Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05

OBJECTIVE: To perform an open-label, long-term efficacy and safety/tolerability study of vagus nerve stimulation (VNS) of 454 patients with refractory epilepsy. METHODS: Subjects were enrolled from five clinical trials of VNS between 1988 and 1995 after undergoing an implantation of a pulse generator in the chest and a left cervical vagus nerve-stimulating lead coil. Patients were assessed at 6-month intervals until device approval. Seizure frequencies, medication treatment, and adverse events (AEs) were recorded and entered into a database. RESULTS: A total of 454 patients were implanted, and 440 patients yielded assessable data. A > or =50% seizure reduction postimplantation occurred in 36.8% of patients at 1 year, in 43.2% at 2 years, and in 42.7% at 3 years. Median seizure reductions compared with baseline were 35% at 1 year, 44.3% at 2 years, and 44.1% at 3 years. Most common AEs postimplantation at 1 year were hoarseness (28%) and paraesthesias (12%), at 2 years were hoarseness (19.8%) and headache (4.5%), and at 3 years was shortness of breath (3.2%). Continuation rates were 96.7% at 1 year, 84.7% at 2 years, and 72.1% at 3 years. CONCLUSION: Long-term, open-label vagus nerve stimulation (VNS) provided seizure reduction similar to or greater than acute studies, for median reductions and for those reaching a > or =50% seizure reduction. VNS remained safe and well tolerated, with nearly three-quarters of the patients choosing to continue therapy.     

Positron emission tomography in the clinical staging of patients with Stage I and II testicular germ cell tumors

OBJECTIVES: To evaluate the accuracy of fluorodeoxyglucose positron emission tomography (PET) compared with computed tomography (CT) staging in patients with Stage I and II testicular germ cell tumors (GCTs). METHODS: From January 1995 to July 1997, in 37 patients with clinical Stage (CS) I (n = 25) and CS II (n = 12) GCT (24 nonseminomas, 13 seminomas), PET and CT were compared in the initial staging. After PET, the patients with nonseminomatous GCT were staged surgically by retroperitoneal lymph node dissection and the patients with seminomatous GCT were followed up clinically. RESULTS: Correct staging by PET was achieved in 34 of 37 patients compared with correct CT staging in 29 of 37 patients. Of 10 metastatic lesions, 7 and 4 were detected by PET and CT, respectively. PET did not show false-positive signals. PET was unable to detect vital cancer with a maximal diameter less than 0.5 cm or teratoma at any size. CONCLUSIONS: PET was useful for detecting viable tumor in lesions that are visible on CT scan and, thus, it may omit false-positive CS II lesions. However, PET was not able to identify mature teratoma. In this study, PET did not improve the staging in patients with CS I tumor.     

Application of plantar pressure assessment in footwear and insert design

This clinical perspective describes the application of plantar pressure assessment in footwear and insert design. First, the rationale and evidence for using pressure assessment to assist in the design of footwear for patients with diabetes is described. I discuss 2 important measures obtained from pressure assessment: peak pressure, because it represents the magnitude of potential mechanical stresses that can contribute to skin breakdown, and contact area, because this identifies the treatment areas. Using measures obtained from pressure assessment, guidelines are presented to maximize contact area of the insert to the foot and reduce highest peak pressures on the skin, with the goal of preventing skin breakdown. Second, a rationale and guidelines are presented for the application of plantar pressure assessment in the evaluation and design of footwear for people without impairments (i.e., the general public). Finally, future applications of pressure assessment to improve the design and fit of shoes are discussed. Benefits and limitations of using pressure assessment to assist in footwear design are addressed throughout.     

The Changing Landscape of Health Care Financing and Delivery: How Are Rural Communities and Providers Responding?

Rural communities have not kept pace with the recent dramatic changes in health care financing and organization. However, the Medicare provisions in the Balanced Budget Act of 1997 will require rural providers to participate in the new systems. Case studies revealed the degree of readiness for change in six rural communities and charted their progress along a continuum, as reflected in three sets of activities: the development of networking; the creation of new strategies for managing patient care; and the adoption of new methods for contracting with health insurers. Some communities had constructed highly integrated systems, whereas others were just beginning to change their billing practices; a few were signing contracts for capitated care, in contrast to those that were resisting discounts in current fee structures. These six rural areas still have considerable ground to cover before their health care organization and financing reach the levels achieved by urban communities.     

Treatment of herpes retinitis in an animal model with a sustained delivery antiviral drug, liposomal 1-O-octadecyl-SN-glycerol-3-phosphonoformate.

PURPOSE: To evaluate the clinical treatment efficacy of a long-lasting intravitreous injectable anti-cytomegalovirus (CMV) liposomal drug, 1-O-octadecyl-sn-glycerol-3-phosphonoformate (ODG-PFA). METHODS: Sixty-four pigmented rabbits were used for evaluation of the potency and duration of action of ODG-PFA after intravitreal injection using a herpes simplex virus (HSV)-1 retinitis model. For the potency evaluation, liposomal ODG-PFA was injected into rabbit vitreous at the same time that HSV-1 virus was inoculated onto the retina (simultaneous treatment). For the duration evaluation, ODG-PFA was injected days or weeks before inoculation (pretreatment). Retinitis was clinically graded by indirect ophthalmoscopy, and the retinitis scores were compared across the treatment and control groups. RESULTS: Simultaneous treatment study revealed that ODG-PFA was much more potent than its parent compound, foscarnet (P = 0.0027). Pretreatment study indicated that ODG-PFA possesses a much longer antiviral effect (at least 2 weeks) than foscarnet after a single intravitreal injection. CONCLUSION: Liposomal ODG-PFA is a potent long-lasting intravitreal injectable antiviral compound that may be an ideal alternative for treatment of CMV retinitis in patients with acquired immunodeficiency syndrome.     

Removal of silicone oil with vision improvement after rhegmatogenous retinal detachment following CMV retinitis in patients with AIDS

PURPOSE: To report that silicone oil may be safely removed from immuno-recovered patients with acquired immunodeficiency syndrome (AIDS) after instillation for cytomegalovirus (CMV)-related rhegmatogenous retinal detachment. METHOD: We report two patients with CMV-related retinal detachment who had previously been treated with vitrectomy and silicone oil. RESULTS: Six months after removal of silicone oil, the retina remained attached in both patients. Without specific anti-CMV therapy, there was no relapse of CMV retinitis while patients were undergoing highly active antiretroviral therapy. Best-corrected visual acuity improved in both patients. CONCLUSION: It appears to be possible to remove silicone oil safely from patients with AIDS who show immune recovery, thus avoiding side effects of long-standing silicone oil and increasing quality of life. After silicone oil removal, visual acuity was improved.     

Health care reform in the American states: administrative capacity building

As the nation moves to reform Medicare and the health care industry becomes more competitive which will dramatically change the means by which health care is organized and financed, state governments ought to be establishing administrative capacity to administer new systems. This article describes past experiences of states in similar efforts and uses the legislation written in 13 states to analyze in greater detail current state health reform activities. Policies that create new central authorities have the greatest likelihood of building the appropriate administrative infrastructures. Provisions related to establishing data bases, creating regional authorities or advisory committees, establishing uniform claims, and facilitating integrated systems of care are common to several proposals. Previous state experiences with health planning and citizen involvement are evident in the schemes being proposed and enacted.     

Visual performance in the rhesus monkey after exposure to blue light.

Rhesus monkeys trained to perform a visual task (Landolt ring discrimination) were exposed for 1000 sec to known amounts of 441 nm light by means of a 2500 W xenon lamp with narrow bandpass filter. Radiant exposures to the macula of 30 J/cm² did not impair vision, but 60 J/cm² produced a transient loss of 20/20 vision which lasted from 20 to 30 days. A radiant exposure of 90 J/cm² produced a permanent loss of 20/20 vision. These results, in addition to explaining solar retinitis and eclipse blindness, correlate well with the retinal photopathology of the short wavelength photochemical lesion.