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Angelien Sieben,1 Hein AW van Onzenoort,2,3 Sandra van Dulmen,4–6 CJHM van Laarhoven,7 Sebastian JH Bredie81Department of Surgery, Division of Vascular Surgery, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; 2Department of Clinical Pharmacy, Amphia Hospital, Breda, the Netherlands; 3Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Center+, Maastricht, the Netherlands; 4Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, the Netherlands; 5NIVEL (Netherlands institute for health services research), Utrecht, the Netherlands; 6Faculty of Health and Social Sciences, University of South-Eastern Norway, Drammen, Norway; 7Department of General Surgery, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; 8Department of General Internal Medicine, Division of Vascular Medicine, Radboud University Medical Center, Nijmegen, the NetherlandsBackground: Poor medication adherence is a limitation in the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs.Purpose: To examine the process and effect of a nurse-led, web-based intervention based on behavioral change strategies to improve medication adherence in patients with CVD.Patients and methods: In this single-center, prospective, controlled clinical trial, cardiovascular patients were assigned to usual care, usual care plus a personalized website, or usual care plus a personalized website and personal consultations. Primary outcome was the level of adherence to cardiovascular medication. Data collection occurred between October 2011 and January 2015.Results: In total, 419 patients were randomized. Just 77 patients logged on the website and half of the invited patients attended the group consultation. Due to the limited use of the website, we combined the results of usual care and the usual care plus website group in one group (usual care) and compared these with the results of the group which received the nurse intervention (intervention group). No significant difference in adherence between the usual care group and the intervention group was observed. The adherence level in the usual care group was 93%, compared to 89% in the intervention group (p=0.08). 29% (usual care) and 31% (intervention group) of the patients showed a low adherence according to the Modified Morisky Scale® (p-value=0.94). The mean necessity concern differential was 3.8 with no differences between the two studied groups (mean 3.8 vs mean 3.9, p-value =0.86).Conclusion: Our intervention program did not show an effect. This could indicate that structured usual care provided to all cardiovascular patients already results in high medication adherence or that shortly after a cardiovascular event adherence is high. It could also indicate that the program did not have enough impact because there was not enough compliance with the intervention protocol.Trial registration: ID number NCT01449695, approved May 2011.Keywords: medication adherence, nurses, e-health, Health Belief Model, cardiovascular

Objective: The primary objective of this scoping review was to identify and describe state-of-the-art models that use vital sign monitoring to predict clinical deterioration on the general ward. The secondary objective was to identify facilitators, barriers, and effects of implementing these models., Data Sources: PubMed, Embase, and CINAHL databases until November 2020., Study Selection: We selected studies that compared vital signs-based automated real-time predictive algorithms to current track-and-trace protocols in regard to the outcome of clinical deterioration in a general ward population., Data Extraction: Study characteristics, predictive characteristics and barriers, facilitators, and effects., Results: We identified 1741 publications, 21 of which were included in our review. Two of the these were clinical trials, 2 were prospective observational studies, and the remaining 17 were retrospective studies. All of the studies focused on hospitalized adult patients. The reported area under the receiver operating characteristic curves ranged between 0.65 and 0.95 for the outcome of clinical deterioration. Positive predictive value and sensitivity ranged between 0.223 and 0.773 and from 7.2% to 84.0%, respectively. Input variables differed widely, and predicted endpoints were inconsistently defined. We identified 57 facilitators and 48 barriers to the implementation of these models. We found 68 reported effects, 57 of which were positive., Conclusion: Predictive algorithms can detect clinical deterioration on the general ward earlier and more accurately than conventional protocols, which in one recent study led to lower mortality. Consensus is needed on input variables, predictive time horizons, and definitions of endpoints to better facilitate comparative research.

Background: Periodic vital sign monitoring is commonly used to detect clinical deterioration. Incomplete assessment of Early Warning Score (EWS) and poor protocol compliance may negatively impact nurses' responsiveness to critical situations., Objective: This study assesses the quality of recorded EWSs and the degree of overall protocol compliance and protocol compliance in adverse event patients, in a centre that is an early adopter of an EWS safety protocol., Design: Retrospective single-centre cohort study., Setting: General hospital wards of a tertiary referral university medical centre., Participants: 48,864 patients admitted to general wards between 2015 and 2018., Methods: Vital sign and Modified EWS (MEWS) data were collected from the electronic health record. MEWS completeness was evaluated by determining the proportion of missing values for each vital sign. To evaluate protocol compliance, we assessed whether the elapsed time between consecutive MEWSs was within the protocollary time as dictated by the MEWS protocol. Outcome measures were overall MEWS completeness, and both overall protocol compliance and protocol compliance specifically in the 24 h before adverse events., Results: All required items to calculate a MEWS were present in 76 percent of the 1,663,743 vital sign measurements. Overall protocol compliance was 62 percent. For the low, mid-range and high MEWS groups, protocol compliances were 67, 47 and 30 percent, respectively. Time-to-next-MEWS exceeded protocol-recommended timing by up to 9 h for a substantial amount of MEWSs in the mid- and high-range MEWS groups. In patients with adverse events, compliance to the MEWS protocol during the 24 h prior to the events was 66 percent in aggregate, ranging from 80% in low MEWS groups, 74% in the mid-range, and 49% in the high MEWS groups. In the high MEWS group, improvements in protocol compliance were primarily noted in five hours immediately preceding the event., Conclusions: EWS assessments were incomplete in one-quarter of measurements. Compliance to a MEWS safety protocol was generally low, specifically when the protocol mandated more frequent MEWS assessments. Although more MEWSs were recorded in patients with adverse events, the increase in vital sign measurements' frequency mostly occurred shortly before the event manifested. This finding suggests missed opportunities to detect clinical deterioration., (Copyright © 2020. Published by Elsevier Ltd.)

Background: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD., Objective: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits., Methods: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits., Results: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire., Conclusions: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program., Trial Registration: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303., International Registered Report Identifier (irrid): RR2-10.2196/resprot.6352., (©Marscha M Engelen, Sandra van Dulmen, Saskia Puijk-Hekman, Hester Vermeulen, Maria WG Nijhuis-van der Sanden, Sebastian JH Bredie, Betsie GI van Gaal. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.07.2020.)

Background: Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices., Objective: This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP)., Methods: In this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices., Results: A total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices., Conclusions: Both devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward., Trial Registration: Clinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307., (©Mariska Weenk, Sebastian J Bredie, Mats Koeneman, Gijs Hesselink, Harry van Goor, Tom H van de Belt. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 10.06.2020.)

Background: Frequent home blood pressure (BP) measurements result in a better estimation of the true BP. However, traditional cuff-based BP measurements are troublesome for patients., Objective: This study aimed to evaluate the feasibility of a cuffless device for ambulatory systolic blood pressure (SBP) measurement., Methods: This was a mixed method feasibility study in patients with hypertension. Performance of ambulatory SBPs with the device was analyzed quantitatively by intrauser reproducibility and comparability to a classic home BP monitor. Correct use by the patients was checked with video, and user-friendliness was assessed using a validated questionnaire, the System Usability Scale (SUS). Patient experiences were assessed using qualitative interviews., Results: A total of 1020 SBP measurements were performed using the Checkme monitor in 11 patients with hypertension. Duplicate SBPs showed a high intrauser correlation (R=0.86, P<.001). SBPs measured by the Checkme monitor did not correlate well with those of the different home monitors (R=0.47, P=.007). However, the mean SBPs measured by the Checkme and home monitors over the 3-week follow-up were strongly correlated (R=0.75, P=.008). In addition, 36.4% (n=4) of the participants performed the Checkme measurements without any mistakes. The mean SUS score was 86.4 (SD 8.3). The most important facilitator was the ease of using the Checkme monitor. Most important barriers included the absence of diastolic BP and the incidental difficulties in obtaining an SBP result., Conclusions: Given the good intrauser reproducibility, user-friendliness, and patient experience, all of which facilitate patients to perform frequent measurements, cuffless BP monitoring may change the way patients measure their BP at home in the context of ambulant hypertension management., (©Paula AM Ogink, Jelske M de Jong, Mats Koeneman, Mariska Weenk, Lucien JLPG Engelen, Harry van Goor, Tom H van de Belt, Sebastian JH Bredie. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.06.2019.)

Objective: Changes in heart rate variability (HRV) occur at the initiation of hypoglycemia due to sympathetic nervous system activity. We investigated the use of HRV detection by a wearable device as an early alert for hypoglycemia., Research Design and Methods: This proof-of-principle study included 23 patients with type 1 diabetes (14 women, mean age 42 ± 11 years). Patients wore a VitalConnect HealthPatch for 5 days. Hypoglycemia was defined as glucose ≤70 mg/dL (≤3.9 mmol/L) by fingerstick measurement. HRV was analyzed in standardized periods before the hypoglycemic event., Results: Sixty-six hypoglycemic events were recorded. Hypoglycemia caused a typical HRV pattern in 36 (55%) of the hypoglycemic events. Eighteen events (27%) showed an atypical pattern. Ten events were unclassified (15%), and two did not display a change in HRV (3%)., Conclusions: Hypoglycemia causes early changes in HRV that can be detected by a wearable device. Measuring real-time HRV seems promising for early hypoglycemia detection., (© 2019 by the American Diabetes Association.)

Background: Using a mobile app for self-management could make it easier for patients to get insight into their blood pressure patterns. However, little is known about the availability, quality, and features of mobile apps targeting blood pressure., Objective: The goal of the research was to determine the availability, functionality, and quality of mobile apps that could be used for blood pressure monitoring purposes., Methods: A systematic app search was performed based on the standards for systematic reviews. We searched the Dutch official app stores for Android and iOS platforms using predefined keywords and included all English and Dutch mobile apps targeting blood pressure. Two independent assessors determined eligibility and quality of the apps using the 5-point Mobile App Rating Scale (MARS). Quality scores of the apps with and without 17 a priori selected characteristics were compared using independent sample t tests., Results: A total of 184 apps (104 Android, 80 iOS) met the inclusion criteria. The mean overall MARS score was 2.63 (95% CI 2.55-2.71) for Android and 2.64 (95% CI 2.56-2.71) for iOS. The apps Bloeddruk (4.1) and AMICOMED BP (3.6) had the highest quality scores on the Android and iOS platforms, respectively. Of the app characteristics recorded, only pricing, in-app advertisements, and local data storage were not associated with the quality scores. In only 3.8% (7/184) of the apps, involvement of medical experts in its development was mentioned, whereas none of the apps was formally evaluated with results published in a peer-reviewed journal., Conclusions: This study provides an overview of the best apps currently available in the app stores and important key features for self-management that can be used by health care providers and patients with hypertension to identify a suitable app targeting blood pressure monitoring. However, the majority of the apps targeting blood pressure monitoring were of poor quality. Therefore, it is important to involve medical experts in the developmental stage of health-related mobile apps to improve the quality of these apps., (©Hussein Jamaladin, Tom H van de Belt, Lianda CH Luijpers, Falco R de Graaff, Sebastian JH Bredie, Nel Roeleveld, Marleen MHJ van Gelder. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 14.11.2018.)

Background: Most electronic health (eHealth) interventions offered to patients serve a single purpose and lack integration with other tools or systems. This is problematic because the majority of patients experience comorbidity and chronic disease, see multiple specialists, and therefore have different needs regarding access to patient data, communication with peers or providers, and self-monitoring of vital signs. A multicomponent digital health cloud service that integrates data sharing, collection, and communication could facilitate patient-centered care in combination with a hospital patient portal and care professionals., Objective: This study aimed to assess the feasibility and functionality of a new cloud-based and multicomponent outpatient clinic, the "Virtual Outpatient Clinic" (VOC)., Methods: The VOC consists of 6 digital tools that facilitate self-monitoring (blood pressure, weight, and pain) and communication with peers and providers (chat and videoconferencing) connected to a cloud-based platform and the hospital patient portal to facilitate access to (self-collected) medical data. In this proof-of-concept study, 10 patients from both Departments of Internal Medicine and Dermatology (N=20) used all options of the VOC for 6 weeks. An eNurse offered support to participants during the study. We assessed the feasibility, usage statistics, content, adherence, and identified technical issues. Moreover, we conducted qualitative interviews with all participants by following a standard interview guide to identify user experiences, including barriers, facilitators, and potential effects., Results: Most participants successfully used all options of the VOC and were positive about different tools and apps and the integral availability of their information. The adherence was 37% (7/19) for weight scale, 58% (11/19) for blood pressure monitor, and 70% (14/20) and 85% (17/20) for pain score and daily questions, respectively. The adherence for personal health record was 65% (13/20) and 60% (12/20) for the patient portal system. Qualitative data showed that performance and effort expectancy scored high among participants, indicating that using the VOC is convenient, easy, and time-saving., Conclusions: The VOC is a promising integrated Web-based technology that combines self-management, data sharing, and communication between patients and professionals. The system can be personalized by connecting various numbers of components, which could make it a relevant tool for other patient groups. Before a system, such as the VOC, can be implemented in daily practice, prospective studies focused on evaluating outcomes, costs, and patient-centeredness are needed., (©Jelske Marije de Jong, Paula AM Ogink, Carin GM van Bunningen, Rieke JB Driessen, Lucien JLPG Engelen, Barend Heeren, Sebastian JH Bredie, Tom H van de Belt. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.09.2018.)

Background: Measurement of vital signs in hospitalized patients is necessary to assess the clinical situation of the patient. Early warning scores (EWS), such as the modified early warning score (MEWS), are generally calculated 3 times a day, but these may not capture early deterioration. A delay in diagnosing deterioration is associated with increased mortality. Continuous monitoring with wearable devices might detect clinical deterioration at an earlier stage, which allows clinicians to take corrective actions., Objective: In this pilot study, the feasibility of continuous monitoring using the ViSi Mobile (VM; Sotera Wireless) and HealthPatch (HP; Vital Connect) was tested, and the experiences of patients and nurses were collected., Methods: In this feasibility study, 20 patients at the internal medicine and surgical ward were monitored with VM and HP simultaneously for 2 to 3 days. Technical problems were analyzed. Vital sign measurements by nurses were taken as reference and compared with vital signs measured by both devices. Patient and nurse experiences were obtained by semistructured interviews., Results: In total, 86 out of 120 MEWS measurements were used for the analysis. Vital sign measurements by VM and HP were generally consistent with nurse measurements. In 15% (N=13) and 27% (N=23) of the VM and HP cases respectively, clinically relevant differences in MEWS were found based on inconsistent respiratory rate registrations. Connection failure was recognized as a predominant VM artifact (70%). Over 50% of all HP artifacts had an unknown cause, were self-limiting, and never took longer than 1 hour. The majority of patients, relatives, and nurses were positive about VM and HP., Conclusions: Both VM and HP are promising for continuously monitoring vital signs in hospitalized patients, if the frequency and duration of artifacts are reduced. The devices were well received and comfortable for most patients., (©Mariska Weenk, Harry van Goor, Bas Frietman, Lucien JLPG Engelen, Cornelis JHM van Laarhoven, Jan Smit, Sebastian JH Bredie, Tom H van de Belt. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 05.07.2017.)

Background: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life., Objective: The aim of this paper is to describe the development of "Vascular View," a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT)., Methods: The Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan., Results: The needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction., Conclusion: A comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD., Trial Registration: Nederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40)., (©Saskia Puijk-Hekman, Betsie GI van Gaal, Sebastian JH Bredie, Maria WG Nijhuis-van der Sanden, Sandra van Dulmen. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.02.2017.)

Background: Poor adherence to medication is one of the limitations in the treatment of cardiovascular diseases, thereby increasing the risk of premature death, hospital admissions, and related costs. There is a need for simple and easy-to-implement interventions that are based on patients' perspectives, beliefs, and perceptions of their illness and medication., Objective: The objective is to test the effectivity of this intervention to improve medication adherence in patients with established cardiovascular disease, that is, in secondary prevention., Methods: In this study the effect of a personalized visualization of cardiovascular risk levels through a website aiming at supporting self management in combination with a group consultation and communication intervention by a nurse on adherence to treatment in 600 patients with manifest cardiovascular diseases will be assessed. The health belief model was chosen as main theoretical model for the intervention., Results: Primary outcome is adherence to treatment calculated by refill data. Secondary outcomes include the Beliefs about Medication Questionnaire and the Modified Morisky Scale. Patients are followed for one year. Results are expected by 2015., Conclusions: This study assesses adherence to treatment in a high-risk cardiovascular population by applying an intervention that addresses patients' capacity and practical barriers as well as patients' beliefs and perceptions of their illness and medication., Clinicaltrial: ClinicalTrials.gov NCT01449695; https://clinicaltrials.gov/ct2/show/NCT01449695 (Archived by WebCite at http://www.webcitation.org/6kCzkIKH3)., Competing Interests: Conflicts of Interest: None declared.

Introduction: The incidence of cardiovascular diseases (CVD) is increased in rheumatoid arthritis (RA) patients. It remains unclear whether the load of RA increases cardiovascular (CV) risk especially in female and in younger RA patients. In the present study we aim to analyse the influence of age and gender on CV risk in RA relative to the general population, using meta-analysis of direct comparative studies., Method: Systematic literature search was performed in MEDLINE for studies reporting on occurrence of CV events in RA as compared to the general population, stratified for gender and/or age. Quality was appraised using the Newcastle-Ottawa scale. Meta-analysis was performed on rate ratios using inverse variance methods., Results: There were 1372 records screened and 13 studies included. RA females and males have a similar higher risk (95%CI) to develop stroke with RR 1.35 (1.30-1.40) and RR 1.31 (1.21-1.43); coronary artery disease with RR 1.65 (1.54-1.76) versus RR 1.55 ((1.41-1.69) in men; cardiovascular disease with RR 1.56 (1.49-1.62) versus 1.50 (1.41-1.60). The highest incidence of CV events was observed in the youngest patients, RR 2.59 (1.77-3.79), whereas older patients had the lowest relative risk when compared to the general population, RR 1.27 (1.16-1.38)., Conclusion: The relative risk of RA patients for CVD is age dependent, but does not depend on gender: the relative risk on CVD appears to be equally raised for males and females, while relatively young RA patients (<50 years) have the highest, and older patients the lowest relative risk.

Background: Cuffless blood pressure (BP) monitoring devices, based on pulse transit time, are being developed as an easy-to-use, more convenient, fast, and relatively cheap alternative to conventional BP measuring devices based on cuff occlusion. Thereby they may provide a great alternative to BP self-measurement., Objective: The objective of our study was to evaluate the performance of the first release of the Checkme Health Monitor (Viatom Technology), a cuffless BP monitor, in a real-life setting. Furthermore, we wanted to investigate whether the posture of the volunteer and the position of the device relative to the heart level would influence its outcomes., Methods: Study volunteers fell into 3 BP ranges: high (>160 mmHg), normal (130-160 mmHg), and low (<130 mmHg). All requirements for test environment, observer qualification, volunteer recruitment, and BP measurements were met according to the European Society of Hypertension International Protocol (ESH-IP) for the validation of BP measurement devices. After calibrating the Checkme device, we measured systolic BP with Checkme and a validated, oscillometric reference BP monitor (RM). Measurements were performed in randomized order both in supine and in sitting position, and with Checkme at and above heart level., Results: We recruited 52 volunteers, of whom we excluded 15 (12 due to calibration failure with Checkme, 3 due to a variety of reasons). The remaining 37 volunteers were divided into low (n=14), medium (n=13), and high (n=10) BP ranges. There were 18 men and 19 women, with a mean age of 54.1 (SD 14.5) years, and mean recruitment systolic BP of 141.7 (SD 24.7) mmHg. BP results obtained by RM and Checkme correlated well. In the supine position, the difference between the RM and Checkme was >5 mmHg in 17 of 37 volunteers (46%), of whom 9 of 37 (24%) had a difference >10 mmHg and 5 of 37 (14%) had a difference >15 mmHg., Conclusions: BP obtained with Checkme correlated well with RM BP, particularly in the position (supine) in which the device was calibrated. These preliminary results are promising for conducting further research on cuffless BP measurement in the clinical and outpatient settings.

Fibromuscular dysplasia (FMD) is a non-inflammatory, non-atherosclerotic vasculopathy that can lead to arterial stenosis, occlusion, aneurysms, and dissection. FMD of the renal arteries can lead to renovascular hypertension. Percutaneous angioplasty of the renal arteries (PTRA) can lead to normalization of blood pressure in 45% of patients with renal artery stenosis caused by FMD, particularly in younger patients and patients with a short history of hypertension. A considerable number of the patients with renovascular FMD also have cervical FMD, which can lead to ischaemic or haemorrhagic stroke. In this article we discuss diagnostic and therapeutic options, illustrated by two cases of patients with renovascular and carotid FMD. Most of the recommendations are based on data from retrospective studies and expert opinion; prospective studies on the optimal diagnostic strategy and treatment are therefore, urgently required.

Background: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. The disturbances of the cytokine network detected in CFS patients are highly variable, in part due to the lack of adequate controls in many studies. Furthermore, all studies have been performed on peripheral venous blood of patients. As cytokines mainly act in tissues, for example, the brain, the information that can be derived from peripheral blood cells is limited. The information regarding the possible role of cytokines in the pathophysiology could come from intervention studies in which the activities of relevant cytokines are reduced, for example, reducing interleukin-1, interleukin-6 or tumor necrosis factor. In this study, the clinical usefulness of anakinra, an IL-1 antagonist, will be assessed in patients with CFS., Methods/design: A randomized placebo-controlled, double-blind trial will be conducted. Fifty adult female patients meeting the Centers for Disease Control (CDC) criteria for CFS and without psychiatric co-morbidity will be included. After inclusion, patients will be randomized between treatment with anakinra (recombinant human interleukin-1 receptor antagonist) or placebo. Each group will be treated for 4 weeks. Outcome measures will be assessed at baseline, after 4 weeks of intervention, and 6 months after baseline assessment. The primary outcome measure will be fatigue severity at 4 weeks, measured with the validated Checklist of Individual Strength (CIS). Secondary outcome measures are functional impairment, physical and social functioning, psychological distress, pain severity, presence of accompanying symptoms, and cytokine and cortisol concentrations., Discussion: This is the first randomized placebo-controlled trial that will evaluate the effect of interference with IL-1 on the experience of fatigue in patients with CFS. The results of this study may expand treatment options for patients with CFS, for whom graded exercise therapy and cognitive behavioral therapy are the only evidence-based interventions that exist at this moment., Trial Registration: Clinicaltrials.gov: NCT02108210 . Clinicaltrials.gov registration date: 8 April 2014. EudraCT: 2013-005466-19.

The aim of this study was to evaluate the impact of a structured screening and nurse-based intervention on cardiovascular risk factors. In patients with established cardiovascular disease, a cardiovascular risk profile was assessed, and lifestyle was evaluated by using an automated questionnaire. A multidisciplinary team proposed an integral individualized plan of care on the basis of these assessments. During follow-up, a nurse-led lifestyle intervention program and the best medical treatment were offered. A total of 328 outpatients were included. After screening, a follow-up term of at least 1 year was reached in 176 patients (59.9%). Low-density lipoprotein cholesterol and systolic blood pressure were significantly reduced. A reduction in the amount of smoking, alcohol consumption, and unhealthy eating habits was observed. However, the amount of physical activity was unaffected, and body mass was increased. A structural evaluation of cardiovascular risk factors and an integrated nurse-led approach can successfully reduce risk in cardiovascular patients., (© The Author(s) 2014.)

The Dutch campaign 'Verstandig kiezen', based on the American programme 'Choosing wisely', aims to improve quality in healthcare, with attention to cost control. The 'Choosing wisely'-based programme can be applied in the choice of a statin. Atorvastatin and rosuvastatin are regarded as equal choices in various guidelines regarding cardiovascular risk management. Generic atorvastatin is available, and is approximately 25 times cheaper than rosuvastatin in almost equipotent doses. Rosuvastatin provides a greater LDL reduction than atorvastatin. Patient LDL targets can usually be achieved with atorvastatin, and rosuvastatin is not needed. At group level, there are no relevant differences in adverse-events profile between both statins. Atorvastatin and rosuvastatin do have different pharmacokinetic interactions. When changing medication, good provision of information is a prerequisite for patient satisfaction and compliance. We advise use of atorvastatin instead of rosuvastatin as drug of choice when the LDL target is not reached using simvastatin. However, under specific conditions, rosuvastatin should be the treatment of choice. Efficacy and adverse effects should then be evaluated at individual patient level.

Poor adherence to medication is one of the most important determinants in the treatment of patients with chronic disorders. e-Health-based interventions may be able to improve treatment adherence. This article gives an overview of the available e-Health interventions and the extent to which they can improve adherence. We searched in the PubMed, Cinahl, PsycInfo, and Embase databases for e-Health interventions that aimed at improving adherence to treatment. Of the 16 included studies, 15 used a website and one used an app. Ten studies showed a significant improvement in treatment adherence by using the intervention. e-Health interventions were generally complex. Simple interventions were the most successful in improving treatment adherence.

This study investigated the prevalence of carotid artery stenosis (CS) and the association with various risk factors in male patients (>65 years) diagnosed with cardiovascular diseases. Duplex sonography of the carotid arteries was performed in 434 of 473 eligible patients of whom 118 (27.8%) patients had significant CS ≥50%. The prevalence and severity of CS did not differ between patients who presented with neurological symptoms or acute coronary syndrome/peripheral artery disease (30.8% vs 25.9%, respectively). Among patients with CS, a higher rate of current smoking, a higher systolic blood pressure, and a lower glomerular filtration rate were observed compared with patients without CS. A history of coronary artery bypass graft was a significant predictor of the presence of CS (P = .003, odds ratio [OR] = 2.70 [1.40-5.19]). The prevalence of CS in elderly males with manifest atherosclerotic disease is high, irrespective of presenting clinical manifestation.

Cardiovascular risk management is common in patients suffering from manifest cardiovascular disease, hypertension, hyperlipidaemia and diabetes mellitus. It is generally accepted that medication is the most effective treatment for reducing cardiovascular morbidity and mortality in these patients. Remarkably, cardiovascular risk management is rare in patients suffering from branch retinal vein occlusion. This common retinal vascular disorder in middle aged and elderly people occurs where a thickened retinal artery compresses the affected vein. Although thrombosis is involved, procoagulant disorders are only present in selected cases. On the other hand, prior diabetes, hypertension, and peripheral artery disease are associated with an increased risk of developing branch retinal vein occlusion up to a decade later, and retinal vascular disorder is associated with an increased risk of subsequently developing hypertension, diabetes, congestive heart failure, and cerebrovascular disease later on. Therefore, branch retinal vein occlusion is a marker of developing cardiovascular disease and warrants adequate cardiovascular risk management.

Background: Medicinal treatment of vasospastic Raynaud phenomenon is limited to primarily vasodilator medicines., Objective: To explore the possible beneficial effects and tolerability of 120 mg two times a day of Ginkgo Biloba special extract EGb 761 in patients suffering from Raynaud disease (RD) (primary Raynaud phenomenon)., Methods: In a placebo-controlled, double-blind, pilot study, 41 patients with RD were randomized to either the active treatment group (EGb 761, n = 21) or placebo group for 10 weeks, after an initial 2-week run-in phase. The primary efficacy variables were self-reported changes of the frequency, duration, and severity of vasospastic attacks between the placebo-controlled run-in phase and the end of the study., Results: Most of the patients were female, and both groups were perfectly matched with respect to demographic characteristics. The frequency of daily attacks reduced from 3.6 ± 2.3 to 2.4 ± 2.6 (-33%) in the EGb 761 group and from 2.9 ± 2.0 to 2.0 ± 1.8 (-31%) in the placebo group with no significant difference according to the ordinary least squares test (P = 0.3564). Furthermore, no significant differences were found with respect to the duration and severity of vasospastic attacks between the EGb 761 and placebo groups (P = 0.4392 and P = 0.7187, respectively). In all, 17 adverse events (AEs) were reported, 6 AEs from 5 patients in the EGb 761 group and 11 AEs from 8 patients in the placebo group. Serious AEs did not occur., Conclusion: EGb 761 treatment showed an excellent safety profile in patients with RD but could not demonstrate a statistically significant reduction in clinically relevant symptoms compared with placebo.

Objective: To evaluate the feasibility and effectiveness of Nurse Based Motivational Interviewing (NBMI) on top of a routine patient based Lifestyle Inventory with Feedback (LIFE) in a cardiovascular outpatient secondary prevention setting., Methods: All current smokers (n=112), identified in 619 successive patients with cardiovascular disease, were randomized for either care as usual (LIFE), or LIFE plus NBMI (intervention group). Cumulative time investment was recorded., Results: After 3 months of follow-up, the abstinence rate in the control group was 7%, and another 15% diminished the number of cigarettes, whereas 26% of intervention patients quit smoking (p<0.017) and another 31% diminished smoking. On average, each completed motivational interviewing session took 63.5 min. Per quitter, time investment was 3.8 h and NNT appeared 5.9., Conclusion: NBMI strategy on top of routinely administrated lifestyle self evaluation with professional feedback, significantly increases smoking cessation in an outpatient secondary prevention setting. Although cost effectiveness needs to be addressed, time investment per quitter in this approach appears low., (Copyright © 2010 European Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Background: To evaluate the vigilance of medical specialists as to the lifestyle of their cardiovascular outpatients by comparing lifestyle screening as registered in medical records versus a lifestyle questionnaire (LSQ), a study was carried out at the cardiovascular outpatient clinic of the university hospital of Nijmegen, The Netherlands, between June 2004 and June 2005., Methods: For 209 patients information from medical records on lifestyle habits, physician feedback, and interventions in the past year was compared to data gathered in the last month by a self-report LSQ., Results: Doctors register smoking habits most consistently (90.4%), followed by alcohol use (81.8%), physical activity (50.2%), and eating habits (27.3%). Compared to the LSQ, smoking, unhealthy alcohol use, physical activity, and unhealthy eating habits are underreported in medical records by 31, 83, 54 and 97%, respectively. Feedback, advice or referral was documented in 8% for smoking, 3% for alcohol use, 12% for physical activity, and 26% for eating habits., Conclusion: Lifestyle is insufficiently registered or recognized by doctors providing routine care in a cardiovascular outpatient setting. Of the unhealthy lifestyle habits that are registered, few are accompanied by notes on advice or intervention. A lifestyle questionnaire facilitates screening and interventions in target patients and should therefore be incorporated in the cardiovascular setting as a routine patient intake procedure.

Background: It has been suggested that the T-cell attracting and profibrotic chemokine CCL18 might play a role in the pathogenesis of systemic sclerosis (SSc). However, it is unclear what underlies the higher CCL18 levels in SSc. The aim of our study was to determine whether Toll-like receptor (TLR)-mediated stimulation of monocytes and dendritic cells (DCs) contributes to the higher levels of CCL18 in SSc., Methods: CCL18 levels were measured in 40 patients with SSc, primary Raynaud's phenomenon (RP) and healthy controls. The presence of TLR4 agonists in the circulation of SSc patients was investigated using TLR4 transgenic Chinese hamster ovary (CHO) cells. CCL18 and interleukin (IL)-10 secretion by monocytes/macrophages and monocyte-derived DCs (moDCs) was measured in the supernatant. The indirect effect of lipopolysaccharide (LPS)-stimulated moDCs on CCL18 secretion by monocytes/macrophages was investigated using a transwell system., Results: CCL18 levels were significantly elevated in SSc patients compared to patients with RP and healthy controls. SSc sera strongly induced CD25 expression on CHO cells genetically modified to express TLR4 but not on those expressing CD14 only. By contrast, serum from systemic lupus erythematosus (SLE) patients or healthy individuals did not have an effect. Neither monocytes/macrophages nor moDCs from SSc patients secreted higher levels of CCL18 compared to healthy controls. However, moDCs matured with the TLR4 ligand LPS from patients with SSc did secrete significantly higher amounts of IL-10 compared to those from healthy counterparts, which were IL-10 dependent., Conclusions: Our results suggest that elevated CCL18 levels in SSc are not caused by an intrinsically enhanced CCL18 secretion by monocytes/macrophages but are, at least partly, orchestrated by an enhanced IL-10 secretion by TLR4-stimulated DCs. These observations suggest a role for TLR4 ligands and DCs in the pathogenesis of SSc, a topic that warrants further investigation.

Purpose: To study the potential of integrated positron emission tomography and computed tomography (PET/CT) to identify aneurysm wall inflammation., Methods: The level of F18-fluorodeoxyglucose (FDG) uptake was studied in aneurysmal and normal-sized aortas of 34 male patients [17 with abdominal aortic aneurysm (AAA) and 17 age-matched controls] identified in a database of 278 consecutive patients evaluated for staging of primary lung cancer. The maximal standardized uptake value (SUV) was calculated to quantify FDG uptake in the AAA wall., Results: AAAs showed significantly higher FDG uptake than the normal-sized aorta in age-matched controls (SUV 2.52+/-0.52 versus 1.78+/-0.45, respectively; p<0.001). The level of FDG uptake did not correlate with maximal aneurysm diameter (r=0.09; 95% CI -0.42 to 0.56; p=0.7)., Conclusion: FDG-PET/CT is a promising technique to identify inflammation of the aneurysm wall. Irrespective of aneurysm diameter, asymptomatic AAAs show more FDG uptake and more inflammatory activity in the wall than the non-dilated abdominal aorta of sex/age-matched controls. Future studies will be directed at the predictive value of increased FDG uptake for aneurysm wall strength, rupture risk, and the utility of FDG-PET/CT in assessing the effect of medical interventions.

Introduction: Familial combined hyperlipidemia (FCH) is characterized by several phenotypes, including an atherogenic lipoprotein profile, low grade inflammation, visceral obesity, insulin resistance, and hypertension. In this study, we investigated which of the clinical and biochemical characteristics of FCH patients contributes most to their increased risk of cardiovascular disease, by determining the association of a broad variety cardiovascular risk factors with the intima media thickness (IMT) of the common carotid artery (CCA) in 94 FCH patients and 216 non-affected relatives., Methods: All subjects filled out a questionnaire about their smoking and drinking habits, medical history and medication use, and venous blood was drawn in the fasting state after discontinuation of lipid lowering medication (if used). IMT of the far wall and near wall of both CCAs was measured by high-resolution B-mode ultrasonography., Results: The mean IMT in FCH patients (adjusted for age and gender) was 33 microm thicker when compared to their non-affected relatives (p=0.006). In multivariate analysis, the waist-to-hip ratio, the apoB concentration and the pulse pressure were significant and independent predictors of IMT in both FCH patients and their normolipidemic relatives. The most important independent predictor of IMT in FCH patients however, was the VLDL-c/TG ratio, explaining 32.8% of the variation in age- and gender-adjusted IMT, whereas this ratio was not an independent predictor of IMT at all in their unaffected relatives., Conclusion: Abdominal obesity, a higher blood pressure and dyslipidemia characterised by both an increased number of atherogenic particles and the presence of highly atherogenic remnant lipoproteins play an important role in the development of cardiovascular disease in FCH-patients.

Background: In the present cross-sectional study we investigated whether familial combined hyperlipidemia (FCH) is associated with an increased arterial wall stiffness, and whether measures of arterial wall stiffness in FCH family members could contribute to cardiovascular risk stratification., Methods: Ninety-eight subjects with FCH and 230 unaffected relatives filled out a questionnaire about their smoking habits, medical history, and medication use. Fasting venous blood was drawn after discontinuation of any lipid-lowering medication. Pulse wave velocity (PWV) and augmentation index (AIx) were determined by applanation tonometry as surrogate markers of arterial stiffness., Results: Patients with FCH had a significantly increased PWV compared to their unaffected relatives (9.07 +/- 2.75 v 8.28 +/- 2.62 m/sec, P = .005), whereas AIx was not increased (21.6 +/- 12.7 v 15.6 +/- 14.1, P = .96). Age- and gender-adjusted PWV was an equally good predictor of the presence of cardiovascular disease (CVD) in FCH family members as the most predictive combination of age- and gender-adjusted clinical and biochemical risk factors, including total cholesterol, HDL-cholesterol, and systolic blood pressure (area under the receiver operating curve (ROC) [AUC] 0.83 [0.76-0.90] v AUC 0.84 [0.78-0.91], P = .83). Addition of PWV to the multivariable prognostic model, including these age- and gender-adjusted traditional risk factors, did not increase the predictive ability for CVD (AUC 0.84 [0.79-0.89])., Conclusions: Patients with FCH are characterized by an increased arterial stiffness. The PWV predicts the presence of CVD equally well as any combination of clinical and traditional biochemical risk factors, but PWV has no additional value in addition to traditional risk factor screening in FCH families.

The aim of the present study was to delineate the mechanism(s) responsible for the increased secretion of VLDL (very-low-density lipoprotein) particles in patients with FCH (familial combined hyperlipidaemia). In 194 young adults (<25 years of age) recruited from families with FCH, we investigated how plasma lipids, (apo)lipoproteins and BMI (body mass index) varied with age. Furthermore, we performed a 5-year follow-up study of clinical and biochemical characteristics of a subset of this population (n=85) stratified by apoB (apolipoprotein B) levels (below or above the 75th percentile adjusted for age and gender). Plasma apoB concentration (r=0.45, P<0.0001), triacylglycerol (triglyceride) concentration (r=0.45, P<0.0001), LDL (low-density lipoprotein) subfraction profile (r=-0.46, P<0.0001) and BMI (r=0.51, P<0.0001) were significantly associated with age. Plasma apoB concentration in the hyperapoB group was already elevated at a young age, whereas other characteristics of FCH, as observed in adults, including triacylglycerol levels >1.5 mmol/l and/or small-dense LDL, were observed only sporadically. After the 5-year follow-up, BMI increased in both groups, and this increase was associated with changes in apoB (r=0.27, P<0.05), triacylglycerol (r=0.30, P<0.01), VLDL cholesterol (r=0.22, P<0.05), VLDL triacylglycerol (r=0.25, P<0.05) and high-density lipoprotein cholesterol (r=-0.27, P<0.05). In conclusion, we have found indirect evidence of a primary, presumably genetically determined, increase in plasma apoB concentration occurring early in life of offspring from families with FCH. However, aging-related post-maturation increases in adipose tissue mass also appear to contribute to an aggravation and/or modulation of this genetically determined apoB overproduction.

The autosomal-dominant (AD) form of the hyperimmunoglobulin E syndrome (HIES) has been described as a multisystem disorder including immune, skeletal and dental abnormalities. Recently, the evaluation of patients from families in which HIES was inherited in a manner more consistent with autosomal-recessive (AR) inheritance, showed that AR-HIES is a clinically distinct disease entity. In addition to classical immunologic findings of AD-HIES, the AR form presents with severe recurrent fungal and viral infections with herpes zoster, herpes simplex and characteristic mollusca contagiosa. Furthermore, cerebral vascular sequelae, including vasculitis, infarction and haemorrhage were noted. In this report, we describe the clinical picture of two patients who showed remarkable resemblance to the description of AR-HIES, but also developed fatal aneurysmal dilatation of the thoracic aorta in adolescence. This finding may further consummate the clinical picture of AR-HIES and emphasize the possibility to develop early aortitis, most likely preceding the critical aneurysm formation at older age. This process should be anticipated during childhood in cases with AR-HIES.

Objective: Examining the prevalence of risk behavior and motivation to change among hospital outpatients with a high cardiovascular risk, and the implementation and results of a brief behavioral feedback intervention by internists., Methods: One hundred and sixty-one patients completed a lifestyle questionnaire and were given personalized feedback on the results by their internists. The delivery of the feedback was monitored. In an ad hoc non randomized comparison after four months, 68 patients who received an intervention were compared with 40 who did not receive it., Results: Ninety-six percent of the patients demonstrated at least one risk behavior and 73% were not contemplating change. The intervention was correctly given to 62%. The patients who received the intervention reported more lifestyle changes and altered their motivation to change more often., Discussion: Given the prevalence of risk behavior lifestyle interventions are worthwhile. Internists delivered the intervention to most patients. Small effects of the intervention were found, but the non-experimental nature of the study should be taken into account., Conclusion: Implementation of a behavioral feedback intervention seems to be feasible and can lead to worthwhile lifestyle changes for patients at risk for cardiovascular disease., Practice Implications: Training and education can improve the intervention. Also a nurse practitioner can perform part of it.

In 4 patients with temporal arteritis or polymyalgia rheumatica, women aged 60, 57, 83 and 73 years respectively, signs of aortic involvement were established. The first patient presented with signs of systemic inflammation without signs of temporal arteritis or aortitis. In the second, an acute symptomatic thoracoabdominal aneurysm developed. In the third, temporal arteritis was associated with chronic progressive dilatation ofthe thoracic aorta. The fourth developed signs of intermittent claudication of the extremities. The clinical manifestations in all patients were attributed to chronic inflammation of the aorta caused by giant cell arteritis. Aortic giant cell arteritis frequently accompanies temporal arteritis, but is rarely diagnosed. Up to 75% of patients with temporal arteritis may have some degree of aortic involvement. Thoracic aneurysms, complicated by rupture or dissection, are the most serious complications. Aortic disease associated with signs of systemic inflammation should trigger the suspicion of giant cell arteritis. Corticosteroids are the most important part of treatment. Three patients recovered following treatment; the first two received an endoprosthesis; in the woman aged 83 years, this was not technically possible; she died after 1.5 years.

3 patients, 2 women aged 64 and 44 and 1 man aged 67, had severe dyspnoea and a large centrally-located pulmonary embolism (PE) without any accompanying arterial hypotension. They were all given conventional anticoagulation therapy, although thrombolytic therapy was also considered. The women recovered but the man eventually died of a second massive embolism. PE is a disease with a potentially high mortality. Patients with cardiogenic shock due to PE are candidates for thrombolytic therapy. A subset of patients with right-ventricular dysfunction (submassive PE) also have a poorer prognosis despite the absence ofarterial hypotension or shock. Spiral CT-scan is becoming the first-line imaging test of preference in patients with suspected PE. Spiral CT enables the accurate visualization ofthrombi. The value of risk management using cardial biomarkers, spiral CT and echocardiography is not yet clear. There is no evidence that thrombolytic therapy is beneficial in patients with acute PE and right-ventricular dysfunction without overt shock.

Previous studies have shown an increased risk of retinal vein occlusion (RVO) in patients with hypertension, hypercholesterolemia and diabetes mellitus. Literature on the association between thrombophilic factors and RVO consists of small studies and case reports. The objective was to determine the relationship between thrombophilic risk factors and RVO. Thrombophilic risk factors analyzed were hyperhomocysteinemia, MTHFR gene mutation, factor V Leiden mutation, protein C and S deficiency, antithrombin deficiency, prothrombin gene mutation, anticardiolipin antibodies and lupus anticoagulant. For all currently known thrombophilic risk factors odds ratios for RVO were calculated as estimates of relative risk. The odds ratios were 8.9 (95% CI 5.7 - 13.7) for hyperhomocysteinemia, 3.9 (95% CI 2.3 - 6.7) for anticardiolipin antibodies, 1.2 (95% CI 0.9 - 1.6) for MTHFR, 1.5 (95% CI 1.0 - 2.2) for factor V Leiden mutation and 1.6 (95% CI 0.8 - 3.2) for prothrombin gene mutation. In conclusion, regarding thrombophilic risk factors and RVO there is only evidence for an association with hyperhomocysteinemia and anticardiolipin antibodies, factors that are known as risk factors for venous thrombosis as well as for arterial vascular disease. The minor effect of factor V Leiden mutation and the protrombin gene mutation (risk factors for venous thrombosis only) suggests that atherosclerosis might be an important factor in the development of CRVO.

Pulmonary hypertension is a devastating complication of various, but rare diseases and can also occur as an isolated entity. It causes morbidity and mortality in all patients. Ongoing research has provided some insight into the pathophysiology and clinical manifestations, and new therapeutic options have recently become available for some types of pulmonary hypertension. In order to provide optimal care for an individual patient it is mandatory to establish the type and severity of the pulmonary hypertension in each patient. The diagnostic protocol used in our hospital is presented along with a description of two case histories. An algorithm of the different therapeutic strategies now available is given as well as recommendations for follow-up.

Objectives: Evaluation of the prevalence, diagnostic procedures and clinical outcome of infections of aortoiliac and aortofemoral vascular grafts presented in our centre., Design: Retrospective study., Materials: All patients who underwent a surgical aortoiliac or aortofemoral revascularisation between 1991 and 2001., Methods: Evaluation of several hospital databases., Results: 32 cases of aortoiliac and aortofemoral vascular graft infection with varied clinical presentation were found. Enteral bleeding was the first clinical manifestation in 31% of the cases, inguinal swelling, wound, or fistula in 59% and fever or sepsis in 6.3%. In 3% the cause was unknown. The vast majority (84.5%) of the infections presented three or more months after surgery (late infections). In cases of enteral bleeding, endoscopy procedures only revealed the diagnosis in 55%. Diagnostic algorithms including an abdominal CT scan appeared to have a sensitivity of 94% for establishing an accurate diagnosis. Remarkably, no specific risk factors for graft infection could be demonstrated. Furthermore, a 30-day survival of 20% or less was observed in early graft infections, whereas late infections managed with extra-anatomical bypasses appeared to have a better survival rate of up to 70%., Conclusion: Endoscopy in cases of enteral bleeding and CT scanning overall were shown to be very useful for establishing the diagnosis. Clinical outcome and survival after treatment remain poor.

Background: The aim of the current study was to investigate whether the StethoDop can serve as a valid and reproducible instrument for measuring the ankle-brachial index (ABI) and assessing venous reflux, even when used by inexperienced investigators, in comparison with the classic Doppler., Methods: I) During four weeks, four ankle-brachial index (ABI) measurements were performed on 44 patients: one measurement with the classic Doppler by an experienced investigator, one with the classic Doppler by an inexperienced investigator and two measurements with the StethoDop by the inexperienced investigator. II) 36 patients were screened for venous insufficiency by detecting venous reflux with the StethoDop and classic Doppler at the saphenofemoral and saphenopoplitial junctions by an inexperienced investigator. The results were compared with the results of the duplex as gold standard and with the results of the examination by an experienced dermatologist with the classic Doppler., Results: I) The confidence interval of ABI measurement for both the classic Doppler and the StethoDop by the inexperienced investigator was within an acceptable +/- 0.21 interval of significant change. II) For venous reflux determination, the overall sensitivity and specificity of the StethoDop were comparable with the sensitivity and specificity of the classic Doppler: sensitivity 76.0 and 75.0%, specificity 94.8 and 94.2%, respectively. The positive predictive value of the StethoDop, compared with the duplex, was 87.5%; the negative predictive value was 90.0%., Conclusion: I) For ABI measurement, the StethoDop is a valid instrument with reproducible results, even when used by inexperienced investigators. II) For venous reflux determination, the StethoDop is a valid screening instrument for venous insufficiency. However, as with determination with the classic Doppler, the reflux assessment by StethoDop gives no information about the deep veins and may miss up to 24% of apparent reflux.

Background: F-18-fluorodeoxyglucose (FDG) accumulates in inflammatory cells due to an increased metabolic rate. Therefore, FDG positron emission tomography (PET) represents a promising imaging technique in patients with vasculitis. The aim of this study was to assess the value of FDG PET in the diagnosis of different types of vasculitis., Methods: The results of FDG PET performed because of suspected vasculitis or fever of unknown origin with results indicating vasculitis were reviewed. These results were compared with the final diagnosis, based on the American College of Rheumatology 1990 criteria., Results: FDG PET was ordered because of suspected vasculitis in 20 patients, because of fever of unknown origin in two patients, and for follow-up of vasculitis in five patients. Fourteen patients were diagnosed with vasculitis (giant cell arteritis n = 5, polymyalgia rheumatica n = 2, polyarteritis nodosa n = 3, Takayasu n = 1, Churge-Strauss n = 1, Wegener's granulomatosis n = 1, vasculitis skin n = 1), two patients were diagnosed with fibromuscular dysplasia and one patient had media necrosis of the aorta. In five patients no diagnosis could be reached. FDG PET results were considered to be true-positive in ten patients, true-negative in 14 patients and false-negative in three patients resulting in a positive predictive value of 100% and a negative predictive value of 82%., Conclusions: FDG PET appears to be a promising new imaging technique in diagnosing and determining the extent of various forms of vasculitis. Furthermore, FDG PET may become a useful tool for evaluating the effect of treatment of vasculitis.

Progressive atherosclerosis followed by plaque rupture is the leading cause of acute cardiovascular events. Inhibition of platelet aggregation by acetylsalicylic acid (aspirin) reduces recurrent cardiovascular events in secondary prevention trials. By extracting data from available randomized trials that examined aspirin prevention in persons without previously known cardiovascular disease, we evaluated the use of aspirin as a primary prevention measure. Using the raw data presented in the source publication on death, fatal and nonfatal myocardial infarctions, and cerebrovascular accidents, all relative and absolute risk reductions were recalculated with confidence intervals. In healthy men above 45 years of age, men with an increased cardiovascular risk profile, and persons with diabetes mellitus or hypertension, the use of aspirin reduces the incidence of myocardial infarction and has a neutral effect on cerebrovascular events. The protective effect of aspirin is apparently most prominent in those persons with an increased risk of manifest atherosclerotic vascular disease. Notwithstanding these results, for each patient it remains essential to balance the cardiovascular risk profile against the small increased risk of bleeding complications when prescribing aspirin.

Background: Cardiovascular disease as a result of accelerated atherogenesis is common in patients with end-stage renal disease (ESRD). Dyslipidemia may be a major contributor in this process and can be influenced by lipid-lowering drugs (statins). Moreover, statins may exhibit additional inhibitory effects on the atherogenesis, such as a modulation of the immune system as triggered by oxidatively modified LDL and a reduction of the inflammatory marker C-reactive protein (CRP)., Methods: We evaluated in a single-blind randomized trial of 28 ESRD patients on hemodialysis, the dose-depending effects of both atorvastatin and simvastatin on lipids, lipoproteins, LDL particle heterogeneity, high sensitive-CRP, and markers of in vivo LDL oxidation., Results: Both statin therapies significantly lowered total plasma cholesterol and LDL-cholesterol concentrations to the same extent, whereas reduction in the concentrations of triglyceride-rich particles was less pronounced. Furthermore, statin therapy reduced LDL cholesterol in all LDL subfractions, without altering the overall LDL particle density. After both statins plasma hs-CRP concentrations were not significantly reduced; parameters of in vivo LDL oxidation (plasma ox-LDL concentration and the oxidation level of isolated LDL), were significantly decreased. Autoantibodies against ox-LDL, however, did not change during this trial period., Conclusions: These results show that atorvastatin and simvastatin exhibit comparable favourable effects on lipid profiles in ESRD. Moreover, the reduction of in vivo oxidatively modified LDL as shown in this ESRD population, may indicate that these statins exhibit favourable effects on oxidative stress in vivo.

In 3 patients, 2 women aged 21 and 34 years and a man aged 56 years, with complaints related to wide-ranging and extensive vascular conditions, an organ-specific diagnostic approach and treatment did not lead to the correct diagnosis of the underlying clinical condition. Hereafter a structured, partly protocol-based approach was started which considered the entire vascular system and risk factors for vascular disease. The youngest women died a few years later due to ventricular fibrillation, while the two other patients were assisted in reducing those risk factors that could be influenced. As a result, the planned bypass operation was no longer necessary for the male patient. A structured evaluation by a multidisciplinary team can optimise the care of these patients. The basis of such a team consists of a vascular specialist and vascular nurse-practitioner, both of whom should have specific knowledge of risk factors, aetiology, life style intervention and treatment of these disorders.

Familial combined hyperlipidemia (FCH) is characterized by a variable expression of hypercholesterolemia and/or hypertriglyceridemia. We evaluated the variability in lipid phenotype expression over a 5-year period and studied factors affecting the lipid phenotype expression. A total of 32 families (299 subjects) were studied in 1994 and in 1999. Subjects were classified as having FCH when total cholesterol and/or triglyceride levels exceeded the 90th percentile adjusted for age and sex. In 1994, 93 (31%) of the 299 subjects were affected, whereas 206 (69%) of the subjects were unaffected relatives. In 1999, a diagnosis of FCH was consistent in 69 (74%) of the 93 subjects. So, 26% of the FCH subjects in 1994 showed a sporadic normolipidemic pattern (ie, total cholesterol and/or triglycerides <90th percentile) in 1999. Among the 206 unaffected relatives in 1994, 178 (86%) remained unaffected in 1999, and 28 (14%) developed an FCH lipid phenotype. Multiple regression analysis showed that sex (odds ratio 2.03, 95% CI 1.09 to 3.87; P=0.03) and body mass index (odds ratio 1.14, 95% CI 1.05 to 1.24; P<0.01) significantly contributed to the variability in lipid phenotype expression. Thus, a diagnosis of FCH, based on plasma total cholesterol and/or triglyceride levels, is consistent in only 74% of the subjects over a 5-year period. Two other major characteristics of our FCH group, compared with the unaffected relatives, included elevated apolipoprotein B (apoB) levels and the presence of small dense low density lipoprotein (LDL), as reflected by a low value of the parameter K (apoB 1461 +/- 305 versus 997 +/- 249 mg/L, respectively [P < 0.001]; K value -0.22 +/- 0.19 versus -0.02 +/- 0.19, respectively [P < 0.001]). We now report that the apoB concentration and the K value show less variability in time and are more consistently associated with FCH, inasmuch as affected FCH subjects, compared with the unaffected relatives, persistently show a higher apoB level and a lower value of parameter K, reflecting small dense LDL, even when they present a sporadic normolipidemic pattern. In conclusion, our results emphasize the need for reevaluation of the diagnostic criteria for FCH. We demonstrate that apoB and small dense LDL are attractive new candidates for defining FCH. Further studies are indicated to evaluate the role of apoB and small dense LDL as diagnostic criteria for FCH.

Objective: To evaluate literature data on the use of acetylsalicylic acid (ASA) as a primary prevention measure for cardiovascular events., Design: Literature search., Method: Using Medline, all randomised placebo-controlled trials of ASA published between 1985 and 1 May 2001, and which used cardiovascular morbidity and death as outcome measures were identified (search query: 'aspirin' and 'primary prevention'). Using the raw data presented in the source publication on death, fatal and non-fatal myocardial infarctions and cerebrovascular accidents (CVAs), all relative and absolute risk reductions were recalculated with confidence intervals., Results: In healthy middle-aged men, men with an increased cardiovascular risk profile and persons with diabetes mellitus or hypertension, the use of ASA reduces the incidence of myocardial infarction and has a neutral effect on cerebrovascular events. The protective effect of ASA seemed most marked in those persons with an increased risk of manifest atherosclerotic vascular disease., Conclusion: Notwithstanding these findings, for each patient it remains essential to weigh up the cardiovascular risk profile against the small increased risk of complications when prescribing ASA.

Objective: To examine whether a reduced daily glucose load by overnight application of the less-absorbed glucose polymer icodextrin would have favorable effects on lipid profiles of continuous ambulatory peritoneal dialysis (CAPD) patients., Study Design: Randomized crossover study with two subsequent periods of 6 weeks., Setting: Home PD unit of a secondary-care hospital., Patients: Twenty-one nondiabetic CAPD patients (15 male, 6 female; mean age 50.3+/-11.8 years)., Intervention: Participants were randomly assigned to receive an overnight dwell with either standard glucose solution or with a 7.5% icodextrin-containing solution., Main Outcome Measures: Relation between reduction in the total amount of intraperitoneal infused glucose and parameters of glucose (plasma glucose, insulin, and HbA1C) and lipid metabolism [free fatty acids, plasma lipids, lipoproteins, and low density lipoprotein (LDL) subfraction profile]., Results: After the icodextrin dwells, a reduction of plasma total cholesterol (from 5.43+/-0.85 to 4.86+/-0.70 mmol/L, p < 0.001) and LDL cholesterol (from 3.38+/-0.87 to 2.93+/-0.73 mmol/L, p = 0.001) was observed. Also, high density lipoprotein (HDL) cholesterol (from 0.95+/-0.27 to 0.90+/-0.24 mmol/L, p = 0.029) was reduced, but the plasma total cholesterol-to-HDL ratio remained similar. Plasma free fatty acids and triglyceride levels tended to decrease (from 0.16+/-0.10 to 0.13+/-0.08 mmol/L, p= 0.06, and from 2.14+/-1.96 to 1.92+/-1.03 mmol/L, respectively). Evaluation of LDL subfraction profiles after ultracentrifugation showed a more buoyant LDL subfraction profile with fewer dense LDL particles in 6 patients and no changes in 14 patients after icodextrin. The effects on lipids were not accompanied by a decrease in fasting plasma glucose (from 5.76+/-1.29 to 5.86+/-0.80 mmol/L) or insulin levels (from 19.5+/-14.4 to 20.3+/-13.0 mU/L)., Conclusion: These results suggest a beneficial effect on lipid profiles of CAPD patients with the use of an overnight dwell with icodextrin.