Outpatient Treatment In Patients with Acute Pulmonary Embolism: The Hestia Study

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.

2015 ◽  
Vol 114 (07) ◽  
pp. 26-34 ◽  
Author(s):  
Lucia J. M. Kroft ◽  
Petra M. G. Erkens ◽  
Renée A. Douma ◽  
Inge C. M. Mos ◽  
Gé Jonkers ◽  
...  

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.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3796-3796
Author(s):  
Petra MG Erkens ◽  
Esteban Gandara ◽  
Phil Wells ◽  
Alex Yi-Hao Shen ◽  
Gauruv Bose ◽  
...  

Abstract 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.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2380-2380
Author(s):  
Christina Köhler ◽  
Sebastian Werth ◽  
Luise Tittl ◽  
Jan Beyer-Westendorf

Abstract Background and Objectives In the EINSTEIN PE study rivaroxaban (RX) was found to be as effective as warfarin in the treatment of acute pulmonary embolism (PE) with superior safety. However, study results need to be confirmed in unselected PE patients in daily care. Patients and Methods Using prospectively collected data from a large regional registry of patients treated with novel direct oral anticoagulants (NOAC) in the district of Saxony, Germany, we evaluated the rate of recurrent VTE, other cardiovascular complications and bleeding events in patients receiving rivaroxaban for acute PE. In this ongoing registry, a network of 239 physicians enrols up to 2500 daily care NOAC patients who receive central prospective follow up (FU) by the registry office at day 30 day and quarterly thereafter to collect efficacy and safety data. All outcome events are centrally adjudicated using standard scientific definitions. Results Until July 31th 2013, 2249 patients were enrolled. Of these, 72 patients received RX for acute PE treatment (demographic data in table 1). Registry patients were older than the EINSTEIN PE population (67.3 vs. 55.8 years), 55.6% were female and 23.6% were treated for a recurrent VTE. During follow-up, unplanned rivaroxaban discontinuation rates were low (around 5%; table 1). So far, only one recurrent VTE event occurred (1.7 events per 100 patient years). One patient experienced non-fatal ischaemic stroke within 4 weeks after PE diagnosis (1.7 events per 100 patient years). Bleeding complications were frequent but only 2 major bleeding (non-fatal vaginal bleeds) occurred (3.3 events per 100 patient years). During follow-up three patients died of underlying diseases but none of these deaths were related to VTE or bleeding complications. Conclusion Acute PE treatment with rivaroxaban in daily care is effective, safe and well tolerated with low rates of unplanned treatment discontinuation. Thromboembolic and major bleeding complications are rare and seem to occur predominantly in the early phase of PE treatment. At ASH, updated results from our registry will be presented Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Pfizer: Research Funding, Speakers Bureau; Boehringer Ingelheim: Research Funding, Speakers Bureau; Bayer Healthcare: Research Funding, Speakers Bureau.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Barco ◽  
A Mavromanoli ◽  
F A Klok ◽  
S V Konstantinides

Abstract Background Up to one-third of patients report persisting hemodynamic abnormalities and functional limitation over long-term follow-up after acute pulmonary embolism (PE). Purpose We tested whether a validated algorithm designed to rule-out chronic thromboembolic pulmonary hypertension (CTEPH) after acute PE can be used for identifying patients at lower risk of presenting with persisting symptoms and echocardiographic abnormalities. Methods The multicentre Follow-up of Acute Pulmonary Embolism (FOCUS) cohort study prospectively enrolled 1,100 consecutive patients diagnosed with acute symptomatic PE; two-year follow-up is ongoing. We focused on the scheduled visits for 3- and 12-month follow-up. The rule-out criteria are based on: the absence of ECG signs of right ventricular dysfunction and normal NT-proBNP/BNP values. Echocardiographic abnormalities were defined according to the presence of abnormal parameters indicating an intermediate/high probability of pulmonary hypertension as recommended by the 2015 ESC/ERS Society Guidelines on Pulmonary Hypertension. The presence of functional limitation was defined based on a World Health Organization classification grade ≥3, a Borg dyspnoea index ≥4, or a 6-minute walking distance <300 m. Results We included 323 patients (mean age 61 years, 58% men), of whom 255 have meanwhile completed a one-year follow-up. At 3- and 12-month follow-up, 194 (60%) and 155 (61%) of patients exhibited no abnormal echocardiographic findings or natriuretic peptide levels. The percentage of patients with echocardiographic abnormalities was 20.4% and 18.0%, respectively. The negative predictive value of the score for ruling out the combination of functional limitation and intermediate/high probability of pulmonary hypertension as recommended by the 2015 ESC/ERS Guidelines on Pulmonary Hypertension was 0.96 (95% CI 0.92–0.98) at 3 and 0.97 (0.92–0.99) at 12 months. The corresponding positive predictive values were 0.10 (0.06–0.17) and 0.09 (0.05–0.17), respectively. Conclusions The CTEPH rule-out criteria are capable of excluding functional limitation and evidence of (chronic) pulmonary hypertension 3 and 12 months after the diagnosis of acute PE. Acknowledgement/Funding The sponsor (University Medical Center of the Johannes Gutenberg University, Mainz) has obtained grants from Bayer Vital GmbH and Bayer Pharma AG


2019 ◽  
Vol 25 ◽  
pp. 107602961985303 ◽  
Author(s):  
Belinda Rivera-Lebron ◽  
Michael McDaniel ◽  
Kamran Ahrar ◽  
Abdulah Alrifai ◽  
David M. Dudzinski ◽  
...  

Pulmonary embolism (PE) is a life-threatening condition and a leading cause of morbidity and mortality. There have been many advances in the field of PE in the last few years, requiring a careful assessment of their impact on patient care. However, variations in recommendations by different clinical guidelines, as well as lack of robust clinical trials, make clinical decisions challenging. The Pulmonary Embolism Response Team Consortium is an international association created to advance the diagnosis, treatment, and outcomes of patients with PE. In this consensus practice document, we provide a comprehensive review of the diagnosis, treatment, and follow-up of acute PE, including both clinical data and consensus opinion to provide guidance for clinicians caring for these patients.


2020 ◽  
Vol 4 (2) ◽  
pp. 432-439 ◽  
Author(s):  
Derek Weycker ◽  
Gail DeVecchis Wygant ◽  
Jennifer D. Guo ◽  
Theodore Lee ◽  
Xuemei Luo ◽  
...  

Abstract In the phase 3 trial Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy, apixaban was noninferior to enoxaparin, overlapped and followed by warfarin, in the treatment of venous thromboembolism (VTE) with significantly less bleeding; in a real-world evaluation, risks for bleeding and recurrent VTE were lower with apixaban vs warfarin plus parenteral anticoagulant (PAC) bridge therapy. The present study extends this research by comparing outcomes over time and within selected subgroups. A retrospective observational cohort design and 4 US private health care claims databases were used. Study population included patients who initiated outpatient treatment with apixaban or warfarin (plus PAC bridge therapy) for VTE. Major bleeding, clinically relevant nonmajor (CRNM) bleeding, and recurrent VTE were compared during the 180-day follow-up period, at selected follow-up time points (days 21, 90, 180), and within subgroups (pulmonary embolism [PE] with or without deep vein thrombosis [DVT], DVT only, provoked VTE, unprovoked VTE) using multivariable shared frailty models. Study population consisted of 20 561 apixaban patients and 35 080 warfarin patients; baseline characteristics were comparable. Overall, at selected follow-up time points, and within the aforementioned subgroups, adjusted risks were lower among apixaban vs warfarin patients: major bleeding, by 27% to 39%, CRNM bleeding, by 17% to 28%, and recurrent VTE, by 25% to 39% (all P ≤ .01). In this real-world study of VTE patients, risks of bleeding and recurrent VTE were lower among apixaban (vs warfarin) patients during the 180-day follow-up period, at selected follow-up time points, and within subgroups defined by index VTE episode.


2002 ◽  
Vol 43 (5) ◽  
pp. 486-491 ◽  
Author(s):  
T. Nilsson ◽  
A. Olausson ◽  
H. Johnsson ◽  
U. Nyman ◽  
P. Aspelin

Purpose: To retrospectively evaluate the clinical outcome of non-anticoagulated patients with clinically suspected acute pulmonary embolism (PE) and no symptoms or signs of deep venous thrombosis (DVT) following a negative contrast medium-enhanced spiral CT of the pulmonary arteries (s-CTPA). Material and Methods: During a 24-month period, 739 of 751 patients underwent s-CTPA with acceptable diagnostic quality for clinically suspected acute PE. All patients who had a CT study not positive for PE were followed up with a questionnaire, a telephone interview and review of all medical reports, including autopsies and death certificates for any episodes of venous thromboembolism (VTE) during a 3-month period. Results: PE was diagnosed in 158 patients. Of the remaining 581 patients with a negative s-CTPA, 45 patients were lost to follow-up. 88 patients were excluded because of anticoagulation treatment (cardiac disorder n=32, chronic VTE or acute symptomatic DVT n=31, PE diagnosed at pulmonary angiography n=1, thrombus prophylaxis during diagnostic work-up or other reasons than VTE n=24) and 7 patients undergoing lower extremity venous studies because of symptoms of DVT (all negative). Thus, 441 patients with a negative s-CTPA and no DVT symptoms, venous studies or anticoagulant treatment constituted the follow-up cohort. Four of these patients had proven VTE (all PE) during the 3-month follow-up period. Two of the PE episodes contributed to the patient's death. Conclusion: Patients with clinically suspected acute PE, no symptoms or signs of DVT and a negative single slice s-CTPA using 3–5 mm collimation, may safely be left without anticoagulation treatment unless they are critically ill, have a limited cardiopulmonary reserve and/or if a high clinical suspicion remains.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 419-419
Author(s):  
Liselotte M. Van Der Pol ◽  
Cecile Tromeur ◽  
Ingrid Bistervels ◽  
Thomas van Bemmel ◽  
Francis Couturaud ◽  
...  

Abstract Background Acute pulmonary embolism (PE) is the leading cause of maternal mortality in Western countries, accounting for 20 to 30% of all maternal deaths. Therefore, the threshold to test for PE during pregnancy is low. Because evidence regarding the safety of ruling out PE with clinical decision rules and D-dimer tests in pregnant women is unavailable, all women with a suspected PE need to undergo an imaging test, with potential harm to patient and fetus by exposure to ionizing radiation. In the present international, multicenter, prospective management study, we evaluated the safety and efficiency of the YEARS diagnostic algorithm for ruling out PE in pregnant patients with clinically suspected PE (Netherlands Trial Registry number 5913). YEARS is a simple diagnostic algorithm designed to reduce the number of required computed tomography (CT) scans in the diagnostic work-up of PE in non-pregnant patients, and was recently shown to be as safe as conventional algorithms but associated with a significant absolute 14% reduction in the number of CT scans (van der Hulle et al., Lancet 2017). Methods The Artemis study was performed in 11 Dutch hospitals, 8 French hospitals and 1 Irish hospital. Consecutive pregnant patients with suspected acute PE were included. Exclusion criteria were treatment with therapeutically dosed anticoagulants >24 hours or contraindications for CT. The YEARS algorithm was slightly adjusted for application during pregnancy (figure 1): in patients with signs of deep vein thrombosis (DVT), compression ultrasonography was obligatory before CT scanning was considered. In patients with proven DVT, anticoagulant treatment was initiated and no further diagnostic tests were undertaken. In patients with no YEARS items (Figure 1), a D-dimer threshold of <1.0 µg/ml was sufficient to rule out PE. In the remaining patients D-dimer threshold was <0.5 µg/mL. CT scanning was only performed in patients with a D-dimer level above the threshold. Anticoagulant therapy was withheld if PE was excluded. The primary safety endpoint was the occurrence of symptomatic venous thromboembolism during 3 months of follow-up, the primary efficiency endpoint was the proportion of patients in whom CTPA could be avoided. All safety endpoints were adjudicated by an independent committee. Assuming a 1.0% diagnostic failure rate and defining a maximum acceptable failure rate of 2.7%, a total study population of 472 patients was required (one-sided alpha 0.05, beta 80%). Results and conclusion: The last patient was included in May 2018. At baseline, 48% of pregnant women with suspected acute PE had no YEARS item and a D-dimer threshold of 1.0 µg/mL was applied. A total of 42% had a D-dimer level below the relevant threshold and were managed without CT scanning. Follow-up and endpoint adjudication was not completed at the abstract submission deadline; full study results will be presented at the ASH meeting. Disclosures Couturaud: Pfizer: Research Funding; Bayer: Honoraria, Other: Travel Support; AstraZeneca: Honoraria; Actelion: Other: Travel Support; Intermune: Other: Travel Support; Leo Pharma: Other: Travel Support; Daiichi Sankyo: Other: Travel Support.


2021 ◽  
pp. 2100699
Author(s):  
Natalia J. Braams ◽  
Gudula J. A. M. Boon ◽  
Frances S. de Man ◽  
Josien van Es ◽  
Paul L. den Exter ◽  
...  

IntroductionThe pulmonary arterial morphology of patients with pulmonary embolism (PE) is diverse and it is unclear how the different vascular lesions evolve after initiation of anticoagulant treatment. A better understanding of the evolution of CTPA findings after the start of anticoagulant treatment may help to better identify those PE patients prone to develop CTEPH. We aimed to assess the evolution of various thromboembolic lesions on CTPA over time after the initiation of adequate anticoagulant treatment in individual acute PE patients with and without an ultimate diagnosis of CTEPH.MethodsWe analysed the CTPA at diagnosis of acute PE (baseline) and at follow-up in 41 patients with CTEPH and 124 patients without an ultimate diagnosis of CTEPH, all receiving anticoagulant treatment. Central and segmental pulmonary arteries were scored by expert chest radiologists as normal or affected. Lesions were further sub-classified as: 1. central thrombus, 2. total thrombotic occlusion, 3. mural thrombus, 4. web or 5. tapered pulmonary artery.ResultsCentral thrombi resolved after anticoagulant treatment, while mural thrombi and total thrombotic occlusions either resolved or evolved into webs or tapered pulmonary arteries. Only patients with an ultimate diagnosis of CTEPH exhibited webs and tapered pulmonary arteries on the baseline scan. Moreover, such lesions always persisted after follow-up.ConclusionWebs and tapered pulmonary arteries at the time of PE diagnosis strongly indicate a state of chronic PE and should raise awareness for possible CTEPH, particularly in patients with persistent dyspnea after anticoagulant treatment for acute PE.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3996-3996
Author(s):  
Mariette J Agterof ◽  
Roger E.G. Schutgens ◽  
Repke J Snijder ◽  
G. Epping ◽  
Henny G Peltenburg ◽  
...  

Abstract Abstract 3996 Poster Board III-932 Background NT-proBNP is emerging to be of great importance in risk assessment of patients with acute pulmonary embolism (PE), by identifying both high and low-risk patients. The aim of the present management study was to investigate the safety of out of hospital treatment of patients with acute PE based on a NT-proBNP < 500 pg/ml. Methods Hemodynamically stable outpatients with objectively diagnosed acute PE and a NT-proBNP level < 500 pg/ml, were considered eligible for participation in this multicenter prospective study. Patients were discharged immediately from the emergency room or within the first 24 hours of admission. The primary objective was the 10-days mortality rate. Secondary objectives were the incidence of re-admission to hospital due to PE or its treatment, the patient's satisfaction during the first ten days of treatment and the incidence of serious adverse events in a 3-month follow-up period. Results Approximately 40 percent of all patients presenting at the emergency room with acute PE fulfilled the inclusion criteria. In total, 152 patients (mean age 53.4 ± 14.3 years; 51% female) with PE were treated as outpatients. No deaths, major bleedings or recurrent venous thromboembolism occurred during the first 10 days or in a follow-up period of 3 months. Seven patients required readmission. Three patients were admitted because of complaints of their PE: two patients with anxiety and pain and one patient with dyspnoea and low oxygen saturation. There were no signs of progression of PE in these 3 patients. Four patients were re-admitted because of an illness unrelated to PE. According to the PSQ18 and anxiety score, patients were satisfied with their out of hospital treatment; they had no progression of anxiety during the first ten days of treatment. Conclusion Out of hospital treatment is safe in a group of low risk patients with non-massive PE, based on NT-proBNP levels < 500 pg/ml. Approximately 40 percent of PE-patients can be treated in an outpatient setting. Patients consider out of hospital treatment as comfortable and have no increase in anxiety scores. Disclosures: No relevant conflicts of interest to declare.


Sign in / Sign up

Export Citation Format

Share Document