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. Issue 2 (12th November 2019)

• Record Type: Journal Article
• Authors: Barón-Esquivias, Gonzalo; Moya-Mitjans, Angel; Martinez-Alday, Jesús; Ruiz-Granell, Ricardo; Lacunza-Ruiz, Javier; Garcia-Civera, Roberto; Gutiérrez-Carretero, Encarnación; Romero-Garrido, Rafael; Morillo, Carlos A
• Is Part Of: Europace. Volume 22:Issue 2(2020)
• Page Start: 314
• Page End: 319
• Publication Date: 2019-11-12
• Subjects: Closed loop stimulation -- Quality of life -- SF-36 -- Vasovagal syncope; Arrhythmia -- Treatment -- Periodicals; Cardiac pacing -- Periodicals; Catheter ablation -- Periodicals; Heart -- Physiology -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1093/europace/euz294
• Languages: English
• ISSNs: 1099-5129

Abstract

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.