Risk of ischemic stroke associated with direct oral anticoagulants discontinuation on patients with non-valvular atrial fibrillation.

INTRODUCTION: Although direct oral anticoagulants' (DOACs) prescriptions have experienced immense growth in the last decade, the proportion of discontinuers is still common yielding an increased risk of ischemic stroke (IS) onset. AIMS: We aimed to estimate the association between DOACs discontinuation and risk of IS among patients with non-valvular atrial fibrillation (NVAF). METHODS: We used data from a cohort of new DOACs users, followed patients from the first DOAC prescription date up to IS (index date) and conducted a nested case-control analysis using conditional logistic regression. Adjusted odds ratios, 95% confidence intervals were calculated for discontinuation of DOACs (current use compared with past use). The latter, subdivided among those stopping treatment 3 to 2 months and 6 and 3 months prior to index date. The effect of naïve current users against IS onset compared with non-naïve current users was also evaluated. RESULTS: DOACs discontinuation showed an OR of IS of 1.47 (95% CI: 1.02-2.12); estimates were 2.51 (95% CI: 1.84-3.42) for whom discontinued treatment within months 3 and 2 and 1.43 (95% CI: 0.96-2.13) for those between months 6 and 3 prior to index date. Analyzing DOACs individually, risk of IS associated with past users compared with current users: 1.98 (95% CI: 1.25-3.12) for apixaban, 1.38 (95% CI: 0.40-4.72) for edoxaban, 1.98 (95% CI: 1.24-2.65) for dabigatran and 1.87 (95% CI: 1.26-2.76) for rivaroxaban. Similar results were found when stratified by naïve and non-naïve users. CONCLUSIONS: DOACs' discontinuation is associated with higher risk of IS, especially in the second and third months following interruption.

Neutron radiation hardness of aluminum gallium nitride UV LEDs at various wavelengths.

Radiation hard diagnostics are critical to the success of nuclear fusion at National Ignition Facility, Z, ITER, and prolonged space explorations. We have first demonstrated the exceptional proton radiation hardness of initial GaN devices and qualified their space flight and deployment for missions such as the Laser Interferometer Space Antenna and International Space Station. We have further conducted neutron radiation hardness experiments at Los Alamos Neutron Science Center by opening a new high fluence beam station. During 2014-2016, we irradiated multiple Aluminum Gallium Nitride (AlGaN) LEDs with a maximum fluence of 2.4 × 1013 neutrons/cm2 in 3 years and generated 54 161 current-voltage (I-V) scan traces. Our data processing program analyzes each and all I-V traces. In addition, we retrieved local temperature records to analyze and remove temperature effects in the outdoor environment. The I-V curve families of AlGaN UV LEDs with emitting wavelengths of 265, 275, and 310 nm were compared. The I-V curves of 265 nm AlGaN UV LEDs have the smallest deviations from the average value, while the I-V curves for 310 nm AlGaN LEDs showed the largest deviations from the average value. We have reached another important recommendation for the optimal use of multiple AlGaN optoelectronic devices or imaging arrays for inertially confined fusion diagnostics: Shorter wavelength devices at 265 nm exhibit more consistent radiation hardness performance than the 310 nm devices. Higher aluminum content LEDs or AlxGa1-xN devices with higher mole fraction x for generating shorter wavelengths have better radiation hardness for fusion diagnostics.

Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial.

OBJECTIVES: To test the effect of a structured abdominal hypopressive technique (AHT) programme on pelvic floor muscle (PFM) tone and urinary incontinence (UI) in women. DESIGN: Crossover trial with random assignment of women to one of two groups: Group 1 (AHT followed by rest) and Group 2 (rest followed by AHT). SETTING: Two cultural centres in Madrid, Spain. PARTICIPANTS: Women aged 20-65 years. INTERVENTIONS: Two months of supervised AHT exercises compared with 2 months of rest. MAIN OUTCOME MEASURES: Variation in PFM tone and score on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)]. RESULTS: Forty-two women were randomised to two groups (both n=21). No sequence or period effect was noted. The mean difference in PFM tone after the 2-month AHT programme was 59g/cm² [95% confidence interval (CI) 37 to 82]; the between-group difference was 83g/cm² (95% CI 50 to 116; P<0.001). After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001). The majority of participants reported improved body image and sense of well-being. CONCLUSIONS: A structured 2-month AHT programme for women showed short-term benefits in PFM tone and UI. In addition, study participants reported improved body image and sense of well-being, and programme satisfaction, as demonstrated by questionnaire at the end of the intervention period. Further research is needed to test the long-term effects and effectiveness of AHT compared with other PFM exercises. ClinicalTrials.gov Identifier NCT0221241.

Empleo de malla en U de una pieza y sutura barbada durante la colposacropexia laparoscópica / The use of one-piece U-shaped mesh and barbed sutures in laparoscopic sacrocolpopexy

INTRODUCCIÓN: La colposacropexia laparoscópica (CL) para el manejo del prolapso de órganos pélvicos, es una cirugía compleja que requiere experticia. La complejidad radica en los requerimientos de sutura intracorpórea y en las dificultades para la manipulación intracorpórea de la malla. La sutura barbada (SB) simplifica la sutura intracorpórea y no requiere anudado. Adicionalmente las mallas en U de una sola pieza (MU-P) pueden facilitar su manipulación, estabilización y el ajuste de tensión. Describimos nuestra técnica quirúrgica de CL empleando ambos materiales y valoramos su factibilidad, seguridad y efectividad en una serie prospectiva de pacientes. Materiales y MÉTODOS: Un total de 7 pacientes con prolapso de órganos pélvicos sintomático fueron intervenidas mediante CL empleando MU-P fijada con SB. A todas ellas se les realizó historia uroginecológica, clasificación del prolapso de órganos pélvicos según Baden-Walker y se les administró el cuestionario de calidad de vida específico de prolapso. Se empleó la MU-P de polipropileno, macroporo, no absorbible (Uplift (R)). La rama posterior de la malla se fijó en los músculos elevadores con sendos puntos de sutura no absorbible. Dos hilos de SB (V-Loc (R)), atadas en su extremo se emplearon para fijar la rama anterior de la malla en la vagina con dos líneas de sutura continua en sentidos opuestos con inicio en el punto central y más profundo de la disección vaginal. Se emplearon tackers no metálicos del kit de Uplift(R) para la promontofijación y SB para el cierre del peritoneo. RESULTADOS: La mediana de edad fue 60 años, la mediana de tiempo de fijación de la rama anterior de la malla con SB fue de 23 minutos (rango 21,30 - 26,40 min), la mediana de la estancia hospitalaria fue de 3 días y el sangrado intraoperatoria fue mínimo. Observamos que la MU-P se autoestabiliza al desplegarse longitudinalmente en la cavidad minimizando los requerimientos del asistente quirúrgico. La promontofijación independiente de cada rama de la malla (posterior y anterior) permite un ajuste de tensión más anatómico. La fijación de la malla a la vagina mediante nuestra técnica empleando la SB resulta rápida y sencilla. No se registraron complicaciones intraoperatorias y no se han evidenciado erosiones vaginales ni recurrencias durante el seguimiento (mediana 14 meses. ) Todas las pacientes presentaron mejoría clínica del prolapso y están satisfechas con la cirugía. CONCLUSIONES: La CL empleando MU-P y SB es factible, segura, efectiva y podría simplificar la cirugía

INTRODUCTION: Laparoscopic sacrocolpopexy (LS) is considered a safe and effective surgery for the treatment of pelvic organ prolapse (POP), but it requires expertise in laparoscopic surgery. The complexity of the intervention is due to the requirements of intracorporeal sutures and the manipulation of the mesh inside the cavity, which may be cumbersome. The barbed sutures (BS) simplify intracorporeal suturing and do not require knotting. Additionally, one-piece U-mesh (OP-UM) may facilitate handling, stabilization and tension adjustment. We describe our LS surgical technique using both materials to assess its feasibility, safety and effectiveness in a prospective series of PATIENTS: MATERIALS AND METHODS: A total of 7 patients with symptomatic pelvic organ prolapse were included. Urogynecological history, classification of the pelvic organ prolapse according to Baden-Walker and the application of the Prolapse Quality of Life questionnaire were performed in all cases. The non-absorbable polypropylene OP-UM (UpliftTM) was used. The posterior side of the single sling is sutured to the elevator anus muscles with two non-absorbable stitches. Two strands of BS (V-LocTM), tied at their ends, were used to attach the mesh to the vagina in two lines of continuous sutures in opposite directions. Self-anchoring tackers were used for promontofixation and BS for peritoneal closure. RESULTS: The median age was 60 years, the median time of the anterior branch mesh BS fixation was 23 minutes (range 21,30 - 26,40 min), intraoperative bleeding was minimal, and the median hospital stay was 3 days. No intraoperative complications were recorded, and no mesh erosions or recurrences were observed at a median follow-up of 14 months (range 3-25 months). All patients presented clinical improvement of the prolapse and were satisfied with surgery. We observed that the OP-UM self-stabilizes when it extends longitudinally into the abdominal cavity, reducing the need of the surgical assistant. The independent promontofixation of each part of the mesh (posterior and anterior) allows a more anatomical tension adjustment. Fixing the mesh to the vagina is fast and simple with our BS technique. CONCLUSIONS: The use of OP-UM and BS during LS is feasible, safe, effective and could simplify this surgical technique

The use of one-piece U-shaped mesh and barbed sutures in laparoscopic sacrocolpopexy. / Empleo de malla en U de una pieza y sutura barbada durante la colposacropexia laparoscópica.

INTRODUCTION: Laparoscopic sacrocolpopexy (LS) is considered a safe and effective surgery for the treatment of pelvic organ prolapse (POP), but it requires expertise in laparoscopic surgery. The complexity of the intervention is due to the requirements of intracorporeal sutures and the manipulation of the mesh inside the cavity, which may be cumbersome. The barbed sutures (BS) simplify intracorporeal suturing and do not require knotting. Additionally, one-piece U-mesh (OP-UM) may facilitate handling, stabilization and tension adjustment. We describe our LS surgical technique using both materials to assess its feasibility, safety and effectiveness in a prospective series of patients. MATERIALS AND METHODS: A total of 7 patients with symptomatic pelvic organ prolapse were included. Urogynecological history, classification of the pelvic organ prolapse according to Baden-Walker and the application of the Prolapse Quality of Life questionnaire were performed in all cases. The non-absorbable polypropylene OP-UM (Uplift ™) was used. The posterior side of the single sling is sutured to the elevator anus muscles with two non-absorbable stitches. Two strands of BS (V-Loc™), tied at their ends, were used to attach the mesh to the vagina in two lines of continuous sutures in opposite directions. Self-anchoring tackers were used for promontofixation and BS for peritoneal closure. RESULTS: The median age was 60 years, the median time of the anterior branch mesh BS fixation was 23minutes (range 21,30 - 26,40min), intraoperative bleeding was minimal, and the median hospital stay was 3 days. No intraoperative complications were recorded, and no mesh erosions or recurrences were observed at a median follow-up of 14 months (range 3-25 months). All patients presented clinical improvement of the prolapse and were satisfied with surgery. We observed that the OP-UM self-stabilizes when it extends longitudinally into the abdominal cavity, reducing the need of the surgical assistant. The independent promontofixation of each part of the mesh (posterior and anterior) allows a more anatomical tension adjustment. Fixing the mesh to the vagina is fast and simple with our BS technique. CONCLUSIONS: The use of OP-UM and BS during LS is feasible, safe, effective and could simplify this surgical technique.

Factores predictores de complicaciones infecciosas en el postoperatorio de la nefrolitotomía percutánea / Predictive factors of infectious complications in the postoperative period of percutaneous nephrolithotomy

Objetivo: Las complicaciones infecciosas (CI) tras la nefrolitotomía percutánea (NLPC) pueden llegar a ser de gravedad. Nuestro objetivo fue analizar factores predictores preoperatorios de CI tras la NLPC. Materiales y métodos: Se incluyó en un estudio prospectivo a un total de 203 pacientes que se trataron con NLPC entre enero de 2013 y febrero de 2016. Se definió CI postoperatoria como infección urinaria/pielonefritis, síndrome de respuesta inflamatoria sistémica o sepsis. Las variables analizadas fueron: edad, sexo, número, lado y tamaño (cm) de la litiasis; unidades Hounsfield, diabetes (insulinodependiente o no), cultivo de orina preoperatorio, bacteria aislada, multitrayecto, índice de masa corporal y tiempo quirúrgico (min). Se llevó a cabo un análisis multivariante (regresión logística). Resultados: Se produjeron CI en 30 pacientes (14,8%): en 9 de ellos (4,4%) se presentó infección urinaria, en 14 (6,9%) síndrome de respuesta inflamatoria sistémica y en 7 (3,5%) sepsis. Además, 13 (43,3%) tenían un cultivo de orina preoperatorio negativo, 15 (50%) positivo y en 2 (6,7%) no estaba disponible. En la regresión logística, el tamaño de la litiasis, la diabetes insulinodependiente y el sexo femenino resultaron factores predictores independientes de CI (OR: 1,03; 14,6 y 7,8, respectivamente; p = 0,0001). Conclusiones: Pacientes con litiasis de mayor tamaño, diabéticos insulinodependientes y mujeres deberían ser aconsejados de forma preoperatoria sobre el riesgo de CI tras la NLPC, y ser estrechamente seguidos tras la cirugía. Además, un cultivo de orina preoperatorio negativo no ofrece fiabilidad suficiente para excluir el riesgo de CI

Objective: Infectious complications (IC) following percutaneous nephrolithotomy surgery (PCNL) can be life-threatening. Our objective was to analyze preoperative predictors of IC in PCNL. Materials and methods: A total of 203 patients who underwent PCNL were included in a prospective study between January 2013 and February 2016. A postoperative IC was defined as urinary infection/pyelonephritis, systemic inflammatory response syndrome or sepsis. The variables analyzed were age, gender, number, size (cm) and side of stone; Hounsfield units, diabetes (insulin dependent or not), preoperative culture, isolated bacteria, multitract, body mass index and surgical time (min). A multivariate forward stepwise (logistic regression) was performed. Results: IC occurred in 30 patients (14.8%): 9 (4.4%) had urinary infection, 14 (6.9%) systemic inflammatory response syndrome and 7 (3.5%) sepsis. In addition, 13 (43.3%) had negative preoperative urine culture, 15 (50%) positive and in 2 (6.7%) was not available. On the logistic regression analysis, stone size (cm), insulin dependent diabetes and female sex were independently associated with increased risk of IC (odds ratio [OR] 1.03, 14.6 and 7.8, respectively; p = 0.0001). Conclusions: Patients with large stone burdens, insulin-dependentdiabetes condition and female gender, should be counselled properly regarding postoperative infection risks and closely followed up to diagnose IC (specially sepsis) soon enough. Negative preoperative urine culture seems not reliable enough to exclude an infectious complication according to our results

Predictive factors of infectious complications in the postoperative of percutaneous nephrolithotomy. / Factores predictores de complicaciones infecciosas en el postoperatorio de la nefrolitotomía percutánea.

OBJECTIVE: Infectious complications (IC) following percutaneous nephrolithotomy surgery (PCNL) can be life-threatening. Our objective was to analyse preoperative predictors of IC in PCNL. MATERIALS AND METHODS: A total of 203 patients who underwent PCNL were included in a prospective study between January 2013 and February 2016. A postoperative IC was defined as urinary infection/pyelonephritis, systemic inflammatory response syndrome or sepsis. The variables analysed were age, gender, number, size(cm) and side of stone; Hounsfield units,diabetes (insulin dependent or not), preoperative culture, isolated bacteria, multitract, bodymass index and surgical time (min). A multivariate forward stepwise (logistic regression) was performed. RESULTS: IC occurred in 30 patients (14.8%): 9 (4.4%) had urinary infection, 14 (6.9%) systemic inflammatory response syndrome and 7 (3.5%) sepsis. In addition, 13 (43.3%) had negative preoperative urine culture, 15 (50%) positive and in 2 (6.7%) was not available. On the logistic regression analysis, stone size (cm), insulin dependent diabetes and female sex were independently associated with increased risk of IC (odds ratio [OR] 1.03, 14.6 and 7.8, respectively; P=.0001). CONCLUSIONS: Patients with large stone burdens, insulin diabetes condition and female gender, should be counselled properly regarding postoperative infection risks and closely followed up to diagnose IC (specially sepsis) soon enough. Negative preoperative urine culture seems not reliable enough to exclude an infectious complication according to our results.

Propuesta de algoritmo para el manejo de la vía aérea del paciente tras inhalación de humo / Proposal for an algorithm for the management of the patient's airway after smoke inhalation

La inhalación de humo representa la principal causa de morbimortalidad en pacientes quemados. Dadas las lesiones que pueden producirse en la vía aérea tras esta exposición, es imprescindible evaluar en el servicio de urgencias, e incluso en el lugar de primera asistencia por personal sanitario, la necesidad de realizar una intubación orotraqueal. Puesto que los signos clínicos son pobres predictores de la severidad de la lesión, en casos seleccionados es recomendable la realización de una fibroscopia diagnóstica. Presentamos un caso clínico de un paciente con lesión por inhalación de humo en el que la realización de la fibroscopia fue determinante para proceder a la intubación, y proponemos un algoritmo de actuación para el manejo de la vía aérea en este tipo de pacientes (AU)

Smoke inhalation represents the leading cause of mortality and morbidity in burns patients. Given the injuries that can occur in the airway after this exposure, it is imperative to evaluate the need for orotracheal intubation in the emergency department and even in the place of first assistance by healthcare workers. Since the clinical signs are poor predictors of the severity of the lesion, in selected cases, it is advisable to perform a diagnostic fibroscopy. We present a case report of a patient with a smoke inhalation lesion in which the fibroscopy was determinant to proceed to intubation, and we propose an algorithm of action for the management of the airway in this type of patients (AU)

¿3 + 4 = 6? Implicaciones de la estratificación del cáncer de próstata localizado Gleason 7 por número y porcentaje de cilindros positivos de biopsia en la selección de pacientes para vigilancia activa / 3+4 = 6? Implications of the stratification of localised Gleason 7 prostate cancer by number and percentage of positive biopsy cores in selecting patients for active surveillance

Objetivo: Investigar si el número y el porcentaje de cilindros positivos de la biopsia identifica un subgrupo de cáncer de próstata (CaP) Gleason 3 + 4 de comportamiento biológico similar a los Gleason 3 + 3. Material y método: Estudio observacional, tras prostatectomía radical, de una cohorte de 799 pacientes con CaP localizado de riesgo bajo (n = 582; Gleason 6; PSA < 10ng/ml y cT1c-2a) e intermedio favorable (n = 217; Gleason 3 + 4; PSA ≤ 10 ng/ml y pT2abc). Los tumores Gleason 3 + 4 se estratificaron por número (≤ 3 vs .> 3) y porcentaje de cilindros positivos (≤ 33% vs. > 33%). Se analizó su asociación con el riesgo de recidiva bioquímica (ReB) y mortalidad cáncer específica (MCE). Se realizaron diferentes modelos predictivos mediante regresión de Cox y se estimó (C-index) y comparó su capacidad predictiva. Resultados: Con una mediana de seguimiento de 71 meses, la probabilidad de ReB y de MCE en el grupo de pacientes con tumores Gleason 3+4 y número (≤3) o porcentaje bajo (≤33%) de cilindros positivos no fue significativamente diferente de las de los pacientes con tumores Gleason 6. A 5 y 10 años, no se observaron diferencias significativas en el número de ReB, en la probabilidad de permanecer libre de ReB, en el número de muertes por CaP ni en la probabilidad de muerte por CaP entre ambos grupos. Por el contrario, los pacientes con tumores Gleason 3+4 y >33% de cilindros positivos presentaron mayor número de muertes por CaP que los pacientes con tumores Gleason 6 y, a 10 años, la probabilidad de MCE fue significativamente mayor. Este subgrupo de tumores presentó un riesgo significativamente mayor de ReB (RR = 1,6; p = 0,02) respecto a los Gleason 6 y, sobre todo, de MCE (RR = 5,8; p = <0,01). El modelo con Gleason 3 + 4 estratificado por porcentaje de cilindros positivos mejoró significativamente la capacidad predictiva de ReB y MCE. Conclusiones: Un número<3 cilindros y un porcentaje < 33% de cilindros positivos identifica un subgrupo de tumores Gleason 3 + 4 con comportamiento biológico similar a los Gleason 6. A 10 años, no se observaron diferencias en el riesgo de ReB y MCE entre ambos grupos. Estos resultados aportan pruebas que apoyan a la vigilancia activa como alternativa para tumores Gleason 3 + 4 y baja extensión tumoral en biopsia

Objective: To determine whether the number and percentage of positive biopsy cores identify a Gleason 3 + 4 prostate cancer (PC) subgroup of similar biologic behaviour to Gleason 3 + 3. Material and method: An observational post-radical prostatectomy study was conducted of a cohort of 799 patients with localised low-risk (n = 582, Gleason 6, PSA < 10ng/ml and cT1c-2a) and favourable intermediate PC (n = 217, Gleason 3 + 4, PSA ≤ 10 ng/ml and pT2abc). The Gleason 3 + 4 tumours were stratified by number (≤ 3 vs.> 3) and by percentage of positive cores (≤ 33% vs. > 33%). We analysed the tumours’ association with the biochemical recurrence risk (BRR) and cancer-specific mortality (CSM). We conducted various predictive models using Cox regression and estimated (C-index) and compared their predictive capacity. Results: With a median follow-up of 71 months, the BRR and CSM of the patient group with Gleason 3 + 4 tumours and a low number (≤ 3) and percentage (≤ 33%) of positive cores were not significantly different from those of the patients with Gleason 6 tumours. At 5 and 10 years, there were no significant differences in the number of biochemical recurrences, the probability of remaining free of biochemical recurrences, the number of deaths by PC or the probability of death by PC between the 2 groups. In contrast, the patients with Gleason 3+4 tumours and more than 33% of positive cores presented more deaths by PC than the patients with Gleason 6 tumours. At 10 years, the probability of CSM was significantly greater. This subgroup of tumours showed a significantly greater BRR (RR, 1.6; P = .02) and CSM (RR, 5.8, P ≤ .01) compared with the Gleason 6 tumours. The model with Gleason 3 + 4 stratified by the percentage of positive cores significantly improved the predictive capacity of BRR and CSM. Conclusions: Fewer than 3 cores and a percentage < 33% of positive cores identifies a subgroup of Gleason 3 + 4 tumours with biological behaviour similar to Gleason 6 tumours. At 10 years, there were no differences in BRR and CSM between the 2 groups. These results provide evidence supporting active surveillance as an alternative for Gleason 3 + 4 tumours and low tumour extension in biopsy

Proposal for an algorithm for the management of the patient's airway after smoke inhalation. / Propuesta de algoritmo para el manejo de la vía aérea del paciente tras inhalación de humo.

Smoke inhalation represents the leading cause of mortality and morbidity in burns patients. Given the injuries that can occur in the airway after this exposure, it is imperative to evaluate the need for orotracheal intubation in the emergency department and even in the place of first assistance by healthcare workers. Since the clinical signs are poor predictors of the severity of the lesion, in selected cases, it is advisable to perform a diagnostic fibroscopy. We present a case report of a patient with a smoke inhalation lesion in which the fibroscopy was determinant to proceed to intubation, and we propose an algorithm of action for the management of the airway in this type of patients.

3+4 = 6? Implications of the stratification of localised Gleason 7 prostate cancer by number and percentage of positive biopsy cores in selecting patients for active surveillance. / ¿3 + 4 = 6? Implicaciones de la estratificación del cáncer de próstata localizado Gleason 7 por número y porcentaje de cilindros positivos de biopsia en la selección de pacientes para vigilancia activa.

OBJECTIVE: To determine whether the number and percentage of positive biopsy cores identify a Gleason 3+4 prostate cancer (PC) subgroup of similar biologic behaviour to Gleason 3+3. MATERIAL AND METHOD: An observational post-radical prostatectomy study was conducted of a cohort of 799 patients with localised low-risk (n=582, Gleason 6, PSA <10ng/ml and cT1c-2a) and favourable intermediate PC (n=217, Gleason 3+4, PSA ≤10 ng/ml and pT2abc). The Gleason 3+4 tumours were stratified by number (≤3 vs.>3) and by percentage of positive cores (≤33% vs. >33%). We analysed the tumours' association with the biochemical recurrence risk (BRR) and cancer-specific mortality (CSM). We conducted various predictive models using Cox regression and estimated (C-index) and compared their predictive capacity. RESULTS: With a median follow-up of 71 months, the BRR and CSM of the patient group with Gleason 3+4 tumours and a low number (≤3) and percentage (≤33%) of positive cores were not significantly different from those of the patients with Gleason 6 tumours. At 5 and 10 years, there were no significant differences in the number of biochemical recurrences, the probability of remaining free of biochemical recurrences, the number of deaths by PC or the probability of death by PC between the 2 groups. In contrast, the patients with Gleason 3+4 tumours and more than 33% of positive cores presented more deaths by PC than the patients with Gleason 6 tumours. At 10 years, the probability of CSM was significantly greater. This subgroup of tumours showed a significantly greater BRR (RR, 1.6; P=.02) and CSM (RR, 5.8, P≤.01) compared with the Gleason 6 tumours. The model with Gleason 3+4 stratified by the percentage of positive cores significantly improved the predictive capacity of BRR and CSM. CONCLUSIONS: Fewer than 3 cores and a percentage <33% of positive cores identifies a subgroup of Gleason 3+4 tumours with biological behaviour similar to Gleason 6 tumours. At 10 years, there were no differences in BRR and CSM between the 2 groups. These results provide evidence supporting active surveillance as an alternative for Gleason 3+4 tumours and low tumour extension in biopsy.

Incidence of intracranial bleeds in new users of low-dose aspirin: a cohort study using The Health Improvement Network.

Essentials Intracranial bleeds (ICB) are serious clinical events that have been associated with aspirin use. Incidence rates of ICB were calculated among new-users of low-dose aspirin in the UK (2000-2012). Over a median follow-up of 5.58 years, the incidence of ICB was 0.08 per 100 person-years. Our estimates are valuable for inclusion in risk-benefit assessments of low-dose aspirin use. SUMMARY: Background Low-dose aspirin protects against both ischemic cardiovascular (CV) events and colorectal cancer (CRC). However, low-dose aspirin may be associated with a slightly increased risk of intracranial bleeds (ICBs). Objectives To obtain the incidence rates of ICBs overall and by patient subgroups among new users of low-dose aspirin. Patients/Methods Using The Health Improvement Network (THIN) UK primary-care database (2000-2012), we identified a cohort of new users of low-dose aspirin aged 40-84 years (N = 199 079; mean age at start of follow-up, 63.9 years) and followed them for up to 14 years (median 5.58 years). Incident ICB cases were identified and validated through linkage to hospitalization data and/or review of THIN records with free-text comments. Incidence rates with 95% confidence intervals (CIs) were calculated. Results Eight hundred and eighty-one incident ICBs cases were identified: 407 cases of intracerebral hemorrhage (ICH), 283 cases of subdural hematoma (SDH), and 191 cases of subarachnoid hemorrhage (SAH). Incidence rates per 100 person-years were 0.08 (95% CI 0.07-0.08) for all ICBs, 0.04 (95% CI 0.03-0.04) for ICH, 0.03 (95% CI 0.02-0.03) for SDH, and 0.02 (95% CI 0.01-0.02) for SAH. The ICB incidence rates per 100 person-years for individuals with an indication of primary CV disease prevention were 0.07 (95% CI 0.06-0.07) and 0.09 (95% CI 0.08-0.10) for secondary CV disease prevention. Incidence rates were higher in men for SDH, and higher in women for ICH and SAH. Conclusions Our results provide valuable estimates of the absolute ICB risk for incorporation into risk-benefit assessments of low-dose aspirin use.