Two-year clinical outcomes of radiofrequency focal ablation using a navigable plasma disc decompression device in patients with lumbar disc herniation: Efficacy and complications

Abstract

Purpose: To report on the 2-year clinical outcomes of focal ablation using a navigable plasma disc decompression device in patients with lumbar herniated nucleus pulposus (HNP). Patients and methods: This was a prospective, single-cohort study conducted in a clinical center. A total of 170 patients with lumbar HNP were assessed for pain intensity using the visual analog scale (VAS), for disability level using the Oswestry Disability Questionnaire (ODI), for health-related quality of life using the short form-36 version 2 of the bodily pain scale (SF-36 BP), and for the angles of passive straight leg raise (SLR) test. The herniated portions of the target discs were ablated using a navigable catheter under a well-instructed protocol with informed consent. Outcome data were prospectively collected before the procedure: 1 week after the procedure: and then 1, 3, 6, 12, and 24 months postoperatively. For statistical analysis, repeated-measures analysis of variance was performed. Results: Two years after the procedure, the mean VAS decreased from 7.1±1.7 to 2.1±1.9, the mean ODI decreased from 50.9±17.2 to 20.3% ± 14.6%, and the mean SF-36 BP increased from 38.8±8.4 to 45.8±9.4 (P<0.05). On the SLR test, the angular change after 2 years improved considerably from 51.2±17.3 to 85.0±9.3 degrees. There was 90%–100% VAS improvement in 25.9% and 50%–90% VAS improvement in 52.4% of the patients; 1.8% experienced pain aggravation compared with the initial VAS. Two subjects showed short-term foot drop, whereas one subject showed the severe complication of foot drop for more than 6 months. The recurrence rate ranged from 4.7% to 11.5%. Conclusion: These findings suggest that focal ablation of herniated discs using a navigable disc decompression device is worth considering for relieving pain related to lumbar HNP. However, the development of more advanced technologies and methods for safety and efficiency is necessary.