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Von Birgelen C.,Spectrum | Von Birgelen C.,University of Twente | Basalus M.W.Z.,Spectrum | Tandjung K.,Spectrum | And 12 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up. Background: Only 1 randomized trial previously compared these stents. Methods: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat. Results: Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p noninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy. Conclusions: Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650) © 2012 American College of Cardiology Foundation.


Vermeer M.,University of Twente | Vermeer M.,Spectrum | Kuper H.H.,Spectrum | Moens H.J.B.,Ziekenhuisgroep Twente | And 4 more authors.
Arthritis Care and Research | Year: 2013

Objective Treat-to-target (T2T) leads to improved clinical outcomes in early rheumatoid arthritis (RA). The question is whether these results sustain in the long term. Our objective was to investigate the 3-year results of a protocolized T2T strategy in daily clinical practice. Methods In the Dutch Rheumatoid Arthritis Monitoring remission induction cohort, patients newly diagnosed with RA were treated according to a T2T strategy aimed at remission (Disease Activity Score in 28 joints [DAS28] <2.6). Patients were treated with methotrexate, followed by the addition of sulfasalazine, and exchange of sulfasalazine with anti-tumor necrosis factor α agents in case of failure. Primary outcomes were disease activity, Health Assessment Questionnaire (HAQ) score, Short Form 36 physical component summary (PCS) and mental component summary (MCS) scores, and the Sharp/van der Heijde score (SHS) after 3 years. Secondary outcomes were sustained DAS28 remission (≥6 months) and remission according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition. Results After 3 years (n = 342), 61.7% of patients were in DAS28 remission and 25.3% met the provisional ACR/EULAR definition of remission. Sustained remission was experienced by 70.5%, which in the majority was achieved with conventional disease-modifying antirheumatic drugs only. The median scores were 0.4 (interquartile range [IQR] 0.0-1.0) for the HAQ, 45.0 (IQR 38.4-53.2) for the PCS, 53.1 (IQR 43.2-60.8) for the MCS, and 6.0 (IQR 3.0-13.0) for the total SHS. Conclusion In very early RA, T2T leads to high (sustained) remission rates, improved physical function and health-related quality of life, and limited radiographic damage after 3 years in daily clinical practice. Copyright © 2013 by the American College of Rheumatology.


Van Netten J.J.,Ziekenhuisgroep Twente | Fortington L.V.,University of Ballarat | Hinchliffe R.J.,St Georges Vascular Institute | Hijmans J.M.,University of Groningen
European Journal of Vascular and Endovascular Surgery | Year: 2016

Objective Lower limb amputation is often associated with a high risk of early post-operative mortality. Mortality rates are also increasingly being put forward as a possible benchmark for surgical performance. The primary aim of this systematic review is to investigate early post-operative mortality following a major lower limb amputation in population/regional based studies, and reported factors that might influence these mortality outcomes. Methods Embase, PubMed, Cinahl and Psycinfo were searched for publications in any language on 30 day or in hospital mortality after major lower limb amputation in population/regional based studies. PRISMA guidelines were followed. A self developed checklist was used to assess quality and susceptibility to bias. Summary data were extracted for the percentage of the population who died; pooling of quantitative results was not possible because of methodological differences between studies. Results Of the 9,082 publications identified, results were included from 21. The percentage of the population undergoing amputation who died within 30 days ranged from 7% to 22%, the in hospital equivalent was 4-20%. Transfemoral amputation and older age were found to have a higher proportion of early post-operative mortality, compared with transtibial and younger age, respectively. Other patient factors or surgical treatment choices related to increased early post-operative mortality varied between studies. Conclusions Early post-operative mortality rates vary from 4% to 22%. There are very limited data presented for patient related factors (age, comorbidities) that influence mortality. Even less is known about factors related to surgical treatment choices, being limited to amputation level. More information is needed to allow comparison across studies or for any benchmarking of acceptable mortality rates. Agreement is needed on key factors to be reported. © 2015 European Society for Vascular Surgery.


Vermeer M.,University of Twente | Kuper H.H.,Spectrum | Hoekstra M.,Isala Klinieken | Haagsma C.J.,Ziekenhuisgroep Twente | And 4 more authors.
Arthritis and Rheumatism | Year: 2011

Objective Clinical remission is the ultimate therapeutic goal in rheumatoid arthritis (RA). Although clinical trials have proven this to be a realistic goal, the concept of targeting at remission has not yet been implemented. The objective of this study was to develop, implement, and evaluate a treat-to-target strategy aimed at achieving remission in very early RA in daily clinical practice. Methods Five hundred thirty-four patients with a clinical diagnosis of very early RA were included in the Dutch Rheumatoid Arthritis Monitoring remission induction cohort study. Treatment adjustments were based on the Disease Activity Score in 28 joints (DAS28), aiming at a DAS28 of <2.6 (methotrexate, followed by the addition of sulfasalazine, and exchange of sulfasalazine with biologic agents in case of persistent disease activity). The primary outcome was disease activity after 6 months and 12 months of followup, according to the DAS28, the European League Against Rheumatism (EULAR) response criteria, and the modified American College of Rheumatology (ACR) remission criteria. Secondary outcomes were time to first DAS28 remission and outcome of radiography. Results Six-month and 12-month followup data were available for 491 and 389 patients, respectively. At 6 months, 47.0% of patients achieved DAS28 remission, 57.6% had a good EULAR response, and 32.0% satisfied the ACR remission criteria. At 12 months, 58.1% of patients achieved DAS28 remission, 67.9% had a good EULAR response, and 46.4% achieved ACR remission. The median time to first remission was 25.3 weeks (interquartile range 13.0-52.0). The majority of patients did not have clinically relevant radiographic progression after 1 year. Conclusion The successful implementation of this treat-to-target strategy aiming at remission demonstrated that achieving remission in daily clinical practice is a realistic goal. Copyright © 2011 by the American College of Rheumatology.


Schipper L.G.,Radboud University Nijmegen | Vermeer M.,University of Twente | Kuper H.H.,University of Twente | Hoekstra M.O.,Isala Klinieken | And 5 more authors.
Annals of the Rheumatic Diseases | Year: 2012

There is strong evidence from clinical trials that a 'treat to target' strategy is effective in reaching remission in rheumatoid arthritis (RA). However, the question is whether these results can be translated into daily clinical practice and clinical remission is a reachable target indeed. Objective: The study aims to investigate whether in early RA a treatment strategy aiming at Disease Activity Score (DAS) 28 <2.6 is more effective than 'usual care'treatment for reaching clinical remission after 1 year. Methods: Two early RA inception cohorts from two different regions including patients who fulfilled the American College of Rheumatology criteria for RA were compared. Patients in the tight-control cohort (n=126) were treated according to a DAS28-driven step-up treatment strategy starting with methotrexate, addition of sulphasalazine (SSZ) and exchange of SSZ by anti-tumour necrosis factor in case of failure. Patients in the usual-care cohort (n=126) were treated with methotrexate or SSZ, without DAS28-guided treatment decisions. The primary outcome was the percentage remission (DAS28<2.6) at 1 year. Time to first remission and change in DAS28 were secondary outcomes. Results: After 1 year, 55% of tight-control patients had a DAS28<2.6 versus 30% of usual care patients (OR 3.1, 95% CI 1.8 to 5.2). The median time to first remission was 25 weeks for tight control and more than 52 weeks for usual care (p<0.0001). The DAS28 decreased with -2.5 in tight control and -1.5 in usual care (p<0.0001). Conclusion: In early RA, a tight control treatment strategy aiming for remission leads to more rapid DAS28 remission and higher percentages of remission after 1 year than does a usual care treatment.


Mes M.,University of Twente | Bruens M.,Ziekenhuisgroep Twente
Proceedings - Winter Simulation Conference | Year: 2012

This paper discusses the development of a discrete-event simulation model for an integrated emergency post. This post is a collaboration between a general practitioners post and an emergency department within a hospital. We present a generalized and flexible simulation model, which can easily be adapted to several emergency departments as well as to other departments within the hospital, as we demonstrate with our application to the integrated emergency post. Here, generalization relates to the way we model patient flow, patient prioritization, resource allocation, and process handling. After presenting the modeling approach, we shortly describe the implemented and validated model of the integrated emergency post, and describe how it is currently being used by health care managers to analyze the effects of organizational interventions. © 2012 IEEE.


Bus S.A.,University of Amsterdam | van Netten J.J.,Ziekenhuisgroep Twente
Diabetes/Metabolism Research and Reviews | Year: 2016

Diabetic foot ulceration poses a heavy burden on the patient and the healthcare system, but prevention thereof receives little attention. For every euro spent on ulcer prevention, ten are spent on ulcer healing, and for every randomized controlled trial conducted on prevention, ten are conducted on healing. In this article, we argue that a shift in priorities is needed. For the prevention of a first foot ulcer, we need more insight into the effect of interventions and practices already applied globally in many settings. This requires systematic recording of interventions and outcomes, and well-designed randomized controlled trials that include analysis of cost-effectiveness. After healing of a foot ulcer, the risk of recurrence is high. For the prevention of a recurrent foot ulcer, home monitoring of foot temperature, pressure-relieving therapeutic footwear, and certain surgical interventions prove to be effective. The median effect size found in a total of 23 studies on these interventions is large, over 60%, and further increases when patients are adherent to treatment. These interventions should be investigated for efficacy as a state-of-the-art integrated foot care approach, where attempts are made to assure treatment adherence. Effect sizes of 75-80% may be expected. If such state-of-the-art integrated foot care is implemented, the majority of problems with foot ulcer recurrence in diabetes can be resolved. It is therefore time to act and to set a new target in diabetic foot care. This target is to reduce foot ulcer incidence with at least 75%. © 2016 John Wiley & Sons, Ltd.


To evaluate the effects of the implementation of a multidisciplinary treatment approach at Hospital Group Twente in Almelo, Netherlands, of hip fracture patients aged 65 years and older. Historical comparative cohort study. Two groups of patients with hip fractures were retrospectively compared. One of these groups had been treated in 2009 according to the new, multidisciplinary treatment approach; the other in 2007 by usual means. Observations included the duration of hospital stay, as well as the numbers of complications, readmissions and consultations by other specialities. Included were 101 patients from 2009 and 69 from 2007. In 2009, the mean duration of hospital stay was 1 day longer than in 2007. Patients admitted to a nursing home for rehabilitation increased by 16 percentage points. The incidence of minor complications decreased by 7 percentage points; that of severe complications, 5 percentage points. The diagnosis of delirium was made significantly more often (15 percentage points more; p-value: 0.051). The rate of death decreased by 5 percentage points. The number of readmissions within 30 days declined by 14 percentage points (p-value: 0.001). Due to geriatric co-treatment (co-managed care), consultations by various specialities were fewer per patient. No reduction in the duration of hospital stay was achieved by implementation of the multidisciplinary treatment approach. It did appear that a relationship with better short-term treatment outcomes for the elderly with hip fractures existed.


Bernelot Moens H.J.,Ziekenhuisgroep Twente
Nederlands Tijdschrift voor Geneeskunde | Year: 2015

Three patients with signs of temporal arteritis are presented. In two patients a normal ESR resulted in the diagnosis 'temporal arteritis' being discarded, prompting clinicians to consider meningitis, sinusitis, and blindness due to atherosclerosis. In the third case, the ESR measured with the Alifax Test1TH apparatus was 17 mm/h, whereas the Westergren method used on the same sample resulted in an ESR of 83 mm/h. In all three cases CRP was elevated. On the basis of literature on the sensitivity of ESR and CRP it is advisable to use both measures when temporal arteritis is being considered. It is noted that in one hospital using the Alifax Test1TH, only 52% of 25 patients with biopsyproven temporal arteritis had an ESR over 40 mm/h, while 96% had elevated CRP. This observation requires further evaluation. The significance of signs, symptoms and new imaging techniques for recognising cranial giant cell arteritis is summarised. © 2015 NED Tijdschr Geneeskd.


Otte J.,Ziekenhuisgroep Twente | Van Netten J.J.,Ziekenhuisgroep Twente | Woittiez A.-J.J.,Ziekenhuisgroep Twente
Journal of Vascular Surgery | Year: 2015

Objective The objective of this study was to investigate the risk of chronic kidney disease (CKD) stage 4-5 and dialysis treatment on incidence of foot ulceration and major lower extremity amputation in comparison to CKD stage 3. Methods In this retrospective study, all individuals who visited our hospital between 2006 and 2012 because of CKD stages 3 to 5 or dialysis treatment were included. Medical records were reviewed for incidence of foot ulceration and major amputation. The time from CKD 3, CKD 4-5, and dialysis treatment until first foot ulceration and first major lower extremity amputation was calculated and analyzed by Kaplan-Meier curves and multivariate Cox proportional hazards model. Diabetes mellitus, peripheral arterial disease, peripheral neuropathy, and foot deformities were included for potential confounding. Results A total of 669 individuals were included: 539 in CKD 3, 540 in CKD 4-5, and 259 in dialysis treatment (individuals could progress from one group to the next). Unadjusted foot ulcer incidence rates per 1000 patients per year were 12 for CKD 3, 47 for CKD 4-5, and 104 for dialysis (P <.001). In multivariate analyses, the hazard ratio for incidence of foot ulceration was 4.0 (95% confidence interval [CI], 2.6-6.3) in CKD 4-5 and 7.6 (95% CI, 4.8-12.1) in dialysis treatment compared with CKD 3. Hazard ratios for incidence of major amputation were 9.5 (95% CI, 2.1-43.0) and 15 (95% CI, 3.3-71.0), respectively. Conclusions CKD 4-5 and dialysis treatment are independent risk factors for foot ulceration and major amputation compared with CKD 3. Maximum effort is needed in daily clinical practice to prevent foot ulcers and their devastating consequences in all individuals with CKD 4-5 or dialysis treatment. © 2015 Society for Vascular Surgery.

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