TY - JOUR
T1 - Atrial Tachyarrhythmia Recurrence Temporal Patterns in Bradycardia Patients Implanted with Antitachycardia Pacemakers
AU - Ricci, Renato
AU - Santini, Massimo
AU - Padeletti, Luigi
AU - Boriani, Giuseppe
AU - Capucci, Alessandro
AU - Botto, Gianluca
AU - Gulizia, Michele
AU - Inama, Giuseppe
AU - Galati, Antonio
AU - Solimene, Francesco
AU - Pepe, Massimilano
AU - Grammatico, Andrea
PY - 2004/1
Y1 - 2004/1
N2 - 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 <0.01). A minority of patients had a uniform time distribution of AT recurrences: 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.
AB - 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 <0.01). A minority of patients had a uniform time distribution of AT recurrences: 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.
KW - Atrial fibrillation
KW - Atrial tachyarrhythmia recurrences
KW - Clinical trial design
KW - Exponential function
KW - Pacemaker
KW - Pacing
KW - Power law function
KW - Statistical modeling
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U2 - 10.1046/j.1540-8167.2004.03317.x
DO - 10.1046/j.1540-8167.2004.03317.x
M3 - Article
C2 - 15028071
AN - SCOPUS:9144273733
SN - 1045-3873
VL - 15
SP - 44
EP - 51
JO - Journal of Cardiovascular Electrophysiology
JF - Journal of Cardiovascular Electrophysiology
IS - 1
ER -