Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up.

Importance: Patients with large annular defects following lumbar microdiscectomy for disc herniation are at increased risk for symptomatic recurrence and reoperation. Objective: To determine whether a bone-anchored annular closure device in addition to lumbar microdiscectomy resulted in lower reherniation and reoperation rates vs lumbar microdiscectomy alone. Design, Setting, and Participants: This secondary analysis of a multicenter randomized clinical trial reports 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites. Patients in this study had a large annular defect (6-10 mm width) following lumbar microdiscectomy for treatment of lumbar disc herniation. Statistical analysis was performed from November to December 2020. Interventions: Lumbar microdiscectomy with additional bone-anchored annular closure device (device group) or lumbar microdiscectomy only (control group). Main Outcomes and Measures: The incidence of symptomatic reherniation, reoperation, and adverse events as well as changes in leg pain, Oswestry Disability Index, and health-related quality of life when comparing the device and control groups over 5 years of follow-up. Results: Among 554 randomized participants (mean [SD] age: 43 [11] years; 327 [59%] were men), 550 were included in the modified intent-to-treat efficacy population (device group: n = 272; 270 [99%] were White); control group: n = 278; 273 [98%] were White) and 550 were included in the as-treated safety population (device group: n = 267; control group: n = 283). The risk of symptomatic reherniation (18.8% [SE, 2.5%] vs 31.6% [SE, 2.9%]; P < .001) and reoperation (16.0% [SE, 2.3%] vs 22.6% [SE, 2.6%]; P = .03) was lower in the device group. There were 53 reoperations in 40 patients in the device group and 82 reoperations in 58 patients in the control group. Scores for leg pain severity, Oswestry Disability Index, and health-related quality of life significantly improved over 5 years of follow-up with no clinically relevant differences between groups. The frequency of serious adverse events was comparable between the treatment groups. Serious adverse events associated with the device or procedure were less frequent in the device group (12.0% vs 20.5%; difference, -8.5%; 95% CI, -14.6% to -2.3%; P = .008). Conclusions and Relevance: In patients who are at high risk of recurrent herniation following lumbar microdiscectomy owing to a large defect in the annulus fibrosus, this study's findings suggest that annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation over 5 years of follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT01283438.

Screening in cryptogenic brain abscess: Do not forget pulmonary arteriovenous malformations.

BACKGROUND: Brain abscess usually occurs secondary to trauma, through contiguous spread (e.g.; dental infections, [paranasal] sinusitis, otitis, and mastoiditis), after intracranial neurosurgical procedures, or through hematogenous spread in case of an arteriovenous (AV) shunt, for example; atrial septum defect. Although uncommon, another possible cause of AV shunt which can facilitate brain abscess is a pulmonary arteriovenous malformation (PAVM). We report a case of brain abscess secondary to a solitary PAVM and review the literature. CASE DESCRIPTION: A 74-year-old male patient presented with headaches, fatigue, low-grade fever, and homonymous hemianopsia. He was diagnosed with a brain abscess in the left occipital lobe. A chest computed tomography (CT) with intravenous (IV) contrast was performed because of fever and respiratory insufficiency in a period where screening for COVID-19 in suspected patients was important. A solitary PAVM of the left lung was diagnosed. Initial stereotactic burr hole drainage of the abscess was insufficient and resection of the abscess was deemed necessary. Routine workup did not reveal any additional pathology apart from the PAVM. After treatment of the cerebral abscess, the PAVM was treated with embolization using an endovascular plug. CONCLUSION: It is recommended to screen for PAVM by chest CT with IV contrast in patients with brain abscess when no obvious source of infection can be identified.

Clinical Implications of Vertebral Endplate Disruptions After Lumbar Discectomy: 3-Year Results from a Randomized Trial of a Bone-Anchored Annular Closure Device.

OBJECTIVE: Vertebral endplate disruptions (VEPD) are common findings on imaging after lumbar surgery. The objective of this study was to explore the clinical implications of VEPD development following lumbar discectomy with or without implant with a bone-anchored annular closure device (ACD). METHODS: This was a multicenter randomized controlled trial of patients with large postsurgical annular defects after limited lumbar discectomy who were randomized to additionally receive an ACD or no additional treatment. VEPD were identified on computed tomography and confirmed by an imaging core laboratory. Clinical outcomes included recurrent herniation, reoperation, Oswestry Disability Index, leg pain, and back pain. Patient follow-up in this study was 3 years. RESULTS: In the ACD group (n=272), the risk of reoperation was lower in patients with vs without VEPD (8% vs 24%, p<0.01), but no other clinical outcomes differed when stratified by VEPD prevalence or size. In the Control group (n=278), the risk of symptomatic reherniation was higher in patients with VEPD (41% vs 23%, p<0.01) and patients with the largest VEPD had the highest reoperation rates. Patient-reported outcomes were not associated with VEPD prevalence or size in the Control group. CONCLUSION: VEPD had no significant influence on patient-reported outcomes at 3 years after lumbar discectomy. VEPD increased the risk of recurrence in patients treated with lumbar discectomy only, but had no negative influence in patients treated with the ACD.

Reoperation After Primary Lumbar Discectomy with or without Implantation of a Bone-Anchored Annular Closure Device: Surgical Strategies and Clinical Outcomes.

OBJECTIVE: To determine whether presence of a bone-anchored annular closure device (ACD) impacts reoperation strategies and subsequent outcomes. METHODS: Patients with large annular defects after single-level limited lumbar discectomy were randomly allocated to receive an ACD or discectomy alone (controls) and were followed for at least 3 years. RESULTS: Among 550 patients, reoperation risk was lower with ACD (11.0% vs. 19.3%). The types of reoperations and operative time were similar in each group, and the ACD did not interfere with surgical planning or operative technique. Fusion success was 87% with ACD versus 85% for controls. Perioperative complications occurred in 22% and 19% of reoperations, respectively. Leg pain and back function were improved with ACD versus controls after fusion procedures, and no group differences were observed after non-fusion reoperations. CONCLUSIONS: In patients undergoing post-discectomy reoperation, patients with an ACD were treated with similar operative techniques, were not exposed to additional surgical risks, and reported comparable clinical outcomes versus those without an ACD.

Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial.

BACKGROUND: The purposes of the present study were to (1) confirm the risk of recurrent lumbar disc herniation in patients with a large anular defect who had undergone limited discectomy and (2) assess potential risk factors within this population. METHODS: The patient population was extracted from the control cohort of a prospective, randomized, multicenter controlled trial investigating the efficacy of an anular closure device following standard limited discectomy. All control patients underwent limited discectomy for the treatment of a single-level symptomatic posterior or posterolateral lumbar disc herniation. Only patients presenting with a large anular defect (6 to 10 mm wide by 4 to 6 mm long) were included in the study (n = 278). Baseline demographic, clinical, and surgical characteristics were recorded. Follow-up evaluations were performed at 6 weeks and at 3, 6, 12, and 24 months. Imaging modalities included magnetic resonance imaging, low-dose computed tomography, and radiographs. Symptomatic recurrent lumbar disc herniation was defined as any symptomatic postoperative herniation on either side of the index level. A multivariate logistic regression analysis of demographic and surgical variables associated with the incidence of recurrent lumbar disc herniation was performed. RESULTS: The mean anular defect area (and standard deviation) was 39.3 ± 9.1 mm2, and the mean excised nuclear tissue volume was 1.3 ± 0.8 mL. At 2 years, the incidence of symptomatic recurrent lumbar disc herniation was 25.3% (64 of 253), with the herniation occurring at a mean of 264 days after the index procedure. Of the 64 patients with recurrent lumbar disc herniation, 36 underwent a subsequent surgical procedure. Logistic regression analysis identified an increased risk for recurrent lumbar disc herniation in females (odds ratio, 2.2) and in patients with greater anular defect widths (odds ratio, 1.3). Furthermore, multivariate logistic regression analyses revealed a significant interaction between age and sex (p = 0.005). CONCLUSIONS: The outcomes of the present study provide the most substantial evidence to date in confirming previous reports of a high risk of reherniation among patients with large anular defects. Among those with large anular defects (width, ≥6 mm), females ≤50 years of age had the highest risk (up to ∼10 times higher) of recurrent lumbar disc herniation. It is recommended that an anular repair or closure should be performed after limited discectomies in patients with large anular defects. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial.

BACKGROUND CONTEXT: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PURPOSE: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DESIGN: This is a multicenter, randomized superiority study. PATIENT SAMPLE: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study. OUTCOME MEASURES: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. METHODS: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. RESULTS: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. CONCLUSIONS: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.

Treatment of lumbar spinal stenosis with a total posterior arthroplasty prosthesis: implant description, surgical technique, and a prospective report on 29 patients.

OBJECT: Total disc replacement is an alternative to lumbar fusion, but patients with spinal stenosis, spondylolisthesis, and facet arthropathy are often excluded from this procedure because increased adjacent-segment motion can exacerbate dorsal spondylotic changes. In such cases of degenerative spondylolisthesis with stenosis, decompression and fusion remain the gold standard of treatment. To avoid attendant loss of motion at the treated segment, the TOPS system is a novel total posterior arthroplasty prosthesis that allows for an alternative dynamic, multiaxial, three-column stabilization and motion preservation. The purpose of this study is to report preliminary surgical data and clinical outcomes in patients treated with the TOPS lumbar total posterior arthroplasty system. METHODS: Twenty-nine patients were enrolled in a nonrandomized, multicenter, prospective pilot study outside the US. All patients had spinal stenosis and/or spondylolisthesis at L4-5 due to facet arthropathy. Radiographs and scores on outcome measures including the visual analog scale (VAS) for pain, Oswestry Disability Index (ODI), Short Form-36, and Zurich Claudication Questionnaire were prospectively recorded before surgery and at 6-week, 3-month, 6-month, and 1-year intervals after surgery. Prior to instrumentation, a bilateral total facetectomy and laminectomy at L4-5 or L3-4 was performed via a standard midline posterior approach. After decompression, the TOPS screws were inserted into four pedicles to achieve maximal purchase with triangulating bicortical trajectories. An appropriately sized TOPS arthroplasty implant was then applied. The mean surgical time was 3.1 hours, and patients' clinical status improved significantly following treatment with the TOPS device. The mean ODI score decreased compared with baseline by 41% at 1 year, and the 100-mm VAS score declined by 76 mm over the same time period. Radiographic analysis showed that lumbar motion was maintained, disc height was preserved, and no evidence of screw loosening was found. No device malfunctions or migrations and no device-related adverse events were reported during the study. CONCLUSIONS: The TOPS total posterior arthroplasty system represents a novel, dynamic, posterior arthroplasty device that provides multiaxial stability in flexion, extension, rotation, and lateral bending after total facetectomy and neural decompression. The surgical data indicate that it can be safely applied via a traditional approach with low surgical morbidity and excellent 1-year functional and radiographic outcomes in patients with degenerative spondylolisthesis accompanied by stenosis and back pain.