(Circulation. 2000;102:294.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Dual-Chamber Pacing in the Treatment of Neurally Mediated Tilt-Positive Cardioinhibitory Syncope
Pacemaker Versus No Therapy: A Multicenter Randomized Study
From the Departments of Cardiology of Royal Brompton Hospital, London, UK (R.S.); Ospedali Riuniti, Lavagna, Italy (M.B.); Ospedale S Maria Nuova, Reggio Emilia, Italy (C.M.); Ospedale Umberto I, Mestre, Italy (A.R.); Ospedale Civile, Cento, Italy (P.A.); Ospedale Bolognini, Seriate, Italy (P.G.); and Hospital Vall d’Hebron, Barcelona, Spain (A.M.).
Correspondence to Michele Brignole, MD, Via A Grilli 164, 16041 Borzonasca, Italy. E-mail brignole{at}omninet.it
Background—This study was performed to compare implantation of a DDI pacemaker with rate hysteresis with no implant in respect to syncopal recurrences in patients with severe cardioinhibitory tilt-positive neurally mediated syncope.
Methods and Results—Forty-two patients from 18 European centers
were randomized to receive a DDI pacemaker programmed to 80 bpm with
hysteresis of 45 bpm (19 patients) or no pacemaker (23 patients).
Inclusion criteria were 
3 syncopes over the last 2 years and a
positive cardioinhibitory (Vasovagal Syncope International
Study types 2A and 2B) response to tilt testing. The median number of
previous syncopal episodes was 6; asystolic response to tilt
testing was present in 36 patients (86%) (mean asystole,
13.9±10.2 seconds). All patients were followed up for a minimum of 1.0
years and a maximum of 6.7 years (mean, 3.7±2.2). One patient (5%) in
the pacemaker arm experienced recurrence of syncope compared
with 14 patients (61%) in the no-pacemaker arm
(P=0.0006). In the no-pacemaker arm, the median time to
first syncopal recurrence was 5 months, with a rate of 0.44 per
year. On repeated tilt testing performed within 15 days after
enrollment, positive responses were observed in 59% of patients with
pacemakers and in 61% of patients without pacemakers
(P=NS).
Conclusions—In a limited, select group of patients with tilt-positive cardioinhibitory syncope, DDI pacing with hysteresis reduced the likelihood of syncope. The benefit of the therapy was maintained over the long term. Even in untreated patients, the syncopal recurrence burden was low. A negative result of tilt testing was not a useful means to evaluate therapy efficacy.
Key Words: syncope • nervous system, autonomic • pacemakers
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