Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Analysis of Outcomes in COVID-19 Patients With Varying Degrees of Hyperlipasemia.

OBJECTIVES: Coronavirus disease 2019 (COVID-19) patients may have varying degrees of hyperlipasemia. The aim was to compare outcomes among different levels of hyperlipasemia in patients with COVID-19. METHODS: This is a retrospective study examining outcomes among hospitalized COVID-19 patients with a lipase <3× upper limit of normal (ULN), asymptomatic hyperlipasemia (>3× ULN), secondary pancreatitis (typical respiratory COVID-19 symptoms and found to have pancreatitis), and primary pancreatitis (presenting with pancreatitis). RESULTS: Of 11,883 patients admitted with COVID-19, 1560 patients were included: 1155 patients had normal serum lipase (control group), 270 had elevated lipase <3× ULN, 46 patients had asymptomatic hyperlipasemia with lipase >3× ULN, 57 patients had secondary pancreatitis, and 32 patients had primary pancreatitis. On adjusted multivariate analysis, the elevated lipase <3× ULN and asymptomatic hyperlipasemia groups had worse outcomes with higher mortality (odds ratio [OR], 1.6 [95% confidence interval [CI], 1.2-2.2) and 1.1 [95% CI, 0.5-2.3], respectively), higher need for mechanical ventilation (OR, 2.8 [95% CI, 1.2-2.1] and 2.8 [95% CI, 1.5-5.2], respectively), and longer length of stay (OR, 1.5 [95% CI, 1.1-2.0] and 3.16 [95% CI, 1.5-6.5], respectively). CONCLUSIONS: Patients with COVID-19 with elevated lipase <3× ULN and asymptomatic hyperlipasemia have generally worse outcomes than those with pancreatitis.

Current and future implications of COVID-19 on gastroenterology training and clinical practice.

The novel coronavirus disease 2019 (COVID-19) pandemic has affected almost every country on the globe, affecting 185 countries with more than 2.6 million cases and 182,000 deaths as of April 22, 2020. The United States (US) has seen an exponential surge in the COVID-19 patients and has become the epicentre with more than 845,000 confirmed cases and 46,000 deaths. The governments and healthcare providers all over the world are racing with time to reduce the rate of increase in active cases by social distancing to flatten the curve of this pandemic. Practicing gastroenterologists are facing multiple challenges in the safe practice of medicine because of patient's inability to visit physicians' offices, endoscopy centers and the threat of potential virus spread through gastrointestinal secretions by endoscopies in emergent cases. The gastroenterological associations from Europe and North America have made position statements to guide gastroenterologists to navigate through the clinical practice during the COVID-19 pandemic. Gastroenterology fellows are on the frontlines during the COVID-19 pandemic, experiencing personal, physical and economic stresses. They had to balance the programmatic changes to meet the demands of the patient care with the additional pressure to meet training requirements. Given the imperatives for social and physical distancing, training programmes have to implement innovative educational methods to substitute traditional teaching. Healthcare organisations must synchronise institutional workforce needs with trainee safety, education and well-being. In this perspective, we have discussed the challenges that can be anticipated and implementing strategies to support fellows during the times of the COVID-19 pandemic.

Gastrointestinal Bleeding in Patients with Severe SARS-CoV-2.

Gastrointestinal symptoms are common and frequently reported in Coronavirus Disease-2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is unclear if SARS-CoV-2 is associated with increased risk of gastrointestinal bleeding (GIB). Nevertheless, GIB in COVID-19 patients poses unique challenges to patients due to high-risk of concomitant respiratory failure and to endoscopy personnel due to risk of airborne transmission during endoscopic procedures. Many management issues related to COVID-19 are still being studied. In this case series, we attempt to discuss the important clinical implications related to the management of GIB in COVID-19 patients.