The antiarrhythmic drug dronedarone was compared with placebo in 4628 patients with atrial fibrillation. At a mean follow-up of 21 months, the rate of first hospitalization due to cardiovascular ...events or death was significantly lower with dronedarone than with placebo. The dronedarone group had higher rates of bradycardia, QT-interval prolongation, nausea, diarrhea, rash, and increase in the serum creatinine level.
The antiarrhythmic drug dronedarone was compared with placebo in patients with atrial fibrillation. At a mean follow-up of 21 months, the rate of first hospitalization due to cardiovascular events or death was significantly lower with dronedarone.
Atrial fibrillation is the most common type of cardiac arrhythmia requiring medical care, with a prevalence of almost 1% in the adult population in the United States.
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Its prevalence increases with age, affecting 3.8% of the U.S. population over 60 years of age and 9.0% of the population older than 80 years. Over the past two decades, hospitalizations for atrial fibrillation in the United States have increased by a factor of two to three, resulting in a substantial public health burden.
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Despite advances in nonpharmacologic therapy,
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many symptomatic patients receive medical treatment for rhythm control. Currently available antiarrhythmic agents are . . .
In this multicenter, randomized trial comparing early rhythm control with usual care in patients with early atrial fibrillation and cardiovascular conditions, early rhythm control reduced the rate of ...death from cardiovascular causes and cardiovascular complications and did not affect the number of nights in the hospital.
This clinical trial of outcomes in patients with atrial fibrillation showed that lenient rate control (resting heart rate, <110 beats per minute) was not inferior to strict rate control (resting ...heart rate, <80 beats per minute). On the basis of the results, strict rate control may be abandoned as a therapeutic strategy in many patients with permanent atrial fibrillation.
In patients with atrial fibrillation, lenient rate control (resting heart rate, <110 beats per minute) was not inferior to strict rate control (resting heart rate, <80 beats per minute).
Atrial fibrillation is not a benign condition.
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It may cause symptoms and is associated with stroke and heart failure. Previous studies have established that the rates of complications and death were similar in patients with atrial fibrillation receiving rate-control therapy and in those receiving rhythm-control therapy.
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Therefore, rate control has become front-line therapy in the management of atrial fibrillation. The optimal level of heart-rate control, however, is unknown, as is whether strict rate control is associated with an improved prognosis as compared with a more lenient approach.
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Guidelines, though empirical and not evidence-based, recommend the use of strict . . .
In two multicenter, randomized trials, the antiarrhythmic agent dronedarone was compared with placebo for the maintenance of sinus rhythm in patients with atrial fibrillation. With pooled data from ...the two trials, the median time to the recurrence of atrial fibrillation was 116 days in the dronedarone group and 53 days in the placebo group.
With pooled data from two trials, the median time to the recurrence of atrial fibrillation was 116 days in the dronedarone group and 53 days in the placebo group.
Atrial fibrillation is the most common arrhythmia requiring hospitalization.
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Although arrhythmia-related symptoms and thromboembolic strokes are significantly reduced by anticoagulation therapy and rate control, sinus rhythm is often associated with improvement in exercise capacity and quality of life.
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Therefore, restoration and maintenance of sinus rhythm remain major therapeutic goals for patients with atrial fibrillation.
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Amiodarone is an especially potent atrial antifibrillatory agent,
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but it induces potentially serious side effects in some patients.
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Thus, compounds that are devoid of such effects but that retain the antiarrhythmic potential of amiodarone are therapeutically desirable.
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Dronedarone is a benzofuran derivative . . .
In a randomized trial involving patients with advanced heart failure and atrial fibrillation, catheter ablation decreased the risk of cardiovascular events at a median of 18 months.
ASSERT demonstrated that subclinical atrial fibrillation (SCAF) is common in pacemaker patients without prior AF and is associated with increased risk of ischemic stroke or systemic embolism. SCAF ...episodes vary in duration and little is known about the incidence of different durations of SCAF, or their prognosis.
ASSERT followed 2580 patients receiving a pacemaker or ICD, aged >65 years with hypertension, without prior AF. The effect of SCAF duration on subsequent risk of ischemic stroke or embolism was evaluated with time-dependent covariate Cox models. Patients in whom the longest SCAF was ≤6 min were excluded from the analysis (n=125). Among 2455 patients during mean follow-up of 2.5 years, the longest single episode of SCAF lasted >6 min to 6 h in 462 patients (18.8%), >6-24 h in 169 (6.9%), and >24 h in 262 (10.7%). SCAF duration >24 h was associated with a significant increased risk of subsequent stroke or systemic embolism (adjusted hazard ratio HR 3.24, 95% confidence interval CI 1.51-6.95, P=0.003). The risk of ischemic stroke or systemic embolism in patients with SCAF between 6 min and 24 h was not significantly different from patients without SCAF.
SCAF >24 h is associated with an increased risk of ischemic stroke or systemic embolism.
In chronic heart failure (CHF), reduced vagal activity correlates with increased mortality and acute decompensation. Experimentally, chronic vagus nerve stimulation (VNS) improved left ventricular ...(LV) function and survival; clinically, it is used for the treatment of drug-refractory epilepsy. We assessed safety and tolerability of chronic VNS in symptomatic CHF patients, using a novel implantable nerve stimulation system. The secondary goal was to obtain preliminary data on clinical efficacy.
This multi-centre, open-label phase II, two-staged study (8-patient feasibility phase plus 24-patient safety and tolerability phase) enrolled 32 New York Heart Association (NYHA) class II-IV patients age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8%. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 2-4 weeks after implant, slowly raising intensity; patients were followed 3 and 6 months thereafter with optional 1-year follow-up. Overall, 26 serious adverse events (SAEs) occurred in 13 of 32 patients (40.6%), including three deaths and two clearly device-related AEs (post-operative pulmonary oedema, need of surgical revision). Expected non-serious device-related AEs (cough, dysphonia, and stimulation-related pain) occurred early but were reduced and disappeared after stimulation intensity adjustment. There were significant improvements (P < 0.001) in NYHA class quality of life, 6-minute walk test (from 411 ± 76 to 471 ± 111 m), LVEF (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year.
This open-label study shows that chronic VNS in CHF patients with severe systolic dysfunction may be safe and tolerable and may improve quality of life and LV function. A controlled clinical trial appears warranted.
The EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot) provides systematic collection of contemporary data regarding the management and treatment of ...3119 subjects with AF from 9 member European Society of Cardiology (ESC) countries. In this analysis, we report the development of symptoms, use of antithrombotic therapy and rate vs. rhythm strategies, as well as determinants of mortality and/or stroke/transient ischaemic attack (TIA)/peripheral embolism during 1-year follow-up in this contemporary European registry of AF patients.
The registry population comprised consecutive in- and out-patients with AF presenting to cardiologists in participating ESC countries. Consecutive patients with AF documented by ECG were enrolled. Follow-up was performed by the local investigator, initially at 1 year, as part of a long-term cohort study.
At the follow-up, patients were frequently asymptomatic (76.8%), but symptoms are nevertheless common among paroxysmal and persistent AF patients, especially palpitations, fatigue, and shortness of breath. Oral anticoagulant (OAC) use remains high, ∼78% overall at follow-up, and of those on vitamin K antagonist (VKA), 84% remained on VKA during the follow-up, while of those on non-VKA oral anticoagulant (NOAC) at baseline, 86% remained on NOAC, and 11.8% had changed to a VKA and 1.1% to antiplatelet therapy. Digitalis was commonly used in paroxysmal AF patients. Of rhythm control interventions, electrical cardioversion was performed in 9.7%, pharmacological cardioversion in 5.1%, and catheter ablation in 4.4%. Despite good adherence to anticoagulation, 1-year mortality was high (5.7%), with most deaths were cardiovascular (70%). Hospital readmissions were common, especially for atrial tachyarrhythmias and heart failure. On multivariate analysis, independent baseline predictors for mortality and/or stroke/TIA/peripheral embolism were age, AF as primary presentation, previous TIA, chronic kidney disease, chronic heart failure, malignancy, and minor bleeding. Independent predictors of mortality were age, chronic kidney disease, AF as primary presentation, prior TIA, chronic obstructive pulmonary disease, malignancy, minor bleeding, and diuretic use. Statin use was predictive of lower mortality.
In this 1-year follow-up analysis of the EORP-AF pilot general registry, we provide data on the first contemporary registry focused on management practices among European cardiologists, conducted since the publication of the new ESC guidelines. Overall OAC use remains high, although persistence with therapy may be problematic. Nonetheless, continued OAC use was more common than in prior reports. Despite the high prescription of OAC, 1-year mortality and morbidity remain high in AF patients, particularly from heart failure and hospitalizations.
Even on optimal therapy, many patients with heart failure and atrial fibrillation experience cardiovascular complications. Additional treatments are needed to reduce these events, especially in ...patients with heart failure and preserved left ventricular ejection fraction.
This prespecified subanalysis of the randomized EAST-AFNET4 trial (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) assessed the effect of systematic, early rhythm control therapy (ERC; using antiarrhythmic drugs or catheter ablation) compared with usual care (allowing rhythm control therapy to improve symptoms) on the 2 primary outcomes of the trial and on selected secondary outcomes in patients with heart failure, defined as heart failure symptoms New York Heart Association II to III or left ventricular ejection fraction LVEF <50%.
This analysis included 798 patients (300 37.6% female, median age 71.0 64.0, 76.0 years, 785 with known LVEF). The majority of patients (n=442) had heart failure and preserved LVEF (LVEF≥50%; mean LVEF 61±6.3%), the others had heart failure with midrange ejection fraction (n=211; LVEF 40%-49%; mean LVEF 44 ± 2.9%) or heart failure with reduced ejection fraction (n=132; LVEF<40%; mean LVEF 31±5.5%). Over the 5.1-year median follow-up, the composite primary outcome of cardiovascular death, stroke, or hospitalization for worsening of heart failure or for acute coronary syndrome occurred less often in patients randomly assigned to ERC (94/396; 5.7 per 100 patient-years) compared with patients randomly assigned to usual care (130/402; 7.9 per 100 patient-years; hazard ratio, 0.74 0.56-0.97;
=0.03), not altered by heart failure status (interaction
value=0.63). The primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) occurred in 71 of 396 (17.9%) patients with heart failure randomly assigned to ERC and in 87 of 402 (21.6%) patients with heart failure randomly assigned to usual care (hazard ratio, 0.85 0.62-1.17;
=0.33). LVEF improved in both groups (LVEF change at 2 years: ERC 5.3±11.6%, usual care 4.9±11.6%,
=0.43). ERC also improved the composite outcome of death or hospitalization for worsening of heart failure.
Rhythm control therapy conveys clinical benefit when initiated within 1 year of diagnosing atrial fibrillation in patients with signs or symptoms of heart failure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01288352. URL: http://www.controlled-trials.com; Unique identifier: ISRCTN04708680. URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2010-021258-20.
Patients presenting within 36 hours after the onset of atrial fibrillation were randomly assigned to undergo early cardioversion or to receive rate-control medication followed by delayed ...cardioversion within 48 hours if there was no conversion to sinus rhythm. The wait-and-see approach was noninferior to early cardioversion for the primary outcome of sinus rhythm at 4 weeks.
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