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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.
Figure 4: Kaplan–Meier analysis of event-free survival to first delivered therapy for appropriate (A) or inappropriate episodes (B). (Reprinted from Gasparini M, Menozzi C, Proclemer A, et al. 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. Eur Heart J. 2009;30:2758-2767, with permission from The European Society of Cardiology.)
Figure 5: Kaplan–Meier analysis of event-free survival to first heart failure hospitalizations. (Reprinted from Gasparini M, Menozzi C, Proclemer A, et al. 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. Eur Heart J. 2009;30:2758-2767, with permission from The European Society of Cardiology.)
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