Dual-chamber implantable cardioverter defibrillators reduce clinical adverse events related to atrial fibrillation when compared with single-chamber defibrillators: a subanalysis of the DATAS trial.

AIMS: The aim of the present analysis of the DATAS study was to compare the impact of dual- vs. single-chamber defibrillators on atrial fibrillation (AF) occurrence and AF-related clinical events in patients with Class I indication for implantable cardioverter defibrillators (ICDs) and no indication for dual-chamber pacing. METHODS AND RESULTS: Three hundred and thirty-four patients were randomized, through a centralized assignment, to single-chamber ICDs, dual-chamber ICDs programmed as single-chamber ICDs, and dual ICDs with full diagnostics and AF prevention and therapy capabilities. The latter two groups in the first 8 months of the study, when the study design was that of a randomized parallel trial, were compared in the present analysis. The primary endpoint was composed by the following AF-related clinical events: permanent AF, AF-related hospitalizations, cardiac-embolic events, and inappropriate ICD shocks due to AF misclassification. Two hundred and twenty-three patients were available for this analysis, of whom 111 in the single-chamber-simulated group and 112 in the dual-chamber true group. Atrial fibrillation-related composite endpoint raw incidence was 9 of 111 (8.1%) in the single-chamber group vs. 1 of 112 (0.9%) in the dual-chamber group (P = 0.0098 by Fisher's exact test). Single-chamber ICDs were associated with a significantly higher risk to develop the AF-related composite endpoint by Cox regression analysis (hazard ratio 8.25, 95% CI 1.03-65.96, P = 0.047) and by the Kaplan-Meier survival analysis (log-rank test, P = 0.047). CONCLUSION: Dual-chamber ICDs compared with single-chamber ICDs reduced the incidence of an endpoint composed by permanent AF, AF-related hospitalizations, and ICD shocks deemed inappropriate due to AF misclassification.

Temporal variability of atrial fibrillation in pacemaker recipients for bradycardia: implications for crossover designed trials, study sample size, and identification of responder patients by means of arrhythmia burden.

BACKGROUND: Most clinical trials that have tested pacing therapies to prevent and treat atrial tachyarrhythmias (AT) have chosen endpoints such as AT frequency or burden (defined as percentage of time a patient is in AT), but failed to show unequivocal evidence of a clinical impact. AIM: The aim of our multicenter prospective observational study was to measure the variability of AT burden and estimate its impact on study outcomes. METHODS AND RESULTS: Two hundred and fifty patients indicated for permanent pacing and suffering from AT (age 71 +/- 9 years; 47.2% male) received a dual-chamber pacemaker. AT burden was measured in two consecutive, 2-month observation periods; the Monte Carlo method was then applied to simulate findings of a crossover design study. We simulated several models of therapy impact, each model being characterized by the percentage of responder patients and the percentage reduction in AT burden. To show a significant impact of AT therapies in a sample of 250 patients in whom 100, 75, or 50% would be theoretical responders to therapies, AT burden reduction should be at least 27, 32, or 57%, respectively. Temporal fluctuations in AT burden were so high that about 60% of patients would falsely appear as responders or nonresponders in a crossover study, regardless of AT burden reduction. CONCLUSIONS: In patients paced for bradycardia and suffering from AT, high intrapatient variability in AT burden was measured. Various models of therapy impact showed that, in crossover trials of AT therapies, time-related fluctuations in AT burden negatively impact on sample sizes and impair the ability to identify patients as responders or nonresponders.

Long-term reduction of atrial tachyarrhythmia recurrences in patients paced for bradycardia-tachycardia syndrome.

BACKGROUND: Atrial tachyarrhythmias (AT) are considered progressive diseases. Several rhythm control therapies for treatment of AT have been proposed. OBJECTIVES: The Italian AT500 Registry was designed to prospectively study long-term AT evolution in patients paced for the brady-tachy form of sinus node disease (BT-SND). METHODS: Three hundred forty-six BT-SND patients received an antitachycardia dual-chamber pacemaker and were followed-up for a minimum of 12 months (median 19 months). Prevention and antitachycardia pacing (ATP) features were enabled in all patients. RESULTS: During the observation period, 224 (65%) patients were treated by antiarrhythmic drugs and 45 (13%) patients were cardioverted. Five patients suffered a stroke, 4 transient ischemic attack, 22 permanent AT, and 98 AT recurrences longer than 7 days. AT mean cycle length changed from 246 to 270 ms, and the percentage of patients with AT-related hospitalizations significantly decreased with an annual 28% relative reduction. AT burden and the percentage of patients with AT recurrences longer than 2 days remained constant with time in the overall population but decreased significantly in the subgroup of patients who did not develop permanent AT. High ATP efficacy was associated with an increasingly higher prevention of AT recurrences longer than 2 days. CONCLUSION: In a long-term observation of BT-SND patients, AT-related hospitalizations decreased significantly and mean AT cycle length increased significantly. The data suggest that rhythm control therapies induce inversion of AT progression.