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.

Randomized controlled trial of vacuum therapy for intermittent claudication.

OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program. METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life. RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups. CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.

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.

Limited Adherence to Peripheral Arterial Disease Guidelines and Suboptimal Ankle Brachial Index Reliability in Dutch Primary Care.

OBJECTIVE/BACKGROUND: The Dutch College of General Practitioners' guideline on peripheral arterial disease (PAD) provides clear recommendations on the management of PAD. An ankle brachial index (ABI) measurement, prescription of antiplatelet drugs and statins, and supervised exercise therapy (SET) for intermittent claudication (IC) are advised. The aims of this study were to determine the adherence of general practitioners (GPs) to their own guideline on PAD and to evaluate the reliability of primary care ABI measurements. METHODS: This was a cross-sectional study. All patients suspected of having symptomatic PAD who were referred by GPs to a large hospital in 2015 were evaluated regarding three of the guideline criteria: (i) ABI measurement; (ii) prescription of secondary prevention; (iii) initiation of SET. ABI values obtained in primary care and the hospital's vascular laboratory were compared using correlation coefficients and regression analysis. An abnormal ABI was defined as a value <.9 (normal ABI ≥.9). RESULTS: Of 308 potential patients with new onset PAD, 58% (n = 178) had undergone ABI measurement prior to referral. A modest correlation between ABI values obtained in primary care and the vascular laboratory was found (r = .63, p < .001). Furthermore, a moderate reliability was calculated (intraclass correlation coefficient 0.60, 95% confidence interval 0.49-0.69, p < .001). Of the new patients with an abnormal ABI, 59% used antiplatelet drugs and 55% used statins. A referral for SET was initiated by a GP in 10% of new PAD patients with IC symptoms. CONCLUSIONS: Adherence by Dutch GPs to their own society's PAD guideline has room for improvement. The reliability of ABI measurements is suboptimal, whereas rates of prescription of secondary prevention and initiation of SET as primary treatment for IC need upgrading.

Supervised Exercise Therapy for Intermittent Claudication Is Increasingly Endorsed by Dutch Vascular Surgeons.

BACKGROUND: Although supervised exercise therapy (SET) is generally accepted as an effective noninvasive treatment for intermittent claudication (IC), Dutch vascular surgeons were initially somewhat hesitant as reported by a 2011 questionnaire study. Later on, a nationwide multidisciplinary network for SET was introduced in the Netherlands. The aim of this questionnaire study was to determine possible trends in conceptions among Dutch vascular surgeons regarding the prescription of SET. METHODS: In the year of 2015, Dutch vascular surgeons, fellows, and senior residents were asked to complete a 26-item questionnaire including issues that were considered relevant for prescribing SET such as patient selection criteria and comorbidity. Outcome was compared to the 2011 survey. RESULTS: Data of 124 respondents (82% males; mean age 46 years; 64% response rate) were analyzed. SET referral rate of new IC patients was not different over time (2015: 81% vs. 2011: 75%; P = 0.295). However, respondents were more willing to prescribe SET in IC patients with chronic obstructive pulmonary disease (2015: 86% vs. 2011: 69%; P = 0.002). Nevertheless, a smaller portion of respondents found that SET was also indicated for aortoiliac disease (2015: 63% vs. 2011: 76%; P = 0.049). Insufficient health insurance coverage and/or personal financial resources were the most important presumed barriers preventing patients from initiating SET (80% of respondents). Moreover, 94% of respondents judged that SET should be fully reimbursed by all Dutch basic health insurances. CONCLUSIONS: The concept of SET for IC is nowadays generally embraced by the vast majority of Dutch vascular surgeons. SET may have gained in popularity in IC patients with cardiopulmonary comorbidity. However, SET remains underutilized for aortoiliac disease. Reimbursement is considered crucial for a successful SET implementation.

Prolonged stance phase during walking in intermittent claudication.

BACKGROUND: Patients with intermittent claudication (IC) tend to walk slower and consume approximately 40% more oxygen during walking compared with healthy individuals. An unfavorable locomotion pattern has been suggested to explain this metabolic inefficiency. However, detailed knowledge of gait parameters in IC is lacking. METHODS: In a cross-sectional study, the gait pattern of newly diagnosed IC patients was compared with that of healthy controls. Spatiotemporal gait parameters such as step length and duration of stance phase were obtained by a photoelectric technique (OptoGait; Microgate, Bolzano, Italy). This system was previously found to have favorable concurrent validity and test-retest reliability characteristics. Parameters were determined during pain-free and painful treadmill walking at a comfortable self-determined walking pace. Each parameter was averaged on the basis of 80 steps. RESULTS: A total of 28 patients and 28 controls were examined. IC patients walked 1.2 km/h (-27%) slower than controls (P < .001), coinciding with a significantly shorter step length (-20%) and lower cadence (-11%). IC patients demonstrated a longer stance and double support phase, even before the onset of ischemic pain. Differences were also observed in segments of the stance phase, as a 14% shorter propulsion (P < .001) and 17% longer flat foot phase (P < .001) during painful walking were found. In considering the absolute duration of these stance phase segments, differences were found only for the flat foot time (Δ0.10 second; P < .001). CONCLUSIONS: Patients with IC demonstrate an altered gait pattern compared with healthy controls. The most prominent differences were a prolonged relative and absolute duration of the flat foot position during the stance phase. This adaptation may be intuitive as an augmented arterial blood flow into skeletal muscles is allowed during a prolonged relaxation phase. Therefore, not only the lack of propulsion but also a gain of relaxation may explain these gait alterations.

Minimal correlation between physical exercise capacity and daily activity in patients with intermittent claudication.

BACKGROUND: Walking capacity measured by a treadmill test (TT) reflects the patient's maximal capacity in a controlled setting and is part of the physical exercise capacity (PEC). Daily physical activity (PA) is defined as the total of actively freely produced movements per day. A lower PA level has been increasingly recognized as a strong predictor of increased morbidity and mortality in patients with intermittent claudication (IC). Recent insights suggested that an increased PEC does not automatically lead to an increase in daily PA. However, the precise relation between PEC and PA in patients with IC is still unclear. METHODS: A cross-sectional study was conducted to assess the association between several PEC outcomes and PA in a general IC population. PEC was determined by well-established tests (Gardner-Skinner TT, a physical performance battery, a timed up-and-go test, and a 6-minute walk test distance). PA was obtained during 7 consecutive days using a triaxial accelerometer (Dynaport MoveMonitor; McRoberts BV, The Hague, The Netherlands). Five PA components (lying, sitting, standing, shuffling, and locomotion) and four parameters (total duration, number of periods, mean duration per period, and mean movement intensity per period) were analysed. Correlation coefficients between PEC and PA components were calculated. RESULTS: Data of 46 patients were available for analysis. Patients were sedentary (sitting and lying) during 81% of the day and were physically active (standing, shuffling, and locomotion) for the remaining 19% of the time. Correlations between PEC outcomes and PA ranged from very weak (0.025) to moderate (0.663). Moderate correlations (as therefore assumed to be relevant) were only found for outcomes of both the TT and 6-minute walk test and the locomotion components of PA. For instance, functional claudication distance (measured by TT) and number of steps per day correlated reasonably well (Spearman correlation ρ = 0.663; P < .01). CONCLUSIONS: Exercise capacity and PA correlate minimally in patients with IC. PA may be preferred as a novel outcome measure and future treatment target in patients with IC.

Altered joint kinematics and increased electromyographic muscle activity during walking in patients with intermittent claudication.

BACKGROUND: Patients with intermittent claudication (IC) tend to walk at a slower pace, have less lower leg muscle strength, and consume approximately 40% more oxygen during walking compared with healthy individuals. An unfavorable locomotion pattern has been suggested to explain this metabolic inefficiency. However, knowledge on gait patterns in IC is limited. Muscle activity patterns during walking measured using surface electromyography (EMG) have not been investigated in this patient population. METHODS: In this cross-sectional study, gait pattern of patients newly diagnosed with IC and age-matched controls were evaluated using kinematic parameters and medial gastrocnemius (MG) and tibialis anterior (TA) muscles activity patterns. The protocol included pain-free and painful (only IC patients) treadmill walking sessions. RESULTS: A total of 22 IC patients and 22 healthy control subjects were included. Patients walked 1.4 km/h slower (3.2 km/h vs 4.6 km/h; P < .001) than control subjects, coinciding with a 10% slower cadence (110 steps/min vs 122 steps/min; P < .001). The kinematic analysis resulted in a patient's ankle plantar flexion reduction of 45% during the propulsion phase, and ankle dorsal flexion reduction of 41% at initial contact. No additional kinematic changes were observed when claudication pain presented. Interestingly, kinematic differences did not influence the muscle activity duration during walking, because equal duration of muscle activity was found in IC patients and healthy controls. However, the amount of muscle activity in microvolts did significantly increase in IC patients when claudication pain presented (TA: Δ23%; P < .001; MG: Δ54%; P = .007). CONCLUSIONS: Patients with IC show significant kinematic changes during walking. These alterations did not affect EMG activity duration of MG and TA muscles. However, EMG amplitude of both muscles did significantly increase during painful walking in IC patients.

Safety of supervised exercise therapy in patients with intermittent claudication.

BACKGROUND: Supervised exercise therapy (SET) is recommended as the primary treatment for patients with intermittent claudication (IC). However, there is concern regarding the safety of performing SET because IC patients are at risk for untoward cardiovascular events. The Dutch physical therapy guideline advocates cardiac exercise testing before SET, if indicated. Perceived uncertainties concerning safety may contribute to the underuse of SET in daily practice. The objective of this review was to analyze the safety of supervised exercise training in patients with IC. METHODS: Two authors independently studied clinical trials investigating SET. Data were obtained from MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials. Complication rates were calculated and expressed as number of events per number of patient-hours. The usefulness of cardiac screening before SET was evaluated in a subanalysis. RESULTS: Our search strategy revealed 2703 abstracts. We selected 121 articles, of which 74 met the inclusion criteria. Studies represent 82,725 hours of training in 2876 IC patients. Eight adverse events were reported, six of cardiac and two of noncardiac origin, resulting in an all-cause complication rate of one event per 10,340 patient-hours. CONCLUSIONS: SET can safely be prescribed in patients with IC because an exceedingly low all-cause complication rate was found. Routine cardiac screening before commencing SET is not required. Our results may diminish perceived uncertainties regarding safety and will possibly increase the use of SET in daily practice.

Gender differences following supervised exercise therapy in patients with intermittent claudication.

OBJECTIVE: Prevalence of peripheral arterial disease is equal in men and women. However, women seem to suffer more from the burden of disease. Current studies on gender-related outcomes following supervised exercise therapy (SET) for intermittent claudication (IC) yield conflicting results. METHODS: A follow-up analysis was performed on data from the 2010 Exercise Therapy in Peripheral Arterial Disease (EXITPAD) study, a multicenter randomized controlled trial including IC patients receiving SET or a walking advice. The SET program was supervised by physiotherapists and included interval-based treadmill walking approximating maximal pain combined with activities such as cycling and rowing. Patients usually started with three 30-minute sessions a week. Training frequency was adapted during the following year on the basis of individual needs. The primary outcome was gender differences regarding the change in absolute claudication distance (ACD) after SET. ACD was defined as the number of meters that a patient had covered just before he or she was forced to stop walking because of intolerable pain. Secondary outcomes were gender differences in change of functional walking distance, quality of life, and walking (dis)ability after SET. Walking distances were obtained by standardized treadmill testing according to the Gardner-Skinner protocol. Quality of life was measured by the 36-Item Short Form Health Survey, and walking (dis)ability was determined by the Walking Impairment Questionnaire (WIQ). Measurements were performed at baseline and after 3, 6, 9, and 12 months. Only patients who met the 12-month follow-up measure were included in the analysis. RESULTS: A total of 113 men and 56 women were available for analysis. At baseline, groups were similar in terms of clinical characteristics and ACD walking distances (men, 250 meters; women, 270 meters; P = .45). ACD improved for both sexes. However, ACD increase was significantly lower for women than for men during the first 3 months of SET (Δ 280 meters for men vs Δ 220 meters for women; P = .04). Moreover, absolute walking distance was significantly shorter for women compared with men after 1 year (565 meters vs 660 meters; P = .032). Women also reported less on several WIQ subdomains, although total WIQ score was similar (0.69 for men vs 0.61 for women; P = .592). No differences in quality of life after SET were observed. CONCLUSIONS: Women with IC benefit less during the first 3 months of SET and have lower absolute walking distances after 12 months of follow-up compared with men. More research is needed to determine whether gender-based IC treatment strategies are required.

Preoperative exercise therapy in surgical care: a scoping review.

OBJECTIVES: Several systematic reviews have focused on the role of preoperative exercise therapy (PET) in various fields of surgical care. Aims of the present scoping review are to summarize research findings and to identify gaps in existing literature. METHODS: Two authors independently conducted a comprehensive literature search on systematic reviews regarding PET. The risk of bias was assessed using "the methodology checklist for systematic reviews and meta-analyses of the Scottish Intercollegiate Guidelines Network (SIGN)." Findings of the included systematic reviews were summarized according to type of surgery and type of PET. RESULTS: Twenty-one reviews on PET with a low risk of bias were included. Seven reviews investigated PET in multiple surgical fields and 14 in just a single surgical field. PET was studied before cardiac surgery (n = 9), orthopedic surgery (n = 8), abdominal surgery (n = 8), thoracic surgery (n = 8), vascular surgery (n = 3), and urologic surgery (n = 1). CONCLUSION: Overall, it seems that PET exerts beneficial effects on physical fitness and postoperative outcome measures. Gaps in current literature are the heterogeneity in selected patient populations and outcome measures as well as lack of guidelines on the specific PET regimes. Therefore, there is increasing need for multicenter randomized trials with specifically designed PET programs and a carefully selected patient population to strengthen current evidence.

[Infantile myofibroma: a neonate with a swelling on the arm]. / Het infantiel myofibroom: een neonaat met een gezwel van de onderarm.

BACKGROUND: An infantile myofibroma (IM) is a benign congenital soft-tissue tumour. IM is found in 1 per 150,000 live births, making it the most common fibrous tumour of infancy and early childhood. CASE DESCRIPTION: We report on a full-term neonate presenting with an irregular tumour mass on the right lower-arm. The mass measured 5 cm in diameter, with surface ulceration. Magnetic resonance imaging (MRI) revealed characteristics that could be consistent with malignancy. On the basis of a biopsy and subsequent polymerase chain reaction we were able to make a diagnosis of 'benign infantile myofibroma'. We chose for conservative treatment in the expectation that the tumour would regress spontaneously. CONCLUSION: Infantile myofibroma should be considered when a newborn presents with an atypical mass. It is difficult to make a diagnosis on the basis of the clinical characteristics alone due to the heterogeneous presentation. A definitive diagnosis can only be made following histological investigation.