The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes.

BACKGROUND: Prior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate. OBJECTIVE: This WOVEN study assesses the 1-year follow-up from this cohort. METHODS: Twelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis. RESULTS: In the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up. CONCLUSIONS: The WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.

Cost-effectiveness model for first-trimester versus second-trimester ultrasound screening for Down syndrome.

PURPOSE: To develop a cost-effectiveness analysis model from the perspective of Medicare reimbursement to evaluate the costs and potential risks involved in performing second-trimester genetic sonography following the first-trimester sonographic measurement of nuchal translucency and serology for Down syndrome screening. METHODS: Three clinical screening algorithms were constructed that detailed the diagnostic evaluation of the target population by using first-trimester or second-trimester ultrasound and appropriate serologies or first-trimester and second-trimester screening in combination. The cost analysis was then created by using a computer spreadsheet program by applying Medicare reimbursement, the prevalence of Down syndrome, and reported sensitivities of first-trimester and second-trimester ultrasound and analytes for Down syndrome for each clinical algorithm. Medicare Current Procedural Terminology codes, total relative value units, and payments for first-trimester and second-trimester ultrasound, chorionic villous sampling, amniocentesis, and serum analytes were obtained from the Medicare Part B Washington 2002 Provider Disclosure Report. RESULTS: At any given prevalence of Down syndrome, first-trimester screening is always slightly less expensive to society than the other two models for both total cost and cost to diagnose each case of Down syndrome. Even if second-trimester screening were 100% sensitive, the sensitivity of first-trimester screening would have to fall below 55% for model 2 to be cheaper than model 1. Combining both first-trimester and second-trimester screening was substantially more expensive than models 1 or 2. More iatrogenic fetal deaths occur with combined screening than with either first or second trimester screening alone. CONCLUSIONS: Screening using first-trimester ultrasound and serologic markers to screen for Down syndrome is always slightly less expensive to society than second-trimester serologic and ultrasound screening. However, there is a significantly increased risk for iatrogenic fetal death if second-trimester genetic sonography is performed following normal first-trimester screening using currently accepted risk ratios. Patients should be counseled appropriately with this information, because an individual's circumstances will affect that person's perception of risk and subsequently affect his or her decision making.