Abstract
Objectives
Minimally invasive MR-guided laser interstitial thermal therapy (MRgLITT) has been proposed as an alternative to open epilepsy surgery, to address concerns regarding the risk of open surgery. Our primary hypothesis was seizure freedom one-year after MRgLITT was noninferior to open surgery in children with drug-resistant epilepsy (DRE). The secondary hypothesis was MRgLITT has fewer complications and shorter hospitalization than surgery. The primary objective was to compare seizure outcome of MRgLITT to open surgery in children with DRE. The secondary objective was to compare complications and length of hospitalization of the two treatments.
Methods
This retrospective multi-center cohort study included children with DRE treated with MRgLITT or open surgery with one-year follow-up. Exclusion criteria were corpus callosotomy, neurostimulation, multilobar or hemispheric surgery and lesion with maximal dimension greater than 60 mm. MRgLITT were propensity matched to open surgery patients. The primary outcome was seizure freedom one-year post treatment. The difference in seizure freedom was compared using noninferiority test, with noninferiority margin of -10%. The secondary outcomes were complications and length of hospitalization.
Results
185 MRgLITT patients were matched to 185 open surgery patients. Seizure freedom at one-year follow-up was observed in 89/185 (48.1%) MRgLITT and 114/185 (61.6%) open surgery patients (difference= -13.5%, one-sided 97.5%CI: -23.8% to ∞, PNoninferiority=0.79). The lower confidence interval boundary of -23.8% was below the prespecified noninferiority margin of -10%. Overall complications were lower in MRgLITT compared to open surgery (10.8% vs. 29.2% respectively, p<0.001). Hospitalization was shorter for MRgLITT than open surgery (3.1±2.9 vs. 7.2±6.1 days, p<0.001).
Significance
Seizure outcome of MRgLITT one-year post treatment was inferior to open surgery. However, MRgLITT has the advantage of better safety profile and shorter hospitalization. The findings will help counsel children and parents on the benefits and risks of MRgLITT and contribute to informed decision making on treatment options.
NOV