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

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

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.

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.

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.

Is it justified to search for cancer in patients with peripheral arterial disease?

BACKGROUND: Cancer is the leading cause of death in European countries, ahead of cardiovascular diseases. Cancer is also the most common co-morbidity among patients hospitalized for the management of cardiovascular diseases. Through an overview, we searched for the frequency and types of cancer associated with peripheral arterial disease (PAD) in order to address the relevance of cancer screening in patients with PAD. METHODS: We searched in PubMed database from 1996 to 2020 for retrospective and prospective cohort or cross-sectional or randomized studies evaluating the frequency of all types of cancer in patients with PAD excluding patients with aneurysmal disease. The keywords used were: peripheral arterial disease, arterial thrombosis, acute leg ischemia, critical leg ischemia, chronic leg ischemia, intermittent claudication, malignant tumor, cancer. RESULTS: Based on published studies, the frequency of cancer in patients with PAD varied widely from 3.8 to 30.4% depending on study design, population, method used to screen for cancer and study period. In medical records database and registers,cancer prevalence varied from 3,8% to 22,4% in 4 retrospective studies of patients with acute limb ischemia and from 10.5 to 30.4% in 3 prospective studies of patients with acute limb ischemia, critical ischemia or intermittent claudication. In 3 retrospective analyses from 2 population-based cohorts and health insurance claims data, incidence of cancer in patients with intermittent claudication, acute limb ischemia or peripheral arterial disease varied from 8% to 11.7%. The frequency of cancer in PAD patients appeared higher than in the general population. Tobacco-dependent cancers seemed to be the most common cancers in PAD. Cancers were also more frequent in case of anemia, amputation and iterative bypass thrombosis in few studies. CONCLUSION: Although there is no recommendation for cancer screening in patients with PAD, the high prevalence of cancer raises the question of screening patients at high risk such as those with acute or critical limb ischemia and especially in case of severe tobacco use, anemia, amputation and iterative bypass thrombosis. These results call for further studies with larger sample size and long term follow-up.

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.

Additive prognosis of clinical presentation in revascularized peripheral arterial disease patients.

BACKGROUND: Peripheral artery disease (PAD) is a frequent cause of morbidity and mortality. It may present with diverse clinical presentations. The aim of this study was to evaluate the prognosis of these clinical presentations. METHODS: We performed a retrospective cohort study, in which symptomatic PAD patients were included from 2014 to 2020 at a university hospital in Argentina. We classified symptomatic PAD in intermittent claudication (IC), chronic limb-threatening ischemia (CLTI) and acute ischemia (AI). Our primary endpoint was to compare the composite of all-cause mortality and major amputation events between the three groups. RESULTS: We included 309 patients, with a median follow up of 1.87 years (IQR 0.72-3.67). The primary endpoint was more prevalent in CLTI and AI patients (33% and 33.3%) compared to IC patients (8.1%), P<0.001. CLTI and AI were independently associated with the primary endpoint after adjusting for clinical variables of interest (OR 4.04 95%CI [1.86-9.07], P<0.001 and OR 5.40 95%CI [2.18-13.7], P<0.001, respectively). Mortality incidence rate (per 100 patients/year) was similar between AI and CLTI patients (14.2 95% CI [8.0-24.1] and 13.1 95%CI [8.8-19.7], respectively, P=0.67) but higher compared to IC (2.9 95%CI [1.6-5.1], P<0.01). Major amputation events were more prevalent in CLTI (16.5%) compared to AI (8.9%) and IC patients (1.2%), P<0.01. CONCLUSIONS: Those with CLTI and AI have a particular increased risk of all-cause death and major amputation events. Although mortality incidence was similar between AI and CLTI patients, the latter have an increased risk of major amputation events compared to AI and IC patients.

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.

Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry.

BACKGROUND: There are limited data on differences in angiographic distribution of peripheral artery disease and endovascular revascularization strategies in patients presenting with intermittent claudication (IC) and critical limb ischemia (CLI). We aimed to compare anatomic features, treatment strategies, and clinical outcomes between patients with IC and CLI undergoing endovascular revascularization. METHODS: We examined 3326 patients enrolled in the Excellence in Peripheral Artery Disease registry from 2006 to 2019 who were referred for endovascular intervention for IC (n=1983) or CLI (n=1343). The primary outcome was 1-year major adverse limb events, which included death, repeat target limb revascularization, or target limb amputation. RESULTS: Patients with CLI were older and more likely to have diabetes and chronic kidney disease and less likely to receive optimal medical therapy compared with IC. Patients with IC had higher femoropopliteal artery interventions (IC 87% versus CLI 65%; P<0.001), while below the knee interventions were more frequent in CLI (CLI 47% versus IC 12%; P<0.001). Patients with CLI were more likely to have multilevel peripheral artery disease (CLI 32% versus IC 15%, P<0.001). Patients with IC were predominantly revascularized with stents (IC 48% versus CLI 37%; P<0.001) while balloon angioplasty was more frequent in CLI (CLI 37% versus IC 25%; P<0.001). All-cause mortality was higher in patients with CLI (CLI 4% versus IC 2%; P=0.014). Major adverse limb event rates for patients with IC and CLI were 16% and 26%, respectively (P<0.001) and remained higher in CLI after multivariable adjustment of baseline risk factors. CONCLUSIONS: Patients with IC and CLI have significant anatomic, lesion, and treatment differences with significantly higher mortality and adverse limb outcomes in CLI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01904851. Graphic Abstract: A graphic abstract is available for this article.

Physical activity practice during COVID-19 pandemic in patients with intermittent claudication.

OBJECTIVE: To describe physical activity habits and barriers for physical activity practice in patients with peripheral artery disease and claudication symptoms during Coronavirus 2019 (COVID-19) pandemic. METHODS: In this cross-sectional survey study, 127 patients with peripheral artery disease (59.8% men; 68±9 years old; and 81.9% had the peripheral artery disease diagnosis ≥5 years old) were included. The physical activity habits and barriers for physical activity practice were assessed through telephone interview using a questionnaire with questions related to: (a) COVID-19 personal care; (b) overall health; (c) physical activity habits; (d) for those who were inactive, the barriers for physical activity practice. RESULTS: Only 26.8% of patients reported practicing physical activity during the COVID-19 pandemic. Exercise characteristics more common among these patients include walking, performed at least 5 days a week, during 31-60 min at light intensity. In contrast, among physically inactive patients, pain, injury or disability (55%), the COVID-19 pandemic (50%), the need to rest due to leg pain (29%), and lack of energy (27%) were the most frequent barriers to physical activity practice. CONCLUSION: The physical activity level of patients with peripheral artery disease is impacted by the COVID-19 pandemic.

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.

Sex related differences in therapy and outcome of patients with intermittent claudication in a real-world cohort.

BACKGROUND AND AIMS: The prevalence of lower extremity artery disease (LEAD) is increasing worldwide and sex-related differences are a current matter of debate. METHODS: We analysed claims data on unselected patients with in-patient treatment for LEAD with intermittent claudication (IC; Rutherford grade 1-3) from 01.01.2014 to 31.12.2015. Data files included diagnostic and procedural information from two years before index, and a five-year follow-up. RESULTS: Our analysis comprised 42,197 IC patients, thereof 28,520 (68%) male. Male patients were younger (median: 66.4 years vs. 72.6 years) but presented with higher frequency of cardiovascular risk factors such as diabetes (40% female vs. 46% male), atrial fibrillation (13% vs. 17%), chronic coronary syndrome (41% vs. 53%), chronic heart failure (23% vs. 27%), or chronic kidney disease (29% vs. 32%; all p < 0.001; age adjusted). Revascularisation applied in 80% of patients, thereof endovascular approach predominantly in female and surgery in male patients. Concomitant pharmacotherapy with statins (74% at 2 years) and platelet inhibitors (75% respectively) were long lasting below guideline recommendation, under-use being more pronounced in women. Two years after index, one-third of IC patients had subsequent revascularisation, one-quarter progressed to chronic limb threatening ischemia (CLTI), and 2% underwent amputation. Male sex was an independent risk factor for long-term mortality (female HR 0.75; 95%-CI 0.72-0.79; p < 0.001) and CLTI (female HR 0.89; 95%-CI 0.86-0.92; p < 0.001) during follow-up. CONCLUSIONS: The majority of in-patient treated patients for IC are male, presenting with worse cardiovascular risk profiles. In view of a general under-supply with statins and platelet inhibitors, women received somewhat less often preventive medication. Despite low LEAD stages at index, serious prognosis was observed in the long term. Particularly male patients were at high risk for all-cause mortality and the combined endpoint CLTI and death.

Brachiocephalic and subclavian stenosis: Current concepts for cardiovascular specialists.

Brachiocephalic and subclavian artery stenoses are less common manifestations of peripheral arterial disease (PAD) compared to lower extremity PAD. However, even among asymptomatic patients, a diagnosis of PAD portends worse long-term mortality. Symptoms may include subclavian steal syndrome and arm claudication. Among patients with internal mammary coronary bypass grafts, symptoms may include those of myocardial ischemia. Symptomatic subclavian stenosis can be readily treated using endovascular techniques with durable outcomes.

Effect of Target Lesion Revascularization on Restenosis Lesions of the Superficial Femoral Artery without Recurred Symptoms after Endovascular Therapy.

AIM: This study aims to elucidate the effects of early application of target lesion revascularization (TLR) to restenosis lesions of the superficial femoral artery (SFA) without recurrence of symptoms. Despite recent improvements in endovascular therapy (EVT) for the SFA, restenosis remains to be a problem. However, restenosis is not always associated with the recurrence of limb symptoms. Although early application of TLR is not generally approved for restenosis lesions of the SFA without recurred symptoms, it is expected to contribute to long-term patency and other favorable outcomes. Nonetheless, its effectiveness remains to be determined. METHODS: We retrospectively analyzed 616 patients who developed restenosis after undergoing femoro-popliteal EVT for claudication (Rutherford category 1 to 3) due to de novo femoro-popliteal lesions between January 2010 and December 2016 at 11 centers in Japan. Recurred symptoms were defined as symptoms of the same or higher Rutherford categories than those immediately before the initial EVT. RESULTS: Of the patients, 291 (47 %) lacked recurred symptoms; 69 (24 %) underwent TLR for restenosis. After propensity matching, the risk of occlusion was determined to be not significantly different between the TLR and observation groups; the 3-year occlusion-free rate was 68 % and 62 %, respectively (P=0.84). The risk of recurring symptoms, critical limb ischemia, and all-cause death was also found to be comparable between groups. The incidence of target vessel revascularization was significantly higher in the TLR than in the observation group (1.55 [95 % confidence interval: 1.25-1.93] vs. 0.59 [0.41-0.85] per 3 person-years). CONCLUSIONS: In patients with SFA restenosis without recurred symptoms, early application of TLR showed no advantages.

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.

Peripheral arterial disease and intermittent claudication in coronary heart disease patients.

BACKGROUND AND AIM: Peripheral artery disease (PAD) is associated with an increased risk of fatal and non-fatal coronary heart disease (CHD). The aims of the this study were 1) to investigate the prevalence of PAD and suspected PAD in a large population of established CHD patients, and 2) to assess the prevalence and control of risk factors in these patients as well health-related quality of life. MATERIAL AND METHODS: In the EUROASPIRE V survey, 8243 patients with documented CHD were recruited from 27 ESC member countries and were invited to attend a study visit. Patients were investigated using questionnaires, in-depth interviews and a clinical examination. Intermittent claudication (IC) was assessed using the Edinburgh Claudication Questionnaire. Patients without previously diagnosed PAD were suspected of having PAD if they were found to have IC. RESULTS: Overall, 6.4% of the patients had already a confirmed diagnosis of PAD and another 6.3% were suspected of having PAD. Independent of age and gender, patients with previously diagnosed PAD were significantly more frequently current smokers, had the lowest smoking cessation rates, were less physically active, reported more often previously diagnosed diabetes and had significantly higher blood pressure levels, compared to patients without PAD. They had also significantly higher levels of serum triglycerides, lower HDL-C levels, and had more often renal insufficiency. In comparison with patients without PAD, those with suspected PAD demonstrated significantly higher smoking cessation rates but their obesity rates were significantly higher. In CHD patients with a history of PAD, the use of calcium channel blockers and diuretics was significantly higher than in patients without PAD. Compared to the latter group, the use of diuretics, anti-arrhythmics and anti-depressants in patients with suspected PAD was significantly higher. Moreover, patients with previously diagnosed PAD had significantly higher levels of anxiety and depression and reported a significantly worse health-related quality of life (HRQoL), in comparison with those without PAD. HRQoL levels were significantly reduced in patients with suspected PAD as well. CONCLUSION: In CHD patients without a previous diagnosis of PAD, IC is not infrequent. Diagnosed PAD was significantly associated with a worse CHD risk factor profile. Patients with known PAD as well as those with suspected PAD had a considerable loss of health-related quality of life. Therefore, physicians should consider to screen for IC in all their CHD patients.

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.

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.

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.

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.