Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).

BACKGROUND: Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy. METHODS: An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes. RESULTS: A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194). CONCLUSION: Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).

ANTECEDENTES: Varios estudios no aleatorizados y retrospectivos sugieren que la anastomosis intracorpórea (intracorporeal anastomosis, IA) tiene ventajas sobre la anastomosis extracorpórea (extracorporeal anastomosis, EA) en la colectomía laparoscópica derecha, pero no hay suficientes evidencias científicas. El objetivo del estudio fue comparar los resultados a corto plazo y definir los posibles beneficios de la anastomosis intracorpórea versus extracorpórea en la colectomía derecha laparoscópica electiva. MÉTODOS: Se realizó un ensayo clínico prospectivo y aleatorizado de mayo de 2015 a junio de 2018. El criterio de valoración principal fue la duración de la estancia hospitalaria. Los criterios de valoración secundarios fueron los eventos técnicos intraoperatorios y los resultados clínicos postoperatorios. RESULTADOS: Se aleatorizaron 140 pacientes. El tiempo quirúrgico fue más largo para la IA que para la EA (149,49 ± 27,24 versus 123,35 ± 36,56 min; P = 0,001). La longitud de la herida fue más corta en la IA (6,65 ± 1,21 versus 8,72 ± 1,44 cm; P < 0,001). La función digestiva se recuperó antes en la IA que en la EA (2,3 versus 3,3 días, P = 0,003) y la incidencia de íleo paralítico fue menor (13% versus 30%, P = 0,022). Los requisitos de analgesia postoperatoria fueron menores con la IA (39 ± 24,3 versus 53 ± 26; P < 0,001) y la puntuación de dolor (EVA) también fue menor (P < 0,035). El descenso de la hemoglobina en el postoperatorio y la hemorragia gastrointestinal baja fueron menores en la IA que en la EA (-8,83 ± 1,7 versus -17,07 ± 1,7 mg/dl; P = 0,001) y (2,8% versus 14%; P = 0,031), respectivamente. La clasificación de Clavien-Dindo mostró que la IA se asoció con resultados significativamente mejores que la EA: grado I (10% versus 27% P = 0,016); grado II (18% versus 35%, P = 0,0369). La puntuación del índice de complicación integral (comprehensive complication index, CCI) fue menor en el grupo IA (5,33 ± 9,2 versus 11,15 ± 14,34; P = 0,006). La estancia hospitalaria fue más corta en el grupo de IA pero sin diferencia significativa (5,65 ± 3,75 versus 6,58 ± 4,63 días; P = 0,194). CONCLUSIÓN: La IA presenta ventajas clínicas sobre la EA en la colectomía derecha laparoscópica.

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up.

BACKGROUND: Patient self-management (PSM) of vitamin K antagonists (VKA) seems a very promising model of care for oral anticoagulation in terms of efficacy and safety. In comparison with other management models of VKA therapy, the number of scientific publications supporting the advantages of PSM is more limited. Currently, most of the scarce information comes from randomized clinical trials. Moreover, a small number of studies have assessed PSM of VKA therapy in real life conditions. METHODS: We analyzed clinical outcomes of 927 patients in a single center (6018.6 patient-years of follow-up). Recruitment took place between 2002 and 2017. All patients followed a structured training program, conducted by specialized nurses. RESULTS: Fifty percent of individuals had a mechanical heart valve (MHV), 23% suffered from recurrent venous thromboembolism (VTE) or high-risk thrombophilia, and 13% received VKA therapy because of atrial fibrillation (AF). Median follow-up was 6.5 years (range 0.1-15.97 years), median age was 58.1 years (IQR 48-65.9) and 46.5% were women. The incidence of major complications (either hemorrhagic or thromboembolic) was 1.87% patient-years (pt-ys) with a 95% CI of 1.54-2.27. The incidence of major thromboembolic events was 0.86% pt-ys (95% CI 0.64-1.13) and that of major hemorrhagic events was 1.01% pt-ys (95% CI 0.77-1.31). The incidence of intracranial bleeding was 0.22% pt-ys (95% CI 0.12-0.38). In terms of clinical indication for VKA therapy, the incidence of total major complications was 2.4% pt-ys, 2.0% pt-ys, 0.9% pt-ys and 1.34% pt-ys for MHV, AF, VTE and other (including valvulopathies and myocardiopathies), respectively. Clinical outcomes were worse in patients with multiple comorbidities, previous major complications during conventional VKA therapy, and in older individuals. The percentage of time in therapeutic range (TTR) was available in 861 (93%) patients. Overall, the mean (SD) of TTR was 63.6 ± 13.4%, being higher in men (66.2 ± 13.1%) than women (60.6 ± 13.2%), p < 0.05. CONCLUSIONS: In terms of clinically relevant outcomes (incidence of major complications and mortality), PSM in real life setting seems to be a very good alternative in properly trained patients.

[Evaluation of pain during mobilization and endotracheal aspiration in critical patients]. / Evaluación del dolor durante la movilización y la aspiración endotraqueal en pacientes críticos.

OBJECTIVES: 1) To assess the prevalence of pain during nursing care procedures, and 2) to evaluate the usefulness of certain vital signs and the bispectral index (BIS) in detecting pain. METHODS: A prospective, observational analytical study was made of procedures (endotracheal aspiration and mobilization with turning) in critically ill sedated patients on mechanical ventilation. The Behavioral Pain Scale was used to assess pain, with scores of ≥3 indicating pain. Various physiological signs and BIS values were recorded, with changes of >10% being considered clinically relevant. RESULTS: A total of 146 procedures in 70 patients were analyzed. Pain prevalence during the procedures was 94%. Vital signs and BIS values increased significantly during the procedures compared to resting conditions, but only the changes in BIS were considered clinically relevant. In the subgroup of patients receiving preemptive analgesia prior to the procedure, pain decreased significantly compared to the group of patients who received no such analgesia (-2 [IQR: {-5}-0] vs. 3 [IQR: 1-4]; P<.001, respectively). CONCLUSIONS: The procedures evaluated in this study are painful. Changes in vital signs are not good indicators of pain. Changes in BIS may provide useful information about pain, but more research is needed. The administration of preemptive analgesia decreases pain during the procedures.

Mohs micrographic surgery for basal cell carcinomas: results of a Spanish retrospective study and Kaplan­Meier survival analysis of tumour recurrence.

BACKGROUND: Mohs micrographic surgery (MMS) is a specialized procedure usually limited to specific indications (e.g. high-risk basal cell carcinomas [BCCs]). OBJECTIVE: To determine the recurrence rate of MMS for BCC at a tertiary referral centre in Barcelona, Spain. METHODS: Review of medical records of patients undergoing 534 consecutive MMS interventions for confirmed BCCs. The main outcome measure was biopsy-proven recurrence of BCC at the same anatomical location after MMS. RESULTS: A total of 489 patients underwent MMS for 534 BCCs from April 1999 to December 2011. The patients' mean age was 66 years. The most frequent location was the nasal/perinasal region (38.4%, n = 205). The surgical interventions of 47.9% (n = 256) were for primary BCCs and 52.1% (n = 278) procedures were for recurrent or residual BCCs. The mean follow-up was 30.5 months (range 1­145 months). Thirty-two recurrences were identified in total. The raw recurrence rate following MMS for primary BCCs was 1.2% (3/256) compared to 10.4% (32/278) for recurrent BCC. On multivariate analysis (Cox proportional hazard model) only prior treatment (P = 0.018, hazard ratio [HR] 4.68 with 95% confidence intervals [CI] 1.30­16.79), multiple prior treatments (P = 0.013, HR 2.72 [95%CI 1.24­5.96]), and healing by secondary intention (P = 0.041, HR 2.88 [95%CI 1.04­7.97]) were independent prognostic factors of recurrence after MMS. LIMITATIONS: The limitations of our study are those of a retrospective study. CONCLUSION: Mohs micrographic surgery for primary high-risk BCCs has a high success rate but the cumulative probability of recurrence increases significantly when tumours with recurrences are referred for MMS.

Adalimumab for the treatment of psoriasis in real life: a retrospective cohort of 119 patients at a single Spanish centre.

BACKGROUND: Patients with moderate-to-severe psoriasis treated with adalimumab in daily clinical practice are different from those in clinical trials, and outcomes may differ in different geographical settings. OBJECTIVES: To analyse the efficacy, retention of treatment and adverse events in a cohort of such patients at a referral centre in Barcelona, Spain. METHODS: Data from a cohort of 119 consecutive patients treated between January 2008 and March 2013 were retrospectively collected. Drug survival was analysed by the Kaplan-Meier method with log-rank test and Cox regression. RESULTS: The mean duration of treatment was 25 months (median 22, range 2-60). The 75% improvement in Psoriasis Area and Severity Index (PASI 75) response rates at 16 weeks, 6 months and 1 year of treatment were 64%, 58% and 53%, respectively (intention-to-treat analysis). The corresponding PASI 90 values were 49%, 52% and 50%. Biologic-naive patients (41%) had significantly higher PASI 75 and PASI 90 response rates at 6 months and 1 year. On multivariate analysis, only PASI 90 response at 6 months was significantly associated with treatment retention (P = 0.0009), with a hazard ratio of 7.3 (95% confidence interval 2.3-23.6). Forty-eight adverse events (AEs) occurred in 29 patients, and were serious in eight (0.032 events per patient-year). Paradoxical flares of psoriasis or arthritis were seen in five patients. Infections accounted for seven serious AEs, and were the reason for discontinuation in two patients. CONCLUSIONS: PASI 90 response at 6 months was the only independent variable predicting drug survival on multivariate analysis. Infections, including de novo infection by Mycobacterium tuberculosis, accounted for seven serious AEs.

Risk of early breastfeeding cessation among symmetrical, small for gestational age infants.

BACKGROUND: Many studies have shown that children born small for gestational age are at a metabolic disadvantage. Breastfeeding is associated with reduced risk of developing metabolic syndrome. OBJECTIVE: To determine whether ponderal index, weight, length or head circumference at birth affect early exclusive breastfeeding discontinuation. DESIGN: Information from medical records of full-term infants attending the same paediatric clinic was used to examine the relationship between birth size and failure to breastfeed within 28 days after birth. Details of demographics and diagnoses were prospectively recorded. Feeding method was assessed at each child visit by their healthcare provider. Feeding practices were compared between infants of high, normal and low ponderal index at birth. RESULTS: Multivariate models (p's ≤ 0.02) confirmed that the chance of exclusive breastfeeding continuation within 4 weeks of life was less in infants whose birth weight was below 2780 g or whose neonatal head circumference was < 33 cm. Birth length did not account for this effect. Ponderal index was not associated with a higher risk of early discontinuation of exclusive breastfeeding. CONCLUSIONS: This study reports that birth weight ≥ 2780 g and head circumference at birth ≥ 33 cm are independent predictors of breastfeeding onset success.

[Hemodynamic and antipyretic effects of paracetamol, metamizol and dexketoprofen in critical patients]. / Efectos hemodinámicos y antipiréticos del paracetamol, metamizol y dexketoprofeno en pacientes críticos.

BACKGROUND: The objective was to study the antipyretic and hemodynamic effects of three different drugs used to treat fever in critically ill patients. DESIGN AND SETTING: Prospective, observational study in a 16-bed, general ICU of a university hospital. PATIENT POPULATION: We studied 150 patients who had a febrile episode (temperature>38°C): 50 received paracetamol, 50 metamizol and 50 dexketoprofen. INTERVENTIONS: None. Body temperature, systolic, diastolic and mean arterial pressure, heart rate, central venous pressure and oxygen saturation were determined at baseline and at 30, 60 and 120minutes after infusion of the drug. Additionally, we recorded temperature 180minutes after starting drug infusion. Diuresis and the need for or change of dose of vasodilator or vasoconstrictor drugs were also recorded. RESULTS: Patient characteristics, baseline temperature and hemodynamics were similar in all groups. We observed a significant decrease of at least 1°C in temperature after 180minutes in 38 patients treated with dexketoprofen (76%), in 36 with metamizol (72%), and in 20 with paracetamol (40%) (p<0.001). After 120minutes, the mean decrease in mean arterial pressure was 8.5±13.6mmHg with paracetamol, 14.9±11.8mmHg with metamizol, and 16.8±13.7mmHg with dexketoprofen (p=0.005). CONCLUSIONS: Dexketoprofen was the most effective antipyretic agent at the doses tested. Although all three drugs reduced mean arterial pressure, the reduction with paracetamol was less pronounced.

[Mortality, cardiovascular risk, and health status in a male cohort initiated in 1968. The Manresa study]. / Mortalidad, riesgo cardiovascular y estado de salud actual de una cohorte de varones iniciada en el año 1968. Estudio Manresa.

OBJECTIVES: To analyse mortality and its causes in the Manresa male cohort followed over 42 years; to compare the initial risk of cardiovascular mortality with actual mortality; and to describe the health status of the participants at the end of the study. METHODS: Prospective observational study, in which an analysis of the cumulative incidence of mortality was performed. The association of cardiovascular risk factors with mortality was calculated with a logistic regression analysis of mixed effect. The risk of mortality of individuals was evaluated and compared with true cardiovascular mortality using ROC curves. At the end of the study, a descriptive analysis of CVRF and health status of participants in the last survey was performed. RESULTS: The number of deaths was 457 (43%). Cumulative incidence for cardiovascular diseases was 10.6%. Cardiovascular risk factors significantly associated with cardiovascular mortality were age, cholesterol, and smoking. The use of risk score charts for cardiovascular mortality was found to be useful, and there were no differences between tables. In the last health screening of cardiovascular risk factors levels in an elderly population, a high prevalence was found of hypertension and of regular physical activity, together with a low prevalence of smoking. CONCLUSIONS: Cardiovascular mortality remained high, although it has become the second cause after tumoural diseases. The comparison of predictions from cardiovascular mortality risk tables with actual mortality rates in our area over more than 4 decades demonstrated the importance of assessing cardiovascular risk in the adult population.

Insulin requirements throughout pregnancy in women with type 1 diabetes mellitus: three changes of direction.

AIMS/HYPOTHESIS: The aim of the study was to analyse the insulin requirements of women with type 1 diabetes mellitus throughout pregnancy. METHODS: We have examined the weekly mean blood glucose (mmol/l), insulin requirements (U kg(-1) day(-1)) and total insulin requirements (U/day) in 65 women with type 1 diabetes mellitus and tight metabolic control since before pregnancy (HbA(1c) < or =6.0%). RESULTS: Both insulin requirement and total insulin requirement displayed a peak in week 9, a nadir in week 16 and a second peak in week 37. For the change in insulin requirement (4.08% per week) and in total insulin requirement (5.19% per week), the sharpest slope was observed from week 16 to week 37. However, two changes of direction took place in the first 11 weeks and eight out of nine episodes of severe hypoglycaemia requiring treatment with glucagon or i.v. glucose took place in the first 16 weeks. CONCLUSIONS/INTERPRETATION: Pregnant women with type 1 diabetes mellitus and tight metabolic control since before pregnancy displayed changes in insulin requirement and total insulin requirement with successive changes of direction. The sharpest slope was observed between 16 and 37 weeks, but insulin requirements were more unstable in the first 16 weeks. This information could help patients and physicians to react to changes in glycaemic pattern in a prompt and adequate way.

A novel GSK-3beta inhibitor reduces Alzheimer's pathology and rescues neuronal loss in vivo.

Amyloid deposits, neurofibrillary tangles, and neuronal cell death in selectively vulnerable brain regions are the chief hallmarks in Alzheimer's (AD) brains. Glycogen synthase kinase-3 (GSK-3) is one of the key kinases required for AD-type abnormal hyperphosphorylation of tau, which is believed to be a critical event in neurofibrillary tangle formation. GSK-3 has also been recently implicated in amyloid precursor protein (APP) processing/Abeta production, apoptotic cell death, and learning and memory. Thus, GSK-3 inhibition represents a very attractive drug target in AD and other neurodegenerative disorders. To investigate whether GSK-3 inhibition can reduce amyloid and tau pathologies, neuronal cell death and memory deficits in vivo, double transgenic mice coexpressing human mutant APP and tau were treated with a novel non-ATP competitive GSK-3beta inhibitor, NP12. Treatment with this thiadiazolidinone compound resulted in lower levels of tau phosphorylation, decreased amyloid deposition and plaque-associated astrocytic proliferation, protection of neurons in the entorhinal cortex and CA1 hippocampal subfield against cell death, and prevention of memory deficits in this transgenic mouse model. These results show that this novel GSK-3 inhibitor has a dual impact on amyloid and tau alterations and, perhaps even more important, on neuronal survival in vivo further suggesting that GSK-3 is a relevant therapeutic target in AD.

A randomized, double-blind multicentre clinical trial comparing the efficacy of calcium dobesilate with placebo in the treatment of chronic venous disease.

OBJECTIVE: To assess the efficacy of calcium dobesilate on the quality-of-life (QoL) of patients with chronic venous disease (CVD). DESIGN: Randomised, parallel, double blind, placebo-controlled clinical trial. METHODS: Patients were recruited from vascular surgery clinics and randomised to 500mg capsules of calcium dobesilate twice a day for 3 months or placebo. The primary outcome measure was 'QoL after 3 months' treatment measured by the specific Chronic Insufficiency Venous International Questionnaire (CIVIQ). Secondary outcomes were QoL at 12 months and assessment of the CVD signs and symptoms. The principal analysis was undertaken on the intention-to-treat (ITT) data. RESULTS: Five hundred and nine patients were recruited (246 to calcium dobesilate and 263 to placebo). The analysis of the 'QoL after 3 months' showed no significant differences between groups (p=0.07). For secondary outcomes, oedema and symptoms of CVD, there were no significant differences between groups. In a multi-factorial analysis, the 'QoL at 12 months' was better in the calcium dobesilate group than in placebo group (p=0.02). CONCLUSIONS: Treatment with calcium dobesilate was not found to be superior to placebo on the QoL of CVD patients. The sustained effect of calcium dobesilate observed after treatment should be confirmed in future studies.

Clinical factors that affect perceived quality of life in arthroscopic reconstruction for acromioclavicular joint dislocation. / Factores clínicos que afectan a la calidad de vida percibida en la reconstrucción artroscópica de las luxaciones acromioclaviculares.

OBJECTIVE: To analyse the results of arthroscopic repair of acromioclavicular dislocation in terms of health-related quality of life. MATERIAL AND METHOD: Prospective study of patients with acromioclavicular dislocation Rockwood grade iii-v, treated arthroscopically with a mean follow up of 25.4 months. The demographics of the series were recorded and evaluations were performed preoperatively, at 3 months and 2 years with validated questionnaires as Short Form-36 Health Survey (SF-36), visual analogue scale (VAS), The Disabilities of the Arm, Shoulder and Hand (DASH), Constant-Murley Shoulder Outcome Score (Constant) and Walch-Duplay Score (WD). RESULTS: Twenty patients, 17 men and 3 women with a mean age of 36.1 years, were analysed. According to the classification of Rockwood, 3 patients were grade iii, 3 grade iv and 14 grade v. Functional and clinical improvement was detected in all clinical tests (SF-36, VAS and DASH) at 3 months and 2 years follow up (P<.001). The final Constant score was 95.3±2.4 and the WD was 1.8±0.62. It was not found that the health-related quality of life was affected by any variable studied except the evolution of DASH. CONCLUSIONS: The health-related quality of life (assessed by SF-36) in patients undergoing arthroscopic repair of acromioclavicular joint dislocation grades iii-v was not influenced by gender, age, grade, displacement, handedness, evolution of the VAS, scoring of the Constant or by the WD. However, it is correlated with the evolution in the DASH score.

[Total enteral nutrition vs. total parenteral nutrition in patients with severe acute pancreatitis]. / Nutrición enteral total vs. nutrición parenteral total en pacientes con pancreatitis aguda grave.

OBJECTIVE: To compare the efficacy of early total enteral nutrition (TEN) vs. total parenteral nutrition (TPN) in patients with severe acute pancreatitis (SAP). METHODS: A total of 22 consecutive patients with SAP were randomized to receive TPN (group I) or TEN (group II). SAP was defined applying APACHE II score, C-reactive protein (CRP) measurements and/or Balthazar CT scan score. Acute inflammatory response (CRP, TNF-a, IL-6), visceral proteins (pre-albumin, albumin), complications (systemic inflammatory response syndrome, multiorgan failure, infections), surgical interventions, length of hospital stay and mortality were evaluated. RESULTS: No significant differences were found between the two groups in the APACHE II score, in CRP, TNF-a and IL-6 concentrations or in pre-albumin and albumin levels over the first 10 days. Seven patients in group I and 4 in group II suffered severe complications. Three patients in group I required surgical intervention. Length of hospital stay was alike in the two groups. Two patients from group I died in the course of the hospitalization. CONCLUSIONS: SAP patients with TEN feeding showed a tendency towards a better outcome than patients receiving TPN.

Mortalidad, riesgo cardiovascular y estado de salud actual de una cohorte de varones iniciada en el año 1968. Estudio Manresa / Mortality, cardiovascular risk, and health status in a male cohort initiated in 1968. The Manresa study

Objetivos: Analizar la mortalidad y sus causas en la cohorte Manresa de varones seguida durante 42 años; comparar el riesgo de mortalidad cardiovascular al inicio del seguimiento con la mortalidad acontecida; describir el estado de salud de los participantes al final del estudio. Métodos: Estudio observacional prospectivo. Se calculó la incidencia de mortalidad acumulada de la cohorte. La asociación de los factores de riesgo cardiovasculares (FRCV) con la mortalidad fue calculada mediante análisis de regresión logística de efectos mixtos. Se evaluó la curva ROC comparando cada ecuación predictiva con la mortalidad real. Se llevó a cabo un análisis descriptivo del estado de salud en la última encuesta del estudio. Resultados: Las defunciones fueron 457 (43%). La incidencia acumulada fue del 10,6% para las enfermedades cardiovasculares. Los factores de riesgo cardiovasculares asociados significativamente a la mortalidad cardiovascular fueron: edad, colesterol y tabaquismo. El uso de tablas para el cálculo del riesgo cardiovascular resultó ser útil, con pocas diferencias según la tabla utilizada. Entre los factores de riesgo cardiovasculares analizados en el último examen de salud, y por tanto en una población anciana, destacan la alta prevalencia de hipertensión y de actividad física regular, junto con la baja prevalencia en tabaquismo. Conclusión: La mortalidad cardiovascular se mantuvo alta, aunque ha pasado a ser la segunda causa tras las enfermedades tumorales. Se compararon en nuestro medio las predicciones de las tablas de riesgo de mortalidad cardiovascular con la mortalidad real durante más de 4 décadas, mostrándose la importancia de estimar el riesgo cardiovascular en la población adulta.(AU)

Objectives: To analyse mortality and its causes in the Manresa male cohort followed over 42 years; to compare the initial risk of cardiovascular mortality with actual mortality; and to describe the health status of the participants at the end of the study. Methods: Prospective observational study, in which an analysis of the cumulative incidence of mortality was performed. The association of cardiovascular risk factors with mortality was calculated with a logistic regression analysis of mixed effect. The risk of mortality of individuals was evaluated and compared with true cardiovascular mortality using ROC curves. At the end of the study, a descriptive analysis of CVRF and health status of participants in the last survey was performed. Results: The number of deaths was 457 (43%). Cumulative incidence for cardiovascular diseases was 10.6%. Cardiovascular risk factors significantly associated with cardiovascular mortality were age, cholesterol, and smoking. The use of risk score charts for cardiovascular mortality was found to be useful, and there were no differences between tables. In the last health screening of cardiovascular risk factors levels in an elderly population, a high prevalence was found of hypertension and of regular physical activity, together with a low prevalence of smoking. Conclusions: Cardiovascular mortality remained high, although it has become the second cause after tumoural diseases. The comparison of predictions from cardiovascular mortality risk tables with actual mortality rates in our area over more than 4 decades demonstrated the importance of assessing cardiovascular risk in the adult population.(AU)

Immediate peritoneal response to bacterial contamination during laparoscopic surgery.

BACKGROUND: Several studies have shown that laparoscopic surgery (LS) minimizes surgical trauma and the immune function is better preserved. Another major advantage of LS is the lower incidence of septic complications. However, several in vitro studies have shown that CO(2) severely impairs macrophage physiology. In theory, this would reduce the ability to respond to peritoneal contamination. However, there is some controversy in view of the evidence of a better preserved peritoneal response to sepsis. This study analyzed the early response of the peritoneum to contamination in a CO(2) ambience. METHODS: A total of 192 CD-1 mice were distributed in three groups: group 1, laparotomy (LAP, n = 64); group 2, CO(2) laparoscopy (CO(2)-LC, n = 64); and group 3, wall lift laparoscopy (WL-LC, n = 64). Mice in each group were randomized to receive 1 ml of Escherichia coli suspension (1 x 10(4) colony-forming units/ml) or saline. Peritoneal fluid was obtained at 1.5, 3, 6, and 12 h after surgery. Monocyte chemoattractant protein-1 (MCP-1), interleukin-6 (IL-6), and prostaglandin E(2) (PGE(2)) were measured. RESULTS: MCP-1 levels were significantly greater and higher earlier in group 2 (CO(2)-LC) than in group 1 (LAP) (p < 0.007). Simultaneously, the increment in the traction group (WL-LC, group 3) was significantly higher (p < 0.002) than after laparotomy, with no differences in group 2 (CO(2)-LC). When a contamination was added to the laparotomy subgroup, there was a significant increase compared to the group without contamination (p < 0.5). MCP-1 modifications after contamination in the LAP group were statistically significant and appeared later than in the WL-LC (p < 0.002) and CO(2)-LC groups (p < 0.02). For IL-6, the three models presented a significant increase in the noncontaminated groups. This occurred significantly later in the LAP group. Simultaneously, the increase in IL-6 occurred earlier and was significantly higher in the WL-LC group compared to the LAP group (p < 0.003), without differences between CO(2)-LC and wall lift groups. Significant differences between contaminated and noncontaminated subgroups were only observed in the LC-CO(2) groups. When contaminated, the traction model sustained a higher and earlier rise in IL-6 levels compared to the LAP and LC-CO(2) groups (p < 0.001). For PGE(2), The three models showed a significant increase in PGE(2) levels in the noncontaminated groups. However, there were no significant differences between them. In the contaminated groups, there was no statistical difference between the groups. CONCLUSION: Despite a transient impairment of the immediate peritoneal response to a septic challenge, the degree of injury with LS is lower than that with open surgery, and abdominal infection can therefore be better controlled.

Predictive factors for successful laparoscopic splenectomy in immune thrombocytopenic purpura: study of clinical and laboratory data.

BACKGROUND: Laparoscopic splenectomy (LS) offers better short-term results than open surgery for the treatment of immune thrombocytopenic purpura (ITP), but long-term follow-up is required to ensure its efficacy. The remission rate after splenectomy ranges from 49 to 86% and the factors that predict a successful response to surgical management have not been clearly defined. The goal of this study was to determine the preoperative factors that predict a successful outcome following LS. METHODS: From February 1993 to December 2003, LS was consecutively performed in a series of 119 nonselected patients diagnosed with ITP (34 men and 85 women; mean age, 41 years), and clinical results were prospectively recorded. Postoperative follow-up was based on clinical records, follow-up data provided by the referring hematologist, and a phone interview with the patient and/or relative. Univariate and multivariate analyses were performed for clinical preoperative variables to identify predictive factors of success following LS. RESULTS: Over a mean period of 33 months, 103 patients (84%) were available for follow-up with a remission rate of 89% (92 patients, 77 with complete remission with platelet count > 150,000). Eleven patients did not respond to surgery (platelet count < 50,000). Mortality during follow-up was 2.5% (two cases not related to hematological pathology and one case without response to splenectomy). Preoperative clinical variables evaluated to identify predictive factors of response to surgery were sex, age, treatment (corticoids alone or associated with Ig or chemotherapy), other immune pathology, duration of disease, and preoperative platelet count. In a subgroup of 52 patients, we also evaluated the type of autoantibodies and corticoid doses required to maintain a platelet count > 50,000. Multivariate analysis showed that none of the variables evaluated could be considered as predictive factors of response to LS due to the high standard error. CONCLUSION: Long-term clinical results show that LS is a safe and effective therapy for ITP. However, a higher number of nonresponders is needed to determine which variables predict response to LS for ITP.

Predictive model of mortality in patients with spontaneous bacterial peritonitis.

BACKGROUND: Hospital mortality in patients with spontaneous bacterial peritonitis (SBP) is high despite albumin treatment, particularly in those with worse liver and/or renal function. AIM: To determine the independent predictive factors of in-hospital mortality and to create and validate a predictive model of mortality in patients with SBP. METHODS: We analysed all cirrhotic patients with high-risk SBP (serum urea ≥11 mmol/L and/or serum bilirubin ≥68 µmol/L) between 2001 and 2011. We developed a predictive model of in-hospital mortality and validated this in a different cohort. RESULTS: We included 118 high-risk SBP episodes treated with antibiotics and albumin. In-hospital mortality was 33/118 (28%). The independent predictive factors of in-hospital mortality at SBP diagnosis were serum urea, blood leucocyte count, Child-Pugh score and mean arterial pressure. A predictive model including these four variables showed a discrimination accuracy (AUC) of 0.850, 95% CI 0.777-0.922. A cut-off point of 0.245 showed a sensitivity of 0.85 and specificity of 0.75. The in-hospital mortality was 28/49 (57.1%) in patients with a model value ≥0.245, and 5/69 (7.2%) in patients with a model value <0.245 (P < 0.001). The validation series included 161 patients with an in-hospital mortality of 40/161 (24.8%), 30/77 (39.0%) in patients with a model value ≥0.245, and 10/84 (11.9%) in those with a model value <0.245 (P < 0.001). CONCLUSIONS: We developed and validated a predictive model of mortality that includes serum urea, blood leucocyte count, Child-Pugh score and mean arterial pressure in high-risk patients with spontaneous bacterial peritonitis. These findings may help to identify patients who would benefit from additional therapeutic strategies.

Multicenter study of the multiple organ dysfunction syndrome in intensive care units: the usefulness of Sequential Organ Failure Assessment scores in decision making.

OBJECTIVE: This study examined the incidence and mortality of multiple organ dysfunction syndrome (MODS) in intensive care units, evaluated the limitation of life support in these patients, and determined whether daily measurement of the Sequential Organ Failure Assessment (SOFA) is useful for decision making. DESIGN AND SETTING: Prospective, observational study in 79 intensive care units. PATIENTS AND PARTICIPANTS: Of the 7,615 patients admitted during a 2-month period we found 1,340 patients to have MODS. MEASUREMENTS AND RESULTS: We recorded mortality and length of stay in the intensive care unit and the hospital and the maximum and minimum total SOFA scores during MODS. Limitation of life support in MODS patients was also evaluated. Stepwise logistic regression was used to determine the factors predicting mortality. The in-hospital mortality rate in patients with MODS was 44.6%, and some type of limitation of life support was applied in 70.6% of the patients who died. The predictive model maximizing specificity included the following variables: maximum SOFA score, minimum SOFA score, trend of the SOFA for 5 consecutive days, and age over 60 years. The model diagnostic yield was: specificity 100%, sensitivity 7.2%, positive predictive value 100%, and negative predictive value 57.3%; the area under the receiver operating characteristic curve was 0.807. CONCLUSIONS: This model showed that in our population with MODS those older than 60 years and with SOFA score higher than 9 for at least 5 days were unlikely to survive.

Determining factors of the response to hyperhomocysteinemia treatment in renal transplant patients.

Hyperhomocysteinemia (hyperHcy) is a risk factor for cardiovascular disease. The benefits of lowering homocysteinemia (Hcy) in renal transplant recipients through vitamin treatment are not clearly understood. The objective of this study was to establish the demographic, renal, Hcy metabolism, and microinflammation factors that determined the response to folic acid and vitamin B complex treatment in stable patients with renal transplants and hyperHcy. We studied 65 renal transplant patients with baseline hyperHcy. The mean baseline Hcy level of these patients was 22.5 micromol/L. Following treatment it fell to 14.5 micromol/L, an overall reduction of 35.5%. Forty-one patients (63%) were classified as responders; the remainder (37%), nonresponders. A bivariance analysis suggested the only significant differences between responding and nonresponding patients were the pre-treatment Hcy level and the renal function level.

Factors involved in baseline hyperhomocysteinemia in renal transplantation.

Hyperhomocysteinemia (hyperHcy) is one cardiovascular risk. The objective of this study was to establish the prevalence demographic, and clinical and analytical factors related to hyperhomocysteinemia among renal transplant patients. The mean Hcy level was 17.3 micromol/L; the prevalence of hyperHcy was 61.2%. The population was categorized as hyperHcy and normal-homocysteinemia (Hcy) patients. Those subjects with hyperHcy were mostly men, with lower intraerythrocyte folate and vitamin B(12) levels, higher fibrinogen levels, and poorer renal function. Multivariate evaluation showed that creatinine clearance, plasma intraerythrocyte folate and vitamin B(12) levels, and plasma fibrinogen levels were independently associated with Hcy levels. Even though the Hcy level was slightly higher among patients who suffered a posttransplantation cardiovascular event, this was statistically significant.