From Swansea University Medical School, UK (J.P.J.H., K.W., M.B.G.); Swansea University College of Health and Human Sciences, UK (C.P., A.C.); Princess of Wales Hospital, Cardiology, Bridgend, UK (M.G.); and Regional Cardiac Centre, Morriston Hospital, Swansea, UK (J.P.B.).
Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.
Asymptomatic atrial fibrillation (AF) is increasingly common in the aging population and implicated in many ischemic strokes. Earlier identification of AF with appropriate anticoagulation may decrease stroke morbidity and mortality.
We conducted a randomized controlled trial of AF screening using an AliveCor Kardia monitor attached to a WiFi-enabled iPod to obtain ECGs (iECGs) in ambulatory patients. Patients ≥65 years of age with a CHADS-VASc score ≥2 free from AF were randomized to the iECG arm or routine care (RC). iECG participants acquired iECGs twice weekly over 12 months (plus additional iECGs if symptomatic) onto a secure study server with overread by an automated AF detection algorithm and by a cardiac physiologist and/or consultant cardiologist. Time to diagnosis of AF was the primary outcome measure. The overall cost of the devices, ECG interpretation, and patient management were captured and used to generate the cost per AF diagnosis in iECG patients. Clinical events and patient attitudes/experience were also evaluated.
We studied 1001 patients (500 iECG, 501 RC) who were 72.6±5.4 years of age; 534 were female. Mean CHADS-VASc score was 3.0 (heart failure, 1.4%; hypertension, 54%; diabetes mellitus, 30%; prior stroke/transient ischemic attack, 6.5%; arterial disease, 15.9%; all CHADS-VASc risk factors were evenly distributed between groups). Nineteen patients in the iECG group were diagnosed with AF over the 12-month study period versus 5 in the RC arm (hazard ratio, 3.9; 95% confidence interval=1.4-10.4; =0.007) at a cost per AF diagnosis of $10 780 (£8255). There was a similar number of stroke/transient ischemic attack/systemic embolic events (6 versus 10, iECG versus RC; hazard ratio=0.61; 95% confidence interval=0.22-1.69; =0.34). The majority of iECG patients were satisfied with the device, finding it easy to use without restricting activities or causing anxiety.
Screening with twice-weekly single-lead iECG with remote interpretation in ambulatory patients ≥65 years of age at increased risk of stroke is significantly more likely to identify incident AF than RC over a 12-month period. This approach is also highly acceptable to this group of patients, supporting further evaluation in an appropriately powered, event-driven clinical trial.
URL: https://www.isrctn.com. Unique identifier: ISRCTN10709813.
无症状性心房颤动（AF）在老龄化人群中越来越常见，并与许多缺血性中风有关。早期发现 AF 并进行适当的抗凝治疗可能会降低中风的发病率和死亡率。
我们进行了一项使用 AliveCor Kardia 监测仪（附带有线网络功能的 iPod 以获取心电图（iECG））对无症状性 AF 进行筛查的随机对照试验。年龄在 65 岁及以上、CHADS-VASc 评分为 2 分及以上且无 AF 的患者被随机分配到 iECG 组或常规护理（RC）组。iECG 组患者在 12 个月内每周接受两次 iECG（如果出现症状则增加 iECG），并将 iECG 记录到安全的研究服务器上，由自动 AF 检测算法以及心脏生理学家和/或顾问心脏病专家进行复查。AF 的诊断时间是主要的观察终点。记录设备、心电图解读和患者管理的总成本，并用于生成 iECG 患者的每例 AF 诊断的成本。还评估了临床事件和患者的态度/经验。
我们研究了 1001 名患者（500 名 iECG，501 名 RC），他们的年龄为 72.6±5.4 岁；534 名为女性。平均 CHADS-VASc 评分为 3.0（心力衰竭 1.4%；高血压 54%；糖尿病 30%；既往中风/短暂性脑缺血发作 6.5%；动脉疾病 15.9%；所有 CHADS-VASc 危险因素在两组间均匀分布）。在 12 个月的研究期间，iECG 组有 19 名患者被诊断为 AF，而 RC 组有 5 名（风险比 3.9；95%置信区间 1.4-10.4；=0.007），每例 AF 诊断的成本为 10780 美元（8255 英镑）。中风/短暂性脑缺血发作/系统性栓塞事件的数量相似（6 例与 10 例，iECG 组与 RC 组；风险比 0.61；95%置信区间 0.22-1.69；=0.34）。大多数 iECG 患者对该设备感到满意，他们发现该设备使用方便，不会限制活动或引起焦虑。
在年龄在 65 岁及以上、中风风险较高的患者中，每周两次进行单次导联 iECG 筛查并进行远程解读，与 RC 相比，在 12 个月内更有可能发现新发 AF。这种方法也非常受这组患者的欢迎，支持在适当的、以事件为驱动的临床试验中进一步评估。
