Percutaneous Image-guided Lumbar Decompression and Outpatient Laminectomy for the Treatment of Lumbar Spinal Stenosis: A 2-Year Medicare Claims Benchmark Study
Source— Interventional Pain MedicineAuthor— Peter S. Staats, MD; Michael J. Dorsi, MD; David E. Reece, DO; Natalie H. Strand, MD; Lawrence Poree, MD, MPH, PhD; Jonathan M. Hagedorn, MD.
Published
April 22, 2024
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).
The study included 2,197 mild® patients and 7,416 laminectomy patients. Several factors evaluated were age, gender, baseline comorbidities, subsequent surgical procedure rates, and rates of harms. Baseline data were extracted individually to allow for longitudinal analysis through a two-year follow-up.
Overall, the 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. 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.
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2012 data from Health Market Sciences report for Vertos Medical 2013.
Data on file with Vertos Medical.
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Based on mild® Procedure data collected in all clinical studies. Major complications are defined as dural tear and blood loss requiring transfusion.
MiDAS ENCORE responder data. On file with Vertos Medical.
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Treatment options shown are commonly offered once conservative therapies (e.g., physical therapy, pain medications, chiropractic) are not providing adequate relief. This is not intended to be a complete list of all treatments available. Doctors typically recommend treatments based on their safety profile, typically prioritizing low risk/less aggressive procedures before higher risk/more aggressive procedures, but will determine which treatments are appropriate for their patients.
Although the complication rate for the mild® Procedure is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood or fat that migrates to the lungs or heart). Other risks include infection and bleeding, spinal cord and nerve injury that can, in rare instances, cause paralysis. This procedure is not for everyone. Physicians should discuss potential risks with patients. For complete information regarding indications for use, warnings, precautions, and methods of use, please reference the devices’Instructions for Use.
Patient stories on this website reflect the results experienced by individuals who have undergone the mild® Procedure. Patients are not compensated for their testimonial. The mild® Procedure is intended to treat lumbar spinal stenosis (LSS) caused by ligamentum flavum hypertrophy. Although patients may experience relief from the procedure, individual results may vary. Individuals may have symptoms persist or evolve or other conditions that require ongoing medication or additional treatments. Please consult with your doctor to determine if this procedure is right for you.
Reimbursement, especially coding, is dynamic and changes every year. Laws and regulations involving reimbursement are also complex and change frequently. Providers are responsible for determining medical necessity and reporting the codes that accurately describe the work that is done and the products and procedures that are furnished to patients. For this reason, Vertos Medical strongly recommends that you consult with your payers, your specialty society, or the AMA CPT regarding coding, coverage and payment.
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Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.
Mobility Matters: Low Back Pain in America, Harris Poll Survey, 2022. View data and full summary here.
Deer TR, Grider JS, Pope JE, et al. Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2022;15:1325-1354. Published 2022 May 5. doi:10.2147/JPR.S355285.
