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European Heart Journal Advance Access published online on June 29, 2009

European Heart Journal, doi:10.1093/eurheartj/ehp247
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study

Maurizio Gasparini1,*, Carlo Menozzi2, Alessandro Proclemer3, Maurizio Landolina4, Severio Iacopino5, Angelo Carboni6, Ernesto Lombardo7, François Regoli1, Mauro Biffi8, Valeria Burrone9, Alessandra Denaro9 and Giuseppe Boriani8

1 Department of Cardiology, IRCCS Istituto Clinico Humanitas, Via Manzoni, 56, Rozzano (MI) IT-2089, Italy
2 S. Maria Nuova Hospital, Reggio Emilia, Italy
3 Az. Ospedaliera S.Maria della Misericordia, Udine, Italy
4 Policlinico San Matteo, Pavia, Italy
5 Villa S. Anna S.p.A., Catanzaro, Italy
6 Azienda Ospedaliera Universitaria, Parma, Italy
7 Villa Maria Eleonora S.r.l., Palermo, Italy
8 Policlinico Sant'Orsola-Malpighi, Bologna, Italy
9 Medtronic, Italy

Received 16 January 2009; revised 10 April 2009; accepted 2 June 2009 * Corresponding author. Tel: +39 0282244622, Fax: +39 0282244693, Email: maurizio.gasparini{at}humanitas.it

Aims: To investigate the efficacy and safety of a cardiac resynchronization therapy with cardioverter–defibrillator (CRT-D) device with simplified ventricular tachycardia management in patients with non-ischaemic heart failure (HF) and primary prevention implantable cardioverter defibrillator (ICD) indication.

Methods and results: Prospective, controlled, parallel, multicentre, non-randomized study enrolling 324 primary prevention non-ischaemic HF patients implanted with CRT-D devices from 2004 to 2007: Protect group, 164 patients implanted with a Medtronic Insync III Protect device and Control group, 160 patients utilizing other Medtronic CRT-D devices.

Efficacy was assessed by computing appropriate and inappropriate detections and therapies during follow-up; safety compared hospitalizations and syncopal events between groups. Ninety per cent of both ventricular and supraventricular tachyarrhythmias terminated within the 13–29 beat detection interval with the Protect algorithm. The Protect group showed a significantly better event-free survival to first delivered therapy for total (P = 0.0001), appropriately treated (P = 0.002), and inappropriately treated episodes (P = 0.017). The total number of delivered shocks was significantly lower in the Protect group (22 vs. 59, P < 0.0001). In the Protect group, a significantly reduced HF hospitalization (hazard ratio 0.38, 95% CI 0.15–0.98, P = 0.044) was observed without any increase of syncope or death.

Conclusion: A simplified CRT-D device with fixed long detection reduced overall ICD therapy burden and HF hospitalizations without entailing any additional adverse events in primary prevention non-ischaemic HF patients.

Key Words: Cardiac resynchronization therapy • Implantable • Defibrillators • Non-ischaemic • Tachyarrhythmias


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