Abstract
BACKGROUND: This prospective longitudinal study compares outcomes for Medicare beneficiaries receiving outpatient percutaneous image-guided lumbar decompression (PILD) using the mild® procedure to patients undergoing outpatient laminectomy. All patients were diagnosed with lumbar spinal stenosis (LSS) with neurogenic claudication (NC). METHODS: All medical claims for 100 % of Medicare beneficiaries were reviewed, with study subjects identified using Centers for Medicare and Medicaid Research Identifiable Files. Baseline data were extracted individually to allow for longitudinal analysis through two-year follow-up. The index procedure was defined as the first mild or outpatient laminectomy during the enrollment period. The rate of subsequent surgical procedures and incidence of harms were used as study outcomes. RESULTS: Cohorts included 2197 mild and 7416 laminectomy patients. mild patients were significantly older (76.7 years versus 73.4 years, respectively; p < 0.0001), and 57.4 % of mild were female, compared to 43.3 % of laminectomy (p < 0.0001). mild patients presented with significantly more baseline comorbidities compared to laminectomy patients (mean of 5.7 versus 4.8, respectively; p < 0.0001). Subsequent surgical procedure rate of 9.0 % for mild was significantly higher than 5.5 % for laminectomy (p < 0.0001). mild experienced harms at a significantly lower rate than laminectomy (1.9 % versus 5.8 %, respectively; p < 0.0001). The composite rate of subsequent surgical procedures and harms was similar between groups at 10.8 % for mild and 11.0 % for laminectomy. CONCLUSIONS: mild can be considered a viable option for treatment of LSS with NC as evidenced by real-world data in this study. At two-years, mild patients experienced fewer harms and underwent more subsequent surgical procedures than laminectomy patients. The higher rate of subsequent surgical procedures for mild may be attributable to its position earlier in the LSS treatment algorithm. The overall rate of harms and subsequent surgical procedures was similar between groups, suggesting that mild should be considered as a treatment option, particularly for older patients with multiple comorbidities.