未经证实:睡眠呼吸紊乱(SDB)可能会引发射血分数(HFrEF)降低的心力衰竭患者的夜间心律失常(NCA)。ADVENT-HF试验的NCA辅助研究将测试是否,在SDB的HFrEF患者中,峰值流量触发自适应伺服通气(ASVpf)可降低NCA。为此,需要通过多导睡眠图(PSG)对NCA进行准确评分.
UNASSIGNED:开发一种方法,从PSG期间记录的单导联心电图(ECG)中准确检测NCA,并评估观察者之间的NCA检测协议。
未经评估:心电图分析的质量保证包括对研究者的培训,发展标准化的技术质量,通过Holter-ECG软件进行符合指南的半自动NCA评分,并实施心律失常裁决委员会。评估观察员之间的协议,由两名独立的研究者分析心电图,并比较室性早搏(PVC)/h的一致性,来自ADVENT-HF试验两个中心的62名患者的心房早搏/h(PAC)以及其他NCA。
UNASSIGNED:PVC/h和PAC/h的组内相关系数非常好:0.99(95%-置信区间[CI]:0.99-0.99)和0.99(95%-CI:0.97-0.99),分别。在其他NCA的观察者间分类中未发现临床相关差异。两位研究者对非持续性室性心动过速(18%对19%)和心房颤动(10%对11%)的检测结果相似。未检测到持续性室性心动过速。
UNASSIGNED:这些发现表明,我们的方法对于对NCA进行评分非常可靠,并且足以适用于ADVENT-HF试验的整个PSG数据集。
UNASSIGNED: Sleep disordered breathing (SDB) may trigger nocturnal cardiac arrhythmias (NCA) in patients with heart failure with reduced ejection fraction (HFrEF). The NCA ancillary study of the ADVENT-HF trial will test whether, in HFrEF-patients with SDB, peak-flow-triggered adaptive servo-ventilation (ASVpf) reduces NCA. To this end, accurate scoring of NCA from polysomnography (PSG) is required.
UNASSIGNED: To develop a method to detect NCA accurately from a single-lead electrocardiogram (ECG) recorded during PSG and assess inter-observer agreement for NCA detection.
UNASSIGNED: Quality assurance of ECG analysis included training of the investigators, development of standardized technical quality, guideline-conforming semi-automated NCA-scoring via Holter-ECG software and implementation of an arrhythmia adjudication committee. To assess inter-observer agreement, the ECG was analysed by two independent investigators and compared for agreement on premature ventricular complexes (PVC) /h, premature atrial complexes/h (PAC) as well as for other NCA in 62 patients from two centers of the ADVENT-HF trial.
UNASSIGNED: The intraclass correlation coefficients for PVC/h and PAC/h were excellent: 0.99 (95%- confidence interval [CI]: 0.99-0.99) and 0.99 (95%-CI: 0.97-0.99), respectively. No clinically relevant difference in inter-observer classification of other NCA was found. The detection of non-sustained ventricular tachycardia (18% versus 19%) and atrial fibrillation (10% versus 11%) was similar between the two investigators. No sustained ventricular tachycardia was detected.
UNASSIGNED: These findings indicate that our methods are very reliable for scoring NCAs and are adequate to apply for the entire PSG data set of the ADVENT-HF trial.