Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms.

BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial-the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS: Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.

When unequals are treated equally: the 2002 commission of inquiry into Orica's Geomelt proposal.

This paper deals with the Commission of Inquiry (COI) established by the NSW Department of Planning to examine Orica's proposal to build a Geomelt plant at its Botany site to destroy its stockpile of Hexachlorobenzene. The Inquiry is analysed in light of the literature on democracy/democratisation. The paper argues that the standard operating procedures of the Inquiry ensured that all stakeholders were treated equally. However, this equality was found to be purely formal, and drawing on the critique of formal equality dating back to Aristotle, it is argued that treating unequals equally results in the circumvention of deliberative democratic ideals by perpetuating entrenched structural inequalities while nonetheless giving the superficial appearance of fair play.

Prospective grading of graft-versus-host disease after unrelated donor marrow transplantation: a grading algorithm versus blinded expert panel review.

In conjunction with a randomized trial of T-cell depletion versus conventional graft-versus-host disease (GVHD) prophylaxis, we assessed GVHD grading by comparing the transplant center 100-day score, a clinically calculated algorithm, and a blinded expert panel review (PR). Weekly skin, gut, and liver clinical staging; clinically verified differential diagnosis; biopsy information; cyclosporine levels; and initiation of treatment were reviewed and graded according to the consensus GVHD grading method modified by a prospectively determined grading algorithm that specified liver and gut downstaging if a differential diagnosis in that organ was identified. Transplant center (TC) determination of maximum grade was compared with the algorithm-calculated grade and the final expert PR. Of 404 patients reviewed, the TC grade concurred with the calculated algorithm grade in 72% (the algorithm upgraded 18% and downgraded 10%), whereas the TC grade agreed with the PR in 77% (the PR upgraded 12% and downgraded 11%). The calculated algorithm grade was nearly fully (92%) concordant with the final PR grade (the PR upgraded 0.7% and downgraded 7%). Blinded, duplicate reviews for quality control (n = 108) agreed with the initial review in 89% of cases. Algorithm and/or PR review reduced the TC-reported incidence of grade II (28% to 23%) and increased grade III (11% to 20%), whereas grade 0 (41% to 42%), grade I (13% to 12%), and grade IV (7% to 6%) were invariant. Recalculation of the algorithm grading without differential diagnosis downstaging reduced agreement with the TC to a small extent. The original algorithm changed 51 (13%) of 404 from grade 0 to II into grade III or IV or vice versa; calculation without the downgrade modified 44 cases (11%). Maximum acute GVHD grade had a major effect on 2-year disease-free survival, but assignment by TC, calculated algorithm, or final PR grade had little effect on survival within grades or grade categories 0 through II versus III or IV. We conclude that detailed and expert PR yields GVHD scoring that is internally consistent and reproducible with 89% concordance. Weekly recording of GVHD stage along with a calculated grading algorithm acknowledging differential diagnoses results in a final and maximum grade nearly fully concordant with the expert blinded PR. Multicenter prospective GVHD scoring using all available weekly staging and differential diagnosis data can be reliably assessed with a clinically relevant algorithm. This approach can thereby reduce investigator bias, facilitate comparison between centers, and perhaps eliminate the need for an expert PR. This technique should be used in future prospective studies of GVHD prophylaxis.