Impact of surrogate outcomes in randomized controlled trials for shoulder rotator cuff tears.

PURPOSE: Surrogate outcomes are clinical endpoints that are used as substitutes for direct measures of how a patient feels, functions, or survives. The present study aims to analyze the impact of surrogate outcomes on the results of randomized controlled trials on shoulder rotator cuff tears disorders. METHODS: Randomized controlled trials (RCTs) related to rotator cuff tear conditions published up until 2021 were retrieved from the PubMed and ACCESSSS databases. The primary outcome of the article was considered a surrogate outcome when the authors used radiological, physiologic, or functional variables. The result of the article was considered positive when results supported the intervention based on the trial's primary outcome. We recorded the sample size, the mean follow-up, and the type of funding. Statistical significance was set at p < 0.05. RESULTS: A total of 112 papers were included in the analysis. The mean sample size was 87.6 patients; mean follow-up period was 25.97 months. Thirty-six out of 112 RCTs used a surrogate outcome as a primary endpoint. More than half of papers using surrogate outcomes reported a positive finding (20 out of 36), while 10 out of 71 RCTs using patient-centered outcomes favored the intervention (14.08%, p < 0.001) [RR = 3.94 (95% CI 2.07-7.51)]. The mean sample size was smaller in trials using surrogate endpoints (75.11 vs 92.35 patients, respectively, p = 0.049), while the follow-up was shorter (14.12 m vs. 31.9 m, p < 0.001). Approximately 25% of the papers that reported surrogate endpoints (22.58%) were industry-funded projects. CONCLUSIONS: The substitution of surrogate endpoints for patient-important outcomes in shoulder rotator cuff trials quadruplicates the chances of obtaining a favorable result that favors the analyzed intervention.

Cancer-related fatigue and its determinants in a cohort of women with breast cancer: the DAMA Cohort.

Cancer-related fatigue (CRF) is one of the most prolonged discomforts suffered by people who have had cancer. Seventy-eight to ninety-six percent of cancer patients experience fatigue, especially while undergoing treatment. CRF is related to insomnia, anxiety, depression, and also varies depending on age. However, little is known about the factors contributing to CRF and better understanding of determinants of CRF makes it easier to identify early patients at risk and in designing intervention planning. The aim of this study was to assess the influence of precipitating factors (diagnosis of breast cancer and other clinical aspects) and perpetuating factors (social network, quality of life, mental disorders) on the presence of chronic fatigue in women from our cultural context, by social class each other determinants. METHODS: It was carried out a mixed cohort study (prospective and retrospective) using a convenience sample of women diagnosed with breast cancer. The information sources were data from the Brief Fatigue Inventory questionnaire and hospital medical records. The dependent variable was fatigue and the independent variables were age, social class, time since diagnoses, cohabitation, comorbidity, relapse, body mass index, mental health (anxiety and depression), social network, social support, and quality of life. RESULTS: Seventy-two percent of the women in the DAMA cohort reported moderate to severe fatigue. Risk of suffering from severe fatigue was greatest among individuals with low social class, those aged under 50 years, those with chronic disorders who had relapsed, and those with symptoms of anxiety and depression. In our study, CRF did not appear to be related to the stage of the cancer at diagnosis, or to the time since diagnosis. CONCLUSIONS: CRF is an element that the professionals responsible for the control and monitoring of women should take into account as another element to be taken into consideration.

Treatment and Outcome of Patients with Stage IS Testicular Cancer: A Retrospective Study from the Spanish Germ Cell Cancer Group.

PURPOSE: Stage IS testicular cancer is defined by the persistence of elevated serum tumor markers, including α-fetoprotein and/or ß-human chorionic gonadotropin, after orchiectomy without radiological evidence of metastatic disease. Current treatment recommendations include cisplatin based chemotherapy up front but the recommendations are based on limited single center series. MATERIALS AND METHODS: We retrospectively analyzed clinical and pathological characteristics, and long-term outcomes in 110 patients uniformly treated with primary chemotherapy between 1994 and 2016. The primary objective was to evaluate long-term disease-free survival. We also explored factors associated with the need for additional treatment. RESULTS: The elevated prechemotherapy tumor markers were α-fetoprotein in 48% of cases, ß-human chorionic gonadotropin in 14%, and α-fetoprotein and ß-human chorionic gonadotropin in 38%. Median α-fetoprotein and ß-human chorionic gonadotropin values were 71 ng/ml and 80 mIU/ml, respectively. The IGCCCG (International Germ Cell Cancer Collaborative Group) prognostic classification was good in 94% of cases. Mixed nonseminomatous germ cell tumor was found in 78% of cases. Of the patients 103 achieved a complete response to chemotherapy. In 6 patients radiological signs of progressive disease developed during chemotherapy, while 8 experienced relapse after an initial complete response. At a median followup of 108 months 108 patients were alive and disease-free. Five and 10-year disease-free survival rates were 87% and 85%, respectively. The predominance of embryonal carcinoma in the primary tumor was the only factor associated with the probability of needing additional therapy. CONCLUSIONS: Stage IS testicular cancer is more commonly associated with elevated α-fetoprotein, an IGCCCG good prognosis and mixed nonseminomatous germ cell tumor. Treatment with cisplatin based chemotherapy leads to cure in most cases. However, a proportion of patients require the integration of additional therapies, including more frequently when embryonal carcinoma is not predominant.

Subclinical cardiovascular disease in patients starting contemporary protease inhibitors.

OBJECTIVES: The aim of the study was to assess changes in and factors associated with anatomical [carotid artery intima-media thickness (CIMT)] and functional (arterial stiffness) markers of subclinical cardiovascular disease progression in antiretroviral-naïve patients starting triple combination antiretroviral therapy containing contemporary protease inhibitors. METHODS: This was a planned substudy of the ATADAR (Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients) clinical trial (ClinicalTrials.gov identifier NCT01274780). ATADAR is a multicentre, randomized, open-label clinical trial comparing the effects of ritonavir-boosted atazanavir and darunavir, both with tenofovir/emtricitabine, in antiretroviral-naïve HIV-infected patients. Common CIMT and aortic augmentation index (AIx@75) were measured at baseline and after 12 months of follow-up. Antiretroviral treatment, traditional cardiovascular risk factors and HIV-related factors were assessed as potential predictors of CIMT and Aix@75 changes using linear regression analysis. RESULTS: Thirty-three patients were included in this pilot study. While CIMT significantly increased in the pooled population [median (interquartile range (IQR)) 68 (-13, 128) µm; P = 0.0511], AIx@75 did not [median (IQR) 1 (-6, 5)%; P = 0.8964]. Patients on darunavir showed a trend to faster CIMT progression than those on atazanavir [median change (IQR) 117 (-2, 143) vs. -6 (-58, 89) µm, respectively; P = 0.0917]. However, after adjustment in the multivariate analysis, a higher baseline Framingham score was the only factor associated with CIMT progression (coefficient 16.02; 95% confidence interval -1.04, 33.08; P = 0.064). AIx@75 change was not associated with any baseline factor. CONCLUSIONS: CIMT was a more sensitive marker of subclinical vascular disease progression than arterial stiffness in antiretroviral-naïve patients starting antiretroviral therapy with contemporary protease inhibitors. Classical risk factors but not antiretroviral therapy were associated with faster CIMT progression.

AGO1 controls arabidopsis inflorescence architecture possibly by regulating TFL1 expression.

BACKGROUND AND AIMS: The TERMINAL FLOWER 1 (TFL1) gene is pivotal in the control of inflorescence architecture in arabidopsis. Thus, tfl1 mutants flower early and have a very short inflorescence phase, while TFL1-overexpressing plants have extended vegetative and inflorescence phases, producing many coflorescences. TFL1 is expressed in the shoot meristems, never in the flowers. In the inflorescence apex, TFL1 keeps the floral genes LEAFY (LFY) and APETALA1 (AP1) restricted to the flower, while LFY and AP1 restrict TFL1 to the inflorescence meristem. In spite of the central role of TFL1 in inflorescence architecture, regulation of its expression is poorly understood. This study aims to expand the understanding of inflorescence development by identifying and studying novel TFL1 regulators. METHODS: Mutagenesis of an Arabidopsis thaliana line carrying a TFL1::GUS (ß-glucuronidase) reporter construct was used to isolate a mutant with altered TFL1 expression. The mutated gene was identified by positional cloning. Expression of TFL1 and TFL1::GUS was analysed by real-time PCR and histochemical GUS detection. Double-mutant analysis was used to assess the contribution of TFL1 to the inflorescence mutant phenotype. KEY RESULTS: A mutant with both an increased number of coflorescences and high and ectopic TFL1 expression was isolated. Cloning of the mutated gene showed that both phenotypes were caused by a mutation in the ARGONAUTE1 (AGO1) gene, which encodes a key component of the RNA silencing machinery. Analysis of another ago1 allele indicated that the proliferation of coflorescences and ectopic TFL1 expression phenotypes are not allele specific. The increased number of coflorescences is suppressed in ago1 tfl1 double mutants. CONCLUSIONS: The results identify AGO1 as a repressor of TFL1 expression. Moreover, they reveal a novel role for AGO1 in inflorescence development, controlling the production of coflorescences. AGO1 seems to play this role through regulating TFL1 expression.

Pellagra. A challenging differential diagnosis in burn injuries.

With this case report we want to emphasize the importance of performing a thorough physical examination of the burn and detailed review of the patient's history. This is a challenging case because it deals with an uncommon disease nowadays, pellagra, which presents lesions with an appearance very similar to burns; on the other hand the management of pellagra is different to the management of the common burns we are used to handling day-to-day. With this case report we will be able to revise the broad list of different injuries that can bring up an issue related to a correct diagnosis, caused by a large diversity of different etiologies with cutaneous expression. We will look over the diagnostic process of pellagra, management, treatment and results in this patient.

Identification of the hemodynamic modulators and hemodynamic status in uncontrolled hypertensive patients.

Only 20-30% out of the treated hypertensive patients in Europe are achieving blood pressure (BP) control. Among other recognized factors, these poor results could be attributable to the fact that for many doctors it is very difficult to detect which is the predominant hemodynamic cause of the hypertension (hypervolemia, hyperinotropy or vasoconstriction). The aim of the study was to use non-invasive thoracic electrical bioimpedance (TEB) to evaluate hemodynamic modulators and subsequent hemodynamic status in uncontrolled hypertensive patients, receiving at least two antihypertensive drugs. A number of 134 uncontrolled hypertensive patients with essential hypertension were evaluated in nine European Hypertension Excellence centers by means of TEB (the HOTMAN(®) System). Baseline office systolic and diastolic BP averaged 156/92 mmHg. Hemodynamic measurements show that almost all patients (98.5%) presented at least one altered hemodynamic modulator: intravascular hypervolemia (96.4%) and/or hypoinotropy (42.5%) and/or vasoconstriction (49.3%). Eleven combinations of hemodynamic modulators were present in the study population, the most common being concomitant hypervolemia, hypoinotropy and vasoconstriction in 51(38%) patients. Six different hemodynamic states (pairs of mean arterial pressure and stroke index) were found. Data suggest that there is a strong relation between hypertension and abnormal hemodynamic modulators. This method might be helpful for treatment individualization of hypertensive patients.

As and S speciation in a submarine sulfide mine tailings deposit and its environmental significance: The study case of Portmán Bay (SE Spain).

The dumping of an estimated amount of 57 million tons of hazardous sulfide mine waste from 1957 to 1990 into Portmán's Bay (SE Spain) caused one of the most severe cases of persistent anthropogenic impact in Europe's costal and marine environments. The resulting mine tailings deposit completely infilled Portmán's Bay and extended seawards on the continental shelf, bearing high levels of metals and As. The present work, where Synchrotron XAS, XRF core scanner and other data are combined, reveals the simultaneous presence of arsenopyrite (FeAsS), scorodite (FeAsO4·2H2O), orpiment (As2S3) and realgar (AsS) in the submarine extension of the mine tailings deposit. In addition to arsenopyrite weathering and scorodite formation, the, the presence of realgar and orpiment is discussed, considering both potential sourcing from the exploited ores and in situ precipitation from a combination of inorganic and biologically mediated geochemical processes. Whereas the formation of scorodite relates to the oxidation of arsenopyrite, we hypothesize that the presence of orpiment and realgar is associated to scorodite dissolution and subsequent precipitation of these two minerals within the mine tailings deposit under moderately reducing conditions. The occurrence of organic debris and reduced organic sulfur compounds evidences the activity of sulfate-reducing bacteria (SRB) and provides a plausible explanation to the reactions leading to the formation of authigenic realgar and orpiment. The precipitation of these two minerals in the mine tailings, according to our hypothesis, has important consequences for As mobility since this process would reduce the release of As into the surrounding environment. Our work provides for the first time valuable hints on As speciation in a massive submarine sulfide mine tailings deposit, which is highly relevant for similar situations worldwide.

Novel APOB mutation in familial hypobetalipoproteinemia.

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Isolation and characterisation of antibacterial and anti-inflammatory compounds from Gnaphalium polycaulon.

ETHNO-PHARMACOLOGICAL RELEVANCE: Gnaphalium polycaulon commonly known as "cudweed" has been used throughout South America as an infusion to treat colds, bronchitis, fever or pneumonia. AIM OF THE STUDY: This study aimed to determine the antibacterial and anti-inflammatory activities of the aqueous extract of Gnaphalium polycaulon and identify the related compounds. MATERIALS AND METHODS: A bio-guided isolation of the active compounds of Gnaphalium polycaulon was carried out, selecting the fractions depending on their antibacterial, anti-inflammatory and cytotoxic activities. The antibacterial effect was studied against Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus and Streptococcus pneumoniae; and the anti-inflammatory study was performed by measuring the inhibition of NF-κB in BEAS-2B and IMR-90 cell cultures. RESULTS: Three compounds were obtained and characterised by nuclear magnetic resonance and mass spectrometry. These compounds are 2-(4-(1-H-tetrazol-1-yl) phenyl)-2-aminopropanoic acid (1), N-phenyl-4-(3-phenyl-1,2,4-thiadiazol-5-yl) piperazine-1-carboxamide (2) and N-(4-ethoxyphenyl)-4-(2-methylimidazo-[1,2-α] pyridine-3-yl) thiazol-2-amine (3). All compounds showed antibacterial activity with MIC values of 44.80-44.85, 0.017-0.021 and 0.0077-0.0079 µM, respectively, in the Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus and Streptococcus pneumoniae strains, while the positive control, Ofloxacin, had a MIC value of 27.64-27.67 µM. This was corroborated through a zone inhibition assay, where compound 3 (11.36-11.67 mm) was much more active than the positive control (Ofloxacin, 23.41-24.12 mm), while compounds 2 (26.47-27.64 mm) and 1 (28.39-29.76 mm) displayed similar antibacterial potential to the positive control. Finally, all the compounds presented NF-κB inhibitory activity, compounds 3 (IC50 = 0.0071-0.0073 µM) and 2 (IC50 = 0.016-0.019 µM) being the most promising. Compound 1 (IC50 = 44.24-44.26 µM) had less anti-inflammatory potential, being also the closest to the values displayed by the positive control (Celastrol, IC50 = 7.41 µM). CONCLUSION: In the present study, three compounds were isolated for the first time from the aqueous extract of Gnaphalium polycaulon. Their antibacterial and anti-inflammatory potential was tested and showcased.

[2022 Practice guidelines for the management of arterial hypertension of the Spanish Society of Hypertension]. / Guía práctica sobre el diagnóstico y tratamiento de la hipertensión arterial en España, 2022. Sociedad Española de Hipertensión - Liga Española para la Lucha contra la Hipertensión Arterial (SEH-LELHA).

Hypertension is the most important risk factor for global disease burden. Detection and management of hypertension are considered as key issues for individual and public health, as adequate control of blood pressure levels markedly reduces morbidity and mortality associated with hypertension. Aims of these practice guidelines for the management of arterial hypertension of the Spanish Society of Hypertension include offering simplified schemes for diagnosis and treatment for daily practice, and strategies for public health promotion. The Spanish Society of Hypertension assumes the 2018 European guidelines for management of arterial hypertension developed by the European Society of Cardiology and the European Society of Hypertension, although relevant aspects of the 2017 American College of Cardiology/American Heart Association guidelines and the 2020 International Society of Hypertension guidelines are also commented. Hypertension is defined as a persistent elevation in office systolic blood pressure ≥ 140 and/or diastolic blood pressure ≥ 90 mmHg, and assessment of out-of-office blood pressure and global cardiovascular risk are considered of key importance for evaluation and management of hypertensive patients. The target for treated blood pressure should be < 130/80 for most patients. The treatment of hypertension involves lifestyle interventions and drug therapy. Most people with hypertension need more than one antihypertensive drug for adequate control, so initial therapy with two drugs, and single pill combinations are recommended for a wide majority of hypertensive patients.

Anti-inflammatory, pro-proliferative and antimicrobial potential of the compounds isolated from Daemonorops draco (Willd.) Blume.

ETHNO-PHARMACOLOGICAL RELEVANCE: Daemonorops draco (D. draco) commonly known as "Dragon's blood" is one of the most used plants by Momok, Anak Dalam and Talang Mamak tribes from Indonesia as a remedy for wound healing. AIM OF THE STUDY: This study aimed to identify the extract, fractions and compounds responsible for the anti-inflammatory and pro-proliferative activities of the D. draco resin. Additionally, the antimicrobial activity against two bacteria and one yeast species was analysed. MATERIALS AND METHODS: Bio-guided isolation of compounds with anti-inflammatory, pro-proliferative and antimicrobial activities from the D. draco resin was carried out by measuring: the inhibition of NF-κB and activation of Nrf2 in THP-1, HaCaT, NIH-3T3 cells; cell proliferation in NIH-3T3 and HaCaT cells; and the antimicrobial effect on E. coli, S. aureus and C. albicans. RESULTS: Guided isolation by bioassay gave rise to the isolation and characterisation by nuclear magnetic resonance and mass spectrometry of three compounds: 1 (Bexarotene), 2 (Taspine) and 3 (2-hydroxy-1-naphthaldehyde isonicotinoyl hydrazone). All compounds showed NF-κB inhibitory activity with IC50 values of 0.10-0.13, 0.22-0.24 and 3.75-4.78 µM, respectively, while the positive control, Celastrol, had an IC50 of 7.96 µM. Likewise, all compounds showed an activating effect of Nrf2 with EC50 values of 5.34-5.43, 163.20-169.20 and 300.82-315.56 nM, respectively, while the positive control, CDDO-Me, had an EC50 of 0.11 nM. In addition, concerning the pro-proliferative activity, compound 1 (IC50 = 8.62-8.71 nM) showed a capacity of 100%, compound 2 (IC50 = 166-171 nM) showed a capacity of 75%, and compound 3 (IC50 = 469-486 nM) showed a capacity of 65%, while FSB 10% (positive control) had a pro-proliferative activity of 100% in the NIH3T3 cell lines (fibroblasts) and HaCaT (keratinocytes). Finally, all the compounds showed antimicrobial activity with MIC values of 0.12-0.16, 0.31-0.39 and 3.96-3.99 µM, respectively, in S. aureus, E. coli and C. albicans strains, while the positive control, Ofloxacin, had a MIC of 27.65 µM. CONCLUSION: This study managed to isolate, for the first time, three compounds (Bexarotene, Taspine and 2-hydroxy-1-naphthaldehyde isonicotinoyl hydrazone) from the resin of D. draco, with anti-inflammatory, and pro-proliferative as well as antimicrobial activities.

Motor deficit in the puerperium. Is neuroaxial analgesia the most frequent cause? / Déficit motor en el puerperio. ¿Es la analgesia neuroaxial la causa más frecuente?

Motor deficits of lower limbs during pregnancy and the puerperium are relatively frequent. They are usually attributed to complications which are associated with neuroaxial techniques performed by the anesthesiologist. But there are other possible causes, such as transient osteoporosis of the hips. Transient osteoporosis of pregnancy is a rare and self-limited pathology of unknown etiology. The most severe complication that can occur are pathological fractures, mainly in the load joints. This pathology usually occurs in the third trimester of pregnancy and is showed up with pain and functional impotence of the lower limb affected. We present the case of a 35-year-old woman, 40+3 weeks of pregnancy who starts labour. Normally functioning epidural catheter is placed and finally cesarean section is decided because failure to progress; 48h later the patient begins with functional impotence and pain in the lower left limb. MRI is performed, epidural hematoma is ruled out and osteopenia of the hips is proved. The patient is diagnosed with transient osteoporosis of pregnancy.

Calibrating high resolution XRF core scanner data to obtain absolute metal concentrations in highly polluted marine deposits after two case studies off Portmán Bay and Barcelona, Spain.

X-ray fluorescence core scanners (XRF-CS) allow rapid, non-destructive, continuous and high-resolution analyses of the elemental composition of sediment cores, providing large sets of semi-quantitative data. These data can be converted to quantitative data through the linear regression approach using a relatively small number of discrete samples analyzed by techniques providing absolute concentrations. However, a precise characterization of the errors associated with the linear function is required to evaluate the quality of the calibrated element concentrations. Here we present a calibration of high-resolution XRF-CS for six metals (Ti, Mn, Fe, Zn, Pb and As) measured in heavily contaminated marine deposits so that absolute concentrations are obtained. In order to determine the best linear function for conversion of XRF data, we have tested three regression methods: the ordinary least-squares (OLS), which does not consider the standard error in any variable (x and y), the weighted ordinary least-squares (WOLS), which considers the weighted standard error of the vertical variable (y), and the weighted least-squares (WLS), which incorporates the standard error in both x and y variables. We demonstrate that the calibration method presented in this study significantly increases the correlation coefficient, higher than r2 = 0.94, and reduces both the data deviation and the errors of the linear function for the three regression methods. Nonetheless, the WLS appears as the best regression method to minimize errors in the calibrated element concentrations. Our results open the door to use calibrated XRF-CS data to evaluate marine sediment pollution according to the levels of the strictest sediment quality guidelines (SQG) with errors lower than 0.4%-2% for Fe, 1%-7% for Zn, 3-14% for Pb and 5%-16% for Mn. They highlight the robustness of the calibration procedure here presented for accurate and precise quantification of element concentrations from XRF-CS semi-quantitative data.

Correction to: SEOM Clinical Guideline for treatment of muscle-invasive and metastatic urothelial bladder cancer (2016).

Due to a technical issue, the family name of the author.

The impact of hip fracture on health-related quality of life and activities of daily living: the SPARE-HIP prospective cohort study.

PURPOSE: The medical morbidity and mortality associated with neck of femur fractures is well-documented, whereas there is limited data for patient-reported outcomes. The aim of this study was to characterize the impact of neck of femur fractures on activities of daily living and patient-reported health-related quality of life. METHODS: Design and participants: Multicentric prospective cohort study. Consecutive sample patients with fragility hip fracture over 50 years old admitted in 48 hospitals in Spain. OUTCOMES: daily living activity function (Barthel Index) and health-related quality of life (EQ-5D) pre-fracture, admission to hospital and at 1- and 4-month follow-up post-fracture. STATISTICS: Barthel and EQ-5D over time are described as mean (SD) and median (interquartile range). RESULTS: A total of 997 patients were recruited at baseline with 4-month outcomes available for, and 856 patients (89.5%). Barthel Index fell from 78.77 (23.75) at baseline to 43.62 (19.86) on admission to hospital with the fracture. Scores partially recovered to 54.89 (25.40) and 64.09 (21.35) at 1- and 4-month post-fracture, respectively. EQ-5D fell from a median of 0.75 (0.47-0.91) to - 0.01 (- 0.03 to 0.51) on admission. Partial recovery was observed again to (0.51 (- 0.06 to 0.67)) and (0.60 (0.10 to 0.80)) at 1- and 4-month post-fracture, respectively. CONCLUSIONS: Hip fracture results in a large decline in the ability to perform activities of daily living and patient-reported health-related quality of life with only partial recovery amongst survivors 4-month post-fracture.

Anxiety and depression in women with breast cancer: Social and clinical determinants and influence of the social network and social support (DAMA cohort).

BACKGROUND: Anxiety and depression are the most prevalent mental health pathologies among women with breast cancer. Social, clinical and contextual variables may influence emotional stress among women with breast cancer. The aim of this work is to study anxiety and depression in a cohort of women diagnosed with breast cancer between 2003 and 2013 in Barcelona. We evaluate social and clinical determinants. METHODS: We performed a mixed cohort study (prospective and retrospective) using a convenience sample of women diagnosed with breast cancer. The information sources were the Hospital Anxiety and Depression questionnaire and hospital medical records. Dependent variables were anxiety and depression; independent variables were social class, age, employment status, tumour stage at diagnosis, time since diagnosis, social network and social support. We performed a descriptive analysis, a bivariate analysis, and a multivariate logistic regression analysis. RESULTS: A total of 1086 (48.6%) women had some degree of anxiety-related problem. As for depression. In the case of depression, 225 (15%) women had some degree of depression-related problem. Low emotional support and social isolation were clear risk factors for having more anxiety and depression. Low social class was also a risk factor, and age also played a role. DISCUSSION: Our results show that women long period of cancer survival have high prevalences of anxiety than depression, and this prevalence of anxiety is higher than the general population. In addition, we found inequalities between social classes and the isolation and social support are worse too in low social class.

Long-Term Follow-Up After Ablation of Intra-Atrial Re-Entrant Tachycardia in Patients With Congenital Heart Disease: Types and Predictors of Recurrence.

OBJECTIVES: The aim of this study was to analyze the long-term outcomes after intra-atrial re-entrant tachycardia (IART) ablation in congenital heart disease (CHD). BACKGROUND: IART increases morbidity and mortality in CHD patients. Radiofrequency catheter ablation has evolved into the first-line treatment of this complication. METHODS: This was a prospective, single-center study of all consecutive CHD patients who underwent first ablation for IART from January 2009 to December 2015 (n = 94, 39.4% female, age 36.55 ± 14.9 years, follow-up 44.45 ± 22.7 months). RESULTS: During the study period, 130 procedures were performed (n = 94, 1.21 ± 0.41 IART/patient). In the first procedure, 114 IART were ablated (short-term success 74.66%). Forty-nine percent of the patients whose IART was ablated had non-cavotricuspid isthmus (CTI)-related IART (alone or with concomitant CTI IART). After the first ablation, 54.3% maintained sinus rhythm (SR), 23.9% presented with recurrence of the ablated IART, 14.2% developed new IART, and 7.6% presented with atrial fibrillation (AF). After the second radiofrequency catheter ablation, 78.3% were in SR, 8.7% presented with AF, and 23.0% presented with IART (50% new IART). Multivariate predictors of recurrences were non-CTI IART (hazard ratio [HR]: 5.06; 95% confidence interval [CI]: 1.6 to 15.9; p = 0.006), PR interval >200 ms (HR: 4.02; 95% CI: 1.9 to 11.3; p = 0.009), AF induction (HR: 3.11; 95% CI: 1.1 to 9.1; p = 0.04). and previous AF (HR: 3.08; 95% CI: 1.1 to 9.3; p = 0.04). A risk score according multivariate model identified 3 levels of recurrence risk: 5.8%, 20%, and 58.5% (area under the receiver-operating characteristic curve 0.8 ± 0.03; p < 0.0001). CONCLUSIONS: Ablation of IART in CHD is a challenging procedure, but after ablation in experienced centers, SR can be maintained in 78.3%. Predictors of recurrences are non-CTI-related IART, long PR interval, and previous or induced AF. A risk score based on these factors can be useful for recurrence prediction.

HIF pathway and c-Myc as biomarkers for response to sunitinib in metastatic clear-cell renal cell carcinoma.

BACKGROUND: Clear-cell renal cell carcinoma (ccRCC) is a heterogeneous disease with a different clinical behavior and response to targeted therapies. Differences in hypoxia-inducible factor (HIF) expression have been used to classify von Hippel-Lindau gene (VHL)-deficient ccRCC tumors. c-Myc may be driving proliferation in HIF-2α-expressing tumors in a growth factor-independent manner. OBJECTIVE: To explore the HIF-1α, HIF-2α and c-Myc baseline expression as potential predictors of sunitinib outcome as well as the effectiveness and safety with sunitinib in patients with metastatic ccRCC in routine clinical practice. METHODS: This was an observational and prospective study involving 10 Spanish hospitals. Formalin-fixed, paraffin-embedded primary tumor samples from metastatic ccRCC patients who received sunitinib as first-line treatment were analyzed. Association between biomarker expression and sunitinib treatment outcomes was evaluated. Kaplan-Meier method was applied to measure progression-free survival (PFS) and overall survival. RESULTS: Eighty-one patients were included: median PFS was 10.8 months (95% CI: 7.4-13.5 months), median overall survival was 21.8 months (95% CI: 14.7-29.8 months) and objective response rate was 40.7%, with 7.4% of patients achieving a complete response. Molecular marker staining was performed in the 69 available tumor samples. Significant association with lower PFS was identified for double c-Myc/HIF-2α-positive staining tumors (median 4.3 vs 11.5 months, hazard ratio =2.64, 95% CI: 1.03-6.80, P=0.036). A trend toward a lower PFS was found in positive c-Myc tumors (median 5.9 vs 10.9 months, P=0.263). HIF-1α and HIF-2α expression levels were not associated with clinical outcome. CONCLUSION: These preliminary results suggest that predictive subgroups might be defined based on biomarkers such as c-Myc/HIF-2α. Further validation with more patients will be needed in order to confirm it. Outcomes with sunitinib in metastatic ccRCC in daily clinical practice resemble those obtained in clinical trials.

18F-FDG-PET/CT angiography in the diagnosis of infective endocarditis and cardiac device infection in adult patients with congenital heart disease and prosthetic material.

OBJECTIVES: Infective endocarditis (IE) and cardiac device infection (CDI) are a major complication in the growing number of patients with congenital heart disease (CHD) reaching adulthood. We aimed to evaluate the added value of 18F-FDG-PET/CT angiography (PET/CTA) in the diagnosis of IE-CDI in adults with CHD and intravascular or intracardiac prosthetic material, in whom echocardiography (ECHO) and modified Duke Criteria (DC) have limitations because of the patients' complex anatomy. METHODS: A prospective study was conducted in a referral center with multidisciplinary IE and CHD Units. PET/CTA and ECHO findings were compared in consecutive adult (≥18years) patients with CHD who have prosthetic material and suspected IE-CDI. The initial diagnosis using the DC and the diagnosis with the additional PET/CTA data (DC+PET/CTA) were compared with the final diagnostic consensus established by an expert team at three months. RESULTS: Between November-2012 and April-2017, 25 patients (15 men; median age 40years) were included. Cases were initially classified as definite in 8 (32%), possible in 14 (56%) and rejected in 3 (12%). DC+PET/CTA allowed reclassification of 12/14 (86%) cases initially identified as possible IE. The sensitivity, specificity, PPV, NPV, and accuracy of DC at IE suspicion were 39.1%/83.3%/90.4%/25.5%/61.2%, respectively. The diagnostic performance increased significantly with addition of PET/CTA data: 87%/83.3%/95.4%/61.5%/85.1%, respectively. PET/CTA also provided an alternative diagnosis in 3 patients with rejected IE, and detected pulmonary embolisms in 3 patients. CONCLUSIONS: PET/CTA was a useful diagnostic tool in the complex group of adult patients with CHD who have cardiac or intravascular prosthetic material and suspected IE or CDI, providing added diagnostic value to the modified DC (increased sensitivity) and improving case classification.