Barricaid®
Barricaid is designed to close large defects in the annulus, so to prevent recurrent disc herniation, while allowing the surgeon to preserve more of the patient’s lumbar disc.
The Barricaid Anular Closure device consists of a woven polyester occlusion component intended to block an anular defect, while anchored to the adjacent vertebral body by a titanium bone anchor.
Reinforcing the annulus fibrosus with Barricaid during lumbar discectomy may slow the progression of facet joint degeneration 1).
The polymer mesh is placed on the inner surface of the disc annulus, using the disc pressure to help seal the defect against leakage of nucleus. Once wound dissection and (partial, hemi-) laminectomy have been done, discectomy is followed. However, aggressive nucleus removal has been shown to result in significant back pain and worsened clinical outcomes. After discectomy, the annular defect size is measured and the appropriate sized device is chosen. The titanium anchor is inserted into the bone (parallel to the surface of the endplate) and the mesh forms a barrier that blocks the defect.
The device provides permanent fixation through bone anchorage and remains inside the disc. During the procedure, fluoroscopic guidance is required to ensure appropriate location of the device.
Annular closure device insertion allows more nucleus to be left inside of annulus and restores intra-discal pressure. Because only partial volume is removed from the intervertebral disc, this procedure can preserve disc height and motion and reduce facet degeneration.
Case series
Forty-six consecutive patients undergoing lumbar discectomy for single-level herniated disk at 2 institutions were followed prospectively with clinical and radiographic evaluations at 6 weeks and 3, 6, 12, and 24 months (control cohort). A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed similarly. Incidence of recurrent disk herniation, disk height loss, the leg and back pain visual analog scale (VAS), and the Oswestry Disability Index were assessed at each follow-up.
Cohorts were well matched at baseline. By 2 years of follow-up, symptomatic recurrent same-level disk herniation occurred in 3 (6.5%) patients in the control cohort versus 0 (0%) patients in the annular repair cohort (P=0.27). A trend of greater preservation of disk height was observed in the annular repair versus the control cohort 3 months (7.9 vs. 7.27 mm, P=0.08), 6 months (7.81 vs. 7.18 mm, P=0.09), and 12 months (7.63 vs. 6.9 mm, P=0.06) postoperatively. The annular closure cohort reported less leg pain (VAS-LP: 5 vs. 16, P<0.01), back pain (VAS-BP: 13 vs. 22, P<0.05), and disability (Oswestry Disability Index: 16 vs. 22, P<0.05) 1 year postoperatively.
Implantation of a novel annular repair device was associated with greater maintenance of disk height and improved 1-year leg pain, back pain, and low-back disability. Recurrent disk herniation did not occur in any patient after annular repair. Closure of annular defect after lumbar discectomy may help preserve the physiological disk function and prevent long-term disk height loss and associated back and leg pain 2).
Hahn et al., demonstrated the preliminary reports of Barricaid® insertion in 3 patients who underwent surgery for lumbar disc herniation.
The early experience of Barricaid® implantation showed preserved disc heights and delayed disc degeneration, and improved leg and back pain. However, greater number of cohort and longer duration of follow-up would be necessary in the future study to estimate the effectiveness and safety of this device. We hope our experience to be shared with others and helpful to future trial of Barricaid® insertion. 3).
While widely perceived as a successful procedure, discectomy surgery has a high failure rate over time. The overall risk of recurrent disc herniation varies between 2-18% in reported literature. The Barricaid® anular closure device was designed as an adjunct to lumbar limited microdiscectomy to block large anular defects while maintaining as much native nucleus within the disc space. Patients that are considered for anular closure have a minimum posterior disc height of 5mm, and an intra-operatively measured anular defect between 5mm and 12mm wide. The aim of this study was determined as to assess the cost effectiveness of the use of Barricaid® in this group of patients in Turkey. Methods: A simple decision analysis model was used to assess the cost effectiveness of the use of Barricaid®. The primary clinical endpoint was determined as the number of prevented reherniations. According to the literature, the use of Barricaid® reduced the number of reherniations by 18%. Resource utilization data were obtained via expert clinical opinion and included pre-op, post-op and follow-up costs, etc. Unit costs were taken from the Social Security Institution’s official price list. Results were presented as incremental cost/number of prevented reherniations. The comparison was made between using and not using the Barricaid®. Results: According to the results of the cost effectiveness analysis, the incremental number of prevented reherniation was 4.398 with Barricaid® and incremental cost was 119.343.000 TL. The ICER was within the limits of the threshold recommended by the World Health Organization with 27.136 TL. Conclusions: Use of Barriciad® in lumbar discectomy surgery is a cost-effective treatment option in Turkey 4).
Trummer et al., investigated whether implantation with the Barricaid annular closure device (ACD) during discectomy reduced the rate of facet degeneration. Inclusion criteria were primary lumbar disc herniation failing conservative treatment, Visual Analog Scale (VAS) Leg≥40/100, Oswestry Disability Index (ODI)≥40/100 and defects that were ≤60 mm2 (Barricaid arm only), and patient age 18-75. CT interpretations were collected preoperatively and 12 months post-discectomy. Patients implanted with Barricaid had significantly reduced rates and grades of facet degeneration than patients without Barricaid. Reinforcing the annulus fibrosus with Barricaid during lumbar discectomy may slow the progression of facet joint degeneration 5).
Case reports
Lange et al., from the Department of Neurosurgery, Klinikum Rechts der Isar, Technische Universität Munich, Germany, report the unusual case of a young patient with reoperation after annuloplasty using the Barricaid® (Intrinsic Therapeutics, Woburn, MA, USA) closure device.
A 32-year-old man underwent lumbar discectomy and annuloplasty of the level L5-S1. Five years later, the patient presented with a new onset of low back pain radiating into the right leg. Imaging revealed loosening of the annulus repair device. The device was removed surgically and the patient was pain free thereafter. Annular closure devices such as the Barricaid system aim to improve outcome after lumbar discectomy by reducing the risk of recurrent disc herniation of the same level. Data on long-term follow-up are missing. This is the first case of symptomatic device loosening 6).
Krutko et al.,described a case of reoperation after microdiscectomy and annuloplasty using the Barricaid®.
A month after the operation, the patient complained of back and right leg pain. Examination revealed bone resorption around the implant and signs of inflammatory changes in the adjacent tissues. Laboratory analysis revealed no increase in acute-phase response indicators. Taking into account the clinical data, the data obtained by instrumental methods, and resistance to conservative therapy, the patient underwent revision surgery. No signs of purulent inflammation around the implant were revealed intraoperatively. The implant resided at a typical site but was easy to displace. The adjacent tissue was harvested for bacteriological examination. The revealed changes were regarded as aseptic loosening of the implant. A decision was made to remove the implant and perform transpedicular and interbody fixation of the functional spinal unit. The bacteriological study of peri-implant tissues revealed no microflora growth. The patient was mobilized on the day of surgery. The wounds healed by primary intention. On day 7, the patient was discharged for outpatient treatment. At discharge, the VAS scores of leg pain and back pain were 0 and 4, respectively. Patient’s condition remained stable within the subsequent 9 months: he had no complaints and experienced no pain 7).