Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole

Michele Brignole, Vincenzo Russo, Francesco Arabia, Mario Oliveira, Alonso Pedrote, Arnaud Aerts, Antonio Rapacciuolo, Serge Boveda, Jean Claude Deharo, Giampiero Maglia, Gerardo Nigro, Daniele Giacopelli, Alessio Gargaro, Marco Tomaino, BioSync CLS trial Investigators, Michele Brignole, Vincenzo Russo, Francesco Arabia, Mario Oliveira, Alonso Pedrote, Arnaud Aerts, Antonio Rapacciuolo, Serge Boveda, Jean Claude Deharo, Giampiero Maglia, Gerardo Nigro, Daniele Giacopelli, Alessio Gargaro, Marco Tomaino, BioSync CLS trial Investigators

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.

Keywords: Asystolic syncope; Cardiac pacing; Closed loop; Pacemaker; Reflex syncope; Syncope; Tilt testing; stimulation.

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Study flow. FU, follow-up.
Figure 2
Figure 2
Kaplan–Meier curves comparing survival free of symptoms. (A) Primary endpoint and (B) combined endpoint of syncope or presyncope.
Figure 3
Figure 3
Subgroup analyses of the primary endpoint (forest plot). Hazard ratios are based on Cox proportional hazard model analyses.
Take home figure
Take home figure
Kaplan–Meier curves comparing survival free of syncope.

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Source: PubMed

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