Coste-efectividad del implante percutáneo de válvula aórtica con SAPIEN 3 en pacientes con bajo riesgo de mortalidad quirúrgica en España

España; Prótesis valvular cardiaca; Coste-efectividadSpain; Prosthetic heart valve; Cost-effectiveness analisyEspanya; Pròtesis valvular cardíaca; Cost-efectivitatIntroduction and objectives: Transcatheter aortic valve implantation (TAVI) was first introduced in 2007 as an alternative to open heart surgery to treat patients with severe symptomatic aortic stenosis (sSAS) with various indication expansions since that date. Recently, the PARTNER 3 study (Placement of aortic transcatheter valve) demonstrated clinical benefits with TAVI with the SAPIEN 3 valve vs surgical aortic valve replacement (SAVR) in selected low surgical mortality risk patients. We reviewed data from the PARTNER 3 and economic data from Spain to assess the cost-effectiveness ratio of TAVI vs SAVR in patients with sSAS and low surgical mortality risk. Methods: A 2-stage model was used to estimate direct healthcare costs and health-related quality of life data regarding TAVI with the SAPIEN 3 valve and SAVR. Early adverse events associated with TAVI from the PARTNER 3 were fed into a Markov model that captured longer-term outcomes after TAVI or SAVR. Results: TAVI with SAPIEN 3 improved quality-adjusted life years per patient (+ 1.00) with an increase in costs vs SAVR (€6971 per patient). This meant an incremental cost-effectiveness ratio/quality-adjusted life year of €6952 per patient. The results were robust with TAVI with the SAPIEN 3 valve remaining cost-effective across several sensitivity analyses. Conclusions: TAVI with the SAPIEN 3 valve is cost effective compared to SAVR in patients with sSAS and low surgical mortality risk. These findings can inform policymakers to facilitate policy development in Spain on intervention selection in this patient population.Introducción y objetivos: El implante percutáneo de válvula aórtica (TAVI) se introdujo en 2007 como una alternativa a la cirugía a corazón abierto para tratar a pacientes con estenosis aórtica grave sintomática, y desde entonces han aumentado las indicaciones autorizadas. Recientemente, el Placement of Aortic Transcatheter Valve Study (PARTNER) 3 ha demostrado beneficios clínicos con el TAVI con la válvula SAPIEN 3 frente al reemplazo quirúrgico de válvula aórtica (RVAo) en pacientes seleccionados con bajo riesgo de mortalidad quirúrgica. Utilizando los datos del PARTNER 3 junto con datos económicos de España, se evaluó la relación coste-efectividad del TAVI en comparación con el RVAo en pacientes con estenosis aórtica grave sintomática con bajo riesgo de mortalidad quirúrgica. Métodos: Se utilizó un modelo en dos etapas para estimar los costes directos sanitarios y los datos de calidad de vida relacionados con la salud para TAVI con la válvula SAPIEN 3 y RVAo. Los eventos adversos tempranos relacionados con TAVI del PARTNER 3 se incluyeron en un modelo de Markov, que capturó los resultados a más largo plazo tras TAVI o RVAo. Resultados: El TAVI con SAPIEN 3 mejoró los años de vida ajustados por calidad por paciente (+1,00), con un aumento en el coste frente al RVAo de 6.971 € por paciente. Esto representó una ratio coste-efectividad incremental por año de vida ganado ajustado por calidad de 6.952€ por paciente. Los resultados fueron robustos en los diversos análisis de sensibilidad realizados, en los que el TAVI con SAPIEN 3 se mantiene como una opción coste-efectiva. Conclusiones: El TAVI con SAPIEN 3 es coste-efectivo en comparación con el RVAo en pacientes con estenosis aórtica grave sintomática con bajo riesgo de mortalidad quirúrgica. Estos resultados pueden informar a los decisores políticos en España para facilitar el desarrollo de políticas sobre la selección de opciones terapéuticas en esta población de pacientes. Palabras clave: España. Implante percutáneo de válvula aórtica. Cirugía cardiaca. Prótesis valvular cardiaca. Reemplazo quirúrgico de válvula aórtica. Análisis coste-beneficio. Análisis coste-efectividad. Estenosis aórtica. Bajo riesgo.Edwards Lifesciences SA, Switzerland provided funding for the economic assessment and was involved in the analysis as well as in the drafting of this manuscript

Héðinsdalsjökull, northern Iceland: geomorphology recording the recent complex evolution of a glacier

The objective of this work is to conduct a detailed mapping of the Héðinsdalsjökull foreland, northern Iceland (65°39′N, 18°55′W). This cirque currently shows a variety of glacial and periglacial landforms derived from a complex deglaciation. Mapping was performed combining traditional hand-drawn and digital mapping. A hand-drawn sketch was georeferenced in ArcMap 10.7.1, supported on an aerial photograph (year 2000). Its vectorization, symbolization and final design were done in the computer-aided design (CAD) software MicroStation Connect. Complementary high-resolution Digital Surface Models were obtained from historical aerial photographs and ground-view field photographs through the application of Structure from Motion (SfM) photogrammetry. To improve the topographic expression of the geomorphological map, a photorealistic 3D view has been generated. The final map highlights the complexity of the foreland and the coexistence existence of a range of different units and landforms. The map will ease future studies on the transformation of receding glaciers.info:eu-repo/semantics/publishedVersio

SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve

AIMS: Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA). METHODS AND RESULTS: Participating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6\u2009\ub1\u20096.7\u2009years, 52% male) were enrolled in 80 centres from 10 European countries. At 1\u2009year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1\u2009year. CONCLUSION: In SOURCE 3, we observe a low complication rate and mortality at 1\u2009year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956

Myocardial injury determination improves risk stratification and predicts mortality in COVID-19 patients

Background: Despite being associated with worse prognosis in patients with COVID-19, systematic determination of myocardial injury is not recommended. The aim of the study was to study the effect of myocardial injury assessment on risk stratification of COVID-19 patients.Methods: Seven hundred seven consecutive adult patients admitted to a large tertiary hospital with confirmed COVID-19 were included. Demographic data, comorbidities, laboratory results and clinical outcomes were recorded. Charlson comorbidity index (CCI) was calculated in order to quantify the degree of comorbidities. Independent association of cardiac troponin I (cTnI) increase with outcomes was evaluated by multivariate regression analyses and area under curve. In addition, propensity-score matching was performed to assemble a cohort of patients with similar baseline characteristics.Results: In the matched cohort (mean age 66.76 ± 15.7 years, 37.3% females), cTnI increase above the upper limit was present in 20.9% of the population and was associated with worse clinical outcomes, including all-cause mortality within 30 days (45.1% vs. 23.2%; p = 0.005). The addition of cTnI to a multivariate prediction model showed a significant improvement in the area under the time-dependent receiver operating characteristic curve (0.775 vs. 0.756, DC-statistic = 0.019; 95% confidence interval 0.001–0.037). Use of renin–angiotensin–aldosterone system inhibitors was not associated with mortality after adjusting by baseline risk factors.Conclusions: Myocardial injury is independently associated with adverse outcomes irrespective of baseline comorbidities and its addition to multivariate regression models significantly improves their performance in predicting mortality. The determination of myocardial injury biomarkers on hospital admission and its combination with CCI can classify patients in three risk groups (high, intermediate and low) with a clearly distinct 30-day mortality

Reversible glacial-periglacial transition in response to climate changes and paraglacial dynamics: a case study from Héðinsdalsjökull (northern Iceland)

The objective of this work is to chronologically establish the origin of the different glacial and rock glacier complex landforms deposited by Héðinsdalsjökull glacier (65°39′ N, 18°55′ W), in the Héðinsdalur valley (Skagafjörður fjord, Tröllaskagi peninsula, central northern Iceland). Multiple methods were applied: geomorphological analysis and mapping, glacier reconstruction and equilibrium-line altitude calculation, Cosmic-Ray Exposure dating (in situ cosmogenic 36Cl), and lichenometric dating. The results reveal that a debris-free glacier receded around 6.6 ± 0.6 ka, during the Holocene Thermal Maximum. The retreat of the glacier exposed its headwall and accelerated paraglacial dynamics. As a result, the glacier terminus evolved into a debris-covered glacier and a rock glacier at a slightly higher elevation. The front of this rock glacier stabilized shortly after it formed, although nuclide inheritance is possible, but its sector close the valley head stabilized between 1.5 and 0.6 ka. The lowest part of the debris-covered glacier (between 600 and 820 m altitude) collapsed at ca. 2.4 ka. Since then, periods of glacial advance and retreat have alternated, particularly during the Little Ice Age. The maximum advance during this phase occurred in the 15th to 17th centuries with subsequent re-advances, namely at the beginning of the 19th and 20th centuries. After a significant retreat during the first decades of the 20th century, the glacier advanced in the 1960s to 1990s, and then retreated again, in accordance with the local climatic evolution. The internal ice of both the debris-covered and the rock glacier have survived until the present day, although enhanced subsidence provides evidence of their gradual degradation. A new rock glacier developed from an ice-cored moraine from around 1940–1950 CE. Thus, the Holocene coupling between paraglacial and climatic shifts has resulted in a complex evolution of Héðinsdalsjökull, which is conflicting with previously proposed models: a glacier, which had first evolved into a debris-covered and rock glacier, could later be transformed into a debris-free glacier, with a higher sensitivity to climatic variability.info:eu-repo/semantics/publishedVersio

Sex-Related Disparities in the Prevalence of Depression among Patients Hospitalized with Type 2 Diabetes Mellitus in Spain, 2011–2020

(1) Background: Recent reports suggest a decrease in the prevalence of depression among people with diabetes and important sex-differences in the association between these conditions, however data from Spain is sparse. We aim to assess trends in the prevalence of depression and in-hospital outcomes among patients with type 2 diabetes (T2DM) hospitalized (2011–2020) identifying sex-differences. (2) Methods: Using the Spanish national hospital discharge database we analysed the prevalence of depression globally, by sex, and according to the conditions included in the Charlson comorbidity index (CCI). We tested factors associated with the presence of depression and with in-hospital mortality (IHM). Time trends in the prevalence of depression and variables independently associated with IHM were analyzed using multivariable logistic regression. (3) Results: From 2011 to 2020, we identified 5,971,917 hospitalizations of patients with T2DM (5.7% involved depression). The prevalence of depression decreased significantly between 2011 and 2020. The adjusted prevalence of depression was 3.32-fold higher in women than in men (OR 3.32; 95%CI 3.3–3.35). The highest prevalence of depression among men and women with T2DM was found among those who also had a diagnosis of obesity, liver disease, and COPD. Older age, higher CCI, pneumonia, and having been hospitalized in 2020 increased the risk of IHM in patients with T2DM and depression. Obesity was a protective factor for IHM in both sexes, with no differences detected for IHM between men and women. Among patients hospitalized with T2DM, concomitant depression was associated with lower IHM than among patients without depression (depression paradox). (4) Conclusions: The prevalence of depression decreased over time in both sexes. The prevalence of depression was over three-fold higher in women. Female sex and depression were not associated with higher IHM. Based on our results we recommend that clinicians screen regularly for depression in patients with T2DM, particularly women, younger patients, and those with multiple comorbidities.Depto. de Salud Pública y Materno - InfantilFac. de MedicinaTRUEUnión EuropeaComunidad de MadridInstituto de Salud Carlos IIIUniversidad Complutense de MadridUniversidad Complutense de Madrid. Grupo de Investigación en Epidemiología de las Enfermedades Crónicas de Alta Prevalencia en España (970970)pu

Efficacy of Manual Therapy on Facilitatory Nociception and Endogenous Pain Modulation in Older Adults with Knee Osteoarthritis: A Case Series.

Background: manual therapy (MT) has been shown to have positive effects in patients with osteoarthritis (OA)-related pain, and its use in clinical settings is recommended. However, the mechanisms of action for how these positive effects occur are not yet well understood. The aim of the present study was to investigate the influence of MT treatment on facilitatory nociception and endogenous pain modulation in patients with knee OA related pain. Methods: Twenty-eight patients with knee OA were included in this study. Pain intensity using the numerical pain rating scale (NPRS), temporal summation (TS), conditioned pain modulation (CPM), and local (knee) and distant (elbow) hyperalgesia through the pressure pain threshold (PPT), were assessed to evaluate the pain modulatory system. Patients underwent four sessions of MT treatments within 3 weeks and were evaluated at the baseline, after the first session and after the fourth session. Results: the MT treatment reduced knee pain after the first session (p = 0.03) and after the fourth session (p = 0.04). TS decreased significantly after the fourth session of MT (p = 0.02), while a significant increase in the CPM assessment was detected after the fourth session (p = 0.05). No significant changes in the PPT over the knee and elbow were found in the follow-ups. Conclusions: The results from our study suggest that MT might be an effective and safe method for improving pain and for decreasing temporal summation.post-print502 K

Four chamber right ventricular longitudinal strain versus right free wall longitudinal strain. Prognostic value in patients with left heart disease

Background: There is no consensus on which right ventricle (RV) strain parameter should be used in the clinical practice: four chamber RV longitudinal strain (4CH RV-LS) or free wall longitudinal strain (FWLS). The aim of this study was to analyze which RV strain parameter better predicts prognosis in patients with left heart disease. Methods: One hundred and three outpatients with several degrees of functional tricuspid regurgitation severity secondary to left heart disease were prospectively included. 4CH RV-LS and FWLS were assessed using speckle tracking. Left ventricular (LV) systolic function was determined using LV ejection fraction and RV systolic function using tricuspid annular plane systolic excursion (TAPSE). Patients were followed up for 23.1 ± 12.4 months for an endpoint of cardiac hospitalization due to heart failure. Results: The cutoff value related to RV dysfunction (TAPSE < 17 mm) was lower, in absolute value, for 4CH RV-LS (4CH RV-LS = –17.3%; FWLS = –19.5%). There were 33 adverse events during the follow-up. Patients with 4CH RV-LS > –17.3% (log rank [LR] = 22.033; p < 0.001); FWLS > –19.5% (LR = 12.2; p < 0.001), TAPSE < 17 mm (LR = 17.4; p < 0.001) and LV systolic dysfunction (LR = 13.3; p < 0.001) had lower event-free survival (Kaplan Meier). In Cox multivariate analysis, 4CH RV-LS > –17.3% (hazard ratio [HR] = 3.593; p < 0.002), TAPSE < 17 (HR = 2.093; p < 0.055) and LV systolic dysfunction (HR = 2.087; p < 0,054) had prognostic value, whereas FWLS did not reach significance. Conclusions: Although both 4CH RV-LS and FWLS have prognostic value, 4CH RV-LS is a better predictor of episodes of heart failure in patients with left heart disease, providing additional information to that obtained by TAPSE.

NIL10: A New IL10-Receptor Binding Nanoparticle That Induces Cardiac Protection in Mice and Pigs Subjected to Acute Myocardial Infarction through STAT3/NF-kB Activation.

Background: Early response after acute myocardial infarction (AMI) prevents extensive cardiac necrosis, in which inflammation resolution, including expression of anti-inflammatory interleukin-10 (IL-10), may play a key role. (2) Methods: We synthesized NIL10, a micelle-based nanoparticle, to target IL-10 receptor in mice and pigs subjected to AMI. (3) Results: Administration of NIL10 induced cardiac protection of wild-type and IL-10 knockout mice and pigs subjected to AMI. Cardiac protection was not induced in IL-10-receptor null mice, as shown by a significant recovery of cardiac function, in which inflammatory foci and fibrosis were strongly reduced, together with the finding that resolving M2-like macrophage populations were increased after day 3 of reperfusion. In addition, anti-inflammatory cytokines, including IL-4, IL-7, IL-10, IL-13, IL-16, and IL-27 were also elevated. Mechanistically, NIL10 induced activation of the IL-10 receptor/STAT-3 signaling pathway, and STAT3-dependent inhibition of nuclear translocation of pro-inflammatory NF-kB transcription factor. (4) Conclusions: Taken together, we propose using NIL10 as a novel therapeutic tool against AMI-induced cardiac damagepost-print4711 K