可穿戴设备究竟如何真正融入在医疗场景中，今年ACC上的mSToPS研究给出了一个很好的场景。无症状房颤是很常见的情况，一般的Holter、ELM在识别无症状房颤发作时都有很大的局限性，而植入式的ILR又代价太高。所以如果能有一种合适长时间佩戴的可穿戴式设备，是最好的方式。

今天的文章，就让我们来看一下mSToPS研究。

随着起搏器置入的增加，以及无创心电技术的发展，无症状房颤成为近几年心律学关注的热点之一，目前也有很多临床研究如ARTESIA以及NOAH关注给无症状房颤患者抗凝是否可以带来临床获益。

2018的ACC年会上也发表了一项类似的观察性研究（mSToPS STUDY），该研究纳入共1,738名患者，平均年龄73.7岁，40.5%为女性，CHA2DS2-VASc评分中位数为3分，他们没有临床诊断的心律失常，但都是心律失常的高危人群，所有患者佩戴来自iRhythm科技公司的Zio XT贴片（14天Holter），对照组是年龄、性别以及CHA2DS2-VASc评分匹配的3476名对照，他们接受常规治疗，不佩戴贴片。

经过1年的随访发现，佩戴贴片组有6.3%的患者新诊断房颤，而对照组仅2.3%（调整的OR为3，95%CI 2.2-4.0，P<0.001），总体的房颤负荷较小，中位值为0.9%，每个患者平均有10次发作，93%的患者有一次超过5min的房颤发作，从临床结局来看，两组在卒中（1.9%Vs 2.0%，P=0.73）、心梗（1.78%Vs 1.84%，P=0.88）及系统性栓塞事件（0 Vs 1次，P=1.0）上无差异，但佩戴贴片组的抗凝率（5.4%Vs 3.4%，P=0.0004）、看心内科医生次数（31.6%Vs 23.6%，P<0.0001）以及起搏器/自动除颤器置入（13 Vs 0，P<0.0001）均要多于不佩戴贴片组，两组患者急诊就诊以及住院次数类似。

John Mandrola教授评论：为无症状房颤进行筛查工作很令人钦佩，但真实世界的情况要复杂的多。在高龄或者高危患者中进行心律监测，肯定能发现无症状房颤，这些人肯定会就诊以期获得治疗。但对这些人进行治疗，能否改善预后，目前仍不得而知。该研究中两组器械置入治疗对比高达13/0，这让我觉得很不安。期待正在进行ARTESIA以及NOAH研究能给我们解惑。

来源：American College of Cardiology (ACC) 2018 Annual Scientific Session: Presentation 402-19. March 10, 2018.

附：mSToPS研究信息（NCT02506244）

mHealth Screening to Prevent Strokes (mSToPS)

Brief Summary:

The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.

Condition or disease: Atrial Fibrillation

Intervention/treatment:

Device: iRhythm ZIO XT Patch

Device: Wristband by Amiigo

Study Type  : Interventional  (Clinical Trial)

Actual Enrollment  : 2274 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Prevention

Official Title: mHealth Screening to Prevent Strokes (mSToPS)

Study Start Date  : November 2015

Estimated Primary Completion Date  : March 2019

Estimated Study Completion Date  : September 2020

Primary Outcome Measures  :

Incidence of newly diagnosed AF [ Time Frame: End of 4 month monitoring period ]

Incidence of newly diagnosed AF as defined by at least 30 seconds of AF or atrial flutter at the end of the 4 month monitoring period compared to the delayed monitoring cohort (primary) and observational control (secondary)

Criteria

Participants:

The study population will be derived from the Aetna and Medicare populations.

Inclusion Criteria:

• Male or females age > 75 or

• Male age > 55, or females age > 65, and

• Prior CVA, or

• Heart failure, or

• Diagnosis of both diabetes and hypertension, or

• Mitral valve disease, or

• Left ventricular hypertrophy, or

• COPD requiring home O2, or

• Sleep apnea, or

• History of pulmonary embolism, or

• History of myocardial infarction, or

• Diagnosis of obesity

Exclusion Criteria:

• Current or prior diagnosis of atrial fibrillation, atrial flutter or atrial tachycardia

• Receiving chronic anticoagulation therapy

• Hospice care

• End stage renal disease

• Diagnosis of moderate or greater dementia

• Implantable pacemaker and/or defibrillator

• History of skin allergies to adhesive patches

• Known metastatic cancer

• Aetna Compassionate Care Program (ACCP) participants - individuals with advanced illness and limited life expectancy

作者：马上的跳蚤

来源：心血管笔记