Patient-centered communication, patient satisfaction, and retention in care in assisted reproductive technology visits.

PURPOSE: To explore the association between patient-centered communication, patients' satisfaction, and retention in care in assisted reproductive technology (ART) visits. METHODS: ART visits at eight Italian clinics were videotaped and coded using the Roter Interaction Analysis System, which includes a Patient-Centered Index (PCI), a summary "patient-centered communication" ratio. After the visit, patients completed a satisfaction questionnaire (SATQ). After 3 months, patients were asked about their retention in care. Spearman correlations and Mann-Whitney tests were used to test associations between the study variables; the open-ended item of SATQ was analyzed through content analysis. RESULTS: Eighty-five visits were videotaped (involving 28 gynecologists and 160 patients). PCI score (µ = 0.51 ± 0.28) revealed a more disease-oriented communication during the visit. Patients reported high levels of satisfaction with the visit and identified in the information provision or in the doctor's humanity or kindness the main reasons of satisfaction. At the follow-up, the majority of the couples declared to have followed the clinicians' recommendations and to have remained related to the ART center. No associations were found among the study variables, except for a lower male satisfaction among couples who declared to have changed ART clinic. CONCLUSIONS: Contrary to what was expected, the style of physician-patient communication was not found to be associated with patient satisfaction and retention in care. However, patients were highly satisfied and engaged. The actual meaning of a communication that is "patient-centered" in the ART context might be wider, including the couples' need for information, as suggested by qualitative findings.

Oxygen saturation or respiratory rate to improve risk stratification in hemodynamically stable patients with acute pulmonary embolism.

Essentials In acute pulmonary embolism (PE), risk stratification is essential to drive clinical management. Improving the 2014-ESC risk stratification strategy is crucial in hemodynamically stable patients. Oxygen saturation and respiratory rate improve risk stratification in hemodynamically stable PE. Simple and routine tests improve risk stratification of hemodynamically stable PE. SUMMARY: Background In patients with acute pulmonary embolism (PE), risk stratification for short-term death is recommended to drive clinical management. A risk stratification strategy combining the simplified Pulmonary Embolism Severity Index (PESI), echocardiography and troponin was proposed by the European Society of Cardiology (ESC) in 2014. The identification of hemodynamically stable patients at increased risk of death by this strategy needs improvement. Objective To assess whether further stratification by serial cut-off values of oxygen saturation or respiratory rate improves the accuracy of the ESC risk stratification strategy in hemodynamically stable PE patients. Methods Prospective cohorts of hemodynamically stable patients with PE were merged in a collaborative database. The accuracy of risk stratification for 30-day mortality by the original and a modified 2014 ESC strategy was assessed. Results Overall, 255 patients (27%) were categorized as low, 510 (54%) as intermediate-low and 181 (19%) as intermediate-high risk according to the original 2014 ESC strategy. Thirty-day mortality was 1.2% in low, 10% in intermediate-low and 11% in intermediate-high-risk patients. By adding oxygen saturation in air of < 88%, the discriminatory power of the 2014 ESC model improved for 30-day mortality (c-statistics, 0.71; 95% confidence interval [CI], 0.65-0.77 vs. 0.63, 95% CI, 0.56-0.69) and for PE-related death (c-statistics, 0.75; 95% CI, 0.69-0.81 vs. 0.63, 95% CI 0.56-0.69). Conclusions Simple and routine tests, such as oxygen saturation or respiratory rate, could be added to the 2014 ESC strategy for risk stratification to identify hemodynamically stable PE patients at increased risk of death who are potentially candidates for more aggressive treatment.

Predicting Post-Thrombotic Syndrome with Ultrasonographic Follow-Up after Deep Vein Thrombosis: A Systematic Review and Meta-Analysis.

BACKGROUND: Post-thrombotic syndrome (PTS) is a common and potential severe complication of deep venous thrombosis (DVT). Elastic compression stocking therapy may prevent PTS if worn on a daily basis, but stockings are cumbersome to apply and uncomfortable to wear. Hence, identification of predictors of PTS may help physicians to select patients at high risk of PTS. AIMS: This article identifies ultrasonography (US) parameters assessed during or after treatment of DVT of the leg, that predict PTS. METHODS: This is a systematic review and meta-analysis study. Databases were searched for prospective studies including consecutive patients with DVT who received standardized treatment, had an US during follow-up assessing findings consistent with vascular damage after DVT and had a follow-up period of at least 6 months for the occurrence of PTS assessed by a standardized protocol. RESULTS: The literature search revealed 1,156 studies of which 1,068 were irrelevant after title and abstract screening by three independent reviewers. After full-text screening, 12 relevant studies were included, with a total of 2,684 analysed patients. Two US parameters proved to be predictive of PTS: residual vein thrombosis, for a pooled odds ratio (OR) of 2.17 (95% confidence interval [CI], 1.79-2.63) and venous reflux at the popliteal level, for a pooled OR of 1.34 (95% CI, 1.03-1.75). CONCLUSION: The US features reflux and residual thrombosis measured at least 6 weeks after DVT predict PTS. Whether these features may be used to identify patients who may benefit from compression therapy remains to be assessed in further studies.

Doctor-couple communication during assisted reproductive technology visits.

STUDY QUESTION: What are the characteristics of doctor-couple communication content during actual ART visits? SUMMARY ANSWER: Physicians were mainly focused on providing biomedical information, while communication content from couples had a 2-fold focus on providing biomedical information and on positive talk. WHAT IS KNOWN ALREADY: Communication aspects in ART seem crucial for clinical decision-making, retention in care and critical conversations with couples due to low treatment success rates. However, no studies have been carried out on the actual interaction between the doctor and the couple in this context. STUDY DESIGN, SIZE, DURATION: This observational study involved 28 clinicians and 160 patients referred to eight Italian ART clinics during a one-year recruitment period. PARTICIPANTS/MATERIALS, SETTING, METHODS: ART visits at eight Italian clinics were videotaped. The visits were coded using the Roter Interaction Analysis System (RIAS), particularly focusing on RIAS composite categories, verbal dominance and patient-centeredness score. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 85 visits were eligible for analysis (62% acceptance rate), involving 28 clinicians and 160 patients (including 75 couples). The average visit duration was 37 ± 17.7 min. The mean verbal dominance was 1.9 ± 0.86 (range: 0.72-5.74). Physicians mainly focused on providing biomedical information. Communication content from couples had a 2-fold focus on providing biomedical information and on positive talk. The mean of patient centeredness index (PCI) was 0.51 (SD = 0.28; range 0.08-1.77); visits in which the doctor was a woman or the treatment indication was for heterologous fertilization showed higher PCI scores. Overall, females accounted for 67% of all patient talk. Taking this imbalance into account as expected frequencies for each composite category, males reported significantly more utterances in almost all of the socioemotional categories. LIMITATIONS, REASONS FOR CAUTION: These results are preliminary and observational and only regard Italy. Communication during visits may have been biased since the professionals who agreed to participate showed an interest in communication issues. Another limitation is a possible Hawthorne effect due to the fact that participants were aware of being videotaped. WIDER IMPLICATIONS OF THE FINDINGS: Our study showed that ART physicians mainly adopted an informative model of communication and a more disease-oriented approach. Findings revealed the complexity of communication content during ART consultations, given its triadic characteristic in which the third party is also a patient; clinicians should be aware of this complex aspect and of the specific male and female perspectives to be taken into account. The results could be useful for training ART professionals. STUDY FUNDING/COMPETING INTEREST(S): This study was possible thanks to an unconditional grant from Ferring Spa to the Department of Health Sciences, University of Milan. There are no competing interests to declare. TRIAL REGISTRATION NUMBER: N/A.

Variation of renal function over time is associated with major bleeding in patients treated with direct oral anticoagulants for atrial fibrillation.

Essential In patients on treatment with direct anticoagulants (DOACs) variation of renal function is common. The effect of variations of renal function over time on major bleeding is not well defined. Variation of renal function over time is an independent predictor of major bleeding. Identifying conditions associated with variation of renal function may increase safety of DOACs. SUMMARY: Background Chronic kidney disease is a risk factor for major bleeding in patients with atrial fibrillation (AF) treated with warfarin. Objective To assess the effect of variations in renal function over time on the risk of major bleeding during treatment with direct oral anticoagulants (DOACs) in patients with non-valvular AF. Methods Consecutive AF patients were prospectively followed after they had received the first DOAC prescription. Estimated glomerular filtration rate (eGFR) was periodically assessed, and the incidence of major bleeding was recorded. A joint survival model was used to estimate the association between variation in eGFR and the risk of major bleeding. Results During a mean follow-up of 575 days, 44 major bleeds occurred in 449 patients (6.1% per patient-year). eGFR over time was inversely and independently associated with the risk of major bleeding; every 1 mL min-1 absolute decrease in eGFR was associated with a 2% increase in the risk of major bleeding (hazard ratio [HR] 1.02, 95% confidence interval [CI] 1.01-1.04). A similar effect of the variation in eGFR over time was observed on the risk of clinically relevant non-major bleeding (HR 1.02, 95% CI 1.01-1.03). Deterioration of renal function leading to a change in eGFR staging was associated with an increase in the risk of major bleeding (HR 2.43, 95% CI 1.33-4.45). Conclusions Variation in renal function over time is associated with the risk of major bleeding in AF patients treated with DOACs in real life. Identification of intervening clinical conditions associated with variation in renal function is essential to reduce the risk of major bleeding and to make DOAC treatment more safe.

Anticoagulation in patients with isolated distal deep vein thrombosis: a meta-analysis.

Essentials The optimal management of isolated distal deep vein thrombosis (IDDVT) is undefined. This meta-analysis aimed to assess the clinical benefit of anticoagulation for IDDVT. Anticoagulation reduced the rate of pulmonary embolism without increasing major bleeding risk. Recurrent thromboembolism was less common with more than 6 weeks vs. 6 weeks of anticoagulation. SUMMARY: Background The optimal management of patients with isolated distal deep vein thrombosis (IDDVT), concerning both the need for anticoagulation and its duration, is undefined. Objectives We performed a meta-analysis of randomized and cohort studies in patients with IDDVT to assess the clinical benefit of: (i) anticoagulation versus no anticoagulation; and (ii) anticoagulant treatment for 6 weeks versus for > 6 weeks. Methods The primary outcome of this analysis was recurrent venous thromboembolism (proximal propagation, recurrence of deep vein thrombosis, and pulmonary embolism). Data were pooled and compared by the use of odds ratio (OR) and 95% confidence interval (CI). Results A reduction in the rate of recurrent venous thromboembolism was observed in patients who received anticoagulation relative to those who did not receive anticoagulation (either therapeutic or prophylactic) (20 studies, 2936 patients; OR 0.50, 95% CI 0.31-0.79), without an increase in the risk of major bleeding (OR 0.64, 95% CI 0.15-2.73). The rate of pulmonary embolism was lower in anticoagulant-treated patients than in controls (15 studies, 1997 patients; OR 0.48, 95% CI 0.25-0.91). A lower rate of recurrent venous thromboembolism was observed in patients who received > 6 weeks of anticoagulant therapy than in those who received 6 weeks of anticoagulant therapy (four studies, 1136 patients; OR 0.39, 95% CI 0.17-0.90). Conclusions In patients with IDDVT, anticoagulation (both therapeutic and prophylactic) reduces the rate of recurrent venous thromboembolism and the incidence of pulmonary embolism as compared with no anticoagulation, without an increased risk of major bleeding. Anticoagulation for > 6 weeks should be preferred over shorter durations.

Clinical management and outcome of major bleeding in patients on treatment with vitamin K antagonists.

BACKGROUND: The optimal management of major bleeding associated with vitamin K antagonists remains unclear. OBJECTIVES: The aim of the study was to assess the determinants of outcome of vitamin K antagonists-associated major bleeding and the outcome of bleeding in relation with the therapeutic management. METHODS: Patients hospitalized for major bleeding while on vitamin K antagonists were included in a prospective, cohort study. Major bleeding was defined according to the criteria of the International Society of Thrombosis Haemostasis. The primary study outcome was death at 30days from major bleeding. RESULTS: 544 patients were included in this study, of which 282 with intracranial hemorrhage. Prothrombin complex concentrates were used in 51% and in 23% of patients with intracranial hemorrhage or non-intracranial major bleeding, respectively (p<0.001); fresh frozen plasma was used in 7% and in 17% of patients with intracranial hemorrhage or non-intracranial major bleeding (p<0.001). Death at 30days occurred in 100 patients (18%), 72 patients with intracranial hemorrhage and 28 patients with non-intracranial major bleeding. Age over 85years, low Glasgow Coma Scale score and shock were independent predictors of death at 30days. Invasive procedures were associated with decreased risk of death. CONCLUSIONS: Among the patients hospitalized for major bleeding while on vitamin K antagonists, the risk for death is substantial. The risk for death is associated with the clinical severity of major bleeding as assessed by the GCS score and by the presence of shock more than with the initial localization of major bleeding (ICH vs other sites).

PO-40 - Real-life use of non-vitamin k antagonist oral anticoagulants in patients with cancer associated venous thromboembolism: data from a prospective cohort.

INTRODUCTION: Cancer associated thrombosis (CAT) has an increased risk of recurrent venous thromboembolism (VTE). Type, stage of cancer and chemotherapy (CHT) influence thromboembolic risk. The use of novel oral anticoagulants (NOACs) is controversial in patients with CAT. AIM: The aim of this study is to assess mortality, recurrent VTE and bleeding complications in patients with CAT and in patients without cancer receiving NOACs. MATERIALS AND METHODS: Consecutive patients with acute objectively confirmed VTE receiving NOACs within 1 month from diagnosis are included from September 2013 in an ongoing prospective cohort study. Characteristics of patients and outcome are reported according to the presence of CAT. Chi-squared test and Student' t-test are used. RESULTS: As for November 10(th) 2015, 472 patients were included in the study: 78 with CAT (16.5%). Lung, breast, gastrointestinal and genitourinary cancer was observed in 16%, 24%, 20% and 24% of patients with CAT, respectively. 31 patients with CAT (40%) were on CHT or radiotherapy (RT). 10 patients with CAT (13%) had at least an additional risk factor for VTE (4 had a CVC related thrombosis) and 34 (43.5%) were inpatients. Baseline characteristics of patients with and without CAT are reported in the Table. Pulmonary embolism was index VTE in 152 patients: 24.4% of patients with CAT and in 33.8% of those without cancer (p=0.10). DVT only was present in 320 patients and 78 had both DVT and PE. Among NOACs patients, 312 (66%) received initial loading dose: 61% of those with CAT and 67% without. 53 (11%) received reduced maintenance doses (10% with CAT, 11% without). As for nowadays, 272 patients had at least 3 months of follow-up, the mean follow-up being 8.6 months. 20 patients died (7.3%): 17 were cancer related deaths. Non cancer related death occurred in 1 patient with CAT (2%) and in 2 patients without (0.9%). No fatal bleedings or fatal VTE recurrences occurred. Patients recruitment and follow-up is currently ongoing aimed at assessing mortality, recurrent VTE and bleeding complications. Updated results on clinical outcomes will be presented at the congress. CONCLUSIONS: Patients with CAT receiving NOACs are treated as patients without CAT in terms of use of loading doses and maintenance treatment. Upper arm thrombosis is more frequently involved in CAT patients and proximal lower vein in patients without CAT. Non cancer related mortality was higher in CAT patients but no fatal recurrences or fatal bleedings were observed so far.

To drain or not to drain extraperitoneal colorectal anastomosis? A systematic review and meta-analysis.

AIM: Anastomotic leakage is the one of the most serious complications in rectal cancer surgery and is associated with high mortality, morbidity and an increased incidence of local recurrence. Although many studies have compared drained and undrained colorectal anastomoses, to date the role of pelvic drainage in extraperitoneal colorectal anastomosis remains undefined. METHOD: We carried out a systematic review of the literature, performing an unrestricted search in MEDLINE and Embase up to 30 October 2012. Reference lists of retrieved articles and review articles were manually searched for other relevant studies. We performed a meta-analysis of the data currently available on the incidence of extraperitoneal anastomotic leakage, according to the presence or absence of pelvic drainage. RESULTS: Overall, eight studies - three randomized clinical trials (RCTs) and five non-RCTs, comprising a total of 2277 patients - were included in the meta-analysis. Pelvic drainage was demonstrated to reduce both the leak rate and the rate of reintervention in patients who underwent anterior rectal resection with extraperitoneal colorectal anastomosis (OR = 0.51, 95% CI: 0.36-0.73; and OR = 0.29, 95% CI: 0.18-0.46, respectively) compared with patients without drainage. Overall mortality and infection rates were also evaluated, but a nonsignificant correlation was found with the presence of drainage. CONCLUSION: The meta-analysis shows that the presence of a pelvic drain reduces the incidence of extraperitoneal colorectal anastomotic leakage and the rate of reintervention after anterior rectal resection.

Prognostic role of embolic burden assessed at computed tomography angiography in patients with acute pulmonary embolism: systematic review and meta-analysis.

BACKGROUND: In patients with acute pulmonary embolism (PE), risk stratification is indicated for tailoring of both diagnostic strategies and acute treatment. Whether embolic burden assessed at computed tomography (CT) angiography has a role in risk stratification in these patients is debated. OBJECTIVE: To systematically review and perform a meta-analysis to evaluate the role of CT-assessed burden associated with embolic obstruction and embolic localization in the prognostic stratification of patients with acute PE. METHODS: We performed a systematic search in EMBASE and MEDLINE up until 30 June 2013. Studies reporting on the 30-day outcome of patients with confirmed PE and CT-assessed embolic burden were included. The study outcome was death. RESULTS: Thirty studies reporting on the prognostic value of CT-assessed embolic burden met the inclusion criteria for this systematic review; of these, 19 were included in the meta-analysis. Five studies (2215 patients) were included in the analysis of localization: an association between embolus localization in the central arteries and 30-day mortality was found after heterogeneity was resolved (odds ratio [OR] 2.24, 95% confidence interval [CI] 1.29-3.89, I(2)  = 0%). No correlation was observed between obstruction index (according to the Qanadli scoring system) and 30-day mortality after heterogeneity was reduced (16 studies, 3884 patients, OR 1.22, 95% CI 0.99-1.51, I(2)  = 27%). CONCLUSION: Localization of emboli assessed at CT angiography can be used for risk stratification in patients with acute PE. Moreover, no correlation was observed between obstruction index and prognosis.

Prognostic role of sentinel node biopsy in patients with thick melanoma: a meta-analysis.

OBJECTIVES: Sentinel lymph node (SLN) biopsy is a prognostic tool for patients with intermediate-thickness melanomas. However, controversies exist regarding its role in patients with thick melanomas (tumour thickness greater than 4.0 mm). We performed a meta-analysis to assess the prognostic role of SLN in thick melanoma in terms of disease-free survival (DFS) and overall survival (OS). METHODS: An electronic search in MEDLINE and EMBASE databases using the terms 'melanoma' and 'sentinel lymph node' was performed. Studies were considered if they reported data on thick melanoma and SLN biopsy results (positive and negative) and outcomes (DFS or OS). A proportion meta-analysis was used to calculate weighted means and an incidence rate ratio meta-analysis was used to compare outcomes according to SLN biopsy results. RESULTS: Nine studies were included. The weighted mean thickness of melanoma was 4.4 mm, 42% of patients had ulcerated melanoma. SLN was positive in 36% of the patients. Overall, DFS was 71% in patients with a negative SLN and 39% in patients with a positive SLN after a median follow-up of 33 months (IRR 1.83, 95% CI = 1.56-2.14). OS was 71% in patients with a negative SLN and 49% in patients with a positive SLN (IRR 1.44, 95% CI = 1.25-1.65). CONCLUSIONS: The results of this analysis showed that thick melanoma patients with a positive SLN had a significantly worse survival compared with SLN negative patients, thus supporting the routine adoption of SLN biopsy as a prognostic tool also for this subgroup of patients.

The sentinel node biopsy in patients with thick melanoma: outcome analysis from a single-institution database.

BACKGROUND: We examined the impact of sentinel lymph node (SLN) biopsy among patients with primary melanoma that exceeded 4.0 mm in Breslow thickness, treated in our Institution from 1998 until 2009. PATIENTS AND METHODS: According to Kaplan-Meier statistics, overall survival (OS) and disease-free survival (DFS) were assessed in patients with: i) disseminated disease at diagnosis with respect to patients undergoing SLN biopsy and ii) positive SLN and negative SLN. The effect of age, thickness and number of positive SLN on survival was also calculated. RESULTS: Forty-three patients with thick melanoma were included (29 men and 14 women; mean age 65 ± 17 years, tumor thickness ranging from 4 to 20 mm). Thirteen patients (30%) were not eligible for SLN biopsy due to metastatic disease or poor clinical condition. Biopsy was performed on 30 patients: 14 with positive SLN (46.7%, group A) and 16 with negative SLN (53.3%, group B). Seven patients (50%) died in group A and 2 patients (13%) in group B (mean follow-up 28 and 59 months, respectively); all 7 patients in group A and no patient in group B died because of melanoma. OS and DFS were both significantly higher in group B than group A. CONCLUSION: Our experience demonstrates a high rate of positive SLNs in patients with thick melanoma, and significant differences regarding the general outcomes between those with positive and negative SLNs, the latter group having a good prognosis despite the thick primary tumor. This observation stresses the importance of SLN biopsy as a staging tool in patients with thick melanoma.

Prevalence and clinical history of incidental, asymptomatic pulmonary embolism: a meta-analysis.

CONTEXT: Recently, there has been an increasing number of reports of incidental pulmonary embolism (PE) in patients undergoing chest computer tomography (CT) for reasons other than the research of suspected PE. Natural history of incidental PE remains unclear. OBJECTIVES: To estimate the prevalence of incidental PE, to assess potential factors associated with incidental PE, and to evaluated its clinical history. DATA SOURCES: MEDLINE, EMBASE databases (up to January 2009). STUDY SELECTION: Studies were included if the prevalence of incidental PE was assessed using CT scanning. DATA EXTRACTION: The prevalence of incidental PE in these patients was documented. Separate data for inpatients and outpatients and according to the reason for CT scanning were collected. Weighted mean proportion of the prevalence of incidental PE was calculated. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated to test the association with potential predictors of incidental PE. RESULTS: Twelve studies for a total of more than 10 thousand patients were included. The weighted mean prevalence of incidental PE was 2.6% (95% CI 1.9, 3.4). Hospitalization at the time of CT scanning and the presence of cancer were associated with a significantly increased risk of incidental PE (OR 4.27 and OR 1.80 respectively). CONCLUSIONS: The prevalence of incidental PE is clinically relevant. Future studies are necessary to properly evaluate the clinical history of these patients.

Incidence of arterial cardiovascular events after venous thromboembolism: a systematic review and a meta-analysis.

SUMMARY BACKGROUND: Whether patients with unprovoked venous thromboembolism (VTE) have a higher risk of arterial cardiovascular events than the general population and patients with provoked VTE is a matter of debate. OBJECTIVE: To perform a systematic review and a meta-analysis aimed at assessing the risk of arterial cardiovascular events in patients with unprovoked VTE as compared with both patients with provoked VTE and controls. METHODS: A systematic search was performed. Studies reporting on (i) patients with confirmed VTE, (ii) a follow-up of at least 6 months and (iii) the incidence of arterial cardiovascular events (acute myocardial infarction and ischemic stroke) were included in the systematic review. Those studies reporting separate incidences of cardiovascular events in patients with unprovoked and provoked VTE or patients with unprovoked VTE and controls were included in the incidence rate meta-analysis. RESULTS: Overall, 17 studies were included in the systematic review. The weighted mean incidence of arterial cardiovascular events was 0.46% [95% confidence interval (CI) 0.34-0.59] and 0.35% (95% CI 0.24-0.49) per patient-year in patients with unprovoked and provoked VTE, respectively. Six studies were included in the meta-analysis. The risk of arterial cardiovascular events appeared to be higher in patients with unprovoked VTE than in controls [incidence rate ratio (IRR) 1.87, 95% CI 1.32-2.65] and than in patients with provoked VTE (IRR 1.86, 95% CI 1.19-2.89). CONCLUSIONS: Patients with unprovoked VTE have a higher risk of arterial cardiovascular events than patients with provoked VTE over long-term follow-up.

Loop ileostomy versus loop colostomy for fecal diversion after colorectal or coloanal anastomosis: a meta-analysis.

BACKGROUND: Sphincter-saving surgery for the treatment of middle and low rectal cancer has spread considerably when total mesorectal excision became standard treatment. In order to reduce leakage-related complications, surgeons often perform a derivative stoma, a loop ileostomy (LI), or a loop colostomy (LC), but to date, there is no evidence on which is the better technique to adopt. METHODS: We performed a systematic review and meta-analysis of all randomized controlled trials until 2007 and observational studies comparing temporary LI and LC for temporary decompression of colorectal and/or coloanal anastomoses. Clinically relevant events were grouped into four study outcomes: general outcome measures: dehydratation and wound infection GOM construction of the stoma outcome measures: parastomal hernia, stenosis, sepsis, prolapse, retraction, necrosis, and hemorrhage closure of the stoma outcome measures: anastomotic leak or fistula, wound infection COM, occlusion and hernia functioning of the stoma outcome measures: occlusion and skin irritation. RESULTS: Twelve comparative studies were included in this analysis, five randomized controlled trials and seven observational studies. Overall, the included studies reported on 1,529 patients, 894 (58.5%) undergoing defunctioning LI. LI reduced the risk of construction of the stoma outcome measure (odds ratio, OR = 0.47). Specifically, patients undergoing LI had a lower risk of prolapse (OR = 0.21) and sepsis (OR = 0.54). LI was associated with an excess risk of occlusion after stoma closure (OR = 2.13) and dehydratation (OR = 4.61). No other significant difference was found for outcomes. CONCLUSION: Our overview shows that LI is associated with a lower risk of construction of the stoma outcome measures.

Patients with primary antiphospholipid antibody syndrome and without associated vascular risk factors present a normal endothelial function.

INTRODUCTION: Primary antiphospholipid antibody syndrome (PAPS) is characterized by venous or arterial thrombosis and positive antiphospholipid antibodies. It is controversial whether PAPS patients have early atherosclerosis. Endothelial dysfunction is an early event in the natural history of atherosclerosis. Aim of our study was to compare endothelial function of patients with PAPS and no associated risk factors with that of age- and sex-matched controls. MATERIALS AND METHODS: Patients with PAPS, carefully selected to exclude all known risk factors for cardiovascular diseases, estrogen therapy, pregnancy, intake of drugs affecting endothelial function, vitamins or antioxidants, were included in a case-control study. Controls were age- (+/-5 years) and sex-matched subjects with the same exclusion criteria but without PAPS. Flow-mediated dilation of the brachial artery and some plasmatic markers of endothelial and platelet activation were measured. Measures are expressed as mean+/-SEM. RESULTS: Twenty cases (mean age 42+/-4.0 years, 11 females) and 39 controls (mean age 41+/-2.9, 22 females) were studied. FMD was 5.7+/-0.8% in cases (95% CI: 4.1 to 7.3) and 6.8+/-0.5% (5.7 to 7.9) in controls (p=NS). Plasma von Willebrand factor was 128+/-11.3% and 134.2+/-16.1% in cases and controls, respectively (p=NS). Soluble P-selectin and soluble CD40L were 94.1+/-4.9 ng/ml and 0.7+/-0.1 ng/ml in cases and 87.7+/-4.0 ng/ml and 1.0+/-0.2 in controls, respectively (p=NS). In a substudy, circulating progenitor and mature endothelial cells were comparable between the two groups. CONCLUSIONS: Endothelial function in patients with PAPS and no associated risk factors is similar to that of age- and sex- matched controls. These data suggest that the alterations leading to thrombosis in PAPS concern primarily the clotting system.

Acute pulmonary embolism: risk stratification in the emergency department.

Pulmonary embolism is a common disease associated with a high mortality rate. Death due to pulmonary embolism occurs more commonly in undiagnosed patients before hospital admission or during the initial in-hospital stay. Thus, mortality could be reduced by prompt diagnosis, early prognostic stratification and more intensive treatment in patients with adverse prognosis. Mortality is particularly high in patients with pulmonary embolism presenting with arterial hypotension or cardiogenic shock. In patients with pulmonary embolism and normal blood pressure, a number of clinical features and objective findings have been associated with a high risk of adverse in-hospital outcome. Advanced age and concomitant cardiopulmonary disease are clinical risk factors for in-hospital mortality. The Bburden of thromboembolism, as assessed by lung scan or spiral CT, and right ventricle overload, as assessed by echocardiography and probably spiral CT, have been claimed to be risk factors for in-hospital mortality. Elevated serum levels of troponins have been shown to be associated with right ventricular overload and adverse in-hospital outcomes in patients with pulmonary embolism. Despite the currently available evidence, no definite prognostic value can be assigned to any of the individual risk factors or cluster of them. Large prospective trials should be carried out to validate individual risk factors or clusters of risk factors able to identify patients with acute pulmonary embolism at high risk for in-hospital mortality. These patients could afford the trade-off of an increased risk of side effects related to a more aggressive treatment, such as thrombolysis or surgical or interventional procedures.

Incidence of cancer after a first episode of idiopathic venous thromboembolism treated with 3 months or 1 year of oral anticoagulation.

BACKGROUND: A prolonged treatment with oral anticoagulants has been claimed to reduce the incidence of newly diagnosed cancer in the long-term follow-up of patients with venous thromboembolism. OBJECTIVES: In a multicenter prospective study we assessed the incidence of newly diagnosed clinically overt cancer in patients with a first episode of idiopathic venous thromboembolism (VTE) treated with oral anticoagulants for 3 months or 1 year. PATIENTS AND METHODS: Consecutive patients with an idiopathic venous thromboembolism who had completed 3 months of oral anticoagulant therapy without having a recurrence, bleeding or newly diagnosed cancer were randomized to discontinue oral anticoagulant therapy or to continue it for nine additional months. Idiopathic venous thromboembolism was defined as thrombosis occurring in the absence of known cancer, known thrombophilia, or temporary risk factors for venous thromboembolism. All patients were followed up for at least 1 year after randomization. RESULTS: A total of 429 patients, 265 patients with DVT and 164 with PE, were followed up for an average of 43.7 months after randomization. A newly diagnosed cancer occurred in 32 patients (7.5%), 13 (6.2%) of the 210 patients treated for 3 months and 19 (8.7%) of the 219 patients treated for 1 year (RR = 0.71, 95% confidence interval 0.36-1.41). CONCLUSIONS: The incidence of newly diagnosed clinically overt cancer is not reduced in patients with idiopathic venous thromboembolism treated with 1-year anticoagulant treatment compared with patients treated for 3 months.

Risk factors for adverse short-term outcome in patients with pulmonary embolism.

Pulmonary embolism (PE) is a common and potentially fatal disease. Death usually occurs before hospital admission or in the initial in-hospital phase. A number of clinical and instrumental findings have been associated with a high risk of adverse short-term clinical outcomes in patients with PE. Advanced age, concomitant cardiopulmonary disease, and haemodynamic instability, as well as large perfusion defects at lung scanning and acute right heart dysfunction as assessed by echocardiography, are associated with adverse in-hospital outcome. Elevated serum levels of troponin I have been recently demonstrated to be associated with severe right ventricular dysfunction and adverse in-hospital outcome in patients with PE. Early recurrence of PE is associated with a high mortality rate. Right heart dysfunction, as assessed by echocardiography and an acute fall in platelet count, have been suggested as risk factors for recurrence of PE. A reduction in mortality in the subgroup of patients with a poor prognosis might be achieved by using more aggressive treatments such as thrombolysis and surgical or interventional procedures. However, such treatments are invariably associated with bleeding and other procedural complications.