Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients--results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study.
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.


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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov identifier NCT00745745.
Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany. Electronic address: kolb@dhm.mhn.de.
Christof
C
Kolb
Ostalbklinikum, Abteilung für Innere Medizin II, Aalen, Germany.
Ulrich
U
Solzbach
Heart Centre Freiburg University, Department of Cardiology and Angiology I, Freiburg, Germany.
Jürgen
J
Biermann
Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany.
Verena
V
Semmler
Klinikum Lüdenscheid, Abteilung für Innere Medizin III, Lüdenscheid, Germany; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik II, Ruhr Universität Bochum, Bochum, Germany.
Axel
A
Kloppe
Universitätsklinikum Leipzig, Medizinische Klinik I, Leipzig, Germany.
Norbert
N
Klein
Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany.
Carsten
C
Lennerz
Kliniken Maria Hilf, Klinik für Kardiologie, Mönchengladbach, Germany.
Istvan
I
Szendey
Henry Dunant Hospital, Department of Cardiology, Athens, Greece.
George
G
Andrikopoulos
Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany; Henry Dunant Hospital, Department of Cardiology, Athens, Greece.
Stylianos
S
Tzeis
Heart Centre Freiburg University, Department of Cardiology and Angiology I, Freiburg, Germany.
Stefan
S
Asbach
D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000639:trends*; D018572:Disease-Free Survival; D004567:Electrodes, Implanted / Q000009:adverse effects* / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000000981:diagnostic imaging* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011859:Radiography; D016037:Single-Blind Method; D054088:Ventricular Septum / Q000000981:diagnostic imaging* / Q000601:surgery
Alternative pacing site; Defibrillation threshold; Implantable cardioverter defibrillator; Mid-septum; Safety