Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients — Results of the SPICE ( S eptal P ositioning of ventricular IC D E lectrodes) study

Abstract Background Detrimental effects of right ventricular (RV) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum. As safety data are scarce for implantable cardioverter defibrillator (ICD) recipients the study aims to evaluate ICD lead performance...

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Bibliographic Details
Published in:International journal of cardiology 2014-07, Vol.174 (3), p.713-720
Main Authors: Kolb, Christof, Solzbach, Ulrich, Biermann, Jürgen, Semmler, Verena, Kloppe, Axel, Klein, Norbert, Lennerz, Carsten, Szendey, Istvan, Andrikopoulos, George, Tzeis, Stylianos, Asbach, Stefan
Format: Article
Language:English
Subjects:
Aged
Alternative pacing site
Biological and medical sciences
Cardiology. Vascular system
Cardiovascular
Defibrillation threshold
Defibrillators, Implantable - adverse effects
Defibrillators, Implantable - trends
Disease-Free Survival
Electrodes, Implanted - adverse effects
Electrodes, Implanted - trends
Female
Follow-Up Studies
Heart
Heart Ventricles - diagnostic imaging
Heart Ventricles - surgery
Humans
Implantable cardioverter defibrillator
Male
Medical sciences
Mid-septum
Middle Aged
Radiography
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Safety
Single-Blind Method
Ventricular Septum - diagnostic imaging
Ventricular Septum - surgery
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Summary:Abstract Background Detrimental effects of right ventricular (RV) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum. As safety data are scarce for implantable cardioverter defibrillator (ICD) recipients the study aims to evaluate ICD lead performance in the mid-septal position. Methods and results A total of 299 ICD recipients (79% male, aged 65.2 ± 12.1 years, 83% primary prevention of sudden cardiac death) were randomized to receive the RV ICD electrode either in a mid-septal (n = 145) or apical (n = 154) location. Event-free survival was evaluated at 3 (primary endpoint) and 12 months (secondary endpoint). Events included a composite of lead revision, suboptimal right ventricular electrode performance (including defibrillation thresholds (DFT) > 25 J) or lead position not in accordance with randomized location. Event-free survival at 3 (12) months was observed in 80.6% (72.3%) of patients randomized to a mid-septal and in 82.2% (72.1%) of patients randomized to an apical lead position, p = 0.726 (p = 0.969). Pre-defined margins for non-inferiority were not reached at 3 or 12 months. High DFT was found in 7 patients (5.0%) of the mid-septal and in 3 (2.2%) patients of the apical group (p = 0.209). Conclusion In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision, suboptimal right ventricular electrode performance or non-randomized lead position. Non-inferiority of the mid-septal lead location cannot be concluded. This should be taken into consideration when a mid-septal lead position is pursued. Clinical trial registration ClinicalTrials.gov identifier NCT00745745.
ISSN:0167-5273
1874-1754
DOI:10.1016/j.ijcard.2014.04.229