RT Journal Article
T1 Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole.
A1 Brignole, Michele
A1 Russo, Vincenzo
A1 Arabia, Francesco
A1 Oliveira, Mario
A1 Pedrote, Alonso
A1 Aerts, Arnaud
A1 Rapacciuolo, Antonio
A1 Boveda, Serge
A1 Deharo, Jean Claude
A1 Maglia, Giampiero
A1 Nigro, Gerardo
A1 Giacopelli, Daniele
A1 Gargaro, Alessio
A1 Tomaino, Marco
A1 BioSync CLS trial Investigators, 
K1 Asystolic syncope
K1 Cardiac pacing
K1 Closed loop
K1 Pacemaker
K1 Reflex syncope
K1 Syncope
K1 Tilt testing
K1 stimulation
AB 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. 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%). 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. ClinicalTrials.gov identifier NCT02324920, Eudamed number CIV-05-013546.
YR 2021
FD 2021
LK http://hdl.handle.net/10668/16739
UL http://hdl.handle.net/10668/16739
LA en
DS RISalud
RD Apr 17, 2025