Analysis of complications of minimally invasive approaches for symptomatic lumbar spinal stenosis.

INTRODUCTION

Current treatment modalities of lumbar spinal stenosis range from conservative medical management and physical therapy to open surgical decompression. Minimally invasive lumbar decompression (MILD) and Superion interspinous spacers (SISS) Vertiflex offer the promise of effective pain relief with shorter recovery time and lesser potential complications compared with open surgical decompression procedures and general anesthesia. Despite their increasing utilization, their complication profile is not well established in the literature.

METHODS

We searched the FDA's Manufacturer and User facility Device Experience (MAUDE) database for all entries on MILD product code 'HRX' and SISS product code 'NQO'. MAUDE database was queried from 2010 to 2021. Duplicate entries were removed, and complications were classified based on the event descriptions.

RESULTS

For the MILD procedure, a total of 10 entries were found in the MAUDE database. Among these, 8 were classified as surgical complications and 2 were device related. On the other hand, a total of 919 reports were found in the MAUDE database for Vertiflex, with 385 medical device reports were included in the analysis. Device-related were the most reported complication, accounting for 189 cases.

CONCLUSION

As with any new intervention, we must proceed with caution and evaluate the procedure performance over time. Such data should aid physicians to make informed decisions before choosing either technique for their patients. The findings from this study provide insight into the complication profile associated with both MILD and Vertiflex procedures, highlighting the need for continued evaluation and careful consideration in clinical decision-making.