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1.
Ann Vasc Surg ; 78: 302-309, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34543716

ABSTRACT

BACKGROUND: Patient reported outcome measures (PROMs) such as health status (HS) and quality of life (QOL) are frequently used interchangeably while they represent different outcomes. Whether a discrepancy exists in patients with intermittent claudication (IC) in changes over time between HS and QOL is unclear. This study aimed to investigate the strength and the direction of the association between HS and QOL over time in patients with IC that underwent supervised exercise therapy (SET). MATERIAL AND METHODS: Patients were part of the ELECT multi-center prospective cohort study. One goal of this study was to obtain data on HS and QOL at different time intervals of patients with IC that underwent SET. HS (VascuQOL-6) and QOL (WHOQOL-BREF) were completed at baseline, 3 months, and 6 months follow up. Pearson's correlation coefficients and the associated common variances (R2) were calculated to measure the strength and the direction of the association between HS and QOL in changes between baseline and follow-up moments. RESULTS: In total, 177 patients were included in data analyses. Only changes in physical QOL and overall QOL had a small correlation with changes over time in HS, at both 3- and 6 months follow up (respectively R2=.14; P < 0.001 and R2 = 0.12; P < 0.001 for physical QOL and R2 = 0.18; P < 0.001 and R2 = 0.13; P < 0.001 for overall QOL). CONCLUSIONS: This study showed that HS and QOL provide different outcomes in patients with IC that underwent SET. Future studies should be aware of these differences before PROMs are being incorporated as an outcome measure in clinical studies.


Subject(s)
Exercise Therapy , Health Status , Intermittent Claudication/therapy , Patient Reported Outcome Measures , Quality of Life , Aged , Female , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/physiopathology , Male , Middle Aged , Netherlands , Prospective Studies , Time Factors , Treatment Outcome
2.
Ned Tijdschr Geneeskd ; 161: D1385, 2017.
Article in Dutch | MEDLINE | ID: mdl-29241462

ABSTRACT

Neurogenic thoracic outlet syndrome (nTOS) is a type of thoracic outlet syndrome (TOS) where compression of the brachial plexus is responsible for development of upper-extremity, head and neck symptoms. We present a 16-year-old and a 34-year-old patient with nTOS. Diagnosis in both cases was done by following the recently published reporting standards for (n)TOS. After this multidisciplinary diagnostic work-up we performed a transaxillary thoracic outlet decompression (TOD). Due to lack of literature, difficult nomenclature and complexity of diagnosis and treatment, diagnosis of nTOS is often delayed. Recent experience shows that treatment of nTOS is safe and effective, both in the short term and the long term.


Subject(s)
Decompression, Surgical , Thoracic Outlet Syndrome/diagnosis , Thoracic Outlet Syndrome/surgery , Adolescent , Adult , Brachial Plexus , Female , Humans , Male , Neurosurgical Procedures , Treatment Outcome
3.
Eur J Vasc Endovasc Surg ; 54(1): 51-57, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28539212

ABSTRACT

OBJECTIVE/BACKGROUND: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period. METHODS: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. RESULTS: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; +22% [p < .001]) and INT in 44% (2009: 66%; -22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; +13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; -16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; +19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (€6885 vs. €7300; p = .020). CONCLUSION: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system.


Subject(s)
Exercise Therapy/economics , Guideline Adherence/economics , Health Care Costs , Intermittent Claudication/economics , Intermittent Claudication/therapy , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/therapy , Practice Guidelines as Topic , Practice Patterns, Physicians'/economics , Process Assessment, Health Care/economics , Aged , Aged, 80 and over , Budgets , Cost Savings , Cost-Benefit Analysis , Databases, Factual , Female , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/physiopathology , Male , Middle Aged , Netherlands , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Recovery of Function , Retrospective Studies , Time Factors , Treatment Outcome
4.
Br J Surg ; 103(12): 1616-1625, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27513296

ABSTRACT

BACKGROUND: Current guidelines recommend supervised exercise therapy (SET) as the preferred initial treatment for patients with intermittent claudication. The availability of SET programmes is, however, limited and such programmes are often not reimbursed. Evidence for the long-term cost-effectiveness of SET compared with endovascular revascularization (ER) as primary treatment for intermittent claudication might aid widespread adoption in clinical practice. METHODS: A Markov model was constructed to determine the incremental costs, incremental quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio of SET versus ER for a hypothetical cohort of patients with newly diagnosed intermittent claudication, from the Dutch healthcare payer's perspective. In the event of primary treatment failure, possible secondary interventions were repeat ER, open revascularization or major amputation. Data sources for model parameters included original data from two RCTs, as well as evidence from the medical literature. The robustness of the results was tested with probabilistic and one-way sensitivity analysis. RESULTS: Considering a 5-year time horizon, probabilistic sensitivity analysis revealed that SET was associated with cost savings compared with ER (-€6412, 95 per cent credibility interval (CrI) -€11 874 to -€1939). The mean difference in effectiveness was -0·07 (95 per cent CrI -0·27 to 0·16) QALYs. ER was associated with an additional €91 600 per QALY gained compared with SET. One-way sensitivity analysis indicated more favourable cost-effectiveness for ER in subsets of patients with low quality-of-life scores at baseline. CONCLUSION: SET is a more cost-effective primary treatment for intermittent claudication than ER. These results support implementation of supervised exercise programmes in clinical practice.


Subject(s)
Endovascular Procedures/economics , Exercise Therapy/economics , Intermittent Claudication/therapy , Aged , Cost Savings , Cost-Benefit Analysis , Exercise Therapy/methods , Female , Health Status , Humans , Male , Middle Aged , Quality of Life , Quality-Adjusted Life Years , Reperfusion/economics , Reperfusion/methods , Walking/economics , Walking/physiology
5.
PLoS One ; 11(6): e0157921, 2016.
Article in English | MEDLINE | ID: mdl-27336741

ABSTRACT

OBJECTIVE: The aim of the present study was to assess the degree and impact of patient selection of patients with intermittent claudication undergoing supervised exercise therapy in Randomized Controlled Trials (RCTs) by describing commonly used exclusion criteria, and by comparing baseline characteristics and treatment response measured as improvement in maximum walking distance of patients included in RCTs and patients treated in standard care. METHODS: We compared data from RCTs with unselected standard care data. First, we systematically reviewed RCTs that investigated the effect of supervised exercise therapy in patients with intermittent claudication. For each of the RCTs, we extracted and categorized the eligibility criteria and their justifications. To assess whether people in RCTs (n = 1,440) differed from patients treated in daily practice (n = 3,513), in terms of demographics, comorbidity and walking capacity, we assessed between group-differences using t-tests. To assess differences in treatment response, we compared walking distances at three and six months between groups using t-tests. Differences of ≥15% were set as a marker for a clinically relevant difference. RESULTS: All 20 included RCTs excluded large segments of patients with intermittent claudication. One-third of the RCTs eligibility criteria were justified. Despite, the numerous eligibility criteria, we found that baseline characteristics were largely comparable. A statistically significant and (borderline) clinically relevant difference in treatment response after three and six months between trial participants and standard care patients was found. Improvements in maximum walking distance after three and six months were significantly and clinically less in trial participants. CONCLUSIONS: The finding that baseline characteristics of patients included in RCTs and patients treated in standard care were comparable, may indicate that RCT eligibility criteria are used implicitly by professionals when referring patients to standard physiotherapy care. The larger treatment response reported in standard physiotherapy care compared to clinical trials, might suggest that scientific studies underestimate the benefits of supervised exercise therapy in patients with intermittent claudication.


Subject(s)
Exercise Therapy , Intermittent Claudication/therapy , Randomized Controlled Trials as Topic/standards , Standard of Care/standards , Female , Humans , Male , Physical Therapy Modalities/standards , Treatment Outcome
6.
Physiotherapy ; 102(2): 196-201, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26626054

ABSTRACT

OBJECTIVES: The aim of the study was to develop quality indicators (QIs) for physiotherapy management of patients with intermittent claudication (IC) in the Netherlands. DESIGN: As part of an international six-step method to develop QIs, an online survey Delphi-procedure was completed. After two Delphi-rounds a validation round was performed. PARTICIPANTS: Twenty-six experts were recruited to participate in this study. Twenty-four experts completed two Delphi-rounds. A third round was conducted inviting 1200 qualified and registered physiotherapists of the Dutch integrated care network 'Claudicationet' to validate a draft set of quality indicators. RESULTS: Out of 83 potential QIs in the Dutch physiotherapy guideline on 'Intermittent claudication', consensus among the experts selected nine indicators. All nine quality indicators were validated by 300 physiotherapists. CONCLUSION: A final set of nine indicators was derived from (1) a Dutch evidence-based physiotherapy guideline, (2) an expert Delphi procedure and (3) a validation by 300 physiotherapists. This set of indicators should be validated in clinical practice.


Subject(s)
Intermittent Claudication/rehabilitation , Physical Therapy Modalities/standards , Quality Indicators, Health Care/standards , Adult , Delphi Technique , Female , Humans , Male , Middle Aged , Netherlands , Practice Guidelines as Topic
7.
Eur J Vasc Endovasc Surg ; 51(3): 404-9, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26715076

ABSTRACT

OBJECTIVE: Disease severity and treatment outcomes in patients with intermittent claudication (IC) are commonly assessed using walking distance measured with a standardized treadmill test. It is unclear what improvement or deterioration in walking distance constitutes a meaningful, clinically relevant, change from the patients' perspective. The purpose of the present study was to estimate the minimally important difference (MID) for the absolute claudication distance (ACD) and functional claudication distance (FCD) in patients with IC. METHOD: The MIDs were estimated using an anchor based approach with a previously defined clinical anchor derived from scores of the walking impairment questionnaire (WIQ) in a similar IC population. Baseline and 3 month follow up data on WIQ scores and walking distances (ACD and FCD) were used from 202 patients receiving supervised exercise therapy from the 2010 EXITPAD randomized controlled trial. The external WIQ anchor was used to form three distinct categories: patients with "clinically relevant improvement," "clinically relevant deterioration," and "no clinically relevant change." The MIDs for improvement and deterioration were defined by the upper and lower limits of the 95% confidence interval of the mean change in ACD and FCD, for the group of IC patients that remained unchanged according to the WIQ anchor. RESULTS: For the estimation of the MID of the ACD and FCD, 102 and 101 patients were included, respectively. The MID for the ACD was 305 m for improvement, and 147 m for deterioration. The MID for the FCD was 250 m for improvement, and 120 m for deterioration. CONCLUSION: The MIDs for the treadmill measured ACD and FCD can be used to interpret the clinical relevance of changes in walking distances after supervised exercise therapy and may be used in both research and individual care.


Subject(s)
Exercise Therapy/methods , Intermittent Claudication/physiopathology , Surveys and Questionnaires , Walking/physiology , Aged , Exercise Test , Female , Follow-Up Studies , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/rehabilitation , Male , Retrospective Studies , Severity of Illness Index , Time Factors , Treatment Outcome
8.
Eur J Vasc Endovasc Surg ; 50(6): 810-4, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26391963

ABSTRACT

OBJECTIVE: Haemodialysis access induced distal ischemia (HAIDI) induced by an autogenous arteriovenous fistula (AVF) is caused by loss of blood pressure somewhere along the arterial blood supply of the arm. In some patients, side branches of the access' venous outflow tract may contribute to this blood pressure loss. Beneficial effects of side branch ligation (SBL) as a first step approach to ischemic symptoms have been reported. However, effects on access flow and AVF function after prolonged follow up are unknown. MATERIALS AND METHODS: Prior to SBL, HAIDI patients with a brachial artery based AVF were studied using a questionnaire quantifying hand ischemia, digital brachial index (DBI, finger plethysmography), and Duplex analysis. Access flow volume, patency rates, hand perfusion, and complications were determined during a 12 month observation period following SBL. RESULTS: In 9 years, SBLs were performed in 20 haemodialysis patients, either as a single operative procedure (n = 10) or supplemented (n = 10) with additional surgical techniques during the same procedure (banding, n = 5; basilic vein transposition, n = 4; DRIL, n = 1). Follow up data after 12 months were available in 18 patients. One patient with progressive hand ischemia required access ligation 3 months after SBL. Hand ischemia was attenuated or abolished in the remaining 17 patients (94% clinical success rate). DBI improved from 0.51 ± 0.05 (pre-operative) to 0.68 ± 0.04 (immediate post-operative) and 0.83 ± 0.07 (at 1 year follow up). One year primary, assisted primary, and secondary patency rates were 67% (12/18), 83% (15/18), and 94% (17/18), respectively, while mean access flows remained acceptable at 710 ± 70 mL/min. CONCLUSIONS: Ligation of non-functional venous side branches of an autogenous brachial artery AVF causing hand ischemia leads to prolonged attenuation of hand ischemia whereas access flow volumes are maintained after 1 year of follow up. Side branch ligation must be considered prior to embarking on more invasive surgery for HAIDI.


Subject(s)
Arteriovenous Shunt, Surgical/adverse effects , Brachial Artery/surgery , Graft Occlusion, Vascular/surgery , Hand/blood supply , Ischemia/surgery , Renal Dialysis , Veins/surgery , Aged , Blood Flow Velocity , Brachial Artery/physiopathology , Female , Graft Occlusion, Vascular/diagnosis , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/physiopathology , Humans , Ischemia/diagnosis , Ischemia/etiology , Ischemia/physiopathology , Ligation , Male , Plethysmography , Regional Blood Flow , Reoperation , Surveys and Questionnaires , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Duplex , Vascular Patency , Veins/physiopathology
11.
Eur J Vasc Endovasc Surg ; 50(3): 313-9, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26027898

ABSTRACT

OBJECTIVE: To compare the mid-term results of endovascular aortic aneurysm repair (EVAR) for ruptured abdominal aortic aneurysms (RAAAs) in patients with favourable aortic neck anatomy (FNA) and hostile aortic neck anatomy (HNA). METHODS: Patients treated for a RAAA in a high volume endovascular centre in the Netherlands between February 2009 and January 2014 were identified retrospectively and divided into two groups based on aortic neck anatomy, FNA and HNA. HNA was defined as RAAA with a proximal neck of <10 mm, or a proximal neck of 10-15 mm with a suprarenal angulation (α) >45° and/or an infrarenal angulation (ß) >60°, or a proximal neck of >15 mm combined with α >60° and/or ß >75°. Patient demographics, procedure details, 30 day and 1 year outcomes were recorded. RESULTS: Of 39 included patients, 17 (44%) had HNA. Technical success was 100% for FNA and 88% for HNA (p = .184). There were no type IA endoleaks on completion angiography in either group; however, more adjunctive procedures were necessary for intra-operative type IA endoleaks in the HNA group (24% vs. 0%, p = .029). Thirty day mortality rates were comparable, FNA 14% vs. HNA 12% (p = 1.000). There were no statistically significant differences at 1 year follow up in type I endoleaks, secondary endovascular procedures, or all cause mortality. CONCLUSION: Emergency EVAR provides excellent results for treatment of RAAA patients with both FNA and HNA. EVAR in RAAAs with HNA is technically feasible and safe in experienced endovascular centres. Article history.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnosis , Aortic Rupture/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endoleak/etiology , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Hospitals, High-Volume , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Netherlands , Retrospective Studies , Risk Factors , Time Factors , Tomography, X-Ray Computed , Treatment Outcome
12.
Eur J Vasc Endovasc Surg ; 49(1): 66-76, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25457300

ABSTRACT

OBJECTIVE/BACKGROUND: The impact of post-operative complications in abdominal aortic aneurysm (AAA) surgery is substantial, and increases with age and concomitant co-morbidities. This systematic review focuses on the possible effects of pre-operative exercise therapy (PET) in patients with AAA on post-operative complications,aerobic capacity, physical fitness, and recovery. METHODS: A systematic search on PET prior to AAA surgery was conducted. The methodological quality of the included studies was rated using the Physiotherapy Evidence Database scale. The agreement between the reviewers was assessed with Cohen's kappa. RESULTS: Five studies were included, with a methodological quality ranging from moderate to good. Cohen's kappa was 0.79. Three studies focused on patients with an AAA (without indication for surgical repair) with physical fitness as the outcome measure. One study focused on PET in patients awaiting AAA surgery and one study focused on the effects of PET on post-operative complications, length of stay, and recovery. CONCLUSION: PET has beneficial effects on various physical fitness variables of patients with an AAA. Whether this leads to less complications or faster recovery remains unclear. In view of the large impact of post-operative complications, it is valuable to explore the possible benefits of a PET program in AAA surgery.


Subject(s)
Aortic Aneurysm, Abdominal/rehabilitation , Aortic Aneurysm, Abdominal/surgery , Exercise Therapy , Preoperative Care , Hemodynamics , Humans , Patient Satisfaction , Physical Fitness , Postoperative Complications/prevention & control , Respiratory Function Tests , Risk Reduction Behavior , Treatment Outcome
13.
Eur J Vasc Endovasc Surg ; 49(2): 184-91, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25496986

ABSTRACT

OBJECTIVE/BACKGROUND: Intermittent claudication (IC) is associated with a reduction in physical activity (PA) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals. Supervised exercise therapy (SET) is known to increase the walking capacity of patients with IC. However, it is unclear whether SET increases PA. The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC. METHODS: Patients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET. The primary outcome was the percentage of patients meeting the minimum recommendations of PA (American College of Sports Medicine [ACSM]/American Heart Association [AHA] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day, in bouts of ≥ 10 min) at baseline and after 3 months of SET. Additionally, daily PA level (METs/min), duration of ambulatory activities, daily number of steps, pain free walking distance (PFWD), maximal walking distance (MWD), and Short Form Health Survey (SF-36) health surveys were compared before and after SET. RESULTS: Data from 41 participants were available for analysis. A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up (baseline: 43%; 3 months: 63%; p = .003). Despite significant increases in PFWD (baseline: 210 m; 3 months: 390 m; p = .001), MWD (baseline: 373 m; 3 months: 555 m; p = .002) and physical functioning score (SF-36) following SET, no increase in the mean daily PA level was found (395 ± 220 vs. 411 ± 228 METs/min; p = .43). Furthermore, the total number of steps and time spent in ambulatory activities did not change following SET. CONCLUSION: Three months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA. Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease.


Subject(s)
Exercise Therapy , Intermittent Claudication/therapy , Motor Activity , Peripheral Arterial Disease/therapy , Actigraphy , Aged , Aged, 80 and over , Exercise Tolerance , Female , Health Behavior , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/physiopathology , Intermittent Claudication/psychology , Male , Middle Aged , Netherlands , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/psychology , Sedentary Behavior , Time Factors , Treatment Outcome , Walking
14.
Eur J Vasc Endovasc Surg ; 48(4): 423-9, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24951374

ABSTRACT

OBJECTIVES: International guidelines recommend supervised exercise therapy (SET) as primary treatment for intermittent claudication (IC). The aim of this study was to calculate treatment costs in patients with IC and to estimate nationwide annual savings if a stepped care model (SCM, primary SET treatment followed by revascularization in case of SET failure) was followed. METHODS: Invoice data of all patients with IC in 2009 were obtained from a Dutch health insurance company (3.4 million members). Patients were divided into three groups based on initial treatment after diagnosis (t0). The SET group received SET initiated at any time between 12 months before and up to 3 months after t0. The intervention group (INT) underwent endovascular or open revascularization between t0 and t+3 months. The third group (REST) received neither SET nor any intervention. All peripheral arterial disease related invoices were recorded during 2 years and average costs per patient were calculated. Savings following use of a SCM were calculated for three scenarios. RESULTS: Data on 4954 patients were analyzed. Initial treatment was SET (n = 701, 14.1%), INT (n = 1363, 27.5%), or REST (n = 2890, 58.3%). Within 2 years from t0, invasive revascularization in the SET group was performed in 45 patients (6.4%). Additional interventions (primary at other location and/or re-interventions) were performed in 480 INT patients (35.2%). Some 431 REST patients received additional SET (n = 299, 10.3%) or an intervention (n = 132, 4.5%). Mean total IC related costs per patient were €2,191, €9851 and €824 for SET, INT, and REST, respectively. Based on a hypothetical worst, moderate, and best case scenario, some 3.8, 20.6, or 33.0 million euros would have been saved per annum if SCM was implemented in the Dutch healthcare system. CONCLUSION: Implementation of a SCM treatment for patients with IC may lead to significant savings of health care resources.


Subject(s)
Exercise Therapy/economics , Intermittent Claudication/economics , Intermittent Claudication/therapy , Models, Organizational , Vascular Surgical Procedures/economics , Aged , Cost Savings , Cost-Benefit Analysis , Female , Follow-Up Studies , Guidelines as Topic , Hospital Costs , Humans , Male , Netherlands , Retrospective Studies
15.
Eur J Vasc Endovasc Surg ; 48(2): 169-84, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24928167

ABSTRACT

BACKGROUND: A number of reviews have reported the influence of exercise therapy (ET) for the treatment of intermittent claudication (IC). However, a complete overview of different types of ET is lacking. The aim of this meta-analysis was to study the effect of supervision on walking capacity in patients with IC. It was hypothesized that there was a positive treatment effect in relation to the intensity of supervision and improvement in walking capacity (i.e., a "dose-response" hypothesis). METHODS: A systematic search in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases was performed. Only randomized controlled trials (RCTs) evaluating the efficacy of an ET in IC were included. Type of supervision, treadmill protocol, length of ET, total training volume, and change in walking distance were extracted. RCTs were categorised according to type of support: no exercise, walking advice, home-based exercise (HB-ET), and supervised exercise therapy (SET). A standardised mean difference between pre- and post-training maximal walking distance (MWD) and pain-free walking distance (PFWD) was calculated for all subgroups at 6 weeks, and 3 and 6 months of follow up. RESULTS: Thirty studies involving 1406 patients with IC were included. The overall quality was moderate-to-good, although number of included patients varied widely (20-304). The intensity of supervision was directly related to MWD and PFWD. SET was superior to other conservative treatment regimens with respect to improvement in walking distances at all follow-ups. However, the difference between HB-ET and SET at 6 months of follow up was not significant. CONCLUSION: Supervised exercise therapy for intermittent claudication is superior to all other forms of exercise therapy. Intensity of supervision is related to improved walking distance.


Subject(s)
Exercise Therapy/methods , Exercise Tolerance , Home Care Services , Intermittent Claudication/therapy , Walking , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/physiopathology , Recovery of Function , Time Factors , Treatment Outcome
16.
Eur J Vasc Endovasc Surg ; 48(2): 194-200, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24880631

ABSTRACT

OBJECTIVES: The daily life physical activity (PA) of patients with peripheral arterial disease (PAD) may be severely hampered by intermittent claudication (IC). From a therapeutic, as well as research, point of view, it may be more relevant to determine improvement in PA as an outcome measure in IC. The aim of this study was to validate daily activities using a novel type of tri-axial accelerometer (Dynaport MoveMonitor) in patients with IC. METHODS: Patients with IC were studied during a hospital visit. Standard activities (locomotion, lying, sitting, standing, shuffling, number of steps and "not worn" detection) were video recorded and compared with activities scored by the MoveMonitor. Inter-rater reliability (expressed in intraclass correlation coefficients [ICC]), sensitivity, specificity, and positive predictive values (PPV) were calculated for each activity. RESULTS: Twenty-eight hours of video observation were analysed (n = 21). Our video annotation method (the gold standard method) appeared to be accurate for most postures (ICC > 0.97), except for shuffling (ICC = 0.38). The MoveMonitor showed a high sensitivity (>86%), specificity (>91%), and PPV (>88%) for locomotion, lying, sitting, and "not worn" detection. Moderate accuracy was found for standing (46%), while shuffling appeared to be undetectable (18%). A strong correlation was found between video recordings and the MoveMonitor with regard to the calculation of the "number of steps" (ICC = 0.90). CONCLUSIONS: The MoveMonitor provides accurate information on a diverse set of postures, daily activities, and number of steps in IC patients. However, the detection of low amplitude movements, such as shuffling and "sitting to standing" transfers, is a matter of concern. This tool is useful in assessing the role of PA as a novel, clinically relevant outcome parameter in IC.


Subject(s)
Actigraphy/instrumentation , Motor Activity , Peripheral Arterial Disease/diagnosis , Aged , Equipment Design , Exercise Tolerance , Female , Humans , Male , Middle Aged , Peripheral Arterial Disease/physiopathology , Predictive Value of Tests , Reproducibility of Results , Video Recording , Walking
17.
J Cardiovasc Surg (Torino) ; 55(5): 699-704, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24846671

ABSTRACT

AIM: The aim of this study was to collect clinical information on the performance of the Endurant® (II) Stent Graft System for endovascular repair in anatomically challenging infrarenal aneurysms, and to critically assess whether the current instructions for anatomic eligibility for endovascular treatment with this system are still applicable. METHODS: Initiated by doctors, EAGLE is a prospective, non-interventional study, aiming to enrol 250 patients in 20 experienced centres across several countries worldwide. EAGLE focuses on patients with challenging angulation or neck length. To minimize the risk of selection bias and enhance data quality, EAGLE eligibility will be determined by an independent core-lab and efforts will be made to secure consecutive enrolment of challenging cases. The EAGLE database is designed to merge with the on-going ENGAGE database, which enables comparative analysis of cases and results. RESULTS: The primary endpoint is treatment success at 30 days, 12 months and yearly up to 5 years postimplant. CONCLUSION: Separate studies on the performance of EVAR in challenging anatomy are necessary to demonstrate safety and effectiveness of the latest generation stent-grafts, which is essential in making a balanced judgment about the optimal management of AAAs.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Registries , Research Design , Stents , Aortic Aneurysm, Abdominal/diagnosis , Blood Vessel Prosthesis Implantation/adverse effects , Databases, Factual , Endovascular Procedures/adverse effects , Humans , Prospective Studies , Prosthesis Design , Risk Factors , Time Factors , Treatment Outcome
18.
Eur J Vasc Endovasc Surg ; 47(6): 656-63, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24735778

ABSTRACT

OBJECTIVES: Reduced physical activity (PA) is associated with a higher mortality rate and more rapid functional decline in patients with intermittent claudication (IC). The newest generation of accelerometers can assess both direction and intensity of activities three-dimensionally and may also adequately calculate energy expenditure in daily life. The aim of this study was to quantify daily PA level and energy expenditure of newly diagnosed patients with IC and healthy controls. PA outcomes are compared with contemporary public health physical activity guidelines. METHODS: Before initiating treatment, 94 patients with newly diagnosed IC and 36 healthy controls were instructed to wear a tri-axial seismic accelerometer for 1 week. Daily PA levels (in metabolic equivalents, METs) were compared with the ACSM/AHA public health PA minimum recommendations (≥64 METs·min·day, in bouts of ≥10 minutes). A subgroup analysis assessed the effect of functional impairment on daily PA levels. RESULTS: Data from 56 IC patients and 27 healthy controls were available for analysis. Patients with IC demonstrated significantly lower mean daily PA levels (±SD) than controls (387 ± 198 METs·min vs. 500 ± 156 METs·min, p = .02). This difference was solely attributable to a subgroup of IC patients with the largest functional impairment (WIQ-score < 0.4). Only 45% of IC patients met the public health physical activity guidelines compared with 74% of the healthy controls (p = .01). CONCLUSIONS: More than half of patients with IC do not meet recommended standards of PA. Considering the serious health risks associated with low PA levels, these findings underscore the need for more awareness to improve physical exercise in patients with IC.


Subject(s)
Actigraphy , Intermittent Claudication/diagnosis , Motor Activity , Actigraphy/instrumentation , Activities of Daily Living , Aged , Awareness , Case-Control Studies , Equipment Design , Female , Health Behavior , Health Knowledge, Attitudes, Practice , Humans , Intermittent Claudication/physiopathology , Male , Middle Aged , Patient Compliance , Predictive Value of Tests , Prospective Studies , Sedentary Behavior , Time Factors
19.
Eur J Clin Microbiol Infect Dis ; 33(7): 1089-94, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24430618

ABSTRACT

Detection of antibodies using immunofluoresence tests (IFAT) is recommended for diagnosis of chronic Q fever, but other commercial antibody assays are also available. We compared an enzyme-linked immunosorbent assay (ELISA) (Virion/Serion) and a complement fixation test (CFT) (Virion/Serion) for the detection of Coxiella burnetii IgG phase I and IgA phase I in early- and follow-up serum samples from patients with chronic Q fever, diagnosed according to an algorithm that involves IFAT. For this, we tested sera of 49 patients, including 30 proven, 14 probable and five possible chronic Q fever cases. Sensitivity of CFT for diagnosis of chronic Q fever was suboptimal (85 %), as eight patients, including five with chronic Q fever, tested negative at time of diagnosis, whereas IgG phase I antibodies were detected in these five patients by ELISA. Sensitivity of ELISA was higher, although three probable patients were missed. No differences in ELISA IgA phase I detection between proven chronic Q fever and probable were observed; instead possible patients were in majority IgA negative (60 %). Serological examination using ELISA and CFT in follow-up sera from 26 patients on treatment was unsatisfactory. Like IFAT, all kinetic options were possible: decreasing, remaining stable or even increase during time. This study demonstrated that the sensitivity of CFT-based phase I antibody detection is low and therefore not recommended for diagnosis of chronic Q fever. Based on our results, serological follow-up to guide treatment decisions was of limited value.


Subject(s)
Antibodies, Bacterial/blood , Complement Fixation Tests/methods , Coxiella burnetii/immunology , Q Fever/diagnosis , Q Fever/immunology , Enzyme-Linked Immunosorbent Assay/methods , Fluorescent Antibody Technique , Humans , Immunoglobulin A/blood , Immunoglobulin G/blood , Sensitivity and Specificity
20.
Eur J Vasc Endovasc Surg ; 47(3): 268-72, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24445087

ABSTRACT

OBJECTIVES: Because of the increasing number of interventional endovascular procedures with fluoroscopy and the corresponding high annual dose for interventionalists, additional dose-protecting measures are desirable. The purpose of this study was to evaluate the effect of disposable radiation-absorbing surgical drapes in reducing scatter radiation exposure for interventionalists and supporting staff during an endovascular aneurysm repair (EVAR) procedure. MATERIALS: This was a randomized control trial in which 36 EVAR procedures were randomized between execution with and without disposable radiation-absorbing surgical drapes (Radpad: Worldwide Innovations & Technologies, Inc., Kansas City, US, type 5511A). Dosimetric measurements were performed on the interventionalist (hand and chest) and theatre nurse (chest) with and without the use of the drapes to obtain the dose reduction and effect on the annual dose caused by the drapes. RESULTS: Use of disposable radiation-absorbing surgical drapes resulted in dose reductions of 49%, 55%, and 48%, respectively, measured on the hand and chest of the interventionalist and the chest of the theatre nurse. CONCLUSIONS: The use of disposable radiation-absorbing surgical drapes significantly reduces scatter radiation exposure for both the interventionalist and the supporting staff during EVAR procedures.


Subject(s)
Endovascular Procedures , Occupational Health , Radiology, Interventional , Surgical Drapes , Equipment Design , Humans , Operating Room Nursing , Radiometry
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