Analysis of Reported Adverse Events Related to Hemospray: An FDA MAUDE Database Study.

BACKGROUND: Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. METHODS: We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. RESULTS: Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). CONCLUSION: Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

A Consensus Diagnosis Utilizing Surface KI-67 Expression as an Ancillary Marker in Low-Grade Dysplasia Helps Identify Patients at High Risk of Progression to High-Grade Dysplasia and Esophaegal Adenocarcinoma.

Esophageal adenocarcinoma (EAC) develops in a step-wise manner, from low-grade dysplasia (LGD) to high-grade dysplasia (HGD), and ultimately to invasive EAC. However, there remains diagnostic uncertainty about LGD and its risk of progression to HGD/EAC. The aim is to investigate the role of Ki-67, immune-histochemical marker of proliferation, surface expression in patients with confirmed LGD, and risk stratify progression to HGD/EAC. A retrospective cohort study was conducted. Patients with confirmed LGD and indefinite for dysplasia (IND), with a mean follow-up of ≥1 year, were included. Pathology specimens were stained for Ki-67 and analyzed for evidence of surface expression. Our results reveal that 29% of patients with confirmed LGD who stained positive with Ki-67 progressed to HGD/EAC as opposed to none (0%) of the patients who stained negative, a statistically significant result (P = 0.003). Similarly, specimens from patients with IND were stained and analyzed revealing a nonsignificant trend toward a higher rate of progression for Ki-67 positive cases versus Ki-67 negative, 30% versus 21%, respectively. Ki-67 expression by itself can identify patients with LGD at a high risk of progression.

Persistent indefinite for dysplasia in Barrett's esophagus is a risk factor for dysplastic progression to low-grade dysplasia.

Patients with Barrett's esophagus (BE) are at increased risk of esophageal adenocarcinoma (EAC). The risk is largely based on the degree of dysplasia. Dysplasia cannot always be differentiated from inflammatory changes, and therefore may be classified as indefinite for dysplasia (IND). The risk of progressive dysplasia in patients with IND is unclear. Our aim is to characterize the risk of progression in US veterans with BE-IND. We performed a single-center retrospective cohort study of patients with BE-IND between 2006 and 2016. All IND was diagnosed by consensus conference with an expert gastrointestinal (GI) pathologist or review by an expert GI pathologist and persistence was defined as IND present on subsequent endoscopic biopsy. The primary outcome was the incidence rate of high-grade dysplasia (HGD)/EAC. Secondary outcomes included any progression including incident low-grade dysplasia (LGD), any prevalent dysplasia and risk factors for dysplastic progression, namely persistent IND. Risk factors for progression were assessed using univariate and multivariate analysis with logistic regression. Among 107 patients with BE-IND, there were no incident cases of HGD/EAC. Twenty patients (18.7%) developed incident LGD during a median follow-up of 2.39 years (interquartile range, 1.13-5.17). The annual rate of progression to LGD was 5.95 per 100 patient-years (95% CI, 3.73-9.02). Prevalent dysplasia was common (9.3%). Eight patients had prevalent LGD, one patient had prevalent HGD and one patient had prevalent EAC. Twenty-eight patients (30.1%) were found to have persistent IND. Among those with persistent IND, 10 (36%) patients progressed to LGD (none to HGD/EAC). The progression rate to LGD for patients with persistent IND was 7.86 (95% CI, 3.99-14.02) cases per 100 patient-years versus 4.78 (95% CI, 2.48-8.52) for nonpersistent IND (P = 0.036). The odds ratio for progression to LGD in persistent IND was 3.06 (95% CI, 1.08-8.64). In multivariate analysis adjusting for age, smoking history, presence of hiatal hernia and BMI > 30, persistent IND remained significant (OR 3.23; 95% CI, 1.04-9.98). Regression to nondysplastic BE was very common. Seventy-one (61%) patients developed complete and sustained regression of all dysplastic changes at last follow-up. Persistent IND, present in one-third of patients with IND, is an independent risk factor for progression to LGD. Although no patients in this cohort developed HGD/EAC, prevalent dysplasia was common (9.3%). Taken together, patients with IND should receive close surveillance for both prevalent and incident dysplasia especially if IND is persistent.

Not Too Hot, Not Too Cold, but "Just Right".

When ordering diagnostic tests, physicians are faced with a problem of not too many tests, not too few, but 'just right'. However, in medical diagnostics 'just right' may be very difficult to identify. Such is the conundrum presented in study by Rubenstein and colleagues regarding appropriate use of repeat esophagogastroduodenoscopy (EGD) in Veterans Health Administration (VHA) medical facilities. The important message of this paper is that out of 235,855 patients with an index EGD, 36% underwent repeat EGD over 5 years, of which only 9% (range 3-18%a cross VHA facilities) were classified as probable overuse.

Single-center experience with intraprocedural cleansing system to improve inadequate bowel preparation during colonoscopy.

Inadequate bowel preparation is common despite various preprocedure interventions. There is a need for an intervention at the time of colonoscopy to combat poor preparation. In this retrospective, observational study of 46 patients, we evaluated the clinical efficacy and feasibility of implementing the third generation of the Pure-Vu EVS System, a US Food and Drug Administration-cleared over-the-scope-based intraprocedural cleansing device, into our practice at the Minneapolis VA Medical Center (Minneapolis, Minnesota, United States). To study clinical efficacy, we measured bowel preparation adequacy before and after using the device, as measured by the Boston Bowel Preparation Score, and reviewed colonoscopy surveillance interval recommendations. Technical success and feasibility of using the device were measured by procedure success rates and duration. We found that BBPS scores increased from 4.4 to 7.9 when using the device. Technical success was achieved 78.3% of the time (36/46 cases). Median colonoscopy duration was 46 minutes, although there was a trend toward shorter procedures over time. This is the first clinical evaluation of the third generation of an intraprocedural cleansing device. We found the device efficacious and easy to use with low procedure failure rates, but it does come with a learning curve. We suspect that adoption of this device mutually will benefit patients and health systems with the potential to improve resource utilization.

Management of Opioid-Induced and Non-Opioid-Related Constipation in Patients With Cancer: Systematic Review and Meta-Analysis.

PROBLEM IDENTIFICATION: A systematic review and meta-analysis was conducted to inform the development of national clinical practice guidelines on the management of cancer constipation. LITERATURE SEARCH: PubMed®, Wiley Cochrane Library, and CINAHL® were searched for studies published from May 2009 to May 2019. DATA EVALUATION: Two investigators independently reviewed and extracted data from eligible studies. The Cochrane Collaboration risk-of-bias tool was used, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to assess the certainty of the evidence. SYNTHESIS: For patients with cancer and opioid-induced constipation, moderate benefit was found for osmotic or stimulant laxatives; small benefit was found for methylnaltrexone, naldemedine, and electroacupuncture. For patients with cancer and non-opioid-related constipation, moderate benefit was found for naloxegol, prucalopride, lubiprostone, and linaclotide; trivial benefit was found for acupuncture. IMPLICATIONS FOR PRACTICE: Effective strategies for managing opioid-induced and non-opioid-related constipation in patients with cancer include lifestyle, pharmacologic, and complementary approaches. SUPPLEMENTAL MATERIAL CAN BE FOUND AT HTTPS: //bit.ly/3c4yewT.

ONS Guidelines™ for Opioid-Induced and Non-Opioid-Related Cancer Constipation.

PURPOSE: This evidence-based guideline intends to support clinicians, patients, and others in decisions regarding the treatment of constipation in patients with cancer. METHODOLOGIC APPROACH: An interprofessional panel of healthcare professionals with patient representation prioritized clinical questions and patient outcomes for the management of cancer-related constipation. Systematic reviews of the literature were conducted. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to assess the evidence and make recommendations. FINDINGS: The panel agreed on 13 recommendations for the management of opioid-induced and non-opioid-related constipation in patients with cancer. IMPLICATIONS FOR NURSING: The panel conditionally recommended a bowel regimen in addition to lifestyle education as first-line treatment for constipation. For patients starting opioids, the panel suggests a bowel regimen as prophylaxis. Pharmaceutical interventions are available and recommended if a bowel regimen has failed. Acupuncture and electroacupuncture for non-opioid-related constipation are recommended in the context of a clinical trial. SUPPLEMENTARY MATERIAL CAN BE FOUND AT HTTPS: //bit.ly/30y29sI.

Safety and Outcomes of Capsule Endoscopy in Patients with Left Ventricular Assist Device: a Single-Center Retrospective Case Series.

Obscure gastrointestinal bleeding (GIB) in patients with continuous-flow left ventricular assist devices (CF-LVAD) is common. Capsule endoscopy (CE) can be used in the diagnosis of obscure GIB. Safety and outcomes of CE in patients with CF-LVAD are unknown. The aim is to define the safety and outcomes of CE in this population. Paitents with CF-LVAD undergoing CE at a single center between 2007 and 2014 were retrospectively reviewed. Thirty-four CE studies were performed. Positive CE occurred in 19 studies. No clinically significant cardiac events occurred. Medical intervention was the most common management strategy. Rebleeding after CE occurred in 10 patients. Patients with active bleeding or lesions such as arteriovenous malformations (AVM) incurred a higher risk of rebleeding, transfusion, and repeated endoscopy. CE is safe in patients with CF-LVAD. The risk of rebleeding was more common in patients with active bleeding or AVM lesions although this result did not reach statistical significance.