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Manmeet Ahluwalia, Gene H. Barnett, Di Deng, Stephen B. Tatter, Adrian W. Laxton, Alireza M. Mohammadi, Eric Leuthardt, Roukoz Chamoun, Kevin Judy, Anthony Asher, Marco Essig, Jorg Dietrich and Veronica L. Chiang

OBJECTIVE

Laser Ablation After Stereotactic Radiosurgery (LAASR) is a multicenter prospective study of laser interstitial thermal (LITT) ablation in patients with radiographic progression after stereotactic radiosurgery for brain metastases.

METHODS

Patients with a Karnofsky Performance Scale (KPS) score ≥ 60, an age > 18 years, and surgical eligibility were included in this study. The primary outcome was local progression-free survival (PFS) assessed using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Secondary outcomes were overall survival (OS), procedure safety, neurocognitive function, and quality of life.

RESULTS

Forty-two patients—19 with biopsy-proven radiation necrosis, 20 with recurrent tumor, and 3 with no diagnosis—were enrolled. The median age was 60 years, 64% of the subjects were female, and the median baseline KPS score was 85. Mean lesion volume was 6.4 cm3 (range 0.4–38.6 cm3). There was no significant difference in length of stay between the recurrent tumor and radiation necrosis patients (median 2.3 vs 1.7 days, respectively). Progression-free survival and OS rates were 74% (20/27) and 72%, respectively, at 26 weeks. Thirty percent of subjects were able to stop or reduce steroid usage by 12 weeks after surgery. Median KPS score, quality of life, and neurocognitive results did not change significantly for either group over the duration of survival. Adverse events were also similar for the two groups, with no significant difference in the overall event rate. There was a 12-week PFS and OS advantage for the radiation necrosis patients compared with the recurrent tumor or tumor progression patients.

CONCLUSIONS

In this study, in which enrolled patients had few alternative options for salvage treatment, LITT ablation stabilized the KPS score, preserved quality of life and cognition, had a steroid-sparing effect, and was performed safely in the majority of cases.

Clinical trial registration no.: NCT01651078 (clinicaltrials.gov)

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Jason P. Sheehan, Brian D. Kavanagh, Anthony Asher and Robert E. Harbaugh

Stereotactic radiosurgery (SRS) represents a multidisciplinary approach to the delivery of ionizing high-dose radiation to treat a wide variety of disorders. Much of the radiosurgical literature is based upon retrospective single-center studies along with a few randomized controlled clinical trials. More timely and effective evidence is needed to enhance the consistency and quality of and clinical outcomes achieved with SRS. The authors summarize the creation and implementation of a national SRS registry.

The American Association of Neurological Surgeons (AANS) through NeuroPoint Alliance, Inc., started a successful registry effort with its lumbar spine initiative. Following a similar approach, the AANS and NeuroPoint Alliance collaborated with corporate partners and the American Society for Radiation Oncology to devise a data dictionary for an SRS registry. Through administrative and financial support from professional societies and corporate partners, a framework for implementation of the registry was created. Initial plans were devised for a 3-year effort encompassing 30 high-volume SRS centers across the country. Device-specific web-based data-extraction platforms were built by the corporate partners. Data uploaders were then used to port the data to a common repository managed by Quintiles, a national and international health care trials company.

Audits of the data for completeness and veracity will be undertaken by Quintiles to ensure data fidelity. Data governance and analysis are overseen by an SRS board comprising equal numbers of representatives from the AANS and NeuroPoint Alliance. Over time, quality outcome assessments and post hoc research can be performed to advance the field of SRS.

Stereotactic radiosurgery offers a high-technology approach to treating complex intracranial disorders. Improvements in the consistency and quality of care delivered to patients who undergo SRS should be afforded by the national registry effort that is underway.

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Richard P. Menger, Bharat Guthikonda, Christopher M. Storey, Anil Nanda, Matthew McGirt and Anthony Asher

Neurosurgeons provide direct individualized care to patients. However, the majority of regulations affecting the relative value of patient-related care are drafted by policy experts whose focus is typically system- and population-based. A central, prospectively gathered, national outcomes-related database serves as neurosurgery’s best opportunity to bring patient-centered outcomes to the policy arena.

In this study the authors analyze the impact of the Affordable Care Act (ACA) on the determination of quality and value in neurosurgery care through the scope, language, and terminology of policy experts. The methods by which the ACA came into law and the subsequent quality implications this legislation has for neurosurgery will be discussed. The necessity of neurosurgical patient-oriented clinical registries will be discussed in the context of imminent and dramatic reforms related to medical cost containment.

In the policy debate moving forward, the strength of neurosurgery’s argument will rest on data, unity, and proactiveness. The National Neurosurgery Quality and Outcomes Database (N2QOD) allows neurosurgeons to generate objective data on specialty-specific value and quality determinations; it allows neurosurgeons to bring the patient-physician interaction to the policy debate.