Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema : Subgroup analysis of the MEAD study

Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34.68 Early Treatment Diabetic Retinopathy Study letters (20/200.20/50 Snellen equivalent), and central retinal thickness (CRT) 65300 \u3bcm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was 6515-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n=261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had 6515-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 \u3bcm with DEX 0.7 versus -39.0 \u3bcm with sham(P < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population

Bowel ultrasound in Crohn's disease : surgical perspective

Background: Bowel ultrasound has been proven to be a useful tool in the management of Crohn's disease, particularly in the assessment of intra-abdominal complications, most of which require surgery. Materials and methods: The National Library of Medicine has been searched for articles on the use of bowel ultrasound in Crohn's disease focusing on aspects of interest to the surgeon. Results and conclusions: Several studies have demonstrated that bowel ultrasound may be useful to reduce the risk of unnecessary laparotomy in patients presenting acute abdomen with suspected chronic inflammatory bowel disease. Bowel ultrasound has been proven to be of value in the follow-up of Crohn's disease patients since allowing early diagnosis of intra-abdominal complications and, therefore, optimising the diagnostic and surgical approach. At followup, bowel ultrasound may accurately diagnose early postoperative complications and long-term disease recurrence. In patients submitted to conservative surgery, ultrasonography reveals changes in diseased bowel walls that may be predictive of recurrence of the disease, and hence determinant in the choice of medical treatment

A novel indocyanine green fluorescence-guided video-assisted technique for sentinel node biopsy in breast cancer

Background: The equipment to detect indocyanine green (ICG) fluorescence for sentinel lymph node (SLN) biopsy in breast cancer is not widely accessible nor optimal. The fluorescence appears as a poorly defined white shine on a black background, and dimmed lighting is required. The aim of this study was to assess the feasibility, accuracy and healthcare costs of a novel approach for SLN biopsy by a video-assisted ICG-guided technique. Methods: The technique for detecting SLN was radioisotope (RI) in 194 cases, video-assisted ICG-guided in 70 cases, and a combined method in 71 cases. In the video-assisted ICG group a full HD laparoscopic system equipped with Xenon lamps was used for a laser-free detection of ICG within a colored and magnified high-resolution image. Results: Detection of ICG fluorescence using a laparoscope with a near-infrared filter provided a highly-defined and coloured image during SLN biopsy. SLN was identified in 100% of patients in all groups. Multiple SLNs were identified in 0.5% of RI patients, in 12.9% of ICG patients and in 14.1% of ICG+RI patients (p<0.0001). In ICG + RI group, 95.1% of lymph nodes were radioactive and 92.7% were fluorescent. Operative times and healthcare costs were equivalent between groups. Conclusions: Video-assisted ICG-guided technique is a feasible and surgeon-friendly method for SLN biopsy, with equivalent efficacy compared to RI, providing an accurate staging of the axilla

L'ecografia intestinale nel morbo di Crohn. Rilevanza chirurgica

The use of ultrasound in Crohns disease has a recent history. This method is useful in various situations like: the diagnosis of the disease, the diagnosis of intra-abdominal complications and the follow-up of the operated patient. Moreover, thanks to its practicality of use, ripetibility and accuracy, ultrasounds can represent a first line diagnostic instrument for Crohns disease both in elective and emergency conditions. The authors, in this paper, consider its usefulness and various aspects in these conditions