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BACKGROUND: The effect of supplemental oxygen therapy in patients with intermediate-risk pulmonary embolism (PE) who do not have hypoxemia at baseline is uncertain. RESEARCH QUESTION: Does supplemental oxygen improve echocardiographic parameters in nonhypoxemic patients with intermediate-risk PE? STUDY DESIGN AND METHODS: This pilot trial randomly assigned nonhypoxemic patients with stable PE and echocardiographic right ventricle (RV) enlargement to receive anticoagulation plus supplemental oxygen for the first 48 h vs anticoagulation alone. The primary outcome was normal echocardiographic RV size 48 h after randomization. Secondary efficacy outcomes were the numerical change in the RV to left ventricle (LV) diameter ratio measured 48 h and 7 days after randomization with respect to the baseline ratio measured at inclusion. RESULTS: The study was stopped prematurely because of the COVID-19 pandemic after recruiting 70 patients (mean ± SD age, 67.3 ± 16.1 years; 36 female [51.4%]) with primary outcome data. Forty-eight h after randomization, normalization of the RV size occurred in 14 of the 33 patients (42.4%) assigned to oxygen and in eight of the 37 patients (21.6%) assigned to ambient air (P = .08). In the oxygen group, the mean RV to LV ratio was reduced from 1.28 ± 0.28 at baseline to 1.01 ± 0.16 at 48 h (P < .001); in the ambient air group, mean RV to LV ratios were 1.21 ± 0.18 at baseline and 1.08 ± 0.19 at 48 h (P < .01). At 90 days, one major bleeding event and one death (both in the ambient air group) had occurred. INTERPRETATION: In analyses limited by a small number of enrollees, compared with ambient air, supplemental oxygen did not significantly increase the proportion of patients with nonhypoxemic intermediate-risk PE whose RV to LV ratio normalized after 48 h of treatment. This pilot trial showed improvement in some ancillary efficacy outcomes and provides support for a definitive clinical outcomes trial. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04003116; URL: www. CLINICALTRIALS: gov.
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COVID-19 , Embolia Pulmonar , Humanos , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Pandemias , Embolia Pulmonar/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Oxígeno/uso terapéutico , Enfermedad Aguda , Resultado del TratamientoRESUMEN
BACKGROUND: In patients with intermediate-risk pulmonary embolism (PE), reversal of hypoxic vasoconstriction could constitute a target for treatment that protects the right ventricular (RV) function until endogenous fibrinolysis occurs. The Air vs oxygen for Intermediate-Risk pulmonary embolism (AIR) trial aims to assess the effect of oxygen therapy in patients with intermediate-risk acute PE who do not have hypoxemia at baseline. METHODS AND ANALYSES: AIR is a prospective, multicenter, randomized, open-label, parallel-group, proof-of-concept trial. A total of 90 patients hospitalized with intermediate-risk PE and an oxygen saturation of 90% or higher at baseline will be randomized in a 1:1 fashion to receive supplemental oxygen or ambient air. The primary outcome is a RV/LV diameter ratio equal or less than 1.0 on echocardiography measured 48 hours after the start of treatment. Secondary efficacy outcomes are the numerical change in the ratio of the RV to the LV diameter measured 48 hours and 7 days after the start of treatment, with respect to the baseline ratio measured at randomization. Clinical adverse events will be also collected. RESULTS: Enrollment started in July 2019 and is expected to proceed until 2022. Median age of the first 50 patients was 74 years (interquartile range, 61-81), and 50% were female. CONCLUSIONS: This multicenter trial will provide information about the value of supplemental oxygen in patients with intermediate-risk acute PE who do not have hypoxemia at baseline. The results will contribute to research that may assist patients with intermediate-risk PE in the future.
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Embolia Pulmonar , Humanos , Femenino , Anciano , Masculino , Estudios Prospectivos , Embolia Pulmonar/tratamiento farmacológico , Terapia por Inhalación de Oxígeno , Oxígeno/uso terapéutico , Hipoxia/terapia , Hipoxia/complicaciones , Resultado del Tratamiento , Enfermedad AgudaRESUMEN
CASE PRESENTATION: An 84-year-old man with an active smoking habit presented to the ED with dyspnea, hemoptysis, and thick phlegm that was difficult to clear. He reported no weight loss, no fever, and no chest pain or dysphonia. He denied both international travel and previous contact with confirmed cases of TB or SARS-CoV-2. He had no known occupational exposures. The patient's personal history included a resolved complete atrioventricular block that required a permanent pacemaker, moderate-to-severe COPD, rheumatoid arthritis (treated with oral prednisone, 2.5 mg/d) and B-chronic lymphocytic leukemia (treated with methotrexate and prophylactic oral supplements of ferrous sulfate). Moreover, he was in medical follow up because of a peptic ulcer, atrophic gastritis, and colonic diverticulosis. The patient also had a history of thoracic surgery after an episode of acute mediastinitis from an odontogenic infection, which required ICU management and temporal tracheostomy.
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Broncoscopía/métodos , COVID-19/diagnóstico , Compuestos Ferrosos , Enfermedades Pulmonares , Afecciones Crónicas Múltiples/terapia , Aspiración Respiratoria , Anciano de 80 o más Años , Biopsia/métodos , Lavado Broncoalveolar/métodos , COVID-19/epidemiología , Diagnóstico Diferencial , Compuestos Ferrosos/administración & dosificación , Compuestos Ferrosos/efectos adversos , Hematínicos/administración & dosificación , Hematínicos/efectos adversos , Hemoptisis/diagnóstico , Hemoptisis/etiología , Humanos , Enfermedades Pulmonares/inducido químicamente , Enfermedades Pulmonares/diagnóstico por imagen , Enfermedades Pulmonares/fisiopatología , Enfermedades Pulmonares/terapia , Masculino , Aspiración Respiratoria/complicaciones , Aspiración Respiratoria/diagnóstico , Aspiración Respiratoria/fisiopatología , SARS-CoV-2 , Tomografía Computarizada por Rayos X/métodos , Privación de TratamientoRESUMEN
BACKGROUND: The length of hospital stay (LOS) for acute pulmonary embolism (PE) varies considerably. Whether the upfront use of a PE prognostic assessment and management pathway is effective in reducing the LOS remains unknown. METHODS: We conducted a randomised controlled trial of adults hospitalised for acute PE: patients were assigned either to a prognostic assessment and management pathway involving risk stratification followed by predefined criteria for mobilisation and discharge (intervention group) or to usual care (control group). The primary end-point was LOS. The secondary end-points were the cost of prognostic tests and of hospitalisation, and 30-day clinical outcomes. RESULTS: Of 500 patients who underwent randomisation, 498 were included in the modified intention-to-treat analysis. The median LOS was 4.0â days (interquartile range (IQR) 3.7-4.2â days) in the intervention group and 6.1â days (IQR 5.7-6.5â days) in the control group (p<0.001). The mean total cost of prognostic tests was EUR 174.76 in the intervention group, compared with EUR 233.12 in the control group (mean difference EUR -58.37, 95% CI EUR -84.34- to -32.40). The mean total hospitalisation cost per patient was EUR 2085.66 in the intervention group, compared with EUR 3232.97 in the control group (mean difference EUR -1147.31, 95% CI EUR -1414.97- to -879.65). No significant differences were observed in 30-day readmission (4.0% versus 4.8%), all-cause mortality (2.4% versus 2.0%) or PE-related mortality (0.8% versus 1.2%) rates. CONCLUSIONS: The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE.
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Readmisión del Paciente , Embolia Pulmonar , Enfermedad Aguda , Adulto , Humanos , Tiempo de Internación , Pronóstico , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/terapiaRESUMEN
Importance: Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD). Objective: To compare usual care plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation. Design, Setting, and Participants: Randomized clinical trial conducted across 18 hospitals in Spain. A total of 746 patients were randomized from September 2014 to July 2020 (final follow-up was November 2020). Interventions: Usual care plus an active strategy for diagnosing PE (D-dimer testing and, if positive, computed tomography pulmonary angiogram) (n = 370) vs usual care (n = 367). Main Outcomes and Measures: The primary outcome was a composite of nonfatal symptomatic venous thromboembolism (VTE), readmission for COPD, or death within 90 days after randomization. There were 4 secondary outcomes, including nonfatal new or recurrent VTE, readmission for COPD, and death from any cause within 90 days. Adverse events were also collected. Results: Among the 746 patients who were randomized, 737 (98.8%) completed the trial (mean age, 70 years; 195 [26%] women). The primary outcome occurred in 110 patients (29.7%) in the intervention group and 107 patients (29.2%) in the control group (absolute risk difference, 0.5% [95% CI, -6.2% to 7.3%]; relative risk, 1.02 [95% CI, 0.82-1.28]; P = .86). Nonfatal new or recurrent VTE was not significantly different in the 2 groups (0.5% vs 2.5%; risk difference, -2.0% [95% CI, -4.3% to 0.1%]). By day 90, a total of 94 patients (25.4%) in the intervention group and 84 (22.9%) in the control group had been readmitted for exacerbation of COPD (risk difference, 2.5% [95% CI, -3.9% to 8.9%]). Death from any cause occurred in 23 patients (6.2%) in the intervention group and 29 (7.9%) in the control group (risk difference, -1.7% [95% CI, -5.7% to 2.3%]). Major bleeding occurred in 3 patients (0.8%) in the intervention group and 3 patients (0.8%) in the control group (risk difference, 0% [95% CI, -1.9% to 1.8%]; P = .99). Conclusions and Relevance: Among patients hospitalized for an exacerbation of COPD, the addition of an active strategy for the diagnosis of PE to usual care, compared with usual care alone, did not significantly improve a composite health outcome. The study may not have had adequate power to assess individual components of the composite outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT02238639.
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Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Embolia Pulmonar/diagnóstico , Tromboembolia Venosa , Anciano , Causas de Muerte , Angiografía por Tomografía Computarizada/estadística & datos numéricos , Intervalos de Confianza , Progresión de la Enfermedad , Femenino , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Hemorragia/etiología , Hospitalización , Humanos , Masculino , Readmisión del Paciente , Enfermedad Pulmonar Obstructiva Crónica/terapia , Embolia Pulmonar/sangre , Embolia Pulmonar/etiología , Embolia Pulmonar/terapia , Recurrencia , España , Resultado del TratamientoRESUMEN
OBJECTIVES: To describe the changes in ventilator management over time in patients with neurologic disease at ICU admission and to estimate factors associated with 28-day hospital mortality. DESIGN: Secondary analysis of three prospective, observational, multicenter studies. SETTING: Cohort studies conducted in 2004, 2010, and 2016. PATIENTS: Adult patients who received mechanical ventilation for more than 12 hours. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among the 20,929 patients enrolled, we included 4,152 (20%) mechanically ventilated patients due to different neurologic diseases. Hemorrhagic stroke and brain trauma were the most common pathologies associated with the need for mechanical ventilation. Although volume-cycled ventilation remained the preferred ventilation mode, there was a significant (p < 0.001) increment in the use of pressure support ventilation. The proportion of patients receiving a protective lung ventilation strategy was increased over time: 47% in 2004, 63% in 2010, and 65% in 2016 (p < 0.001), as well as the duration of protective ventilation strategies: 406 days per 1,000 mechanical ventilation days in 2004, 523 days per 1,000 mechanical ventilation days in 2010, and 585 days per 1,000 mechanical ventilation days in 2016 (p < 0.001). There were no differences in the length of stay in the ICU, mortality in the ICU, and mortality in hospital from 2004 to 2016. Independent risk factors for 28-day mortality were age greater than 75 years, Simplified Acute Physiology Score II greater than 50, the occurrence of organ dysfunction within first 48 hours after brain injury, and specific neurologic diseases such as hemorrhagic stroke, ischemic stroke, and brain trauma. CONCLUSIONS: More lung-protective ventilatory strategies have been implemented over years in neurologic patients with no effect on pulmonary complications or on survival. We found several prognostic factors on mortality such as advanced age, the severity of the disease, organ dysfunctions, and the etiology of neurologic disease.
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Unidades de Cuidados Intensivos/estadística & datos numéricos , Enfermedades del Sistema Nervioso/mortalidad , Enfermedades del Sistema Nervioso/terapia , Respiración Artificial/métodos , Respiración Artificial/tendencias , Adulto , Factores de Edad , Anciano , Lesiones Traumáticas del Encéfalo/mortalidad , Lesiones Traumáticas del Encéfalo/terapia , Femenino , Accidente Cerebrovascular Hemorrágico/mortalidad , Accidente Cerebrovascular Hemorrágico/terapia , Mortalidad Hospitalaria/tendencias , Humanos , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/terapia , Tiempo de Internación/tendencias , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Ventilación no Invasiva/tendencias , Estudios Observacionales como Asunto , Estudios Prospectivos , Factores de Riesgo , Puntuación Fisiológica Simplificada Aguda , Traqueotomía/estadística & datos numéricos , Traqueotomía/tendencias , Desconexión del Ventilador/tendenciasRESUMEN
Among patients with pulmonary embolism (PE), various permutations of normal or abnormal cardiac troponin results and normal or abnormal echocardiographic right ventricular function are encountered in clinical practice. We aimed to explore whether there is a true gradient of risk based on troponin and echocardiographic results. This study included normotensive patients with PE from the PROgnosTic valuE of CT scan in hemodynamically stable patients with acute symptomatic pulmonary embolism (PROTECT) study. Patients were categorized as having -Troponin/-Echo, -Troponin/+Echo, +Troponin/-Echo, and +Troponin/+Echo. The primary outcome was 30-day "complicated course," including death from any cause, hemodynamic collapse, or recurrent PE. Secondary outcomes included individual adverse event rates. Of the 834 patients who had echocardiographic and troponin results, 569 patients (68%) had -Troponin/-Echo, 126 patients (15%) had -Troponin/+Echo, 74 patients (8.9%) had +Troponin/-Echo, and 65 patients (7.8%) had +Troponin/+Echo. The incidence of 30-day complicated course was 4.6% in patients with -Troponin/-Echo, 11.9% in patients with -Troponin/+Echo, 13.5% in patients with +Troponin/-Echo, and 16.9% in patients with +Troponin/+Echo (P for trend <0.001). In the subgroup of patients with a high-risk sPESI (i.e., intermediate-risk according to the ESC guidelines) (n = 527), the incidence of 30-day complicated course was 14.9% in patients with -Troponin/+Echo, 18.5% in patients with +Troponin/-Echo, and 17.5% in patients with +Troponin/+Echo (P for trend <0.01). In patiens with PE, there seems to be a risk gradient based on troponin and echocardiographic results. This study did not detect a significant risk difference in those with +Troponin/-Echo compared with -Troponin/+Echo.
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Embolia Pulmonar/sangre , Troponina/sangre , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Presión Sanguínea , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/fisiopatología , Función Ventricular DerechaRESUMEN
Limited information exists about the prevalence, management, and outcomes of intermediate-high risk patients with acute pulmonary embolism (PE). In a prospective cohort study, we evaluated consecutive patients with intermediate-high risk PE at a large, tertiary, academic medical center between January 1, 2015 and March 31, 2019. Adjudicated outcomes included PE-related mortality and a complicated course through 30 days after initiation of PE treatment. Repeat systolic blood pressure (SBP), heart rate (HR), brain natriuretic peptide (BNP), and cardiac troponin I (cTnI) measurements, and echocardiography were performed within 48 hours after diagnosis. Among 1,015 normotensive patients with acute PE, 97 (9.6%) had intermediate-high risk PE. A 30-day complicated course and 30-day PE-related mortality occurred in 23 (24%) and 7 patients (7.2%) with intermediate-high risk PE. Seventeen (18%) intermediate-high risk patients received reperfusion therapy. Within 48 hours after initiation of anticoagulation, normalization of SBP, HR, cTnI, BNP, and echocardiography occurred in 82, 86, 78, 72, and 33% of survivors with intermediate-high risk PE who did not receive immediate thrombolysis. A complicated course between day 2 and day 30 after PE diagnosis for the patients who normalized SBP, HR, cTnI, BNP, and echocardiography measured at 48 hours occurred in 2.9, 1.4, 4.5, 3.3, and 14.3%, respectively. Intermediate-high risk PE occurs in approximately one-tenth of patients with acute symptomatic PE, and is associated with high morbidity and mortality. Normalization of HR 48 hours after diagnosis might identify a group of patients with a very low risk of deterioration during the first month of follow-up.
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There remains limited information about the prevalence and outcomes of hemodynamic unstable patients with acute pulmonary embolism (PE). We performed a systematic review and meta-analysis of prospective registries that enrolled patients with acute PE to assess the prevalence and prognostic significance of hemodynamic instability for the primary outcome of short-term all-cause mortality, and the secondary outcome of short-term PE-related mortality. We also assessed the association between use of thrombolytic therapy versus no use and short-term outcomes in the subgroup of unstable patients. We used a random-effects model to pool study results; and I2 testing to assess for heterogeneity. The authors' search retrieved 4 studies that enrolled 1,574 patients with unstable PE (1,574/40,363; 3.9%; 95% confidence interval [CI], 3.7% to 4.1%). Hemodynamic instability had a significant association with short-term all-cause mortality (odds ratio [OR], 5.9; 95% CI, 2.7 to 13.0; I2â¯=â¯94%), and with PE-related death (OR, 8.2; 95% CI, 3.4 to 19.7). In unstable patients, thrombolytic therapy was associated with reduced odds of short-term all-cause mortality (OR, 0.69; 95% CI, 0.49 to 0.95), and PE-related death (OR, 0.66; 95% CI, 0.45 to 0.97). In conclusion, hemodynamic instability significantly increased the risk of death shortly after PE diagnosis. Use of thrombolytic therapy was associated with significantly reduced short-term mortality.
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Embolia Pulmonar/diagnóstico , Embolia Pulmonar/epidemiología , Enfermedad Aguda , Hemodinámica , Humanos , Prevalencia , Pronóstico , Embolia Pulmonar/complicaciones , Tasa de SupervivenciaRESUMEN
OBJECTIVES: The objective was to assess and compare the accuracy and interobserver reliability of the simplified Pulmonary Embolism Severity Index (sPESI) and the Hestia criteria for predicting short-term mortality in patients with pulmonary embolism (PE). METHODS: This prospective cohort study evaluated consecutive eligible adults with PE diagnosed in the emergency department (ED) at a large, tertiary, academic medical center in the era January 1, 2015, to December 30, 2017. We assessed and compared sPESI and Hestia criteria prognostic accuracy for 30-day all-cause mortality after PE diagnosis and their interobserver reliability for classifying patients as low risk or high risk. Two clinician investigators scored both prediction tools during the ED evaluation. We used the kappa statistic to test for agreement. RESULTS: The 488-patient cohort had a mean (±SD) age of 69.0 (±17.1) years and an approximately even sex distribution. The investigators classified one-quarter of patients as low risk using the sPESI and Hestia criteria (28% vs. 27%, respectively). During the 30-day follow-up, 31 of the 488 (6.4%) patients died. Patients classified as low risk according to the sPESI and the Hestia criteria had a similar 30-day mortality (sPESI 0.7% [1/135], 95% confidence interval [CI] = 0.0%-4.0%; Hestia 2.3% [3/132], 95% CI = 0.5%-6.5%). The two observers had good agreement (κ = 0.80) for the Hestia criteria and very good agreement (κ = 0.97) for the sPESI. CONCLUSION: The sPESI and the Hestia criteria had similar risk classification determination and prognostic accuracy for 30-day mortality after PE. However, the succinct and more objective sPESI had higher interobserver reliability than the Hestia criteria.
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Embolia Pulmonar/diagnóstico , Índice de Severidad de la Enfermedad , Anciano , Anciano de 80 o más Años , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Estudios Prospectivos , Embolia Pulmonar/mortalidad , Reproducibilidad de los Resultados , Medición de Riesgo , Factores de RiesgoRESUMEN
Fundamento y objetivos: Determinar la utilidad de la estratificación pronóstica empírica para identificar a pacientes con tromboembolia de pulmón (TEP) aguda sintomática y bajo riesgo de complicaciones precoces. Pacientes y métodos: Este estudio incluyó a un total de 154 pacientes consecutivos diagnosticados de TEP aguda sintomática en un hospital universitario terciario. Comparamos la capacidad pronóstica de la escala clínica Pulmonary Embolism Severity Index (PESI), la escala PESI simplificada (PESIs) y la evaluación empírica de: 1) 2médicos adjuntos (uno con y otro sin experiencia en el manejo de pacientes con TEP); 2) un residente de cuarto año de Neumología; 3) un residente de tercer año de Neumología, y 4) un residente de segundo año de Neumología. El evento primario de mal pronóstico fue la mortalidad por todas las causas durante el primer mes después del diagnóstico de la TEP. Resultados: Durante los primeros 30 días después del diagnóstico de la TEP se produjo el fallecimiento de 13 pacientes (8,4%; intervalo confianza [IC] del 95%, 4,1-12,8%). Hubo una tendencia (no estadísticamente significativa) a clasificar más pacientes de bajo riesgo mediante la escala PESI o la evaluación empírica que con la escala PESIs (36,4, 31,3 y 28,6%, respectivamente). No se produjo ningún evento en el grupo de pacientes de bajo riesgo según la escala PESIs. Se detectó una mayor eficacia pronóstica de la estratificación empírica conforme mayor fue la experiencia clínica de los evaluadores (84,6 vs. 92,3%; p = 0,049). Conclusiones: La escala PESIs es la herramienta más eficaz para identificar pacientes con TEP aguda sintomática y bajo riesgo de muerte por todas las causas durante el primer mes de seguimiento. La evaluación pronóstica empírica realizada por médicos experimentados no es menos eficaz que la realizada mediante escalas estandarizadas
Background and objective: To determine the accuracy of clinical gestalt to identify patients with acute symptomatic pulmonary embolism (PE) at low-risk for short-term complications. Patients and methods: This study included a total of 154 consecutive patients diagnosed with acute symptomatic PE in a tertiary university hospital. We compared the prognostic accuracy of the Pulmonary Embolism Severity Index (PESI), the simplified PESI (sPESI), and clinical gestalt of 1) 2senior physicians (one with and one without experience in the management of patients with PE), 2) a fourth-year resident of Pneumology, 3) a third-year resident of Pneumology, and 4) a second-year resident of Pneumology. The primary outcome was all-cause mortality during the first month after the diagnosis of PE. Results: Thirty-day all-cause mortality was 8.4% (13/154; 8.4%; 95% confidence interval [CI], 4.1-12.8%). The PESI and clinical gestalt classified more patients as low-risk, compared to the sPESI (36.4%, 31.3% y 28.6%, respectively). There were no deaths in the sPESI low-risk category (negative predictive value 100%). Prognostic accuracy increased with increasing experience (84.6 vs. 92.3%; P=.049). Conclusions: The sPESI showed the best accuracy at correctly identifying low-risk patients with acute symptomatic PE. Clinical gestalt is not inferior to standardized clinical prediction rules to prognosticate patients with acute PE
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Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Embolia Pulmonar/mortalidad , Pesos y Medidas , Pronóstico , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/complicaciones , Enoxaparina/administración & dosificación , Vitamina K/antagonistas & inhibidoresRESUMEN
BACKGROUND: Limited information exists about the epidemiology, management and outcomes of hemodynamically unstable patients with acute pulmonary embolism (PE). We aimed to evaluate the prevalence and outcomes of unstable PE, and to assess the acute management in routine clinical practice. METHODS: This study included 34,380 patients from the RIETE registry with PE between 2001 and 2016. Primary outcomes included all-cause and PE-specific 30-day mortality. We used multivariable adjustments to calculate hazard ratios among unstable patients who did and did not receive reperfusion. RESULTS: Overall, 1207 patients (3.5%) presented with hemodynamic instability. All-cause 30-day mortality was 14% and 5.4% in those with versus those without hemodynamic instability (Pâ¯<â¯0.001). Two hundred and thirty eight (20%) unstable patients received reperfusion therapy. After multivariable adjustment, reperfusion therapy was associated with non-significantly reduced 30-day all-cause mortality (hazard ratio [HR] 0.71; 95% CI, 0.45 to 1.10; Pâ¯=â¯0.12), and significantly reduced 30-day PE-related mortality (HR 0.56; 95% CI, 0.31 to 0.99; Pâ¯=â¯0.04). When limiting the adjusted analyses to unstable patients with right ventricular dysfunction, the difference was significant for both all-cause (HR 0.65; 95% CI, 0.42 to 1.00; Pâ¯=â¯0.05) and PE-related mortality (HR 0.52; 95% CI, 0.30 to 0.92; Pâ¯=â¯0.02). CONCLUSIONS: In a multinational registry of patients with PE, prevalence of hemodynamic instability was 3.5%, with high associated 30-day mortality rates. Although use of reperfusion was associated with lower mortality rates, particularly in patients with right ventricular dysfunction, it was used in only a fifth of patients.
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Hemodinámica/fisiología , Internacionalidad , Embolia Pulmonar/epidemiología , Embolia Pulmonar/mortalidad , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mortalidad/tendencias , Estudios Prospectivos , Embolia Pulmonar/terapia , Sistema de RegistrosRESUMEN
No disponible
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Humanos , Neoplasias/epidemiología , Tromboembolia Venosa/complicaciones , Embolia Pulmonar/etiología , Profilaxis Antibiótica/tendencias , Medición de Riesgo/métodos , Tromboembolia Venosa/inducido químicamente , Sociedades Médicas/normas , Recurrencia , Heparina de Bajo-Peso-Molecular/uso terapéuticoRESUMEN
The impact of adherence to published guidelines on the outcomes of patients with acute pulmonary embolism (PE) has not been well defined by previous studies.In this prospective cohort study of patients admitted to a respiratory department (n=2096), we evaluated whether patients with PE had better outcomes if they were acutely managed according to international guidelines. Outcomes consisted of all-cause mortality, PE-related mortality, recurrent venous thromboembolism (VTE) and major bleeding events during the first month of follow-up after diagnosis.Overall, 408 patients (19% (95% CI 18-21%)) did not receive guideline-adherent PE management. Patients receiving non-adherent management were significantly more likely to experience all-cause mortality (adjusted odds ratio (OR) 2.39 (95% CI 1.57-3.61) or PE-related mortality (adjusted OR 5.02 (95% CI 2.42-10.42); p<0.001) during follow-up. Non-adherent management was also a significant independent predictor of recurrent VTE (OR 2.19 (95% CI 1.11-4.32); p=0.03) and major bleeding (OR 2.65 (95% CI 1.66-4.24); p<0.001). An external validation cohort of 34â380 patients with PE from the RIETE registry confirmed these findings.PE management that does not adhere to guidelines for indications related to anticoagulation, thrombolytics and inferior vena cava filters is associated with worse patient outcomes.
Asunto(s)
Anticoagulantes/uso terapéutico , Fibrinolíticos/uso terapéutico , Manejo de Atención al Paciente , Embolia Pulmonar , Filtros de Vena Cava/estadística & datos numéricos , Tromboembolia Venosa , Anciano , Estudios de Cohortes , Femenino , Adhesión a Directriz/normas , Adhesión a Directriz/estadística & datos numéricos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Manejo de Atención al Paciente/métodos , Manejo de Atención al Paciente/normas , Manejo de Atención al Paciente/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Estudios Prospectivos , Embolia Pulmonar/etiología , Embolia Pulmonar/mortalidad , Embolia Pulmonar/terapia , Mejoramiento de la Calidad , Recurrencia , Unidades de Cuidados Respiratorios/estadística & datos numéricos , España , Tromboembolia Venosa/complicaciones , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/terapiaRESUMEN
To externally validate the prognostic impact of copeptin, either alone or integrated in risk stratification models, in pulmonary embolism (PE), we performed a post hoc analysis of 843 normotensive PE patients prospectively included in three European cohorts.Within the first 30â days, 21 patients (2.5%, 95% CI 1.5-3.8) had an adverse outcome and 12 (1.4%, 95% CI 0.7-2.5) died due to PE. Patients with copeptin ≥24â pmol·L-1 had a 6.3-fold increased risk for an adverse outcome (95% CI 2.6-15.5, p<0.001) and a 7.6-fold increased risk for PE-related death (95% CI 2.3-25.6, p=0.001). Risk classification according to the 2014 European Society of Cardiology (ESC) guideline algorithm identified 248 intermediate-high-risk patients (29.4%) with 5.6% (95% CI 3.1-9.3) at risk of adverse outcomes. A stepwise biomarker-based risk assessment strategy (based on high-sensitivity troponin T, N-terminal pro-brain natriuretic peptide and copeptin) identified 123 intermediate-high-risk patients (14.6%) with 8.9% (95% CI 4.5-15.4) at risk of adverse outcomes. The identification of patients at higher risk was even better when copeptin was measured on top of the 2014 ESC algorithm in intermediate-high-risk patients (adverse outcome OR 11.1, 95% CI 4.6-27.1, p<0.001; and PE-related death OR 13.5, 95% CI 4.2-43.6, p<0.001; highest risk group versus all other risk groups). This identified 85 patients (10.1%) with 12.9% (95% CI 6.6-22.0) at risk of adverse outcomes and 8.2% (95% CI 3.4-16.2) at risk of PE-related deaths.Copeptin improves risk stratification of normotensive PE patients, especially when identifying patients with an increased risk of an adverse outcome.
Asunto(s)
Glicopéptidos/sangre , Embolia Pulmonar/sangre , Embolia Pulmonar/diagnóstico , Medición de Riesgo/métodos , Anciano , Anciano de 80 o más Años , Algoritmos , Biomarcadores/sangre , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Curva ROC , Factores de RiesgoRESUMEN
BACKGROUND: In patients with acute pulmonary embolism (PE), studies have shown an association between coexisting deep vein thrombosis (DVT) and short-term prognosis. It is not known whether complete compression ultrasound testing (CCUS) improves the risk stratification of their disease beyond the recommended prognostic models. METHODS: We included patients with normotensive acute symptomatic PE and prognosticated them with the European Society of Cardiology (ESC) risk model for PE. Subsequently, we determined the prognostic significance of coexisting DVT in patients with various ESC risk categories. The primary endpoint was a complicated course after the diagnosis of PE, defined as death from any cause, haemodynamic collapse, or adjudicated recurrent PE. RESULTS: According to the ESC model, 37% of patients were low-risk, 56% were intermediate-low risk, and 6.7% were intermediate-high risk. CCUS demonstrated coexisting DVT in 375 (44%) patients. Among the 313 patients with low-risk PE, coexisting DVT (46%) did not show a significant increased risk of complicated course (2.8%; 95% confidence interval [CI], 0.8%-7.0%), compared with those without DVT (0.6%; 95% CI, 0%-3.2%), (Pâ¯=â¯0.18). Of the 478 patients with intermediate-low risk PE, a complicated course was 14% and 6.8% for those with and without DVT, respectively (Pâ¯=â¯0.01). Of the 57 patients that had intermediate-high risk PE, a complicated course occurred in 17% and 18% for those with and without DVT, respectively (Pâ¯=â¯1.0). CONCLUSIONS: In normotensive patients with PE, testing for coexisting DVT might improve risk stratification of patients at intermediate-low risk for short-term complications.
Asunto(s)
Embolia Pulmonar/etiología , Trombosis de la Vena/complicaciones , Enfermedad Aguda , Anciano , Femenino , Humanos , Masculino , Pronóstico , Estudios Prospectivos , Embolia Pulmonar/patología , Factores de Riesgo , Trombosis de la Vena/patologíaRESUMEN
For patients who have acute symptomatic pulmonary embolism (PE), risk of short-term death and adverse outcomes should drive the initial treatment decisions. Practice guidelines recommend that patients who have a high-risk of PE-related death and adverse outcomes, determined by the presence of haemodynamic instability (i.e., shock or hypotension), should receive systemically administered thrombolytic therapy. Intermediate-high risk patients might benefit from close observation, and some should undergo escalation of therapy beyond standard anticoagulation, particularly if haemodynamic deterioration occurs. Low-risk for adverse outcomes should lead to early hospital discharge or full treatment at home. Validated prognostic tools (i.e., clinical prognostic scoring systems, imaging studies, and cardiac laboratory biomarkers) assist with risk classification of patients who have acute symptomatic PE.