Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry.

BACKGROUND: The aim of this study was to evaluate 12-month effectiveness of the endovascular treatment of femoropopliteal (FP) atherosclerotic lesions with the Ranger drug-coated balloon (DCB) in a real-world setting. METHODS: In this prospective, observational, multicenter trial (ClinicalTrials.gov Identifier: NCT02462005) 172 consecutive patients with 226 de novo, restenosed, or reoccluded native superficial femoral and/or popliteal artery lesions were treated with the Ranger paclitaxel-coated balloon angioplasty. Mean lesion length was 129 mm (5-400 mm). Fifty-nine (26%) of 226 lesions were moderately or heavily calcified. Provisional stenting was conducted in 55 (22%) of 226 lesions. Main effectiveness outcomes were procedural success, 6- and 12-month hemodynamic or clinical improvement, and primary patency based and clinically driven target lesion revascularization (TLR) at 6 and 12 months. RESULTS: Procedural success (<30% residual stenosis and no major adverse event within 30 days) was achieved in 126 (73%) of 172 patients with DCB alone and in all patients if bailout procedures were included. Primary patency was 91.0% at 6 months and 84.1% at 12 months. Freedom TLR was 92.4% at 6 months and 89.2% at 12 months. ABI, pain-free walking distance and Rutherford category improved significantly (P<0.001) after 6 and 12 months. CONCLUSIONS: Results suggest that angioplasty with the Ranger paclitaxel-coated balloon with provisional stenting is efficacious for the treatment of a broad range of femoropopliteal atherosclerotic lesions. No safety concerns arose.

Adaptation of mastication mechanics and eating behaviour to small differences in food texture.

Eating behaviour is significantly modified with the consumption of soft or hard textures. However, it is of interest to describe how adaptive is mastication to a narrow range of texture. ElectroMyoGraphy (EMG) and Kinematics of Jaw Movements (KJM) techniques were used simultaneously to follow mastication muscle activity and jaw motion during mastication of seven cereal products. We show that parameters such as the time of chewing activity, the number of chewing cycles, the chewing muscle EMG activity and the volume occupied for each chewing cycle are amongst others significantly different depending on products tested, even though the textural product space investigated is quite narrow (cereal finger foods). In addition, through a time/chewing cycle dependent analysis of the chewing patterns, we demonstrate that different foods follow different breakdown pathways during oral processing, depending on their initial structural properties, as dictated by their formulation and manufacturing process. In particular, we show that mastication behaviour of cereal foods can be partly classified based on the process that is used to generate product internal structure (e.g. baking vs extrusion). To the best of our knowledge, such time dependent analyses have not yet been reported. Those results suggest that it is possible to influence the chewing behaviour by modifying food textures within the same "food family". This opens new possibilities to design foods for specific populations that cannot accomplish specific oral processing tasks.

Acrylamide formation from asparagine under low moisture Maillard reaction conditions. 2. Crystalline vs amorphous model systems.

The formation of acrylamide was investigated in model systems based on asparagine and glucose under low moisture Maillard reaction conditions as a function of reaction temperature, time, physical state, water activity, and glass transition temperature. Equimolar amorphous glucose/asparagine systems with different water activities were prepared by freeze drying and were shown to quickly move to the rubbery state already at room temperature and a water activity of above 0.15. The acrylamide amounts were correlated with physical changes occurring during the reaction. Pyrolysis and kinetics of acrylamide release in amorphous and crystalline glucose/asparagine models indicated the importance of the physical state in acrylamide formation. In amorphous systems, acrylamide was generated in higher concentrations and at lower temperatures as compared to the crystalline samples. Time and temperature are covariant parameters in both systems affecting the acrylamide formation by thermal processes. On the other side, the water activity and glass transition temperature do not seem to be critical parameters for acrylamide formation in the systems studied.

Acrylamide formation from asparagine under low-moisture Maillard reaction conditions. 1. Physical and chemical aspects in crystalline model systems.

The formation of acrylamide in crystalline model systems based on asparagine and reducing sugars was investigated under low-moisture reaction conditions. The acrylamide amounts were correlated with physical changes occurring during the reaction. Molecular mobility of the precursors turned out to be a critical parameter in solid systems, which is linked to the melting behavior and the release of crystallization water of the reaction sample. Heating binary mixtures of asparagine monohydrate and anhydrous reducing sugars led to higher acrylamide amounts in the presence of fructose compared to glucose. Differential scanning calorimetry measurements performed in open systems indicated melting of fructose at 126 degrees C, whereas glucose and galactose fused at 157 and 172 degrees C, respectively. However, glucose was the most reactive and fructose the least efficient sugar in anhydrous liquid systems, indicating that at given molecular mobility the chemical reactivity of the sugar was the major driver in acrylamide formation. Furthermore, reaction time and temperature were found to be covariant parameters: acrylamide was preferably formed by reacting glucose and asparagine at 120 degrees C for 60 min, whereas 160 degrees C was required at shorter reaction time (5 min). These results suggest that, in addition to the chemical reactivity of ingredients, their physical state as well as reaction temperature and time would influence the formation of acrylamide during food processing.