Expanding congenital abnormalities of the kidney and urinary tract (CAKUT) genetics: basonuclin 2 (BNC2) and lower urinary tract obstruction

his work was supported by FIS PI16/02057, PI19/00588, PI19/00815, DTS18/00032, REDinREN RD016/0009 Fondos FEDER, ERA-PerMed-JTC2018 (KIDNEY ATTACK AC18/00064 and PERSTIGAN AC18/00071), Sociedad Española de Nefrología, FRIAT, and Comunidad de Madrid B2017/BMD-3686 CIFRA2 and Rio Hortega to MV Perez-Gome

Reactions to synthetic membranes dialyzers: Is there an increase in incidence?

Background: Reactions to dialyzers used in dialysis have been reported more frequently in recent years. Evidence, however, shows that the reaction rate has remained stable for years. Summary: One explanation for the apparent increase in publication frequency could be the lack of knowledge that dialyzer reactions may well occur with biocompatible membranes. Studies showed that the cause of these reactions is very diverse and varied, involving multiple materials. However, polyvinylpyrrolidone continues to be the main suspect, but without conclusive results. There are no differences between the different fibers, and although polysulfone is the most described, it is also the most used. Key Messages: The change to cellulose triacetate continues to be the most appropriate form of treatment. The classification of these reactions into type A and B complicates the diagnosis, and its true usefulness is in doubtThe research presented in this article is supported by the grants from the Spanish Ministry of Economy and Competitiveness and European Regional Development Funds (ERDF/FEDER) through ISCIII/FIS grants PI16/01298, PI17/01495, CIBERDEM and REDINREN RD016/0019 and through the Madrid Renal Society (SOMANE) grant

Clarifying the concept of chronic kidney disease for non-nephrologists

Chronic kidney disease (CKD) expands the prior concept of chronic renal insufficiency by including patients with relatively preserved renal function, as assessed by the estimated glomerular filtration rate (eGFR), as even these early CKD stages are associated with an increased risk for all-cause death and cardiovascular death, CKD progression and acute kidney injury. A decreased eGFR (3 months. However, when eGFR is 60 mL/min/1.73m2, an additional criterion is required to diagnose CKD. In a recent clinical trial published in The New England Journal of Medicine, all 6190 participants were reported to have CKD: 47% had Stages 1 and 2 CKD and 53% had Stage 3 CKD. This illustrates a widespread misunderstanding of the concept of CKD. Moreover, CKD categories in this study were assigned based on the estimated creatinine clearance. Since both estimated creatinine clearance and creatinine clearance overestimate eGFR, this illustrates another frequent misunderstanding: equating GFR with creatinine clearance. In this commentary, we clarify the concept of CKD and of CKD categories for non-nephrologists. Assigning a diagnosis of CKD to a patient with normal renal function and absence of other evidence of CKD may have negative consequences for the individual (e.g. insurance and others) as well as for the medical community at large by creating confusion about the concept.This research was supported by FIS PI16/02057, ISCIII-RETIC REDinREN RD016/0009 FEDER funds, Sociedad Española de Nefrología, Fundación Renal Iñigo Ávarez de Toledo (FRIAT), ISCIII Rio Hortega (MVPG) and Comunidad de Madrid Biomedicina B2017/BMD-3686 CIFRA2-CM

The Passivhaus Standard in the Spanish Mediterranean: Evaluation of a House’s Thermal Behaviour of Enclosures and Airtightness

Few houses have been built in the Spanish Mediterranean in accordance with the Passivhaus (PH) standard. This standard is adapted to the continental climates of Central Europe and thorough studies are necessary to apply this standard in Spain, especially in the summer. High relative air humidity levels in coastal areas and solar radiation levels of west-facing façades require adapted architectural designs, as well as greater control of air renewal and dehumidification. A priori, energy consumptions undergo big variations. In this study, the construction of a single-family house in the Spanish Levante was analysed. All enclosure layers were monitored using sensors of surface temperature, solar radiation, indoor and outdoor air temperature, relative humidity, and air speed. The thermal behaviour of the façade enclosure and air infiltration through the enclosure were examined using the blower door test and impacts on annual energy demand were quantified. Using simulation tools, improvements are proposed, and the results are compared with examples of PH housing in other geographical areas. The annual energy demand of PH housing was 69.19% below the usual value for buildings in the Mediterranean region. Very thick thermal insulation and low values of airtightness could be applied to the envelope, which would work very well in the winter. These technique solutions could provide optimal comfort conditions with a well-designed air conditioning system in summer and low energy consumption.This research has been funded by the Vicerectorate of Campus Facilities & Technology of the Universidad de Alicante, ref. 2018 34406P0002 P102 68000 (VIGROB 223)

Analysis of the average ultrafiltration rate per session of patients in a hemodialysis unit

Introduction: In haemodialysis (HD) patients, the wrong adjustment of the ideal weight can lead to fluid overload, which can cause episodes of heart failure or, conversely, to a low weight situation, generating hypotension that triggers ischemic heart disease. A maximum ultrafiltration (UF) of 10 ml/kg/hr is considered adequate. A higher value is associated with an increase in mortality. Objectives: To analyse the average ultrafiltration rate used in the study centre, and to know what percentage of patients exceeded the maximum recommended ultrafiltration. Material and Method: An observational, prospective study in 58 haemodialysis patients was carried out, analysing the ultrafiltration rate expressed in ml/kg/hr per session for 6 months. A UF rate>10 ml/kg/hr was defined as the cut-off point, according to the current criteria of adequate rate, to determine which patients had a UF greater than 10 ml/kg/hr in more than 25% of the sessions. Results: During the study period, the average UF rate of all patients was 8.78±2.76 ml/kg/hr, although the percentage of sessions per patient with a UF rate greater than 10 ml/kg/hr was 35.9±29.74%. Conclusion: A high percentage of patients present UF rates above the recommended values. Strategies to decrease values must be sought, with health education on diet and individualized adjustment of dialysis sessions being fundamental aspects.Introducción: En los pacientes en hemodiálisis (HD), el ajuste erróneo del peso ideal puede llevarlos a la sobrecarga de líquido que puede desembocar en episodios de insuficiencia cardiaca o a la inversa, a una situación de bajo peso generando hipotensiones que pueden originar cardiopatía isquémica. Se estima como adecuada una ultrafiltración (UF) máxima de 10 mililitro/kilogramo/hora, valor por encima del cual está demostrado el aumento de la mortalidad. Objetivos: Analizar que tasa de ultrafiltración media usamos en nuestra unidad, y conocer qué porcentaje de pacientes sobrepasaban la ultrafiltración máxima recomendada. Material y Método: Realizamos un estudio observacional, prospectivo, en 58 pacientes en hemodiálisis, analizando la tasa de ultrafiltración expresada en ml/kg/hora por sesión durante 6 meses. Se definió una tasa de UF>10 mililitro/kilogramo/hora como punto de corte para, según los criterios actuales de tasa adecuada, deCorrespondencia: Mónica Pereira García. Email: [email protected] terminar que pacientes presentaban una UF superior a 10 ml/Kg/h en más de un 25% de las sesiones. Resultados: Durante el periodo de estudio la tasa media de UF de todos los pacientes fue de 8,78±2,76 ml/kg/h, aunque el porcentaje de sesiones por paciente con tasa de UF superior a 10 ml/kg/h fue de un 35,9±29,74%. Conclusión: Un porcentaje alto de pacientes presentan tasas de UF por encima de los valores recomendados. Se han de buscar estrategias para minimizar esta situación, donde la educación sanitaria sobre alimentación y el ajuste individualizado de las sesiones de diálisis son aspectos fundamentale

Epidemiological characterization of ischemic heart disease at different altitudes: a nationwide population-based analysis from 2011 to 2021 in Ecuador

Background Cardiovascular diseases, including ischemic heart disease, are the leading cause of prema- ture death and disability worldwide. While traditional risk factors such as smoking, obesity, and diabetes have been thoroughly investigated, non-traditional risk factors like high-alti- tude exposure remain underexplored. This study aims to examine the incidence and mortal- ity rates of ischemic heart disease over the past decade in Ecuador, a country with a diverse altitude profile spanning from 0 to 4,300 meters. Methods We conducted a geographic distribution analysis of ischemic heart disease in Ecuador, uti- lizing hospital discharge and mortality data from the National Institute of Census and Statis- tics for the years 2011–2021. Altitude exposure was categorized according to two distinct classifications: the traditional division into low ( 2,500 m) altitudes, as well as the classification proposed by the International Society of Mountain Medicine, which delineates low (2500 m. Men had more pronounced rates across altitudes, exhibiting 138.7% and 150.0% higher incidence at low and high altitudes respectively, and mortality rates increased by 48.3% at low altitudes and 23.2% at high altitudes relative to women. Conclusion Ecuador bears a significant burden of ischemic heart disease (IHD), with men being more affected than women in terms of incidence. However, women have a higher percentage of mortality post-hospital admission. Regarding elevation, our analysis, using two different alti- tude cutoff points, reveals higher mortality rates in low-altitude regions compared to high- altitude areas, suggesting a potential protective effect of high elevation on IHD risk. Never- theless, a definitive dose-response relationship between high altitude and reduced IHD risk could not be conclusively established

Instantaneous Wave-Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations With Fractional Flow Reserve/Intravascular Ultrasound and Prognostic Implications: The iLITRO-EPIC07 Study

Background: There is little information available on agreement between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in left main coronary artery (LMCA) intermediate stenosis. Besides, several meta-analyses support the use of FFR to guide LMCA revascularization, but limited information is available on iFR in this setting. Our aims were to establish the concordance between FFR and iFR in intermediate LMCA lesions, to evaluate with intravascular ultrasound (IVUS) in cases of FFR/iFR discordance, and to prospectively validate the safety of deferring revascularization based on a hybrid decision-making strategy combining iFR and IVUS. Methods: Prospective, observational, multicenter registry with 300 consecutive patients with intermediate LMCA stenosis who underwent FFR and iFR and, in case of discordance, IVUS and minimal lumen area measurements. Primary clinical end point was a composite of cardiovascular death, LMCA lesion-related nonfatal myocardial infarction, or unplanned LMCA revascularization. Results: FFR and iFR had an agreement of 80% (both positive in 67 and both negative in 167 patients); in case of disagreement (31 FFR+/iFR- and 29 FFR-/iFR+) minimal lumen area was & GE;6 mm(2) in 8.7% of patients with FFR+ and 14.6% with iFR+. Among the 300 patients, 105 (35%) underwent revascularization and 181 (60%) were deferred according to iFR and IVUS. At a median follow-up of 20 months, major adverse cardiac events incidence was 8.3% in the defer group and 13.3% in the revascularization group (hazard ratio, 0.71 [95% CI 0.30-1.72]; P=0.45). Conclusions: In patients with intermediate LMCA stenosis, a physiology-guided treatment decision is feasible either with FFR or iFR with moderate concordance between both indices. In case of disagreement, the use of IVUS may be useful to indicate revascularization. Deferral of revascularization based on iFR appears to be safe in terms of major adverse cardiac events

Análisis de las habilidades de pensamiento crítico de los tutores de la práctica clínica del grado en enfermería: ensayo clínico multicéntrico

Objetivos: analizar el nivel de pensamiento crítico y variables de los tutores académicos de los centros de práctica clínica. Metodología: Escuela Universitaria de Enfermería de la Facultad de Medicina y Ciencias de la Salud durante noviembre 2019-mayo 2020. Diseño transversal descriptivo y segunda fase un estudio psicométrico. Discusión: el estudio permitirá explorar qué nivel de pensamiento crítico presentan las enfermeras vinculadas a la docencia

Incidence of Hypersensitivity Reactions During Hemodialysis

Background/Aims: A recent alert from Spanish health authorities warned of a higher incidence of reported hypersensitivity reactions to hemodialysis membranes with polysulfone, in the 2017 review of acute reactions to dialyzers found only published reports in the 21st century on polysulfone and its derivatives. The aim is to assess/evaluate the current incidence and characteristics of hypersensitivity reactions in hemodialysis patients. Methods: A retrospective multicentre study in 9 Spanish hospitals evaluated patients in whom a hypersensitivity reaction required a change in dialyzer membrane. Results: A total of 37 patients out of 1561 (2.37%) had hypersensitivity reactions and clinical, epidemiological and analytical data were available for 33 patients (2.11%). The membranes involved were polysulfone (n=23), polynephron (n=8), polyethersulfone (n=1) and polyacrylonitrile (n=1). This distribution reflected the frequency of use of membranes in the participating dialysis units. The reactions were described as type A in 18 cases and type B in 15 cases. There were no significant differences between the two types in clinical symptoms, the composition of the membrane involved, the method of sterilization, the season, or the time during the session in which they occurred. The most frequent symptom was dyspnea/breathlessness (64% of reactions). Eosinophilia was common (74%). 54% of the reactions occurred within the first 30 minutes of hemodialysis, 64% occurred during the first year of dialysis, and 54% required discontinuation of dialysis session. Cellulose triacetate was used as an alternative dialyzer in 78% of the cases. Conclusion: The incidence of hypersensitivity reactions was in the range found in reports from 20 years ago and is observed associated with synthetic membranes, not just polysulfones. Cellulose triacetate appears to be a good alternative for these patients

Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19 : a multicentre, randomised, double-blind, non-inferiority phase IIb trial

A SARS-CoV-2 protein-based heterodimer vaccine, PHH-1V, has been shown to be safe and well-tolerated in healthy young adults in a first-in-human, Phase I/IIa study dose-escalation trial. Here, we report the interim results of the Phase IIb HH-2, where the immunogenicity and safety of a heterologous booster with PHH-1V is assessed versus a homologous booster with BNT162b2 at 14, 28 and 98 days after vaccine administration. The HH-2 study is an ongoing multicentre, randomised, active-controlled, double-blind, non-inferiority Phase IIb trial, where participants 18 years or older who had received two doses of BNT162b2 were randomly assigned in a 2:1 ratio to receive a booster dose of vaccine-either heterologous (PHH-1V group) or homologous (BNT162b2 group)-in 10 centres in Spain. Eligible subjects were allocated to treatment stratified by age group (18-64 versus ≥65 years) with approximately 10% of the sample enrolled in the older age group. The primary endpoints were humoral immunogenicity measured by changes in levels of neutralizing antibodies (PBNA) against the ancestral Wuhan-Hu-1 strain after the PHH-1V or the BNT162b2 boost, and the safety and tolerability of PHH-1V as a boost. The secondary endpoints were to compare changes in levels of neutralizing antibodies against different variants of SARS-CoV-2 and the T-cell responses towards the SARS-CoV-2 spike glycoprotein peptides. The exploratory endpoint was to assess the number of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster. This study is ongoing and is registered with , . From 15 November 2021, 782 adults were randomly assigned to PHH-1V (n = 522) or BNT162b2 (n = 260) boost vaccine groups. The geometric mean titre (GMT) ratio of neutralizing antibodies on days 14, 28 and 98, shown as BNT162b2 active control versus PHH-1V, was, respectively, 1.68 (p < 0.0001), 1.31 (p = 0.0007) and 0.86 (p = 0.40) for the ancestral Wuhan-Hu-1 strain; 0.62 (p < 0.0001), 0.65 (p < 0.0001) and 0.56 (p = 0.003) for the Beta variant; 1.01 (p = 0.92), 0.88 (p = 0.11) and 0.52 (p = 0.0003) for the Delta variant; and 0.59 (p ≤ 0.0001), 0.66 (p < 0.0001) and 0.57 (p = 0.0028) for the Omicron BA.1 variant. Additionally, PHH-1V as a booster dose induced a significant increase of CD4 + and CD8 + T-cells expressing IFN-γ on day 14. There were 458 participants who experienced at least one adverse event (89.3%) in the PHH-1V and 238 (94.4%) in the BNT162b2 group. The most frequent adverse events were injection site pain (79.7% and 89.3%), fatigue (27.5% and 42.1%) and headache (31.2 and 40.1%) for the PHH-1V and the BNT162b2 groups, respectively. A total of 52 COVID-19 cases occurred from day 14 post-vaccination (10.14%) for the PHH-1V group and 30 (11.90%) for the BNT162b2 group (p = 0.45), and none of the subjects developed severe COVID-19. Our interim results from the Phase IIb HH-2 trial show that PHH-1V as a heterologous booster vaccine, when compared to BNT162b2, although it does not reach a non-inferior neutralizing antibody response against the Wuhan-Hu-1 strain at days 14 and 28 after vaccination, it does so at day 98. PHH-1V as a heterologous booster elicits a superior neutralizing antibody response against the previous circulating Beta and the currently circulating Omicron BA.1 SARS-CoV-2 variants in all time points assessed, and for the Delta variant on day 98 as well. Moreover, the PHH-1V boost also induces a strong and balanced T-cell response. Concerning the safety profile, subjects in the PHH-1V group report significantly fewer adverse events than those in the BNT162b2 group, most of mild intensity, and both vaccine groups present comparable COVID-19 breakthrough cases, none of them severe. HIPRA SCIENTIFIC, S.L.U