Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis.

OBJECTIVE

This systematic safety review reports multicenter safety results of symptomatic lumbar spinal stenosis (LSS) patients treated with percutaneous lumbar decompression.

DESIGN

All percutaneous lumbar decompression institutional review board-approved study patients, as well as a retrospective safety survey, were included in this review.

METHODS

All study centers followed the same widely accepted and standardized procedure for percutaneous decompression and utilized the same criteria when observing and reporting device- or procedure-related adverse events.

OUTCOME MEASURES: In addition to safety data, Oswestry Disability Index scores were used to document baseline functional disability, and visual analog scale values defined the intensity of baseline back and leg pain. Treatment outcomes of patients who reached 1-year follow-up were also included.

RESULTS

Of the 373 patients included in this safety review, there were no reports of major device- or procedure-related adverse events, and there were no mortalities. Major complications were defined as any device- or procedure-related event that required intervention, including events such as incidental durotomy, epidural hematoma, infection, or bleeding that required transfusion. One-year efficacy data showed statistically significant improvement in pain and mobility, further supporting the excellent safety profile of percutaneous lumbar decompression.

CONCLUSIONS

In this safety review, percutaneous lumbar decompression proved to be a safe procedure. Compared with other more invasive lumbar decompression techniques, percutaneous lumbar decompression has demonstrated significantly better safety. This high level of safety is particularly vital for the rapidly growing elderly LSS patient population with increased treatment risks related to comorbid medical issues.