Trends and incidence of reported events associated with staplers: An analysis of the food and drug administration's manufacturer and user facility device experience database

Introduction & Objectives: To summarize medical device reports (MDRs) between 2012 and 2022 relating to staplers within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). Material(s) and Method(s): The MAUDE database was analyzed for all MDRs relating to each FDA-approved stapler for the last ten years. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific staplers and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Pooled Relative risk was used to compare data. Result(s): Overall, 712 reports were retrieved in 10 years, between 2013 and 2015 a higher number of events were reported. In all, 413/712 (58%) were reported as malfunction of the device while 292/712 (41%) as injury. The most frequently reported adverse events (AEs) were Misfire (111/712: 15.6%), Failure to form staple (92/712: 12.9%), Mechanical jam (76/712: 10.7%) and Failure to fire (72/712: 10.1%). In terms of manufacturer: 401/712 (56%) were Covidien, 172/712 (24%) were Teleflex Medical and 139/712 (19.5%) were Ethicon Instruments. When comparing on disproportional analysis the different manufacturers, in terms of Misfire, Covidien presented the better profile when compared to Teleflex Medical and Ethicon (PRR= 0.32-0.65;p<0.05);in terms of failure to form staple Teleflex Medical presented the better profile when compared to Covidien and Ethicon (PRR 0.27-0.49;p<0.05);in terms of mechanical jam Covidien and Ethicon presented the best profile compared to Teleflex Medical (PRR 0.10-0.15;p<0.05). Lastly, in terms of failure to fire Teleflex presented the best profile (0% of events). Table 1: Trends and principal patient problems reported by the MAUDE database. Conclusion(s): Standing to MAUDE database the most frequent complications related to stapler are misfire, failure to form staple, mechanical jam and failure to fire. As well, the reported adverse events vary among the different manufacturers. [Figure presented]Copyright © 2023.

ACUTE MYOCARDITIS FOLLOWING COVID-19 VACCINATION: A PECULIAR CASE SERIES

Objective: Although acute myocarditis has not been observed as an adverse event in landmark trials of COVID-19 vaccines, it has been reported as a rare complication in real-world. The study aims to report a single-center experience on this issue. Design and method: We identified five cases of acute myocarditis with consistent temporal association to administration of COVID-19 vaccine and described clinical, serological, echocardiographic and cardiac magnetic resonance findings both in the acute phase and after a median follow up of 6 months. Results: All five patients received a COVID-19 vaccination dose within 24 to 96 hours before the onset of symptoms. Four patients received an mRNA vaccine (Comirnaty or Spikevax) and one received the adenovirus vaccine (Janssen). Only one patient had a known prior COVID-19 infection. All patients presented with chest pain and troponin I elevation occurring after the first vaccine dose in four cases. All patients tested negative for acute COVID-19 infection by polymerase chain reaction at admission. Blood tests revealed no or only mild inflammatory serological changes. Only one patient developed an increase in white blood cell count. None had specific changes on electrocardiography and echocardiography demonstrated preserved left ventricular systolic function and no regional wall motion abnormalities in all patients. Three patients underwent coronary angiography since risk factors and troponin trends raised clinical suspicion of acute coronary syndrome, none showed evidence of obstructive coronary artery disease. All patients had a mild to moderate disease not complicated by acute heart failure or arrhythmias. Cardiac Magnetic Resonance was performed in four cases and showed myocardial oedema and late gadolinium enhancement during the acute phase with persistence of areas of late gadolinium enhancement after a median follow-up of 6 months. None had further symptoms or hospitalizations since discharge. Conclusions: Acute myocarditis following COVID-19 vaccination is a well-defined clinical entity. Our findings suggest an immune rather than inflammatory pathogenesis and a benign course without clinical complication after a median follow-up of 6 months, but further studies are needed to define the prognostic significance of persistent findings on cardiac magnetic resonance.

High efficiency particulate air filters and heat & moisture exchanger filters increase positive end-expiratory pressure in helmet continuous positive airway pressure: A bench-top study.

BACKGROUND: Helmet continuous positive airway pressure (CPAP) has been widely used during the COVID-19 pandemic. Specific filters (i.e. High Efficiency Particulate Air filter: HEPA; Heat & Moisture Exchanger Filter: HMEF) were used to prevent Sars-CoV2 environmental dispersion and were connected to the CPAP helmet. However, HEPA and HMEF filters may act as resistors to expiratory gas flow and increase the levels of pressure within the hood. METHODS: In a bench-top study, we investigated the levels of airway pressure generated by different HEPA and HMEF filters connected to the CPAP helmet in the absence of a Positive End Expiratory Pressure (PEEP) valve and with two levels of PEEP (5 and 10 cmH2O). All steps were performed using 3 increasing levels of gas flow (60, 80, 100 L/min). RESULTS: The use of 8 different commercially available filters significantly increased the pressure within the hood of the CPAP helmet with or without the use of PEEP valves. On average, the increase of pressure above the set PEEP ranged from 3 cmH2O to 10 cmH2O across gas flow rates of 60 to 100 L/min. The measure of airway pressure was highly correlated between the laboratory pressure transducer and the Helmet manometer. Bias with 95% Confidence Interval of Bias between the devices was 0.7 (-2.06; 0.66) cmH2O. CONCLUSIONS: The use of HEPA and HMEF filters placed before the PEEP valve at the expiratory port of the CPAP helmet significantly increase the levels of airway pressure compared to the set level of PEEP. The manometer can detect accurately the airway pressure in the presence of HEPA and HMEF filters in the helmet CPAP and its use should considered.

Clinical biomarkers and its outcome and complications prediction in Covid-19: An analysis among hospitalized patients

Introduction: In December 2019 a new pathology emerged in the region of Hubei, China. It is provoked by a virus that was later named 2019-nCov, and then renamed as SARSCoV-2.Considering previous studies and publications, we decided to evaluate biomarkers to determinate if and how they could be a useful tool to predict complications and lethality. Goals: we used the clinical data of 147 patients, whom we made a retrospective analysis of. We created two groups: survival and non survivals. We also divided them into two further classes: complications and non complications. We considered the following parameters: age, lymphocyte, neutrophil, platelet, Neutrohpile-tolymphocyte ratio (NLR), platelets-to-lymphocyte ratio (PLR), CRP and procalcitonine. The Majority of these markers were collected at the emergency room. Materials and methods: We built a database from 146 Patients that were randomly included, using as criteria of inclusion PCR test positive and admission at the ER, followed by hospitalization. All the data comes from the analytics at the moment of the admission for the big part of them, or, when incompletes, in the next 48/72 hour. We considered as complications the following ones: Trombosis, septic shock, superinfection, acute renal failure and hyponatremia. We collected the data from our Hospital Database, then we performed all the statistical analysis using the IBM SPSS software, version 25. All the findings were considered statistically significative if P value <0.05. Results: All the patients were included in the study. Among them, 44 were female patiens, 103 were male. We performed Kolgomoroff-Smirnoff test of normality, with the following results: All the parameters showed an asymmetric distribution but CRP. T student and Mann-Whitney tests were performed. Our result showed that the differences in Age, CRP and procalcitonine were significative as p<0,05 between the groups of survaivals and non survivals, while all the rest of parameters showed a non significative result. Conlcusion: Our results showed a significative difference for the parameters of Age, procalcitonine and CRP when it comes to survival and no survival group. This findigs suggest and somehow confirm the importance of this biomarkers in the evaluation of Covid-19 patients.

Preventing transmission among operating room staff during COVID-19 pandemic: the role of the Aerosol Box and other personal protective equipment.

The COVID-19 pandemic is highly challenging for the operating room staff and healthcare workers in emergency departments. SARS-CoV-2 is a positive-sense single-stranded RNA beta-coronavirus that primarily targets the human respiratory system, with fever, cough, myalgia, and pneumonia as the most common manifestations. However, since SARS-CoV-2 RNA was detected in stool specimens much more attention has been paid to gastrointestinal symptoms such as loss of appetite, nausea, and diarrhea. Furthermore, the expression of ACE-2 receptors in absorptive enterocytes from ileum and colon suggests that these organs should also be considered as a potential high risk for SARS-CoV-2 infection. During aerosol-generating medical procedures (AGMP; e.g. intubating and extubating patients or any surgical procedures), the production of both airborne particles and droplets may increase the risk of infection. In this situation, the surgical staff is strongly recommended to wear personal protective equipment (PPE). A transparent plastic cube, the so-called "Aerosol Box" (AB), has been recently designed to lend further protection against droplets and aerosol exposure during the AGMP.

Coronavirus pandemic and colorectal surgery: practical advice based on the Italian experience.

AIM: The current COVID-19 pandemic is challenging healthcare systems at a global level. We provide a practical strategy to reorganize pathways of emergency and elective colorectal surgery during the COVID-19 pandemic. METHOD: The authors, all from areas affected by the COVID-19 emergency, brainstormed remotely to define the key-points to be discussed. Tasks were assigned, concerning specific aspects of colorectal surgery during the pandemic, including the administrative management of the crisis in Italy. The recommendations (based on experience and on the limited evidence available) were collated and summarized. RESULTS: Little is known about the transmission of COVID-19, but it has shown a rapid spread. It is prudent to stop non-cancer procedures and prioritize urgent cancer treatment. Endoscopy and proctological procedures should be performed highly selectively. When dealing with colorectal emergencies, a conservative approach is advised. Specific procedures should be followed when operating on COVID-19-patients, using dedicated personal protective equipment and adhering to specific rules. Some policies are described, including minimally-invasive surgery. These policies outline the strict regulation of entry/ exit into theatres and operating building as well as advice on performing procedures safely to reduce risk of spreading the virus. It is likely that a reorganization of health system is required, both at central and local levels. A description of the strategy adopted in Italy is provided. CONCLUSION: Evidence on the management of patients needing surgery for colorectal conditions during the COVID-19 pandemic is currently lacking. Lessons learnt from healthcare professionals that have managed high volumes of surgical patients during the pandemic could be useful to mitigate some risks and reduce exposure to other patients, public and healthcare staff.