Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry

Introduction Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. Methods and analysis This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1–3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient a

Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): Study protocol for a randomized controlled trial

Background: Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly highe

The long term prognosis of patients with peripheral arterial disease after infrainguinal bypass surgery : the follow-up of the Dutch Bypass and Oral anticoagulants or Aspirin Study

Peripheral arterial disease (PAD) is a major public health burden with a prevalence of approximately 27 million people in Europe and North America. PAD is characterised by a progressive narrowing or occlusion of the major arteries in the lower limbs as a result of atherosclerosis. Because atherosclerosis is a systemic disease, patients with PAD are at high risk of lower limb complications and of cardiovascular and cerebrovascular ischaemic events. Despite the growing awareness that PAD is an important marker of generalized atherosclerosis, its systemic consequences are still underestimated and undertreated in comparison with coronary artery disease or cerebrovascular disease. To raise awareness and improve secondary prevention, this thesis focussed on the long-term prognosis of patients with PAD who were treated with infrainguinal bypass surgery. Our primary aim was to quantify the risk of ischaemic complications throughout the whole arterial tree up to 10 years after bypass surgery and elucidate its determinants. Data on fatal and non-fatal vascular events that occurred between 1995 and 2009 were recorded in nearly 500 patients who had participated in the Dutch Bypass and Oral anticoagulants or Aspirin (BOA) Study (The Lancet 2000;355:346-351). The follow-up data were complete in 94% of patients and enabled us to give a fairly accurate insight in the long-term course of PAD and to produce an easy to use tool to determine a patient’s vascular risk profile. This so called BOA Risk Chart helps to predict a patient’s long-term prognosis quickly and effortlessly without the need for any additional testing. Furthermore, we studied the former and currently applied drug treatments (i.e. antithrombotic, antihypertensive, and lipid lowering drugs) and cardiovascular risk management in PAD patients after they underwent peripheral bypass surgery. Both the results of our international survey among vascular surgeons throughout Europe and of our drug registration over the past decade in a sample of patients from the Dutch BOA study showed an improvement in the application of secondary prevention therapy, but also for it to remain far from optimal. Although these results should be interpreted with caution because of possible selection and survival bias, they do underline the frequently reported undertreatment of patients with PAD. Lately, bleeding –the main adverse effect of antithrombotic therapy– is reported to lead to a four- to five-fold or even a nine-fold increase in the risk of death, myocardial infarction, or ischaemic stroke in patient with coronary artery disease or cerebrovascular disease. As this association has not been reported in PAD patients before, we studied the consequences of bleeding in patients with PAD from the Dutch BOA Study and again in a pooled dataset of the Dutch BOA Study and the Warfarin Antiplatelet Vascular Evaluation (WAVE) Trial (N Engl J Med 2007;357:217-227). Our results confirmed the previous findings of non-fatal major bleeding being independently associated with a three-fold increased risk of new ischaemic events. Further research is required to elucidate the causal underlying mechanism of this new association. Until then, the prevention of bleeding is equally important as the prevention of ischaemic events. Finally, in daily life the prognosis after peripheral bypass surgery is determined by a patient’s perception of health, rather than by clinical risk estimates. Therefore we studied the changes in patients’ health related quality of life (HR-QoL) after peripheral bypass surgery over time. Their HR-QoL was substantially impaired in comparison with the HR-QoL of the general population at the same mean age, even if the patient had a patent graft or experienced no other vascular event during follow-up. Over time their HR-QoL worsened, mainly their physical health, and especially after the occurrence of a vascular event. Given that peripheral bypass cannot prevent the HR-QoL in patients with PAD to deteriorate over time, atherosclerotic risk management through lifestyle modifications and drug treatments might be just as important to stabilise the HR-QoL for as long as possible. In conclusion, PAD is a major public health burden, not only because PAD has a high prevalence and a progressive pathology, but especially because its the long term systemic consequences are largely disabling and currently largely underestimated

Adenoidectomy and/or tonsillectomy in childhood is not associated with atopic disease later in life.

Contains fulltext : 51271.pdf (publisher's version ) (Closed access)OBJECTIVE: To investigate the association between adenoidectomy and/or tonsillectomy in childhood and asthma, allergic rhinitis (AR), and eczema in adolescence. METHODS: Longitudinal birth cohort study of 1328 members born in the city of Nijmegen. Information on ear-nose-throat surgery was documented at 2, 4, and 8 years of age. In 1055 cohort members the incidence of asthma, AR, and eczema at 21 years of age was determined using the International Study of Asthma and Allergic disease in Childhood Core Questionnaire. To analyse the association between adenoidectomy and/or tonsillectomy in childhood and asthma, AR, and eczema at age 21 years, relative risks (RR) were calculated. RESULTS: Six hundred and ninety-three (66%) members completed the questionnaire at age 21 years, of whom 104 (15%) had undergone adenoidectomy and/or tonsillectomy and 262 (38%) reported atopic disease. Children who underwent adenoidectomy and/or tonsillectomy before the age of 8 years were not more likely to develop asthma, AR, or eczema at the age of 21 years than children who did not; RR 0.93 (95% confidence limits (CL) 0.52-1.64), RR 0.94 (CL 0.68-1.30), and RR 1.00 (CL 0.59-1.68), respectively. CONCLUSIONS: Our data show no association between adenoidectomy and/or tonsillectomy in childhood and the incidence of atopic disease in young adults

Comparison of performance, health and welfare aspects between commercially housed hatchery-hatched and on-farm hatched broiler flocks

On-farm hatching systems for broiler chicks are increasingly used in practice. We studied whether or not performance, health and welfare aspects differed between commercial flocks hatched on-farm or in a hatchery (control). In two successive production cycles on seven farms, a total of 16 on-farm hatched flocks were paired to 16 control flocks, housed at the same farm. Paired flocks originated from the same batch of eggs and were subjected to similar on-farm management. On-farm hatched and control flocks only differed with respect to hatching conditions, with on-farm hatched flocks not being exposed to, for example, chick handling, post-hatch feed and water deprivation and transport, in contrast to control flocks that were subjected to standard hatchery procedures, subsequently transported and placed in the poultry house. Day-old chick quality (navel and hock scores), 1st week mortality, total mortality, BW at day (d) 0, d7 and at depopulation, and (total) feed conversion ratio were determined. Prevalence of footpad dermatitis, hock burn, breast discoloration/blisters and cleanliness, litter quality and gait score were determined at d21 of age and around depopulation (d39 on average). Gross pathology and gut morphology were examined at depopulation age in a sample of birds of five flocks per treatment. On-farm hatching resulted in a higher BW at d0 (=5.4 g) and d7 (=11.5 g) (Pst week and total mortality, and feed conversion ratio at slaughter age were similar for both on-farm hatched and control flocks. On-farm hatched flocks had less footpad dermatitis (P=0.05), which indicated a better welfare. This was likely related to a tendency for better litter quality in on-farm hatched flocks at 21 days of age in comparison to control flocks (P=0.08). No major differences in gross pathology or in intestinal morphology at depopulation age were found between treatments. In conclusion, on-farm hatching resulted in better 1st week broiler performance and better welfare compared to conventional hatching in a hatchery.</p

Multicenter Case Series and Literature Review on Durability of Stents in the Thoracic Outlet

Purpose: The aim of this paper was to report our experience with arterial and venous endovascular stent placement in the thoracic outlet (TO) and review available literature. Methods: All patients that underwent arterial or venous stent placement in the TO between 2013 and 2020 in 5 Dutch vascular teaching-hospitals were retrospectively identified. Primary endpoint was symptomatic stent failure due to stenosis, chronic or posture dependent compression, fracture, or occlusion of the stent. Secondary endpoints were symptoms at last follow-up and re-interventions. For the literature review, we searched studies reporting on stenting in the TO. Results: Twenty-six patients were included with 11 arterial and 15 venous stents implanted to treat angioplasty resistant stenosis in arterial or venous TO syndrome, iatrogenic or traumatic vascular injury, radiotherapy fibrosis, or arterial dissection. Median follow-up was 19 and 14 months in the arterial and venous-group, respectively. Eight (73%) patients in the arterial, and 9 (60%) in the venous-group suffered symptomatic stent failure. Seven (64%) patients in the arterial, and 9 (60%) in the venous-group required at least 1 re-intervention. When comparing all patients with stent placement after TO decompression (TOD) to patients without, there were substantially more symptomatic stent failures and re-interventions required in the patients without TOD. Six patients (54%) in the arterial-group and 11 (73%) in the venous-group were symptom-free at last follow-up. Five articles describing 51 patients with arterial and 6 articles describing 81 patients with venous stents were included in the literature review. In the arterial-group, no TOD prior to stent placement was performed, while in the venous-group all but 1 article performed TOD prior to stent placement. Results showed comparable rates of symptomatic stent failure (24% vs 30%), and patients requiring re-interventions (29% vs 21%) between groups. Conclusion: Based on our multicenter series and review, stents in the TO have a considerable risk of failure, both in the venous and the arterial territory. Especially in patients without TOD: the need for re-interventions is high and half the patients eventually undergo TOD. Based on the currently available data, stenting in the TO should be applied cautiously while TOD should be considered

Post-thrombotic syndrome after upper extremity deep vein thrombosis: An international Delphi consensus study

OBJECTIVES: Primary deep vein thrombosis of the upper extremity (UEDVT) is a rare condition but up to 60% of patients may develop post-thrombotic syndrome in the upper extremity (UE-PTS) with significant morbidity and decreased quality of life. However, there is no universally accepted method to diagnose and classify UE-PTS, hampering scientific research on UEDVT treatment. Through this international Delphi consensus study we aimed to determine what a clinical score for diagnosing UE-PTS should entail. METHODS: An online focus group survey among 20 patients treated for UEDVT was performed to provide clinical parameters before the start of a four round electronic Delphi consensus study among 25 international experts. The CREDES recommendations on Conducting and Reporting Delphi Studies were applied. Open text questions, multiple selection questions, and 9-point Likert scales were used. Consensus was set at 70% agreement. RESULTS: After four rounds, agreement was reached on a composite score of five symptoms and three clinical signs, combined with a functional disability score. The signs and symptom will each be scored on a severity scale of 0-3 and the total score expressed as an ordinal variable; no/mild/moderate/or severe PTS. The functional disability portion measures the impact of the signs and symptoms on the functionality of the patient's arm. CONCLUSION: Consensus was reached on a composite score of signs and symptoms of UE-PTS combined with a functional disability score. Clinical validation of the UE-PTS score in a large patient cohort is mandatory to facilitate application in future research

Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry

textabstractIntroduction Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. Methods and analysis This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1–3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves. Ethics and dissemination This study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United ‘MEC-U’ (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally. Trial registration number NTR7332; Pre-results