Gonzalo Baron-Esquivias1, Carlos A Morillo2, Angel Moya-Mitjans3, Jesus Martinez-Alday4, Ricardo Ruiz-Granell5, Javier Lacunza-Ruiz6, Roberto Garcia-Civera5, Encarnacion Gutierrez-Carretero7, Rafael Romero-Garrido8. 1. Servicio de Cardiologia y Cirugia Cardíaca, Hospital Universitario Virgen del Rocio, Universidad de Sevilla, Sevilla, Spain; Agencia de Investigación de la Sociedad Española de Cardiologia, Madrid, Spain. Electronic address: gonzalo.baron.sspa@juntadeandalucia.es. 2. Department of Cardiac Sciences, Libin Cardiovacular Institue of Alberta, University of Calgary and Population Health Research Institute-McMaster University, Hamilton, Ontario, Canada. 3. Agencia de Investigación de la Sociedad Española de Cardiologia, Madrid, Spain; Servicio de Cardiologia, Hospital Universitario Vall d'Hebron, Barcelona, Spain. 4. Agencia de Investigación de la Sociedad Española de Cardiologia, Madrid, Spain; Hospital Universitario Basurto, Bilbao, Spain; Clínica IMQ Zorrotzaurre, Bilbao, Spain. 5. Agencia de Investigación de la Sociedad Española de Cardiologia, Madrid, Spain; Servicio de Cardiología, Hospital Universitario Clinico de Valencia, Valencia, Spain. 6. Agencia de Investigación de la Sociedad Española de Cardiologia, Madrid, Spain; Servicio de Cardiologia, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain. 7. Servicio de Cardiologia y Cirugia Cardíaca, Hospital Universitario Virgen del Rocio, Universidad de Sevilla, Sevilla, Spain; CIBER-CV, Centro de Investigación Biomedica en Red de Enfermedades Cardiovasculares, Madrid, Spain. 8. Servicio de Cardiologia y Cirugia Cardíaca, Hospital Universitario Virgen del Rocio, Universidad de Sevilla, Sevilla, Spain; Agencia de Investigación de la Sociedad Española de Cardiologia, Madrid, Spain; Servicio de Cardiologia, Hospital Nuestra Señora de la Candelaria, Tenerife, Spain.
Abstract
BACKGROUND: 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 [SPAIN Study]; NCT01621464).
RCT Entities:
BACKGROUND: 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 [SPAIN Study]; NCT01621464).
Authors: Mohammed Ruzieh; Mehrdad Ghahramani; Matthew Nudy; Gerald V Naccarelli; John Mandrola; Blair P Grubb; Andrew J Foy Journal: J Interv Card Electrophysiol Date: 2019-03-12 Impact factor: 1.900
Authors: Richard Sutton; Jelle S Y de Jong; Julian M Stewart; Artur Fedorowski; Frederik J de Lange Journal: Heart Rhythm Date: 2020-02-06 Impact factor: 6.343
Authors: Lucas Lauder; Bruno R da Costa; Sebastian Ewen; Sean S Scholz; William Wijns; Thomas F Lüscher; Patrick W Serruys; Elazer R Edelman; Davide Capodanno; Michael Böhm; Peter Jüni; Felix Mahfoud Journal: Eur Heart J Date: 2020-07-14 Impact factor: 35.855
Authors: Ekrem Yasa; Fabrizio Ricci; Hannes Holm; Torbjörn Persson; Olle Melander; Richard Sutton; Artur Fedorowski; Viktor Hamrefors Journal: Front Cardiovasc Med Date: 2019-10-25