Background: 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.Objective: 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.Methods: 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 imple-mentation 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.Results: The intraclass correlation coefficients for PVC/h and PAC/h were excellent: 0.99 (95%-confidence in-terval [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. Conclusion: 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.

Methodology for the nocturnal cardiac arrhythmia ancillary study of the ADVENT-HF trial in patients with heart failure with reduced ejection fraction and sleep-disordered breathing

Castiglioni, Paolo;
2022-01-01

Abstract

Background: 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.Objective: 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.Methods: 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 imple-mentation 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.Results: The intraclass correlation coefficients for PVC/h and PAC/h were excellent: 0.99 (95%-confidence in-terval [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. Conclusion: 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.
Heart failure; Premature ventricular complex; Premature atrial complex; Sleep-disordered breathing; Inter-observer reliability; Methods; ADVENT-HF
Horvath, Cm; Fisser, C; Bradley, Td; Floras, Js; Sossalla, S; Parati, G; Zeman, F; Castiglioni, Paolo; Faini, A; Rankin, F; Arzt, M
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11383/2146053
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