New-Onset Paroxysmal Atrial Fibrillation in the Setting of Acute Pulmonary Embolism Is Associated with All-Cause Hospital Mortality in Women but Not in Men.

BACKGROUND: Patients with acute pulmonary embolism (PE) may have various types of atrial fibrillation (AF). The role of AF in hemodynamic states and outcomes may differ between men and women. METHODS: In total, 1600 patients (743 males and 857 females) with acute PE were enrolled in this study. The severity of PE was assessed using the European Society of Cardiology (ESC) mortality risk model. Patients were allocated into three groups according to their electrocardiography recordings taken during hospitalization: sinus rhythm, new-onset paroxysmal AF, and persistent/permanent AF. The association between the types of AF and all-cause hospital mortality was tested using regression models and net reclassification index (NRI) and integrated discrimination index (IDI) statistics with respect to sex. RESULTS: There were no differences between the frequencies of the types of AF between men and women: 8.1% vs. 9.1% and 7.5% vs. 7.5% (p = 0.766) for paroxysmal and persistent/permanent AF, respectively. We found that the rates of paroxysmal AF significantly increased across the mortality risk strata in both sexes. Among the types of AF, the presence of paroxysmal AF had a predictive value for all-cause hospital mortality independent of mortality risk and age in women only (adjusted HR, 2.072; 95% CI, 1.274-3.371; p = 0.003). Adding paroxysmal AF to the ESC risk model did not improve the reclassification of patient risk for the prediction of all-cause mortality, but instead enhanced the discriminative power of the existing model in women only (NRI, not significant; IDI, 0.022 (95% CI, 0.004-0.063); p = 0.013). CONCLUSION: The occurrence of paroxysmal AF in female patients with acute PE has predictive value for all-cause hospital mortality independent of age and mortality risk.

A prospective cohort study for prediction of difficult laparoscopic cholecystectomy.

INTRODUCTION: Difficult laparoscopic cholecystectomy (DLC) is a stressful condition for surgeon which is followed by greater risk for various injuries (biliary, vascular etc.) Preoperative factors that are related to DLC are landmarks for surgeon to assess the possibilities for overcoming difficulties and making early decision about conversion to an open surgery. In prospective cohort study we evaluated and defined the importance and impact of preoperative parameters on difficulties encountered during surgery, defined DLC, predictors of DLC and index of DLC. MATERIALS AND METHODS: All patients in the study were operated by the same surgeon. We defined the total duration of the operation as the time from insertion of Veress needle to the extraction of gallbladder (GB) and DLC as a laparoscopic cholecystectomy (LC) that lasted longer than the average duration of LC and the value of one standard deviation. RESULTS: Multivariate logistic regression analysis identified five predictors significantly related to DLC: GB wall thickness > 4 mm, GB fibrosis, leukocytosis ˃10 × 109 g/L, ˃ 5 pain attacks that lasted longer than 4 h and diabetes mellitus. The sensitivity of the generated index of DLC in our series is 81.8% and specificity 97.2%. CONCLUSION: Preoperative prediction of DLC is important for the surgeon, for his operating strategy, better organization of work in operating room, reduction of treatment expenses, as well as for the patient, for his timely information, giving a consent for an operation and a better psychological preparation for possible open cholecystectomy (OC).

Impact on long-term mortality of access and non-access site bleeding after primary percutaneous coronary intervention.

OBJECTIVES: The influence of the bleeding site on long-term survival after the primary percutaneous coronary intervention (PCI) is poorly understood. This study sought to investigate the relationship between in-hospital access site versus non-access site bleeding and very late mortality in unselected patients treated with primary PCI. METHODS: Data of the 2715 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI, enrolled in a prospective registry of a high volume tertiary centre, were analysed. Bleeding events were assessed according to the Bleeding Academic Research Consortium (BARC) criteria. The primary outcome was 4-year mortality. RESULTS: The BARC type ≥2 bleeding occurred in 171 patients (6.3%). Access site bleeding occurred in 3.8%, and non-access site bleeding in 2.5% of patients. Four-year mortality was significantly higher for patients with bleeding (BARC type ≥2) than in patients without bleeding (BARC type 0+1), (36.3% vs 16.2%, p<0.001). Patients with non-access site bleeding had higher 4 year mortality (50.7% vs 26.5%, p=0.001). After multivariable adjustment, BARC type ≥2 bleeding was the independent predictor of 4 year mortality (HR 2.01; 95% CI 1.49 to 2.71, p<0.001). Patients with a non-access site bleeding were at 2-fold higher risk of very late mortality than patients with an access site bleeding (HR 2.62; 1.78 to 3.86, p<0.001 vs HR 1.57; 1.03 to 2.38, p=0.034). CONCLUSIONS: Both access and non-access site BARC type ≥2 bleeding is independently associated with a high risk of 4-year mortality after primary PCI. Patients with non-access site bleeding were at higher risk of late mortality than patients with access site bleeding.

Biomarkers for the prediction of early pulmonary embolism related mortality in spontaneous and provoked thrombotic disease.

Factors associated with provoked PE may influence a biomarker's predictive value for the primary outcome. The aim of this study was to investigate the value of BNP, cTnI, CRP and D-Dimer measurements taken soon after hospital admission for the prediction of 30-day PE-caused death in patients with spontaneous versus provoked PE.Data were extracted from a pool of 726 consecutive PE patients enrolled in the multicenter Serbian PE registry. Blood concentrations of BNP, cTnI, CRP and D-dimer were measured during the first 24 h of hospitalization. BNP blood level had strong predictive value for the primary outcome in spontaneous PE (c-statistics 0.943, 95% CI 0.882-1.000, p = .001) and a slightly lower predictive outcome in provoked PE (c-statistics 0.824, 95% CI 0.745-0.902, p < .001). NRI and IDI showed that none of the markers, when added to BNP, could improve Cox regression prediction models for 30-day PE-related mortality in either the spontaneous or provoked PE group. Blood levels of BNP measured during the first 24 h of hospital admission had an excellent predictive value for 30-day PE-related mortality in spontaneous PE and slightly lower predictive value in provoked PE, whereas CRP, cTnI and D-Dimer did not contribute significantly to the predictive value of BNP in either group.

The importance of angiotensin II type 1 receptor gene polymorphism to losartan treatment in improving glomerulopathy in type 1 diabetic patients.

OBJECTIVE: Diabetic nephropathy (DN) is a clinical syndrome characterized by persistent albuminuria, increasing arterial blood pressure and progressive decline in glomerular filtration rate (GFR). When persistent albuminuria is established, antihypertensive treatment becomes most important factor in slowing the progression of diabetic glomerulopathy. Aim of this study was to examine if renoprotective response to losartan therapy, in patients with diabetic nephropathy, depends on 1166 A/C gene polymorphism for its target receptor, angiotensin II type 1 receptor (AT1R). SUBJECTS AND METHODS: The study included 35 patients with diabetes mellitus type 1 and high urinary albumin excretion rate (>30mg/24h) genotyped for the 1166 A/C gene polymorphism for the AT1R. The participants were segregated into three genotype groups according to combinations of A or C allele: AA-16, AC-15 and CC-4 patients. The patients received losartan 50mg daily for 4 weeks, following 100mg daily for 8 weeks. At baseline and after losartan therapy period, blood pressure, GFR (Gates method) and filtration fraction (FF) were calculated. FF was calculated by dividing GFR by ERPF (Schlegels method). RESULTS: GFR remained unchanged in all genotype groups. FF was significantly reduced from baseline by 0.018±0.024 (P=0.012) only in the AC group. In the AA genotype FF was reduced from baseline by 0.017±0.03 (P=0.052) and in the CC group by 0.01±0.008 (P=0.092). In the AA group, systolic blood pressure declined from 136±24mmHg at baseline, to an average of 121±18mmHg at the end of the study (P=0.001). The AC group achieved reduction from 131±10mmHg at baseline to 115±7mmHg (P=0.001) during the investigation period. In the AA genotype group losartan reduced diastolic blood pressure from 86±13mmHg at baseline to 78±8mmHg (P=0.004), and in the AC genotype from 88±5mmHg at baseline to 11.7±5.6mmHg during the investigation period (P=0.001). In the CC genotype diastolic blood pressure reduction remained nonsignificant (P=0.066). CONCLUSION: The results of our small sample size study provide the evidence that 1166 A/C AT1R polymorphism could be associated with the renoprotective response to losartan therapy.

Incidence, predictors and prognostic implications of bleeding complicating primary percutaneous coronary intervention.

BACKGROUND/AIM: Data about bleeding complicating primary percutaneous coronary intervention (PCI) are more frequently obtained from randomized clinical trials on patients with acute coronary syndromes (ACS), but less frequently from surveys or registries on patients with ST-elevation myocardial infarction (STEMI). The aim of this study was to investigate the incidence, predictors and prognostic impact of in-hospital major bleeding in the population of unselected real-world patients with acute STEMI undergoing primary PCI. METHODS: All consecutive patients presenting with STEMI who underwent primary PCI at a single large tertiary healthcare center between January 2005 and July 2009, were studied. Major bleeding was defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) study criteria. We examined the association between in-hospital major bleeding and death or major adverse cardiac events (MACE) in patients treated with PCI. The primary outcomes were in-hospital and 6-month mortality and MACE. RESULTS: Of the 770 STEMI patients treated with primary PCI, in-hospital major bleeding occurred in 32 (4.2%) patients. Independent pre-dictors of major bleeding were advanced age (≥ 65 years), female gender, baseline anemia and elevated white blood cell (WBC) count and signs of congestive heart failure at admission (Killip class II-IV). In-hospital and 6 month mortality and MACE, rates were more than 2.5-fold-higher in patients who developed major bleeding compared with those who did not. Major bleeding was predictor of 6-month MACE, independent of a few risk factors (previous MI, previous PCI, diabetes mellitus and hypertension); (OR = 3.02; 95% CI for OR 1.20-7.61; p = 0.019) but was not a true independent predictor of MACE and mortality in the fully adjusted models. CONCLUSION: Patients of advanced age, female gender, with baseline anemia and elevated WBC count and those with Killip class II-IV at presentation are at particularly high risk of bleeding after primary PCI. Bleeding is associated with adverse outcome and may be an important marker of patient frailty, but it is not a true independent predictor of mortality/MACE.

Quality of life after peripheral bypass surgery: a 1 year follow-up.

OBJECTIVES: The aim of the study was to assess quality of life (QoL) in patients with peripheral arterial disease (PAD) after aortobifemoral bypass. METHODS: QoL assessments were completed by 78 patients, 61 (78.2 %) men and 17 (21.8 %) women. QoL was measured, using Medical Outcome Survey Short Form 36 (SF-36), before surgery and 1 year later. RESULTS: QoL significantly improved after revascularization in about two-third of patients with PAD. Improvement was present in all the SF-36 subscales with the exception of the score for mental health which significantly decreased after operation. Mean SF-36 scores, which were for almost all subscales significantly decreased in patients with PAD in comparison with reference populations, after operation reached or exceeded values of the populations with which they were compared. CONCLUSIONS: In the present study 1 year after revascularization QoL in patients with PAD was significantly improved in comparison with QoL before operation. Long-term follow-up is needed in order to assess duration of this beneficial effect of bypass surgery.

The association of CHA2DS2-VASc score and blood biomarkers with ischemic stroke outcomes: the Belgrade stroke study.

BACKGROUND: Many blood biomarkers have a positive association with stroke outcome, but adding blood biomarkers to the National Institutes of Health Stroke Scale (NIHSS) did not significantly improve its discriminatory ability. We investigated the association of the CHA2DS2-VASc score with unfavourable functional outcome (defined as a 30-day modified Rankin Scale [mRS] ≥ 3) in patients presenting with acute ischemic stroke (AIS), and examined whether the addition of blood biomarkers (troponin I [TnI], fibrinogen, C-reactive protein [CRP]) affects the model discriminatory ability. METHODS: We conducted an observational single-centre study of consecutive patients with AIS. All patients were admitted to hospital within 24 hours from the neurological symptoms onset. RESULTS: Of 240 patients (mean age 70.0 ± 8.9 years), unfavourable 30-day outcome occurred in 92 (38.3%). Patients with mRS ≥ 3 were older and more likely to have atrial fibrillation or other comorbidities (all p<0.001). They had higher levels of CRP, fibrinogen, TnI and higher CHA2DS2-VASc and CHADS2 scores (all p<0.05). The adjusted CHA2DS2-VASc score had excellent predictive ability for poor stroke outcome (c-statistic 0.982;95%CI,0.964-1.000, p<0.001). Whilst CRP had the highest sensitivity (83.7%), cardiac TnI was the most specific (97.3%) for prediction of poor stroke outcome (cut-off: >0.09 µg/L). Compared with each of these biomarkers, CHA2DS2-VASc score had significantly better predictive ability for poor stroke outcome (c-statistic for CRP, Fibrinogen and TnI was 0.853;95%CI,0.802-0.895, 0.848;95%CI,0.796-0.891, and 0.792;95%CI,0.736-0.842, all p<0.001, respectively, versus 0.932;95%CI,0.892-0.960, p<0.001 for the CHA2DS2-VASc, all p for the comparisons<0.01). There was no significant difference in the predictive ability of the CHA2DS2-VASc score vs. combinations of the CHA2DS2-VASc and TnI or TnI, fibrinogen and CRP (z statistic 0.369, p = 0.7119; integrated discrimination index 0.00801 and 0.00172, respectively, both p>0.05). CONCLUSIONS: The CHA2DS2-VASc score alone reliably predicts 30-day unfavourable outcome of stroke. Adding blood biomarkers to the CHA2DS2-VASc score did not significantly increase the predictive ability of the model.

Health-related quality of life among patients with peripheral arterial disease.

We evaluated health-related quality of life (HRQoL) among patients with peripheral arterial disease (PAD) and compared the results with those of the general population. We also evaluated the possible association between some demographic and clinical characteristics of patients with PAD and HRQoL. A cross-sectional study involved 102 consecutive patients with verified PAD referred to the Dedinje Vascular Surgery Clinic in Belgrade. The HRQoL was measured using Medical Outcome Survey Short Form 36 (SF-36). Patients with PAD had significantly lower mean SF-36 scores for physical functioning, role-physical, bodily pain, social functioning, role-emotional, and mental health in comparison with the general population. The HRQoL was significantly more impaired in patients with severe PAD. Patients with PAD had a reduced HRQoL compared with the general population. The impact of PAD on HRQoL was independent of other factors related to both the disease and the HRQoL.

Prognostic implications of bleeding measured by Bleeding Academic Research Consortium (BARC) categorisation in patients undergoing primary percutaneous coronary intervention.

OBJECTIVE: To investigate the relationship between inhospital bleeding as defined by Bleeding Academic Research Consortium (BARC) consensus classification and short-term and long-term mortality in unselected patients admitted for primary percutaneous coronary intervention (PCI). METHODS: We analysed data of all consecutive patients with ST segment elevation myocardial infarction (STEMI) admitted for primary PCI, enrolled in a prospective registry of a high volume centre. The BARC-defined bleeding events were reconstructed from the detailed, prospectively collected clinical data. The primary outcome was mortality at 1 year. RESULTS: Of the 1808 patients with STEMI admitted for primary PCI, 115 (6.4%) experienced a BARC type ≥2 bleeding. As the BARC bleeding severity worsened, there was a gradient of increasing rates of 1-year death. The 1-year mortality rate increased from 11.5% with BARC 0+1 type to 43.5% with BARC type 3b bleeding. After multivariable adjustment for demographic and clinical characteristics of patients, the independent predictors of 1-year death were BARC type 3a (HR 1.99; 95% CI 1.16 to 3.40, p=0.012) and BARC type 3b bleeding (HR 3.22; 95% CI 1.67 to 6.20, p<0.0001). CONCLUSIONS: The present study demonstrated that bleeding events defined according to the BARC classification hierarchically correlate with 1-year mortality after admission for primary PCI. The strongest predictor of 1-year mortality is the BARC type 3b bleeding.

Feasibility of applying data mining techniques for predicting technical difficulties during laparoscopic cholecystectomy based on routine patient work-up in a small community hospital.

BACKGROUND/AIMS: Predicting technical difficulties in laparoscopic cholecystectomy (LC) in a small regional hospital increases efficacy, cost-benefit and safety of the procedure. The aim of the study was to assess whether it is possible to accurately predict a difficult LC (DLC) in a small regional hospital based only on the routine available clinical work-up parameters (patient history, ultrasound examination and blood chemistry) and their combinations. METHODOLOGY: A prospective, cohort, of 369 consecutive patients operated by the same surgeon was analyzed. Conversion rate was 10 (2.7%). DLC was registered in 55 (14.90%). Various data mining techniques were applied and assessed. RESULTS: Seven significant predictors of DLC were identified: i) shrunken (fibrotic) gallbladder (GB); ii) ultrasound (US) GB wall thickness >4 mm; iii) >5 attacks of pain lasting >5 hours; iv) WBC >10x109 g/L; v) pericholecystic fluid; vi) urine amylase >380 IU/L, and vii) BMI >30kg/m2. Bayesian network was selected as the best classifier with accuracy of 94.57, specificity 0.98, sensitivity 0.77, AUC 0.96 and F-measure 0.81. CONCLUSION: It is possible to predict a DLC with high accuracy using data mining techniques, based on routine preoperative clinical parameters and their combinations. Use of sophisticated diagnostic equipment is not necessary.

Pancreatic cancer mortality in Serbia from 1991-2010 - a joinpoint analysis.

AIM: To analyze the trends of pancreatic cancer mortality in Serbia. METHODS: The study covered the population of Serbia in the period 1991 to 2010. Mortality trends were assessed by the joinpoint regression analysis by age and sex. RESULTS: Age-standardized mortality rates ranged from 5.93 to 8.57 per 100 000 in men and from 3.51 to 5.79 per 100 000 in women. Pancreatic cancer mortality in all age groups was higher among men than among women. It was continuously increasing since 1991 by 1.6% (95% confidence interval [CI] 1.1 to 2.0) yearly in men and by 2.2% (95% CI 1.7 to 2.7) yearly in women. Changes in mortality were not significant in younger age groups for both sexes. In older men (≥55 years), mortality was increasing, although in age groups 70-74 and 80-84 the increase was not significant. In 65-69 years old men, the increase in mortality was significant only in the period 2004 to 2010. In ≥50 years old women, mortality significantly increased from 1991 onward. In 75-79 years old women, a non-significant decrease in the period 1991 to 2000 was followed by a significant increase from 2000 to 2010. CONCLUSION: Serbia is one of the countries with the highest pancreatic cancer mortality in the world, with increasing mortality trend in both sexes and in most age groups.

Biomarkers of acute kidney injury in pediatric cardiac surgery.

OBJECTIVES: Acute kidney injury (AKI) is a significant problem in children undergoing cardiopulmonary bypass (CPB). The aims of this study were to assess the diagnostic validity of serum CysC (sCysC), serum neutrophil gelatinase lipocalin (sNGAL), urine neutrophil gelatinase lipocalin (uNGAL), urine kidney injury molecule (uKIM)-1, and urine liver fatty acid-binding protein (uL-FABP) to predict AKI presence and severity in children undergoing CPB. DESIGN AND METHODS: We performed a prospective single-center evaluation of sCysC, sNGAL, uNGAL, uKIM-1 and uL-FABP at 0, 2, 6, 24 and 48 h postoperatively in children undergoing CPB during cardiac surgery. AKI was defined as ≥25% decrease in the estimated creatinine clearance (eCCl) from pre-operative baseline at 48h after surgery. RESULTS: Of the 112 patients, 18 patients (16.1%) developed AKI; four of them needed acute dialysis treatment and three AKI patients died. In the AKI compared to the non-AKI group, sCysC at 2h, and uNGAL and uL-FABP at 2-48 h were significantly increased, as well as CPB, aortic cross clamp time and length of hospital stay. Biomarkers increased with worsening AKI severity. At 2h after CPB the best accuracy for diagnosis of AKI had uL-FABP and sCysC with area under the receiver operator curve (AUC) of 0.89 and 0.73, respectively. At 6 and 24h after CPB the best AUC was found for uL-FABP (0.75 and 0.87 respectively) and for uNGAL (0.70 and 0.93, respectively). CONCLUSIONS: sCysC, uNGAL and uL-FABP are reliable early predictors for AKI after CPB. By allowing earlier timing of injury and earlier intervention, they could improve AKI outcome.

Simple risk algorithm to predict serious bleeding in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: RISK-PCI bleeding score.

BACKGROUND: Bleeding is a potentially catastrophic complication after primary percutaneous coronary intervention (PPCI). It occurs most frequently within the first 30 days following the intervention. The aim of this study was to generate a simple and accurate risk model for the prediction of bleeding after PPCI. METHODS AND RESULTS: The training set included 2,096 patients enrolled in the RISK-PCI trial. The model was validated using a database of 961 patients enrolled in the ART-PCI trial. Bleeding was defined as type ≥3a bleeding according to the Bleeding Academic Research Consortium definition. Multivariate logistic regression was used to evaluate the predictors of outcome. A sum of weighted points for specific predictors was calculated to determine the final score. The model included 5 independent predictors of 30-day bleeding: gender (female); history of peptic ulcer; creatinine clearance at admission (<60 ml/min); hemoglobin at presentation (<125 g/dl); and Killip class >1 heart failure at admission. The model showed good discrimination and calibration for the prediction of bleeding in the derivation set (C-statistic, 0.79; goodness of fit, P=0.12) and in the validation set (C-statistic, 0.76; goodness of fit, P=0.37). Patients were classified into 3 risk classes and the observed incidence of 30-day bleeding of 1.0%, 3.5% and 10.7% corresponded to the low-, intermediate- and high-risk classes, respectively. CONCLUSIONS: A simple risk model was developed that has a reasonably good capacity for the prediction of 30-day bleeding after PPCI.

L-FABP can be an early marker of acute kidney injury in children.

BACKGROUND: Acute kidney injury (AKI) is a common postoperative complication following cardiopulmonary bypass (CPB) surgery. New biomarkers to identify patients with early AKI (before increases in serum creatinine) are needed to facilitate appropriate treatment. This study aimed to test the role of urinary liver fatty-acid-binding protein (L-FABP) as an early biomarker for AKI in children undergoing CPB surgery. METHODS: This is a case-control study of children undergoing CPB. AKI was defined as 50 % increase in serum creatinine at 48 h after surgery. For each patient, five serum and urine samples were obtained corresponding to time 0 h (presurgery) and 2, 6, 24, and 48 h after surgery. RESULTS: Twenty-seven patients, median age 360 days, were enrolled. AKI developed in 11 patients (41 %); three needed renal replacement therapy (peritoneal dialysis); there were two deaths. There were significant differences between patients with and without AKI in L-FABP levels at 2, 6, and 48 h after surgery, length of hospital stay, and CPB time; there were no differences in gender, patient age, and body weight. L-FABP was normalized to urinary creatinine concentration at all time points, with area under the receiver operator curve (AUC ROC) 0.867 at 2 and 6 h postoperatively. Correlation coefficient between L-FABP and length of hospital stay after surgery was statistically significant (r = 0.722, p value = 0.000). CONCLUSIONS: Our results suggest that urinary L-FABP can be used to diagnose AKI earlier than rise in serum creatinine in children undergoing CPB.

Impact of high post-loading platelet aggregation on 30-day clinical outcomes after primary percutaneous coronary intervention. The antiplatelet regimen tailoring after primary PCI (ART-PCI) trial.

BACKGROUND: Patients with high post-loading platelet aggregation (PPA) are at increased risk of stent thrombosis and death after primary percutaneous coronary intervention (pPCI). The objective of the present trial was to examine whether high PPA is associated with adverse clinical outcomes in pPCI patients whose therapy was modified in accordance with PPA. METHODS: We analyzed 961 consecutive pPCI patients who underwent pPCI between February 2008 and June 2011. High PPA was defined as PPA >50%, 24h after the loading dose. Patients with high PPA were treated with aspirin 300 mg, clopidogrel 150 mg or ticlopidine 500 mg for 30 days. The co-primary efficacy and safety end points at 30 days were major adverse cardiovascular events (MACE) and major bleeding. RESULTS: We detected high PPA to clopidogrel and aspirin in 44.4% and 16.5% of patients, respectively. The rates of 30-day MACE (adjusted OR 1.76, 95% CI 1.05-2.97), definite subacute stent thrombosis (DSST, adjusted OR 2.15, 95% CI 1.09-4.22) and nonfatal infarction (adjusted OR 3.99, 95% CI 1.57-10.13) were higher in patients with high PPA to clopidogrel compared with responders. High PPA to aspirin was not associated with an adverse 30-day clinical outcome. Compared with high PPA patients who were not tailored, a significantly better outcome with respect to the primary end point was observed in the tailored group (OR 0.42, 95% CI 0.19-0.93). CONCLUSION: High PPA to clopidogrel was an independent predictor of 30-day adverse events after pPCI. Among high PPA patients, tailoring was associated with an improved primary outcome.

Health-related quality of life among patients with symptomatic carotid disease.

OBJECTIVES: To evaluate health-related quality of life (HRQoL) in patients with symptomatic carotid disease (amaurosis fugax, transient ischaemic attack, stroke); to compare it with that of the general population; to explore whether HRQoL depends on the severity of the disease and to investigate the possible association between some demographic and clinical characteristics of patients and HRQoL. METHODS: This cross-sectional study involved 175 patients with symptomatic carotid atherosclerotic disease who were referred for endarterectomy between January 2011 and December 2011. HRQoL was measured using Medical Outcome Survey Short Form 36 (SF-36). RESULTS: In comparison to both referent populations, patients with carotid disease had significantly lower mean SF-36 scores for role-physical (41.6 vs. 61.5 and 67.8), social functioning (65.4 vs. 73.8 and 80.0), role-emotional (48.2 vs. 68.6 and 80.5) and mental health (51.5 vs. 61.9 and 66.0). The SF-36 scores were significantly lower in female patients with carotid disease than in men (for role-physical 32.3 vs. 46.5; for bodily pain 57.0 vs. 73.0; for general health 55.6 vs. 61.5; for vitality 55.4 vs. 60.1; for social functioning 57.1 vs. 69.8 and for role-emotional 37.2 vs. 54.1). Significantly lower SF-36 scores were also found in patient with comorbidity (for physical functioning 68.1 vs. 77.7; for role-physical 35.1 vs. 52.3; for bodily pain 62.6 vs. 75.4; for general health 56.8 vs. 63.8; for social functioning 61.9 vs. 71.0, for role-emotional 41.6 vs. 59.1and for mental health 52.5 vs 49.8). In a multivariable analysis, education, occupation, body mass index, metabolic syndrome and severity of the disease had a weak influence on patients' HRQoL, while age, marital status, smoking, alcohol consumption, physical activity and the degree of carotid stenosis had no effect on patients' HRQoL. The SF-36 scores did not substantially change after adjustment for confounding variables. CONCLUSIONS: Patients with symptomatic carotid disease had poorer HRQoL, especially its mental components, than the general population. The severity of the disease was significantly associated only with the SF-36 role-physical subscale. HRQoL in patients with symptomatic carotid disease was poorer in women than in men, and was not affected by age and other demographic and clinical characteristics of patients.

The influence of maternal smoking and exposure to residential ETS on pregnancy outcomes: a retrospective national study.

In a nationwide study of Serbian births, in 2008, we estimated the influence of maternal prenatal smoking and environmental tobacco smoke (ETS) exposure on birth outcomes. Using stratified two-stage random cluster sampling, 2,721 women were interviewed in-person (response rates 98.1 %), and 2,613 singleton live births were included. Date of birth, gender, birthweight, birth height and head circumference were copied from the official hospital Birth Certificate. Six exposure categories were defined according to mother's smoking history and exposure to ETS. We calculated adjusted mean values and group differences by analysis of covariance, and adjusted odds ratios for the low birthweight (LBW < 2,500 g). Compared to the reference category (non-smoking, non-exposed to ETS) we observed birthweight reductions in infants whose mothers smoked continuously during the pregnancy and were exposed to ETS (-162.6 g) and whose mothers were not exposed to ETS (-173 g) (p = 0.000, and p = 0.003, respectively), as well as reduction in birth length (-1.01 and -1.06 cm; p = 0.003 and p = 0.000, respectively). Reduction in birthweight and birth length related to exposure categories was not linear. Adjusted OR for LBW was almost tripled for mothers who smoked over the entire pregnancy and were non-exposed to ETS (aOR 2.85; 95 % CI 1.46-5.08), and who were exposed to ETS (aOR 2.68; 95 % CI 1.15-6.25). Our results showed strong effects of smoking throughout the pregnancy on reduced birthweight, birth length and head circumference, and increased risk for LBW. We were not able to detect an effect for ETS exposure alone.

Predicting 30-day major adverse cardiovascular events after primary percutaneous coronary intervention. The RISK-PCI score.

BACKGROUND: Identification of patients at risk for major adverse cardiovascular events (MACE) might help selecting candidates for aggressive treatment or early discharge after primary percutaneous coronary intervention (pPCI). METHODS: The RISK-PCI is an observational trial of 2096 consecutive patients who underwent pPCI between 2006 and 2009, randomly allocated to derivation and validation sets with a set ratio of 80% to 20%. Thirty-day MACE comprising death, nonfatal reinfarction and stroke was the primary end point. Multivariable logistic regression was used to determine the independent predictors of outcome. A sum of weighted points for specific predictors was calculated to define the final score. RESULTS: The RISK-PCI score comprised 12 independent predictors of 30-day MACE, with a graded 125-fold increase in the primary end point with increasing risk score from ≤ 1 to ≥ 15. The model showed good discrimination and calibration for the prediction of 30-day MACE (c-statistic 0.83, goodness-of-fit p = 0.72) and 30-day death (c-statistic 0.87, goodness-of-fit p = 0.56). Bootstrapping with 1000 resample confirmed the stability of the model's performance. Patients were classified into risk classes, with the observed incidence of 30-day MACE of 1.9, 5.9, 13.3 and 39.4% in the low, intermediate, high and very high-risk classes, respectively. An 18-fold graded increase in the primary end point was observed between patients in a low risk class and those in a very high risk class. CONCLUSION: We derived a novel risk model to predict 30-day MACE after pPCI, which might help clinician decide the most appropriate treatment in accordance with the patient's risk profile.

Prevalence and predictors of smoking and quitting during pregnancy in Serbia: results of a nationally representative survey.

OBJECTIVES: Middle- and low-income countries rarely have national surveillance data on smoking in pregnancy. This nationwide population-representative survey investigated pre- and post-partum smoking and their predictors in Serbia. METHODS: Using stratified two-stage random cluster sampling, 2,721 women in 66 health care centres were interviewed at 3 and 6 months post-partum. RESULTS: 37.2% of women smoked at some point in pregnancy (average 8.8 cigarettes/per day). Smoking at pregnancy onset and during pregnancy was associated with smoking by others in the home and lower education and family socio-economic status. Almost a quarter of women (23.2%) who quit smoking during pregnancy did not relapse 6 months post-partum. Older women, primiparae, university students and white-collar workers were more likely to successfully quit smoking. More than a half of women were exposed to SHS in their homes (57.6%) and 84.6% allowed smoking in their homes. CONCLUSION: Smoking during pregnancy in Serbia was two- to threefold higher than in the most affluent western countries. Target groups for action are women with lower education and socio-economic status, as well as health professionals and family members who smoke.