Clinical characteristics, management and outcome of patients with invasive candidiasis hospitalized in Internal Medicine Units: findings from a registry by the Italian Scientific Society FADOI.

PURPOSE: Invasive candidiasis (IC) is a challenging clinical condition, burdened by relevant mortality and morbidity. There is limited knowledge on the occurrence and management of IC in Internal Medicine Units (IMUs). Aim of this study was to provide real-world data on this topic. METHODS: Consecutive objectively diagnosed cases of IC were collected in this prospective registry, which involved 18 IMUs in Italy. Patients were followed-up to 90 days from the diagnosis of candidemia. RESULTS: A total of 111 patients were observed (median age 78, IQR 67-83) for an overall incidence of infection of 1.89 cases/1000 hospital admissions. Candida albicans was the most frequent isolated species (62%), followed by Candida parapsilosis (17%) and Candida glabrata (13%). Echinocandins and fluconazole were used as initial therapy in 56.8 and 43.2% of patients, respectively. Antifungal therapy was started within 24 h in 18.9% of patients, in 40.6% in the period 1-3 days, and in 40.5% of patients more than 3 days after blood cultures. Death rate was 19.8% at 30 days and 40.5% at 90 days. At multivariable analysis concomitant bacteremia (i.e. polymicrobial sepsis), and fluconazole as the initial therapy were associated with an increased risk of death at 90 days. CONCLUSIONS: The incidence of IC is not negligible, and our registry confirmed that these patients have a relevant mortality rate at 90 days. Concomitant bacteremia, featuring polymicrobial sepsis, and starting antifungal treatment with fluconazole instead of echinocandins independently increase the risk of death. Efforts are needed to improve the awareness and management of IC in IMUs.

Residual vein obstruction in patients diagnosed with acute isolated distal deep vein thrombosis associated with active cancer.

After acute proximal deep vein thrombosis (DVT) the thrombotic mass decreases, especially during the first months of anticoagulation. The persistence of residual vein obstruction (RVO) may predict future recurrence in patients with cancer-associated DVT. We aimed to evaluate the proportion of patients with RVO after an episode of cancer associated isolated distal DVT (IDDVT), to identify variables associated with RVO, and to provide initial evidence of its association with recurrent VTE. We performed a post-hoc analysis of a multicenter cohort study of patients with isolated cancer-associated acute IDDVT. We included patients who underwent a control ultrasonography at the end of the anticoagulant treatment between day 30 and day 365 after index IDDVT, given that no recurrent VTE had already occurred on anticoagulant treatment. A total of 153 patients had ultrasonographic follow-up after a median of 92 days from index IDDVT: 45.8% had RVO and 54.2% exhibited complete recanalization. Female sex, Body Mass Index > 30 Kg/m2 and involvement of axial calf veins showed the strongest association with RVO. The risk of recurrence was twofold higher in patients with (versus without) RVO. RVO persisted in approximately half of patients with an episode of cancer-associated IDDVT at anticoagulant discontinuation. Patients with RVO appeared to be at a higher risk for recurrent events.

European Stroke Organization guideline for the diagnosis and treatment of cerebral venous thrombosis - endorsed by the European Academy of Neurology.

BACKGROUND AND PURPOSE: Current guidelines on cerebral venous thrombosis (CVT) diagnosis and management were issued by the European Federation of Neurological Societies in 2010. We aimed to update the previous European Federation of Neurological Societies guidelines using a clearer and evidence-based methodology. METHOD: We followed the Grading of Recommendations, Assessment, Development and Evaluation system, formulating relevant diagnostic and treatment questions, performing systematic reviews and writing recommendations based on the quality of available scientific evidence. RESULTS: We suggest using magnetic resonance or computed tomographic angiography for confirming the diagnosis of CVT and not routinely screening patients with CVT for thrombophilia or cancer. We recommend parenteral anticoagulation in acute CVT and decompressive surgery to prevent death due to brain herniation. We suggest preferentially using low-molecular-weight heparin in the acute phase and not direct oral anticoagulants. We suggest not using steroids and acetazolamide to reduce death or dependency. We suggest using antiepileptics in patients with an early seizure and supratentorial lesions to prevent further early seizures. We could not make recommendations concerning duration of anticoagulation after the acute phase, thrombolysis and/or thrombectomy, therapeutic lumbar puncture, and prevention of remote seizures with antiepileptic drugs. We suggest that, in women who have suffered a previous CVT, contraceptives containing oestrogens should be avoided. We suggest that subsequent pregnancies are safe, but use of prophylactic low-molecular-weight heparin should be considered throughout pregnancy and puerperium. CONCLUSIONS: Multicentre observational and experimental studies are needed to increase the level of evidence supporting recommendations on the diagnosis and management of CVT.

Left ventricular remodeling in patients with metabolic syndrome: influence of gender.

AIM: The study was aimed to evaluate the influence of gender on left ventricular (LV) remodeling in metabolic syndrome (MetS). METHODS AND RESULTS: We enrolled 200 subjects without diabetes or overt cardiovascular diseases, never treated with anti-hypertensive drugs or statins: 60 men and 40 women with MetS matched by age, gender and 24 h systolic and diastolic blood pressure (BP) with 60 men and 40 women without MetS. The patients underwent blood tests, 24 h our BP monitoring, LV echocardiographic examination. LV mass indexed by eight(2.7) was significantly greater in men and women with MetS than without MetS. Compared with women without MetS, women with MetS had significantly higher posterior wall thickness and relative wall thickness, greater prevalence of LV concentric remodeling/hypertrophy and lower indices of LV diastolic function, whereas all these parameters were not significantly different between men with and without MetS. MetS was an independent predictor of relative wall thickness and LV mass index in women, but not in men. CONCLUSION: The impact of MetS on LV remodeling is significantly influenced by gender: the effects of MetS are more pronounced in women, with development of LV concentric hypertrophy/remodeling and preclinical diastolic dysfunction.

Emergency reversal of anticoagulation with vitamin K antagonists with 3-factor prothrombin complex concentrates in patients with major bleeding.

Major bleeding is a serious and potentially fatal complication of treatment with vitamin K antagonists (VKAs). Prothrombin complex concentrates (PCCs) can substantially shorten the time needed to reverse VKA effects. To determine the efficacy and safety of 3-factor PCCs for the rapid reversal of VKAs in patients with major bleeding. Patients receiving VKAs and suffering from acute major bleeding were eligible for this prospective cohort study if their international normalized ratio (INR) was higher than or equal to 2.0. Stratified 35-50 IU kg(-1) PCC doses were infused based on initial INR. A total of 126 patients (62 males; mean age: 74 years, range 37-96 years) were enrolled. The mean INR at presentation was 3.3 (range 2-11). At 30 min after PCC administration the mean INR was 1.4 (range: 0.9-3.1), declining to less than or equal to 1.5 in 75 % of patients. The benefit of PCC was maintained for a long time, since in 97 % of all post-infusion time points through 96 h the mean INR remained lower than or equal to 1.5 (mean: 1.19; range: 0.9-2.3). During hospitalization neither thrombotic complications nor significant adverse events were observed and 12 patients died (10 %); none of the deaths was judged to be related to PCC administration. 3-factor PCC administration is an effective, rapid ad safe treatment for the urgent reversal of VKAs in patients with acute major bleeding. Broader use of PCC in this clinical setting appears to be appropriate.

What gastroenterologists should know about direct oral anticoagulants.

Direct oral anticoagulants are being increasingly used in patients with non-valvular atrial fibrillation and venous thromboembolism, due to their improved efficacy/ safety ratio, a predictable anticoagulant effect without need for routine coagulation monitoring, and fewer food and drug interactions compared with vitamin K antagonists. Gastrointestinal bleeding remains a serious complication, whose management is challenging for gastroenterologists due to the lack of a standardized clinical approach. Clinical experience on periendoscopic management of these drugs is still limited and there is a paucity of clinical data supporting guidelines recommendations', and this ultimately turns out in different, unsubstantiated and potentially harmful practices of patient management. Present study will provide a thorough revision on the risk of GI bleeding for DOAC therapy and the identification of patient risk factors to individualize treatment. Moreover, the approach to management of DOACs in case of bleeding complications is discussed, and an algorithm of different strategies in presence or not of plasma level measurement is proposed. Finally the periendoscopic management for elective procedures will be reviewed, at the light of the guideline recommendations and new evidences from observational studies.

Diabetes and CoViD-19: Experience from the frontline of Internal Medicine wards in Italy.

Available data suggest that the issue of CoViD-19 is particularly critical in patients with diabetes. In Italy, Internal Medicine (IM) wards have played a pivotal role in contrasting the spread of SARS-Cov2. During this pandemic, FADOI submitted a brief questionnaire to a group of its members acting as Head of IM units. Considering 38 units, 58% of beds dedicated to CoViD patients in CoViD Hospitals were in charge of IM, and globally cared for 6650 patients during a six-week period. Of these patients, 1264 (19%) had diabetes. Mortality rate in CoViD patients with or without diabetes were 20.5% and 14%, respectively (p < 0.001). Our survey seems to confirm that diabetes is a major comorbidity of CoViD-19, but it does not support an increased incidence of CoViD-19 infection in people with diabetes, if compared with the figures of patients with diabetes and hospitalized before the outbreak. On the other side, patients with diabetes appeared at a significantly increased risk of worse outcome. This finding underlines the importance of paying special attention to this patient population and its management.

Hospitalization and mortality for acute exacerbation of chronic obstructive pulmonary disease (COPD): an Italian population-based study.

OBJECTIVE: Patients with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) have a significant mortality and morbidity. Previous studies have identified a number of independent prognostic factors. However, information on hospital admission databases is limited and data regarding short-term prognosis of these patients in Italian hospitals are lacking. Thus, we performed an epidemiological study on hospital admission for COPD acute exacerbation in Italy. PATIENTS AND METHODS: Patients were identified using clinical Modification (ICD-9-CM) codes. Information was collected on baseline characteristics, vital status at discharge, duration of hospitalization, and up to five secondary discharge diagnoses. Comorbidity was evaluated using the Charlson comorbidity index (CCI). RESULTS: During the observation period (2013-2014), 170,684 patients with COPD acute exacerbation were hospitalized. Mean length of hospitalization (LOH) was 9.95±8.69 days and mean in-hospital mortality was 5.30%. These data correspond to the 4.1% of all hospitalizations and to the 2.8% of all the days of hospitalization in Italy during the study period. In-hospital mortality and LOH varied among different regions (from 3.13 to 7.59% and from 8.22 to 11.28 days respectively). Old age, male gender, low discharge volume, previous hospitalization for COPD exacerbation and CCI resulted as significantly associated with higher in-hospital mortality. CONCLUSIONS: Hospitalization for COPD exacerbation is extremely frequent even in contemporary Italian population. COPD exacerbation is clinically demanding with a not negligible short-term mortality rate and a mean LOH approaching 10 days. These latter findings were quite variable in different regions but should be further analyzed to set up appropriate health-care policies on COPD patients.

Outpatient treatment and early discharge of symptomatic pulmonary embolism: a systematic review.

The published literature regarding the safety of outpatient treatment of symptomatic pulmonary embolism (PE) was systematically summarised. A literature search was performed using the PubMed and EMBASE databases. Studies in which patients had symptomatic PE and the antithrombotic treatment was administered completely at home or the patients were discharged early were selected. A scoring system was used to divide studies into three quality categories. Short- and long-term outcomes were extracted: all-cause mortality, death from PE or from major haemorrhage, recurrent venous thromboembolism, and major bleeding. Eleven observational studies were included. No randomised controlled studies were identified. No study fulfilled the criteria for high quality. A total of 928 patients with symptomatic PE were treated completely as outpatients or discharged early; haemodynamic instability and hypoxia were the main exclusion criteria. No patient died during the first 7 days of antithrombotic treatment. Outpatient treatment of symptomatic PE is not based on high-quality evidence. Although the published data suggest that certain subgroups of haemodynamically and respiratorily stable patients may be safely treated at home when a well-defined management programme is applied, further studies are warranted for a short-term prognostic risk stratification of this PE subgroup.

Early alert from the microbiology laboratory improves the outcome of elderly patients with Enterococcus spp. bloodstream infection: Results from a multicentre prospective study.

OBJECTIVES: This study describes the clinical features and outcomes of patients with bloodstream infection (BSI) due to Enterococcus spp. and identified factors predictive of mortality. METHODS: This analysis is part of a prospective multicentre observational study of consecutive hospitalised patients with BSI conducted from March 2012 to December 2012 in 31 internal medicine wards in Italy. Patients with enterococcal BSI were selected from the entire cohort. Patient characteristics, therapeutic interventions and outcome were reviewed. Cox regression analysis was performed to identify factors associated with in-hospital mortality. Hazard ratios (HRs) and 95% interval confidences (CIs) were calculated. RESULTS: Among 533 patients with BSI, 41 (7.7%) had BSI by Enterococcus spp. (28 Enterococcus faecalis, 4 Enterococcus faecium and 3 each of Enterococcus avium, Enterococcus casseliflavus and Enterococcus gallinarum). Six BSIs (14.6%) were polymicrobial. Median (IQR) patient age was 73 (66-85.5) years. In-hospital mortality was 24.4%. Polymicrobial infection (HR = 9.100, 95% CI 1.295-63.949; P = 0.026), age (HR = 1.261, 95% CI 1.029-1.546; P = 0.025) and SOFA score (HR = 1.244, 95% CI 1.051-1.474; P = 0.011) were risk factors for in-hospital mortality. Conversely, receiving an alert from the microbiology laboratory before obtaining final antimicrobial susceptibility results was associated with survival (HR = 0.073, 95% CI 0.007-0.805; P = 0.033). CONCLUSION: BSI due to Enterococcus spp. in elderly patients is associated with high mortality. Polymicrobial infection, age and SOFA score are factors associated with poor outcome. Conversely, early alert from the microbiology laboratory improves patient survival.

Intracranial bleeding risk after minor traumatic brain injury in patients on antithrombotic drugs.

BACKGROUND: Intracranial haemorrhage (ICH) risk after minor traumatic brain injury (mTBI) in patients on antithrombotic treatment is unclear. We compared ICH rates in mTBI patients on single, double and no antithrombotic therapy. Antithrombotic drugs encompassed vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) and antiplatelets. Secondary aim was to identify potential predictors of ICH. METHODS: We retrospectively analysed consecutive adults referred to our emergency department for mTBI. All clinical information was retrieved by patients' charts review. Patients were divided in 5 groups: 1) no antithrombotic users, 2) antiplatelet users, 3) vitamin K antagonist users, 4) direct oral anticoagulants users, and 5) double antithrombotic users. RESULTS: A total of 1846 patients were enrolled, mean age 71 years (IQR 46-83); 1222 (66.2%) were in group 1, 407 (22.0%) in group 2, 120 (6.5%) in group 3, 51 (2.7%) in group 4 and 46 (2.5%) in group 5. At entry, 1387 (75.1%) patients underwent brain CT, 787 (64.4%) in group 1, 387 (95.1%) in group 2, 119 (99.2%) in group 3 and 51 (100%) in group 4 and 43 (93.5%) in group 5. ICH was documented in 36 patients (4.6%; CI 95%: 3.2-6.3) in group 1, 22 (5.9%; CI 95%: 3.6-8.5) in group 2, 5 (4.2%; CI 95%: 1.4-9.5) in group 3, 2 (3.9%; CI 95%: 0.5-13.5) in group 4 and 3 (7.0%; CI 95%: 1.5-19.1) in group 5 (p-value for across groups comparison = 0.86). At multivariable analysis GCS < 15 (OR 7.95 CI 95%: 3.12-20.28), post-traumatic amnesia (OR 6.49; CI 95%:3.57-11.82), vomiting (OR 4.45 CI 95%:1.47-13.50), clinical signs of cranial fractures (OR 8.41 CI 95%: 2.12-33.33), scalp lesions (OR 2.31 CI 95%: 1.09-4.89), but none of antithrombotic drugs were independently associated with ICH. CONCLUSION: mTBI-related ICH rate was similar in patients with and without antithrombotic use. Potential predictors of ICH can be drawn from patients' clinical examination.

Association between inherited thrombophilic abnormalities and central venous catheter thrombosis in patients with cancer: a meta-analysis.

BACKGROUND: The risk of deep vein thrombosis (DVT) is increased in cancer patients with central venous catheters (CVC). Factor (F)V Leiden and the G20210A prothrombin mutation (PTM) may play a role in causing catheter-related DVT in patients with cancer. However, information on the association between these thrombophilic abnormalities and CVC-related thrombosis are scarce. PURPOSE: To assess the risk of CVC-related thrombosis associated with these two thrombophilic disorders. METHODS: MEDLINE and EMBASE databases (up to March 2007); reference lists of retrieved articles. Studies comparing the prevalence of prothrombotic abnormalities in cancer patients with CVC-related thrombosis and in a control group of cancer subjects with CVC without thrombosis. Two reviewers independently selected studies and extracted study characteristics, quality and outcomes. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each trial and pooled. RESULTS: Ten studies involving 1000 patients were included. The pooled OR for CVC-related thrombosis was 4.6 (95% CI: 2.6, 8.1) in patients with FV Leiden. The pooled OR for CVC-related thrombosis was 4.9 (95% CI: 1.7, 14.3) in patients with PTM. The estimated attributable risk of CVC-related thrombosis was 13.1% for FV Leiden and 4.5% for PTM. CONCLUSION: Our meta-analysis suggests that the presence of FV Leiden and PTM is associated with CVC-related thrombosis.

The effect of recanalization on long-term neurological outcome after cerebral venous thrombosis.

Essentials The role of cerebral venous thrombosis (CVT) recanalization on neurologic outcome is still debated. We studied a large cohort of 508 CVT patients with 419 patient years of radiological follow-up. Recanalization rate is high during the first months after CVT and neurologic outcome is favorable. High recanalization grade of CVT independently predicts good neurological outcome. SUMMARY: Background Studies with limited sample size and with discordant results described the recanalization time-course of cerebral venous thrombosis (CVT). The neurological outcome after a first episode of CVT is good, but the role of recanalization on neurological dependence is still debated. Objectives The aim of the study is to assess the recanalization rate after cerebral venous thrombosis (CVT) and its prognostic role in long-term neurological outcome. Patients/Methods In a retrospective observational multicenter cohort study, patients with an acute first episode of CVT with at least one available imaging test during follow-up were enrolled. Patency status of the vessels was categorized as complete, partial or not recanalized. Neurological outcome was defined using the modified Rankin scale (mRS) as good (mRS = 0-1) or poor (mRS = 2-6). Results Five-hundred and eight patients (median [IQR] age, 39 [28.5-49] years; 26% male) were included. Complete or partial recanalization was not differently represented in patients undergoing scans at different periods of time (from 28-day to 3 month-period up to a 1-3 year-period). mRS at the time of follow-up imaging was available in 483 patients; 92.8% of them had a mRS of 0-1. CVT recanalization (odds ratio [OR], 2.56; 95% confidence interval [CI], 1.59-4.13) was positively associated, whereas cancer (OR, 0.29; 95% CI, 0.09-0.88), and personal history of venous thromboembolism (VTE) (OR, 0.36; 95% CI, 0.14-0.92) were negatively associated as independent predictors of favorable (mRS = 0-1) outcome at follow-up. Conclusions Most patients with a first CVT had complete or partial recanalization at follow-up. Recanalization was independently associated with a favorable neurological outcome.

Ultrasound elastography is useful to distinguish acute and chronic deep vein thrombosis.

Essentials Ultrasound elastography uses tissue deformation to assess the relative quantification of its elasticity. Compression and duplex ultrasonography may be unable to correctly determine the thrombus age. Ultrasound elastography may be useful to distinguish between acute and chronic deep vein thrombosis. The exact determination of the thrombus age could have both therapeutic and prognostic implications. BACKGROUND: Background Ultrasound elastography (UE) imaging is a novel sonographic technique that is commonly employed for relative quantification of tissue elasticity. Its applicability to venous thromboembolic events has not yet been fully established; in particular, it is unclear whether this technique may be useful in determining the age of deep vein thrombosis (DVT). Thus, the aim of this study was to assess the role of UE in distinguishing acute from chronic DVT. Methods Consecutive patients with a first unprovoked acute and chronic (3 months old) DVT of the lower limbs were analyzed. Patients with recurrent DVT or with a suspected recurrence were excluded. The mean elasticity index (EI) values of acute and chronic popliteal and femoral vein thrombosis were compared. The accuracy of the EI in distinguishing acute from chronic DVT was also assessed by measuring the sensitivity, specificity, positive and negative predictive values, and likelihood ratios. Results One-hundred and forty-nine patients (mean age 63.9 years, standard deviation 13.6; 73 males) with acute and chronic DVT were included. The mean EI of acute femoral DVT was higher than that of chronic femoral DVT (5.09 versus 2.46), and the mean EI of acute popliteal DVT was higher than that of chronic popliteal DVT (4.96 versus 2.48). An EI value of > 4 resulted in a sensitivity of 98.9% (95% confidence interval [CI] 93.3-99.9), a specificity of 99.1% (95% CI 94.8-99.9), a positive predictive value of 91.1% (95% CI 77.9-97.1), a negative predictive value of 98.6% (95% CI 91.3-99.9), a positive likelihood ratio of 13.23 (95% CI 93-653) and a negative likelihood ratio of 0.001 (95% CI 0.008-0.05) for acute DVT. Conclusions UE appears to be a promising technique for distinguishing between acute and chronic DVT. Larger prospective studies are warranted to confirm our preliminary findings.

McMaster RARE-Bestpractices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome.

Background The McMaster RARE-Bestpractices project group selected the catastrophic antiphospholipid syndrome (CAPS) for a pilot exercise in guideline development for a rare disease. Objectives The objectives of this exercise were to provide a proof of principle that guidelines can be developed for rare diseases and assist in clinical decision making for CAPS. Patients/Methods The GIN-McMaster Guideline Development checklist and GRADE methodology were followed throughout the guideline process. The CAPS guideline was coordinated by a steering committee, and the guideline panel was formed with representation from all relevant stakeholder groups. Systematic reviews were performed for the key questions. To supplement the published evidence, we piloted novel methods, including use of an expert-based evidence elicitation process and ad hoc analysis of registry data. Results This paper describes the CAPS guideline recommendations, including evidence appraisal and discussion of special circumstances and implementation barriers identified by the panel. Many of these recommendations are conditional, because of subgroup considerations in this heterogeneous disease, as well as variability in patient values and preferences. Conclusions The CAPS clinical practice guideline initiative met the objective of the successful development of a clinical practice guideline in a rare disease using GRADE methodology. We expect that clinicians caring for patients with suspected CAPS will find the guideline useful in assisting with diagnosis and management of this rare disease.

The incidence of venous thromboembolism following gynecologic laparoscopy: a multicenter, prospective cohort study.

BACKGROUND: Information on the incidence of venous thromboembolism (VTE) following laparoscopic procedures is inadequate and there is currently no solid evidence to guide the use of thromboprophylaxis in this setting. Gynecologic laparoscopy is a common procedure, and is frequently performed in low-risk patients. To our knowledge, there are no clinical studies specifically designed to assess the incidence of VTE in this setting. METHODS: In a prospective cohort study, consecutive patients undergoing gynecologic laparoscopy underwent compression ultrasonography (CUS) and clinical assessment to evaluate the incidence of clinically relevant VTE. CUS was performed 7 +/- 1 and 14 +/- 1 days postoperatively. A subsequent telephone contact was scheduled at 30 and 90 days. No patient received pharmacologic or mechanical prophylaxis. Patients with malignancy or previous VTE were excluded from the study. RESULTS: We enrolled 266 consecutive patients; mean age was 36.3 years, range: 18-72. The most common indications for laparoscopy were ovarian cysts in 25.6% of patients, endometriosis in 21.0% of patients, unexplained adnexal masses in 12.4% of patients, and infertility in 7.5% of patients. The mean duration of the procedure was 60.5 min (range: 10-300 min). In particular, in 55.6% of patients the duration exceeded 45 min. There were neither episodes of CUS detected DVT (0/247; 0%, 95% CI 0-1.51%) or clinically relevant VTE after follow-up (0/256; 0%, 95% CI 0-1.48%). No patient died of fatal pulmonary embolism (0/266; 0%, 95% CI 0-1.42%). CONCLUSIONS: Gynecologic laparoscopy in non-cancer patients is a low-risk procedure for postoperative VTE.

Survival and recurrent venous thromboembolism in patients with first proximal or isolated distal deep vein thrombosis and no pulmonary embolism.

Essentials The long-term risk of recurrence and death after distal deep vein thrombosis (DVT) is uncertain. We included subjects with first proximal or isolated distal DVT (IDDVT) and no pulmonary embolism. The risk of symptomatic and asymptomatic recurrence is lower after IDDVT (vs. proximal). IDDVT may be associated with a lower long-term risk of death, especially after unprovoked DVT. SUMMARY: Background A few studies have focused on the risk of recurrence after first acute isolated distal deep vein thrombosis (IDDVT) compared with proximal DVT (PDVT), whereas the incremental risk of death has never been explored beyond the first 3 years after acute event. Methods Our single-center cohort study included patients with first symptomatic acute PDVT or IDDVT. Patients were excluded if they had concomitant pulmonary embolism (PE) or prior venous thromboembolism. The primary outcomes were symptomatic objectively diagnosed recurrent PDVT or PE and all-cause death. Results In total, 4759 records were screened and 831 subjects included: 202 had symptomatic IDDVT and 629 had PDVT. The median age was 66 years and 50.5% were women. A total of 125 patients had recurrent PDVT or PE during 3175 patient-years of follow-up: 109 events occurred after PDVT (17.3%) and 16 after IDDVT (7.9%). Annual recurrence rates were 4.5% (95% confidence interval [CI], 3.7-5.4%) and 2.0% (95% CI, 1.1-3.2%), respectively, for an adjusted hazard ratio (aHR) for IDDVT patients of 0.32 (95% CI, 0.19-0.55). Death occurred in 263 patients (31.6% [95% CI, 28.6-34.9%]) during 5469 patient-years of follow-up for an overall annual incidence rate of 4.8% (95% CI, 4.2-5.4%). The mortality rate was 33.5% (n = 211) in PDVT patients and 25.7% (n = 52) in IDDVT patients. The long-term hazard of death appeared lower for IDDVT patients (aHR, 0.75 [95% CI, 0.55-1.02]), especially after unprovoked events (aHR, 0.58 [95% CI, 0.26-1.31]). Conclusions Compared with PDVT, IDDVT patients were at a lower risk of recurrent VTE. The risk of death appeared lower after IDDVT during a median follow-up of 7.6 years.

Evaluation of the threshold value for the modified early warning score (MEWS) in medical septic patients: a secondary analysis of an Italian multicentric prospective cohort (SNOOPII study).

BACKGROUND: Due to aging and resources limitation, septic patients are often admitted to medical wards (MWs). Early warning deterioration is a relevant issue in this setting. Unfortunately, a suitable prognostic score has not been identified, yet. AIM: To explore the ability of Modified Early Warning Score (MEWS) to predict the in-hospital mortality in septic patients admitted to MWs. DESIGN: Secondary analysis of a multicentric prospective study. METHODS: Consecutive septic patients with positive blood culture admitted to 31 Italian MWs were included. Baseline characteristics, clinics, isolates, rate of transfer to ICU, MEWS was collected on admission according to the study protocol. The accuracy of MEWS in predicting the in-hospital mortality was assessed with the area under the receiver-operating characteristic curves. Sensitivity, specificity, positive and negative predictive value (PPV and NPV), likelihood ratio (LR) were calculated for different MEWS cut-offs and age/comorbidities subgroups. RESULTS: In total 526 patients were included in this analysis. Median MEWS was (range 0-11). In-hospital mortality was 14.8% and transfer to ICU 1.3%. Mortality progressively increased according to MEWS (3% in MEWS 0 vs. 27% in MEWS >5; Chi square for trend P < 0.05). The AUC of MEWS in predicting in-hospital mortality was 0.596 (95% CI, 0.524, 0.669). MEWS did not appear to have an adequate sensitivity, sensibility, PPV, NPV and LR both in the whole population and in the pre-specified subgroups. CONCLUSIONS: Our findings do not seem to support the use of MEWS to predict the in-hospital mortality risk of sepsis in MWs.

Clinical course of isolated distal deep vein thrombosis in patients with active cancer: a multicenter cohort study.

Essentials Isolated distal deep vein thrombosis (IDDVT) is frequently associated with cancer. No study has specifically evaluated the long-term clinical course of cancer-associated IDDVT. Patients with cancer-associated IDDVT are at very high risk of symptomatic recurrence and death. We observed low rates of major bleeding during anticoagulation. SUMMARY: Background Although isolated distal deep vein thrombosis (IDDVT) is frequently associated with cancer, no study has specifically evaluated the long-term clinical course of IDDVT in this setting. Aim To provide data on the rate of recurrent venous thromboembolism (VTE), major bleeding events and death in IDDVT patients with active cancer. Patients and Methods Consecutive patients with active cancer and an objective IDDVT diagnosis (January 2011 to September 2014) were included from our files. We collected information on baseline characteristics, IDDVT location and extension, VTE risk factors, and type and duration of anticoagulant treatment. Results A total of 308 patients (mean age 66.2 [standard deviation (SD), 13.2 years]; 57.1% female) with symptomatic IDDVT and a solid (n = 261) or hematologic (n = 47) cancer were included at 13 centers. Cancer was metastatic in 148 (48.1%) patients. All but three (99.0%) patients received anticoagulant therapy, which consisted of low-molecular-weight heparin in 288 (93.5%) patients. Vitamin K antagonists were used for the long-term treatment in 46 (14.9%) patients, whereas all others continued the initial parenteral agent for a mean treatment duration of 4.2 months (SD, 4.6 months). During a total follow-up of 355.8 patient-years (mean, 13.9 months), there were 47 recurrent objectively diagnosed VTEs for an incidence rate of 13.2 events per 100 patient-years. During anticoagulant treatment, the annual incidence of major bleeding was 2.0 per 100 patient-years. Conclusions Cancer patients with IDDVT have a high risk of VTE recurrence. Additional studies are warranted to investigate the optimal intensity and duration of anticoagulant treatment for these patients.