Copyright © 2004 by the European Society of Cardiology.
Clinical research
A randomized, double-blind, placebo-controlled study of permanent cardiac pacing for the treatment of recurrent tilt-induced vasovagal syncope. The vasovagal syncope and pacing trial (SYNPACE)
a Department of Cardiology, Ospedale Umberto I, Via Circonvallazione 50, 30174 Mestre-Venice, Italy
b Department of Cardiology, Ospedale S Maria Nuova, Reggio Emilia, Italy
c Department of Cardiology, Ospedale Civile, Teramo, Italy
d Department of Cardiology, Ospedale Civile, Rieti, Italy
e Department of Cardiology, Royal Brompton Hospital, London, UK
f Department of Cardiology, Ospedale Riuniti, Lavagna, Italy
Received April 4, 2004; revised May 30, 2004; accepted June 17, 2004 * Corresponding author. Tel.: +39-41-260-7201; fax: +39-41-260-7235 (E-mail: araviele{at}tin.it).
AIMS: Recently, some studies revealed the efficacy of pacemaker implantation in decreasing recurrences in patients with vasovagal syncope. As these studies were not blinded or placebo-controlled, the benefits observed might have been due to a bias in the assessment of outcomes or to a placebo effect of the pacemaker. We performed a randomized, double-blind, placebo-controlled study in order to ascertain if pacing therapy reduces the risk of syncope relapse.
METHODS AND RESULTS: Twenty-nine patients (53±16 years; 19 women) with severe recurrent tilt-induced vasovagal syncope (median 12 syncopes in the lifetime) and 1 syncopal relapse after head-up tilt testing underwent implantation of a pacemaker, and were randomized to pacemaker ON or to pacemaker OFF.
During a median of 715 days of follow-up, 8 (50%) patients randomized to pacemaker ON had recurrence of syncope compared to 5 (38%) of patients randomized to pacemaker OFF (p=n.s.); the median time to first syncope was longer in the pacemaker ON than in pacemaker OFF group, although not significantly so (97 [38–144] vs 20 [4–302] days; p=0.38). There was also no significant difference in the subgroups of patients who had had a mixed response and in those who had had an asystolic response during head-up tilt testing.
CONCLUSION: Our data were unable to show a superiority of active pacing versus inactive pacing in preventing syncopal recurrence in patients with severe recurrent tilt-induced vasovagal syncope.
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