The diagnosis of recurrent ipsilateral deep vein thrombosis (DVT) is challenging, because persistent intravascular abnormalities after previous DVT often hinder a diagnosis by compression... Show moreThe diagnosis of recurrent ipsilateral deep vein thrombosis (DVT) is challenging, because persistent intravascular abnormalities after previous DVT often hinder a diagnosis by compression ultrasonography. Magnetic resonance direct thrombus imaging (MRDTI), a technique without intravenous contrast and with a 10-minute acquisition time, has been shown to accurately distinguish acute recurrent DVT from chronic thrombotic remains. We have evaluated the safety of MRDTI as the sole test for excluding recurrent ipsilateral DVT. The Theia Study was a prospective, international, multicenter, diagnostic management study involving patients with clinically suspected acute recurrent ipsilateral DVT. Treatment of the patients was managed according to the result of the MRDTI, performed within 24 hours of study inclusion. The primary outcome was the 3-month incidence of venous thromboembolism (VTE) after a MRDTI negative for DVT. The secondary outcome was the interobserver agreement on the MRDTI readings. An independent committee adjudicated all end points. Three hundred five patients were included. The baseline prevalence of recurrent DVT was 38%; superficial thrombophlebitis was diagnosed in 4.6%. The primary outcome occurred in 2 of 119 (1.7%; 95% confidence interval [CI], 0.20-5.9) patients with MRDTI negative for DVT and thrombophlebitis, who were not treated with any anticoagulant during follow-up; neither of these recurrences was fatal. The incidence of recurrent VTE in all patients with MRDTI negative for DVT was 1.1% (95% CI, 0.13%-3.8%). The agreement between initial local and post hoc central reading of the MRDTI images was excellent (κ statistic, 0.91). The incidence of VTE recurrence after negative MRDTI was low, and MRDTI proved to be a feasible and reproducible diagnostic test. This trial was registered at www.clinicaltrials.gov as #NCT02262052. Show less
Wall, S.J. van der; Rein, N. van; Bemt, B. van den; Kruip, M.J.H.A.; Meijer, K.; Boome, L.C.J. te; ... ; Huisman, M.V. 2019
BACKGROUND: The exact prevalence and etiology of exertional dyspnea in the clinical course of acute pulmonary embolism (PE) have not yet been established. METHODS: A large cohort of consecutive... Show moreBACKGROUND: The exact prevalence and etiology of exertional dyspnea in the clinical course of acute pulmonary embolism (PE) have not yet been established. METHODS: A large cohort of consecutive patients diagnosed with acute PE was subjected to a dyspnea questionnaire and invited for cardiopulmonary work-up including the 6-min walk test, spirometry and echocardiography. The prevalence, severity, determinants and underlying diseases of exertional dyspnea were evaluated. RESULTS: Of the registered 877 patients, 259 (30%) had died and 11 (1.3%) were excluded for geographical reasons. From the remaining 607 patients, 217 reported exertional dyspnea (36%; 95% CI 32-40%) 3.6 +/- 1.7 years after the PE. In 76% this dyspnea had developed or worsened after the acute PE. 421 patients completed the cardiopulmonary work-up. Cardiopulmonary comorbidity (OR 12; 95% CI 6.5-20), advanced age (OR 1.02 per year; 95% CI 1.01-1.03), higher BMI (OR 1.06 per kg/m(2); 95% CI 1.01-1.1) and a smoking history (OR 1.6; 95% CI 1.02-2.6) were identified as independent predictors of exertional dyspnea. A pre-defined dyspnea explaining diagnosis could be established in all patients with exertional dyspnea. In only 4 patients, this diagnosis was directly correlated to the acute PE. Increased severity of dyspnea was associated with decreased exercise performance (p < 0.001) and a higher number of dyspnea-related diagnoses (p < 0.001). CONCLUSION: Exertional dyspnea is a frequent symptom in the long term clinical course of acute PE. More severe dyspnea results in decreased exercise capacity and increased burden of cardiopulmonary comorbidity. This dyspnea is likely to be unrelated to the past thromboembolic event in the vast majority of patients. Show less
Abstract BACKGROUND: Studies evaluating the quality of life (QoL) in patients with a history of acute pulmonary embolism (PE) are not available, even though QoL is a key component of outcome of... Show moreAbstract BACKGROUND: Studies evaluating the quality of life (QoL) in patients with a history of acute pulmonary embolism (PE) are not available, even though QoL is a key component of outcome of medical care and a predictor of disease specific prognosis. METHODS: As part of a large follow-up study the Short Form-36 (SF-36) was presented to consecutive patients who had survived one or more episodes of acute PE. The results of all 9 subscales of the SF-36 were compared to sex and age adjusted Dutch population norms. Single and multivariate analyses were performed to identify independent determinants of the quality of life in our study population. RESULTS: The SF-36 was completed by 392 patients. Except for the subscale health change, patients had substantially lower QoL than population norms on all 8 remaining subscales. After multivariate analysis, the time interval between the last thromboembolic episode and study inclusion was inversely related to QoL, and significant determinants of poor QoL were prior PE, age, obesity, active malignancy and cardiopulmonary comorbid conditions. Regression models including all identified significant determinants proved to be quite modest predictors for QoL in the individual patient. Illness cognitions, coping mechanisms and self management behaviour might be additional important indicators of QoL in our study population but remain to be studied. CONCLUSION: We identified several PE- and non-PE related determinants of QoL in patients with a history of acute PE, which is impaired compared to sex and age adjusted population norms. QoL after acute PE should be studied more extensively and added as standard measure to outcome studies. Show less
Klok, F.A.; Bijl, N. van der; Roos, A. de; Kroft, L.J.M.; Huisman, M.V. 2010
