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Purpose This study aims to provide a detailed description of the nurses in the lead (NitL) programme for empowering community nurse leadership in implementing evidence. Design/methodology/approach The NitL programme is described using the template for intervention description and replication-checklist. Findings The NitL programme consists of two components. The first component is a systematic approach with implementation steps and tools to empower community nurses in implementing evidence targeted at encouraging functional activities of older adults offered via a Web-based eLearning programme. The second component is training to empower community nurses in enabling team members to change their practice, which focussed on motivational interviewing, influencing behaviour, dealing with resistance to change and coaching delivered as a combination of group training in practice and background theory via a web-based eLearning programme. Research limitations/implications Further research is needed to evaluate the feasibility and effects of the NitL programme. Practical implications The NitL programme has been developed in cooperation with community nurses to meet their needs in practice and has the potential to develop leadership for the core tasks of community nurses. Originality/value The NitL programme has been developed to empower the leadership of community nurses in implementing evidence targeted at encouraging functional activities of older adults. The leadership role of community nurses is key for delivering high-quality care and implementing evidence within the community care setting for encouraging functional activities of older adults to preserve their independence.

ObjectiveTo determine the diagnostic accuracy of three tests—radial pulse palpation, an electronic blood pressure monitor and a handheld single-lead ECG device—for opportunistic screening for unknown atrial fibrillation (AF).DesignWe performed a diagnostic accuracy study in the intention-to-screen arm of a cluster randomised controlled trial aimed at opportunistic screening for AF in general practice. We performed radial pulse palpation, followed by electronic blood pressure measurement (WatchBP Home A) and handheld ECG (MyDiagnostick) in random order. If one or more index tests were positive, we performed a 12-lead ECG at shortest notice. Similarly, to limit verification bias, a random sample of patients with three negative index tests received this reference test. Additionally, we analysed the dataset using multiple imputation. We present pooled diagnostic parameters.Setting47 general practices participated between September 2015 and August 2018.ParticipantsIn the electronic medical record system of the participating general practices (n=47), we randomly marked 200 patients of ≥65 years without AF. When they visited the practice for any reason, we invited them to participate. Exclusion criteria were terminal illness, inability to give informed consent or visit the practice or having a pacemaker or an implantable cardioverter-defibrillator.OutcomesDiagnostic accuracy of individual tests and test combinations to detect unknown AF.ResultsWe included 4339 patients; 0.8% showed new AF. Sensitivity and specificity were 62.8% (range 43.1%–69.7%) and 91.8% (91.7%–91.8%) for radial pulse palpation, 70.0% (49.0%–80.6%) and 96.5% (96.3%–96.7%) for electronic blood pressure measurement and 90.1% (60.8%–100%) and 97.9% (97.8%–97.9%) for handheld ECG, respectively. Positive predictive values were 5.8% (5.3%–6.1%), 13.8% (12.2%–14.8%) and 25.2% (24.2%–25.8%), respectively. All negative predictive values were ≥99.7%.ConclusionIn detecting AF, electronic blood pressure measurement (WatchBP Home A), but especially handheld ECG (MyDiagnostick) showed better diagnostic accuracy than radial pulse palpation.Trial registration numberNetherlands Trial Register No. NL4776 (old NTR4914).

Background The Nurses in the Lead (NitL) programme consists of a systematic approach and training to 1) empower community nurses in implementing evidence, targeted at encouraging functional activities of older adults, and 2) train community nurses in enabling team members to change their practice. This article aims to describe the process evaluation of NitL. Methods A mixed-methods formative process evaluation with a predominantly qualitative approach was conducted. Qualitative data were collected by interviews with community nurses (n = 7), focus groups with team members (n = 31), and reviewing seven implementation plans and 28 patient records. Quantitative data were collected among community nurses and team members (N = 90) using a questionnaire to assess barriers in encouraging functional activities and attendance lists. Data analysis was carried out through descriptive statistics and content analysis. Results NitL was largely executed according to plan. Points of attention were the use and value of the background theory within the training, completion of implementation plans, and reporting in patient records by community nurses. Inhibiting factors for showing leadership and encouraging functional activities were a lack of time and a high complexity of care; facilitating factors were structure and clear communication within teams. Nurses considered the systematic approach useful and the training educational for their role. Most team members considered NitL practical and were satisfied with the coaching provided by community nurses. To optimise NitL, community nurses recommended providing the training first and extending the training. The team members recommended continuing clinical lessons, which were an implementation strategy from the community nurses. Conclusions NitL was largely executed as planned, and appears worthy of further application in community care practice. However, adaptations are recommended to make NitL more promising in practice in empowering community nurse leadership in implementing evidence.

Background Community care professionals need to encourage older adults in performing functional activities to maintain independence. However, professionals often perform functional activities on behalf of older adults. To change this, insights into the behavior and barriers of professionals in encouraging activities are required. In the current study, the MAINtAIN questionnaire, which was developed for nursing homes, was adopted. The objective was to create a modified version that is suitable for measuring behavior and barriers of community care professionals in encouraging functional activities of clients in the community care setting. The overall aims were to assess the content validity, construct validity, and internal consistency of the modified version. Methods Data was collected by qualitative and quantitative methods in two phases. During phase one, the MAINtAIN was assessed on appropriateness and feasibility by community nurses (N = 7), and the adapted questionnaire was assessed on content validity by research experts (N = 9) and community care professionals (N = 18). During phase two, the psychometric properties of the adapted MAINtAIN-C were assessed in community care professionals (N = 80). Construct validity was evaluated by an Exploratory Factor Analysis (EFA), and internal consistency was determined by calculating Cronbach’s alpha coefficients. Results The formulation, verbs, and wording of the MAINtAIN were adapted; some items were excluded and relevant items were added, resulting in the MAINtAIN-C with two scales, showing good content validity. The Behaviors scale (20 items) measures perceived behavior in encouraging functional activities, expressing good internal consistency (Cronbach’s alpha: .92). The Barriers scale measures barriers in encouraging functional activities related to two dimensions: 1) the clients’ context (7 items), with good internal consistency (.78); and 2) the professional, social, and organizational contexts (21 items), showing good internal consistency (.83). Conclusions The MAINtAIN-C seems promising to assess the behavior and barriers of community care professionals in encouraging functional activities. It can be used to display a possible difference between perceived and actual behavior, to develop strategies for removing barriers in encouraging activities to foster behavioral change. The results also provide guidance for further research in a larger sample to obtain more insight into the psychometric properties.

ObjectiveTo investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.DesignCluster randomised controlled trial.Setting47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.ParticipantsIn each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.InterventionsOpportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.Main outcome measuresDifference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.ResultsFollow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.ConclusionsOpportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.Trial registrationNetherlands Trial Register No NL4776 (old NTR4914).

Wijkverpleegkundigen staan op de voorgrond in het proces van kwaliteitsverbetering binnen het eigen team. Dit vereist leiderschap. Het project Nurses in the Lead richt zich op het versterken van leiderschapscompetenties van wijkverpleegkundigen bij het implementeren van evidence-based innovaties gericht op het stimuleren van zelfredzaamheid bij ouderen.

Introduction Detection of atrial fibrillation (AF) is important given the risk of complications, such as stroke and heart failure, and the need for preventive measures. Detection is complicated because AF can be silent or paroxysmal. Describing current practice may give clues to improve AF detection. The aim of this study was to describe how cardiologists currently detect AF.Methods Between December 2014 and May 2015, we sent Dutch cardiologists an online questionnaire. Firstly, we asked which tools for detection of AF their department has. Secondly, we presented six case vignettes related to AF, in which they could choose a diagnostic tool. Thirdly, we compared the results with current guidelines.Results We approached 90 cardiology departments and 48 (53%) completed the questionnaire. In asymptomatic patients with risk factors according to CHA(2)D(S)2-VASc, 40% of the cardiologists would screen for AF. In patients with signs or symptoms of AF, all but one cardiologist would start a diagnostic process. In both vignettes describing patients with non-frequent symptoms, 46% and 54% of the responders would use short-term (i.e. 24-or 48hour) electrocardiographic monitoring, 48% and 27% would use longterm (i.e. 7 day, 14 day or one month) monitoring. In both cases describing patients with frequent symptoms, 85% of the responders would use short-term and 15% and 4% longterm monitoring.Conclusion Dutch cardiologists have access to a wide variety of ambulatory arrhythmia monitoring tools. Nearly half of the cardiologists would perform opportunistic screening. In cases with non-frequent symptoms, monitoring duration was shorter than recommended by NICE.

Hendriksen JM, Lucassen WA, Erkens PM, Stoffers HE, Van Weert HC, Büller HR, Hoes AW, Moons KG, Geersing GJ. Klinische blik versus beslisregel bij longembolie. Huisarts Wet 2017;60(4):152-4.Achtergrond Om de diagnose ‘longembolie’ uit te sluiten adviseert de NHG-Standaard een diagnostisch predictiemodel te gebruiken, zoals de Wells-beslisregel, in combinatie met een D-dimeerbepaling. Veel huisartsen gebruiken echter geregeld hun eigen impliciete kansschatting. Wij onderzochten of longembolie bij eerstelijnspatiënten met de klinische blik even veilig en efficiëntkan worden uitgesloten als met de Wells-beslisregel.Methode In een cohort van 598 patiënten met mogelijk een longembolie gaf de huisarts de eigen klinische inschatting aan op een schaal van 0-100%, met daarnaast de kans volgens de Wells-beslisregel. Alle patiënten werden vervolgens verwezen naar het ziekenhuis voor een referentietest. Wij deelden de patiënten in in laag- en hoogrisicogroepen op basis van beide strategieën. Als afkapwaarden kozen we een score < 20% voor de klinische blik respectievelijkeen score ≤ 4 voor de Wells-beslisregel, beide in combinatie met een negatieve D-dimeerbepaling. Wij vergeleken de efficientie en de veiligheid van beide strategieen.Resultaten Van de 598 deelnemers hadden er 73 (12%) een veneuzetrombo-embolie. Op basis van klinische blik werden 152 patientenals laag risico geclassificeerd (efficientie 25%; 95%-BI 22-29). Van deze 152 bleken er twee alsnog een longembolie te hebben(veiligheid 1,3%; 95%-BI 0,2-4,7). Met de Wells-beslisregel warden 272 patienten als laag risico geclassificeerd (efficientie 45%; 95%-BI 41-50), van wie er vier alsnog een longembolie hadden (veiligheid 1,5%; 95%-BI 0,4-3,7).Conclusie Om een longembolie veilig uit te sluiten, is de Wellsbeslisregeleven veilig als de klinische blik van de huisarts, en aanzienlijk efficiënter.

Background Direct oral anticoagulants (DOACs) are used for treatment of venous thromboembolism (VTE) and stroke prevention in atrial fibrillation (AF). Given the shorter half-life and lack of laboratory monitoring compared to vitamin-K antagonists (VKAs), adequate adherence to DOACs is important. Reported anticoagulation adherence is unclear in clinical practice. Objectives To assess self-reported anticoagulation adherence in a tertiary center anticoagulation clinic. Patients/Methods Cross-sectional study of patients on oral anticoagulants (VKAs, rivaroxaban, dabigatran and apixaban). Anticoagulation adherence was assessed using the 4-item Morisky score. Baseline characteristics were evaluated for association with adherence. Results Five hundred patients completed the survey; 74% were on VKAs and 26% on DOACs: rivaroxaban 102 (79%); dabigatran 26 (19%); apixaban 2 (2%). Main indications for anticoagulation were VTE (72%) and AF (18%). Self-reported anticoagulation adherence using the 4-item Morisky scale was 56.2% for patients on VKAs and 57.1% for patients on DOACs. Predictors of anticoagulation adherence were age (OR = 1.02; 95% CI:1.01-1.03), female gender (OR = 1.58; 95% CI:1.10-2.27), use of additional oral medications (OR = 2.78; 95% CI:1.67-4.63), and retired employment status (OR = 2.31; 95% CI:1.51-3.55). In backward selection multivariate analyses age, female gender and use of other oral medications remained significantly associated with anticoagulation adherence. Conclusions Self-reported anticoagulation adherence was similar between VKAs and DOACs. Until laboratory assays are universally available to evaluate DOAC adherence, physicians should emphasize the importance of anticoagulation adherence at each patient encounter. The Morisky scale provides simple assessment of anticoagulation adherence; however it has not yet been validation for this purpose.

BackgroundGeneral practitioners can safely exclude pulmonary embolism (PE) by using the Wells PE rule combined with D-dimer testing.ObjectiveTo compare the accuracy of a strategy using the Wells rule combined with either a qualitative point-of-care (POC) D-dimer test performed in primary care or a quantitative laboratory-based D-dimer test.MethodsWe used data from a prospective cohort study including 598 adults suspected of PE in primary care in the Netherlands. General practitioners scored the Wells rule and carried out a qualitative POC test. All patients were referred to hospital for reference testing. We obtained quantitative D-dimer test results as performed in hospital laboratories. The primary outcome was the prevalence of venous thromboembolism in low-risk patients.ResultsPrevalence of PE was 12.2%. POC D-dimer test results were available in 582 patients (97%). Quantitative test results were available in 401 patients (67%). We imputed results in 197 patients. The quantitative test and POC test missed one (0.4%) and four patients (1.5%), respectively, with a negative strategy (Wells 4 points and D-dimer test negative) (P=0.20). The POC test could exclude 23 more patients (4%) (P=0.05). The sensitivity and specificity of the Wells rule combined with a POC test were 94.5% and 51.0% and, combined with a quantitative test, 98.6% and 47.2%, respectively.ConclusionsCombined with the Wells PE rule, both tests are safe to use in excluding PE. The quantitative test seemed to be safer than the POC test, albeit not statistically significant. The specificity of the POC test was higher, resulting in more patients in whom PE could be excluded.

SummaryThe systematic assessment of residual thromboembolic obstruction after treatment for acute pulmonary embolism (PE) has been under-studied. This assessment is of potential clinical importance, should clinically suspected recurrent PE occur, or as tool for risk stratification of cardiopulmonary complications or recurrent venous thromboembolism (VTE). This study aimed to assess the rate of PE resolution and its implications for clinical outcome. In this prospective, multi-center cohort study, 157 patients with acute PE diagnosed by CT pulmonary angiography (CTPA) underwent follow-up CTPA-imaging after six months of anticoagulant treatment. Two expert thoracic radiologists independently assessed the presence of residual thromboembolic obstruction. The degree of obstruction at baseline and follow-up was calculated using the Qanadli obstruction index. All patients were followed-up for 2.5 years. At baseline, the median obstruction index was 27.5 %. After six months of treatment, complete PE resolution had occurred in 84.1 % of the patients (95 % confidence interval (CI): 77.4–89.4 %). The median obstruction index of the 25 patients with residual thrombotic obstruction was 5.0 %. During follow-up, 16 (10.2 %) patients experienced recurrent VTE. The presence of residual thromboembolic obstruction was not associated with recurrent VTE (adjusted hazard ratio: 0.92; 95 % CI: 0.2–4.1). This study indicates that the incidence of residual thrombotic obstruction following treatment for PE is considerably lower than currently anticipated. These findings, combined with the absence of a correlation between residual thrombotic obstruction and recurrent VTE, do not support the routine use of follow-up CTPA-imaging in patients treated for acute PE.

International audience; IMPORTANCE: D-dimer measurement is an important step in the diagnostic strategy of clinically suspected acute pulmonary embolism (PE), but its clinical usefulness is limited in elderly patients. OBJECTIVE: To prospectively validate whether an age-adjusted D-dimer cutoff, defined as age × 10 in patients 50 years or older, is associated with an increased diagnostic yield of D-dimer in elderly patients with suspected PE. DESIGN, SETTINGS, AND PATIENTS: A multicenter, multinational, prospective management outcome study in 19 centers in Belgium, France, the Netherlands, and Switzerland between January 1, 2010, and February 28, 2013. INTERVENTIONS: All consecutive outpatients who presented to the emergency department with clinically suspected PE were assessed by a sequential diagnostic strategy based on the clinical probability assessed using either the simplified, revised Geneva score or the 2-level Wells score for PE; highly sensitive D-dimer measurement; and computed tomography pulmonary angiography (CTPA). Patients with a D-dimer value between the conventional cutoff of 500 µg/L and their age-adjusted cutoff did not undergo CTPA and were left untreated and formally followed-up for a 3-month period. MAIN OUTCOMES AND MEASURES: The primary outcome was the failure rate of the diagnostic strategy, defined as adjudicated thromboembolic events during the 3-month follow-up period among patients not treated with anticoagulants on the basis of a negative age-adjusted D-dimer cutoff result. RESULTS: Of the 3346 patients with suspected PE included, the prevalence of PE was 19%. Among the 2898 patients with a nonhigh or an unlikely clinical probability, 817 patients (28.2%) had a D-dimer level lower than 500 µg/L (95% CI, 26.6%-29.9%) and 337 patients (11.6%) had a D-dimer between 500 µg/L and their age-adjusted cutoff (95% CI, 10.5%-12.9%). The 3-month failure rate in patients with a D-dimer level higher than 500 µg/L but below the age-adjusted cutoff was 1 of 331 patients (0.3% [95% CI, 0.1%-1.7%]). Among the 766 patients 75 years or older, of whom 673 had a nonhigh clinical probability, using the age-adjusted cutoff instead of the 500 µg/L cutoff increased the proportion of patients in whom PE could be excluded on the basis of D-dimer from 43 of 673 patients (6.4% [95% CI, 4.8%-8.5%) to 200 of 673 patients (29.7% [95% CI, 26.4%-33.3%), without any additional false-negative findings. CONCLUSIONS AND RELEVANCE: Compared with a fixed D-dimer cutoff of 500 µg/L, the combination of pretest clinical probability assessment with age-adjusted D-dimer cutoff was associated with a larger number of patients in whom PE could be considered ruled out with a low likelihood of subsequent clinical venous thromboembolism. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01134068.

INTRODUCTION: Although quality of life (QoL) is recognized as an important indicator of the course of a disease, it has rarely been addressed in studies evaluating the outcome of care for patients with pulmonary embolism (PE). This study primarily aimed to evaluate the QoL of patients with acute PE in comparison to population norms and to patients with other cardiopulmonary diseases, using a generic QoL questionnaire. Secondary, the impact of time period from diagnosis and clinical patient characteristics on QoL was assessed, using a disease-specific questionnaire.METHODS: QoL was assessed in 109 consecutive out-patients with a history of objectively confirmed acute PE (mean age 60.4 ± 15.0 years, 56 females), using the generic Short Form-36 (SF-36) and the disease specific Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL). The score of the SF-36 were compared with scores of the general Dutch population and reference populations with chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), a history of acute myocardial infarction (AMI), derived from the literature. Scores on the SF-35 and PEmb-QoL were used to evaluate QoL in the short-term and long-term clinical course of patients with acute PE. In addition, we examined correlations between PEmb-QoL scores and clinical patient characteristics.RESULTS: Compared to scores of the general Dutch population, scores of PE patients were worse on several subscales of the SF-36 (social functioning, role emotional, general health (PCONCLUSION: Our study demonstrated an impaired QoL in patients after treatment of PE. The results of this study provided more knowledge about QoL in patients treated for PE.

Lucassen WAM, Erkens PMG, Geersing GJ. Diagnostiek van longembolie. Huisarts Wet 2013;56(6):264-8. Wanneer de huisarts bij een patient longembolie vermoedt, kan hij eigenlijk niets anders doen dan verwijzen naar de tweede lijn. Dit is vaak nogal onbevredigend, omdat uiteindelijk slechts 10- 20% van de verwezen patienten de diagnose longembolie krijgt. In de tweede lijn bleek het mogelijk om longembolie veilig uit te sluiten met behulp van de Wells-beslisregel en een D-dimeertest. Daarom voerden we een prospectief onderzoek uit om eenzelfde strategie te valideren voor de eerste lijn (AMUSE-2). Huisartsen in heel Nederland includeerden 598 patienten bij wie zij een longembolie vermoedden. De huisartsen pasten de Wells-beslisregel toe en voerden een point of care D-dimeertest uit. Alle patienten kregen vervolgens volgens protocol een verwijzing naar de tweede lijn. Bij 73 patienten (prevalentie 12,2%) stelde men de diagnose longembolie. Bij 272 van de 598 patienten (45%) was er sprake van een negatieve Wells-beslisregel (score ≤ 4) en een negatieve kwalitatieve D-dimeertest. Slecht 4 van de 272 patienten kregen de diagnose longembolie (failure rate 1,5%; 95%-BI 0,4-3,7%), hetgeen niet verschilde van een negatieve CT-scan. De conclusie is dat de huisarts longembolie veilig kan uitsluiten aan de hand van de Wells-beslisregel en een kwalitatieve D-dimeertest.

After excluding pulmonary embolism (PE) with an unlikely Wells-decision rule and a negative D-dimer test, the general practitioner still has to differentiate between clinically relevant and clinically non-relevant diseases accounting for the presented symptoms. A negative D-dimer test makes clinically relevant disease less likely. The C-reactive protein (CRP) test could be of additional value to make this differentiation. Objectives: To assess whether an unlikely Wells-decision rule in combination with a negative point of care D-dimer test not only can safely exclude PE but also, in combination with a negative CRP-test, any other clinically relevant disease. Methods: We used data of a prospective study including 598 primary care patients suspected of pulmonary embolism. We included all patients, referred to secondary care for reference testing, with an unlikely Wells-decision rule and a negative point of care D-dimer test. We included 191 patients and imputed the CRP-test results in 60 patients. Alternative diagnoses were divided in clinically relevant diseases and clinically non-relevant diseases. A ROC-curve was constructed to determine the optimal CRP-cut-off. Results: The optimal CRP cut-off value appeared to be 10 mg/l. A total of 116 patients had a CRP

PURPOSE Diagnostic prediction models such as the Wells rule can be used for safely ruling out pulmonary embolism (PE) when it is suspected. A physician’s own probability estimate (“gestalt”), however, is commonly used instead. We evaluated the diagnostic performance of both approaches in primary care. METHODS Family physicians estimated the probability of PE on a scale of 0% to 100% (gestalt) and calculated the Wells rule score in 598 patients with suspected PE who were thereafter referred to secondary care for definitive testing. We compared the discriminative ability (c statistic) of both approaches. Next, we stratified patients into PE risk categories. For gestalt, a probability of less than 20% plus a negative point-of-care d-dimer test indicated low risk; for the Wells rule, we used a score of 4 or lower plus a negative d-dimer test. We compared sensitivity, specificity, efficiency (percentage of low-risk patients in total cohort), and failure rate (percentage of patients having PE within the low-risk category). RESULTS With 3 months of follow-up, 73 patients (12%) were confirmed to have venous thromboembolism (a surrogate for PE at baseline). The c statistic was 0.77 (95% CI, 0.70–0.83) for gestalt and 0.80 (95% CI, 0.75–0.86) for the Wells rule. Gestalt missed 2 out of 152 low-risk patients (failure rate = 1.3%; 95% CI, 0.2%–4.7%) with an efficiency of 25% (95% CI, 22%–29%); the Wells rule missed 4 out of 272 low-risk patients (failure rate = 1.5%; 95% CI, 0.4%–3.7%) with an efficiency of 45% (95% CI, 41%–50%). CONCLUSIONS Combined with d-dimer testing, both gestalt using a cutoff of less than 20% and the Wells rule using a score of 4 or lower are safe for ruling out PE in primary care. The Wells rule is more efficient, however, and PE can be ruled out in a larger proportion of suspected cases.

Hendriksen JM, Geersing GJ, Lucassen WA, Erkens PM, Stoffers HE, vanWeert HC, Buller HR, Hoes AW, Moons KG. Een bruikbare klinische beslisregelvoor longembolie. Huisarts Wet 2016;59(5):200-3. Om overdiagnostiek te voorkomen, is in de huisartsenpraktijk behoefte aan een bruikbare, efficiente en veilige beslisregel om longembolie bij een patient met klachten uit te sluiten. Wij valideerden in de eerste lijn een aantal klinische beslisregels die gebruikt worden in de tweede en derde lijn. In een systematisch literatuuronderzoek zochten wij naar klinische beslisregels voor longembolie. De beslisregels die bruikbaar leken voor de huisarts, valideerden we in een cohort van 598 deelnemers aan het AMUSE-2-onderzoek, allen met vermoede longembolie, uit 300 Nederlandse huisartsenpraktijken in 2007-2010. Van iedere beslisregel bepaalden we de efficientie, dat wil zeggen het percentage laagrisicopatienten dat de beslisregel identificeerde, en de veiligheid, dat wil zeggen het percentage patienten met een longembolie dat de beslisregel ten onrechte als laagrisicopatient categoriseerde. In de literatuur vonden wij tien klinische beslisregels voor longembolie, waarvan er vijf gevalideerd konden worden in onze dataset: de originele, gemodificeerde en gesimplificeerde Wells-beslisregel, de gereviseerde Geneva-score en de gesimplificeerde gereviseerde Geneva-score. Alle beslisregels sloten, in combinatie met een D-dimeersneltest, longembolie uit bij 43-48% van de patienten, het percentage foutnegatieven lag tussen 1,2% (95%-BI 0,2-3,3) voor de gesimplificeerde Wells-beslisregel en 3,1% (95%-BI 1,4-5,9) voor de gesimplificeerde gereviseerde Geneva-score. De vijf klinische beslisregels die wij valideerden voor de huisartsenpraktijk waren alle ongeveer even efficient. Het veiligst zijn de drie Wells-beslisregels. Met deze beslisregels, in combinatie met een D-dimeersneltest, kan de huisarts bij ongeveer 4 op de 10 patienten longembolie uitsluiten met een percentage foutnegatieven van nog geen 2%, hetgeen naar omstandigheden acceptabel is.

Background Prevalence of metabolic factors such as diabetes, hypertension, obesity, HDL and total cholesterol that are associated with an increased risk of coronary heart disease (CHD) is increasing worldwide. However, less is known about combinations of these factors that are associated with the highest CHD risk. Therefore, the associations between combinations of these metabolic factors and the incidence of CHD, acute myocardial infarction (AMI), and unstable angina pectoris (UAP) were studied in the Cardiovascular Registry Maastricht (CAREMA) cohort study. Methods The CAREMA study consists of 21,148 participants, born in 1927–1977 and randomly sampled from Maastricht and surrounding communities in 1987–1997. At baseline, all participants completed a self-administered questionnaire. Height, weight, blood pressure, total and HDL cholesterol levels were measured during a physical examination. After follow-up of maximally 16.9years, 780 CHD, 437 AMI, and 286 UAP cases of first occurrence were registered. Incidence rate ratios (RRs) were estimated using Cox proportional hazards models adjusted for age, sex, smoking, and alcohol consumption. Results Compared with subjects without any of the metabolic factors, the RRs of CHD were 2.37, 4.34, and 7.36 for subjects with 1, 2, or ≥3 metabolic factors, respectively. These RRs were higher for AMI but lower for UAP. Especially combinations of metabolic factors that included diabetes or both a low HDL (≤0.9mmol/L in men; ≤1.0mmol/L in women) and high total cholesterol (≥6.21mmol/L) were associated with increased risks. Conclusion The risk of total CHD, AMI, and UAP varies considerably between different combinations of metabolic factors.

Clinical probability assessment is combined with d-dimer testing to exclude pulmonary embolism (PE). To compare the test characteristics of gestalt (a physician's unstructured estimate) and clinical decision rules for evaluating adults with suspected PE and assess the failure rate of gestalt and rules when used in combination with d-dimer testing. Articles in MEDLINE and EMBASE in English, French, German, Italian, Spanish, or Dutch that were published between 1966 and June 2011. Study Selection: 3 reviewers, working in pairs, selected prospective studies in consecutive patients suspected of having PE. Studies had to estimate the probability of PE by using gestalt or a decision rule and verify the diagnosis by using an appropriate reference standard. Data on study characteristics, test performance, and prevalence were extracted. Reviewers constructed 2 × 2 tables and assessed the methodological quality of the studies. 52 studies, comprising 55 268 patients, were selected. Meta-analysis was performed on studies that used gestalt (15 studies; sensitivity, 0.85; specificity, 0.51), the Wells rule with a cutoff value less than 2 (19 studies; sensitivity, 0.84; specificity, 0.58) or 4 or less (11 studies; sensitivity, 0.60; specificity, 0.80), the Geneva rule (5 studies; sensitivity, 0.84; specificity, 0.50), and the revised Geneva rule (4 studies; sensitivity, 0.91; specificity, 0.37). An increased prevalence of PE was associated with higher sensitivity and lower specificity. Combining a decision rule or gestalt with d-dimer testing seemed safe for all strategies, except when the less-sensitive Wells rule (cutoff value ≤4) was combined with less-sensitive qualitative d-dimer testing. Studies had substantial heterogeneity due to prevalence of PE and differences in threshold. Many studies (63%) had potential bias due to differential disease verification. Clinical decision rules and gestalt can safely exclude PE when combined with sensitive d-dimer testing. The authors recommend standardized rules because gestalt has lower specificity, but the choice of a particular rule and d-dimer test depend on both prevalence and setting

Introduction: Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Approval in this indication was supported by results from EINSTEIN PE, a large, randomised, open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic PE with or without DVT.Materials and Methods: Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and, therefore, patient compliance. As part of EINSTEIN PE, 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction, the Anti-Clot Treatment Scale (ACTS) throughout the duration of treatment (up to 12 months).Results: Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm. Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater.Conclusion: Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden. (C) 2014 Published by Elsevier Ltd.

Objective To validate all diagnostic prediction models for ruling out pulmonary embolism that are easily applicable in primary care. Design Systematic review followed by independent external validation study to assess transportability of retrieved models to primary care medicine. Setting 300 general practices in the Netherlands. Participants Individual patient dataset of 598 patients with suspected acute pulmonary embolism in primary care. Main outcome measures Discriminative ability of all models retrieved by systematic literature search, assessed by calculation and comparison of C statistics. After stratification into groups with high and low probability of pulmonary embolism according to pre-specified model cut-offs combined with qualitative D-dimer test, sensitivity, specificity, efficiency (overall proportion of patients with low probability of pulmonary embolism), and failure rate (proportion of pulmonary embolism cases in group of patients with low probability) were calculated for all models. Results Ten published prediction models for the diagnosis of pulmonary embolism were found. Five of these models could be validated in the primary care dataset: the original Wells, modified Wells, simplified Wells, revised Geneva, and simplified revised Geneva models. Discriminative ability was comparable for all models (range of C statistic 0.75-0.80). Sensitivity ranged from 88% (simplified revised Geneva) to 96% (simplified Wells) and specificity from 48% (revised Geneva) to 53% (simplified revised Geneva). Efficiency of all models was between 43% and 48%. Differences were observed between failure rates, especially between the simplified Wells and the simplified revised Geneva models (failure rates 1.2% (95% confidence interval 0.2% to 3.3%) and 3.1% (1.4% to 5.9%), respectively; absolute difference −1.98% (−3.33% to −0.74%)). Irrespective of the diagnostic prediction model used, three patients were incorrectly classified as having low probability of pulmonary embolism; pulmonary embolism was diagnosed only after referral to secondary care. Conclusions Five diagnostic pulmonary embolism prediction models that are easily applicable in primary care were validated in this setting. Whereas efficiency was comparable for all rules, the Wells rules gave the best performance in terms of lower failure rates.

Introduction. Pulmonary embolism (PE) of ten presents with nonspecific symptoms and may be an easily missed diagnosis. When the differential diagnosis includes PE, an empirical list of frequently occurring alternative diagnoses could support the GP in diagnostic decision making. Objectives. To identify common alternative diagnoses in patients in whom the GP suspected PE but in whom PE could be ruled out. To investigate how the Wells clinical decision rule for PE combined with a point-of-care d-dimer test is associated with these alternative diagnoses. Methods. Secondary analysis of the Amsterdam Maastricht Utrecht Study on thrombo-Embolism (Amuse-2) study, which validated the Wells PE rule combined with point-of-care d-dimer testing in primary care. All 598 patients had been referred to and diagnosed in secondary care. All diagnostic information was retrieved from the GPs’ medical records. Results. In 516 patients without PE, the most frequent alternati ve diagnoses were nonspecific thoracic pain/dyspnoea (42.6%), pneumonia (13.0%), myalgia (11.8%), asthma/chronic obstructive pulmonary disease (4.8%), panic disorder/hyperventilation (4.1%) and respiratory tract infection (2.3%). Pneumonia occurred almost as frequent as PE. Patients without PE with either a positive Wells rule (>4) or a positive d-dimer test, were more often (odds ratio = 2.1) diagnosed with a clinically relevant disease than patients with a negative Wells rule and negative d-dimer test. Conclusion. In primary care patients suspected of PE, the most common clinically relevant diagnosis other than PE w as pneumonia. A positive Wells rule or a positive d-dimer test are not only positively associated with PE, but also with a high probability of other clinically relevant disease.

Introduction D-dimer testing allows to safely rule out pulmonary embolism (PE) without imaging test in approximately one third of outpatients. However, D-Dimer test is less useful as age increases because of a lower specificity. We recently derived an age-adjusted D-dimer cut-off value (age-adjusted cut-off = patient’s age x 10 in patients aged > 50 years, in μg/L), which allowed to significantly increase the proportion of patients in whom PE could be non-invasively excluded, without compromising safety. However, before being implemented in clinical practice, the safety of the age-adjusted cut-off should be verified in a management outcome study. Methods We designed a multicentre multinational prospective management outcome study. All consecutive outpatients seen in the emergency room of 22 centres in 4 countries with clinically suspected PE were assessed by a sequential diagnostic strategy based on the assessment of clinical probability, D-dimer measurement and computed tomography pulmonary angiography (CTPA). Patients with a D-dimer value between the usual threshold of 500 μg/L and their age-adjusted cut-off did not undergo CTPA and were left untreated and formally followed for a three-month period. Results Between January 1, 2010 and February 28, 2013, we included 3,377 patients. Mean age was 62 years, and 57% were females. Overall, the proportion of confirmed PE was 18%. Among the 2,927 patients with a non-high clinical probability, 832 (28.4%) had a D-Dimer < 500 μg/L, and 345 additional patients (11.8%) had a D-Dimer comprised between 500 μg/L and their age-adjusted cut-off. During the 3-month follow-up period, out of the 345 patients with a D-Dimer between 500 μg/L and their age-adjusted cut-off, 18 patients received anticoagulation for another indication than PE. Of the remaining 327 patients, 7 died, and 7 underwent testing for suspected venous thromboembolism (VTE), of which one was confirmed. Therefore, the failure rate of the age-adjusted cut-off was 1/327: 0.3%, (95% CI 0.1 to 1.7%). Overall, 789 patients were aged 75 years or more, of them 697 had a non-high clinical probability. The proportion of patients with D-Dimer < 500 μg/L was 50/697 (7.2%). Another 161 patients had a D-Dimer above 500 μg/L and under their age-adjusted cut-off. Therefore, the proportion of patients > 75 with a negative D-Dimer using the age-adjusted cut-off was 211/697 (30.3%), of them none had a confirmed VTE during follow-up: 0.0%, (95%CI: 0.0 to 1.9%). Conclusions Our study demonstrates that the age-adjusted D-Dimer cut-off may now be used in clinical practice in emergency room patients with suspected PE. Combined with clinical probability, it increases the number of patients in whom PE can be excluded without imaging test, and this is particularly true among elderly patients, with a four-fold increased yield of D-dimer. A D-Dimer above 500 μg/L but under the age-adjusted cut-off safely excludes the diagnosis of PE, with a 3-month risk of VTE in line with that observed in patients with a D-Dimer under 500 μg/L or after a negative pulmonary angiography, the gold-standard test for PE. Disclosures: No relevant conflicts of interest to declare.

Background: The non-specific clinical presentation of pulmonary embolism (PE) frequently leads to delay in its diagnosis. Aims: To assess the impact of delay in presentation on the diagnostic management and clinical outcome of patients with suspected PE. Methods: For this post-hoc analysis, we used the combined data of two large multi-center, prospective studies that investigated the diagnostic management of patients with suspected PE. Patients presenting > 7 days from the onset of symptoms were contrasted to those presenting within 7 days as regards the safety of excluding PE on the basis of a clinical decision rule (CDR) combined with D-dimer testing. Patients were followed for 3 months to assess the rates of recurrent venous thromboembolism (VTE) and mortality. Results: Diagnostic delay (presentation > 7 days) was present in 754 (18.6%) of the total of 4044 patients. The failure rate of an unlikely clinical probability and normal D-dimer test was 0.5% (95% CI: 0.01- 2.7) for patients with and 0.5% (95% CI: 0.2-1.2) for those without diagnostic delay. D-dimer testing yielded a sensitivity of 99% (95%CI: 96-99%) and 98% (95%CI: 97-99%) in these groups respectively. PE patients with diagnostic delay more frequently had centrally located PE (41% vs. 26%, P > 0.001). The cumulative rates of recurrent VTE (4.6% vs. 2.7%, P = 0.14) and mortality (7.6% vs. 6.6%, P = 0.31) were not different for patients with and without diagnostic delay. Conclusions: PE can be safely excluded based on a CDR and D-dimer testing in patients with a delayed clinical presentation. Diagnostic delay for patients who survived acute PE was associated with a more central PE location although this did not affect the clinical outcome at 3 months.

Introduction Multi-detector computed tomography (MDCT) is considered to be the reference standard in diagnosing pulmonary embolism (PE). However, two concerns remain. Firstly, with the introduction of MDCT the prevalence of (sub)segmental emboli increased but the clinical implications of these small clots are uncertain. Secondly, we are not well informed about the number of false-positive CT-scans due to the lack of a gold standard. Patients and Methods We used data from a prospective primary care study including patients suspected of pulmonary embolism. CT-scan-reading by the local radiologist in daily care was retrospectively compared with expert reading as reference standard. Final diagnosis was categorized as central/lobar, segmental or subsegmental PE. Results A total of 79 patients were included. In 3 of 30 patients (10%) diagnosed with PE by the local radiologist the experts refuted the diagnosis. In 7 of 49 patients (14%) not diagnosed with PE by the local radiologist the experts confirmed the presence of PE. The experts diagnosed 17 of 32 PE-patients (53%) with a central or lobar PE. All these 17 patients were also diagnosed with PE by the local radiologist. The experts diagnosed 15 patients with (sub)segmental PE. In 7 of these 15 patients (47%) the local radiologist refuted PE. Conclusions Accuracy of MDCT using the expert radiologist as reference standard is not optimal. On the one hand it shows 10% false-positives exposing patients to anticoagulant treatment unnecessarily. On the other hand small emboli seem to be missed although the clinical implications of this finding are not fully clear.

Objective To validate the use of the Wells clinical decision rule combined with a point of care D-dimer test to safely exclude pulmonary embolism in primary care. Design Prospective cohort study. Setting Primary care across three different regions of the Netherlands (Amsterdam, Maastricht, and Utrecht). Participants 598 adults with suspected pulmonary embolism in primary care. Interventions Doctors scored patients according to the seven variables of the Wells rule and carried out a qualitative point of care D-dimer test. All patients were referred to secondary care and diagnosed according to local protocols. Pulmonary embolism was confirmed or refuted on the basis of a composite reference standard, including spiral computed tomography and three months’ follow-up. Main outcome measures Diagnostic accuracy (sensitivity and specificity), proportion of patients at low risk (efficiency), number of missed patients with pulmonary embolism in low risk category (false negative rate), and the presence of symptomatic venous thromboembolism, based on the composite reference standard, including events during the follow-up period of three months. Results Pulmonary embolism was present in 73 patients (prevalence 12.2%). On the basis of a threshold Wells score of ≤4 and a negative qualitative D-dimer test result, 272 of 598 patients were classified as low risk (efficiency 45.5%). Four cases of pulmonary embolism were observed in these 272 patients (false negative rate 1.5%, 95% confidence interval 0.4% to 3.7%). The sensitivity and specificity of this combined diagnostic approach was 94.5% (86.6% to 98.5%) and 51.0% (46.7% to 55.4%), respectively. Conclusion A Wells score of ≤4 combined with a negative qualitative D-dimer test result can safely and efficiently exclude pulmonary embolism in primary care.

Introduction The percentage of time within the target INR range 2.0 to 3.0 (TTR) in patients treated with vitamin K antagonists varies considerably among efficacy-studies of novel anticoagulants. In order to properly asses the quality of anticoagulant control in upcoming cost-effectiveness studies and real life registries this systematic review reports a benchmark of TTR for different treatment durations in patients with venous thromboembolism and discusses ways to calculate TTR. Methods Medline and Embase were searched for studies published between January 1990 and May 2012. Randomized controlled trials and cohort studies reporting the TTR in patients with objectively confirmed venous thromboembolism treated with vitamin K antagonists (VKA) were eligible. Duplicate reports, studies only reporting INR during initial treatment or with VKA treatment less than 3 months were excluded. Three authors assessed trials for inclusion and extracted data independently. Discrepancies were resolved by discussion between the reviewers. A meta-analysis was performed by calculating a weighted mean, based on the number of participants in each included study, for each time-period in which the TTR was measured since the confirmation of the diagnosis of VTE. Results Forty studies were included (26064 patients). The weighted means of TTR were 54.0% in the first month since the start of treatment, 55.6% in months 1 to 3, 60.0% in months 2 to 3, 60.0% in the months1 to 6+ and 75.2% in months 4 to 12+. Five studies reported TTR in classes. The INR in these studies was ≥67% of time in therapeutic range in 72.0% of the patients. Conclusion Reported quality of VKA treatment is highly dependent on the time-period since the start of treatment, with TTR ranging from approximately 56% in studies including the 1st month to 75% in studies excluding the first 3 months.

International audience; INTRODUCTION: The pulmonary embolism severity index (PESI) and the recently derived simplified PESI prognostic model have been developed to estimate the risk of 30-day mortality in patients with acute PE. We sought to assess if the PESI and simplified PESI prognostic models can accurately identify adverse events and to determine the rates of events in patients treated as outpatients. METHODS: A retrospective cohort study of patients with acute pulmonary embolism (PE) presenting at the Ottawa Hospital (Canada) was conducted between 1 January 2007 and 31 December 2008. RESULTS: Two hundred and forty three patients were included. A total of 118 (48.6%) and 81 (33.3%) were classified as low risk patients using the original and simplified PESI prognostic models respectively. None of the low risk patients died within the 3months of follow-up. One hundred and fifteen (47.3%) patients were safely treated as outpatients with no deaths or bleeding episodes and only 1 recurrent event within the first 14days or after 30days of follow-up. Thirty four (29.6%) of these outpatients were classified as high risk patients according to the original PESI and 54 (47.0%) to the simplified PESI prognostic model. CONCLUSION: Both PESI strategies accurately identify patients with acute PE who are at low risk and high risk for short-term adverse events. However, 30 to 47% of patients with acute PE and a high risk PESI score were safely managed as outpatients. Future research should be directed at developing tools that predict which patients would benefit from inpatient management.

Correctly stratifying the risk of death in patients with pulmonary embolism (PE) has been a matter of debate in the literature; and certain forms of presentation, such as central saddle emboli, have been considered to lead to increased risk

Background: The ability of a miniaturized, skin-attached, 3-channel electrocardiogram (ECG) recorder prototype to detect ventricular ectopic beats (VEBs) and ventricular fibrillation (VF) was compared with that of standard Holter ECG. Methods: Concurrent 15-hour ECG recordings were made in 143 patients using an experimental device provided by Philips Healthcare (Seattle, WA) and a commercially available Holter recorder. In a consensus review process, 3 physicians (M.L., A.J., and A.G.), blinded for the recording device, analyzed 1804 seven-second strips for total number of VEBs, total number of their QRS configurations, and presence of VF. Agreement between the experimental and standard devices was calculated using Spearman correlation coefficients. Results: There was 100% agreement regarding VF recognition. Spearman correlation coefficients were 0.98 (P

Abstract 3796 Introduction: Systematic reviews have shown that subcutaneous low molecular weight heparins (LMWH) are at least as safe and effective in the treatment of venous thromboembolism (VTE) as intravenous unfractionated heparin (UFH). LMWH allows patients with VTE to be treated as outpatients. However, patients with pulmonary embolism (PE) are still systematically admitted to the hospital for a few days to avoid potential complications. Physicians are reluctant to discharge patients due to insufficient data supporting the safety of outpatient management of PE. This study evaluates the safety of outpatient treatment of acute PE at the Ottawa Hospital. Methods: This is a retrospective cohort study of consecutive patients presenting at the Ottawa Hospital with acute PE diagnosed between January 1, 2007 and December 31, 2008. PE was defined as an arterial filling defect on CTPA or a high probability V/Q scan. Patients diagnosed with PE during hospitalization, patients with chronic PE and patients in whom anticoagulation treatment was not initiated (e.g. palliative care patients, small clinical non-significant PE) were excluded from the analyses. Patients were managed as outpatients if they were hemodynamically stable, did not require supplemental oxygenation and did not have contraindications to low molecular weight heparin therapy. Results: In this cohort of 473 patients with acute PE, 260 (55.0%) were treated as outpatients and 213 (45.0%) were admitted to the hospital. The majority of the patients were admitted because of severe comorbidities (45.5%) or hypoxia (22.1%).No outpatient died of fatal PE during the 3 month follow-up period. At the end of follow-up, the overall mortality was 5.0% (95% CI: 2.7 to 8.4%). The rates of recurrent venous thromboembolism (VTE) in the outpatient group were 0.4% (95% CI: 0.0 to 2.1%) and 3.8% (95% CI: 1.9 to 7.0%) within 14 days and 3 months, respectively. The rates of major bleeding episodes were 0% (95% CI: 0 to 1.4%) and 1.5% (95% CI: 0.4 to 3.9%) within 14 days and 3 months, respectively. Four (1.5%) outpatients were admitted to hospital within the first 14 days because of progressive shortness of breath and pain, a pre-syncopal episode or heparin induced thrombocytopenia. Conclusion: A majority of patients with acute PE can be managed as outpatients with a low risk of mortality, recurrent VTE and major bleeding episodes. Outpatient treatment in PE is feasible and safe in uncomplicated patients. Disclosures: Rodger: Pfizer: Research Funding; Leo Pharma: Research Funding; Sanofi Aventis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Canadian Institutes of Health Research: Research Funding; Heart and Stroke Foundation: Research Funding.

Background Low molecular weight heparins (LMWHs) have been shown to be effective and safe in preventing venous thromboembolism (VTE). They may also be effective for the initial treatment of VTE. This is an update of a Cochrane review first published in 1999 and previously updated in 2004. Objectives To determine the effect of LMWH compared with unfractionated heparin (UFH) for the initial treatment of VTE. Search methods Trials were identified by searching the Cochrane Peripheral Vascular Diseases Group Specialised Register and CENTRAL (The Cochrane Library). Colleagues and pharmaceutical companies were contacted for additional information. Selection criteria Randomised controlled trials comparing fixed dose subcutaneous LMWH with adjusted dose intravenous or subcutaneous UFH in people with VTE. Data collection and analysis Two review authors assessed trials for inclusion and quality, and extracted data independently. Main results Twenty-three studies were included (n = 9587). Thrombotic complications occurred in 3.6% of participants treated with LMWH compared with 5.3% treated with UFH (odds ratio (OR) 0.70; 95% confidence interval (CI) 0.57 to 0.85). Thrombus size was reduced in 53% of participants treated with LMWH and 45% treated with UFH (OR 0.69; 95% CI 0.59 to 0.81). Major haemorrhages occurred in 1.1% of participants treated with LMWH compared with 1.9% treated with UFH (OR 0.58; 95% CI 0.40 to 0.83). In 19 trials, 4.3% of participants treated with LMWH died compared with 5.8% of participants treated with UFH (OR 0.77; 95% CI 0.63 to 0.93). Nine studies (n = 4451) examined proximal thrombosis, 2192 participants were treated with LMWH and 2259 with UFH. Subgroup analysis showed statistically significant reductions favouring LMWH in thrombotic complications and major haemorrhage. By end of follow up, 80 (3.6%) participants treated with LMWH had thrombotic complications compared with 143 (6.3%) treated with UFH (OR 0.57; 95% CI 0.44 to 0.75). Major haemorrhages occurred in 18 (1.0%) participants treated with LMWH compared with 37 (2.1%) treated with UFH (OR 0.50; 95% CI 0.29 to 0.85). Nine studies showed a statistically significant reduction in mortality favouring LMWH. By the end of follow up, 3.3% (70/2094) of participants treated with LMWH had died and 5.3% (110/2063) treated with UFH. Authors' conclusions Fixed dose LMWH is more effective and safer than adjusted dose UFH for the initial treatment of VTE. Compared to UFH, LMWH significantly reduced the incidence of thrombotic complications, the occurrence of major haemorrhage during initial treatment and overall mortality at follow up.

Background The Pulmonary Embolism Severity Index (PESI) has been validated in the setting of standard treatment of pulmonary embolism with initial low molecular weight heparin followed by vitamin K antagonists. We evaluated the proposed simplified PESI in a large, phase III randomized trial involving patients with symptomatic pulmonary embolism with or without deep vein thrombosis, who were treated with rivaroxaban or standard therapy. Methods The EINSTEIN PE study was an open-label, randomized, phase III study that compared oral rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous enoxaparin overlapping with and followed by a vitamin K antagonist (warfarin or acenocoumarol, target international normalized ratio 2.0–3.0) for 3, 6, or 12 months in patients with acute, symptomatic pulmonary embolism. At baseline, the simplified PESI score was assessed, with 1 point each assigned for age >80 years, history of cancer, chronic cardiopulmonary disease, heart beat ≥110 beats per minute, systolic blood pressure Results It was possible to calculate the simplified PESI score in 4831 of the 4832 included patients, of whom 2589 (53.6%) had a PESI score of 0; 1775 (36.7%) had a score of 1; and 467 (9.7%) had a score of 2 or 3. No patient had a simplified PESI score greater than 3. Incidences of outcomes in relation to time period, simplified PESI score and treatment are presented in the following table. Conclusions Among patients with a simplified PESI score of 0 or 1, major clinical outcome events were rare during the first 30 days of treatment and were similar in patients treated with rivaroxaban or standard therapy. Patients with a simplified PESI score of 2 or more in both treatment groups had more frequent adverse outcomes both initially and in the long term. Disclosures: Fermann: Novartis: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Radiometer: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Cubist: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Cardiorentis: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Pfizer: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity’s Board of Directors or advisory committees, Research Funding. Prins:Bayer HealthCare: Consultancy; Sanofi-aventis: Consultancy; Boehringer Ingelheim: Consultancy; GlaxoSmithKline: Consultancy; Daiichi Sankyo: Consultancy; Leo Pharma: Consultancy; Thrombogenics: Consultancy; Pfizer: Consultancy. Wells:BMS/Pfizer: Research Funding; Pfizer: Honoraria; Bayer Schering Pharma: Honoraria; Boehringer Ingelheim: Honoraria; Bayer HealthCare Pharmaceuticals: Honoraria; Biomerieux: Honoraria. Pap:Bayer Pharma AG: Employment. Lensing:Bayer Pharma AG: Employment.

Background: Several clinical decision rules (CDRs) are available to exclude acute pulmonary embolism (PE), but they have not been directly compared. Objective: To directly compare the performance of 4 CDRs (Wells rule, revised Geneva score, simplified Wells rule, and simplified revised Geneva score) in combination with D-dimer testing to exclude PE. Design: Prospective cohort study. Setting: 7 hospitals in the Netherlands. Patients: 807 consecutive patients with suspected acute PE. Intervention: The clinical probability of PE was assessed by using a computer program that calculated all CDRs and indicated the next diagnostic step. Results of the CDRs and D-dimer tests guided clinical care. Measurements: Results of the CDRs were compared with the prevalence of PE identified by computed tomography or venous thromboembolism at 3-month follow-up. Results: Prevalence of PE was 23%. The proportion of patients categorized as PE-unlikely ranged from 62% (simplified Wells rule) to 72% (Wells rule). Combined with a normal D-dimer result, the CDRs excluded PE in 22% to 24% of patients. The total failure rates of the CDR and D-dimer combinations were similar (1 failure, 0.5% to 0.6% [upper-limit 95% CI, 2.9% to 3.1%]). Even though 30% of patients had discordant CDR outcomes, PE was not detected in any patient with discordant CDRs and a normal D-dimer result. Limitation: Management was based on a combination of decision rules and D-dimer testing rather than only 1 CDR combined with D-dimer testing. Conclusion: All 4 CDRs show similar performance for exclusion of acute PE in combination with a normal D-dimer result. This prospective validation indicates that the simplified scores may be used in clinical practice. Primary Funding Source: Academic Medical Center, VU University Medical Center, Rijnstate Hospital, Leiden University Medical Center, Maastricht University Medical Center, Erasmus Medical Center, and Maasstad Hospital. © 2011 American College of Physicians.

Abstract 3180 Introduction: Pulmonary embolism (PE) is a continuous risk up to 3 months after surgery. Management of anticoagulation can be challenging in those diagnosed with PE after a major surgical procedure. The aim of this study is to evaluate the outcomes and characteristics of patients diagnosed with PE after a major surgery. Methods: A retrospective cohort of consecutive patients with suspected acute PE that underwent computed tomographic pulmonary angiography (CTPA) or lung ventilation/perfusion scans between 1 January 2007 and 31 December 2008 was constructed by two independent investigators by reviewing each patient's diagnostic images. Patients were included in the study if they had a major surgical procedure (admitted to the hospital for more than 24 hours) and developed PE within 12 weeks of the operation. Patients' follow-up for the first 3 months was recorded. Outcomes included major bleeding, as defined by the ISTH guidelines; recurrent venous thromboembolism (VTE), including PE or deep vein thrombosis (DVT); and mortality. The number of days between treatment initiation and major hemorrhage, recurrent VTE, or death, was recorded. Results: Out of the 842 patients diagnosed with PE at the Ottawa Hospital within the timeframe of the study, 160 (19%) were diagnosed during the post-operative period and were eligible for this study. The mean age (SD) in years was 63 (±15.5), 53% were males, 37% had a cancer related surgery, 37% had orthopedic procedures, and 31% had emergency procedures. The mean time (SD) from surgery to PE diagnosis was 13 (±11) days. All patients were followed-up until the end of their treatment; six patients were transferred to end of life care. Initial treatment was low molecular-weight heparin (LMWH) in 124 (78%) patients, unfractionated heparin (UFH) was given intravenously in 27 (17%) patients, and 5 (3%) requiered an inferior vena cava (IVC) filter to be inserted as the initial treatment. During the 90 days of follow up, there were 17 major bleeding events (12%), 6 recurrent VTEs (4%), and 15 deaths (9%). Of the 17 bleeding events, 13 of them (76%) occurred within the first two weeks of initiation of therapy. No bleeding events occurred after the first month. Two patients died (11.7%) from bleeding, one intracranial and one gastrointestinal (GI). Bleeding was from the GI tract in 47% of cases. Of the 5 patients with IVC filters, 3 developed recurrent DVT in the first two weeks after IVC insertion. The other 3 recurrent VTEs occurred on patients receiving anticoagulation. All cause mortality was 8.7% at 3 months. Within the first 14 days, 8 patients died (5%): 3 patients from PE. Outcomes did not vary by type of surgery, initial treatment or by presence of malignancy. Conclusions: Major bleeding is a common and deadly complication in patients diagnosed with PE after a major surgical procedure. The reported rates of bleeding in this population have varied widely in the literature (between 2 to 9%), according to the type of surgery or population. Our results suggest that alternative triaging and treatment strategies may be indicated in these patients. Disclosures: No relevant conflicts of interest to declare.

Abstract 1102 Introduction: The management of saddle pulmonary embolism (PE) is controversial. Evidence about outcomes and management strategies is scarce in the literature due to the small prevalence of saddle PE. Historically it has been recommended that this group of patients should be treated aggressively. Purpose: To determine the prevalence and outcomes of patients diagnosed with saddle PE. Methods: Retrospective cohort study of consecutive patients with saddle PE diagnosed at the Ottawa Hospital between January 2007 and December 2008. Patients were included if a thrombus was present on computed tomographic pulmonary angiography (CTPA) in the main pulmonary arteries spanning the bifurcation of the main pulmonary trunk. These cases were each matched with two non-saddle controls with proximal PE (thromboemboli in the main pulmonary arteries) based on age, sex, systolic blood pressure greater than or less than 90 mmHg, and the presence or absence of cancer. Demographics, prognostic factors, treatment, and outcomes were collected. Patients were followed over a 30 day period following the diagnosis. RESULTS: A total of 32 (5%) of 724 patients with PE had a saddle event. Baseline characteristics are depicted in Table 1. Differences between the saddle case group and non-saddle control group include the presence of right ventricular dilation (59% of saddle cases vs. 22% of controls, p-value: 0.0007) and in the proportion of patients managed as outpatients (7% of saddle cases vs. 33% of controls, p-value: 0.02). At 30 days no differences were found in patients with saddle PE or proximal PE for all cause mortality (6% vs. 10%; OR: 0.64; 95% CI: 0.08–3.2), PE related mortality (0% vs. 6%; OR: 0.52; 95% CI: 0.01–6.1), major bleeding (3% vs. 5%; OR: 0.65; 95% CI: 0.02–6.4), or recurrent venous thromboembolism (6% vs. 10%; OR: 0.64; 95% CI: 0.08–3.2). Conclusions: Patients with saddle PE do not have a worse 30-day prognosis than patients with proximal PE matched by age, sex, systolic blood pressure, and presence of cancer. Disclosures: No relevant conflicts of interest to declare.

Abstract 3186 Background Several clinical decision rules (CDRs) are available for the exclusion of acute pulmonary embolism (PE). This prospective multi-center study compared the safety and clinical utility of four CDRs (Wells rule, revised Geneva score, simplified Wells rule and simplified revised Geneva score) in excluding PE in combination with D-dimer testing. Methods Clinical probability of patients with suspected acute PE was assessed using a computerized based “black box”, which calculated all CDRs and indicated the next diagnostic step. A “PE unlikely” result according to all CDRs in combination with a normal D-dimer result excluded PE, while patients with “PE likely” according to at least one of the CDRs or an abnormal D-dimer result underwent CT-scanning. Patients in whom PE was excluded were followed for three months. Results 807 consecutive patients were included and PE prevalence was 23%. The number of patients categorized as “PE unlikely” ranged from 62% (simplified Wells rule) to 72% (Wells rule). Combined with a normal D-dimer level, the CDRs excluded PE in 22–24% of patients. The total failure rates of the CDR-D-dimer combinations were similar (1 failure, 0.5– 0.6%, upper 95% CI 2.9– 3.1%). Despite 30% of the patients had discordant CDR outcomes, PE was missed in none of the patients with discordant CDRs and a normal D-dimer result. Conclusions All four CDRs show similar safety and clinical utility for exclusion of acute PE in combination with a normal D-dimer level. With this prospective validation, the more straightforward simplified scores are ready for use in clinical practice. Disclosures: No relevant conflicts of interest to declare.

Background Atrial fibrillation is a common cause of stroke and other morbidity. Adequate treatment with anticoagulants reduces the risk of stroke by 60 %. Early detection and treatment of atrial fibrillation could prevent strokes. Atrial fibrillation is often asymptomatic and/or paroxysmal. Case-finding with pulse palpation is an effective screening method, but new methods for detecting atrial fibrillation have been developed. To detect paroxysmal atrial fibrillation ambulatory rhythm recording is needed. This study aims to determine the yield of case-finding for atrial fibrillation in primary care patients. In addition, it will determine the diagnostic accuracy of three different case-finding methods. Methods/Design In a multicenter cluster randomised controlled trial, we compare an enhanced protocol for case-finding of atrial fibrillation with usual care. We recruit 96 practices. We include primary care patients aged 65 years or older not diagnosed with atrial fibrillation. Within each practice, a cluster of 200 patients is randomly selected and marked. Practices are evenly randomised to intervention or control group. The allocation is not blinded. When a marked patient visits an intervention practice, the case-finding protocol starts, consisting of: pulse palpation, sphygmomanometer with automated atrial fibrillation detection and handheld single-lead electrocardiogram (ECG). All patients with at least 1 positive test and a random sample of patients with negative tests receive a 12-lead ECG. Patients without atrial fibrillation on the 12-lead ECG, undergo additional continuous Holter and use the handheld single-lead ECG at home for 2 weeks. Control practices provide care as usual. The study runs for 1 year in each cluster. The primary outcomes are the difference in detection rate of new AF between intervention and control practices and the accuracy of three index tests to diagnose AF. We are currently recruiting practices. The ‘Detecting and Diagnosing Atrial Fibrillation’ (D2AF) study will determine the yield of an intensive case-finding strategy and the diagnostic accuracy of three index tests to diagnose atrial fibrillation in a primary care setting. Trial registration Netherlands Trial Register: NTR4914, registered on the 25 of November 2014.