Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Division of Cardiology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
JAMA Cardiol. 2020 Apr 1;5(4):458-463. doi: 10.1001/jamacardio.2019.5963.
Arrhythmias are an important cause of maternal morbidity and mortality but remain difficult to diagnose.
To compare implantable loop recorder (ILR) plus 24-hour Holter electrocardiographic (ECG) monitoring with standard 24-hour Holter ECG monitoring alone in terms of acceptability, ability to identify significant arrythmias, and effect on management and pregnancy outcome in women who were symptomatic or at high risk of arrythmia because of underlying structural heart disease.
DESIGN, SETTING, AND PARTICIPANTS: This single-center, prospective randomized clinical trial recruited 40 consecutive patients from the Cardiac Disease and Maternity Clinic at Groote Schuur Hospital in Cape Town, South Africa. Pregnant patients with symptoms of arrhythmia and/or structural heart disease at risk of arrhythmia were included.
Patients were randomized to standard care (SC; 24-hour Holter ECG monitoring [n = 20]) or standard care plus ILR (SC-ILR; 24-hour Holter ECG monitoring plus ILR [n = 20]). Only 17 consented to ILR insertion, and the 3 who declined ILR were allocated to the SC group.
Arrhythmias considered included atrial fibrillation, atrial flutter, premature ventricular complexes, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation.
Among the 40 women in this trial, the mean (SD) age was 28.4 (5.5) years. Holter monitoring detected arrhythmias in 3 of 23 patients (13%) in the SC group and 4 of 17 patients (24%) in the SC-ILR group compared with 9 of 17 patients (53%) patients who had arrhythmias detected by ILR. Seven patients (4 with supraventricular tachycardia, 1 with premature ventricular complexes, and 2 with paroxysmal atrial fibrillation recorded by ILR) did not have arrhythmias detected by 24-hour Holter monitoring. Three of these 7 patients (43%) had a change in management as a result of their ILR recordings. There were no maternal deaths. However, the SC group had a significantly lower mean (SD) gestational stage at delivery (35 [5] weeks vs 38 [2], P = .04).
The ILR was better than 24-hour Holter monitoring in detecting arrhythmias, which led to a change in management for a significant proportion of patients. Our findings suggest that ILR may be beneficial for pregnant women at risk of arrhythmia.
ClinicalTrials.gov Identifier: NCT02249195.
心律失常是孕产妇发病率和死亡率的一个重要原因，但仍难以诊断。
比较植入式循环记录仪（ILR）加 24 小时动态心电图（ECG）监测与单独标准 24 小时动态心电图监测在接受程度、识别显著心律失常的能力以及对因结构性心脏病而出现心律失常症状或处于心律失常高风险的女性的管理和妊娠结局的影响。
设计、地点和参与者：这项单中心、前瞻性随机临床试验在南非开普敦格罗特舒尔医院的心脏病和产科诊所招募了 40 名连续患者。纳入有心律失常症状和/或结构性心脏病风险的妊娠患者。
患者随机分为标准治疗（SC；24 小时动态心电图监测[n=20]）或标准治疗加 ILR（SC-ILR；24 小时动态心电图监测加 ILR[n=20]）。只有 17 名患者同意插入 ILR，而 3 名拒绝 ILR 的患者被分配到 SC 组。
考虑到的心律失常包括心房颤动、心房扑动、室性早搏、室上性心动过速、室性心动过速或心室颤动。
在这项试验中的 40 名女性中，平均（SD）年龄为 28.4（5.5）岁。与 SC 组的 3 例（13%）和 SC-ILR 组的 4 例（24%）相比，ILR 检测到心律失常的患者为 17 例中的 9 例（53%）。7 例患者（4 例室上性心动过速、1 例室性早搏和 2 例 ILR 记录的阵发性心房颤动）未通过 24 小时动态心电图监测检测到心律失常。这 7 例患者中的 3 例（43%）的治疗方案因 ILR 记录而发生改变。没有孕产妇死亡。然而，SC 组的分娩时平均（SD）孕龄明显较低（35[5]周 vs 38[2]周，P=0.04）。
ILR 在检测心律失常方面优于 24 小时动态心电图监测，这导致很大一部分患者的治疗方案发生改变。我们的发现表明，ILR 可能对有发生心律失常风险的孕妇有益。
ClinicalTrials.gov 标识符：NCT02249195。
