Precardioversion Heart Rhythm Monitoring Using Smartphone Photoplethysmography: The SMARTBEATS Randomized Clinical Trial.

Cancellations of cardioversion procedures are common due to spontaneous conversion to sinus rhythm.

由于自发性转复为窦性心律，心脏复律程序的取消很常见。

Background

To study the efficacy and feasibility of precardioversion rhythm monitoring using smartphone photoplethysmography compared to standard of care in scheduled cardioversion of atrial fibrillation.

研究使用智能手机光电容积描记法进行心房颤动计划性复律前节律监测的有效性和可行性，与标准护理进行比较。

DESIGN, SETTING, AND PARTICIPANTS: This randomized, single-blinded study took place at a tertiary hospital in Sweden.

设计、环境和参与者：这是一项在瑞典一家三级医院进行的随机、单盲研究。

Adult patients (≥18 years) with persistent atrial fibrillation or flutter scheduled for cardioversion were included.

纳入标准为年龄≥18岁，持续性房颤或房扑患者，计划进行电复律。

Exclusion criteria were having a cardiac implantable electronic device or inability to consent or comply with study procedures.

排除标准包括有心脏植入式电子设备、无法同意或遵守研究程序。

The study took place from September 2022 to February 2025.

研究从2022年9月持续到2025年2月。

Methods

Precardioversion ambulatory heart rhythm monitoring using smartphone photoplethysmography and reminders to support adherence to anticoagulation in the intervention group compared to standard of care (no intervention).

在干预组中，研究使用智能手机光体积描记法进行心律监测，并通过提醒来支持抗凝治疗的依从性，与标准护理（无干预）进行比较。

Heart rhythm recordings were automatically transferred following recording and overread daily.

心律记录在录制后自动传输，并且每天进行复核。

A single-lead electrocardiogram recording was made simultaneous to each photoplethysmography recording for validation purposes.

在每次光电容积描记法记录的同时，制作单导联心电图记录以供验证。

In case of spontaneous conversion to sinus rhythm in the intervention group, participants were contacted and cardioversion was canceled.

在干预组中，如果出现自发性窦性心律转换，将联系参与者并取消心脏复律。

In the control group, no further action was taken in case of rhythm conversion.

在对照组中，如果出现心律转换，则不采取进一步行动。

main_outcome_and_measures

The primary efficacy outcome was proportion of same-day cancellations of scheduled atrial fibrillation or flutter cardioversions.

主要疗效结果是计划进行的房颤或房扑电复律当日取消的比例。

Results

In total, 206 patients were randomized, with 105 participants assigned to intervention and 101 assigned to control (standard care).

共有206名患者被随机分配，其中105名参与者被分配到干预组，101名被分配到对照组（标准护理）。

Three participants were excluded after randomization due to having a cardiac implantable device, leaving 104 and 99 participants for final analysis in the intervention and control group, respectively.

随机化后，由于有三名参与者安装了心脏植入装置，因此分别有104名和99名参与者进入干预组和对照组进行最终分析。

The median (IQR) age was 69.7 (61.6-75.6) years and 149 (72.3%) were male.

中位数（四分位数间距）年龄为69.7（61.6-75.6）岁，149名（72.3%）为男性。

The participants performed 5226 heart rhythm recordings precardioversion, and the median (IQR) number of daily recordings per participant precardioversion was 2.1 (2.0-2.3).

参与者在电复律前进行了5226次心律记录，电复律前每位参与者每天记录的中位数（四分位数间距）为2.1（2.0-2.3）。

There were 4.8% (5/104) same-day cancellations of scheduled cardioversions in the intervention group compared to 23.2% (23/99) in the control group (P < .001).

干预组中有4.8%（5/104）的计划电复律在同一天被取消，而对照组中这一比例为23.2%（23/99）（P < .001）。

For same-day cancellations due to spontaneous sinus rhythm conversion, the corresponding results were 1.0% (1/104) vs 18.2% (18/99) (P < .001).

由于自发性窦性心律转换导致的当日取消，相应的结果为1.0%（1/104）对比18.2%（18/99）（P < .001）。

conclusions_and_relevance

The results of this study suggest that precardioversion monitoring using smartphone photoplethysmography represents a highly scalable digital intervention that significantly reduced same-day cancellations.

本研究的结果表明，使用智能手机光体积描记法进行心律转复前监测是一种高度可扩展的数字干预措施，显著降低了当日取消率。

trial_registration

ClinicalTrials.gov Identifier: NCT04300270.

临床试验注册号：NCT04300270。