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European Heart Journal Advance Access originally published online on December 6, 2004
European Heart Journal 2005 26(2):165-172; doi:10.1093/eurheartj/ehi059
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European Heart Journal vol. 26 no. 2 © The European Society of Cardiology 2004; all rights reserved.

Temporal variability of atrial tachyarrhythmia burden in bradycardia–tachycardia syndrome patients

Luigi Padeletti1,*, Massimo Santini2, Giuseppe Boriani3, GianLuca Botto4, Alessandro Capucci5, Michele Gulizia6, Renato Ricci2, Andrea Spampinato7, Paolo Pieragnoli1, Eduardo Warman8,{dagger}, Marco Vimercati9,{ddagger} and Andrea Grammatico9,{ddagger}

1Institute of Internal Medicine and Cardiology, University of Florence, Viale Morgagni 85, 50134 Florence, Italy
2Institute of Cardiology, S.Filippo Neri Hospital, Rome, Italy
3Institute of Cardiology, University of Bologna, Bologna, Italy
4Institute of Cardiology, S.Anna Hospital, Como, Italy
5Institute of Cardiology, Civile Hospital, Piacenza, Italy
6Institute of Cardiology, S.Luigi-S.Currò Hospital, Catania, Italy
7Institute of Cardiology, Villa Tiberia Hospital, Rome, Italy
8Medtronic Inc., Minneapolis, MN, USA
9Medtronic Italy, Milan, Italy

Received 26 July 2004; revised 25 August 2004; accepted 16 September 2004; online publish-ahead-of-print 6 December 2004.

* Corresponding author. Tel: +39 554277634; fax: +39 554378638. E-mail address: lpadeletti{at}interfree.it

See page 110 for the editorial comment on this article (doi:10.1093/eurheartj/ehi056)

Aims Several studies have tested non-pharmacological therapies for atrial tachyarrhythmias (ATs) by measuring the cumulative time (burden) the patient spends in arrhythmia. Contradictory results questioned either therapy efficacy or statistical power of the trials. We studied AT burden variability in patients paced for sinus node disease (SND) in order to interpret currently published data appropriately and to evaluate reliable sample sizes.

Methods and results One hundred and five patients with AT and SND received a dual chamber pacemaker with antitachyarrhythmia-pacing capability, and were followed for 13 months. Seventy-eight patients (74%) suffered AT recurrences. Device-gathered diagnostic measures were used to simulate results of randomized studies both with crossover and parallel design. The sample size required for statistically significant results was calculated as a function of the expected therapy-induced burden reduction. AT burden intra-patient variability was high: 43% of patients showed intrinsic fluctuations hiding any therapy-induced burden reduction lower than 30%. Demonstrating therapeutic breakthrough through a 6 month study would require 290 patients with crossover design and 5800 patients with parallel design. Doubling the study period requires 400 and 3000 patients, respectively.

Conclusion Patients with AT and paced for SND showed high intra-patient burden variability, which could possibly hide an AT burden reduction induced by a therapy. Previous studies involving non-pharmacological therapies utilizing AT burden endpoints could lack the power to reach statistical significance.

Key Words: Tachyarrhythmia • Atrial fibrillation • Non-pharmacological therapies • Pacing • Sample size • Trials


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