19,133 results on '"Stroke prevention & control"'
Search Results
2. Comparison of American and European Guideline Recommendations for Diagnostic Workup and Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack.
- Author
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Mulder MJHL, Cras TY, Shay J, Dippel DWJ, and Burke JF
- Subjects
- Humans, Europe, United States, American Heart Association, Evidence-Based Medicine standards, Stroke prevention & control, Stroke diagnosis, Ischemic Attack, Transient prevention & control, Ischemic Attack, Transient diagnosis, Secondary Prevention methods, Secondary Prevention standards, Ischemic Stroke prevention & control, Ischemic Stroke diagnosis, Practice Guidelines as Topic
- Abstract
Guidelines help to facilitate treatment decisions based on available evidence, and also to provide recommendations in areas of uncertainty. In this paper, we compare the recommendations for stroke workup and secondary prevention of ischemic stroke and transient ischemic attack of the American Heart Association (AHA)/American Stroke Association (ASA) with the European Stroke Organization (ESO) guidelines. The primary aim of this paper is to offer clinicians guidance by identifying areas where there is consensus and where consensus is lacking, in the absence or presence of high-level evidence. We compared AHA/ASA with the ESO guideline recommendations for 7 different topics related to diagnostic stroke workup and secondary prevention. We categorized the recommendations based on class and level of evidence to determine whether there were relevant differences in the ratings of evidence that the guidelines used for its recommendations. Finally, we summarized major topics of agreement and disagreement, while also prominent knowledge gaps were identified. In total, we found 63 ESO and 82 AHA/ASA recommendations, of which 38 were on the same subject. Most recommendations are largely similar, but not all are based on high-level evidence. For many recommendations, AHA/ASA and ESO assigned different levels of evidence. For the 10 recommendations with Level A evidence (high quality) in AHA/ASA, ESO only labeled 4 of these as high quality . There are many remaining issues with either no or insufficient evidence, and some topics that are not covered by both guidelines. Most ESO and AHA/ASA Guideline recommendations for stroke workup and secondary prevention were similar. However not all were based on high-level evidence and the appointed level of evidence often differed. Clinicians should not blindly follow all guideline recommendations; the accompanying level of evidence informs which recommendations are based on robust evidence. Topics with lower levels of evidence, or those with recommendations that disagree or are missing, may be an incentive for further clinical research., Competing Interests: Dr Dippel reports grants from Stryker, Medtronic, Penumbra, Cerenovus, and Thrombolytic Science, paid to the institution for research outside the submitted work.
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- 2024
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3. Guideline Updates Needed: Closure Devices to Prevent Recurrent Stroke in Patients With Patent Foramen Ovale.
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Saver JL
- Subjects
- Humans, Cardiac Catheterization instrumentation, Cardiac Catheterization methods, Foramen Ovale, Patent complications, Foramen Ovale, Patent surgery, Foramen Ovale, Patent therapy, Secondary Prevention methods, Stroke prevention & control, Stroke etiology, Septal Occluder Device, Practice Guidelines as Topic, Recurrence
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- 2024
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4. Stroke in Patients Undergoing Transcatheter Aortic Valve Replacement: Embracing the Unpredictable.
- Author
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Elkaryoni A and Saad M
- Subjects
- Humans, Risk Factors, Treatment Outcome, Risk Assessment, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis surgery, Stroke etiology, Stroke prevention & control, Stroke epidemiology
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- 2024
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5. Device-Detected Atrial Fibrillation and the Impact of Prior Stroke in Stroke Prevention.
- Author
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Siegler JE and Brorson JR
- Subjects
- Humans, Risk Factors, Risk Assessment, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Stroke prevention & control, Stroke etiology
- Published
- 2024
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6. Reducing Rates and Risk of Stroke in Adults With Congenital Heart Disease: What Can We Do Now, and What Should We Do Next?
- Author
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Alsaeed M and Field TS
- Subjects
- Humans, Adult, Risk Factors, Risk Assessment, Heart Defects, Congenital complications, Heart Defects, Congenital epidemiology, Stroke prevention & control, Stroke epidemiology, Stroke etiology
- Published
- 2024
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7. Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial.
- Author
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Diener HC, Becher N, Sehner S, Toennis T, Bertaglia E, Blomstrom-Lundqvist C, Brandes A, Beuger V, Calvert M, Camm AJ, Chlouverakis G, Dan GA, Dichtl W, Fierenz A, Goette A, de Groot JR, Hermans A, Lip GYH, Lubinski A, Marijon E, Merkely B, Mont L, Nikorowitsch J, Ozga AK, Rajappan K, Sarkozy A, Scherr D, Schnabel RB, Schotten U, Simantirakis E, Vardas P, Wichterle D, Zapf A, and Kirchhof P
- Subjects
- Humans, Female, Aged, Male, Double-Blind Method, Administration, Oral, Aged, 80 and over, Treatment Outcome, Hemorrhage chemically induced, Time Factors, Pacemaker, Artificial, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Ischemic Attack, Transient prevention & control, Ischemic Attack, Transient etiology, Anticoagulants administration & dosage, Anticoagulants adverse effects, Anticoagulants therapeutic use, Stroke prevention & control, Stroke etiology
- Abstract
Background: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear., Methods and Results: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients)., Conclusions: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.
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- 2024
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8. Residual Stroke Risk Among Patients With Atrial Fibrillation Prescribed Oral Anticoagulants: A Patient-Level Meta-Analysis From COMBINE AF.
- Author
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Johnson LS, Benz AP, Shoamanesh A, Eikelboom JW, Ezekowitz M, Giugliano RP, Wallentin L, Ruff CT, Lopes RD, Jolly S, Whitlock R, Granger CB, Connolly S, and Healey JS
- Subjects
- Humans, Administration, Oral, Risk Assessment, Risk Factors, Aged, Female, Male, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Ischemic Stroke prevention & control, Ischemic Stroke epidemiology, Ischemic Stroke etiology, Ischemic Stroke diagnosis, Randomized Controlled Trials as Topic, Middle Aged, Aged, 80 and over, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Anticoagulants administration & dosage, Anticoagulants therapeutic use, Anticoagulants adverse effects
- Abstract
Background: Despite oral anticoagulation, patients with atrial fibrillation (AF) remain at risk of ischemic stroke and systemic embolism (SE) events. For patients whose residual risk is sufficiently high, additional therapies might be useful to mitigate stroke risk., Methods and Results: Individual patient data from 5 landmark trials testing oral anticoagulation in AF were pooled in A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in AF (COMBINE AF). We calculated the rate of ischemic stroke/SE among oral anticoagulation-treated patients with a CHA
2 DS2 -VASc score≥2, across strata of CHA2 DS2 -VASc score, stroke history, and AF type, as either paroxysmal or nonparoxysmal. We included 71 794 patients with AF (median age 72 years, interquartile range, 13 years, 61.3% male) randomized to a direct oral anticoagulant or vitamin K antagonist, and followed for a mean of 2.1 (±0.8) years. The median CHA2 DS2 -VASc score was 4 (interquartile range, 3-5), 18.8% had a prior stroke, and 76.4% had nonparoxysmal AF. The overall rate of stroke/SE was 1.33%/y (95% CI, 1.27-1.39); 1.38%/y (95% CI, 1.31-1.45) for nonparoxysmal AF, and 1.15%/y (95% CI, 1.05-1.27) for paroxysmal AF. The rate of ischemic stroke/SE increased by a rate ratio of 1.36 (95% CI, 1.32-1.41) per 1-point increase in CHA2 DS2 -VASc, reaching 1.67%/y (95% CI, 1.59-1.75) ≥4 CHA2 DS2 -VASc points. Patients with both nonparoxysmal AF and CHA2 DS2 -VASc ≥4 had a stroke/SE rate of 1.75%/y (95% CI, 1.66-1.85). In patients with a prior stroke, the risk was 2.51%/y (95% CI, 2.33-2.71)., Conclusions: AF type, CHA2 DS2 -VASc score, and stroke history can identify patients with AF, who despite oral anticoagulation have a residual stroke/SE risk of 1.5% to 2.5% per year. Evaluation of additional stroke/SE prevention strategies in high-risk patients is warranted.- Published
- 2024
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9. The Post-Left Atrial Appendage Occlusion Antithrombotic Selection Conundrum: Are We There Yet?
- Author
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Katapadi A and Lakkireddy D
- Subjects
- Humans, Stroke prevention & control, Stroke etiology, Atrial Appendage surgery, Atrial Appendage diagnostic imaging, Atrial Fibrillation drug therapy, Fibrinolytic Agents therapeutic use
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Lakkireddy has received research and educational grants to the institution from Abbott, AtriCure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific. Dr Katapadi has reported that he has no relationships relevant to the contents of this paper to disclose.
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- 2024
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10. Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion.
- Author
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Reinhardt SW, Gibson DN, Hsu JC, Kapadia SR, Yeh RW, Price MJ, Piccini JP, Nair DG, Christen T, Allocco DJ, and Freeman JV
- Subjects
- Humans, Male, Female, Aged, Registries, Aged, 80 and over, Dual Anti-Platelet Therapy methods, Drug Therapy, Combination, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Middle Aged, Atrial Appendage surgery, Aspirin administration & dosage, Aspirin adverse effects, Aspirin therapeutic use, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Anticoagulants administration & dosage, Anticoagulants adverse effects, Platelet Aggregation Inhibitors administration & dosage, Platelet Aggregation Inhibitors adverse effects, Platelet Aggregation Inhibitors therapeutic use
- Abstract
Background: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described., Objectives: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens., Methods: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression., Results: Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y
12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus., Conclusions: In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin., Competing Interests: Funding Support and Author Disclosures This analysis was supported by the Boston Scientific Corporation. Although Boston Scientific had no role in the data collection, development of study questions, or analytic approaches, it paid for the statistical analytical work and manuscript support. No authors were compensated for their work on this study. The views expressed here represent those of the authors, and do not necessarily represent the official views of the American College of Cardiology Foundation’s National Cardiovascular Data Registry or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Hsu has received honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol Myers Squibb, Pfizer, Sanofi, Zoll Medical, iRhythm, Acutus Medical, Galvanize Therapeutics, and Biosense Webster; has received research grants from Biotronik and Biosense Webster; and has equity in Vektor Medical. Dr Yeh has received research funding and consulting fees from Abbott Vascular, Boston Scientific, and Medtronic; and has received research funding from Bard, Cook, and Philips. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria and speaker fees from Medtronic, W.L. Gore, Philips, and Shockwave; and has equity in Indian Wells, Inc. Dr Piccini is supported by grant R01AG074185 from the National Institutes of Aging; receives grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips; and serves as a consultant to Abbott, Abbvie, ARCA biopharma, Bayer, Boston Scientific, Bristol Myers Squibb (Myokardia), Element Science, Itamar Medical, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, ReCor, Sanofi, Philips, and Up-to-Date. Drs Christen and Allocco are full-time employees and stockholders of Boston Scientific. Dr Freeman has received research funding from the National Institutes of Health/National Heart, Lung, and Blood Institute, and the American College of Cardiology National Cardiovascular Data Registry; has received consulting/advisory board fees from Medtronic, Boston Scientific, Biosense Webster, and PaceMate; and has equity in PaceMate. All other authors have reported that they have no relationships relevant to the contents of this paper., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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11. Carotid endarterectomy has lower stroke risk than carotid artery stenting for patients with asymptomatic carotid stenosis and chronic kidney disease.
- Author
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Li R, Thompson J, Peshel E, Recarey M, Hata K, Sidawy AN, Lala S, and Nguyen BN
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- Humans, Asymptomatic Diseases, Risk Factors, Treatment Outcome, Retrospective Studies, Carotid Stenosis surgery, Carotid Stenosis complications, Endarterectomy, Carotid adverse effects, Renal Insufficiency, Chronic complications, Stents adverse effects, Stroke prevention & control, Stroke etiology, Stroke epidemiology
- Abstract
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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- 2024
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12. COVID-19 Diagnosis, Oral Anticoagulation, and Stroke Risk in Patients with Atrial Fibrillation.
- Author
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Yang L, Tang S, Guo J, Gabriel N, Gellad WF, Essien UR, Magnani JW, and Hernandez I
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- Humans, Aged, Female, Male, Retrospective Studies, Aged, 80 and over, Administration, Oral, Risk Factors, Proportional Hazards Models, SARS-CoV-2, COVID-19 epidemiology, COVID-19 complications, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Atrial Fibrillation epidemiology, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Anticoagulants adverse effects, Stroke prevention & control, Stroke epidemiology, Stroke etiology
- Abstract
Background: Coronavirus disease 2019 (COVID-19) has been associated with an increased risk of stroke. It remains unclear whether the risk of stroke associated with a diagnosis of COVID-19 differed with oral anticoagulation (OAC) use. The aim of this study was to evaluate the association between COVID-19 infection, OAC use, and stroke in patients with atrial fibrillation (AF)., Methods: A retrospective cohort study was conducted in individuals with established AF using data from Optum's deidentified Clinformatics
® Data Mart Database. Cox proportional hazard models with time-dependent variables were employed to assess the association between possession of OAC, COVID-19 diagnosis in both inpatient and outpatient setting, and time to ischemic stroke., Results: A total of 561,758 individuals aged 77 ± 10 were included in the study, with a mean follow up time of 1.3 years. OAC use was associated with a reduced stroke risk [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.82-0.88]. COVID-19 infection was associated with an increased risk of stroke (HR 2.11, 95% CI 1.87-2.38); this increased risk was particularly pronounced for patients diagnosed with an inpatient diagnosis of COVID-19 (HR 3.95, 95% CI 3.33-4.68). There was no significant interaction between OAC use and COVID-19 diagnosis (p value = 0.96). As a result, the relative increase in stroke risk associated with COVID-19 did not differ between patients on OAC (HR 2.12; 95% CI 1.71-2.62) and those not on OAC (HR 2.11; 95% CI 1.83-2.43)., Conclusion: In a nationwide sample of patients with established AF, we found the relative increase in stroke risk associated with COVID-19 was independent of OAC use., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)- Published
- 2024
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13. Apixaban Use in Patients with Kidney Impairment: A Review of Pharmacokinetic, Interventional, and Observational Study Data.
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Mandt SR, Thadathil N, Klem C, Russ C, McNamee PL, Stigge K, and Cheng D
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- Humans, Stroke prevention & control, Stroke epidemiology, Observational Studies as Topic, Anticoagulants adverse effects, Anticoagulants pharmacokinetics, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Pyridones pharmacokinetics, Pyridones adverse effects, Pyridones therapeutic use, Pyridones administration & dosage, Pyrazoles pharmacokinetics, Pyrazoles therapeutic use, Pyrazoles adverse effects, Pyrazoles administration & dosage, Factor Xa Inhibitors pharmacokinetics, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors therapeutic use, Factor Xa Inhibitors administration & dosage, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Renal Insufficiency, Chronic complications, Renal Insufficiency, Chronic drug therapy, Venous Thromboembolism drug therapy
- Abstract
Chronic kidney disease (CKD) remains a significant global health issue and is a leading cause of mortality worldwide. Patients with CKD have an increased risk of developing atrial fibrillation (AF) and venous thromboembolism (VTE). While direct oral anticoagulants (DOACs) have become a standard of care for anticoagulation (AC) in patients with AF and VTE, the appropriate use of these agents in comorbid kidney impairment warrants detailed discussion. This scientific narrative review summarizes the effectiveness and safety of apixaban use in patients with renal dysfunction by assessing the current published pharmacokinetic, interventional, observational, and guideline data. Apixaban is a highly selective, orally active, direct inhibitor of factor Xa, with well-established pharmacokinetics and consistent clinical outcomes across a broad range of patient populations, including those with kidney impairment. Overall, the scientific literature has shown that apixaban has a favorable clinical efficacy and safety profile compared with vitamin K antagonists for patients with AF or VTE and comorbid kidney impairment. These data support the approved label dosing strategy of apixaban in reducing the risk of stroke/systemic embolism in patients with nonvalvular AF and in treating VTE across all ranges of kidney function. Both clinician experience and knowledge of patient-specific factors may be required in the management of comorbid patients with advanced CKD or those requiring dialysis, as data on these patients are limited., (© 2024. The Author(s).)
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- 2024
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14. Sharing Results from the Field-Linking Community Resources and Clinical Services: Examples of Practice-Based Evidence from Recipients of CDC's Heart Disease and Stroke Prevention Funding.
- Author
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Patanian M
- Subjects
- Humans, United States, Heart Diseases prevention & control, Evidence-Based Practice methods, Information Dissemination methods, Centers for Disease Control and Prevention, U.S. organization & administration, Stroke prevention & control
- Abstract
Competing Interests: The author declares no conflict of interest with respect to the authorship and/or publication of this article. The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
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- 2024
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15. Sharing Results From the Field-Implementing Team-Based Care: Examples of Practice-Based Evidence From Recipients of CDC's Heart Disease and Stroke Prevention Funding.
- Author
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Patanian M
- Subjects
- Humans, United States, Heart Diseases prevention & control, Heart Diseases therapy, Evidence-Based Practice methods, Patient Care Team, Centers for Disease Control and Prevention, U.S. organization & administration, Stroke prevention & control
- Abstract
Competing Interests: The author declares no conflict of interest with respect to the authorship and/or publication of this article. The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
- Published
- 2024
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16. Effect of health lifestyle on the risk of stroke: A prospective cohort study from Chongqing, China.
- Author
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Liu X, Hu Y, Chen L, Luo Y, Tang W, Liu X, Qiu J, and Tang X
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- Humans, Middle Aged, Male, Prospective Studies, Female, China epidemiology, Aged, Risk Factors, Adult, Risk Assessment, Ischemic Stroke epidemiology, Ischemic Stroke prevention & control, Ischemic Stroke diagnosis, Alcohol Drinking epidemiology, Alcohol Drinking adverse effects, Health Status, Time Factors, Prognosis, Healthy Lifestyle, Risk Reduction Behavior, Diet, Healthy, Exercise, Sleep, Stroke epidemiology, Stroke prevention & control, Stroke diagnosis, Protective Factors
- Abstract
Objective: To prospectively investigate the associations of healthy lifestyle factors on the risk of stroke and stroke subtypes, as studies exploring this relationship are limited in China., Methods: The 22,661 participants in the prospective cohort study in Chongqing, China, aged 30-79 years and stroke-free at baseline completed follow-up from 2018 to 2022. We included seven healthy lifestyle factors, including non-smoking, non-excessive drinking, sufficient physical activity, healthy diet, sleep duration of 7-9 h/d, and standard range of body mass index and waist-to-hip ratio. The healthy lifestyle score was calculated based on the number of healthy lifestyle factors., Results: Compared with participants who had scores ≤2, participants with scores ≥6 had an HRs (95 % CIs) of 0.56 (0.34, 0.92) for total stroke and 0.53 (0.30, 0.93) for ischemic stroke. For every 1-point increase in healthy lifestyle scores, the HRs (95 % CIs) for total stroke and ischemic stroke was 0.86 (0.78, 0.95) and 0.86 (0.77, 0.96), respectively., Conclusions: Maintaining multiple healthy lifestyle factors can significantly reduce the risk of stroke. As the number of healthy lifestyle factors increased, the stroke risk gradually decreased. Our findings emphasize the significance of comprehensive lifestyle interventions., Competing Interests: Declaration of competing interest No potential conflict of interest was reported by the author., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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17. Adherence to oral anticoagulants in patients with non-valvular atrial fibrillation: the role of patients' characteristics and out-of-pocket payments.
- Author
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Al-Obaidi S, Hijazeen R, Arabyat RM, and Alabbadi I
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- Humans, Cross-Sectional Studies, Female, Male, Middle Aged, Administration, Oral, Aged, Iraq, Adult, Warfarin administration & dosage, Warfarin economics, Aged, 80 and over, Insurance Coverage, Income, Atrial Fibrillation drug therapy, Anticoagulants administration & dosage, Anticoagulants economics, Medication Adherence statistics & numerical data, Health Expenditures statistics & numerical data, Stroke prevention & control, Stroke economics
- Abstract
Background: Recent practice guidelines favor direct oral anticoagulants (DOACs) over warfarin for primary stroke prevention in patients with non-valvular atrial fibrillation (NVAF). However, challenges persist in Iraq's private pharmaceutical sector. DOACs have been sold at high and inconsistent retail prices and lack insurance coverage, leading to significant out-of-pocket (OOP) costs. The objective of this study is to investigate the impact of OOP costs on oral anticoagulants (OAC) adherence among NVAF patients., Research Design and Methods: This multicenter cross-sectional study interviewed 359 eligible patients attending three private cardiology clinics within Iraq's southern region from December 2022 to February 2023. The 8-item Morisky Adherence Scale evaluated patient adherence. Statistical analyses, including descriptive analysis, ANOVA, and chi-square. p < 0.05 was considered statistically significant., Results: The most frequently prescribed OAC were DOACs (62.8%). Patient adherence level to OAC was chiefly medium (54.6%) with no significant difference in adherence based on OAC type. Patient adherence was significantly associated with monthly income ( p = 0.001), number of daily pills ( p = 0.006), and OACs' average monthly cost ( p = 0.011)., Conclusion: Addressing the issue of cost-related non-adherence to OACs requires multiple actions. These include ensuring comprehensive health insurance coverage for OACs, increasing the use of affordable generic alternatives, and establishing effective cost-related discussions between healthcare providers and patients.
- Published
- 2024
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18. Are we ready for new strategies to prevent stroke in children with sickle cell disease?
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Russo G and Colombatti R
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- Humans, Child, Anemia, Sickle Cell complications, Stroke prevention & control, Stroke etiology
- Published
- 2024
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19. [Open surgical treatment for carotid stenoses].
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Shayesteh-Kheslat R and Lescan M
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- Humans, Endarterectomy, Carotid, Male, Aged, Germany epidemiology, Stroke etiology, Stroke prevention & control, Carotid Stenosis surgery
- Abstract
Background: Globally, stroke is considered the second most common cause of death. According to the German Federal Statistical Office, 33.6% of mortality was due to cardiovascular diseases, making them the most prevalent cause of death., Problem: Specifically, cerebral infarctions were recorded as the cause in over 16,000 cases. These figures underscore the significant role that cerebrovascular diseases play in Germany's mortality statistics. Notably, about 80% of strokes are ischemic. Moreover, one-fifth of all strokes result from extracranial carotid stenosis. The increase in stroke risk with advancing age, especially among men, is particularly striking. This trend highlights the growing importance of efficient stroke prevention and treatment in an aging society., Conclusion: Open surgical therapy, as a crucial treatment method, is increasingly important, especially as an emergency intervention. Its role in modern medicine emphasizes the urgency of prioritizing this life-saving procedure in healthcare and making it widely available., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2024
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20. Carotid Stenosis and Stroke: Medicines, Stents, Surgery-"Wait-and-See" or Protect?
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Musialek P, Rosenfield K, Siddiqui AH, and Grunwald IQ
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- Humans, Endarterectomy, Carotid adverse effects, Treatment Outcome, Stents adverse effects, Carotid Stenosis surgery, Carotid Stenosis complications, Carotid Stenosis therapy, Stroke prevention & control, Stroke etiology
- Abstract
Competing Interests: P.M. is a recipient of research grants for basic and clinical investigations in atherosclerosis, and he has proctored and/or consulted for Abbott Vascular, Balton, Gore InspireMD, and Medtronic. P.M. has performed clinical trials of novel minimally invasive methods in carotid revascularization in primary and secondary stroke prevention including CARENET (Co-Principal Investigator), PARADIGM/PARADIGM-Extend (Principal Investigator), OPTIMA (Principal Investigator), TOP-Guard (Principal Investigator), and he is Global Co-Principal Investigator in FDA IDE CGUARDIANS trial. P.M. is the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the ESC Stroke Council Scientif Documents Task Force. K.R. reports receiving fees for serving on advisory boards from Abbott Vascular, Cardinal Health, Surmodics, Inari Medical, Volcano/Philips, and Proteon; receiving fees and stock options for serving on advisory boards from Cruzar Systems, Valcare, and Eximo; receiving stock options for serving on advisory boards from Capture Vascular, Shockwave, Micell, Endospan, and Silk Road Vascular; receiving stock options for serving on the advisory boards of and the holding of equity positions in Contego, Access Vascular, and MD Insider; holding stock/stock options in Embolitech, Janacare, Primacea, and PQ Bypass; receipt of a future payout from a previous equity position in Vortex; and receiving grant support paid to his institution from Abbott Vascular, Atrium/Maquet, and Lutonix/Bard. A.H.S. has consulted for Amnis Therapeutics Ltd, Cerebrotech Medical, Systems Inc., CereVasc LLC, Claret Medical Inc., Codman, Corindus Inc., GuidePoint Global Consulting, Medtronic (Formerly Covidien), MicroVention, Neuravi, Penumbra, Pulsar Vascular, Rapid Medical, Rebound Therapeutics Corporation, Silk Road Medical, Stryker, The Stroke Project Inc., Three Rivers Medical Inc., and W.L. Gore & Associates, and is a Board Member of Intersocietal Accreditation Commission. He has been Principal Investigator and/or served on Steering Committees for: Codman & Shurtleff, LARGE Trial, Covidien (Now Medtronic), SWIFT PRIME and SWIFT DIRECT Trials; MicroVention, FRED Trial, CONFIDENCE Study, MUSC, POSITIVE Trial; Penumbra, 3D Separator Trial, COMPASS Trial, INVEST Trial. A.H.S. has financial interests in BuffaloTechnology Partners Inc., Cardinal, International Medical Distribution Partners, Medina Medical Systems, Neuro Technology Investors, StimMed, and Valor Medical. I.Q.G. is Vice President of the World Federation for Interventional Stroke Treatment (WIST).
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- 2024
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21. Comparison of factor X inhibitors versus vitamin K antagonists in atrial fibrillation patients on dialysis.
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Chen X, Zhu W, and Lin M
- Subjects
- Humans, Aged, Male, Female, Stroke prevention & control, Stroke etiology, Kidney Failure, Chronic therapy, Kidney Failure, Chronic complications, Middle Aged, Hemorrhage chemically induced, Warfarin therapeutic use, Warfarin adverse effects, Atrial Fibrillation drug therapy, Vitamin K antagonists & inhibitors, Renal Dialysis, Anticoagulants therapeutic use, Anticoagulants adverse effects, Factor Xa Inhibitors therapeutic use, Factor Xa Inhibitors adverse effects
- Abstract
Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest.
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- 2024
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22. Advances in Primordial, Primary, and Secondary Prevention of Stroke in Diverse Populations.
- Author
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Adeniji O, Olowoyo P, Akinyemi R, Fisher M, and Owolabi M
- Subjects
- Humans, Primary Prevention, Stroke prevention & control, Secondary Prevention methods
- Abstract
Competing Interests: M. Owolabi is supported by SIREN (U54HG007479), SIBS Genomics (R01NS107900), ARISES (R01NS115944–01), CANVAS (1R01NS114045-01), TALENTS (D43TW012030), and GRASP (UE5HL172183). M. Owolabi is an Associate Editor of Stroke. M. Owolabi reports employment by no commercial entity. Dr Fisher is a senior guest editor of Stroke and has received compensation from the American Heart Association (AHA). Dr Fisher reports compensation from Lumosa for consultant services; employment by Beth Israel Deaconess Medical Center; and compensation from Simcere USA for consultant services. The other authors report no conflicts.
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- 2024
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23. Anticoagulation for stroke prevention in atrial fibrillation and treatment of venous thromboembolism and portal vein thrombosis in cirrhosis: guidance from the SSC of the ISTH.
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Carlin S, Cuker A, Gatt A, Gendron N, Hernández-Gea V, Meijer K, Siegal DM, Stanworth S, Lisman T, and Roberts LN
- Subjects
- Humans, Risk Factors, Treatment Outcome, Hemorrhage chemically induced, Blood Coagulation drug effects, Risk Assessment, Heparin, Low-Molecular-Weight therapeutic use, Heparin, Low-Molecular-Weight administration & dosage, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Liver Cirrhosis complications, Liver Cirrhosis drug therapy, Portal Vein, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Anticoagulants adverse effects, Venous Thromboembolism prevention & control, Venous Thromboembolism drug therapy, Venous Thromboembolism etiology, Venous Thromboembolism diagnosis, Venous Thrombosis prevention & control, Venous Thrombosis drug therapy, Venous Thrombosis etiology, Venous Thrombosis diagnosis, Stroke prevention & control, Stroke etiology
- Abstract
While advanced liver disease was previously considered to be an acquired bleeding disorder, there is increasing recognition of an associated prothrombotic state with patients being at higher risk of atrial fibrillation (AF) and stroke and venous thromboembolism (VTE) including portal vein thrombosis (PVT). We review the available literature on epidemiology, pathophysiology, and risk factors and provide guidance on anticoagulant management of these conditions in adults with cirrhosis. In patients with Child-Pugh A or B cirrhosis and AF, we recommend anticoagulation with standard-dose direct oral anticoagulants (DOACs) in accordance with cardiology guideline recommendations for patients without liver disease. In those with Child-Pugh C cirrhosis, there is inadequate evidence with respect to the benefit and risk of anticoagulation for stroke prevention in AF. In patients with cirrhosis and acute deep vein thrombosis or pulmonary embolism, we recommend anticoagulation and suggest use of either a DOAC or low-molecular-weight heparin (LMWH)/vitamin K antagonist (VKA) in Child-Pugh A or B cirrhosis and LMWH alone (or as a bridge to VKA in patients with a normal baseline international normalized ratio) in Child-Pugh C cirrhosis. We recommend anticoagulation for patients with cirrhosis and symptomatic PVT. We suggest anticoagulation for those with asymptomatic, progressing PVT and recommend continuing extended anticoagulation for liver transplant candidates with PVT., Competing Interests: Declaration of competing interests S.C. has received speaker or advisory board fees from AstraZeneca, BMS/Pfizer, Fresenius Kabi, Leo Pharma, and Servier. A.C. has served as a consultant for MingSight Pharmaceuticals, the New York Blood Center, Sanofi, and Synergy, and has received authorship royalties from UpToDate. A.G. has received travel/conference awards from Octapharma and CSL Behring. N.G. has received consulting fees or travel awards from Bayer, Bristol-Myers Squibb/Pfizer, LEO Pharma, and Diagnostica Stago. V.H.G. has received speaker fees from Cook Medical and Gore Medical. K.M. has received speaker fees from Alexion, Bayer, and CSL Behring; fees for participation in trial steering committees for Bayer and AstraZeneca; consulting fees from uniQure and Therini, and fees for participation in data monitoring and endpoint adjudication committee for Octapharma. D.M.S. has received honoraria paid indirectly to her research institute from AstraZeneca, BMS-Pfizer, Roche, and Servier for educational presentations. D.M.S. is supported by a Tier 2 Canada Research Chair in Anticoagulant Management of Cardiovascular Disease. L.R. has received speaker or advisory fees from Chugai and Hemab. S.S. and T.L. have no competing interests to disclose., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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24. Rethinking stroke prevention for patients with atrial fibrillation.
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Healey JS
- Subjects
- Humans, Anticoagulants therapeutic use, Risk Factors, Atrial Fibrillation complications, Stroke prevention & control, Stroke etiology
- Abstract
Competing Interests: Disclosures Dr Healey has received an unrestricted grant for the conduct of the ARTESIA trial from BMS/Pfizer and Medtronic and a grant for the LAAOS4 trial from Boston Scientific. He has served on the scientific advisory board of Boston Scientific. He has received speaking fees for presentations from BMS/Pfizer, Servier, Novartis, and Boston Scientific. He has served as an expert witness for Bayer. He has served as a data and safety monitoring board member for the PRAETORIAN DFT trial of Boston Scientific.
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- 2024
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25. Trends in percutaneous left atrial appendage occlusion and 1-year mortality 2013-2021: A nationwide observational study.
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Jung M, Kim SW, and Park JW
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Cardiac Catheterization methods, Cardiac Catheterization trends, Mortality trends, Stroke mortality, Stroke prevention & control, Time Factors, Atrial Appendage surgery, Atrial Fibrillation mortality, Atrial Fibrillation surgery
- Abstract
Competing Interests: Declaration of competing interest The authors have nothing to disclose.
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- 2024
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26. Employing Real-World Evidence for the Economic Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation in Thailand.
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Krittayaphong R and Permsuwan U
- Subjects
- Humans, Thailand, Aged, Male, Female, Middle Aged, Administration, Oral, Markov Chains, Stroke prevention & control, Stroke economics, Aged, 80 and over, Registries, Atrial Fibrillation drug therapy, Atrial Fibrillation economics, Anticoagulants economics, Anticoagulants therapeutic use, Cost-Benefit Analysis, Warfarin economics, Warfarin therapeutic use, Quality-Adjusted Life Years
- Abstract
Background: This study aimed to assess the cost-effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) in comparison with warfarin using data from real practice based on the perspective of the health care system in Thailand., Methods: A four-state Markov model encompassing well-controlled atrial fibrillation (AF), stroke and systemic embolism, major bleeding and death was utilised to forecast clinical and economic outcomes. Transitional probabilities, direct medical costs and utilities were derived from the real-world data of the 'COOL-AF Thailand' registry, Thailand's largest nationwide registry spanning 27 hospitals. The cohort comprised AF patients. The primary outcomes assessed were total costs, life years, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio. All costs and outcomes were subject to an annual discount rate of 3.0%. A spectrum of sensitivity analyses was conducted., Results: The mean age of the cohort was 68.8 ± 10.7 years. The NOACs group incurred a marginally lower total lifetime cost than the warfarin group (247,857 Thai baht [THB] vs 253,654 THB or 7137 USD vs 7304 USD) and experienced gains of 0.045 life years and 0.043 QALYs over the warfarin group. Given the lower cost and higher benefits associated with NOACs, this implies that NOAC treatment is a dominant strategy compared to warfarin for AF patients. At a ceiling ratio of 160,000 THB (4607 USD) per QALY, NOACs presented a 61.2% probability of being cost effective., Conclusions: Non-vitamin K antagonist oral anticoagulants represent a cost-saving alternative to warfarin in the real clinical practice. However, with a probability of being cost effective below 65%, it suggests some parameter uncertainty regarding their overall cost effectiveness compared to warfarin., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
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- 2024
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27. Percutaneous left atrial appendage closure for stroke prevention in hypertrophic cardiomyopathy patients with atrial fibrillation.
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Aglan A, Fath AR, Maron BJ, Maron MS, Prasad A, Almomani A, Hammadah M, Reynolds MR, and Rowin EJ
- Subjects
- Humans, Male, Female, Aged, Retrospective Studies, Cardiac Catheterization methods, Propensity Score, Treatment Outcome, Follow-Up Studies, Anticoagulants therapeutic use, Middle Aged, Septal Occluder Device, Survival Rate trends, Left Atrial Appendage Closure, Atrial Fibrillation complications, Atrial Fibrillation surgery, Atrial Appendage surgery, Cardiomyopathy, Hypertrophic complications, Stroke prevention & control, Stroke etiology
- Abstract
Background: Percutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in patients with atrial fibrillation (AF) at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain., Objective: The study aimed to compare risk of stroke in HCM-AF patients treated with LAAC with those treated with AC., Methods: By use of the TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were assigned to categories of treatment with LAAC and treatment solely with AC and observed for 3 years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity score matching was used to limit confounders., Results: Of 14,867 HCM-AF patients identified, 364 (2.5%) were treated with LAAC vs 14,503 (97.5%) treated with AC. HCM LAAC patients were older (72 vs 67 years; P < .001) and had more comorbidities and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs 18%; P < .001), compared with HCM patients treated solely with AC. After propensity score matching, there was no baseline difference between groups including prior bleeding events (P > .05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs 8%; hazard ratio, 1.9; P = .006) and systemic embolism (14% vs 9%; hazard ratio, 1.8; P = .006) but no difference in mortality compared with matched HCM patients receiving AC., Conclusion: These real-world data do not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy during long-term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC because of prohibitive bleeding risk., Competing Interests: Disclosures Martin S. Maron: consultant for Cytokinetics, iRhythm (with grant), Imbria Pharmaceuticals, Takeda Pharmaceuticals (with grant). Ethan J. Rowin: research funding from Pfizer, iRhythm. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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- 2024
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28. Long-Term Drug Therapy Following Carotid Endarterectomy Aimed at Reducing Major Adverse Cardiovascular Events.
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Baker D, Chen X, Rahm L, and Hirschowitz D
- Subjects
- Humans, Time Factors, Aged, Male, Female, Treatment Outcome, Risk Factors, Practice Patterns, Physicians', Drug Administration Schedule, Middle Aged, Antihypertensive Agents therapeutic use, Antihypertensive Agents adverse effects, Electronic Health Records, Aged, 80 and over, Cardiovascular Agents therapeutic use, Cardiovascular Agents adverse effects, Retrospective Studies, Hypolipidemic Agents therapeutic use, Hypolipidemic Agents adverse effects, Drug Prescriptions, Stroke prevention & control, Stroke etiology, Stroke mortality, Carotid Artery Diseases mortality, Carotid Artery Diseases surgery, Fibrinolytic Agents adverse effects, Fibrinolytic Agents administration & dosage, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents adverse effects, Anticoagulants adverse effects, Anticoagulants therapeutic use, Risk Assessment, Endarterectomy, Carotid adverse effects, Endarterectomy, Carotid mortality
- Abstract
Background: Timely carotid endarterectomy (CEA) reduces the risk of future stroke. This benefit is maximized with lifelong drug therapy aimed at reducing further major adverse cardiovascular events (MACEs), including stroke. Studies suggest that around half discontinue these drugs within 12 months. To assess if this is the case following CEA, we considered the MACE-reducing drugs prescribed several years later and compared this with the drugs they were prescribed at CEA., Methods: The electronic primary care records of 347 post-CEA patients a mean of 108 (range 43-185) months after surgery were interrogated. The prescriptions of generic MACE-reducing drugs (antithrombotic, lipid-lowering, antihypertension and diabetes) of the 187 alive were compared with their prescriptions at CEA and with the last prescription of the 160 who had died before the late review. The post-CEA incidence of further MACE in survivors was determined., Results: At late review, fewer of the post-CEA patients alive were taking antiplatelet drugs (143, 76% vs. 170, 91% P < 0.01), but more were fully anticoagulated (37v4 P < 0.01) when compared with prescriptions at CEA. Overall, there was no change in antithrombotic drug prescription rates (167, 89% vs. 172, 92%). Lipid-regulating drugs were well prescribed both at late review and at CEA (173, 93% vs. 169, 90%). The number prescribed antihypertension drugs was significantly higher at late review than at CEA (166, 89% vs. 67, 35% P < 0.01). The number treated for diabetes was similar (64, 34% vs. 42, 23%). There was no difference in the numbers of any of the MACE-reducing drugs prescribed between those who had survived to late review and those who had not. At late review, of those alive, there were 22 (12%) new strokes, and 24 (14%) had developed new or worsening ischemic cardiac symptoms., Conclusions: We found a higher than expected prescription rate of MACE-reducing drugs many years after CEA. This finding may be due, in part, to the nationalized health service in the United Kingdom., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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29. Efficacy and safety of left atrial appendage closure procedure in patients with non-valvular atrial fibrillation with contraindication and/or failure for oral anticoagulants: A systematic review and meta-analysis.
- Author
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Simões RDS, Bortoluzzi AFR, Marinho JCN, Galendi JSC, and Bernardo WM
- Subjects
- Humans, Stroke prevention & control, Stroke etiology, Treatment Outcome, Administration, Oral, Randomized Controlled Trials as Topic, Contraindications, Drug, Left Atrial Appendage Closure, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Atrial Fibrillation surgery, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Atrial Appendage surgery
- Abstract
Background: With the aim of reducing the risk of Cerebrovascular Accident (CVA) in patients with Non-Valvular Atrial Fibrillation (NVAF), Left Atrial Appendage Occlusion (LAAO) devices are emerging as an alternative to oral anticoagulants., Objective: To analyze the efficacy and safety of the LAAO procedure in patients with NVAF and contraindications and/or failure for oral anticoagulants., Method: The search for evidence was carried out in the electronic databases Medline and Embase till January 2024. Additional searches were conducted on Google Scholar. The clinical trials registry database was also consulted. Two blinded investigators performed the search, study selection, and data collection, and assessed quality and risk of bias using the Cochrane tool for randomized clinical trials. Meta-analyses of eligible trials were performed using RevMan 5.4.1 software. The random effects model was used for all analyses., Results: Five articles were selected, among which three were non-inferiority randomized clinical trials that analyzed the performance and safety of LAAO devices compared to the use of Vitamin K Antagonists (AVKs) or Novel Oral Anticoagulants (NOACs). No randomized clinical trials were found that analyzed populations with absolute contraindications to oral anticoagulants. Having as primary outcomes analyzed the occurrence of stroke (ischemic or hemorrhagic), cardiovascular or unexplained death and systemic embolism, the non-inferiority of the LAAO procedure compared to the use of oral anticoagulants was verified., Conclusions: For patients with an absolute contraindication to anticoagulation and/or failure to use oral anticoagulants, evidence for the use of LAAO devices is scarce., Competing Interests: Conflicts of interest The authors declare that they are collaborators and consultants at Unimed do Brasil., (Copyright © 2024. Published by Elsevier España, S.L.U.)
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- 2024
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30. Using real-world evidence to complement evidence from randomized controlled trials on oral anticoagulants for stroke prevention.
- Author
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Smeets MJR and Cannegieter SC
- Subjects
- Humans, Administration, Oral, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Stroke prevention & control, Randomized Controlled Trials as Topic
- Abstract
Mark J. R. Smeets and Suzanne C. Cannegieter discuss the use of real world data to complement data generated by clinical trials of systemic anticoagulants., Competing Interests: SCC is a member of the PLOS Medicine Editorial Board., (Copyright: © 2024 Smeets, Cannegieter. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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31. Comparison of oral anticoagulants for stroke prevention in atrial fibrillation using the UK clinical practice research Datalink Aurum: A reference trial (ARISTOTLE) emulation study.
- Author
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Powell EM, Gungabissoon U, Tazare J, Smeeth L, Baptiste PJ, Bin Hammad TM, Wong AYS, Douglas IJ, and Wing K
- Subjects
- Humans, United Kingdom epidemiology, Female, Aged, Male, Administration, Oral, Aged, 80 and over, Middle Aged, Treatment Outcome, Hemorrhage chemically induced, Factor Xa Inhibitors therapeutic use, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors administration & dosage, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Warfarin therapeutic use, Warfarin adverse effects, Warfarin administration & dosage, Anticoagulants therapeutic use, Anticoagulants adverse effects, Anticoagulants administration & dosage, Stroke prevention & control, Stroke etiology, Pyridones therapeutic use, Pyridones administration & dosage, Pyridones adverse effects, Pyrazoles therapeutic use, Pyrazoles administration & dosage
- Abstract
Background: Stroke prevention guidance for patients with atrial fibrillation (AF) uses evidence generated from randomised controlled trials (RCTs). However, applicability to patient groups excluded from trials remains unknown. Real-world patient data provide an opportunity to evaluate outcomes in a trial analogous population of direct oral anticoagulants (DOACs) users and in patients otherwise excluded from RCTs; however, there remains uncertainty on the validity of methods and suitability of the data. Successful reference trial emulation can support the generation of evidence around treatment effects in groups excluded or underrepresented in trials. We used linked United Kingdom primary care data to investigate whether we could emulate the pivotal ARISTOTLE trial (apixaban versus warfarin) and extend the analysis to investigate the impact of warfarin time in therapeutic range (TTR) on results., Methods and Findings: Patients with AF in the UK Clinical Practice Research Datalink (CPRD Aurum) prescribed apixaban or warfarin from 1 January 2013 to 31 July 2019 were selected. ARISTOTLE eligibility criteria were applied to this population and matched to the RCT apixaban arm on baseline characteristics creating a trial-analogous apixaban cohort; this was propensity-score matched to warfarin users in the CPRD Aurum. ARISTOTLE outcomes were assessed using Cox proportional hazards regression stratified by prior warfarin exposure status during 2.5 years of patient follow-up and results benchmarked against the trial results before treatment effectiveness was further evaluated based on (warfarin) TTR. The dataset comprised 8,734 apixaban users and propensity-score matched 8,734 warfarin users. Results [hazard ratio (95% confidence interval)] confirmed apixaban noninferiority for stroke or systemic embolism (SE) [CPRD 0.98 (0.82,1.19) versus trial 0.79 (0.66,0.95)] and death from any cause [CPRD 1.03 (0.93,1.14) versus trial 0.89 (0.80,0.998)] but did not indicate apixaban superiority. Absolute event rates for stroke/SE were similar for apixaban in CPRD Aurum and ARISTOTLE (1.27%/year), whereas a lower event rate was observed for warfarin (CPRD Aurum 1.29%/year, ARISTOTLE 1.60%/year). Analysis by TTR suggested similar effectiveness of apixaban compared with poorly controlled warfarin (TTR < 0.75) for stroke/SE [0.91 (0.73, 1.14)], all-cause death [0.94 (0.84, 1.06)], and superiority for major bleeding [0.74 (0.63, 0.86)]. However, when compared with well-controlled warfarin (TTR ≥ 0.75), apixaban was associated with an increased hazard for all-cause death [1.20 (1.04, 1.37)], and there was no significant benefit for major bleeding [1.08 (0.90, 1.30)]. The main limitation of the study's methodology are the risk of residual confounding, channelling bias and attrition bias in the warfarin arm, and selection bias and misclassification in the analysis by TTR., Conclusions: Analysis of noninterventional data generated results demonstrating noninferiority of apixaban versus warfarin consistent with prespecified benchmarking criteria. Unlike in ARISTOTLE, superiority of apixaban versus warfarin was not seen, possible due to the lower proportion of Asian patients and higher proportion of patients with well-controlled warfarin compared to ARISTOTLE. This methodological template can be used to investigate treatment effects of oral anticoagulants in patient groups excluded from or underrepresented in trials and provides a framework that can be adapted to investigate treatment effects for other conditions., Competing Interests: EMP was funded by a Medical Research Council studentship for this work, and is an employee of and holds stock in Compass Pathways outside the submitted work. UG is an employee of and holds stock in GSK. JT reports no conflict of interest and is supported by an unrestricted grant from GSK. LS reports grants from Wellcome, MRC, NIHR, BHF, Diabetes UK, ESRC, EU and GSK, personal fees from GSK and AstraZeneca, and is a trustee of the British Heart Foundation, outside the submitted work. PJB is supported by Barts Charity (MGU0504) and was supported by a GSK studentship at the time of writing. TBH reports no conflict of interest. AW reports no conflict of interest and is supported by a fellowship from British Heart Foundation (FS/19/19/34175). IJD reports grants, and holds stocks in GSK, outside the submitted work. KW has nothing to disclose., (Copyright: © 2024 Powell et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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32. Robotic-assisted left atrial appendage occlusion.
- Author
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Baudo M, Yakobitis A, Murray C, and Torregrossa G
- Subjects
- Humans, Atrial Appendage surgery, Robotic Surgical Procedures methods, Atrial Fibrillation surgery, Stroke prevention & control, Stroke etiology, Coronary Artery Bypass methods
- Abstract
Atrial fibrillation poses significant stroke risks, particularly in patients undergoing cardiac surgery. Left atrial appendage occlusion has emerged as a crucial strategy for stroke prevention, garnering a Class I recommendation. This paper presents a technical framework for performing robotic left atrial appendage occlusion as an isolated procedure or concurrently with robotic coronary artery bypass grafting using the AtriCure AtriClip Pro2 device., (© The Author 2024. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2024
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33. Novel Mouse Model of Myocardial Infarction, Plaque Rupture, and Stroke Shows Improved Survival With Myeloperoxidase Inhibition.
- Author
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Shamsuzzaman S, Deaton RA, Salamon A, Doviak H, Serbulea V, Milosek VM, Evans MA, Karnewar S, Saibaba S, Alencar GF, Shankman LS, Walsh K, Bekiranov S, Kocher O, Krieger M, Kull B, Persson M, Michaëlsson E, Bergenhem N, Heydarkhan-Hagvall S, and Owens GK
- Subjects
- Animals, Male, Mice, Diet, Western adverse effects, Disease Models, Animal, Enzyme Inhibitors therapeutic use, Enzyme Inhibitors pharmacology, Mice, Inbred C57BL, Mice, Knockout, Receptors, LDL genetics, Receptors, LDL deficiency, Rupture, Spontaneous, Scavenger Receptors, Class B genetics, Scavenger Receptors, Class B metabolism, Myocardial Infarction pathology, Myocardial Infarction drug therapy, Peroxidase metabolism, Plaque, Atherosclerotic drug therapy, Stroke drug therapy, Stroke prevention & control
- Abstract
Background: Thromboembolic events, including myocardial infarction (MI) or stroke, caused by the rupture or erosion of unstable atherosclerotic plaques are the leading cause of death worldwide. Although most mouse models of atherosclerosis develop lesions in the aorta and carotid arteries, they do not develop advanced coronary artery lesions. Moreover, they do not undergo spontaneous plaque rupture with MI and stroke or do so at such a low frequency that they are not viable experimental models to study late-stage thrombotic events or to identify novel therapeutic approaches for treating atherosclerotic disease. This has stymied the development of more effective therapeutic approaches for reducing these events beyond what has been achieved with aggressive lipid lowering. Here, we describe a diet-inducible mouse model that develops widespread advanced atherosclerosis in coronary, brachiocephalic, and carotid arteries with plaque rupture, MI, and stroke., Methods: We characterized a novel mouse model with a C-terminal mutation in the scavenger receptor class B, type 1 (SR-BI), combined with Ldlr knockout (designated SR-BI
∆CT/∆CT / Ldlr-/- ). Mice were fed Western diet (WD) for 26 weeks and analyzed for MI and stroke. Coronary, brachiocephalic, and carotid arteries were analyzed for atherosclerotic lesions and indices of plaque stability. To validate the utility of this model, SR-BI∆CT/∆CT / Ldlr-/- mice were treated with the drug candidate AZM198, which inhibits myeloperoxidase, an enzyme produced by activated neutrophils that predicts rupture of human atherosclerotic lesions., Results: SR-BI∆CT/∆CT / Ldlr-/- mice show high (>80%) mortality rates after 26 weeks of WD feeding because of major adverse cardiovascular events, including spontaneous plaque rupture with MI and stroke. Moreover, WD-fed SR-BI∆CT/∆CT / Ldlr-/- mice displayed elevated circulating high-sensitivity cardiac troponin I and increased neutrophil extracellular trap formation within lesions compared with control mice. Treatment of WD-fed SR-BI∆CT/∆CT / Ldlr-/- mice with AZM198 showed remarkable benefits, including >90% improvement in survival and >60% decrease in the incidence of plaque rupture, MI, and stroke, in conjunction with decreased circulating high-sensitivity cardiac troponin I and reduced neutrophil extracellular trap formation within lesions., Conclusions: WD-fed SR-BI∆CT/∆CT / Ldlr-/- mice more closely replicate late-stage clinical events of advanced human atherosclerotic disease than previous models and can be used to identify and test potential new therapeutic agents to prevent major adverse cardiac events.- Published
- 2024
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34. Stroke Care in South Asia - Identifying Gaps for Future Action.
- Author
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Mishra SR, Wei K, O'Hagan E, Khanal V, Laaksonen MA, and Lindley RI
- Subjects
- Humans, Asia epidemiology, Risk Factors, Nepal epidemiology, Developing Countries, Stroke Rehabilitation methods, Asia, Southern, Stroke epidemiology, Stroke therapy, Stroke prevention & control
- Abstract
Stroke causes around 730,000 deaths in South Asia, nearly half of stroke-related deaths in developing countries. This highlights the need to address health system responses, considering poverty, service quality, and availability. The article identifies four key challenges in stroke management and rehabilitation in South Asia, emphasizing long-term monitoring, risk factor control, and community surveillance, drawing on experiences from Nepal., Competing Interests: Shiva Raj Mishra serves as a deputy editor in Global Heart. The authors have no competing interests to declare., (Copyright: © 2024 The Author(s).)
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- 2024
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35. Multicomponent Support Program for Secondary Prevention of Stroke Using Digital Health Technology: Co-Design Study With People Living With Stroke or Transient Ischemic Attack.
- Author
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Silvera-Tawil D, Cameron J, Li J, Varnfield M, Allan LP, Harris M, Lannin NA, Redd C, and Cadilhac DA
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- Aged, Female, Humans, Male, Middle Aged, Australia, Biomedical Technology methods, Digital Technology, Surveys and Questionnaires, Telemedicine, Digital Health, Ischemic Attack, Transient prevention & control, Secondary Prevention methods, Stroke prevention & control
- Abstract
Background: Few individuals (<2%) who experience a stroke or transient ischemic attack (TIA) participate in secondary prevention lifestyle programs. Novel approaches that leverage digital health technology may provide a viable alternative to traditional interventions that support secondary prevention in people living with stroke or TIA. To be successful, these strategies should focus on user needs and preferences and be acceptable to clinicians and people living with stroke or TIA., Objective: This study aims to co-design, with people with lived experience of stroke or TIA (referred to as consumers) and clinicians, a multicomponent digital technology support program for secondary prevention of stroke., Methods: A consumer user needs survey (108 items) was distributed through the Australian Stroke Clinical Registry and the Stroke Association of Victoria. An invitation to a user needs survey (135 items) for clinicians was circulated via web-based professional forums and national organizations (eg, the Stroke Telehealth Community of Practice Microsoft Teams Channel) and the authors' research networks using Twitter (subsequently rebranded X, X Corp) and LinkedIn (LinkedIn Corp). Following the surveys, 2 rounds of user experience workshops (design and usability testing workshops) were completed with representatives from each end user group (consumers and clinicians). Feedback gathered after each round informed the final design of the digital health program., Results: Overall, 112 consumers (male individuals: n=63, 56.3%) and 54 clinicians (female individuals: n=43, 80%) responded to the survey; all items were completed by 75.8% (n=85) of consumers and 78% (n=42) of clinicians. Most clinicians (46/49, 94%) indicated the importance of monitoring health and lifestyle measures more frequently than current practice, particularly physical activity, weight, and sleep. Most consumers (87/96, 90%) and clinicians (41/49, 84%) agreed that providing alerts about potential deterioration in an individual's condition were important functions for a digital program. Intention to use a digital program for stroke prevention and discussing the data collected during face-to-face consultations was high (consumers: 79/99, 80%; clinicians 36/42, 86%). In addition, 7 consumers (male individuals: n=5, 71%) and 9 clinicians (female individuals: n=6, 67%) took part in the user experience workshops. Participants endorsed using a digital health program to help consumers manage stroke or TIA and discussed preferred functions and health measures in a digital solution for secondary prevention of stroke. They also noted the need for a mobile app that is easy to use. Clinician feedback highlighted the need for a customizable clinician portal that captures individual consumer goals., Conclusions: Following an iterative co-design process, supported by evidence from user needs surveys and user experience workshops, a consumer-facing app that integrates wearable activity trackers and a clinician web portal were designed and developed to support secondary prevention of stroke. Feasibility testing is currently in progress to assess acceptability and use., (©David Silvera-Tawil, Jan Cameron, Jane Li, Marlien Varnfield, Liam P Allan, Mitch Harris, Natasha A Lannin, Christian Redd, Dominique A Cadilhac. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 22.08.2024.)
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- 2024
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36. Impact of Total Indoor Smoking Ban on Cardiovascular Disease Hospitalizations and Mortality: The Case of Chile.
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Montes de Oca D, Paraje G, and Cuadrado C
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- Humans, Chile epidemiology, Adult, Middle Aged, Aged, Male, Female, Young Adult, Smoke-Free Policy legislation & jurisprudence, Myocardial Infarction mortality, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Smoking legislation & jurisprudence, Smoking epidemiology, Stroke mortality, Stroke prevention & control, Hospitalization statistics & numerical data, Tobacco Smoke Pollution prevention & control, Tobacco Smoke Pollution legislation & jurisprudence, Tobacco Smoke Pollution adverse effects, Cardiovascular Diseases mortality, Cardiovascular Diseases prevention & control
- Abstract
Introduction: The harmful effects of first and secondhand smoking are well-established. Smoke-free laws aim at protecting nonsmokers. This study aimed to assess the impact of the 2013 total ban on indoor smoking in Chile on hospitalizations and deaths of major cardiovascular events., Aims and Methods: The logarithm of the monthly hospitalization and death rates, standardized by age for every 100 000 inhabitants, were estimated for ischemic heart disease, acute myocardial infarction, strokes, and a composite outcome of ischemic heart diseases (which includes acute myocardial infarction) and strokes. In addition, interrupted time series with synthetic control groups were used to assess changes in levels and trends after the intervention., Results: The total ban on indoor smoking caused significant reductions in death rates for the three diseases studied for age groups above 20 years old. In addition, there were substantial decreases in the post-intervention hospitalization rates for ischemic heart disease: for the 20-44 age group, the decrease was 8.7% compared to the pre-intervention period (p < .01). In comparison, such a reduction was 4% (p < .01) for the ≥65 age group. For acute myocardial infarction, the decrease was 11.5% (p < .01) for the 20-44 age group, while for stroke, it was a 1.2% (p < .01) decrease for the total population. It is estimated that the smoking ban averted 15.6% of the deaths compared with the synthetic control groups., Conclusions: The implementation of total smoke-free environments in Chile contributed to the reduction of mortality for main cardiovascular diseases. This study provides additional evidence of causality linking the policy to health outcomes., Implications: The total indoor smoking ban significantly affected age-standardized hospitalization and deaths. The number of deaths averted by this policy is estimated at approximately 4758 and 5256 for IHD and stroke, respectively, during the 2013-2017 period (15.6% fewer deaths than predicted by the synthetic control groups). The study contributes to the body of evidence that supports total indoor smoking bans., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)
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- 2024
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37. Left atrial appendage closure for stroke prevention in atrial fibrillation: current status and perspectives.
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Landmesser U, Skurk C, Tzikas A, Falk V, Reddy VY, and Windecker S
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- Humans, Atrial Appendage surgery, Randomized Controlled Trials as Topic, Septal Occluder Device, Anticoagulants therapeutic use, Atrial Fibrillation complications, Left Atrial Appendage Closure instrumentation, Stroke prevention & control, Stroke etiology
- Abstract
Atrial fibrillation (AF) is associated with an increased risk of stroke and systemic embolism, and the left atrial appendage (LAA) has been identified as a principal source of thromboembolism in these patients. While oral anticoagulation is the current standard of care, LAA closure (LAAC) emerges as an alternative or complementary treatment approach to reduce the risk of stroke or systemic embolism in patients with AF. Moderate-sized randomized clinical studies have provided data for the efficacy and safety of catheter-based LAAC, largely compared with vitamin K antagonists. LAA device iterations, advances in pre- and peri-procedural imaging, and implantation techniques continue to increase the efficacy and safety of LAAC. More data about efficacy and safety of LAAC have been collected, and several randomized clinical trials are currently underway to compare LAAC with best medical care (including non-vitamin K antagonist oral anticoagulants) in different clinical settings. Surgical LAAC in patients with AF undergoing cardiac surgery reduced the risk of stroke on background of anticoagulation therapy in the LAAOS III study. In this review, we describe the rapidly evolving field of LAAC and discuss recent clinical data, ongoing studies, open questions, and current limitations of LAAC., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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38. Acute Brain Infarctions and Periprocedural Stroke: Implications for Evaluating Cerebral Embolic Protection Devices.
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Kapadia S, Krishnaswamy A, and Mack M
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- Humans, Brain Infarction prevention & control, Brain Infarction etiology, Stroke prevention & control, Stroke etiology, Male, Embolic Protection Devices
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Kapadia is the study principal investigator (PI) for the Sentinel trial, Boston Scientific. Dr Mack is the trial co-PI or study chair for Abbott, Edwards Lifesciences, and Medtronic Corporate Board Member of Carmat. Dr Krishnaswamy has reported that he has no relationships relevant to the contents of this paper to disclose.
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- 2024
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39. Left Atrial Appendage Closure Compared With Oral Anticoagulants for Patients With Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.
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Oliva A, Ioppolo AM, Chiarito M, Cremonesi A, Azzano A, Miccichè E, Mangiameli A, Ariano F, Ferrante G, Reimers B, Garot P, Amabile N, Mehran R, Condorelli G, Stefanini G, and Cao D
- Subjects
- Humans, Administration, Oral, Hemorrhage chemically induced, Network Meta-Analysis, Risk Factors, Stroke prevention & control, Stroke etiology, Treatment Outcome, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Anticoagulants adverse effects, Atrial Fibrillation complications, Atrial Fibrillation therapy, Left Atrial Appendage Closure adverse effects, Left Atrial Appendage Closure methods
- Abstract
Background: Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long-term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation., Methods and Results: Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta-analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62-1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71-1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61-1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58-1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all-cause death compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53-0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85-0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%)., Conclusions: As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.
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- 2024
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40. Risk of Major Bleeding, Stroke/Systemic Embolism, and Death Associated With Different Oral Anticoagulants in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease.
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Xu Y, Ballew SH, Chang AR, Inker LA, Grams ME, and Shin JI
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- Humans, Female, Male, Aged, Administration, Oral, Risk Assessment, Aged, 80 and over, Risk Factors, Retrospective Studies, Severity of Illness Index, Incidence, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors therapeutic use, Factor Xa Inhibitors administration & dosage, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Atrial Fibrillation mortality, Renal Insufficiency, Chronic complications, Renal Insufficiency, Chronic mortality, Hemorrhage chemically induced, Hemorrhage epidemiology, Stroke prevention & control, Stroke epidemiology, Stroke etiology, Stroke mortality, Anticoagulants adverse effects, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Warfarin adverse effects, Warfarin therapeutic use, Rivaroxaban adverse effects, Rivaroxaban therapeutic use, Rivaroxaban administration & dosage, Embolism prevention & control, Embolism epidemiology, Embolism etiology, Pyrazoles adverse effects, Pyrazoles therapeutic use, Pyridones adverse effects, Pyridones therapeutic use, Pyridones administration & dosage
- Abstract
Background: Patients with atrial fibrillation and severe chronic kidney disease have higher risks of bleeding, thromboembolism, and mortality. However, optimal anticoagulant choice in these high-risk patients remains unclear., Methods and Results: Using deidentified electronic health records from the Optum Labs Data Warehouse, adults with atrial fibrillation and severe chronic kidney disease (estimated glomerular filtration rate <30 mL/min per 1.73 m
2 ) initiating warfarin, apixaban, or rivaroxaban between 2011 and 2021 were included. Using inverse probability of treatment weighting, adjusted risks of major bleeding, stroke/systemic embolism, and death were compared among agents. A total of 6794 patients were included (mean age, 78.5 years; mean estimated glomerular filtration rate, 24.7 mL/min per 1.73 m2 ; 51% women). Apixaban versus warfarin was associated with a lower risk of major bleeding (incidence rate, 1.5 versus 2.9 per 100 person-years; subdistribution hazard ratio [sub-HR], 0.53 [95% CI, 0.39-0.70]), and similar risks for stroke/systemic embolism (incidence rate, 1.9 versus 2.4 per 100 person-years; sub-HR, 0.80 [95% CI, 0.59-1.09]) and death (incidence rate, 4.6 versus 4.5 per 100 person-years; HR, 1.03 [95% CI, 0.82-1.29]). Rivaroxaban versus warfarin was associated with a higher risk of major bleeding (incidence rate, 4.9 versus 2.9 per 100 person-years; sub-HR, 1.65 [95% CI, 1.10-2.48]), with no difference in risks for stroke/systemic embolism and death. Apixaban versus rivaroxaban was associated with a lower risk of major bleeding (sub-HR, 0.53 [95% CI, 0.36-0.78])., Conclusions: These real-world findings are consistent with potential safety advantages of apixaban over warfarin and rivaroxaban for patients with atrial fibrillation and severe chronic kidney disease. Further randomized trials comparing individual oral anticoagulants are warranted.- Published
- 2024
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41. Left atrial appendage occlusion needs lifetime management not lifetime medications.
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Gafoor S and Panaich S
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- Humans, Anticoagulants therapeutic use, Stroke prevention & control, Stroke etiology, Treatment Outcome, Cardiac Catheterization methods, Atrial Appendage surgery, Atrial Fibrillation therapy
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- 2024
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42. A comparison of simplified or conventional antithrombotic regimens after left atrial appendage closure in patients at high bleeding risk: the PLATEBRISK study.
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Antúnez-Muiños P, López-Tejero S, Cepas-Guillén P, Mon-Noboa M, Ruiz-Nodar JM, Andrés-Lalaguna L, Rivero F, Córdoba-Soriano JG, Amat-Santos IJ, Caneiro-Queija B, Sánchez DM, Sánchez JJ, Mezcua FT, Blanco-Fernández F, Sánchez JS, Moreno-Ambroj C, Estévez-Loureiro R, Nombela-Franco L, Freixa-Rofastes X, and Cruz-González I
- Subjects
- Humans, Male, Female, Aged, Retrospective Studies, Aged, 80 and over, Treatment Outcome, Risk Factors, Anticoagulants therapeutic use, Anticoagulants adverse effects, Stroke prevention & control, Stroke etiology, Risk Assessment, Dual Anti-Platelet Therapy methods, Middle Aged, Left Atrial Appendage Closure, Atrial Appendage surgery, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Platelet Aggregation Inhibitors therapeutic use, Platelet Aggregation Inhibitors adverse effects, Fibrinolytic Agents therapeutic use, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced
- Abstract
Background: Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk., Aims: This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients., Methods: This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy)., Results: A total of 1,135 patients were included. The mean CHA
2 DS2 -VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049)., Conclusions: In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.- Published
- 2024
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43. Determinants of adverse outcomes following patent foramen ovale closure in elderly patients.
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Farjat-Pasos JI, Guedeney P, Horlick E, Abtan J, Nombela-Franco L, Hibbert B, Sondergaard L, Freixa X, Masson JB, Cruz-González I, Estévez-Loureiro R, Faroux L, Shah AH, Abrahamyan L, Mesnier J, Jerónimo A, Abdel-Razek O, Jørgensen TH, Asmar MA, Sitbon S, Abalhassan M, Robichaud M, Houde C, Côté M, Chamorro A, Lanthier S, Verreault S, Montalescot G, and Rodés-Cabau J
- Subjects
- Humans, Female, Male, Aged, Middle Aged, Risk Factors, Treatment Outcome, Stroke etiology, Stroke epidemiology, Stroke prevention & control, Embolism, Paradoxical etiology, Embolism, Paradoxical epidemiology, Embolism, Paradoxical prevention & control, Septal Occluder Device adverse effects, Aged, 80 and over, Age Factors, Incidence, Foramen Ovale, Patent complications, Foramen Ovale, Patent surgery, Cardiac Catheterization adverse effects, Cardiac Catheterization methods, Atrial Fibrillation complications, Atrial Fibrillation epidemiology
- Abstract
Background: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly., Aims: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events., Methods: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted., Results: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF., Conclusions: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.
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- 2024
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44. Addressing the deficiencies in stroke care in Pakistan.
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Javed S, Zaidi DA, and Yaqoob E
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- Humans, Pakistan epidemiology, Stroke prevention & control, Stroke epidemiology
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- 2024
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45. Safety and effectiveness of left atrial appendage closure in atrial fibrillation patients with different types of heart failure.
- Author
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Liu L, Yan W, Xu X, Wan C, Liu F, Yao Q, Song L, Wang B, Song Z, and Li H
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Atrial Appendage diagnostic imaging, Atrial Appendage physiopathology, Atrial Appendage surgery, Recovery of Function, Retrospective Studies, Risk Assessment, Risk Factors, Stroke Volume, Time Factors, Treatment Outcome, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Atrial Fibrillation surgery, Atrial Function, Left, Heart Failure complications, Heart Failure diagnosis, Heart Failure physiopathology, Heart Failure surgery, Left Atrial Appendage Closure adverse effects, Stroke epidemiology, Stroke etiology, Stroke prevention & control, Ventricular Function, Left
- Abstract
Background: Both atrial fibrillation (AF) and heart failure (HF) are common cardiovascular diseases. If the two exist together, the risk of stroke, hospitalization for HF and all-cause death is increased. Currently, research on left atrial appendage closure (LAAC) in patients with AF and HF is limited and controversial. This study was designed to investigate the safety and effectiveness of LAAC in AF patients with different types of HF., Methods: Patients with non-valvular atrial fibrillation (NVAF) and HF who underwent LAAC in the First Affiliated Hospital of Army Medical University from August 2014 to July 2021 were enrolled. According to left ventricular ejection fraction (LVEF), the study divided into HF with reduced ejection fraction (LVEF < 50%, HFrEF) group and HF with preserved ejection fraction (LVEF ≥ 50%, HFpEF) group. The data we collected from patients included: gender, age, comorbid diseases, CHA
2 DS2 -VASc score, HAS-BLED score, NT-proBNP level, residual shunt, cardiac catheterization results, occluder size, postoperative medication regimen, transthoracic echocardiography (TTE) results and transesophageal echocardiography (TEE) results, etc. Patients were followed up for stroke, bleeding, device related thrombus (DRT), pericardial tamponade, hospitalization for HF, and all-cause death within 2 years after surgery. Statistical methods were used to compare the differences in clinical outcome of LAAC in AF patients with different types of HF., Results: Overall, 288 NVAF patients with HF were enrolled in this study, including 142 males and 146 females. There were 74 patients in the HFrEF group and 214 patients in the HFpEF group. All patients successfully underwent LAAC. The CHA2 DS2 -VASc score and HAS-BLED score of HFrEF group were lower than those of HFpEF group. A total of 288 LAAC devices were implanted. The average diameter of the occluders was 27.2 ± 3.5 mm in the HFrEF group and 26.8 ± 3.3 mm in the HFpEF group, and there was no statistical difference between the two groups (P = 0.470). Also, there was no statistically significant difference in the occurrence of residual shunts between the two groups as detected by TEE after surgery (P = 0.341). LVEF was significantly higher in HFrEF group at 3 days, 3 months and 1 year after operation than before (P < 0.001). At 45-60 days after surgery, we found DRT in 9 patients and there were 4 patients (5.4%) in HFrEF group and 5 patients (2.3%) in HFpEF group, with no significant difference between the two groups (P = 0.357). One patient with DRT had stroke. The incidence of stroke was 11.1% in patients with DRT and 0.7% in patients without DRT (P = 0.670). There was one case of postoperative pericardial tamponade, which was improved by pericardiocentesis at 24 h after surgery in the HFpEF group, and there was no significant difference between the two groups (P = 1.000). During a mean follow-up period of 49.7 ± 22.4 months, there were no significant differences in the incidence of stroke, bleeding, DRT and HF exacerbation between the two groups. We found a statistical difference in the improvement of HF between HFrEF group and HFpEF group (P < 0.05)., Conclusions: LAAC is safe and effective in AF patients with different types of HF. The improvement of cardiac function after LAAC is more pronounced in HFrEF group than in HFpEF group., (© 2024. The Author(s).)- Published
- 2024
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46. Atrial fibrillation burden: a new outcome predictor and therapeutic target.
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Becher N, Metzner A, Toennis T, Kirchhof P, and Schnabel RB
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- Humans, Catheter Ablation, Anticoagulants therapeutic use, Atrial Fibrillation complications, Atrial Fibrillation therapy, Stroke prevention & control, Stroke etiology, Heart Failure therapy
- Abstract
Atrial fibrillation (AF), the most common sustained cardiac arrhythmia, is not a dichotomous disease trait. Technological innovations enable long-term rhythm monitoring in many patients and can estimate AF burden. These technologies are already used to detect and monitor AF. This review describes the relation between AF burden and outcomes and potential effects of AF burden reduction. A lower AF burden is associated with a lower risk of stroke and heart failure in patients with AF: stroke risk without anticoagulation is lower in patients with device-detected AF and a low AF burden (stroke rate 1%/year) than in patients with persistent and permanent AF (stroke rate 3%/year). Paroxysmal AF shows intermediate stroke rates (2%/year). Atrial fibrillation burden-reducing interventions can reduce cardiovascular outcomes in patients with AF: early rhythm control reduces cardiovascular events including stroke and heart failure in patients with recently diagnosed AF and cardiovascular conditions. In patients with heart failure and AF, early rhythm control and AF ablation, interventions that reduce AF burden, reduce mortality and heart failure events. Recent technological innovations allow to estimate AF burden in clinical care, creating opportunities and challenges. While evidence remains limited, the existing data already suggest that AF burden reduction could be a therapeutic goal. In addition to anticoagulation and treatment of cardiovascular conditions, AF burden reduction emerges as a therapeutic goal. Future research will define the AF burden that constitutes a relevant risk of stroke and heart failure. Technologies quantifying AF burden need careful validation to advance the field., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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47. Oral anticoagulation in patients with left ventricular thrombus: a systematic review and meta-analysis.
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Haller PM, Kazem N, Agewall S, Borghi C, Ceconi C, Dobrev D, Cerbai E, Grove EL, Kaski JC, Lewis BS, Niessner A, Rocca B, Rosano G, Savarese G, Schnabel RB, Semb AG, Sossalla S, Wassmann S, and Sulzgruber P
- Subjects
- Humans, Administration, Oral, Treatment Outcome, Risk Factors, Anticoagulants adverse effects, Anticoagulants administration & dosage, Heart Ventricles drug effects, Female, Risk Assessment, Male, Stroke mortality, Stroke diagnosis, Stroke prevention & control, Aged, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors administration & dosage, Vitamin K antagonists & inhibitors, Middle Aged, Thrombosis mortality, Thrombosis drug therapy, Thrombosis prevention & control, Thrombosis diagnosis, Hemorrhage chemically induced, Heart Diseases mortality, Heart Diseases diagnosis, Heart Diseases drug therapy, Heart Diseases complications
- Abstract
Aims: Direct oral anticoagulants (DOACs) are increasingly used off-label to treat patients with left ventricular thrombus (LVT). We analysed available meta-data comparing DOACs and vitamin K antagonists (VKAs) for efficacy and safety., Methods: We conducted a systematic search and meta-analysis of observational and randomized data comparing DOACs vs. VKAs in patients with LVT. Endpoints of interest were stroke or systemic embolism, thrombus resolution, all-cause death, and a composite bleeding endpoint. Estimates were pooled using a random-effects model meta-analysis, and their robustness was investigated using sensitivity and influential analyses., Results: We identified 22 articles (18 observational studies, 4 small randomized clinical trials) reporting on a total of 3587 patients (2489 VKA vs. 1098 DOAC therapy). The pooled estimates for stroke or systemic embolism [odds ratio (OR): 0.81; 95% confidence interval (CI): 0.57, 1.15] and thrombus resolution (OR: 1.12; 95% CI: 0.86, 1.46) were comparable, and there was low heterogeneity overall across the included studies. The use of DOACs was associated with lower odds of all-cause death (OR: 0.65; 95% CI: 0.46, 0.92) and a composite bleeding endpoint (OR: 0.67; 95% CI: 0.47, 0.97). A risk of bias was evident particularly for observational reports, with some publication bias suggested in funnel plots., Conclusion: In this comprehensive analysis of mainly observational data, the use of DOACs was not associated with a significant difference in stroke or systemic embolism, or thrombus resolution, compared with VKA therapy. The use of DOACs was associated with a lower rate of all-cause death and fewer bleeding events. Adequately sized randomized clinical trials are needed to confirm these findings, which could allow a wider adoption of DOACs in patients with LVT., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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48. Impact of cerebral protection on observed versus predicted in-hospital stroke in a high stroke risk TAVR cohort.
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Marcusohn E, Manoragavan R, Fremes S, Tarola C, Sathananthan J, Barabash IM, Orbach A, Sachedina AK, Radhakrishnan S, and Wijeysundera HC
- Subjects
- Humans, Male, Female, Aged, Risk Factors, Risk Assessment, Aged, 80 and over, Treatment Outcome, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Time Factors, Intracranial Embolism prevention & control, Intracranial Embolism etiology, Intracranial Embolism epidemiology, Intracranial Embolism diagnosis, Retrospective Studies, Decision Support Techniques, Predictive Value of Tests, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement instrumentation, Stroke prevention & control, Stroke etiology, Stroke diagnosis, Stroke epidemiology, Embolic Protection Devices
- Abstract
Background: Despite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke., Methods: The Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores., Results: The study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07-3.73). The observed versus expected ratio was 0.57 (95% CI 0.52-0.64)., Conclusion: In this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate., Clinical Trial Number: N/A., (© 2024. The Author(s).)
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- 2024
- Full Text
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49. Position Statement on Cardiac Computed Tomography Following Left Atrial Appendage Occlusion.
- Author
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Korsholm K, Iriart X, Saw J, Wang DD, Berti S, Galea R, Freixa X, Arzamendi D, De Backer O, Kramer A, Cademartiri F, Cochet H, Odenstedt J, Aminian A, Räber L, Cruz-Gonzalez I, Garot P, Jensen JM, Alkhouli M, and Nielsen-Kudsk JE
- Subjects
- Humans, Treatment Outcome, Risk Factors, Echocardiography, Transesophageal, Atrial Appendage diagnostic imaging, Atrial Appendage physiopathology, Atrial Fibrillation diagnostic imaging, Atrial Fibrillation therapy, Atrial Fibrillation physiopathology, Predictive Value of Tests, Consensus, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization standards, Stroke prevention & control, Stroke etiology, Tomography, X-Ray Computed
- Abstract
Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists., Competing Interests: Funding Support and Author Disclosures Dr Korsholm has received speaker honorarium from Abbott and Boston Scientific. Dr Saw has received unrestricted research grant support from AstraZeneca, Abbott, Boston Scientific, and Servier; has received speaker honorarium from AstraZeneca, Abbott, Boston Scientific, and Sunovion; and is a consultant/proctor for Boston Scientific, AstraZeneca, and Abbott. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Boston Scientific, and Materialise. Dr Berti is a proctor for Abbott and Edwards Lifesciences. Dr Galea has received speaker honorarium from Boston Scientific. Dr De Backer is a consultant for Abbott. Dr Räber has received research grants to the institution from Abbott Vascular, Biotronik, Boston Scientific, Heartflow, Sanofi, Regeneron, Medis Medical Imaging Systems, and Bangerter-Rhyner Stiftung; and has received speaker or consultation fees from Abbott Vascular, Amgen, AstraZeneca, Canon, Novo Nordisk, Medtronic, Occlutech, and Sanofi outside the submitted work. Dr Alkhouli is on the Advisory Board for Abbott and Boston Scientific. Dr Nielsen-Kudsk is a consultant for Boston Scientific; and is a consultant/proctor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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50. Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure (?) vs Anticoagulation Contraindication (!).
- Author
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Ruggiero R
- Subjects
- Humans, Risk Factors, Stroke prevention & control, Stroke etiology, Risk Assessment, Hemorrhage chemically induced, Clinical Decision-Making, Female, Aged, Male, Patient Selection, Atrial Appendage physiopathology, Atrial Appendage diagnostic imaging, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Anticoagulants adverse effects, Anticoagulants administration & dosage, Contraindications, Drug, Treatment Failure, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation
- Published
- 2024
- Full Text
- View/download PDF
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