RESUMEN
BACKGROUND: Temporary sympathectomy by injection of bupivacaine at the site of the left stellate ganglion is used in the management of refractory angina at several UK centres. Although patients frequently report significant reduction in symptoms, efficacy has not been established by double-blind, randomised placebo-controlled trial (RCT). OBJECTIVE: To investigate the efficacy of the procedure for the first time by a double-blind RCT. METHODS: Consecutive patients referred to the authors' National Health Service (NHS) angina centre who were candidates for temporary sympathectomy were invited to participate in a trial. A total of 65 patients were randomised to receive either bupivacaine or saline injections. Identical syringes were prepared remotely, blinding patients and staff from randomisation. Cardiac autonomic function was measured 3 hours pre- and post-injection using new heart rate variability (HRV) analyses. Angina episodes were recorded contemporaneously by patients in study diaries in the 7-day periods pre- and post-injection. RESULTS: In 51 patients suitable for analysis, no significant differences between the active and placebo groups were found in patient-recorded frequency or intensity of angina episodes pre- and post-injection. However, across both groups combined, a significant difference was found in the frequency of angina episodes pre- and post-injection. CONCLUSION: The reduction in frequency of angina episodes produced by this procedure may not be due to drug pharmacology. It may be a placebo response or due to the mechanical effects of the injection of fluid. There is a need for further work using a larger patient cohort considering both mechanical and psychological factors.
RESUMEN
Chronic refractory angina is an increasingly prevalent, complex chronic pain condition, which results in frequent hospitalization for chest pain. We have previously shown that a novel outpatient cognitive-behavioral chronic disease management program (CB-CDMP) improves angina status and quality of life in such patients. In the present study of 271 chronic refractory angina patients enrolled in our CB-CDMP, total hospital admissions were reduced from 2.40 admissions per patient per year to 1.78 admissions per patient per year (P<0.001). The rising trend of total hospital bed day occupancy prior to enrollment fell from 15.48 days per patient per year to a stable 10.34 days per patient per year (P<0.001). There were 32 recorded myocardial infarctions prior to enrollment compared to eight in the year following enrollment (14% vs. 2.3%, P<0.001) and overall mortality was lower that comparable groups treated with surgery. This study shows that educating patients and demystifying angina using a brief outpatient CB-CDMP produces an immediate and sustained reduction in hospital admission costs that represents a major potential health care saving. This benefit accrues in addition to the known effects of CB-CDMP on symptoms and quality of life. These data suggest that a CB-CDMP approach to symptom palliation represents a low cost alternative to palliative revascularization.