Outpatient treatment was noninferior to inpatient treatment for preventing recurrent VTE in low-risk patients with acute PE

2011 ◽  
Vol 155 (8) ◽  
pp. JC4
Author(s):  
Shannon M. Bates ◽  
Gordon H. Guyatt
Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5779-5779
Author(s):  
Kavita Agrawal ◽  
Nirav Agrawal ◽  
Harsha Adnani ◽  
Anjali Kakwani

OBJECTIVE: Several randomized controlled trials and meta-analysis has proven safety and efficacy of outpatient based treatment in appropriately selected low-risk patients with pulmonary embolism (PE). Despite the fact that outpatient treatment has been proven safe, prior studies have shown that it is not commonly practiced. Our current multi-center study focuses on identifying practices of outpatient versus inpatient treatment of low risk PE patients in two community hospitals between 2018-2019. METHODS: A retrospective chart review of the patients in two community hospitals with the principal discharge diagnosis of pulmonary embolism aged 18 years or older was conducted. The study period included February 2018 to February 2019. The high risk patients defined as simplified pulmonary embolism severity index (PESI) score of 1 or above were excluded from the study. Low risk patients were defined as with a simplified PESI score of 0. Criteria were established to determine the appropriateness of inpatient admission for low risk patients with PE. The group of low risk patients with thrombocytopenia (platelets less than 70,000/mm3), glomerular filtration rate (GFR) of less than 30 ml/ minute, international normalized ratio (INR) greater than 1.5, pregnancy, active bleeding as documented in the medical records, total bilirubin greater than 3.0 mg/dl, extreme obesity (weight greater than 150 kg), diagnosis of acute PE while on oral anticoagulation, requiring narcotics for chest pain, need for supplemental oxygen , poor social support or presence of concomitant extensive deep vein thrombosis were deemed appropriate for inpatient treatment. The patients without these baseline characteristics were considered appropriate for outpatient treatment. RESULTS: The cohort comprised of 442 patients in two community hospitals. Among these, 172 patients had a simplified PESI score of 1 or above and were excluded from the study. The remaining 270 patients had a simplified PESI score of 0 and were considered low risk. Based on the study criteria, 54% (145 patients out of 270) of the low risk patients were deemed appropriate for outpatient treatment. Out of these, only 16% (23 patients out of 145) were treated at home. The remaining 84% (122 patients out of 145) of the low risk PE patients considered safe for outpatient treatment were actually treated as inpatient. The mean length of hospital stay for this group of patients was 3 days. Anti-coagulation therapy for those treated on outpatient basis was novel oral anticoagulants in 79% (18 patients out of 23) and low molecular weight heparin or warfarin in 21% (5 patients out of 23). CONCLUSION: Our study demonstrates that majority of low risk PE patients deemed appropriate for outpatient based treatment are treated on inpatient basis. This study shows that there is a need to implement interventions to improve practices of outpatient management of appropriately selected low-risk PE patients. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. LBA-1-LBA-1
Author(s):  
Wendy Zondag ◽  
Inge Mos ◽  
Dina Creemers ◽  
Lidia Hoogerbrugge ◽  
Olaf Dekkers ◽  
...  

Abstract Abstract 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.


2008 ◽  
Vol 100 (05) ◽  
pp. 756-761 ◽  
Author(s):  
Muhammad Janjua ◽  
Aaref Badshah ◽  
Fadi Matta ◽  
Liviu G. Danescu ◽  
Abdo Y. Yaekoub ◽  
...  

SummaryThe purpose of this systematic review is to test the hypothesis that carefully selected low-risk patients with acute pulmonary embolism (PE) can safely be treated entirely as outpatients or after early hospital discharge.Included articles were required to describe inclusion or exclusion criteria and outcome of patients treated for PE.Early hospital discharge was defined as an average hospital stay ≤3 days.Six investigations included patients with PE who were treated entirely as outpatients; two investigations included patients with PE who were treated after early discharge. All investigations included only low-risk patients or patients with small or medium sized PE. Outcome after 3-46 months in patients treated entirely as outpatients showed recurrent PE in 0% to 6.2% of patients, major bleeding in 0% to 2.8% with one death from an intracerebral bleed. Definite death from PE did not occur, but there was one possible death from PE. Outcome in three months in patients treated after early discharge showed no instances of recurrent PE. Major bleeding occurred in 0% to 3.7% of patients.There were no deaths from PE, but there was one death from bleeding. In conclusion, outpatient therapy of acute PE is probably safe in low-risk,carefully selected compliant patients who have access to outpatient care if necessary. Such outpatient treatment would be cost-effective.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2305-2305
Author(s):  
Thomas L. Ortel ◽  
Michele Beckman ◽  
W Craig Hooper ◽  
Deborah A Lewis ◽  
Jen-Tsan A. Chi ◽  
...  

Abstract Abstract 2305 Background. Recurrent venous thromboembolism (VTE) occurs in ∼30% of patients with spontaneous VTE after completion of a standard course of anticoagulant therapy. D-dimer levels and selected clinical parameters have been used to identify patients at low risk for recurrent VTE, who may safely discontinue antithrombotic therapy. We have used gene expression profiles to distinguish patients with a single VTE from patients with recurrent VTE. The purpose of this study was to extend this initial report and identify unique gene expression patterns from whole blood that correlate with different risk profiles for VTE recurrence. Methods. Patients with ≥1 prior VTE, with the first event occurring at age 18 years or older and >3 months from the most recent event were recruited for this study. Patients were allocated into 4 groups: (1) ‘low-risk’ patients had sustained ≥1 provoked VTE; (2) ‘moderate-risk’ patients had sustained 1 unprovoked VTE (with or without provoked VTE); (3) ‘high-risk’ patients had sustained ≥2 unprovoked VTE and had no evidence for antiphospholipid antibodies; and (4) antiphospholipid syndrome (APS) patients met established consensus criteria for APS. A similar number of individuals with no prior history of VTE were enrolled as a control population. Citrated plasma, serum and PAXgene RNA tubes were collected, processed and stored at −80°C until shipped to the CDC for analysis. Antiphospholipid testing was performed on all participants to confirm correct group distribution. Total RNA was isolated from whole blood drawn into PAXgene tubes. Following sample labeling and normalization, cRNA samples were hybridized to Illumina HT-12 Beadchips to assay whole genome gene expression with over 47,000 probes against human transcripts. Two hundred and twenty six unique samples passed initial quality control measures. Quality assessment of raw data was done using GenomeStudio. The raw data files were converted to a text file using the IlluminaExpression FileCreator in GenePattern and then log transformed, normalized and median-centered using Cluster. Both unsupervised (hierarchical clustering using Cluster) and supervised analyses (SAM) were used to identify genes that were differentially expressed between the groups. GATHER was used to help understand the biological processes and gene ontology of the gene lists generated by Cluster and SAM. Results. A total of 226 participants were enrolled into the study. Characteristics of the patient groups are summarized in the Table. Demographically, the groups were similar except that patients in the high-risk group tended to be older and were more likely male. The number of events per patient, and the proportion on anticoagulant therapy, increased with the risk group. Antiphospholipid antibodies were detected in several patients in each of the 3 non-APS VTE patient groups, but in most cases this was a single test positive; antiphospholipid antibodies were present in the majority of patients with APS, typically with more than one test positive (37 of 45 with complete testing, 82%). Preliminary analysis of the gene expression profiles using an unsupervised clustering by gene on the high-risk and low-risk groups identified multiple genes that distinguished the two groups, including 18 immune response genes identified by GATHER. These two patient groups were also distinguished by SAM analysis, and multiple genes in the MAPK signaling pathway that separated the two groups were identified by the KEGG pathways in GATHER. Additional analyses are being performed on all of the groups. Conclusions. Whole blood gene expression profiling can be used to develop profiles that distinguish patients with VTE who differ based on their risk of recurrent events. Individual genes identified in these profiles may provide biological insights into the molecular basis for recurrent VTE. Disclosures: Heit: Daiichi Sankyo: Honoraria; Ortho-McNeil Janssen: Honoraria; Covidien: Honoraria. Manco-Johnson:Octapharma AG: Consultancy; Bayer: Research Funding.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F A Klok ◽  
E Presles ◽  
C Tromeur ◽  
S Barco ◽  
S V Konstantinides ◽  
...  

Abstract Introduction VTE-BLEED is a validated score for identification of patients at a 3 to 5-fold increased risk of major bleeding during extended anticoagulation for venous thromboembolism (VTE; table 1). It is unknown whether VTE-BLEED high-risk patients also have an increased risk for recurrent VTE, which would limit the potential usefulness of the score. Methods This was a post-hoc analysis of the randomised double-blind placebo-controlled PADIS-PE trial, in which patients with a first unprovoked pulmonary embolism (PE) initially treated for 6 months were randomised to receive an additional 18-month of warfarin versus placebo. Primary outcome of the current analysis was recurrent VTE during 2-year follow-up after anticoagulant discontinuation, i.e. after the initial 6-month treatment in the placebo arm and after 24 months of anticoagulation in the active treatment arm. This rate, adjusted on study treatment allocation, was compared between patients in the high- versus low-risk VTE-BLEED group. Results In complete case analysis (n=308; 82.4% of total population), 89 (28.9%) patients were classified as VTE-BLEED high risk. A total of 44 VTE events occurred after anticoagulant discontinuation during 668 patient-years. The cumulative incidence of recurrent VTE was 16.4% (95% CI 10.0–26.1%; 14 events) and 14.6% (95% CI 10.4–20.3%; 30 events) in the high-risk and low-risk VTE-BLEED groups, respectively, for an adjusted Hazard Ratio of 1.16 (95% CI 0.62–2.19; Figure 1). Figure 1 Conclusion In this study, patients with unprovoked PE classified at high risk of major bleeding by VTE-BLEED did not have a higher incidence of recurrent VTE after cessation of anticoagulant therapy, supporting the potential yield of the score for making management decisions on the optimal duration of anticoagulant therapy.


2020 ◽  
Vol 7 ◽  
Author(s):  
Mike Wenzel ◽  
Marina Deuker ◽  
Maria N. Welte ◽  
Benedikt Hoeh ◽  
Felix Preisser ◽  
...  

Objective: This study aims to evaluate catheter management in acute epididymitis (AE) patients requiring inpatient treatment and risk factors predicting severity of disease.Material and Methods: Patients with diagnosed AE and inpatient treatment between 2004 and 2019 at the University Hospital Frankfurt were analyzed. A risk score, rating severity of AE, including residual urine > 100 ml, fever > 38.0°C, C-reactive protein (CRP) > 5 mg/dl, and white blood count (WBC) > 10/nl was introduced.Results: Of 334 patients, 107 (32%) received a catheter (transurethral (TC): n = 53, 16%, suprapubic (SPC): n = 54, 16%). Catheter patients were older, exhibited more comorbidities, and had higher CRP and WBC compared with the non-catheter group (NC). Median length of stay (LOS) was longer in the catheter group (7 vs. 6 days, p < 0.001), whereas necessity of abscess surgery and recurrent epididymitis did not differ. No differences in those parameters were recorded between TC and SPC. According to our established risk score, 147 (44%) patients exhibited 0–1 (low-risk) and 187 (56%) 2–4 risk factors (high-risk). In the high-risk group, patients received a catheter significantly more often than with low-risk (TC: 22 vs. 9%; SPC: 19 vs. 12%, both p ≤ 0.01). Catheter or high-risk patients exhibited positive urine cultures more frequently than NC or low-risk patients. LOS was comparable between high-risk patients with catheter and low-risk NC patients.Conclusion: Patients with AE who received a catheter at admission were older, multimorbid, and exhibited more severe symptoms of disease compared with the NC patients. A protective effect of catheters might be attributable to patients with adverse risk constellations or high burden of comorbidities. The introduced risk score indicates a possibility for risk stratification.


2012 ◽  
Vol 129 (6) ◽  
pp. 710-714 ◽  
Author(s):  
Petra M.G. Erkens ◽  
Esteban Gandara ◽  
Philip S. Wells ◽  
Alex Yi-Hao Shen ◽  
Gauruv Bose ◽  
...  

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3416-3416
Author(s):  
Sebastian Werth ◽  
Virginia Kamvissi ◽  
Eberhard Kuhlisch ◽  
Jan Beyer-Westendorf

Abstract Abstract 3416 Introduction: Therapy of pulmonary embolism (PE) today is based on risk stratification scores. Outpatient treatment for selected low-risk patients seems feasible, but data are derived from selected patient cohorts. Little is known about risk factors or clinical outcomes in unselected cohorts. In our hospital, outpatient treatment of low-risk-PE has been standard for nearly ten years. We retrospectively analyzed risk profile and 6-month-outcome of in-hospital or outpatient treatment in patients with community-aquired acute PE (CA-PE). Objectives: To evaluate the proportion of patients with outpatient or early discharge treatment of CA-PE, to evaluate the value of HESTIA score to discriminate between low and high risk patients and to assess 6-month outcome. Methods: Retrospective evaluation of all cases with CA-PE. Inclusion criteria: 1) PE symptoms as reason for hospitalization (exclusion of hospital-aquired PE); 2) symptomatic and confirmed PE (CT or V/Q scan). Evaluation of patient characteristics, hemodynamic and echocardiographic parameters and lab values and group comparisons between outpatient treatment (OT; hospitalized < 24h), early discharge (ED; hospitalized < 72h) and in-hospital treatment (HT) were performed. Result: Between 2000 and 2010, 439 patients were diagnosed with acute CA-PE (table 1). About 25% of patients could be treated as outpatients (n=49; 11.2%) or early discharged (n=63; 14.4%). Patients with in-hospital treatment of PE were significantly older and had more severe PE. Interestingly, the rate of patients with a positive history of VTE was highest in the group of outpatients (45%), followed by the early-discharge group (32%), indicating that these patients are diagnosed at an earlier stage with less severe PE. In contrast, only 25% of patients requiring in-hospital treatment of PE had a positive VTE history. Despite the differences in baseline characteristics, outcomes with regard to recurrent VTE, pulmonary hypertension or mortality were not significantly different between outpatients and early discharge patients. In contrast, outcomes of patients with in-hospital treatment was significantly different with higher mortality (0.0% vs. 3.2% vs. 15.8%). Conclusion: Even before ESC and Hestia scores were implemented, physicians subjective assessment based on hemodynamic, echocardiographic and laboratory parameters clearly discriminated between low, intermediate and high risk PE patients and allowed for outpatient treatment in low-risk PE in 11% of all PE patients. Early discharge was possible in 14% of all patients, despite higher HESTIA scores and a higher rate of elevated troponin levels, initial oxygen requirement or right heart strain in echocardiography. In contrast, patients requiring in-hospital PE treatment were older, had more severe PE and a high 6-month mortality. Despite a positive Hestia score in many patients, about 25% of all community-aquired PE patients can be safely treated as outpatient or early discharge treatment with low 6-month mortality. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3230-3230
Author(s):  
Cecilia Becattini ◽  
Giancarlo Agnelli ◽  
Aldo P Maggioni ◽  
Francesco Dentali ◽  
Andrea Fabbri ◽  
...  

Abstract Background. New management strategies, risk stratification procedures and treatments have become available over the last years for patients with acute pulmonary embolism (PE), leading to changes in clinical practice and potentially influencing patient's course and outcome. Methods: The COntemporary management of Pulmonary Embolism (COPE) is an academical prospective, non-interventional, multicentre study in patients with confirmed acute symptomatic PE. In-hospital and 30-day mortality were the co-primary study outcomes. At first evaluation, patients were categorized at low-risk (simplified PESI [sPESI]=0), intermediate-risk (further classified based presence/absence of increased levels and right ventricle dysfunction [RVD] at echocardiography) and high-risk (shock or cardiac arrest). Results. Among 5213 study patients, PE was confirmed by computed tomography in 96.3% and at least one test for risk stratification was obtained in more than 80% (81% echocardiography, 83% troponin, 56% brain natriuretic peptide/NT-pro BNP). Among 4885 patients entering the Emergency Department for acute PE, 1.2% were managed as outpatients and 5.8% by short-observation. In-hospital, 289 patients underwent reperfusion (5.5%); at discharge, 6.7% received a vitamin K antagonist and 75.6% a direct oral anticoagulant. Median duration of hospitalization was 7 days (IQR 5-12 days). Overall in-hospital mortality was 3.4% (49% due to PE, 16% cancer and 4.5% major bleeding) and 30-day mortality 4.8% (36% PE, 28% cancer and 4% major bleeding). In-hospital major bleeding was 2.6%. Death at 30 days occurred in 22.6% of 177 high-risk patients, in 6% of the 3281 intermediate-risk and in 0.5% of 1702 low-risk patients. Time to death at 30 days in patients at low, intermediate and high risk for death is reported in the Figure. Conclusions: COPE is the largest ever cohort of patients with acute PE. In this contemporary scenario, the majority of patients received CT for diagnosis, at least one test for risk stratification and direct oral anticoagulants as long-term treatment. Short term death remains not negligible in patients with high and intermediate-risk PE. Figure 1 Figure 1. Disclosures Becattini: Bristol Myers Squibb: Honoraria; Daiichi Sankyo: Honoraria; Bayer HealthCare: Honoraria. Agnelli: Bristol Myers Squibb: Honoraria; Pfizer: Honoraria; Daiichi Sankyo: Honoraria; Bayer HealthCare: Honoraria. Dentali: Daiichi Sankyo: Honoraria; Bayer: Honoraria; Sanofi: Honoraria; Pfizer: Honoraria; Bristol-Myers Squibb: Honoraria; Novartis: Honoraria; Boehringer: Honoraria; Alfa Sigma: Honoraria.


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