scholarly journals Prognostic stratification of pulmonary embolism: what does it change from 2014 European Society of Cardiology guidelines?

2014 ◽  
Vol 5 (4) ◽  
pp. 153-160
Author(s):  
Luca Masotti ◽  
Giancarlo Landini ◽  
Gianni Lorenzini ◽  
Irene Chiti ◽  
Grazia Panigada

Prognostic stratification is of utmost importance for clinical management of acute pulmonary embolism (PE). Clinical presentation, echocardiography and biomarkers represented the key points on which recommendations of European Society of Cardiology (ESC) released in 2008 were based. In fact, in 2008 the ESC prognostic model suggested to divide acute PE in high risk, heamodynamically unstable, based on presentation with shock or hypotension, and non high risk, haemodynamically stable. The non high risk PE was divided in intermediate rand low risk PE based on echocardiographicand biomarkers signs of right heart dysfunction (RHD) and myocardial damage. This approach was not an academic speculation but permitted to define the early mortality risk (>15% in high risk, 3-15% in intermediate risk, <1% in low risk) and bring the most appropriate treatment. Over the years it became clear that co-morbidity influenced the early mortality risk and may define better the low mortality risk. Practical clinical scores, such as the Pulmonary Embolism Severity Index, PESI, in its original or simplified version, demonstrated to have high prognostic power to identify high (early mortality risk over 10%) and low risk (early mortality risk ≤ 1%) patients. Furthermore, it has become clear that the combination of ESC prognostic model, based on haemodynamics, and clinical prognostic scores may improve the prognostic stratification of acute PE, especially for patients with intermediate risk in whom the range of early mortality risk is wide The latest version of ESC recommendations on management of acute PE released in August 2014 go toward this direction and suggest to divide the non high risk PE in low or intermediate risk taking in account the PESI score. In this review we describe the prognostic strategy of acute PE suggested from the latest version of ESC recommendations.

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.


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.


TH Open ◽  
2018 ◽  
Vol 02 (03) ◽  
pp. e265-e271 ◽  
Author(s):  
Massimo Cugno ◽  
Federica Depetri ◽  
Laura Gnocchi ◽  
Fernando Porro ◽  
Paolo Bucciarelli

Background Acute pulmonary embolism (PE) is burdened by high mortality, especially within 30 days from the diagnosis. The development and the validation of predictive models for the risk of early mortality allow to differentiate patients who can undergo home treatment from those who need admission into intensive care units. Methods To validate the prognostic model for early mortality after PE diagnosis proposed by the European Society of Cardiology (ESC) in 2014, we analyzed data of a cohort of 272 consecutive patients with acute PE, observed in our hospital during a 10-year period. Moreover, we evaluated the additional contribution of D-dimer, measured at PE diagnosis, in improving the prognostic ability of the model. All cases of PE were objectively diagnosed by angiography chest CT scan or perfusion lung scan. Results The overall mortality rate within 30 days from PE diagnosis was 10% (95% confidence interval [CI]: 6.4–13.5%). According to the ESC prognostic model, the risk of death increased 3.23 times in the intermediate-low-risk category, 5.55 times in the intermediate-high-risk category, and 23.78 times in the high-risk category, as compared with the low-risk category. The receiver operating characteristic analysis showed a good discriminatory power of the model (area under the curve [AUC] = 0.77 [95% CI: 0.67–0.87]), which further increased when D-dimer was added (AUC = 0.85 [95% CI: 0.73–0.96]). Conclusion This study represents a good validation of the ESC predictive model whose performance can be further improved by adding D-dimer plasma levels measured at PE diagnosis.


2016 ◽  
Vol 174 (5) ◽  
pp. 681-691 ◽  
Author(s):  
Lars Sävendahl ◽  
Effie Pournara ◽  
Birgitte Tønnes Pedersen ◽  
Oliver Blankenstein

AbstractObjectiveConcerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice.DesignNordiNet®International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin®(somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark).MethodsLong-term safety data (1998–2013) were collected on 13 834 growth hormone treated pediatric patients with short stature. Incidence rates (IRs) of adverse events (AEs) defined as adverse drug reactions (ADRs), serious ADRs (SADRs), and serious AEs (SAEs) were calculated by mortality risk group (low/intermediate/high). The effect of growth hormone dose on IRs and the occurrence of cerebrovascular AEs were investigated by the risk group.ResultsWe found that 61.0% of patients were classified as low-risk, 33.9% intermediate-risk, and 5.1% high-risk. Three hundred and two AEs were reported in 261 (1.9%) patients during a mean (s.d.) treatment duration of 3.9 (2.8) years. IRs were significantly higher in the high- vs the low-risk group (high risk vs low risk—ADR: 9.11 vs 3.14; SAE: 13.66 vs 1.85; SADR: 4.97 vs 0.73 events/1000 patient-years of exposure;P< 0.0001 for all). Except for SAEs in the intermediate-risk group (P= 0.0486) in which an inverse relationship was observed, no association between IRs and growth hormone dose was found. No cerebrovascular events were reported.ConclusionsWe conclude that safety data from NordiNet®IOS do not reveal any new safety signals and confirm a favorable overall safety profile in accordance with other pediatric observational studies. No association between growth hormone dose and the incidence of AEs during growth hormone treatment in childhood was found.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4691-4691
Author(s):  
Ramadevi Prathapam ◽  
Najuma Maharjan ◽  
Sheila B Powers ◽  
Tracey Allen K Freitas ◽  
Guoli Sun ◽  
...  

Abstract Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in western countries and typically occurs in elderly individuals. There will be an estimated 21,250 newly diagnosed cases in the United States this year and 4,320 deaths. Due to the highly variable clinical course of this disease, prognostication and risk stratification methods are necessary for guiding decisions on clinical management. Integrated prognostic models incorporating laboratory testing for multiple molecular, cytogenetic, and other biomarkers have recently been proposed by major clinical guidelines to classify patients into risk subgroups. The current NCCN Guidelines for Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia describe such an integrated prognostic model known as the Rossi model that includes TP53, NOTCH1, SF3B1, and BIRC3 mutations along with the cytogenetic abnormalities detected by fluorescence in situ hybridization (FISH) to classify CLL patients into 4 distinct prognostic subgroups: high-risk (TP53 and/or BIRC3 abnormalities), intermediate-risk (NOTCH1 and/or SF3B1 mutations and/or deletion 11q), low-risk (trisomy 12 and wild-type for all genetic lesions), and very low-risk (deletion 13q only). The 10-year survival rates for these subgroups are 29%, 37%, 57%, and 69%, respectively. To assess the clinical value of an integrated biomarker testing approach, we analyzed results of 651 consecutive cases submitted to our clinical diagnostic laboratory for testing on our integrated panel of molecular and cytogenetic biomarkers for CLL. Our panel includes detection of genomic alterations by FISH (deletion 6q, 13q, 11q, 17p, trisomy 12, IGH rearrangement, and IGH/CCND1 translocation) and detection of sequence variants in BIRC3, BTK, MYD88, NOTCH1, PCLG2, SF3B1, and TP53 by next-generation sequencing (NGS). In total, 472 cases had positive findings by either FISH (90%) or NGS (46%) for a detection rate of 72.5%. Using the Rossi integrated prognostic model, 17.5% of cases fell into the high-risk subgroup, 20% of cases fell into the intermediate-risk subgroup, 43.5% of cases fell into the low-risk subgroup, and 19% of cases fell into the very low-risk subgroup. Importantly, among cases with positive FISH findings, 40.1% of cases also had positive molecular findings. In approximately 84% of cases belonging to the low-risk cytogenetic subgroups by FISH assessment alone, the incorporation of molecular findings resulted in reclassification into a higher-risk subgroup. Among the FISH-negative cases, 17% were classified as high-risk or intermediate-risk based on the molecular findings. Together, these findings support the clinical value of an integrative biomarker testing approach that includes both molecular and cytogenetic biomarkers to stratify CLL patients into risk subgroups to help guide decisions on clinical management. Disclosures Prathapam: Quest Diagnostics: Current Employment. Maharjan: Quest Diagnostics: Current Employment. Powers: Quest Diagnostics: Current Employment. Freitas: Quest Diagnostics: Current Employment. Sun: Quest Diagnostics: Current Employment. Tan: Quest Diagnostics: Current Employment. Gupta: Quest Diagnostics: Current Employment. Hucthagowder: Quest Diagnostics: Current Employment. Graham: Quest Diagnostics: Current Employment. Whitman: Quest Diagnostics: Current Employment. Khadgi: Quest Diagnostics: Current Employment. Daniel: Quest Diagnostics: Current Employment. Racke: Quest Diagnostics: Current Employment. Champion: Quest Diagnostics: Current Employment.


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 ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1015-1015 ◽  
Author(s):  
Ash A Alizadeh ◽  
James S. McClellan ◽  
Jason R. Gotlib ◽  
Steven Coutre ◽  
Ravindra Majeti ◽  
...  

Abstract Abstract 1015 Poster Board I-37 Background: Early mortality, mostly from hemorrhagic complications, occurs in less than 10% of patients currently treated in clinical trials for acute promyelocytic leukemia (APL). However, data about the proportion of patients developing such complications prior to clinical trial enrollment are scarce in the literature (Sanz M, et al Blood 2009). Approximately 5% of newly diagnosed patients with APL have been reported not to be eligible for participation in clinical trials due to very poor clinical condition, and their outcome has never been reported. However, enrollment on clinical trials may be difficult in specific clinical situations, such as after hours/weekend admissions and/or emergent requirement for therapy. This study reports the incidence, time of occurrence and clinical features of APL patients with a focus on early mortality. Methods: 150 consecutive APL patients treated at Stanford University between 8/1986 and 7/2009 were identified. Thirteen patients were excluded for lack of appropriate clinical information. Clinical features of patients with APL were analyzed for factors that might be relate to prognosis, including age, gender, white blood cell count, platelet count, fibrinogen, PTT, and INR. Continuous variables were compared with the t-test and categorical variables by Fisher's exact test or X-square statistic. The Kaplan–Meier method was applied to assess overall survival time. Results: Of the 137 patients included in this analysis, the median age at diagnosis was 45 (1-93) years and 78 (57%) were females. Using the PETHEMA criteria, there were 37, 46 and 20 patients with high-, intermediate- and low-risk disease (34 patients could not be classified based on partial/missing data). With a median follow-up time of 748 (0-6,235) days for the entire cohort, 52 (38%) have died. 19 (14%) and 11 (8%) of these patients died within 7 and 3 days of presentation, respectively. Patients with high-risk features had a 13% and 24% chance of dying with 3 and 7 days of presentation, respectively, with significantly inferior outcomes (p=0.045) when compared to those with intermediate-risk patients (6% and 13%) and low-risk disease (5% and 5%). Patients with unknown risk category faired similarly to low-risk patients. The most common cause of early mortality in these 19 patients was intracranial hemorrhage (n=11). Patients with early death (ED) (either <=3 or <=7 days) tended to be older than APL patients with non-early deaths (>7d), or APL patients alive as of their last follow-up (median age 54 years vs. 50 years vs. 39 years), and were more likely to have higher risk disease, though coagulopathy appeared not significantly different amongst the groups. Median fibrinogen, PTT and INR for each individual group are presented on Table 1. The 3-year overall survival (% +/- SE) of the low, intermediate, and high risk patients was 90+/-7, 74+/-7, and 64+/-8, respectively, though early mortality (death within 7 days) was a major determinant of this stratification (p=0.045). Conclusions: Risk of early death in APL patients appears to be higher than previously reported in clinical trials, where trial registration may exclude patients requiring urgent therapeutic interventions. In this cohort, 25% and 13% patients with high- and intermediate-risk APL died within 7 days of presentation, respectively. Risk group stratification was very predictive of risk of early death. Disclosures: No relevant conflicts of interest to declare.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
M Kleissner ◽  
L Vojtickova ◽  
J Kettner ◽  
J Kautzner ◽  
M Sramko

Abstract Funding Acknowledgements Type of funding sources: None. Background Recent data on mortality of hospitalised patients with pulmonary embolism (PE) are scarce. Purpose To compare in-hospital mortality between a contemporary and a historical cohort of patients treated for PE. Methods We retrospectively analysed clinical and imaging data of 372 consecutive patients who were admitted to our department for PE between February 2010 and November 2020. Patients in whom PE presented as an out-of-hospital cardiac arrest without sustained return of spontaneous circulation (n = 12) were not included. In-hospital mortality was compared between patients admitted before and after January 2016 (n = 178 and n = 194, respectively). The patients were classified as low, intermediate and high clinical risk, according to the 2019 European Society of Cardiology guidelines. Results The diagnosis of PE was based on computed tomography angiography (85%), ventilation/perfusion lung scan (7%), echocardiography (7%), and autopsy (1%). The majority of patients presented with intermediate-risk (288 [77%]), followed by low-risk (46 [12%]) and high-risk PE (38 [10%]). The risk profile did not differ between the contemporary vs. historical cohort (78% vs. 77%, 13% vs. 11%, and 9% vs. 12%, respectively, all p &gt;0.05). Eleven patients (3%) died of PE during the index hospitalization: eight with high-risk PE (21%), three (1%) with intermediate-risk and zero (0%) with low-risk PE (p &lt; 0.0001). The in-hospital mortality did not differ between the contemporary vs. historical cohort (5 [3%] vs. 6 [3%], p = 0.76). In the multivariate regression analysis, the initial manifestation of cardiogenic shock, presence of provoking factors for PE, and a history of stroke were associated with higher in-hospital mortality. Conclusion The mortality of hospitalised patients with intermediate and low-risk PE is lower than previously reported and did not change over the last decade. High-risk PE is associated with in-hospital mortality of 21%. Abstract Figure.


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.


Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001725
Author(s):  
Fabio Dardi ◽  
Alessandra Manes ◽  
Daniele Guarino ◽  
Elisa Zuffa ◽  
Alessandro De Lorenzis ◽  
...  

ObjectiveTo optimise treatment of patients with pulmonary arterial hypertension (PAH), the 2015 European Society of Cardiology/European Respiratory Society guidelines recommend using risk stratification, with the aim of patients achieving low-risk status. Previous analyses of registries made progress in using risk stratification approaches, however, the focus is often on patients with a low-risk prognosis, whereas most PAH patients are in intermediate-risk or high-risk categories. Using only six parameters with high prognostic relevance, we aimed to demonstrate a pragmatic approach to individual patient risk assessment to discriminate between patients at low risk, intermediate risk and high risk of death.MethodsRisk assessment was performed combining six parameters in four criteria: (1) WHO functional class, (2) 6 min walk distance, (3) N-terminal pro-brain natriuretic peptide (BNP)/BNP plasma levels or right atrial pressure and (4) cardiac index or mixed venous oxygen saturation. Assessments were made at baseline and at first follow-up after 3–4 months.Results725 PAH treatment-naive patients were analysed. Survival estimates between risk groups were statistically significant at baseline and first follow-up (p<0.001), even when the analysis was performed within PAH etiological subgroups. Similar results were observed in 208 previously treated PAH patients. Furthermore, patients who remained at or improved to low risk had a significantly better estimated survival compared with patients who remained at or worsened to intermediate risk or high risk (p≤0.005).ConclusionThe simplified risk-assessment method can discriminate idiopathic, connective-tissue-disease-associated and congenital-heart-disease-associated PAH patients into meaningful high-risk, intermediate-risk and low-risk groups at baseline and first follow-up. This pragmatic approach reinforces targeting a low-risk profile for PAH patients.


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