Vicente Gómez

Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism.

BACKGROUND The Pulmonary Embolism Severity Index (PESI) estimates the risk of 30-day mortality in patients with acute pulmonary embolism (PE). We constructed a simplified version of the PESI. METHODS The study retrospectively developed a simplified PESI clinical prediction rule for estimating the risk of 30-day mortality in a derivation cohort of Spanish outpatients. Simplified and original PESI performances were compared in the derivation cohort. The simplified PESI underwent retrospective external validation in an independent multinational cohort (Registro Informatizado de la Enfermedad Tromboembólica [RIETE] cohort) of outpatients. RESULTS In the derivation data set, univariate logistic regression of the original 11 PESI variables led to the removal of variables that did not reach statistical significance and subsequently produced the simplified PESI that contained the variables of age, cancer, chronic cardiopulmonary disease, heart rate, systolic blood pressure, and oxyhemoglobin saturation levels. The prognostic accuracy of the original and simplified PESI scores did not differ (area under the curve, 0.75 [95% confidence interval (CI), 0.69-0.80]). The 305 of 995 patients (30.7%) who were classified as low risk by the simplified PESI had a 30-day mortality of 1.0% (95% CI, 0.0%-2.1%) compared with 10.9% (8.5%-13.2%) in the high-risk group. In the RIETE validation cohort, 2569 of 7106 patients (36.2%) who were classified as low risk by the simplified PESI had a 30-day mortality of 1.1% (95% CI, 0.7%-1.5%) compared with 8.9% (8.1%-9.8%) in the high-risk group. CONCLUSION The simplified PESI has similar prognostic accuracy and clinical utility and greater ease of use compared with the original PESI.

Combinations of prognostic tools for identification of high-risk normotensive patients with acute symptomatic pulmonary embolism

Background In haemodynamically stable patients with acute symptomatic pulmonary embolism (PE), studies have not evaluated the usefulness of combining the measurement of cardiac troponin, transthoracic echocardiogram (TTE), and lower extremity complete compression ultrasound (CCUS) testing for predicting the risk of PE-related death. Methods The study assessed the ability of three diagnostic tests (cardiac troponin I (cTnI), echocardiogram, and CCUS) to prognosticate the primary outcome of PE-related mortality during 30 days of follow-up after a diagnosis of PE by objective testing. Results Of 591 normotensive patients diagnosed with PE, the primary outcome occurred in 37 patients (6.3%; 95% CI 4.3% to 8.2%). Patients with right ventricular dysfunction (RVD) by TTE and concomitant deep vein thrombosis (DVT) by CCUS had a PE-related mortality of 19.6%, compared with 17.1% of patients with elevated cTnI and concomitant DVT and 15.2% of patients with elevated cTnI and RVD. The use of any two-test strategy had a higher specificity and positive predictive value compared with the use of any test by itself. A combined three-test strategy did not further improve prognostication. For a subgroup analysis of high-risk patients, according to the pulmonary embolism severity index (classes IV and V), positive predictive values of the two-test strategies for PE-related mortality were 25.0%, 24.4% and 20.7%, respectively. Conclusions In haemodynamically stable patients with acute symptomatic PE, a combination of echocardiography (or troponin testing) and CCUS improved prognostication compared with the use of any test by itself for the identification of those at high risk of PE-related death.

A Strategy Combining Imaging and Laboratory Biomarkers in Comparison With a Simplified Clinical Score for Risk Stratification of Patients With Acute Pulmonary Embolism

BACKGROUND This study aimed to assess the performance of two prognostic models-the European Society of Cardiology (ESC) model and the simplified Pulmonary Embolism Severity Index (sPESI)-in predicting short-term mortality in patients with pulmonary embolism (PE). METHODS We compared the test characteristics of the ESC model and the sPESI for predicting 30-day outcomes in a cohort of 526 patients with objectively confirmed PE. The primary end point of the study was all-cause mortality. The secondary end point included all-cause mortality, nonfatal symptomatic recurrent VTE, or nonfatal major bleeding. RESULTS Overall, 40 of 526 patients died (7.6%; 95% CI, 5.3%-9.9%) during the first month of follow-up. The sPESI classified fewer patients as low risk (31% [165 of 526], 95% CI, 27%-35%) compared with the ESC model (39% [207 of 526], 95% CI, 35% to 44%; P < .01). Importantly however, low-risk patients based on the sPESI had no 30-day mortality compared with 3.4% (95% CI, 0.9-5.8) in low-risk patients by the ESC model. The secondary end point occurred in 1.8% of patients in the sPESI low-risk and 5.8% in the ESC low-risk group (difference, 4.0 percentage points; 95% CI, 0.2-7.8). The prognostic ability of the ESC model remained significant in the subgroup of patients at high-risk according to the sPESI model (OR 1.95, 95% CI, 1.41 to 2.71, P < .001). CONCLUSIONS Both the sPESI and the ESC model successfully predict 30-day mortality after acute symptomatic PE, but exclusion of an adverse early outcome does not appear to require routine imaging procedures or laboratory biomarker testing.

Computed tomography-assessed right ventricular dysfunction and risk stratification of patients with acute non-massive pulmonary embolism: systematic review and meta-analysis.

The ability of computed tomography (CT)‐assessed right ventricular dysfunction (RVD) to identify normotensive patients with acute pulmonary embolism (PE) at high risk of mortality or adverse outcome lacks clarity.

The shock index and the simplified PESI for identification of low-risk patients with acute pulmonary embolism

We compared the test characteristics of the shock index (SI) and the simplified pulmonary embolism severity index (sPESI) for predicting 30-day outcomes in a cohort of 1,206 patients with objectively confirmed pulmonary embolism (PE). The primary outcome of the study was all-cause mortality. The secondary outcome was nonfatal symptomatic recurrent venous thromboembolism (VTE) or nonfatal major bleeding. Overall, 119 (9.9%) out of 1,206 patients died (95% CI 8.2–11.5%) during the first month of follow-up. The sPESI classified fewer patients as low-risk (369 (31%) out of 1,206 patients, 95% CI 28–33%) compared to the SI (1,024 (85%) out of 1,206 patients, 95% CI 83–87%) (p<0.001). Low-risk patients based on the sPESI had a lower 30-day mortality than those based on the SI (1.6% (95% CI 0.3–2.9%) versus 8.3% (95% CI 6.6–10.0%)), while the 30-day rate of nonfatal recurrent VTE or major bleeding was similar (2.2% (95%CI 0.7–3.6%) versus 3.3% (95%CI 2.2–4.4%)). The net reclassification improvement with the sPESI was 13.4% (p = 0.07). The integrated discrimination improvement was estimated as 1.8% (p<0.001). The sPESI quantified the prognosis of patients with PE better than the SI.

A clinical prognostic model for the identification of low-risk patients with acute symptomatic pulmonary embolism and active cancer.

BACKGROUND Physicians need a specific risk-stratification tool to facilitate safe and cost-effective approaches to the management of patients with cancer and acute pulmonary embolism (PE). The objective of this study was to develop a simple risk score for predicting 30-day mortality in patients with PE and cancer by using measures readily obtained at the time of PE diagnosis. METHODS Investigators randomly allocated 1,556 consecutive patients with cancer and acute PE from the international multicenter Registro Informatizado de la Enfermedad TromboEmbólica to derivation (67%) and internal validation (33%) samples. The external validation cohort for this study consisted of 261 patients with cancer and acute PE. Investigators compared 30-day all-cause mortality and nonfatal adverse medical outcomes across the derivation and two validation samples. RESULTS In the derivation sample, multivariable analyses produced the risk score, which contained six variables: age > 80 years, heart rate ≥ 110/min, systolic BP < 100 mm Hg, body weight < 60 kg, recent immobility, and presence of metastases. In the internal validation cohort (n = 508), the 22.2% of patients (113 of 508) classified as low risk by the prognostic model had a 30-day mortality of 4.4% (95% CI, 0.6%-8.2%) compared with 29.9% (95% CI, 25.4%-34.4%) in the high-risk group. In the external validation cohort, the 18% of patients (47 of 261) classified as low risk by the prognostic model had a 30-day mortality of 0%, compared with 19.6% (95% CI, 14.3%-25.0%) in the high-risk group. CONCLUSIONS The developed clinical prediction rule accurately identifies low-risk patients with cancer and acute PE.

Incidence of Symptomatic and Asymptomatic Chronic Thromboembolic Pulmonary Hypertension

Abstract Introduction and objectives To assess the incidence of long-term symptomatic and asymptomatic chronic thromboembolic pulmonary hypertension (CTPH) in a cohort of patients with acute symptomatic pulmonary embolism (PE), and the potential risk factors for its diagnosis. Methods We conducted a prospective, long-term, follow-up study in 110 consecutive patients with an acute episode of pulmonary embolism (PE). All patients underwent transthoracic echocardiography (TTE) two years after the diagnosis of PE was made. If systolic pulmonary artery pressure exceeded 40 mm Hg and there was evidence of residual PE either by ventilation-perfusion or CT scan, patients underwent right heart catheterisation to confirm the diagnosis. In asymptomatic patients, right heart catheterisation was performed if a repeated TTE still demonstrated persistent pulmonary hypertension six months after the first. Results CTPH was diagnosed in 10 cases (6 patients during follow-up, and 4 at the end of the study) of the 110 patients (9.1%; 95% confidence interval [CI], 3.7-14.5). All patients had symptoms related to the disease according to a structured questionnaire. In the multivariate regression analysis, only concomitant age (relative risk [RR] 1.2 per age; 95% CI, 1.0-1.3; P=.03) and previous PE (RR 5.7; IC 95%, 1.5-22.0; P=.01) were independent predictors of CTPH. Conclusions The cumulative incidence of CTPH appears to be higher than previously reported. All patients had symptoms related to the disease.

Incidencia de hipertensión pulmonar tromboembólica crónica sintomática y asintomática

INTRODUCTION AND OBJECTIVES To assess the incidence of long-term symptomatic and asymptomatic chronic thromboembolic pulmonary hypertension (CTEPH) in a cohort of patients with acute symptomatic pulmonary embolism (PE), and the potential risk factors for its diagnosis. METHODS We conducted a prospective, long-term, follow-up study in 110 consecutive patients with an acute episode of pulmonary embolism (PE). All patients underwent transthoracic echocardiography (TTE) two years after the diagnosis of PE was made. If systolic pulmonary artery pressure exceeded 40 mm Hg and there was evidence of residual PE either by ventilation-perfusion or CT scan, patients underwent right heart catheterisation to confirm the diagnosis. In asymptomatic patients, right heart catheterisation was performed if a repeated TTE still demonstrated persistent pulmonary hypertension six months after the first. RESULTS CTEPH was diagnosed in 10 (6 patients during follow-up, and 4 at the end of the study) of the 110 patients (9.1%; 95% confidence interval [CI], 3.7 to 14.5%). All patients showed symptoms related to the disease according to a structured questionnaire. In the multivariate regression analysis, only concomitant age (relative risk [RR] 1.2 per age; 95% CI, 1.0 to 1.3; P=0.03) and previous PE (RR 5.7; IC 95%, 1.5 a 22.0; P=0.01) were independent predictors of CTEPH. CONCLUSIONS CTEPH cumulative incidence appears to be higher than previously reported. All patients had symptoms related to the disease.

Changes in PESI scores predict mortality in intermediate-risk patients with acute pulmonary embolism

Although the Pulmonary Embolism Severity Index (PESI) accurately identifies 35% of patients with acute pulmonary embolism (PE) as being low risk, some patients deemed high risk by the PESI on admission might be treated safely in the outpatient environment. This retrospective cohort study included a total of 304 consecutive patients with acute PE, classified at the time of hospital admission into PESI class III. The PESI was recalculated 48 h after admission (PESI48) and each patient reclassified into the corresponding risk category. The primary outcome of the study was all-cause mortality between day 2 and day 30 after PE diagnosis. 26 (8.5%) patients (95% CI 5.4–11.7%) died between day 2 and day 30 after PE diagnosis. Investigators reclassified 83 (27.3%) patients (95% CI 22.3–32.3%) as low risk (classes I and II) at 48 h. 30-day mortality in these patients was 1.2% (95% CI 0–3.5%) as opposed to 11.3% (95% CI 7.1–15.5%) in those who remained high risk. The net improvement in reclassification was estimated at 54% (p<0.001). In a cohort of intermediate-risk patients with acute PE, calculation of the PESI48 allows identification of those patients at very low risk of dying during the first month of follow-up.

Identification of reduced circulating haptoglobin concentration as a biomarker of the severity of pulmonary embolism: a nontargeted proteomic study.

Risk stratification of patients with pulmonary embolism (PE) may identify patients at high risk of early death who may benefit from more intensive surveillance or aggressive therapy. Nontargeted proteomics may identify biomarkers useful for the risk stratification of patients with acute symptomatic pulmonary embolism (PE). We studied 6 patients presenting with low-risk PE and 6 patients presenting with intermediate (n = 3) or high-risk (n = 3) PE. Two-dimensional difference gel electrophoresis was used to compare their plasma protein abundances. Candidate protein markers were identified by matrix assisted laser desorption ionization time-of-flight mass spectrometry. A panel of four biomarkers (haptoglobin, hemopexin, α2-macroglobulin, and Ig α1-chain C region) showed differences in plasma abundance among patients with acute symptomatic PE of different severity. Haptoglobin and hemopexin were decreased, whereas α2-macroglobulin and Ig α1-chain C region were increased, in patients with high or intermediate-risk PE compared with low-risk PE patient. In a separate clinical population consisting of 104 adults with acute PE, serum haptoglobin concentrations had an 85% chance of correctly identifying patients with high-risk PE according to receiving operating characteristics curve analysis. Moreover, serum haptoglobin concentrations ≤1 g/l showed an 80% sensitivity and a 96% specificity for the diagnosis of high-risk PE. Nontargeted proteomics identified protein biomarkers for the severity of PE that are involved in iron metabolism pathways and acute-phase response. Among them, reduced serum haptoglobin concentrations show a high accuracy for the biochemical detection of high-risk PE.