The Effect of Arterial Disease Level on Outcomes of Supervised Exercise Therapy for Intermittent Claudication: A Prospective Cohort Study.

OBJECTIVE: To assess whether level of arterial obstruction determines the effectiveness of SET in patients with IC. BACKGROUND DATA: Guidelines advocate SET before invasive treatment for IC, but early revascularization remains widespread, especially in patients with aortoiliac disease. METHODS: Patients were recruited from 10 Dutch centers between October 2017 and October 2018. Participants received SET first, followed by endovascular or open revascularization in case of insufficient effect. They were grouped according to level of stenosis (aortoiliac, femoropopliteal, multilevel, or rest group with no significant stenosis). Changes from baseline walking performance (maximal and functional walking distance on a treadmill test, 6-minute walk test) and vascular quality of life questionnaire-6 at 3 and 6 months were compared, after multivariate adjustment for possible confounders. Freedom from revascularization was estimated with Kaplan-Meier analysis. RESULTS: Some 267 patients were eligible for analysis (aortoiliac n = 70, 26%; femoropopliteal n = 115, 43%; multilevel n = 69, 26%; rest n = 13, 5%). No between group differences in walking performance or vascular quality of life questionnaire-6 were found. Mean improvement in maximal walking distance after 6 months was 439 m [99% confidence interval (CI) 297-581], 466 m (99% CI 359-574), 353 m (99% CI 210-496), and 403 m (99% CI 58-749), respectively (P = 0.40). Freedom from intervention was 73.9% for aortoiliac disease and 88.6% for femoropopliteal disease (hazard ratio 2.46, 99% CI 0.96 - 6.30, P = 0.013). CONCLUSIONS: Short-term effectiveness of SET for IC is not determined by the location of stenosis. Although aortoiliac disease patients improved walking performance and health-related quality of life similarly compared to other arterial disease level groups, they underwent revascularization more often.

Vascular Quality of Life Questionnaire-6 Before and After Supervised Exercise Therapy in Patients with Intermittent Claudication.

OBJECTIVE: The Vascular Quality of Life Questionnaire-6 (VascuQoL-6) is a short, disease specific instrument used to determine health related quality of life (HRQoL) in patients with peripheral arterial disease. This study aimed to assess the minimally important difference (MID) and substantial clinical benefit (SCB) of the VascuQoL-6 in Dutch patients with intermittent claudication (IC) receiving supervised exercise therapy (SET). METHODS: Consecutive patients with IC who were recruited from a single centre between January 2016 and December 2016 completed the VascuQoL-6 before initiation and after three months of SET. They subsequently answered an anchor question rating their current health status as much improved, improved, unchanged, deteriorated, or much deteriorated, compared with baseline. The MID for improvement and deterioration and SCB were calculated using anchor based and distribution based methods. RESULTS: A total of 124 patients with IC (58% male, mean age 68 years) completed the study protocol. Baseline VascuQoL-6 scores increased from 16.3 ± 4.4 to 18.7 ± 3.8 after three months of SET (p < .001). MID values ranged from +2.0 to +3.8 points regarding HRQoL improvement and from +0.2 to -2.2 points regarding HRQoL deterioration. The SCB ranged from +3.7 to +5.0 points. Depending on the MID approach, 32% - 41% of patients achieved a clinically meaningful improvement in HRQoL. CONCLUSION: Approximately one in three patients with IC reported a clinically meaningful improvement in HRQoL after three months of SET. The range of MID and SCB values provides caregivers with an idea of how much change in VascuQoL-6 scores is considered relevant or substantial by their patients. Applying cutoff points for MID and SCB may optimise the interpretation of trial results and may help to set a benchmark for success of SET.

Diagnostic accuracy of automated oscillometric determination of the ankle-brachial index in peripheral artery disease.

OBJECTIVE: Peripheral artery disease (PAD) is underdiagnosed in primary care settings, partly because of limited accuracy of the Doppler ankle-brachial index (ABI). This study aimed to assess the diagnostic accuracy of an automated oscillometric ABI device compared with reference standard vascular laboratory Doppler ABI equipment and to examine the influence of oscillometric errors on performance. METHODS: Consecutive patients who were referred to a large general hospital for an ABI measurement were invited to participate. In each patient, the oscillometric analysis was followed by the Doppler analysis. Legs with incompressible ankle arteries were excluded from analysis. ABI values were compared using the Bland-Altman method. Oscillometric errors were defined as the incapacity of the oscillometer to report a value of ABI. A receiver operating characteristic curve was constructed, and the area under the curve was computed. RESULTS: A total of 201 patients participated. The Bland-Altman plot showed a mean difference of 0.05 ± 0.12 (limits of agreement, -0.20 to 0.29), representing a small ABI overestimation after oscillometry. Oscillometric errors occurred more commonly in limbs with PAD than in limbs without PAD (28% and 7%, respectively; P < .001). Considering a 0.9 threshold and after oscillometric error exclusion, the oscillometric ABI showed a 74% sensitivity and a 97% specificity for a diagnosis of PAD. When oscillometric errors were considered as abnormal ABIs, sensitivity increased to 86% and specificity was maintained at 95%. The receiver operating characteristic curve showed an area under the curve of 0.96. The best oscillometric ABI cutoff point was 1.00. Using this threshold and when considering oscillometric errors as abnormal ABIs, sensitivity improved to 94% while maintaining specificity at 92%. CONCLUSIONS: Oscillometric ABI showed good diagnostic accuracy compared with the reference standard. However, the high incidence of oscillometric errors and the challenges to correctly interpret readings may limit the use of the oscillometric method in PAD diagnosis.

A Comparison of Quality of Life in Elderly Patients with Intermittent Claudication and Chronic Limb-Threatening Ischemia.

BACKGROUND: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI. METHODS: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means. RESULTS: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain. CONCLUSIONS: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

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

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

The Effect of Supervised Exercise, Home Based Exercise and Endovascular Revascularisation on Physical Activity in Patients With Intermittent Claudication: A Network Meta-analysis.

BACKGROUND: It is unclear whether supervised exercise therapy (SET), home based exercise therapy (HBET), and endovascular revascularisation (ER) for intermittent claudication (IC) have a meaningful impact on physical activity, despite extensive research on their effect on walking performance. METHODS: Multiple databases were searched systematically up to May 2018 for randomised controlled trials with objective measurements of physical activity in patients with IC. A Bayesian network meta-analysis was performed comparing the change in physical activity between baseline and follow up between treatments (SET, HBET, ER) and control (usual care). The standardised mean difference (SMD) with 95% credible interval (CI) was calculated as a summary statistic and converted into steps per day to aid interpretation. RESULTS: Eight trials involving 656 patients with IC investigating the short-term effect of treatment on daily physical activity were included. Both SET (SMD 0.41, 95% CI 0.10-0.72: this corresponds to a difference of + 803 steps/day on a pedometer) and HBET (SMD 0.50, 95% CI 0.18-0.88: + 980 steps/day) displayed a benefit over control, based on evidence of moderate and low quality, respectively. The benefit of ER compared with control was SMD 0.36 (95% CI -0.22 to 0.99: + 705 steps/day), but only one trial supplied direct evidence, resulting in a low rating of the quality of evidence. Comparisons between treatments yielded no statistically significant differences. The results were robust to several sensitivity analyses. CONCLUSION: SET improves daily physical activity levels in patients with IC over control. HBET may have a similar benefit, while invasive treatment failed to lead to a statistically significant improvement of physical activity compared with control. However, the underlying quality of evidence for comparisons with ER and HBET is low, impeding definite conclusions.

User Preferences for Mobile Health Interventions: A Survey among Intermittent Claudication Patients and Their Physical Therapists.

BACKGROUND: Smartphone apps provide novel ways for triggering lifestyle change by coupling objective measurements of health behavior with tailored feedback. Little is known about end-user preferences regarding the content of mobile health (mHealth) interventions. The aim of this study was to assess smartphone use and preferences regarding app content among intermittent claudication patients and their treating physical therapists. METHODS: A cross-sectional survey was sent via an internal email system to 1,514 physical therapists specialized in treating patients with intermittent claudication. They were asked to complete one questionnaire themselves and administer a second to their intermittent claudication patients currently under treatment. Data on participant characteristics and smartphone use were collected from all respondents. The preferred app components were obtained from participants owning a smartphone. Binary logistic regression analysis was used to explore the adjusted association between age and attained educational level, and smartphone use. RESULTS: The response rate of therapists was 40.8% (617/1,514), and a total of 488 patients completed the survey. After excluding incomplete forms, a total of 615 physical therapist forms and 483 patient forms were analyzed. Overall, 40.6% of patients and 95% of therapists owned a smartphone. Higher educational level was associated with smartphone ownership (adjusted odds ratio = 2.46, 95% confidence interval (CI) = 1.41-4.27, P = 0.001). Compared to patients aged ≥75 years, lower age was associated with higher odds of owning a smartphone (adjusted odds ratios for patients aged ≤54 years = 21.27, 95% CI = 6.82-66.30, P < 0.001; aged 55-64 years = 4.76, 95% CI = 2.52-9.00, P < 0.001; and aged 65-74 years = 2.58, 95% CI = 1.54-4.33, P < 0.001). The most preferred app components for intermittent claudication patients in possession of a smartphone included monitoring treadmill-measured walking distances (71%), global positioning system tracking of walks (50%), and daily physical activity monitoring (49%). Physical therapists were most interested in global positioning system tracking of walks (89%), daily physical activity monitoring (82%), keeping track of treadmill-measured walking distance (79%), help with smoking cessation (65%). CONCLUSIONS: Smartphone ownership is associated with younger age and a higher educational level in patients with intermittent claudication. This study provides a framework of end-user preferences regarding desired features to guide the development of an app to potentiate health outcomes of intermittent claudication treatment.

Agreements and discrepancies between the estimated walking distance, nongraded and graded treadmill testing, and outside walking in patients with intermittent claudication.

BACKGROUND: Disease severity in patients with intermittent claudication (IC) is often assessed using walking distances and treadmill tests. The aim of this study was to determine the agreement between walking distance as estimated by the patient, as measured during outside walking, and as determined using a nongraded treadmill protocol (NGTP), and an incremental graded (Gardner-Skinner) treadmill protocol (GSP). METHODS: In this prospective observational study, 30 patients with IC estimated their maximal walking distance (MWD) and completed a "Walking Impairment Questionnaire" (WIQ). Outside walking was determined using a measuring wheel and a GSP controlled device. Primary outcomes were differences in MWD and variability (coefficient of variation, COV). Secondary outcomes were results of WIQ and differences in walking speed. RESULTS: Estimated walking distance was significantly higher than MWD as objectively measured during outside walking (400 m vs. 309 m, respectively, P = 0.02). A substantial variability (COV = 55%) was found between both parameters. A small 35-m MWD difference between outside walking and GSP was found with a substantial scatter (COV = 42%). In contrast, a much larger 122-m MWD difference was present between outside walking and NGTP (COV = 89%). Patients walked significantly faster in the open air than on treadmills (median outside walking speed = 3.8 km/hr, GSP = 3.2 km/hr, NGTP = 2.8 km/hr; P < 0.001). CONCLUSIONS: An incremental graded (Gardner-Skinner) treadmill protocol demonstrated the best agreement to outside walking. Discrepancies between treadmill tests and outside walking may be explained by a difference in walking speed. A single determination of a walking distance is a poor reflection of true walking capacity.

Venous Thoracic Outlet Syndrome Caused by Double Compression of the Axillosubclavian Vein: A Case Report.

INTRODUCTION: In venous thoracic outlet syndrome (VTOS), pathology around the axillosubclavian vein causes venous compression with the subsequent development of upper extremity symptoms. This case report describes the analysis of all possible compression sites and subsequent treatment of VTOS patients with multiple compression points. REPORT: A 22 year old male presented with severe pain and swelling in his right arm, which persisted after a conservatively managed primary upper extremity deep vein thrombosis. Compression of the axillosubclavian vein was seen both at the level of the pectoralis minor and the costoclavicular spaces. Both compression points were successfully treated by combining thoracic outlet decompression surgery with pectoralis minor tenotomy. DISCUSSION: This report underlines the importance of considering the possibility of multiple compression sites in patients with VTOS. Incomplete surgical release of all compression points leaves patients prone to re-thrombosis and/or persistent post-thrombotic syndrome. Timely recognition of all abnormalities on venography may allow for adjustment of surgical treatment accordingly.

Supervised exercise therapy: it does work, but how to set up a program?

Intermittent claudication (IC) is a manifestation of peripheral arterial disease. IC has a high prevalence in the older population, is closely associated with other expressions of atherosclerotic disease and often co-exists in multimorbid patients. Treatment of IC should address reduction of cardiovascular risk and improvement of functional capacity and health-related quality of life (QoL). As recommended by contemporary international guidelines, the first-line treatment includes supervised exercise therapy (SET). In several randomized controlled trials and systematic reviews, SET is compared with usual care, placebo, walking advice and endovascular revascularization. The evidence supporting the efficacy of SET programs to alleviate claudication symptoms is robust. SET improves walking distance and health-related QoL and appears to be the most cost-effective treatment for IC. Nevertheless, only few of all newly diagnosed IC patients worldwide receive this safe, efficient and structured treatment. Worldwide implementation of structured SET programs is seriously impeded by outdated arguments favoring an invasive intervention, absence of a network of specialized physical therapists providing standardized SET and lack of awareness and/or knowledge of the importance of SET by referring physicians. Besides, misguiding financial incentives and lack of reimbursement hamper actual use of SET programs. In the Netherlands, a national integrated care network (ClaudicatioNet) was launched in 2011 to combat treatment shortcomings and stimulate cohesion and collaboration between stakeholders. This care intervention has resulted in optimized quality of care for all patients with IC.

Treatment of upper-extremity outflow thrombosis.

Approximately 10% of all cases of deep vein thrombosis (DVT) occur in the upper extremities. The most common secondary cause of upper-extremity DVT (UEDVT) is the presence of a venous catheter. Primary UEDVT is far less common and usually occurs in patients with anatomic abnormalities of the costoclavicular space causing compression of the subclavian vein, called venous thoracic outlet syndrome (VTOS). Subsequently, movement of the arm results in repetitive microtrauma to the vein and its surrounding structures causing apparent 'spontaneous' thrombosis, or Paget-Schrötter syndrome. Treatment of UEDVT aims at elimination of the thrombus, thereby relieving acute symptoms, and preventing recurrence. Initial management for all UEDVT patients consists of anticoagulant therapy. In patients with Paget-Schrötter syndrome the underlying VTOS necessitates a more aggressive management strategy. Several therapeutic options exist, including catheter-directed thrombolysis, surgical decompression through first rib resection, and percutaneous transluminal angioplasty of the vein. However, several controversies exist regarding their indication and timing.