Dietmar Bänsch1, Hendrik Bonnemeier2, Johan Brandt3, Frank Bode4, Jesper Hastrup Svendsen5, Oliver Ritter6, Johannes Aring7, Klaus-Jürgen Gutleben8, Ralph Schneider1, Angelika Felk9, Tino Hauser9, Anika Buchholz10, Gerhard Hindricks11, Karl Wegscheider10. 1. Heart Center Rostock, Department of Internal Medicine I, Divisions of Cardiology, University Hospital Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany. 2. Department of Internal Medicine III Cardiology and Angiology, University Hospital Schleswig-Holstein, Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany. 3. Arrhythmia Department, Skane University Hospital, SE-221 85 Lund, Sweden. 4. Medical Clinic II Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany. 5. Heart Center, Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen and Danish Arrhythmia Research Centre, University of Copenhagen, Blegdamsvej 9, 2100 København Ø, Denmark. 6. Department Cardiology, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany. 7. Department of Internal Medicine I, Divisions of Cardiology, Internal and Intersive Care Medicine, Hospital Leverkusen, Am Gesundheitspark 11, 51375 Leverkusen, Germany. 8. Heart and Diabetes Center North Rhine-Westphalia, University Clinic, Ruhr-University Bochum, Georgstr. 11, 32545 Bad Oeynhausen, Germany. 9. Biotronik, Woermannkehre 1, 12359 Berlin, Germany. 10. Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Martinistr. 52, 20246 Hamburg, Germany. 11. Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.
Abstract
Aims: Dual coil (DC) electrodes are preferred to single coil (SC) electrodes because of an assumed higher shock efficacy. However, DC-electrodes may be associated with an increased difficulty and risk of lead extraction. We aimed to compare SC- and DC-electrodes with respect to the first shock efficacy (FSE) after implantable cardioverter defibrillator (ICD) implantation. Methods and results: One thousand and seventy-seven patients of the NORDIC ICD trial were randomly assigned to first time ICD implantation with or without defibrillation (DF) testing. The electrode configuration was determined before randomization. One thousand and sixty-seven patients eventually received an ICD, 516 (48.4%) with a SC- and 551 (51.6%) with a DC-electrode. DC-electrodes were preferentially selected in older patients, renal failure, atrial fibrillation, dual chamber, Cardiac Resynchronization Therapy (CRT) devices, angiotensin-converting-enzyme (ACE) inhibitors/angiotensin (AT) receptor blockers and without Sotalol. However, the preference of the investigational site was dominant over clinical parameters. The DF energy at the final electrode position was higher in SC-electrodes (adjusted difference +1.15 J; P = 0.005; only patients tested). Less patients with DC-electrodes required intra-operative system reconfiguration (adjusted difference -3.9; P = 0.046; only patients tested). Using mixed logistic regression, the FSE was 92.6% in SC- and 97.8% in DC-electrodes (adjusted odds ratio 4.3 (95% confidence interval [1.9, 9.8]; P < 0.001)). Conclusion: Dual coil-electrode selection mainly depends on the preference of the investigational site and seems to be preferred in older patients, renal failure, atrial fibrillation, dual chamber, and CRT devices. Patients with DC-electrodes required less intraoperative system reconfigurations. Dual coil-electrodes provided a substantially higher FSE during follow-up. Mortality rates were not significantly different in patients with DC- and SC-electrodes.
RCT Entities:
Aims: Dual coil (DC) electrodes are preferred to single coil (SC) electrodes because of an assumed higher shock efficacy. However, DC-electrodes may be associated with an increased difficulty and risk of lead extraction. We aimed to compare SC- and DC-electrodes with respect to the first shock efficacy (FSE) after implantable cardioverter defibrillator (ICD) implantation. Methods and results: One thousand and seventy-seven patients of the NORDIC ICD trial were randomly assigned to first time ICD implantation with or without defibrillation (DF) testing. The electrode configuration was determined before randomization. One thousand and sixty-seven patients eventually received an ICD, 516 (48.4%) with a SC- and 551 (51.6%) with a DC-electrode. DC-electrodes were preferentially selected in older patients, renal failure, atrial fibrillation, dual chamber, Cardiac Resynchronization Therapy (CRT) devices, angiotensin-converting-enzyme (ACE) inhibitors/angiotensin (AT) receptor blockers and without Sotalol. However, the preference of the investigational site was dominant over clinical parameters. The DF energy at the final electrode position was higher in SC-electrodes (adjusted difference +1.15 J; P = 0.005; only patients tested). Less patients with DC-electrodes required intra-operative system reconfiguration (adjusted difference -3.9; P = 0.046; only patients tested). Using mixed logistic regression, the FSE was 92.6% in SC- and 97.8% in DC-electrodes (adjusted odds ratio 4.3 (95% confidence interval [1.9, 9.8]; P < 0.001)). Conclusion: Dual coil-electrode selection mainly depends on the preference of the investigational site and seems to be preferred in older patients, renal failure, atrial fibrillation, dual chamber, and CRT devices. Patients with DC-electrodes required less intraoperative system reconfigurations. Dual coil-electrodes provided a substantially higher FSE during follow-up. Mortality rates were not significantly different in patients with DC- and SC-electrodes.