Journal of neurosurgery
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Journal of neurosurgery · Jan 2022
Long-term stability of Onyx: is there any indication for repeated angiography after dural arteriovenous fistula embolization?
The natural course of dural arteriovenous fistulas (DAVFs) is unfavorable. Transarterial embolization with Onyx is currently the therapeutic method of choice, although the long-term stability of Onyx has been questioned. The literature reports a significant difference in the recurrence rate after complete DAVF occlusion and lacks larger series with long-term follow-up. The authors present the largest series to date with a long-term follow-up to determine the stability of Onyx, prospectively comparing magnetic resonance angiography (MRA) and digital subtraction angiography (DSA) as follow-up diagnostic methods. ⋯ Onyx is a stable embolic material, although recurrence of seemingly completely occluded DAVFs may develop because of postembolization hemodynamic changes that accentuate primarily graphically absent residual fistula. These residuals can be diagnosed with MRA at follow-up. The authors' data suggest that MRA could be sufficient as the follow-up diagnostic method after complete DAVF occlusion with Onyx. However, larger prospective studies on this topic are needed.
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Journal of neurosurgery · Jan 2022
Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials.
The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials. ⋯ The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.
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Journal of neurosurgery · Jan 2022
Trends in physician reimbursements and procedural volumes for radiosurgery versus open surgery in brain tumor care: an analysis of Medicare data from 2009 to 2018.
Given its minimally invasive nature and effectiveness, stereotactic radiosurgery (SRS) has become a mainstay for the multimodal treatment of intracranial neoplasm. However, no studies have evaluated recent trends in the use of SRS versus those of open resection for the management of brain tumor or trends in the involvement of neurosurgeons in SRS (which is primarily delivered by radiation oncologists). Here, the authors used publicly available Medicare data from 2009 to 2018 to elucidate trends in the treatment of intracranial neoplasm and to compare reimbursements between these approaches. ⋯ Over a decade, the number of open resections for intracranial neoplasm in Medicare enrollees declined slightly, while the number of SRS procedures increased greatly. This latter expansion is largely attributable to radiation oncologists; meanwhile, neurosurgeons have shifted their involvement in SRS toward sessions for the management of multiple lesions.