Higher accuracy of genotypic identification compared to phenotyping in the diagnosis of coagulase-negative staphylococcus infection in orthopedic surgery.

PURPOSE: To determine whether Repetitive Extragenic Palindromic PCR (rep-PCR) genotyping can improve the diagnosis of coagulase-negative staphylococcal (CoNS) orthopaedic infections in comparison to phenotyping. METHODS: Prospective study comparing the results of phenotypic/genotypic (rep-PCR) testing in patients with suspected CoNS infection. Each strain was analysed using both methods. Strains identified as identical in ≥2 samples were considered as pathogenic. RESULTS: 255 CoNS strains from 52 surgical episodes were included. Infection was diagnosed by phenotyping in 38(73%) cases and by genotyping in 40(77%). The Kappa index was 0.59. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for phenotyping (vs. rep-PCR) were: 88%, 75%, 92%, and 64%. 5/14(36%) of cases not considered as true infections by phenotyping were diagnosed as infections with genotyping. In a subgroup of 203 strains from 41 surgical procedures with orthopaedic implants, the kappa index was 0.68. Sensitivity, Specificity, PPV, and NPV for phenotyping were: 93%, 73%, 90% and 80%. Again, 2/10 episodes in which CoNS were considered non-infective by phenotyping were diagnosed as infected by genotyping. CONCLUSIONS: Rep-PCR genotyping can identify identical CoNS strains that differ in their phenotype and should be used as a complementary technique. One-third of infected cases may be misdiagnosed without genotypic analysis.

Differences in Hypotensive vs. Non-Hypotensive Sepsis Management in the Emergency Department: Door-to-Antibiotic Time Impact on Sepsis Survival.

BACKGROUND: Sepsis diagnosis can be incorrectly associated with the presence of hypotension during an infection, so the detection and management of non-hypotensive sepsis can be delayed. We aimed to evaluate how the presence or absence of hypotension, on admission at the emergency department, affects the initial management and outcomes of patients with community-onset severe sepsis. METHODS: Demographic, clinical, laboratory, process of care, and outcome variables were recorded for all patients, at the emergency department of our university hospital, who presented with community-onset severe sepsis, between 1 March and 31 August in three consecutive years. Patient management consisted of standardized bundled care with five measures: Detection, blood cultures and empirical antibiotics, oxygen supplementation and fluid resuscitation (if needed), clinical monitoring, and noradrenalin administration (if needed). We compared all variables between patients who had hypotension (mean arterial pressure <65 mmHg), on admission to the emergency department, and those who did not. RESULTS: We identified 153 episodes (84 (54.5%) men; mean age 73.6 ± 1.2; mean Sequential Organ Failure Assessment (SOFA) score 4.9 ± 2.7, and 41.2% hospital mortality). Hypotension was present on admission to the emergency department in 57 patients (37.2%). Hemodynamic treatment was applied earlier in patients who presented hypotension initially. Antibiotics were administered 48 min later in non-hypotensive sepsis (p = 0.08). A higher proportion of patients without initial hypotension required admission to the intensive care unit (ICU) (43.1% for patients initially hypotensive vs. 56.9% in those initially non-hypotensive, p < 0.05). Initial hypotension was not associated with mortality. A delay in door-to-antibiotic administration time was associated with mortality [OR 1.150, 95%CI: 1.043⁻1.268). CONCLUSIONS: Initial management of patients with community-onset severe sepsis differed according to their clinical presentation. Initial hypotension was associated with early hemodynamic management and less ICU requirement. A non-significant delay was observed in the administration of antibiotics to initially non-hypotensive patients. The time of door-to-antibiotic administration was related to mortality.

Fracción gamma del proteinograma y agudizaciones de la enfermedad pulmonar obstructiva crónica / Gamma globulin fraction of the proteinogram and chronic obstructive pulmonary disease exacerbations

Objetivos: Se pretende evaluar los niveles de la fracción de gammaglobulinas en suero como un marcador biológico para valorar la gravedad y predecir la mortalidad y nuevas agudizaciones en los pacientes ingresados por una agudización de la EPOC. Pacientes y métodos: El estudio VIRAE es una cohorte de pacientes ingresados por una agudización de probable causa infecciosa de la EPOC en un período de 2 años. Se analizaron los niveles de la fracción de gammaglobulinas del proteinograma en 120 pacientes. Se evaluaron los principales indicadores clínicos de gravedad. Se compararon las características principales en 2 grupos (mayor o menor de 6,6g/dl de la fracción gamma del proteinograma). Resultados: Los niveles de la fracción gamma del proteinograma se correlacionan con el valor del FEV1 (p=0,009), la PCR (p=0,04) y el número de reingresos a los 6 meses de la hospitalización (p=0,04). Se demuestra una buena asociación con la escala GOLD, el índice BODE y la escala de disnea de mMRC; y también con el tratamiento con corticoides orales y la oxigenoterapia domiciliaria. No hemos observado que sea un buen predictor de mortalidad, aun observando una mayor mortalidad al año del ingreso hospitalario en los pacientes con niveles bajos. Conclusiones: Los niveles de la fracción de gammaglobulinas en el proteinograma tienen una buena correlación con el FEV1. Además, se asocian a una mayor gravedad de los pacientes con EPOC. Este biomarcador sencillo puede ser útil para identificar pacientes de alto riesgo (AU)

Objectives: To evaluate the levels of the serum gamma globulin fraction in proteinograms as a biomarker to assess the severity, and to predict the mortality and new exacerbations in patients admitted for an exacerbation of a COPD. Patients and methods: The VIRAE study was carried out on a cohort of patients hospitalized for an exacerbation of probable infectious origin of COPD over a period of 2 years. The levels of the serum gamma globulin fraction were analyzed in the proteinogram of 120 patients. The main clinical indicators of severity were also evaluated. Key features were compared in 2 groups (gamma fraction in the proteinogram greater or less than 6.6g/dl). Results: The levels of the serum gamma fraction in the proteinogram correlated with the FEV1 (P=.009), the CRP (P=.04), and the number of readmissions after 6 months of hospitalization (P=.04). We observed a good association with the GOLD scale, the BODE index and the mMRC dyspnea scale; and also with treatment with oral corticoids and home oxygen therapy. We did not find it to be a good predictor of mortality, despite observing increased mortality rates one year after hospital admission in patients with low levels of the factor. Conclusions: The levels of the gamma globulin fraction in proteinograms has a good correlation with the FEV1. In addition, they are associated with a greater severity of patients with COPD. This simple biomarker may be useful in identifying high-risk patients (AU)

Gamma globulin fraction of the proteinogram and chronic obstructive pulmonary disease exacerbations. / Fracción gamma del proteinograma y agudizaciones de la enfermedad pulmonar obstructiva crónica.

OBJECTIVES: To evaluate the levels of the serum gamma globulin fraction in proteinograms as a biomarker to assess the severity, and to predict the mortality and new exacerbations in patients admitted for an exacerbation of a COPD. PATIENTS AND METHODS: The VIRAE study was carried out on a cohort of patients hospitalized for an exacerbation of probable infectious origin of COPD over a period of 2 years. The levels of the serum gamma globulin fraction were analyzed in the proteinogram of 120 patients. The main clinical indicators of severity were also evaluated. Key features were compared in 2 groups (gamma fraction in the proteinogram greater or less than 6.6g/dl). RESULTS: The levels of the serum gamma fraction in the proteinogram correlated with the FEV1 (P=.009), the CRP (P=.04), and the number of readmissions after 6 months of hospitalization (P=.04). We observed a good association with the GOLD scale, the BODE index and the mMRC dyspnea scale; and also with treatment with oral corticoids and home oxygen therapy. We did not find it to be a good predictor of mortality, despite observing increased mortality rates one year after hospital admission in patients with low levels of the factor. CONCLUSIONS: The levels of the gamma globulin fraction in proteinograms has a good correlation with the FEV1. In addition, they are associated with a greater severity of patients with COPD. This simple biomarker may be useful in identifying high-risk patients.

Rotura esplénica como complicación de una tuberculosis miliar / Spontaneous splenic rupture as a complication of extrapulmonary tuberculosis

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Pneumonia as comorbidity in chronic obstructive pulmonary disease (COPD). Differences between acute exacerbation of COPD and pneumonia in patients with COPD.

INTRODUCTION: Pneumonia is considered an independent entity in chronic obstructive pulmonary disease (COPD), to be distinguished from an infectious exacerbation of COPD. The aim of this study was to analyze the clinical characteristics and progress of the exacerbation of COPD (ECOPD) compared to pneumonia in COPD (PCOPD) patients requiring hospitalization. PATIENTS AND METHODS: Prospective, longitudinal, observational cohort study including 124 COPD patients requiring hospital admission for lower respiratory tract infection. Patients were categorized according to presence of ECOPD (n=104) or PCOPD (n=20), depending on presence of consolidation on X-ray. Demographic, clinical, laboratory, microbiological and progress variables were collected. RESULTS: Patients with ECOPD showed more severe respiratory disease according to the degree of obstruction (P<.01) and need for oxygen therapy (P<.05). PCOPD patients showed increased presence of fever (P<.05), lower blood pressure (P<.001), more laboratory abnormalities (P<.05; leukocytosis, elevated CRP, low serum albumin) and increased presence of crepitus (P<.01). Microbiological diagnosis was achieved in 30.8% of cases of ECOPD and 35% of PCOPD; sputum culture yielded the highest percentage of positive results, predominantly Pseudomonas aeruginosa. Regarding the progress of the episode, no differences were found in hospital stay, need for ICU or mechanical ventilation. CONCLUSIONS: Our data confirm clinical and analytical differences between ECOPD and PCOPD in patients who require hospital admission, while there were no differences in subsequent progress.

La neumonía como comorbilidad en la enfermedad pulmonar obstructiva crónica (EPOC). Diferencias entre la exacerbación aguda de la EPOC y la neumonía en los pacientes con EPOC / Pneumonia as comorbidity in chronic obstructive pulmonary disease (COPD). Differences between acute exacerbation of COPD and pneumonia in patients with COPD

Introducción: La neumonía se considera una entidad propia, diferente a la exacerbación de la enfermedad pulmonar obstructiva crónica (EPOC) de causa infecciosa. El objetivo de nuestro estudio fue analizar las características clínicas y la evolución según se presentara una agudización de la EPOC (AEPOC) o una neumonía (NEPOC) en los pacientes con EPOC que precisaban un ingreso hospitalario. Pacientes y métodos: Estudio de cohortes, prospectivo, longitudinal y observacional que incluyó 124 pacientes con EPOC que precisaron ingreso hospitalario por una infección respiratoria baja. Se categorizaron según presentaran una AEPOC (n = 104) o una NEPOC (n = 20), en función de la aparición de condensación radiológica. Recogida de variables demográficas, clínicas, de laboratorio, microbiológicas y evolutivas. Resultados: Los pacientes con AEPOC mostraban mayor gravedad de la enfermedad respiratoria según el grado de obstrucción (p < 0,01) y necesidad de oxigenoterapia crónica (p < 0,05). Los pacientes con NEPOC mostraban mayor presencia de fiebre (p < 0,05), mayor hipotensión arterial (p < 0,001), mayor alteración analítica (p < 0,05; leucocitosis, elevación de la PCR, hipoalbuminemia), así como mayor presencia de crepitantes (p < 0,01). El diagnóstico microbiológico se obtuvo en el 30,8% de los casos de AEPOC y en el 35% de las NEPOC, siendo el cultivo de esputo la técnica con mayor porcentaje de resultados positivos, mostrando una preponderancia de Pseudomonas aeruginosa. La evolución del episodio no mostró diferencias en la estancia hospitalaria, ni la necesidad de UCI o ventilación mecánica. Conclusiones: Nuestros datos confirman diferencias clínicas y analíticas entre una AEPOC y una NEPOC en los pacientes que precisan ingreso hospitalario, aunque sin diferencias en la evolución posterior

Introduction: Pneumonia is considered an independent entity in chronic obstructive pulmonary disease (COPD), to be distinguished from an infectious exacerbation of COPD. The aim of this study was to analyze the clinical characteristics and progress of the exacerbation of COPD (ECOPD) compared to pneumonia in COPD (PCOPD) patients requiring hospitalization. Patients and methods: Prospective, longitudinal, observational cohort study including 124 COPD patients requiring hospital admission for lower respiratory tract infection. Patients were categorized according to presence of ECOPD (n = 104) or PCOPD (n = 20), depending on presence of consolidation on X-ray. Demographic, clinical, laboratory, microbiological and progress variables were collected. Results: Patients with ECOPD showed more severe respiratory disease according to the degree of obstruction (P < .01) and need for oxygen therapy (P < .05). PCOPD patients showed increased presence of fever (P < .05), lower blood pressure (P < .001), more laboratory abnormalities (P < .05; leukocytosis, elevated CRP, low serum albumin) and increased presence of crepitus (P < .01). Microbiological diagnosis was achieved in 30.8% of cases of ECOPD and 35% of PCOPD; sputum culture yielded the highest percentage of positive results, predominantly Pseudomonas aeruginosa. Regarding the progress of the episode, no differences were found in hospital stay, need for ICU or mechanical ventilation. Conclusions: Our data confirm clinical and analytical differences between ECOPD and PCOPD in patients who require hospital admission, while there were no differences in subsequent progress

Prevalence and risk factors for meticillin-resistant Staphylococcus aureus in an acute care hospital and long-term care facilities located in the same geographic area / Prevalencia y factores de riesgo de Staphylococcus aureus resistente a meticilina en un hospital de agudos y cuatro centros sociosanitarios de una misma área geográfica

To determine the prevalence and risk factors (RF) for methicillin-resistant Staphylococcus aureus (MRSA) during stay in 1 acute care hospital (ACH) and 4 long-term care facilities (LTCF). After obtaining the informed consent, nasal and skin ulcer swabs were taken and a survey was conducted to determine RF for MRSA. Six hundred and ninety nine patients were included, 413 LTCF and 286 ACH patients and MRSA prevalence were 22.5% and 7.3% respectively. MRSA was located in the nares, skin ulcers, and in both in 61.4%, 21.1%, and 17.5%. Among MRSA carriers, 81% of the ACH and 66.7% of the LTCF patients were only colonized. The multivariate analysis for the ACH revealed the following factors to be associated with MRSA: referral from an LTCF (OR 4.84), pressure ulcers (OR 4.32), a Barthel score < 60 (OR 2.60), and being male (OR 5.21). For the LTCF: urinary catheterisation (OR 3.53), pressure ulcers (OR 2.44), other skin lesions (OR 2.64), antibiotic treatment in ≤ 6 months, (OR 2.23), previous MRSA colonization (OR 2.15), and a Barthel score <20 (OR 1.28). Molecular typing identified 2 predominant clones Q, P, present in all centres. No relationship was found between clones and antibiotic susceptibility. In conclusion: MRSA prevalence is high in all centres but is 3 times greater in LTCF. The risk factors most strongly associated with MRSA were pressure ulcers and a stay in an LTCF. We propose preventive isolation in these cases (AU)

El objetivo de este estudio es determinar la prevalencia y factores de riesgo de Staphylococcus aureus resistente a meticilina (SARM) en 1 hospital de agudos y 4 centros socio sanitarios (CSS) de la misma área geográfica. Después de obtener el consentimiento informado de los pacientes se efectuó un frotis nasal y de úlceras cutáneas a los pacientes ingresados en las 5 instituciones. Al mismo tiempo se pasó un cuestionario para establecer los factores de riesgo de SARM. Se estudiaron 699 enfermos, 413 en los CSS y 286 en el hospital. La prevalencia de SARM en los CSS fue del 22,5% y del 7,3% en el hospital. Las localizaciones fueron nasal 61,4%, úlceras de decúbito 21,1% y ambas localizaciones 17,5%. El 81% de los portadores de SARM en el hospital y el 66,7% en los CSS estaban exclusivamente colonizados. El análisis multivariado en el hospital mostró que eran factores independientemente asociados a SARM: proceder de un CSS o residencia (OR 4,84), tener úlceras de decúbito (OR 4,32), un índice de Barthel <60 (OR 2,60) y ser varón (OR 5,21). En los CSS los factores independientemente asociados a SARM eran el sondaje urinario (OR 3,53), las úlceras de decúbito (OR 2,44) y otras lesiones cutáneas (OR 2,64), haber tomado antibióticos en los últimos 6 meses (OR 2,23), la colonización previa por SARM (OR 2,15) y un índice de Barthel < 20 (OR 1,28). Mediante tipificación molecular se han identificado 2 clones epidémicos predominantes Q y P distribuidos en todos los centros. No se ha observado relación entre los genotipos y la sensibilidad antibiótica. Conclusión: La prevalencia de SARM es alta en los 5 centros, siendo en los CSS tres veces superior a la del hospital. Las úlceras de decúbito y proceder de un CSS son los factores más fuertemente asociados a SARM por lo que proponemos que un aislamiento preventivo en estos pacientes (AU)

Microbiological study of patients hospitalized for acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and the usefulness of analytical and clinical parameters in its identification (VIRAE study).

PURPOSE: Respiratory infection is the most common cause for acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). The aim of this work was to study the etiology of the respiratory infection in order to assess the usefulness of the clinical and analytical parameters used for COPD identification. PATIENTS AND METHODS: We included 132 patients over a period of 2 years. The etiology of the respiratory infection was studied by conventional sputum, paired serology tests for atypical bacteria, and viral diagnostic techniques (immunochromatography, immunofluorescence, cell culture, and molecular biology techniques). We grouped the patients into four groups based on the pathogens isolated (bacterial versus. viral, known etiology versus unknown etiology) and compared the groups. RESULTS: A pathogen was identified in 48 patients. The pathogen was identified through sputum culture in 34 patients, seroconversion in three patients, and a positive result from viral techniques in 14 patients. No significant differences in identifying etiology were observed in the clinical and analytical parameters within the different groups. The most cost-effective tests were the sputum test and the polymerase chain reaction. CONCLUSION: Based on our experience, clinical and analytical parameters are not useful for the etiological identification of COPD exacerbations. Diagnosing COPD exacerbation is difficult, with the conventional sputum test for bacterial etiology and molecular biology techniques for viral etiology providing the most profitability. Further studies are necessary to identify respiratory syndromes or analytical parameters that can be used to identify the etiology of new AE-COPD cases without the laborious diagnostic techniques.

[Peripheral venous catheter-related bacteremia in a general hospital]. / Características de la bacteriemia relacionada con catéter venoso periférico en un hospital general.

INTRODUCTION: Catheter sepsis is a constant and serious problem in our hospitals for the cost it generates, both in terms of morbidity and economics. It's becoming more frequent also in peripherally inserted catheters. Our study aims to know the importance and characteristics of peripheral venous catheter bacteremia in a general hospital. MATERIAL AND METHODS: Prospective and comparative analysis of all episodes of central and peripheral venous catheter-related bacteraemia, in 2009. RESULTS: Twenty-eight episodes of catheter-related bacteraemia in a total of 25 patients. Sixteen episodes originated in central catheter (57.2%), 11 in peripheral (39.3%) and 1 in peripherally inserted central catheter (3.5%). Two cases of exitus directly related to the peripheral catheter infection. ETIOLOGY: 13 episodes of S. aureus (3 MRSA), including 8 in peripheral catheter (8/13, 61.5%), 12 episodes of plasma coagulase negative staphylococcus, including 2 in peripheral catheter (2/12, 16.6%). CONCLUSIONS: Peripheral catheter-related bacteraemia is an emerging health problem with important clinical and prognostic connotations for patients. It is necessary continuous training on correct handling measures to prevent intravascular catheters infections including peripheral catheters in every hospital ward.

Características de la bacteriemia relacionada con catéter venoso periférico en un hospital general / Peripheral venous catheter-related bacteremia in a general hospital

Introducción. La bacteriemia por catéter es un problema constante y grave en nuestros hospitales, por el coste que genera, tanto en términos de morbilidad como económico. Cada vez es más frecuente la bacteriemia originada en catéteres de inserción periférica. Nuestro trabajo pretende conocer la importancia y características de la bacteriemia de catéter venoso periférico en un hospital general. Material y métodos. Análisis prospectivo y comparativo de todos los episodios de infección de catéter venoso central y periférico, durante el año 2009. Resultados. 28 episodios de bacteriemia por catéter en 25 pacientes. Dieciséis episodios se originaron en catéter central (57,2%), 11 en periférico (39,3%) y 1 en catéter central de inserción periférica (3,5%). Hubo dos casos de fallecimiento relacionados directamente con la infección del catéter periférico. Etiología. 13 episodios por Staphylococcus aureus (3 S. aureus resistente a meticilina, SARM), de ellos 8 en catéter periférico (8/13; 61,5%), 12 episodios por estafilococo coagulasa negativo (ECN), de ellos 2 en periférico (2/12; 16,6%). Conclusiones. La bacteriemia relacionada con catéter periférico es un problema sanitario emergente con importantes connotaciones clínicas y pronósticas para los pacientes. Es necesaria una formación continuada sobre normas de actuación consensuadas para prevenir las infecciones de catéteres intravasculares incluidos los periféricos, en todos los dispositivos asistenciales hospitalarios(AU)

Introduction. Catheter sepsis is a constant and serious problem in our hospitals for the cost it generates, both in terms of morbidity and economics. It’s becoming more frequent also in peripherally inserted catheters. Our study aims to know the importance and characteristics of peripheral venous catheter bacteremia in a general hospital. Material and methods. Prospective and comparative analysis of all episodes of central and peripheral venous catheter- related bacteraemia, in 2009. Results. Twenty-eight episodes of catheter-related bacteraemia in a total of 25 patients. Sixteen episodes originated in central catheter (57.2%), 11 in peripheral (39.3%) and 1 in peripherally inserted central catheter (3.5%). Two cases of exitus directly related to the peripheral catheter infection. Etiology: 13 episodes of S. aureus (3 MRSA), including 8 in peripheral catheter (8/13, 61.5%), 12 episodes of plasma coagulase negative staphylococcus, including 2 in peripheral catheter (2/12, 16.6%). Conclusions. Peripheral catheter-related bacteraemia is an emerging health problem with important clinical and prognostic connotations for patients. It is necessary continuous training on correct handling measures to prevent intravascular catheters infections including peripheral catheters in every hospital ward(AU)

Sistema formativo MIR: propuesta de cambios para la adecuación a las necesidades del modelo sanitario / No disponible

No disponible

Efficacy of three different valve systems of needle-free closed connectors in avoiding access of microorganisms to endovascular catheters after incorrect handling.

OBJECTIVE: Disinfectable needle-free closed connectors were designed to avoid needle-stick injuries and to be easily disinfected before handling. Workloads or lack of knowledge, however, could impede the correct handling of these devices, allowing endoluminal catheter colonization. The aim of our study was to assess the barrier effect of different disinfectable needle-free closed connectors during correct and incorrect handling using an experimental model. DESIGN: We used a model consisting of a blood culture bottle with a peripheral venous catheter inserted under sterile conditions. Three different disinfectable needle-free closed connectors with different valve designs (microClave, Bionector, and Smartsite plus) were used to close the catheters. The external surfaces of the disinfectable needle-free closed connectors were contaminated with different concentrations of a Staphylococcus epidermidis culture broth. After contamination, 10 units of each connector and each concentration were assigned to the correct handling group (cleaned with 70% ethylic alcohol before handling) and the same number to the incorrect handling group (handled without disinfection) with a total of 180 bottles. RESULTS: Increases in concentrations of external contamination and incorrect handling of the connectors resulted in an increase in connectors' permeability to the pass of microorganisms to the endoluminal way. MicroClave proved the best barrier in the experimental conditions described. CONCLUSION: The barrier effect of disinfectable needle-free closed connectors is adversely affected by incorrect handling, the quantity of external valve colonization, and the valve design.

Evaluación crítica de las guías de práctica clínica / Critical evaluation of clinical practice guidelines

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Clinical outcome of patients with venous thromboembolism and renal insufficiency. Findings from the RIETE registry.

There is little information on the clinical outcome of patients with venous thromboembolism and renal insufficiency. RIETE is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE). In this analysis we analyzed the three-month outcome in patients with creatinine clearance (CrCl) <30 ml/min. As of March 2007, 1,037 of the 18,251 (5.7%) patients enrolled in RIETE had CrCl <30 ml/min. During the three-month study period these patients had an increased incidence of fatal bleeding, fatal PE, and overall death compared to those with CrCl >30 ml/min. Of the 579 patients presenting with clinically overt PE, 52 (9.0%) died of the initial PE, 13 (2.2%) of recurrent PE, and nine (1.6%) died of bleeding complications. During the first 15 days of therapy the 10% incidence of fatal PE was 10-fold their 1.0% of fatal bleeding. From day 16 to 90, the 1.0% rate of fatal PE was not significantly higher than the 0.5% of fatal bleeding. Of the 458 DVT patients with CrCl <30 ml/min, 14 (3.1%) had fatal bleeding and only one (0.2%) died of PE. In patients with CrCl <30 ml/min presenting with clinically overt PE the main threat is PE itself. On the contrary, in those with DVT the main threat is bleeding.