The adult evidence came from a prospective, multicenter, real-world study involving 124 patients with drug-resistant epilepsy at 83 epilepsy centers across China. All participants received a domestic VNS system as add-on therapy. A responder was defined as a patient whose seizure frequency fell by at least 50%.

The responder proportion was 35.4% one month after implantation, 41.6% at three months, 62.2% at six months, 64.2% at nine months and 76.6% at 12 months. The seizure-free proportion was 2.4% at one month, 9.2% at six months and 10.9% at 12 months. These were available-case calculations rather than analyses based on the full baseline cohort.

The number contributing data declined over follow-up: 49 patients were classified as responders and 15 as nonresponders at 12 months, compared with 124 patients at baseline. The synthesis did not apply a repeated-measures model, and the original study’s analytical approach is required for further interpretation of attrition and time-specific estimates. The adult study recorded adverse events in 34 of 124 patients, or 26.6%.

Voice changes or hoarseness were reported in 20.3% and cough in 8.6%. Nausea, headache, infection, hematoma and pain were each reported in 1.6% or fewer patients. The source describes most events as stimulation-related, mild to moderate and transient, and reports no serious adverse event that required device removal.

The progressive pattern nevertheless resembled the time-dependent “staircase” response described elsewhere in the VNS literature. The synthesis also notes that the adult cohort and a separate comorbidity cohort may overlap in participants, centers or recruitment periods, and it did not independently verify or adjust for that overlap. A separate multicenter cohort examined 87 children aged 1 to 16 years with refractory epilepsy across 86 centers and completed six-month follow-up assessments.

When seizure freedom, a 75% seizure reduction and a 50% reduction were combined into a common category of at least a 50% reduction, the rates were 18.4% at the baseline visit, 43.4% at visit 2, 40.6% at visit 3, 56.6% at visit 4 and 55.8% at visit 5. Seizure freedom was recorded in 1.1% of children at baseline, 3.9% at visit 2, 4.3% at visit 3, 5.7% at visit 4 and 9.3% at visit 5. Only two cases of mild dizziness were reported, and no serious adverse events occurred.

The synthesis identifies inconsistencies between narrative figures in the original pediatric report and its visit-level table, stating that the pediatric figures should be verified against the original source and corrected throughout the manuscript. The shorter follow-up and the severity and etiologic heterogeneity of pediatric epilepsy further restrict comparisons with the adult cohort. Beyond seizure outcomes, a longitudinal study of 113 adults found improvements over time in sleep quality, depressive symptoms, anxiety and quality of life.

Mean Pittsburgh Sleep Quality Index scores decreased from 5.43 at baseline to 4.44 at the last follow-up. The mean Neurological Disorders Depression Inventory for Epilepsy score decreased from 6.49 to 4.83, and the Generalized Anxiety Disorder-7 score decreased from 7.15 to 4.95. The Quality of Life in Epilepsy-31 score increased from 54.40 to 61.33.

All four changes were reported as statistically significant, with p values below 0.001. The original analysis suggested that some improvement might be partly independent of seizure control and reported that the changes were already evident at the second follow-up, one month after implantation. A generalized estimation equation model indicated that the improvements persisted over follow-up, despite fluctuations in the last two assessments.

The single-arm observational design, however, cannot establish a direct causal effect of VNS on mood, sleep or quality of life independent of seizure improvement. The Chinese three-tier epilepsy network provides the organizational framework for domestic VNS delivery. CAAE accreditation records identified 526 centers: 45 Tier-3 comprehensive epilepsy centers, 259 Tier-2 epilepsy centers and 222 Tier-1 epilepsy specialty clinics.

Tier-3 centers undertake complex VNS implantation, individualized parameter adjustment, new-technology development and professional training. Tier-2 centers provide standardized diagnosis and treatment within regional networks, including preoperative assessment, surgery, multidisciplinary management and referrals to higher or lower tiers. They are intended to perform most routine VNS procedures.

Tier-1 clinics provide initial screening, referral coordination, postoperative programming and long-term follow-up. Telemedicine platforms and data-sharing mechanisms are intended to support cross-institutional collaboration. A cloud database is designed to manage electronic medical records, treatment parameters and follow-up information, with secure sharing intended to assist clinical research and quality monitoring.

Standardized procedures are intended to support consistent device use across the network. CAAE experts have formulated normative documents, including a Chinese expert consensus on VNS for drug-resistant epilepsy and a draft standard operating procedure for VNS in epilepsy treatment. These documents specify requirements for indications and contraindications, preoperative assessment, implantation, postoperative follow-up and programming.

The network therefore combines a common procedural framework with a division of clinical responsibilities. However, the synthesis is descriptive and does not demonstrate that the network itself increased access, improved outcomes or reduced delays. Uneven regional capacity remains.

Eastern China accounted for 43.91% of epilepsy centers and 66.47% of cumulative VNS procedures performed from 2022 through 2023, while the western and northeastern regions together accounted for less than 15%. Treatment gaps were reported in areas including Tibet and Inner Mongolia. A 2023 survey also found that 45 Tier-3 centers handled 66.37% of VNS treatment volume, suggesting that the capacity of the more numerous Tier-2 centers had not been fully realized.

Economically, market research cited in the synthesis placed the cost of a complete domestic VNS system at approximately 100,000 renminbi, compared with about 230,000 renminbi for an imported device. The comparison includes the principal system and procedure-related costs described by the source, including high-value consumables, surgery and programming components. The figures were drawn from provincial and municipal tender data for high-value consumables and approximate estimates of average surgery-related costs.

The domestic pulse generator weighs approximately 17 g, has a reported service life of 20 years, includes rechargeable and sensing capabilities and has a minimum programming increment of 0.05 mA. Approximate market data show domestic implantations increasing from 900 in 2022 to 1,500 in 2024, with a projected 1,800 in 2025. Imported implantations were estimated at 200 in 2022 and 2023 and 300 in 2024 and 2025.

These are market-survey estimates rather than prospectively collected clinical or economic data. The lower purchase price does not by itself establish that domestic VNS is more cost-effective. A comprehensive comparison would need to account for generator longevity, replacement costs, programming and follow-up, management of complications, technical support, hospitalization, long-term healthcare utilization and quality-adjusted life-years.

The synthesis did not calculate incremental cost-effectiveness ratios, QALYs, health-state utilities or discounting, and it did not construct a decision-analytic model. It also reports no head-to-head clinical comparison demonstrating equivalent effectiveness between domestic and imported systems. Regulatory and procurement conditions may affect the price difference.

Domestic VNS received approval from China’s National Medical Products Administration and entered clinical use in 2016, whereas imported devices had been used internationally for more than two decades. Import tariffs of approximately 3% and value-added tax of 13% are described in the source, while eligible institutions in the Hainan Free Trade Port may import approved devices under zero-tariff and VAT-exempt policies. Taken together, the synthesis describes domestic VNS as a promising component of a strategy combining locally produced devices, national guidelines and tiered specialist care.

The clinical results remain preliminary: the studies were uncontrolled, adult and pediatric follow-up was short, pediatric outcome figures require verification, and the economic work is a cost comparison rather than a formal cost-effectiveness analysis. The accredited-center setting may also limit how well the results represent smaller, non-accredited facilities. Prospective comparative studies, longer follow-up, independent confirmation of the pediatric data and formal economic modeling would be required before the relative effectiveness, durability, long-term safety and economic value of domestic and imported devices can be established.

The present evidence instead identifies a structured, lower-cost route for further study of VNS in a large and geographically uneven epilepsy-care system.

Subject of Research: Clinical outcomes, health-system delivery and cost comparison of domestic vagus nerve stimulation for drug-resistant epilepsy in China

Article Title: Promotion and economic considerations of domestic Vagus nerve stimulation within the Chinese three-tier epilepsy center system

Article References: Ou, Z., Le, Z., Mi, J., Yan, R., Liu, W., Zhang, E., Xiong, W., Chen, D., Zhou, D., Xue, R., & Wu, X. (2026). Promotion and economic considerations of domestic Vagus nerve stimulation within the Chinese three-tier epilepsy center system. Frontiers in Neurology, 17, Article 1963297. https://doi.org/10.3389/fneur.2026.1963297

Image Credits: AI Generated

DOI: 10.3389/fneur.2026.1963297

Keywords: domestic VNS, drug-resistant epilepsy, seizure reduction, neuromodulation, China, epilepsy centers, patient safety, quality of life, health economics, pediatric epilepsy, Promotion, economic