Complications associated with deep brain stimulation for Parkinson's disease: a MAUDE study.

INTRODUCTION: Deep brain stimulation (DBS) is a common surgical option for the treatment of medically refractory Parkinson's disease (PD). Manufacturer and User Facility Device Experience (MAUDE), a United States Food and Drug Administration (FDA)-compiled database of adverse event reports related to medical devices, is a public resource that can provide insight into the relative frequency of complications and patient complaints. MATERIALS AND METHODS: We accessed the MAUDE database and queried for adverse reports for deep brain stimulators implanted for PD from January 1, 2009 to December 31, 2018. Complaints were classified into device malfunction, patient non-compliance, patient complaint, surgically managed complications (i.e. complications that are corrected via surgery), and death. Patient complaints were further stratified into ineffective stimulation, shock, overstimulation, battery-related problems, or pain at the pulse generator site. Surgically managed complications were classified as intraoperative complications, impedance, migration, erosion, infection, lead fracture, and lead disconnection. Each event could receive multiple classifications and subclassifications. RESULTS: A total of 4,189 adverse event reports was obtained. These encompassed 2,805 patient complaints. Within this group, 797 (28%) events were classified as ineffective stimulation. There were 1,382 surgically managed complications, 104 (8%) of which were intraoperative complications, 757 (55%) documented impedance issues, 381 (28%) infections, and 413 (30%) lead-related issues. There were 53 documented deaths. CONCLUSIONS: The MAUDE database has potential use as a real time monitor for elucidating the relative occurrence of complications associated with deep brain stimulation. It also allows for the analysis of device-related complications in specific patient populations. Although the database is useful in this endeavor, it requires improvements particularly in the standardization of reporting adverse events.

Systemic Outcomes in Adults Undergoing Emergent Repair of Orbital Blowout Fractures.

Purpose: To analyze the association between emergent surgery status and systemic adverse outcomes in patients undergoing open orbital floor blowout fracture repair. Methods: This retrospective cohort analysis utilized the 2005-2018 National Surgery Quality Improvement Program (NSQIP) database. Current Procedural Terminology (CPT) codes were used to identify cases with open treatment of orbital floor blowout fractures (21385, 21386, 21387, 21390, 21395). Demographics, comorbidities, and complication incidences were compared between patients undergoing emergent surgery and those undergoing non-emergent orbital blowout fracture repair using chi-square analyses. The independent effect of preoperative emergent status on adverse outcomes was analyzed using binary logistic regression. Results: 1,146 (96.0%) non-emergent and 48 (4.0%) emergent orbital blowout fracture repairs were identified from 2005 to 2018. Chi-square analysis indicated patients undergoing emergent repairs had higher incidences of preoperative wound infection (8.3% vs. 2.3%; p = 0.029) and systemic sepsis (8.3% vs. 0.6%; p = 0.001). The emergent cohort had a higher proportion of patients with Hispanic ethnicity (p = 0.011). Unadjusted chi-square analysis indicated the emergent cohort had a higher incidence of prolonged length of stay (50.1% vs. 10.1%; p < 0.001). After adjusting for confounders, logistic regression analysis indicated emergent status was an independent risk factor for prolonged length of stay (OR 13.05; 95% CI 5.26-32.37; p < 0.001). Conclusion: Emergent surgery status is an important factor associated with increased odds of prolonged length of stay in patients undergoing open orbital blowout fracture repair. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-024-04681-0.

Racial Disparities in Charges, Length of Stay, and Complications Following Adult Inpatient Epistaxis Treatment.

BACKGROUND: Although recent studies have identified an association between race and adverse outcomes in head and neck surgeries, there are limited data examining the impact of racial disparities on adult inpatient outcomes following epistaxis management procedures. OBJECTIVE: To analyze the association between race and adverse outcomes in hospitalized patients undergoing epistaxis treatment. METHODS: This retrospective cohort analysis utilized the 2003 to 2014 National Inpatient Sample. International Classification of Diseases, Ninth Revision codes were used to identify cases with a primary diagnosis of epistaxis that underwent a procedure for epistaxis control. Cases with missing data were excluded. Higher total charges and prolonged length of stay (LOS) were indicated by values greater than the 75th percentile. Demographics, hospital characteristics, Elixhauser comorbidity score, and complications were compared among race cohorts using univariate chi-square analysis and one-way analysis of variance (ANOVA). The independent effect of race on adverse outcomes was analyzed using multivariate binary logistic regression while adjusting for the aforementioned variables. RESULTS: Of the 83 356 cases of epistaxis included, 80.3% were White, 12.5% Black, and 7.2% Hispanic. Black patients had increased odds of urinary/renal complications (odds ratio [OR] 2.148, 95% confidence interval [CI] 1.797-2.569, P < .001) compared to White patients. Additionally, Black patients experienced higher odds of prolonged LOS (OR 1.227, 95% CI 1.101-1.367, P < .001) and higher total charges (OR 1.257, 95% CI 1.109-1.426, P < .001) compared to White patients. Similarly, Hispanic patients were more likely to experience urinary/renal complications (OR 1.605, 95% CI 1.244-2.071, P < .001), higher total charges (OR 1.519, 95% CI 1.302-1.772, P < .001), and prolonged LOS (OR 1.157, 95% CI 1.007-1.331, P = .040) compared to White patients. CONCLUSION: Race is an important factor associated with an increased incidence of complications in hospitalized patients treated for epistaxis.

The Impact of Diabetes on Morbidity and Mortality Following Thyroidectomy.

OBJECTIVES: To explore the association between diabetes and outcomes in thyroidectomy patients. METHODS: This retrospective cohort analysis used the 2015-2017 American College of Surgeons National Surgery Quality Improvement Program database. Current Procedural Terminology (CPT) codes were used to identify thyroidectomy cases (60210, 60212, 60220, 60225, 60240, 60252, 60254, 60260, 60270, and 60271). Demographics, comorbidities, and complication incidences were compared between diabetic and nondiabetic patients using Pearson's chi-square test/Fisher's exact test as appropriate. The independent effect of diabetes on outcomes was analyzed using binary logistic regression. RESULTS: A total of 47,776 (95.4%) nondiabetic and 2307 (4.6%) diabetic patients undergoing thyroidectomy were identified from 2015 to 2017. Chi-square analysis demonstrated that diabetic patients had higher incidences of obesity (55.2% vs. 33.2%; p < 0.001), dyspnea (12.7% vs. 4.8%; p < 0.001), poor functional status (1.9% vs. 0.4%; p < 0.001), ventilator dependence (0.6% vs. 0.1%; p < 0.001), chronic obstructive pulmonary disease (COPD; 6.8% vs. 2.2%; p < 0.001), congestive heart failure (1.1% vs. 0.3%; p < 0.001), acute renal failure (0.3% vs. 0.0%; p < 0.001), hypertension (79.2% vs. 32.4%; p < 0.001), dialysis (2.0% vs. 0.4%; p < 0.001), open wound (1.1% vs. 0.1%; p < 0.001), steroid use (5.3% vs. 2.3%; p < 0.001), bleeding disorders (3.6% vs. 0.9%; p < 0.001), preoperative blood transfusions (0.2% vs. 0.0%; p = 0.001), and systemic sepsis (1.0% vs. 0.3%; p < 0.001). Demographic characteristics were significantly different between the cohorts including gender (p < 0.001), age (p < 0.001), race (p < 0.001), and Hispanic ethnicity (p = 0.033). After adjusting for these factors, logistic regression analyses showed that diabetes was associated with acute renal failure (OR: 5.836; 95% CI: 1.060-32.134; p = 0.043), wound disruption (OR: 6.194; 95% CI: 1.752-21.900; p = 0.005), prolonged length of stay (OR: 1.430; 95% CI: 1.261-1.622; p < 0.001), unplanned readmission (OR: 1.380; 95% CI: 1.096-1.737; p = 0.006), superficial incisional surgical site infections (OR: 0.240; 95% CI: 0.058-0.995; p = 0.049), urinary tract infection occurrences (OR: 2.173; 95% CI: 1.186-3.980; p = 0.012), organ space surgical site infection occurrences (OR: 3.322; 95% CI: 1.016-10.864; p = 0.047), pneumonia occurrences (OR: 2.091; 95% CI: 1.125-3.884; p = 0.020), any medical complication (OR: 1.697; 95% CI: 1.246-2.313; p = 0.001), and any complication (OR: 1.495; 95% CI: 1.136-1.968; p = 0.004). CONCLUSION: Diabetes mellitus is a significant factor associated with increased odds of complications following thyroidectomy. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:3628-3632, 2023.

Effect of Hypoalbuminemia in Patients Undergoing Parathyroidectomy for Primary Hyperparathyroidism.

OBJECTIVES: Treatment for primary hyperparathyroidism is parathyroidectomy. This study identifies the association between hypoalbuminemia (HA) and outcomes in patients undergoing parathyroidectomy for primary hyperparathyroidism. METHODS: This retrospective cohort analysis utilized the 2006-2015 National Surgical Quality Improvement Program database. Current Procedure Terminology codes were used to identify patients undergoing parathyroidectomy for primary hyperparathyroidism. Prolonged length of stay (LOS) was defined as a duration of 2 days or greater. Demographics and comorbidities were compared between HA (serum albumin <3.5 g/dL) and non-HA cohorts using chi-square analysis. The independent effect of HA on adverse outcomes was analyzed using binary logistic regression. RESULTS: A total of 7183 cases with primary hyperparathyroidism were classified into HA (n = 381) and non-HA (n = 6802) cohorts. HA patients had increased complications, including renal insufficiency (0.8% vs. 0.0%, p = 0.001), sepsis (1.0% vs. 0.1%, p = 0.003), pneumonia (0.8% vs. 0.1%, p = 0.018), acute renal failure (1.0% vs. 0.0%, p < 0.001), and unplanned intubation (1.3% vs. 0.2%, p = 0.004). HA patients had increased risk of death (1.6% vs. 0.1%, p < 0.001), prolonged LOS (40.9% vs. 6.3%, p < 0.001), and any complication (5.5% vs. 1.2%, p < 0.001). Adjusted binary logistic regression indicated HA patients experienced increased odds of progressive renal insufficiency (OR 18.396, 95% CI 1.844-183.571, p = 0.013), prolonged LOS (OR 4.892; 95% CI 3.571-6.703; p < 0.001), unplanned reoperation (OR 2.472; 95% CI 1.012-6.035; p = 0.047), and unplanned readmission (OR 3.541; 95% CI 1.858-6.748; p < 0.001). CONCLUSIONS: HA may be associated with adverse complications in patients undergoing parathyroidectomy for primary hyperparathyroidism. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:2035-2039, 2023.

Cutaneous sarcoidosis: Lupus pernio and more.

Sarcoidosis is a multiorgan disease commonly evident with skin involvement. Cutaneous manifestations occur in about 25% of sarcoid patients and are of two types: histologically specific sarcoidal infiltrations and a cutaneous reaction pattern not containing sarcoidal changes, usually erythema nodosum. Cutaneous plaques, nodules, and tumors, sometimes with disfiguring facial features are associated with pain and paresthesia. The disease itself may produce substantial morbidity due to visceral involvement. Advances in therapeutic options include tocilizumab, an IL-6 inhibitor, and tofacitinib - a Janus kinase inhibitor. This review discusses sarcoidosis etiology and pathogenesis, its clinical features, differential diagnosis, and management.

Racial and Socioeconomic Disparities in Necrotizing Soft-Tissue Infection.

Necrotizing soft-tissue infection (NSTI) is a medical emergency. We investigated the impact of racial, socioeconomic disparities, and comorbidities on mortality, complications, length of stay, and charges in patients with NSTI.Data were acquired from the National Inpatient Sample from Q4 2015 to 2017. ICD-10, Clinical Modification codes were utilized to identify relevant cases. Logistic regression was used to assess socioeconomic, racial, and health risk factors for adverse outcomes in NSTI patients.Of 16,071,053 cases identified during the study period, 15,078 (0.094%) NSTI cases were recognized. Black patients had increased odds of amputation (OR 1.40 95% CI 1.24-1.58, p < 0.001), prolonged hospital stay (OR 1.40 95% CI 1.24-1.58, p < 0.001), excessive charges (OR 1.22 95% CI 1.03-1.43, p = 0.019), and adverse discharge disposition (OR 1.32 95% CI 1.19-1.46, p < 0.001) compared to white patients. Hispanic patients had increased odds of mortality (OR 1.30 95% CI 1.05-1.60, p = 0.014) and amputation (OR 1.21 95% CI 1.04-1.42, p = 0.016) compared to white patients. Medicare patients had increased odds of mortality (OR 1.35 95% CI 1.09-1.67, p = 0.006), Medicaid patients had increased odd of amputation (OR 1.33 95% CI 1.17-1.51, p < 0.001) and prolonged LOS (OR 1.33 95% CI 1.17-1.51, p < 0.001). Patients in the lower income quartiles had decreased odds of amputation compared to the highest income quartile, including the 26th to 50th income quartile (OR 0.84 95% CI 0.73-0.98, p = 0.022) and 51st to 75th income quartile (OR 0.84 95% CI 0.73-0.98, p = 0.022).Racial and socioeconomic disparities exist for patients being treated for NSTIs.

Impact of Diabetes Mellitus on Adverse Outcomes After Meningioma Surgery.

OBJECTIVE: We sought to investigate the association between diabetes mellitus and incidence of adverse outcomes in patients who underwent meningioma surgery. METHODS: The 2012-2014 National Inpatient Sample database was used. Prolonged length of stay was indicated by values greater than the 90th percentile of the sample. The Fisher exact test and analysis of variance were used to compare demographics, hospital characteristics, comorbidity, and complications among race cohorts. Logistic regression was used to analyze the independent effect of diabetes on adverse outcomes. RESULTS: After selecting for patients with primary diagnosis of meningioma who underwent a resection procedure, 7745 individuals were identified and divided into diabetic (n = 1518) and nondiabetic (n = 6227) cohorts. Demographics, hospital characteristics, and comorbidities were significantly different among the 2 cohorts. Average length of stay was longer in diabetic patients (8.15 vs. 6.04 days, P < 0.001), and total charges were higher in diabetic patients ($139,462.66 vs. $123,250.71, P < 0.001). Multivariate regression indicated diabetic patients have higher odds of experiencing a complication (odds ratio [OR] 1.442, 95% confidence interval [CI] 1.255-1.656, P < 0.001) and in-hospital mortality (OR 1.672, 95% CI 1.034-2.705, P = 0.036) after meningioma surgery. Analysis of individual postoperative complications revealed that diabetic patients experienced increased odds of pulmonary (OR 1.501, 95% CI 1.209-1.864, P < 0.001), neurologic (OR 1.690, 95% CI 1.383-2.065, P < 0.001), and urinary/renal complications (OR 2.618, 95% CI 1.933-3.545, P < 0.001). In addition, diabetic patients were more likely to have a prolonged length of stay (OR 1.694, 95% CI 1.389-2.065, P < 0.001). CONCLUSIONS: Diabetes is an important factor associated with complications after meningioma surgery. Preventative measures must be taken to optimize postoperative outcomes in these patients.