Schwab Jörg Otto, Bonnemeier Hendrik, Kleemann Thomas, Brachmann Johannes, Fischer Sven, Birkenhauer Frank, Eberhardt Frank
Cardiology, Beta Klinik, Joseph-Schumpeter-Allee 15, Bonn, 53227, Germany.
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Innere Medizin III, Kiel, Germany.
Clin Res Cardiol. 2015 Dec;104(12):1021-32. doi: 10.1007/s00392-015-0870-z. Epub 2015 May 23.
A significant number of patients with an implantable cardioverter/defibrillator (ICD) for primary prevention receive inappropriate shocks. Previous studies have reported a reduction of inappropriate therapies with simple modifications of ICD detection settings, however, inclusion criteria and settings varied markedly between studies. Our aim was to investigate the effect of raising the ICD detection zone in the entire primary prevention ICD population.
543 patients receiving an ICD for primary prevention were randomized to either conventional or progressive ICD programming. The detection rate was programmed at 171 bpm for ventricular tachycardia (VT) and 214 bpm for ventricular fibrillation (VF) in the Conventional group and 187 bpm for VT and 240 bpm for VF in the Progressive group. 43 % of patients received single-chamber and 57 % dual-chamber detection devices (DDD-ICD 19 %; CRT-D 38 %). The primary endpoint consisted of inappropriate therapies and untreated VT/VF. The primary endpoint was reached in 35 patients (13 %) in the Conventional group and 17 patients (6 %) in the Progressive group (p = 0.004). Progressive ICD programming led to significantly fewer amount of patients with ICD therapies (26 vs. 14 %; p < 0.001) and shocks (11 vs. 5 %; p = 0.023) compared to conventional ICD programming. Sub-analyses showed the greatest reduction of inappropriate therapies and shocks in dual-chamber detection devices with progressive compared to single-chamber detection devices with conventional ICD programming (p < 0.001).
Progressive ICD programming reduces the number of inappropriate therapies and shocks in a broad primary prevention ICD population particularly in combination with dual-chamber detection algorithms.
http://clinicaltrials.gov ; ClinicalTrials.gov identifier NCT01217528.
大量植入式心脏复律除颤器(ICD)用于一级预防的患者会接受不适当的电击。既往研究报道,通过对ICD检测设置进行简单调整可减少不适当治疗,但各研究的纳入标准和设置差异显著。我们的目的是研究提高整个一级预防ICD人群中ICD检测区的效果。
543例接受ICD一级预防的患者被随机分为传统ICD程控组或进阶ICD程控组。传统组中,室性心动过速(VT)的检测率设定为171次/分,室颤(VF)为214次/分;进阶组中,VT为187次/分,VF为240次/分。43%的患者接受单腔检测设备,57%接受双腔检测设备(DDD-ICD 19%;CRT-D 38%)。主要终点包括不适当治疗和未治疗的VT/VF。传统组35例患者(13%)达到主要终点,进阶组17例患者(6%)达到主要终点(p = 0.004)。与传统ICD程控相比,进阶ICD程控导致接受ICD治疗的患者数量显著减少(26%对14%;p < 0.001),电击次数也显著减少(11%对5%;p = 0.023)。亚组分析显示,与采用传统ICD程控的单腔检测设备相比,采用进阶程控的双腔检测设备中不适当治疗和电击次数减少最多(p < 0.001)。
进阶ICD程控可减少广泛的一级预防ICD人群中的不适当治疗和电击次数,尤其是与双腔检测算法联合使用时。
http://clinicaltrials.gov ;ClinicalTrials.gov标识符NCT01217528。