Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. (5th December 2020)

• Record Type: Journal Article
• Authors: Brignole, Michele; Russo, Vincenzo; Arabia, Francesco; Oliveira, Mario; Pedrote, Alonso; Aerts, Arnaud; Rapacciuolo, Antonio; Boveda, Serge; Deharo, Jean Claude; Maglia, Giampiero; Nigro, Gerardo; Giacopelli, Daniele; Gargaro, Alessio; Tomaino, Marco
• Is Part Of: European heart journal. Volume 42:Number 5(2021)
• Page Start: 508
• Page End: 516
• Publication Date: 2020-12-05
• Subjects: Syncope -- Reflex syncope -- Tilt testing -- Asystolic syncope -- Pacemaker -- Cardiac pacing -- Closed loop -- stimulation; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.12005
• DOI: 10.1093/eurheartj/ehaa936
• Languages: English
• ISSNs: 0195-668X

Abstract

Abstract: Aim: The benefit of cardiac pacing in patients with severe recurrent reflex syncope and asystole induced by tilt testing has not been established. The usefulness of tilt-table test to select candidates for cardiac pacing is controversial. Methods and results: We randomly assigned patients aged 40 years or older who had at least two episodes of unpredictable severe reflex syncope during the last year and a tilt-induced syncope with an asystolic pause longer than 3 s, to receive either an active (pacing ON; 63 patients) or an inactive (pacing OFF; 64 patients) dual-chamber pacemaker with closed loop stimulation (CLS). The primary endpoint was the time to first recurrence of syncope. Patients and independent outcome assessors were blinded to the assigned treatment. After a median follow-up of 11.2 months, syncope occurred in significantly fewer patients in the pacing group than in the control group [10 (16%) vs. 34 (53%); hazard ratio, 0.23; P = 0.00005]. The estimated syncope recurrence rate at 1 year was 19% (pacing) and 53% (control) and at 2 years, 22% (pacing) and 68% (control). A combined endpoint of syncope or presyncope occurred in significantly fewer patients in the pacing group [23 (37%) vs. 40 (63%); hazard ratio, 0.44; P = 0.002]. Minor device-related adverse events were reported in five patients (4%). Conclusion: In patients aged 40 years or older, affected by severe recurrent reflex syncope and tilt-induced asystole, dual-chamber pacemaker with CLS is highly effective in reducing the recurrences of syncope. Our findings support the inclusion of tilt testing as a useful method to select candidates for cardiac pacing. Study registration: ClinicalTrials.gov identifier NCT02324920, Eudamed number CIV-05-013546. Graphical Abstract: