TRIAL FIBRILLATION (AF) REPresents an important public health problem. Patients with AF have an increased longterm risk of stroke, heart failure, and all-cause mortality. [1][2][3][4] Furthermore, patients with AF describe a considerably impaired quality of life (QOL) that is independent of the severity of the disease. 5,6 Restoration and maintenance of normal sinus rhythm following treat-ment directly correlates with improved QOL in these patients. [5][6][7][8] Although antiarrhythmic drugs are generally used as first-line therapy to treat patients with AF, effectiveness remains inconsistent. The likelihood of AF recurrence within 6 to 12 months approaches 50% with most drugs. [9][10][11] Antiarrhythmic drugs are also associ-ated with cumulative adverse effects over time. 1 Catheter ablation has accordingly become an alternative therapy for AF. 12 Several recent studies have See also Patient Page.
In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).
T ranscatheter ablation represents a valid treatment option in patients with drug-refractory symptomatic atrial fibrillation (AF). 1 The majority of catheter ablation trials have mainly enrolled patients with preserved left ventricular (LV) systolic function. In these patients, the ablative treatment has been shown to be effective in reducing morbidity, 2-4 improving the quality of life (QoL), [3][4][5][6] and improving functional capacity. 5-7Background-Whether catheter ablation (CA) is superior to amiodarone (AMIO) for the treatment of persistent atrial fibrillation (AF) in patients with heart failure is unknown. Methods and Results-Thiswas an open-label, randomized, parallel-group, multicenter study. Patients with persistent AF, dualchamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, New York Heart Association II to III, and left ventricular ejection fraction <40% within the past 6 months were randomly assigned (1:1 ratio) to undergo CA for AF (group 1, n=102) or receive AMIO (group 2, n=101). Recurrence of AF was the primary end point. All-cause mortality and unplanned hospitalization were the secondary end points. Patients were followed up for a minimum of 24 months. At the end of follow-up, 71 (70%; 95% confidence interval, 60%-78%) patients in group 1 were recurrence free after an average of 1.4±0.6 procedures in comparison with 34 (34%; 95% confidence interval, 25%-44%) in group 2 (log-rank P<0.001). The success rate of CA in the different centers after a single procedure ranged from 29% to 61%. After adjusting for covariates in the multivariable model, AMIO therapy was found to be significantly more likely to fail (hazard ratio, 2.5; 95% confidence interval, 1.5-4.3; P<0.001) than CA. Over the 2-year follow-up, the unplanned hospitalization rate was (32 [31%] in group 1 and 58 [57%] in group 2; P<0.001), showing 45% relative risk reduction (relative risk, 0.55; 95% confidence interval, 0.39-0.76). A significantly lower mortality was observed in CA (8 [8%] versus AMIO (18 [18%]; P=0.037). Conclusions-This multicenter randomized study shows that CA of AF is superior to AMIO in achieving freedom from AF at long-term follow-up and reducing unplanned hospitalization and mortality in patients with heart failure and persistent AF. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729911. However, a significant number of patients with AF also have LV systolic dysfunction. AF and heart failure (HF) frequently coexist and are often associated with several common predisposing risk factors such as hypertension, coronary artery disease, structural heart disease (nonischemic, valvular), diabetes mellitus, obesity, and obstructive sleep apnea . 8,9 Importantly, the prevalence of AF increases with HF severity, ranging from 5% in functional class I patients to ≈50% in class IV patients.Also, the prevalence of HF in patients with AF has been estimated at 42%. 8 The combination of HF and AF leads to deleterious hemodynamic and symp...
BACKGROUND-For patients who have a ventricular tachyarrhythmic event, implantable cardioverter-defibrillators (ICDs) are a mainstay of therapy to prevent sudden death. However, ICD shocks are painful, can result in clinical depression, and do not offer complete protection against death from arrhythmia. We designed this randomized trial to examine whether prophylactic radiofrequency catheter ablation of arrhythmogenic ventricular tissue would reduce the incidence of ICD therapy.
clinicaltrials.gov Identifier: NCT00129545.
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