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Background: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking., Objective: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database., Methods: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events., Results: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events)., Conclusion: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications., (© 2023 Wiley Periodicals LLC.)

Background: Thromboembolic (TE) events are among the most common and devastating adverse events in patients with continuous-flow left ventricular assist device (cf-LVAD). Given the high burden of AF among cf-LVAD patients, we sought to evaluate the effect of concomitant surgical LAAO in patients receiving cf-LVAD., Methods: A systematic search using electronic databases was performed using the keywords: "left atrial appendage occlusion" and "left ventricular assist device." Statistical analysis was performed using metapackage for R version 4.0 and Rstudio version 1.2. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data between two groups. The primary outcomes included: (a) stroke; (b) LVAD pump thrombosis; (c) all-cause mortality RESULTS: Three studies with a total of 305 patients (LAAO = 68 and No-LAAO = 237) were included in the analysis. HeartMate II (39%) and Heartware (27.5%) were the two most common cf-LVADs utilized, while only 5% received HeartMate III. At a mean follow up of 1.47 years, LAAO group had a lower risk of stroke (8.8% vs. 15.2%, RR 0.64; 95% CI 0.28-1.49), LVAD pump thrombosis (1.5% vs. 3.8%, RR 0.28; 95% CI 0.05-1.55) and all-cause mortality (5.9% vs. 20.2%, RR 0.69; 95% CI 0.19-2.52) when compared with no-LAAO group, but the difference did not reach statistical significance., Conclusion: Concomitant surgical LAAO at the time of cf-LVAD implantation demonstrated a trend toward positive outcomes and was not associated with adverse outcomes during the follow-up period, though the results were not statistically significant., (© 2022 Wiley Periodicals LLC.)

Background: Patients with pre-existing vascular disease are known to have worse outcomes after acute myocardial infarction (AMI). However, there is limited data for outcomes stratified by type and number of vascular territories involved., Methods: Using the Nationwide Inpatient Sample (2015-2017), we examined outcomes of AMI in patients with pre-existent vascular disease stratified by number as well as types of diseased beds including all five major vascular sites: cardiac, cerebrovascular, renal, aortic and peripheral vascular disease (PVD). Multivariable logistic regression was used to determine the adjusted odds ratios (aOR) of adverse outcomes and invasive procedure utilization., Results: Out of 2,184,614 AMI admissions, 49.7% had pre-existent vascular disease. The odds of major adverse cardiovascular and cerebrovascular events (MACCE), mortality, ischemic stroke and major bleeding incrementally increased and was highest in those with ≥3 vascular sites involved (aOR for MACCE 1.16, CI 1.13-1.19; mortality 1.3, CI 1.26-1.34; stroke 1.15, CI 1.1-1.2; major bleeding 1.21, CI 1.16-1.25). Amongst those with a single pre-existent diseased vascular bed, the adjusted odds of MACCE appeared to be higher in those with PVD (1.28, CI 1.26-1.31), aortic disease (1.24, CI 1.19-1.29), and cerebrovascular disease (1.22, CI 1.2-1.25). Patients with pre-existent vascular disease had a lower overall likelihood of undergoing invasive revascularization procedures., Conclusions: Approximately half of the population presenting with AMI have pre-existent vascular disease. There is an incremental increase in adverse outcomes with increasing number of diseased vascular beds, with further differences in outcomes and utilization of invasive procedures based on sub-types of sites involved., Competing Interests: Declaration of competing interest The authors declared that they have no conflict of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Direct oral anticoagulants (DOACs) have been developed as a viable and in some cases superior alternative to warfarin. These agents have overcome some of the limitations of warfarin, which has a narrow therapeutic window and many food and drug interactions. DOACs have been demonstrated to have a more predictable and reliable pharmacology and, unlike warfarin, do not require frequent monitoring of anticoagulant effect. For these reasons, the use of DOACs is increasing. Despite the many positive attributes of these agents, limitations and contraindications do exist. An understanding of the pharmacology, indications, and contraindications is therefore crucial for effective patient management. We review the available agents to aid in effective drug utilization.

Atrial fibrillation (AF) is an important cause of ischemic stroke and is the underlying cause of > 20% of all strokes, with increasing age being a risk factor. Until recently, warfarin was the only available oral anticoagulant used to decrease this risk in patients with AF. However, there are several disadvantages of warfarin use, such as the requirement for monitoring the international normalized ratio, its wide range of drug-food interactions, and its narrow therapeutic index. Thus, there has been a strong impetus for the development of newer oral anticoagulants with predictable pharmacokinetics that obviate the need for monitoring the international normalized ratio. The US Food and Drug Administration has approved a direct thrombin inhibitor (dabigatran) and 2 factor Xa inhibitors (rivaroxaban and apixaban) for stroke prevention in patients with nonvalvular AF. There are several other new oral anticoagulant agents on the horizon, including the factor Xa inhibitor edoxaban. This review article discusses the pharmacological properties, clinical trial data, and practical issues associated with the use of these novel oral anticoagulants.