scholarly journals Contemporary clinical management of acute pulmonary embolism: the COPE study

Author(s):  
Cecilia Becattini ◽  
Giancarlo Agnelli ◽  
Aldo Pietro Maggioni ◽  
Francesco Dentali ◽  
Andrea Fabbri ◽  
...  

Abstract Background New management, risk stratification and treatment strategies have become available over the last years for patients with acute pulmonary embolism (PE), potentially leading to changes in clinical practice and improvement of patients’ outcome. Methods The COntemporary management of Pulmonary Embolism (COPE) is a prospective, non-interventional, multicentre study in patients with acute PE evaluated at internal medicine, cardiology and emergency departments in Italy. The aim of the COPE study is to assess contemporary management strategies in patients with acute, symptomatic, objectively confirmed PE concerning diagnosis, risk stratification, hospitalization and treatment and to assess rates and predictors of in-hospital and 30-day mortality. The composite of death (either overall or PE-related) or clinical deterioration at 30 days from the diagnosis of PE, major bleeding occurring in hospital and up to 30 days from the diagnosis of PE and adherence to guidelines of the European Society of Cardiology (ESC) are secondary study outcomes. Participation in controlled trials on the management of acute PE is the only exclusion criteria. Expecting a 10–15%, 3% and 0.5% incidence of death for patients with high, intermediate or low-risk PE, respectively, it is estimated that 400 patients with high, 2100 patients with intermediate and 2500 with low-risk PE should be included in the study. This will allow to have about 100 deaths in study patients and will empower assessment of independent predictors of death. Conclusions COPE will provide contemporary data on in-hospital and 30-day mortality of patients with documented PE as well as information on guidelines adherence and its impact on clinical outcomes. Trail registration NCT number: NCT03631810.

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.


Hematology ◽  
2016 ◽  
Vol 2016 (1) ◽  
pp. 404-412 ◽  
Author(s):  
Cecilia Becattini ◽  
Giancarlo Agnelli

Abstract The clinical management of patients with acute pulmonary embolism is rapidly changing over the years. The widening spectrum of clinical management strategies for these patients requires effective tools for risk stratification. Patients at low risk for death could be candidates for home treatment or early discharge. Clinical models with high negative predictive value have been validated that could be used to select patients at low risk for death. In a major study and in several meta-analyses, thrombolysis in hemodynamically stable patients was associated with unacceptably high risk for major bleeding complications or intracranial hemorrhage. Thus, the presence of shock or sustained hypotension continues to be the criterion for the selection of candidates for thrombolytic treatment. Interventional procedures for early revascularization should be reserved to selected patients until further evidence is available. No clinical advantage is expected with the insertion of a vena cava filter in the acute-phase management of patients with acute pulmonary embolism. Direct oral anticoagulants used in fixed doses without laboratory monitoring showed similar efficacy (odds ratio [OR], 0.89; 95% confidence interval [CI], 0.70-1.12) and safety (OR, 0.89; 95% CI, 0.77-1.03) in comparison with conventional anticoagulation in patients with acute pulmonary embolism. Based on these results and on their practicality, direct oral anticoagulants are the agents of choice for the treatment of the majority of patients with acute pulmonary embolism.


2016 ◽  
Vol 48 (3) ◽  
pp. 780-786 ◽  
Author(s):  
Cecilia Becattini ◽  
Giancarlo Agnelli ◽  
Mareike Lankeit ◽  
Luca Masotti ◽  
Piotr Pruszczyk ◽  
...  

The European Society of Cardiology (ESC) has proposed an updated risk stratification model for death in patients with acute pulmonary embolism based on clinical scores (Pulmonary Embolism Severity Index (PESI) or simplified PESI (sPESI)), right ventricle dysfunction (RVD) and elevated serum troponin (2014 ESC model).We assessed the ability of the 2014 ESC model to predict 30-day death after acute pulmonary embolism. Consecutive patients with symptomatic, confirmed pulmonary embolism included in prospective cohorts were merged in a collaborative database. Patients’ risk was classified as high (shock or hypotension), intermediate-high (RVD and elevated troponin), intermediate-low (RVD or increased troponin or none) and low (sPESI 0). Study outcomes were death and pulmonary embolism-related death at 30 days.Among 906 patients (mean±sd age 68±16, 489 females), death and pulmonary embolism-related death occurred in 7.2% and 4.1%, respectively. Death rate was 22% in “high-risk” (95% CI 14.0–29.8), 7.7% in “intermediate-high-risk” (95% CI 4.5–10.9) and 6.0% in “intermediate-low-risk” patients (95% CI 3.4–8.6). One of the 196 “low-risk” patients died (0.5%, 95% CI 0–1.0; negative predictive value 99.5%).By using the 2014 ESC model, RVD or troponin tests would be avoided in about 20% of patients (sPESI 0), preserving a high negative predictive value. Risk stratification in patients at intermediate risk requires further improvement.


2020 ◽  
Vol 76 (4) ◽  
pp. S57-S58
Author(s):  
W.J. Schaeffer ◽  
K.A. Grace ◽  
J.A. Cranford ◽  
K.E. Kocher ◽  
G.D. Barnes ◽  
...  

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.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Yevgeniy Brailovsky ◽  
Siri Kunchakarra ◽  
Katerina Porcaro ◽  
Demetrios Doukas ◽  
Andrew Stiff ◽  
...  

Introduction: Pulmonary embolism (PE) is associated with significant acute morbidity, mortality, and long term functional limitations. There is paucity of data on acute and short term functional assessment after acute PE. Hypothesis: Functional capacity will improve from baseline to follow up among patients with acute PE. Methods: We prospectively analyzed patients who underwent evaluation by the pulmonary embolism response team (PERT) at Loyola University Medical Center between 2016 and 2018. We included patients with acute PE who underwent six-minute walk test (6MWT) at discharge and during outpatient follow up (50±72 days post discharge). We collected demographic and clinical characteristics. We used paired sampled t-test to compare continuous variables. Results: Among the 204 patients evaluated by PERT, 38 patients (18.6%) underwent 6MWT at baseline and follow up. Patients were classified as low risk (6 patients), submassive (29 patients), and massive (3 patients). Mean age was 61.3±14.2, 50% were female, 60.5% were white, 26.3% were black, 29% had cancer, and 68.4% had concomitant DVT, mean BMI 36.4±10.3, and mean PESI score was 96.8+44.4. Overall the mean 6MWT distance increased significantly from a baseline of 726.9±73.7 feet to 1042±72.8 feet at follow up (p<0.001). Low risk (786±204 to 1115.8+177.6 p=0.63), Submassive (700.2±85 to 995.6±82.8 p<0.001), and Massive PE (859±261.7 to 1343.3±307 p=0.168) groups all demonstrated improvement in 6MWT distance. Conclusions: Functional capacity as measured by 6MWT significantly improved during follow up after acute PE. Future studies are needed to determine predictors of favorable functional outcome and best treatment strategies.


Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Romain Chopard ◽  
David Jimenez ◽  
Guillaume Serzian ◽  
Fiona Ecarnot ◽  
Nicolas Falvo ◽  
...  

Abstract Background Renal dysfunction influences outcomes after pulmonary embolism (PE). We aimed to determine the incremental value of adding renal dysfunction, defined by estimated glomerular filtration rate (eGFR), on top of the European Society of Cardiology (ESC) prognostic model, for the prediction of 30-day mortality in acute PE patients, which in turn could lead to the optimization of acute PE management. Methods We performed a multicenter, non-interventional retrospective post hoc analysis based on a prospectively collected cohort including consecutive confirmed acute PE stratified per ESC guidelines. We first identified which of three eGFR formulae most accurately predicted death. Changes in global model fit, discrimination, calibration and reclassification parameters were evaluated with the addition of eGFR to the prognostic model. Results Among 1943 patients (mean age 67.3 (17.1), 50.4% women), 107 (5.5%) had died at 30 days. The 4-variable Modification of Diet in Renal Disease (eGFRMDRD4) formula predicted death most accurately. In total, 477 patients (24.5%) had eGFRMDRD4 < 60 ml/min. Observed mortality was higher for intermediate–low-risk and high-risk PE in patients with versus without renal dysfunction. The addition of eGFRMDRD4 information improved model fit, discriminatory capacity, and calibration of the ESC model. Reclassification parameters were significantly increased, yielding 18% reclassification of predicted mortality (p < 0.001). Predicted mortality reclassifications across risk categories were as follows: 63.1% from intermediate–low risk to eGFR-defined intermediate–high risk, 15.8% from intermediate–high risk to eGFR-defined intermediate–low risk, and 21.0% from intermediate–high risk to eGFR-defined high risk. External validation in a cohort of 14,234 eligible patients from the RIETE registry confirmed our findings with a significant improvement of Harrell’s C index and reclassification parameters. Conclusion The addition of eGFRMDRD4-derived renal dysfunction on top of the prognostic algorithm led to risk reclassification within the intermediate- and high-risk PE categories. The impact of risk stratification integrating renal dysfunction on therapeutic management for acute PE requires further studies.


Author(s):  
Yaser Jenab ◽  
Ali-Mohammad Haji-Zeinali ◽  
Mohammad Javad Alemzadeh-Ansari ◽  
Shapour Shirani ◽  
Mojtaba Salarifar ◽  
...  

Background: In patients with heart failure, elevated levels of blood urea nitrogen (BUN) is a prognostic factor. In this study, we investigated the prognostic value of elevated baseline BUN in short-term mortality among patients with acute pulmonary embolism (PE). Methods: Between 2007 and 2014, cardiac biomarkers and BUN levels were measured in patients with acute PE. The primary endpoint was 30-day mortality, evaluated based on the baseline BUN (≥14 ng/L) level in 4 groups of patients according to the European Society of Cardiology’s risk stratification (low-risk, intermediate low-risk, intermediate high-risk, and high-risk). Results: Our study recruited 492 patients with a diagnosis of acute PE (mean age=60.58±16.81 y). The overall 1-month mortality rate was 6.9% (34 patients). Elevated BUN levels were reported in 316 (64.2%) patients. A high simplified pulmonary embolism severity index (sPESI) score (OR: 5.23, 95% CI: 1.43–19.11; P=0.012), thrombolytic or thrombectomy therapy (OR: 2.42, 95% CI: 1.01–5.13; P=0.021), and elevated baseline BUN levels (OR: 1.04, 95% CI: 1.01–1.03; P=0.029) were the independent predictors of 30-day mortality. According to our receiver-operating characteristics analysis for 30-day mortality, a baseline BUN level of greater than 14.8 mg/dL was considered elevated. In the intermediate-low-risk patients, mortality occurred only in those with elevated baseline BUN levels (7.2% vs. 0; P=0.008). Conclusion: An elevated baseline BUN level in our patients with PE was an independent predictor of short-term mortality, especially among those in the intermediate-risk group.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
L Hobohm ◽  
I Sagoschen ◽  
T Gori ◽  
FP Schmidt ◽  
T Muenzel ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Extracorporeal membrane oxygenation (ECMO) is a life-saving therapy for patients with acute pulmonary embolism (PE) and concomitant cardiac arrest with the necessity of cardiopulmonary resuscitation (CPR). Little is known about the use and clinical outcome of veno-arterial (VA)-ECMO and adjunctive treatment strategies in patients with acute PE and CPR. Purpose In this context, we aimed to investigate the use of VA-ECMO alone or after systemic thrombolysis and its impact on in-hospital outcomes of patients with acute PE and CPR. Methods We analyzed data on the characteristics, treatments and in-hospital outcomes for all patients with acute PE (ICD-code I26) and CPR in Germany between the years 2005 and 2018 (source: Research Data Center (RDC) of the Federal Statistical Office and the Statistical Offices of the federal states, DRG Statistics 2005-2018, own calculations). Results Between 2005 and 2018, 1,172,354 patients with acute PE (53.5% females) were included in this analysis; of those, 77,196 (6.5%) presented with cardiac arrest and CPR. While more than one fourth of those patients were treated with systemic thrombolysis alone (n = 20,839 patients; 27.0%), a minority received a combination of thrombolysis + VA-ECMO (n = 165; 0.2%) or singular approach with VA-ECMO treatment alone (n = 588; 0.8%). The overall in-hospital mortality rate of PE patients with cardiac arrest was high with 83.8%. Non-survivors were considerable older than survivors (74 [IQR 63-81] vs. 69 [58-77]). In patients treated with VA ECMO alone the mortality rate was 71.1% and 69.7% when patients received Thrombolysis + VA-ECMO. Patients, who received thrombolysis without VA-ECMO had a higher mortality rate (83.8%). In order to investigate the impact of those different treatment strategies, a multivariate logistic regression analysis (adjusted for age, sex and comorbidities) demonstrated the lowest risk for in-hospital death in patients, who underwent the combination of Thrombolysis + VA-ECMO (OR, 0.61 [95% CI, 0.43-0.86], P = 0.004) or VA-ECMO alone (OR, 0.70 [0.58-0.84], P &lt; 0.001) compared to patients without VA-ECMO and without thrombolysis. Use of thrombolysis alone in patients with PE and CPR lowering the risk regarding in-hospital death as well (OR, 0.95 [0.91-0.99], P = 0.013). Regarding temporal trends, the annual use of VA-ECMO increased from 0 in the year 2005 to the number of 138 in 2018 (ß 6.13 (4.62-6.76); p &lt; 0.001) as well as for the combined treatment Thrombolysis + VA-ECMO (from 0 to 39 [ß 4.28 (3.68-4.89); p &lt; 0.001]). Conclusion Patients with acute PE and CPR had a very high in-hospital mortality rate. Our data suggest, that VA-ECMO alone or after systemic thrombolysis should be considered as an option in this outstanding life-threatening situation to improve in-hospital outcome. Furthermore, our data highlight a marked increase in the number of PE patients treated with VA-ECMO indicating the structural health care progress between 2005 and 2018.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I M Cigalini ◽  
C E Scatularo ◽  
J C C Jauregui ◽  
J I Ortego ◽  
D Cornejo ◽  
...  

Abstract Background Pulmonary embolism (PE) represents the third cause of cardiovascular death and one of the leading causes of preventable in-hospital mortality. However, there is lack of information about this entity in our country. Purpose To describe baseline characteristics, in-hospital evolution and treatments among patients (P) admitted for acute PE in Argentina. Methods A prospective multicentric registry of P with acute PE was conducted in 75 academic centers between October 2016 and November 2017. Conventional analysis was used for descriptive and comparative statistics, with a p value <0.05 considered as significant. Cross audit was performed at 20% of participating centers. Results We included 684 consecutive P with an average age of 63,8 years (SD 16,8), with slight majority of female sex (57%). PE was the reason for admission in 484 (71%) of the cases; 68% of those others who developed PE as a complication during hospital stay were under adequate venous thromboembolism prophylaxis. The most frequent predisposing factors were obesity (34%), recent hospitalization (34%), transient rest (30%) and active cancer (22%). Multislice computed tomography was the diagnostic method of choice (81%). An echocardiogram was performed in 625 P (91%), showing right ventricular dilatation or dysfunction in 41% and 35% of the cases, respectively. After initial diagnosis, P were stratified as low risk (24%), intermediate-low risk (34%), intermediate-high risk (27%) and high risk (15%). Anticoagulation was indicated in 661 (97%), mainly with low-molecular-weight heparins (LMWH) (59%) as initial strategy. Reperfusion with either thrombolytics or mechanical therapies was performed in 91 (13%) cases. However, only 50 of the 102 P who presented with hemodynamic instability received any reperfusion therapy (49%). Overall in-hospital mortality was 12%, mainly related to PE (51%), with significant differences according to risk stratification (p<0,01) (Figure 1). 579 out of 601 survivors received anticoagulants at discharge: 60% vitamin K antagonists, 21% LMWH and 19% direct oral anticoagulants (49% Rivaroxaban, 34% Apixaban and 17% Dabigatran). Mortality according risk stratification Conclusions PE presents with high in-hospital mortality in our setting mainly due to the embolic event. This finding could be related to a low use of reperfusion therapies in P with hemodynamic instability, reflecting low adherence to guideline recommendations even in academic centers. This issue should be taken into consideration to improve PE prognosis in Argentina.


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