Postsurgical morbidity and mortality favorably informs deep brain stimulation for new indications including schizophrenia and schizoaffective disorder.

Autor:	Gault JM; Department of Neurosurgery, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.; Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, United States., Hosokawa P; Department of Neurosurgery, University of Colorado Anschutz Medical Campus, Aurora, CO, United States., Kramer D; Department of Neurosurgery, University of Colorado Anschutz Medical Campus, Aurora, CO, United States., Saks ER; The Law School, University of Southern California, Los Angeles, CA, United States., Appelbaum PS; Department of Psychiatry, Columbia University, New York, Ny, United States Of America., Thompson JA; Department of Neurosurgery, University of Colorado Anschutz Medical Campus, Aurora, CO, United States., Olincy A; VA Eastern Colorado Medical Center, Aurora, CO, United States., Cascella N; Department of Psychiatry, Johns Hopkins University, Baltimore, MD, United States., Sawa A; Department of Psychiatry, Johns Hopkins University, Baltimore, MD, United States., Goodman W; Department of Psychiatry, Baylor College of Medicine, Houston, TX, United States., Moukaddam N; Department of Psychiatry, Baylor College of Medicine, Houston, TX, United States., Sheth SA; Department of Neurosurgery, Baylor College of Medicine, Houston, TX, United States., Anderson WS; Department of Neurosurgery, Johns Hopkins University, Baltimore, MD, United States., Davis RA; Department of Neurosurgery, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.; Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in surgery [Front Surg] 2023 Mar 30; Vol. 10, pp. 958452. Date of Electronic Publication: 2023 Mar 30 (Print Publication: 2023).
DOI:	10.3389/fsurg.2023.958452
Abstrakt:	Background: Deep brain stimulation (DBS) shows promise for new indications like treatment-refractory schizophrenia in early clinical trials. In the first DBS clinical trial for treatment refractory schizophrenia, despite promising results in treating psychosis, one of the eight subjects experienced both a symptomatic hemorrhage and an infection requiring device removal. Now, ethical concerns about higher surgical risk in schizophrenia/schizoaffective disorder (SZ/SAD) are impacting clinical trial progress. However, insufficient cases preclude conclusions regarding DBS risk in SZ/SAD. Therefore, we directly compare adverse surgical outcomes for all surgical procedures between SZ/SAD and Parkinson's disease (PD) cases to infer relative surgical risk relevant to gauging DBS risks in subjects with SZ/SAD. Design: In the primary analysis, we used browser-based statistical analysis software, TriNetX Live (trinetx.com TriNetX LLC, Cambridge, MA), for Measures of Association using the Z-test. Postsurgical morbidity and mortality after matching for ethnicity, over 39 risk factors, and 19 CPT 1003143 coded surgical procedures from over 35,000 electronic medical records, over 19 years, from 48 United States health care organizations (HCOs) through the TriNetX Research Network™. TriNetXis a global, federated, web-based health research network providing access and statistical analysis of aggregate counts of deidentified EMR data. Diagnoses were based on ICD-10 codes. In the final analysis, logistic regression was used to determine relative frequencies of outcomes among 21 diagnostic groups/cohorts being treated with or considered for DBS and 3 control cohorts. Results: Postsurgical mortality was 1.01-4.11% lower in SZ/SAD compared to the matched PD cohort at 1 month and 1 year after any surgery, while morbidity was 1.91-2.73% higher and associated with postsurgical noncompliance with medical treatment. Hemorrhages and infections were not increased. Across the 21 cohorts compared, PD and SZ/SAD were among eight cohorts with fewer surgeries, nine cohorts with higher postsurgical morbidity, and fifteen cohorts within the control-group range for 1-month postsurgical mortality. Conclusions: Given that the subjects with SZ or SAD, along with most other diagnostic groups examined, had lower postsurgical mortality than PD subjects, it is reasonable to apply existing ethical and clinical guidelines to identify appropriate surgical candidates for inclusion of these patient populations in DBS clinical trials. Competing Interests: SAS is a consultant for Boston Scientific, Zimmer Biomet, Neuropace, Abbott. WKG received honorarium from Biohaven Pharmaceuticals, royalties from NView, LLC, and donated devices from Medtronic for an NIH funded research study. RAD provides paid Ad Hoc consultation for Medtronic. JMG owns Pfizer stock. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2023 Gault, Hosokawa, Kramer, Saks, Appelbaum, Thompson, Olincy, Cascella, Sawa, Goodman, Moukaddam, Sheth, Anderson and Davis.)
Databáze:	MEDLINE
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