Morbidity and mortality in 229 elderly patients with nonrheumatic atrial fibrillation. A five-year follow-up. [Study of combined anticoagulant (fluindione)-aspirin therapy in patients with atrial fibrillation at high risk for thromboembolic complications. A randomized trial (FFAACS)]. Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non–vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH–AFNET 6) trial Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device – the role of anticoagulation Anticoagulant and/or Antiplatelet Treatment in Patients with Atrial Fibrillation after Percutaneous Coronary Intervention Anticoagulant (Fluindione)-Aspirin Combination in Patients with High-Risk Atrial Fibrillation Transesophageal echocardiographic correlates of thromboembolism in high-risk patients with nonvalvular atrial fibrillation. The Stroke Prevention in Atrial Fibrillation Investigators Committee on Echocardiography. Risk factors for thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Atrial thrombi-a prospective follow-up study over 3 years with transesophageal echocardiography and cranial magnetic resonance imaging. Embolic events in patients with atrial fibrillation and effective anticoagulation: value of transesophageal echocardiography to guide direct-current cardioversion. Final results of the Ludwigshafen Observational Cardioversion Study. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study. Clinical characteristics and long-term outcome of patients in whom congestive heart failure develops after thrombolytic therapy for acute myocardial infarction: development of a predictive model. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Cardioversion from atrial fibrillation without prolonged anticoagulation with use of transesophageal echocardiography to exclude the presence of atrial thrombi. Novel oral anticoagulants in a real-world cohort of patients undergoing catheter ablation of atrial fibrillation. Incidence of Thromboembolic Events in Congestive Heart Failure Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices.
BACKGROUND In the elderly the impact of atrial fibrillation on mortality and morbidity is substantial . Oral anticoagulant therapy reduces the risk of stroke by 70 % ; nevertheless , it remains largely underused . We evaluated , in a community prospect i ve study , the factors associated with embolic events and death and the feasibility of oral anticoagulant therapy managed by general practitioners . METHODS We enrolled at the Trieste Cardiovascular Center 229 patients aged > or = 65 years with non-rheumatic atrial fibrillation . At baseline , each patient underwent a transesophageal echocardiography and received instructions about oral anticoagulation . Patients were regularly followed by their general practitioner and finally evaluated at the Center . RESULTS At baseline , the mean age was 73 years , 14 % of patients were free of heart disease , 27 % had had a previous embolic event , and 33 % had an atrial thrombus . After a 5-year follow-up , 85 % of the patients had been admitted to hospital , 17 % had suffered an embolic event , and 35 % were dead . Diabetes and the presence of a low flow in the left atrial appendage were predictive of embolic events . Heart failure , spontaneous echocontrast and aortic plaques were predictive of death . Anticoagulant therapy increased from 14 to 34 % but the incidence of major bleeding did not change . The patients on anticoagulant therapy at follow-up constituted the group with the worst cardiovascular profile and embolic rate , but had a lower death rate ( 19 % ) compared with those on antiplatelet therapy ( 32 % ) and with those without antithrombotic therapy ( 67 % ) . The hospitalization rates were respectively 78 , 83 and 100 % . CONCLUSIONS In a group of elderly patients followed by their general practitioner with the support of a specialized cardiologic unit , oral anticoagulant therapy was well tolerated and associated with a significant decrease in mortality and hospitalization BACKGROUND A combination of low-dose aspirin ( A ) and anticoagulation ( AC ) may provide better protection against thromboembolic events compared with AC alone in high-risk patients with atrial fibrillation ( AF ) . METHODS We performed a multicentric placebo-controlled double blind-trial to test the preventive efficacy against thromboembolic events of the addition of aspirin ( A ) ( 100 mg ) or placebo ( P ) to anticoagulant treatment in patients with high-risk atrial fibrillation . A total of 157 patients were included , with atrial fibrillation and previous thromboembolic event or older than 65 years with either a history of hypertension , a recent episode of heart failure or a left ventricular dysfunction . All patients received fluindione ( F ) and P or F and A , with an INR target between 2 and 2.6 . The primary endpoint was a combined endpoint of stroke ( ischaemic or haemorrhagic ) , myocardial infa rct ion , systemic arterial emboli or vascular death . RESULTS The study had to be stopped prematurely owing to a too low recruitment rate . During follow-up ( 0.84 years ) 3 non-fatal thromboembolic events were recorded ( 1P , 2A ) and 6 patients died ( 3P , 3A ) , none of them from a thromboembolic complication . However , 3 deaths were secondary to severe haemorrhagic complications ( 1P , 2A ) . Non-fatal haemorrhagic complications occurred more often in group A ( n = 10 , 13.1 pour cent ) compared with group P ( n = 1 , 1.2 pour cent ) , p = 0.003 . CONCLUSION The FFAACS study was not able to show any therapeutic benefit from the addition of aspirin to anticoagulant in patients with high-risk AF . Such a combination increased the incidence rate of bleeding complications , which therefore greatly reduces its potential overall benefit Background Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation ( AF ) . Early detection of AF and subsequent initiation of oral anticoagulation help to prevent strokes in AF patients . Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes ( AHRE ) , but the best antithrombotic therapy in patients with AHRE is not known . Rationale Stroke risk is higher in pacemaker patients with AHRE than in those without , but the available data also show that stroke risk in patients with AHRE is lower than in patients with AF . Furthermore , only a minority of patients with AHRE will develop AF , many strokes occur without a temporal relation to AHRE , and AHRE can reflect other arrhythmias than AF or artifacts . An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed . Design The Non – vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes ( NOAH – AFNET 6 ) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared with aspirin or no antithrombotic therapy based on evidence ‐based indications . The primary safety outcome will be major bleeding . NOAH – AFNET 6 will r and omize 3,400 patients with AHRE , but without documented AF , aged ≥65 years with at least 1 other stroke risk factor , to oral anticoagulation therapy ( edoxaban ) or no anticoagulation . All patients will be followed until the end of this investigator‐driven , prospect i ve , parallel‐group , r and omized , event‐driven , double‐blind , multicenter phase IIIb trial . Patients will be censored when they develop AF and offered open‐label anticoagulation . The sponsor is the Atrial Fibrillation NETwork ( AFNET ) . The trial is supported by the DZHK ( German Centre for Cardiovascular Research ) , the BMBF ( German Ministry of Education and Research ) , and Daiichi Sankyo Europe . Conclusion NOAH – AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices . Graphical abstract Figure . No Caption available Background and purpose It is unknown what the optimal anticoagulant level is to prevent thromboembolic stroke in patients with left ventricular assist device ( LVAD ) support . We aim ed to evaluate the relation between coagulation status and the occurrence of thromboembolic stroke in HeartMate-II LVAD assisted patients . Methods Thirty-eight consecutive patients with a HeartMate-II LVAD were included . Coagulation status was classified according to INR and aPTT ratio at : 1 ) the moment of first thromboembolic stroke ; and 2 ) during the two weeks preceding the first thromboembolic stroke to assess long-term coagulation status . In patients without stroke , coagulation status was determined just before heart transplant , VAD explantation or death , whichever came first , and at two weeks preceding these surrogate endpoints . Based on coagulation status , patients were divided in two groups : Group I ( reference group ) was defined as INR below 2 and aPTT ratio below 1.5 ; Group II ( adequate anticoagulation ) as INR above 2 or aPTT ratio above 1.5 . Logistic regression analysis was performed to assess the odds ratio for developing stroke for patients with adequate anticoagulation compared to the reference Group . Results Thromboembolic stroke occurred in six ( 16 % ) patients , none within 2 weeks after LVAD implantation . Considering coagulation status at the time of event , patients in coagulation Group II had no decreased risk for thromboembolic stroke ( OR 0.78 ; 95 % CI 0.12–5.0 ) . Results for coagulation status 2 weeks prior of event could not be calculated as all six strokes occurred in Group II . Conclusion In our experience anticoagulation within predefined targets is not associated with a reduced thromboembolic stroke risk in patients with a HeartMate-II LVAD on antiplatelet therapy . However , no firm statement about the effect of either anticoagulant or antiaggregant therapy can be made based on our study . A larger r and omized study is needed to support the hypothesis that there may be no additional benefit of coumarin or heparin therapy compared with antiplatelet therapy alone Background : Atrial fibrillation ( AF ) is the most common cardiac arrhythmia sustained and frequently occurs in patients with coronary heart disease . Thus , a large number of patients requiring percutaneous coronary intervention ( PCI  ) also suffer from AF . An anticoagulant regimen has not been st and ardized for patients with AF after coronary stent implantation . Patients and Methods : The authors investigated data from 159 patients with AF who underwent PCI in their department . Baseline variables and incidence of a combined endpoint ( stroke , myocardial infa rct ion , cardiovascular death , severe bleeding ) were compared in patients receiving clopidogrel and acetylsalicylic acid ( ASA ; group 1 ) versus patients receiving the combination of clopidogrel and ASA with low-molecular-weight heparin ( LMWH ; group 2 ) versus patients receiving the combination of clopidogrel and ASA with oral anticoagulation ( OAC ; group 3 )  at discharge . Results : Patients discharged with triple therapy including OAC seemed to be at higher risk : patients in group 3 had decreased left ventricular ejection fraction and increased inflammatory state as measured by plasma fibrinogen and C-reactive protein . Moreover , previous OAC treatment and strokes were found more often in this subgroup of patients . In a median follow-up of 1.4 years , two severe bleeding events ( both in group 1 ) , four myocardial infa rct ions ( all in group 1 ) , 13 strokes ( nine in group 1 , four in group 2 ) , and nine cardiovascular deaths ( three in group 1 , five in group 2 , one in group 3 ) occurred . Conclusion : In this analysis , no treatment regimen seemed to be clearly superior . It underlines the importance of prospect i ve , r and omized trials to investigate the optimal antithrombotic/antiplatelet treatment for patients with AF after PCI.ZusammenfassungHintergrund : Vorhofflimmern ( VHF ) ist die häufigste Herzrhythmusstörung und wichtige Komorbidität bei Patienten mit koronarer Herzkrankheit . Welche antithrombotische/antithrombozytäre Therapiestrategie bei Patienten mit Vorhofflimmern nach perkutaner Koronarintervention ( PCI ) verfolgt werden sollte , ist aktuell nicht eindeutig zu beantworten . Patienten und Method ik : Die Autoren identifizierten retrospektiv 159 Patienten mit VHF , die in ihrer Abteilung in den Jahren 1999–2004 eine PCI erhalten hatten . Die Grunderkrankungen und die Inzidenz eines kombinierten Endpunkts ( Schlaganfall , Myokardinfarkt , kardiovaskulär bedingter Tod , schwere Blutung ) wurden bei Patienten verglichen , die Clopidogrel und Acetylsalicylsäure ( ASS ; Gruppe 1 ) , Clopidogrel und ASS in Kombination mit niedermolekularem Heparin ( Gruppe 2 ) sowie Clopidogrel und ASS und zusätzlich orale Antikoagulation erhalten hatten ( Gruppe 3).Ergebnisse : Die Grunderkrankungen der Patienten in den drei Gruppen waren nicht signifikant unterschiedlich . In einem medianen Beobachtungszeitraum von 1,4 Jahren konnten zwei schwere Blutungen ( in Gruppe 1 ) , vier Myokardinfarkte ( in Gruppe 1 ) , 13 Schlaganfälle ( neun in Gruppe 1 , vier in Gruppe 2 ) und neun kardiovaskulär bedingte Todesfälle ( drei in Gruppe 1 , fünf in Gruppe 2 , einer in Gruppe 3 ) nachgewiesen werden . Schlussfolgerung : In dieser Untersuchung erwies sich keine Therapiestrategie einer and eren gegenüber als eindeutig überlegen . Die erhobenen Date n zeigen , wie wichtig es ist , prospektive , r and omisierte Studien bezüglich der antithrombotischen/antithrombozytären Therapie durchzuführen , um Patienten mit AF nach PCI optimal beh and eln zu können Background : A combination of low-dose aspirin with anticoagulants may provide better protection against thromboembolic events compared to anticoagulants alone in high-risk patients with atrial fibrillation . Objective : Evaluation of the preventive efficacy against nonfatal thromboembolic events and vascular deaths of the combination of the oral anticoagulant fluindione and aspirin ( 100 mg ) in patients with high-risk atrial fibrillation . Methods : A multicenter , placebo-controlled , double-blind , r and omized trial was conducted at 49 investigating centers in France . Atrial fibrillation patients with a previous thromboembolic event or older than 65 years and with either a history of hypertension , a recent episode of heart failure or decreased left ventricular function were included in the study . Patients were treated with fluindione plus placebo ( i.e. anticoagulant alone ) or fluindione plus aspirin ( i.e. combination therapy ) , with an international normalized ratio target of between 2 and 2.6 . The combined primary endpoint was stroke ( ischemic or hemorrhagic ) , myocardial infa rct ion , systemic arterial emboli or vascular death . The secondary endpoint was the incidence of hemorrhagic complications . Results : The 157 participants ( average age 74 years ; 52 % women ; 42 % with paroxysmal atrial fibrillation ) were followed for an average of 0.84 years . Three nonfatal thromboembolic events were observed ( 1 in the anticoagulation group , 2 in the combination group ) and 6 patients died ( 3 in the anticoagulation group , 3 in the combination group ) , none of them from a thromboembolic complication . However , 3 deaths were secondary to severe hemorrhagic complications ( 1 in the anticoagulation group , 2 in the combination group ) . Nonfatal hemorrhagic complications occurred more often in the combination group ( n = 10 , 13.1 % ) compared to the anticoagulation group ( n = 1 , 1.2 % ) ( p = 0.003 ) . Conclusion : The combination of aspirin with anticoagulant is associated with increased bleeding in elderly atrial fibrillation patients . The effect on thromboembolism and the overall balance of benefit to risk could not be accurately assessed in this study due to the limited number of ischemic events The risk for ischemic stroke in patients with atrial fibrillation is related to underlying structural heart disease [ 1 - 3 ] . Although most strokes are believed to arise from embolism of left atrial thrombi [ 4 , 5 ] , other mechanisms may contribute . Transesophageal echocardiography ( TEE ) provides a unique diagnostic window for evaluating the left atrium , left atrial appendage , and thoracic aorta , but the manner in which specific TEE findings in patients with atrial fibrillation correlate with thromboembolic risk and response to therapy has not been fully established [ 6 - 13 ] . We performed TEE in patients with nonvalvular atrial fibrillation who were at high intrinsic risk for thromboembolism and were participating in the Stroke Prevention in Atrial Fibrillation ( SPAF-III ) study , a r and omized clinical trial . In that study , adjusted-dose warfarin ( target international normalized ratio [ INR ] , 2 to 3 ) was compared with combination therapy consisting of low-intensity warfarin ( INR , 1.2 to 1.5 ) plus aspirin , 325 mg/d . The trial was stopped after an interim analysis indicated that the efficacy of adjusted-dose warfarin therapy was superior to that of combination therapy . Low anticoagulation intensity in the combination therapy group yielded high stroke rates that were similar to those expected during treatment with aspirin alone [ 14 , 15 ] . In the current analysis , we 1 ) correlate TEE observations among patients with atrial fibrillation at high risk for thromboembolism with rate of subsequent stroke and 2 ) compare treatment responses . Methods Patients Patients were recruited from the SPAF-III multicenter trial , which was design ed to compare two antithrombotic medication regimens for prevention of ischemic stroke and systemic embolism ( primary events ) . The study , whose design is described else-where in detail [ 14 ] , involved patients with nonvalvular atrial fibrillation who were stratified for risk on the basis of clinical and transthoracic echocardiographic criteria derived from previous analyses [ 15 ] . Women older than 75 years of age and patients of any age and either sex with systolic hypertension ( systolic blood pressure > 160 mm Hg ) , previous thromboembolism , or impaired left ventricular function ( M-mode echocardiographic fractional shortening of 0.25 or recent clinical congestive heart failure ) were r and omly assigned to receive adjusted-dose warfarin ( target INR , 2.0 to 3.0 ) or a combination of low-intensity warfarin ( 0.5 to 3.0 mg/d ; dose was initially adjusted to cause deviation of the INR to 1.2 to 1.5 and was then fixed ) and aspirin . Seventy-three percent of the patients were receiving warfarin at various dose intensities before trial entry ; these patients were equally distributed between assigned treatment groups . Antithrombotic treatment was assigned before performance of TEE and was not influenced by TEE findings . Patients were followed monthly by telephone and in clinic every 3 months , and a st and ard question naire on stroke symptoms was administered annually . All patients whose responses to the question naire suggested the occurrence of stroke were referred for clinical examination by a local affiliated neurologist who was blinded to treatment , and all events were adjudicated by a blinded event verification committee [ 14 ] . This project was design ed to supplement the SPAF-III clinical trial on the basis of the hypothesis that spontaneous echocardiographic contrast detected by TEE identifies patients at high risk for thromboembolism for whom adjusted-dose warfarin  would prove superior to  combination therapy . All participants in the parent study were encouraged , but not required , to provide separate , written informed consent for TEE after r and om assignment to antithrombotic treatment . This was done to prevent the results of TEE from influencing recruitment of patients into the trial or from altering treatment . The intended sample size of 412 TEE examinations was selected to detect an absolute difference in event rates of 3.9 % per year ( based on projected event rates of 5.4 % per year in patients with spontaneous echocardiographic contrast and 1.5 % per year in patients without contrast ) over a mean observation period of 2.5 years . Secondary objectives were to correlate clinical thromboembolic events with function of the left atrial appendage , thrombus of the left atrium and left atrial appendage , and atherosclerotic lesions in the thoracic aorta imaged by TEE . Transesophageal Echocardiography Transesophageal echocardiography was performed within 3 months of enrollment with patients under light sedation and topical anesthesia , according to specific protocol s for acquisition and interpretation [ 16 ] . Commercially available ultrasonography equipment incorporated biplane or multiplane transducers with at least 48 crystals operating at a st and ard frequency of 5 MHz with gray-scale imaging . Signal processing , log compression , and persistence values were established for each manufacturer . Images were interpreted locally , and data were entered into st and ardized forms by echocardiographers who were blinded to antithrombotic treatment assignment but not to patient demographic or clinical features . Original videotaped recordings were collected in a central echocardiographic registry for validation and quality control . To assure generalizability of the results to laboratories used in clinical practice , the analyses reported here are based on image interpretation at the local laboratories . The following features were specifically assessed : left atrial appendage size , peak ante grade ( emptying ) velocity of blood flow in the left atrial appendage , spontaneous echocardiographic contrast in the left atrium or left atrial appendage , thrombus of the left atrium or left atrial appendage , and atherosclerotic disease of the thoracic aorta . Spontaneous echocardiographic contrast was defined as a pattern of slowly swirling intracavitary echodensities imaged with gain setting s adjusted to distinguish background noise . Contrast was classified as faint when visualized intermittently during the cardiac cycle or when enhanced gain setting s were required for detection and was classified as dense when continuously present at st and ard gain . Aortic plaque was classified by location and as either simple or complex according to mobility , ulceration , pedunculation , or thickness greater than 4 mm [ 16 ] . We postulated that reduced emptying velocity from the left atrial appendage , which reflects stasis , would be associated with dense spontaneous echocardiographic contrast and thrombus formation , whereas complex aortic plaque would be a consequence of atherosclerotic vascular abnormality . We also postulated that these findings would predispose patients to ischemic stroke through separate pathogenic mechanisms . Statistical Analysis The analyses reported here were limited to variables accessible only by TEE and were hypothesized a priori to have potential predictive relations to clinical thromboembolism . Baseline comparisons between groups were done by using the chi-square test for categorical data and the Student t-test for continuous variables . The Cox proportional-hazards regression model was used to estimate the univariate relative risk associated with TEE characteristics . The primary analysis compared rates of cerebral ischemic events and systemic embolism among patients who had dense spontaneous echocardiographic contrast detected in the left atrium or left atrial appendage with rates in patients who did not have dense contrast ; the log-rank statistic was used to compare the times to events between these groups . Secondary analyses , conducted similarly , compared event rates in groups that were identified by left atrial appendage size , flow velocity , thrombus , and aortic plaque . For these comparisons , the area of the left atrial appendage was dichotomized at the upper quartile ; flow velocity was dichotomized at the lower quartile . When interaction was seen between treatment and TEE characteristics , analysis of the relation of TEE findings to events was confined to the combination therapy group and treatment effect was described separately ; when no interaction was seen , the analysis was stratified by therapy . The relative reduction in event rate associated with adjusted-dose warfarin therapy was computed as the difference between unity and the rate ratio determined by a Poisson regression model [ 17 ] . A Cox proportional-hazards regression model was fit to confirm the independence of TEE characteristics identified as univariate thromboembolic risk factors . Confidence intervals for event rates were calculated by using a Poisson regression model ; tests of significance were two-sided and were not adjusted for multiple comparisons . All analyses were done according to the intention-to-treat principle . Results Of 1044 high-risk patients with atrial fibrillation enrolled in the r and omized trial , 382 ( 37 % ) volunteered for TEE ( range , 10 % to 80 % of SPAF-III participants recruited at 18 clinical centers offering TEE ) . Salient features of these 382 patients were similar to those of the 662 participants who did not undergo transesophageal imaging ( Table 1 ) . The mean patient age was 71 years , 36 % of patients had clinical ischemic heart disease , and almost half had a history of congestive heart failure . Balanced proportions of patients were assigned to therapy with adjusted-dose warfarin ( n = 190 ) or fixed-dose warfarin and aspirin ( n = 192 ) . Time from r and om assignment of treatment to TEE was similar in the two groups ( mean , 23 days ) . The trial was stopped after a mean observation period of 1.1 years because an interim analysis indicated the lack of efficacy of the combination regimen [ 18 ] . Up to that point , 23 primary events ( all of which were ischemic strokes ) occurred in the subset of participants who had undergone TEE ( event rate , 3.1 % per year in patients assigned to adjusted-dose warfarin compared with 7.8 % per year in those assigned to combination therapy ; P = 0.04 ) . As previously reported , 1007 patients with chronic atrial fibrillation participated in the Copenhagen AFASAK study . Before inclusion to trial , they all had a physical examination , chest roentgenogram , and echocardiogram with determination of left atrial size . This study evaluated the importance of cardiovascular risk factors for development of thromboembolic complications . To exclude any treatment effects on occurrence of thromboembolic complications , we included only the 336 patients from the placebo group . Using Cox 's regression model , previous myocardial infa rct ion was a significant risk factor for development of thromboembolic complications . Age , gender , heart failure , chest pain , hypertensive heart disease , diabetes , systolic and diastolic blood pressure , smoking , relative heart volume , and left atrial size were all without statistical importance BACKGROUND Patients with atrial fibrillation ( AF ) and atrial thrombi have an increased risk for cerebral embolism . However , there is little knowledge about the long-term fate of atrial thrombi and the incidence of cerebral embolism in patients under oral anticoagulation . METHODS Consecutive patients with persistent or permanent AF and left atrial ( LA ) thrombi were included in the study . We performed serial and prospect i ve transesophageal echocardiography , cranial magnetic resonance imaging , and clinical examinations during a period of 3 years . Oral anticoagulation was continued or initiated in all patients . A target INR of 2.5 was intended in all patients . RESULTS Forty-three patients with LA thrombi and persistent or permanent AF were included . During the follow-up period 31(72 % ) of the thrombi disappeared . Patients with disappearance of thrombi had significantly smaller thrombi ( P < 0.01 ) , a lower echogenicity of thrombi ( P < 0.01 ) , and a lower LA volume ( P = 0.02 ) . Twenty-two ( 51 % ) patients suffered from cerebral embolism and /or death during the observation period . Five patients died due to embolic events . The only independent predictors of cerebral embolism were an elevated peak emptying velocity of the LA appendage ( P < 0.001 ) and a history of previous thromboembolism ( P < 0.01 ) . CONCLUSIONS Patients with persistent or permanent AF and atrial thrombi have a high long-term risk of cerebral embolism and /or death ( 51 % ) even despite the oral anticoagulation therapy . Thrombus size may predict thrombus resolution under continued anticoagulation OBJECTIVES The primary objective was to evaluate the usefulness of transesophageal echocardiography (TEE)-guided cardioversion to prevent thromboembolic complications in patients with atrial fibrillation ( AF ) and effective anticoagulation ( International Normalized Ratio of 2 or 3 ) at least three weeks before cardioversion . BACKGROUND Transesophageal echocardiography has been proposed as a method of screening patients for left atrial thrombi before direct-current cardioversion of AF . The usefulness of TEE as a screening tool has always been evaluated in patients without long-term anticoagulation before cardioversion . METHODS This prospect i ve , single-center , observational study , performed on an intention-to-cardiovert basis , comprised 1,076 consecutive , unselected patients with AF . The initial two years were design ed to be the control phase , during which the conventional approach was used . After that , cardioversion guided by TEE was performed in consecutive patients . RESULTS The prevalence of left atrial thrombi was 7.7 % in patients with persistent AF and effective anticoagulation . During the first four weeks after electrical cardioversion , six thromboembolic complications were observed in patients in whom the TEE-guided approach was employed ( 6 [ 0.8 % ] of 719 patients ) , compared with three thromboembolic complications in patients in whom the conventional approach was used ( 3 [ 0.8 % ] of 357 patients ) . None of the patients in whom electrical cardioversion was not performed experienced an embolic event . CONCLUSIONS There were no differences in the rate of embolic events between the two treatment groups . In patients with AF and effective anticoagulation , TEE-guided electrical cardioversion does not reduce the embolic risk . However , TEE revealed left atrial thrombi in 7.7 % of patients with AF and effective anticoagulation , before direct-current cardioversion Atrial fibrillation and atrial flutter are common cardiac arrhythmias associated with an increased risk of stroke in patients with additional risk factors .  Anticoagulation ameliorates stroke risk , but because these arrhythmias may occur intermittently without symptoms , initiation of prophylactic therapy is often delayed until electrocardiographic documentation is obtained . The IMPACT study is a multicenter , r and omized trial of remote surveillance technology in patients with implanted dual-chamber cardiac resynchronization therapy defibrillator ( CRT-D ) devices design ed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial electrogram improve clinical outcomes by reducing the combined rate of stroke , systemic embolism , and major bleeding compared with conventional clinical management . For those in the intervention group , early detection of atrial high-rate episodes ( AHRE ) generates an automatic alert to initiate anticoagulation based on patient-specific stroke risk stratification . Subsequently , freedom from AHRE for predefined periods prompts withdrawal of anticoagulation to avoid bleeding . Patients in the control arm are managed conventionally , the anticoagulation decision prompted by incidental detection of atrial fibrillation or atrial flutter during routine clinical follow-up . The results will help define the clinical utility of wireless remote cardiac rhythm surveillance and help establish the critical threshold of AHRE burden warranting anticoagulant therapy in patients at risk of stroke . In this report , we describe the study design and baseline demographic and clinical features of the initial cohort ( 227 patients ) Ischemic heart disease is the most common cause of congestive heart failure , which often begins after acute myocardial infa rct ion . To better delineate the clinical characteristics and outcomes of patients in whom congestive heart failure develops after acute myocardial infa rct ion in the thrombolytic era , we prospect ively evaluated patients enrolled in six of the TAMI trials . The study cohort comprised 1619 consecutive patients who had at least 1 mm of ST-segment elevation in two contiguous electrocardiographic leads within 6 hours of the onset of acute myocardial infa rct ion and who received intravenous thrombolytic therapy .  We prospect ively collected clinical characteristics , baseline demographics , acute and 1-week angiographic variables , and in-hospital and 1-year outcome data . We performed stepwise multivariable regression analysis to determine the noninvasive and invasive predictors of the development of in-hospital congestive heart failure . Congestive heart failure  developed in 301 patients in the hospital ( 19 % of 1521 patients admitted were not in heart failure ) . These patients were likely to be older and female , have diabetes mellitus and previous myocardial infa rct ion , and have an anterior wall myocardial infa rct ion . On acute angiography , they had lower ejection fractions and a higher incidence of multivessel disease . Patency at 90 minutes was lower in the patients with congestive heart failure , and acute mitral regurgitation occurred in 1.6 % versus 0.21 % of patients without congestive heart failure . Patients with congestive heart failure had higher mortality , more in-hospital complications , and longer hospitalizations . At 1-year follow up , 21 % of the patients in whom congestive heart failure developed had died versus 5 % in the group without congestive heart failure . Predictors of new congestive heart failure included increased age , anterior wall myocardial infa rct ion , lower pulse pressure and systolic blood pressure , diabetes mellitus , and the presence of rales on admission . The acute angiographic variables of reduced ejection fraction , increased number of diseased vessels , and attempted percutaneous intervention improved the concordance of the predictive model by 6 % . Congestive heart failure remains a common clinical problem after acute myocardial infa rct ion and is associated with a twofold increase in in-hospital morbidity and a fourfold increase in in-hospital and 1-year mortality . The development of congestive heart failure in the hospital can be predicted from noninvasive and invasive baseline characteristics . We present a simple table to predict congestive heart failure from baseline characteristics and invasive information AIMS The impact of some risk factors for stroke and bleeding , and the value of stroke and bleeding risk scores , in atrial fibrillation ( AF ) , has been debated , as clinical trial cohorts have not adequately tested these . Our objective was to investigate risk factors for stroke and bleeding in AF , and application of the new CHA(2)DS(2)-VASc and HAS-BLED schemes for stroke and bleeding risk assessment s , respectively . METHODS AND RESULTS We used the Swedish Atrial Fibrillation cohort study , a nationwide cohort study of 182 678 subjects with a diagnosis of AF at any Swedish hospital between 1 July 2005 and 31 December 2008 , who were prospect ively followed for an average of 1.5 years ( 260 000 years at risk ) . With the use of the National Swedish Drug Registry , all patients who used an oral anticoagulant  anytime during follow-up were identified . Most of the analyses were made on a subset of 90 490 patients who never used anticoagulants .  Risk factors for stroke , the composite thromboembolism endpoint ( stroke , TIA , or systemic embolism ) , and bleeding , and the performance of published stroke and bleeding risk stratification schemes were investigated . On multivariable analysis , significant associations were found between the following ' new ' risk factors and thromboembolic events ; peripheral artery disease [ hazard ratio ( HR ) 1.22 ( 95 % CI 1.12 - 1.32 ) ] , ' vascular disease ' [ HR 1.14 ( 1.06 - 1.23 ) ] , prior myocardial infa rct ion [ HR 1.09 ( 1.03 - 1.15 ) ] , and female gender [ HR 1.17 ( 1.11 - 1.22 ) ] . Previous embolic events , intracranial haemorrhage ( ICH ) , hypertension , diabetes , and renal failure were other independent predictors of the composite thromboembolism endpoint , while thyroid disease ( or hyperthyroidism ) was not an independent stroke risk factor . C-statistics for the composite thromboembolic endpoint with the CHADS(2 ) and CHA(2)DS(2)-VASc schemes were 0.66 ( 0.65 - 0.66 ) and 0.67 ( 0.67 - 0.68 ) , respectively . On multivariable analysis , age , prior ischaemic stroke or thromboembolism , prior major bleeding events , and hypertension were significant predictors of ICH and major bleeding . Heart failure , diabetes , renal failure , liver disease , anaemia or platelet/coagulation defect , alcohol abuse , and cancer were other significant predictors for major bleeding , but not ICH . The ability for predicting ICH and major bleeding with both bleeding risk schemes ( HEMORR(2)HAGES , HAS-BLED ) were similar , with c-statistics of ~0.6 . CONCLUSION Several independent risk factors ( prior ICH , myocardial infa rct ion , vascular disease , and renal failure ) predict ischaemic stroke and /or the composite thromboembolism endpoint in AF , but thyroid disease ( or hyperthyroidism ) was not an independent risk factor for stroke . There is a better performance for CHA(2)DS(2)-VASc over CHADS(2 ) schemes for the composite thromboembolism endpoint . While both tested bleeding risk schemes have similar predictive value , the HAS-BLED score has the advantage of simplicity BACKGROUND Because atrial thrombi are poorly detected by conventional noninvasive techniques such as transthoracic echocardiography , patients with prolonged atrial fibrillation usually receive several weeks of oral anticoagulation therapy before cardioversion is attempted . We wondered whether transesophageal echocardiography , an accurate method of detecting atrial thrombi , would allow early cardioversion to be performed safely if no thrombi were identified . METHODS A total of 669 consecutive patients admitted with the diagnosis of atrial fibrillation were screened . Patients were excluded if they were receiving long-term anticoagulation , if the duration of atrial fibrillation was two days or less , if they were not c and i date s for cardioversion , or if transesophageal echocardiography was contraindicated . Of 119 qualifying patients , 94 agreed to participate ; the average duration of atrial fibrillation was 4.5 weeks . Participating patients underwent transthoracic echocardiography and transesophageal echocardiography followed by cardioversion if no thrombi were seen . Short-term anticoagulation with heparin was used in 80 patients before cardioversion , and 60 patients received warfarin for one month after cardioversion . RESULTS Fourteen atrial thrombi were identified in 12 patients ( 13 percent ) , and 12 of the 14 thrombi were visualized only on transesophageal echocardiography . Cardioversion was deferred in all 12 patients . Two of these 12 patients died suddenly ; 4 of the 10 surviving patients underwent uneventful cardioversion after prolonged oral anticoagulation . Seventy-eight of the 82 patients without thrombi underwent successful cardioversion to sinus rhythm ( 47 by means of antiarrhythmic drugs and 31 by electrical cardioversion ) , all without long-term oral anticoagulation . None of these patients ( 95 percent confidence interval , 0 to 4.6 percent ) had an embolic event . CONCLUSIONS In patients with atrial fibrillation of unknown or prolonged duration who are not receiving long-term anticoagulation , atrial thrombi are detected by transesophageal echocardiography in only a small minority ( 13 percent in our study ) . Our preliminary data suggest that if transesophageal echocardiography excludes the presence of thrombi , early cardioversion can be performed safely without the need for prolonged oral anticoagulation before the procedure AIMS Experiences with novel oral anticoagulants ( NOACs )  early after atrial fibrillation ( AF ) catheter ablation are limited and show controversial results . We aim ed to assess the longer-term safety , efficacy , and acceptance of NOACs in a large real-world cohort of patients presenting for AF catheter ablation . METHODS AND RESULTS From July 2010 until June 2012 , 259 patients undergoing AF catheter ablation were prospect ively included .  Novel oral anticoagulants were given for at least 3 months post-ablation . Clinical outcome ( stroke , thromboembolic events , major bleeding ) , adverse effects , and drug adherence were assessed at discharge and follow-up . On admission patients were presented with a variety of  anticoagulants  including 54 patients ( 21 % ) already on NOACs prior ablation . After ablation 38 % of patients received dabigatran 110 mg , 56 % 150 mg , and 6 % received rivaroxaban 20 mg . There were four periprocedural thromboembolic and major bleeding complications ( 1.5 % ) , all in patients without NOACs prior ablation ( two on warfarin and two on heparin ) . During long-term follow-up [ 311 ( 199 ; 418 ) days ] no stroke , systemic embolism , or major haemorrhage could be observed . Uneventful electrical cardioversions and reablation procedures were performed in 27 and 12 patients on dabigatran , respectively . Novel oral anticoagulants were prematurely stopped or switched to another anticoagulant due to side effects or at the preference of the treating general practitioner in 9 and 10 patients , respectively . CONCLUSION In this prospect i ve observational study , anticoagulation with NOACs following AF catheter ablation was safe and effective at long-term follow-up . Fast onset of action makes NOACs especially attractive in patients without effective anticoagulation on admission and in patients following periprocedural complications Background The incidence of thromboembolism and the benefit of anticoagulation in congestive heart failure are controversial . Methods and Results The data base provided by the Veterans Affairs Vasodilator-Heart Failure Trials ( V-HeFT I and II ) was examined retrospectively to address these issues . In V-HeFT I , 642 men with heart failure were followed an average of 2.28 years , providing 1,464 patient-years of follow-up . In V-HeFT II , 804 men were followed an average of 2.56 years , with 2,061 patient-years of follow-up . Mean left ventricular ejection fraction was 30%o in V-HeFT I and 29 % in V-HeFT II . Functional capacity was at the interface of classes II and III with a peak exercise oxygen consumption of 14.7 mL. kg -1 . min-1 in V-HeFT I and 13.7 mL- kg-1 min-1 in V-HeFT II . Warfarin and antiplatelet agents were administered at the discretion of individual investigators . The incidence of all thromboembolic events during 1,068 patient-years without warfarin in V-HeFIT I was 2.7/100 patient-years and during 1,188 patient-years in V-HeFT II was 2.1/100 patient-years and was not reduced in patients treated with warfarin . Patients experiencing events had a lower peak exercise oxygen consumption ( P<0.03 in V-HeFT I and P<0.001 in V-HeFT II ) and a lower mean ejection fraction ( P=0.10 in V-HeFT I and P=0.07 in V-HeFT II ) . Atrial fibrillation was not associated with an increased risk of thromboembolic events . Conclusions The incidence of thromboembolism and stroke in class II or III congestive heart failure is not high and may not be significantly reduced with warfarin treatment . Routine use of anticoagulants in patients with heart failure may not be justified AIMS Atrial tachyarrhythmias ( ATs ) detected by implanted devices are often atrial fibrillation or flutter ( AF ) associated with stroke . We hypothesized that introduction and termination of anticoagulation based upon AT monitoring would reduce both stroke and bleeding . METHODS AND RESULTS We r and omized 2718 patients with dual-chamber and biventricular defibrillators to start and stop anticoagulation based on remote rhythm monitoring vs. usual office-based follow-up with anticoagulation determined by st and ard clinical criteria .  The primary analysis compared the composite endpoint of stroke , systemic embolism , and major bleeding with the two strategies . The trial was stopped after 2 years median follow-up based on futility of finding a difference in primary endpoints between groups . A total of 945 patients ( 34.8 % ) developed AT , 264 meeting study anticoagulation criteria . Adjudicated atrial electrograms confirmed AF in 91 % ; median time to initiate anticoagulation was 3 vs. 54 days in the intervention and control groups , respectively ( P < 0.001 ) . Primary events ( 2.4 vs. 2.3 per 100 patient-years ) did not differ between groups ( HR 1.06 ; 95 % CI 0.75 - 1.51 ; P = 0.732 ) . Major bleeding occurred at 1.6 vs. 1.2 per 100 patient-years ( HR 1.39 ; 95 % CI 0.89 - 2.17 ; P = 0.145 ) . In patients with AT , thromboembolism rates were 1.0 vs. 1.6 per 100 patient-years ( relative risk -35.3 % ; 95 % CI -70.8 to 35.3 % ; P = 0.251 ) . Although AT burden was associated with thromboembolism , there was no temporal relationship between AT and stroke . CONCLUSION In patients with implanted defibrillators , the strategy of early initiation and interruption of anticoagulation based on remotely detected AT did not prevent thromboembolism and bleeding . CLINICAL TRIAL REGISTRATION IMPACT Clinical Trials.gov identifier : NCT00559988 ( http:// clinical trials.gov/ct2/show/NCT00559988?term=NCT00559988&rank=1 )
Based on the two major r and omised trials ( HELAS 2006 ; WASH 2004 ) , there is no convincing evidence that oral anticoagulant therapy modifies mortality or vascular events in patients with heart failure and sinus rhythm .
Although oral anticoagulation is indicated in certain groups of patients with heart failure ( for example those with atrial fibrillation ) , the available data does not support the routine use of anticoagulation in heart failure patients who remain in sinus rhythm
BACKGROUND Patients with chronic heart failure ( heart failure ) are at risk of thromboembolic events , including stroke , pulmonary embolism and peripheral arterial embolism , whilst coronary ischaemic events also contribute to the progression of heart failure .
Long-term oral anticoagulation is established in certain patient groups , including patients with heart failure and atrial fibrillation , but there is wide variation in the indications and use of oral anticoagulation in the broader heart failure population .
OBJECTIVES To determine whether long-term oral anticoagulation reduces total deaths , cardiovascular deaths and major thromboembolic events in patients with heart failure .