Barón-Esquivias, GonzaloMorillo, Carlos A.Moya Mitjans, ÁngelMartínez Alday, JesúsRuiz Granell, RicardoLacunza Ruiz, JavierGarcía Civera, RobertoGutiérrez Carretero, EncarnaciónRomero Garrido, Rafael2025-10-062025-10-062017-09-25Barón-Esquivias, G., Morillo, C.A., Moya Mitjans, Á., Martínez Alday, J., Ruiz Granell, R., Lacunza Ruiz, J., García Civera, R., Gutiérrez Carretero, E., Romero Garrido, R. (2017). Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The Spain Study. Journal of the American College of Cardiology, 70 (14), 1720-1728.http://dx.doi.org/10.1016/j.jacc.2017.08.026.0735-10970735-1097https://hdl.handle.net/11441/177499Background: Pacing in vasovagal syncope remains controversial. Objectives: The authors evaluated dual-chamber pacing with closed loop stimulation (DDD-CLS) in patients with cardioinhibitory vasovagal syncope. Methods: This randomized, double-blind, controlled study included Canadian and Spanish patients age ≥40 years, with high burden syncope (≥5 episodes, ≥2 episodes in the past year), and a cardioinhibitory head-up tilt test (bradycardia <40 beats/min for 10 s or asystole >3 s). Patients were randomized to either DDD-CLS pacing for 12 months followed by sham DDI mode pacing at 30 pulses/min for 12 months (group A), or sham DDI mode for 12 months followed by DDD-CLS pacing for 12 months (group B). Patients in both arms crossed-over after 12 months of follow-up or when a maximum of 3 syncopal episodes occurred within 1 month. Results: A total of 46 patients completed the protocol; 22 were men (47.8%), and mean age was 56.30 ± 10.63 years. The mean number of previous syncopal episodes was 12 (range 9 to 20). The proportion of patients with ≥50% reduction in the number of syncopal episodes was 72% (95% confidence interval [CI]: 47% to 90%) with DDD-CLS compared with 28% (95% CI: 9.7% to 53.5%) with sham DDI mode (p = 0.017). A total of 4 patients (8.7%) had events during DDD-CLS and 21 (45.7%) during sham DDI (hazard ratio: 6.7; 95% CI: 2.3 to 19.8). Kaplan-Meier curve was significantly different between groups in time to first syncope: 29.2 months (95% CI: 15.3 to 29.2 months) versus 9.3 months (95% CI: 6.21 months, NA; p < 0.016); odds ratio: 0.11 (95% CI: 0.03 to 0.37; p < 0.0001). Conclusions: DDD-CLS pacing significantly reduced syncope burden and time to first recurrence by 7-fold, prolonging time to first syncope recurrence in patients age ≥40 years with head-up tilt test–induced vasovagal syncope compared with sham pacing. (Closed Loop Stimulation for Neuromediated Syncope.application/pdfengAttribution-NonCommercial-NoDerivates 4.0 Internationalhttps://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccesshttp://dx.doi.org/10.1016/j.jacc.2017.08.026