Abstract
This study evaluated a possible placebo effect by pacemaker implantation. The study
design was a 3-month multicenter, double-blind, randomized cross-over study to compare
the effects of atrioventricular (AV) synchronous pacing with an optimal AV delay to
inactive pacing in patients with obstructive hypertrophic cardiomyopathy (HC). Quality
of life and left ventricular (LV) outflow tract obstruction were evaluated after the
first study period in 40 patients assigned to inactive pacing. Data were compared
with the corresponding results among the 41 subjects assigned to a first study period
of active pacing. During inactive pacing, there was a significant improvement in perceived
chest pain, dyspnea, and palpitations. Moreover, LV outflow tract gradient decreased
from 71 ± 32 mm Hg to 52 ± 34 mm Hg (p = 0.04). In patients assigned to active pacing
the reduction of the gradient was significantly more pronounced (70 ± 24 mm Hg to
33 ± 27 mm Hg; p <0.0001). The difference in gradient reduction between the groups
was highly significant (p <0.00001). In the group assigned to active pacing there
was also significant improvement in perceived symptoms as well as in alertness, the
ability to be self-autonomous, and strenuous physical exercise. The improvements in
the latter were significantly greater in those paced actively compared with patients
paced inactively, whereas the changes in perceived symptoms did not differ between
groups. In conclusion, pacemaker implantation had a placebo effect on objective and
subjective parameters in this group of patients with obstructive HC.
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Article info
Publication history
Published online: August 16, 2004
Accepted:
November 2,
1998
Received in revised form:
November 2,
1998
Received:
July 20,
1998
Footnotes
☆This study was supported by grants from the Swedish Heart and Lung Foundation, The Swedish Society of Medicine, The Swedish Medical Research Council (grant no. B96-19X-11626-01), the Foundation of Claes Groschinsky, Stockholm, Sweden; The Swiss National Foundation for Scientific Research (grant no. 32-37275.93), Geneva, Switzerland; and Bakken Research Center, Medtronic, Maastricht, The Netherlands.
Identification
Copyright
© 1999 Excerpta Medica Inc. Published by Elsevier Inc. All rights reserved.
