Why the study?
Does withholding chronic electrical neuromodulation cause reoccurrence of myocardial ischemia or adverse clinical rebound in patients with severe coronary artery disease and refractory angina?
Does withholding chronic electrical neuromodulation cause reoccurrence of myocardial ischemia or adverse clinical rebound in patients with severe coronary artery disease and refractory angina?
Withholding chronic electrical neuromodulation in patients with refractory angina does not cause an adverse clinical rebound phenomenon or increased ischemia.
Supports temporary withholding of neuromodulation without rebound ischemia in refractory angina; confirms absence of adverse withdrawal effects in this RCT.
The present study assessed the reoccurrence of myocardial ischemia after withholding electrical neurostimulation. After randomization, in the study or withdrawal group, spinal cord stimulation (SCS) was set active during the first 4 weeks, followed by 4 weeks of withholding stimulation. In the control group, SCS was switched off during 4 weeks before the end of the study. The control group had no crossover period. Measurements were done at baseline, then after 4 and 8 weeks. The first periods at 4 weeks of each sequence of both groups were compared. In addition, a comparison of clinical variables was performed between the study group 4 weeks after withholding stimulation and the control group 4 weeks following randomization. A total number of 24 patients with refractory angina and an implanted spinal cord stimulator were included in the study (n = 12) and control group. Angina pectoris complaints, nitroglycerin intake, ischemia, and heart rate variability using 48-hour ambulatory electrocardiographic monitoring were assessed. In addition, neurohormonal status and symptom-limited aerobic capacity were evaluated. There was no increase of anginal complaints or ischemia after withholding stimulation. Neurohormonal levels and aerobic capacity were not altered. We conclude that there is no adverse clinical rebound phenomenon after withholding neurostimulation in patients with refractory angina pectoris.
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JESSURUN et al. (1999) studied this question.
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