Follow‐up
infection, fracture, dislocation
INFECTION, MYOCARDIAL ISCHEMIA, COMPLICATIONS
At baseline the SAQ, RAND‐36, NRS‐scale, and CCS class will be completed when the patient is seen for the initial standardized TENS treadmill test. The baseline 6‐MWT will be performed after the baseline myocardial perfusion PET scan has shown myocardial ischemia. After spinal cord stimulator implantation the follow‐up appointments will take place at the outpatient clinic of the department of anesthesiology. Patients will be seen at the outpatient clinic one week (to check the surgical wounds), 1, 3, 6 months, and 1 year after initial spinal cord stimulator implantation.At 6 months the myocardial perfusion PET scan will be repeated before the 6‐month outpatient clinic appointment. The SAQ, RAND‐36, NRS‐scale, CCS class, and 6‐MWT will be completed when the patient is seen for the 6‐month outpatient clinic visit. After confirmation that all data are complete by a member of the research team (excluding the study nurse), the patient has an appointment with the study nurse. At this appointment the study nurse will change the programming according to the randomization, from “SCS ON” to “SCS OFF” or vice versa. The programming of the spinal cord stimulator is performed in the same manner and by the same study nurse as was done at baseline ensuring that the blinding of the patient and the rest of the research team remains intact. At 12 months the myocardial perfusion PET scan will be repeated before the final, 12‐month outpatient clinic appointment. Additionally the SAQ, RAND‐36, NRS‐scale, CCS class, and 6‐MWT will be completed when the patient is seen for the final outpatient clinic appointment by a member of the research team in the same fashion as the 6 month appointment. At this final appointment, after confirmation of complete data, the spinal cord stimulator settings will be set to conventional spinal cord stimulation by the study nurse in the same manner as the 6 month appointment. In addition the patient will be asked during which period of the study, the first or second 6 months, it was thought that the spinal cord stimulator was turned on.For the duration of the study patients are asked to contact our center to inform us if visits to the emergency room, admissions to hospital and/or the undergoing of a PCI and/or CABG have occurred. If complications arise related to the implanted spinal cord stimulator (i.e., signs of infection, battery dislocation, lead dislocation, and/or lead fracture) patients will be asked to contact the outpatient clinic of the department of anesthesiology to determine the appropriate course of action.After completion of the study patients will be invited to the outpatient clinic each year for a total duration of 5 years for long‐term follow‐up. At each outpatient clinic appointment patients will be asked to complete the SAQ, RAND‐36, NRS‐scale, CCS class, and 6‐MWT.