Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope The SPAIN Study

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:70

Article

Baron-Esquivias, Gonzalo^1,2  Morino, Carlos A.^3,4  Moya-Mitjans, Angel^2,5  Martinez-Alday, Jesus^2,6,7  Ruiz-Granell, Ricardo^2,8  Lacunza-Ruiz, Javier^2,9  Garcia-Civera, Roberto^2,8  Gutierrez-Carretero, Encarnacion^1,10  Romero-Garrido, Rafael^1,2,11 

[1] Univ Seville, Hosp Univ Virgen Rocio, Serv Cardiol & Cirugia Cardiaca, Ave Portugal 19, Seville 41004, Spain

[2] Agencia Invest Sociedad Espanola Cardiol, Madrid, Spain

[3] Univ Calgary, Dept Cardiac Sci, Libin Cardiovacular Inst Alberta, Calgary, AB, Canada

[4] McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada

[5] Hosp Univ Vall Hebron, Serv Cardiol, Barcelona, Spain

[6] Hosp Univ Basurto, Bilbao, Spain

[7] Clin IMQ Zorrotzaurre, Bilbao, Spain

[8] Hosp Univ Clin Valencia, Serv Cardiol, Valencia, Spain

[9] Hosp Univ Virgen Arrixaca, Serv Cardiol, Murcia, Spain

[10] Ctr Invest Biomed Red Enfermedades Cardiovasc, CIBER CV, Madrid, Spain

[11] Hosp Nuestra Senora Candelaria, Serv Cardiol, Tenerife, Spain

关键词: asystole;    pacemaker;    syncope;    tilt table testing;   

DOI  :  10.1016/j.jacc.2017.08.026

来源: Elsevier

【 摘 要 】

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) (C) 2017 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

【 授权许可】

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