Comparison of Adverse Outcomes Following Placement of Superion Interspinous Spacer Device Versus Laminectomy and Laminotomy

Abstract

Background: Current evidence suggests placement of the Superion interspinous spacer (SISS) device compared with laminectomy or laminotomy surgery offers an effective, less invasive treatment option for patients with symptomatic lumbar spinal stenosis. Both SISS placement and laminectomy or laminotomy have risks of complications and a direct comparison of complications between the 2 procedures has not been previously studied. The purpose of this study is to compare the short-term complications of the SISS with laminectomy or laminotomy and highlight device-specific long-term outcomes with SISS.Methods: Via retrospective review, 189 patients who received lumbar level SISSs were compared with 378 matched controls who underwent primary lumbar spine laminectomy or laminotomy; data were collected from the American College of Surgeons National Surgical Quality Improvement Program database. Complications analyzed included rates of wound infection, pulmonary embolism, deep venous thrombosis, urinary tract infection, sepsis, septic shock, cardiac arrest, death, and reoperation within 30 days of index surgery. Differences between groups were analyzed using the v 2 test. Device-specific complication (DSC) rates included device malfunction or misplacement (DM), device explantation (DE), spinous process fracture (SPF), and subsequent spinal surgery (SSS).Results: No differences in demographics or comorbidities existed between groups. There was no significant difference in rates of complications between groups. A total of 44.4% of patients in the SISS group experienced DSCs with 11.1% of patients experiencing DM, 21.1% experiencing an SPF, 20.1% requiring DE, and 24.3% requiring SSS. Having at least 1 DSC significantly increased odds of SSS, odds ratio .120, P , .0001.Conclusion: Rates of 30-day complications in the SISS group were not significantly different from patients undergoing laminectomy or laminotomy. Rates of 2-year DSC within SISS and cumulative risk associated with these complications should be considered further as they likely represent need for additional procedures for patients and substantial cost to the healthcare system.Level of Evidence: 4. Clinical Relevance: Having no differences in adverse events between laminectomies or laminotomies and SISS plus evidence of substantial device-specific long-term adverse outcomes and reoperation should be given consideration when deciding on surgical intervention of 1-2 level lumbar spinal stenosis.

Percutaneous image‐guided lumbar decompression and interspinous spacers for the treatment of lumbar spinal stenosis: A 2‐year Medicare Claims Benchmark Study

“…The rate of mechanical complications in the Medicare claims interspinous spacer cohort of 10.3% may similarly be overstated, but this rate is actually lower than a recent study by Welton et al 7 which reported spacer complication rates of 11.1% for device misplacement/malfunction, 20.1% for device explant, and 21.1% for spinous process fracture. This marked difference in mechanical complication rates may be attributed to coding practice for the Medicare claims dataset.…”

“…Without mechanical complications, the mild cohort harm rate would be approximately 2% which is in line with other safety reports of the mild procedure at 2-year followup including a 1.3% rate of device or procedure-related adverse events in the ENCORE randomized controlled trial, and a 0% rate in the MOTION randomized controlled trial. 1,6 The rate of mechanical complications in the Medicare claims interspinous spacer cohort of 10.3% may similarly be overstated, but this rate is actually lower than a recent study by Welton et al 7 which reported spacer complication rates of 11.1% for device misplacement/malfunction, 20.1% for device explant, and 21.1% for spinous process fracture. This marked difference in mechanical complication rates may be attributed to coding practice for the Medicare claims dataset.…”

Neurosurgical Management of Interspinous Device Complications: A Case Series

“…Complications of IPD placement have been explored previously in patient series large and small (28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38). The present study is novel in several ways.…”

Comparison analysis of safety outcomes and the rate of subsequent spinal procedures between interspinous spacer without decompression versus minimally invasive lumbar decompression

“…Rates of subsequent spine surgery vary in previous studies. For example, Welton et al identified a subsequent spine surgery in 24.3% of patients receiving ISD over a 2-year follow-up, 27 while Hagerdone et al report that 5.3% of MILD patients and 0.8% ISD patients underwent subsequent lumbar spine surgery (p=0.093), representing either fusion or laminectomy. 28 …”

“…Rates of subsequent spine surgery vary in previous studies. For example, Welton et al identified a subsequent spine surgery in 24.3% of patients receiving ISD over a 2-year follow-up, 27 while Hagerdone et al report that 5.3% of MILD patients and 0.8% ISD patients underwent subsequent lumbar spine surgery (p=0.093), representing either fusion or laminectomy. 28 In the current data, reoperation occurred in 9.8% of the ISD cohort, which is less than half of that reported in the Superion †In claims data outcomes determined by ICD-10-PC or CPT codes are limited to a procedure rather than a device.…”