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June 8, 1999Circulation

Dual-chamber pacing showed no significant differences compared to pacing backup for subjective or objective measures of symptoms or exercise capacity in patients with obstructive HCM.

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Why the study?

Does dual-chamber pacing improve symptoms or exercise capacity in symptomatic patients with obstructive hypertrophic cardiomyopathy refractory to drug therapy?

Population

48 symptomatic patients with obstructive hypertrophic cardiomyopathy with ≥50 mm Hg basal gradient…

Comparison

Dual-chamber pacing (DDD) for 3 months vs Pacing backup (AAI-30) for 3 months

Design

RCT, Randomized to 3 months each of DDD pacing and pacing backup in a…

Follow-up

12 months

Key result

Dual-chamber pacing showed no significant differences compared to pacing backup for subjective or objective measures of symptoms or exercise capacity in patients with obstructive HCM.

Authors

BMBarry J. MaronRNRick A. NishimuraWMWilliam J. McKenna

Discussion

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Member takes

Overview

No benefit over backup pacing in obstructive HCM; challenges perceived gains from prior uncontrolled observations.

Study Design

Type

RCT (n=48)

Blinding

Double-blind

Randomization

crossover

Multicenter

Yes

Structured PICO

Does dual-chamber pacing improve symptoms or exercise capacity in symptomatic patients with obstructive hypertrophic cardiomyopathy refractory to drug therapy?

P
Population
48 symptomatic patients with obstructive hypertrophic cardiomyopathy (HCM) with ≥50 mm Hg basal gradient, refractory to drug therapy
I
Intervention
Dual-chamber pacing (DDD) for 3 months
C
Comparator
Pacing backup (AAI-30) for 3 months
O
Outcome
Subjective or objective measures of symptoms or exercise capacity, including NYHA functional class, quality of life score, treadmill exercise time or peak oxygen consumptionsurrogate

Main Result

p-value: p=NS

Dual-chamber pacing does not provide objective improvement in symptoms or exercise capacity compared to backup pacing in patients with obstructive HCM, suggesting perceived benefits in uncontrolled settings are largely due to a placebo effect.

Cite This Study

Maron et al. (1999) conducted an RCT in obstructive hypertrophic cardiomyopathy (HCM) (n=48). Dual-chamber pacing (DDD) vs. pacing backup (AAI-30) was evaluated on subjective or objective measures of symptoms or exercise capacity (NYHA class, quality of life, treadmill time, peak oxygen consumption) (p=NS). Dual-chamber pacing showed no significant differences compared to pacing backup for subjective or objective measures of symptoms or exercise capacity in patients with obstructive HCM.

synapsesocial.com/papers/6a0f05c42eca052da6480698https://doi.org/10.1161/01.cir.99.22.2927
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