Dolores Nauffal

Home treatment in pulmonary embolism

BACKGROUND Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE). METHODS We conducted a multicenter randomized clinical trial in acute symptomatic PE to compare the efficacy and safety of early discharge versus standard hospitalization. A clinical prediction rule was used to identify low-risk patients. All patients were followed for three months. The primary outcomes were venous thromboembolic recurrences, major and minor bleeding, and overall mortality. RESULTS One hundred and thirty two low-risk patients with acute symptomatic PE were randomized to early discharge (n=72) or standard hospitalization (n=60). Overall mortality was 4.2% (95% CI, 0.5-8.9) in the early discharge group and 8.3% (95% CI, 1.1-15) in the standard hospitalization group (Relative Risk (RR) 0.5; 95% confidence interval [CI], 0.12-2.01). Non-fatal recurrences were 2.8% (95% CI, 1.1-6.6) in the early discharge group and 3.3% (95% CI, 1.3-8%) in the standard hospitalization group (RR 0.8; 95% CI, 0.12-5.74). The rates of clinically relevant bleeding were 5.5% in the early discharge group and 5% in the standard hospitalization group (P=0.60). Short-term mortality was 2.8% (95% CI, 0.8-9.6%) in the early discharge group as compared with 0% in the standard hospitalization group. Based on the rate of short-term death in a carefully selected population, the study was suspended. CONCLUSIONS In spite of the number of complications in patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. The rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE. The accuracy of clinical prediction scores needs to be validated in well designed clinical trials. (ClinicalTrials.gov number, NCT00214929.).

Vocal cord paresis and diaphragmatic dysfunction are severe and frequent symptoms of GDAP1-associated neuropathy

Cranial nerve involvement in Charcot-Marie-Tooth disease (CMT) is rare, though there are a number of CMT syndromes in which vocal cord paralysis is a characteristic feature. CMT disease due to mutations in the ganglioside-induced differentiation-associated protein 1 gene (GDAP1) has been reported to be associated with vocal cord and diaphragmatic palsy. In order to address the prevalence of these complications in patients with GDAP1 mutations we evaluated vocal cord and respiratory function in nine patients from eight unrelated families with this disorder. Hoarseness of the voice and inability to speak loudly were reported by eight patients and one had associated symptoms of respiratory insufficiency. Patients were investigated by means of peripheral and phrenic nerve conduction studies, flexible laryngoscopy, pulmonary function studies and polysomnography. Nerve conduction velocities and pathological studies were compatible with axonal CMT (CMT2). Flexible laryngoscopy showed left vocal cord palsy in four cases, bilateral cord palsies in four cases and was normal in one case. Restrictive respiratory dysfunction was seen in the eight patients with vocal cord paresis who were all chair-bound. These eight had confirmed phrenic nerve dysfunction on neurophysiology evaluation. The patient with normal vocal cord and pulmonary function had a less severe clinical course.This study shows that CMT patients with GDAP1 mutations develop severe disability due to weakness of limb muscles and that laryngeal and respiratory muscle involvement occurs late in the disease process when significant proximal upper limb weakness has developed. The early and predominant involvement of the left vocal cord innervated by the longer left recurrent laryngeal nerve suggests a length dependent pattern of nerve degeneration. In GDAP1 neuropathy, respiratory function should be thoroughly investigated because life expectancy can be compromised due to respiratory failure.

Short-term clinical outcome after acute symptomatic pulmonary embolism

Though studies have identified clinical variables that predict adverse events in patients with acute pulmonary embolism (PE), they have typically not differentiated short-term from long-term predictors. This multicenter prospective cohort study included consecutive outpatients with objectively confirmed symptomatic acute PE. We analyzed the incidence and time course of death, venous thromboembolism (VTE) recurrence, and major bleeding, and we compared event rates during short-term (first week) and long-term (3 months) follow-up after the diagnosis of PE. We also assessed risk factors for short-term mortality. During the first three months after diagnosis of PE, 142 of 1,338 (10.6%) patients died. Thirty-six deaths (2.7%) occurred during the first week after diagnosis of PE, and 61.1% of these were due to PE. Thirty-eight patients (2.8%) had recurrent VTE during the three-month follow-up, though none of the recurrences occurred during the first week after diagnosis of PE. During the three-month follow-up, major bleeding occurred in 48 patients (3.6%). Twenty-one (1.6%) major bleeds occurred during the first week of follow-up, and nine of these were fatal. Short-term mortality was significantly increased in patients who initially presented with systolic arterial hypotension (odds ratio [OR] 3.35; 95% CI, 1.51-5.41) or immobilization due to a medical illness (OR 2.89; 95% confidence interval [CI], 1.31-6.39). In conclusion, during the first week after the diagnosis of PE, death and major bleeding occur more frequently than recurrent VTE. Patients with systolic arterial hypotension and immobilization at the time of PE diagnosis had an increased risk of short-term mortality.

A Clinical Prediction Rule for Identifying Short-Term Risk of Adverse Events in Patients With Pulmonary Thromboembolism

OBJECTIVE To identify patients with a low short-term risk of complications following acute pulmonary thromboembolism. PATIENTS AND METHODS A prospective multicenter study was conducted in 8 Spanish hospitals; 681 consecutive outpatients diagnosed with pulmonary thromboembolism were enrolled. Clinically significant variables were weighted using coefficients derived from a logistic regression model in order to optimize the diagnostic performance of a clinical prediction rule to predict the following complications within 10 days of acute pulmonary thromboembolism: death, recurrent thromboembolism, and major or minor bleeding. RESULTS Forty-three patients (6.3%) had 51 complications. These included 33 deaths, 12 major bleeding episodes, and 6 minor bleeding episodes. The clinical variables used in the prediction rule were assigned the following scores: recent major bleeding episode and cancer with metastasis, 4 points each; creatinine levels of over 2 mg/dL, 3 points; cancer without metastasis and immobility due to a recent medical condition, 2 points each; and absence of surgery in the past 2 months and an age of over 60 years, 1 point each. A risk score of 2 or less, obtained by 47.8% of patients, indicated a low short-term risk of developing complications following pulmonary thromboembolism. The area under the receiver operating characteristic curve for the prediction rule was 0.75 (95% confidence interval [CI], 0.67-0.83). For this cutoff point, sensitivity was 82.9% (95% CI, 68.7-91.5) and the likelihood ratios for a positive and negative test result were 1.63 (95% CI, 1.39-1.92), and 0.35 (95% CI, 0.18-0.69), respectively. CONCLUSIONS Our clinical prediction rule could be useful for identifying patients with a low risk of complications in the 10 days following acute pulmonary thromboembolism. Those patients would be eligible for consideration for outpatient treatment.

Echocardiographic assessment of pulmonary arterial pressure in the follow-up of patients with pulmonary embolism

BACKGROUND Echocardiography remains a clinically useful screening test for chronic thromboembolic pulmonary hypertension (CTEPH) in patients with a history of pulmonary embolism (PE). To devise an effective screening strategy, the definition of a high-risk group is necessary. METHODS We examined a total of 744 patients with acute symptomatic pulmonary embolism (PE) who were enrolled in a Spanish multicenter study. Patients were monitored every 6months during the first two years, and then once a year thereafter. Transthoracic echocardiography was used to screen patients with a clinical suspicion of CTEPH during follow-up. Pulmonary arterial hypertension was defined as an estimated pulmonary artery systolic pressure (PAP)>50mm Hg. The index thromboembolic episode was considered severe if: (a) the patient was immobilized for medical reasons; or (b) systolic blood pressure was less than 90mm Hg; or (c) troponin T values were above the reference range. RESULTS The incidence of PAP>50mm Hg at 36months was 8.3% (95% confidence interval=4.6%-14.5%). Statistical analysis showed a highly significant association between a severe index thromboembolic episode and the subsequent detection of PAP>50mm Hg on echocardiography, with high positive likelihood ratio (2.40) and negative predictive value (>0.97). CONCLUSIONS Patients with a severe index thromboembolic episode would constitute a high-risk group for the development of CTEPH. This group of patients should be subjected to a strict follow-up protocol.

Complicaciones precoces en pacientes con embolia de pulmón

Fundamento y objetivo: Las complicaciones precoces mas graves de la embolia pulmonar (EP) son la mortalidad, las recidivas y las hemorragias. Los objetivos de este estudio fueron conocer cuales son las complicaciones mas frecuentes y los factores a ellas asociados en los primeros 10 dias siguientes al diagnostico de EP. Pacientes y metodo: Se incluyo prospectivamente en el estudio a todos los pacientes ingresados por sospecha de EP entre diciembre de 2003 y agosto de 2004, procedentes de 8 hospitales. Se evaluo la aparicion de complicaciones durante los primeros 10 dias. Las variables clinicas recogidas se incluyeron en el Registro Informatizado de la Enfermedad Tromboembolica en Espana (RIETE). El analisis estadistico se realizo mediante las pruebas de la *2 y de la t de Student para la comparacion de los grupos segun presentaran o no complicaciones; se efectuo un analisis multivariado para averiguar que factores estaban relacionados con la aparicion de complicaciones. Resultados: El numero de pacientes fue de 681, 336 hombres y 345 mujeres, edad media 66 y 70 anos, respectivamente. En los primeros 10 dias, 33 (4,8%) fallecieron y 22 (3,2%) presentaron alguna hemorragia. No hubo ninguna recidiva de la EP. El antecedente de inmovilizacion y la presencia de insuficiencia respiratoria, de un cancer o de insuficiencia renal fueron las variables asociadas con mas frecuencia a la aparicion de complicaciones. La cirugia y el dolor toracico fueron las asociadas a menos complicaciones. Conclusiones: La frecuencia de presentacion de complicaciones precoces de la EP y una parte de los factores asociados a ellas coinciden con los ya conocidos. Sin embargo, este estudio demuestra que otros factores como la cirugia previa o el dolor toracico protegen a los pacientes frente a su aparicion.

Recurrence of venous thromboembolism in patients with recent gestational deep vein thrombosis or pulmonary embolism: Findings from the RIETE Registry

INTRODUCTION The aim of this study was to investigate the recurrence rate of venous thromboembolism (VTE) and the prevalence of major bleeding or death in patients with previous VTE in pregnancy and puerperium. Risk factors for VTE recurrence were also assessed. MATERIALS AND METHODS We evaluated a cohort of patients enrolled in the international, multicenter, prospective Registro Informatizado de la Enfermedad Trombo-Embólica (RIETE) registry with objectively confirmed VTE. RESULTS In the registry, 607 women were presenting with VTE that occurred during pregnancy or puerperium. The 2-year VTE recurrence rate was 3.3% (CI: 95 1.5-5.0%) and the recurrent VTE incidence rate was 2.28events/100 patients-year. Among the 16 cases of VTE recurrence 11 cases appeared during drug treatment while only five cases were diagnosed after therapy discontinuation. No significant difference was found in treatment duration among these two subgroups of VTE recurrence cases and women without recurrence. Furthermore, the use of thrombolytics and inferior vena cava filter in initial treatment was associated to an increased risk of VTE recurrence. CONCLUSIONS The current study provides new insights on VTE recurrence rate in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) that occurred in pregnancy or postpartum period. These findings can contribute to risk assessment of thrombotic burden, thereby allowing for better decision making regarding antithrombotic management in this clinical setting.

Venous thromboembolism in patients immobilised at home

The natural history of venous thromboembolism (VTE), its impact on outcome and the rationale for prophylaxis are well established for hospitalised, acutely ill medical patients [1–10], but are less clear for nonhospitalised immobilised patients. Current guidelines for antithrombotic therapy recommend the use of prophylaxis in hospitalised, acutely ill medical patients, and suggest against its use in chronically immobilised persons at home and in patients with isolated lower-leg injuries requiring leg immobilisation [11]. However, there are no suggestions on the use of VTE prophylaxis in acutely ill medical patients immobilised at home. Fatal PE after immobility at home was more frequent than after immobility in hospital http://ow.ly/J0UIr

Factors Associated with elevated Pulmonary Arterial Pressure Levels on the Echocardiographic Assessment in Patients with Prior Pulmonary Embolism

BACKGROUND Factors associated with the detection of raised systolic pulmonary artery pressure (sPAP) levels in patients with a prior episode of pulmonary embolism (PE) are not well known. METHODS We used the RIETE Registry database to identify factors associated with the finding of sPAP levels ≥50 mm Hg on trans-thoracic echocardiography, in 557 patients with a prior episode of acute, symptomatic PE. RESULTS Sixty-two patients (11.1%; 95% CI: 8.72-14.1) had sPAP levels ≥50 mm Hg. These patients were more likely women, older, and more likely had chronic lung disease, heart failure, renal insufficiency or leg varicosities than those with PAP levels <50mm Hg. During the index PE event, they more likely had recent immobility, and more likely presented with hypoxemia, increased sPAP levels, atrial fibrillation, or right bundle branch block. On multivariate analysis, women aged ≥70 years (hazard ratio [HR]: 2.0; 95% CI: 1.0-3.7), chronic heart or chronic lung disease (HR: 2.4; 95% CI: 1.3-4.4), atrial fibrillation at PE presentation (HR: 2.8; 95% CI: 1.3-6.1) or varicose veins (HR: 1.8; 95% CI: 1.0-3.3) were all associated with an increased risk to have raised sPAP levels. Chronic heart disease, varicose veins, and atrial fibrillation were independent predictors in women, while chronic heart disease, atrial fibrillation, a right bundle branch block or an S1Q3T3 pattern on the electrocardiogram were independent predictors in men. CONCLUSIONS Women aged ≥70 years more likely had raised sPAP levels than men after a PE episode. Additional variables influencing this risk seem to differ according to gender.

Tomografía computarizada o gammagrafía en el diagnóstico de la embolia pulmonar

La gammagrafia de ventilacion-perfusion pulmonar (GVP) ha sido hasta la actualidad la tecnica no invasiva de imagen esencial en el diagnostico de la embolia de pulmon (EP). Sin embargo, sus limitaciones, por una parte, y la gran resolucion alcanzada por la tomografia computarizada (TC) multidetectora del torax, por otra, han contribuido a relegarla a un segundo termino en el proceso diagnostico de la enfermedad. El estudio PIOPED, acronimo en ingles de Investigacion Prospectiva en el Diagnostico de la EP, establecio los criterios de probabilidad gammagrafica alta, intermedia y baja de EP mediante la evaluacion conjunta de la GVP y de la radiografia de torax. Las conclusiones obtenidas fueron las siguientes: a) una GVP normal descarto la posibilidad de EP en la mayor parte de los pacientes; b) el valor predictivo positivo (VPP) de la GVP de alta probabilidad fue del 87%, y c) la GVP establecio o descarto el diagnostico de EP en el 52% de los pacientes con una radiografia normal. Dados estos resultados, junto con el hecho de que la GVP es una prueba no invasiva y segura, y que la TC no se habia aplicado todavia al estudio vascular pulmonar, aquella se convirtio en la primera tecnica a realizar a todos los pacientes con sospecha de EP. Sin embargo, el mismo PIOPED mostro sus limitaciones: a) la gran mayoria de los pacientes tenian una GVP de probabilidad intermedia; b) la GVP fue de alta probabilidad unicamente en el 41% de los casos en que se confirmo la EP en la angiografia, la prueba de referencia en esta enfermedad; c) el 64% de los pacientes con GVP anormal no tenian EP en la angiografia, y d) la variabilidad interobservador en su interpretacion fue muy alta, de un 30%, en los casos de baja probabilidad, para descender al 10% cuando la GVP era de alta probabilidad. Posteriormente los mismos autores del estudio encontraron que el VPP de la GVP mejoraba cuando la probabilidad clinica de presentar la enfermedad era mayor. Asi, la posibilidad de tener una EP con una GVP de baja probabilidad es del 4% cuando la probabilidad clinica es pequena, pero llega al 40% si esta es elevada; cuando la GVP es de probabilidad intermedia y la probabilidad clinica es baja, el riesgo de presentar una EP es del 16%, y del 66% si la probabilidad clinica es alta; con la GVP de alta probabilidad y una probabilidad clinica pequena, la posibilidad de EP es del 56%, pero si la probabilidad clinica es elevada llega a ser del