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.

Breaking Down the Gut: A Case of Severe Toxin-Mediated Colitis.

Shiga-toxin-producing Escherichia coli (STEC) is a worldwide, foodborne pathogen that can lead to life-threatening complications. Transmission has been associated with undercooked meat products, contaminated food and water sources, person-to-person contact, and direct exposure to infected farm animals. As the name suggests, the major virulence factors contributing to its pathogenicity are Shiga toxins, which can cause a spectrum of clinical presentations ranging from mild watery diarrhea to severe hemorrhagic colitis due to its toxic effects on the gastrointestinal tract. We report a case of a 21-year-old man seeking medical attention due to severe crampy abdominal pain and bloody diarrhea who was ultimately diagnosed with a less commonly encountered severe form of colitis in the setting of STEC infection. Thorough investigations while maintaining a high level of clinical suspicion allowed prompt medical care with a complete resolution of symptoms. This case highlights the importance of having high clinical suspicion for STEC even with more severe forms of colitis and sheds light on the role of medical personnel in managing such cases.

EUS-Guided Vascular Interventions.

Endoscopic ultrasound (EUS) has numerous advanced applications as a diagnostic and therapeutic modality in contemporary medicine. Through intraluminal placement, EUS offers a real-time Doppler-guided endoscopic visualization and access to intra-abdominal vasculature, which were previously inaccessible using historical methods. We aim to provide a comprehensive review of key studies on both current and future EUS-guided vascular applications. This review details EUS-based vascular diagnostic techniques of portal pressure measurements in the prognostication of liver disease and portal venous sampling for obtaining circulating tumor cells in the diagnosis of cancer. From an interventional perspective, we describe effective EUS-guided treatments via coiling and cyanoacrylate injections of gastric varices and visceral artery pseudoaneurysms. Specific attention is given to clinical studies on efficacy and procedural techniques described by investigators for each EUS-based application. We explore novel and future emerging EUS-based interventions, such as liver tumor ablation and intrahepatic portosystemic shunt placement.

Prevalence of Colonic Polyps in Patients Undergoing Kidney Transplant Evaluation: A Meta-Analysis and Systematic Review.

OBJECTIVES: Colorectal canceris the third most common cancer worldwide, and kidney transplant patients have up to a 2.5-fold increased risk of colorectal cancer compared with the general population. Presently, colorectal cancer screening recommendations in kidney transplant candidates are the same as for the general population. We explored the literature on the prevalence of colonic polyps in patients with renal failure undergoing screening colonoscopy as part of kidney transplant evaluation. MATERIALS AND METHODS: We conducted a systematic review in PubMed, Embase, and Cochrane databases from inception through June 2023 to identify studies that explored the prevalence of colonic polyps in patients with chronic kidney disease undergoing a screening colonoscopy as part of their pretransplant evaluation. RESULTS: Of 937 patients, 371 had ≥1 polyp on their screening colonoscopy (39.6%; 95% CI, 29.3%-50.3%), 243 patients had ≥1 adenoma (25.9%; 95% CI, 14.3%- 39.6%), and 75 had ≥1 high-risk adenoma (8.7%; 95% CI, 6.9%-10.7%). Pooled analysis of the 2 studies comparing patients with end-stage renal disease versus matched control groups indicated higher pooled prevalence of adenomas in the end-stage renal disease group (33.4%) versus the control group (23.9%). CONCLUSIONS: Our results suggest an average or increased prevalence of polyps and adenomatous polyps in patients with chronic kidney disease undergoing colonoscopy during evaluation for kidney transplant. The pooled analysis of the studies comparing the end-stage renal disease population versus a matched control group indicates higher prevalence of adenomatous polyps in patients with end-stage renal disease. Multiple studies have shown that screening colonoscopy in this patient group is safe and does not delay kidney transplant evaluation or waitlistrates; hence, screening colonoscopy should be routinely considered.

Two Sisters From Qatar With TUSC3 Genetic Mutation: Psychiatric Considerations.

Defects in the tumor suppressor candidate 3 (TUSC3) gene have been identified in individuals with autosomal recessive intellectual disability (ARID). Our report on two sisters from Qatar with a mutation in the TUSC3 gene focuses on the behavioral manifestations and management provided to them. The sisters, daughters of consanguineous parents, exhibited aggressive and impulsive behavior, along with hyperactivity and emotional dysregulation. They also exhibited abnormal sleep and eating patterns. Behavioral therapy and psychotropic medications including aripiprazole 3.75mg, clonidine 0.025mg, and guanfacine 1mg were used for the management of aggressive and agitated behavior. The two girls showed a reduction in aggressive behavior, hyperactivity, impulsivity, and insomnia in response to 2mg daily of guanfacine. Few families around the world were reported to have mutations in the TUSC3 gene resulting in intellectual disability. We describe the first two reported cases of TUSC3 gene mutation in Qatar. We encourage further research to study the effects of TUSC3 gene mutation, its manifestations, and treatment.

Masturbatory Guilt Leading to Severe Depression.

Masturbation is a common sexual behavior in humans. However, it is viewed negatively across cultures and is prohibited by almost all religions. These views lead to certain cultural beliefs that affect the sexual behavior of people and have implications on the mental health of the individual. There is limited literature linking masturbatory guilt with psychopathology. Here, we present a case in which masturbatory guilt contributed to the development of a depressive illness in a young male. The patient presented with typical symptoms of severe major depressive disorder with resulting impairment of academic and social performance. Our approach to treatment included utilizing a combination of psychotherapy, antidepressant and antipsychotic medications and vitamin supplementation with notable clinical improvement. The article highlights the importance of incorporating various cultural beliefs into an individualized treatment plan, particularly in unique cases where behaviors that may be stigmatized - perhaps wrongfully so - are involved.

Polysubstance Use Disorder After Sleeve Gastrectomy.

We describe a case of polysubstance use disorder that occurred after sleeve gastrectomy. Alcohol, cannabis, and stimulant use disorder was diagnosed a few years after the bariatric surgery when the patient developed a substance-induced psychotic disorder. Treatments included psychotropic medications to treat his psychosis and involvement in a drug rehabilitation and relapse prevention program. This case highlights the importance of a preoperative assessment of substance use risk in patients undergoing bariatric surgeries as well as the need for close follow-up postoperatively.

Coughing Up a Lung: A Curious Case of Pertussis.

Pertussis is a commonly underdiagnosed infection with incidence that has been steadily rising in adolescents and adults over the last three decades. Some reports suggested cyclical pattern of pertussis infection occurrence with peaks every two to five years. The complications of pertussis can be infectious or mechanical in the setting of persistent cough. We report an unusual case of a 67-year-old woman who presented with combined lung and liver extrusion in the setting of pertussis infection. This article will review the systematic approach of diagnosis and management of pertussis infections in adults.

Adaptive optimal input design and parametric estimation of nonlinear dynamical systems: application to neuronal modeling.

OBJECTIVE: Many physical models of biological processes including neural systems are characterized by parametric nonlinear dynamical relations between driving inputs, internal states, and measured outputs of the process. Fitting such models using experimental data (data assimilation) is a challenging task since the physical process often operates in a noisy, possibly non-stationary environment; moreover, conducting multiple experiments under controlled and repeatable conditions can be impractical, time consuming or costly. The accuracy of model identification, therefore, is dictated principally by the quality and dynamic richness of collected data over single or few experimental sessions. Accordingly, it is highly desirable to design efficient experiments that, by exciting the physical process with smart inputs, yields fast convergence and increased accuracy of the model. APPROACH: We herein introduce an adaptive framework in which optimal input design is integrated with square root cubature Kalman filters (OID-SCKF) to develop an online estimation procedure that first, converges significantly quicker, thereby permitting model fitting over shorter time windows, and second, enhances model accuracy when only few process outputs are accessible. The methodology is demonstrated on common nonlinear models and on a four-area neural mass model with noisy and limited measurements. Estimation quality (speed and accuracy) is benchmarked against high-performance SCKF-based methods that commonly employ dynamically rich informed inputs for accurate model identification. MAIN RESULTS: For all the tested models, simulated single-trial and ensemble averages showed that OID-SCKF exhibited (i) faster convergence of parameter estimates and (ii) lower dependence on inter-trial noise variability with gains up to around 1000 ms in speed and 81% increase in variability for the neural mass models. In terms of accuracy, OID-SCKF estimation was superior, and exhibited considerably less variability across experiments, in identifying model parameters of (a) systems with challenging model inversion dynamics and (b) systems with fewer measurable outputs that directly relate to the underlying processes. SIGNIFICANCE: Fast and accurate identification therefore carries particular promise for modeling of transient (short-lived) neuronal network dynamics using a spatially under-sampled set of noisy measurements, as is commonly encountered in neural engineering applications.

Liraglutide-induced Acute Gastroparesis.

We describe a case of liraglutide-induced acute gastroparesis in a 52-year-old man with a history of well-controlled type 2 diabetes who presented with symptoms of gastric outlet obstruction. The patient responded markedly to conservative treatment with gastric suctioning, antiemetic and prokinetic therapy, and discontinuation of liraglutide with a resolution of his symptoms. This case highlights the importance of considering drug-induced gastroparesis as an etiology of unexplained upper abdominal pain, nausea, and early satiety, especially in the absence of mechanical obstruction.

Hybrid Cubature Kalman filtering for identifying nonlinear models from sampled recording: Estimation of neuronal dynamics.

Kalman filtering methods have long been regarded as efficient adaptive Bayesian techniques for estimating hidden states in models of linear dynamical systems under Gaussian uncertainty. Recent advents of the Cubature Kalman filter (CKF) have extended this efficient estimation property to nonlinear systems, and also to hybrid nonlinear problems where by the processes are continuous and the observations are discrete (continuous-discrete CD-CKF). Employing CKF techniques, therefore, carries high promise for modeling many biological phenomena where the underlying processes exhibit inherently nonlinear, continuous, and noisy dynamics and the associated measurements are uncertain and time-sampled. This paper investigates the performance of cubature filtering (CKF and CD-CKF) in two flagship problems arising in the field of neuroscience upon relating brain functionality to aggregate neurophysiological recordings: (i) estimation of the firing dynamics and the neural circuit model parameters from electric potentials (EP) observations, and (ii) estimation of the hemodynamic model parameters and the underlying neural drive from BOLD (fMRI) signals. First, in simulated neural circuit models, estimation accuracy was investigated under varying levels of observation noise (SNR), process noise structures, and observation sampling intervals (dt). When compared to the CKF, the CD-CKF consistently exhibited better accuracy for a given SNR, sharp accuracy increase with higher SNR, and persistent error reduction with smaller dt. Remarkably, CD-CKF accuracy shows only a mild deterioration for non-Gaussian process noise, specifically with Poisson noise, a commonly assumed form of background fluctuations in neuronal systems. Second, in simulated hemodynamic models, parametric estimates were consistently improved under CD-CKF. Critically, time-localization of the underlying neural drive, a determinant factor in fMRI-based functional connectivity studies, was significantly more accurate under CD-CKF. In conclusion, and with the CKF recently benchmarked against other advanced Bayesian techniques, the CD-CKF framework could provide significant gains in robustness and accuracy when estimating a variety of biological phenomena models where the underlying process dynamics unfold at time scales faster than those seen in collected measurements.