Treating Lumbar Spinal Stenosis: When Do You Move On From ESIs?
Author— Harry Sukumaran, MD
July 1, 2021
A discussion with Dr. Harry Sukumaran as featured in the June 2021 issue of Pain Medicine News.
Q: You recently authored an abstract that examined patients’ pain response after the mild® Procedure, based on the number of epidural steroid injections (ESIs) they received prior. First, what is the mild® Procedure?
Dr. Sukumaran:mild® is a technique in which we debulk the hypertrophic ligamentum flavum (HLF), increasing the canal diameter and giving patients a minimally invasive decompression. The patient who is a candidate for the mild® Procedure has signs and symptoms consistent with lumbar spinal stenosis (LSS) with neurogenic claudication, meaning the patient has discomfort with standing and walking for extended periods of time. They tend to get relief being in a flexed position, using a shopping cart, or sitting/lying down.
Q: What makes mild® different than the other treatment options typically used to treat LSS?
Dr. Sukumaran:Until mild® entered my practice, the number one procedure that we did to alleviate the symptoms of LSS was an ESI. Typically, patients do well with the injections, but they experience declining efficacy over time as the stenosis would progress. The reason why I now place mild® so early in my treatment algorithm is that it’s as safe as an ESI, it is minimally invasive, and there are no postoperative restrictions. There really is no downside to having this procedure moved up early in the treatment algorithm. If they’ve haven’t had an epidural, I typically do one first for procedure planning. If they’ve had epidurals in the past, I move straight to mild®.
Q: How does your recent research change the way you and other Interventionalists treat LSS?
Dr. Sukumaran:The abstract shows that regardless of the number of ESIs that a patient has, whether it’s one or multiple, the long-term pain relief after mild® isn’t any different. This has changed my practice significantly; I may offer them an ESI, but I move to mild® pretty quickly and the discussion that we have is more about durable, long-term pain relief. It’s really changed how I practice.
Q: Why aren’t ESIs the most effective option for treating neurogenic claudication?
Dr. Sukumaran:It goes back to the pathology. If a patient has disc bulges, hypertrophic facet joints, and HLF, those are all fixed pathologies. Decreasing inflammation with an ESI isn’t going to decrease the HLF, and it’s not going to decrease the size of the facet joint. An ESI isn’t going to have sustained long-term benefit for the patient. What they really need is to be decompressed. And mild® really allows us to achieve that.
Q: Who is the ideal candidate for mild®?
Dr. Sukumaran:As studies have shown us (as well as my own personal experience), patients that have multiple comorbidities do just as well with mild® as those who don’t. The reason being that LSS is really a constellation of conditions. Circumferential stenosis is often made up of HLF, hypertrophic facets, disc bulge, etc. In my experience, when we debulk that ligament and give more space, most of those patients do quite well.
Q: How does your practice look at treating pain vs. function?
Dr. Sukumaran:If we can get somebody to function better, and we can get them to do the things that give them enjoyment, I think pain relief comes along with that. The number one complaint I have from patients that suffer from LSS is they can’t do the things that they used to enjoy in life; they no longer engage in life. Functional restoration is at the forefront when it comes to treating patients with LSS. My joy comes from the patient returning at the two-or four-week mark and saying, “My life is much better, I’m not sure why I didn’t do this earlier.”
View Dr. Sukumaran’s abstract presentation from ASRA’s 46th Annual Meeting to learn more about the new data surrounding serial ESIs. The “Assessment of Epidural Steroid Injection Usage Prior to Treatment with the mild® Procedure: A Five-Center Retrospective Report” compares pain reduction for patients receiving multiple injections versus those receiving a single or no injection prior to the mild® Procedure.
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.
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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 decompression for lumbar spinal stenosis: the impact of moving to Mild directly or after initial epidural steroid injection (ESI) failure on clinical performance – a six center retrospective report. Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.