Participants' experiences and acceptability of a home-based walking exercise behaviour-change intervention (MOtivating Structure walking Activity in people with Intermittent Claudication (MOSAIC)).

OBJECTIVES: This study explored the experiences and acceptability of a novel, home-based, walking exercise behaviour-change intervention (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in adults with Peripheral Arterial Disease (PAD). DESIGN AND SETTING: Individual semi-structured audio-recorded interviews were conducted with adults with Peripheral Arterial Disease who had completed the MOSAIC intervention as part of a randomised clinical trial. Data were analysed using inductive reflexive thematic analysis and interpreted using the seven-construct theoretical framework of acceptability of healthcare interventions (TFA). PARTICIPANTS: Twenty participants (mean age (range) 67(54-80) years, 70% male, 55% White British) were interviewed. RESULTS: One central theme was identified: Acceptability of walking exercise as a treatment. This theme was explained by four linked themes: Exploring walking exercise with a knowledgeable professional, Building confidence with each step, Towards self-management-learning strategies to continue walking and The impact of walking exercise. These themes were interpreted using six of the seven TFA constructs: affective attitude, burden, perceived effectiveness, intervention coherence, opportunity costs, and self-efficacy. CONCLUSIONS: Participants perceived MOSAIC as an effective, acceptable, and low burden intervention. Physiotherapists were regarded as knowledgeable and supportive professionals who helped participants understand PAD and walking exercise as a treatment. Participants developed confidence to self-manage their condition and their symptoms. As participants confidence and walking capacity improved, they expanded their activities and gained a more positive outlook on their future. MOSAIC is an acceptable intervention that may facilitate adoption of and access to exercise for people with PAD.

[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.

Impact of the COVID-19 pandemic on health lifestyle in patients with peripheral artery disease: A cross-sectional study.

BACKGROUND: Social isolation has been one of the main strategies to prevent the spread of Coronavirus 2019 (COVID-19). However, the impact of social isolation on the lifestyle of patients with peripheral artery disease (PAD) and claudication symptoms remains unclear. OBJECTIVES: To analyze the perceptions of patients with PAD of the impact of social isolation provoked by COVID-19 pandemic on health lifestyle. DESIGN: Cross-sectional. SETTING: The database of studies developed by our group involving patients with PAD from public hospitals in São Paulo. METHODS: In this cross-sectional survey study, 136 patients with PAD (61% men, 68 ± 9 years old, 0.55 ± 0.17 ankle-brachial index, 82.4% with a PAD diagnosis ≥5 years old) were included. Health lifestyle factors were assessed through a telephone interview using a questionnaire containing questions related to: (a) COVID-19 personal care; (b) mental health; (c) health risk habits; (d) eating behavior; (e) lifestyle; (f) physical activity; (g) overall health; and (h) peripheral artery disease health care. RESULTS: The majority of patients self-reported spending more time watching TV and sitting during the COVID-19 pandemic and only 28.7% were practicing physical exercise. Anxiety and unhappiness were the most prevalent feelings self-reported among patients and 43.4% reported a decline in walking capacity. CONCLUSION: Most patients with PAD self-reported increased sedentary behavior, lower physical activity level, and worse physical and mental health during the COVID-19 pandemic. Thus, it is necessary to adopt strategies to improve the quality of life of these patients during this period.

Evidence-Experience Gap and Future Perspective on the Treatment of Peripheral Artery Disease.

Peripheral artery disease (PAD) is a systemic disease associated with impaired limb function, poor quality of life, and increased cardiovascular morbidity. Its incidence has been dramatically increasing over years because of the emergence of an aging society and the increase in the number of patients with atherosclerotic risk factors. The clustering of these risk factors promotes disease development, reportedly leading to the differential location of atherosclerotic lesions in lower extremity arteries. The clinical presentations of PAD include intermittent claudication and chronic limb-threatening ischemia (CLTI). PAD is associated with a high risk of mortality and morbidity from both cardiovascular and limb events. The therapeutic goals for patients with PAD include 1) relief from PAD-related limb symptoms, 2) the prevention of new-onset and the development and recurrence of PAD, and 3) the prevention of concomitant adverse events due to coronary artery disease (CAD) and cerebrovascular disease (CVD). There are several types of antithrombotic agents, and their main role in patients with PAD is to reduce systemic events mainly including cardiovascular and lower extremity-related events. Currently, the efficacy of direct oral anticoagulant (DOAC) is also suggested by recent clinical trials. Although endovascular therapy (EVT) has been a first-line revascularization strategy for symptomatic PAD, whether clinical outcomes after EVT are comparable to those after surgical bypass therapy remains inconclusive.

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".

Association of perceived stress with health status outcomes in patients with peripheral artery disease.

OBJECTIVE: To assess association of chronic self-perceived stress with health status outcomes of patients with peripheral artery disease. METHODS: The PORTRAIT study is a prospective registry that enrolled 1275 patients with symptoms of peripheral artery disease across 16-sites in US, Netherlands, and Australia from June 2011 to December 2015. Demographics, comorbidities and diagnostic information was abstracted from chart review. Self-perceived stress was assessed using the 4-item perceived stress scale at baseline, 3- and 6-month follow-up. Scores range from 0 to 16 with higher scores indicating greater stress. Sum scores were calculated at each time point and averaged to quantify average exposure to stress from enrollment through 6 months. Disease-specific health status were assessed at baseline and 12-months using the peripheral artery disease questionnaire summary score. RESULTS: The mean age of the analytical cohort (n = 1060) was 67.7 ± 9.3 years, 37.1% were females, and 82.3% were white. Comorbidities were highly prevalent with 80.9% having hypertension, 32.6% having diabetes, and 36.4% being smokers. In models adjusted for demographics, comorbidities, disease severity and socioeconomic status, having a higher average stress score was associated with poorer recovery (from baseline) in peripheral artery disease questionnaire summary score at 12-months (-1.4 points per +1-point increase in averaged 4-point perceived stress score, 95% CI -2.1, -0.6 p < 0.001). CONCLUSION: In patients with peripheral artery disease, experiencing higher chronic stress throughout the 6-months following their diagnosis, was independently associated with poorer recovery in 12-month disease-specific health status outcomes. (ClinicalTrial.gov identifier: NCT01419080).

Hungarian adaptation of the Peripheral Artery Disease Quality of Life questionnaire / A perifériás veroérbetegek életminoségét vizsgáló angol nyelvu kérdoív magyar adaptálása.

Összefoglaló. Bevezetés: A perifériás veroérbetegség napjaink egyik világméretu népegészségügyi problémája, több mint 200 millió embert érint világszerte. A Peripheral Artery Disease Quality of Life (PADQOL) kérdoívet azzal a céllal fejlesztették ki, hogy a betegség fizikai tünetein kívül annak szubjektív betegségterhét, pszichoszociális és emocionális hatásait is vizsgálja. Célkituzés: Az eredeti, angol nyelvu PADQOL betegségspecifikus, önkitöltos kérdoív magyar nyelvu, érvényes változatának kifejlesztése, annak fordítása, kultúrközi adaptációja és magyar nyelvi validálása. Módszerek: Az életminoség-kérdoív lingvisztikai validálása nemzetközi protokoll alapján történt: két szakfordító külön-külön lefordította a kérdoívet angol forrásnyelvrol magyarra; egy harmadik szakfordító bevonásával elkészült a két verzió szintézise, majd azt két, angol anyanyelvu fordító visszafordította angol forrásnyelvre, amit konszenzusmegbeszélés követett. A "pre-final" magyar verzió érthetoségét 30, angiológiai járó és fekvo beteg bevonásával, kognitív interjúk lefolytatásával, pilotvizsgálat során teszteltük. A PADQOL kérdoív faktorstruktúrájának feltárásához faktoranalízist végeztünk, az alskálák megbízhatóságát, a tételek belso konzisztenciáját a Cronbach-alfa-együttható kiszámításával vizsgáltuk. Az elemzésekhez IBM SPSS 23.0 programcsomagot használtunk. Eredmények: A PADQOL nyelvi validálása jelentéstani, tapasztalati és idiomatikus ekvivalencia tekintetében nem jelentett nehézséget. A kognitív interjúk során egy kérdés esetén tapasztaltunk értelmezési nehézséget. A kérdoív "pre-final" verziója tartalmilag és nyelvileg könnyen értheto, kitöltése nem okoz nehézséget. Az egyes dimenziók Cronbach-α-értéke 0,624 és 0,887 között volt. A legrosszabb értéket a Félelem és bizonytalanság (score-átlag: 14,07) életminoség-dimenzió mutatta. Következtetés: Létrehoztuk a PADQOL kérdoív végso magyar verzióját, mely méroeszköz alkalmas a nyelvi és kultúrközi adaptáció következo lépésének elvégzésére, nagyobb betegpopuláción történo pszichometriai és klinikometriai vizsgálat által a perifériás veroérbetegek életminoségének, szubjektív betegségterhének felmérését célzó validálásra. Orv Hetil. 2020; 161(51): 2153-2161. INTRODUCTION: Peripheral artery disease is one of the greatest, global public health concerns affecting more than 200 million people worldwide. The Peripheral Artery Disease Quality of Life questionnaire was developed to assess the subjective disease burden of peripheral artery disease, by focusing on psychosocial and emotional effects besides physical symptoms and functional limitations. OBJECTIVE: To develop the valid Hungarian version of the original PADQOL via the standard linguistic validation and cross-cultural adaptation procedure. METHODS: The linguistic validation was conducted according to an international protocol: two independent forward translations, a synthesis of the translations, back translations and consensus team review. The pilot-testing of the 'pre-final' Hungarian version was conducted via cognitive interviews with 30 in- and outpatients attending the Department of Angiology. Factor analysis was performed, Cronbach-alpha values were calculated to establish the reliability of subscales and to determine the internal consistency if items. IBM SPSS 23.0 was used. RESULTS: The linguistic validation of PADQOL into Hungarian posed no difficulties in terms of semantic, experiential and idiomatic equivalence. One item was found difficult to interpret during cognitive interviewing. The 'pre-final' version of the questionnaire was easy to understand and complete. Cronbach-alpha values of factors ranged between 0.624 and 0.887. The lowest value was that of factor 4: Fear and Uncertainty (mean score: 14.07). CONCLUSION: The linguistic validation of PADQOL into Hungarian was successful, the final Hungarian version is a tool that should reveal valuable insights with regard to subjective disease burden of patients living with peripheral artery disease subsequent to psychometric and clinicometric validation on a larger patient population. Orv Hetil. 2020; 161(51): 2153-2161.

Two-year Outcome of Quality of Life and Health Status for the Elderly with Chronic Limb-threatening Ischemia.

PURPOSE: In elderly patients with chronic limb-threatening ischemia (CLTI), there is little scientific understanding of the long-term changes of quality of life (QoL) and health status (HS) after treatment. The primary goal of this study was to provide long-term QoL and HS results for elderly CLTI patients after therapy. Treatments consisted of endovascular revascularization, surgical revascularization, or conservative treatment. Furthermore, the aim of this study was to identify the distinctive trajectories of QoL and HS. PATIENTS AND METHODS: CLTI patients aged ≥70 years were included in a prospective observational cohort study with a two-year follow-up. The WHOQOL-BREF was used to asses QoL. The 12-Item Short Form Health Survey was used to measure HS. The QoL and HS scores were compared to the scores in the general elderly Dutch population. Latent class trajectory analysis was used. RESULTS: A total of 195 patients were included in this study. After two years, in all treatment groups patients showed significantly higher physical QoL score compared to baseline and there was no significant difference with the corresponding values in the elderly Dutch population. In the latent class trajectory analysis, there were no overlapping risk factors for poorer QoL or HS. CONCLUSION: This study shows that QoL levels in surviving elderly CLTI patients in the long-term do not differ from the corresponding values for elderly in the general population. There were no disparities in sociodemographic, clinical and treatment characteristics associated with poorer QoL and HS. This study was carried out to encourage further analysis of the influence of biopsychosocial characteristics on QoL and HS in elderly CLTI patients.

Health-related quality of life amongst people diagnosed with abdominal aortic aneurysm and peripheral artery disease and the effect of fenofibrate.

The aims of this study were, firstly, to assess the effect of concurrent peripheral artery disease (PAD) on the health-related quality of life (QOL) of people diagnosed with a small abdominal aortic aneurysm (AAA); and secondly, to test whether the peroxisome proliferator-activated receptor α agonist fenofibrate improved QOL of people diagnosed with a small AAA, including those diagnosed with concurrent PAD. The study included both a cross-sectional observational study and a randomized placebo-controlled clinical trial. 140 people diagnosed with a 35-49 mm diameter AAA, 56 (40%) of whom had concurrent PAD, and 25 healthy controls were prospectively recruited. QOL was assessed with the short form (SF) 36. Findings in participants that were diagnosed with both AAA and PAD were compared separately with those of participants that had a diagnosis of AAA alone or who had neither AAA nor PAD diagnosed (healthy controls). All participants diagnosed with an AAA were then randomly allocated to 145 mg of fenofibrate per day or identical placebo. Outcomes were assessed by changes in the domains of the SF-36 and ankle brachial pressure Index (ABPI) from randomization to 24 weeks. Data were analyzed using Mann-Whitney U tests. Participants diagnosed with both AAA and PAD had significantly worse QOL than participants diagnosed with AAA alone or healthy controls. Fenofibrate did not significantly alter SF-36 scores or ABPI over 24 weeks. Fenofibrate does not improve QOL of people diagnosed with small AAA, irrespective of whether they have concurrent PAD.Trial registration: ACTN12613001039774 Australian New Zealand Clinical Trials Registry.

Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial.

Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5-Dimensions [EQ-5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization procedures during trial follow-up and the association between 12-month health status change scores and subsequent end points during follow-up. There were 13 217 (95%) patients with EQ-5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ-5D tertile (0 to <0.69) were more likely to be female with severe claudication compared with the highest tertile (0.79-1.0; P<0.01). Patients in the lowest VAS (0-60) and peripheral artery questionnaire (0-49) tertiles had lower ankle-brachial indices compared with the highest tertiles (80-100 and 76-108, respectively; P<0.01). There was a significant association between baseline EQ-5D, VAS, and peripheral artery questionnaire scores and adjusted major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization (P<0.05). Improved EQ-5D and VAS scores over 12 months were associated with reduced risk of subsequent major adverse cardiovascular events or lower-extremity revascularization (all P<0.01). Conclusions Although health status instruments are rarely used in clinical practice, these measures are associated with outcomes, including major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization. Further research is needed to determine the relationship between changes in these instruments, revascularization, and outcomes.

Relationship Between Depressive Symptoms and Health Status in Peripheral Artery Disease: Role of Sex Differences.

Background The association of depressive symptoms with health status in peripheral artery disease (PAD) is understudied. No reports of differential impact on women have been described. Methods and Results The PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Artery Disease Investigating Trajectories) registry enrolled 1243 patients from vascular specialty clinics with new or worsening PAD symptoms. Depressive symptoms were assessed at baseline and 3 months using the 8-Item Patient Health Questionnaire (score ≥10 indicating clinically relevant depressive symptoms). Disease-specific and generic health status were measured by Peripheral Artery Questionnaire and EQ-5D Visual Analogue Scale at baseline and 3, 6, and 12 months. An adjusted general linear model for repeated measures was constructed for baseline and 3-, 6-, and 12-month health status outcomes by depressive symptoms at baseline. Differences by sex were tested with interaction effects. The mean age was 67.6±9.4 years with 38% (n=470) women. More women than men (21.1% versus 12.9%; P<0.001) presented with severe depressive symptoms. In the adjusted model, patients with depressive symptoms had worse health status at each time point (all P<0.0001). Results were similar for EQ-5D Visual Analogue Scale scores. The magnitude in 1-year change in health status scores did not differ by sex. Depressive symptoms explained 19% of the association between sex differences in 1-year Peripheral Artery Questionnaire summary scores. Conclusions Women with PAD have a high burden of depressive symptoms. Depressive symptoms were associated with a strikingly worse disease-specific health status recovery path over the year following PAD diagnosis in men and women. Developing and testing interventions to address depressive symptoms in PAD are urgently needed. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.

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.

Association of Perceived Stress Levels With Long-term Mortality in Patients With Peripheral Artery Disease.

Importance: Identifying modifiable risk factors, such as stress, that could inform the design of peripheral artery disease (PAD) management strategies is critical for reducing the risk of mortality. Few studies have examined the association of self-perceived stress with outcomes in patients with PAD. Objective: To examine the association of high levels of self-perceived stress with mortality in patients with PAD. Design, Setting, and Participants: This cohort study analyzed data from the registry of the Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a multicenter study that enrolled patients with new or worsening symptoms of PAD who presented to 16 subspecialty clinics across the US, the Netherlands, and Australia from June 2, 2011, to December 3, 2015. However, the present study included only patients in the US sites because assessments of mortality for patients in the Netherlands and Australia were not available. Data analysis was conducted from July 2019 to March 2020. Exposure: Self-perceived stress was quantified using the 4-item Perceived Stress Scale (PSS-4), with a score range of 0 to 16. A score of 6 or higher indicated high stress in this cohort. Missing scores were imputed using multiple imputation by chained equations with predictive mean matching. Stress was assessed at baseline and at 3-, 6-, and 12-month follow-up. Patients who reported high levels of stress at 2 or more follow-up assessments were categorized as having chronic stress. Main Outcomes and Measures: All-cause mortality was the primary study outcome. Such data for the subsequent 4 years after the 12-month follow-up were obtained from the National Death Index. Results: The final cohort included 765 patients, with a mean (SD) age of 68.4 (9.7) years. Of these patients, 57.8% were men and 71.6% were white individuals. High stress levels were reported in 65% of patients at baseline and in 20% at the 12-month follow-up. In an adjusted Cox proportional hazards regression model accounting for demographics, comorbidities, disease severity, treatment type, and socioeconomic status, exposure to chronic stress during the 12 months of follow-up was independently associated with increased risk of all-cause mortality in the subsequent 4 years (hazard ratio, 2.12; 95% CI, 1.14-3.94; P = .02). Conclusions and Relevance: In thie cohort study of patients with PAD, higher stress levels in the year after diagnosis appeared to be associated with greater long-term mortality risk, even after adjustment for confounding factors. These findings suggest that, given that stress is a modifiable risk factor for which evidence-based management strategies exist, a holistic approach that includes assessment of chronic stress has the potential to improve survival in patients with PAD.

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.

Patient perceptions of peripheral artery disease: A cross-sectional study of hospitalized adults.

Patients with peripheral artery disease (PAD) have increased risk for complications of cardiovascular disease. Smoking cessation, physical activity, and adherence to treatment are critical for limiting the progression of this chronic disease and improving health-related quality of life in patients with PAD.The aim of the study was to explore patient perceptions of PAD and views on medication, tobacco use, and physical activity. This descriptive, cross-sectional study included patients with PAD admitted to a vascular surgery unit at a tertiary academic medical center (October 2017 to January 2018). Sociodemographic data and medical information were collected during hospitalization. Patients completed the Brief Illness Perception Questionnaire, Beliefs about Medicines Questionnaire, and Cigarette Dependence Scale. Additional questions examined physical activity. In total, 32 patients participated in the study. About half (16/30) were active smokers, whereas the remainder had smoked in the past. Only half of patients (16/32) considered smoking as contributing to PAD. Most patients (18/30) perceived PAD as a chronic problem, yet 8/30 (27%) considered PAD a rather acute illness. Patients reported significant cognitive and emotional consequences of PAD (mean 6.2 ± 1.8 and 8.3 ± 2.9, maximum score 10, respectively). They rated relatively low perceived personal control (mean 4.8 ± 2.8, maximum score 10) and weak beliefs about the necessity of medication (mean 12.5 ± 3.3, maximum score 25). Most patients (21/32) perceived physical activity as a protective factor for PAD. Patients perceive PAD as having significant impact on their life and report low levels of personal control in managing PAD. Understanding patient health beliefs may inform more tailored therapeutic education and health promoting interventions to limit disease progression.

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.

Psychological factors associated with functional recovery among patients with a peripheral arterial disease after lower extremity bypass.

Functional recovery, described by walking ability, is one of the significant outcomes for patients with peripheral arterial disease (PAD) after lower extremity bypass. Little is known about associated factors that help to improve this outcome. The purpose of this study was to examine factors associated with functional recovery among patients with PAD after lower extremity bypass, such as postoperative period, social support, and depression. Data were collected in a University Hospital in Bangkok, Thailand. A sample of 77 patients with PAD receiving lower extremity bypass treatment was recruited into the study. The interview questionnaires consisted of demographic characteristics, Medical Outcome Study social survey, Thai Geriatric Depression Scale, and Walking Impairment Questionnaire. Reliability of each instrument was 0.97, 0.87, and 0.92, respectively. Pearson's correlation was performed to identify the factors associated with functional recovery. The mean values of age, postoperative period, and walking ability score were 63.92 years (standard deviation [SD] = 11.21), 4.19 years (SD = 3.52), and 62.52 (SD = 13.83). Functional recovery and social support were significantly associated with depression (r = -0.272, P < .05; r = -0.463, P < .01, respectively). The postoperative period was also significantly associated with social support (r = 0.247, P < .03).In conclusion, psychological factors were significantly related to functional recovery among patients with PAD after lower extremity bypass. Therefore, health-care providers should consider these factors during discharge planning, and screening depression score as baseline should be performed.