Wyniki leczenia bólem stymulacji nerwu błędnego u pacjentów z lekooporną epilepsją: efekty na napady i inne objawy po 36 miesiącach obserwacji

OBJECTIVES: Drug-resistant epilepsy (DRE) affects approximately one-third of all people with epilepsy and carries a disproportionate comorbidity burden. Many people with DRE are not candidates for, or do not want, resective surgery or disconnection procedures; therefore, vagus nerve stimulation (VNS) can be used for treatment. Despite its long-standing use, there is a notable lack of data regarding the newer generations of VNS Therapy devices. This study provides long-term, real-world data on the outcomes of contemporary responsive VNS Therapy devices. MATERIALS AND METHODS: Comprehensive Outcomes From Real-World Evidence for VNS Therapy (CORE-VNS; NCT03529045) is a large, international, observational, prospective study designed to systematically and comprehensively evaluate the clinical and safety outcomes of people with DRE who receive a contemporary VNS system as part of their treatment plan. We report seizure, nonseizure, and safety outcomes data for participants who received their first VNS Therapy implant with at least 36 months of follow-up postimplantation. RESULTS: Initial implantation of the VNS Therapy System was performed in 531 participants, and 426 (80.2%) completed the study. Monthly seizure frequency for combined and individual seizure types was significantly reduced from baseline by the first three-month visit (p < 0.0001) and continued to improve throughout the study. At 36 months, the median percentage change in seizure frequency for all seizures reported at baseline was -76.3% (95% CI -83.33% to -66.67%, p < 0.0001), and 27.6% (n = 108/392; 95% CI 23.9% to 31.5%) of participants no longer reported baseline seizure types. Seizure freedom from all seizures reported during the study was achieved in 16.3% (n = 64/392; 95% CI 13.3% to 19.7%) of participants at the 36-month study visit. CONCLUSIONS: Results of the CORE-VNS study indicate that contemporary VNS Therapy was associated with an early and sustained benefit on seizures in participants with DRE. This reinforces adjunctive VNS Therapy as an important therapeutic option for those who cannot undergo resective surgery or disconnection procedures.