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.

Association of a healthy ageing index with health-related outcomes in a multi-ethnic cohort from Singapore.

BACKGROUND: The global population is ageing rapidly and it is important to promote healthy ageing. The Healthy Ageing Index (HAI) is a comprehensive measure of health, but there is limited research on its association with other age-related outcomes. The management of an aging population necessitates considerations even among generally healthy adults, as age-related diseases often remain unaccounted for until later stages of life. This study explores the association of risk factors with HAI and its association with peripheral artery disease (PAD), muscle strength, health-related quality of life (HRQoL), and psychological distress in the Singapore Multi-Ethnic Cohort study. METHODS: This cross-sectional study involved 1909 participants (median (Q1, Q3) age: 53 (48, 60) years and 59.3% females) from Singapore Multi-Ethnic Cohort study. The risk factors of HAI included age, gender, ethnicity, education level, smoking, alcohol consumption, employment, BMI and past medical histories. PAD was assessed using ankle-brachial index (ABI), handgrip strength (HGS), HRQoL with the EQ-5D-5 L questionnaire and psychological distress via the Kessler Psychological Distress Scale (K10). HAI components were assessed using relevant marker tests. RESULTS: Older age, Malay and Indian ethnicities, unemployment, high BMI and histories of CHD, hypercholesterolaemia, tumours and TIA/stroke were associated with lower HAI scores indicative of poorer health. Higher HAI scores were associated with females and higher education levels. Lower HAI scores were significantly associated with low ABI, high K10 scores, mobility and anxiety/depression dimensions of EQ-5D-5 L. CONCLUSION: The most important factors associated with HAI were age, sex, ethnicity, education, unemployment, BMI and a history of health conditions. Lower HAI scores were significantly associated with PAD, lower HRQoL and psychological distress. Thus, the HAI demonstrates promise as an evaluation method for assessing PAD, overall muscle strength and HRQoL in a population-based setting.

Illness beliefs relation to physical activity and quality of life in patients with peripheral arterial disease.

Intermittent claudication is the most common symptom of Peripheral Arterial Disease (PAD) and is associated with decreased quality of life (QoL) due to walking impairment. The level of threat attributed to the disease affects QoL and physical activity. This study explores beliefs and illness drawings, and their relationship with quality of life and physical activity in patients undergoing conservative treatment for PAD. A cross-sectional study was carried out including 119 patients with PAD and Intermittent Claudication, in which patients were asked to freely draw their disease and 33 agreed to participate. The profile of beliefs about PAD is characterized by a low level of threat. Belief in the emotional impact of the disease, representations about the consequences and concern about the disease were associated with worse quality of life; the belief of having a high personal control over the disease was associated with more physical activity. The analysis of the disease drawings revealed three categories: extension of the disease (category 1), location and representations of the disease (category 2), and level of detail and complexity of the drawings (category 3). Greater disease extent was associated with more disease symptoms (IPQ 6) (rs = 0.399, p = .021). It is necessary to address beliefs and representations about the disease in consultations with patients with PAD. Patient drawings are a useful, practical, and free tool that does not require a lot of time and can facilitate the approach of health professionals to patient training and education.

[The quality of life of patients with atherosclerosis of lower extremities - 15-year observation]. / Jakosc zycia chorych z miazdzyca zarostowa tetnic konczyn dolnych ­ obserwacja 15-letnia.

An improving quality of life of a patient seems to be the primary goal of contemporary medicine facing the controversies arising over the duration of persistent therapy, on the one hand, and mounting costs of health care, on the other. AIM: The aim of the study was to assess the applicability of the SF-36 (Short Form Health Survey) quality-of-life scale to the evaluation of patients with lower-extremity atherosclerosis and to find a link with the new composite endpoint of the study which the quality of life predisposes to. MATERIALS AND METHODS: The patients operated on for lower-extremity atherosclerosis (y-graft) in one centre in the years 1999-2004 were invited to take part in the study. 64 out of 172 patients joined the study. The study participants were assessed for the quality of life, distance intermittent claudication and lower-extremity pulse presence. Information was also collected on their past medical history and life style. The works of the study group undertaken in 2021 thanks to cooperation with the Ministry of Digitalization allowed to determine deaths among the study participants and link them to the information collected earlier, including the quality of life. RESULTS: It was confirmed that the SF-36 scale, a tool from the group of general tools, i.e. a tool not dedicated to any particular disease, allows to perfectly assess the quality of life in the studied group of patients. The assessments obtained in the SF-36 subscales were higher for patients with an at least 10-year post-surgery survival. Yet, it is the differences observed in the analysis of the three variables, namely, social functioning (t=3.825, p<0.001), limitations due to emotional problems (t=3.496, p=0.001) and emotional well-being (t+2.179, p=0.033) that are statistically significant. CONCLUSIONS: The results of the study indicate that the main factors differentiating patients who die within 10 years from the surgery and those with an over-10 survival are primarily emotional well-being related issues.

Clinical Benefit, Harm, and Cost Effectiveness of Screening Men for Peripheral Artery Disease: A Markov Model Based on the VIVA Trial.

OBJECTIVE: Although screening for peripheral arterial disease (PAD) seems obvious due to its two to three times increased mortality, high prevalence in the elderly, ease of detection, and relatively harmless prevention, the evidence is sparse. METHODS: A Markov decision model was created to model the lifetime effectiveness and cost effectiveness of general population PAD screening and relevant intervention in 65 year old men. The model was informed by original estimates from the VIVA trial data except for ankle brachial systolic blood pressure index test accuracy, quality of life, and background mortality, which were adopted from the literature. A Markov model was designed for 65 year old men, who were distributed in the starting states of no/detected/undetected PAD. The main outcomes were life years, quality adjusted life years, and costs of healthcare. RESULTS: Screening for PAD reduced the rates of amputations and stroke by 10.9% and 2.4%, respectively, while it increased the rates of revascularisation, acute myocardial infarction, and major bleeding by 5.5%, 7.1%, and 4.3% respectively. The overall life expectancy was increased by 14 days per invited subject. The cost per life year/quality adjusted life year was estimated at €16 717/€20 673. On the addition of low dose rivaroxaban reduced the costs per life year gained by 40%. If the model ran for only five follow up years, screening reduced relative mortality by 1.71%, suggesting PAD screening accounts for one fourth of the reported overall 7% relative mortality risk reduction of combined abdominal aortic aneurysm, PAD, and hypertension screening. CONCLUSION: Screening of men for PAD is likely to be both clinically effective and cost effective in a lifetime perspective.

The Limitations of Social Behaviour Imposed by CoVid-19 Impacted the Perception and the Evolution of Peripheral Arterial Disease Negatively.

BACKGROUND: The novel acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic imposed a national lockdown at the beginning of 2020. People faced social distancing, being forced to stay at home. Peripheral arterial disease (PAD) typically influences life habits and psycho-social relationship. It is now questionable how PAD can be affected by changes in lifestyle imposed by the Sars-CoV-19 Pandemic. This study's main objective is to evaluate how the limitations of social behavior set by Sars-CoV-19 Pandemic impact the perception and evolution of the disease in a group of patients with a diagnosed PAD. METHODS: The changes in the in the perception and the evolution of the PAD were evaluated by comparing results of a modified VascuQol-6 quality of life (QoL) survey referring to the time frame defined "No-Sars-CoV-2 period" (from July to December 2019) with results referring to the time frame defined "Sars-CoV-2 period" (from January to June 2020). An overall score (range 4-60) was calculated, and a comparison between the two period studies was reported. Receiver Operating Characteristics (ROC) Curves evaluated a delta value for each patient with revascularization of lower limb peripheral arteries. Optimal cut-offs were chosen based on their specificity, sensitivity. RESULTS: One-hundred-two PAD patients gave their informed consent to take part in the study. A significant general worsening of patients PAD perception in the Sars-CoV-2 period was recorded for the following items: lower limbs health status perception; overall activity limitation; walking ability limitation; overall daily walking distance; lower limbs fatigue perception; concerns about PAD worsening; pain discomfort (P < 0.05). The pain intensity changed from 4.7 ± 2.9 in the No-Sars-CoV-2 period to 6.3 ± 2.9 in the Sars-CoV-2 period significantly (P < 0.0001), even though analgesic drug intake did not increase considerably in Sars-CoV-2 period (P = 0.15). The overall score was 20.3 ± 7.4 for the No-Sars-CoV-2 period and 27.4 ± 7.6 in the Sars-CoV-2 period (P = 0.0001). The ROC curve built to analyze the relation between Delta-score and the need for revascularization identifies a cut-off > 8.5 (Area Under the Curve 0.5436; CI 95% 0.4252 to 0.6620) with a sensitivity and specificity respectively of 52.6% (CI 95% 37.26-67.52%) and 65.6% (CI 95% 53.40-76.08%). CONCLUSIONS: Patients with PAD were significantly hit by all the restrictions and the social limitations imposed to reduce the Sars-CoV-19 virus diffusion. Our study confirms that the perception and the evolution of PAD were significantly affected during the "Sars-CoV-2 period".

Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.

BACKGROUND: Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted. METHODS: In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements. RESULTS: Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent. CONCLUSION: Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).

ANTECEDENTES: Los programas de ejercicio supervisado (supervised exercise programmes, SEP) para la claudicación intermitente (intermittent claudication, IC) tienen un acceso y un cumplimiento deficientes. La estimulación eléctrica neuromuscular (neuromuscular electrical stimulation, NMES) puede ser una alternativa clínicamente efectiva. Se realizó un estudio de prueba de concepto y un ensayo controlado aleatorizado. MÉTODOS: Estudio 1: Veinte pacientes elegibles se sometieron a una evaluación inicial que incluía una prueba en la cinta de correr para la distancia inicial de claudicación (initial claudication distance, ICD) y la distancia máxima de claudicación (maximum claudication distance, MCD), EuroQoL-5D (EQ-5D), valoración mediante el cuestionario de claudicación intermitente (intermittent claudication questionnaire, ICQ), y hemodinámica por ecografía de la arteria femoral superficial. Después de familiarizarse con el dispositivo NMES, los participantes se sometieron a una sesión de estimulación de 30 minutos con el registro concomitante de medidas hemodinámicas a los 15 minutos y después del cese del dispositivo. Se realizaron mediciones repetidas después de 6 semanas de uso diario de NMES. Estudio 2: Se reclutaron 42 pacientes que tras una evaluación inicial y posterior aleatorización al azar en línea, se asignaron al Grupo A, utilizando SEP solamente; o al el Grupo B, con tratamiento NMES complementario durante 6 semanas seguido de medidas repetidas. RESULTADOS: El estudio 1 mostró una mejoría significativa de la MCD (46%, P < 0,0001) y de la ICD (71%, P < 0.004). El ensayo clínico mostró un beneficio coadyuvante significativo de NMES en la ICD (46%, P = 0,014). Se observaron mejorías en la puntuación del ICQ (9 puntos, P < 0,01) y del EQ-5D (P < 0,05) en el estudio 1, con un beneficio coadyuvante significativo de NMES en la puntuación del ICQ (11 puntos, P < 0,05). El flujo de volumen de sangre (CC/min) y TAMV (cm/s) aumentaron significativamente con el dispositivo en funcionamiento (P < 0,05). El cumplimiento global de la NMES superó el 95%. CONCLUSIÓN: La plataforma de NMES para el pie mejora significativamente las distancias de caminar en la claudicación intermitente cuando se usa de forma independiente y también proporciona un beneficio complementario al ejercicio supervisado en la distancia caminada sin dolor. La mejora del flujo sanguíneo puede ser un mecanismo para explicar estos resultados.

Self-reported health status and disease-specific quality of life one year after treatment for peripheral arterial disease in clinical practice.

BACKGROUND: VascuQoL-6 (VQ-6) is a disease-specific quality of life (QoL) instrument validated for use in clinical practice and vascular registries before and after treatment for peripheral arterial disease (PAD). To improve future interpretation of self-reported outcome, an unselected cohort was followed through one year to provide observational data after both conservative and invasive treatment. METHODS: Consecutive patients with intermittent claudication (IC) or critical limb ischemia (CLI) were included. All patients completed VQ-6 and Short Form-36 (SF-36), and were evaluated with ankle-brachial index (ABI) measurement pre- and post-exercise, a constant load treadmill test and clinical consultation at baseline and after one year. Change statistics and correlation analysis were used to describe self-reported outcome after conservative and invasive treatment for PAD. RESULTS: One hundred seventy-one patients with peripheral arterial disease (PAD) were included, 70 (41%) female. 147 (86%) of the patients suffered from IC. 136 (80%) patients had one-year follow up, death, amputation and withdrawal were the major causes of loss to follow-up. Forty-eight patients (35%) evaluated their health to be unchanged compared to one year ago. There was a strong correlation between self-reported general health status based on SF-36 item 2 and VQ-6 summary score (Spearmans rho = - 0.536). Patients admitted to invasive intervention (endovascular or surgery) improved in all domains of SF-36, and in the physical component summary score (SF-36 PCS). Patients admitted to best medical treatment, smoking cessation and walking exercise (conservative group) improved only in the physical domains. There was significant improvement in VQ-6 summary score for both groups, mean 2.20 (95%CI 1.14-3.27) in the conservative group, 4.68 (95%CI 3.67-5.70) in the invasive group. VQ-6 sum score improved more than four points for 56% in the invasive group, 36% in the conservative group. CONCLUSIONS: Treatment for symptomatic PAD, both invasive and conservative, improves self-reported health status and disease specific QoL after one year. Interpretation of patient-reported outcome measured with VQ-6 after surgery or endovascular treatment must be seen in light of the improvement from conservative treatment alone. TRIAL REGISTRATION: ISRCTN14846962 (retrospectively registered).

Depressive symptomatology and personality traits in patients with symptomatic and asymptomatic peripheral arterial disease.

BACKGROUND: The aim of this study was to examine the relationship of depressive symptomatology and personality traits with peripheral arterial disease (PAD). METHODS: The sample of this cross-sectional study comprised of 300 individuals (Mage = 65.3 ± 8.7 years, 61.0% female) recruited from the offices of 33 general practitioners. Based on at-rest ankle-brachial index (ABI) values and claudication symptoms, four subsamples were formed: clear PAD-positive, clear PAD-negative, ABI-negative but symptomatic, and a non-compressible-artery group. The concurrent role of depression (assessed by a shortened version of the Beck Depression Inventory) and personality traits (measured by the Big Five Inventory) in predicting PAD status was examined using multinomial logistic regression - controlled for sex, age, hypertonia, diabetes, smoking, hazardous drinking, and body mass index. RESULTS: Depressive symptomatology was significant in predicting peripheral arterial disease status even after controlling for both traditional risk factors and personality traits. Among the Big Five personality traits, neuroticism showed a significant, positive relationship with PAD - independently of depression. CONCLUSIONS: Patients with PAD - even those with asymptomatic forms of the disease - are at higher risk for suffering from depression compared to individuals without PAD, independently of neuroticism, other Big Five personality dimensions or traditional risk factors for cardiovascular diseases.

Delayed gratification and adherence to exercise among patients with claudication.

Few studies have explicitly identified factors that explain an individual's willingness to engage in community-based exercise for claudication. Identifying the unique characteristics of those inclined toward physical activity would inform interventions that encourage walking. We examined the utility of behavioral economics-related concepts in understanding walking among Veterans with claudication. Patients who received care at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, were surveyed on symptom severity, behavioral economics, stress, and depression. The primary outcome was a binary variable measuring current walking for exercise and defined as walking for at least 30 minutes every day. Multivariable logistic regression models were used to identify variables, both clinically and statistically significant, at a p-value < 0.05. Between April 2017 and March 2018, we received 148 (30%) responses. A total of 35% (n = 51) of respondents indicated that they walked recreationally for exercise compared to 65% (n = 94) who did not. Characteristics that were significantly associated with walking included regularly saving money (adjusted odds ratio (aOR) = 10.7, p = 0.001), seeking complex problem-solving (aOR = 0.12, p = 0.002), and severe symptoms (aOR = 0.24, p = 0.017). Individuals describing a preference for the future rather than immediate benefit also reported currently walking for exercise. Defining the characteristics of those who exercise may help inform strategies designed to increase walking among those who do not adhere to recommendations.

Comparison of three generic quality-of-life metrics in peripheral arterial disease patients undergoing conservative and invasive treatments.

PURPOSE: To determine the effect of revascularisation for peripheral arterial disease (PAD) on QoL in the first and second year following diagnosis, to compare the effect depicted by Short Form Six Dimensions (SF-6D) and EuroQoL five Dimensions (EQ-5D) utilities, and Visual Analogue Scale (VAS) scores and to analyse heterogeneity in treatment response. METHODS: Longitudinal data from 229 PAD patients were obtained in an observational study in southern Netherlands. Utility scores were calculated with the international (SF-6D) and Dutch (EQ-5D) tariffs. We analysed treatment effect at years 1 and 2 through propensity score-matched ANCOVAs. Thereby, we estimated the marginal means (EMMs) of revascularisation and conservative treatment, and identified covariates of revascularisation effect. RESULTS: A year after diagnosis, 70 patients had been revascularised; the EMMs of revascularisation were 0.038, 0.077 and 0.019 for SF-6D, EQ-5D and VAS, respectively (always in this order). For conservative treatment these were - 0.017, 0.038 and 0.021. At 2-year follow-up, the EMMs of revascularisation were 0.015, 0.077 and 0.027, for conservative treatment these were - 0.020, 0.013 and - 0.004. Baseline QoL (and rest pain in year 2) were covariates of treatment effect. CONCLUSIONS: We measured positive effects of revascularisation and conservative treatment on QoL a year after diagnosis, the effect of revascularisation was sustained over 2 years. The magnitude of effect varied between the metrics and was largest for the EQ-5D, which may be most suitable for QoL measurement in PAD patients. Baseline QoL influenced revascularisation effect, in clinical practice this may inform expected QoL gain in individual patients.

Successful Smoking Cessation Associated with Walking Behavior in Patients with Claudication.

BACKGROUND: Behavioral economics theories suggest that a preference for delayed benefits promotes positive behavioral change, a concept relevant to both smoking cessation and community-based exercise regimens for claudication. Given the high rate of smoking among older veterans, we were interested in examining the association between smoking cessation, exercise regimen adherence, and preferences for delayed versus immediate benefits. METHODS: Between April 2017 and March 2018, patients with claudication at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, received questionnaires collecting information on social, behavioral, and psychological characteristics. A dual validation system, via the electronic medical record and survey data, measured the primary outcome-smoking cessation versus current smoking. Self-reported physical activity was measured through the validated Ainsworth's compendium of Physical Activities and binary survey questions. The Walking Impairment and Barratt's Impulsivity Questionnaires measured subjective symptom severity and behavioral economics factors, respectively. Multivariable, logistic regression models identified significant associations. RESULTS: The survey was mailed to 500 patients who met the eligibility criteria. We received responses from 148 individuals (30%), and 67 of 141 (48%) indicated that they had successfully quit smoking. In unadjusted comparisons, the median cognitive complexity score in the smoking cessation group was higher than that in the current smoking group. A greater proportion of patients who reported walking for exercise (n = 46) also reported successful smoking cessation (28/46, 61%). Among those who were not walking for exercise (n = 88), more individuals reported current smoking (49/88, 56%). In the multivariable model, individuals who had successfully stopped smoking were older (odds ratio [OR]: 7.59, P < 0.001), more likely to walk for exercise (OR: 3.94, P = 0.009), more interested in the future than in the present (OR: 1.73, P = 0.030), and more likely to regularly save money (OR: 3.49, P = 0.046). CONCLUSIONS: We found that participants who reported successful smoking cessation were more likely to report walking for exercise. Our findings suggest that adherence to walking may be less challenging for patients who have already successfully implemented and continue to implement another beneficial health behavior (smoking cessation). Patients with claudication who are current smokers may be less likely to adopt exercise recommendations.

Quantification of Daily Physical Activity and Sedentary Behavior of Claudicating Patients.

BACKGROUND: Claudication is the most common manifestation of peripheral artery disease (PAD), producing significant ambulatory compromise. Limited information exists on the routine physical activity of claudicating patients. Our objective was to record the intensity/time profiles of physical activity and the timing and duration of sedentary behavior of a sample of community-dwelling claudicating patients. METHODS: Forty-four claudicating patients referred to our vascular clinic were recruited. Physical activity was recorded using the ActiGraph GT1M activity monitor. The Actigraph monitor is a lightweight instrument designed to measure human movement through changes in acceleration, measured as counts over 1-minute time periods. Data from 7 consecutive days were used for the calculations. We processed the data using the ActiLife software program. RESULTS: The average daily activity of the claudicating patients shows a steady increase beginning approximately 05:30 AM until a peak plateau from approximately 10:00 AM to 01:30 PM followed by a steady decrease until approximately 09:30 PM, when a sustained period of inactivity begins. The average claudicating patient takes 3586 steps per day at an average intensity of 1.77 metabolic equivalents of task (METs, a physiological measure expressing the energy cost of physical activities). Average physical activity intensity and peak intensity fluctuate very little during the day, and they rarely exceed the level of light activity (light = <3 METs maximum effort, such as casual walking or light housework). During awake time, approximately 7 hours are spent in sedentary behaviors (<1.5 METs), and sedentary time is spread throughout the day mostly in short intervals between periods of low-energy activity. CONCLUSIONS: Our study objectively demonstrates the reduced physical activity of claudicating patients and documents physical activity/duration profiles throughout the day. The intensity of the physical activity of the average claudicating patient fluctuates very little during the day and rarely exceeds a light intensity level. Claudicating patients spend approximately half of their awake time in sedentary behavior and when they walk they do it in short bursts followed by several minutes of rest. We anticipate that changes in routine physical activity/duration profiles of patients with PAD will provide relevant, sensitive, and direct measures of the effectiveness of therapeutic interventions.

Is There an Important Role for Anxiety and Depression in the Elderly Patients with Critical Limb Ischemia, Especially After Major Amputation?

BACKGROUND: In patients with critical limb ischemia, an association is assumed between depression and worse outcome for morbidity, such as major limb amputation. After major amputation, anxiety and depression are common. We aimed to determine the association of depressive and anxiety symptoms in the elderly with critical limb ischemia, especially after major limb amputation. METHODS: Patients with critical limb ischemia aged ≥70 years were included in this prospective observational cohort study between January 2012 and February 2016 in 2 Dutch hospitals. After a multidisciplinary vascular conference, patients were divided into 4 treatment groups: endovascular revascularization, surgical revascularization, conservative therapy, and primary major amputation. In a 1-year follow-up period, depression and anxiety were measured 4 times using the Dutch versions of the Center for Epidemiological Studies Depression Scale and the State-Trait Anxiety Inventory. RESULTS: One Hundred eighty-seven patients were included. Within 1 year, 44 patients underwent a major limb amputation. Lower amputation-free survival did not differ significantly for patients with versus without greater anxiety (X2 [1] = 0.689, P = 0.407) and also not for patients with versus without more depressive symptoms (X2 [1] = 0.614, P = 0.433). For both groups, there were no significant changes in anxiety scores over time. After a median follow-up time of 336.5 days and 365 days, depressive symptoms significantly decreased in amputees, respectively, 8.5 vs. 4.5 (95% CI 1.76-7.48, P = 0.002) and 8.5 vs. 4.3 (95% CI 0.61-9.82, P = 0.027) when compared to the baseline measurement. Similarly, nonamputees had significantly lower overall score for depressive symptoms after a median follow-up time of 365 days (10.1 vs. 4.1, 95% CI 4.49 to 6.90, P < 0.001). CONCLUSIONS: In the opinion of the medical health care provider, amputation is a severe and unwanted end phase of critical limb ischemia. However, depressive symptoms seem to decrease over time and anxiety symptoms do not seem to be affected in patients after major limb amputation. In addition, patients with greater trait anxiety or more depressive symptoms at baseline did not have significantly higher amputation rates. These findings are similar to the course of depressive and anxiety symptoms for the elderly patients without major limb amputation.

Predictors of health-related quality of life in patients with symptomatic peripheral artery disease.

OBJECTIVE: The aim of this study was to identify predictors of baseline measures of health-related quality of life (HRQoL) in symptomatic patients with peripheral artery disease (PAD) from objective markers of severity of PAD, clinical and demographic characteristics, comorbid conditions, cardiovascular risk factors, objectively measured physical activity, and patient-based measures of physical function. METHODS: HRQoL measurements of 216 symptomatic men and women with PAD were assessed with the Medical Outcomes Study 36-Item Short Form Health Survey. Patients were further characterized on demographic variables, comorbid conditions, cardiovascular risk factors, ankle-brachial index, peak walking time during a maximal treadmill test, 6-minute walk distance, gait speed, ambulatory activity monitored during 1 week, activities of daily living (ADLs), Mini-Mental State Examination questionnaire, and Walking Impairment Questionnaire (WIQ). RESULTS: For the physical function HRQoL subscale, the significant predictors included WIQ speed score (P < .001), history of stumbling (P < .001), WIQ stair climbing score (P < .001), ADL associated with bathing (P = .001), 6-minute walk distance (P = .004), and daily walking cadence (P = .043). For the role emotional function HRQoL subscale, the significant predictors included a history of stumbling (P < .001), the ADL associated with transferring from a bed to a chair (P < .001), and the WIQ distance score (P = .022). CONCLUSIONS: Physical and mental subscales of HRQoL in symptomatic patients with PAD are primarily predicted by patient-based physical function rather than by more specific markers of PAD severity and comorbid conditions. The clinical significance is that interventions designed to improve HRQoL should focus on improving the quality of executing functional tasks, such as walking more steadily without stumbling; completing ADLs that are not specific to walking, such as bathing and transferring; and improving patient-based ability to walk various distances and speeds and to climb stairs.

Patient satisfaction with the consent discussion is not improved by showing patients their computed tomography or angiography images before they undergo vascular surgery.

OBJECTIVE: Patient-based decision aids and other multimedia tools have been developed to help enrich the preoperative discussion between surgeon and patient. Use of these tools, however, can be time-consuming and logistically challenging. We investigated whether simply showing patients their images from preoperative computed tomography (CT) or angiography would improve patients' satisfaction with the preoperative discussion. We also examined whether this improved the patient's understanding and trust and whether it contributed to increased preoperative anxiety. METHODS: Patients undergoing either elective abdominal aortic aneurysm repair or lower limb revascularization were randomly assigned to either standard perioperative discussion or perioperative discussion and review of images (CT image or angiogram). Randomization was concealed and stratified by surgeon. Primary outcome was patient satisfaction with the preoperative discussion as measured by a validated 7-item scale (score, 0-28), with higher scores indicating improved satisfaction. Secondary outcomes included patient understanding, patient anxiety, patient trust, and length of preoperative discussion. Scores were compared using t-test. RESULTS: Overall, 51 patients were randomized, 25 to the intervention arm (discussion and imaging) and 26 to the control arm. Most patients were male (69%), and the average age was 70 years. Forty percent of patients underwent abdominal aortic aneurysm repair, whereas 60% underwent lower limb revascularization. Patient satisfaction with the discussion was generally high, with no added improvement when preoperative images were reviewed (mean score, 24.9 ± 3.02 vs 24.8 ± 2.93; P = .88). Similarly, there was no difference in the patient's anxiety, level of trust, or understanding when the imaging review was compared with standard discussion. There was a trend toward longer preoperative discussions in the group that underwent imaging review (8.18 vs 6.35 minutes; P = .07). CONCLUSIONS: Showing patients their CT or angiography images during the preoperative discussion does not improve the patient's satisfaction with the consent discussion. Similarly, there was no effect on the patient's trust, understanding, or anxiety level. Our conclusions are limited by the lack of a standardized measure of patient understanding and not measuring outcomes postoperatively, both of which should be considered in future studies.

Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study.

OBJECTIVES: To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. BACKGROUND: Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. METHODS: In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). RESULTS: At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). CONCLUSIONS: In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

Association between physical activity and walking capacity with cognitive function in peripheral artery disease patients.

OBJECTIVE: To identify the association between objectively measured physical activity and walking capacity with cognitive function in patients with symptomatic peripheral artery disease. METHODS: This was an observational, cross sectional study. One hundred and thirty patients (age 67 ± 8 years) were recruited at a tertiary centre specializing in vascular disease. Cognitive function (global, memory, executive function and attention) was evaluated using the Montreal Cognitive Assessment tool. Physical activity levels (total, light, and moderate-vigorous) were obtained using an accelerometer. A 6 min and 4 m walk test were undertaken to assess walking capacity. Crude and covariate adjusted, linear regression analyses confirmed significant associations between physical activity levels and walking capacity with cognitive function. RESULTS: Positive and significant associations were observed between moderate to vigorous physical activity (p = .039) and walking capacity (p = .030) with memory after adjusting for covariates. No significant association was identified between light physical activity and usual gait speed with any cognitive function outcome. CONCLUSION: Greater memory performance was associated with greater moderate to vigorous physical activity levels and walking capacity in patients with symptomatic peripheral artery disease. Clinical interventions focused on improving moderate to vigorous physical activity levels and walking capacity may provide important therapies to potentially enhance cognitive health in patients with peripheral artery disease.

Inadequate Health Literacy in Patients with Arterial Vascular Disease.

OBJECTIVE: The aim was to identify the prevalence of inadequate health literacy in patients with arterial vascular disease. This was a cross sectional study. METHODS: Patients with arterial vascular disease visiting the outpatient clinic between January 5, 2015 and December 28, 2016, were randomly included and screened for inadequate health literacy with the Newest Vital Sign-Dutch (NVS-D), a validated health literacy assessment measure. A score of <4 out of six identified individuals with inadequate health literacy. Age, gender, highest education level, and reason for consultation were also registered. Data analysis was performed using Student's t-test or the Mann-Whitney U test and chi-square test. Logistic regression with backward elimination was applied to identify independent predictors. RESULTS: A total of 202 patients were included. The mean NVS-D score was 1.91 (SD ± 1.948, median 1). The prevalence of inadequate health literacy was 76.7%. A significantly higher prevalence of inadequate health literacy was found in patients ≥65 years (p < .001) and patients with a lower education level (p < .001). No significant difference was found between female/male patients (p = .056), nor between participants with peripheral arterial occlusive disease and abdominal aortic aneurysm (p = .116). Age (OR 1.060; 95% CI 1.017-1.104; p = .005) and education level (OR 0.164; 95% CI 0.078-0.346; p < .001) were identified as independent predictors of inadequate health literacy. CONCLUSION: This study shows a prevalence of inadequate health literacy of 76.7% in patients with arterial vascular disease, with a significantly higher prevalence in patients ≥ 65 years and patients with a lower education level. The high prevalence of inadequate health literacy should be considered when information is provided, and suggests the need to further investigate the best methods to convey medical information to this group of vulnerable patients.

Review of biologic and behavioral risk factors linking depression and peripheral artery disease.

The incidence of depression has been rising rapidly, and depression has been recognized as one of the world's leading causes of disability. More recently, depression has been associated with an increased risk of symptomatic atherosclerotic disease as well as worse perioperative outcomes in patients with cardiovascular disease. Additionally, recent studies have demonstrated an association between depression and peripheral artery disease (PAD), which has been estimated to affect more than 200 million people worldwide. These studies have identified that depression is associated with poor functional and surgical outcomes in patients with PAD. Although the directionality and specific mechanisms underlying this association have yet to be clearly defined, several biologic and behavioral risk factors have been identified to play a role in this relationship. These factors include tobacco use, physical inactivity, medical non-adherence, endothelial and coagulation dysfunction, and dysregulation of the hypothalamic-pituitary-adrenal axis, autonomic system, and immune system. In this article, we review these potential mechanisms and the current evidence linking depression and PAD, as well as future directions for research and interventional strategies. Understanding and elucidating this relationship may assist in preventing the development of PAD and may improve the care that patients with PAD and comorbid depression receive.