Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.

Polytomous Rasch Analyses of Surgeons' Decision-Making on Choice of Procedure in Endoscopic Lumbar Spinal Stenosis Decompression Surgeries.

BACKGROUND: With the growing prevalence of lumbar spinal stenosis, endoscopic surgery, which incorporates techniques such as transforaminal, interlaminar, and unilateral biportal (UBE) endoscopy, is increasingly considered. However, the patient selection criteria are debated among spine surgeons. OBJECTIVE: This study used a polytomous Rasch analysis to evaluate the factors influencing surgeon decision-making in selecting patients for endoscopic surgical treatment of lumbar spinal stenosis. METHODS: A comprehensive survey was distributed to a representative sample of 296 spine surgeons. Questions encompassed various patient-related and clinical factors, and responses were captured on a logit scale graphically displaying person-item maps and category probability curves for each test item. Using a Rasch analysis, the data were subsequently analyzed to determine the latent traits influencing decision-making. RESULTS: The Rasch analysis revealed that surgeons' preferences for transforaminal, interlaminar, and UBE techniques were easily influenced by comfort level and experience with the endoscopic procedure and patient-related factors. Harder-to-agree items included technological aspects, favorable clinical outcomes, and postoperative functional recovery and rehabilitation. Descriptive statistics suggested interlaminar as the best endoscopic spinal stenosis decompression technique. However, logit person-item analysis integral to the Rasch methodology showed highest intensity for transforaminal followed by interlaminar endoscopic lumbar stenosis decompression. The UBE technique was the hardest to agree on with a disordered person-item analysis and thresholds in category probability curve plots. CONCLUSION: Surgeon decision-making in selecting patients for endoscopic surgery for lumbar spinal stenosis is multifaceted. While the framework of clinical guidelines remains paramount, on-the-ground experience-based factors significantly influence surgeons' selection of patients for endoscopic lumbar spinal stenosis surgeries. The Rasch methodology allows for a more granular psychometric evaluation of surgeon decision-making and accounts better for years-long experience that may be lost in standardized clinical guideline development. This new approach to assessing spine surgeons' thought processes may improve the implementation of evidence-based protocol change dictated by technological advances was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the International Society for Minimal Intervention in Spinal Surgery (ISMISS), the Mexican Spine Society (AMCICO), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Society (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS).

Comparative Analysis of Learning Curve, Complexity, Psychological Stress, and Work Relative Value Units for CPT 62380 Endoscopic Lumbar Spinal Decompression vs Traditional Lumbar Spine Surgeries: A Paired Rasch Survey Study.

BACKGROUND: Effective 1 January 2017, single-level endoscopic lumbar discectomy received a Category I Current Procedural Terminology (CPT) code 62380. However, no work relative value units (RVUs) are currently assigned to the procedure. An international team of endoscopic spine surgeons conducted a study, endorsed by several spine societies, analyzing the learning curve, difficulty, psychological intensity, and estimated work RVUs of endoscopic lumbar spinal decompression compared with other common lumbar spine surgeries. METHODS: A survey comparing CPT 62380 to 10 other comparator CPT codes reflective of common spine surgeries was developed to assess the work RVUs in terms of learning curve, difficulty, psychological intensity, and work effort using a paired Rasch method. RESULTS: The survey was sent to 542 spine specialists. Of 322 respondents, 150 completed the survey for a 43.1% completion rate. Rasch analysis of the submitted responses statistically corroborated common knowledge that the learning curve with lumbar endoscopic spinal surgery is steeper and more complex than with traditional translaminar lumbar decompression surgeries. It also showed that the psychological stress and mental and work effort with the lumbar endoscopic decompression surgery were perceived to be higher by responding spine surgeons compared with posterior comparator decompression and fusion surgeries and even posterior interbody and posterolateral fusion surgeries. The regression analysis of work effort vs procedural difficulty showed the real-world evaluation of the lumbar endoscopic decompression surgery described in CPT code 62380 with a calculated work RVU of 18.2464. CONCLUSION: The Rasch analysis suggested the valuation for the endoscopic lumbar decompression surgery should be higher than for standard lumbar surgeries: 111.1% of the laminectomy with exploration and/or decompression of spinal cord and/or cauda equina (CPT 63005), 118.71% of the laminectomy code (CPT 63047), which includes foraminotomy and facetectomy, 152.1% of the hemilaminectomy code (CPT 63030), and 259.55% of the interlaminar or interspinous process stabilization/distraction without decompression code (CPT 22869). This research methodology was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the Mexican Society of Spinal Surgeons (AMCICO), the International Society For Minimally Invasive Spine Surgery (ISMISS), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Surgery (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS). CLINICAL RELEVANCE: This study provides an updated reimbursement recommendation for endoscopic spine surgery. LEVEL OF EVIDENCE: Level 3.

Disability-adjusted life years from bone and joint infections associated with antimicrobial resistance: an insight from the 2019 Global Burden of Disease Study.

PURPOSE: Bone and joint infections, complicated by the burgeoning challenge of antimicrobial resistance (AMR), pose significant public health threats by amplifying the disease burden globally. We leveraged results from the 2019 Global Burden of Disease Study (GBD) to explore the impact of AMR attributed to bone and joint infections in terms of disability-adjusted life years (DALYs), elucidating the contemporary status and temporal trends. METHODS: Utilizing GBD 2019 data, we summarized the burden of bone and joint infections attributed to AMR across 195 countries and territories in the 30 years from 1990 to 2019. We review the epidemiology of AMR in terms of age-standardized rates, the estimated DALYs, comprising years of life lost (YLLs) and years lived with disability (YLDs), as well as associations between DALYs and socio-demographic indices. RESULTS: The GBD revealed that DALYs attributed to bone and joint infections associated with AMR have risen discernibly between 1990 and 2019 globally. Significant geographical disparities and a positive correlation with socio-demographic indicators were observed. Staphylococcus aureus infections, Group A Streptococcus, Group B Streptococcus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter-related bone and joint infections were associated with the highest DALYs because of a high proportion of antimicrobial resistance. Countries with limited access to healthcare, suboptimal sanitary conditions, and inconsistent antibiotic stewardship were markedly impacted. CONCLUSIONS: The GBD underscores the escalating burden of bone and joint infections exacerbated by AMR, necessitating urgent, multi-faceted interventions. Strategies to mitigate the progression and impact of AMR should emphasize prudent antimicrobial usage and robust infection prevention and control measures, coupled with advancements in diagnostic and therapeutic modalities.

Perspective on Intradiscal Therapies for Lumbar Discogenic Pain: State of the Science, Knowledge Gaps, and Imperatives for Clinical Adoption.

Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration's (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.

Randomized Clinical Trials and Observational Tribulations: Providing Clinical Evidence for Personalized Surgical Pain Management Care Models.

Proving clinical superiority of personalized care models in interventional and surgical pain management is challenging. The apparent difficulties may arise from the inability to standardize complex surgical procedures that often involve multiple steps. Ensuring the surgery is performed the same way every time is nearly impossible. Confounding factors, such as the variability of the patient population and selection bias regarding comorbidities and anatomical variations are also difficult to control for. Small sample sizes in study groups comparing iterations of a surgical protocol may amplify bias. It is essentially impossible to conceal the surgical treatment from the surgeon and the operating team. Restrictive inclusion and exclusion criteria may distort the study population to no longer reflect patients seen in daily practice. Hindsight bias is introduced by the inability to effectively blind patient group allocation, which affects clinical result interpretation, particularly if the outcome is already known to the investigators when the outcome analysis is performed (often a long time after the intervention). Randomization is equally problematic, as many patients want to avoid being randomly assigned to a study group, particularly if they perceive their surgeon to be unsure of which treatment will likely render the best clinical outcome for them. Ethical concerns may also exist if the study involves additional and unnecessary risks. Lastly, surgical trials are costly, especially if the tested interventions are complex and require long-term follow-up to assess their benefit. Traditional clinical testing of personalized surgical pain management treatments may be more challenging because individualized solutions tailored to each patient's pain generator can vary extensively. However, high-grade evidence is needed to prompt a protocol change and break with traditional image-based criteria for treatment. In this article, the authors review issues in surgical trials and offer practical solutions.

Patient Perceptions of Paramedian Minimally Invasive Spine Skin Incisions.

BACKGROUND: In clinical outcome studies, patient input into the factors that drive higher satisfaction with lumbar minimally invasive spinal surgery (MISS) is rare. The skin incision is often the only visible consequence of surgery that patients can assess. The authors were interested in patients' opinions about the type of lumbar paramedian minimally invasive spinal (MIS) skin incision employed during MISS and how novel skin incisions could impact patients' interpretation of the outcome. The authors wanted to compare traditional lumbar stab incisions to three novel lumbar paramedian (MIS) skin incisions to determine if further study is indicated. The primary objective was to examine patient satisfaction and perceptions regarding lumbar paramedian MIS skin incisions. METHODS: We reviewed the literature and conducted a patient opinion survey. Responses were solicited from back pain patients from a single chiropractic office. Survey questions regarding novel skin incisions for minimally invasive spine surgery (NSIMISS) were conceptualized. The three novel skin incisions were designed using Langer's lines to reduce the total number of incisions; improve patient satisfaction; increase ease of surgical approach/fixation; and reduce operative time/radiation exposure. RESULTS: One hundred and six participants were surveyed. When shown traditional lumbar paramedian MIS skin stab incisions, 76% of respondents indicated negative responses, n = 65. The majority of patients chose traditional stab incisions (n = 41) followed by novel larger intersecting incisions (n = 37). The least popular incisions were the novel horizontal (n = 20) and the novel mini oblique (n = 5) incisions. Female patients worried more than male patients about how their incision looked. However, there was no statistically significant difference (p value of 0.0418 via Mann-Whitney U one-tailed test and p value of 0.0836 via Mann-Whitney U two-tailed test). Patients less than or equal to 50 years of age worried more than patients over 51 years of age, which was statistically significant (p value of 0.0104 via Mann-Whitney U one-tailed test and p value of 0.0208 via Mann-Whitney U two-tailed test). CONCLUSIONS: Patients do have opinions on the type of lumbar paramedian MIS skin incision used. It appears that younger patients and female patients worry most about how the incision on their back looks after surgery. A larger population of patients across many demographics is needed to validate these findings.

Personalized Interventional Surgery of the Lumbar Spine: A Perspective on Minimally Invasive and Neuroendoscopic Decompression for Spinal Stenosis.

Pain generator-based lumbar spinal decompression surgery is the backbone of modern spine care. In contrast to traditional image-based medical necessity criteria for spinal surgery, assessing the severity of neural element encroachment, instability, and deformity, staged management of common painful degenerative lumbar spine conditions is likely to be more durable and cost-effective. Targeting validated pain generators can be accomplished with simplified decompression procedures associated with lower perioperative complications and long-term revision rates. In this perspective article, the authors summarize the current concepts of successful management of spinal stenosis patients with modern transforaminal endoscopic and translaminar minimally invasive spinal surgery techniques. They represent the consensus statements of 14 international surgeon societies, who have worked in collaborative teams in an open peer-review model based on a systematic review of the existing literature and grading the strength of its clinical evidence. The authors found that personalized clinical care protocols for lumbar spinal stenosis rooted in validated pain generators can successfully treat most patients with sciatica-type back and leg pain including those who fail to meet traditional image-based medical necessity criteria for surgery since nearly half of the surgically treated pain generators are not shown on the preoperative MRI scan. Common pain generators in the lumbar spine include (a) an inflamed disc, (b) an inflamed nerve, (c) a hypervascular scar, (d) a hypertrophied superior articular process (SAP) and ligamentum flavum, (e) a tender capsule, (f) an impacting facet margin, (g) a superior foraminal facet osteophyte and cyst, (h) a superior foraminal ligament impingement, (i) a hidden shoulder osteophyte. The position of the key opinion authors of the perspective article is that further clinical research will continue to validate pain generator-based treatment protocols for lumbar spinal stenosis. The endoscopic technology platform enables spine surgeons to directly visualize pain generators, forming the basis for more simplified targeted surgical pain management therapies. Limitations of this care model are dictated by appropriate patient selection and mastering the learning curve of modern MIS procedures. Decompensated deformity and instability will likely continue to be treated with open corrective surgery. Vertically integrated outpatient spine care programs are the most suitable setting for executing such pain generator-focused programs.

Defining the Patient with Lumbar Discogenic Pain: Real-World Implications for Diagnosis and Effective Clinical Management.

There is an enormous body of literature that has identified the intervertebral disc as a potent pain generator. However, with regard to lumbar degenerative disc disease, the specific diagnostic criteria lack clarity and fail to capture the primary components which include axial midline low back pain with or without non-radicular/non-sciatic referred leg pain in a sclerotomal distribution. In fact, there is no specific ICD-10-CM diagnostic code to classify and define discogenic pain as a unique source of pain distinct from other recognized sources of chronic low back pain including facetogenic, neurocompressive including herniation and/or stenosis, sacroiliac, vertebrogenic, and psychogenic. All of these other sources have well-defined ICD-10-CM codes. Corresponding codes for discogenic pain remain absent from the diagnostic coding vernacular. The International Society for the Advancement of Spine Surgery (ISASS) has proposed a modernization of ICD-10-CM codes to specifically define pain associated with lumbar and lumbosacral degenerative disc disease. The proposed codes would also allow the pain to be characterized by location: lumbar region only, leg only, or both. Successful implementation of these codes would benefit both physicians and payers in distinguishing, tracking, and improving algorithms and treatments for discogenic pain associated with intervertebral disc degeneration.

The Changing Environment in Postgraduate Education in Orthopedic Surgery and Neurosurgery and Its Impact on Technology-Driven Targeted Interventional and Surgical Pain Management: Perspectives from Europe, Latin America, Asia, and The United States.

Personalized care models are dominating modern medicine. These models are rooted in teaching future physicians the skill set to keep up with innovation. In orthopedic surgery and neurosurgery, education is increasingly influenced by augmented reality, simulation, navigation, robotics, and in some cases, artificial intelligence. The postpandemic learning environment has also changed, emphasizing online learning and skill- and competency-based teaching models incorporating clinical and bench-top research. Attempts to improve work-life balance and minimize physician burnout have led to work-hour restrictions in postgraduate training programs. These restrictions have made it particularly challenging for orthopedic and neurosurgery residents to acquire the knowledge and skill set to meet the requirements for certification. The fast-paced flow of information and the rapid implementation of innovation require higher efficiencies in the modern postgraduate training environment. However, what is taught typically lags several years behind. Examples include minimally invasive tissue-sparing techniques through tubular small-bladed retractor systems, robotic and navigation, endoscopic, patient-specific implants made possible by advances in imaging technology and 3D printing, and regenerative strategies. Currently, the traditional roles of mentee and mentor are being redefined. The future orthopedic surgeons and neurosurgeons involved in personalized surgical pain management will need to be versed in several disciplines ranging from bioengineering, basic research, computer, social and health sciences, clinical study, trial design, public health policy development, and economic accountability. Solutions to the fast-paced innovation cycle in orthopedic surgery and neurosurgery include adaptive learning skills to seize opportunities for innovation with execution and implementation by facilitating translational research and clinical program development across traditional boundaries between clinical and nonclinical specialties. Preparing the future generation of surgeons to have the aptitude to keep up with the rapid technological advances is challenging for postgraduate residency programs and accreditation agencies. However, implementing clinical protocol change when the entrepreneur-investigator surgeon substantiates it with high-grade clinical evidence is at the heart of personalized surgical pain management.

Endoscopic Posterior Cervical Decompression for Ossified Posterior Longitudinal Ligament: A Technical Note.

BACKGROUND: Ossification of the posterior longitudinal ligament (OPLL) may cause cervical myelopathy. In its multilevel form, it may not be easy to manage. Minimally invasive endoscopic posterior cervical decompression may be an alternative to traditional laminectomy surgery. METHODS: Thirteen patients with multilevel OPLL and symptomatic cervical myelopathy were treated with endoscopic spine surgery from January 2019 to June 2020. In this consecutive observational cohort study, pre- and postoperative Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) were analyzed at a final follow-up of 2 years postoperatively. RESULTS: There were 13 patients consisting of 3 women and 10 men. The patient's average age was 51.15 years. At the final 2-year follow-up, the JOA score improved from a preoperative value of 10.85 ± 2.91 to 14.77 ± 2.13 postoperatively (P < 0.001). The corresponding NDI scores decreased from 26.61 ± 12.88 to 11.12 ± 10.85 (P < 0.001). There were no infections, wound complications, or reoperations. CONCLUSION: Direct posterior endoscopic decompression for multilevel OPLL is feasible in symptomatic patients when executed at a high skill level. While 2-year outcomes were encouraging and on par with historic data obtained with traditional laminectomy, future studies will need to show whether any long-term shortcomings exist.

Determination of Work Related to Endoscopic Decompression of Lumbar Spinal Stenosis.

Background: Effective 1 January 2017, single-level endoscopic lumbar discectomy received a Category I Current Procedural Terminology (CPT®) code 62380. However, no work relative value units (wRVUs) are currently assigned to the procedure. A physician's payment needs to be updated to commensurate with the work involved in the modern version of the lumbar endoscopic decompression procedure with and without the use of any implants to stabilize the spine. In the United States, the American Medical Association (AMA) and its Specialty Society Relative Value Scale Update Committee (RUC) proposes to the Centers for Medicare and Medicaid Services (CMS) what wRVUs to assign for any endoscopic lumbar surgery codes. Methods: The authors conducted an independent survey between May and June 2022 which reached 210 spine surgeons using the TypeForm survey platform. The survey link was sent to them via email and social media. Surgeons were asked to assess the endoscopic procedure's technical and physical effort, risk, and overall intensity without focusing just on the time required to perform the surgery. Respondents were asked to compare the work involved in modern comprehensive endoscopic spine care with other commonly performed lumbar surgeries. For this purpose, respondents were provided with the verbatim descriptions of 12 other existing comparator CPT® codes and associated wRVUs of common spine surgeries, as well as a typical patient vignette describing an endoscopic lumbar decompression surgery scenario. Respondents were then asked to select the comparator CPT® code most reflective of the technical and physical effort, risk, intensity, and time spent on patient care during the pre-operative, peri- and intra-operative, and post-operative periods of a lumbar endoscopic surgery. Results: Of the 30 spine surgeons who completed the survey, 85.8%, 46.6%, and 14.3% valued the appropriate wRVU for the lumbar endoscopic decompression to be over 13, over 15, and over 20, respectively. Most surgeons (78.5%; <50th percentile) did not think they were adequately compensated. Regarding facility reimbursement, 77.3% of surgeons reported that their healthcare facility struggled to cover the cost with the received compensation. The majority (46.5%) said their facility received less than USD 2000, while another 10.7% reported less than USD 1500 and 17.9% reported less than USD 1000. The professional fee received by surgeons was

Clinical Consequences of Incidental Durotomy during Full-Endoscopic Lumbar Decompression Surgery in Relation to Intraoperative Epidural Pressure Measurements.

Background: Seizures, neurological deficits, bradycardia, and, in the worst cases, cardiac arrest may occur following incidental durotomy during routine lumbar endoscopy. Therefore, we set out to measure the intraoperative epidural pressure during lumbar endoscopic decompression surgery. Methods: We conducted a retrospective observational cohort study to obtain intraoperative epidural measurements with an epidural catheter-pressure transducer assembly through the spinal endoscope on 15 patients who underwent lumbar endoscopic decompression of symptomatic lumbar herniated discs and spinal stenosis. The endoscopic interlaminar technique was employed. Results: There were six (40.0%) female and nine (60.0%) male patients aged 49.0667 ± 11.31034, ranging from 36 to 72 years, with an average follow-up of 35.15 ± 12.48 months. Three of the fifteen patients had seizures with durotomy and one of these three had intracranial air on their postoperative brain CT. Another patient developed spinal headaches and diplopia on postoperative day one when her deteriorating neurological function was investigated with a brain computed tomography (CT) scan, showing an intraventricular hemorrhage consistent with a Fisher Grade IV subarachnoid hemorrhage. A CT angiogram did not show any abnormalities. Pressure recordings in the epidural space in nine patients ranged from 20 to 29 mm Hg with a mean of 24.33 mm Hg. Conclusion: Most incidental durotomies encountered during lumbar interlaminar endoscopy can be managed without formal repair and supportive care measures. The intradural spread of irrigation fluid and intraoperatively used drugs and air entrapment through an unrecognized durotomy should be suspected if patients deteriorate in the recovery room. Ascending paralysis may cause nausea, vomiting, upper and lower motor neuron symptoms, cranial nerve palsies, hypotension, bradycardia, and respiratory and cardiac arrest. The recovery team should be prepared to manage these complications.

Comparison of Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center and Traditional Hospital Settings, Part 2: Assessment of Surgical Safety in Medicare Beneficiaries.

(1) Background: The clinical benefits and procedural efficiencies of performing minimally invasive fusion procedures, such as transforaminal lumbar interbody fusion (TLIF), in the ambulatory surgery center (ASC) are becoming increasingly well established. Currently, Medicare does not provide reimbursement for its beneficiaries eligible for TLIF in the ASC due to a lack of evidence regarding procedural safety. However, the initiation of the Hospital Without Walls program allowed for traditional hospital procedures to be relocated to other facilities such as ASCs, providing a unique opportunity to evaluate the utility of TLIF in the ASC in Medicare-age patients. (2) Methods: This single-center, retrospective study compared baseline characteristics, intraoperative variables, and 30-day postoperative safety outcomes between 48 Medicare-age patients undergoing TLIF in the ASC and 48 patients having the same procedure as hospital in-patients. All patients had a one-level TLIF using the VariLift®-LX expandable lumbar interbody fusion device. (3) Results: There were similar patient characteristics, procedural efficiency, and occurrence of clinical 30-day safety events between the two study groups. However, there was a marked and statistically significant difference in the median length of stay favoring TLIF patients treated in the ASC (23.9 h vs. 1.6 h, p = 0.001). All ASC-treated patients were discharged on the day of surgery. Postoperative visits to address adverse events were rare in either group. (4) Conclusions: These findings provide evidence that minimally invasive TLIF can be performed safely and efficiently in the ASC in Medicare-age patients. With same-day discharge, fusion procedures performed in the ASC offer a similar safety and more attractive cost-benefit profile for older patients than the same surgery undertaken in the traditional hospital setting. The Centers for Medicare and Medicaid Services should strongly consider extending the appropriate reimbursement codes (CPT ® 22630, 22633) for minimally invasive TLIF and PLIF to the ASC Covered Procedure List so that Medicare-age patients can realize the clinical benefits of surgeries performed in this setting.

Pain Relief After Allogenic Stem Cell Disc Therapy.

BACKGROUND: Treatment of intermediate-stage painful degenerative disc disease is controversial, with few reliable options. Allogenic mesenchymal stem cells (MSCs)are an alternative to autologous stem cell transplantation. Allogeneic MSCs in the treatment of discogenic low back pain have some practical advantages, ranging from availability to ease of treatment in a procedure-room setting. OBJECTIVES: To assess the efficacy and safety of allogenic MSC injection into painful lumbar intervertebral discs and associated clinical outcomes. STUDY DESIGN: Retrospective observational cohort study. SETTING: Private practice. METHODS: There were 33 patients: 15 women and 18 men with an average age of 47.6 years. The patients' average follow-up was 26.88 months Patients were treated with intradiscal injection of approximately 5 million allogeneic polyclonal MSCs in 1% hyaluronic acid derived from immunoselected umbilical cord stem cells. Patients were monitored for adverse event reactions. Clinical outcomes were assessed with reductions in the reported Visual Analog Scale (VAS) for back pain, the Oswestry Disability Index (ODI) scores, and the use of the modified Macnab criteria. RESULTS: No patient required any additional treatments for low back pain stemming from the level treated with MSC injections. At a 2-year follow-up, the average VAS low back score reduction was 6.565 ± 1.619 and 38.333 ± 14.865 for the ODI (P < 0.001). Reported Macnab outcomes were excellent in 11 patients (33.3%), good in 19 (57.6%), and fair in 3 (9.1%). LIMITATIONS: Our observational study is limited by patient selection, hindsight bias, and low patient numbers. CONCLUSION: The results of our feasibility study suggest that the injection of allogeneic MSCs to treat patients with painful intermediate-stage degenerative disc disease has merit. No adverse reactions were observed. The authors recommend further study in a randomized prospective study setting with a placebo control group or a natural history study group of patients to solidify this research.

Comparison of Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center and Traditional Hospital Settings, Part 1: Multi-Center Assessment of Surgical Safety.

(1) Background: The technological advances achieved with minimally-invasive surgery have enabled procedures to be undertaken in outpatient settings, and there has been growing acceptance of performing minimally-invasive transforaminal interbody fusion (TLIF) in the ambulatory surgery center (ASC). The purposeof this study was to determine the comparative 30 day safety profile for patients treated with TLIF in the ASC versus the hospital setting. (2) Methods: This multi-center study retrospectively collected baseline characteristics, perioperative variables, and 30 day postoperative safety outcomes for patients having a TLIF using the VariLift®-LX expandable lumbar interbody fusion device. Outcomes were compared between patients undergoing TLIF in the ASC (n = 53) versus in the hospital (n = 114). (3) Results: Patients treated in-hospital were significantly older, frailer and more likely to have had previous spinal surgery than ASC patients. Preoperative back and leg pain scores were similar between study groups (median, 7). ASC patients had almost exclusively one-level procedures (98%) vs. 20% of hospital procedures involving two-levels (p = 0.004). Most procedures (>90%) employed a stand-alone device. The median length of stay for hospital patients was five times greater than for ASC patients (1.4 days vs. 0.3 days, p = 0.001). Emergency department visits, re-admissions and reoperations were rare whether the patients were managed in the traditional hospital setting or the ASC. (4) Conclusions: There were equivalent 30 day postoperative safety profiles for patients undergoing a minimally-invasive TLIF irrespective of surgical setting. For appropriately selected surgical candidates, the ASC offers a viable and attractive option for their TLIF procedure with the advantage of same-day discharge and at-home recovery.

Identification of the Magna Radicular Artery Entry Foramen and Adamkiewicz System: Patient Selection for Open versus Full-Endoscopic Thoracic Spinal Decompression Surgery.

BACKGROUND: Casually cauterizing the radicular magna during routine thoracic discectomy may have dire consequences. METHODS: We performed a retrospective observational cohort study on patients scheduled for decompression of symptomatic thoracic herniated discs and spinal stenosis who underwent a preoperative computed tomography angiography (CTA) to assess the surgical risks by anatomically defining the foraminal entry level of the magna radicularis artery into the thoracic spinal cord and its relationship to the surgical level. RESULTS: Fifteen patients aged 58.53 ± 19.57, ranging from 31 to 89 years, with an average follow-up of 30.13 ± 13.42 months, were enrolled in this observational cohort study. The mean preoperative VAS for axial back pain was VAS of 8.53 ± 2.06 and reduced to a postoperative VAS of 1.60 ± 0.92 (p < 0.0001) at the final follow-up. The Adamkiewicz was most frequently found at T10/11 (15.4%), T11/12 (23.1%), and T9/10 (30.8%). There were eight patients where the painful pathology was found far from the AKA foraminal entry-level (type 1), three patients with near location (type 2), and another four patients needing decompression at the foraminal (type 3) entry-level. In five of the fifteen patients, the magna radicularis entered the spinal canal on the ventral surface of the exiting nerve root through the neuroforamen at the surgical level requiring a change of surgical strategy to prevent injury to this important contributor to the spinal cord's blood supply. CONCLUSIONS: The authors recommend stratifying patients according to the proximity of the magna radicularis artery to the compressive pathology with CTA to assess the surgical risk with targeted thoracic discectomy methods.

Joint International SILACO, SICCMII, ISASS Symposium as a Model for a Collaborative Framework to Create Literature on Advances in Spine Surgery, Patient Care, and Policy.

International collaborations can be the key to overcoming innovation implementation hurdles. The authors report on a joint symposium between the International Society For The Advancement of Spine Surgery (ISASS) and La Sociedad Iberolatinoamerica de Columna (SILACO), and La Sociedad Interamericana de Cirurgia de columna de Minima invasión (SICCMII) aimed at improving joint surgeon education programs. The symposium highlighted that patient-related spine care issues are similar across geographical, cultural, and language barriers. The sustainability of such programs depends on funding and mutually respectful relationships orchestrated by multi-lingual leaders who will bridge gaps created by geographical, cultural, and language barriers to effectively develop clinical research content focused on advancing surgeon education and improving patient outcomes across the Americas.

A Proposed Personalized Spine Care Protocol (SpineScreen) to Treat Visualized Pain Generators: An Illustrative Study Comparing Clinical Outcomes and Postoperative Reoperations between Targeted Endoscopic Lumbar Decompression Surgery, Minimally Invasive TLIF and Open Laminectomy.

Background: Endoscopically visualized spine surgery has become an essential tool that aids in identifying and treating anatomical spine pathologies that are not well demonstrated by traditional advanced imaging, including MRI. These pathologies may be visualized during endoscopic lumbar decompression (ELD) and categorized into primary pain generators (PPG). Identifying these PPGs provides crucial information for a successful outcome with ELD and forms the basis for our proposed personalized spine care protocol (SpineScreen). Methods: a prospective study of 412 patients from 7 endoscopic practices consisting of 207 (50.2%) males and 205 (49.8%) females with an average age of 63.67 years and an average follow-up of 69.27 months was performed to compare the durability of targeted ELD based on validated primary pain generators versus image-based open lumbar laminectomy, and minimally invasive lumbar transforaminal interbody fusion (TLIF) using Kaplan-Meier median survival calculations. The serial time was determined as the interval between index surgery and when patients were censored for additional interventional and surgical treatments for low back-related symptoms. A control group was recruited from patients referred for a surgical consultation but declined interventional and surgical treatment and continued on medical care. Control group patients were censored when they crossed over into any surgical or interventional treatment group. Results: of the 412 study patients, 206 underwent ELD (50.0%), 61 laminectomy (14.8%), and 78 (18.9%) TLIF. There were 67 patients in the control group (16.3% of 412 patients). The most common surgical levels were L4/5 (41.3%), L5/S1 (25.0%), and L4-S1 (16.3%). At two-year f/u, excellent and good Macnab outcomes were reported by 346 of the 412 study patients (84.0%). The VAS leg pain score reduction was 4.250 ± 1.691 (p < 0.001). No other treatment during the available follow-up was required in 60.7% (125/206) of the ELD, 39.9% (31/78) of the TLIF, and 19.7% (12/61 of the laminectomy patients. In control patients, only 15 of the 67 (22.4%) control patients continued with conservative care until final follow-up, all of which had fair and poor functional Macnab outcomes. In patients with Excellent Macnab outcomes, the median durability was 62 months in ELD, 43 in TLIF, and 31 months in laminectomy patients (p < 0.001). The overall survival time in control patients was eight months with a standard error of 0.942, a lower boundary of 6.154, and an upper boundary of 9.846 months. In patients with excellent Macnab outcomes, the median durability was 62 months in ELD, 43 in TLIF, and 31 months in laminectomy patients versus control patients at seven months (p < 0.001). The most common new-onset symptom for censoring was dysesthesia ELD (9.4%; 20/206), axial back pain in TLIF (25.6%;20/78), and recurrent pain in laminectomy (65.6%; 40/61) patients (p < 0.001). Transforaminal epidural steroid injections were tried in 11.7% (24/206) of ELD, 23.1% (18/78) of TLIF, and 36.1% (22/61) of the laminectomy patients. The secondary fusion rate among ELD patients was 8.8% (18/206). Among TLIF patients, the most common additional treatments were revision fusion (19.2%; 15/78) and multilevel rhizotomy (10.3%; 8/78). Common follow-up procedures in laminectomy patients included revision laminectomy (16.4%; 10/61), revision ELD (11.5%; 7/61), and multilevel rhizotomy (11.5%; 7/61). Control patients crossed over into ELD (13.4%), TLIF (13.4%), laminectomy (10.4%) and interventional treatment (40.3%) arms at high rates. Most control patients treated with spinal injections (55.5%) had excellent and good functional outcomes versus 40.7% with fair and poor (3.7%), respectively. The control patients (93.3%) who remained in medical management without surgery or interventional care (14/67) had the worst functional outcomes and were rated as fair and poor. Conclusions: clinical outcomes were more favorable with lumbar surgeries than with non-surgical control groups. Of the control patients, the crossover rate into interventional and surgical care was 40.3% and 37.2%, respectively. There are longer symptom-free intervals after targeted ELD than with TLIF or laminectomy. Additional intervention and surgical treatments are more often needed to manage new-onset postoperative symptoms in TLIF- and laminectomy compared to ELD patients. Few ELD patients will require fusion in the future. Considering the rising cost of surgical spine care, we offer SpineScreen as a simplified and less costly alternative to traditional image-based care models by focusing on primary pain generators rather than image-based criteria derived from the preoperative lumbar MRI scan.