Unadjusted Median Monthly Seizure Frequency Change From Baseline to 2 Years: Full Analysis Set
ideation, death, memory impairment complaints, head injury, SUDEP, B), cognitive impairment, seizure, depressive mood, epilepsy, anxiety, depressive mood complaints, infection, memory impairment, headache, depression, deaths, irritability
ADVERSE EVENT, EPILEPSY, ADVERSE EVENTS, INFECTION, INTRACRANIAL HEMORRHAGES
(A) By center implant group. (B) By cognitive impairment. Error bars represent the interquartile range. Differences (A) between center implant groups and (B) cognitive impairment groups are not statistically significantly different using a generalized linear mixed model.Although baseline characteristics of responders, improvers, and no-benefit groups appeared to differ (eTable 2A, We observed an overall 2-point mean improvement in QOLIE-31 (No statistically significant change in the prevalence or severity of depression was observed (The most frequently reported adverse events were changes (e.g., increased frequency/severity) in seizure (16%), memory impairment (patient-reported complaint, 15%), depressive mood (patient-reported complaint, 13%), and epilepsy (12%). Thirty-nine percent of the memory impairment complaints and 44% of the depressive mood complaints were related to worsening of preexisting conditions per site assessment. Other adverse events included headache (7%), head injury (5%), irritability (5%), anxiety (5%), and cognitive impairment (5%, Total Number of Adverse Events by Period (in ≥3% of PatientsThe subgroup of 24 patients with both DBS and VNS had a similar safety profile as the rest of the population (data not shown). A total of 160 serious AEs (SAEs) were reported in 83 subjects (43.5%) from baseline to 2-year follow-up. The most frequently reported SAE was seizure in 18 subjects (10.1%). In this study, SAEs reported as related to procedure, lead, neurostimulator, extension, other DBS component, or programming/stimulation were classified as DBS related. Overall, 59 DBS-related SAEs were reported in 42 subjects (23%) in the 2 years after implant. None of these SAEs led to discontinuation from the study. As with general SAEs, the most frequently reported DBS-related SAEs were seizure in 7 subjects (3.9%). DBS-related SAEs were connected to the procedure (n = 24) or to stimulation/programming (n = 21), whereas 11 (6.1%) were linked to implanted system components. A total of 11 subjects (6.1%) had lead modifications, the most frequent being explant with replacement. There were 2 explants due to infection in 2 (1%) subjects, 1 explant due to suicidal ideation in 1 subject, no intracranial hemorrhages, and no deaths related to DBS. During the second year of follow-up, 1 patient had died with definite sudden unexpected death in epilepsy (SUDEP).