Validated diagnostic algorithms in patients with suspected pulmonary embolism are often not used correctly or only benefit subgroups of patients, leading to overuse of computed tomography pulmonary ...angiography (CTPA). The YEARS clinical decision rule that incorporates differential D-dimer cutoff values at presentation, has been developed to be fast, to be compatible with clinical practice, and to reduce the number of CTPA investigations in all age groups. We aimed to prospectively evaluate this novel and simplified diagnostic algorithm for suspected acute pulmonary embolism.
We did a prospective, multicentre, cohort study in 12 hospitals in the Netherlands, including consecutive patients with suspected pulmonary embolism between Oct 5, 2013, to July 9, 2015. Patients were managed by simultaneous assessment of the YEARS clinical decision rule, consisting of three items (clinical signs of deep vein thrombosis, haemoptysis, and whether pulmonary embolism is the most likely diagnosis), and D-dimer concentrations. In patients without YEARS items and D-dimer less than 1000 ng/mL, or in patients with one or more YEARS items and D-dimer less than 500 ng/mL, pulmonary embolism was considered excluded. All other patients had CTPA. The primary outcome was the number of independently adjudicated events of venous thromboembolism during 3 months of follow-up after pulmonary embolism was excluded, and the secondary outcome was the number of required CTPA compared with the Wells' diagnostic algorithm. For the primary outcome regarding the safety of the diagnostic strategy, we used a per-protocol approach. For the secondary outcome regarding the efficiency of the diagnostic strategy, we used an intention-to-diagnose approach. This trial is registered with the Netherlands Trial Registry, number NTR4193.
3616 consecutive patients with clinically suspected pulmonary embolism were screened, of whom 151 (4%) were excluded. The remaining 3465 patients were assessed of whom 456 (13%) were diagnosed with pulmonary embolism at baseline. Of the 2946 patients (85%) in whom pulmonary embolism was ruled out at baseline and remained untreated, 18 patients were diagnosed with symptomatic venous thromboembolism during 3-month follow-up (0·61%, 95% CI 0·36–0·96) of whom six had fatal pulmonary embolism (0·20%, 0·07–0·44). CTPA was not indicated in 1651 (48%) patients with the YEARS algorithm compared with 1174 (34%) patients, if Wells' rule and fixed D-dimer threshold of less than 500 ng/mL would have been applied, a difference of 14% (95% CI 12–16).
In our study pulmonary embolism was safely excluded by the YEARS diagnostic algorithm in patients with suspected pulmonary embolism. The main advantage of the YEARS algorithm in our patients is the absolute 14% decrease of CTPA examinations in all ages and across several relevant subgroups.
This study was supported by unrestricted grants from the participating hospitals.
The HAS-BLED score enables a risk estimate of major bleeds in patients with atrial fibrillation on vitamin K-antagonists (VKA) treatment, but has not been validated for patients with venous ...thromboembolism (VTE). We analyzed whether the HAS-BLED score accurately identifies patients at high risk of major bleeds during VKA treatment for acute VTE.
Medical records of 537 patients with acute VTE (primary diagnosis pulmonary embolism in 223, deep vein thrombosis in 314) starting VKA treatment between 2006-2007 were searched for items on the HAS-BLED score and the occurrence of major bleeds during the first 180 days of follow-up. The hazard ratio (HR) for the occurrence of major bleeds comparing non-high with high-risk patients as defined by a HAS-BLED score ≥ 3 points was calculated using Cox-regression analysis.
Major bleeds occurred in 11/537 patients (2.0%, 5.2/100 person years, 95% CI 2.8-9.2). Cumulative incidences of major bleeds were 1.3% (95% CI 0.1-2.5) in the non-high (HAS-BLED < 3) and 9.6% (95%CI 2.2-17.0) in the high-risk group (HAS-BLED ≥ 3), (p <0.0001 by Log-Rank test), with a HR of 8.7 (95% CI 2.7-28.4). Of the items in the HAS-BLED score, abnormal renal function (HR 10.8, 95% CI 1.9-61.7) and a history of bleeding events (HR 10.4, 95% CI 2.5-42.5) were independent predictors of major bleeds during follow-up.
Acute VTE patients with a HAS-BLED score ≥ 3 points are at increased risk of major bleeding. These results warrant for correction of the potentially reversible risk factors for major bleeding and careful International Normalized Ratio monitoring in acute VTE patients with a high HAS-BLED score.
Accurate diagnostic assessment of suspected ipsilateral recurrent deep vein thrombosis (DVT) is a major clinical challenge because differentiating between acute recurrent thrombosis and residual ...thrombosis is difficult with compression ultrasonography (CUS). We evaluated noninvasive magnetic resonance direct thrombus imaging (MRDTI) in a prospective study of 39 patients with symptomatic recurrent ipsilateral DVT (incompressibility of a different proximal venous segment than at the prior DVT) and 42 asymptomatic patients with at least 6-month-old chronic residual thrombi and normal D-dimer levels. All patients were subjected to MRDTI. MRDTI images were judged by 2 independent radiologists blinded for the presence of acute DVT and a third in case of disagreement. The sensitivity, specificity, and interobserver reliability of MRDTI were determined. MRDTI demonstrated acute recurrent ipsilateral DVT in 37 of 39 patients and was normal in all 42 patients without symptomatic recurrent disease for a sensitivity of 95% (95% CI, 83% to 99%) and a specificity of 100% (95% CI, 92% to 100%). Interobserver agreement was excellent (κ = 0.98). MRDTI images were adequate for interpretation in 95% of the cases. MRDTI is a sensitive and reproducible method for distinguishing acute ipsilateral recurrent DVT from 6-month-old chronic residual thrombi in the leg veins.
•Diagnostic management of ipsilateral recurrent DVT of the leg is complicated because residual DVT is common and mimics acute DVT on CUS.•MRDTI is able to reproducibly distinguish acute ipsilateral recurrent DVT from 6-month-old chronic residual thrombi in the leg veins.
Whereas accumulating studies on patients with coronavirus disease 2019 (COVID‐19) report high incidences of thrombotic complications, large studies on clinically relevant thrombosis in patients with ...other respiratory tract infections are lacking. How this high risk in COVID‐19 patients compares to those observed in hospitalized patients with other viral pneumonias such as influenza is unknown.
To assess the incidence of venous and arterial thrombotic complications in hospitalized patients with influenza as opposed to that observed in hospitalized patients with COVID‐19.
This was a retrospective cohort study; we used data from Statistics Netherlands (study period: 2018) on thrombotic complications in hospitalized patients with influenza. In parallel, we assessed the cumulative incidence of thrombotic complications—adjusted for competing risk of death—in patients with COVID‐19 in three Dutch hospitals (February 24 to April 26, 2020).
Of the 13 217 hospitalized patients with influenza, 437 (3.3%) were diagnosed with thrombotic complications, versus 66 (11%) of the 579 hospitalized patients with COVID‐19. The 30‐day cumulative incidence of any thrombotic complication in influenza was 11% (95% confidence interval CI, 9.4–12) versus 25% (95% CI, 18–32) in COVID‐19. For venous thrombotic (VTC) complications and arterial thrombotic complications alone, these numbers were, respectively, 3.6% (95% CI, 2.7–4.6) and 7.5% (95% CI, 6.3–8.8) in influenza versus 23% (95% CI, 16–29) and 4.4% (95% CI, 1.9–8.8) in COVID‐19.
The incidence of thrombotic complications in hospitalized patients with influenza was lower than in hospitalized patients with COVID‐19. This difference was mainly driven by a high risk of VTC complications in the patients with COVID‐19 admitted to the Intensive Care Unit. Remarkably, patients with influenza were more often diagnosed with arterial thrombotic complications.
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Essential information regarding efficacy and safety of vitamin K-antagonists (VKA) treatment for atrial fibrillation (AF) in non-dialysis dependent chronic kidney disease (CKD) is still lacking in ...current literature. The aim of our study was to compare the risks of stroke or transient ischemic attack (TIA) and major bleeds between patients without CKD (eGFR >60 ml/min), and those with moderate (eGFR 30-60 ml/min), or severe non-dialysis dependent CKD (eGFR <30 ml/min).
We included 300 patients without CKD, 294 with moderate, and 130 with severe non-dialysis dependent CKD, who were matched for age and sex. Uni- and multivariate Cox regression analyses were performed reporting hazard ratios (HRs) for the endpoint of stroke or TIA and the endpoint of major bleeds as crude values and adjusted for comorbidity and platelet-inhibitor use.
Overall, 6.2% (45/724, 1.7/100 patient years) of patients developed stroke or TIA and 15.6% (113/724, 4.8/100 patient years) a major bleeding event. Patients with severe CKD were at high risk of stroke or TIA and major bleeds during VKA treatment compared with those without renal impairment, HR 2.75 (95%CI 1.25-6.05) and 1.66 (95%CI 0.97-2.86), or with moderate CKD, HR 3.93(1.71-9.00) and 1.86 (95%CI 1.08-3.21), respectively. These risks were similar for patients without and with moderate CKD. Importantly, both less time spent within therapeutic range and high INR-variability were associated with increased risks of stroke or TIA and major bleeds in severe CKD patients.
VKA treatment for AF in patients with severe CKD has a poor safety and efficacy profile, likely related to suboptimal anticoagulation control. Our study findings stress the need for better tailored individualised anticoagulant treatment approaches for patients with AF and severe CKD.
Several noninvasive methods are available to investigate the severity of extracoronary atherosclerotic disease. No population-based study has yet examined whether differences exist between these ...measures with regard to their predictive value for myocardial infarction (MI) or whether a given measure of atherosclerosis has predictive value independently of the other measures.
At the baseline (1990-1993) examination of the Rotterdam Study, a population-based cohort study among subjects age > or =55 years, carotid plaques and intima-media thickness (IMT) were measured by ultrasound, abdominal aortic atherosclerosis by x-ray, and lower-extremity atherosclerosis by computation of the ankle-arm index. In the present study, 6389 subjects were included; 258 cases of incident MI occurred before January 1, 2000. All 4 measures of atherosclerosis were good predictors of MI independently of traditional cardiovascular risk factors. Hazard ratios were equally high for carotid plaques (1.83 1.27 to 2.62, severe versus no atherosclerosis), carotid IMT (1.95 1.19 to 3.19), and aortic atherosclerosis (1.94 1.30 to 2.90) and slightly lower for lower-extremity atherosclerosis (1.59 1.05 to 2.39), although differences were small. The hazard ratio for MI for subjects with severe atherosclerosis according to a composite atherosclerosis score was 2.77 (1.70 to 4.52) compared with subjects with no atherosclerosis. The predictive value of MI for a given measure of atherosclerosis was independent of the other atherosclerosis measures.
Noninvasive measures of extracoronary atherosclerosis are strong predictors of MI. The relatively crude measures directly assessing plaques in the carotid artery and abdominal aorta predict MI equally well as the more precisely measured carotid IMT.
Studies have shown the safety of home treatment of patients with pulmonary embolism (PE) at low risk of adverse events. Management studies focusing on home treatment have suggested that 30% to 55% of ...acute PE patients could be treated at home, based on the HESTIA criteria, but data from day-to-day clinical practice are largely unavailable.
To determine current practice patterns of home treatment of acute PE in the Netherlands.
We performed a post-hoc analysis of the YEARS study. The main outcomes were the proportion of patients who were discharged <24 h and reasons for admission if treated in hospital. Further, we compared the 3-month incidence of PE-related unscheduled readmissions between patients treated at home and in hospital.
Of the 404 outpatients with PE included in this post-hoc analysis of the YEARS study, 184 (46%) were treated at home. The median duration of admission of the hospitalized patients was 3.0 days. The rate of PE-related readmissions of patients treated at home was 9.7% versus 8.6% for hospitalized patients (crude hazard ratio 1.1 (95% CI 0.57–2.1)). The 3-month incidence of any adverse event was 3.8% in those treated at home (2 recurrent VTE, 3 major bleedings and two deaths) compared to 10% in the hospitalized patients (3 recurrent VTE, 6 major bleedings and fourteen deaths).
In the YEARS study, 46% of patients with PE were treated at home with low incidence of adverse events. PE-related readmission rates were not different between patients treated at home or in hospital.
•Several studies have shown the safety and feasibility of home treatment in pulmonary embolism (PE) patients.•Detailed information of home treatment in daily clinical practice is largely unavailable.•In the YEARS study, 46% of patients with PE were treated at home with low incidence of adverse events.•PE-related readmission rates were not different between patients treated at home or in hospital.
Abstract Introduction The Wells rule is the recommended first step in the work-up of suspected deep vein thrombosis (DVT). However, it is often incorrectly used leading to an excessive number of ...diagnostic tests used in daily practice and diagnostic failures. A simpler objective risk stratification tool may improve adherence to the guidelines. We evaluated the diagnostic performance of the I-DVT score, which consists of four easy assessable variables: I mmobilization, > 3 cm D ifference in calve circumferences, prior V enous thromboembolism (VTE) and active malignant T umor. Methods We performed an observational study in 617 consecutive patients with suspected DVT. All patients were managed according to the recommended algorithm starting with the Wells rule followed by D-dimer test and/or compression ultrasonography (CUS). The I-DVT score was prospectively calculated at baseline and evaluated post-hoc. Results The DVT prevalence was 36%. DVT could be excluded in 13% of patients without CUS by the Wells rule and a normal D-dimer test, with a 3-month VTE incidence of 1.2% (95%CI 0.03–6.5%). Using the I-DVT score, DVT would have been excluded in 9.1% of patients without additional CUS, with a 3-month VTE incidence of 0% (95%CI 0.0–6.4%). The area under the ROC curve (AUC) was 0.70 (95%CI 0.66–0.74) and 0.65 (95%CI 0.61–0.70) for the Wells rule and I-DVT score respectively (difference 0.049, 95%CI − 0.01–0.11; p = 0.13). Conclusions The simple I-DVT score and Wells rule have comparable diagnostic accuracy. It's safety, efficiency and associated potential improvement of guideline adherence in clinical practice has to be further evaluated in a prospective management study.
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