Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study.

Abstract

AIMS:

Reflex vasovagal syncope (VVS) is the most common cause of syncope and patients with recurrent episodes may severely impair quality of life (QoL). This pre-specified analysis evaluated whether the clinically significant reduction in syncope burden demonstrated by dual-chamber pacing with closed loop stimulation (DDD-CLS) reported in the SPAIN trial translates into improved QoL.

METHODS AND RESULTS:

Patients aged ≥40 years with ≥5 VVS episodes and cardioinhibitory response induced by head-up tilt testing were included. Patients were randomized 1:1 to active DDD-CLS pacing algorithm for 12 months followed by sham DDI mode for the remaining 12 months (Group A) or vice versa (Group B). QoL was assessed using the Short Form-36 (SF-36) health survey, Physical Component Score (PCS), and Mental Component Score (MCS) before randomization (baseline) and at 12- and 24-month follow-up. Fifty-four patients were enrolled from 11 participating centres. No significant carryover effect was detected for any variable, and the only period effect was observed in the vitality subdomain (P = 0.033). Mean SF-36 scores were higher in the DDD-CLS group vs. the DDI group for the eight subdomains and significantly different in physical role, bodily pain, and vitality (P < 0.05). The analysis of component summary scores indicated that DDD-CLS benefited both mental and physical components with significant differences in PCS when compared with the DDI group.

CONCLUSION:

Dual-chamber pacing with closed loop stimulation determined a significant and clinically relevant improvement in QoL across both mental and physical components in patients with recurrent VVS.

REGISTRATION:

Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study); NCT01621464.

• Authors: Gonzalo Barón-Esquivias, Angel Moya-Mitjans, Jesús Martinez-Alday, Ricardo Ruiz-Granell, Javier Lacunza-Ruiz, Roberto Garcia-Civera, Encarnación Gutiérrez-Carretero, Rafael Romero-Garrido, Carlos A Morillo
• Journal: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology (Europace) Vol. 22 Issue 2 Pg. 314-319 (02 01 2020) ISSN: 1532-2092 [Electronic] England
• PMID: 31713631 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: [email protected].

Topics

• Cardiac Pacing, Artificial
• Humans
• Quality of Life
• Recurrence
• Reflex
• Spain
• Syncope, Vasovagal (diagnosis, therapy)