Resective Surgery for Drug-Resistant Epilepsy in Patients With Tuberous Sclerosis Complex: A Prospective Nationwide Multicenter Cohort Study.
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BACKGROUND AND OBJECTIVES: Resective surgery is an effective treatment for tuberous sclerosis complex (TSC)-related drug-resistant epilepsy (DRE). However, high-level evidence validating the effectiveness and safety of this technique is lacking. This study aimed to provide prospective multicenter data comparing resective surgery with medicine treatments. METHODS: This prospective cohort study included patients with TSC-related DRE who were suitable for resective surgery from 2019 to 2022 were identified from 21 centers in China. After collection, patients who underwent resective surgery were entered into the surgery group, whereas those who refused surgery and continued medicine treatment were included in the medicine group. Follow-ups for ≥2 years tracked seizure control, IQ, quality of life (QOL), antiseizure medications (ASMs), and adverse events. Propensity score matching (PSM) was performed to balance baseline demographics and clinical characteristics. Seizure-freedom probabilities were estimated using Kaplan-Meier analysis, and the mixed effects Cox proportional hazards model assessed the risk of seizure recurrence alongside other covariates. RESULTS: Each group comprised 100 patients with a total median age of 6.70 years (interquartile range, 3.73-12.80), and 35% were female patients. PSM-adjusted seizure-freedom rates in the surgery group were 77%, 67%, 66%, and 67% at 1-, 2-, 3-, and 4-year follow-ups, respectively, compared with 13%, 7%, 6%, and 4% in the medicine group. The surgery group had a higher probability of achieving seizure freedom. Resective surgery was identified as the strongest independent predictor reducing post-collection seizure recurrence (hazard ratio, 0.10; 95% CI, 0.05-0.17; p < 0.0001). Significant improvements in IQ and QOL were found at the 2-year follow-up, along with reductions in ASMs across all follow-ups after surgery (p < 0.01). Outstanding tubers were the independent factor for postoperative low seizure recurrence. Serious complications were not found, and no significant differences in adverse events were observed. DISCUSSION: Resective surgery demonstrates significantly higher effectiveness than medicine in seizure control and improvements of IQ and QOL in patients with TSC-related DRE, achieving a 1-year seizure-freedom rate of 77%. Furthermore, the safety of resective surgery is comparable with that of medicine. Outstanding tubers on MRI is an independent predictor of postoperative seizure freedom. Selection bias and possible confounding by site are limitations of this study. TRIAL REGISTRATION INFORMATION: Registered with ClinicalTrials.gov as TRE-RES. Registration number: NCT04198181. Date of the registration submitted to the registry: November 10, 2019. Date of first patient enrollment: December 12, 2019. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that resective surgery provides better seizure control, and improved IQ and quality of life, than medication alone in patients with TSC.