Summary. Background: Traditionally, patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The results of a few small non-randomized studies suggest that, in selected patients with proven PE, outpatient treatment is potentially feasible and safe. Objective: To evaluate the efficacy and safety of outpatient treatment according to predefined criteria in patients with acute PE. Patients and Methods: A prospective cohort study of patients with objectively proven acute PE was conducted in 12 hospitals in The Netherlands between 2008 and 2010. Patients with acute PE were triaged with the predefined criteria for eligibility for outpatient treatment, with LMWH (nadroparin) followed by vitamin K antagonists. All patients eligible for outpatient treatment were sent home either immediately or within 24 h after PE was objectively diagnosed. Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep vein thrombosis (DVT), major hemorrhage and total mortality during 3 months of follow-up. Results: Of 297 included patients, who all completed the follow-up, six (2.0%; 95% confidence interval
Our aim was to study the safety of outpatient treatment in low risk patients with acute pulmonary embolism compared with inpatient treatment, the current clinical standard.We searched Medline, Web of Science, Cochrane and EMBASE databases and included studies on outpatient treatment of pulmonary embolism. The outcomes were 3-month recurrent venous thromboembolism, major bleeding and all-cause mortality. We identified 13 studies (1657 patients) with outpatients (discharge ,24 h), three studies (256 patients) with early discharge patients (discharged within 72 h) and five studies (383 patients) with inpatients. The pooled incidence of recurrent venous thromboembolism was 1.7% (95% CI 0.92-3.1%) in outpatients, 1.1% (0.22-5.4%) in patients discharged early and 1.2% (0.16-8.1%) in inpatients. The pooled incidence of major bleeding was 0.97% (0.58-1.6%) in outpatients, 0.78% (0.16-3.7%) in early discharge patients and 1.0% (0.39-2.8%) in inpatients. The pooled incidence of mortality was 1.9% (0.79-4.6%) in outpatients, 2.3% (1.1-5.1%) in early discharge patients and 0.74% (0.04-11%) in inpatients.Incidences of recurrent venous thromboembolism, major bleeding and, after correction for malignancies, mortality were comparable between outpatients, patients discharged early and inpatients. We conclude that home treatment or early discharge of selected low-risk patients with pulmonary embolism is as safe as inpatient treatment. @ERSpublications Home treatment or early discharge of selected low-risk patients with pulmonary embolism is as safe as inpatient treatment
LBA-1 Introduction: Patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The most recent guideline of the American College of Chest Physicians on Antithrombotic therapy 2008 reports some small studies on outpatient treatment in patients with pulmonary embolism, which suggest outpatient treatment in selected patients with PE is potentially effective and safe but firm recommendations for clinical practice are lacking. Clinicians urgently need reliable, easy-to-use selection criteria for selection of patients with pulmonary embolism eligible for outpatient treatment. Objective: To evaluate the efficacy and safety of outpatient treatment according to predefined criteria (Hestia criteria) in patients with acute PE. Patients and Methods: Open-label, single-arm, multicenter clinical trial of patients with objectively proven acute pulmonary embolism, conducted in twelve hospitals in the Netherlands from 2008 to 2010. Follow-up was completed in September 2010. Patients with acute PE were triaged with the predefined Hestia criteria for eligibility for outpatient treatment starting with therapeutic weight adjusted doses of LMWH (Nadroparin), followed by vitamin K antagonists. All patients eligible for outpatient treatment according to the Hestia criteria, were sent home either immediately or within 24 hours after PE was objectively diagnosed. Outcome: Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep venous thrombosis (DVT), major haemorrhage and total mortality during initial LMWH treatment and 3 months follow up. We considered outpatient treatment to be effective if the upper limit of the 95% confidence interval of the incidence of recurrent VTE would not exceed 7%. Results: Of 297 included patients, who all completed follow-up, 6 patients (2.0%; 95% confidence interval [CI], 0.8–4.3) had recurrent VTE (5 PE (1.7%), 1 DVT (0.3 %)). Three patients (1.0%, 95% CI 0.2–2.9) died during three months follow-up, but none as a result of fatal PE. One patient died of fatal intracerebral haemorrhage, the other two patients died of progressive malignancy. In addition to the patient with intracranial bleeding, one other patient had a major bleeding event (0.7 %, 95% CI 0.08%-2.4%). Conclusion: Outpatient anticoagulant treatment is effective and safe for patients with pulmonary embolism who have been selected with the Hestia criteria. (Dutch Trial Register NTR1319). Disclosures: Huisman: GSK: Research Funding; Actelion: Research Funding; Bayer: Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Pfizer: Speakers Bureau.
Outpatient treatment of patients with PE selected on the basis of the Hestia criteria alone was associated with a low risk of adverse events. Given the low number of patients with elevated NT-proBNP levels, this trial was unable to draw definite conclusions regarding the incremental value of NT-proBNP testing in patients who fulfill the Hestia criteria. Clinical trial registered with www.trialregister.nl/trialreg/admin/rctview.asp?TC=2603 (NTR2603).
A number of studies have linked chronic exposure to infectious agents such as Helicobacter pylori, Chlamydia pneumoniae, and herpes viruses to coronary artery disease and stroke (Wimmer MLJ, et al [Stroke 1996;27:2207-10] and Ridker PM et al [Circulation 1998;98: 2796-2799) with atherosclerosis. It has been thought that chronic infections may lead to an inflammatory process through remote signaling of inflammatory mediators that ultimately begin the process of atherosclerosis. The authors postulate that it is more likely that an aggregate of infectious burden, rather than a single infection, would lead to such a proinflammatory state.This study measured antibody titers to common infectious microorganisms (Chlamydia pneumoniae, Helicobacter pylori, cytomegalovirus, and herpes viruses 1 and 2) in community participants who were stroke free. A weighted index of infectious burden was then calculated based on Cox models derived from the association of each infection with stroke risk. Maximum carotid plaque thickness was then determined with highresolution carotid artery duplex scanning. The association between infectious burden and maximum carotid plaque thickening after adjustment for other risk factors was determined using weighted least squares regression.Serologic results for all five infectious organisms were available for 861 participants (mean age, 67.2 Ϯ 9.6 years) in whom maximum carotid plaque thickness measurements were also available. The infectious burden index was a mean of 1.0 Ϯ 0.35 (median, 1.08), and 52% of the participants had detectible plaque (mean, 0.90 Ϯ 1.04 mm). Infectious burden was associated with maximum carotid plaque thickness (adjusted increase in maximum carotid plaque thickness 0.09 mm; 95% confidence interval, 0.03-0.15 mm per standard deviation increase of infectious burden).Comment: An implication of the study is that infectious burden may be a modifiable risk of atherosclerosis and that measurement of carotid plaque thickness may provide a way to assess the effects of an anti-infective strategy. A weakness of the study is that serologic measurements of infection and carotid plaque thickness were determined at only a single time. Temporal relationships between carotid plaque thickness and infectious burden cannot be determined from these data. Another problem with the infectious etiology of atherosclerosis theory is that clinical trials of antibiotic therapy for infectious agents thought to be associated with atherosclerosis have not been shown to reduce vascular risk (O'Connor CM, et al [JAMA 2003;2901: 1459 and Cameron CP, et al [N Engl J Med 2005;352:1646-54]). Limb-Shaking Transient Ischaemic Attacks in Patients WithInternal Carotid Artery Occlusion: A Case-Control Study Persoon S, Kappelle LJ, Klijn CJM. Brain 2010;133:915-22.
Summary. Background: There has been debate over how patients with pulmonary embolism (PE) can be safely selected for outpatient treatment. Objectives: To compare the Hestia criteria with the European Society of Cardiology (ESC) criteria for selecting low-risk patients with PE for outpatient treatment. Methods: From 2008 to 2010, 496 patients with acute, symptomatic PE were screened and 275 treated at home and 221 treated in the hospital according to the Hestia Study protocol. The Hestia criteria were used to select patients for outpatient treatment. Right and left ventricular (RV and LV) diameters were measured on computed tomography images. RV dysfunction was defined as an RV/LV ratio > 1.0. Patients were classified according to the ESC criteria into low, intermediate and high-risk groups, based on blood pressure and RV dysfunction. During 3 months follow-up adverse events were scored. Results: Adverse events occurred in 22 patients (4.5%) treated in the hospital vs. none of the patients treated at home (P < 0.001). Sensitivity and negative predictive value for adverse outcome were 100% for the Hestia criteria and 96% and 99% for the ESC criteria, respectively. Of the patients treated at home according to the Hestia criteria, 35% were normotensive but had RV dysfunction and were classified as intermediate risk according to the ESC criteria. No adverse events happened in these patients treated at home. Conclusions: Clinical criteria, such as the Hestia criteria, could be helpful in selecting patients, including those with RV dysfunction who have a low risk of adverse clinical outcome and could be candidates for outpatient treatment.
We investigated whether the clinical criteria used in the Hestia study for selection of pulmonary embolism (PE) patients for outpatient treatment could discriminate PE patients with high and low risk for adverse clinical outcome.We performed a cohort study with PE patients who were triaged with 11 criteria for outpatient treatment. Patients not eligible for outpatient treatment were treated in hospital. Study outcomes were recurrent venous thromboembolism, major bleeding and all-cause mortality during 3 months.In total, 530 patients were included, of which 297 were treated at home. In the outpatient group, six patients (2.0%, 95% CI 0.7-4.3%) had recurrent venous thromboembolism versus nine inpatients (3.9%, 95% CI 1.9-7.0%). Three patients (1.0%, 95% CI 0.2-2.9) died during the 3-months follow-up in the outpatient group versus 22 patients (9.6%, 95% CI 6.3-14) in the in-patient group (p,0.05). None of the outpatients died as a result of fatal PE versus five (2.2%) in-patients (p,0.05). In the outpatient group, 0.7% (95% CI 0.08-2.4) had major bleeding events versus 4.8% (95% CI 2.4-8.4) of in-patients (p,0.05).This study showed that the Hestia criteria can discriminate PE patients with low risk from patients with high risk for adverse clinical outcome. The low-risk patients can safely be treated at home.
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