Platelet activation is a preoperative risk factor for the development of thromboembolic complications in patients with continuous‐flow left ventricular assist device Thromboembolic event rate in paroxysmal and persistent atrial fibrillation: Data from the GISSI-AF trial Detection of atrial high-rate events by continuous Home Monitoring: clinical significance in the heart failure–cardiac resynchronization therapy population The Relationship Between Daily Atrial Tachyarrhythmia Burden From Implantable Device Diagnostics and Stroke Risk: The TRENDS Study Attenuation in peripheral endothelial function after continuous flow left ventricular assist device therapy is associated with cardiovascular adverse events. Risk factors for thromboembolic stroke in elderly patients with chronic atrial fibrillation. Warfarin or aspirin in embolism prevention in patients with mitral valvulopathy and atrial fibrillation. Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device – the role of anticoagulation Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. Gains and losses of warfarin therapy as performed in an anticoagulation clinic. Periprocedural anticoagulation management of patients with nonvalvular atrial fibrillation. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. Pathophysiologic correlates of thromboembolism in nonvalvular atrial fibrillation: I. Reduced flow velocity in the left atrial appendage (The Stroke Prevention in Atrial Fibrillation [SPAF-III] study). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Quality of life and functional status in patients surviving 12 months after left ventricular assist device implantation. Periprocedural Stroke and Bleeding Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation With Different Anticoagulation Management: Results From the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) Rand Complications of atrial fibrillation ablation in a high-volume center in 1,000 procedures: still cause for concern? Association between atrial fibrillation and appropriate implantable cardioverter defibrillator therapy: results from a prospective study. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure Atrial fibrillation: the rate versus rhythm management controversy. Management of anticoagulation following central nervous system hemorrhage in patients with high thromboembolic risk. Aortic plaque in atrial fibrillation: prevalence, predictors, and thromboembolic implications.
AIMS To correlate the dynamics of platelet activation with the development of thromboembolic events in patients with continuous-flow left ventricular assist device ( cf-LVAD ) . METHODS AND RESULTS The  platelet activity state ( PAS ) assay  was utilized to evaluate platelet activation in 68 cf-LVAD patients implanted with the HeartMate II ( n = 15 , 22 % ) , HeartMate 3 ( n = 15 , 22 % ) , or HeartWare HVAD ( n = 38 , 56 % ) .  PAS  was measured preoperatively , early post-implant , and at long-term follow-up ( 1 , 3 , 6 , 12 , 18 , and 24 months post-implant ) .  PAS  was also measured at the occurrence of adverse events in patients who developed thrombotic complications . Data on patient demographics , medical history , antithrombotic therapy , and coagulation parameters were also analysed . Over a median follow-up of 602 ( 234 - 942 ) days , PAS values did not increase over time in the overall population ( P = 0.15 ) . However , PAS measured at event was 15-fold higher in the six patients ( 9 % ) who suffered pump thrombosis ( n = 2 ) or ischaemic stroke ( n = 4 ) vs. the rest of the population [ 6.67 % ( 5.59%-11.98 % ) vs. 0.45 % ( 0.33%-0.75 % ) ; P = 0.012 ] , despite comparable coagulation profile . Pre-implant PAS values were 4.5-fold higher in these patients [ 1.90 % ( 1.24%-3.17 % ) vs. 0.42 % ( 0.32%-0.72 % ) ; P = 0.006 ] . Neither preoperative variables nor the type of the pump or the antiplatelet strategy were associated with a higher risk of complications . CONCLUSIONS Thrombotic events are associated with altered PAS values . Moreover , baseline elevated PAS values in patients who developed thrombotic events suggest patient-specific tendency to post-implant thromboembolic complications . Prospect ively , systematic monitoring of PAS might guide the development of refined patient-tailored antithrombotic strategies and the technological improvement of LVAD design Background Few data on the thromboembolic ( TE ) risk of paroxysmal and persistent atrial fibrillation ( AF ) are available . This study aim ed to assess the incidence of TE events in paroxysmal and persistent AF . Methods We performed a subset post hoc analysis of 771 patients with paroxysmal and 463 with persistent AF enrolled in the multicenter , prospect i ve , r and omized , double-blind , placebo-controlled GISSI-AF trial - comparing the efficacy of valsartan versus placebo in preventing AF recurrences – where the choice of antithrombotic treatment was left to the judgment of the referring physician . TE and major outcome events were central ly vali date d. AF recurrences were detected by frequent clinic visits and a transtelephonic monitoring device with weekly and symptomatic transmissions . Results Eighty-five percent of patients had a history of hypertension , and the 7.7 % had heart failure , left ventricular dysfunction , or both .  The mean CHADS2 score was 1.41±0.84 . TE and major bleeding events were observed at a low incidence among the overall population at 1-year follow-up ( 0.97 % and 0.81 % , respectively ) . The univariate and multivariable analyses revealed no statistically significant differences in the incidence of TE , major bleeding events or mortality in paroxysmal and persistent AF patients . TE events were more common among women than men ( p=0.02 ) . The follow-up examination showed under- or overtreatment with warfarin in many patients , according to guideline suggestions . Warfarin was more frequently prescribed to patients with persistent AF ( p<0.0001 ) and patients with AF recurrences ( p<0.0001 ) . AF recurrences were noninvasively detected in 632 ( 51.2 % ) patients . In patients without AF recurrences , the TE event rate was 0.5 % versus 1.74 % , 1.28 % , and 1.18 % for those with only symptomatic , only asymptomatic or both symptomatic and asymptomatic AF recurrences , respectively , but the difference was not statistically significant , even after adjusting for warfarin treatment and the CHADS2 score ( HR 2.93 ; CI 95 % ; 0.8 - 10.9 ; p=0.11 ) . Conclusions TE and major bleeding events showed a very low incidence in the GISSI-AF trial population , despite under- or overtreatment with warfarin in many patients . TE events had a similar rate in paroxysmal and persistent AF.Trial registration Trial registration number : Aims Uncertainty exists over the importance of device-detected short- duration atrial arrhythmias . Continuous atrial diagnostics , through home monitoring ( HM ) technology ( BIOTRONIK , Berlin , Germany ) , provides a unique opportunity to assess frequency and quantity of atrial fibrillation ( AF ) episodes defined as atrial high-rate events ( AHRE ) . Methods and results Prospect i ve data from 560 heart failure ( HF ) patients ( age 67 ± 10 years , median ejection fraction 27 % ) patients with a cardiac resynchronization therapy ( CRT ) device capable of HM from two multi-centre studies were analysed . Atrial high-rate events burden was defined as the duration of mode switch in a 24-h period with atrial rates of > 180 beats for at least 1 % or total of 14 min per day . The primary endpoint was incidence of a thromboembolic ( TE ) event . Secondary endpoints were cardiovascular death , hospitalization because of AF , or worsening HF . Over a median 370-day follow-up AHRE occurred in 40 % of patients with 11 ( 2 % ) patients developing TE complications and mortality rate of 4.3 % ( 24 deaths , 16 with cardiovascular aetiology ) . Compared with patients without detected AHRE , patients with detected AHRE>3.8 h over a day were nine times more likely to develop TE complications ( P= 0.006 ) . The majority of patients ( 73 % ) did not show a temporal association with the detected atrial episode and their adverse event , with a mean interval of 46.7 ± 71.9 days ( range 0–194 ) before the TE complication . Conclusion In a high-risk cohort of HF patients , device-detected atrial arrhythmias are associated with an increased incidence of TE events . A cut-off point of 3.8 h over 24 h was associated with significant increase in the event rate . Routine assessment of AHRE should be considered with other data when assessing stroke risk and considering anti-coagulation initiation and should also prompt the optimization of cardioprotective HF therapy in CRT patients Background —It is unknown if brief episodes of device-detected atrial fibrillation ( AF ) increase thromboembolic event ( TE ) risk . Methods and Results —TRENDS was a prospect i ve , observational study enrolling patients with ≥1 stroke risk factor ( heart failure , hypertension , age ≥65 years , diabetes , or prior TE ) receiving pacemakers or defibrillators that monitor atrial tachycardia (AT)/AF burden ( defined as the longest total AT/AF duration on any given day during the prior 30-day period ) . This time-varying exposure was up date d daily during follow-up and related to TE risk . Annualized TE rates were determined according to AT/AF burden subsets : zero , low ( < 5.5 hours [ median duration of subsets with nonzero burden ] ) , and high ( ≥5.5 hours ) . A multivariate Cox model provided hazard ratios including terms for stroke risk factors and time-varying AT/AF burden and antithrombotic therapy . Patients ( n=2486 ) had at least 30 days of device data for analysis . During a mean follow-up of 1.4 years , annualized TE risk ( including transient ischemic attacks ) was 1.1 % for zero , 1.1 % for low , and 2.4 % for high burden subsets of 30-day windows . Compared with zero burden , adjusted hazard ratios ( 95 % CIs ) in the low and high burden subsets were 0.98 ( 0.34 to 2.82 , P=0.97 ) and 2.20 ( 0.96 to 5.05 , P=0.06 ) , respectively . Conclusions —The TE rate was low compared with patients with traditional AF with similar risk profiles . The data suggest that TE risk is a quantitative function of AT/AF burden . AT/AF burden ≥5.5 hours on any of 30 prior days appeared to double TE risk . Additional studies are needed to more precisely investigate the relationship between stroke risk and AT/AF burden BACKGROUND Patients with heart failure ( HF ) have abnormal endothelial function . Although use of a continuous flow left ventricular assist device ( CF-LVAD ) results in significant hemodynamic improvement , the effects on systemic endothelial function are unclear . METHODS AND RESULTS Eighteen HF patients with CF-LVAD implantation were included in this prospect i ve observational study . We measured  reactive hyperemia index ( RHI ) before and after CF-LVAD implantation to evaluate sequential changes in endothelial function . Patients were followed clinical ly for the occurrence of adverse cardiovascular events , a composite of death , thrombosis , bleeding , HF , renal failure , and arrhythmia . Preoperative RHI was 1.77±0.39 . Early in the postoperative period ( 7 - 14 days after operation ) RHI significantly decreased to 1.19±0.31 ( P<0.001 , compared with preoperative RHI ) . At first and second follow-up ( 4 - 6 weeks and 3 - 7 months after operation ) RHI remained lower at 1.48±0.50 ( P=0.030 ) and 1.26±0.37 ( P=0.002 ) , respectively , compared with preoperative RHI . The decrease in early postoperative RHI relative to preoperative RHI was significantly associated with adverse cardiovascular events  after CF-LVAD ( age-adjusted risk ratio for 0.25 decrease in RHI , 1.35 ; 95 % confidence interval : 1.13 - 1.62 , P=0.001 ) . CONCLUSIONS Peripheral endothelial function had a significant and persistent decline up to 5 months following implantation of CF-LVAD , and this decline was associated with adverse cardiovascular events . These findings may provide insight into some of the vascular complications following CF-LVAD in HF patients Abstract Chronic atrial fibrillation ( AF ) in the presence or absence of rheumatic valvular heart disease is associated with an increased incidence of stroke . 1,2 We reported in a prospect i ve study that at 27-month follow-up , echocardiographic left ventricular ( LV ) hypertrophy in elderly patients with systolic or diastolic hypertension was associated with an increased incidence of new atherothrombotic brain infa rct ion . 3 We also demonstrated in a prospect i ve study that at 3-year follow-up , risk factors for atherothrombotic brain infa rct ion were cigarette smoking , systolic or diastolic hypertension and diabetes mellitus in elderly men and systolic or diastolic hypertension , diabetes mellitus and obesity in elderly women . 4 This report correlates in elderly patients with chronic AF the prevalence of thromboembolic ( TE ) stroke with the presence or absence of rheumatic mitral stenosis , mitral anular calcium , valvular aortic stenosis , systolic or diastolic hypertension , prior myocardial infa rct ion , left atrial enlargement and LV hypertrophy BACKGROUND Atrial fibrillation ( AF ) associated to rheumatic mitral valve disease ( RMVD ) increases the incidence of thromboembolism ( TE ) , with warfarin being the st and ard therapy , in spite of difficulties in treatment adherence and therapeutic control . OBJECTIVE To compare the effectiveness of Aspirin vs Warfarin in TE prevention in patients with AF and RMVD . METHODS A total of 229 patients ( pts ) with AF and RMVD were followed in a prospect i ve and r and omized study . The first group consisted of 110 pts receiving Aspirin - 200 mg/day ( Group Aspirin - GA ) and the second group consisted of 119 pts receiving Warfarin at individually-adjusted doses ( Group Warfarin - GW ) . RESULTS There were 15 embolic events in GA and 24 in GW ( p = 0.187 ) , of which 21 presented INR < 2.0 . Thus , after excluding patients with inadequate INR , there was a higher number of embolic events in GA than in GW ( 15 vs 3 ) ( p < 0.0061 ) . The GW showed lower treatment adherence ( p = 0.001 ) . Neither group presented episodes of major bleeding . Small bleeding episodes were more frequent in the GW ( p < 0.01 ) . Increased serum levels of cholesterol and triglycerides constituted a risk factor for a higher number of thromboembolic events in the studied population , with no difference between the groups . CONCLUSION In patients presenting RMVD with AF for less than a year and no previous embolism , Aspirin is little effective in preventing TE . Patients with lower-risk mitral valvulopathy ( mitral regurgitation and mitral biological prosthesis ) , especially in cases presenting contraindication to or low adherence to Warfarin , Aspirin use can present some benefit in TE prevention 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 OBJECTIVES This study sought to evaluate the use of a continuous-flow rotary left ventricular assist device ( LVAD ) as a bridge to heart transplantation . BACKGROUND LVAD therapy is an established treatment modality for patients with advanced heart failure . Pulsatile LVADs have limitations in design precluding their use for extended support . Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism . METHODS In a prospect i ve , multicenter study , 281 patients urgently listed ( United Network of Organ Sharing status 1A or 1B ) for heart transplantation underwent implantation of a continuous-flow LVAD .  Survival and transplantation rates were assessed at 18 months . Patients were assessed for adverse events throughout the study and for quality of life , functional status , and organ function for 6 months . RESULTS Of 281 patients , 222 ( 79 % ) underwent transplantation , LVAD removal for cardiac recovery , or had ongoing LVAD support at 18-month follow-up . Actuarial survival on support was 72 % ( 95 % confidence interval : 65 % to 79 % ) at 18 months . At 6 months , there were significant improvements in functional status and 6-min walk test ( from 0 % to 83 % of patients in New York Heart Association functional class I or II and from 13 % to 89 % of patients completing a 6-min walk test ) and in quality of life ( mean values improved 41 % with Minnesota Living With Heart Failure and 75 % with Kansas City Cardiomyopathy question naires ) . Major adverse events included bleeding , stroke , right heart failure , and percutaneous lead infection . Pump thrombosis occurred in 4 patients . CONCLUSIONS A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplantation , with improved functional status and quality of life . ( Thoratec HeartMate II Left Ventricular Assist System [ LVAS ] for Bridge to Cardiac Transplantation ; NCT00121472 ) BACKGROUND Knowledge of the net benefit of warfarin therapy in routine care is needed to define realistic management recommendations , but lack of r and omized controls precludes conventional risk-benefit analysis . OBJECTIVE Assess risk and benefit of routine warfarin therapy in an anticoagulation clinic . DESIGN Retrospective observational analysis . PATIENTS A total of 1435 out patients on warfarin for a total of 1613 patient years , treated to prevent the target events recurrent venous thromboembolism ( VTE ) or myocardial infa rct ion ( MI ) , and stroke in patients with atrial fibrillation ( AF ) or mechanical heart valves . MEASUREMENTS Major bleeding and thromboembolic ( TE ) events and all deaths . CALCULATIONS Expected annual target event rates without warfarin were from published data . Differences between combined major events observed with warfarin , and expected without warfarin were calculated . RESULTS In the total material , annual rates were 3.0 % major TE events , 1.1 % major bleeding events , 0.12 % fatal bleeding , and a benefit/risk ratio of 3.8 . The net gain , expressed in reduced combined bleeding and target TE annual event rate , was 9.9 % in secondary prophylaxis in AF , 4.4 % in VTE patients , 2.7 % in post-MI patients , 2.4 % in primary prophylaxis in AF and 0.6 in patients with mechanical heart valves . The apparent benefit/risk ratio was 3.9 in VTE patients , 5.8 in AF patients and 1.1 in patients with mechanical heart valves . CONCLUSION Net effects of prolonged warfarin therapy in patients with VTE and AF performed in an anticoagulation clinic have an acceptable risk/benefit ratio , comparable with what has been obtained in elective clinical trials OBJECTIVE To estimate the 3-month cumulative incidence of thromboembolism ( TE ) , bleeding , and death among consecutive patients with nonvalvular atrial fibrillation ( AF ) who were receiving long-term anticoagulation therapy and were referred to the Thrombophilia Center at Mayo Clinic for periprocedural anticoagulation management . PATIENTS AND METHODS In a prospect i ve cohort study of consecutive patients receiving long-term anticoagulation therapy who were referred to the Thrombophilia Center for periprocedural anticoagulation management over the 7-year period , January 1 , 1997 , to December 31 , 2003 , 345 patients with nonvalvular AF were eligible for inclusion .  Warfarin was stopped 4 to 5 days before and was restarted after surgery as soon as hemostasis was assured . The decision to provide bridging therapy with heparin was individualized and based on the estimated risks of TE and bleeding . RESULTS The 345 patients with AF ( mean + /- SD age , 74+/-9 years ; 33 % women ) underwent 386 procedures . Warfarin administration was not interrupted for 44 procedures . Periprocedural heparin was provided for 204 procedures . Patients receiving heparin were more likely to have prior TE ( 43 % vs 24 % ; P<.001 ) and a higher CHADS2 ( congestive heart failure , hypertension , age , diabetes , stroke ) score ( 2.2 vs 1.9 ; P=.06 ) . Four patients had 6 episodes of TE ( 3 strokes and 3 acute coronary episodes ; TE rate , 1.1 % ; 95 % confidence interval , 0.0%-2.1 % ) . Nine patients had 10 major bleeding events ( major bleeding rate , 2.7 % ; 95 % confidence interval , 1.0%-4.4 % ) . There were no deaths . Neither bleeding nor TE rates differed by anticoagulant management strategy . CONCLUSION The 3-month cumulative incidence of TE and bleeding among patients with AF in whom anticoagulation was temporarily interrupted for an invasive procedure was low and was not significantly influenced by bridging therapy OBJECTIVES The aim of this multicenter study was to evaluate the safety of discontinuing oral anticoagulation therapy ( OAT ) after apparently successful pulmonary vein isolation . BACKGROUND Atrial fibrillation ( AF ) is associated with an increased risk of thromboembolic events ( TE ) and often requires OAT . Pulmonary vein isolation is considered an effective treatment for AF . METHODS We studied 3,355 patients , of whom 2,692 ( 79 % male , mean age 57 + /- 11 years ) discontinued OAT 3 to 6 months after ablation ( Off-OAT group ) and 663 ( 70 % male , mean age 59 + /- 11 years ) remained on OAT after this period ( On-OAT group ) . CHADS(2 ) ( congestive heart failure , hypertension , age [ 75 years and older ] , diabetes mellitus , and a history of stroke or transient ischemic attack ) risk scores of 1 and > or = 2 were recorded in 723 ( 27 % ) and 347 ( 13 % ) Off-OAT group patients and in 261 ( 39 % ) and 247 ( 37 % ) On-OAT group patients , respectively . RESULTS During follow-up ( mean 28 + /- 13 months vs. 24 + /- 15 months ) , 2 ( 0.07 % ) Off-OAT group patients and 3 ( 0.45 % ) On-OAT group patients had an ischemic stroke ( p = 0.06 ) . No other thromboembolic events occurred . No Off-OAT group patient with a CHADS(2 ) risk score of > or = 2 had an ischemic stroke . A major hemorrhage was observed in 1 ( 0.04 % ) Off-OAT group patient and 13 ( 2 % ) On-OAT group patients ( p < 0.0001 ) . CONCLUSIONS In this nonr and omized study , the risk-benefit ratio favored the suspension of OAT after successful AF ablation even in patients at moderate-high risk of TE . This conclusion needs to be confirmed by future large r and omized trials Stroke associated with atrial fibrillation ( AF ) is mainly due to embolism of thrombus formed during stasis of blood in the left atrial appendage ( LAA ) . Pathophysiologic correlates of appendage flow velocity as assessed by transesophageal echocardiography ( TEE ) in patients with AF have not been defined . To evaluate the hypothesis that reduced velocity is associated with spontaneous echocardiographic contrast and thrombus in the LAA and with clinical embolic events , we measured LAA flow velocity by TEE in 721 patients with nonvalvular AF entering the Stroke Prevention in Atrial Fibrillation ( SPAF-III ) study . Patient features , TEE findings , and subsequent cardioembolic events were correlated with velocity by multivariate analysis . Patients in AF during TEE displayed lower peak ante grade ( emptying ) flow velocity ( Anu(p ) ) than those with intermittent AF in sinus rhythm during TEE ( 33 cm/s vs 61 cm/s , respectively , P < .0001 ) . Anu(p ) < 20 cm/s was associated with dense spontaneous echocardiographic contrast ( P < .001 ) , appendage thrombus ( P < .01 ) , and subsequent cardioembolic events ( P < .01 ) . Independent predictors of Anu(p ) < 20 cm/s included age ( P = .009 ) , systolic blood pressure ( P < .001 ) , sustained AF ( P = .01 ) , ischemic heart disease ( P = .01 ) , and left atrial area ( P = .04 ) . Multivariate analysis found both Anu(p ) < 20 cm/s ( relative risk 2.6 , P = .02 ) and clinical risk factors ( relative risk 3.3 , P = .002 ) independently associated with LAA thrombus . LAA Anu(p ) is reduced in AF and associated with spontaneous echocardiographic contrast , appendage thrombus , and cardioembolic stroke . Systolic hypertension and aortic atherosclerosis , independent clinical predictors of stroke in patients with AF , also correlated with LAA Anu(p ) . Our results support the role of reduced LAA Anu(p ) in the generation of stasis , thrombus formation , and embolism in patients with AF , although other mechanisms also contribute to stroke ACCF : American College of Cardiology Foundation ACCP : American College of Chest Physicians ACS : acute coronary syndrome ACT : Atrial arrhythmia Conversion Trial ADONIS : American – Australian – African trial with DronedarONe In atrial fibrillation or flutter for the maintenance of Sinus rhythm AF : atrial fibrillation AHA : American Heart Association AND ROMEDA : ANtiarrhythmic trial with DROnedarone in Moderate-to-severe congestive heart failure Evaluating morbidity DecreAse APHRS : Asia Pacific Heart Rhythm Society aPTT : activated partial thromboplastin time ARB : angiotensin-receptor blocker ARISTOTLE : Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation ATHENA : A placebo-controlled , double-blind , parallel arm Trial to assess the efficacy of dronedarone 400 mg b.i.d . for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter ATRIA : AnTicoagulation and Risk factors In Atrial fibrillation AVERROES : Apixaban VErsus acetylsalicylic acid ( ASA ) to Reduce the Rate Of Embolic Stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment AVRO : A prospect i ve , r and omized , double-blind , Active-controlled , superiority study of Vernakalant vs. amiodarone in Recent Onset atrial fibrillation b.i.d : bis in die ( twice daily ) b.p.m . : beats per minute CABANA : Catheter ABlation vs . ANtiarrhythmic drug therapy for Atrial fibrillation CABG : coronary artery bypass graft CAP : Continued Access to Protect AF CHA2DS2-VASc : Congestive heart failure or left ventricular dysfunction Hypertension , Age ≥75 ( doubled ) , Diabetes , Stroke (doubled)-Vascular disease , Age 65–74 , Sex category ( female ) CHADS2 : Congestive heart failure , Hypertension , Age ≥75 , Diabetes , Stroke ( doubled ) CI : confidence interval CRAFT : Controlled R and omized Atrial Fibrillation Trial CrCl : creatinine clearance DAFNE : Dronedarone Atrial FibrillatioN study after Electrical cardioversion DIONYSOS : R and omized Double blind trIal to evaluate efficacy and safety of drOnedarone ( 400 mg b.i.d . ) vs . amiodaroNe ( 600 mg q.d . for 28 daYS , then 200 mg qd thereafter ) for at least 6 mOnths for the maintenance of Sinus rhythm in patients with atrial fibrillation EAST : Early treatment of Atrial fibrillation for Stroke prevention Trial EHRA : European Heart Rhythm Association ECG : electrocardiogram EMA : European Medicines Agency ERATO : Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation EURIDIS : EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm FAST : atrial Fibrillation catheter Ablation vs . Surgical ablation Treatment FDA : Food and Drug Administration Flec-SL : Flecainide Short-Long trial HAS-BLED : Hypertension , Abnormal renal/liver function , Stroke , Bleeding history or predisposition , Labile INR , Elderly , Drugs/alcohol concomitantly HF-PEF : heart failure with preserved ejection fraction HF-REF : heart failure with reduced ejection fraction HR : hazard ratio HRS : Heart Rhythm Society ICH : intracranial haemorrhage INR : international normalized ratio i.v . : intravenous J-RHYTHM : Japanese RHYTHM management trial for atrial fibrillation LAA : left atrial appendage LoE : level of evidence LVEF : left ventricular ejection fraction MANTRA-PAF : Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation NICE : National Institute for Health and Clinical Excellence NOAC : novel oral anticoagulant NSAID : non-steroidal anti-inflammatory drug NYHA : New York Heart Association OAC : oral anticoagulant or oral anticoagulation o.d . : omni die ( every day ) PALLAS : Permanent Atrial fibriLLAtion outcome Study using dronedarone on top of st and ard therapy PCI : percutaneous coronary intervention PREVAIL : Prospect i ve R and omized EVAluation of the LAA closure device In patients with atrial fibrillation v s. Long-term warfarin therapy PROTECT AF : WATCHMAN LAA system for embolic PROTECTion in patients with Atrial Fibrillation PT : prothrombin time RAAFT : Radio frequency Ablation Atrial Fibrillation Trial RE-LY : R and omized Evaluation of Long-term anticoagulant therapY with dabigatran etexilate ROCKET-AF : Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in atrial fibrillation RRR : relative risk reduction TE : thromboembolism TIA : transient ischaemic attack t.i.d . : ter in die ( three times daily ) TOE : transoesophageal echocardiogram TTR : time in therapeutic range VKA : vitamin K antagonist Guidelines summarize and evaluate all currently available evidence on a particular issue with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition , taking into account the impact on BACKGROUND As  left ventricular assist device ( LVAD ) support duration increases , quality of life ( QoL ) becomes a concern . We review ed the QoL in patients on LVAD support for > or=1 year . METHODS We retrospectively review ed our prospect i ve data base for patients supported > or=1 year by HeartMate pulsatile- ( HM1 ) or continuous-flow ( HM2 ) LVADs from 2000 to 2009 . Transplant or death before 1 year merited exclusion . Metabolic equivalents of tasks ( METs ) , the Minnesota Living with Heart Failure Question naire ( MLHFQ ) , the 6-minute  walk  distance ( 6MWD ) , and New York Heart Association ( NYHA ) class were review ed . Complications and re-admissions were assessed . RESULTS Thirty patients were supported for > or=1 year ( 7 HM1s , 23 HM2s ) . Mean support duration was 594 + /- 173 days . Mean QoL metrics/functional status indicators at 12 months were : 6MWD , 393 + /- 290 m ; MET tolerance , 3.3 + /- 1 ; MLHFQ , 35 + /- 31 ; and NYHA , 1.4 + /- 0.6 . Mean re-admissions/year was 2.9 + /- 2 , with a duration of 13.8 + /- 21 days . Three patients were never re-admitted . Mean out-of-hospital time was 471 + /- 172 days ( 87.3 % of days ) . Infectious complications led to 43 % of re-admissions and occurred in the : drive-line ( 47 % ) at 442 + /- 236 days ; blood ( 37 % ) at 472 + /- 257 days ; and LVAD pocket ( 20 % ) at 550 + /- 202 days . Twenty-three patients ( 77 % ) required additional operations ( 1.7 + /- 1.8/year ) . The most common indication was drive-line infection , but ranged from ischemic bowel to defibrillator exchange . Eight required LVAD exchanges for mechanical ( n = 4 ) , electrical ( n = 3 ) , and thrombotic ( n = 1 ) issues . CONCLUSIONS Although LVAD support is not without complications , patients spend the majority of time outside the hospital enjoying a good quality of life Background — Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation ( AF ) . The periprocedural anticoagulation management could play a role in the incidence of these complications . Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk , no r and omized study exists . Methods and Results — This was a prospect i ve , open-label , r and omized , parallel-group , multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation . Patients with CHADS2 score ≥1 were included . Patients were r and omly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm . The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study . The study enrolled 1584 patients : 790 assigned to discontinue warfarin ( group 1 ) and 794 assigned to continuous warfarin ( group 2 ) . No statistical difference in baseline characteristics was observed . There were 39 thromboembolic events ( 3.7 % strokes [ n=29 ] and 1.3 % transient ischemic attacks [ n=10 ] ) in group 1 : two events ( 0.87 % ) in patients with paroxysmal AF , 4 ( 2.3 % ) in patients with persistent AF , and 33 ( 8.5 % ) in patients with long-st and ing persistent AF . Only 2 strokes ( 0.25 % ) in patients with long-st and ing persistent AF were observed in group 2 ( P<0.001 ) . Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism ( odds ratio , 13 ; 95 % confidence interval , 3.1–55.6 ; P<0.001 ) . Conclusion — This is the first r and omized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01006876 INTRODUCTION Catheter ablation is potentially curative treatment for atrial fibrillation ( AF ) . However , complications are more frequent and more severe compared with other ablation procedures . We investigated the complication rate in 1,000 AF ablation procedures in a high-volume center and examined possible risk factors . METHODS AND RESULTS One thous and consecutive circumferential pulmonary vein radiofrequency ablations were performed for symptomatic , drug-refractory AF . Major complications were defined as the ones that were life threatening , caused permanent harm , and required intervention or prolonged hospitalization . Thirty-nine ( 3.9 % ) major periprocedural complications were observed . There was no death immediately associated with the procedure . However , there were 2 deaths ( 0.2 % ) of unclear cause , 14 days and 4 weeks after ablation . The most common complications were tamponade ( 1.3 % ) , treated mainly by percutaneous drainage , and vascular complications ( 1.1 % ) . There were also 4 thromboembolic events ( 0.4 % ) : 3 nonfatal strokes and one transient ischemic attack . Importantly , 2 cases ( 0.2 % ) of atrial-esophageal fistula and 2 cases ( 0.2 % ) of endocarditis were observed . Factors associated with an increased complication risk were age > or = 75 years ( hazard ratio 3.977 , P = 0.022 ) and congestive heart failure ( hazard ratio 5.174 , P = 0.001 ) . CONCLUSION AF ablation still has a considerable number of major complications that may be life threatening or may lead to severe residues . Atrial-esophageal fistula is still observed despite continuous systematic methods to prevent it . Stroke , tamponade , and vascular complications are the most frequent major complications . However , in most patients treatment can be conservative and results in complete recovery . Advanced age and congestive heart failure seem to be associated with an increased risk of complications INTRODUCTION  Atrial fibrillation ( AF ) is associated with significant morbidity and mortality that may be related to hemodynamic impairment , thromboembolic events , or enhanced electrical instability of the ventricular myocardium . There is , however , a lack of data concerning the association of AF and ventricular tachyarrhythmias . METHODS AND RESULTS Consecutive patients with indication for an implantable cardioverter defibrillator ( ICD ) were classified for the presence or absence of persistent AF at the time of device implantation .  Incidence of device therapy , stored electrograms , and clinical events during follow-up were evaluated prospect ively . Two hundred fifty patients were included . During follow-up ( 20+/-14 months ) , patients in AF experienced appropriate device therapy for recurrent ventricular arrhythmias more frequently compared with patients in sinus rhythm ( SR ) ( 63 % vs 38 % , P = 0.01 ) . On multivariate analysis , AF was an independent predictor of appropriate ICD therapy ( relative risk 1.8 ; 95 % confidence interval [ CI ] 1.2 to 2.9 ) and inappropriate device therapy ( relative risk 2.3 ; 95 % CI 1.2 to 4.5 ) . Predefined clinical events ( cluster endpoint : death , syncope , and hospitalizations ) were observed more frequently in AF than in SR patients ( 55 % vs 31 % , P = 0.01 ) . Analysis of device-stored electrograms revealed a higher incidence of short-long-short cycles preceding ventricular arrhythmias in AF compared with SR patients ( 50 % vs 16 % , P = 0.002 ) . Baseline heart rate preceding ventricular arrhythmias did not differ between the two groups . CONCLUSION AF is an independent predictor of recurrent ventricular arrhythmias in ICD recipients . The underlying electrophysiologic mechanism seems to be irregular rather than rapid ventricular activation , with a high incidence of short-long-short sequences preceding ventricular tachyarrhythmias in AF patients BACKGROUND Oral anticoagulation ( OAC ) is the recommended therapy for patients with atrial fibrillation ( AF ) because it reduces the risk of stroke and other thromboembolic events . Dual antiplatelet therapy ( DAPT ) is required after percutaneous coronary intervention and stenting ( PCI-S ) . In patients with AF requiring PCI-S  , the association of DAPT and OAC carries an increased risk of bleeding , whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events . OBJECTIVE The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy ( TT ) in patients with nonvalvular AF at low-to-moderate risk of stroke ( CHADS2 score ≤2 ) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications . DESIGN The MUSICA-2 is a multicenter , open-label r and omized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S.  The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events : death , myocardial infa rct ion , stent thrombosis , or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients . CONCLUSIONS The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications Background Mechanical circulatory support with a left ventricular assist device ( LVAD ) is an established treatment for patients with advanced heart failure . We compared a newer LVAD design ( a small intrapericardial centrifugal‐flow device ) against existing technology ( a commercially available axial‐flow device ) in patients with advanced heart failure who were ineligible for heart transplantation . Methods We conducted a multicenter r and omized trial involving 446 patients who were assigned , in a 2:1 ratio , to the study ( centrifugal‐flow ) device or the control ( axial‐flow ) device . Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial . The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure . The trial was powered to show noninferiority with a margin of 15 percentage points . Results The intention‐to treat‐ population included 297 participants assigned to the study device and 148 participants assigned to the control device . The primary end point was achieved in 164 patients in the study group and 85 patients in the control group . The analysis of the primary end point showed noninferiority of the study device relative to the control device ( estimated success rates , 55.4 % and 59.1 % , respectively , calculated by the Weibull model ; absolute difference , 3.7 percentage points ; 95 % upper confidence limit , 12.56 percentage points ; P=0.01 for noninferiority ) . More patients in the control group than in the study group had device malfunction or device failure requiring replacement ( 16.2 % vs. 8.8 % ) , and more patients in the study group had strokes ( 29.7 % vs. 12.1 % ) . Quality of life and functional capacity improved to a similar degree in the two groups . Conclusions In this trial involving patients with advanced heart failure who were ineligible for heart transplantation , a small , intrapericardial , centrifugal‐flow LVAD was found to be noninferior to an axial‐flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure . ( Funded by HeartWare ; ENDURANCE Clinical Trials.gov number , NCT01166347 . The fundamental management strategy for atrial fibrillation ( AF ) is still debated . There is no doubt that those patients at risk of thromboembolic events should be offered anticoagulant therapy . However , it is uncertain whether rhythm control ( restoration and maintenance of sinus rhythm ) or rate control ( adjustment to a physiological ventricular rate while allowing AF to continue ) is the preferred primary treatment option for the reduction of symptoms and major cardiovascular ( CV ) outcomes associated with AF . Several well conducted trials comparing the two strategies led to the conclusion that there was little to choose between them . However , guidelines leaned towards recommending rate control as the initial strategy , and reserved rhythm control for those who remained symptomatic . Recently this status quo is being increasingly challenged by the clear demonstration that left atrial catheter ablation is effective at suppressing AF resistant to traditional antiarrhythmic drugs , such as those that failed to demonstrate any superiority when compared with rate control . Also , recently introduced antiarrhythmic therapy may have superior efficacy with regard to reducing unexpected CV hospitalization , CV mortality and stroke . In addition , there is a growing perception that atrial remodelling should be best prevented by early rhythm control rather than delaying until rate control has proven unsatisfactory . For these reasons the results of large r and omised clinical trials , which recruit patients soon after the presentation of AF and compare ' aggressive ' modern rhythm control against the guideline approach of primary rate control , are eagerly awaited . In the meantime the pendulum of clinical opinion has begun to swing towards a rhythm control strategy SUMMARY BACKGROUND Patients who present with central nervous system ( CNS ) hemorrhage while on anticoagulation ( AC ) for thromboembolic ( TE ) risk factors are a challenge to manage . OBJECTIVE We sought to inform decisions surrounding the timing and intensity of AC resumption by performing a systematic review . METHODS Three review ers screened publications from Medline and EMBASE and extracted data . Hemorrhagic and TE adverse events that occurred subsequent to the index hemorrhage were recorded , as was their timing relative to presentation and covariates that might influence their occurrence . RESULTS Data were extracted from 63 publications detailing 492 patients ; 7.7 % of patients experienced hemorrhagic complications and 6.1 % experienced TE complications . Hemorrhagic complications were more common within 72 h of presentation while TE complications were more common thereafter . Patients restarted on AC after 72 h were significantly more likely to have a TE complication ( P = 0.006 ) and those restarted before 72 h were more likely to hemorrhage ( P = 0.0727 ) . Factors associated with re-hemorrhage included younger age , traumatic cause , subdural hematomas and failure to reverse AC . TE complications were more common in younger patients and those with spinal hemorrhage , multiple hemorrhages , and non-traumatic causes of the index hemorrhage . Re-initiation of AC at a lower intensity also significantly increased the risk of TE complications . INTERPRETATION Our results suggest that it may be prudent to re-initiate AC earlier than previously thought , with the timing and intensity modified based on predictors of TE and hemorrhagic complications . These findings must be explored in a prospect i ve study because of limitations inherent to the analyzed studies BACKGROUND AND PURPOSE Thoracic aortic plaque identified by transesophageal echocardiography heightens the risk of stroke associated with atrial fibrillation ( AF ) . We sought to identify the prevalence , predictors , and implication s of aortic plaque in patients with nonvalvular AF . METHODS Thoracic aortic plaque was prospect ively sought in 770 persons with AF with the use of transesophageal echocardiography and classified as simple or complex on the basis of thickness > /=4 mm , ulceration , or mobility .  Clinical and echocardiographic features of thromboembolism were correlated by multivariate analysis . RESULTS Aortic plaque was detected in 57 % of the cohort , and complex plaque was detected in 25 % . Both were found more frequently in the descending than in the proximal aorta . Potentially etiologic patient characteristics independently associated with complex plaque included advanced age , history of hypertension , diabetes , and past or present tobacco use . Comorbidities associated with aortic plaque were prior thromboembolism , increased pulse pressure , ischemic heart disease , stenosis or sclerosis of the aortic valve , mitral annular calcification ( > 10 % ) , elevated serum creatinine concentration , spontaneous echo contrast in the left atrium or appendage , and left atrial appendage thrombus . The prevalence of complex plaque in patients aged < 70 years with < 10 % mitral annular calcification , without ischemic heart disease , or without pulse pressure > /=65 mm Hg was 4 % ( 95 % CI , 1 % to 6 % ) . CONCLUSIONS Aortic plaque is prevalent in patients with AF and is associated with atherosclerosis risk factors and with left atrial stasis or thrombosis , which are themselves independent stroke risk factors . Since the predominant location of complex plaque was in the descending aorta , the role of aortic plaque as a source of embolism in AF is uncertain
AF in CF-LVAD patients was not associated with overall TE , stroke , or device thrombosis events .
These findings might be explained by the highly thrombogenic property of CF-LVADs that exceeds the thromboembolic risk driven by AF
Atrial fibrillation ( AF ) is a well-established risk factor of thromboembolism ( TE ) .
Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices ( CF-LVADs ) .
However , the association between AF and TE complications in this population is controversial .
We conducted a systematic review and meta- analysis to assess the association between AF and overall TE , stroke , and device thrombosis events in CF-LVAD patients .