Prevalence of the use of antidepressants in patients with venous thromboembolism / Prevalencia del uso de antidepresivos en pacientes con enfermedad tromboembólica venosa.

OBJECTIVE: To estimate the prevalence of Antidepressant use in patients with a history of venous thromboembolism (VTE). Describe the patient's characteristics and which drugs are the most prescribed. METHODS: A cross-sectional study involving a consecutive sample of patients included in the Registro de Enfermedad Tromboembólica (RIET) from the Hospital Italiano de Buenos Aires in a period between 01/01/2014 to 01/09/2018. All patients presented symptomatic VTE and confirmed diagnosis. Drugs considered included in this study were: Selective Serotonin Reuptake Inhibitors (SSRI), Dopamine and Norepinephrine Reuptake Inhibitors (NDRI), Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) and Tricyclic antidepressants (TCA). RESULTS: From a total of 2373 patients with VTE, 472 were active users of antidepressants, showing a prevalence of antidepressant use of 19.9% (CI 95%). The most frequently prescribed drugs by drug classification were: SSRI 83.9%, TCA 20.5%, ISRN 14.6%, and NDRI 2.5%. Patients presented a median age of 76 years, predominantly women (71.4%), with several comorbidities: 52.24% arterial hypertension, 37.29% overweight, and 34.75% history of smoking. Concerning relevant history, we observed: 29.03% active oncologic disease, 26.27% major surgery before the VTE, and 21.61% previous VTE. CONCLUSION: The prevalence of antidepressant use in patients with VTE is 19.9%, superior by far to that of the general population. Depression is a major cause of morbidity worldwide, and its prevalence is increasing over the years.

OBJETIVOS: Estimar la prevalencia de consumo de fármacos antidepresivos en pacientes que hayan sufrido un evento tromboembólico venoso (TEV), describir esta población y las drogas más utilizadas. MATERIAL Y MÉTODOS: Corte transversal que incluyó una muestra consecutiva de adultos incluidos en el Registro de Enfermedad Tromboembólica (RIET) del Hospital Italiano de Buenos Aires entre el 01/01/2014 y el 1/09/2018. Se consideraron los siguientes fármacos: Inhibidores Selectivos de la Recaptación de Serotonina (IRSS), Inhibidores de la Recaptación de Dopamina y Noradrenalina (IRDN), Inhibidores de la Recaptación de Serotonina y Noradrenalina (IRSN), y Antidepresivos Tricíclicos (ATC). RESULTADOS: De un total de 2373 pacientes, 472 se identificaron como usuarios activos de antidepresivos, arrojando una prevalencia de 19,9% (IC95% de 18,3-21,6). Según familia farmacológica, en orden de mayor a menor frecuencia, se indicaron: IRSS 83,9%, ATC 20,5%, IRS 14,6% e IRDN y IRDN 2,5%. Los pacientes bajo tratamiento con antidepresivos presentaron una mediana de edad de 76 años, mayoritariamente mujeres (71,4%), con alta carga de comorbilidad: 52,24% hipertensión arterial, 37,29% sobrepeso, 34,75% ex tabaquismo. Los antecedentes de mayor frecuencia resultaron enfermedad oncológica activa (29,03%), cirugía mayor en último mes (26,27%), y el 21,61% presentaba ETV previa. CONCLUSIONES: La prevalencia de uso de antidepresivos en pacientes con ETV resultó 19,9%, superior a la población general. La depresión es una causa principal de enfermedad y discapacidad en todo el mundo, cuya prevalencia aumentó durante los últimos años.

Hospitalization for venous thromboembolic disease management: a 10 years Registry in Buenos Aires, Argentina.

Venous thromboembolism (VTE) is the most frequent cause of preventable mortality in hospitalized patients and the third leading cause of mortality due to vascular diseases. We aim to describe patients with VTE who required hospitalization, their clinical characteristics, management and evolution after discharge. Prospective cohort which included patients with acute and symptomatic VTE who required hospitalization in a single tertiary center for their management in a 10 years´ period (between 2006 and 2016). Patients were included at the time of VTE diagnosis; we collected baseline characteristics, risk stratification and initial therapeutic approach. They were periodically, prospectively and systematically followed up to evaluate recurrence, bleeding and/or death. Time-to-event analysis was performed for these outcomes related to evolucion after discharge. 3457 confirmed VTE episodes were included for the analysis (1985 DVT, 930 PE and 542 DVT + DVT), corresponding to 3157 patients. Most were elderly, the median age was 68 years (SD 16) with a predominance of women 57% (1955). Most frequent predisposing factors were immobility (45%), active cancer (35%), recent surgery (33%), obesity (26%), recent hospitalization (22%) and previous VTE (21%). One-fourth of pulmonary embolism had sPESI 0 points. Mortality, recurrence and bleeding rates within 30 days were 14%, 10% and 5% respectively. High proportion of VTE require hospitalization for their management, even PE with low sPESI. Mortality and complication remain elevated. We encourage the development and maintenance of more VTE registries in Latin America, to fully understand local characteristics of this disease.

Clinical characteristics and outcomes of venous thromboembolic events after hallux valgus surgery: insights from the RIETE registry.

Hallux valgus surgery (HVS) is one of the most common orthopedic procedures, often occurring in older adults. Guidelines provide inconsistent recommendations about venous thromboembolism (VTE) prophylaxis after HVS and data are scarce regarding VTE presentation and outcomes in this population. We reported the clinical characteristics and outcomes of VTE following HVS among patients enrolled in Registro Informatizado Enfermedad TromboEmbolica (RIETE), a prospective multicenter VTE registry. We compared the findings with those of other patients in RIETE. Consecutive patients with VTE post HVS were included in the study. Baseline characteristics, administration of VTE prophylaxis prior to diagnosis, presenting symptoms and signs, risk factors for VTE, and 90-day outcomes including recurrent VTE, major bleeding and death were determined. A total of 54 patients with VTE post HVS were identified in RIETE [median age: 64 (interquartile range 56-71) years; 85.2% female] and were compared with 74,111 VTE patients who had not undergone HVS. Among those with VTE post HVS, 63.0% had received VTE prophylaxis, in contrast to 35.6% in the rest of the RIETE cohort. Simplified Pulmonary Embolism Severity Index was zero in 66.7% of the patients with pulmonary embolism post HVS and 33.3% of other RIETE patients (P = 0.011). Compared with other VTE patients, use of estrogens was higher in HVS group (13.0% vs 5.4%, P = 0.01). All patients with VTE post HVS (100%) and most of other VTE patients (99.6%) were treated with anticoagulation, most commonly with low-molecular weight heparins. In contrast to the rest of the patients in RIETE, the absolute number of all fatal and non-fatal outcomes at 90 days was zero in the post HVS group (i.e. no deaths, no recurrence of VTE, and no major bleeding). In a large registry of patients with VTE, all patients with VTE post HVS underwent anticoagulation. These patients had much better outcomes than the rest of VTE patients, with no deaths, recurrences or major bleeding events at 90-day follow-up.

Inhospital mortality among clinical and surgical inpatients recently diagnosed with venous thromboembolic disease.

Venous thromboembolism (VTE) is the most common cause of preventable mortality in hospitalized patients, and pulmonary embolism is responsible for 5-10 % of all hospital deaths. To estimate the hospital mortality in hospitalized patients who developed VTE during hospitalization. Prospective cohort of all adult inpatients >17 years admitted to the hospital between August 2006 and August 2013, and follow-up until discharge to measure death. VTE incident cases were captured prospectively from the Institutional Registry of Thromboembolic disease in a tertiary hospital care in Buenos Aires. In hospital global mortality and fatality rate of inpatients with VTE was calculated. The cumulative incidence of VTE was 1.8 % (95 % CI 1.77-1.93 %), representing 1.32 % (95 % CI 1.23-1.41 %) in the subgroup of surgical patients and 2.1 % (95 % CI 1.9-2.2 %) in clinical inpatients. The overall hospital mortality was 2.4 % (95 % CI 2.35-2.53); being 3.95 % (95 % CI 3.78-4.12) in clinical inpatients and 1.15 % (95 % CI 1.06-1.23) in surgical patients. The death in patients who had developed VTE, represented between 4 and 7 % of hospital deaths, and it increases with age in both clinical and surgical patients. In Argentina there are few data of hospital mortality in patients with VTE. This information is useful when assessing the need for resources for prevention, diagnosis and treatment in inpatients.

Prognosis of patients with suspected pulmonary embolism in Buenos Aires: a prospective cohort study.

BACKGROUND: The prognosis of patients with suspected pulmonary embolism (PE) in whom PE has been ruled out (RPE) is unclear. We aimed to evaluate survival and diagnosis of new cancer in suspected PE patients at follow up. METHODS: A prospective cohort study nested in a prospective Institutional Registry of Venous Thromboembolic Disease was performed between 2006 and 2011. This study was designed to evaluate all consecutive, incident cases of suspected PE in adults. The study was performed at the Hospital Italiano de Buenos Aires, a tertiary level hospital, in hospitalized patients and outpatients. Suspected PE cases were collected using a computerized system that alerts whenever a physician requests pulmonary angiography, angiotomography, or ventilation-perfusion scintigraphy. PE was defined by pre-specified criteria and RPE was defined when diagnostic tests were negative for PE. RESULTS: We included 1736 cases of suspected PE. The prevalence of PE was 29% (n = 504). There was no difference in the overall survival at 30 days and follow-up between PE and RPE patients. The presence of provoked or unprovoked venous thromboembolic disease in these patients did not affect survival. The main causes of death were PE in the confirmed PE group (60%), and neoplasm (42%) and sepsis (37%) in the RPE group. Survival at 90 days was 63% for PE (95% CI 58-67%) and 67% for RPE patients (95% CT 64-69%). At follow-up, there was no difference in diagnosis of new cancer between PE and RPE patients (2% vs 2%, p = 0.82), even when taking into account the unprovoked group. CONCLUSIONS: Even when the main cause of death in PE patients is PE itself, the overall mortality is similar between PE and RPE patients. The reason for this finding could be because of the more frequent and severe comorbidities in RPE than in PE patients. TRIAL REGISTRATION: HomeClinicalTrial.gov: NCT01372514.

Comparison of clinical outcomes of venous thromboembolic disease between outpatient and inpatient management.

Objectives: To compare the occurrence of death, bleeding, and recurrence according to inpatient or outpatient management of venous thromboembolic disease (VTE). Materials and methods: . Retrospective cohort that included a consecutive sampling of VTE consultations between 2016 and 2019 diagnosed in the Emergency Center of a private hospital in Argentina. Results: There were 1202 cases, 908 with isolated deep vein thrombosis (DVT), 205 with isolated pulmonary embolism (PE), and 89 cases of combined DVT - PE. 66% were women, with a median age of 77 years; 72% of cases were managed on an outpatient basis (n= 862). Comorbidities associated with hospitalization were obesity (p=0.03), chronic obstructive pulmonary disease (COPD) (p=0.01), heart failure (CHF) (p=0.01), chronic renal failure (CKD) (p=0.01), and cancer (p=0.01). At 90 days, the cumulative incidence of bleeding was 2.6% in inpatient compared to 2.9% in outpatient management (p=0.81); recurrence was 0% versus 0.9% (p=0.07), and mortality was 42.9% versus 18.9%, respectively (p=0.01). The HR for 90-day mortality in hospitalized patients adjusted for confounders (sex, age, type of VTE, obesity, CKD, CHF, COPD, and cancer) was 1.99 (95% CI 1.49-2.64; p=0.01). Conclusions: In this elderly, and predominantly female Argentine population, the 90-day mortality in patients hospitalized for VTE was higher than mortality in patients with outpatient management, without differences in recurrence or major bleeding.

Incidence rate of symptomatic venous thromboembolic disease in patients from a medical care program in Buenos Aires, Argentina: a prospective cohort.

BACKGROUND: The incidence of venous thromboembolic disease (VTED) is estimated to be, on average, 1-2 cases per 1,000 individuals per year worldwide. There are few data concerning the incidence rate (IR) of VTED in the Argentinean population at large.Our aim was to estimate the IR of VTED at the Italian Hospital Medical Care Program (IHMCP) in Buenos Aires, the most populous city in Argentina. METHODS: This prospective cohort study evaluated all consecutive incident cases of pulmonary thromboembolism (PTE) and deep vein thrombosis (DVT) confirmed in patients over the age of 17 who were members of the IHMCP from June 2006 to May 2012. Any patient who had an initial confirmed VTED episode and was a member of the IHMCP at the time of diagnosis was considered an incident case. RESULTS: There were 1,138 cases of VTED for 687,871 person-years of follow-up. The crude IR of VTED was 1.65 (95% CI: 1.56 to 1.75) per 1,000 person-years. The highest IR was found in subjects >80 years old (5.92 per 1,000 person years; 95% CI: 5.41 to 6.49).The IRs adjusted to the population of the city of Buenos Aires were 0.90 (95% CI: 0.84 to 0.95) for VTED, 0.71 (95% CI: 0.66 to 0.76) for DVT, and 0.34 (95% CI: 0.31 to 0.37) for PTE. CONCLUSIONS: VTED is a common health problem with a high IR in members of the IHMCP, especially the elderly. This is the first paper to report prospectively the cumulative incidence of VTED in Latin America.

[Venous thromboembolic prophylaxis. Guidelines for adults in Argentina]. / Guía de recomendaciones para la profilaxis de la enfermedad tromboembólica venosa en adultos en la Argentina.

The venous thromboembolic disease (VTD) in adults has a high morbidity and mortality. It can be also associated to disabling chronic conditions. In spite of this, prophylaxis in healthcare assistance is still underused. In this article, the available evidence in thromboprophylaxis was analyzed to offer recommendations (1) or suggestions (2) classified according to different levels of evidence (A, B or C). Different medical scenarios and types of thromboprophylaxis were analyzed. In major orthopedic surgeries low molecular weight heparins, LMWH, inhibitors of the Xa and IIa factors are recommended (1B) to be started during hospitalization and continued for 35 days in hip replacement surgery and for 10 days in total knee replacement surgery. Knee arthroscopy and spine surgery do not require pharmacologic treatment (2B) unless the patient has other risks factors for thrombosis. In such cases, LMWH are recommended. Non-surgical patients who have at least one risk factor should receive LMWH, NFH or fondaparinux (1B) if they are to be bedridden or unable to walk for three or more days. Patients undergoing neurosurgery or with intracranial hemorrhage should receive mechanic prophylaxis (2C), and accordingly they should start LMWH or NFH 24 to 72 hours afterwards (2C). The latter two drugs are recommended for critically ill patients. Patients with low risk for VTD undergoing other type of surgeries should be prescribed with mechanical prophylaxis (2C) and encouraged to walk promptly (2C), while those with high risk should be prescribed with LMWH or NFH (1B or 2C according to bleeding risk factors).

Thrombotic events following Covid-19 vaccines compared to Influenza vaccines.

IMPORTANCE: The actual risk of thrombotic events after Covid-19 vaccination is unknown. OBJECTIVE: To evaluate the risk of thrombotic events after Covid-19 vaccination. DESIGN: Retrospective cohort study which included consecutive adult patients vaccinated with the first dose of Covid-19 vaccine between January 1 and May 30, 2021, and a historic control group, defined as consecutive patients vaccinated with influenza vaccine between March 1 and July 30, 2019. SETTING: Hospital Italiano de Buenos Aires, a tertiary hospital in Argentina. PARTICIPANTS: Non-Hospitalized Adults vaccinated with the first dose of a Covid-19 vaccine. EXPOSURE: Vaccination with Covid-19 vaccines available during the study period: Gam-COVID-Vac (Sputnik), ChAdOx1 nCoV-19 (AstraZeneca/Oxford or Covishield), BBIBP-CorV (Beijing Institute of Biological Products) (Sinopharm). Active comparator group exposure was Influenza vaccine. MAIN OUTCOME: Primary endpoint was cumulative incidence of any symptomatic thrombotic event at 30 days, defined as the occurrence of at least one of the following: symptomatic acute deep venous thrombosis (DVT); symptomatic acute pulmonary embolism (PE); acute ischemic stroke (AIS); acute coronary syndrome (ACS) or arterial thrombosis. RESULTS: From a total of 29,985 adult patients who received at least a first dose of Covid-19 vaccine during study period and 24,777 who received Influenza vaccine in 2019, we excluded those who were vaccinated during hospitalization. We finally included 29,918 and 24,753 patients respectively. Median age was 73 years old (IQR 75-81) and 67% were females in both groups. Thirty six subjects in the Covid-19 vaccination group (36/29,918) and 15 patients in the Influenza vaccination group (15/24,753) presented at least one thrombotic event. The cumulative incidence of any thrombotic event at 30 days was 12 per 10,000 (95%CI 9-17) for Covid-19 group and 6 per 10,000 (95%CI 4-10) for Influenza group (p-value=0.022). CONCLUSIONS AND RELEVANCE: This study shows a significant increase in thrombotic events in subjects vaccinated with Covid-19 vaccines in comparison to a control group. The clinical implication of these findings should be interpreted with caution, in light of the high effectiveness of vaccination and the inherent risk of thrombosis from Covid-19 infection itself.

Predictors of recurrence of venous thromboembolic disease after discontinuing of anticoagulation: a prospective cohort study. / Predictores de recurrencia de enfermedad tromboembólica venosa post suspensión de anticoagulación: estudio de cohorte prospectiva.

OBJECTIVE: We aim to evaluate factors associated with the recurrence of thromboembolic episodes among patients with a first episode of venous thromboembolic disease during anticoagulation treatment and at least one year after treatment suspension. METHODS: A prospective cohort of patients with a first episode of deep vein thrombosis confirmed by Doppler ultrasound and initiated anticoagulation treatment. Participants were registered in the Institutional Registry of Thromboembolic Disease between June 2015 and March 2019. Patients with cancer, with permanent inferior vena cava filter implant, and those who refused to participate or did not provide informed consent were excluded. All patients were evaluated within treatment at 30 days and at least one year after the suspension of anticoagulation with a D-dimer study and an ultrasound. All patients were evaluated for recurrence, bleeding (major and minor), and death. RESULTS: A total of 304 patients were recruited during the study period. Seventy-three percent were female, and the median age was 80 years. The rate of recurrence rate during anticoagulation treatment was 5% (N = 16/303; 95% confidence interval: 3 to 8), and 5% during post-suspension follow-up (N = 11/202; 95%CI: 3 to 9). The overall bleeding rate was 13% (N = 39; 95%CI: 9 to 17), and 5% for major bleeding. Patients who recurred had higher basal D-dimer mean, higher neutrophils and monocytes, and a higher prevalence of age-adjusted D-dimer ratio greater than 0.5 before discontinuation. In addition, they more frequently had complete leg involvement by ultrasound and received a shorter treatment. CONCLUSIONS: Although some baseline and pre-suspension parameters had a higher recurrence incidence, statistical significance was not reached, probably due to small statistical power and a short-term follow-up.

OBJETIVO: Evaluar factores asociados a la recurrencia de episodios tromboembólicos en pacientes con un primer evento de enfermedad tromboembólica venosa intra-tratamiento, al año de suspendida la anticoagulación. MÉTODO: Cohorte prospectiva con todos los pacientes consecutivos con un primer episodio de trombosis venosa profunda confirmado por eco Doppler, que iniciaron tratamiento anticoagulante incluidos en el Registro Institucional de Enfermedad Tromboembólica, entre junio de 2015 y marzo de 2019. Se excluyeron los pacientes con cáncer, con implante de filtro de vena cava inferior permanente y quienes se negaron a participar o no entregaron el consentimiento informado. Todos los pacientes fueron evaluados a los 30 días, pre-suspensión de anticoagulación con estudio de dímero D y la realización de una ecografía, y al menos un año de suspendida la anticoagulación. Todos los pacientes fueron evaluados para recurrencia, sangrado (mayor y menor) y muerte. RESULTADOS: Se reclutó a 304 pacientes durante el periodo de estudio. La tasa de recurrencia durante la anticoagulación fue de 5% (N = 16/303; intervalo de confianza 95%: 3 a 8), y durante el seguimiento post suspensión fue también 5% (N = 11/220; 95%: 2 a 9). La tasa de sangrado global fue del 13% (N = 39; 95%: 9 a 17), siendo mayor del 5% para sangrado. Los pacientes que recurrieron tenían una media más elevada de dímero D, neutrófilos, monocitos basales y mayor prevalencia de razón de dímero D ajustada por edad mayor a 0,5 previo a la suspensión. Además, presentaban más afectación de la pierna completa por ecografía y recibieron tratamiento anticoagulante de menor duración. CONCLUSIÓN: Si bien algunos parámetros basales y pre-suspensión dieron valores más altos, no se alcanzó significación estadística, probablemente debido al tamaño muestral y a la baja tasa de recurrencia post suspensión asociada al corto seguimiento.

Comparative clinical prognosis of massive and non-massive pulmonary embolism: A registry-based cohort study.

AIMS: Little is known about the prognosis of patients with massive pulmonary embolism (PE) and its risk of recurrent venous thromboembolism (VTE) compared with non-massive PE, which may inform clinical decisions. Our aim was to compare the risk of recurrent VTE, bleeding, and mortality after massive and non-massive PE during anticoagulation and after its discontinuation. METHODS AND RESULTS: We included all participants in the RIETE registry who suffered a symptomatic, objectively confirmed segmental or more central PE. Massive PE was defined by a systolic hypotension at clinical presentation (<90 mm Hg). We compared the risks of recurrent VTE, major bleeding, and mortality using time-to-event multivariable competing risk modeling. There were 3.5% of massive PE among 38 996 patients with PE. During the anticoagulation period, massive PE was associated with a greater risk of major bleeding (subhazard ratio [sHR] 1.72, 95% confidence interval [CI] 1.28-2.32), but not of recurrent VTE (sHR 1.15, 95% CI 0.75-1.74) than non-massive PE. An increased risk of mortality was only observed in the first month after PE. After discontinuation of anticoagulation, among 11 579 patients, massive PE and non-massive PE had similar risks of mortality, bleeding, and recurrent VTE (sHR 0.85, 95% CI 0.51-1.40), but with different case fatality of recurrent PE (11.1% versus 2.4%, P = .03) and possibly different risk of recurrent fatal PE (sHR 3.65, 95% CI 0.82-16.24). CONCLUSION: In this large prospective registry, the baseline hemodynamic status of the incident PE did not influence the risk of recurrent VTE, during and after the anticoagulation periods, but was possibly associated with recurrent PE of greater severity.

[Mortality and recurrence of venous thromboembolic disease in adult patients: prospective cohort]. / Mortalidad y recurrencia de la enfermedad tromboembólica venosa en pacientes adultos: cohorte prospectiva.

INTRODUCTION: Venous thromboembolic disease (VTE) is a pathology that increases with age. RESULTS: 446 patients were included, 63% (292) were older than 65 years. Survival was lower in the elderly compared to the young (p 0.007), at 3 months 87% vs. 95% and at one year 73% vs. 87%, respectively. The elderly had a HRc1.71 and HR at 1.68. The overall recurrence was 5% (95% CI 3-8) at one month, 6% (95% CI 4-9) at 3 months, 8% (95% CI). 6-11) at one year and 13% (95% CI 9-18) at two years. No association was found between age and recurrence sub hazard 0.8 (CI 0.34-1.86). Bleeding occurred in 9% (39) of the patients. OBJECTIVE: to compare the survival of the elderly and the young with a first episode of acute and symptomatic VTE. MATERIALS AND METHODS: Prospective cohort of incident VTE cases included in the Institutional Registry of Venous Thromboembolic Disease (NCT01372514) of the Italian Hospital of Buenos Aires between 2012-2014, divided into young groups (17-64 years old) and elderly (65 years old). All the patients were followed annually to assess the time to recurrence (progression or new symptomatic event of VTE) as competitive events in the context of death and major bleeding. Raw (c) and adjusted (a) risks were presented. CONCLUSIONS: The overall mortality in patients with confirmed VTE is higher in the elderly population. There were no differences in relation to the recurrence of VTE, or bleeding, and neither with age.

INTRODUCCIÓN: La enfermedad tromboembólica venosa (ETV) es una patología que aumenta con la edad. CONCLUSIONES: La mortalidad global en pacientes con ETV confirmada es mayor en la población anciana. No hubo diferencias en relación a la recurrencia de ETV, ni   el sangrado y tampoco con la edad. OBJETIVO: Comparar la sobrevida de los ancianos y los jóvenes con un primer episodio de ETV aguda y sintomática. MATERIALES Y MÉTODOS: Cohorte prospectiva de casos incidentes de ETV incluidos en el Registro Institucional de Enfermedad Tromboembólica venosa (NCT01372514) del Hospital Italiano de Buenos Aires entre 2012-2014, dividido en grupos jóvenes (17-64 años) y ancianos (≥ 65 años). Todos los pacientes fueron seguidos anualmente para evaluar el tiempo a la recurrencia (progresión o nuevo evento sintomático de ETV) como eventos competitivos en contexto de muerte y sangrado mayor. Se presentaron los riesgos crudos (c) y ajustados. (a). RESULTADOS: Se incluyeron 446 pacientes, el 63% (292) fueron mayores de 65 años. La sobrevida fue menor en los ancianos comparados con los jóvenes (p 0.007), a los 3 meses 87% vs 95% y al año 73% vs 87%, respectivamente. Los ancianos presentaron un HRc1,71 y HR a 1.68. La recurrencia global fue 5% (IC 95% 3-8) al mes, 6% (IC 95% 4-9) a los 3 meses, 8% (IC 95% 6-11) al año y 13% (IC 95% 9-18) a los dos años. No se encontró asociación entre la edad y la recurrencia sub hazard 0.8(IC 0,34-1,86). El sangrado ocurrió en un 9% (39) de los pacientes.

Management and outcomes of cancer patients with venous thromboembolism presenting with thrombocytopenia.

INTRODUCTION: Treatment of venous thromboembolism (VTE) in cancer patients with thrombocytopenia is challenging due to perceived higher risk of bleeding. MATERIAL AND METHODS: We used the RIETE registry to compare the 10- and 30-day outcomes in cancer patients with acute VTE, according to platelet count at baseline. RESULTS: As of December 2018, 15,337 cancer patients with VTE were included: 166 (1.1%) had <50 × 109 platelets/L (severe thrombocytopenia), 711 (4.6%) had 50-99 × 109/L (mild thrombocytopenia) and 14,460 (94.3%) had ≥100 × 109/L (normal count). Most patients in all subgroups received initial therapy with low-molecular-weight heparin (LMWH), but 62% of those with severe thrombocytopenia received <150 IU/kg/day LMWH, 42% received <100 IU/kg/day. The mortality rate progressively decreased with increasing platelet counts (12%, 9.4% and 3.3% respectively at 10 days, 27%, 18% and 9.4% at 30 days), but the major bleeding rates did not (1.2%, 2.5% and 1.3% respectively at 10 days, 2.4%, 4.4% and 2.2% at 30 days). On multivariable analysis, patients with severe thrombocytopenia had a similar risk for major bleeding at 10 days (OR 0.84; 95%CI 0.20-3.49) and at 30 days (OR 0.90; 95%CI 0.32-2.49), but those with mild thrombocytopenia were at increased risk both at 10 days (OR 2.11; 95%CI 1.27-3.49) and at 30 days (OR 1.91; 95%CI 1.29-2.84). CONCLUSIONS: Cancer patients with acute VTE and baseline thrombocytopenia often receive initial lower-than recommended doses of LMWH. Although caution is required, this practice seems to be safe in patients with severe thrombocytopenia. Nonetheless, there was an inverse correlation between baseline platelet count and mortality.

Diagnosis of pulmonary embolism in patients with acute exacerbations of chronic obstructive pulmonary disease: A cross-sectional study.

INTRODUCTION: Pulmonary embolism (PE) remains a frequent complication in patients with chronic obstructive pulmonary disease (COPD). It is unclear that the extent to which the traditional risk stratifying scores for PE are accurate in this population. METHODS: Cross-sectional study of adult patients with COPD and suspected PE included in an Institutional Registry of Thromboembolic Disease at a tertiary teaching hospital in the city of Buenos Aires, Argentina. We estimated the area under the receiver operating characteristic curves (AU-ROC), sensitivity and specificity of the Wells and Geneva scores using a positive computed tomography angiography as the gold standard for PE. We also estimated the sensitivity and specificity for the presence of isolated worsening of dyspnea at presentation, without other cardinal symptoms of acute exacerbation of COPD. RESULTS: A total of 168 patients were included, of which 22% had confirmed PE. The AUC was 0.66 (95% CI 0.56-0.76) and 0.56 (95% CI 0.45-0.67) for the Wells and Geneva, respectively. Considering the most widely used cutoff points, the sensitivity and specificity were 24% and 90% for the Wells and 59% and 43% for the Geneva score, respectively. Isolated worsening of dyspnea on presentation had a sensitivity of 92% and specificity of 37%. CONCLUSIONS: Both Wells and Geneva scores exhibit poor diagnostic accuracy for the diagnosis of PE in patients with COPD. The presence of isolated worsening of dyspnea on presentation could be an easy to identify criteria for the initial triage in this population. Further validation of our findings remains warranted.

Prevalence of Deep Vein Thrombosis in Hospitalized Patients With Suspected Pulmonary Embolism Ruled Out by Multislice CT Angiography.

Current evidence suggests that for outpatients with suspected pulmonary embolism (PE), multislice computed tomographic angiography (CTPA) is sufficient to rule out PE. However, the accuracy of CTPA alone has not been established for hospitalized patients. Our goal was to determine the prevalence of deep vein thrombosis (DVT) in hospitalized patients who had PE ruled out by CTPA. We conducted a prospective cohort study of patients who developed symptoms indicative of PE, after being admitted to the hospital for any reason other than PE and were evaluated with multislice CTPA. The main outcome was proximal DVT. Between November 2011 and December 2014, 191 hospitalized patients were screened. A total of 99 patients satisfied our inclusion criteria. The average length of hospitalization for this group was 14 days (range: 2-127 days). While hospitalized, 54 (28%) patients underwent a major surgical procedure and 80 (79%) were receiving thromboprophylaxis. Of the 99 patients included, 7 (7.07%; 95% confidence intervals [CIs]: 3.4-13.8) were diagnosed with a proximal DVT. The likelihood of developing a proximal DVT was higher for those with subtle and nonspontaneously reported symptoms of DVT, odds ratio [OR] was 50.93 (95% CI: 5.35-2572) and for those classified as PE likely OR was 37.54 (95% CI: 4.05-186.1). Given the prevalence of DVT in hospitalized patients with suspected PE ruled out by a negative multislice CTPA, our study suggests that compression ultrasonography would, in fact, be justified for patients with these characteristics.

Incidence of hospital-acquired venous thromboembolic disease.

BACKGROUND: There is limited knowledge of the incidence of venous thromboembolic disease (VTE) during hospitalization, since most of these are community-based data. PURPOSE: To estimate the incidence rate (IR) of VTE developed during hospitalization. METHODS: Prospective cohort of all inpatients admitted in a university tertiary hospital, in Argentina. The inclusion criteria were defined as: adult patients consecutively admitted from July/2006 to August/2013, for any cause. Patients admitted for VTE were excluded; all patients at the time of admission were free of event. Each person was followed contributing time at risk, from admission to event, discharge or death. VTE incident cases were captured from the Institutional Registry of Thromboembolic Disease (ClinicalTrials.gov Identifier NCT01372514). Incidence rate was calculated with 95% confidence intervals. RESULTS: The crude incidence rate of VTE for clinical patients was 0.49 (95%CI 0.45-0.55) per 1,000 cases person-days, and IR adjusted for WHO was 0.23 (95%CI 0.19-0.26). The crude IR of VTE for surgical patients was 0.25 (95%CI 0.23-0.27), and IR adjusted for WHO was 0.13 (95%CI 0.10-0.17). The incidence rate ratio (IRR) for VTE shows that surgical admission reduces the IRR and age categories increases the thrombosis rate risk, after adjustment for age category, sex and surgical admission. CONCLUSIONS: This study suggests that there is a high risk of VTE in hospitalized patients and is still a frequent problem.

Statistical Process Control: A Quality Tool for a Venous Thromboembolic Disease Registry.

OBJECTIVE: We aim to describe Statistical Control Process as a quality tool for the Institutional Registry of Venous Thromboembolic Disease (IRTD), a registry developed in a community-care tertiary hospital in Buenos Aires, Argentina. METHODS: The IRTD is a prospective cohort. The process of data acquisition began with the creation of a computerized alert generated whenever physicians requested imaging or laboratory study to diagnose venous thromboembolism, which defined eligible patients. The process then followed a structured methodology for patient's inclusion, evaluation, and posterior data entry. To control this process, process performance indicators were designed to be measured monthly. These included the number of eligible patients, the number of included patients, median time to patient's evaluation, and percentage of patients lost to evaluation. Control charts were graphed for each indicator. RESULTS: The registry was evaluated in 93 months, where 25,757 patients were reported and 6,798 patients met inclusion criteria. The median time to evaluation was 20 hours (SD, 12) and 7.7% of the total was lost to evaluation. Each indicator presented trends over time, caused by structural changes and improvement cycles, and therefore the central limit suffered inflexions. CONCLUSION: Statistical process control through process performance indicators allowed us to control the performance of the registry over time to detect systematic problems. We postulate that this approach could be reproduced for other clinical registries.

Improving adherence rate of extended prophylaxis for venous thromboembolic disease after abdominal and pelvic oncologic surgery: a pilot educational study.

BACKGROUND: Venous thromboembolic disease (VTE) is higher among patients with cancer. For those undergoing abdominal or pelvic surgery for cancer, it is suggested to extend thromboprophylaxis during 4 weeks with low-molecular-weight heparin over limited-duration of 7 days. There is no published local data from our country about compliance with recommended guidelines of extended prophylaxis (EP) in patients with cancer undergoing surgical procedures. Our aim was to evaluate the adherence rate to extended pharmacological thromboprophylaxis after abdominal-pelvic surgery for cancer, before and after an educational intervention program (EIP) geared toward surgeons. METHODS: Prospective cross-sectional study before and after an EIP aimed for surgeons. All consecutive patients older than 65 years who underwent surgery for abdominal-pelvic neoplasm, at the Hospital Italiano de Buenos Aires, Argentina, between September 2013 and May 2014, were evaluated for inclusion. RESULTS: A total of 120 patients were included, 60 before and 60 after the EIP aimed for surgeons. None of the initial 60 patients received EP, while 13 (21.6%) of 60 patients received prophylaxis for 28 days (all with colon or rectal cancer) after the intervention. There were no bleeding or death during 90 days of follow-up, and there were 7 of 120 VTE events, none in the group receiving extended thromboprophylaxis. CONCLUSION: The EIP for the surgical team significantly improved their adherence but only in the colon-rectal surgeries. The adherence to the recommended guidelines is still low. Reasons could be the subjective perception of elevated bleeding risk and the variable grade of recommendation in different guidelines.

Performance of the Wells score in patients with suspected pulmonary embolism during hospitalization: a delayed-type cross sectional study in a community hospital.

INTRODUCTION: The role of the Wells score for patients who develop signs and symptoms of pulmonary embolism (PE) during hospitalization has not been sufficiently validated. The aim of this study is to evaluate the performance of the Wells score for inpatients with suspected PE and to evaluate the prevalence of pulmonary embolism. MATERIALS AND METHODS: We conducted a cross sectional study nested in the prospective Institutional Registry of Thromboembolic Disease at Hospital Italiano de Buenos Aires from June 2006 to March 2011. We included patients who developed symptoms of pulmonary embolism during hospitalization. Patients were stratified based on the Wells score as PE likely (>4 points) or PE unlikely (≤4 points). The presence of pulmonary embolism was defined by pre-specified criteria. RESULTS: Six hundred and thirteen patients met the inclusion criteria, with an overall prevalence of PE of 36%. Two hundred and nineteen (34%) were classified as PE likely and 394 (66%) as PE unlikely with a prevalence of PE of 66% and 20%, respectively. The Wells score showed a sensitivity of 65 (95% CI 59-72), specificity 81 (95% CI 77-85), positive predictive value 66 (95% CI 60-72) and negative predictive value 80 (95% CI 77-84). CONCLUSIONS: The Wells Score is accurate to predict the probability of PE in hospitalized patients and this population had a higher prevalence of PE than other cohorts. However, the score is not sufficiently predictive to rule out a potentially fatal disorder.