Clinical Outcomes Associated With Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation

ObjectivesThis study sought to investigate clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs) in patients with high-risk atrial fibrillation (AF).BackgroundLAAO has been shown to be noninferior to warfarin for stroke prevention in AF. However, anticoagulation with DOACs is now preferred over warfarin as thromboprophylaxis in AF.MethodsPatients with AF enrolled in the Amulet Observational Registry (n = 1,088) who had successful LAAO with the Amplatzer Amulet device (n = 1,078) were compared with a propensity score–matched control cohort of incident AF patients (n = 1,184) treated by DOACs identified from Danish national patient registries. Propensity score matching was based on the covariates of the CHA₂DS₂-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores for predicting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium ≥3), or all-cause mortality, and follow-up was 2 years.ResultsAF patients treated with LAAO had a significantly lower risk of the primary composite outcome as compared with patients treated with DOACs (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.49 to 0.67). Total events and event rates per 100 patient-years were (LAAO vs. DOACs) 256 vs. 461 and 14.5 vs. 25.7, respectively. The risk of ischemic stroke was comparable between groups (HR: 1.11; 95% CI: 0.71 to 1.75), while risk of major bleeding (HR: 0.62; 95% CI: 0.49 to 0.79) and all-cause mortality (HR: 0.53; 95% CI: 0.43 to 0.64) were significantly lower in patients treated with LAAO.ConclusionsAmong high-risk AF patients, LAAO in comparison with DOACs may have similar stroke prevention efficacy but lower risk of major bleeding and mortality.     

Dabigatran,rivaroxaban, and apixaban are superior to warfarin in Asian patients with non-valvular atrial fibrillation: An updated meta-analysis

BACKGROUNDMost of the randomized clinical trials that led to the wide use of non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with atrial fibrillation (AF) originated from western countries. AIMTo systematically review and quantitatively synthesize the real-world data regarding the efficacy and safety of dabigatran, rivaroxaban, and apixaban compared to warfarin for stroke prevention in Asian patients with non-valvular AF.METHODSMedline, Cochrane, and ClinicalTrial.gov databases were reviewed. A random-effect model meta-analysis was used and I-square was utilized to assess the heterogeneity. The primary outcome was ischemic stroke. The secondary outcomes were all-cause mortality, major bleeding, intracranial hemorrhage, and gastrointestinal bleeding.RESULTSTwelve studies from East Asia or Southeast Asia and 441450 patients were included. Dabigatran, rivaroxaban, and apixaban were associated with a significant reduction in the incidence of ischemic stroke [hazard ratio (HR) = 0.78, 95% confidence interval (CI): 0.65-0.94; HR = 0.79, 95%CI: 0.74-0.85, HR = 0.70, 95%CI: 0.62-0.78; respectively], all-cause mortality (HR = 0.68, 95%CI: 0.56-0.83; HR = 0.66, 95%CI: 0.52-0.84; HR = 0.66, 95%CI: 0.49-0.90; respectively), and major bleeding (HR = 0.61, 95%CI: 0.54-0.69; HR = 0.70, 95%CI: 0.54-0.90; HR = 0.58, 95%CI: 0.43-0.78; respectively) compared to warfarin.CONCLUSIONDabigatran, rivaroxaban, and apixaban appear to be superior to warfarin in both efficacy and safety in Asians with non-valvular AF.     

Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation

Background:?The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF. Methods and Results:?J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio [HR] 1.11; 95% confidence interval 0.87-1.42; P<0.001 [non-inferiority]). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050). Conclusions:?J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice. (Circ J?2012; 76: 2104-2111).     

Sex-related differences in outcome after left atrial appendage occlusion: Insights from Europe and the EWOLUTION registry

Background

Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO).

Aims

The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION.

Methods

A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival.

Results

Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile.

Conclusions

Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men.     

Comparative Stroke,Bleeding, and Mortality Risks in Older Medicare Patients Treated with Oral Anticoagulants for Nonvalvular Atrial Fibrillation

BackgroundNonvitamin K antagonist oral anticoagulants (NOACs) are alternatives to warfarin in patients with nonvalvular atrial fibrillation. Randomized trials compared NOACs with warfarin, but none have compared individual NOACs against each other for safety and effectiveness.MethodsWe performed a retrospective new-user cohort study of patients with nonvalvular atrial fibrillation enrolled in US Medicare who initiated warfarin (n = 183,318), or a standard dose of dabigatran (150 mg twice daily; n = 86,198), rivaroxaban (20 mg once daily; n = 106,389), or apixaban (5 mg twice daily; n = 73,039) between October 2010 and September 2015. Propensity score-adjusted Cox proportional hazards regression was used to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI) for the outcomes of thromboembolic stroke, intracranial hemorrhage, major extracranial bleeding, and all-cause mortality, comparing each NOAC with warfarin, and with each other NOAC.ResultsCompared with warfarin, each NOAC was associated with reduced risks of thromboembolic stroke (20%-29% reduction; P = .002 [dabigatran], P < 0.001 [rivaroxaban, apixaban]), intracranial hemorrhage (35%-62% reduction; P < 0.001 [each NOAC]), and mortality (19%-34% reduction; P < .001 [each NOAC]). The NOACs were similar for thromboembolic stroke but rivaroxaban was associated with increased risks of intracranial hemorrhage (vs dabigatran: HR = 1.71; 95% CI, 1.35-2.17), major extracranial bleeding (vs dabigatran: HR = 1.32; 95% CI, 1.21-1.45; vs apixaban: HR = 2.70; 95% CI, 2.38-3.05), and death (vs dabigatran: HR = 1.12; 95% CI, 1.01-1.24; vs apixaban: HR = 1.23; 95% CI, 1.09-1.38). Dabigatran was associated with reduced risk of intracranial hemorrhage (HR = 0.70; 95% CI ,0.53-0.94) and increased risk of major extracranial bleeding (HR = 2.04; 95% CI, 1.78-2.32) compared with apixaban.ConclusionsAmong patients treated with standard-dose NOAC for nonvalvular atrial fibrillation and warfarin users with similar baseline characteristics, dabigatran, rivaroxaban, and apixaban were associated with a more favorable benefit–harm profile than warfarin. Among NOAC users, dabigatran and apixaban were associated with a more favorable benefit–harm profile than rivaroxaban.     

Percutaneous devices for left atrial appendage occlusion: A contemporary review

Patient with atrial fibrillation(AF) are at risk of developing stroke with the left atrial appendage(LAA) being the most common site for thrombus formation. If left untreated, AF is associated with 4 to 5 folds increase in the risk of ischemic stroke in all age groups. About 5% to 15% of AF patients have atrial thrombi on transesophageal echocardiography, and 91% of those thrombi are located in the LAA in patient with nonrheumatic AF. Although oral anticoagulants are the gold-standard treatment for stroke prevention in patients with non-valvular AF,some patients are at high risk of bleeding and deemed not candidates for anticoagulation. Therefore, LAA occlusion(LAAO) has emerged as alternative approach for stroke prevention in those patients. Surgical LAAO is associated with high rate of unsuccessful closure and recommended only in patients with AF and undergoing cardiac surgery. Percutaneous LAAO uses transvenous access with trans-septal puncture and was first tested using the PLAATO device.Watchman is the most common and only Food and Drug Administration(FDA)approved device for LAAO. LAAO using Watchman device is non-inferior to warfarin therapy in preventing ischemic stroke/systemic thromboembolism.However, it is associated with lower rates of hemorrhagic stroke, bleeding and death. Amplatzer is another successful LAAO device that has CE mark and is waiting for FDA approval. Optimal antithrombotic therapy post LAAO is still under debate and highly patient-specific. The aim of this paper is to systematically review the current literature to evaluate the efficacy and safety of different LAAO devices.     

Outcomes of radiofrequency catheter ablation for persistent and long-standing persistent atrial fibrillation

ObjectiveTo assess one-year outcomes in patients with persistent and long-standing persistent atrial fibrillation (AF) treated by catheter ablation.MethodsA retrospective observational study was conducted of consecutive patients referred for catheter ablation of persistent or long-standing persistent AF between May 2016 and October 2018. Patients underwent two different ablation strategies: pulmonary vein isolation (PVI) plus complex fractionated atrial electrograms (CFAE) (from May 2016 to June 2017) or a tailored approach (from July 2017 to October 2018). The overall recurrence rate at one year was analyzed. The secondary endpoint was arrhythmia recurrence according to the type of AF (persistent vs. long-standing persistent AF) and according to the ablation strategy employed.ResultsDuring the study period, 67 patients were included (40% with long-standing persistent AF). During a mean follow-up of 16±6 months, 27% of the patients had arrhythmia recurrence. Patients with long-standing persistent AF had a higher recurrence rate than those with persistent AF (44.4% vs. 15%, p=0.006), while patients who underwent a tailored approach presented better outcomes than those undergoing PVI plus CFAE ablation (17.5% vs. 40.7%, p=0.024). Ablation strategy (HR 6.457 [1.399-29.811], p=0.017), time in continuous AF (HR 1.191 [1.043-1.259], p=0.010) and left atrial volume index (HR 1.160 [1.054-1.276], p=0.002) were independent predictors of arrhythmia recurrence.ConclusionCatheter ablation is an effective treatment for patients with persistent and long-standing persistent AF. Patients with persistent AF and those undergoing a tailored approach presented lower arrhythmia recurrence.     

Net Clinical Benefit of Non-Vitamin K Antagonist vs Vitamin K Antagonist Anticoagulants in Elderly Patients with Atrial Fibrillation

BackgroundThe risks of thromboembolic and hemorrhagic events in patients with atrial fibrillation both increase with age; therefore, net clinical benefit analyses of anticoagulant treatments in the elderly population are crucial to guide treatment. We evaluated the 1-year clinical outcomes with non-vitamin-K antagonist and vitamin K antagonist oral anticoagulants (NOACs vs VKAs) in elderly (≥75 years) patients with atrial fibrillation in a prospective registry setting.MethodsData on 3825 elderly patients were pooled from the PREFER in AF and PREFER in AF PROLONGATION registries. The primary outcome was the incidence of the net composite endpoint, including major bleeding and ischemic cardiovascular events on NOACs (n = 1556) compared with VKAs (n = 2269).ResultsThe rates of the net composite endpoint were 6.6%/year with NOACs vs 9.1%/year with VKAs (odds ratio [OR] 0.71; 95% confidence interval [CI], 0.51-0.99; P = .042). NOAC therapy was associated with a lower rate of major bleeding compared with VKA use (OR 0.58; 95% CI, 0.38-0.90; P = .013). Ischemic events were nominally reduced too (OR 0.71; 95% CI, 0.51-1.00; P = .050). Major bleeding with NOACs was numerically lower in higher-risk patients with low body mass index (BMI; OR 0.50; 95% CI, 0.22-1.12; P = .07) or with age ≥85 years (OR 0.44; 95% CI, 0.13-1.49; P = .17).ConclusionsOur real-world data indicate that, compared with VKAs, NOAC use is associated with a better net clinical benefit in elderly patients with atrial fibrillation, primarily due to lower rates of major bleeding. Major bleeding with NOACs was numerically lower also in higher-risk patients with low BMI or age ≥85 years.     

心房颤动合并肥厚型心肌病患者服用NOAC的有效性和安全性评价

目的:评估心房颤动（房颤）合并肥厚型心肌病（HCM）患者服用非维生素K拮抗剂口服抗凝药（NOAC）的有效性与安全性。方法:本研究为前瞻性队列研究,数据来自前瞻性、多中心的中国房颤注册研究（CAFR）,CAFR研究从31家医院入选住院和门诊房颤患者。选取CAFR研究中2011年8月至2018年12月的房颤合并HCM患者。...     

Neue orale Antikoagulanzien zur Prophylaxe von Schlaganfällen

Geriatric patients with non-valvular atrial fibrillation (AF) are increasingly being treated with novel oral anticoagulants (NOAC) to prevent ischemic stroke. This article highlights the outcome of an expert meeting on the practical use of NOAC in elderly patients. An interdisciplinary group of experts discussed the current situation of stroke prevention in geriatric patients and its practical management in daily clinical practice. The topic was examined through focused impulse presentations and critical analyses as the basis for the expert consensus. The key issues are summarized in this paper. The European Society of Cardiology (ESC) guidelines from 2012 for the management of patients with non-valvular AF recommend NOAC as the preferred treatment and vitamin K antagonists (VKA) only as an alternative option. Currently, the NOAC factor Xa inhibitors apixaban and rivaroxaban and the thrombin inhibitor dabigatran are more commonly used in clinical practice for patients with AF. Although these drugs have many similarities and are often grouped together it is important to recognize that the pharmacology and dose regimes differ between compounds. Especially n elderly patients NOAC drugs have some advantages compared to VKA, e.g. less drug-drug interactions with concomitant medication and a more favorable risk-benefit ratio mostly driven by the reduction of bleeding. Treatment of anticoagulation in geriatric patients requires weighing the serious risk of stroke against an equally high risk of major bleeding and pharmacoeconomic considerations. Geriatric patients in particular have the greatest benefit from NOAC, which can also be administered in cases of reduced renal function. Regular control of the indications is indispensable, as also for all other medications of the patient. The use of NOAC should certainly not be withheld from geriatric patients who have a clear need for oral anticoagulation.     

Efficacy of extended antrum ablation based on substrate mapping plus pulmonary vein isolation in the treatment of atrial fibrillation

Introduction and objectivesPulmonary vein isolation (PVI) technique has become the cornerstone of atrial fibrillation (AF) catheter ablation. The objective of this study was to assess the efficacy and safety of extended antrum ablation based on electrophysiological substrate mapping plus PVI in AF patients who underwent cryoballoon ablation.MethodsIn this observational study, a total of 121 paroxysmal AF patients and 80 persistent AF patients who did not achieve the procedure endpoint after cryoballoon ablation received extra extended antrum ablation (EAA) based on electrophysiological substrate mapping via radiofrequency ablation (EAA group). As a control group (PVI group), among paroxysmal AF and persistent AF patients, we conducted a propensity score-matched cohort, in whom only PVI was completed.ResultsThe average follow-up time was 15.27±7.34 months. Compared with PVI group, paroxysmal AF patients in the EAA group had a significantly higher rate of AF-free survival (90.1% vs. 80.2%, p=0.027) and AF, atrial flutter, or atrial tachycardia (AFLAT) -free rate survival (89.3% vs. 79.3%, p=0.031). Persistent AF patients in the EAA group also had a significantly higher rate of AF-free survival (90.0% vs. 75.0%, p=0.016) and AFLAT-free survival (88.8% vs. 75.0%, p=0.029) than PVI group. Complication rates did not significantly differ between both groups, in either paroxysmal AF or persistent AF patients.ConclusionOur findings demonstrate that extra extended antrum ablation based on electrophysiological substrate mapping is effective and safe. Moreover, the strategy can improve the outcome of AF cryoablation.     

Edoxaban Treatment in routiNe clinical prActice in patients with non-valvular Atrial Fibrillation (ETNA-AF) in Iberia: Baseline data

Introduction and ObjectivesAtrial fibrillation (AF) is the most common form of arrhythmia worldwide and a significant health burden. Edoxaban, a recent novel oral anticoagulant (NOAC), is being investigated in the European real-world ETNA-AF study of patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to characterize the Iberian edoxaban-treated cohort of ETNA-AF at baseline and to compare it with previously retrieved Portuguese data.MethodsPatients with NVAF treated with edoxaban and followed in Portuguese and Spanish centers were consecutively enrolled between June 2017 and January 2018. Only patients with a previous clinical decision to receive edoxaban were included. Patients’ baseline demographic and clinical parameters, medical history, and AF-related characteristics were retrieved.ResultsA total of 892 NVAF patients, with a mean age of 73.9 years, were included, 75.3% of whom received high-dose (60 mg) and 24.7% low-dose (30 mg) edoxaban. Most patients (55.9%) were male. Of the patients receiving 30 mg and 60 mg edoxaban, 55.9% and 37.9%, respectively, had an estimated CHA₂DS₂-VASc score ≥4. Previous bleeding event rates were low, with a predominance of clinically relevant non-major bleeding (1.9%). Most patients (47.5%) with NVAF had paroxysmal AF, followed by 26.4% with permanent AF. Median overall CHA₂DS₂-VASc score was 3.0 and median HAS-BLED score was 2.0. Previous treatments mostly included vitamin K antagonists (35.7%). A considerably higher proportion of patients on low-dose edoxaban required dose adjustments (71.4% vs. 8.6%). Overall adherence to label dosing recommendations was 86.5%.ConclusionsThis study provides valuable data on disease and patient profiles and will provide valuable insights into disease management and progression, as well as the safety, effectiveness, and patterns of cardiovascular events associated with edoxaban.     

Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices

BackgroundProcedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described.ObjectivesThe aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.MethodsThe National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX.ResultsThe study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001).ConclusionsTranscatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.     

Direct oral anti-coagulants compared to vitamin-K antagonists in cardioversion of atrial fibrillation: an updated meta-analysis

Pharmacological or electrical cardioversion allows immediate symptoms improvement in the setting of paroxysmal or persistent atrial fibrillation (AF), although the periprocedural risk of systemic embolism should be considered. Recently, there was a great interest on the safety and efficacy of direct oral anticoagulants (DOACs) when used for the cardioversion of non-valvular AF. We performed a random-effects meta-analysis of patients undergoing both electrical and pharmacologic cardioversion for non-valvular AF in the RE-LY, ROCKET-AF, ARISTOTLE, ENGAGE AF-TIMI 48, X-VeRT, ENSURE-AF, and EMANATE trials. We assessed Mantel–Haenszel pooled estimates of risk ratios (RRs) and 95% confidence intervals (CIs) for stroke/systemic embolism (SSE) and major bleeding (MB) at follow-up. A total of 8564 patients have been included in the analysis. When compared with patients receiving vitamin-K antagonists (VKAs), patients receiving DOACs had a lower risk of SSE (RR 0.70, 95% CI 0.33–1.546, P?=?0.34), as well as of MB (RR 0.86;,95% CI 0.47–1.58, P?=?0.62), although both were non-significant. Funnel plot analysis showed, however, lower RRs with more recent ad hoc studies in comparison with registrational studies, even though statistical significance was not reached. DOACs are as effective and as safe as VKAs for thromboembolic prevention in non-valvular AF in the setting of cardioversion. There are differences, although non-significant, between registrational studies and studies enrolling exclusively patients undergoing cardioversion of AF.     

Optimizing prognosis in atrial fibrillation: A call to action in Portugal

Atrial fibrillation (AF), the most common arrhythmia in the adult population worldwide, represents a significant burden in terms of cardiovascular mortality and morbidity and has repercussions on health economics. Oral anticoagulation (OAC) is key to stroke prevention in AF and, in recent years, results from landmark clinical trials of non-vitamin K oral anticoagulants (NOAC) have triggered a paradigm shift in thrombocardiology. Despite these advances, there is still a significant residual vascular risk associated with silent AF, bleeding, premature sudden death and heart failure.The authors review AF epidemiologic data, the importance of new tools for early AF detection, the current role of catheter ablation for rhythm control in AF, the state-of-the-art in periprocedural OAC, the optimal management of major bleeding, the causes of residual premature death and future strategies for improvements in AF prognosis.     

Efficacy of anticoagulation for secondary stroke prevention in older people with non-valvular atrial fibrillation: a prospective case series study

BACKGROUND AND PURPOSE: Despite large randomised trials that demonstrated the efficacy of oral anticoagulants in the primary and secondary prevention of stroke in patients with non-valvular atrial fibrillation (AF), anticoagulation therapy remains largely under-used in older patients, who are at risk of first ever or recurrent stroke. The aim of the present study was to assess the influence of anticoagulation therapy on long-term prognosis in the oldest old stroke patients with AF after adjusting for baseline risk factors. METHODS: We evaluated prospectively a consecutive series of 207 older people (>75 years) with AF and first ever ischaemic stroke. During the follow-up period (mean 88.4 months, range 3-120), the study population was under either oral anticoagulants (n = 72) or aspirin (n = 135). Death and recurrent vascular events (stroke and systemic embolism) were documented. Statistical analyses were performed by means of the Kaplan-Meier product limit method and the Cox proportional hazards model. RESULTS: The cumulative 10 year mortality and recurrence rate were 92.5% (95% CI 85.7-99.3) and 66.1% (95% CI 43.1-89.1), respectively. Cox regression analysis revealed increasing age, functional dependency at hospital discharge and antiplatelet versus anticoagulation therapy as independent determinants of mortality. Antiplatelet versus anticoagulation therapy was the sole determinant of vascular recurrence. Anticoagulation was associated with decreased risk of death (hazards ratio (HR) 0.47, 95% CI 0.31-0.72, P = 0.001)) and recurrent thromboembolism (HR 0.31, 95% CI 0.16-0.62, P = 0.002). CONCLUSIONS: Our results suggest that the benefits of anticoagulation for secondary stroke prevention in AF patients extend to the oldest old. Prospective randomised clinical trials are needed to verify the potential benefit of anticoagulation in such patients.     

Atrial fibrillation predicts appropriate shocks in primary prevention implantable cardioverter-defibrillator patients.

AIMS: Atrial fibrillation (AF) is often present in patients with left ventricular dysfunction who receive an implantable cardioverter-defibrillator (ICD). The purpose of this study was to investigate whether AF is associated with appropriate shocks and cardiovascular mortality in primary prevention ICD patients with left ventricular dysfunction. METHODS AND RESULTS: We included 80 primary prevention ICD patients with left ventricular dysfunction and compared the outcome between patients with a history of AF (n=29) and patients with no history of AF (n=51). The primary endpoint was occurrence of appropriate shocks. Secondary endpoints were: (1) the composite of cardiovascular mortality/appropriate shocks; and (2) inappropriate shocks. During follow-up (median 8 months, range 1-60), patients with a history of AF more often received appropriate shocks than patients with no history of AF (24 vs. 6%, P=0.03). The composite endpoint of cardiovascular mortality/appropriate shocks was also more likely to occur in patients with a history of AF (34 vs. 12%, P=0.02). History of AF predicted appropriate shocks (HR 6.9, 95% CI 1.7-27.5, P=0.006) and the composite endpoint of cardiovascular mortality/appropriate shocks (adjusted HR 5.1, 95% CI 1.7-15.1, P=0.003). There were no differences in occurrence of inappropriate shocks. CONCLUSION: Our study demonstrates that history of AF is associated with increased risk of appropriate shocks and cardiovascular mortality in primary prevention ICD patients with left ventricular dysfunction.     

Efficacy and safety of rivaroxaban compared with warfarin in patients with carotid artery disease and nonvalvular atrial fibrillation: Insights from the ROCKET AF trial

Background

Atrial fibrillation (AF) increases risk of stroke 5‐fold. Carotid artery disease (CD) also augments the risk of stroke, yet there are limited data about the interplay of these 2 diseases and clinical outcomes in patients with comorbid AF and CD.

Hypothesis

Among patients with both AF and CD, use of rivaroxaban when compared with warfarin is associated with a lower risk of stroke.

Methods

This post hoc analysis from ROCKET AF aimed to determine absolute rates of stroke/systemic embolism (SE) and bleeding, and the efficacy and safety of rivaroxaban compared with warfarin in patients with AF and CD (defined as history of carotid occlusive disease or carotid revascularization [endarterectomy and/or stenting]).

Results

A total of 593 (4.2%) patients had CD at enrollment. Patients with and without CD had similar rates of stroke or SE (adjusted hazard ratio [HR]: 0.99, 95% confidence interval [CI]: 0.66‐1.48, P = 0.96), and there was no difference in major or nonmajor clinically relevant bleeding (adjusted HR: 1.04, 95% CI: 0.88‐1.24, P = 0.62). The efficacy of rivaroxaban compared with warfarin for the prevention of stroke/SE was not statistically significant in patients with vs those without CD (interaction P = 0.25). The safety of rivaroxaban vs warfarin for major or nonmajor clinically relevant bleeding was similar in patients with and without CD (interaction P = 0.64).

Conclusions

Patients with CD in ROCKET AF had similar risk of stroke/SE compared with patients without CD. Additionally, there was no interaction between CD and the treatment effect of rivaroxaban or warfarin for stroke prevention or safety endpoints.     

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

ObjectivesThe aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.BackgroundThe National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of “real-world” patients have not been previously reported.MethodsPatients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.ResultsThe study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA₂DS₂-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier–estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.ConclusionsThis study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.