A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

The National Burden of Colorectal Cancer in the United States from 1990 to 2019.

CRC accounts for approximately a tenth of all cancer cases and deaths in the US. Due to large differences in demographics among the different states, we aim to determine trends in the CRC epidemiology and across different states, age groups, and genders. CRC rates, age-adjusted to the standard US population, were obtained from the GBD 2019 database. Time trends were estimated as annual percentage change (APC). A pairwise comparison was conducted between age- and gender-specific trends using the tests of parallelism and coincidence. Age-specific trends were also assessed in two age subgroups: younger adults aged 15-49 years and older adults aged 50-74 years. We also analyzed the prevalence, incidence, mortality, and DALYs in the US between 1990 and 2019. A total of 5.53 million patients were diagnosed with CRC in the US between 1990 and 2019. Overall, CRC incidence rates have significantly increased in younger adults (11.1 per 100,000 persons) and decreased in older adults (136.8 per 100,000 persons) (AAPC = 1.2 vs. -0.6; AAPC difference = 1.8, p < 0.001). Age-specific trends were neither identical (p < 0.001) nor parallel (p < 0.001), suggesting that CRC incidence rates are different and increasing at a greater rate in younger adults compared to older adults. However, for both men and women (49.4 and 35.2 per 100,000 persons), incidence rates have decreased over the past three decades at the same rate (AAPC = -0.5 vs. -0.5; AAPC difference = 0, p = 0.1). Geographically, the southern states had the highest mortality rates with Mississippi having the highest rate of 20.1 cases per 100,000 population in 2019. Massachusetts, New York, and the District of Colombia had the greatest decreases in mortality over the study period (-42.1%, -41.4%, and -40.9%). Decreased mortality was found in all states except Mississippi, where the mortality of CRC increased over the study period (+1.5%). This research provides crucial insights for policymakers to tailor resource allocation, emphasizing the dynamic nature of CRC burden across states and age groups, ultimately informing targeted strategies for prevention and intervention.

Racial Disparities in Liver Transplantation for Hepatocellular Carcinoma in the United States: An Update.

BACKGROUND: Previous studies have demonstrated a disparity in liver transplantation (LT) for hepatocellular carcinoma (HCC) among races in the United States (U.S.). AIMS: We aimed to update the literature on the odds, trends, and complications of LT in the treatment of hepatocellular carcinoma (HCC), among individuals of different racial backgrounds. METHODS: This is a nationwide study of adult individuals admitted for LT with a primary diagnosis of HCC. Using weighted data from the National Inpatient Sample (NIS) database, we compared the odds of LT among different races from 2016 to 2020, using a multivariate regression analysis. We further assessed the trends and outcomes of LT among races. RESULTS: A total of 112,110 adult were hospitalized with a primary diagnosis of HCC. 3020 underwent LT. When compared to Whites, the likelihood of undergoing LT for HCC was significantly reduced in Blacks (OR = 0.60, 95% CI = 0.46-0.78). Further, Blacks had increased mortality rates (7% in Blacks vs. 1% in Whites, p < 0.001), sepsis (11% in Blacks vs. 3% in Whites, p = 0.015), and acute kidney injury (AKI) (54% in Blacks vs. 31% in Whites, p < 0.001) following LT. CONCLUSIONS: Individuals identifying as Blacks were less likely to undergo LT for HCC, and more likely to develop complications. Further initiatives are warranted to mitigate the existing disparities among racial groups.

Vanishing Lung Syndrome, or Idiopathic Giant Bullous Emphysema, with Pneumothorax, and Subcutaneous Emphysema in a 58-Year-Old Female Smoker with Chronic Obstructive Pulmonary Disease.

BACKGROUND Vanishing lung syndrome (VLS), also known as idiopathic giant bullous emphysema, is a rare manifestation of chronic obstructive pulmonary disease (COPD) and usually occurs in middle-aged smokers. This report presents a 58-year-old female smoker with COPD and VLS who presented with spontaneous pneumothorax. The pneumothorax was managed with a chest tube and was later complicated by massive subcutaneous emphysema. CASE REPORT A 58-year-old woman with a past medical history of long-term smoking and COPD presented with worsening shortness of breath. Upon initial evaluation, she had tachypnea and hypoxia (SpO2 93%). Chest radiography revealed a new right-sided pneumothorax on top of extensive bullous disease, which the patient already had. The drainage of the pneumothorax was successful with a pigtail catheter. However, during the following night, after insertion of the pigtail catheter, the patient developed massive subcutaneous emphysema, which was confirmed with imaging. The patient remained hemodynamically stable, and diffuse subcutaneous crepitus was present on examination. The pigtail catheter was repositioned, resulting in complete resolution of the subcutaneous emphysema in the following 2 weeks. CONCLUSIONS This case highlights the importance of a timely diagnosis and management of the possible presentations and complications of VLS. Complications such as pneumothorax are life-threatening and require urgent management, taking precedence over the curative treatment for VLS, surgical bullectomy.

The Relationship Between Obstructive Sleep Apnea (OSA) and Gastroesophageal Reflux Disease (GERD) in Inpatient Settings: A Nationwide Study.

INTRODUCTION: Several studies identified a link between gastroesophageal reflux disease (GERD) and obstructive sleep apnea (OSA). GERD is a condition in which acid reflux from the stomach to the esophagus causes troublesome symptoms. On the other hand, OSA is defined as a sleep-related breathing disorder in which airflow significantly decreases or ceases due to upper airway obstruction, leading to arousal from sleep. OSA was found to be associated with GERD. In this study, we aim to study the characteristics and concurrent risk factors associated with GERD and OSA in a large population-based study. METHODS: Patients with the diagnosis of GERD were extracted from the National Inpatient Database (NIS) for the years 2016 to 2019. Patients' age, gender, race, and hospital information, including region and bed size, were extracted and considered as baseline characteristics. The comorbidities included are hypertension (HTN), atrial fibrillation (AFib), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), pulmonary hypertension (PHTN), obesity, and smoking. Patients younger than 18 years old were excluded from this study.  Results: Out of 22,677,620 patients with the diagnosis of GERD, 12.21% had a concurrent diagnosis of OSA (compared to 4.79% in patients without GERD, p-value <0.001). The mean age of patients with GERD and OSA was 64.47 years vs 65.42 years in patients without OSA (p-value <0.001). The GERD and OSA group had almost identical gender distribution compared to the GERD only group, as it was predominantly female patients. The white and black races were slightly more prevalent in the GERD and OSA group compared to the GERD only group. Regarding comorbidities, the prevalence of obesity was more clear in the GERD and OSA group. It was noted that the group of patients who carry a diagnosis of GERD and OSA have more prevalence of diabetes (DM), hypertension (HTN), obesity, atrial fibrillation (Afib), congestive heart failure (CHF), and pulmonary hypertension (PHTN). Patients with GERD and OSA were 21% less likely to be older than 65 years rather than younger (95% CI: 0.79-0.8, p-value <0.001), 35% less likely to be females (95% CI: 0.65-0.65, p-value <0.001), and 22% less likely to be non-white (95% CI: 0.77-0.8, p-value <0.001). Obesity was found to be the strongest association with this population, followed by PHTN, CHF, DM, HTN, Afib, and lastly smoking. CONCLUSION:  Patients with GERD and OSA were found more likely to be female, white, living in the southern part of the United States, obese, diabetes mellitus type 2, and being active smokers.

Non-islet cell tumor hypoglycemia as an initial presentation of hepatocellular carcinoma coupled with end-stage liver cirrhosis: A case report and review of literature.

BACKGROUND: Non-islet cell tumor hypoglycemia (NICTH) is a rare cause of persistent hypoglycemia seen in patients with hepatocellular carcinoma (HCC). It is likely to be underdiagnosed especially in the patients with poor hepatic function and malnutrition. Herein, we report a rare case of NICTH as the initial presentation of HCC in a patient with chronic hypoglycemia due to end-stage liver cirrhosis. CASE SUMMARY: A 62-year-old male with chronic fasting hypoglycemia secondary to end-stage hepatitis C-related cirrhosis, presented with altered mental status and dizziness. He was found to have severe hypoglycemia refractory to glucose supplements. Imaging studies and biopsy discovered well differentiated HCC without metastasis. Further evaluation showed low insulin, C-peptide and beta-hydroxybutyrate along with a high insulin-like growth factor-2/insulin-like growth factor ratio, consistent with the diagnosis of NICTH. As patient was not a candidate for surgical resection or chemotherapy, he was started on prednisolone with some improvements in the glucose homeostasis, but soon decompensated after a superimposed hospital acquired pneumonia. CONCLUSION: NICTH can occur as the sole initial presentation of HCC and is often difficult to correct without tumor removal. Clinicians should maintain high clinical suspicion for early recognition of paraneoplastic NICTH in patients at risk for HCC, even those with chronic fasting hypoglycemia in the setting of severe hepatic failure and malnutrition.