In patients with sinus bradycardia and AT, mean time to first AT recurrence (48.2 days) was significantly longer than time between first and second episode (10.3 days, P<0.01).
Observational (n=240)
Yes
Atrial tachyarrhythmia recurrences in bradycardia patients do not follow a uniform or random distribution, questioning the validity of using time to first recurrence as a clinical outcome in AT therapy trials.
Absolute Event Rate: 48.2% vs 10.3%
p-value: p=<0.01
INTRODUCTION: New-generation pacemakers allow continuous atrial tachyarrhythmia (AT) monitoring that provides accurate information about AT type, frequency, burden, and temporary evolution. METHODS AND RESULTS: We performed a prospective multicenter study to describe AT temporal patterns in patients with sinus bradycardia and AT. Two hundred forty patients (123 men; age 71 +/- 8 years) were implanted with a DDDRP pacemaker (model AT500, Medtronic Inc.). All patients were followed for 13 months. The first-month stabilization period of all patients was discarded from analysis. Seventy percent of patients had AT recurrences. Mean time to first AT recurrence (48.2 days, 95% confidence interval CI 37.0-59.5 days) was significantly longer than the time between first and second AT episode (10.3 days, 95% CI 6.7-13.9 days, P 25 AT episodes and fitted by power law and exponential functions. The best fit was obtained by power law function in 60% of patients, by exponential function in 10%, and the two models gave comparable results in 30% of patients. CONCLUSION: In our population of patients with a history of sinus bradycardia and AT who were implanted with a new device equipped with atrial pacing therapies, 30% did not experience AT recurrences in the 12-month study period. Analysis of interevent time showed that in 60% of patients AT recurrences do not follow a uniform or random distribution. These findings bring into question the use of cross-over design and time to first AT recurrence as a clinical outcome in trials for AT therapy in this patient population.
Ricci et al. (Thu,) conducted a observational in Sinus bradycardia and atrial tachyarrhythmia (n=240). DDDRP pacemaker (model AT500) was evaluated on Mean time to first AT recurrence vs time between first and second AT episode (p=<0.01). In patients with sinus bradycardia and AT, mean time to first AT recurrence (48.2 days) was significantly longer than time between first and second episode (10.3 days, P<0.01).