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1.
Blood Adv ; 4(7): 1250-1264, 2020 Apr 14.
Artigo em Inglês | MEDLINE | ID: mdl-32227213

RESUMO

Deep vein thrombosis (DVT) of the lower extremities can be associated with significant morbidity and may progress to pulmonary embolism and postthrombotic syndrome. Early diagnosis and treatment are important to minimize the risk of these complications. We systematically reviewed the accuracy of diagnostic tests for first-episode and recurrent DVT of the lower extremities, including proximal compression ultrasonography (US), whole leg US, serial US, and high-sensitivity quantitative D-dimer assays. We searched Cochrane Central, MEDLINE, and EMBASE for eligible studies, reference lists of relevant reviews, registered trials, and relevant conference proceedings. Two investigators screened and abstracted data. Risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. We pooled estimates of sensitivity and specificity. The review included 43 studies. For any suspected DVT, the pooled estimates for sensitivity and specificity of proximal compression US were 90.1% (95% confidence interval [CI], 86.5-92.8) and 98.5% (95% CI, 97.6-99.1), respectively. For whole-leg US, pooled estimates were 94.0% (95% CI, 91.3-95.9) and 97.3% (95% CI, 94.8-98.6); for serial US pooled estimates were 97.9% (95% CI, 96.0-98.9) and 99.8% (95% CI, 99.3-99.9). For D-dimer, pooled estimates were 96.1% (95% CI, 92.6-98.0) and 35.7% (95% CI, 29.5-42.4). Recurrent DVT studies were not pooled. Certainty of evidence varied from low to high. This systematic review of current diagnostic tests for DVT of the lower extremities provides accuracy estimates. The tests are evaluated when performed in a stand-alone fashion, and in a diagnostic pathway. The pretest probability of DVT often assessed by a clinical decision rule will influence how, together with sensitivity and specificity estimates, patients will be managed.

2.
Sci Rep ; 10(1): 2495, 2020 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-32051462

RESUMO

The association of glycated hemoglobin (HbA1c) with venous thromboembolism (VTE) and death in the elderly is unknown. In the SWEETCO 65+ study we analyzed prospectively a Swiss Cohort of Elderly Patients with Venous Thromboembolism (SWITCO 65+). 888 patients were enrolled for the SWEETCO 65+ analysis. HbA1c was determined at baseline and divided into three categories (HbA1c < 5.7%, normal range; 5.7-6.49%, pre-diabetic range; and >6.5%, diabetic range). Median follow-up was 2.5 years. The primary endpoint was recurrent VTE. Secondary endpoints included all-cause mortality and major bleeds. The total prevalence of diabetes was 22.1%. The risk of recurrent VTE was similar in patients with HbA1c with pre-diabetes (adjusted subhazard ratio (aSHR) 1.07 [0.70 to 1.63]) and diabetes (aSHR 0.73 [0.39 to 1.37]) as compared to those with a HbA1c in the normal range. However, a HbA1c ≥ 6.5% (median IQ range 7.0 [6.70;7.60]) was significantly associated with a higher risk of all-cause mortality (adjusted hazard ratio [aHR] 1.83 [1.21 to 2.75]). In summary we found no association between HbA1c and major bleeding. Elevated HbA1c levels are not associated with recurrent VTE but with increased all-cause mortality in an elderly population with acute VTE.

3.
J Thromb Haemost ; 2020 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-32073218

RESUMO

INTRODUCTION: Pulmonary embolism (PE)-related death is often part of the primary outcome in venous thromboembolism (VTE) studies. The Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis developed a definition for PE-related death and classification of the cause of death. The present survey evaluated a preliminary version of this definition and classification. METHODS: Sixty-nine VTE experts from nine countries were invited for a cross-sectional online survey on January 15, 2019, including multiple-choice and open-ended questions on a seven-subcategory classification of the cause of death. Descriptive statistics were used to describe the results; qualitative comments were summarized. RESULTS: Forty of 69 (58%) invitees completed the survey. All respondents agreed that guidance on classification of the cause of death in VTE studies is required. There was high agreement on the proposal (median overall score, 6; interquartile range, 6-7; scale from 1 [poor] to 7 [excellent]). All respondents approved the wording and content of the seven subcategories, except for one disagreeing vote for two subcategories (A3: "PE is not objectively confirmed, but is most likely the main cause of death" and C1: "Another cause of death is more likely than PE but has not been objectively confirmed"). Suggestions for improvement mainly concerned the extensiveness of the criteria and clinical situations described to define the cause of death. CONCLUSION: Acceptance of the proposal was excellent. Suggestions for improvement were incorporated in the SSC communication on the definition of PE-related death and classification of the cause of death in VTE studies.

4.
J Thromb Haemost ; 18(4): 857-864, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31899848

RESUMO

BACKGROUND: After a proximal lower limb deep vein thrombosis (DVT; involving popliteal veins or above), up to 40% of patients develop postthrombotic syndrome (PTS) as assessed by the Villalta scale (VS). Poor initial anticoagulant treatment is a known risk factor for PTS. The risk of developing PTS after isolated distal DVT (infra-popliteal DVT without pulmonary embolism), and the impact of anticoagulant treatment on this risk, are uncertain. METHODS: Long-term follow-up of CACTUS double-blind trial comparing 6 weeks of s.c. nadroparin (171 IU/kg/d) versus s.c. placebo for a first symptomatic isolated distal DVT. At least 1 year after randomization, patients had a PTS assessment in clinic or by phone using the VS. RESULTS: After a median follow-up of 6 years, PTS was present in 30% (n = 54) of the 178 patients who had a PTS assessment. PTS was moderate or severe in 24% (n = 13) of cases. There was no statistically significant difference in prevalence of PTS in the nadroparin versus placebo groups (29% versus 32%, P = .6), except in patients without evidence of primary chronic venous insufficiency (9% versus 24%, P = .04). Rates of venous thromboembolism recurrence during follow-up in the nadroparin and placebo groups were, respectively, 8% (n = 7) and 14% (n = 13; P = .2). CONCLUSION: After a first isolated distal DVT, the risk of PTS is substantial but much lower than that reported after proximal DVT. Anticoagulation with nadroparin doesn't provide any clear benefit to prevent PTS, except in patients without preexisting chronic venous insufficiency. Anticoagulation might be associated with a lower risk of venous thromboembolism recurrence.

5.
J Thromb Haemost ; 18(4): 865-875, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31925875

RESUMO

BACKGROUND: In patients with suspected pulmonary embolism (PE) and a non-high pretest probability, the use of an age-adjusted D-dimer cutoff (AADD, <500 ng/mL up to 50 years, then $200 000/lost QALY was 79.4%. In sensitivity analyses, the DCER became <+$200 000/lost QALY only if, among patients with D-dimer below the AADD cutoff, the mortality of an undiagnosed PE was >6% or the prevalence of PE was >0.6%. CONCLUSIONS: The AADD cutoff results in a clinically nonsignificant decrease in QALY but important costs reductions. It is a decrementally cost-effective innovation, with a potential of cost savings of >$80 million per year for the United States health care system.

6.
Thromb Res ; 185: 102-108, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31790999

RESUMO

AIMS: Polycystic ovary syndrome (PCOS) is very prevalent and commonly treated with prothrombotic combined oral contraceptives (COC). Our aim was to systematically review the available evidence to evaluate the risk of venous thromboembolism (VTE) associated with PCOS, and whether observed increased risks may be explained by a higher prevalence of obesity and hormonal treatments. METHOD: For this systematic review and meta-analysis, two authors independently searched MEDLINE, EMBASE and conference proceedings (ISTH, WHITH) from inception through 4.2019 for studies reporting the association of PCOS with VTE risk. Study quality was assessed and relative risk estimates were pooled through random effect models. RESULTS: We identified 5 large observational studies published between 2004 and 2018, most commonly using administrative data, set in Denmark, the USA or the United Kingdom. Compared with participants without PCOS, participants with PCOS had greater risks of VTE in unadjusted analyses (pooled OR 1.70, 95%CI 1.42-2.04, I2 67%). In three studies reporting analyses adjusted for at least obesity and hormonal treatments, PCOS was still associated with greater risks of VTE (pooled OR 1.89, 95%CI 1.60-2.24, I2 27%). CONCLUSIONS: PCOS appears to be a risk factor for VTE, independently of its associated excess weight and greater use of combined oral contraceptives. This should be taken into account in the pharmacological management of PCOS.

8.
Thromb Res ; 185: 5-12, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31731089

RESUMO

BACKGROUND: Recent data have raised concerns about the risk/benefit ratio of thrombolysis in non-high risk pulmonary embolism patients due to increased serious bleeding events. Whether cardiac biomarkers could be of help for bleeding risk stratification in this setting remains elusive. OBJECTIVES: To determine the prognostic accuracy of hs-cTnT, NT-proBNP, RIETE and PESI score for the occurrence of clinically relevant bleeding (CRB) in elderly patients under conventional anticoagulation therapy for non-massive pulmonary embolism (NMPE). METHODS: We evaluated 230 elderly patients with available blood sample taken within one day from diagnosis. The primary study endpoint was CRB at 1, 3 and 24 months. Prognostic accuracies and associations were determined using C-statistics and subhazard ratios (SHR), respectively. RESULTS: hs-cTnT displayed the highest discriminatory power at 1 month (C-statistics: 0.77, 95% CI: 0.68-0.88) which remained stable over time. Although C-statistics comparison indicated that hs-cTnT was not statistically superior to RIETE score (0.77 vs 0.67, p = 0.11), adding hs-cTnT to RIETE score significantly improved the C-statistics from 0.67 to 0.78 (p = 0.02). SHRs indicated that for each hs-cTnT log-unit increase, there was a 58% increase in the risk of CRB independently of the RIETE score (adjusted SHR: 1.58, 95% CI: 1.31-1.92). At the pre-specified cut-off of 14 ng/l, the negative predictive value of hs-cTnT was 96.9% (95% CI: 91.4-99.0) and 94.9 (95%CI: 88.6-97.8) at 1 and 3 months, respectively. CONCLUSION: In elderly, hs-cTnT provides incremental prognostic information over the RIETE score and could represent a valuable tool to identify NMPE patients at low risk of bleeding.

9.
J Thromb Haemost ; 18(3): 676-680, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31782886

RESUMO

BACKGROUND: The simplified Geneva risk assessment model (RAM) predicts the risk of hospitalization-related venous thromboembolism (VTE) in medical inpatients in its developmental cohort but has not been validated. OBJECTIVES: To externally validate the simplified Geneva RAM. PATIENTS/METHODS: For this secondary analysis of a prospective cohort set in Padua, we calculated the simplified Geneva RAM for all participants. They were followed up for 90 days for the occurrence of adjudicated VTE. Thirty- and 90-day risks of VTE were estimated by the Kaplan-Meier method, and categories of risks compared with a Cox regression model adjusted for the use of thromboprophylaxis. RESULTS: Among 1180 medical inpatients, the 90-day risk of symptomatic VTE was 3.1%. The simplified Geneva RAM classified 56.9% as high risk (≥3 points; 90-day risk of VTE of 5.2%) and 43.1% as low risk (<3 points; 90-day risk of VTE of 0.4%). Compared with low-risk participants, high-risk participants had an 18-fold greater risk of VTE than low-risk participants (hazard ratio [HR] 17.9, 95% confidence interval [CI] 4.3-74.7). A very high-risk category (≥7 points) identified 5.3% of participants with a 9.5% probability of VTE at 90 days. CONCLUSIONS: In this external validation study, we confirm the excellent discrimination and clinically adequate calibration of the simplified Geneva RAM as a stratification tool to guide the use of thromboprophylaxis.

11.
Rev Med Suisse ; 15(674): 2232-2235, 2019 Dec 04.
Artigo em Francês | MEDLINE | ID: mdl-31804034

RESUMO

The use of direct oral anticoagulants (DOACs) has been largely -implemented in the management of venous thromboembolic disease in non-cancer patients. In cancer-associated thrombosis, low molecular weight heparins (LMWHs) and especially dalteparin have long been the reference standard therapy. Following the publication of two randomised trials comparing edoxaban and rivaroxaban to -dalteparin, DOACs now represent an alternative with an interesting efficacy and safety profile. Moreover, they offer the comfort of an oral administration and a lower cost. In patients with gastrointestinal or genitourinary cancers however, a higher bleeding risk has been shown with DOACs. LMWHs thus remain the treatment of choice in this group of patients.


Assuntos
Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Neoplasias/complicações , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Dalteparina/administração & dosagem , Dalteparina/uso terapêutico , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Rivaroxabana/administração & dosagem , Rivaroxabana/uso terapêutico , Tiazóis/administração & dosagem , Tiazóis/uso terapêutico
13.
Thromb Res ; 184: 24-30, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31683107

RESUMO

OBJECTIVES: Data are limited on clinical presentation and outcomes in elderly patients with acute symptomatic isolated subsegmental pulmonary embolism (SSPE). We compared clinical presentation, risk factors, processes of care, and outcomes between elderly patients with SSPE and patients with more proximal pulmonary embolism (PE). METHODS: We prospectively followed 578 patients aged ≥65 years with acute symptomatic isolated SSPE or proximal PE in a multicentre Swiss cohort study. We compared quality of life at three months using the PEmb-QoL, and examined the independent association between localization of PE and clinical outcomes (recurrent venous thromboembolism [VTE], overall mortality) using regression models with adjustment for potential confounders. RESULTS: Overall, 11% of patients had isolated SSPE. Patients with SSPE were less likely to have a pulse ≥110/min (3% vs. 13%), but more likely to have active cancer (28% vs. 15%) and to receive outpatient care (11% vs. 4%) than patients with proximal PE. Virtually all patients (98%) with SSPE received anticoagulants. Quality of life did not differ between the groups at 3 months. No patient with SSPE vs. seven patients with proximal PE died from the index PE event. No significant difference was observed for the 3-year cumulative incidence of recurrent VTE (7% vs. 12%) and death (29% vs. 20%). After adjustment, SSPE was not associated with a lower risk of clinical outcomes than proximal PE. CONCLUSIONS: Clinical presentation and incidences of adverse outcomes did not differ significantly between elderly patients with SSPE or proximal PE, although the power to detect differences might have been limited given the small number of events. Thus, our study does not provide evidence that unselected, elderly patients with SSPE have a more benign clinical course.

14.
Endocr Connect ; 8(11): 1447-1454, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31614338

RESUMO

Objective: Vitamin D deficiency is associated with increased risks of arterial and venous cardiovascular events. Hypothetically, supplementation with vitamin D may lead to a less prothrombotic phenotype, as measured by global coagulation assays and fibrin clot structure. Methods: In this prospective cohort study, we enrolled adult outpatients attending the Primary Care Division of the Geneva University Hospitals with a severe vitamin D deficiency (25-hydroxyvitamin-D3 (25-OHD) <25 nmol/L), excluding obese patients or with a recent acute medical event. We evaluated changes in coagulation times, thrombin generation assay, clot formation and clot lysis time, 25-OHD and parathormone before and 1-3 months after cholecalciferol oral supplementation with one-time 300,000 IU then 800 IU daily. Paired t-tests with a two-sided alpha of 0.05 compared absolute mean differences. Results: The 48 participants had a mean age of 43.8 ± 13.8 years. After supplementation, 25-OHD levels increased from 17.9 ± 4.6 nmol/L to 62.5 ± 20.7 nmol/L 6.4 ± 3.0 weeks after inclusion. Endogenous thrombin potential and thrombin generation peak values both decreased significantly (-95.4 nM × min (95%CI -127.9 to -62.8), P < 0.001; -15.1 nM (-23.3 to -6.8), P < 0.001). The maximum absorbance by turbidimetry decreased significantly (P = 0.001) after supplementation. There was no change in clot lysis time, coagulation times or plasminogen activator inhibitor-1 and homocysteine levels. Conclusions: In severe vitamin D deficiency, a high-dose cholecalciferol supplementation was associated with a reduction in thrombin generation and an average decreased number of fibrin protofibrils per fibers and fibrin fiber size measured by turbidimetry. This suggests that severe vitamin D deficiency may be associated with a potentially reversible prothrombotic profile.

15.
J Vasc Surg Venous Lymphat Disord ; 7(6): 865-869.e1, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31495770

RESUMO

BACKGROUND: Surgical venous cutdown is a method for totally implantable venous access device (TIVAD) insertion. The main drawback of this technique is its higher failure rate when compared with the percutaneous approach, which is mostly related to anatomic variations of the cephalic vein. The aim of this study was to assess preoperative ultrasound imaging as a tool to predict cephalic vein cutdown failure for TIVAD insertion. METHODS: Ultrasound and operative reports of a cohort of patients undergoing TIVAD insertion by cephalic vein cutdown were reviewed. Ultrasound venous (vein visibility, diameter, length, subcutaneous depth, vein path, and subclavian junction visibility) and patient variables were tested by logistic regression as predictors of TIVAD insertion failure. RESULTS: One hundred sixty consecutive patients underwent cephalic vein cutdown for attempted TIVAD insertion. An inability to visualize the vein on the preoperative ultrasound examination (odds ratio, 4.39; 95% confidence interval, 1.57-12.30; P < .05) and depth of the vein (odds ratio, 1.07; 95% confidence interval, 1.00-1.15; P = .042) were predictors of failure of TIVAD insertion by cephalic vein cutdown. CONCLUSIONS: Preoperative ultrasound examination allows identifying patients at risk of failure of TIVAD insertion by cephalic vein cutdown. Preoperative ultrasound examination constitutes an efficient tool for choosing the most appropriate surgical approach and improving patient comfort.

17.
Thromb Res ; 181: 120-123, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31400622

RESUMO

Disease mongering is an expression created in 1992 by a medical journalist, Lynn Payer, to qualify the "selling of sickness that widens the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments". This interesting concept led us to question whether, as researchers with publication and career interests in superficial vein thrombosis, we were not shaping a benign condition into a disease. Since the publication of the CALISTO trial in 2010, anticoagulant management of superficial vein thrombosis remains debated. Issues raised, such as the cost-effectiveness of the treatment strategy, the use of a composite endpoint including death, the low event rate without mortality reduction and conflict of interest due to industrial funding. We searched Embase, Medline, Web of science, and Opengrey databases to review all aspects about disease mongering raised in the literature and created a checklist with seventeen items. We used this checklist as support for a narrative review, questioning known literature on superficial vein thrombosis. The main issues pointing towards disease mongering concerned definition and promotion; whereas management seemed rather spared. Many arguments could be counterbalanced, but researchers should pay particular attention to three major points: exaggeration of the severity of the disease and potential adverse outcomes without treatment, promotion by opinion leaders, and an openly declared, yet undoubtedly present, conflict of interest situation.


Assuntos
Médicos/normas , Pesquisadores/normas , Doenças Vasculares/epidemiologia , Lista de Checagem , Gerenciamento Clínico , Humanos
19.
Eur J Clin Invest ; 49(9): e13154, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31246275

RESUMO

BACKGROUND: Combining high-sensitivity cardiac Troponin T (hs-cTnT), NT-pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity C-reactive protein (hs-CRP) may improve risk stratification of patients with pulmonary embolism (PE) beyond the PESI risk score. METHODS: In the prospective multicentre SWITCO65+ study, we analysed 214 patients ≥ 65 years with a new submassive PE. Biomarkers and clinical information for the PESI risk score were ascertained within 1 day after diagnosis. Associations of hs-TnT, NT-proBNP, hs-CRP and the PESI risk score with the primary endpoint defined as 6-month mortality were assessed. The discriminative power of the PESI risk score and its combination with hs-cTnT, NT-proBNP and hs-CRP for 6-month mortality was compared using integrated discrimination improvement (IDI) index and net reclassification improvement (NRI). RESULTS: Compared with the lowest quartile, patients in the highest quartile had a higher risk of death during the first 6 months for hs-cTnT (adjusted HR 10.22; 95% CI 1.79-58.34; P = 0.009) and a trend for NT-proBNP (adjusted HR 4.3; 95% CI 0.9-20.41; P = 0.067) unlike hs-CRP (adjusted HR 1.97; 95% CI 0.48-8.05; P = 0.344). The PESI risk score (c-statistic 0.77 (95% CI 0.69-0.84) had the highest prognostic accuracy for 6-month mortality, outperforming hs-cTnT, NT-proBNP and hs-CRP (c-statistics of 0.72, 0.72, and 0.54), respectively. Combining all three biomarkers had no clinically relevant impact on risk stratification when added to the PESI risk score (IDI = 0.067; 95% CI 0.012-0.123; P = 0.018; NRI = 0.101 95% CI -0.099-0.302; P = 0.321). CONCLUSIONS: In elderly patients with PE, 6-month mortality can adequately be predicted by the PESI risk score alone.

20.
J Thromb Haemost ; 17(8): 1329-1334, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31108013

RESUMO

INTRODUCTION: The recently proposed YEARS algorithm was shown to safely exclude pulmonary embolism (PE) and reduce the use of computed tomography pulmonary angiography (CTPA) among pregnant women with suspected PE. Our aim was to externally validate this finding. METHODS: We performed a post hoc analysis of a prospective management outcome study for PE diagnosis in pregnant women. PE was diagnosed with an algorithm that combined the revised Geneva score, D-dimer testing, bilateral lower-limb compression ultrasonography, and CTPA. All women had a 3-month follow-up. All of the items necessary to use the YEARS algorithm were prospectively collected at the time of the study. RESULTS: Of the 395 women included in the original study, 371 were available for the present analysis. The PE prevalence was 6.5%. Ninety-one women had no YEARS items, and 280 had one or more items. When the YEARS items were combined with D-dimer levels (<1000 ng/mL in women with no items, and <500 ng/mL in women with one or more items), 77 women (21%) met the criteria for PE exclusion and would not have undergone CTPA as per the YEARS algorithm. None of these 77 women had PE diagnosed during the initial work-up or 3-month follow-up. Therefore, the failure rate of the YEARS algorithm in our pregnant women population was 0/77 (95% confidence interval 0.0-3.9). CONCLUSION: In our study, application of the YEARS algorithm would have resulted in safe exclusion of PE in one of five pregnant women without the need for radiation exposure, further supporting the use of the algorithm in this population.

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