Long-Term Atrioventricular Block Following Valve Surgery: Electrocardiographic and Surgical Predictors.

BACKGROUND: Bradyarrhythmia requiring pacemaker implantation among patients undergoing valve surgery may occur even after several years, with unclear predictors. Our aim was to investigate the incidence of pacemaker implantation at different follow-up times and identify associated predictors. METHODS: We conducted a retrospective study evaluating 1046 consecutive patients who underwent valve surgery at the Cardiac Surgery Division of Bologna University Hospital from 2005 to 2010. RESULTS: During 10 ± 4 years of follow-up, 11.4% of these patients required pacemaker implantation. Interventions on both atrioventricular valves independently predicted long-term pacemaker implantation (SHR 2.1, 95% CI 1.2-3.8, p = 0.014). Preoperative atrioventricular conduction disease strongly predicted long-term atrioventricular block, with right bundle branch block as the major predictor (SHR 7.0, 95% CI 3.9-12.4, p < 0.001), followed by left bundle branch block (SHR 4.9, 95% CI 2.4-10.1, p < 0.001), and left anterior fascicular block (SHR 3.9, 95% CI 1.8-8.3, p < 0.001). CONCLUSION: Patients undergoing valvular surgery have a continuing risk of atrioventricular block late after surgery until the 12-month follow-up, which was clearly superior to the rate of atrioventricular block observed at long-term. Pre-operative atrioventricular conduction disease and combined surgery on both atrioventricular valves are strong predictors of atrioventricular block requiring pacemaker implantation.

[Detection of adverse events in patients interned in medical clinic using the Global Trigger Tool]. / Detección de eventos adversos en pacientes internados en clínica médica utilizando la herramienta Global Trigger Tool.

INTRODUCTION: The Global Trigger Tool (GTT) is a tool that accurately identifies adverse events that represent a significant problem in hospitals. METHODS: Cross-sectional study based on retrospective review of randomized medical records using the GTT tool. RESULTS: A total of 161 adverse events (AEs) were detected: 51 events per 100 admissions, 66 per 1000 patient-days, and 30% of admissions with AEs. The most frequent triggers were from the care module, with 25% complications associated with the use of procedures, 10% pressure ulcers, and 9% care-associated infections. The presence of AEs had a statistically significant association with a stay of more than 5 days, and a moderate association with age and number of triggers. Regarding the damage, 78% of the patients presented mild events and 4% fatal events. The ROC curves analysis showed that the triggers with the greatest area under the curve were: procedural complication (0.70), pressure ulcers (0.61) and rapid response code (0.60). DISCUSSION: The number of events per 100 admissions was higher than that reported in the literature, but there were no differences in events per 1000 patientdays. Fatal cases were caused by respiratory infectious diseases in patients with comorbidities, nasogastric tube needs and cognitive decline. The study highlights the scarce use of the tool in public hospitals and the implementation of trigger analysis with ROC curves. Knowing the frequency and the most frequent type of event will allow the implementation of measures that improve patient safety.

Introducción: El Global Trigger Tool (GTT) es una herramienta que identifica con precisión los eventos adversos, estos representan un problema relevante y prevenible en los hospitales. Métodos: Estudio de corte transversal basado en la revisión retrospectiva de historias clínicas aleatorizadas utilizando el GTT. Resultados: Se detectaron 161 eventos adversos (EA): 51 por cada 100 admisiones, 66 por cada 1000 días paciente y 30% de admisiones con EA. Los disparadores más frecuentes fueron del módulo cuidados, 25% complicaciones asociadas al uso de procedimientos, 10% úlceras por presión y 9% infecciones asociadas a la atención. La presencia de EA tuvo asociación estadísticamente significativa con estancia mayor a 5 días, y asociación moderada con edad y número de disparadores. En cuanto al daño, 78% de los pacientes presentaron eventos leves y 4% eventos fatales. En el análisis con curvas ROC, los disparadores con mayor área bajo la curva fueron: complicación de procedimientos (0.70), úlceras por presión (0.61) y código de respuesta rápida (0.60). Discusión: Los eventos por 100 admisiones fueron superiores a la bibliografía pero no hubo diferencias en eventos por cada 1000 días paciente. Los casos fatales se produjeron por enfermedades infecciosas respiratorias en pacientes con comorbilidades, necesidad de sonda nasogástrica y deterioro cognitivo. Se destaca la escasa aplicación de la herramienta en hospitales públicos, y la implementación de análisis de disparadores con curvas ROC. Conocer la frecuencia y el tipo de evento más frecuente permitirá implementar medidas que mejoren la seguridad de los pacientes.

Response to glecaprevir/pibrentasvir in HIV/HCV-coinfected patients in clinical practice.

OBJECTIVES: HIV infection has been associated with lower rates of sustained viral response (SVR) with direct-acting antivirals (DAAs). There are few data on glecaprevir/pibrentasvir (G/P) in HIV/HCV coinfection outside clinical trials. METHODS: The HEPAVIR-DAA cohort, which recruits HIV/HCV-coinfected patients (NCT02057003) and the GEHEP-MONO cohort (NCT02333292), including HCV-monoinfected individuals, are two concurrent ongoing multicentre cohorts of patients receiving anti-HCV treatment. Patients starting G/P included in those cohorts were analysed. Overall SVR (ITT), discontinuations due to adverse effects, and dropouts were evaluated and compared between both cohorts. RESULTS: Of the 644 patients who started G/P with evaluable SVR, 132 were HIV/HCV coinfected. Overall SVR rates were 487/512 (95.1%) in HCV-monoinfected patients versus 126/132 (95.5%) in HIV/HCV-coinfected patients (P = 1.000). One patient (0.8%) relapsed, and another (0.8%) discontinued treatment due to side effects. SVR to 8 or 12 weeks of treatment with G/P was similar in HIV/HCV-coinfected versus HCV-monoinfected patients. The main reason for not reaching SVR among HIV/HCV-coinfected patients was premature dropout linked to active drug use. CONCLUSIONS: G/P in HIV/HCV coinfection was highly effective and tolerable in clinical practice. SVR to 8 or 12 weeks of treatment with G/P was similar in HIV/HCV-coinfected compared with HCV-monoinfected patients but active drug use is still a barrier to reach HCV microelimination.

Mediterranean diet and psychological well-being intervention to reverse metabolic syndrome in Chile (CHILEMED trial).

Psychosocial status and lifestyle are key risk factors of non-communicable diseases (NCDs), which, in turn, are main drivers of healthcare costs and morbimortality worldwide, including Chile. Mediterranean diet (MedDiet) is one of the healthiest dietary patterns under study. However, its impact on high-risk conditions, such as metabolic syndrome (MetS), and NCDs outside the Mediterranean Basin remains mostly unexplored. Even though Central Chile has an environment, food production, and culinary traditions comparable to those present in Mediterranean countries, few studies -some with significant methodological limitations- have evaluated the effect of MedDiet on health and/or disease in Chilean subjects. Importantly, a Mediterranean lifestyle is a modus vivendi that integrates physical health with mental and social well-being. Psychological well-being (PWB) is associated with healthy behaviors, positive health outcomes, and longevity, thereby emerging as a novel healthcare goal. We report here an ongoing randomized controlled clinical trial in Chilean patients with MetS seeking to test whether (1) a PWB theory-based intervention facilitates induction to and increases long-term adherence to a locally adapted MedDiet, and (2) a MedDiet intervention -implemented alone or combined with well-being promotion- is more effective at reversing MetS compared to individuals following a low-fat diet without psychological support. The CHILEan MEDiterranean (CHILEMED) diet intervention study is a 1-year trial including patients with MetS living in Chile. Participants will be assigned randomly by a computer-generated random number sequence to one of the three intervention arms: a) low-fat diet as control group, b) MedDiet alone, and c) MedDiet plus well-being support. Patients will be followed-up by individual and/or group online nutritional sessions or phone cal as well as 6- and 12-month in-person re-assessment of medical history, medication use, food intake, PWB, anthropometrics/physical exam, and blood collection for laboratory analysis. The primary outcome of the trial will be the effect of the MedDiet -with or without PWB intervention- on overall reversal of MetS compared to low-fat diet alone. Based on a statistical superiority trial, expected impact, and patient loss, the estimated study sample is 339 subjects (113 individuals per arm in 3 equal-sized groups). Currently, we have enrolled 179 patients, predominantly women, evenly distributed by age (group means ranging from 45.7 to 48,9 years-old), 3/4 are obese with almost all of them showing abdominal obesity, 70% are hypertensive, whereas <10% exhibit diabetes. If findings turn out as expected (e.g., MedDiet -with or without PWB intervention- is better than the low-fat diet for reversion of MetS at 1-year follow-up), CHILEMED will provide further beneficial evidence of the MedDiet on NCD risk conditions beyond the Mediterranean region.

Clinical Evaluation of Serum Levels of SARS-CoV-2 Anti-Spike Protein IgG Antibodies in Infected Patients and Vaccinated Subjects.

BACKGROUND: The aim was clinical evaluation of immune response against SARS-CoV-2, analyzing serum levels of IgG antibodies against the SARS-CoV-2 protein S in infected and vaccinated patients, as well as in subjects with and without frequent comorbidities (arterial hypertension, diabetes mellitus, heart disease, and chronic respiratory disease). METHODS: Patients infected by SARS-CoV-2 confirmed by RT-PCR and subjects vaccinated with vaccines based on the mRNA encoding the SARS-CoV-2 protein S were studied. SARS-CoV-2 anti-S IgG serum levels were quantified by chemiluminescent microparticle immunoassay. RESULTS: There were 79 infected patients with a median age of 53.0 years; 35 women and 44 men; 42 patients with any comorbidities and 37 without comorbidities. The median of SARS-CoV-2 anti-S IgG serum level was 203.4 BAU/mL (11.6 - 5,620.6). The median antibody level in the infected patients with any comorbidities was higher than those without comorbidities. The group of vaccinated subjects included 96 subjects with a median age of 49.5 years; 77 women and 19 men; 31 subjects with any comorbidities and 65 without comorbidities. The median of SARS-CoV-2 anti-S IgG serum levels was 1,145.6 BAU/mL (138.3 - 4,828.1). No significant differences were found in terms of specific or global comorbidities in the vaccinated subjects. CONCLUSIONS: SARS-CoV-2 anti-S IgG serum levels were 5.6 times higher in vaccinated subjects than infected patients. The vaccination produces higher serum antibody levels than SARS-CoV-2 infection. This reinforces the indication for the vaccine in infected patients. These antibodies did not decrease significantly in patients with frequent comorbidities such as hypertension, diabetes, heart disease or chronic respiratory disease.

Determination of puberty in gilts: contrast of diagnostic methods.

BACKGROUND: Early onset of a gilt´s puberty is needed for adequate economic performance in farms, because it indicates her reproductive performance and longevity. Therefore, an effective diagnosis is needed. Our purpose was to compare different procedures (external characteristics, blood progesterone analysis and ultrasonography diagnosis) to detect puberty in 70 gilts (Topigs TN70; 240 days old) on farm conditions. Postmortem examination was the standard reference. Multiple logistic regression analysis was used to identify which combination of independent variables (predictors) best predicts the status of gilts. RESULTS: Puberty (46/70 gilts; 65.71%) was characterized by the presence of follicles larger than 6 mm, corpus albicans, corpus rubrum, and corpus luteum (postmortem examination). Vaginal length, body condition, backfat, carcass weight and progesterone blood concentration were significantly higher in pubertal than prepubertal gilts (P < 0.05). Two types of ultrasonography equipment (DELTA and W3) were compared and performed by the same senior technician (V1). The results obtained by two technicians with different levels of experience (V1 and V2, a junior technician) using W3 were also compared. Ultrasonography provided better results than other diagnostic techniques, although the effectiveness of the ultrasonography changed with technological improvements and with increased expertise of technicians. The most accurate results were found by V1/DELTA (Nagelkerke´s R2 = 0.846; Sensitivity = 0.956; Specificity = 0.958; Positive predictive value = 0.978; Negative predictive value = 0.920; Area under ROC curve = 0.957). Results using the W3 equipment could be improved when used in conjunction with vaginal length (V1; Nagelkerke´s R2 = 0.834; Sensitivity = 0.933; Specificity = 0.958; Positive predictive value = 0.977; Negative predictive value = 0.885; Area under ROC curve = 0.972) or progesterone concentration (V2; Nagelkerke´s R2 = 0.780; Sensitivity = 0.955; Specificity = 0.826; Positive predictive value = 0.915; Negative predictive value = 0.905; Area under ROC curve = 0.970). CONCLUSIONS: Ultrasonography provided better results than other diagnostic techniques. The effectiveness of the ultrasonography changes with technological improvements and with increased expertise of technicians. Results using the W3 equipment could be improved when used along with vaginal length (V1) or progesterone concentration (V2). Accuracy parameters are a guide to choose puberty diagnosis, but the farms must also evaluate effect on gilts, ease and cost of administration.

[Evaluation of susceptibility of multidrug-resistant Pseudomonas aeruginosa strains against ceftolozane/tazobactam]. / Evaluación de la sensibilidad de cepas de Pseudomonas aeruginosa multi-resistentes frente a ceftolozano/tazobactam.

BACKGROUND: Pseudomonas aeruginosa is an opportunistic pathogen associated with high morbidity and mortality. For multidrug-resistant strains (MDR), ceftolozane/tazobactam (CTZ) has been authorized by the European Medicines Agency (EMA) for complicated urinary tract infections, acute pyelonephritis, and complicated intraabdominal infections. AIM: To determine the susceptibility to CTZ of P. aeruginosa MDR in isolated clinical samples at the University Hospital Puerto Real. METHODS: The susceptibility according to the EUCAST to CTZ criteria of strains of P. aeruginosa MDR, between January 2015 and August 2017 has been studied. The multiresistance criteria were those defined by the Centers for Disease Control and Prevention. The antibiotic susceptibility was obtained by automated MicroScan® system (Beckman Coulter). Susceptibility to CTZ was determined using gradient strips (Liofilchem®, Werfen). RESULTS: Of 1253 strains isolated, 7% presented MDR. We studied the susceptibility of a total of 78 strains of MDR P. aeruginosa, of which 5 (6.4%) were resistant to CTZ according to the EUCAST criteria. CONCLUSIONS: In our environment, the in vitro resistance to CTZ in MDR P. aeruginosa strains is approximately 6%. CTZ is an option for the treatment of infections by MDR P. aeruginosa when there is no other alternative and its in-vitro susceptibility has been proven.

Evaluación de la sensibilidad de cepas de Pseudomonas aeruginosa multi-resistentes frente a ceftolozano/tazobactam / Evaluation of susceptibility of multidrug-resistant Pseudomonas aeruginosa strains against ceftolozane/tazobactam

Resumen Introducción: Pseudomonas aeruginosa es un patógeno oportunista asociado a alta morbi-mortalidad. Para cepas multi-resistentes (MDR), ceftolozano/tazobactam (CTZ) se ha autorizado por la Agencia Europea del Medicamento (EMA) para infecciones del tracto urinario complicadas, pielonefritis aguda e infecciones intra-abdominales complicadas. Objetivo: Determinar la sensibilidad a CTZ de P. aeruginosa MDR en muestras clínicas aisladas en el Hospital Universitario Puerto Real. Material y Métodos: Se estudió la sensibilidad según criterios EUCAST a CTZ de cepas de P. aeruginosa MDR, entre enero de 2015 y agosto de 2017. Los criterios de multi-resistencia fueron definidos por el Centers for Disease Control and Prevention. La sensibilidad antimicrobiana se obtuvo mediante sistema MicroScan® (Beckman Coulter). La sensibilidad a CTZ se determinó mediante tiras de gradiente (Liofilchem®, Werfen). Resultados: De 1253 cepas, 7% fueron MDR. Se estudió la sensibilidad de 78 cepas de P. aeruginosa MDR, de las cuales cinco (6,4%) resultaron resistentes a CTZ según criterios EUCAST. Conclusiones: En nuestro medio la resistencia in vitro a CTZ en cepas de P. aeruginosa MDR es aproximadamente 6%; CTZ es una opción de tratamiento de infecciones por cepas de P. aeruginosa MDR cuando no exista otra alternativa y se haya comprobado su sensibilidad in vitro.

Background: Pseudomonas aeruginosa is an opportunistic pathogen associated with high morbidity and mortality. For multidrug-resistant strains (MDR), ceftolozane/tazobactam (CTZ) has been authorized by the European Medicines Agency (EMA) for complicated urinary tract infections, acute pyelonephritis, and complicated intraabdominal infections. Aim: To determine the susceptibility to CTZ of P. aeruginosa MDR in isolated clinical samples at the University Hospital Puerto Real. Methods: The susceptibility according to the EUCAST to CTZ criteria of strains of P. aeruginosa MDR, between January 2015 and August 2017 has been studied. The multiresistance criteria were those defined by the Centers for Disease Control and Prevention. The antibiotic susceptibility was obtained by automated MicroScan® system (Beckman Coulter). Susceptibility to CTZ was determined using gradient strips (Liofilchem®, Werfen). Results: Of 1253 strains isolated, 7% presented MDR. We studied the susceptibility of a total of 78 strains of MDR P. aeruginosa, of which 5 (6.4%) were resistant to CTZ according to the EUCAST criteria. Conclusions: In our environment, the in vitro resistance to CTZ in MDR P. aeruginosa strains is approximately 6%. CTZ is an option for the treatment of infections by MDR P. aeruginosa when there is no other alternative and its in-vitro susceptibility has been proven.

Contact lens-induced corneal peripheral swelling: Orbscan repeatability.

PURPOSE: To compare the repeatability and agreement of corneal thickness measurements using central and peripheral ultrasound and Orbscan pachymetry to detect contact lens (CL)-induced corneal swelling after extended wear (EW). METHODS: Corneal thickness was measured in five corneal locations (central, superior, inferior, nasal, and temporal) with ultrasound and Orbscan pachymetry 1 week before CL wear commenced and after 1 week of EW. High oxygen permeability (lotrafilcon A) and low oxygen permeability (etafilcon A) CL were randomly fitted for EW in the right and left eyes of 20 subjects with normal ocular health to induce different amount of corneal swelling. RESULTS: Poor repeatability and poor agreement in peripheral ultrasound and Orbscan pachymetry was found between corneas with and without corneal swelling. Ultrasound coefficients of repeatability (central, superior, inferior, nasal, and temporal) in corneas without (0.95, 2.1, 3.2, 3.9, and 3.8%) and with (0.91, 1.89, 2.45, 2.66, and 2.26%) corneal swelling were higher than Orbscan coefficients of repeatability without (0.74, 1.67, 1.29, 1.11, and 1.11%) and with (0.74, 1.47, 1.28, 1.78, and 1.23%) corneal swelling. Lotrafilcon A induced significantly less corneal swelling in all five corneal locations compared with etafilcon A. Peripheral corneal swelling differences between lens types were significant only with Orbscan measurements (p < 0.05, Paired t-test and re-analysis of variance). CONCLUSIONS: The assessment of corneal thickness shows higher repeatability using Orbscan pachymetry than using ultrasound to measure corneas with and without corneal swelling and could be useful to study central and peripheral corneal swelling variations in CL EW.

Contact lens-induced corneal peripheral swelling differences with extended wear.

PURPOSE: To compare central and peripheral corneal swelling with high-Dk (lotrafilcon A) and low-Dk (etafilcon A) contact lenses (CLs) during extended wear (EW). METHODS: Corneal thickness was measured in 5 corneal locations (central, superior, inferior, nasal, and temporal) with Orbscan II pachymetry 1 week before the wearing of CLs and after 1 week of EW. High-Dk (lotrafilcon A) and low-Dk (etafilcon A) soft CLs were randomly fitted for EW in the right and left eyes of 20 subjects with normal ocular health. Orbscan was also performed before CL removal after 3 and 7 days of EW. RESULTS: Lotrafilcon A induced a lower percentage of corneal swelling in all 5 corneal locations than etafilcon A (P < 0.05, paired t test). Lotrafilcon A swelling percentages were as follows: central (1.67% +/- 2.22%), superior (2.04% +/- 3.25%), inferior (1.38% +/- 1.74%), nasal (1.50% +/- 2.00%), and temporal (1.27% +/- 1.47%). Etafilcon A swelling percentages were as follows: central (4.98% +/- 3.07%), superior (6.62% +/- 8.39%), inferior (5.24% +/- 5.54%), nasal (3.41% +/- 3.14%), and temporal (4.46% +/- 3.32%). Differences between the central and peripheral corneal swelling during EW of both types of lenses were not significant (P > 0.05, repeated-measures analysis of variance). CONCLUSIONS: Central and peripheral corneal thicknesses increase more with etafilcon A than with lotrafilcon A during EW, as measured by Orbscan pachymetry.

Initial comfort of lotrafilcon A silicone hydrogel contact lenses versus etafilcon A contact lenses for extended wear.

PURPOSE: To compare the initial comfort afforded by silicone hydrogel lenses (lotrafilcon A) versus the comfort afforded by conventional hydrogel lenses (etafilcon A) in extended wear (EW). DESIGN: Prospective, double-masked and randomized controlled trial. METHODS: Lotrafilcon A and etafilcon A contact lenses were eye randomly fitted on an EW basis for 7 days and nights in 20 subjects. A forced-choice subject preference questionnaire was made. Subjects were comfort, dryness, red eye and visual quality after night wear and at the end of the day. Subjective scored satisfaction (scale: 1-5) and lens preference were assessed. RESULTS: Lotrafilcon A proved more comfortable after night wear (60%, CI95% 38-82%) and at the end of the day (70%, CI95% 49-90%) than etafilcon A after night wear (10%, CI95% 0-23%, P<0.05) and at the end of the day (20%, CI95% 2-38%, P<0.05). The feeling of dryness was more marked with etafilcon A after night wear (50%, CI95% 27-72%) and at the end of the day (50%, CI95% 27-72%) than it was with lotrafilcon A (15%, CI95% 0%-31%) after night wear (P>0.05) and at the end of the day (25%, CI95% 5%-44%, P<0.05). General satisfaction with the lotrafilcon A lens was 3.65 points (CI95% 3-4.2) and with etafilcon A 2.95 points (CI95% 2.5-3.3, P<0.05). Eighty percent (CI95% 62%-98%) of subjects preferred lotrafilcon A (P<0.05) for EW. CONCLUSIONS: In EW, lotrafilcon A contact lenses were more comfortable and led to less dryness after night wear and at the end of the day than etafilcon A contact lenses.