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

INTRODUCTION: Treatment for degenerative lumbar spinal stenosis (LSS) typically begins with conservative care and progresses to minimally invasive procedures, including interspinous spacer without decompression or fusion (ISD) or minimally invasive lumbar decompression (MILD). This study examined safety outcomes and the rate of subsequent spinal procedures among LSS patients receiving an ISD versus MILD as the first surgical intervention. METHODS: 100% Medicare Standard Analytical Files were used to identify patients with an ISD or MILD (first procedure=index date) from 2017 to 2021. ISD and MILD patients were matched 1:1 using propensity score matching based on demographics and clinical characteristics. Safety outcomes and subsequent spinal procedures were captured from index date until end of follow-up. Cox models were used to analyze rates of subsequent surgical interventions, LSS-related interventions, open decompression, fusion, ISD, and MILD. Cox models were used to assess postoperative complications during follow-up and logistic regression to analyze life-threatening complications within 30 days of index procedure. RESULTS: A total of 3682 ISD and 5499 MILD patients were identified. After matching, 3614 from each group were included in the analysis (mean age=74 years, mean follow-up=20.0 months). The risk of undergoing any intervention, LSS-related intervention, open decompression, and MILD were 21%, 28%, 21%, and 81% lower among ISD compared with MILD patients. Multivariate analyses showed no significant differences in the risk of undergoing fusion or ISD, experiencing postoperative complications, or life-threatening complications (all p≥0.241) between the cohorts. CONCLUSIONS: These results showed ISD and MILD procedures have an equivalent safety profile. However, ISDs demonstrated lower rates of open decompression and MILD.

Longitudinal Comparative Analysis of Complications and Subsequent Interventions Following Stand-Alone Interspinous Spacers, Open Decompression, or Fusion for Lumbar Stenosis.

INTRODUCTION: For individuals with lumbar spinal stenosis (LSS), minimally invasive procedures such as an interspinous spacer device without decompression or fusion (ISD) or open surgery (i.e., open decompression or fusion) may relieve symptoms and improve functions when patients fail to respond to conservative therapies. This research compares longitudinal postoperative outcomes and rates of subsequent interventions between LSS patients treated with ISD and those with open decompression or fusion as their first surgical intervention. METHODS: This retrospective, comparative claims analysis identified patients age ≥ 50 years with LSS diagnosis and with a qualifying procedure during 2017-2021 in the Medicare database which includes healthcare encounters in inpatient and outpatient settings. Patients were followed from the qualifying procedure until end of data availability. The outcomes assessed during the follow-up included subsequent surgical interventions, including subsequent fusion and lumbar spine surgeries, long-term complications, and short-term life-threatening events. Additionally, the costs to Medicare during a 3-year follow-up were calculated. Cox proportional hazards, logistic regression, and generalized linear models were used to compare outcomes and costs, adjusted for baseline characteristics. RESULTS: A total of 400,685 patients who received a qualifying procedure were identified (mean age 71.5 years, 50.7% male). Compared to ISD patients, patients receiving open surgery (i.e., decompression and/or fusion) were more likely to have a subsequent fusion [hazard ratio (HR), 95% confidence intervals (CI): 1.49 (1.17, 1.89)-2.54 (2.00, 3.23)] or other lumbar spine surgery [HR (CI): 3.05 (2.18, 4.27)-5.72 (4.08, 8.02)]. Short-term life-threatening events [odds ratio (CI): 2.42 (2.03, 2.88)-6.36 (5.33, 7.57)] and long-term complications [HR (CI): 1:31 (1.13, 1.52)-2.38 (2.05, 2.75)] were more likely among the open surgery cohorts. Adjusted mean index costs were lowest for decompression alone (US$7001) and highest for fusion alone ($33,868). ISD patients had significantly lower 1-year complication-related costs than all surgery cohorts and lower 3-year all-cause costs than fusion cohorts. CONCLUSIONS: ISD resulted in lower risks of short- and long-term complications and lower long-term costs than open decompression and fusion surgeries as a first surgical intervention for LSS.

A wearable epidural catheter infusion system for patients with intractable spontaneous intracranial hypotension.

BACKGROUND AND OBJECTIVES: Spontaneous intracranial hypotension is an important cause of secondary headaches, and most patients respond well to epidural blood patching or direct repair of the underlying spinal cerebrospinal fluid leak. However, options are limited for those patients who have exhausted these traditional treatments, especially when spinal imaging is normal. We describe a wearable epidural catheter infusion system for patients with intractable spontaneous intracranial hypotension. METHODS: Six patients with intractable spontaneous intracranial hypotension (4 women and 2 men; mean age, 53 years; mean duration of symptoms, 50 months) underwent placement of a permanent indwelling spinal epidural catheter attached to an external infusion pump. The Migraine Disability Assessment questionnaire was used to assess the severity of the symptoms, before and during treatment. RESULTS: The infusion resulted in complete or near-complete symptom relief in 5 of 6 patients (Migraine Disability Assessment score decreased from grade IV to grade I or II). However, the epidural catheter infusion system was removed in 2 patients because of infection, in 1 patient because of delayed failure to provide adequate symptom control, and in 1 patient because of minimal symptom relief. Two patients reported excellent and sustained symptom relief over 27 and 36 months of follow-up. CONCLUSIONS: This wearable epidural catheter infusion system showed promising efficacy results but the high rate of complications limits its use to a very select group of patients.