Relationship between device acceptance and patient-reported outcomes in left ventricular assist device (LVAD) recipients

The number of Left Ventricular Assist Devices (LVADs) implanted each year is rising. Nevertheless, there are minimal data on device acceptance after LVAD implant, and on its relationship with patient-reported outcomes. We designed a cross-sectional study to address this knowledge gap and test the hypothesis that low device acceptance is associated with poorer quality of life, depression and anxiety. Self-report questionnaires were administered to assess quality of life (12-item Kansas City Cardiomyopathy Questionnaire quality of life subscale), level of anxiety (7-item Generalized Anxiety Disorder; GAD-7), level of depression (9-item Patient Health Questionnaire; PHQ-9) and device acceptance (Florida Patient Acceptance Survey; FPAS) to 101 consecutive patients presenting to LVAD clinic. Regression analysis showed a strong correlation between device acceptance and both psychological distress (p\u2009<\u20090.001) and quality of life (p\u2009<\u20090.001). Analysis of the sub-scales of the FPAS showed that patients had significant body image concerns, but return to function and device-related distress were the main drivers of the observed correlation between device acceptance and patient well-being. Younger age was associated with lower device acceptance (r\u2009=\u20090.36, p\u2009<\u20090.001) and lower quality of life (r\u2009=\u20090.54, p\u2009<\u20090.001). These findings suggest that interventions targeting device acceptance should be explored to improve outcomes in LVAD recipients

Sentinel-2 Remote Sensed Image Classification with Patchwise Trained ConvNets for Grassland Habitat Discrimination

The present study focuses on the use of Convolutional Neural Networks (CNN or ConvNet) to classify a multi-seasonal dataset of Sentinel-2 images to discriminate four grassland habitats in the “Murgia Alta” protected site. To this end, we compared two approaches differing only by the first layer machinery, which, in one case, is instantiated as a fully-connected layer and, in the other case, results in a ConvNet equipped with kernels covering the whole input (wide-kernel ConvNet). A patchwise approach, tessellating training reference data in square patches, was adopted. Besides assessing the effectiveness of ConvNets with patched multispectral data, we analyzed how the information needed for classification spreads to patterns over convex sets of pixels. Our results show that: (a) with an F1-score of around 97% (5 x 5 patch size), ConvNets provides an excellent tool for patch-based pattern recognition with multispectral input data without requiring special feature extraction; (b) the information spreads over the limit of a single pixel: the performance of the network increases until 5 x 5 patch sizes are used and then ConvNet performance starts decreasing

Biodegradation of two new biomaterials

Introduction. As in the previous experiments the haemostatic swab Antema revealed the disadvantage of troublesome adhesion both to surgical instruments and to serous surfaces of internal organs, the addition of Matemo could speed up the haemostatic performances of both biomaterials reducing the adhesion. For that reason Antema pads were treated with Matemo obtaining new haemostatic swabs. A comparison between the Matemo and the Antema + Matemo pads was then performed to test the haemostatic power and the biodegradation of both biomaterials. Materials and methods. For the experimental protocol the dorsal skin of each anesthetized animal was shaved, incised and two pouches were performed inside the subcutaneous tissue of the back, to introduce a specimen (1 cm2 of size) of Matemo on the left side, and Matemo+Antema on the right side. The same operation was repeated in 3 animals, and 3 other rats were used as controls and treated only with the selected anesthetic without intervention. The treated animals were all killed after 90 days from the operation. All the animals were daily controlled and no accident happens during the post-operation time. After death the dorsal skin of each animal was inspected in the two sides of implant and the samples from the skin and the subcutaneous tissues were taken in both sides of the back, to submit to the histological studies. Results. The microscopic analysis of the histological sections showed that at the deadline of the experiment both biomaterials disappeared from the site of implant, but the two regions were very different. In the left side (Matemo) the subcutaneous tissue appeared quite normal and very poorly infiltrated by the inflammatory cells, without proliferation of new fibrous tissue, neither dermal adhesion to the musculature. In the right side (Antema + Matemo) indeed, a significant infiltration of inflammatory cells was jet detectable and many dense neo-proliferate connective tissue attached the dermal plane to the muscular layer. Then, this protocol confirmed the very interesting results obtained in these studies in which the new synthesized haemostatic biomaterial Matemo was compared with Tabotamp and Antema, both currently used surgical sponges. Also in this experiment Matemo revealed a significant decrease in bleeding time with an absorption rate of the blood very quick and fast and its biodegradation at the 90th day were almost perfect

In vivo biodegradation of new haemostatic biomaterials

Introduction. The new synthesized haemostatic biomaterial Matemo, is a protein meal produced by fractionation of human plasma. In previous studies it revealed its excellent haemostatic properties, so that it could become the best biomaterial to prefer in large surgical demolition. It also showed an excellent biocompatibility for its composition of human proteins, very similar to that of human tissues. This work now intended to study the in vivo biodegradation of this new biomaterial compared with another horse collagen-based haemostatic biomaterial (Antema) in order to find the best material to fill the empty cavities resulting after surgical resection of tumor masses. Materials and methods. For the experimental protocol the dorsal skin of each anesthetized animal was shaved, incised and two pouches were performed inside the subcutaneous tissue of the back, to introduce a specimen (1 cm2 of size) of Matemo on the left side, and on the right side the horse-collagen biomaterials (Antema). The same operation was repeated in 3 animals, and 3 other rats were used as controls and treated only with the selected anesthetic cocktail without intervention. The treated animals were killed all after 90 days from the operation. After death the dorsal skin of each animal was inspected in the two sides of implant and the samples from the skin and the subcutaneous tissues were taken in both sides of the back, to submit to the histological studies. Results The histological exams carried out in this experiment showed that at the 90th day post-implant both biomaterials were completely reabsorbed, but the sites of implantation were very different between them. In the side of the implanted Matemo the subcutaneous tissue showed a very poor infiltration of inflammatory cells, with a foreign body reaction fully resolved without proliferation of new fibrous tissue, neither dermal adhesion to the muscular plane. In the site of Antema implant, indeed, at the same dead line a significant infiltration of inflammatory cells jet persisted and much dense fibrous tissue attached the dermal plane to the underlying muscles

Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

Background and Objectives: Considering the clinical and economic burden of biological drugs in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological drugs for cancer treatment in a general population of Southern Italy in the years 2010–2014. Methods: This was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010–2014. In this study, users of biological drugs for cancer treatment were characterized and the prevalence of use and costs were calculated over time. The potential impact of biosimilars on the expenditure was also estimated. Results: Of a population of 653,810 residents in the Messina area during the study years, 2491 (0.4%) patients received at least one study drug. The most frequently used were monoclonal antibodies (mAbs) (n = 1607; 64.5%) and tyrosine kinase inhibitors (TKIs) (n = 609; 24.4%). mAbs were mainly used by females (60.3%) for metastasis due to an unspecified primary tumor, lymphomas, or breast cancer (24.2, 16.7, and 13.7%, respectively). Most users of small molecules were males (56.3%) being treated for multiple myeloma, metastasis due to unspecified primary tumor, leukemia, and lung cancer (13.1, 12.6, 9.5, and 8.9%, respectively). During the study years, the prevalence of use doubled from 0.9 to 1.8 per 1000 inhabitants; likewise, the related expenditure grew from €6.6 to €13.6 million. Based on our forecasts, this expenditure will grow to €25 million in 2020. Assuming a 50% biosimilar uptake (trastuzumab and rituximab), a potential yearly saving of almost €1 million may be achieved. Conclusions: In recent years, the use and costs of biological drugs in cancer patients have increased dramatically in a large population from Southern Italy. This trend may be counterbalanced by adopting biosimilars once they are available. Claims databases represent a valid tool to monitor the uptake of newly marketed biological drugs and biosimilars

Author Correction to: Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

Unfortunately, many errors were identified in the published article. The original article was corrected

Frequency and spectrum of PIK3CA somatic mutations in breast cancer

Purpose: The therascreen PIK3CA mutation assay and the alpha-specific PI3K inhibitor alpelisib are FDA-approved for identifying and treating patients with advanced PIK3CA-mutated (PIK3CAmut) breast cancer (BC). However, it is currently unknown to what extend this assay detects most PIK3CA mutations in BC. This information is critical as patients and clinicians are using this and other genomic assays to indicate alpelisib. Methods: Data from 6338 patients with BC was explored across 10 publicly available studies. The primary objective was to evaluate the proportion and distribution of PIK3CA mutations in BC. Secondary objectives were (1) to evaluate in silico the spectrum of PIK3CA mutations in BC that would be captured by the therascreen panel; (2) to evaluate the proportion and distribution of PIK3CA mutations in hormone receptor-positive/HER2-negative (HR+/HER2-), HER2+, and triple-negative BC (TNBC); and (3) to explore the identification of PIK3CA mutations in a cohort of 48 HR+/HER2- advanced BC patients by the Guardant B360 circulating tumor DNA (ctDNA) assay. Results: Patients with PIK3CAmut tumors represented 35.7% (2261/6338). Five PIK3CA mutations comprised 73% of all PIK3CA mutations: H1047R (35%), E545K (17%), E542K (11%), N345K (6%), and H1047L (4%). Therascreen gene list would capture 72% of all PIK3CA mutations and 80% of patients with a known PIK3CAmut BC. Among patients with double PIK3CAmut tumors (12% of all PIK3CAmut), the therascreen panel would capture 78% as harboring 1 single PIK3CA mutation, 17% as PIK3CAmut undetected, and 5% as PIK3CA double-mut. PIK3CA mutation rates were lower in TNBC (16%) compared to HR+/HER2 (42%) and HER2+ (31%) BC; however, the distribution of the 4 main PIK3CA mutations across subtypes was similar. Finally, 28% of PIK3CA mutations identified in ctDNA in 48 patients with advanced HR+/HER2- BC were not part of the therascreen panel. Conclusion: PIK3CA mutations in BC are heterogenous and ~ 20% of patients with a known PIK3CA mutation, and 95% with a known double PIK3CAmut tumor, would not be captured by the therascreen panel. Finally, the clinical utility of PIK3CA mutations not present in the therascreen companion diagnostic assay or identified by other sequencing-based assays needs further investigation

The importance of a taste. A comparative study on wild food plant consumption in twenty-one local communities in Italy

A comparative food ethnobotanical study was carried out in twenty-one local communities in Italy, fourteen of which were located in Northern Italy, one in Central Italy, one in Sardinia, and four in Southern Italy. 549 informants were asked to name and describe food uses of wild botanicals they currently gather and consume. Data showed that gathering, processing and consuming wild food plants are still important activities in all the selected areas. A few botanicals were quoted and cited in multiple areas, demonstrating that there are ethnobotanical contact points among the various Italian regions (Asparagus acutifolius, Reichardia picroides, Cichorium intybus, Foeniculum vulgare, Sambucus nigra, Silene vulgaris, Taraxacum officinale, Urtica dioica, Sonchus and Valerianella spp.). One taxon (Borago officinalis) in particular was found to be among the most quoted taxa in both the Southern and the Northern Italian sites

La vesícula extracelular TGF-β basal es un biomarcador predictivo de la respuesta a los inhibidores del punto de control inmunitario y de la supervivencia en el cáncer de pulmón no microcítico

Antecedentes: Los inhibidores de los puntos de control inmunitarios (ICI) son una estrategia terapéutica eficaz que mejora la supervivencia de los pacientes con cáncer de pulmón en comparación con los tratamientos convencionales. terapéutica eficaz que mejora la supervivencia de los pacientes con cáncer de pulmón en comparación con los tratamientos convencionales. Sin embargo, se necesitan biomarcadores predictivos novedosos para estratificar qué pacientes obtienen un beneficio clínico, ya que el histológico PD-L1, actualmente utilizado y altamente heterogéneo, ha mostrado una baja precisión. La biopsia líquida es el análisis de biomarcadores en fluidos corporales y representa una herramienta mínimamente invasiva que puede utilizarse para monitorizar la evolución del tumor y los efectos del tratamiento, reduciendo potencialmente los sesgos asociados a la heterogeneidad tumoral asociada a las biopsias de tejidos. En este contexto citoquinas, como el factor de crecimiento transformante-β (TGF-β), pueden encontrarse libres en circulación en la sangre y empaquetadas en vesículas extracelulares (VE), que tienen un tropismo de administración específico y pueden afectar a la interacción entre el tumor y el sistema inmunitario. El TGF-β es una citocina inmunosupresora que desempeña un papel crucial en el escape inmunitario de los tumores, la resistencia al tratamiento y la metástasis. Así pues, nuestro objetivo era evaluar el valor predictivo predictivo del TGF-β circulante y EV en pacientes con cáncer de pulmón no microcítico que reciben ICI.Background: Immune‐checkpoint inhibitors (ICIs) are an effective therapeutic strategy, improving the survival of patients with lung cancer compared with conventional treatments. However, novel predictive biomarkers are needed to stratify which patients derive clinical benefit because the currently used and highly heterogenic histological PD‐L1 has shown low accuracy. Liquid biopsy is the analysis of biomarkers in body fluids and represents a minimally invasive tool that can be used to monitor tumor evolution and treatment effects, potentially reducing biases associated with tumor heterogeneity associated with tissue biopsies. In this context, cytokines, such as transforming growth factor‐β (TGF‐β), can be found free in circulation in the blood and packaged into extracellular vesicles (EVs), which have a specific delivery tropism and can affect in tumor/immune system interaction. TGF‐β is an immunosuppressive cytokine that plays a crucial role in tumor immune escape, treatment resistance, and metastasis. Thus, we aimed to evaluate the predictive value of circulating and EV TGF‐β in patients with non–small‐cell lung cancer receiving ICIs