Burst Spinal Cord Stimulation for Refractory Angina Pectoris: A Prospective Pilot Study-The BAP Study

Refractory angina pectoris (RAP) is a debilitating disease with few treatment options. According to the Grading of Recommendations, Assessment, Development, and Evaluation approach, there is moderate evidence for the efficacy and safety of conventional spinal cord stimulation (SCS) for RAP. Recently, new subthreshold SCS modes have emerged and have been investigated for other ischemic pain syndromes, but not yet for RAP. To date, two case reports have reported favorable effects of burst SCS in the treatment of RAP compared with conventional SCS. However, no prospective cohort studies have investigated burst SCS as a treatment of RAP.

In a prospective pilot study, patients who had previously been successfully treated with conventional SCS were eligible to enroll. Thereafter, their SCS program was changed to burst SCS. At baseline and at one-month follow-up, the Seattle Angina Questionnaire (SAQ), EQ-5D-3L, and patient satisfaction were recorded. The primary outcomeof SAQ summary score at one-month follow-up, and secondary outcomes-SAQ domain scores, EQ-5D-3L scores, (serious) adverse events (AEs), and patient satisfaction-are descriptively reported.

Ten patients were included in the study over a period of 3.5 years. Patient follow-up and data collection were complete. The median SAQ summary score increased from 60 to 79 points at one-month follow-up under burst SCS. One serious AE and one AE were registered.

In this prospective exploratory study, a substantial improvement in angina symptoms and quality of life with burst SCS compared with conventional SCS was found. Larger randomized controlled trials are necessary, feasible, and valuable to further investigate burst SCS as a potentially advantageous treatment for RAP.