Christof Kolb1, Ulrich Solzbach2, Jürgen Biermann3, Verena Semmler4, Axel Kloppe5, Norbert Klein6, Carsten Lennerz4, Istvan Szendey7, George Andrikopoulos8, Stylianos Tzeis9, Stefan Asbach3. 1. Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany. Electronic address: kolb@dhm.mhn.de. 2. Ostalbklinikum, Abteilung für Innere Medizin II, Aalen, Germany. 3. Heart Centre Freiburg University, Department of Cardiology and Angiology I, Freiburg, Germany. 4. Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany. 5. Klinikum Lüdenscheid, Abteilung für Innere Medizin III, Lüdenscheid, Germany; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik II, Ruhr Universität Bochum, Bochum, Germany. 6. Universitätsklinikum Leipzig, Medizinische Klinik I, Leipzig, Germany. 7. Kliniken Maria Hilf, Klinik für Kardiologie, Mönchengladbach, Germany. 8. Henry Dunant Hospital, Department of Cardiology, Athens, Greece. 9. Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany; Henry Dunant Hospital, Department of Cardiology, Athens, Greece.
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.
RCT Entities:
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.
Authors: Alexander P Benz; Mate Vamos; Julia W Erath; Peter Bogyi; Gabor Z Duray; Stefan H Hohnloser Journal: Clin Res Cardiol Date: 2018-05-24 Impact factor: 5.460
Authors: Johann Christoph Geller; Armin Wöhrle; Mathias Busch; Albrecht Elsässer; Thomas Kleemann; Frank Birkenhauer; Peter Bramlage; Christian Veltmann Journal: J Interv Card Electrophysiol Date: 2020-07-14 Impact factor: 1.900