Device-Assisted vs Standard Valsalva Maneuver for Terminating Supraventricular Tachycardia: A Randomized Clinical Trial.

Background

To assess the efficacy of a novel handheld Valsalva assist device, which can assist in achieving and maintaining target intrathoracic pressures, in improving sinus rhythm restoration rates in patients with SVT.

评估一种新型手持Valsalva辅助装置的有效性，该装置可以帮助达到并维持目标胸腔内压力，以提高SVT患者恢复窦性心律的比率。

DESIGN, SETTING, AND PARTICIPANTS: This single-center, open-label randomized clinical trial conducted at Beijing Anzhen Hospital randomized patients with SVT (aged 16-80 years, enrolled between April 2022 and April 2023) undergoing electrophysiological study at a tertiary hospital. Data analysis was completed from January 2024 to January 2025.

设计、环境和参与者：这项在北京市安贞医院进行的单中心、开放标签的随机临床试验，招募了年龄在16-80岁之间的SVT患者（2022年4月至2023年4月期间入组），这些患者在三级医院接受了电生理研究。数据分析完成于2024年1月至2025年1月。

intervention

Participants received either device-assisted VM (n = 106) or standard VM (n = 106) during induced SVT.

参与者在诱发SVT期间接受了设备辅助的VM（n = 106）或标准VM（n = 106）。

main_outcomes_and_measures

The primary outcome was immediate cardioversion success (12-lead electrocardiogram-confirmed sinus rhythm within 1 minute) postintervention by intention-to-treatanalysis.

主要结果是干预后立即转复成功（1分钟内通过12导联心电图确认的窦性心律），按意向治疗分析。

Results

A total of 212 patients were randomized, among whom 210 completed the randomly assigned VM and were included in the primary analysis (106 in the standard VM group and 104 in the device-assisted VM group).

共有212名患者被随机分配，其中210名完成了随机分配的虚拟现实治疗并被纳入主要分析（标准虚拟现实组106名，设备辅助虚拟现实组104名）。

Mean (SD) patient age was 48.4 (14.0) years, and 114 patients (54.8%) were female.

患者的平均年龄为48.4（标准差14.0）岁，其中114名患者（54.8%）为女性。

After 2 VMs, 67 of 106 participants in the VM with device assist group (63.2%) vs 31 of 106 participants in the standard VM group (29.2%) converted to sinus rhythm within 1 minute (odds ratio, 4.16; 95% CI, 2.36-7.47; P < .001).

在两次心脏复律后，使用设备辅助的心脏复律组中有67名参与者（63.2%）在1分钟内转复为窦性心律，而标准心脏复律组中有31名参与者（29.2%）在1分钟内转复为窦性心律（比值比，4.16；95%置信区间，2.36-7.47；P < .001）。

conclusions_and_relevance

Per the results of this randomized clinical trial, the handheld Valsalva assist device significantly enhances VM effectiveness, providing a potentially implementable solution for SVT management.

根据这项随机临床试验的结果，手持式Valsalva辅助装置显著提高了Valsalva动作的有效性，为室上性心动过速（SVT）管理提供了一个潜在的可实施解决方案。

trial_registration

ClinicalTrials.gov Identifier: NCT06622772.

ClinicalTrials.gov注册号：NCT06622772。