Department of Cardiology, Heart and Lung Center, Helsinki University Hospital, Haartmaninkatu 4, 00290, Helsinki, Finland.
Medical Center Alkmaar, Alkmaar, The Netherlands.
J Interv Card Electrophysiol. 2022 Apr;63(3):601-609. doi: 10.1007/s10840-021-01066-z. Epub 2021 Oct 1.
Cardiac pacing devices can detect and monitor atrial tachyarrhythmias (ATA) which increase the risk of thromboembolic complications. The aim of this study was to compare (1) two different atrial leads and (2) standard and optimized settings to detect ATA and reject far-field R-wave signal (FFRW).
This was a prospective, randomized multi-center trial comparing St. Jude Medical OptiSense lead (tip-to-ring spacing 1.1 mm) and Tendril lead (tip-to-ring spacing 10.0 mm), having programmed atrial sensitivity at 0.2 mV and post-ventricular atrial blanking at 60 ms. We measured intra-atrial amplitudes of FFRW, intrinsic atrial signals, the amount of FFRW oversensing, and other inappropriate mode switching.
One hundred and ten patients were enrolled. The mean amplitude of sensed and paced FFRW bipolar signal was 0.13 mV vs. 0.21 mV (p < 0.001) and 0.13 mV vs. 0.26 mV (p < 0.001) with OptiSense and Tendril lead, respectively. The mean amplitude of the atrial bipolar signal was 2.84 mV with OptiSense and 3.48 mV with Tendril lead, p = 0.014. With the optimized settings with OptiSense lead, one patient out of 20 (5%) had FFRW oversensing, none had undersensing of ATAs due to 2:1-blanking of atrial depolarizations, and the concordance of the ATAs by Holter and pacemaker memory was high (Spearman's rank correlation coefficient = 0.90). In the Tendril group, 12 out of 25 patients (48%) had oversensing and 4 had atrial undersensing (p < 0.001).
The technique with an atrial lead with short tip-to-ring spacing combined with optimized pacemaker programming resulted in reliable and accurate atrial arrhythmia detection.
ClinicalTrials.gov number NCT01074749.
心脏起搏设备可以检测和监测房性心动过速(ATA),这会增加血栓栓塞并发症的风险。本研究的目的是比较(1)两种不同的心房导联和(2)标准和优化设置,以检测 ATA 并拒绝远场 R 波信号(FFRW)。
这是一项前瞻性、随机多中心试验,比较了圣犹达医疗 OptiSense 导联(尖端到环间距 1.1 毫米)和 Tendril 导联(尖端到环间距 10.0 毫米),心房感知灵敏度程控为 0.2 mV,心室后心房空白期为 60 ms。我们测量了 FFRW、固有心房信号、FFRW 过感知量以及其他不适当模式转换的心房内振幅。
共纳入 110 例患者。与 Tendril 导联相比,OptiSense 导联感知和起搏的 FFRW 双极信号的平均幅度分别为 0.13 mV 和 0.21 mV(p<0.001)和 0.13 mV 和 0.26 mV(p<0.001)。OptiSense 导联的心房双极信号平均幅度为 2.84 mV,Tendril 导联为 3.48 mV,p=0.014。使用 OptiSense 导联的优化设置,20 例患者中有 1 例(5%)出现 FFRW 过感知,由于心房去极化的 2:1 空白,没有因 ATA 而出现感知不足,Holter 和起搏器记忆中的 ATA 一致性很高(Spearman 秩相关系数=0.90)。在 Tendril 组中,25 例患者中有 12 例(48%)出现过感知,4 例出现心房感知不足(p<0.001)。
采用尖端到环间距短的心房导联结合优化的起搏器程控技术,可实现可靠、准确的心房心律失常检测。
ClinicalTrials.gov 编号 NCT01074749。