The Reality of Lumbar Discectomy
While widely perceived as a successful procedure, discectomy has a high failure rate over time. Patient satisfaction in larger studies is only about 75% at 1 year1Strömqvist, B, et al: One-Year Report from the Swedish National Spine Register. ACTA ORTHOPAEDICA SUPPLEMENTUM NO. 319, VOL. 76, 2005., and roughly 19% of patients are re-operated by 9 years2Keskimaki I, et al. Reoperations After Lumbar Disc Surgery: A Population-Based Study of Regional and Interspecialty Variations. Spine 25: 1500-8. 2000.,3Malter AD, et al. 5-Year Reoperation Rates After Different Types of Lumbar Spine Surgery. Spine 23: 814-20. 1998..
Failure results from one of two primary causes:
- recurrence of symptoms associated with reherniation
- chronic or worsening back pain
Two parallel studies evaluating reherniation and back pain post-discectomy found that treating these two failure modes created an average additional direct-medical cost of over $7,500 per originally operated patient within the first two years4Garcés Ambrossi GL, et al. Recurrent Lumbar Disc Herniation after Single-Level Lumbar Discectomy: Incidence and Health Care Cost Analysis. Neurosurgery 65:574-578, 2009.,5.Parker SL, etl. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. Journal of Neurosurgy: Spine 12: 178-82. 2010.
With more than 1,000,000 discectomy procedures performed each year, avoiding these failures and improving patient outcomes would result in tremendous savings for patients and payers alike.
Optimally, if only the patients who were at highest risk of failure could be identified and treated with Barricaid®, the average savings could be magnified, as patients who are unlikely to fail would be excepted.
The overall risk of recurrent disc herniation varies between 2-18% in reported literature6Atlas, S, et al: Long-Term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation: 10 Year Results from the Maine Lumbar Spine Study. Spine 2005: 30(8): 927-935.,7Weinstein, J, et al: Surgical Versus Nonoperative Treatment for Lumbar Disc Herniation: Four-Year Results for the Spine Patient Outcomes Research Trial (SPORT). Spine 2008: 33(25):2789-2800.,8Watters WC and McGirt MJ. An evidence-based review of the literature on the consequences of conservative versus aggressive discectomy for the treatment of primary disc herniation with radiculopathy. The Spine Journal 9: 240-57. 2009. There is strong evidence that reherniation rate is influenced by the size of the defect in the anulus. Patients with small or slit defects in the anulus have as low as 1% risk of recurrence while those with larger defects have between 18-27% risk9Carragee, E, et al. Clinical Outcomes After Lumbar Discectomy for Sciatica: The Effects of Fragment Type and Anular Competence. JBJS: 85-A (1): 102-108. 2003.,10McGirt MJ et al. A Prospective Cohort Study of Close Interval Computed Tomography and Magnetic Resonance Imaging After Primary Lumbar Discectomy: Factors Associated With Recurrent Disc Herniation and Disc Height Loss. Spine 34: 2044-51. 2009..
Chronic or worsening back pain
Until the availability of anular closure technologies, surgeons had only one option to reduce the risk of recurrence in these larger defect patients – aggressive removal of the remaining nucleus. This technique is effective at decreasing reherniation, but at the cost of significantly worse clinical outcomes and lower patient satisfaction11McGirt MJ et al. Recurrent Disc Herniation and Long-Term Back Pain After Primary Lumbar Discectomy: Review of Outcomes Reported for Limited Versus Aggressive Disc Removal. Neurosurgery 64: 338-45. 2009..
Chronic or worsening back pain following discectomy has been reported in the literature as another frequent failure mode, with rates between 7-37%12Parker SL, etl. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. Journal of Neurosurgy: Spine 12: 178-82. 2010.,13McGirt MJ et al. Recurrent Disc Herniation and Long-Term Back Pain After Primary Lumbar Discectomy: Review of Outcomes Reported for Limited Versus Aggressive Disc Removal. Neurosurgery 64: 338-45. 2009..
Worsening back pain following discectomy has been correlated with a greater loss of disc height14Yorimitsu E et al. Long-Term Outcomes of Standard Discectomy for Lumbar Disc Herniation: A Follow-Up Study of More Than 10 Years. Spine 26: 652-7. 2001.. Greater disc height loss has in turn been linked to greater nucleus removal at the time of surgery15McGirt MJ et al. A Prospective Cohort Study of Close Interval Computed Tomography and Magnetic Resonance Imaging After Primary Lumbar Discectomy: Factors Associated With Recurrent Disc Herniation and Disc Height Loss. Spine 34: 2044-51. 2009.. As more nuclear material is removed from within the disc, the less capable it is of supporting the weight on the spine and the greater the risk of collapse. Therefore, patients with tall, healthy discs pre-operatively have the most to gain and preserve through limited discectomy combined with anular closure, reducing the amount of nucleus that needs to be removed.