limb ischemia even after adjusting for galectin-3 (adjusted hazard ratio per 1 SD increment 1.34 [1.18-1.52] and 1.34 [1.09-1.65], respectively). The addition of galectin-3 and hs-CRP to traditional atherosclerotic predictors (C statistic of the base model 0.843 [0.815-0.871]) improved the risk prediction of PAD (ΔC statistics, 0.011 [0.002-0.020]). CONCLUSIONS: Galectin-3 and hs-CRP were independently associated with incident PAD in the general population, supporting the involvement of fibrosis and inflammation in the pathophysiology of PAD.

Prevalence and Outcomes of Endovascular Infrapopliteal Interventions for Intermittent Claudication.

BACKGROUND: Although endovascular peripheral vascular interventions (PVI) are typically limited to vessels above the knee in intermittent claudication (IC), some patients have concomitant or isolated infrapopliteal disease with IC. The benefits and risks of undergoing tibial intervention remain unclear in IC patients. The purpose of this study is to evaluate the prevalence and outcomes of infrapopliteal PVI for IC. METHODS: The Vascular Quality Initiative was queried for PVI procedures performed for IC between 2003 and 2018. Patients were divided into 3 groups: isolated femoropopliteal (FP), isolated infrapopliteal (IP), and combined above and below knee interventions (COM). Multivariable logistic regression models identified predictors of minor and major amputation, as well as freedom from reintervention. Kaplan-Meier plots estimate amputation-free survival. RESULTS: We identified 34,944 PVI procedures for IC. There were 31,110 (89.0%) FP interventions, 1,045 (3.0%) IP interventions, and 2,789 (8.0%) COM interventions. Kaplan-Meier plots of amputation-free survival revealed that patients with any IP intervention had significantly higher rates of both minor and major amputation (log rank <0.001). Freedom from reintervention at 1-year was 89.2% for the FP group, 91.3% for the IP group, and 85.3% for the COM group (P < 0.0001). In multivariable analysis, factors associated with an increased risk of major amputation included isolated IP intervention (OR 6.47, 95% CI, 6.45-6.49; P < 0.0001), COM interventions (OR 2.32, 95% CI, 2.31-2.33; P < 0.0001), dialysis dependence (OR 3.34, 95% CI, 3.33-3.35; P < 0.0001), CHF (OR 1.86, 95% CI, 1.85-1.86; P = 0.021) and, nonwhite race (OR 1.64, 95% CI, 1.63-1.64; P = 0.013). CONCLUSIONS: PVI in the infrapopliteal vessels for IC is associated with higher amputation rates. This observation may suggest the need for more careful patient selection when performing PVI in patients with IC where disease extends into the infrapopliteal level.

Higher long-term cardiovascular morbidity after open surgery for intermittent claudication caused by infrainguinal atherosclerotic disease in patients with diabetes - a nationwide observational cohort study.

Background: Diabetes mellitus (DM) is a risk factor for peripheral arterial disease (PAD). Indications for open surgery in infrainguinal intermittent claudication (IC) are limited, and reports are lacking regarding outcomes in DM patients. Study aims were to compare short and long-term effects on major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, major amputation, and mortality after infrainguinal open surgery for IC in patients with and without DM, and to evaluate relationships between glycaemic control and outcomes. Methods: Nationwide observational cohort study of all patients registered in the Swedish Vascular Registry after planned infrainguinal open surgery for IC from January 1st 2010 to December 31st 2014. Patients registered in the National Diabetes Registry were compared with patients without diabetes by propensity score adjusted comparison of MACE, AMI, stroke, major amputation, and mortality. Results: After 30 days, there were no differences in MACE, AMI, stroke, major amputation, or mortality between patients with (n = 323, mean age 70.5 [SD 7.4] years, 92 [28.5%] females) and without (n = 679, mean age 69.7 years [SD 11.2], 234 [34.5%] females) DM. At last follow-up after median 5.2 years, patients with DM showed higher rates of MACE (Hazard ratio [HR] 1.33, confidence interval [CI] 1.08-1.62; p < 0.01), and AMI (HR 2.21, CI 1.46-3.35; p < 0.01) than patients without diabetes. Among DM patients, higher glycated haemoglobin (HbA1c) was associated with higher rates of MACE (HR 1.02, CI 1.00-1.03; p = 0.02), stroke (HR 1.05, CI 1.00-1.11; p = 0.04), and total mortality (HR 1.03, CI 1.01-1.06; p < 0.01), during follow-up, whereas duration of diabetes was associated with higher rate of major amputation (HR 1.08, CI 1.02-1.15; p < 0.01). Conclusions: DM patients showed higher rates of MACE and AMI in propensity score adjusted analysis five years after planned infrainguinal open surgery for IC. Higher HbA1c was associated with MACE, stroke, and total mortality in patients with DM, whereas longer duration of DM was associated with major amputation.

Trends and perioperative outcomes of patients with human immunodeficiency virus (HIV) undergoing lower extremity revascularization.

The development of highly active antiretroviral therapy (HAART) has significantly improved the life expectancy of patients with human immunodeficiency virus (HIV), but has led to the rise of chronic conditions including peripheral artery disease (PAD). However, trends and outcomes among patients with HIV undergoing lower extremity revascularization are poorly characterized. The aim of this study was to investigate the trends and perioperative outcomes of lower extremity revascularization among patients with HIV and PAD in a national database. The National Inpatient Sample (NIS) was reviewed between 2003 and 2014. All hospital admissions with a diagnosis of PAD undergoing lower extremity revascularization were stratified based on HIV status. Outcomes were assessed using propensity score matching and multivariable regression. Among all patients undergoing lower extremity revascularization for PAD, there was a significant increase in the proportion of patients with HIV from 0.21% in 2003 to 0.52% in 2014 (p < 0.01). Patients with HIV were more likely to be younger, male, and have fewer comorbidities, including coronary artery disease and diabetes, at the time of intervention compared to patients without HIV. With propensity score matching and multivariable regression, HIV status was associated with increased total hospital costs, but not length of stay, major amputation, or mortality. Patients with HIV with PAD who undergo revascularization are younger with fewer comorbidities, but have increased hospital costs compared to those without HIV. Lower extremity revascularization for PAD is safe for patients with HIV without increased risk of in-hospital major amputation or mortality, and continues to increase each year.

Inverse association of diabetes and dialysis with the severity of femoropopliteal lesions and chronic total occlusion: a cross-sectional study of 2056 cases.

BACKGROUND: This study aimed to reveal the association of diabetes mellitus and dialysis-dependent renal failure with the lesion severity and chronic total occlusion (CTO) in patients undergoing femoropopliteal endovascular therapy for intermittent claudication. METHODS: This multicenter retrospective study analyzed the data of 2056 consecutive patients with moderate to severe intermittent claudication, who underwent endovascular therapy for de novo lesions in the superficial femoral artery to the proximal popliteal artery between 2010 and 2018 at five cardiovascular centers in Japan. The association of the clinical characteristics with severity of the lesions, as assessed by the Trans-Atlantic Inter-Society Consensus (TASC) II classification, was investigated using the ordinal logistic regression model. Their association with CTO, lesion length, and severity of calcifications was additionally analyzed using the binomial logistic regression model. RESULTS: The prevalence of diabetes mellitus and dialysis-dependent renal failure was 54.7% and 21.4%, respectively; 12.5% of the patients had lesions corresponding to TASC II class D, and 39.3% of the patients had CTO. Current smoking and severe claudication were associated with more severe lesions assessed according to the TASC II classification; diabetes mellitus and dialysis dependence were inversely associated with disease severity. The adjusted odds ratios of diabetes mellitus and dialysis dependence were 0.82 (95% confidence interval 0.70-0.97; p = 0.018) and 0.76 (0.62-0.94; p = 0.009), respectively. Diabetes mellitus and dialysis dependence were also inversely associated with CTO (both p < 0.05). Furthermore, diabetes mellitus was inversely associated with a long lesion (p < 0.05). Diabetes mellitus and dialysis dependence were positively associated with severe calcification (both p < 0.05). CONCLUSIONS: Diabetes mellitus and dialysis-dependent renal failure were inversely associated with the lesion severity, as assessed by the TASC II classification, and CTO in patients undergoing femoropopliteal endovascular therapy for intermittent claudication.

Factors Associated with Amputation after Peripheral Vascular Intervention for Intermittent Claudication.

BACKGROUND: The natural history of intermittent claudication (IC) is that only 25% of patients will experience worsening of their claudication symptoms, and only approximately 1-3% will progress to major amputation. The impact of increasing use of endovascular therapies on the natural history of IC has not been well established. The purpose of this study is to evaluate the incidence and identify predictors of major and minor amputations after peripheral vascular intervention (PVI) for IC. METHODS: A retrospective cohort of patients treated for IC was derived from the national PVI Vascular Quality Initiative database evaluating both preoperative and intraoperative variables from 2003 to 2017. We examined rates of major or minor amputations after ipsilateral PVI for IC. Multivariable logistic regression models were created to identify predictors of amputation along with Kaplan-Meier (KM) plots to estimate amputation-free survival. RESULTS: We identified 11,887 PVI procedures for patients undergoing elective treatment for IC without a previous history of lower extremity PVI or bypass. Major and minor amputations occurred at a combined rate of 1.08% (n = 128). Minor amputations occurred in 0.56% (n = 67) of patients at 1 year, whereas major amputations were reported in 0.51% (n = 61) of cases. KM plots of amputation-free survival revealed that patients with preoperative ankle brachial indexes (ABIs) <0.2 or noncompressible ABIs (>1.3) had significantly higher rates of any amputation compared with subjects with ABIs between 0.20-0.49, 0.50-0.89, and 0.90-1.30 (log rank, <0.001). Multivariate analysis showed that patients with preoperative symptomatic congestive heart failure (CHF) (odds ratio [OR], 6.48; 95% confidence interval [95% CI], 2.43-17.20; P < 0.001), American Society of Anesthesiologists (ASA) class IV (OR, 9.34; 95% CI, 1.94-44.89; P = 0.005), and nonwhite race (OR, 3.32; 95% CI, 1.50-7.36; P = 0.003) had significant increase in risk of major amputation after PVI. Odds of major or minor amputation were increased when patients underwent only a tibial-level intervention (major: OR, 6.26; 95% CI, 1.50-26.10; P = 0.012 and minor: OR, 7.04; 95% CI, 1.02-8.51; P = 0.001). CONCLUSIONS: With relation to amputation, the natural history of IC does not appear to be impacted by PVI sicker patients with higher ASA or symptomatic CHF, and those with isolated tibial interventions are at higher risk for amputation, and we cannot determine if this is due to patient substrate, presentation, or the intervention itself. Importantly, there are key prognostic preoperative and intraoperative indicators that can assist the clinician with predicting patients who are at a higher risk of amputation.

Influence of Changes in Sedentary Time on Outcomes of Supervised Exercise Therapy in Individuals with Comorbid Peripheral Artery Disease and Type 2 Diabetes.

BACKGROUND: Although supervised exercise therapy (SET) is effective in improving walking distance among adults with symptomatic peripheral artery disease (PAD), some research suggests that individuals with comorbid PAD and type 2 diabetes mellitus (T2DM) may experience a blunted response to SET. It is unknown whether free-living sedentary time changes during SET, and if increases in sedentary time could, in part, explain poor response to SET. The purposes of this pilot study were to (1) determine if older adults with PAD (with and without T2DM) engaging in SET change their sedentary behavior and (2) examine the relationship between changes in sedentary behavior and SET outcomes. We hypothesized that decreased sedentary time during SET would be associated with greater improvements in six-minute walk test (6MWT) total distance and other key SET outcomes. METHODS: Participants (n = 44) initiating a 12-week SET program completed the 6MWT, Short Physical Performance Battery, Walking Impairment Questionnaire, and accelerometer-assessed sedentary behavior at SET initiation, 6 weeks, and 12 weeks. RESULTS: Participants' mean age was 72.3 (7.1) years, mean ankle-brachial index was 0.71 (0.25), and 47.7% were female. On average, sedentary time did not change after SET, although there was substantial variability (-40% to +38% change in minutes of sedentary time/day). Participants with T2DM experienced greater improvements in claudication onset distance than participants without T2DM (mean = 35 m, P = 0.044, 95% confidence interval = 1.6 to 115.4 m). Neither changes in sedentary time from baseline to 6 weeks (P = 0.419) nor T2DM (P = 0.154) predicted changes in 6MWT total distance from baseline to 12 weeks. CONCLUSIONS: As SET availability increases, further examination of factors that may influence SET outcomes will help maximize benefits of this proven therapy.

A systematic review and meta-analysis of the effects of supervised exercise therapy on modifiable cardiovascular risk factors in intermittent claudication.

OBJECTIVE: Cardiovascular events, such as myocardial infarction and stroke, contribute significantly to the prognosis of patients with peripheral artery disease. Therefore cardiovascular risk reduction is a vital element of treatment in patients with intermittent claudication (IC). The cardiovascular risk is largely determined by modifiable risk factors, which can be treated with medical care and lifestyle adjustments, such as increasing physical activity. The objective of this study was to determine the effects of supervised exercise therapy (SET) on modifiable cardiovascular risk factors in IC patients. METHODS: This is a systematic review and meta-analysis of prospective studies on the effects of SET on cardiovascular risk factors in symptomatic IC patients. Studies were eligible if they presented baseline and follow-up values for at least one of the following risk factors: blood pressure (systolic or diastolic), heart rate, lipid profile (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol), glucose, glycated hemoglobin, body weight, body mass index, or cigarette smoking. Pooled mean differences between follow-up and baseline were analyzed using a random-effects model. Data were classified into short-term results (6 weeks-3 months) and midterm results (6-12 months). Statistical heterogeneity was presented as I2 and Q statistic. RESULTS: Twenty-seven studies with a total of 808 patients were included in this review. In the short term, SET resulted in significant improvements of systolic blood pressure (decrease of 4 mm Hg; 10 studies; 95% confidence interval [CI], -6.40 to -1.76; I2, 0%) and diastolic blood pressure (decrease of 2 mm Hg; 8 studies; 95% CI, -3.64 to -0.22; I2, 35%). In the midterm, SET contributed to significant lowering of levels of low-density lipoprotein cholesterol (decrease of 0.2 mmol/L; four studies; 95% CI, -0.30 to -0.12; I2, 29%) and total cholesterol (decrease of 0.2 mmol/L, four studies; 95% CI, -0.38 to -0.10; I2, 36%). No significant effects of SET were identified for heart rate, triglycerides, high-density lipoprotein cholesterol, glucose, glycated hemoglobin, body weight, body mass index, or cigarette smoking. CONCLUSIONS: This systematic review and meta-analysis shows favorable effects of SET on modifiable cardiovascular risk factors, specifically blood pressure and cholesterol levels. Despite the moderate quality, small trial sample sizes, and study heterogeneity, these findings support the prescription of SET programs not only to increase walking distances but also for risk factor modification. Future studies should address the potential effectiveness of SET to promote a healthier lifestyle and to improve cardiovascular outcomes in patients with claudication.

A systematic review and meta-analysis of risk factors for and incidence of 30-day readmission after revascularization for peripheral artery disease.

OBJECTIVE: Readmission to the hospital after revascularization for peripheral artery disease (PAD) is frequently reported. No consensus exists as to the exact frequency and risk factors for readmission. This review aimed to determine the incidence of and risk factors for 30-day readmission after revascularization for PAD. METHODS: PubMed/Medline (Ovid), Scopus, Web of Science, the Cochrane Library, and CINAHL were searched systematically from inception until May 20, 2018. Studies were eligible for inclusion if they included patients with diagnosed PAD undergoing revascularization and reported the readmission rate and a statistical evaluation of the association of at least one risk factor with readmission. Studies were excluded if data for other procedures could not be distinguished from revascularization. Two authors undertook study selection independently with the final inclusion decision resolved through consensus. The PRISMA and Meta-analyses of Observational Studies in Epidemiology guidelines were followed regarding data extraction and quality assessment, which was performed by two authors independently. Data were pooled using a random effects model. RESULTS: The primary outcome was readmission within 30 days of revascularization. Fourteen publications reporting the outcomes of 526,008 patients were included. Reported readmission rates ranged from 10.9% to 30.0% with a mean of 16.4% (95% confidence interval [CI], 15.1%-17.9%). Meta-analyses suggested the following risk factors had a significant association with readmission: female sex (odds ratio [OR], 1.13; 95% CI, 1.05-1.21), black race (OR, 1.36; 95% CI, 1.28-1.46), dependent functional status (OR, 1.72; 95% CI, 1.43-2.06), critical limb ischemia (OR, 2.12; 95% CI, 1.72-2.62), emergency admission (OR, 1.75; 95% CI, 1.43-2.15), hypertension (OR, 1.39; 95% CI, 1.26-1.54), heart failure (OR, 1.82; 95% CI, 1.50-2.20), chronic pulmonary disease (OR, 1.19; 95% CI, 1.08-1.32), diabetes (OR, 1.47; 95% CI, 1.32-1.63), chronic kidney disease (OR, 1.93; 95% CI, 1.62-2.31), dialysis dependence (OR, 2.08; 95% CI, 1.75-2.48), smoking (OR, 0.83; 95% CI, 0.78-0.89), postoperative bleeding (OR, 1.70; 95% CI, 1.23-2.35), and postoperative sepsis (OR, 4.13; 95% CI, 2.02-8.47). CONCLUSIONS: Approximately one in six patients undergoing revascularization for PAD are readmitted within 30 days of their procedure. This review identified multiple risk factors predisposing to readmission, which could potentially serve as a way to target interventions to reduce readmissions.

The Impact of Supervised Exercise Training on Traditional Cardiovascular Risk Factors in Patients With Intermittent Claudication: A Systematic Review and Meta-Analysis.

BACKGROUND: Patients with intermittent claudication (IC) are at increased risk of cardiovascular (CV) morbidity and mortality. Whereas extensive evidence supports the beneficial effects of supervised exercise training (SET) on walking capacity, little is known about the effect of SET on the CV risk profile of IC patients. Therefore, the aim was to evaluate the effects of SET on CV risk factors in IC patients by using meta-analysis techniques. METHODS: A systematic search in the electronic databases MEDLINE, EMBASE, CINAHL, and CENTRAL was conducted from the earliest date available until October 2, 2018. Randomised and non-randomised controlled trials lasting ≥ four weeks and investigating the effect of SET on CV risk factors in IC patients were included. Traditional CV risk factors were studied as primary outcomes; pain free walking distance (PFWD) and maximum walking distance (MWD) were included as secondary outcomes. Data were pooled using random effects models with summary data reported as weighted means and 95% confidence interval (CIs). RESULTS: Fifteen trials were included, involving 18 study groups (nine walking, four resistance, two aerobic training, and three combined groups), totalling 725 patients (mean age 66.3 years; mean ankle brachial index, 0.64). Exercise reduced systolic blood pressure (-5.8 mmHg; CI -9.89 to 1.67, p < .01) whereas all other CV risk factors (i.e., body weight, body mass index, diastolic blood pressure, and blood lipids) remained statistically unaltered. Exercise also improved PFWD (+132 m; CI 70-194, p < .001) and MWD (+183 m; CI 98-268, p < .001). CONCLUSION: This meta-analysis supports the beneficial effects of SET on walking capacity. Little evidence for an improvement of the CV risk profile was found following exercise in patients with IC. However, given the scarcity of data, high quality RCTs that include an assessment of CV risk factors are urgently required to determine the effect of exercise therapy in the secondary prevention of CV disease of IC patients.