Watchman FLX's Sophomore Year Report Card.
Ontology highlight
ABSTRACT:
SUBMITTER: Dewland TA
PROVIDER: S-EPMC10111480 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Publications
Watchman FLX's Sophomore Year Report Card.
Journal of the American Heart Association 20230215 4
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Project description:RationaleAmong atrial fibrillation patients with high risk of bleeding, left atrial appendage occlusion has emerged as an alternative to long-term oral anticoagulation therapy for stroke prevention. Device-related thrombus remains a major concern because it may result in recurrent embolic events. To date, there is no consensus on the optimal method of treating device-related-thrombus.Patient concernsA 78-year-old man with atrial fibrillation had an episode of intracranial hemorrhage while taking warfarin. He subsequently underwent percutaneous placement of a 30-mm Watchman device to the left atrial appendage. He was prescribed dual anti-platelet therapy with aspirin and clopidogrel.DiagnosisReassessment echocardiography 3 months later found device-related thrombus.InterventionsThe antithrombotic regimen was switched from dual antiplatelet therapy to apixaban.OutcomesReassessment echocardiography 3 months later revealed complete resolution of the device-related thrombus. Apixaban was stopped. He had dual antiplatelet therapy for 6 more months followed by life-long aspirin. There was no bleeding complication since implantation of Watchman device.LessonsWe demonstrated successful treatment of device-related thrombus with a short course of apixaban with complete resolution of thrombus. Further randomized controlled trials are required to determine the choice and duration of drug therapy for device-related thrombus.
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Project description:Objectives:Mexico's 2018 Report Card evaluates the opportunities available for Mexican children and youth to reach healthy levels of physical activity, sleep, and sedentary behavior. Methods:The Report Card is a surveillance system that gathers data from national surveys, censuses, government documents, websites, grey literature, and published studies to evaluate 16 indicators in four categories: Daily Behaviors; Physical Fitness; Settings and Sources of Influence; and Strategies and Investments. Data were compared to established benchmarks. Each indicator was assigned a grade from 1 - 10 (< 6 is a failing grade) or "incomplete" if data was insufficient/unavailable. Results:Daily Behavior grades were: Overall Physical Activity, 4; Organized Sport Participation, 5; Active Play, 3; Active Transportation, 5; Sleep, 7; and Sedentary Behavior, 3. Physical Fitness, received a 7. Settings and Sources of Influence grades were: Family and Peers, incomplete; School, 3; and Community and Environment, 4. Strategies and Investments were: Government Strategies, 6; and Non-Government Organizations, 2. Conclusion:Low grades in 11 of the 16 indicators indicate that schools, families, communities, and government need to work together to improve physical activity opportunities for children and youth in Mexico.
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Project description:BackgroundThe COVID-19 pandemic constitutes a global health threat and poses a major burden on the African continent. We assessed the real-world burden of COVID-19 infection in African Union (AU) member states to determine the distributional patterns of epidemiological measures during the first 1 year of the pandemic.MethodsThis retrospective cross-sectional study utilized COVID-19 data from publicly available data repositories of the African Center for Disease Control and Prevention and Our World in Data for the period February 2020 to January 2021. AU member states were classified into low, medium, and high burdens based on COVID-19 morbidity. We conducted descriptive and inferential analyses of COVID-19-reported cases, deaths, recoveries, active cases, COVID-19 tests, and epidemiological measures that included morbidity and mortality rates, case fatality rate (CFR), and case ratios.ResultsA total of 3.21 million cases were reported during the 1-year period, with 2.6 million recoveries, 536,784 cases remaining active, and 77,486 deaths. Most countries (49.1%, n = 26) in AU experienced a low burden of COVID-19 infection compared to 28.3% (n = 15) with medium burden and 22.6% (n = 12) with high burden. AU nations with a high burden of the disease were mainly in the northern and southern regions. South Africa recorded the highest number of cases (1.31 million), followed by Morocco with 457,625 and Tunisia with 175,065 cases. Correspondently, death tolls for these countries were 36,467, 7888, and 5528 deaths, respectively. Of the total COVID-19 tests performed (83.8 million) during the first 1 year, 62.43% were from high-burden countries. The least testing occurred in the medium-burden (18.42%) countries. The overall CFR of AU was 2.21%. A morbidity rate of 327.52/105 population and mortality rate of 5.96/105 population were recorded during the first 1-year period with significant variations (p < 0.0001) across burden levels. Continental morbidity and mortality rates of 17,359/105 and 315.933/105 populations were recorded with significant correlation (r = 0.863, p < 0.0001) between them and variations across selected epidemiological measures by COVID-19 burden levels.ConclusionUnderstanding the true burden of the disease in AU countries is important for establishing the impact of the pandemic in the African continent and for intervention planning, preparedness, and deployment of resources during COVID-19 surges and future pandemics.
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Project description:The study provides a comprehensive review of OpenAI's Generative Pre-trained Transformer 4 (GPT-4) technical report, with an emphasis on applications in high-risk settings like healthcare. A diverse team, including experts in artificial intelligence (AI), natural language processing, public health, law, policy, social science, healthcare research, and bioethics, analyzed the report against established peer review guidelines. The GPT-4 report shows a significant commitment to transparent AI research, particularly in creating a systems card for risk assessment and mitigation. However, it reveals limitations such as restricted access to training data, inadequate confidence and uncertainty estimations, and concerns over privacy and intellectual property rights. Key strengths identified include the considerable time and economic investment in transparent AI research and the creation of a comprehensive systems card. On the other hand, the lack of clarity in training processes and data raises concerns about encoded biases and interests in GPT-4. The report also lacks confidence and uncertainty estimations, crucial in high-risk areas like healthcare, and fails to address potential privacy and intellectual property issues. Furthermore, this study emphasizes the need for diverse, global involvement in developing and evaluating large language models (LLMs) to ensure broad societal benefits and mitigate risks. The paper presents recommendations such as improving data transparency, developing accountability frameworks, establishing confidence standards for LLM outputs in high-risk settings, and enhancing industry research review processes. It concludes that while GPT-4's report is a step towards open discussions on LLMs, more extensive interdisciplinary reviews are essential for addressing bias, harm, and risk concerns, especially in high-risk domains. The review aims to expand the understanding of LLMs in general and highlights the need for new reflection forms on how LLMs are reviewed, the data required for effective evaluation, and addressing critical issues like bias and risk.
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Project description:BackgroundLeft atrial appendage occlusion devices are commonly used to prevent stroke in patients with persistent atrial fibrillation who are unable to tolerate anticoagulation. However, certain patient- and device-related characteristics increase the risk for the development of a device-related thrombus (DRT). The presence of a DRT increases the risk of stroke and should be treated. Management of DRT lacks consensus but is mostly focused on anticoagulation. In patients with large thrombi that need to be managed urgently, percutaneous extraction may be a viable option.Case summaryIn this report, we describe the successful management of a DRT via percutaneous thrombus extraction technology in an 81-year-old woman with a large thrombus attached to a WATCHMAN™ device. The patient initially presented with shortness of breath, and on imaging a pedunculated thrombus was detected. The thrombus was extracted using a Penumbra Lightning 12™ (Penumbra Inc., Alameda, CA, USA) catheter with a Sentinel™ (Boston Scientific, Marlborough, MA, USA) cerebral embolic protection device. The patient had no neurologic sequelae and was started on anticoagulation.DiscussionPercutaneous thrombectomy can be safely performed to extract large left atrial occlusion DRT that require urgent management, without any neurologic sequelae. We believe this can be used in patients with a large DRT who would not be adequately managed with anticoagulation and in whom surgery is not feasible.
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Project description:BackgroundDevice-related thrombosis (DRT) is a known complication to left atrial appendage closure (LAAC). The surface of a LAAC device should ideally have antithrombotic properties. The novel WATCHMAN FLX Pro (WFP) incorporates a fluoropolymer-coated fabric membrane designed to increase thromboresistance and facilitate endothelialization. Such features could potentially allow for a minimal post-procedural antithrombotic regimen. Radiopaque platinum markers at the device shoulders and a large 40 mm device are other novel features of the WFP.Case summaryA 75-year-old man with atrial fibrillation was referred for LAAC due to prior subdural haemorrhage during direct-acting anticoagulation treatment. He underwent the first-in-human WFP implantation as part of the WATCHMAN FLX Pro CT study (NCT05567172). Computed tomography (CT) was used for pre-planning, and the procedure was performed under local analgesia guided by intracardiac echocardiography from the left atrium (LA) without any complications. Post-procedural antithrombotic treatment consisted of acetylsalicylic acid 75 mg/day only, and 45-day CT, transoesophageal echocardiography (TEE), and magnetic resonance imaging demonstrated optimal device position with complete LAAC. Hypoattenuated thickening (6 mm) appeared on the device as a smooth surface in continuity with the left atrial wall on CT and TEE. A specific magnetic resonance T1-weighted scan, used for visualization of fresh thrombus, suggested this to represent tissue ingrowth rather than thrombus.DiscussionThe advanced follow-up imaging protocol suggested a good WFP implantation result with signs of tissue ingrowth at 45 days. The added radiopaque markers facilitated optimal deployment, evaluation of device stability during tug test, and assessment of device protrusion into the LA.
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