Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device.

BACKGROUND: A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. METHODS: Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. RESULTS: In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P<.01). The second trial enrolled 27 patients (mean body mass index 39.3+/-.8 kg/m2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7%+/-3.1%, n=24) compared with the initial study and first-generation device (14.2%+/-2.2%, n=29, P=.03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P=.03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. CONCLUSION: This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.

Central corneal thickness in pediatric glaucoma.

PURPOSE: To compare the central corneal thickness (CCT) of children with and without glaucoma and to estimate the effect CCT may have on the intraocular pressure (IOP) assessment of children. PATIENTS AND METHODS: CCT and IOP measurements were performed in an unmasked fashion in 34 consecutive children with glaucoma and 28 consecutive children without glaucoma. Patients with corneal edema or extensive corneal scarring were excluded. IOPs in the pediatric glaucoma group were corrected for CCT using a linear algorithm; adjustments of 3 mm Hg or more were considered clinically significant. RESULTS: Mean CCT for eyes with glaucoma was 610.2+/-121.9 microm; for the control eyes, mean CCT was 555.6+/-38.4 microm (P < .001). Mean CCT was 543.3+/-66.9 microm for eyes with primary congenital glaucoma, 591.9+/-23.1 pm for those with Sturge-Weber syndrome, 662.7+/-68.7 microm for those with aphakic glaucoma, 754.5 +/-92.6 microm for those with aniridia, and 820.6+/-133.7 microm for those with microcornea (P < .001). Applying a correction formula for IOP with CCT adjustment, the adjusted IOP was overestimated by > or =3 mm Hg in 14 (41.2%) eyes and underestimated by > or = 3 mm Hg in 5 (14.7%) eyes. CONCLUSIONS: The mean CCT was higher for the pediatric glaucoma group than for the control group. However, the CCTs varied significantly depending on the specific diagnoses. CCT was estimated to have a clinically significant effect on IOP measurements in more than half of the patients with pediatric glaucoma. Pachymetry results should be considered in the management of these patients.

Tube occlusion from the external ostium after implantation of an aqueous shunt.

Two patients had undergone double-plate Molteno shunt implantation. Both patients required surgical revision, the first at 41 months and the second at 8 months postoperatively, because of a failure of previously functioning tube shunts caused by blockage of the external ostium and intraluminal invasion of the tube by fibrous tissue. At the time of surgical revision, fibrous tissue extended down the lumen of the tube, occluding its external ostium. After excision of this tissue, both shunts became fully functional. When functioning aqueous shunts fail and there is no evidence of a bleb over the shunt reservoir or blockage of the internal ostium, ingrowth of fibrous tissue into the external ostium should be considered as a potential cause, especially if a ripcord or Latina suture has been left in place.

Senior living environments: evidence-based lighting design strategies.

OBJECTIVE: To review from an architectural lighting perspective the effects of indoor lighting on the health and well-being of people in senior living environments. BACKGROUND: The role of circadian rhythms in people with chronic disorders continues to be a focus of laboratory research and clinical trials. Beneficial, evidence-based indoor lighting design strategies are being considered for senior living environments, particularly for residents who have limited access to natural bright light. METHODS: Articles published 2002-2012 reporting the results of prospective, randomized, controlled clinical trials (RCTs) were accessed using the U.S. National Library of Medicine PubMed site using the following search terms: "light, sleep, circadian, randomized, controlled, nursing home" and "light, sleep, circadian, randomized, controlled, elderly." RESULTS: The search resulted in 48 citations, of which 18 meet our pre-search criteria. Data from these RCTs indicate options such as programmable, 24-hour lighting algorithms that may involve light intensity, lighting duration, spectra (wavelength) and lighting timing sequences CONCLUSIONS: Valid and actionable data are available about circadian rhythms, sleep, and human health and well-being that can inform the design of lighting for long-term care. Evidence-based architectural design of a 24-hour light/dark environment for residents may mitigate symptoms of circadian disruption; evidence-based management of darkness is as important as evidence-based management of light. Further research is needed into the long-term circadian health needs of night staff members in order to understand the effects of shift work while, at the same time providing the highest level of care. KEYWORDS: Design process, elderly, evidence-based design, lighting, literature review.