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Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study
Gonzalo Baron-Esquivias1, Carlos A Morillo2, Angel Moya-Mitjans3
1Servicio 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.
Insights
Dual-chamber pacing with closed loop stimulation (DDD-CLS) significantly reduced vasovagal syncope episodes and time to recurrence in patients over 40. This pacing method offers a promising treatment for recurrent syncope.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Vasovagal syncope (VVS) management, particularly pacing, remains a debated clinical area.
- Cardioinhibitory VVS presents a significant burden, impacting patient quality of life.
Purpose of the Study:
- To evaluate the efficacy of dual-chamber pacing with closed loop stimulation (DDD-CLS) in patients aged 40 and above experiencing cardioinhibitory VVS.
- To compare the syncope burden and recurrence rates between DDD-CLS pacing and sham pacing.
Main Methods:
- A randomized, double-blind, controlled trial involving Canadian and Spanish patients (age ≥40) with high-burden, cardioinhibitory VVS.
- Patients were randomized to DDD-CLS pacing or sham pacing, with a crossover design after 12 months or a specified number of syncopal episodes.
Main Results:
- DDD-CLS pacing resulted in a ≥50% reduction in syncope episodes in 72% of patients, compared to 28% with sham pacing (p=0.017).
- The incidence of syncopal events was significantly lower with DDD-CLS (8.7%) versus sham pacing (45.7%).
- Time to first syncope recurrence was significantly prolonged with DDD-CLS (29.2 months) compared to sham pacing (9.3 months).
Conclusions:
- DDD-CLS pacing demonstrates significant efficacy in reducing syncope burden and delaying recurrence in older adults with VVS.
- The study provides strong evidence supporting DDD-CLS as a therapeutic option for managing recurrent cardioinhibitory vasovagal syncope.
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).
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