Video-assisted thoracoscopic image-guided spine surgery: evolution of 19 years of experience, from endoscopy to fully integrated 3D navigation.

OBJECTIVE: The purpose of this study was to describe the evolution of thoracoscopic spine surgery from basic endoscopic procedures using fluoroscopy and anatomical localization through developmental iterations to the current technology use in which endoscopy and image-guided surgery are merged with intraoperative CT scanning. METHODS: The authors provided detailed explanations of their thoracoscopic spine surgery techniques, beginning with their early-generation endoscopy with fluoroscopic localization, which was followed with point surface matching techniques and early image guidance. The authors supplanted this with the modern era of image guidance, thoracoscopic spine surgery, and seamless integration that has reached its current level of refinement. RESULTS: A retrospective review of single-institution thoracoscopic procedures performed by the senior author over the course of 19 years yielded a total of 160 patients, including 73 women and 87 men. The mean patient age was 55 years, and the range included patients 16-94 years of age. There were no patients with worsened neurological function. One hundred sixteen patients underwent surgery for thoracic disc herniation, 18 for underlying neoplasms with spinal cord compression, 14 for osteomyelitis and discitis, 12 for thoracic deformity with neurological changes, and 8 for traumatic etiologies. CONCLUSIONS: More than 19 years of experience has revealed the benefits of integrating thoracoscopic spine surgery with intraoperative CT scanning and image-guided surgery, including direct decompression without manipulation of neural elements, superior 3D spatial orientation, and localization of complex spinal anatomy. With the exponential growth of machine learning, robotics, artificial intelligence, and advances in imaging techniques and endoscopic imaging, there may be further refinements of this technique on the horizon.

Epidural hematoma in patients with ankylosing spondylitis requiring surgical stabilization: a single-institution retrospective review with literature analysis.

OBJECTIVE: Ankylosing spondylitis (AS) is a chronic inflammatory disease affecting the sacroiliac joints and axial spine that is closely linked with human leukocyte antigen-B27. There appears to be an increased frequency of associated epidural hematomas in spine fractures in patients with AS. The objective was to review the incidence within the literature and a single-institution experience of the occurrence of epidural hematoma in the context of patients with AS requiring spine surgery. METHODS: Deep 6 AI software was used to search the entire database of patients at a single level I trauma center (since the advent of the institution's modern electronic health record system) to look at all patients with AS who underwent spinal surgery and who had a diagnosis of epidural hematoma. Additionally, a systemic literature review was performed of all papers evaluating the incidence of epidural hematoma in patients with spine fractures. RESULTS: A single-institution, retrospective review of records from 2009 to 2020 yielded a total of 164 patients with AS who underwent spine surgery. Of those patients, 17 (10.4%) had epidural hematomas on imaging, with the majority requiring surgical decompression. These spine fractures occurred close to the cervicothoracic or thoracolumbar junction. The patients ranged in age from 51 to 88 years, and there were 14 males and 3 females in the cohort. Eight patients were administered an antiplatelet and/or anticoagulant agent, and the rest were not. All patients required surgical stabilization, with 64.7% of patients also requiring decompressive laminectomies for evacuation of the hematoma and spinal cord decompression. Only 1 death was reported in the series. There was a tendency toward neurological improvement after surgical intervention. CONCLUSIONS: AS has been a well-described pathologic process that leads to an increased risk of three-column injury in spine fracture, with an increased incidence of symptomatic epidural hematoma compared with patients without AS. Early recognition of this entity is important to ensure that appropriate surgical management includes addressing compression of the neural elements in addition to surgical stabilization.

Image-guided resection of aggressive sacral tumors.

OBJECTIVE The aim of this study was to identify and discuss operative nuances utilizing image guidance in the surgical management of aggressive sacral tumors. METHODS The authors report on their single-institution, multi-surgeon, retrospective case series involving patients with pathology-proven aggressive sacral tumors treated between 2009 and 2016. They also reviewed the literature to identify articles related to aggressive sacral tumors, their diagnosis, and their surgical treatment and discuss the results together with their own experience. Information, including background, imaging, treatment, and surgical pearls, is organized by tumor type. RESULTS Review of the institutional records identified 6 patients with sacral tumors who underwent surgery between 2009 and 2016. All 6 patients were treated with image-guided surgery using cone-beam CT technology (O-arm). The surgical technique used is described in detail, and 2 illustrative cases are presented. From the literature, the authors compiled information about chordomas, chondrosarcomas, giant cell tumors, and osteosarcomas and organized it by tumor type, providing a detailed discussion of background, imaging, and treatment as well as surgical pearls for each tumor type. CONCLUSIONS Aggressive sacral tumors can be an extremely difficult challenge for both the patient and the treating physician. The selected surgical intervention varies depending on the type of tumor, size, and location. Surgery can have profound risks including neural compression, lumbopelvic instability, and suboptimal oncological resection. Focusing on the operative nuances for each type can help prevent many of these complications. Anecdotal evidence is provided that utilization of image-guided surgery to aid in tumor resection at our institution has helped reduce blood loss and the local recurrence rate while preserving function in both malignant and aggressive benign tumors affecting the sacrum.

National trends following decompression, discectomy, and fusion in octogenarians and nonagenarians.

BACKGROUND: The National Inpatient Sample (NIS) database is used to evaluate a wide variety of surgical procedures across a range of specialties. The authors of this study assess national trends of the three commonest spine procedures performed (decompression, fusion, and discectomy) in patients between the ages of 80 and 100 years (octogenarians and nonagenarians). METHODS: The NIS database was queried to identify patients between the ages of 80 and 100 with a primary diagnosis of spinal stenosis, disk herniation without myelopathy, or protrusion due to degeneration of spine/disk disorders and who have undergone spinal decompression, fusion, or discectomy between the years 1998 and 2011. Variables of concern included length-of-stay (LOS), non-routine discharge, average total charges, in-hospital complications, and mortality rate. RESULTS: Decompression was the most common procedure performed (n = 113,267, 50.5%). Fusion (n = 60,345, 26.9%) was associated with the longest LOS (5.1 days), highest in-hospital complication and mortality rates (n = 13,170, 21.8% and n = 449, 0.7%, respectively), most non-routine discharges (n = 42,662, 70.7%), and highest mean for average total charges ($69,295) (p < 0.001). Discectomy (n = 50,740, 22.6%), had the shortest LOS (3.7 days), lowest complication and mortality rates (n = 6823, 13.4% and n = 102, 0.2%, respectively), fewest non-routine discharges (n = 22,861, 45.1%), and lowest mean for average total charges ($22,787) (p < 0.001). CONCLUSIONS: Decompression was most common. Fusion had the longest LOS, highest complication and mortality rates, most non-routine discharges, and was most expensive. Discectomy was least commonly performed, had the shortest LOS, lowest complication and mortality rates, fewest non-routine discharges, and was least expensive.

Clinical and radiographic outcomes of minimally invasive percutaneous pedicle screw placement with intraoperative CT (O-arm) image guidance navigation.

OBJECT: Intraoperative CT image-guided navigation (IGN) has been increasingly incorporated into minimally invasive spine surgery (MIS). The vast improvement in image resolution and virtual real-time images with CT-IGN has proven superiority over traditional fluoroscopic techniques. The authors describe their perioperative MIS technique using the O-arm with navigation, and they report their postoperative experience, accuracy results, and technical aspects. METHODS: A retrospective review of 48 consecutive adult patients undergoing minimally invasive percutaneous posterior spinal fusion with intraoperative CT-IGN between July 2010 and August 2013 at Cedars-Sinai Medical Center was performed. Two surgeons assessed 290 screws in a blinded fashion on intraoperative O-arm images and postoperative CT scans for bony pedicle wall breach. Grade 1 breach was defined to be < 2 mm, Grade 2 breach to be between 2 and 4 mm, and a Grade 3 breach to be > 4 mm. Additionally, anterior vertebral body breach was recorded. RESULTS: Of 290 pedicle screws placed, 280 (96.6%) were in an acceptable position without cortical wall or anterior breach. Of the 10 breaches (3.4%) 5 were lateral (50%), 4 were medial, and 1 was anterior; 90% of breaches were Grade 1-2 and all medial breaches were Grade 1. The one Grade 3 breach was lateral. No vascular or neurological complications were observed intraoperatively, and no significant postoperative complications were noted. The mean clinical follow-up period was 18 months (range 3-39 months). The overall clinical outcomes, measured using the visual analog scale (back pain scores), were improved significantly postoperatively at 3 months compared with preoperatively (visual analog score 6.35 vs 3.57; p < 0.0001). No revision surgery was performed for screw misplacement or neurological deterioration. CONCLUSIONS: New CT-IGN with the mobile O-arm scanner has increased the accuracy of pedicle screw/instrumentation placement using MIS techniques. The authors' high (96.6%) accuracy rate in MIS compares favorably with historical published accuracy rates for fluoroscopy-based techniques. Additional advantages of CT-IGN over fluoroscopic imaging methods are lower occupational radiation exposure for the surgical team, reduced need for postoperative imaging, and decreased rates of revision surgery. For now, the authors simply conclude that use of intraoperative CT-IGN is safe and accurate.

Image-guided navigation and video-assisted thoracoscopic spine surgery: the second generation.

OBJECT: Video-assisted thoracoscopic surgery (VATS) has evolved for treatment of a variety of spinal disorders. Early incorporation with image-guided surgery (IGS) was challenged due to reproducibility and adaptability, limiting the procedure's acceptance. In the present study, the authors report their experience with second-generation IGS and VATS technologies for anterior thoracic minimally invasive spinal (MIS) procedures. METHODS: The surgical procedure is described in detail including operating room set-up, patient positioning (a lateral decubitus position), placement of the spinal reference frame and portal, radiographic localization, registration, surgical instruments, and the image-guided thoracoscopic discectomy. RESULTS: Combined IGS and VATS procedures were successfully performed and assisted in anatomical localization in 14 patients. The mean patient age was 59 years (range 32-73 years). Disc herniation pathology represented the most common indication for surgery (n = 8 patients); intrathoracic spinal tumors were present in 4 patients and the remaining patients had infection and ossification of the posterior longitudinal ligament. All patients required chest tube drainage postoperatively, and all but 1 patient had drainage discontinued the following day. The only complication was a seroma that was presumed to be due to steroid therapy for postoperative weakness. At the final follow-up, 11 of the patients were improved neurologically, 2 patients had baseline neurological status, and the 1 patient with postoperative weakness was able to ambulate, albeit with an assistive device. The evolution of thoracoscopic surgical procedures occurring over 20 years is presented, including their limitations. The combination of VATS and IGS technologies is discussed including their safety and the importance of 3D imaging. In cases of large open thoracotomy procedures, surgeries require difficult, extensive, and invasive access through the chest cavity; using a MIS procedure can potentially eliminate many of the complications and morbidities associated with large open procedures. The authors report their experience with thoracic spinal surgeries that involved MIS procedures and the new technologies. CONCLUSIONS: The most significant advance in IGS procedures has resulted from intraoperative CT scanning and automatic registration with the IGS workstation. Image guidance can be used in conjunction with VATS techniques for thoracic discectomy, spinal tumors, infection, and ossification of the posterior longitudinal ligament. The authors' initial experience has revealed this technique to be useful and potentially applicable to other MIS procedures.

Accuracy of intraoperative computed tomography image-guided surgery in placing pedicle and pelvic screws for primary versus revision spine surgery.

OBJECT: Revision spine surgery, which is challenging due to disrupted anatomy, poor fluoroscopic imaging, and altered tactile feedback, may benefit from CT image-guided surgery (CT-IGS). This study evaluates accuracy of CT-IGS-navigated screws in primary versus revision spine surgery. METHODS: Pedicle and pelvic screws placed with the O-arm in 28 primary (313 screws) and 33 revision (429 screws) cases in which institutional postoperative CT scans were available were retrospectively reviewed for placement accuracy. Screw accuracy was categorized as 1) good (< 1-mm pedicle breach in any direction or "in-out-in" thoracic screws through the lateral thoracic pedicle wall and in the costovertebral joint); 2) fair (1- to 3-mm breach); or 3) poor (> 3-mm breach). RESULTS: Use of CT-IGS resulted in high rates of good or fair screws for both primary (98.7%) and revision (98.6%) cases. Rates of good or fair screws were comparable for the following regions: C7-T3 at 100% (good or fair) in primary versus 100% (good or fair) in revision; T4-9 at 96.8% versus 100%; T10-L2 at 98.2% versus 99.3%; L3-5 at 100% versus 99.2%; and pelvis at 98.7% versus 98.6%, respectively. On the other hand, revision sacral screws had statistically significantly lower rates of good placement compared with primary (100% primary vs 80.6% revision, p = 0.027). Of these revision sacral screws, 11.1% had poor placement, with bicortical screws extending > 3 mm beyond the anterior cortex. Revision pelvic screws demonstrated the highest rate of fair placement (28%), with the mode of medial breach in all cases directed into the sacral-iliac joint. CONCLUSIONS: In the cervical, thoracic, and lumbar spine, CT-IGS demonstrated comparable accuracy rates for both primary and revision spine surgery. Use of 3D imaging of the bony pedicle anatomy appears to be sufficient for the spine surgeon to overcome the difficulties associated with instrumentation in revision cases. Although the bony structures of sacral pedicles and pelvis are relatively larger, the complexity of local anatomy was not overcome with CT-IGS, and an increased trend toward inaccurate screw placement was demonstrated.

Cost-effectiveness analysis in minimally invasive spine surgery.

OBJECT: Medical care has been evolving with the increased influence of a value-based health care system. As a result, more emphasis is being placed on ensuring cost-effectiveness and utility in the services provided to patients. This study looks at this development in respect to minimally invasive spine surgery (MISS) costs. METHODS: A literature review using PubMed, the Cost-Effectiveness Analysis (CEA) Registry, and the National Health Service Economic Evaluation Database (NHS EED) was performed. Papers were included in the study if they reported costs associated with minimally invasive spine surgery (MISS). If there was no mention of cost, CEA, cost-utility analysis (CUA), quality-adjusted life year (QALY), quality, or outcomes mentioned, then the article was excluded. RESULTS: Fourteen studies reporting costs associated with MISS in 12,425 patients (3675 undergoing minimally invasive procedures and 8750 undergoing open procedures) were identified through PubMed, the CEA Registry, and NHS EED. The percent cost difference between minimally invasive and open approaches ranged from 2.54% to 33.68%-all indicating cost saving with a minimally invasive surgical approach. Average length of stay (LOS) for minimally invasive surgery ranged from 0.93 days to 5.1 days compared with 1.53 days to 12 days for an open approach. All studies reporting EBL reported lower volume loss in an MISS approach (range 10-392.5 ml) than in an open approach (range 55-535.5 ml). CONCLUSIONS: There are currently an insufficient number of studies published reporting the costs of MISS. Of the studies published, none have followed a standardized method of reporting and analyzing cost data. Preliminary findings analyzing the 14 studies showed both cost saving and better outcomes in MISS compared with an open approach. However, more Level I CEA/CUA studies including cost/QALY evaluations with specifics of the techniques utilized need to be reported in a standardized manner to make more accurate conclusions on the cost effectiveness of minimally invasive spine surgery.

Robotics and the spine: a review of current and ongoing applications.

OBJECT: Robotics in the operating room has shown great use and versatility in multiple surgical fields. Robot-assisted spine surgery has gained significant favor over its relatively short existence, due to its intuitive promise of higher surgical accuracy and better outcomes with fewer complications. Here, the authors analyze the existing literature on this growing technology in the era of minimally invasive spine surgery. METHODS: In an attempt to provide the most recent, up-to-date review of the current literature on robotic spine surgery, a search of the existing literature was conducted to obtain all relevant studies on robotics as it relates to its application in spine surgery and other interventions. RESULTS: In all, 45 articles were included in the analysis. The authors discuss the current status of this technology and its potential in multiple arenas of spinal interventions, mainly spine surgery and spine biomechanics testing. CONCLUSIONS: There are numerous potential advantages and limitations to robotic spine surgery, as suggested in published case reports and in retrospective and prospective studies. Randomized controlled trials are few in number and show conflicting results regarding accuracy. The present limitations may be surmountable with future technological improvements, greater surgeon experience, reduced cost, improved operating room dynamics, and more training of surgical team members. Given the promise of robotics for improvements in spine surgery and spine biomechanics testing, more studies are needed to further explore the applicability of this technology in the spinal operating room. Due to the significant cost of the robotic equipment, studies are needed to substantiate that the increased equipment costs will result in significant benefits that will justify the expense.

Instrumenting the small thoracic pedicle: the role of intraoperative computed tomography image-guided surgery.

OBJECT: Traditionally, instrumentation of thoracic pedicles has been more difficult because of their relatively smaller size. Thoracic pedicles are at risk for violation during surgical instrumentation, as is commonly seen in patients with scoliosis and in women. The laterally based "in-out-in" approach, which technically results in a lateral breach, is sometimes used in small pedicles to decrease the comparative risk of a medial breach with neurological involvement. In this study the authors evaluated the role of CT image-guided surgery in navigating screws in small thoracic pedicles. METHODS: Thoracic (T1-12) pedicle screw placements using the O-arm imaging system (Medtronic Inc.) were evaluated for accuracy with preoperative and postoperative CT. "Small" pedicles were defined as those ≤ 3 mm in the narrowest diameter orthogonal to the long axis of the pedicle on a trajectory entering the vertebral body on preinstrumentation CT. A subset of "very small" pedicles (≤ 2 mm in the narrowest diameter, 13 pedicles) was also analyzed. Screw accuracy was categorized as good (< 1 mm of pedicle breach in any direction or in-out-in screws), fair (1-3 mm of breach), or poor (> 3 mm of breach). RESULTS: Twenty-one consecutive patients (age range 32-71 years) had large (45 screws) and small (52 screws) thoracic pedicles. The median pedicle diameter was 2.5 mm (range 0.9-3 mm) for small and 3.9 mm (3.1-6.7 mm) for large pedicles. Computed tomography-guided surgical navigation led to accurate screw placement in both small (good 100%, fair 0%, poor 0%) and large (good 96.6%, fair 0%, poor 3.4%) pedicles. Good screw placement in very small or small pedicles occurred with an in-out-in trajectory more often than in large pedicles (large 6.8% vs small 36.5%, p < 0.0005; vs very small 69.2%, p < 0.0001). There were no medial breaches even though 75 of the 97 screws were placed in postmenopausal women, traditionally at higher risk for osteoporosis. CONCLUSIONS: Computed tomography-guided surgical navigation allows for safe, effective, and accurate instrumentation of small (≤ 3 mm) to very small (≤ 2 mm) thoracic pedicles.

A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects.

BACKGROUND CONTEXT: A previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSE: To evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTING: Cost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLE: A multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURES: Cost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODS: The primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTS: The updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of -9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONS: This updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

Urgent Spinal Surgery in a Lateral Decubitus on a Patient with a Left Ventricular Assist Device on Full Anticoagulation: A Case Report.

This case report aims to demonstrate the feasibility of performing spinal surgery in patients with a left ventricular assist device (LVAD), who are traditionally considered unsuitable candidates due to the need for anticoagulation and the challenges associated with the prone position. A case of a patient with an LVAD undergoing microdiscectomy in the left lateral decubitus position is presented. The procedure was carried out by a specialized interdisciplinary team with appropriate monitoring. The patient underwent the procedure safely, demonstrating that spinal surgery can be performed in patients with LVAD without reversing anticoagulation or resorting to the prone position. This approach mitigates the risk of thrombotic events and hemodynamic instability. This case study suggests that spinal surgery, specifically microdiscectomy, can be safely performed in patients with LVAD using the left lateral decubitus position. This finding has significant implications for patients who are unable to ambulate and therefore struggle to qualify for a heart transplant.

Intraoperative neuromonitoring in spine surgery: large database analysis of cost-effectiveness.

Background: Given the increased attention to functional improvement in spine surgery as it relates to activities of daily living and cost, it is critical to fully understand the health care economic impact of enabling technologies. The use of intraoperative neuromonitoring (IOM) during spine surgery has long been controversial. Questions pertaining to utility, medico-legal considerations, and cost-effectiveness continue to be unresolved. The purpose of this study is to determine the cost-effectiveness by assessing quality-of-life due to adverse events averted, decreased postoperative pain, decreased revision rates, and improved patient reported outcomes (PROs). Methods: The study patient population was extracted from a large multicenter database collected by a single, national IOM provider. Over 50,000 patient charts were abstracted and included in this analysis. The analysis was conducted in accordance with the second panel on cost-effectiveness health and medicine. Health-related utility was derived from questionnaire answers and expressed in quality-adjusted life years (QALYs). Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. Cost-effectiveness was calculated as the incremental cost-effectiveness ratio (ICER) for IOM. A value under the commonly accepted United States-based willingness-to-pay (WTP) threshold of $100,000 per QALY was considered cost-effective. Scenario (including litigation), probabilistic (PSA), and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2-years following index surgery. On average, index surgery for patients with IOM costs are approximately $1,547 greater than non-IOM cases. The base case assumed an inpatient Medicare population however multiple outpatient and payer scenarios were assessed in the sensitivity analysis. From a health system perspective IOM is cost-effective, yielding better utilities but at a higher cost than the non-IOM strategy (ICER $60,734 per QALY). From a societal perspective the IOM strategy was dominant, suggesting that better outcomes were achieved at less cost. Except for an entirely privately insured population, alternative scenarios such as, outpatient and a 50:50 Medicare/privately insured population sample also demonstrated cost-effectiveness. Notably, IOM benefits were unable to overcome the sheer costs associated many litigation scenarios, but the data was severely limited. In the 5,000 iteration PSA, at a WTP of $100,000, 74% of simulations using IOM were cost-effective. Conclusions: The use of IOM in spine surgery is cost-effective in most scenarios examined. In the emerging and rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and the health care system.

A Novel Untethering and Duraplasty Technique for Postsurgical Tethered Spinal Cord.

Progressive post-traumatic postsurgical myelopathy (PPPM) is a known entity that can occur months to years after the initial insult. Symptomatic patients can become myelopathic and have rapid and progressive neurological decline. Surgical correction of PPPM usually involves intradural exploration and lysis of adhesions that carries the risk of further injury to the spinal cord. In this manuscript, we provide a report of a patient presenting more than 50 years after the initial resection of an intramedullary tumor. Additionally, we present and describe a novel surgical technique for managing this difficult problem and restoring normal CSF dynamics.

Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.

OBJECTIVE: There are few prior reports of acute pelvic instrumentation failure in spinal deformity surgery. The objective of this study was to determine if a previously identified mechanism and rate of pelvic fixation failure were present across multiple institutions, and to determine risk factors for these types of failures. METHODS: Thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery. Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the screw tulip head (17 cases), screw shaft fracture (9 cases), screw loosening (9 cases), and/or resultant kyphotic fracture of the sacrum (6 cases). Revision strategies involved new pelvic fixation and/or multiple rod constructs. Six patients (16%) who underwent revision with fewer than 4 rods to the pelvis sustained a second acute failure, but no secondary failures occurred when at least 4 rods were used. In the univariate analysis, the magnitude of surgical correction was higher in the failure cohort (higher preoperative T1-pelvic angle [T1PA], presence of a 3-column osteotomy; p < 0.05). Uncorrected postoperative deformity increased failure risk (pelvic incidence-lumbar lordosis mismatch > 10°, higher postoperative T1PA; p < 0.05). Use of pelvic screws less than 8.5 mm in diameter also increased the likelihood of failure (p < 0.05). In the multivariate analysis, a larger preoperative global deformity as measured by T1PA was associated with failure, male patients were more likely to experience failure than female patients, and there was a strong association with implant manufacturer (p < 0.05). Anterior column support with an L5-S1 interbody fusion was protective against failure (p < 0.05). CONCLUSIONS: Acute catastrophic failures involved large-magnitude surgical corrections and likely resulted from high mechanical strain on the pelvic instrumentation. Patients with large corrections may benefit from anterior structural support placed at the most caudal motion segment and multiple rods connecting to more than 2 pelvic fixation points. If failure occurs, salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

A Systematic Review and Meta-Analysis of Silicon Nitride and Biomaterial Modulus as it Relates to Subsidence Risk in Spinal Fusion Surgery.

Introduction: For decades, researchers and surgeons have sought to determine the optimal biomaterial for spinal fusion implants. Successful fusion is associated with improved quality of life while failures are often associated with costly and complex revisions. One common failure is subsidence. Biomaterials with higher modulus are thought to be related to subsidence risk but this has not been thoroughly investigated. The aim of this systematic review and meta-analysis is to assess silicon nitride and biomaterial modulus as they relate to subsidence risk in spinal fusions. Methods: A systematic review was conducted using the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Databases searched included PubMed-Medline, Google Scholar, Embase, EBSCO, and Cochrane Library. Study quality was assessed according to the Newcastle-Ottawa Scale. A network meta-analysis was chosen, allowing for direct and indirect comparisons for multiple treatments using a Bayesian hierarchical framework with Markov chain Monte Carlo methods. Outcomes were reported as odds ratios with 95% confidence intervals. Heterogeneity between studies was evaluated using the I2 test. A pairwise meta-analysis was also produced to compare the results of network analysis for consistency. Publication bias was assessed using a funnel plot, Egger test, and Begg test. All analyses were conducted using R (Project for Statistical Computing, ver. 4.0.4). Results: The initial search yielded a total of 821 articles. After removal of duplicates and screening based on inclusion and exclusion criteria, 64 articles were available for review and 13 were selected for meta-analysis. Biomaterial implant types in the final studies included: silicon nitride (Si3N4), polyetheretherketone (PEEK), titanium (Ti), and two composites, nano-hydroxyapatite/polyamide 66 (n-HA/PA66) and a carbon fiber reinforced polymer (CFRP). A total of 1,192 patients were included in this analysis - 419 with titanium implants, 460 with PEEK, 96 with Si3N4, 332 with n-HA/PA66, and 35 with CFRP. Titanium had the highest rate of subsidence compared to other biomaterials. Pairwise analysis was consistent with these results. Both the Egger test (p = 0.28) and Begg test (p = 0.37) were found to be non-significant for publication bias. Conclusions: Spinal fusion implants derived from Si3N4, compared to PEEK and titanium, do not appear to be correlated with increased subsidence risk.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study.

Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF). Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF. Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF. Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time. Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society.

Trends and Long-term Health Care Utilization of Computer-assisted Neuronavigation in Spine Fusions: An Exact Matched Analysis of National Administrative Database.

BACKGROUND: Computer-assisted neuronavigation (CAN) during spine fusions has increasingly been utilized in the United States. The aim of this study was to analyze the trends, health care utilization, and clinical outcomes associated with CAN use. METHODS: The MarketScan database was queried using the ICD-9/10 and CPT 4th edition, from 2003 to 2019. We included patients aged ≥18 years with at least 2 years of follow-up. Outcomes were repeat/new fusions, length of stay (LOS), discharge disposition, hospital re-admissions, outpatient services, and medication refills for up to 24 months. RESULTS: Of 183,620 patients who underwent spine fusions, 5046 (2.75%) were identified to have CAN utilized. CAN is increasingly being utilized for spine fusions since 2010, reaching 10.76% of all fusions in 2017, compared to 0.38% in 2010. CAN had no impact on LOS, home discharge, or complications at index hospitalization and 30-days post discharge. CAN was associated with lower rates of repeat fusions at 6 months (1% vs. 2%) and 24 months (5% vs. 6%), P < 0.05. Patients who underwent CAN had lower payments at 6 months ($5186 vs. $5527, P = 0.0159), 12 months ($10,267 v.s $11,262, P = 0.0207), and 24 months ($21,453 vs. $24,355, P = 0.0021). CONCLUSIONS: CAN is increasing being used for spine fusions primarily for thoracolumbar procedures. No difference in complications, discharge disposition, and LOS were noted across the cohorts at index hospitalization, with higher index payments with CAN use. CAN was associated with lower rates of repeat fusions and corresponding health care utilization for up to 24 months.

Transplantation of human neural progenitor cells secreting GDNF into the spinal cord of patients with ALS: a phase 1/2a trial.

Amyotrophic lateral sclerosis (ALS) involves progressive motor neuron loss, leading to paralysis and death typically within 3-5 years of diagnosis. Dysfunctional astrocytes may contribute to disease and glial cell line-derived neurotrophic factor (GDNF) can be protective. Here we show that human neural progenitor cells transduced with GDNF (CNS10-NPC-GDNF) differentiated to astrocytes protected spinal motor neurons and were safe in animal models. CNS10-NPC-GDNF were transplanted unilaterally into the lumbar spinal cord of 18 ALS participants in a phase 1/2a study (NCT02943850). The primary endpoint of safety at 1 year was met, with no negative effect of the transplant on motor function in the treated leg compared with the untreated leg. Tissue analysis of 13 participants who died of disease progression showed graft survival and GDNF production. Benign neuromas near delivery sites were common incidental findings at post-mortem. This study shows that one administration of engineered neural progenitors can provide new support cells and GDNF delivery to the ALS patient spinal cord for up to 42 months post-transplantation.