Dataset Information

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

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.

SUBMITTER: Brignole M

PROVIDER: S-EPMC7857694 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Brignole Michele M Russo Vincenzo V Arabia Francesco F Oliveira Mario M Pedrote Alonso A Aerts Arnaud A Rapacciuolo Antonio A Boveda Serge S Deharo Jean Claude JC Maglia Giampiero G Nigro Gerardo G Nigro Gerardo G Giacopelli Daniele D Gargaro Alessio A Tomaino Marco M

European heart journal 20210201 5

<h4>Aim</h4>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.<h4>Methods and results</h4>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 eithe ...[more]

PMID: 33279955

Similar Datasets

Project description:BackgroundThe efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research.Methods/designThe BIOSync study is a multicenter, patient- and outcome-assessor-blind, randomized, parallel-arm, placebo-controlled trial with the objective of assessing the clinical benefit of cardiac pacing in patients with frequently recurrent reflex syncope, suspected (but not proven) to be triggered by asystolic pauses as showing a VASIS 2B response to the TT (>3-s pause regardless of blood pressure drop). The primary and secondary endpoints are time to first post-implantation recurrence of syncope or the combination of pre-syncope or syncope, respectively. One hundred and twenty-eight consenting patients will be 1:1 randomized to dual-chamber cardiac pacing 'on' or 'off' after pacemaker implantation, and followed up until the first adjudicated primary endpoint event for a maximum of 2 years. The so-called Closed Loop Stimulation function on top of dual-chamber pacing is the pacing mode selected in the study active arm. Participating patients are asked to self-report syncopal symptoms at least every 3 months with self-administered questionnaires addressed to an independent Adjudication Committee. Patients and members of the Adjudicating Committee are blinded to randomization. The study is designed to detect a 40% relative reduction in the 2-year incidence of syncopal recurrences with 80% statistical power.DiscussionThe BIOSync study is designed to definitively assess the benefit of pacing against placebo in reflex syncope patients with a cardio-inhibitory response to the TT. The study will also provide important information on the efficiency of the TT in appropriately selecting reflex syncope patients for cardiac pacing.Trial registrationClinicalTrials.gov, identifier: NCT02324920 (27 October 2016, date last accessed).

Dataset Information

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

Aim

Methods and results

Conclusion

Study registration

Publications

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

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