The following study, “Patients with Foraminal Narrowing Benefit from mild® Treatment” investigates procedural outcomes for mild® patients with and without foraminal narrowing as an adjunctive spinal comorbidity. Ninety-one patients from three sites were accepted for analysis and VAS scores were compared within each group over time and between groups. Responder rates were 86.4% in the group with foraminal narrowing, compared to 75.0% in the group having no foraminal narrowing. Though the amount of pain improvement between groups was not significantly different, this study confirms that lumbar spinal stenosis (LSS) patients with a narrowed foramen can benefit from the mild® Procedure and should not be excluded from treatment. View the abstract poster below to learn more about the results.
Watch Dr. Denis Patterson present his abstract from the Pacific Spine & Pain Society (PSPS) 2021 Annual Conference where he reviews the data and shares why LSS patients with a narrowed foramen can benefit from mild®.
Are you ready to put your lumbar spinal stenosis patients on the path to long-term relief? Contact Vertos Medical and discover why leading interventionalists offer mild® in their practice.
Denis G. Patterson, MD (00:00)
Hey, this is Dr. Denis Patterson. I’m a physical medicine rehabilitation physician who specializes in interventional pain management. I am located in the greater Reno, Tahoe area. I’m the owner of Nevada Advanced Pain Specialists. I’ve been seeing and treating patients in the greater Reno, Tahoe area now for about 15 years, and I have to say that one of the best treatment options that I’ve had come around within the past decade has been the mild® Procedure.
Prior to this procedure, as an interventional pain physician, we’re more trying to cover up pain or, alleviate pain, but we never really could treat the underlying pathophysiology. And so it was nice that we finally got a tool in our bag of tricks to help patients that we could actually treat their underlying pathophysiology. So, a patient with wear and tear over the years, not only are they going to get a swollen disc, swollen facet joints, but the ligamentum flavum can also encroach and push into the spinal canal. And that’s what the mild® Procedure does, it allows us to have access to get between the lamina, dig out this ligamentum flavum, create a couple more millimeters of space, and in essence, probably decrease the pressure at that level in their spine and help alleviate their neurogenic claudication symptoms.
Being an advocate for this procedure, I talked to multiple physicians around the country, and one of the interesting comments that I’ve heard over the years is that, “Hey, I can give this or I can treat patients with this, but they can only have central canal stenosis.” And so to me, these physicians are looking for what I would call is a unicorn. A unicorn is a patient who has central canal stenosis only due to the ligament being hypertrophied and that’s simply not the case. When you really look back at the literature and the 2-year study that they did, the MiDAS study, what we see is only 5% of the patients in that study only had central canal stenosis. 95% of those patients had multifactorial stenosis and so that means they can have neuroforaminal stenosis, lateral recess stenosis, and central canal stenosis. And what we saw in the MiDAS study is all those patients benefited.
(02:17) But even though we have that data, over the years of training physicians in the mild® Procedure, I continue to hear, “Well they have neuroforaminal stenosis, they don’t have just central canal stenosis so, I think I’m going to pick a competitive product to treat these patients instead of the mild® Procedure.” So, from the MiDAS data that I had talked about earlier, we’d seen that patients with multifactorial stenosis benefited from the mild® Procedure. Myself, Dr. Pryzbylkowski, and Dr. Khemlani wanted to retrospectively look at patients who we had treated with the mild® Procedure and see if we could validate the results of [what] the MiDAS study had shown. And so we retrospectively reviewed 91 patients from our 3 clinics, and this went back to January of 2020. And what we found is that 32 of the patients that we had treated out of the 91 had no neuroforaminal narrowing. Meaning, they had central canal stenosis, which included ligamentum flavum hypertrophy, but they also could have had multifactorial pathology, including disc bulges and facet hypertrophy. And then the other 59 patients out of the 91, besides having multifactorial pathology, also had neuroforaminal narrowing. And then what we ended up doing is retrospectively looking at our results of these patients, who benefited from the mild® Procedure in these groups; did both groups, 1 group, or neither group benefit? And we looked at our results at one and three months after having the procedure done. And if you look under our results, we look at [how] both groups got significant pain reduction and response rates, what we see is that the foraminal narrowing group did better.
86% of these patients had a positive response rate, while only 75% of the patients that had no neuroforaminal narrowing had a pain reduction. So, when you first look at this, you think, “Oh God, this has got to be statistically significant that the foraminal narrowing group benefited more than the no foraminal narrowing group from the mild® Procedure.” But, when you really look at the “P” value, there is no statistical significance between the 2 groups. And so the conclusion that we came to, is that patients with lumbar stenosis, with neurogenic claudication, whether they have central canal stenosis only, or they have multifactorial stenosis only, both groups can benefit from having the mild® Procedure done. And so, all physicians should know that they should not exclude patients with multifactorial stenosis from having this procedure be considered.
At the American Society of Pain and Neuroscience (ASPN) 2021 meeting in Miami, several abstracts highlighted recent data that supports use of the mild® Procedure as a first line therapy. Additionally, a panel of prominent Interventional Pain Physicians convened to discuss their experiences and clinical pearls for implementing the mild® Procedure in their practices. The consensus? The abstract authors and panelists repeatedly confirmed the rationale, supporting evidence, and benefits of moving to mild® as a first line therapy for lumbar spinal stenosis (LSS).
According to information presented at ASPN, mild® is continuing to be validated as an ideal procedure for LSS patients with neurogenic claudication for several key reasons:
4 speakers on the panel, Drs. Navdeep Jassal, Mark Coleman, Lindsay Shroyer, and David Dickerson, each spoke to the broad patient base that is appropriate for the mild® Procedure.
“For percutaneous image-guided lumbar decompression, any patient with 2.5 millimeters of ligamentum flavum hypertrophy, whether they have central stenosis or lateral stenosis, is a candidate and may achieve pain relief and functional improvement…that’s where I start. The indications are very clear.”
“The fact that they have multilevel disease would lead you towards doing a mild®. A lot of folks were afraid of mild® because of excess radiation, but we can now do these procedures in a fraction of the time that it took in the past. Being able to treat multiple levels of stenosis opens mild® as an option for many more patients.”
“For these procedures, positioning is everything. If you start the procedure with the patient well-positioned, you should be able to access the level you are targeting. Even if you are taking some of the ligament on the opposite side, that can produce good outcomes for the patient. So, for scoliotic curve, there’s not really a maximum or a minimum.”
“This is an elderly patient population. A lot of patients have comorbidities or may be on blood thinners that make them poor candidates for surgery. Why not start with mild®? The excellent safety profile of mild® makes it an excellent option and a procedure I offer to so many of my patients that have lumbar spinal stenosis.”
Clinical approaches that support delivery of the mild® Procedure faster, with less radiation, were a significant focus of the discussions at ASPN. Several leading physicians participated in a clinical study presented by Dr. Dawood Sayed that evaluated the safety and efficacy of the Streamlined Technique compared to the Standard Technique for the Percutaneous Image-Guided Lumbar Decompression (PILD) Procedure.
Their results demonstrated:
In a separate study, Dr. Navdeep Jassal and APP Christine Christensen, MSN, APRN similarly concluded that the Streamlined Technique is a more minimally invasive procedural approach for mild® and is comparable in safety to the Standard Approach, with no increased risk of serious postoperative complications to the patient. Based on this finding, they suggested mild® should be considered the first-line intervention for patients with lumbar spinal stenosis (at least 2.5 mm of hypertrophic ligamentum flavum) and neurogenic claudication after the first epidural steroid injection (ESI) fails.
Finally, Drs. Jason Pope, Timothy Deer, and Steven Falowski submitted a poster investigating the safety of using osteal landmarks instead of an epidurogram to establish a visual safety barrier prior to decompression with mild®. Based on zero complications reported across all 147 patients participating in the study, they assert that an epidurogram is not necessary for safe decompression with the mild® Procedure. Contralateral oblique view of the epidural line provides a clear view of the lamina and osteal landmarks, enabling identification of the targeted location for decompression.
Across the panel, numerous speakers highlighted the particular benefits of mild® to patients and urged early integration of mild® in the treatment algorithm.
“mild® has completely changed the way I practice. I implement it early in my algorithm and my patients are really happy. They don’t want surgery, or may have comorbidities that mean they are not a candidate, and they are so excited about their results with mild®. They’ll go out and tell their friends and neighbors, and then we have more patients coming in asking for mild®.”
“When you start doing mild®, the word will spread like wildfire. I’ve done multiple family members who saw the results their loved ones achieved. I tell people, ‘why keep doing epidural steroid injection after epidural steroid injection?’ We know mild® has excellent safety. With mild®, we can give patients good, durable benefits that let them stand, walk, and enjoy a better quality of life.”
“For pain physicians in practices that include a lot of surgeons, start by picking patients who are not good surgical candidates. There are so many patients that may not be ideal for surgery or don’t want surgery that you can help. When you start there, the surgeons in your practice will see the outcomes you’re able to achieve and you can expand from there. This helps smooth the practice dynamics.”
For clinicians considering integrating mild® in their practice armamentarium, or practices already performing the mild® Procedure for failed serial ESI patients or patients who are not candidates for surgery, the data is clear: performing mild® early in the treatment algorithm can offer your LSS patients lasting functional improvements with a safety profile equivalent to ESIs.,
What was the biggest news at the ASPN 2021 Conference? New mild® data! Five poster presentations highlight the reasons more practices are moving to mild® as a first-line therapy for lumbar spinal stenosis (LSS).
View Dr. Pryzbylkowski’s poster presentation here.
View Dr. Sayed’s poster presentation here.
View Dr. Jassal and Ms. Christensen’s poster presentation here.
Physicians and practices treating lumbar spinal stenosis (LSS) patients with epidural steroid injections (ESIs) will likely recognize a common “condition” among serial ESI patients that our practice typically refers to as “Epidural Exhaustion.” Epidural Exhaustion is typically seen in patients who have tried multiple injections but have experienced only short-term functional improvements with little to no pain relief. Many times, LSS patients who do not improve after a single ESI or series of ESIs can become frustrated, or begin to lose hope in ever feeling relief from their spinal stenosis symptoms.
While “Epidural Exhaustion” is remarkably common among lumbar spinal stenosis (LSS) patients, it is avoidable. In our practice, we have found that moving to mild® (Minimally Invasive Lumbar Decompression) earlier in the patient journey helps drive positive long-term clinical outcomes and stronger patient satisfaction. Today, we have changed our practice workflows to move more patients to mild® after their first failed ESI. We proactively communicate the benefits of the mild® Procedure to our patients at the time of diagnosis or before they begin their treatment journey in our practice, so that they understand the breadth of their treatment options. With the availability of mild® as an early treatment option for more spinal stenosis patients, we can reduce incidences of ESI exhaustion and put more of our LSS patients on the path to long-term relief.
Although repetitive epidural steroid injections are still the standard of care in many practices and instilled during our training, the data show that serial ESIs offer little benefit to long-term patient outcomes.
As noted by Heidi Younan, Director of Patient Marketing & Practice Integration at Vertos Medical, we already know that epidurals are not capable of “curing” neurogenic claudication, which is present in 94% of patients with lumbar spinal stenosis. While repetitive ESIs deliver some chemical benefit and can offer transient, temporary relief for radicular components, ESIs do not address a major root cause of stenosis. Decompression is required to reduce narrowing/triangulation and relieve pressure in the central canal.
A 2016 study conducted by Janna L. Friedly et al., studied the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections on LSS patient outcomes through 12 months. The multicenter, double-blind, randomized, controlled trial with 400 patients concluded that repeated epidural injections offer no additional benefit if injections in the first 6 weeks did not improve pain. Therefore, performing multiple ESIs on patients who did not benefit from the initial injection is essentially delaying treatment that can provide beneficial and long-term outcomes.
Because of its effectiveness and safety profile, I strongly recommend moving to mild® earlier in the patient journey, after the first failed ESI. Recognizing that up to 85% of spinal canal narrowing is the result of hypertrophic ligamentum flavum (HLF), there is tremendous benefit in being able to debulk the HLF and restore space in the spinal canal, thus reducing compression of the nerves. The minimally invasive mild® Procedure enables our practice to offer a treatment option that is a step up from ESIs with the same low complication rate, but with excellent effectiveness and lasting results.
Ms. Younan also highlights that clinical studies of mild® have demonstrated clinically meaningful, statistically significant improvements in mobility, Oswestry Disability Index (ODI), and pain reduction on the numeric pain rating scale (NPRS). More recent 5-year data shows that after undergoing the mild® Procedure, only 12% of patients required surgical decompression at the same level over 5 years. Stated differently, mild® gives the potential to help 88% of patients avoid surgical decompression surgery for at least 5 years, while providing symptomatic relief during that time.
Beyond the individual clinical benefits, I also advise other pain specialists that there are many practice-driven reasons to offer mild® in lieu of serial epidural steroid injections. The MiDAS ENCORE level 1 data demonstrated an exceptionally high 85% patient satisfaction rate among patients who received the mild® Procedure. Patient satisfaction is a key benchmark in our practice. With the mild® Procedure, we have seen tremendous patient satisfaction, and we know that those patients tell their friends, relatives, and neighbors about their positive results, which increases word-of-mouth to our practice.
My goal as a physician is always to assess where the patient is in their treatment journey, the impact of lumbar spinal stenosis symptoms on their lifestyle, their priorities for the procedure (such as a minimally invasive approach or a short recovery time), and their treatment history to determine the best path forward for that individual.
This purpose of this article is certainly not to challenge any and all use of ESIs within the modern pain or spine practice. ESIs can be an effective tool and are a critical part of our practice armamentarium. For some patients, ESIs offer significant benefits; however, evidence and experience demonstrate that ESIs are not a one-size-fits-all solution. Many patients with LSS fail to achieve significant pain reduction, while others who do experience pain reduction or functional improvements find those benefits to have limited durability.
In our practice, we still commonly begin a lumbar spinal stenosis treatment plan with a conservative approach to determine if an ESI will effectively reduce the symptoms of LSS. Once we understand how our patient responds to an ESI, we can determine the best treatment plan for the patient. If they have a good result with an ESI, we suggest that they resume normal activities and self-monitor for changes over time. On the other hand, if they do not see significant benefit from the initial ESI, I will strongly consider them as a candidate for mild®, and barring any contraindications, we typically schedule their mild® Procedure within a few weeks.
A powerful message for patients looking for significant relief is that we will start their LSS treatment with an ESI, but we’ll also be able to know very quickly if the epidural steroid injection is going to be successful for them. When patients understand that they have other minimally invasive, nonsurgical options, they may be less concerned if they experience limited relief from their first ESI.
The key question is, “At what point can we reliably assess whether an individual patient will benefit from serial ESIs?” Here again, we can look to the Friedly data showing that repeated epidural injections offered no additional long-term benefit if injections in the first 6 weeks did not improve pain. Based on this data and the results we’ve seen first-hand in our own practice, we know that we can assess our LSS patient results post-ESI and determine whether we should move them to mild® earlier in their treatment journey.
(Graphic courtesy of Vertos Medical)
One of the most significant ways our practice has shifted after the adoption of mild® is that we now evaluate most patients as potential mild® candidates. If we suspect LSS, we present mild® as a treatment option from the start. In making this shift, we have discovered a few clinical and workflow pearls that optimize success across the practice.
1. Train staff to recognize patient symptoms
Because LSS is especially common among adults over 60 years of age, and our practice treats a high volume of senior patients, we have found that many of our existing and new patients are excellent candidates for mild®.
Our practice trains our APPs and other support staff so they can immediately recognize the signs and symptoms of LSS independently. Of course, we ultimately diagnose LSS and neurogenic claudication with the support of imaging, but I always remind our staff and patients that imaging can’t show pain. As a healthcare team, we need to be proactively asking questions like, “Does hunching forward significantly relieve the pain you’re feeling?” or “Do you feel pain in your back and legs when standing or walking?” If the answer to either question is yes, we know there’s a good chance that patient may be candidate for mild®.
Younan also notes that the Vertos team has developed resources and training to support APPs. All resources are available through your Vertos sales representative.
2. Look for the ligament
When reviewing a patient’s MRIs/CTs, a simple rule we use is “look for the ligament.” Hypertrophic ligamentum flavum is a common problem that contributes up to 85% of spinal canal narrowing. We have trained our APPs to apply this rule while reviewing images to help identify patients who may benefit from the mild® Procedure.
In the image, the thickened ligament can be seen clearly, resulting in compression of the spinal cord nerves.
3. Present mild® in your initial LSS treatment plan
When we work with patients, we make sure they know that our focus is on improving their functionality and reducing pain. We are clear from the start that we’re going to evaluate their symptoms, treatment history, and goals to determine their best treatment pathway based on the latest evidence and techniques.
Patients are generally open to the idea that a therapy that works for one patient might not work for them. So, I typically tell the patient, “We are going to start with a single epidural, and we’ll be able to know quickly if the epidural is going to be effective for you.” I also let them know that if they do not experience a significant improvement after the epidural, or if those results wear off after a short period, we can still help them with proven, minimally invasive options. Then, I tell them about the mild® Procedure, and how it offers a safety profile similar to an epidural, but with lasting results.
By presenting mild® as part of the treatment plan from the start, patients have more confidence that we are going to be proactive in their care and make sure they have the opportunity to access advanced LSS treatment options that offer excellent outcomes.
Overall, the addition of mild® has been a real game-changer in our practice. We see mild® as a safe and effective alternative to serial ESIs that drive long-term patient improvements and high patient satisfaction—a treatment we make available to as many patients as possible, as early as possible. I regularly tell other interventional pain specialists to incorporate mild® in their practice, and once they see the impact it has on their patients, they understand why we are so passionate about moving to mild® after failure of the first ESI.
About Dr. Jason Pope
Jason Pope, MD, is an Interventional Pain Physician trained in Pain Medicine at the Cleveland Clinic with board certifications in Anesthesia and Pain Medicine. He completed an Anesthesiology Residency at Vanderbilt University Medical Center and received his medical degree from the Indiana University School of Medicine. Dr. Pope is the Founder and CEO of Evolve Restorative Center in Northern California and serves as an expert reviewer for the Medical Board of California. Dr. Pope also serves as President Emeritus and Chairman for the Pacific Spine & Pain Society (PSPS), President Elect for the American Society of Pain & Neuroscience (ASPN), Director at Large and Chairman for the International Neuromodulation Society (INS), and Chairman for the North American Neuromodulation Society (NANS).
About Heidi Younan
Heidi Younan is the Director of Patient Marketing & Practice Integration at Vertos Medical. A critical member of the Vertos team for over a decade, Ms. Younan works with clinicians, APPs, and patients to support the successful integration of the mild® Procedure in pain practices and help more patients experience the life-changing benefits of mild®. Ms. Younan also contributed portions of the clinical content within this article.
The objective of the study “Use of Epidurogram is Not Necessary for Safe, Minimally Invasive Direct Lumbar Decompression” was to investigate the safety of using osteal landmarks vs an epidurogram to establish a visual safety barrier prior to decompression with the mild® Procedure. A retrospective data analysis was performed on 147 patients that compared those receiving an epidurogram with performance of the mild® Procedure versus those that did not. View the abstract poster below to learn more about the outcomes.
Watch Dr. Jason Pope present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference where he shares why the use of an epidurogram is not necessary for safe decompression with the mild® Procedure.
Eager to further understand the mild® Procedure and how it can put your lumbar spinal stenosis patients on the path to long-term relief? Contact Vertos Medical and discover why leading interventionalists offer mild® in their practice.
This study was recently published in the Journal of Pain Research, click here to view.
Jason Pope, MD (00:00)
Well, welcome everyone. My name is Dr. Jason Pope. I have a practice in Northern California serving Napa, Sonoma, Mendocino counties and I’m here today to talk a little bit about an innovative strategy that we had in performing the mild® Procedure. And the question that we were trying to answer with this was essentially, “Is the epidurogram necessary when executing the mild® Procedure on patients, whether you’re going to perform a single level or a multilevel strategy?” And so we retrospectively looked at 147 patients. So we can see here the female to male breakdown along with a median age of around 77. And we looked at patients that either got the epidurogram with performance of the mild® [Procedure] versus those that did not. And we did so equitably across the patient population that we were serving. And as we can see with a stenotic level, clearly the most common areas that were performed were at L3-4 and L4-5 and that’s no surprise. And then we looked at patients whether they were done as a single level or a multilevel. And we can see here that the breakdown of these patients where 54 patients received contrast, 42 non-contrast, in a single level. And the most common level that was performed was at L4-5. But what was also very interesting was in this retrospective review, again, of about 147 patients, about 80% of them had the procedure done bilaterally if it was at a single level. And interestingly enough, when we did a multilevel mild®, and in this cohort, it represented at least two levels, the most common level that was the index level of where it was treated was at L3-4 and bilaterally, this was performed nearly 50% of the time. So when people do multiple levels of [the] mild® Procedure, the unilateral reality based on symptoms changes a little bit as compared to if you were doing a single level.
(02:27) And again, this was done over a total cohort of 147 patients. And the way that this came about and again, we highlighted the fact that when we looked at the use of epidurogram in managing patients with spinal stenosis symptomatically, with the mild® Procedure, it wasn’t clear that it really offered an increase in safety. And it wasn’t clear that it highlighted when the decompression was completed because epidural flow after decompression doesn’t necessarily increase after the ligament is trimmed or resected. So we looked at trying to simplify the procedure, and this was done just by using the osteal landmarks. And we can see the facet line and the laminar line in the middle section of the abstract presentation here. And I can say with confidence, using osteal landmarks alone as compared to the epidurogram, and we use the midline incision, the refined Streamlined Technique that you all have come to know and love, that in performing this, there were zero complications, as defined as problems with infection, nerve injury, allergy to contrast, which is something that can happen, but clearly in this cohort, it did not.
And so there were zero complications performing either one level or multilevel [mild®], either unilaterally or bilaterally with contrast or without contrast. So this underscores the importance and the strategy that if one chooses or elects to not use the epidurogram in performance of the mild® [Procedure] you can do so safely, based on this patient cohort. So again, appreciate your time. I want to also thank my co-authors associated with this project, Dr. Timothy Deer and Dr. Steven Falowski. And I want to also thank the Vertos team for helping with the assembly of the abstract. So with that, thank you.
The objective of “Minimally Invasive Decompression for Lumbar Spinal Stenosis: The Impact of Moving to mild® Directly or After Initial ESI Failure on Clinical Performance—A Six Center Retrospective Report” was to understand how epidural steroid injection (ESI) use prior to mild® impacts patient outcomes. In this clinical study, 145 patients were divided into 2 groups receiving either 0-1 or 2+ ESI procedures prior to mild®. View the abstract poster below to discover the results of the retrospective report and learn why moving to mild® after the first ESI fails can put more spinal stenosis patients on the path to long-term relief.
Watch Dr. Peter Pryzbylkowski present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference in which he reviews the data and shares why he moves his lumbar spinal stenosis (LSS) patients to mild® earlier in the treatment journey.
Do you want to learn more about mild® and challenge your thinking around ESIs? Contact Vertos Medical for more information about the minimally invasive mild® Procedure and read about Dr. Jason Pope’s experience dealing with “Epidural Exhaustion” in his new blog.
Peter Pryzbylkowski, MD (00:00)
My name is Dr. Peter Pryzbylkowski. I’m a board certified anesthesiologist and board certified interventional pain specialist with the Relievus Pain Management Group, based out of the Philadelphia area. I want to thank Vertos, number one, for getting me involved with this study.
So, the objective of this study was to determine whether or not, no epidurals, one epidural versus a series of epidurals, made any difference in terms of pain relief, pain reduction, post-mild® Procedure. So, this is a nice clinical study because it kind of expands the bandwidth of practices across the country.
So, we have 6 total centers, 145 patients, that was enrolled in this study. Basically it was a retrospective review of patient charts we all did, and it’s important to notice, specifically under the objective tab, that the comorbid conditions coexisting, with patients with lumbar spinal stenosis with neurogenic claudication, is noted there, so these patients had bulging discs, herniated discs, facet arthropathy, facet hypertrophy, narrowing of the foramen, degenerative disc disease, osteophytes, and other comorbid conditions, so even though these patients had other comorbid conditions that are listed there, these patients still had good clinical and durable clinical results after post decompression procedure.
So, you can see the average ages there, the breakdown of male versus female, and those comorbid conditions I had mentioned before. And the groups we’re looking at, so it’s a group of patients who either had no epidurals or one epidural, versus two or more epidurals. So 145 patients total, were looked at in this retrospective review, and we followed the results, both at the baseline pre-procedure, one week post-operatively, and 3 months after mild® Procedure was performed. And, what you can see in the results section is that multiple epidurals versus no epidurals or one epidural did not make a difference in terms of VAS scores post-mild® Procedure.
(02:13) So, really what this is telling us as pain providers, is it doesn’t matter if you do no epidurals, one epidural or multiple. It’s not gonna affect your clinical outcome post-mild® Procedure, so the take home message from a retrospective review like this is that really, doing epidurals, a series of epidurals, really, we know as pain doctors, doesn’t really provide long-term clinical benefit, and it’s not gonna affect the outcome post-lumbar decompression. So if you have a patient with lumbar spinal stenosis with neurogenic claudication, they have ligamentum flavum hypertrophy, they’re candidates for the mild® Procedure and it’s important to do the procedure sooner rather than later ’cause all you’re really doing with a series of epidurals is delaying appropriate care, so kind of the message that this has hit home in my own personal practice is, I’ve really been able to go to all my advanced providers and say, “Listen, if we have patients who are kind of stuck in this rut of doing multiple epidurals, epidural, epidural, epidural for their lumbar spinal stenosis, we should really be considering doing the mild® Procedure to help give them good long-term benefit, rather than giving them multiple injections, which increases the risk of infection, increases the risk of an untoward side-effect.” Obviously every time we do a procedure there’s always a risk.
It’s nice to do a procedure that can give them long-term benefit, so if you have patients that have spinal stenosis, it’s just important to keep in mind mild® as a first treatment step rather than treatment that you would consider down the road for patients with spinal stenosis with neurogenic claudication. So I would not delay treating these patients when they come to my clinic. So, I used to do an epidural, 2 epidurals, 3 epidurals, for patients with spinal stenosis with neurogenic claudication. The outcomes really were hit or miss, so for me personally, I’m offering these patients percutaneous decompression in the form of the mild® Procedure a lot sooner than I used to 2-3 years ago. And the data from this retrospective study kind of shows that by doing the procedure sooner rather than later, not delaying care, we can give them good long-term benefit, give them a procedure that’s actually indicated for their pathology and approved for their pathology, rather than delaying care with a series of epidurals.
The following study, “Evaluation of Safety and Efficacy of the Streamlined Technique vs the Standard Technique for Accessing Decompression Treatment Zones for the PILD Procedure,” investigates the safety and efficacy of the Streamlined Technique compared to the Standard Technique. While the PILD, or mild® Procedure, may be performed using both methods, the Streamlined Technique enables a single midline incision to access multiple treatment zones whereas the Standard Technique uses one incision per treatment zone. The study involved 243 patients that underwent the mild® Procedure using either technique and tracked their outcomes. The authors concluded that the Streamlined Technique does not compromise the safety or efficacy of the mild® Procedure. View the abstract poster below to learn why the Streamlined Technique is an innovative approach to consider.
Watch Dr. Dawood Sayed present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference, where he discusses how the study found that adopting the Streamlined Technique allowed for efficient and effective decompression of multiple treatment zones, without compromising the safety or efficacy of the mild® Procedure.
Eager to further understand the mild® Procedure and the technique described above? Contact Vertos Medical to learn more about the Streamlined Technique or check out the animation and physician experience from Dr. Navdeep Jassal in this Procedure Evolution blog.
Dawood Sayed, MD (00:00)
Hello, I’m Dr. Dawood Sayed and I’m a Professor of Anesthesiology and Pain Medicine at the University of Kansas. Today on behalf of my co-investigators, I’m gonna be presenting our abstract, an “Evaluation of the Safety and Efficacy of the Streamlined Technique vs the Standard Technique for Accessing Decompression Treatment Zones for the Percutaneous Interlaminar Lumbar Decompression (PILD) Procedure.” Our objectives were to investigate the safety and efficacy of the Streamlined Technique compared to the Standard Technique for the percutaneous image guided lumbar decompressive procedure. In summary, the Streamlined Technique is a single midline incision to access multiple treatment zones versus the more traditional standard techniques, in which multiple incisions are made to access multiple treatments zones. It was the hypothesis of the investigators, that using the Streamlined Technique, that we would be able to perform the procedure in an equal satisfactory manner with the same efficacy, but also performing the procedure in a much less invasive manner for the patient.
(01:03) So our methods were 243 patients with a baseline visual analog score of greater than five. These patients underwent the PILD Procedure at 1 or 2 treatment levels using either the Streamlined Technique which is about 136 patients, or the Standard Technique, which was about 107 patients. If you look at the table here, you can see that most of the patients were treated at either the L-3, L-4 or the L-4, L-5 levels. And again, the Streamlined Technique is a decompression performed using a single midline incision. The technique involves pulling back the portal to the subcutaneous tissue, and triggering tissue to change the level or side of treatment, to access and decompress multiple treatment zones through a single incision. When we look at our results, you can see the average pain level was around an 8 on a VAS mean score. When you look at the immediate pain relief and efficacy at around 2 weeks, you can see that the difference between the results and efficacy between the Standard Technique and the Streamlined Technique was almost identical. When you look at these patients a little further out at 1 to 3 months, again, you can see no difference in the outcomes in pain scores, as well as complication rates between the two arms when comparing the Streamlined and Standard Technique. So in conclusion, the Streamlined Technique does not compromise safety or efficacy of the PILD Procedure. We look forward to evaluating this in a more prospective, rigorous manner, to evaluate it as a true change in the way we do this procedure. Thank you.
Interested in on-demand education through didactic lectures, discussions and a compendium of case reviews from other leading experts? Find a list of webinars and webcasts from reputable societies, including American Society of Pain & Neuroscience (ASPN), Pacific Spine & Pain Society (PSPS), Women Innovators in Pain Management (WIPM) and Florida Society of Pain and Neuroscience (FSPN) below to learn more about identifying and treating patients with the mild® Procedure.
In this webinar, moderators James Lynch, PA and Kelsey Kimball, PA, partnered with their physicians Dr. Michael Verdolin and Dr. Ajay Antony to provide an interactive workshop focused on enhancing imaging review skillsets. View the interactive workshop where they cover imaging basics, navigating software, measuring the ligament and more!
In this Women Innovators in Pain Management (WIPM) webinar, moderator Jacqueline Weisbein, DO and faculty members Jessica Jameson, MD and FASA Lindsay N. Shroyer, MD discuss how to evaluate patients to determine appropriate candidates for PILD, use safety and efficacy data to understand where PILD fits in the LSS treatment algorithm, understand basic tenants and advantages of the Streamlined Technique and apply best practices for forging relationships with surgeon colleagues to help more patients.
“This procedure, you know, it’s not just for patients with stenosis… It’s performed with patients with stenosis, but they have other comorbidities… In my patients that are 70 years and older, they have facet arthropathy, they have stenosis, they have disc bulge and having those other conditions doesn’t make this a contraindication. You can still do this procedure on patients with those other comorbidities as long as they have greater than 2.5 millimeters of ligamentum flavum hypertrophy,” Dr. Shroyer says.
In this Pacific Spine & Pain Society (PSPS) training webinar, moderator Jason Pope, MD, and faculty members Steven Falowski, MD; Denis Patterson, DO and Jacqueline Weisbein, DO discuss how to evaluate patients to determine appropriate candidates for PILD, use safety and efficacy data to understand where PILD fits in the LSS treatment algorithm, understand basic tenants and advantages of the technique and apply best practices for forging relationships with surgeon colleagues to help more patients.
“We have highly under-treated lumbar spinal stenosis patients and the idea of just being able to either offer epidural steroid injections (ESIs) or jumping right to surgery is, I think, becoming a thing of the past and it’s not going to be part of our algorithm in that same manner,” Dr. Falowski says.
In this Florida Society of Pain and Neuroscience webinar, moderator Steven Falowski, MD and faculty members Nomen Azeem, MD; Michael Esposito, MD; Jackie Weisbein, DO; Stanley Golovac, MD; Navdeep Jassal, MD and Miguel Attias, MD discuss pathogenesis of LSS, spinal stenosis treatment algorithm, Vertos Medical’s mild® Procedure and more.
“We’re at a very pivotable point in terms of interventional pain. We’re crossing into the crossroads of interventional spine or minimally invasive spine, so let’s progress forward,” Dr. Jassal shares.
In this ASPN Virtual Think Tank, moderators Timothy Deer, MD and Dawood Sayed, MD discuss minimally invasive procedures for the spine, proper methods of patient selection for interventional pain techniques, and safety and efficacy of patients going forward. The Vertos Medical session, “Redefining the mild® Procedure: Emerging Techniques & Advancing the Treatment Algorithm” is led by Alex Escobar, MD; Denis G. Patterson, DO and Jackie Weisbein, DO.
“One of the many features that we see with innovation comes around optimizing techniques and not recreating something new and what we’ve found through many hours spent in the cadaver lab as well as employing this Streamlined Technique in many of our practices is that we can commonly access both sides of the lamina using the single entry point that we will see in a video shortly.” Dr. Escobar says.
In this American Society of Pain & Neuroscience (ASPN) webinar, moderators Timothy Deer, MD; Dawood Sayed, MD and faculty members Steven Falowski, MD; Anjum Bux, MD; Peter Pryzbylkowski, MD; Navdeep Jassal, MD; Alex Escobar, MD and Zohra Hussaini, MSN, FNP-BC, MBA, discuss how to evaluate patients to determine appropriate candidates for PILD, use safety and efficacy data to understand where PILD fits in the LSS treatment algorithm, and efficiently educate and manage PILD patients to ensure appropriate treatment expectations are established.
“We know that the effect of epidural steroid injections (ESIs) on symptoms of neurogenic claudication (NC) are limited and they’re short term and, as Anjum mentioned earlier, patients receiving steroids do have increased susceptibility to infection and immunosuppression. So, the great thing about this procedure, you don’t have to use steroids. If you’re worried about taking referrals from your surgical colleagues, I’d encourage you to go to your surgical colleagues and say, ‘Give me the patients you don’t want to operate on and see what I can do for them.’ You’ll be impressed and the patients will go back to those surgeons and then all of a sudden, you’ll see surgeons start to refer more and more to you for patients they don’t want to operate on. You can truly help when you do the decompression procedure. So, spinal comorbidities are not contraindicated, so if patients have disc bulges, disc osteophytes, facet arthropathy, facet hypertrophy, that doesn’t preclude those patients from getting a percutaneous decompression, those patients tend to do very well after we decompress them,” Dr. Pryzbylkowski says.
In this five-part webcast series from Ciné-Med and MediaSphere Medical, Timothy Deer, MD, DABPM, FIPP; Stanley Golovac, MD; Navdeep Jassal, MD and Ashley Comer, APRN, NP-C discuss lumbar spinal stenosis and treatment options, typical lumbar spinal stenosis patients and differentiating symptom types, confirming symptoms with an MRI, integrating LSS identification and efficient patient management into a practice’s routine, and FAQ with those that are mild® providers.
“This activity evaluates the promising strategy of the reimbursable mild® Procedure for treating LSS patients minimally invasively, which restores mobility and reduces pain, while offering a low risk of major complications,” the activity description reads.
Collaboration is one of Vertos Medical’s core values as the company partners with the nation’s leading institutions and healthcare providers to ensure LSS patients have access to mild® as a treatment option. Performed through an incision smaller than the size of a baby aspirin (5.1mm), mild® is a minimally invasive lumbar decompression procedure that removes a major root cause of neurogenic claudication by debulking the hypertrophic ligamentum flavum, which reduces the compression of the nerves. Learn more about how mild® can be a valuable part of your practice.
Most Minimally Invasive Lumbar Decompression (mild®) providers are very familiar with the 1-year study conducted by Nagy Mekhail, MD, PhD who, along with a team of investigators from the Department of Pain Management at the Cleveland Clinic, examined the real-world benefit of the mild® Procedure: functional improvement. The 1-year outcomes demonstrated significant functional improvement for lumbar spinal stenosis (LSS) patients in both walking distance and standing time, with continuous mean improvement at each follow-up point. The study results are remarkable, as can be viewed in the figure below.
Patients clearly benefited from this type of treatment with a notable increase in function; this shows the effect the mild® Procedure had on patients who were previously unable to complete simple, everyday tasks beforehand. Now they are able to get out and enjoy life without having to sit down and rest as frequently as they did before the mild® Procedure.
The investigators at the Cleveland Clinic recently published an additional independent, retrospective cohort study which further explores the long-term durability of mild® at 5 years. They followed LSS patients receiving the mild® Procedure at the Cleveland Clinic between 2010 and 2015.
The recently published paper, The Durability of Minimally Invasive Lumbar Decompression Procedure in Patients with Symptomatic Lumbar Spinal Stenosis: Long Term Follow-Up, explores how many patients were able to avoid surgical decompression after the mild® Procedure over a five-year period. Changes in pain level using the Numeric Rating Scale (NRS) and opioid medication utilization using Morphine Milligram Equivalent (MME) dose per day from baseline to 3-, 6-, and 12-months post-mild® Procedure were also collected, along with post-procedure complications.
mild® is a minimally invasive decompression procedure that addresses a major root cause of patients’ stenosis without having to undergo an invasive open surgery or leave implants behind. It has the safety profile equivalent to an epidural steroid injection (ESI), but with lasting results and is often compatible for patients with existing risk factors that, traditionally, may not be candidates for open surgery. According to the study, the mild® Procedure significantly decreased the incidence of surgical decompression at the same treatment level(s) as mild® intervention during five-year follow-up. Nine out of 75 patients required lumbar surgical decompression at the same level during the follow-up period, making the annual incidence of same-level lumbar-decompression surgery just 2.4%. Subjects experienced statistically significant pain relief and reduction of opioid medications utilization at 3, 6, and 12 months compared to baseline. There were no major complications reported.
Here are the 3 key takeaways from the 5-year study, and a link to access the full peer-reviewed articles:
88% of patients avoided surgical decompression for at least 5 years.
“The durability of mild® over 5 years may allow elderly patients with symptomatic lumbar spinal stenosis to avoid lumbar decompression surgery while providing significant symptomatic relief.”
No implants.
“The mild® Procedure allows debulking of the hypertrophic ligamentum flavum without interfering with the integrity of the bony spine, and does not require implants.”
No need to delay patient care.
“Further, because the mild® procedure demonstrated durability up to 5 years, it might also be speculated with caution, that appropriate patients should be encouraged to undergo the mild® procedure as early as needed, rather than waiting until these patients are at an advanced age.”
View 5-Year Paper View 1-Year Paper
Acknowledgments: A special thank you to the investigator and author team from the Evidence-Based Pain Management Research Group at the Cleveland Clinic: Nagy Mekhail, MD, PhD; Shrif Costandi, MD; George Nageeb, BS; Catherine Ekladios, MD; Ogena Saied, MS. Vertos Medical and the mild® patients across the country who benefit from this procedure are grateful for your care and attention in advancing the data around the safety, functional improvement, and long-term durability of mild®.
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.
The mild® Procedure is a minimally invasive treatment for lumbar spinal stenosis. 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.
