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

Abstract

Although Valsalva maneuver (VM) remains the guideline-directed emergent treatment for supraventricular tachycardia (SVT), its success rate remains suboptimal. 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. 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. Participants received either device-assisted VM (n = 106) or standard VM (n = 106) during induced SVT. The primary outcome was immediate cardioversion success (12-lead electrocardiogram-confirmed sinus rhythm within 1 minute) postintervention by intention-to-treat analysis. 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). Mean (SD) patient age was 48.4 (14.0) years, and 114 patients (54.8%) were female. 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). 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. ClinicalTrials.gov Identifier: NCT06622772.