Transcultural adaptation to Spain of the CDPQOL questionnaire specific for coeliac children.

This study aimed to translate, cross-culturally adapt, and validate the CDPQOL questionnaire, a coeliac disease (CD)-specific paediatric health-related quality of life (HRQoL) instrument (CDPQOL), in Spanish children with CD. The CDPQOL questionnaire has two versions for children aged 8-12 and 13-18. Translation and linguistic validation were performed following an international consensus process. Internal consistency was calculated using Cronbach's alpha and McDonald's omega coefficients, and convergent validity was assessed with average variance extracted (AVE). Confirmatory factor analysis (CFA) and exploratory factor analysis (EFA), when necessary, were carried out to assess the construct validity. A total of 235 children were included. In the 8-12 age group, a change in the distribution of items to a new structure of three dimensions (negative emotions, food feelings and social interaction) was required. In this new model, CFA supported the fit of the model (χ2/gl = 1.79, RMSEA = 0.077 (IC 95% 0.05-0.100), CFI = 0.969, TLI 0.960, SRMR = 0.081) and Cronbach's alpha and McDonald's omega coefficients were > 0.7 in all three dimensions. In the 13-18 age group, CFA showed that all fit indexes were acceptable (χ2/gl = 1.702, RMSEA = 0.102 (IC 95% 0.077-0.127), p < 0.001, CFI = 0.956, TLI = 0.947, SRMR = 0.103) and Cronbach's alpha and McDonald's omega coefficients were > 0.7 in all three dimensions, except for uncertainty dimension. Conclusions: The Spanish version of the CDPQOL questionnaire is a useful instrument to assess quality of life in coeliac children whose native language was Spanish spoken in Spain, with changes in item distribution in the younger age group questionnaire. What is Known: • The first specific questionnaire for coeliac children, Dutch Coeliac Disease Questionnaire (CDDUX), which focuses on diet, was translated into Spanish and validated allowing to evaluate the HRQoL of Spanish coeliac children. • Spanish Children and parents feel the disease had no substantial negative impacts on patient HRQoL using this questionnaire, similar to that observed with other countries. What is New: • The age specific for CD children (CDPQOL) was elaborated in the USA and focuses on other aspects not evaluated by CDDUX such as emotional and social issues related to living with CD. • The CDPQOL was translated into Spanish and validated allowing it to be used to assess Spanish coeliac children's QoL.

Incidence, clinical, risk factors and outcomes of Guillain-Barré in Covid-19.

We diagnosed 11 Guillain-Barré syndrome (GBS) cases among 71,904 COVID patients attended at 61 Spanish emergency departments (EDs) during the 2-month pandemic peak. The relative frequency of GBS among ED patients was higher in COVID (0.15‰) than non-COVID (0.02‰) patients (odds ratio [OR] = 6.30, 95% confidence interval [CI] = 3.18-12.5), as was the standardized incidence (9.44 and 0.69 cases/100,000 inhabitant-years, respectively, OR = 13.5, 95% CI = 9.87-18.4). Regarding clinical characteristics, olfactory-gustatory disorders were more frequent in COVID-GBS than non-COVID-GBS (OR = 27.59, 95% CI = 1.296-587) and COVID-non-GBS (OR = 7.875, 95% CI = 1.587-39.09) patients. Although COVID-GBS patients were more frequently admitted to intensive care, mortality was not increased versus control groups. Our results suggest SARS-CoV-2 could be another viral infection causing GBS. ANN NEUROL 2021;89:598-603.

Development and validation of the food allergy severity score.

BACKGROUND: The heterogeneity and lack of validation of existing severity scores for food allergic reactions limit standardization of case management and research advances. We aimed to develop and validate a severity score for food allergic reactions. METHODS: Following a multidisciplinary experts consensus, it was decided to develop a food allergy severity score (FASS) with ordinal (oFASS) and numerical (nFASS) formats. oFASS with 3 and 5 grades were generated through expert consensus, and nFASS by mathematical modeling. Evaluation was performed in the EuroPrevall outpatient clinic cohort (8232 food reactions) by logistic regression with request of emergency care and medications used as outcomes. Discrimination, classification, and calibration were calculated. Bootstrapping internal validation was followed by external validation (logistic regression) in 5 cohorts (3622 food reactions). Correlation of nFASS with the severity classification done by expert allergy clinicians by Best-Worst Scaling of 32 food reactions was calculated. RESULTS: oFASS and nFASS map consistently, with nFASS having greater granularity. With the outcomes emergency care, adrenaline and critical medical treatment, oFASS and nFASS had a good discrimination (receiver operating characteristic area under the curve [ROC-AUC]>0.80), classification (sensitivity 0.87-0.92, specificity 0.73-0.78), and calibration. Bootstrapping over ROC-AUC showed negligible biases (1.0 × 10-6 -1.23 × 10-3 ). In external validation, nFASS performed best with higher ROC-AUC. nFASS was strongly correlated (R 0.89) to best-worst scoring of 334 expert clinicians. CONCLUSION: FASS is a validated and reliable method to measure severity of food allergic reactions. The ordinal and numerical versions that map onto each other are suitable for use by different stakeholders in different settings.

Accuracy of 18F-FDG PET/CT in patients with the suspicion of cardiac implantable electronic device infections.

BACKGROUND: Utility of 18F-FDG PET/CT in diagnosing infective endocarditis (IE) associated with cardiac implantable electronic devices (CIEDs) is not well established. Current ESC guidelines recommend the use of FDG-PET imaging in patients with CIEDs and positive blood cultures, but the number of studies evaluating the diagnostic performance of FDG-PET imaging in these patients remain limited. Our objective was to assess the diagnostic yield of 18F-FDG PET/CT in patients with suspected CIED infections, differentiating between pocket infection (PI) and lead infection (CIED-IE). METHODS AND RESULTS: From 2013 to 2018, all patients (n = 63) admitted to a hospital with suspected CIED infection were prospectively recruited, undergoing a diagnostic work-up including a PET/CT. Explanted devices and material from the pocket were cultured. 14 cases corresponded to isolated PI and 13 were categorized as CIED-IE. Considering radionuclide uptake in the intracardiac portion of the lead, sensitivity and specificity of PET/CT for CIED-IE were 38.5% and 98.0%, respectively. Positive (19.2) and negative (0.6) likelihood ratio values, suggest that a positive PET/CT is much more probable to correspond to a patient with CIED-IE, whereas it is not possible to exclude this diagnosis when negative. For PI, sensitivity and specificity were 72.2% and 95.6%, respectively. CONCLUSIONS: The yield of 18F-FDG PET/CT for suspected CIED infections differs depending on the site of infection. Due to very high specificity but poor sensitivity, negative studies must be interpreted with caution if the suspicion of CIED-IE is high.

Vascular Injury After Stenting　- Insights of Systemic Mechanisms of Vascular Repair.

BACKGROUND: The role of circulating progenitor cells (CPC) in vascular repair following everolimus-eluting stent (EES) implantation is largely unknown. The aim of the study was to investigate the relationship between temporal variation in CPC levels following EES implantation and the degree of peri-procedural vascular damage, and stent healing, as measured by optical coherence tomography (OCT).Methods and Results: CPC populations (CD133+/KDR+/CD45low) included patients with stable coronary artery disease undergoing stent implantation, and were evaluated using a flow cytometry technique both at baseline and at 1 week. OCT evaluation was performed immediately post-implantation to quantify the stent-related injury and at a 9-month follow up to assess the mid-term vascular response. Twenty patients (mean age 66±9 years; 80% male) with EES-treated stenoses (n=24) were included in this study. Vascular injury score was associated with the 1-week increase of CD133+/KDR+/CD45low (ß 0.28 [95% CI 0.15; 0.41]; P<0.001) and with maximum neointimal thickness at a 9-month follow up (ß 0.008 [95% CI 0.0004; 0.002]; P=0.04). Inverse relationships between numbers of uncoated and apposed struts for the 9-month and the 1-week delta values of CD133+/KDR+/CD45low (ß -12.53 [95% CI -22.17; -2.90]; P=0.011), were also found. CONCLUSIONS: The extent of vessel wall injury influences early changes in the levels of CPC and had an effect on mid-term vascular healing after EES implantation. Early CPC mobilisation was associated with mid-term strut coverage.

Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial.

Rationale: Recurrent wheezing in children represents a severe public health concern. Wheezing attacks (WA), mainly associated with viral infections, lack effective preventive therapies. Objectives: To evaluate the efficacy and safety of mucosal sublingual immunotherapy based on whole inactivated bacteria (MV130) in preventing WA in children. Methods: A Phase 3 randomized, double-blind, placebo-controlled, parallel-group trial including a cohort of 120 children <3 years old with ⩾3 WA during the previous year was conducted. Children with a positive skin test to common aeroallergens in the area where the clinical trial was performed were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within 1 year after the first dose comparing MV130 and placebo. Measurements and Main Results: There was a significant lower number of WA in MV130 versus the placebo group, 3.0 (interquartile range [IQR], 2.0-4.0) versus 5.0 (IQR, 3.0-7.0) (P < 0.001). As secondary outcomes, a decrease in the duration of WA and a reduction in symptoms and medication scores in the MV130 versus placebo group were found. No adverse events were reported related to the active treatment. Conclusions: Mucosal bacterial immunotherapy with MV130 shows safety and clinical efficacy against recurrent WA in children.Clinical trial registered with www.clinicaltrials.gov (NCT01734811).

Capacitive resistive monopolar radiofrequency at 448 kHz plus exercising versus exercising alone for subacromial pain: A sham-controlled randomized clinical trial.

OBJECTIVE: To investigate the effectiveness of thermal and sub-thermal capacitive-resistive monopolar radiofrequency at 448 kHz plus exercising compared to sham radiofrequency plus exercising on pain, functionality, and quality of life in patients with subacromial pain. DESIGN: Randomized, controlled, parallel, double-blind, three-arm clinical trial. SETTING: Hospital and Primary Care. SUBJECTS: Eighty-one participants with subacromial pain in three intervention groups. INTERVENTIONS: Three interventions with capacitive-resistive radiofrequency (thermal, sub-thermal, and sham) over 9 sessions (3 per week) plus an exercising protocol identical for all groups over 15 sessions (5 per week). OUTCOME MEASURES: Visual analogue scale and pressure pain threshold for pain, Shoulder Pain and Disability Index and Quick-Disabilities of the Arm, Shoulder and Hand for functionality, and quality of life via the European Quality of Life-Five Dimensions were assessed at baseline, immediately posttreatment, and 1 month and 3 months post-intervention. RESULTS: No between-group differences were found in the pain visual analogue scale (F = 1.0; P = 0.37), Shoulder Pain and Disability Index (F = 1.0; P = 0.36), European Quality of Life-Five Dimensions (F = 0.76; P = 0.47), and pressure pain (F = 0.14; P = 0.86) outcomes, with a statistical power < 0.30 for all comparisons. Between-group differences were found in the Quick-Disabilities of the Arm, Shoulder and Hand (F = 3.4; P < 0.038), with an improvement of -14.1 points (confidence interval at 95% (95% CI) -28.1 to -0.1) in the thermal versus the sham group at 1 month follow-up. The mobility dimension of European Quality of Life-Five Dimensions improved in a greater proportion of participants in the thermal group (22.2% thermal, 7.4% sub-thermal, and 0.0% sham; P = 0.02). CONCLUSION: Adding thermal radiofrequency to exercising can further improve slightly functionality and mobility in people with subacromial pain in the short term, but not pain perception. Future studies with larger sample sizes are warranted to increase statistical power.

Improved short-term outcomes of kidney transplants in controlled donation after the circulatory determination of death with the use of normothermic regional perfusion.

Normothermic regional perfusion (NRP) allows the in situ perfusion of organs with oxygenated blood in donation after the circulatory determination of death (DCDD). We aimed at evaluating the impact of NRP on the short-term outcomes of kidney transplants in controlled DCDD (cDCDD). This is a multicenter, nationwide, retrospective study comparing cDCDD kidneys obtained with NRP versus the standard rapid recovery (RR) technique. During 2012-2018, 2302 cDCDD adult kidney transplants were performed in Spain using NRP (n = 865) or RR (n = 1437). The study groups differed in donor and recipient age, warm, and cold ischemic time and use of ex situ machine perfusion. Transplants in the NRP group were more frequently performed in high-volume centers (≥90 transplants/year). Through matching by propensity score, two cohorts with a total of 770 patients were obtained. After the matching, no statistically significant differences were observed between the groups in terms of primary nonfunction (p = .261) and mortality at 1 year (p =  .111). However, the RR of kidneys was associated with a significantly increased odds of delayed graft function (OR 1.97 [95% CI 1.43-2.72]; p < .001) and 1-year graft loss (OR 1.77 [95% CI 1.01-3.17]; p = .034). In conclusion, compared with RR, NRP appears to improve the short-term outcomes of cDCDD kidney transplants.

Incidence and outcomes of hospital treated acute myocarditis from 2003 to 2015 in Spain.

BACKGROUND: There are no data on population-based epidemiological changes in acute myocarditis in Europe. Our aim was to evaluate temporal trends in incidence, clinical features and outcomes of hospital treated acute myocarditis (AM) in Spain from 2003 to 2015. METHODS: We conducted a retrospective longitudinal study using information of all hospital discharges of the Spanish National Health System. All episodes with a discharge diagnosis of AM from 1 January 2003 to 31 December 2015 were included. The risk-standardized in-hospital mortality ratio (RSMR) was calculated using a multilevel risk-adjustment model developed by the Medicare and Medicaid Services. Temporal trends for in-hospital mortality were modelled using Poisson regression analysis. RESULTS: A total of 11 147 episodes of AM were analysed, most of them idiopathic (94.7%). The rate of AM discharges increased along the period, from 13 to 30/million inhabitants/year (2003-2015), and this increase was statistically significant when weighted by age and sex (incidence rate ratio, IRR 1.06, 95% CI 1.04-1.08, P = .001). In-hospital crude mortality rate was 3.1%, diminishing significantly along 2003-2015 (IRR 0.95, 95% CI 0.92-0.99, P = .02). RSMR also significantly diminished along the period (IRR 0.95, 95% CI 0.92-0.99, P = .01). Renal failure (OR 7.03, 5.38-9.18, P = .001), liver disease (OR 4.61, 2.59-8.21, P = .001), pneumonia (OR 4.13, 2.75-6.20, P = .001) and heart failure (OR 1.91, 95% CI 1.47-2.47, P = .001) were the strongest independent factors associated with in-hospital mortality. CONCLUSIONS: Acute myocarditis is an uncommon entity, although hospital discharges have increased in Spain along the study period. Most of AM were idiopathic. Adjusted mortality was low and seemed to decrease from 2003 to 2015, suggesting an improvement in AM management.

Thirteen-year trends in hospitalization and outcomes of patients with heart failure in Spain.

BACKGROUND: Heart failure is one of the most pressing current public health concerns. However, in Spain there is a lack of population data. We aimed to examine thirteen-year nationwide trends in heart failure hospitalization, in-hospital mortality and 30-day readmission rates in Spain. METHODS: We conducted a retrospective observational study of patients discharged with the principal diagnosis of heart failure from The National Health System' acute hospitals during 2003-2015. The source of the data was the Minimum Basic Data Set. Temporal trends were modelled using Poisson regression analysis. The risk-standardized in-hospital mortality ratio was calculated using a multilevel risk adjustment logistic regression model. RESULTS: A total of 1 254 830 episodes of heart failure were selected. Throughout 2003-2015, the number of hospital discharges with principal diagnosis of heart failure increased by 61%. Discharge rates weighted by age and sex increased during the period [incidence rate ratio (IRR): 1.03; 95% confidence interval (95% CI): 1.03-1.03; P < .001)], although this increase was motivated by the increase in older age groups (≥75 years old). The crude mortality rate diminished (IRR: 0.99; 95% CI: 0.98-1, P < .001), but 30-day readmission rate increased (IRR: 1.05; 95% CI: 1.04-1.06; P < .001). The risk-standardized in-hospital mortality ratio did not change throughout the study period (IRR: 0.997; 95% CI: 0.992-1; P = .32). CONCLUSIONS: From 2003 to 2015, heart failure admission rates increased significantly in Spain as a consequence of the sustained increase of hospitalization in the population ≥75 years. 30-day readmission rates increased, but the risk-standardized in-hospital mortality ratio did not significantly change for the same period.

Predicting food allergy: The value of patient history reinforced.

BACKGROUND: EAACI guidelines emphasize the importance of patient history in diagnosing food allergy (FA) and the need for studies investigating its value using standardized allergy-focused questionnaires. OBJECTIVE: To determine the contribution of reaction characteristics, allergic comorbidities and demographics to prediction of FA in individuals experiencing food-related adverse reactions. METHODS: Adult and school-age participants in the standardized EuroPrevall population surveys, with self-reported FA, were included. Penalized multivariable regression was used to assess the association of patient history determinants with "probable" FA, defined as a food-specific case history supported by relevant IgE sensitization. RESULTS: In adults (N = 844), reproducibility of reaction (OR 1.35 [95% CI 1.29-1.41]), oral allergy symptoms (OAS) (4.46 [4.19-4.75]), allergic rhinitis (AR) comorbidity (2.82 [2.68-2.95]), asthma comorbidity (1.38 [1.30-1.46]) and male sex (1.50 [1.41-1.59]) were positively associated with probable FA. Gastrointestinal symptoms (0.88 [0.85-0.91]) made probable FA less likely. The AUC of a model combining all selected predictors was 0.85 after cross-validation. In children (N = 670), OAS (2.26 [2.09-2.44]) and AR comorbidity (1.47 [CI 1.39-1.55]) contributed most to prediction of probable FA, with a combined cross-validation-based AUC of 0.73. When focusing on plant foods, the dominant source of FA in adults, the pediatric model also included gastrointestinal symptoms (inverse association), and the AUC increased to 0.81. CONCLUSIONS: In both adults and school-age children from the general population, reporting of OAS and of AR comorbidity appear to be the strongest predictors of probable FA. Patient history particularly allows for good discrimination between presence and absence of probable plant FA.

COVID-19 anosmia and gustatory symptoms as a prognosis factor: a subanalysis of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry.

Olfactory and gustatory dysfunctions (OGD) are a frequent symptom of coronavirus disease 2019 (COVID-19). It has been proposed that the neuroinvasive potential of the novel SARS-CoV-2 could be due to olfactory bulb invasion, conversely studies suggest it could be a good prognostic factor. The aim of the current study was to investigate the prognosis value of OGD in COVID-19. These symptoms were recorded on admission from a cohort study of 5868 patients with confirmed or highly suspected COVID-19 infection included in the multicenter international HOPE Registry (NCT04334291). There was statistical relation in multivariate analysis for OGD in gender, more frequent in female 12.41% vs 8.67% in male, related to age, more frequent under 65 years, presence of hypertension, dyslipidemia, diabetes, smoke, renal insufficiency, lung, heart, cancer and neurological disease. We did not find statistical differences in pregnant (p = 0.505), patient suffering cognitive (p = 0.484), liver (p = 0.1) or immune disease (p = 0.32). There was inverse relation (protective) between OGD and prone positioning (0.005) and death (< 0.0001), but no with ICU (0.165) or mechanical ventilation (0.292). On univariable logistic regression, OGD was found to be inversely related to death in COVID-19 patients. The odds ratio was 0.26 (0.15-0.44) (p < 0.001) and Z was - 5.05. The presence of anosmia is fundamental in the diagnosis of SARS.CoV-2 infection, but also could be important in classifying patients and in therapeutic decisions. Even more knowing that it is an early symptom of the disease. Knowing that other situations as being Afro-American or Latino-American, hypertension, renal insufficiency, or increase of C-reactive protein (CRP) imply a worse prognosis we can make a clinical score to estimate the vital prognosis of the patient. The exact pathogenesis of SARS-CoV-2 that causes olfactory and gustative disorders remains unknown but seems related to the prognosis. This point is fundamental, insomuch as could be a plausible way to find a treatment.

Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19.

BACKGROUND: the coronavirus disease 2019 (COVID-19) is characterized by poor outcomes and mortality, particularly in older patients. METHODS: post hoc analysis of the international, multicentre, 'real-world' HOPE COVID-19 registry. All patients aged ≥65 years hospitalised for COVID-19 were selected. Epidemiological, clinical, analytical and outcome data were obtained. A comparative study between two age subgroups, 65-74 and ≥75 years, was performed. The primary endpoint was all cause in-hospital mortality. RESULTS: about, 1,520 patients aged ≥65 years (60.3% male, median age of 76 [IQR 71-83] years) were included. Comorbidities such as hypertension (69.2%), dyslipidaemia (48.6%), cardiovascular diseases (any chronic heart disease in 38.4% and cerebrovascular disease in 12.5%), and chronic lung disease (25.3%) were prevalent, and 49.6% were on ACEI/ARBs. Patients aged 75 years and older suffered more in-hospital complications (respiratory failure, heart failure, renal failure, sepsis) and a significantly higher mortality (18.4 vs. 48.2%, P < 0.001), but fewer admissions to intensive care units (11.2 vs. 4.8%). In the overall cohort, multivariable analysis demonstrated age ≥75 (OR 3.54), chronic kidney disease (OR 3.36), dementia (OR 8.06), peripheral oxygen saturation at admission <92% (OR 5.85), severe lymphopenia (<500/mm3) (OR 3.36) and qSOFA (Quick Sequential Organ Failure Assessment Score) >1 (OR 8.31) to be independent predictors of mortality. CONCLUSION: patients aged ≥65 years hospitalised for COVID-19 had high rates of in-hospital complications and mortality, especially among patients 75 years or older. Age ≥75 years, dementia, peripheral oxygen saturation <92%, severe lymphopenia and qSOFA scale >1 were independent predictors of mortality in this population.

Complications and outcomes of cats with coxofemoral luxation treated with hip toggle stabilization using ultrahigh-molecular-weight-polyethylene or nylon (2009-2018): 48 cats.

OBJECTIVE: To report overall rate and type of complications and outcomes of cats with coxofemoral luxation managed with hip toggle stabilization (HTS), to compare rate of postoperative complications and outcomes of cats treated with ultrahigh-molecular-weight-polyethylene (UHMWPE) or nylon, and to identify risk factors for reluxation and non-excellent outcomes. STUDY DESIGN: Multi-institutional retrospective cohort study. SAMPLE POPULATION: Forty-eight client-owned cats. METHODS: Medical records of cats that underwent HTS from 2008-2018 using UHMWPE or nylon were reviewed. Univariable and multivariable logistic regression was performed to assess for factors associated with reluxation and non-excellent outcome. Final outcome was obtained from owner questionnaire. RESULTS: Intraoperative and postoperative complications were recorded in two (4.2%) and 11 (24.4%) cats, respectively. The most common postoperative complication was reluxation (n = 5 [11.1%]). Outcome was classified as excellent in 81.1% and good in 16.2% of cats after a median of 445.5 days (range, 53-3720). No difference in rate of complications or outcomes was identified between UHMWPE and nylon. Performance of additional orthopedic procedures, occurrence of intraoperative complications, and non-performance of capsulorrhaphy were associated with reluxation. Performance of additional non-hip procedures (orthopedic/nonorthopedic) was associated with non-excellent outcome. CONCLUSION: Hip toggle stabilization was associated with a low rate of intraoperative complications and reluxation and excellent long-term outcomes in most cats. No difference in rate of postoperative complications or outcomes of cats treated using UHMWPE or nylon was identified. Cats that underwent additional orthopedic procedures had greater risk of reluxation. CLINICAL SIGNIFICANCE: Hip toggle stabilization is an effective technique for management of coxofemoral luxation in cats. Comparable results are expected using UHMWPE or nylon.

Uncontrolled donation after circulatory death: A cohort study of data from a long-standing deceased-donor kidney transplantation program.

Despite good long-term outcomes of kidney transplants from controlled donation after circulatory death (DCD) donors, there are few uncontrolled DCD (uDCD) programs. This longitudinal study compares outcomes for all uDCD (N = 774) and all donation after brain death (DBD) (N = 613) kidney transplants performed from 1996 to 2015 at our center. DBD transplants were divided into those from standard-criteria (SCD) (N = 366) and expanded-criteria (N = 247) brain-dead donors (ECD). One-, 5-, and 10-year graft survival rates were 91.7%, 85.7%, and 80.6% for SCD; 86.0%, 75.8%, and 61.4% for ECD; and 85.1%, 78.1%, and 72.2% for uDCD, respectively. Graft survival was worse in recipients of uDCD kidneys than of SCD (P = .004) but better than in transplants from ECD (P = .021). The main cause of graft loss in the uDCD transplants was primary nonfunction. Through logistic regression, donor death due to pulmonary embolism (OR 4.31, 95% CI 1.65-11.23), extrahospital CPR time ≥75 minutes (OR1.94, 95%CI 1.18-3.22), and in-hospital CPR time ≥50 minutes (OR 1.79, 95% CI 1.09-2.93) emerged as predictive factors of primary nonunction. According to the outcomes of our long-standing kidney transplantation program, uDCD could help expand the kidney donor pool.

Long-term impact of diabetes in patients with ST-segment elevation myocardial infarction: Insights from the EXAMINATION randomized trial.

BACKGROUND: Long-term outcomes of diabetic patients suffering from ST-segment elevation myocardial infarction (STEMI) and treated with second-generation drug-eluting stent have been scarcely evaluated. The aim of this posthoc subanalysis of the EXAMINATION trial was to compare 5-year outcomes according to the presence of diabetes mellitus. METHODS: From a total of 1,497 patients included in the trial, 258 were diabetics (n = 137, received everolimus-eluting stent (EES) and n = 121 bare-metal stent (BMS); whereas 1,239 were nondiabetics (n = 613 treated with EES and n = 626 with BMS). Patient-oriented combined endpoint (POCE) defined as all-cause death, any MI or any revascularization, and other clinical parameters were collected up to 5-years. All results were adjusted for various potential confounders. RESULTS: At 5-years, patients with diabetes showed similar rates of POCE between diabetics treated with EES and those treated with BMS (32.8% vs. 32.2%; p = 0.88). However, rates of TLR were significantly lower in the EES group (4.4% vs. 9.9%; HR 0.52 (0.29-0.94); P = 0.03). In non-diabetics, the use of EES was associated with a significant improvement in all-clinical parameters except for MI rate: POCE: [10.0% vs. 12.6%; HR 0.78(0.62-0.98); P = 0.038], all cause death: [7.0% vs. 12.1%; HR 0.62(0.42-0.90); P = 0.014], and [TLR: 4.2 vs. 6.7; HR 0.60 (0.37-0.98); P = 0.04]. Overall, diabetics showed higher rate of POCE at 5-years (32.6% vs. 21.5% in nondiabetics HR1.45[1.03-2.04];p = 0.03) driven by increased rates of MI and the need for revascularization that occurred in coronary segments remote from target lesions [2.7% vs. 1.1%; HR: 2.27 (1.12-5.23); P = 0.02 and 14% vs. 6.2%; HR: 2.11 (1.38-3.22); P = 0.001, respectively]. CONCLUSIONS: Diabetics had worse clinical outcomes than nondiabetics after STEMI mainly due to atherosclerosis progression. At 5-years, the treatment with EES did not reduce the rate of POCE in diabetics but reduced the need for revascularization compared with BMS.

Cohort study showed that growth rate increment has not been enough to prevent growth retardation of preterm infants and raised concerns about unbalanced growth.

AIM: We describe the postnatal weight gain, linear and head growth trends of surviving preterm infants from 2005 to 2017. METHODS: Multicentre cohort study, including surviving preterm infants <32 weeks (n = 21 084), from the Spanish Neonatal Network database, without major congenital malformations who were less than 50 weeks postmenstrual age at discharge. Outcomes were weight gain (g/kg/day), linear and head growth (cm/week) and changes in weight, length and head circumference z-scores from birth to discharge. The study period was divided into 2005-8, 2009-11, 2012-14 and 2015-17. RESULTS: Weight gain, linear growth and head growth were slightly higher in 2015-2017 than in 2005-2008: 12.2 ± 2.6 to 13.1 ± 2.5 g/kg/day, 0.98 ± 0.6 to 1.03 ± 0.6 cm/week and 0.76 ± 0.2 to 0.77 ± 0.3 cm/week, respectively. It was associated with a decreased fall in weigh, length and head circumference z-scores from birth to discharge (-1.32 ± 0.9 to -1.01 ± 0.84, -1.38 ± 1.2 to -1.18 ± 1.2 and -0.41 ± 1.2 to -0.33 ± 1.3, respectively). CONCLUSION: Postnatal growth restriction remained a common complication of prematurity despite some increment over the last years. Growth disproportionality seemed to be worsening as weight gain was increased more than linear growth.

Indocyanine green angiography findings in patients with neovascular age-related macular degeneration refractory to ranibizumab switched to aflibercept.

PURPOSE: To describe indocyanine green angiography (ICGA) and visual acuity (VA) results in patients with neovascular age-related macular degeneration (nAMD) refractory to ranibizumab switched to aflibercept. METHODS: This study is a prospective interventional case series. Thirty-two eyes of 32 patients with nAMD showing a poor response after at least 24 months of ranibizumab were switched to aflibercept. Twenty eyes had type I choroidal neovascularization (CNV group), and 12 eyes had polypoidal choroidal vasculopathy (PCV group). After an initial loading dose of three monthly aflibercept injections, treatment was continued on a treat-and-extend basis. ICGA was performed just before the first aflibercept injection (baseline) and 12 and 24 months later. The variables recorded were: closure of polyps and lesion area, VA, number of aflibercept injections, dry macula, and pigment epithelium detachment. RESULTS: The following means were recorded in the CNV and PCV groups, respectively: number of ranibizumab injections 20.4 ± 11.2 and 22.4 ± 12.9 (p = 0.740); baseline VA (before aflibercept) 73.2 ± 9.1 and 70.3 ± 13.7 letters (p = 0.654); and final VA 73.0 ± 7.6 and 69.3 ± 15.6 letters (p = 0.509). VA remained stable (p = 0.761 and 0.964) after 15.5 ± 3 and 15.1 ± 3.5 aflibercept injections (p = 0.244). At 24 months, dry macula was noted in 40 to 50% of the eyes (p = 0.620). Complete resolution of polyps was observed in 58% at 12 months and 92% at 24 months. CONCLUSIONS: In patients with nAMD refractory to ranibizumab, aflibercept was effective at maintaining VA and closing numerous polyps. In half of the patients, dry macula was observed at 24 months.

Predicting Cardiovascular Events in Familial Hypercholesterolemia: The SAFEHEART Registry (Spanish Familial Hypercholesterolemia Cohort Study).

BACKGROUND: Although risk factors for atherosclerotic cardiovascular disease (ASCVD) in familial hypercholesterolemia (FH) have been described, models for predicting incident ASCVD have not been reported. Our aim was to use the SAFEHEART registry (Spanish Familial Hypercholesterolemia Cohort Study) to define key risk factors for predicting incident ASCVD in patients with FH. METHODS: SAFEHEART is a multicenter, nationwide, long-term prospective cohort study of a molecularly defined population with FH with or without previous ASCVD. Analyses to define risk factors and to build a risk prediction equation were developed, and the risk prediction equation was tested for its ability to discriminate patients who experience incident ASCVD from those who did not over time. RESULTS: We recruited 2404 adult patients with FH who were followed up for a mean of 5.5 years (SD, 3.2 years), during which 12 (0.5%) and 122 (5.1%) suffered fatal and nonfatal incident ASCVD, respectively. Age, male sex, history of previous ASCVD, high blood pressure, increased body mass index, active smoking, and low-density lipoprotein cholesterol and lipoprotein(a) levels were independent predictors of incident ASCVD from which a risk equation with a Harrell C index of 0.85 was derived. The bootstrap resampling (100 randomized samples) of the original set for internal validation showed a degree of overoptimism of 0.003. Individual risk was estimated for each person without an established diagnosis of ASCVD before enrollment in the registry by use of the SAFEHEART risk equation, the modified Framingham risk equation, and the American College of Cardiology/American Heart Association ASCVD Pooled Cohort Risk Equations. The Harrell C index for these models was 0.81, 0.78, and 0.8, respectively, and differences between the SAFEHEART risk equation and the other 2 were significant (P=0.023 and P=0.045). CONCLUSIONS: The risk of incident ASCVD may be estimated in patients with FH with simple clinical predictors. This finding may improve risk stratification and could be used to guide therapy in patients with FH. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT02693548.

Spanish population-study shows that healthy late preterm infants had worse outcomes one year after discharge than term-born infants.

AIM: This study assessed the risks associated with healthy late preterm infants and healthy term-born infants using national hospital discharge records. METHOD: We used the minimum basic data set of the Spanish hospital discharge records database for 2012-2013 to analyse the hospitalisation of newborn infants. The outcomes were in-hospital mortality and hospital re-admissions at 30 days and one year after their first discharge. RESULTS: Of the 95 011 newborn infants who were discharged, 2940 were healthy late preterm infants, born at 34 + 0-36 + 6 weeks, and 18 197 were healthy term-born infants. The mean and standard deviation (SD) length of hospital stay were 6.0 (4.5) days in late preterm infants versus 2.8 (1.3) days in term-born infants (p < 0.001). Re-admissions were also higher in the late preterm group at 30 days (9.0% versus 4.4%) and one year (22.0% versus 12.4) (p < 0.001). The relative risk for death at one year was 4.9 in the late preterm group, when compared to the term-born infants (p = 0.026). CONCLUSION: The hospital discharge codes for otherwise healthy newborn preterm infants were associated with significantly worse 30-day and one-year outcomes when their re-admission and mortality rates were compared with healthy term-born newborn infants.