(Circulation. 1999;99:2927-2933.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Assessment of Permanent Dual-Chamber Pacing as a Treatment for Drug-Refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy
A Randomized, Double-Blind, Crossover Study (M-PATHY)
From the Minneapolis Heart Institute Foundation (B.J.M.), Minneapolis, Minn; Mayo Clinic (R.A.N.), Rochester, Minn; St. George's Hospital Medical School (W.J.M.), London, England; Toronto Hospital (H.R.), Ontario, Canada; Beth Israel Hospital (M.E.J.), Boston, Mass; Medtronic, Inc. (R.S.K.), Minneapolis, Minn.
Correspondence to Barry J. Maron, MD, Minneapolis Heart Institute Foundation, 920 E. 28th Street, Suite 40, Minneapolis, MN 55407. E-mail gencvres{at}skypoint.com
Background—Dual-chamber pacing (DDD) has been proposed as a treatment alternative to surgery for severely symptomatic patients with obstructive hypertrophic cardiomyopathy (HCM), based largely on uncontrolled studies.
Methods and Results—This prospective, multicenter trial assessed
pacing in 48 symptomatic HCM patients with 
50 mm Hg
basal gradient, refractory to drug therapy. Patients were randomized to
3 months each of DDD pacing and pacing backup (AAI-30) in a
double-blind, crossover study design, followed by an uncontrolled and
unblinded 6-month pacing trial. With randomization, no significant
differences were evident between pacing and no pacing for subjective or
objective measures of symptoms or exercise capacity, including NYHA
functional class, quality of life score, treadmill exercise time or
peak oxygen consumption. After 6 additional months of unblinded pacing,
functional class and quality of life score were improved compared with
baseline (P<0.01), but peak oxygen consumption was
unchanged. Outflow gradient decreased 40%, 82±32 mm Hg to
48±32 mm Hg (P<0.001), and was reduced in 57%
of patients but showed no change or an increase in 43%. At 12 months,
6 individual patients (12%) showed improved functional capacity; each
was 65 to 75 years of age. Left ventricular wall
thicknesses in the overall study group showed no remodeling between
baseline (22±5 mm) and 12 months (21±5 mm;
P=NS).
Conclusions—(1) Pacing cannot be regarded as a primary treatment
for obstructive HCM; (2) with randomization, perceived
symptomatic improvement was most consistent with a
substantial placebo effect; (3) longer, uncontrolled pacing periods
were associated with some subjective benefit but unaccompanied by
objective improvement in cardiovascular
performance and should be interpreted cautiously; (4) modest
reduction in outflow gradient was achieved in most patients; and (5) a
small subset (12%) 65 years of age showed a clinical response,
suggesting that DDD pacing could be a therapeutic option for some
elderly patients.
Key Words: cardiomyopathy • pacing • surgery • hypertrophic cardiomyopathy • placebo
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