Does your practice offer the mild® Procedure? Do you manage patient identification and education? Follow these 3 steps to optimize your practice routine:
1. Start with the Symptoms
ID Shopping Cart Syndrome
Shopping Cart Syndrome – lumbar spinal stenosis (LSS) with neurogenic claudication (NC). These patients will often be the first ones to find chairs in your waiting room or use the walking aids, such as a shopping cart, to establish a flexed position. The flexed posture is a common sign of NC because it opens up the spinal canal to alleviate the pressure on the central canal to avoid pain that comes with being straight, upright, or mobile.
Ask patients
Ask patients the following questions to better understand how LSS with neurogenic claudication is limiting their mobility and when they experience symptom onset. Patients commonly report pain, so it is essential to talk about their functional limitations (eg, desire to walk the dog, get the mail, play with their grandchildren, etc.).
Consider incorporating these questions into your EMR or intake process so patients are routinely screened for neurogenic claudication.
How does your pain disrupt your life?
How long can you stand before you need to rest?
How far can you walk before you need to rest?
Ask patients
Ask patients the following questions to better understand how LSS with neurogenic claudication is limiting their mobility and when they experience symptom onset. Patients commonly report pain, so it is essential to talk about their functional limitations (eg, desire to walk the dog, get the mail, play with their grandchildren, etc.).
Consider incorporating these questions into your EMR or intake process so patients are routinely screened for neurogenic claudication.
How does your pain disrupt your life?
How long can you stand before you need to rest?
How far can you walk before you need to rest?
2. Confirm Candidacy:
Look for the ligament
Hypertrophic ligamentum flavum (HLF) contributes up to 85% of spinal canal narrowing
What to look for?
LSS at levels L1-S1
Hypertrophic ligamentum flavum (HLF) – 2.5mm is the starting point
Need additional help establishing comfort with imaging review?
View the CME course on reading MRIs hosted by Advanced Practice Providers (APPs) Ashley Comer, NP-C; Christine Christensen, MSN, APRN; and Zohra Hussaini, MSN, FNP-BC, MBA, APRN
Contact your Vertos representative to set up an onsite or virtual educational session
If HLF is present, confirm candidacy…even in patients with comorbidities. mild® is an option for a broad spectrum of patients.
Candidates may have:
Medical comorbidities:
Osteoporosis
BMI >40
Spinal comorbidities:
Grade 1-2 spondylolisthesis
Foraminal narrowing
Degenerative disc disease
Lateral recess narrowing
Confirm coverage
mild® is covered by Medicare (all ages, all plan types, including Medicare Advantage), the VA, U.S. Military, and IHS. Commercial coverage varies.
3. Educate Patients & Establish Appropriate Outcomes and Expectations
Educate early – move to mild® after the first ESI fails
Establish appropriate outcomes and expectations
mild® helps patients stand longer and walk farther with less pain.
Optimize outcomes with reconditioning
At-home reconditioning walking program can be initiated immediately, as tolerated
Assess outcomes at 2-weeks and 4-6 weeks, then monthly. Assess mobility and Quality of Life (QOL) improvements, such as:
Transfer ability: Getting in and out of the bed/seat/car
Walking and standing times
Activities of daily living: Ability to get dressed, take off shoes, household chores, and grocery shopping
Optimize outcomes with reconditioning
At-home reconditioning walking program can be initiated immediately, as tolerated
Assess outcomes at 2-weeks and 4-6 weeks, then monthly. Assess mobility and Quality of Life (QOL) improvements, such as:
Transfer ability: Getting in and out of the bed/seat/car
Walking and standing times
Activities of daily living: Ability to get dressed, take off shoes, household chores, and grocery shopping
If you would like a mild® Quick Reference Card for your office or to learn more about APP-specific educational opportunities, please contact us and let us know what you need.
Benyamin RM, Staats PS, MiDAS ENCORE Investigators. mild® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4):229-242.
Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012;12(6):417-425. doi:10.1111/j.1533-2500.2012.00565.x.
2012 data from Health Market Sciences report for Vertos Medical 2013.
Data on file with Vertos Medical.
Staats PS, Chafin TB, Golvac S, et al. Long-term safety and efficacy of minimally invasive lumbar decompression procedure for the treatment of lumbar spinal stenosis with neurogenic claudication: 2-year results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43:789-794. doi:10.1097/AAP.0000000000000868.
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.
Jain S, Deer TR, Sayed D, et al. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020;10(5). https://doi.org/10.2217/pmt-2020-0037. Accessed June 1, 2020.
Deer TR, Grider JS, Pope JE, et al. The MIST Guidelines: the Lumbar Spinal Stenosis Consensus Group guidelines for minimally invasive spine treatment. Pain Pract. 2019;19(3)250-274. doi:10.1111/papr.12744.
Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009;18(5):679-686. doi:10.1007/s00586-009-0919-7.
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.
Vertos Medical cannot guarantee coding, coverage, or payment for products or procedures. View our Billing Guide.
Vertos is an equal employment opportunity workplace committed to pursuing and hiring a diverse workforce. We strive to grow our team with highly skilled people who share our culture and values. All qualified applicants will receive consideration for employment without regard to sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender identity, physical & mental disability, medical condition, genetic information, veteran status, or any other basis protected by federal, state or local law.
Hall S, Bartleson JD, Onofrio BM, Baker HL Jr, Okazaki H, O’Duffy JD. Lumbar spinal stenosis. Clinical features, diagnostic procedures, and results of surgical treatment in 68 patients. Ann Intern Med. 1985;103(2):271-275. doi:10.7326/0003-4819-103-2-271.
Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence & association with symptoms: The Framingham Study. Spine J. 2009;9(7):545-550. doi:10.1016/j.spinee.2009.03.005.
Fukusaki M, Kobayashi I, Hara T, Sumikawa K. Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain. 1998;14(2):148-151. doi:10.1097/00002508-199806000-00010.
Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up [published online ahead of print, 2021 May 4]. Pain Pract. 2021;10.1111/papr.13020. doi:10.1111/papr.13020
Friedly JL, Comstock BA, Turner JA, et al. Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2017;98(8):1499-1507.e2. doi:10.1016/j.apmr.2017.02.029
Pope J, Deer TR, Falowski SM. A retrospective, single-center, quantitative analysis of adverse events in patients undergoing spinal stenosis with neurogenic claudication using a novel percutaneous direct lumbar decompression strategy. J Pain Res. 2021;14:1909-1913. doi: 10.2147/JPR.S304997
Pryzbylkowski P, Bux A, Chandwani K, et al. Minimally invasive direct decompression for lumbar spinal stenosis: impact of multiple prior epidural steroid injections [published online ahead of print, 2021 Aug 4]. Pain Manag. 2021;10.2217/pmt-2021-0056. doi:10.2217/pmt-2021-0056
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.
