B-PO05-192 DUAL CHAMBER CLOSED LOOP STIMULATION PACING PREVENTS CARDIOINHIBITORY SYNCOPE IN YOUNG PATIENTS

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.

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2167Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results from the SPAIN study

European Heart Journal ◽

10.1093/eurheartj/ehz748.0095 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

G Baron Esquivias ◽

C M Morillo ◽

A M Moya ◽

J D Martinez Alday ◽

R Ruiz-Granell ◽

...

Keyword(s):

Quality Of Life ◽

Closed Loop ◽

Vasovagal Syncope ◽

P Value ◽

Dual Chamber ◽

Double Blind ◽

Sf 36 ◽

Closed Loop Stimulation

Abstract Background Reflex vasovagal syncope (VVS) is one of the most common causes of syncope and, when recurrent, can have devastating consequences on the quality of life of patients despite pharmacological interventions. The closed loop stimulation (CLS) pacing algorithm converts, during an incipient VVS, variations in right intracardiac impedance into heart rate adaptation. The study SPAIN was the first randomized, double-blind trial robustly showing a strong reduction in syncopal recurrence in patients paced with dual-chamber (DDD)-CLS. (NCT01621464). Purpose To evaluate whether the differences observed in the SPAIN study regarding syncope burden and time to recurrence translate into improvements on quality of life. Methods This study analysed quality of life data from the SPAIN study: a randomized, prospective, double-blind, multicenter trial conducted in 10 Spanish and 1 Canadian centers. Ethics Committee approval was obtained at each participating center. Patients aged ≥40 years, with ≥5 VVS episodes and cardioinhibitory response to head-up tilt testing were included. After implant, patients were randomized 1:1 to active DDD-CLS mode for 12 months followed by sham DDI mode for the remaining 12 months or vice-versa. Quality of life was assessed via the Short Form-36 (SF-36) health survey before randomization (baseline), and at 12- and 24-month follow-up. The change in quality of life during the entire follow-up relative to baseline was compared between each pacing mode (DDD-CLS vs. DDI). Results Fifty-four patients were enrolled with a mean age of 56.3±10.6 years and a median of 12 syncopal episodes before randomization. Median SF-36 scores greatly increased from baseline in the DDD-CLS group across the 8 domains, whereas the response was variable in the DDI group. Comparing both pacing algorithms, median SF-36 scores were higher in the DDD-CLS group, with differences reaching statistical significance for “physical role” and “vitality” domains (p-value =0.006 and 0.014, respectively). Pacing sequence or treatment period did not significantly influence the response (p-value >0.05 for all the domains). Conclusions We demonstrated the beneficial effect of this physiological pacing algorithm on the quality of life of patients, as evidenced by the improvement in all the domains of the SF-36 when stimulated in DDD-CLS as compared to the sham DDI mode.

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