An Overview of mild^® Procedure Abstracts Showcased at the ASPN 2023 Annual Conference

Introduction

In July 2023, the American Society of Pain and Neuroscience (ASPN) held its 5th annual conference in Miami Beach, FL. The society’s goal is to facilitate the role of evidence-based pain medicine research, patient education, and advocacy, and to continue to be on the cutting edge of pain medicine interventions. As part of the conference, a number of abstracts showcased the mild^® Procedure, a minimally invasive procedure that debulks thickened ligament in the spinal canal to address a major root cause of lumbar spinal stenosis (LSS). Below are the featured abstracts and their summaries.

Please view the abstracts to review their associated clinical data.

mild^® and Laminectomy for the Treatment of Lumbar Spinal Stenosis: A 2-Year Medicare Claims Benchmark Study

Author: Peter S. Staats, MD, MBA, Chief Medical Officer, National Spine and Pain Centers

WINNER — Selected as an ASPN Top Abstract 2023

This prospective longitudinal study compared 2-year outcomes for Medicare beneficiaries receiving the mild^® Procedure to those undergoing an outpatient laminectomy, a type of spinal surgery. The objective was to provide a benchmark for the incidence of harms versus the rate of subsequent spinal surgical procedures. Patients receiving a laminectomy experienced 3 times more harms at a 5.8% rate, compared to a 1.9% rate for the mild^® Procedure. At a 2-year follow-up, mild^® patients experienced less harms and more subsequent spinal stenosis surgical procedures compared to outpatient laminectomy patients. The higher rate of subsequent surgical procedures for mild^® may reflect its position earlier in the lumbar spinal stenosis treatment algorithm.

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PILD vs Serial ESIs: Applying a Data-Based Algorithm While Prioritizing the Patient Experience

Authors: Nirav N Shah, MD; Matt Bowersox, MD; Paul Guillod, MD; David M Dickerson, MD, NorthShore University Health System 

This abstract’s objective was to examine and compare the care path, experience, and tradeoff for LSS patients dependent on the treatment they receive, comparing PILD to serial ESIs (epidural steroid injections). As highlighted in the abstract, Percutaneous Image-Guided Lumbar Decompression (PILD) is a proven early treatment option for symptomatic lumbar spinal stenosis resulting from hypertrophic ligamentum flavum (HLF). In contrast, epidural steroid injections (ESIs) typically provide temporary relief in the early stages of LSS but require frequent repetition, delaying improved mobility and comfort. The methodology estimated the 1-year real “costs” for LSS patients including the number of office visits, the number of procedures, the total cost, and patient satisfaction, to name a few.

In terms of office visits, PILD patients typically attend 1—3 visits including a consultation and follow-up visit, whereas serial ESI patients often return for additional injections, increasing their total number of visits to the 5—10+ range. The total cost of multiple visits shows a three-time multiplier for serial ESI patients compared to PILD patients, where the total cost represents both monetary costs like co-pays and transportation, and the time-based opportunity cost such as travel and appointment time. Even the patient satisfaction rate for PILD patients was 11% higher compared to serial ESI patients, 85%—74%.

Due to these differences, PILD offers more patient-centric benefits and fewer costs, and would be recommended:

• At first diagnosis of neurogenic claudication
• After a failure of an epidural steroid injection procedure
• After serial epidural steroid injections fail to provide durable resolution of symptoms

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Percutaneous Image Guided Lumbar Decompression (PILD) Above a Prior Spinal Fusion

Authors: Marcel Komer; Eliyah Malik, MS1; Serena Patel; Felipe Jimenez; Sierra Scott; Kelsey Kimball, PA-C; Lindsay Courson, PA-C; John Stevenson, MD; Ajay Antony, MD

This abstract’s objective was to outline the safe and effective workup for percutaneous image guided lumbar decompression above the level of a prior spinal fusion surgery. In this case study, a 70-year-old female presented with symptoms of lumbar spinal stenosis with neurogenic claudication and felt ongoing pain after a spinal fusion. Despite more than 2 years of physical therapy, multiple epidural steroid injections, and over-the-counter medications, the patient had failed to obtain relief. After an evaluation of MRI and CT scans, the patient underwent a one-level bilateral PILD without complication. Four weeks after the procedure, the patient reported a 50% improvement in ambulation time. In conclusion, with the use of proper preoperative imaging, PILD is a potential option for patients suffering from lumbar spinal stenosis and neurogenic claudication after prior surgery.

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A Novel Approach to Increasing Surgical Referrals Using Percutaneous Image-Guided Lumbar Decompression (PILD)

Authors: Nasir Khatri, MD; Morgan Bridgers, PA-C

This abstract’s objective was to create an approach by which pain practices can increase surgical referrals for PILD by collaborating with surgeon practices, and ultimately optimizing patient care. PILD is an ideal procedure to foster surgeon collaboration since it provides a treatment option for nonsurgical candidates and keeps patient in the practice. Surgical Advanced Practice Providers (APPs) are therefore an ideal PILD referral source as they are familiar with patient histories, have the exposure to nonsurgical candidates, and are eager to optimize patient care. If APPs have knowledge of PILD as a potential treatment, suggesting it as a first option for these nonsurgical patients and collaborating with Interventional Pain Management (IPM) would become routine and enhance patient care.

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Evaluating the Efficacy and Durability of Percutaneous Image-Guided Lumbar (PILD) Decompression

Authors: Nasir Khatri, MD*; Morgan Bridgers, PA-C*; Ahmad Sebai, BS**

^{Authors’ Affiliation
*Novant Spine Specialists, Charlotte, NC, USA
**California University of Science and Medicine, CA, USA}

This abstract’s objective was to determine the efficacy and durability of PILD in patients with lumbar spinal stenosis while also implementing a standardized physical therapy referral protocol. These patients were older than 65 years old, with symptoms of neurogenic claudication. They had MRI evidence of at least mild central spinal stenosis with associated ligamentum flavum hypertrophy measuring at least 2.5mm, with a self-reported waning efficacy of epidural steroid injection results. Data points such as standing time and walking distance were collected at a baseline timeframe and 4 weeks post-operatively. At the 4-week follow-up appointment, patients were also referred to a physical therapy routine for core strengthening and endurance building. At the 3-month follow-up, the mean walking distance showed a 986% improvement and the mean standing time showed a 413% improvement. Abstract authors conclude that PILD is a safe and effective treatment option for patients with lumbar spinal stenosis, providing a minimally invasive alternative to traditional spine surgery.

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The views and opinions expressed in this article are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical.