Axial lumbar interbody fusion: a 6-year single-center experience

Dick J Zeilstra,1 Larry E Miller,2,3 Jon E Block3 1Bergman Clinics, Naarden and NedSpine, Ede, The Netherlands; 2Miller Scientific Consulting, Inc, Arden, NC, USA; 3The Jon Block Group, San Francisco, CA, USA Introduction: The aim of this study is to report our 6-year single-center experience with L5–S1 axial lumbar interbody fusion (AxiaLIF). Methods: A total of 131 patients with symptomatic degenerative disc disease refractory to nonsurgical treatment were treated with AxiaLIF at L5–S1, and were followed for a minimum of 1 year (mean: 21 months). Main outcomes included back and leg pain severity, Oswestry Disability Index score, working status, analgesic medication use, patient satisfaction, and complications. Computed tomography was used to determine postoperative fusion status. Results: No intraoperative complications, including vascular, neural, urologic, or bowel injuries, were reported. Back and leg pain severity decreased by 51% and 42%, respectively, during the follow-up period (both P < 0.001). Back function scores improved 50% compared to baseline. Clinical success, defined as improvement ≥30%, was 67% for back pain severity, 65% for leg pain severity, and 71% for back function. The employment rate increased from 47% before surgery to 64% at final follow-up (P < 0.001). Less than one in four patients regularly used analgesic medications postsurgery. Patient satisfaction with the AxiaLIF procedure was 83%. The fusion rate was 87.8% at final follow-up. During follow-up, 17 (13.0%) patients underwent 18 reoperations on the lumbar spine, including pedicle screw fixation (n = 10), total disc replacement of an uninvolved level (n = 3), facet screw fixation (n = 3), facet screw removal (n = 1), and interbody fusion at L4–L5 (n = 1). Eight (6.1%) reoperations were at the index level. Conclusion: Single-level AxiaLIF is a safe and effective means to achieve lumbosacral fusion in patients with symptomatic degenerative disc disease. Keywords: AxiaLIF, interbody, fusion, lumbosacral, minimally invasive, presacra

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery