Prospective feasibility study of a novel rigidizing stabilizing overtube in the resection of complex gastrointestinal polyps.

BACKGROUND: A novel rigidizing overtube (ROT) was developed to facilitate endoscopic removal of complex gastrointestinal polyps. We aimed to prospectively evaluate the efficacy and safety of the device in the management of large gastrointestinal polyps. METHODS: A prospective, single-center study, conducted between May 2021 and April 2023, enrolled patients undergoing endoscopic resection of colon/duodenal polyps ≥25 mm. Primary outcomes were safety, technical success, and clinical success defined as the ability of ROT to facilitate endoscopic polyp removal without changing the initial resection method. RESULTS: 97 patients (98 polyps), with a mean polyp size of 33.2 mm (median 31.1), were evaluated. Technical and clinical success rates were 100% and 84%, respectively. Ileocecal valve location was the only predictor of clinical failure (P = 0.02). The mean time to reach the lesion was 7.2 minutes (95%CI 5-8), with overall resection and procedure times of 53.6 minutes (95%CI 48-61) and 88.9 minutes (95%CI 79-95), respectively. No device-related adverse events occurred. Lower technical (67%) and clinical (67%) success rates were seen for duodenal polyps (n = 6). CONCLUSION: The novel ROT was safe, with high technical and clinical success during resection of complex colon polyps. Future studies will determine timing of implementation during routine endoscopic resection.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

Direct Endoscopic Necrosectomy With and Without Hydrogen Peroxide for Walled-off Pancreatic Necrosis: A Multicenter Comparative Study.

INTRODUCTION: Endoscopic necrosectomy has emerged as the preferred treatment modality for walled-off pancreatic necrosis. This study was designed to evaluate the safety and efficacy of direct endoscopic necrosectomy with and without hydrogen peroxide (H2O2) lavage. METHODS: Retrospective chart reviews were performed for all patients undergoing endoscopic transmural management of walled-off pancreatic necrosis at 9 major medical centers from November 2011 to August 2018. Clinical success was defined as the resolution of the collection by imaging within 6 months, without requiring non-endoscopic procedures or surgery. RESULTS: Of 293 patients, 204 met the inclusion criteria. Technical and clinical success rates were 100% (204/204) and 81% (166/189), respectively. For patients, 122 (59.8%) patients had at least one H2O2 necrosectomy (H2O2 group) and 82 (40.2%) patients had standard endoscopic necrosectomy. Clinical success was higher in the H2O2 group: 106/113 (93.8%) vs 60/76 (78.9%), P = 0.002. On a multivariate analysis, the use of H2O2 was associated with higher clinical success rate (odds ratio 3.30, P = 0.033) and earlier resolution (odds ratio 2.27, P < 0.001). During a mean follow-up of 274 days, 27 complications occurred. Comparing procedures performed with and without H2O2 (n = 250 vs 183), there was no difference in post-procedure bleeding (7 vs 9, P = 0.25), perforation (2 vs 3, P = 0.66), infection (1 vs 2, P = 0.58), or overall complication rate (n = 13 [5.2%] vs 14 [7.7%], P = 0.30). DISCUSSION: H2O2-assisted endoscopic necrosectomy had a higher clinical success rate and a shorter time to resolution with equivalent complication rates relative to standard necrosectomy.See the visual abstract at http://links.lww.com/AJG/B714.(Equation is included in full-text article.).

Hand-Foot-and-Mouth Disease: Rapid Evidence Review.

Hand-foot-and-mouth disease is caused by human enteroviruses and coxsackieviruses. Outbreaks can occur in the spring to fall and are common in North America, and most cases occur in patients younger than 10 years. Hand-foot-and-mouth disease is transmitted by fecal-oral, oral-oral, and respiratory droplet contact. Patients present with a low-grade fever, a maculopapular or papulovesicular rash on the hands and soles of the feet, and painful oral ulcerations. Lesions usually resolve in seven to 10 days; however, in rare cases, patients may have neurologic or cardiopulmonary complications. The differential diagnosis for childhood rashes and oral enanthems is broad and includes erythema multiforme, herpes, measles, and varicella. Treatment is supportive and directed toward hydration and pain relief as needed with acetaminophen or ibuprofen. Oral lidocaine is not recommended, and antiviral treatment is not available. The best methods to prevent the spread of hand-foot-and-mouth disease are handwashing and disinfecting potentially contaminated surfaces and fomites.

Acute Kidney Injury: Diagnosis and Management.

Acute kidney injury is a clinical syndrome characterized by a rapid decline in glomerular filtration rate and resultant accumulation of metabolic waste products. Acute kidney injury is associated with an increased risk of mortality, cardiovascular events, and progression to chronic kidney disease. Severity of acute kidney injury is classified according to urine output and elevations in creatinine level. Etiologies of acute kidney injury are categorized as prerenal, intrinsic renal, and postrenal. Accurate diagnosis of the underlying cause is key to successful management and includes a focused history and physical examination, serum and urine electrolyte measurements, and renal ultrasonography when risk factors for a postrenal cause are present (e.g., older male with prostatic hypertrophy). General management principles for acute kidney injury include determination of volume status, fluid resuscitation with isotonic crystalloid, treatment of volume overload with diuretics, discontinuation of nephrotoxic medications, and adjustment of prescribed drugs according to renal function. Additional supportive care measures may include optimizing nutritional status and glycemic control. Pharmacist-led quality-improvement programs reduce nephrotoxic exposures and rates of acute kidney injury in the hospital setting. Acute kidney injury care bundles are associated with improved in-hospital mortality rates and reduced risk of progression. Nephrology consultation should be considered when there is inadequate response to supportive treatment and for acute kidney injury without a clear cause, stage 3 or higher acute kidney injury, preexisting stage 4 or higher chronic kidney disease, renal replacement therapy, and other situations requiring subspecialist expertise.

Herpes Zoster and Postherpetic Neuralgia: Prevention and Management.

Herpes zoster, or shingles, is caused by reactivation of varicella zoster virus, which causes chickenpox. There are an estimated 1 million cases in the Unites States annually, with an individual lifetime risk of 30%. Patients with conditions that decrease cell-mediated immunity are 20 to 100 times more likely to develop herpes zoster. Patients may present with malaise, headache, low-grade fever, and abnormal skin sensations for two to three days before the classic maculopapular rash appears. The rash is usually unilateral, confined to a single dermatome, and typically progresses to clear vesicles that become cloudy and crust over in seven to 10 days. Herpes zoster can be treated with acyclovir, valacyclovir, or famciclovir, ideally within 72 hours of the development of the rash. Postherpetic neuralgia is the most common complication, occurring in about one in five patients. It is defined as pain in a dermatomal distribution sustained for at least 90 days after acute herpes zoster. Treatment is focused on symptom control and includes topical lidocaine or capsaicin and oral gabapentin, pregabalin, or tricyclic antidepressants. The varicella zoster virus vaccine decreases the incidence of herpes zoster and is approved for adults 50 years and older. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommends this vaccine for adults 60 years and older, except for certain immunosuppressed patients.

Enhancing the Management of Deployment-Limiting Medical Conditions in the U.S. Department of Navy Leveraging Electronic Health Records and Predictive Analytics Methods.

INTRODUCTION: Deployment-limiting medical conditions (DLMCs) such as debilitating injuries and conditions may interfere with the ability of military service members (SMs) to deploy. SMs in the United States (U.S.) Department of the Navy (DoN) with DLMCs who are not deployable should be placed in the medically restricted status of limited duty (LIMDU) or referred to the Physical Evaluation Board (PEB) for Service retention determination. It is critical to identify SMs correctly and promptly with DLMCs and predict their return-to-duty (RTD) to ensure the combat readiness of the U.S. Military. In this study, an algorithmic approach was developed to identify DoN SMs with previously unidentified DLMCs and predict whether SMs on LIMDU will be able to RTD. MATERIALS AND METHODS: Five years of historical data (2016-2022) were obtained from inpatient and outpatient datasets across direct and purchased care from the Military Health System (MHS) Data Repository (MDR). Key fields included International Classification of Diseases diagnosis and procedure codes, Current Procedure Terminology codes, prescription medications, and demographics information such as age, rank, gender, and service. The data consisted of 44,580,668 medical encounters across 1,065,224 SMs. To identify SMs with unidentified DLMCs, we developed an ensemble model combining outputs from multiple machine learning (ML) algorithms. When the ML ensemble model predicted a SM to have high risk scores, despite appearing healthy on administrative reports, their case was reviewed by expert clinicians to investigate for previously unidentified DLMCs; and such feedback served to validate the developed algorithms. In addition, leveraging 1,735,422 encounters (60,433 SMs) from LIMDU periods, we developed four separate ML models to estimate RTD probabilities for SMs after each medical encounter and predict the final LIMDU outcome. RESULTS: The ensemble model had 0.91 area under the receiver operating characteristic curve (AUROC). Out of 236 (round one) and 314 (round two) SMs reviewed by clinicians, 127 (54%) and 208 (66%) SMs were identified with a previously unidentified or undocumented DLMC, respectively. Regarding predicting RTD for SMs placed on LIMDU, the best performing ML model achieved 0.76 AUROC, 68% sensitivity, and 71% specificity. CONCLUSION: Our research highlighted potential benefits of using predictive analytics in a medical assessment to identify SMs with DLMCs and to predict RTD outcomes once placed on LIMDU. This capability is being deployed for real-time clinical decision support to enhance health care provider's deployability assessment capability, improve accuracy of the DLMC population, and enhance combat readiness of the U.S Military.

Antimicrobial Stewardship Practices in Outpatient Parenteral Antimicrobial Therapy Programs in the United States.

Background: Outpatient parenteral antimicrobial therapy (OPAT) regimens typically prioritize ease of antimicrobial administration, tolerability, safety, and accessibility over using the narrowest-spectrum antimicrobial. In light of this, OPAT providers often utilize different techniques to promote antimicrobial stewardship (AMS) in their OPAT programs. This study aims to characterize the AMS practices of OPAT programs across the United States that might meet The Joint Commission requirements for outpatient AMS metrics. Methods: This is a cross-sectional electronic survey of the Vizient AMS network. A total of 95 possible questions were designed to inquire about demographics, OPAT program structure, AMS initiatives, performance metrics, and resources. Results: Seventy-four survey responses were received, with 58 (78.4%) of the respondents indicating their institution offered OPAT services. Respondents reported having at least 1 AMS protocol and tracking at least 1 metric in 91% and 74% of OPAT programs, respectively. Only 40% of programs reported billing for OPAT-related services. Approximately 45% of respondents disagreed or strongly disagreed that their OPAT program had the resources needed to care for the population it serves. Respondents identified data analytics (69%), funding for expansion of services (67%), and pharmacists (62%) as resources of greatest need for their OPAT programs. Conclusions: This survey collectively describes the AMS practices currently employed by OPAT programs across the United States. The results provide specific examples of AMS initiatives, metrics, and resources that institutions may reference to advance the practices of their OPAT programs to meet The Joint Commission Outpatient Antimicrobial Stewardship standards.

Myocardial infarction: management of the subacute period.

Optimal management of myocardial infarction in the subacute period focuses on improving the discharge planning process, implementing therapies early to prevent recurrent myocardial infarction, and avoiding hospital readmission. Evidence-based guidelines for the care of patients with acute coronary syndrome are not followed up to 25% of the time. Antiplatelet therapy, renin-angiotensin-aldosterone system inhibitors, beta blockers, and statins constitute the foundation of medical therapy. Early noninvasive stress testing is an important risk assessment tool, especially in patients who do not undergo revascularization. Discharge preparation should include a review of medications, referral for exercise-based cardiac rehabilitation, activity recommendations, education about lifestyle modification and recognition of cardiac symptoms, and a clear follow-up plan. Because nonadherence to medications is common in patients after a myocardial infarction and is associated with increased mortality risk, modifiable factors associated with medication self-discontinuation should be addressed before discharge. Structured discharge processes should be used to enhance communication and facilitate the transition from the hospital to the family physician's care.

MUC1 Expressions and Its Prognostic Values in US Gastric Cancer Patients.

This study aims to evaluate the prognostic value of MUC expression in US GC patients. A total of 70 tumor specimens were collected from GC patients who underwent surgery or endoscopic resection between 2013 and 2019 at a tertiary referral center in the US. MUC expression status including MUC1, MUC2, MUC5AC, and MUC6 was evaluated by immunohistochemical staining. The positive rates of MUC1, MUC2, MUC5AC, and MUC6 were 71.4%, 78.6%, 74.3%, and 33.3%, respectively. Patients with positive MUC1 expression had a significantly higher rate of aggressive pathologic features including diffuse-type cancer (42.0% vs. 0%; p < 0.001), advanced GC (80.0% vs. 30.0%, p < 0.001), lymph node metastasis (62.0% vs. 20.0%; p = 0.001), and distant metastasis (32.0% vs. 5.0%; p = 0.017) compared with those with negative MUC1 expression. However, the differences in the pathologic features were not observed according to MUC2, MUC5AC, and MUC6 expression status. In early gastric cancer (EGC), patients with a high level of MUC1 expression showed a higher rate of lymphovascular invasion (71.4% vs. 21.4%; p = 0.026) and EGC meeting non-curative resection (85.7% vs. 42.9%; p = 0.061) than those with negative MUC1. In US GC patients, MUC1 expression is associated with aggressive pathological features, and might be a useful prognostic marker.

Settings of a novel electrosurgical generator to enable efficient and safe submucosal endoscopic procedures.

Background and study aims A novel electrosurgical generator unit (ESU), ConMed Beamer, was recently introduced to facilitate endoscopic submucosal dissection (ESD) by employing Automatic Cutting Effect (ACE) technology. Its use in submucosal endoscopy has yet to be investigated. The aim of this study was to evaluate the feasibility and safety of performing ESD and peroral endoscopic myotomy (POEM) using novel settings generated with ConMed Beamer ESU. Patients and methods This was a single-center prospective study of 59 consecutive patients undergoing ESD/POEM at a tertiary referral center. ESU settings were initially generated by testing in live animal models prior to first in-human study. The primary outcome was technical success. Secondary outcomes were procedure times, rate of en bloc/R0 resection, and rate of adverse events (AEs). Results A total of 44 patients (50 polyps) and 15 patients underwent ESD and POEM, respectively. En bloc resection, R0 resection, and curative resection rates were 90%, 77.1%, and 70.8%, respectively. Mean maximal length of the lesion was 3.07 cm ± 1.43 with an average dissection speed of 14.2 cm 2 /hr ± 11.1. Technical success was achieved in 100% of POEM patients. Mean time (minutes) to complete the POEM procedure was 50.1 min ± 12.4. Two major AEs occurred among all patients (3.4%). All intraprocedural bleeding events were controlled using the ConMed Beamer ESU. Conclusions ConMed Beamer ESU settings generated from this study were proven safe and effective in a prospective cohort of patients who underwent submucosal endoscopic procedures. This novel ESU can be added to the armamentarium of ESD capable generators.

Disparities in Opioid Use Disorder Treatment Admissions.

OBJECTIVES: The Cincinnati region has been at the epicenter of the nation's unfolding opioid epidemic. The objectives of this study were twofold: (1) to compare the Cincinnati region to the United States in length of time to obtain treatment and planned medication-assisted therapy for the treatment for opioid use disorder (OUD); and (2) to assess racial disparities within the Cincinnati region in wait time and type of treatment. METHODS: The 2017 Treatment Episode Data Set: Admissions (TEDS-A) from the Substance Abuse and Mental Health Services Administration (SAMHSA) was used to identify a cohort of eligible individuals with a primary substance use of opioids, including opioid derivatives. Logistic regression models were performed to assess the differences for treatment wait time and type of planned treatment. Model covariates included patient demographics and socioeconomic characteristics. Three different models were performed to assess the influence of covariates of the outcomes. RESULTS: There were 678 766 US and 3298 Cincinnati region individuals admitted for OUD treatment in 2017. The rate per 1000 for treatment admissions was 2.08 and 1.51 (P value < 0.0001) for the United States and Cincinnati, respectively. The fully saturated regression results found that the odds of Cincinnati individuals receiving planned medication-assisted therapy were 0.497 (95% CI, 0.451-0.546; P value < 0.001). The odds of waiting longer for treatment in Cincinnati were higher than in the United States as a whole: 2.33 (95% CI, 2.19-2.48; P value < 0.001). In Cincinnati, there were 3102 Caucasian, 123 African American, and 73 Other admissions. The fully saturated model results found that Caucasians and Other had an increased likelihood of receiving planned medicationassisted therapy (OR 1.89, P value 0.039; OR 7.07, P value 0.002, respectively) compared to African Americans. Within Cincinnati, there was not a statistically significant difference in the likelihood of waiting time to receive treatment by race. CONCLUSION: Individuals seeking treatment for OUD in Cincinnati were less likely to receive planned medication-assisted therapy and were more likely to wait longer than individuals in the United States as a whole. These results suggest that the demand for treatment is greater than the supply in Cincinnati. Within Cincinnati, there does not appear to be a racial disparity in treatment type or length of time to receive treatment for OUD.

ESD with double-balloon endoluminal intervention platform versus standard ESD for management of colon polyps.

Background and study aims Endoscopic submucosal dissection (ESD) with the double-balloon endoluminal intervention platform (DEIP) is a novel technique for removal of complex colon polyps (> 2 cm) or those located in anatomically difficult positions. DEIP helps create a therapeutic zone with improved visualization and stability, facilitating polyp removal. We aimed to compare the outcomes of DEIP with the conventional cap-assisted ESD (standard ESD) technique for colon polyp resection, in particular, the ability to complete the ESD procedure without resorting to hybrid ESD or piecemeal resection. Patients and methods This was a retrospective cohort of all patients who underwent colon ESD in a single large tertiary referral center between September 2016 and October 2019. Information was collected on patient demographics and study outcomes including procedure time, rates of en bloc and curative resection, operative and postoperative complications. All patients were followed up for 1 month after the procedure. Results 111 patients were included in the study (DEIP 60, standard ESD 51). There was no statistically significant difference between mean procedures time (±â€ŠSD) in the two groups, mean (81.9 ±â€Š35.4 min standard vs. 96.4 ±â€Š42.2 min in DEIP). Mean polyp size (±â€ŠSD) was similar between the two groups (7.6 ±â€Š6.0 cm 2 vs. 6.2 ±â€Š5.5 cm 2 , P  = .2). There were no significant differences in en bloc and curative resection rates or operative and postoperative complications between the two techniques. Conclusion Procedure time was similar using both techniques. However, DEIP enabled the entire procedure to be performed using the ESD technique without resorting to snare resection, which may affect the en bloc and curative resection rate. There were no significant differences in en bloc and curative resection rates between the two groups, probably due to the small sample size.

Cultural Sensitivity and Global Pharmacy Engagement in the Caribbean: Dominica, Jamaica, Puerto Rico, and St. Kitts.

Sustainable and reciprocal partnerships in pharmacy education and practice exist between schools and colleges of pharmacy in the United States and Caribbean countries and territories. This paper discusses the cultural considerations for such partnerships to flourish. First, general information on Caribbean countries and territories is covered. Next, the paper transitions into how to ensure culturally sensitive engagements when traveling to or hosting visitors from the Caribbean. This paper is intended to assist practitioners with integrating culturally sensitive considerations into the development of partnerships in this region.