Safety evaluation of high-risk myocardial micro-biopsy in a swine model

The objective of the study was to investigate the safety profile of high-risk micro-endomyocardial biopsy (micro-EMB) compared to conventional EMB in a large animal model. Twenty pigs were subjected to a maximum of 30 consecutive biopsies, including sampling from the free ventricular wall, with either micro-EMB (n = 10) or conventional EMB (n = 10). There were no major complications in the micro-EMB group (0/10), compared to six major complications in the EMB group (6/10; p = 0.003). Survival analysis further highlighted these differences (p = 0.004). There were significantly higher volumes of pericardial effusion in the EMB group (p = 0.01). The study shows a safety advantage of micro-EMB compared to standard EMB in the experimental high-risk circumstances investigated in this animal study. These results indicate enhanced possibilities to collect samples from sensitive areas by using the micro-EMB technique instead of standard EMB.

Aspiration Before Tissue Filler – An Exercise in Futility and Unsafe Practice

Background Aesthetic physicians rely upon certain anecdotal beliefs regarding the safe practice of filler injections. These include a presumed safety advantage of bolus injection after a negative aspiration. Objectives The article aims to review and summarize the published literature on inadvertent intravascular injection of hyaluronic acid and to investigate whether the technique of aspiration confers any safety to the practitioner and the patient. Methods Pertinent literature was analyzed and our understanding of the safety of negative and positive aspiration outlined. Results The available studies demonstrate that aspiration cannot be relied upon and should not be used as a safety measure. It is safer to adopt injection techniques that will avoid injecting an intravascular volume with embolic potential than use an unreliable test to permit a risky injection. Conclusions To prevent intravascular injection, understanding “injection anatomy” and injection plane and techniques such as slow, low-pressure injection are important safety measures. Assurance of safety when delivering a bolus after negative aspiration, does not appear to be borne out by the available literature. If there is any doubt about the sensitivity or reliability of a negative aspiration, then there is no role for its use. Achieving a positive aspiration would just defer the risk to the next injection location where a negative aspiration would then be relied upon.

Mycotoxins in Maize and Implications on Food Security: A Review

Mycotoxin poisoning is not restricted to pets and farm animals, it causes diseases and death in humans. Mycotoxin producing fungi are common components of the epiphytic and endophytic microflora in crops resulting in natural crop contamination in the field and during storage. The level of contamination is influenced by the genetics of the plant and fungi, management practices and prevailing climatic conditions. The Global movement of maize products necessitates global as well as country-specific surveys on mycotoxin occurrence. Significant differences in the concentrations of deoxynivalenol, fumonisins and zearalenone were found in commercial maize for the seven years under review but no significant difference was detected between white and yellow maize types with regards to fumonisins and zearalenone concentrations. The absence of Aflatoxins, Ochratoxin-A, T2-toxin and HT-2 toxin in the commercial maize samples from 2010/2011 to 2016/2017 seasons is a food safety advantage for South Africa maize producers.

The COVID-19 Pandemic Predominantly Hits Poor Neighborhoods, or does it? Evidence from Germany

Background Reports from the UK and the USA suggest that COVID-19 predominantly affects poorer individuals and neighbourhoods. This article paints a more complex picture by distinguishing between a first and second phase of the pandemic. The initial spread of infections and its correlation with socio-economic factors largely depends on how the virus first entered a country. The second phase of the pandemic begins when individuals start taking precautionary measures and governments implement lockdowns. In this phase the further spread of the virus depends on the ability of individuals to socially distance themselves, which is to some extent socially stratified. Methods We analyze the geographical distribution of known cases per capita across 401 local districts in Germany, once for infections in the initial phase and for new infections during the second phase. Results In Germany, the virus first entered via individuals returning from skiing in the Alps and other international travel. In this first phase we find a positive association between the wealth of a district and infection rates and a negative association with indicators of social deprivation. During the second phase, richer districts and districts with a higher share of university-educated employees record fewer new infections, whilst the initial safety advantage of more socially deprived districts disappears. Conclusion The social stratification of Covid-19 changes substantively across the two phases of the pandemic in Germany. Only in the second phase does socio-economic advantage turn into a safety advantage. Thus, suggestions that the pandemic predominantly hits the poor needs to be qualified.

Peptide drugs for photopharmacology: how much of a safety advantage can be gained by photocontrol?

Aim: To verify whether photocontrol of biological activity could augment safety of a chemotherapeutic agent. Materials & methods: LD50 values for gramicidin S and photoisomeric forms of its photoswitchable diarylethene-containing analogs were determined using mice. The results were compared with data obtained from cell viability measurements taken for the same compounds. Absorption, Distribution, Metabolism, and Elimination (ADME) tests using a murine cancer model were conducted to get insight into the underlying reasons for the observed in vivo toxicity. Results: While in vitro cytotoxicity values of the photoisomers differed substantially, the differences in the observed LD50 values were less pronounced due to unfavorable pharmacokinetic parameters. Conclusion: Despite unfavorable pharmacokinetic properties as in the representative case studied here, there is an overall advantage to be gained in the safety profile of a chemotherapeutic agent via photocontrol. Nevertheless, optimization of the pharmacokinetic parameters of photoisomers is an important issue to be addressed during the development of photopharmacological drugs.

Effective accuracy of stereoelectroencephalography: robotic 3D versus Talairach orthogonal approaches

OBJECTIVEStereoelectroencephalography (SEEG) was first developed in the 1950s by Jean Talairach using 2D angiography and a frame-based, orthogonal approach through a metallic grid. Since then, various other frame-based and frameless techniques have been described. In this study the authors sought to compare the traditional orthogonal Talairach 2D angiographic approach with a frame-based 3D robotic procedure that included 3D angiographic interoperative imaging guidance. MRI was used for both procedures during surgery, but MRI preplanning was done only in the robotic 3D technique.METHODSAll study patients suffered from drug-resistant focal epilepsy and were treated at the same center by the same neurosurgical team. Fifty patients who underwent the 3D robotic procedure were compared to the same number of historical controls who had previously been successfully treated with the Talairach orthogonal procedure. The effectiveness and absolute accuracy, as well as safety, of the two procedures were compared. Moreover, in the 3D robotic group, the reliability of the preoperative MRI to avoid vascular structures was evaluated by studying the rate of trajectory modification following the coregistration of the intraoperative 3D angiographic data onto the preoperative MRI-based trajectory plans.RESULTSEffective accuracy (96.5% vs 13.7%) and absolute accuracy (1.15 mm vs 4.00 mm) were significantly higher in the 3D robotic group than in the Talairach orthogonal group. Both procedures showed excellent safety results (no major complications). The rate of electrode modification after 3D angiography was 43.8%, and it was highest for frontal and insular locations.CONCLUSIONSThe frame-based, 3D angiographic, robotic procedure described here provided better accuracy for SEEG implantations than the traditional Talairach approach. This study also highlights the potential safety advantage of trajectory planning using intraoperative frame-based 3D angiography over preoperative MRI alone.

The Rationale for Continuous Glucose Monitoring-based Diabetes Treatment Decisions and Non-adjunctive Continuous Glucose Monitoring Use

Self-monitoring of blood glucose (SMBG) is now recognised as a core component of diabetes self-management. However, there are many limitations to SMBG use in individuals with diabetes who are treated with intensive insulin regimens. Many individuals do not test at the recommended frequencies. Additionally, because SMBG only provides a blood glucose reading at a single point in time, hypoglycaemia and hyperglycaemia can easily go undetected, limiting the user’s ability to take corrective action. Inaccuracies due to user error, environmental factors and weaknesses in SMBG system integrity further limit the utility of SMBG. Real-time continuous glucose monitoring (CGM) displays the current glucose, direction and velocity of glucose change and provides programmable alarms. This trending information and ‘aroundthe- clock’ vigilance provides a significant safety advantage relative to SMBG. No published clinical studies have evaluated outcomes when CGM is used as a replacement for SMBG; however, recent in silico studies support this indication. This article reviews the limitations of SMBG and discusses recent evidence that supports CGM-based decisions as an effective approach to managing insulin-treated diabetes.