Stroke Prevention In Atrial Fibrillation Patients Research Articles

Abstract 4135791: Bleeding risk with non-vitamin K antagonist oral anticoagulants versus single antiplatelet therapy: A systematic review and meta-analysis of randomized controlled trials

Background: While non-vitamin K antagonist oral anticoagulants (NOACs) are more effective than single antiplatelets (mostly low-dose aspirin) at reducing stroke risk in patients with atrial fibrillation (AF), differences in bleeding risk between NOACs and single-dose antiplatelets across various populations remain unclear. Aim: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing bleeding outcomes of NOACs versus single antiplatelet therapy. Methods: We searched MEDLINE, EMBASE, and CENTRAL to June 2024 for RCTs that compared NOAC (therapeutic doses used for stroke prevention in AF patients) versus single antiplatelet therapy for a treatment duration of ≥3 months. For the meta-analyses, we used fixed-effects models and reported results as summary risk ratios (RRs). We used Risk of Bias 2 and GRADE to assess the quality and certainty of the evidence. Results: Eight RCTs with 26,194 participants were included. Mean follow-up time was 18 (±13) months. NOACs included in the studies were apixaban (4 studies), rivaroxaban (2 studies), and dabigatran (2 studies). All studies used low-dose aspirin as the comparator. When compared to aspirin, NOACs had a higher risk of major bleeding (326/13107 [2.5%] vs. 239/13087 [1.8%] events; RR 1.36 95% CI 1.15-1.60, I 2 =52%, 8 trials; high certainty) (Figure A), gastrointestinal bleeding (104/8803 [1.2%] vs. 74/8788 [0.8%] events; RR 1.39; 95%CI, 1.04-1.87; I 2 =0%; 5 trials; high certainty), and clinically relevant non-major bleeding (318/10397 [3.1%] vs. 230/10395 [2.2%] events; RR 1.38; 95%CI, 1.17-1.63; I 2 =16%; 5 trials; high certainty). There was no difference in the risk of intracranial hemorrhage (88/13107 [0.7%] vs. 84/13087 [0.6%] events; RR 1.04, 95%CI 0.78-1.41; I 2 =48%; 9 trials; high certainty) (Figure B) nor fatal bleeding (22/12412 [0.2%] vs. 28/12392 [0.2%] events; RR 0.78; 95%CI, 0.45-1.36; I 2 =8%; 6 trials; high certainty). Conclusion: When compared to aspirin, NOACs are associated with an increased risk of major bleeding and clinically relevant non-major bleeding, but not intracranial hemorrhage. These data are important to inform patients about the risks of antithrombotic treatment.

Abstract 4131630: Comparative Outcomes of Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients with a Lower Stroke Risk

Introduction: Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA 2 DS 2 -VASc score ≥ 2 for stroke prevention. Left atrial appendage occlusion (LAAO) devices serve as alternatives to reduce stroke risk in select AF patients that are unable to tolerate long-term oral anticoagulation. However, Centers for Medicare&Medicaid Services reimburses left atrial appendage occlusion (LAAO) for patients with CHA 2 DS 2 -VASc score ≥ 3. Objective: To evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA 2 DS 2 -VASc score of ≥ 3 versus < 3. Methods: National Inpatient Sample and International Classification of Diseases, 10th Revision codes were used to identify AF patients who underwent LAAO device implantation in the U.S. from 2016−2020. The study population was stratified by stroke risk into two groups, CHA 2 DS 2 -VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization. A multivariable logistic regression model was used to assess the independent association of CHA 2 DS 2 -VASc score with study outcomes. Results: A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA 2 DS 2 -VASc ≥ 3 and < 3, respectively. Compared to patients with CHA 2 DS 2 -VASc score of ≥ 3, patients with CHA 2 DS 2 -VASc < 3 had lower overall (6.9% vs 9.9%, P< 0.01) and major (4.5% vs 6.2%, P< 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA 2 DS 2 -VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 – 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99). Conclusions: Patients with CHA 2 DS 2 -VASc < 3 had lower complications and hospitalization costs after LAAO device implantation than patients with CHA 2 DS 2 -VASc ≥ 3 . These data, if redemonstrated in a large randomized trial can have important clinical implications for stroke prevention in AF patients.

Rheumatoid arthritis and the risk of ischaemic stroke after diagnosis of atrial fibrillation: a Norwegian nationwide register study.

RA patients have an increased risk for cardiovascular diseases, including atrial fibrillation (AF), but the impact of RA on ischaemic stroke risk in the context of AF remains unknown. We explored whether the risk of ischaemic stroke after diagnosis of AF is further increased among patients with RA compared with non-RA patients. In the nationwide Norwegian Cardio-Rheuma Register, we evaluated cumulative incidence and hazard rate of ischaemic stroke after the first AF diagnosis (2750 individuals with RA and 158 879 without RA between 2010 and 2017) by using a competing risk model with a 3-month delayed entry. The 5-year unadjusted cumulative incidence of ischaemic stroke was 7.3% (95% CI: 5.9-8.7%) for patients with RA and 5.0% (95% CI: 4.9-5.2%) for patients without RA. Unadjusted univariate analyses indicated that AF patients with RA had a HR of 1.36 (95% CI: 1.13, 1.62) for ischaemic stroke compared with those without RA. Sex- and age-adjusted HR for ischaemic stroke in RA patients with AF was 1.25 (95% CI: 1.05, 1.50), and the effect size remained unchanged after adjustment for diabetes, hypertension, atherosclerotic cardiovascular disease and oral anticoagulant (OAC) treatment. RA patients were less likely to receive OAC treatment than non-RA patients (adjusted odds ratio 0.88, 95% CI: 0.80, 0.97). RA patients diagnosed with AF are at a further increased risk for stroke compared with non-RA patients with AF, and less likely to receive OAC treatment, emphasizing the need to improve stroke prevention in AF patients with RA.

The Heidelberg registry of atrial fibrillation. a summary in the era of transition of oral anticoagulation regimes over an 11-year period

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): The study was supported by a research grant from Daiichi Sankyo and Bayer diagnostics. The sponsor had no influence on the study concept, data collection, or interpretation. Background Management of patients with atrial fibrillation (AF) has improved in recent years. Particularly, the shift from vitamin-k containing (VKA) oral anticoagulation (OAC) regimes to factor Xa or thrombin inhibitor containing non-vitamin K regimes (NOAC) regimes has revolutionized stroke prevention in AF patients. Purpose This study aimed to illustrate the shift from VKA to NOAC regimes over an 11-year period in an emergency department (ED) setting. Methods The Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is a retrospective, observational single-center study and collected data from patients with AF presenting to the ED of our hospital between 2009 and 2020. Inclusion criteria were (a) diagnosis of AF and (b) age >18 years. Exclusion criteria were (a) non-availability of at least one high sensitive troponin T value and (b) lost to follow-up for all-cause mortality. Repeated visits to the ED were also excluded. Clinical data was accessed retrospectively from available medical records. A sequential follow-up was performed for all-cause mortality, stroke, major bleeding and myocardial infarction. This study was conducted according to ethical principles stated in the Declaration of Helsinki (2008). Results Within the inclusion period of HERA-FIB a total of 76,528 visits to CPU were screened over an 11-year time period. 24.4% were excluded for other diagnosis than AF, resulting in a total of 12,279 visits to ED within the inclusion period. Here, a total of 5.4% of the patients were excluded after re-adjustment of AF diagnosis, 1,5% for non-sufficient laboratory values and 10% for lost-to follow-up. The total study population of HERA-FIB included 10,222 patients with the diagnosis of AF. Within the inclusion period of HERA-FIB, a significant change form VKA containing to NOAC containing anticoagulation regimes could be detected among patients presenting to the ED. Additionally, the number of patients on OAC compared to the number of patients without any OAC regime increased over time. Within the inclusion period, a total of 69.7% received an OAC regime. Here 59.5% of the AF patients received a NOAC and 40.5% VKA at discharge. Hazard ratio for patients on VKA for all-cause mortality was 1.25 (95%CI: 1.11-1.41), p=0.0003. Conclusions HERA-FIB is one of the largest real-world retrospective single-center databases for patients with AF, reflecting the shift from NOAC to VKA containing anticoagulation regimes in AF patients presenting to an ED over an 11-year period.

Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial

IntroductionThe prevalence of atrial fibrillation (AF) is increasing globally, and stroke prevention is the key to reduce the morbidity and mortality related to AF. Currently, direct oral anticoagulants (DOACs) are...

Percutaneous left atrial appendage closure with the Watchman device: a systematic review.

Atrial fibrillation (AF) is the most commonly observed arrhythmia in the world and its prevalence increases with age. The main and most severe complication of AF is ischemic stroke. Oral anticoagulation (OAC) therapy is the standard of care for stroke prevention in the high risk population. Initiation of this treatment is associated with a substantial risk of bleeding complications. Moreover, there is a group of patients who cannot tolerate OAC. In patients with AF the left atrial appendage (LAA) is the main source of thrombus formation. Percutaneous left atrial appendage closure (LAAC) has become an important non-pharmacological intervention for stroke prevention in patients with non-valvular AF. The procedure aims to reduce the risk of thromboembolism without increasing the risk of bleeding. Over the last few years, the safety and long-term efficacy of the procedure in specific populations have increased and more patients are being treated. The Watchman device is the most studied device in this field. Randomized controlled trials demonstrated non-inferiority of percutaneous left atrial appendage closure using the WATCHMAN 2.5 device to OAC (Boston Scientific, Marlborough, MA, USA). The new generation device, WATCHMAN FLX, was introduced and its use was associated with fewer safety events and a higher success rate of effective appendage closure. Nevertheless, several unsolved problems remain, including device-related thrombosis, the post-LAAC antithrombotic regimen, and peri-device leakage. This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized.

Non-vitamin K Antagonist Oral Anticoagulant, Warfarin, and ABC Pathway Adherence on Hierarchical Outcomes: Win Ratio Analysis of the COOL-AF Registry.

Atrial fibrillation (AF) Better Care (ABC) pathway adherence is associated with improved outcomes. Clinical trials have shown that non-vitamin K antagonist oral anticoagulants (NOACs) are as least as effective as warfarin for stroke prevention in AF patients. The Win Ratio method, analyzing hierarchical composite outcomes considering event timing and severity, has limited data on its use in Asians. We aim to apply Win Ratio in a registry to access the comparative effectiveness of NOACs versus warfarin and ABC adherence versus nonadherence in Asian patients with AF. Our study included nonvalvular AF patients from the nationwide prospective COOL-AF registry in Thailand. The NOAC-treated group was compared with the warfarin-treated group using the Win Ratio, with the following order: all-cause death, intracranial hemorrhage (ICH), ischemic stroke/transient ischemic attack/systemic embolism, non-ICH major bleeding, and myocardial infarction or heart failure. ABC pathway adherence versus nonadherence was also compared. A Win Ratio greater than 1.00 indicating a better outcome. The analysis included 2,568 patients, with 228 in the NOAC group and 2,340 in the warfarin group. The NOAC group had more wins than the warfarin group, with an unmatched Win Ratio of 1.64 (95% confidence interval [CI]: 1.22-2.20; p < 0.001). When compared with nonadherence, ABC pathway adherence was associated with a Win Ratio of 1.57 (95% CI: 1.33-1.85; p < 0.001). This Win Ratio analysis demonstrates the significant benefits of NOACs over warfarin and ABC pathway adherence over nonadherence in reducing the composite outcome in patients with AF.

Percutaneous left atrial appendage closure in patients with hypertrophic cardiomyopathy and persistent atrial fibrillation: 3-year-followed case series.

Hypertrophic cardiomyopathy (HCM) patients with atrial fibrillation (AF) are at high risk for stroke. Left atrial appendage closure (LAAC) is a promising alternative for stroke prevention in AF patients. We aimed to review the clinical outcomes of patients with AF and HCM at our center. We reviewed 673 patients who underwent LAAC implantation from 2014 to 2021 in a tertiary center, of whom 15 had HCM. AF Patients with HCM were compared with sex and age matched controls who also underwent LAAC. From 2014 to 2021, 673 AF patients received LAAC in a single center, of whom, 15 patients had HCM. LAAC devices were successfully implanted in 14 HCM patients and 59 patients in the control group. During the follow-up period (median 1151 days range: 132-2457 days), 2 HCM patient had ischemic strokes. There were another 2 HCM patients who had sudden cardiac death (SCD). Compared with the control, HCM patients had higher cumulative rate of combined death and stroke (26.67% vs 3.33%, P = .024). In our initial clinical experience, the cumulative stroke and death rate of the HCM patients was significantly higher than that of the non-HCM patients.

Stroke in Atrial Fibrillation and Other Atrial Dysrhythmias.

Atrial fibrillation (AF) is a major risk factor for systemic embolism and ischaemic stroke. Furthermore, AF-related strokes are associated with higher mortality, greater disability, longer hospital stays and lower rates of hospital discharge than strokes caused by other reasons. The aim of this review to summarise the existing evidence on the association of AF with ischemic stroke and provide insights on the pathophysiological mechanisms and the clinical management of patients with AF in order to reduce the burden of ischemic stroke. Beyond Virchow's triad, several pathophysiological mechanisms associated with structural changes in the left atrium, which may precede the identification of AF, may contribute to the increased risk of arterial embolism in AF patients. Individualised thromboembolic risk stratification based on CHA2DS2-VASc score and clinically relevant biomarkers provides essential tool towards a personalised holistic approach in thromboembolism prevention. Anticoagulation remains the cornerstone of stroke prevention moving from vitamin K antagonists (VKA) to safer non-vitamin K direct oral anticoagulants in the majority of AF patients. Despite the efficacy and safety of oral anticoagulation, still the equilibrium between thrombosis and haemostasis in AF patients remains suboptimal and future directions in anticoagulation and cardiac intervention may provide novel treatment options in stroke prevention. This review summarises the pathophysiologic mechanisms of thromboembolism, aiming the current and potential future perspectives in stroke prevention in AF patients.

Neurology care and the long-term outcomes of atrial fibrillation-related ischaemic stroke in China: median 3-year outcome from a high volume academic tertiary hospital

ObjectivesThe initial medical contact of patients with atrial fibrillation (AF) and ischaemic stroke is often performed by neurologists. However, when stand care with oral anticoagulants (OACs) adherence and persistence was...

Mechanisms and Clinical Manifestations of Cognitive Decline in Atrial Fibrillation Patients: Potential Implications for Preventing Dementia.

Atrial fibrillation (AF) patients face an approximate 1.5-fold increased risk of cognitive decline compared with the general population. Among poststroke AF patients, the risk of cognitive decline is even higher with an estimated threefold increase. This article provides a narrative review on the current evidence and highlights gaps in knowledge and areas for future research. Although earlier studies hypothesized that the association between AF and cognitive decline is mainly a consequence of previous ischemic strokes, more recent evidence also suggests such an association in AF patients without a history of clinical stroke. Because AF and cognitive decline mainly occur among elderly individuals, it is not surprising that both entities share multiple risk factors. In addition to clinically overt ischemic strokes, silent brain infarcts and other brain injury are likely mechanisms for the increased risk of cognitive decline among AF patients. Oral anticoagulation for stroke prevention in AF patients with additional stroke risk factors is one of the only proven therapies to prevent brain injury. Whether a broader use of oral anticoagulation, or more intense anticoagulation in some patients are beneficial in this context needs to be addressed in future studies. Although direct studies are lacking, it is reasonable to recommend optimal treatment of comorbidities and risk factors for the prevention of cognitive decline and dementia.

Family Physician Prescribing Practices and Perspectives on Shared Decision-Making Regarding the Use of Oral Anticoagulants for Stroke Prevention in Patients 75 Years or Older With Atrial Fibrillation.

Atrial Fibrillation (AF) is common in older adults, yet guideline-recommended oral anti-coagulants (OACs) for stroke prevention are underused in this population. With a growing population of older adults at risk of AF seeking primary care, the objective of the study was to determine the management practices and perspectives of family physicians on the initiation of OACs for stroke prevention in AF patients 75 years or older, including their engagement of patients in shared decision-making. This was an online survey of family physicians affiliated with a Primary Care Network in Alberta, Canada. Patient's risk (of falls, bleeding, or stroke) was the most common factor (17/20, 85%) physicians considered when deciding to initiate OAC in older adult patients with AF. Physicians used the CHADS2VASC (13/14, 93%) and HASBLED (11/15, 73%) tools to determine stroke and bleeding risks, respectively. Majority (11/15, 73%) of the physicians agreed that they feel confident initiating OAC for AF patients ≥75, while 20% (3/15) were neutral. All physicians agreed that their patients participated in shared decision-making to initiate OAC for stroke prevention. Family physicians strongly consider patient risks and utilize risk-assessment tools when initiating OAC in older adults with AF. Despite all physicians reporting the use of shared decision-making and that their patients were educated on the indications for OAC, confidence in initiating treatment was variable. Further exploration into factors impacting physician confidence is needed.

Temporal Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients between 2004 and 2019.

Background: In the recent years, antithrombotic prophylaxis in patients with atrial fibrillation (AF) has changed significantly. The main aim of this study is to assess the temporal trends of antithrombotic therapy and identify factors predisposing oral anticoagulant (OAC) use in stroke prevention in AF patients. Methods: The present study is a retrospective, observational, single-center study, which includes consecutively hospitalized patients in the reference cardiology center from January 2004 to December 2019. Results: A total of 9656 patients (43.7% female, mean age 71.2 years) with AF between 2004–2019 are included. Among the total study population, in most of the patients (81.1%), OAC therapy was used, antiplatelet (APT) therapy was prescribed for 13.5% patients, heparins for 2.1% patients and 3.3% of patients did not receive any stroke prevention. OAC prescription significantly increased from 61.6% in 2004 to 97.4% in 2019. The independent predictors of OAC prescription were: the period of hospitalization, non-paroxysmal AF, age, hypertension, diabetes mellitus, previous thromboembolism, hospitalization due to electrical cardioversion, ablation or AF without any procedures. Conclusions: In hospitalized patients with AF, during sixteen years of the study period, a significant increase in OAC use and a decrease in APT use were noted. Factors other than these included in the CHA2DS2-VASc score were independent predictors of OAC use.

Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48.

In patients with atrial fibrillation (AF), peripheral artery disease (PAD) is associated with higher rates of stroke and bleeding. Both higher dose edoxaban (60/30mg) and lower dose edoxaban (30/15mg) were non-inferior to warfarin for stroke and systemic embolism (SSE) and significantly reduced major bleeding in AF patients in the global study to assess the safety and effectiveness of edoxaban vs standard practice of dosing with warfarin in patients with atrial fibrillation (ENGAGE AF-TIMI 48) trial. Whether the efficacy and safety of these dosing strategies vs. warfarin are consistent in patients with AF and PAD has not been described. Of 21 105 patients with AF randomized to warfarin, edoxaban 60/30mg, or edoxaban 30/15mg, 841 were identified with PAD. Endpoints included major adverse cardiovascular events (MACEs), SSE, and major bleeding. Patients with PAD had higher risk of MACEs [adjusted hazard ratio (HRadj) 1.33, 95% confidence interval (CI) 1.12-1.57, P = 0.001] and cardiovascular (CV) death (HRadj 1.49, 95% CI 1.21-1.83, P &lt; 0.001) than those without PAD, but not major bleeding. The efficacy of edoxaban 60/30mg vs. warfarin was consistent regardless of PAD (SSE HR; PAD 1.16, 95% CI 0.42-3.20; no-PAD 0.86, 95% CI 0.74-1.02, P-interaction 0.57) as was major bleeding (PAD 0.96, 95% CI 0.54-1.70; no-PAD 0.80, 95% CI 0.70-0.91, P-interaction 0.54). Edoxaban 30/15mg was inferior for SSE, with significant heterogeneity when stratified by PAD status (P-interaction 0.039). Patients with AF and PAD are at heightened risk of MACEs and CV death vs. those without PAD. The efficacy and safety of edoxaban 60/30mg vs. warfarin in AF are consistent regardless of PAD; however, edoxaban 30/15mg is inferior for stroke prevention in AF patients with PAD. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT00781391.

A Comparison of the Accuracy of WATCHMAN and WATCHMAN FLX Device Sizing between CT, TEE, and Patient Specific 3D Models

Background and Hypothesis: In patients with Atrial fibrillation (AF), the Left Atrial Appendage (LAA) is the most common site of thrombus formation. The LAA occlusion procedure using the WATCHMAN device implant is an alternative for stroke prevention in AF patients. Transesophageal echocardiogram (TEE) and Computed tomography (CT) scans aid in measuring the LAA to predict implant device sizes. However, due to varying LAA anatomy and limited spatial resolution, the current imaging techniques often predict one of two sized devices. The objective of this retrospective study is to compare the accuracy of measurements made preoperatively of the LAA with those on 3D models to determine if they can be used in preoperative planning. We hypothesize 3D models will be more accurate in predicting device size and any anatomical impediments than traditional TEE planning.&#x0D; Project Methods: There were 21 subjects selected who underwent the WATCHMAN FLX procedure at Parkview Heart Institute in 2021. 3D models of LAA were created from CT scans using a Form 2 3D printer. The device sizes predicted for the procedure were determined from Boston Scientific FLX guidelines based on the maximum LAA orifice diameter from TEE, CT, and 3D models.&#x0D; Results: Two-proportion z-test between the 3D model predicted sizes to the actual size deployed demonstrated no statistical significance (p=0.298) demonstrating no difference between 3D model predicted sizes and actual size deployed. Two-proportion z-test between TEE vs actual size and CT vs actual size demonstrated statistical significance, suggesting a difference between the group's predictions. 3D models predicted the accurate device size for 20/21(95%) subjects. TEE measurements of maximum orifice diameter were, on average, lower compared to CT and 3D model measurements.&#x0D; Conclusion and Potential Impact: 3D printed models provide the most accurate device size predictions and can be used to optimize presurgical planning while reducing intraoperative complications.

Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial

The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed. The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA). Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up. The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.

2021 Korean Heart Rhythm Society Guidelines for Stroke Prevention in Atrial Fibrillation

Atrial fibrillation (AF) is a strong risk factor for ischemic stroke and systemic embolism. To prevent thromboembolic events in patients with AF, anticoagulation therapy is essential. The anticoagulant strategy is determined after stroke and bleeding risk assessments using the CHA2DS2-VASc and HAS-BLED scores, respectively; both consider clinical risk factors. Vitamin K antagonists (VKAs) are the sole anticoagulant option in AF patients with a prosthetic mechanical valve or moderate-severe mitral stenosis; in all other AF patients VKA or non-vitamin K antagonist oral anticoagulants are therapeutic options. However, antiplatelet therapy should not be used for stroke prevention in AF patients. Anticoagulation is not needed in AF patients with low stroke risk but strongly recommended in those with a with low bleeding risk. Left atrial appendage (LAA) occlusion offers an alternative in AF patients in whom long-term anticoagulation is contraindicated. Surgical occlusion or the exclusion of LAA can be considered for stroke prevention in AF patients undergoing cardiac surgery. In this article, we review existing data for stroke prevention and suggest optimal strategies to prevent stroke in AF patients.

Initial Experience and Results of Combined Treatment for Atrial Fibrillation: Catheter Ablation with High-Power Short Duration Ablation and Left Atrial Appendage Closure

Introduction: Long-term freedom from atrial fibrillation (AF) after catheter ablation and, consequently, the potential for stroke reduction remain unpredictable. Recently, left atrial appendage closure (LAAC) became an effective mechanical alternative to oral anticoagulation (OAC) for stroke prevention in AF patients. Objective: This study aims to evaluate the feasibility and safety of combined treatment for AF with catheter ablation (CA) with the high-power short duration technique associated with LAAC in one single procedure. Methods: Patients with non-valvular AF who underwent combined CA and LAAC procedure were included in the retrospective observational study. Between April 2018 and October 2020, 13 patients with AF were included, eight (61,54%) males, eight (61.54%) with persistent AF (PersAF), mean age 68.54 (65–84) years old, mean time from AF diagnosis to treatment 13.08 (3–33) months, mean CHA2VASC2 5.08 (3–7), all patients with coronary or vascular disease, 12 (92.31%) with hypertension, five (38.46%) with left ventricular dysfunction, four (30.77%) prior strokes using OAC and four (30.77%) patients with diabetes. Indications for LAAC included history of contraindication to OAC because of severe bleeding in eight (61.54%), previous stroke in four (30.77%) and two (13.08%) patients with LAA thrombus, despite the use of two different OAC (one associated with bleeding). One patient had a pseudoaneurysm in femoral artery, and two patients died of non-procedure complications after 30 days. At six months, angiotomography showed successful complete sealing of the LAA in seven (77.72%) of nine patients evaluated, and the two patients without it had a leak of less than 2 mm. After mean follow-up of 14 months (five to 33), 10 (90.91%) of the 11 patients were in sinus rhythm. Three (27.27%) patients, one in blanking period, recovered sinus rhythm after amiodarone. No cardioembolic or bleeding events occurred. Conclusion: In this small observational study, we showed the feasibility and safety of the combined therapy with AF catheter ablation with LAAC with a high rate of sinus rhythm and no cardioembolic event.

5-year outcomes from rivaroxaban therapy in atrial fibrillation: Results from the Dresden NOAC Registry

IntroductionFollowing successful phase-III trials, direct oral anticoagulants such as rivaroxaban have largely replaced warfarin for stroke prevention in atrial fibrillation (SPAF). However, data from randomized trials should be confirmed in unselected cohorts. Materials and methodsProspective registries can provide such data but often limit follow-up to short periods only. Extending our previously reported follow-up of 2.2 years in 1204 SPAF patients receiving rivaroxaban in the non-interventional DRESDEN NOAC REGISTRY, we now provide prospectively collected 5 years data (mean follow-up 5.5 ± 2.3 years) for this cohort. ResultsBetween 1 October 2011 and 31 December 2019, the combined endpoint of stroke/transient ischemic attack/systemic embolism occurred at a rate of 2.3/100 patient-years in the intention-to-treat analysis (95% confidence interval [CI] 1.9–2.7) and at 1.6/100 patient-years in the on-treatment analysis (events within 3 days after last drug intake). On-treatment rates for major or clinically relevant non-major bleeding were 3.1 and 19.6/100 patient-years, respectively. Rivaroxaban treatment discontinuation occurred in a total of 574 patients during follow-up (11.0/100 patient-years in Kaplan–Meier analysis) and 426 patient died (all-cause mortality 6.3/100 pt. years; mean time from enrolment 3.6 ± 2.1 years), of which the causes of death were reported as arterial or venous embolism for 32 patients (21 occurring after treatment discontinuation and 11 during active treatment) and as bleeding for 24 patients. ConclusionsOur data provide reassuring long-term outcome data for an elderly, co-morbid SPAF population, especially with regard to the low rate of fatal thromboembolic and bleeding complications.

Preserved Left Atrial Function Following Left Atrial Appendage Closure for Stroke Prevention.

Patients with atrial fibrillation (AF) are at high risk of thromboembolism, with most thrombi forming in the left atrial (LA) appendage. LA appendage closure is an alternative therapy to oral anticoagulation for stroke prevention in AF patients with contraindication to oral anticoagulation. LA function is critical for cardiovascular function, and recent studies suggested a direct relationship between LA function and AF recurrence. Deformation imaging characterizes and quantifies myocardial function. This study aims to investigate the impact of LA appendage closure on LA function in patients with paroxysmal AF. We studied patients with paroxysmal AF who underwent LA appendage closure in a single-center, retrospective study. Twelve patients (CHA2DS2-VASc score, 4.12 ± 1.1; age, 75.9 ± 6.9 years; 7 men and 5 women) were eligible. Echocardiography-derived LA global longitudinal strain analysis, LA diameter, and LA volume index were determined before and after a 6-month follow-up. All patients were in sinus rhythm during echocardiography. The LA global longitudinal strain was unchanged after LA appendage closure (from -18.9 ± 2.8% to -19.6 ± 2.6%; P=.66). No changes were observed for LA size (from 49.1 ± 6.1 mm to 50.5 ± 5.2 mm; P=.45) or for LA volume index (from 51.6 ± 4.6 mL/m² to 52.1 ± 4.1 mL/m²; P=.49), corroborating unaltered LA function after LA appendage closure. LA function is crucial for cardiovascular function and recurrence of AF. Our study provides evidence that LA appendage closure preserves LA function, determined by strain imaging in patients with paroxysmal AF and sinus rhythm during echocardiography.