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Rationale and design of the SPICE study—septal positioning of ventricular ICD electrodes

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Aim

Detrimental effects of right ventricular apical pacing have prompted the search for alternative pacing sites. Data from pacemaker studies suggest that the mid-septum may be a hemodynamically favorable pacing site within the right ventricle. However, data on the safety of implantable cardioverter defibrillator (ICD) lead placement in this location are limited. The aim of the SPICE study is to ascertain that implantation of a ventricular ICD lead at the mid-septum is not inferior to the traditional apical site in terms of feasibility and safety.

Methods

In total, 286 patients with the indication for ICD implantation will be included in the study and stratified in a 1:1 ratio to have the lead placed in the right ventricular apex or the mid-septum. Primary outcome measure of this randomized, prospective study is the event-free survival of lead-related complications at 3 months. The combined end point includes the feasibility to reach the randomized pacing site in combination with the achievement of adequate pacing, sensing, and defibrillation thresholds. Data analysis and sample size calculation are based on a non-inferiority design.

Conclusion

This trial will primarily assess the feasibility, safety, and efficacy of right ventricular ICD lead positioning in the mid-septum compared to the traditional apical position. Documentation of non-inferiority of the novel lead position in terms of applicability and safety will be the prerequisite for potential further trials that may evaluate long-term clinical effects associated with mid-septal lead positions.

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Conflict of interest

The study is financially supported by St. Jude Medical Germany; however, St. Jude Medical did not participate in drafting of the study design. Dr. Christof Kolb has received lecture fees from Biotronik, Boston, Medtronic, Sorin, and St. Jude Medical and is or was an advisor to Biotronik, Sorin, and St. Jude Medical. Dr. Stylianos Tzeis was supported by a training fellowship provided by the European Heart Rhythm Association. Frank Birkenhauer is an employee of St. Jude Medical. All other authors state no conflict of interest, especially no financial relationship to the sponsor of the trial.

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Authors and Affiliations

  1. Deutsches Herzzentrum und 1. Medizinische Klinik rechts der Isar, Faculty of Medicine, Technische Universität München, Munich, Germany

    Christof Kolb, Stylianos Tzeis & Isabel Deisenhofer

  2. Department of Cardiology, Dunant Hospital, Athens, Greece

    Stylianos Tzeis & George Andrikopoulos

  3. Medizinische Klinik III der Universitätsklinik Freiburg, Freiburg, Germany

    Stefan Asbach

  4. Abteilung für Innere Medizin III, Klinikum Lüdenscheid, Lüdenscheid, Germany

    Bernd Lemke

  5. Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem, Göttingen, Germany

    Claudius Hansen

  6. Medizinische Klinik I, Krankenhaus Landshut-Achdorf, Landshut, Germany

    Bernhard Zrenner

  7. St. Jude Medical Germany, Eschborn, Germany

    Frank Birkenhauer

  8. Cardiology Department, Heraklion University Hospital, Heraklion, Greece

    Panos E. Vardas

  9. Deutsches Herzzentrum München, Lazarettstr. 36, 80636, Munich, Germany

    Christof Kolb

Authors
  1. Christof Kolb
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  2. Stylianos Tzeis
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  3. George Andrikopoulos
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  4. Stefan Asbach
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  5. Bernd Lemke
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  6. Claudius Hansen
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  7. Isabel Deisenhofer
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  8. Bernhard Zrenner
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  9. Frank Birkenhauer
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  10. Panos E. Vardas
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Correspondence to Christof Kolb.

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Kolb, C., Tzeis, S., Andrikopoulos, G. et al. Rationale and design of the SPICE study—septal positioning of ventricular ICD electrodes. J Interv Card Electrophysiol 31, 247–254 (2011). https://doi.org/10.1007/s10840-011-9575-z

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  • DOI: https://doi.org/10.1007/s10840-011-9575-z

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