Objectives This study introduces an initial evaluation of a novel High‐Intensity Focused Electromagnetic (HIFEM) technology. The primary goal is to quantify any effects the treatments may have on abdominal tissues, as well as to establish hypotheses for future research of this technology. Methods Twenty‐two patients received four abdominal treatments using the EMSCULPT device (BTL Industries Inc., Boston, MA). Anthropometric evaluations were recorded and digital photographs were taken at baseline, at 2 months, and at 6 months post‐treatments. The MRI without contrast determined by vertertebras T12 and S1 (FIESTA and FSPRG sequences) was used to measure dimensions in coronal cross‐sectional images of abdominal muscle and fatty tissues, in order to assess any anatomical changes induced by the application. Results Analysis of the same MRI slices verified by tissue artefacts showed a statistically significant (all P < 0.0001) average 18.6% reduction of adipose tissue thickness, 15.4% increase in rectus abdominis muscle thickness, and 10.4% reduction in rectus abdominus separation (diastasis recti) as measured from the medial border of the muscle 2 months post‐treatment. More significant improvements were observed in patients with BMI 18.5–24.9 (classified as “normal”). MRI data from 6‐month follow‐up suggest the changes can be preserved in longer term. Tape measurements showed on average 3.8 cm subumbilical circumference reduction. The weight of the subjects did not change significantly (average −0.5 lb; P > 0.05). No adverse events were reported. Conclusions MRI, considered as a highly precise diagnostic method, revealed simultaneous muscle growth, fat reduction and reduced abdominal separation at 2 months and at 6 months post treatments, unrelated with dieting. Further research should investigate the exact physiological processes which stand behind the tissue changes observed in this study. Lasers Surg. Med. 51:40–46, 2019. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.
Background Several studies investigating high-intensity focused electromagnetic (HIFEM) treatments have recently been published. However, due to the novelty of the procedure, long-term data are still missing. Objectives The aim of this study was to evaluate changes in abdominal tissues on average 1 year after a series of HIFEM treatments, to determine the long-term durability of patients’ original body responses. Methods Magnetic resonance imaging (MRI) or computed tomography (CT) scanning were performed on 21 patients a mean of 332.6 [88.5] days after their original HIFEM treatment series. The scans were evaluated by a blinded radiologist for abdominal muscle thickness, subcutaneous fat changes, and abdominal separation. The results were compared with the MRI/CT-assisted measurements taken at baseline and 6-week follow-up. Correlations between collected data sets were calculated and tested. The incidence of any adverse events related to earlier treatments was monitored. Results When comparing the 1-year follow-up measurements with the baseline, the MRI/CT-assisted calculations revealed mean reductions of 14.63% (2.97 [2.11] mm) in fat, 19.05% (1.89 [0.88] mm) in muscle thickening, and 10.46% (1.96 [1.71] mm) in diastasis recti. All changes were significant (P < 0.05) and not related to weight fluctuations (P > 0.05). The baseline width of diastasis positively correlated with the degree of improvement at follow-up. No adverse events were reported. Conclusion The HIFEM-induced muscle hypertrophy, fat reduction, and reduction in abdominal separation were maintained 1-year posttreatment. This suggests long-term durability of the original bodily response, which needs to be verified by continuing follow-up of this group and by further studies. Level of Evidence: 4
BackgroundBacterial biofilms have been implicated with breast implant complications including capsular contracture and anaplastic large-cell lymphoma. The actual mechanisms for either are still under active investigation and are not clear. Due to their increased surface area, implants with textured surfaces may harbor greater biofilm loads than those with smooth surfaces.MethodsBiofilm formation on the outer surface material was compared using implants with various surface areas and roughness, including Natrelle® (Smooth), SmoothSilk®/SilkSurface® (Silk), VelvetSurface ® (Velvet), Siltex®, and Biocell®. The roughness and surface area of each material were assessed using non-contact profilometry. Bacterial attachment (2 h) and biofilm formation (24 h) were evaluated for Staphylococcus epidermidis, Pseudomonas aeruginosa, and Ralstonia pickettii over nine independent experiments using a CDC biofilm reactor and viable plate counts (VPCs) as well as confocal scanning laser microscopy. VPCs of the textured implants were compared relative to the Smooth implant.ResultsSurface areas increased with roughness and were similar among the three least rough implants (Smooth, Silk, and Velvet) and among the roughest implants (Siltex and Biocell). Overall, VPC indicated there was significantly more bacterial attachment and biofilm formation on the Siltex and Biocell implants than the Silk or Velvet implants, although there were differences between species and time points. CSLM confirmed the formation of thicker biofilms on the implants with rougher surface textures.ConclusionThis in vitro study confirmed that implant surfaces with rougher texture, resulting in more surface area, harbored greater biofilm loads than those with smoother surfaces.No Level AssignedThis journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
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