Kolb Christof, Solzbach Ulrich, Biermann Jürgen, Semmler Verena, Kloppe Axel, Klein Norbert, Lennerz Carsten, Szendey Istvan, Andrikopoulos George, Tzeis Stylianos, Asbach Stefan
Deutsches Herzzentrum, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany.
Ostalbklinikum, Abteilung für Innere Medizin II, Aalen, Germany.
Int J Cardiol. 2014 Jul 1;174(3):713-20. doi: 10.1016/j.ijcard.2014.04.229. Epub 2014 Apr 26.
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.
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).
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.
ClinicalTrials.gov identifier NCT00745745.
右心室心尖部起搏的有害影响已使人们将兴趣转向其他起搏部位，如右心室中隔部。由于针对植入式心脏复律除颤器（ICD）接受者的安全性数据较少，本研究旨在评估ICD导线在中隔部位置的性能。
总共299例ICD接受者（79%为男性，年龄65.2±12.1岁，83%为心脏性猝死一级预防）被随机分为两组，分别将右心室ICD电极置于中隔部（n=145）或心尖部（n=154）。在3个月（主要终点）和12个月（次要终点）时评估无事件生存率。事件包括导线翻修、右心室电极性能欠佳（包括除颤阈值（DFT）>25 J）或导线位置不符合随机分组位置的综合情况。随机分配至中隔部导线位置的患者中，3个月（12个月）时的无事件生存率为80.6%（72.3%），随机分配至心尖部导线位置的患者中这一比例为82.2%（72.1%），p=0.726（p=0.969）。在3个月或12个月时未达到预先定义的非劣效性边界。中隔部组7例（5.0%）患者和心尖部组3例（2.2%）患者出现高DFT（p=0.209）。
在ICD接受者中，将电极置于右心室中隔部或右心室心尖部，在导线无需翻修、右心室电极性能欠佳或导线位置未随机化方面的生存率略有不同。不能得出中隔部导线位置具有非劣效性的结论。在考虑采用中隔部导线位置时应予以考虑。
ClinicalTrials.gov标识符NCT00745745。
