Mean CHADS2 Research Articles

Abstract 336: Real-World Experiences with Novel Anticoagulants for AF: Initial Insights from ORBIT-AF Phase II

Background: Novel therapies for stroke prevention in atrial fibrillation (AF) are emerging. However, data on use and outcomes of these agents in the community are limited, particularly in patients newly diagnosed with AF or recently transitioned to a novel anticoagulant. Methods: Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, national, AF registry. We are enrolling 15,000 patients with new-onset AF, or those with known AF recently-transitioned to a novel anticoagulant. The primary objective is to evaluate the safety of novel anticoagulants, with specific focus on use, transitions, and management around invasive procedures and bleeding events. An adaptive design is used to ensure diversity of enrollment across geographic, provider, and treatment groups. The primary outcomes are major bleeding and thromboembolic events. Results: Of 1,011 patients in ORBIT-AF II, the median age was 73, 44% were female, 23% had a history of heart failure, 34% had a prior MI, and 11% had a prior stroke/TIA. The mean CHADS2 score was 2. Overall, 76% had AF new-onset, and a range of anticoagulant strategies was used in these patients (Figure). Among the 24% with known AF transitioned to a novel agent, 66% received rivaroxaban, versus 8.1% dabigatran, and 26% apixaban. Compared with patients having new-onset AF, those with known AF recently-transitioned to a novel anticoagulant were slightly older (median age 74 vs. 72), had higher CHADS2 scores (>2 in 70% vs. 62%), but less severe kidney disease (0 vs. 1.7%). Conclusions: Patients with new-onset AF are frequently treated with novel anticoagulants and these patients have lower risk scores than those with known AF transitioned to a novel drug. These data will provide insights into clinical management and patient centered outcomes among those treated with novel anticoagulants in real world practice settings.

Edoxaban: an update on the new oral direct factor Xa inhibitor.

Edoxaban is a once-daily oral anticoagulant that rapidly and selectively inhibits factor Xa in a concentration-dependent manner. This review describes the extensive clinical development program of edoxaban, including phase III studies in patients with non-valvular atrial fibrillation (NVAF) and symptomatic venous thromboembolism (VTE). The ENGAGE AF-TIMI 48 study (N = 21,105; mean CHADS2 score 2.8) compared edoxaban 60 mg once daily (high-dose regimen) and edoxaban 30 mg once daily (low-dose regimen) with dose-adjusted warfarin [international normalized ratio (INR) 2.0–3.0] and found that both regimens were non-inferior to warfarin in the prevention of stroke and systemic embolism in patients with NVAF. Both edoxaban regimens also provided significant reductions in the risk of hemorrhagic stroke, cardiovascular mortality, major bleeding and intracranial bleeding. The Hokusai-VTE study (N = 8,292) in patients with symptomatic VTE had a flexible treatment duration of 3–12 months and found that following initial heparin, edoxaban 60 mg once daily was non-inferior to dose-adjusted warfarin (INR 2.0–3.0) for the prevention of recurrent VTE, and also had a significantly lower risk of bleeding events. Both studies randomized patients at moderate-to-high risk of thromboembolic events and were further designed to simulate routine clinical practice as much as possible, with edoxaban dose reduction (halving dose) at randomisation or during the study if required, a frequently monitored and well-controlled warfarin group, a well-monitored transition period at study end and a flexible treatment duration in Hokusai-VTE. Given the phase III results obtained, once-daily edoxaban may soon be a key addition to the range of antithrombotic treatment options.Electronic supplementary materialThe online version of this article (doi:10.1007/s40265-014-0261-1) contains supplementary material, which is available to authorized users.

Atrial fibrillation in patients with haemophilia: a cross-sectional evaluation in Europe.

Atrial fibrillation (AF) is a common health problem in the general population, but data on prevalence or management in patients with haemophilia (PWH) are lacking. The aims of this study were to analyse the prevalence of AF and risk factors for stroke using a cross-sectional pan-European design and to document current anticoagulation practice. The ADVANCE Working Group consists of members from 14 European haemophilia centres. Each centre retrieved data on their PWH with AF. From the total of 3952 adult PWH, 33 had AF with a mean age of 69years (IQR 62-76). Haemophilia was severe in seven (21%), moderate in six (18%) and mild in 20 (61%) patients. The overall AF prevalence was 0.84% and increased with age; 0.42% in patients 40-60years and 3.4% in patients >60years. The mean CHA2 DS2 -Vasc score was 1.3 (range 0-4), predominantly determined by age and hypertension. Hypertension was reported in 48% of PWH with AF. In 11 patients (33%), anticoagulation was started of whom nine aspirin and two vitamin K antagonists. Of these 11 patients, nine had mild haemophilia. Anticoagulation was given in 42% of patients with a CHA2 DS2 -Vasc score ≥2. During follow-up (mean 57months), there were no thrombotic events reported, nor increases in bleeding severity. The prevalence of AF in haemophilia increases with age and is predominantly present in mild haemophilia. PWH have a low stroke risk based on their CHA2 DS2 -Vasc scores, that might be even lower considering the hypocoagulable state. Only 33% of PWH with AF receives any form of anticoagulation therapy.

Adherence to dabigatran therapy and longitudinal patient outcomes: Insights from the Veterans Health Administration

Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). It does not require routine monitoring with laboratory testing which may have an adverse impact on adherence. We aimed to describe adherence to dabigatran in the first year after initiation and assess the association between non-adherence to dabigatran and clinical outcomes in a large integrated healthcare system. We studied a national cohort of 5,376 patients with NVAF, initiated on dabigatran between October-2010 and September-2012 at all Veterans Affairs hospitals. Adherence to dabigatran was calculated as proportion of days covered (PDC) and association between PDC and outcomes was assessed using standard regression techniques. Mean age of the study cohort was 71.3 ± 9.7 years; 98.3% were men and mean CHADS2 score was 2.4 ± 1.2 (mean CHA2DS2VASc score 3.2 ± 1.4). Median PDC was 94% (IQR 76%-100%; mean PDC 84% ± 22%) over a median follow-up of 244 days (IQR 140-351). A total of 1,494 (27.8%) patients had a PDC <80% and were classified as non-adherent. After multivariable adjustment, lower adherence was associated with increased risk for combined all-cause mortality and stroke (HR 1.13, 95% CI 1.07-1.19 per 10% decrease in PDC). Adherence to dabigatran was not associated with non-fatal bleeding or myocardial infarction. In the year after initiation, adherence to dabigatran for a majority of patients is very good. However, 28% of patients in our cohort had poor adherence. Furthermore, lower adherence to dabigatran was associated with increased adverse outcomes. Concerted efforts are needed to optimize adherence to NOACs.

Prediction of left atrial thrombi in patients with atrial tachyarrhythmias during warfarin administration: retrospective study in Hyogo College of Medicine

Some patients experience a left atrial thrombus (LAT) in spite of taking warfarin. We aimed to clarify the characteristics of patients with LAT during warfarin administration and investigated whether the CHADS2 or CHA2DS2-VASc scores are useful predictors of LAT. We studied 230 patients (169 males, age 65 ± 10 years) who underwent transesophageal echocardiography (TEE) prior to cardioversion or catheter ablation of atrial tachyarrhythmias between 2008 and 2012. All patients were taking oral warfarin. LAT was detected in 19 patients (8.3%) using TEE. LAT was significantly associated with the presence of hypertension (P = 0.0035), prior congestive heart failure (P < 0.0001), structural heart disease (P = 0.0012), persistent arrhythmias (P < 0.0001), the absence of SR during TEE (P = 0.0070), left ventricular ejection fraction (P < 0.0001), left atrial diameter (P = 0.0015), left ventricular dimension during end diastole (P = 0.0215), left ventricular hypertrophy (LVH; P < 0.0001), and the E/e' ratio (P = 0.0074). A multivariate analysis showed that LVH (P = 0.0065, OR 5.591, 95% CI 1.618–19.316) and persistent arrhythmia (P = 0.0364, OR 12.121, 95% CI 1.171–125.451) were independently associated with LAT. Moreover, the mean CHADS2 (2.3 ± 0.9 vs. 1.4 ± 1.2) and CHA2DS2-VASc scores (3.8 ± 1.2 vs. 2.8 ± 1.7) were higher in the patients with than without LAT. However, a multivariate analysis showed that the CHADS2/CHA2DS2-VASc scores did not associate with LAT. LVH and persistent arrhythmia may be useful for predicting LAT in patients with atrial tachyarrhythmias.

Prevalence of stroke and the need for thromboprophylaxis in young patients with atrial fibrillation

Atrial fibrillation is the most common cardiac arrhythmia, and age is a well-established independent risk factor for stroke in these patients. Whereas high-risk patients clearly benefit from anticoagulation to prevent stroke, less is known about how to treat low-risk patients. Despite the recent guidelines and studies demonstrating no benefit and excess bleeding risk with aspirin, many low-risk patients still receive this medication. Our objective was to determine the stroke rate in young patients with atrial fibrillation, a group of previously unstudied and predominantly low-risk patients. We hypothesized that the event rate would be so low as to preclude benefit from antithrombotic medications. A retrospective chart review identified patients with atrial fibrillation between the age of 18 and 35. Exclusion criteria included no ECG documentation of atrial fibrillation, anticoagulation, except around the time of cardioversion, and surgical valve disease. The primary outcome was stroke during the period of observation. The final cohort included 99 patients, mean age 27.6 years, followed for a mean of 4.3 years. Mean CHADS2 and CHA2DS2-VASc scores were 0.26 and 0.4, respectively. A total of 42.4% were taking aspirin for over 50% of the time. There was one event identified, a transient ischemic attack in a man not on aspirin with CHADS2 and CHADS2-VASc scores of 1, resulting in event rates of 0.234 per 100 patient-years overall or 0.392 among those not on aspirin. Patients with nonvalvular atrial fibrillation under age 35 have an exceedingly low stroke risk. We assert that aspirin may be unnecessary for most patients in this population, especially those with a CHA2DS2-VASc score of 0.

The value of diastolic function parameters in the prediction of left atrial appendage thrombus in patients with nonvalvular atrial fibrillation

BackgroundLeft ventricular diastolic impairment and consequently elevated filling pressure may contribute to stasis leading to left atrial appendage thrombus (LAAT) in nonvalvular atrial fibrillation (AF). We investigated whether transthoracic echocardiographic parameters can predict LAAT independent of traditional clinical predictors.MethodsWe conducted a retrospective cohort study of 297 consecutive nonvalvular AF patients who underwent transthoracic echocardiogram followed by a transesophageal echocardiogram within one year. Multivariate logistic regression analysis models were used to determine factors independently associated with LAAT.ResultsNineteen subjects (6.4%) were demonstrated to have LAAT by transesophageal echocardiography. These patients had higher mean CHADS2 scores [2.6 ± 1.2 vs. 1.9 ± 1.3, P = 0.009], higher E:e’ ratios [16.6 ± 6.1 vs. 12.0 ± 5.4, P = 0.001], and lower mean e’ velocities [6.5 ± 2.1 cm/sec vs. 9.1 ± 3.2 cm/sec, P = 0.001]. Both E:e’ and e’ velocity were associated with LAAT formation independent of the CHADS2 score, warfarin therapy, left ventricular ejection fraction (LVEF), and left atrial volume index (LAVI) [E:e’ odds-ratio = 1.14 (95% confidence interval = 1.03 – 1.3), P = 0.009; e’ velocity odds-ratio = 0.68 (95% confidence interval = 0.5 – 0.9), P = 0.007]. Similarly, diastolic function parameters were independently associated with spontaneous echo contrast.ConclusionThe diastolic function indices E:e’ and e’ velocity are independently associated with LAAT in nonvalvular AF patients and may help identify patients at risk for LAAT.

Drivers of hospitalization for patients with atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

Atrial fibrillation (AF) is the most common cardiac dysrhythmia and contributes significantly to health care expenditures. We sought to assess the frequency and predictors of hospitalization in patients with AF. The ORBIT-AF registry is a prospective, observational study of outpatients with AF enrolled from June 29, 2010, to August 9, 2011. The current analysis included 9,484 participants with 1-year follow-up. Multivariable, logistic regression was used to identify baseline characteristics that were associated with first cause-specific hospitalization. Overall, 31% of patients with AF studied (n = 2,963) had 1 or more hospitalizations per year and 10% (n = 983) had 2 or more. The most common hospitalization cause was cardiovascular (20 per 100 patient-years vs 3.3 bleeding vs 17 noncardiovascular, nonbleeding). Compared with those not hospitalized, hospitalized patients were more likely to have concomitant heart failure (42% vs 28%, P < .0001), higher mean CHADS2 (1 point for congestive heart failure, hypertension, age ≥75, or diabetes; 2 points for prior stroke or transient ischemic attack) scores (2.5 vs 2.2, P < .0001), and more symptoms (baseline European Heart Rhythm Association class severe symptoms 18% vs 13%, P < .0001). In multivariable analysis, heart failure (adjusted hazard ratio [HR] 1.57 for New York Heart Association III/IV vs none, P < .0001), heart rate at baseline (adjusted HR 1.11 per 10-beats/min increase >66, P < .0001), and AF symptom class (adjusted HR 1.37 for European Heart Rhythm Association severe vs none, P < .0001) were the major predictors of incident hospitalization. Hospitalization is common in outpatients with AF and is independently predicted by heart failure and AF symptoms. Improved symptom control, rate control, and comorbid condition management should be evaluated as strategies to reduce health care use in these patients.

CHADS2 score predicts atrial fibrillation following cardiac surgery

BackgroundAtrial fibrillation (AF) following cardiac surgery portends higher morbidity and increased health expenditure. Although many anatomic and patient risk factors have been identified, a simple clinical scoring system to identify high-risk patients is lacking. The CHADS2 score is widely used to predict the risk of stroke in patients with AF. We assessed the utility of this scoring algorithm in predicting the development of de novo postoperative atrial fibrillation (POAF) in cardiac surgery patients. Material and methodsA total of 2120 patients from 2008 to 2013 were identified for inclusion in our analysis. CHADS2 scores were calculated, and patients grouped into low- (0), intermediate- (1) and high-risk (≥2) categories. A multivariate regression model was developed to account for known risk factors of AF. ResultsOf the 2120 patients, 344 (16.2%) patients developed de novo POAF during their primary hospitalization. Mean CHADS2 scores for POAF patients and no POAF patients were 2.1 ± 1.2 and 1.7 ± 1.3 (P < 0.0001), respectively. CHADS2 score was a significant predictor of AF on multivariate regression analysis (adjusted odds ratio, 1.26; 95% confidence interval, 1.14–1.40). As CHADS2 score increased from 0 to 6, the probability of POAF increased from 11.1% to 32.7% (P < 0.0001). Compared with the low-risk group, the intermediate-risk and high-risk groups had a 1.73- and 2.58-fold increase in odds of developing POAF, respectively (P < 0.02 and P < 0.0001). ConclusionsCHADS2 score is a powerful and convenient predictor of developing POAF. We recommend its utilization in identifying high-risk patients that may benefit from pharmacologic prophylaxis.

Clinical Characteristics, Management, and Control of Permanent vs. Nonpermanent Atrial Fibrillation: Insights from the RealiseAF Survey

BackgroundAtrial fibrillation can be categorized into nonpermanent and permanent atrial fibrillation. There is less information on permanent than on nonpermanent atrial fibrillation patients. This analysis aimed to describe the characteristics and current management, including the proportion of patients with successful atrial fibrillation control, of these atrial fibrillation subsets in a large, geographically diverse contemporary sample.Methods and ResultsData from RealiseAF, an international, observational, cross-sectional survey of 10,491 patients with atrial fibrillation, were used to characterize permanent atrial fibrillation (N = 4869) and nonpermanent atrial fibrillation (N = 5622) patients. Permanent atrial fibrillation patients were older, had a longer time since atrial fibrillation diagnosis, a higher symptom burden, and were more likely to be physically inactive. They also had a higher mean (SD) CHADS2 score (2.2 [1.3] vs. 1.7 [1.3], p<0.001), and a higher frequency of CHADS2 score ≥2 (67.3% vs. 53.0%, p<0.001) and comorbidities, most notably heart failure. Physicians indicated using a rate-control strategy in 84.2% of permanent atrial fibrillation patients (vs. 27.5% in nonpermanent atrial fibrillation). Only 50.2% (N = 2262/4508) of permanent atrial fibrillation patients were controlled. These patients had a longer time since atrial fibrillation diagnosis, a lower symptom burden, less obesity and physical inactivity, less severe heart failure, and fewer hospitalizations for acute heart failure than uncontrolled permanent atrial fibrillation patients, but with more arrhythmic events. The most frequent causes of hospitalization in the last 12 months were acute heart failure and stroke.ConclusionPermanent atrial fibrillation is a high-risk subset of atrial fibrillation, representing half of all atrial fibrillation patients, yet rate control is only achieved in around half. Since control is associated with lower symptom burden and heart failure, adequate rate control is an important target for improving the management of permanent atrial fibrillation patients.

Safety of Short-Term Use of Dabigatran or Rivaroxaban for Direct-Current Cardioversion in Patients With Atrial Fibrillation and Atrial Flutter

Direct-current cardioversion (DCCV) for persistent atrial fibrillation or atrial flutter (AF) carries a risk of thromboembolic events (TEs). Therapeutic anticoagulation with warfarin is recommended for 3 to 4 weeks before and 4 weeks after DCCV to reduce TE; however, the safety of short-term anticoagulation with the novel oral anticoagulants (dabigatran and rivaroxaban) before DCCV has not been assessed. A retrospective cohort study was performed on all patients undergoing elective DCCV for AF at Northwestern Memorial Hospital from June 1, 2012 to September 30, 2013. Inclusion criteria included patients taking any of the novel oral anticoagulants for 21 to 60 days before DCCV and successful DCCV to sinus rhythm. Patients were monitored for a minimum of 60 days after DCCV to evaluate for TEs including stroke, transient ischemic attack, systemic emboli, and death. In total, 53 patients (47 men, 89%; age 65±10 years, median 66) were evaluated. Agents used were dabigatran (30 patients, 57%) and rivaroxaban (23 patients, 43%) for an average of 38±9 days. The mean CHADS2 score was 1.2±1.1 (score=0, 26%; 1, 43%; 2, 17%; and >3, 13%). Eleven patients (21%) underwent a transesophageal echocardiography before their DCCV; all showed no thrombus. No patients were found to have episodes of TE within 60 days of DCCV. No patients were found to have major bleeding events. In conclusion, the use of short-term dabigatran or rivaroxaban therapy for DCCV of AF appears safe.

One‐Year Outcome of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting: An Analysis of the AFCAS Registry

Most evidence regarding the efficacy and safety of the antithrombotic regimens for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI-S) derives from small, single-center, retrospective datasets. To obtain further data on this issue, we carried out the prospective, multicenter, observational Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) registry (Clinicaltrials.gov identifier NCT00596570). We hypothesize that the antithrombotic treatment of AF patients undergoing PCI-S is variable and the clinical outcome may vary according to the different regimens. Consecutive AF patients undergoing PCI-S at 17 European institutions were included and followed for 1 year. Outcome measures included: (1) major adverse cardiac/cerebrovascular events (MACCE), including all-cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack, and (2) bleeding, and were compared according to the antithrombotic regimen adopted. A propensity-score analysis was carried out to adjust for baseline and procedural differences. Out of the 975 patients enrolled, 914 were included in the final analysis. The mean CHADS2 score was 2.2 ± 1.2, and 71% of patients had a CHADS2 score ≥2. Triple therapy (TT) of vitamin K antagonist (VKA), aspirin, and clopidogrel was prescribed to 74% of patients, dual antiplatelet therapy to 18%, and VKA plus clopidogrel to 8%. At 1-year follow-up, no significant differences were found in the occurrence of MACCE and bleeding among the 3 antithrombotic regimens, even when adjusted for propensity score. In this large, real-world population of AF patients undergoing PCI-S, TT was the antithrombotic regimen most frequently prescribed. Although several limitations need to be acknowledged, in our study the 1-year efficacy and safety of TT, dual antiplatelet therapy, and VKA plus clopidogrel was comparable.

Association of CHADS2, CHA2DS2-VASc, and R2CHADS2 Scores With Left Atrial Dysfunction in Patients With Coronary Heart Disease (from the Heart and Soul Study)

The predictive ability of the CHADS2 index to stratify stroke risk may be mechanistically linked to severity of left atrial (LA) dysfunction. This study investigated the association between the CHADS2 score and LA function. We performed resting transthoracic echocardiography in 970 patients with stable coronary heart disease and normal ejection fraction and calculated baseline LA functional index (LAFI) using a validated formula: (LA emptying fraction×left ventricular outflow tract velocity time integral)/LA end-systolic volume indexed to body surface area. We performed regression analyses to evaluate the association between risk scores and LAFI. Among 970 subjects, mean CHADS2 was 1.7±1.2. Mean LAFI decreased across tertiles of CHADS2 (42.8±18.1, 37.8±19.1, 36.7±19.4, p<0.001). After adjustment for age, sex, race, systolic blood pressure, hyperlipidemia, myocardial infarction, revascularization, body mass index, smoking, and alcohol use, high CHADS2 remained associated with the lowest quartile of LAFI (odds ratio 2.34, p=0.001). In multivariable analysis of component co-morbidities, heart failure, age, and creatinine clearance<60 ml/min were strongly associated with LA dysfunction. For every point increase in CHADS2, the LAFI decreased by 4.0%. Secondary analyses using CHA2DS2-VASc and R2CHADS2 scores replicated these results. Findings were consistent when excluding patients with baseline atrial fibrillation. In conclusion, CHADS2, CHA2DS2-VASc, and R2CHADS2 scores are associated with LA dysfunction, even in patients without baseline atrial fibrillation. These findings merit further study to determine the role of LA dysfunction in cardioembolic stroke and the value of LAFI for risk stratification.

Safety of percutaneous left atrial appendage closure with the amplatzer cardiac plug in patients with atrial fibrillation and contraindications to anticoagulation

To evaluate the safety of percutaneous left atrial appendage (LAA) closure with the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (AF) who are not eligible for oral anticoagulation with warfarin. Anticoagulation is the treatment of choice for prevention of strokes in patients with AF, but some patients have contraindications to anticoagulation. A total of 60 patients with a CHA2 DS2 -VASc score of at least 1 and contraindications to warfarin who underwent percutaneous LAA closure with the ACP were included. Stroke risk assessment was performed with the CHADS2 and CHA2 DS2 -VASc score and the bleeding risk was calculated with the HAS-BLED-score. Follow-up included office visits, telephone inquiries, and mail contact. Mean CHADS2 -, CHA2 DS2 -VASc-, and HAS-BLED scores were 2.6 (± 1.4), 4.3 (± 1.7), and 3.3 (± 1.0), respectively. Twenty-five percent had a history of previous bleeding without oral anticoagulation and 63.3% while receiving oral anticoagulation. In 36.7% other contraindications to warfarin were present. Procedural success was achieved in 95%. Mean follow-up time was 1.8 (1.0-2.8) years. The estimated annual stroke risk based on the CHADS2 -score was 5.8%. The estimated annual bleeding risk on warfarin based on the HAS-BLED score was 3.7%. During follow-up, the annual incidence of stroke was 0%. Major bleeding complications occurred in 1.9% annually. Percutaneous LAA closure with the ACP in patients with contraindications to oral anticoagulation is safe. The stroke and bleeding risk after percutaneous LAA closure is lower than predicted by conventional risk scores.

Current Status of Catheter Ablation for Atrial Fibrillation

The purpose of this study was to provide precise data on the current status of catheter ablation for atrial fibrillation (AF) in Japan. The Japanese Heart Rhythm Society requested that members retrospectively register data for AF ablation performed in September 2011, March 2012, and September 2012. A total of 165 centers submitted data for 3,373 patients (age, 62±11 years; male, 76.1%; paroxysmal AF, 64.4%). Pulmonary vein isolation (PVI) and additional ablation were performed in 97.5% and 77.4% of patients, respectively. 3-D mapping systems and irrigated-tip catheters were used in 94.8% and 87.7% of the patients, respectively. Although the mean CHADS2 score was 1.0±1.0, the majority received oral anticoagulant (OAC) during and following the procedure (69.8% and 97%, respectively). Vitamin K antagonist (VKA) prescription, however, decreased (1st vs. 3rd survey, during and following the procedure, 59.3% vs. 47.8% and 81.7% vs. 55.2%, respectively, P<0.0001, both) and that of new OAC (NOAC) increased drastically (9.6% vs. 24.2% and 15.8% vs. 42.1%, respectively, P<0.0001). Early complications were reported in 4.5% of the patients, but no instance of early death was reported. In addition to PVI, additional ablation procedures are also performed very frequently. Although the mean CHADS2 score was low, peri-procedural OAC therapy was commonly performed, and NOAC drastically superseded VKA.

Left atrial appendage occlusion in octogenarians

To determine the procedural safety, safety, and efficacy of left atrial appendage (LAA) occlusion in octogenarians. Elderly patients with atrial fibrillation (AF) often do not receive appropriate anticoagulation. LAA occlusion is an option for patients with AF and contraindications to anticoagulation. Not much is known about the procedural safety and clinical efficacy of LAA occlusion in the very elderly. A retrospective review of LAA cases at our institution between 2002 and 2013 in patients 80 years of age or older was performed. Demographic, echocardiographic, procedural, and clinical follow-up data were collected. Seventy-five cases were attempted in patients 80 years of age or older (average age 83.4 ± 2.8 years, 53.3% males). Hypertension, coronary artery disease, and heart failure were present in 96, 41.3, and 36%, respectively. Mean CHADS2 and CHA2DS-VASc scores were 3.3 and 5.2. Devices used included the WATCHMAN, ACP, PLAATO, Lariat, and Coherex devices, which were attempted in 34.7, 36, 17.3, 5.3, and 5.3%, respectively. Overall procedural success, safety endpoint, and 1-year device efficacy was 90.1, 3.9, and 97.4%, respectively. LAA closure is a safe and efficacious method of stroke prevention in the very elderly with AF.

Impact of Gender on the Prognosis of Patients With Nonvalvular Atrial Fibrillation

Treatment guidelines for atrial fibrillation (AF) used in Western countries describe female gender as a risk factor for thromboembolic events in patients with nonvalvular AF (NVAF). The present study aimed to determine the impact of gender on prognosis of Japanese patients with NVAF. A subanalysis of 7,406 patients with NVAF (mean age 70 years) who were followed-up prospectively for 2 years was performed using data from the J-RHYTHM registry. The primary end points were thromboembolic events, major hemorrhaging, total mortality, and cardiovascular mortality. Compared with male subjects (n = 5,241), female subjects (n = 2,165) were older and displayed greater prevalences of paroxysmal AF, heart failure, and hypertension but less prevalences of diabetes, previous cerebral infarction, and coronary artery disease. Male and female patients had mean CHADS2 (Congestive heart failure, Hypertension, Age of 75 years or more, Diabetes mellitus and prior Stroke or transient ischemic attack) scores of 1.6 and 1.8, respectively (p <0.001). Warfarin was given to 87% of male patients and 86% of female patients (p = 0.760), and the 2 genders displayed similar mean international normalized ratio of prothrombin time values at baseline (1.91 vs 1.90, respectively, p = 0.756). Multivariate logistic regression analysis indicated that male gender was an independent risk factor for major hemorrhaging (odds ratio 1.59, 95% confidence interval 1.05 to 2.40, p = 0.027) and all-cause mortality (odds ratio 1.78, 95% confidence interval 1.25 to 2.55, p <0.002) but not for thromboembolic events (odds ratio 1.24, 95% confidence interval 0.83 to 1.86, p = 0.297) or cardiovascular mortality (odds ratio 0.96, 95% confidence interval 0.56 to 1.66, p = 0.893). In conclusion, female gender is not a risk factor for thromboembolic events among Japanese patients with NVAF who were treated mostly with warfarin. However, male gender is a risk factor for major hemorrhaging and all-cause mortality.

Abstract 18489: Predictors of Successful Chemical Cardioversion With Dofetilide in Patients With Persistent Atrial Fibrillation

Introduction: Dofetilide induced cardioversion in persistent atrial fibrillation (AF) patients is not well described. We intended to evaluate the incidence and predictors of chemical cardioversion after initiation of Dofetilide in patients with persistent AF. Methods: We performed a retrospective study including all patients with persistent AF who were admitted for initiation of Dofetilide in our center. Patients in sinus rhythm (SR) at the time of initiation were excluded. All patients were in the hospital for a minimum of 5 doses of the drug. If patients did not convert to SR spontaneously on the drug by the 4 th dose, they underwent electrical cardioversion (DCCV). Results: Of the 305 patients who underwent dofetilide initiation at our center, 195 (64%) persistent AF patients were in AF at the time of the first dose. Mean age of the population was 65 ±9 years with 61 (31%) females. Mean CHADS2 score was 1.7 ±1.0. Median duration of AF was 36 (IQ 12-84) months with a mean LA diameter of 4.6±0.8cm. Mean number of prior failed antiarrhythmic drugs (AAD) was 1.4 ±1.1. Spontaneous conversion to SR occurred in 91 (47%) patients. Patients who converted to SR were much more likely to be females (40% vs 24%; p = 0.020) and had smaller left atrial diameter (4.4 vs 4.7cm; p = 0.023). In multivariate analysis including age, gender, duration of AF, number of prior AADs, LA diameter, heart failure and LVED, the only independent predictor of successful chemical cardioversion was female gender (OR: 2.4; p = 0.022). Conclusion: In patients with persistent AF, female gender is independently associated with successful chemical cardioversion with dofetilide.

Evaluation of Dabigatran Utilization and Risk Among Hospitalized Patients

Few data exist to evaluate the use of dabigatran among hospitalized patients and this population that may be at increased risk for toxicity or reduced efficacy. As such, the objectives of this study were to describe the characteristics of hospitalized patients prescribed dabigatran and to compare select characteristics with patients included in the Randomized Evaluation of Long-Term Anticoagulation (RE-LY) phase III clinical trial. A cross-sectional study was performed at Upstate University Hospital. Select patient characteristics, including age, renal function, and drug interaction exposure, were compared with those for patients in the RE-LY trial. The study included 140 patients. Mean age was 69.7 years (SD = 13.8) and 72 (51.4%) were male. The mean CHADS2 score was 2.48 as compared with 2.2 in RE-LY. Significantly more patients in our study had moderate to severe renal dysfunction (creatinine clearance [CrCl] < 50 mL/min) as compared with the RE-LY trial (27.5% vs 19.4%, P = .0207) when analyzing our study patients' worst recorded CrCl. Among the 29 patients prescribed dose-adjusted dabigatran, 3 were correctly dose adjusted, 2 were overdosed, and 26 were underdosed. At least 1 pharmacokinetic drug interaction with dabigatran occurred in 110 study patients (78.6%). Use of proton pump inhibitors was more predominant in our study population when compared with RE-LY (64.3% vs 13.9%, P < .0001). Hospitalized patients exhibit multiple characteristics that place them at heightened risk for altered dabigatran drug concentrations and may have a heightened risk for clinical sequelae related to dabigatran use.

Ischaemic cardiac outcomes in patients with atrial fibrillation treated with vitamin K antagonism or factor Xa inhibition: results from the ROCKET AF trial

We investigated the prevalence of prior myocardial infarction (MI) and incidence of ischaemic cardiovascular (CV) events among atrial fibrillation (AF) patients. In ROCKET AF, 14 264 patients with nonvalvular AF were randomized to rivaroxaban or warfarin. The key efficacy outcome for these analyses was CV death, MI, and unstable angina (UA). This pre-specified analysis was performed on patients while on treatment. Rates are per 100 patient-years. Overall, 2468 (17%) patients had prior MI at enrollment. Compared with patients without prior MI, these patients were more likely to be male (75 vs. 57%), on aspirin at baseline (47 vs. 34%), have prior congestive heart failure (78 vs. 59%), diabetes (47 vs. 39%), hypertension (94 vs. 90%), higher mean CHADS2 score (3.64 vs. 3.43), and fewer prior strokes or transient ischaemic attacks (46 vs. 54%). CV death, MI, or UA rates tended to be lower in patients assigned rivaroxaban compared with warfarin [2.70 vs. 3.15; hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.73-1.00; P = 0.0509]. CV death, MI, or UA rates were higher in those with prior MI compared with no prior MI (6.68 vs. 2.19; HR 3.04, 95% CI 2.59-3.56) with consistent results for CV death, MI, or UA for rivaroxaban compared with warfarin in prior MI compared with no prior MI (P interaction = 0.10). Prior MI was common and associated with substantial risk for subsequent cardiac events. Patients with prior MI assigned rivaroxaban compared with warfarin had a non-significant 14% reduction of ischaemic cardiac events.