Castanedapadilla5402

Food additive E551 consists of synthetic amorphous silica (SAS), comprising agglomerates and aggregates of primary particles in the nanorange ( less then 100 nm), which potential nanospecific risks for humans associated to dietary exposure are not yet completely assessed. In NANoREG project, aim of the study was to identify potential hazards of pyrogenic SAS nanomaterial NM-203 by a 90-day oral toxicity study (OECD test guideline 408). Adult Sprague-Dawley rats of both sexes were orally treated with 0, 2, 5, 10, 20 and 50 mg SAS/kg bw per day; dose levels were selected to be as close as possible to E551 dietary exposure. Several endpoints were investigated, the whole integrative study is presented here along with the results of dispersion characterization, tissue distribution, general toxicity, blood/serum biomarkers, histopathological and immunotoxicity endpoints. No mortality, general toxicity and limited deposition in target tissues were observed. NM-203 affected liver and spleen in both sexes. Proposed NOAEL 5 mg/kg bw per day in male rats for enlarged sinusoids in liver. In female rats, TSH and creatinine levels were affected, proposed LOAEL 2 mg/kg bw per day. Overall, these data provide new insight for a comprehensive risk assessment of SAS exposure by the oral route. BACKGROUND Breast cancer (BC) patients undergoing surveillance often fear recurrence. Given that routine imaging is not recommended, recognizing metastatic disease early requires a knowledge of recurrence patterns. The aim of this study was to analyze the most common presentations of metastatic disease. PATIENTS AND METHODS A retrospective review was conducted of patients who were initially diagnosed with early-stage BC and who later developed metastatic disease. Data collected included method of metastatic disease diagnosis, types of symptoms at diagnosis, and survival. Chi-square tests as well as logistic and Cox regression models were used. RESULTS Metastatic diagnoses were made from reported symptoms in 77.6% of patients, clinical examination in 3.2%, and 7.8% incidentally on imaging. Among those with symptoms, musculoskeletal pain was the most common (33.7%) and was more frequently noted at scheduled (48.9%) compared to acute-care visits (26.0%, P  less then .01). Receptor status was associated with nervous system symptoms at metastasis (P = .01), with higher odds of nervous system symptoms in triple-negative (odds ratio = 3.02) compared to estrogen receptor/progesterone receptor-positive, HER2- cases. On multivariable analysis, initial stage (P = .03), receptor status (P  less then .01), age (P  less then .01), and time to recurrence (P  less then .01) were significantly associated with 10-year survival after diagnosis of metastasis, whereas the presence of symptoms was not (P = .27). Providers of BC patients undergoing surveillance should modify their threshold of suspicion for recurrence depending on the characteristics of the initial diagnosis and the symptoms subsequently reported. CONCLUSION In this retrospective study, patients who presented with symptoms did not have shorter survival compared to those who were diagnosed in other ways. OBJECTIVES This study sought to assess the diagnostic performance of FFRangio (CathWorks, Kfar Saba, Israel), an angiogram-derived fractional flow reserve (FFR) technology. BACKGROUND Despite practice guidelines recommendations, the use of coronary physiologic assessment in daily practice remains low for patients undergoing coronary angiography. Angiogram-derived FFR technologies have the potential to promote the integration of physiologic assessment in daily practice. METHODS The study performed an analysis of pooled patient- and lesion-level data from 5 prospective cohort studies that examined the diagnostic performance of FFRangio compared with the reference standard wire-based FFR. RESULTS A total of 700 lesions from 588 patients were analyzed. Mean age was 65 years, 71% were men, and 40% presented with acute coronary syndromes. Mean FFR and FFRangio were 0.81 ± 0.12 and 0.81 ± 0.11, with 31.6% and 31.4% of lesions were in the 0.75 to 0.85 range, respectively. When using a binary cutoff FFR value of 0.80, FFRangio showed a sensitivity of 91%, a specificity of 94%, and a diagnostic accuracy of 93%. The mean difference between FFR and FFRangio was 0.00 ± 0.12. The correlation coefficient between FFR and FFRangio was 0.83 (p  less then  0.001). The C-statistic for FFRangio was 0.95 (p  less then  0.001). The accuracy of FFRangio was consistent across all subgroups examined. CONCLUSIONS In the largest reported cohort examining the performance of angiogram-derived FFR technology, FFRangio showed excellent diagnostic performance, which was robust and consistent across all patient and lesion subgroups. Additional studies are needed allow FFRangio and fulfill its potential expand the implementation of functional assessment of coronary lesions in routine clinical practice. OBJECTIVES The aim of this study was to randomly compare the double-layer Roadsaver stent (RS) (Terumo, Tokyo, Japan) with the single-layer Carotid Wallstent (CW) (Boston Scientific, Santa Clara, California) in association with either distal embolic protection with the FilterWire (FW) device (Boston Scientific) or proximal protection with the Mo.Ma Ultra device (Medtronic, Santa Rosa, California) in patients with lipid-rich carotid plaques. BACKGROUND The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled. METHODS A total of 104 consecutive patients with carotid artery stenosis were randomized to CAS with FW + RS (group 1, n = 27), FW + CW (group 2, n = 25), Mo.Ma + RS (group 3, n = 27), or Mo.Ma + CW (group 4, n = 25). The primary endpoint was the number of microembolic signals (MES) on transcranial Doppler among groups in the following CAS steps 1 and 2) target vessel access; 3) lesion wiring; 4) pre-dilation; 5) stent crossing; 6) stent deployment; 7) stent Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. Opaganib A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection; NCT02915328).