Details

Autor(en) / Beteiligte

• Raviele, Antonio
• Giada, Franco
• Menozzi, Carlo
• Speca, Giancarlo
• Orazi, Serafino
• Gasparini, Gianni
• Sutton, Richard
• Brignole, Michele

Titel

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)

Ist Teil von

• European heart journal, 2004-10, Vol.25 (19), p.1741-1748

Ort / Verlag

Oxford: Oxford University Press

Erscheinungsjahr

2004

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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.