The Association of Psychiatric Comorbidities With Short-Term and Long-Term Outcomes Following Spinal Cord Stimulator Placement.

BACKGROUND: Outcomes after spinal cord stimulator (SCS) placement are affected by psychologic comorbidities. It is part of routine practice to do psychologic assessments prior to SCS trials to assess for the presence of maladaptive behavioral patterns. However, few studies have sought to quantify the effect of psychiatric comorbidities on complications, reoperation, and readmission rates. The purpose of this study was to assess the association of psychiatric comorbidities with postprocedural outcomes after SCS implantation. MATERIALS AND METHODS: Inclusion criteria included SCS placement between 2015 and 2020 (percutaneous approach or an open laminectomy-based approach) using Healthcare Corporation of America National Database. Data on psychiatric comorbidities present at the time of SCS implantation surgery were collected. Outcomes of interest included complication rates (defined as lead migration, fracture, malfunction, battery failure, postoperative pain, infection, dural puncture, or neurological injury), reoperation rates (defined as either revision or explant [ie, removal]), and readmission rates within 30-day and 1-year time after SCS implantation. We measured the association between psychiatric comorbidities and outcomes using multivariable regression and reported odds ratio (OR) and respective 95% confidence intervals. RESULTS: A total of 12,751 cases were included. The most common psychiatric comorbidities were major depressive disorder (16.1%) and anxiety disorder (13.4%). In unadjusted univariate analysis, patients with any psychiatric comorbidity had heightened rates of any complication (27.1% vs 19.4%), infection (5.9% vs 1.9%), lead displacement (2.2% vs 1.3%), surgical pain (2.1% vs 1.2%), explant (14.7% vs 8.8%), and readmission rates at one year (54.2% vs 33.8%) (all p < 0.001). In multivariable logistic regression, with each additional psychiatric comorbidity, a patient had increased odds of experiencing any complication (OR = 1.5, 95% CI = 1.36-1.57, p < 0.001), requiring a reoperation (OR = 1.5, 95% CI = 1.37-1.6, p < 0.001), and requiring readmission (OR = 1.7, 99% CI = 1.6-1.8, p < 0.001). CONCLUSIONS: The presence of psychiatric comorbidities was found to be associated with postoperative complication rates, reoperation, and readmission rates after SCS placement. Furthermore, each consecutive increase in psychiatric comorbidity burden was associated with increased odds of complications, reoperation, and readmission. Future studies might consider examining the role of presurgical mental health screening (ie, patient selection, psychologic testing) and treatment in optimizing outcomes for patients with psychiatric comorbidities.

Image-Guided Surgical Device Failures in Functional Endoscopic Sinus Surgery: A MAUDE Analysis.

OBJECTIVE: Image-guided surgery (IGS) devices have become widely used for anatomic localization during functional endoscopic sinus surgery (FESS). However, there are no studies that analyze the post-market complications associated with IGS device use during FESS. The objective of this study was to better characterize post-market complications associated with the use of IGS devices during sinus surgery. METHODS: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for event reports associated with neurological stereotaxic devices utilized in IGS between the dates of January 1, 2016 and December 31, 2020. Medical device reports that were analyzed for this study pertained strictly to FESS. RESULTS: There were 1873 reports involving IGS devices for FESS included in this study. Fifty-five reports involved adverse events to patients (2.9%) and 1818 (97.1%) involved device malfunctions. Of the adverse events to patients, the most common included cerebrospinal fluid leakage (45.6%), tissue damage (12.7%), and nervous system injury (3.6%). The most commonly reported device malfunction was imprecision (21.1%). CONCLUSION: IGS devices are widely utilized in FESS. Of the medical device reports between 2016 and 2020, less than 3% resulted in adverse events. Further studies of the infrequent post-market complications of IGS devices used in FESS can help guide surgeons on the risks of their clinical use. LEVEL OF EVIDENCE: 4-Retrospective database survey without controls Laryngoscope, 133:1310-1314, 2023.