Development of Next-Generation COVID-19 Vaccines: BARDA Supported Phase 2b Study Designs.

In response to the COVID-19 pandemic, vaccines were quickly and successfully developed and deployed, saving millions of lives globally. While first generation vaccines are safe and effective in preventing disease caused by SARSCoV-2, next-generation vaccines have the potential to improve efficacy and safety. Vaccines delivered by a mucosal route may elicit greater protective immunity at respiratory surfaces thereby reducing transmission. Inclusion of viral antigens in addition to the spike protein may enhance protection against emerging variants of concern. Next-generation vaccine platforms with a new mechanism of action may necessitate efficacy trials to fulfill regulatory requirements. The Biomedical Advanced Research and Development Authority (BARDA) will be supporting Phase 2b clinical trials of candidate next-generation vaccines. The primary endpoint will be improved efficacy in terms of symptomatic disease relative to a currently approved COVID-19 vaccine. In this paper, we discuss the planned endpoints and potential challenges to this complex program.

Reciprocal changes in sagittal spinal alignment after L5-S1 anterior lumbar interbody fusion.

OBJECTIVE: Degenerative diseases of the lumbar spine decrease lumbar lordosis (LL). Anterior lumbar interbody fusion (ALIF) at the L5-S1 disc space improves segmental lordosis, LL, and sagittal balance. This study investigated reciprocal changes in spinopelvic alignment after L5-S1 ALIF. METHODS: A retrospective chart review identified patients who underwent L5-S1 ALIF with or without posterior fixation at a single institution (November 1, 2016-October 1, 2021). Changes in pelvic tilt, sacral slope, proximal LL (L1-L4), distal LL (L4-S1), total LL (L1-S1), segmental lordosis, pelvic incidence-LL mismatch, thoracic kyphosis, cervical lordosis, and sagittal vertical axis were measured on preoperative and postoperative radiographs. RESULTS: Forty-eight patients were identified. Immediate postoperative radiographs were obtained at a mean (SD) of 17 (20) days after surgery; delayed radiographs were obtained 184 (82) days after surgery. After surgery, patients had significantly decreased pelvic tilt (15.71° [7.25°] vs 17.52° [7.67°], p=0.003) and proximal LL (11.86° [10.67°] vs 16.03° [10.45°], p<0.001) and increased sacral slope (39.49° [9.27°] vs 36.31° [10.39°], p<0.001), LL (55.35° [13.15°] vs 51.63° [13.38°], p=0.001), and distal LL (43.17° [9.33°] vs 35.80° [8.02°], p<0.001). Segmental lordosis increased significantly at L5-S1 and decreased significantly at L2-3, L3-4, and L4-5. Lordosis distribution index increased from 72.55 (19.53) to 81.38 (22.83) (p<0.001). CONCLUSIONS: L5-S1 ALIF was associated with increased L5-S1 segmental lordosis accompanied by pelvic anteversion and a reciprocal decrease in proximal lumbar lordosis. These changes may represent a reversal of compensatory mechanisms, suggesting an overall relaxation of spinopelvic alignment after L5-S1 ALIF.

Headache relief 10 years after cervical disc arthroplasty: multicenter randomized clinical trial post hoc analysis.

OBJECTIVE: Headache relief after anterior cervical spine surgery has been reported. No study, however, has followed patients out to 10 years to assess the durability of headache improvement. The authors analyzed a group of patients with a 10-year follow-up after one- or two-level cervical disc arthroplasty (CDA) from an FDA investigational device exemption (IDE) study. METHODS: The authors performed a post hoc analysis of 189 patients treated with CDA from the 9 highest enrolling sites in a prospective multicenter randomized US FDA IDE clinical trial. Patients had one- or two-level CDA at contiguous levels from C3 to C7 using the Mobi-C device. The authors evaluated headache scores from the headache section of the Neck Disability Index (NDI), along with associated demographic variables (age, sex, race, ethnicity, and BMI). Preoperative and 10-year postoperative headache scores were analyzed. Primary analysis was conducted via the Wilcoxon rank-sum test, followed by univariate and multivariable logistic regression. RESULTS: After accounting for age, BMI, race, ethnicity, and sex, there was sustained headache improvement 10 years after CDA (p = 0.04). Preoperatively, the median NDI score was 3.00 (IQR 1.00-4.00) and after 10 years it was 1.00 (IQR 0.00-2.00), with a decrease in the NDI score by 1.00 point (95% CI 0.00-2.00, p = 0.04). For one-level CDA, the median NDI score was 3.00 (IQR 1.00-4.00) preoperatively but 1.00 (IQR 0.00-2.00) at 10 years, with an estimated reduction in the NDI score of 1 point (95% CI 1.00-2.00, p < 0.0001). For two-level CDA, the median NDI score was 3.00 (IQR 1.75-4.00) preoperatively and 1.00 (IQR 0.00-2.00) at 10 years, with an estimated reduction in the NDI score of 1 point (95% CI 1.00-2.00, p < 0.0001). CONCLUSIONS: Headache relief provided by cervical CDA, for symptomatic C3-7 cervical spondylosis, was sustained even 10 years after surgery. There was no difference in headache improvement between the one- and two-level CDA groups, or among BMI, sex, race, and ethnicity strata.

Reliability of a Novel Classification System for Thoracic Disc Herniations.

STUDY DESIGN: This is a cross-sectional survey. OBJECTIVE: The aim was to assess the reliability of a proposed novel classification system for thoracic disc herniations (TDHs). SUMMARY OF BACKGROUND DATA: TDHs are complex entities varying substantially in many factors, including size, location, and calcification. To date, no comprehensive system exists to categorize these lesions. METHODS: Our proposed system classifies 5 types of TDHs using anatomic and clinical characteristics, with subtypes for calcification. Type 0 herniations are small (≤40% of spinal canal) TDHs without significant spinal cord or nerve root effacement; type 1 are small and paracentral; type 2 are small and central; type 3 are giant (>40% of spinal canal) and paracentral; and type 4 are giant and central. Patients with types 1 to 4 TDHs have correlative clinical and radiographic evidence of spinal cord compression. Twenty-one US spine surgeons with substantial TDH experience rated 10 illustrative cases to determine the system's reliability. Interobserver and intraobserver reliability were determined using the Fleiss kappa coefficient. Surgeons were also surveyed to obtain consensus on surgical approaches for the various TDH types. RESULTS: High agreement was found for the classification system, with 80% (range 62% to 95%) overall agreement and high interrater and intrarater reliability (kappa 0.604 [moderate to substantial agreement] and kappa 0.630 [substantial agreement], respectively). All surgeons reported nonoperative management of type 0 TDHs. For type 1 TDHs, most respondents (71%) preferred posterior approaches. For type 2 TDHs, responses were roughly equivalent for anterolateral and posterior options. For types 3 and 4 TDHs, most respondents (72% and 68%, respectively) preferred anterolateral approaches. CONCLUSIONS: This novel classification system can be used to reliably categorize TDHs, standardize description, and potentially guide the selection of surgical approach. Validation of this system with regard to treatment and clinical outcomes represents a line of future study.

The CathEye: A Forward-Looking Ultrasound Catheter for Image-Guided Cardiovascular Procedures.

Catheter based procedures are typically guided by X-Ray, which suffers from low soft tissue contrast and only provides 2D projection images of a 3D volume. Intravascular ultrasound (IVUS) can serve as a complementary imaging technique. Forward viewing catheters are useful for visualizing obstructions along the path of the catheter. The CathEye system mechanically steers a single-element transducer to generate a forward-looking surface reconstruction from an irregularly spaced 2-D scan pattern. The steerable catheter leverages an expandable frame with cables to manipulate the distal end independently of vessel tortuosity. The tip position is estimated by measuring the cable displacements and used to create surface reconstructions of the imaging workspace with the single-element transducer. CathEye's imaging capabilities were tested with an agar phantom and an ex vivo chronic total occlusion (CTO) sample while the catheter was confined to various tortuous paths. The CathEye maintained similar scan patterns regardless of path tortuosity and was able to recreate major features of the imaging targets, such as holes and extrusions. The feasibility of forward-looking IVUS with the CathEye is demonstrated in this study. The CathEye mechanism can be applied to other imaging modalities with field-of-view (FOV) limitations and represents the basis for an interventional device fully integrated with image guidance.

Minimally Invasive Techniques in the Surgical Management of Traumatic Pediatric Thoracolumbar Fractures.

BACKGROUND: Thoracolumbar (TL) fractures are uncommon in children. While surgical treatment is recommended for unstable TL fractures, there is no consensus on appropriate surgical treatment. We present a case series of pediatric patients with traumatic TL fractures treated with minimally invasive techniques. We discuss our early experience and technical challenges with navigation and robotic-assisted fixation. METHODS: A retrospective review of a prospectively maintained trauma database from February 2018 to February 2023 of all pediatric patients (<18 years old) undergoing percutaneous fixation for unstable TL fractures was performed. Minimally invasive techniques included fluoroscopy and/or navigation-guided or robotic-assisted surgery. Clinical course, radiographic findings, and technical challenges were reviewed. RESULTS: A cohort of 12 patients (age range, 4-17 years) with 6 (50%) Chance fractures, 2 (16%) pars fractures, 2 (16%) pedicle fracture, 1 (8%) burst fracture, and 1 (8%) other fracture were identified. Nine patients had fractures involving the lumbar spine, and the remaining 3 had thoracic fractures. In all cases, percutaneous pedicle screws were placed above and below the fracture with the use of neuronavigation or robotic-assisted navigation (n = 2). Blood loss was <30 mL for single-level fractures and instrumented fusion. Two patients had hardware-related complications. At follow-up (mean 9.67 months after surgery), patients were doing well clinically, and most imaging showed stable alignment. CONCLUSIONS: Our early experience shows that short segment instrumentation through a minimally invasive approach is a safe and effective surgical option for young pediatric patients with good clinical outcomes and favorable radiographic postoperative finding.

Metastasis of Intracranial Meningioma to the Osseous Spine: Systematic Literature Review and Case Report.

BACKGROUND: Osseous spinal metastases from intracranial meningiomas are rare but represent a serious disease progression. A literature review was performed on this topic to understand the clinical course of patients with this disease entity. We also present a case of spinal metastasis in a patient with a World Health Organization grade III meningioma. METHODS: The PubMed/MEDLINE database was queried on August 15, 2021, using the keywords (meningioma) AND (metastasis) AND (vertebra∗ OR spin∗). All publications reporting outcomes of patients with meningioma metastatic to the spine were included. Disease characteristics, treatment modality, and outcomes were extracted from each study. Because data availability varied widely between studies, no meta-analysis was performed. RESULTS: A total of 30 articles with 33 cases were included. Outcome data varied greatly in terms of quality and length of follow-up. Of 28 cases with reported outcomes data, 20 resulted in patient mortality ranging from a few weeks to 5 years after spinal metastasis. Mean (standard deviation) survival time was 5.8 (6.4) years following initial diagnosis, but only 1.4 (3.2) years from spinal metastasis. The longest survivor was noted to have no recurrence of disease 4 years after spinal metastasis. CONCLUSIONS: Bony spinal metastasis from intracranial meningioma is an extremely rare occurrence. Within the limits of the available literature, outcomes of patients with this disease appear to be poor. However, data reporting is inconsistent, and several articles did not report any outcome data. Further study is needed to better clarify the course and prognosis of this disease.

Serum Methamphetamine Positivity in Trauma Patients Undergoing Surgery has No Negative Effect on Postoperative Morbidity and Mortality.

Introduction: The link between methamphetamine (METH) use and mortality or morbidity, particularly perioperative complications, associated with trauma surgery are not well characterized. This study aims to address this by performing a comparison of surgical outcomes between METH-negative (METH-) and METH-positive (METH+) trauma patients. Methods: An Institutional Review Board-approved retrospective chart review was performed on all trauma patients admitted to our Level 1 trauma center who underwent surgical operations between 2015 and 2020. Patients were categorized into METH- and METH+ groups. Patient characteristics such as age, sex, race, Injury Severity Score (ISS), presence of peri-operative complications, and mortality, amongst others, were used to perform univariate comparisons. Additional multi-variate comparisons were performed across both the whole cohort and with age, sex, and ISS-matched groups. Results: Of 571 patients who met the final inclusion criteria, 421 were METH- and 150 METH+. The METH+ group also possessed a lower median ISS (P = 0.0478) and did not possess significantly different mortality or morbidity than their METH- counterparts in univariate analysis. Multivariate analysis in whole-group and matched-group cohorts indicated that METH was not a positive predictor of mortality or morbidity. Instead, ISS predicted mortality (P = 0.048) and morbidity (P < 0.001). Conclusion: Our results suggest that METH use does not exert a positive effect on mortality or morbidity in the acute trauma surgery setting and that ISS may be a more significant contributor, suggesting severity, and etiology of injury are also important considerations for trauma surgery evaluation.

Stable Regional and Global Alignment in Patients Treated With Minimally Invasive Lateral Retropleural Thoracic Diskectomy Without Fixation.

BACKGROUND AND OBJECTIVES: Thoracic disk herniations are challenging to treat, and open transthoracic or minimally invasive thoracoscopic approaches are associated with significant morbidity, substantial costs, and steep learning curves. The minimally invasive lateral retropleural thoracic diskectomy (MIS-LRP-TD) approach is straightforward and is associated with lower perioperative morbidity. With MIS-LRP-TD, the overlying rib, ipsilateral pedicle, ligamentum flavum, posterior longitudinal ligament, and posterior third of the adjacent vertebral bodies are resected. Adjunct fixation is typically not performed, eliminating hardware-related complications and costs. This radiographic study investigates long-term global and thoracic spine alignment after MIS-LRP-TD without fixation. METHODS: This study was a single-institution, retrospective evaluation of all patients who underwent MIS-LRP-TD without fixation between November 7, 2017 and July 19, 2022. Preoperative and the most recent postoperative radiographs were used to determine the C7 plumb line to central sacral vertical line, thoracic Cobb angle (TCA), segmental Cobb angle, C7 to sagittal vertical axis, thoracic kyphosis, and segmental kyphosis. RESULTS: In total, 22 patients with 24 disk herniations underwent MIS-LRP-TD without fixation. The mean (SD) radiographic follow-up was 12.9 (11.2) months. Overall, no significant differences were seen in C7 plumb line to central sacral vertical line (P = .65), C7 to sagittal vertical axis (P = .99), thoracic kyphosis (P = .30), TCA (P = .28), segmental kyphosis (P = .27), or segmental Cobb angle (P = .56) at follow-up. One patient demonstrated a >5° change in TCA but remained asymptomatic. CONCLUSION: Despite requiring extensive resection of the middle column and ipsilateral costovertebral joint at the index level, MIS-LRP-TD without adjunct fixation does not lead to significant global, regional, or segmental deformity. Thus, MIS-LRP-TD appears to be a safe, effective treatment approach for challenging thoracic disk herniations.

Matched-pair analysis of patients with ischemic stroke undergoing thrombectomy using next-generation balloon guide catheters.

BACKGROUND: Balloon guide catheters (BGCs) have not been widely adopted, possibly due to the incompatibility of past-generation BGCs with large-bore intermediate catheters. The next-generation BGC is compatible with large-bore catheters. We compared outcomes of thrombectomy cases using BGCs versus conventional guide catheters. METHODS: We conducted a retrospective study of 110 thrombectomy cases using BGCs (n=55) and non-BGCs (n=55). Sixty consecutive thrombectomy cases in whom the BOBBY BGC was used at a single institution between February 2021 and March 2022 were identified. Of these, 55 BGC cases were 1:1 matched with non-BGC cases by proceduralists, age, gender, stent retriever + aspiration device versus aspiration-only, and site of occlusion. First-pass effect was defined as Thrombolysis In Cerebral Infarction 2b or higher with a single pass. RESULTS: The BGC and non-BGC cohorts had similar mean age (67.2 vs 68.9 years), gender distribution (43.6% vs 47.3% women), median initial National Institutes of Health Stroke Scale score (14 vs 15), and median pretreatment ischemic core volumes (12 mL vs 11.5 mL). BGC and non-BGC cases had similar rates of single pass (60.0% vs 54.6%), first-pass effect (58.2% vs 49.1%), and complications (1.8% vs 9.1%). In aspiration-only cases, the BGC cohort had a significantly higher rate of first-pass effect (100% vs 50.0%, p=0.01). BGC was associated with a higher likelihood of achieving a modified Rankin Scale score of 2 at discharge (OR 7.76, p=0.02). No additional procedural time was required for BGC cases (46.7 vs 48.2 min). CONCLUSION: BGCs may be safely adopted with comparable procedural efficacy, benefits to aspiration-only techniques, and earlier functional improvement compared with conventional guide catheters.

Pseudarthrosis after four-level anterior cervical discectomy and fusion without posterior fixation.

OBJECTIVE: Fusion rates and long-term outcomes are well established for anterior cervical discectomy and fusion (ACDF) of 3 levels or fewer, but there is a paucity of similar data on 4-level fusions. The authors evaluated long-term fusion rates and clinical outcomes after 4-level ACDF without supplemental posterior instrumentation. METHODS: The authors retrospectively reviewed patients who underwent 4-level ACDF at a single institution with at least 1-year of radiological follow-up. Fusion was determined by measuring change in interspinous distance at each segment on dynamic radiographs or by the presence of bridging bone on CT scans at minimum 1-year follow-up. Clinical outcomes were assessed using Neck Disability Index and Short Form-36. RESULTS: A total of 63 patients (252 levels) met the inclusion criteria for the study, with a mean follow-up of 2.6 years. Complete radiographic fusion at all 4 levels was observed in 26 patients (41.3%). Of the 37 patients (58.7%) with radiographic pseudarthrosis, there was a mean of 1.35 nonfused levels. The fusion rate per level, however, was 80.2% (202/252 levels). The most common level demonstrating nonunion was the distal segment (C6-7), showing pseudarthrosis in 29 patients (46.8%), followed by the most proximal segment (C3-4) demonstrating nonunion in 9 patients (14.5%). The mean improvement in Neck Disability Index and Short Form-36 was 15.7 (p < 0.01) and 5.8 (p = 0.14), respectively, with improvement in both scores surpassing the minimum clinically important difference. One patient (1.6%) required revision surgery for symptomatic pseudarthrosis, and 5 patients (7.9%) underwent revision for symptomatic adjacent-segment disease. Patient-reported outcomes results are limited by the low rate of 1-year follow-up (50.8%), whereas reoperation data were available for all 63 patients. CONCLUSIONS: More than half of patients undergoing 4-level ACDF without posterior fixation demonstrated pseudarthrosis of at least 1 level-most commonly the distal C6-7 level. One patient required revision for symptomatic pseudarthrosis. Patient-reported outcomes showed significant improvements at 1-year follow-up, but clinical follow-up was limited. This is the largest series to date to evaluate fusion outcomes in 4-level ACDF.

A comparison of modern-era anterior lumbar interbody fusion and minimally invasive transforaminal lumbar interbody fusion at the lumbosacral junction.

OBJECTIVE: Interbody fusion is the primary method for achieving arthrodesis across the lumbosacral junction in the setting of degenerative pathologies, such as spondylosis and spondylolisthesis. Two common techniques are anterior lumbar interbody fusion (ALIF) and posterior transforaminal lumbar interbody fusion (TLIF). In recent years, interbody design and technology have advanced, and most earlier studies comparing ALIF and TLIF did not specifically assess the lumbosacral junction. This study compared changes in radiographic and clinical parameters between patients undergoing modern-era single-level ALIF and minimally invasive surgery (MIS) TLIF at L5-S1. METHODS: Consecutive patients who underwent single-segment L5-S1 ALIF or MIS TLIF performed by the senior authors over a 6-year interval (January 1, 2016-November 30, 2021) were retrospectively reviewed. Upright radiographs were used to determine pre- and postoperative lumbar lordosis, segmental lordosis, disc angle, and neuroforaminal height. Improvements in patient-reported outcome scores (Oswestry Disability Index and SF-36) were also compared. RESULTS: Overall, 108 patients (58 [54%] men, 50 [46%] women; mean [SD] age 57.6 [13.5] years) were included in the study. ALIF was performed in 49 patients, and TLIF was performed in 59 patients. The most common treatment indications were spondylolisthesis (50%, 54/108) and spondylosis (46%, 50/108). The cohorts did not differ in terms of intraoperative (p > 0.99) or postoperative (p = 0.73) complication rates. The mean (SD) hospital length of stay was significantly shorter for patients undergoing TLIF than ALIF (1.3 [0.6] days vs 2.0 [1.4] days, p < 0.001). Both techniques significantly improved L5-S1 segmental lordosis, disc angle, and neuroforaminal height (p ≤ 0.008). ALIF versus TLIF significantly increased mean [SD] segmental lordosis (12.5° [7.3°] vs 2.0° [5.7°], p < 0.001), disc angle (14.8° [5.5°] vs 3.0° [6.1°], p < 0.001), and neuroforaminal height (4.5 [4.6] mm vs 2.4 [3.0] mm, p = 0.008). Improvements in patient-reported outcome parameters and reoperation rates were similar between cohorts. CONCLUSIONS: When treating patients at a single segment across the lumbosacral junction, ALIF resulted in significantly greater increases in segmental lordosis, L5-S1 disc angle, and neuroforaminal height compared with MIS TLIF. Improvements in clinical parameters and reoperation rates were similar between the 2 techniques.

Bilateral sacroiliac joint fusion in long constructs using self-harvesting porous S2-alar iliac screws with an integrated tulip: technical considerations and early clinical and radiographic experience.

OBJECTIVE: The incidence of sacroiliac joint (SIJ) dysfunction after lumbosacral fusion is high. Upfront bilateral SIJ fusion using novel fenestrated self-harvesting porous S2-alar iliac (S2AI) screws could reduce the incidence of SIJ dysfunction and need for subsequent SIJ fusion. In this study, the authors report their early clinical and radiographic results of SIJ fusion using this novel screw. METHODS: The authors began using self-harvesting porous screws in July 2022. This is a retrospective review of consecutive patients at a single institution who underwent long thoracolumbar surgery with extension to the pelvis using this porous screw. Radiographic parameters of regional and global alignment were collected preoperatively and at the time of last follow-up. The incidence of intraoperative complications and need for revision were collected. The incidences of mechanical complications, including screw breakage, implant loosening/pullout, and screw cap dislocation at the time of last follow-up were also collected. RESULTS: Ten patients with a mean age of 67 years were included, 6 of whom were male. Seven patients had a thoracolumbar construct with extension to the pelvis. Three patients had upper instrumented vertebrae at the proximal lumbar spine. Intraoperative breach was not encountered in any of the patients (0%). Postoperatively, 1 patient (10%) had screw breakage at the neck of the tulip of the modified iliac screw discovered at routine follow-up without clinical sequalae. CONCLUSIONS: Use of self-harvesting porous S2AI screws incorporated into long thoracolumbar constructs was safe and feasible, demanding unique technical considerations. Long-term clinical and radiographic follow-up with a large patient cohort is necessary to determine their durability and efficacy to achieve SIJ arthrodesis and prevent SIJ dysfunction.

Minimally Invasive Surgery Strategies to Prevent Proximal Junctional Kyphosis.

Proximal junctional kyphosis (PJK) is a common complication following long-segment thoracolumbar fusions for patients with adult spinal deformities. PJK is described as a progressive kyphosis at the upper instrumented vertebra or 1 or 2 segments adjacent to the instrumented vertebra. This condition can lead to proximal junction failure, which results in vertebral body fractures, screw pullouts, and neurological deficits. Revision surgery is necessary to address symptomatic PJK. Research efforts have been dedicated to elucidating risk factors and prevention strategies. It has been postulated that minimally invasive surgery (MIS) techniques may help prevent PJK because these techniques aim to preserve the soft tissue integrity at the top of the construct and maintain posterior element support. In this article, the authors define PJK, describe MIS strategies to prevent PJK, and compare PJK rates after MIS with PJK rates after open approaches for long-segment thoracolumbar fusion.

Complications associated with single-position prone lateral lumbar interbody fusion: a systematic review and pooled analysis.

OBJECTIVE: Lateral lumbar interbody fusion (LLIF) is a workhorse surgical approach for lumbar arthrodesis. There is growing interest in techniques for performing single-position surgery in which LLIF and pedicle screw fixation are performed with the patient in the prone position. Most studies of prone LLIF are of poor quality and without long-term follow-up; therefore, the complication profile related to this novel approach is not well known. The objective of this study was to perform a systematic review and pooled analysis to understand the safety profile of prone LLIF. METHODS: A systematic review of the literature and a pooled analysis were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All studies reporting prone LLIF were assessed for inclusion. Studies not reporting complication rates were excluded. RESULTS: Ten studies meeting the inclusion criteria were analyzed. Overall, 286 patients were treated with prone LLIF across these studies, and a mean (SD) of 1.3 (0.2) levels per patient were treated. The 18 intraoperative complications reported included cage subsidence (3.8% [3/78]), anterior longitudinal ligament rupture (2.3% [5/215]), cage repositioning (2.1% [2/95]), segmental artery injury (2.0% [5/244]), aborted prone interbody placement (0.8% [2/244]), and durotomy (0.6% [1/156]). No major vascular or peritoneal injuries were reported. Sixty-eight postoperative complications occurred, including hip flexor weakness (17.8% [21/118]), thigh and groin sensory symptoms (13.3% [31/233]), revision surgery (3.8% [3/78]), wound infection (1.9% [3/156]), psoas hematoma (1.3% [2/156]), and motor neural injury (1.2% [2/166]). CONCLUSIONS: Single-position LLIF in the prone position appears to be a safe surgical approach with a low complication profile. Longer-term follow-up and prospective studies are needed to better characterize the long-term complication rates related to this approach.

The CathPilot: Performance Validation and Preclinical Safety and Feasibility Assessment.

OBJECTIVES: Peripheral endovascular revascularization procedures often fail due to technical limitations of guidewire support, steering, and visualization. The novel CathPilot catheter aims to address these challenges. This study assesses the safety and feasibility of the CathPilot and compares its performance to conventional catheters for peripheral vascular interventions. METHODS: The study compared the CathPilot to non-steerable and steerable catheters. The success rates and access times for a relevant target inside a tortuous vessel phantom model were assessed. The reachable workspace within the vessel and the guidewire's force delivery capabilities were also evaluated. To validate the technology, chronic total occlusion tissue samples were used ex vivo to compare crossing success rates with conventional catheters. Finally, in vivo experiments in a porcine aorta were conducted to evaluate safety and feasibility. RESULTS: The success rates for reaching the set targets were 31%, 69%, and 100% with the non-steerable catheter, the steerable catheter, and the CathPilot, respectively. CathPilot had a significantly larger reachable workspace, and allowed for up to four times higher force delivery and pushability. In crossing of chronic total occlusion samples, the CathPilot achieved a success rate of 83% and 100%, for fresh and fixed lesions respectively, which was also significantly higher than conventional catheters. The device was fully functional in the in vivo study, and there were no signs of coagulation or damage to the vessel wall. CONCLUSION: This study shows the safety and feasibility of the CathPilot system and its potential to reduce failure and complication rates in peripheral vascular interventions. The novel catheter outperformed conventional catheters in all defined metrics. This technology can potentially improve the success rate and outcome of peripheral endovascular revascularization procedures.

Biomechanical Assessment of a Novel Sharp-Tipped Screw for 1-Step Minimally Invasive Pedicle Screw Placement Under Navigation.

BACKGROUND: The objective of this study was to assess the pullout force of a novel sharp-tipped screw developed for single-step, minimally invasive pedicle screw placement guided by neuronavigation compared with the pullout force for traditional screws. METHODS: A total of 60 human cadaveric lumbar pedicles were studied. Three different screw insertion techniques were compared: (A) Jamshidi needle and Kirschner wire without tapping; (B) Jamshidi needle and Kirschner wire with tapping; and (C) sharp-tipped screw insertion. Pullout tests were performed at a displacement rate of 10 mm/min recorded at 20 Hz. Mean values of these parameters were compared using paired t tests (left vs right in the same specimen): A vs B, A vs C, and B vs C. Additionally, 3 L1-L5 spine models were used for timing each screw insertion technique for a total of 10 screw insertions for each technique. Insertion times were compared using 1-way analysis of variance. RESULTS: The mean pullout force for insertion technique A was 1462.3 (597.5) N; for technique B, it was 1693.5 (805.0) N; and for technique C, it was 1319.0 (735.7) N. There was no statistically significant difference in pullout force between techniques (P > 0.08). The average insertion time for condition C was significantly less than that for conditions A and B (P < 0.001). CONCLUSIONS: The pullout force of the novel sharp-tipped screw placement technique is equivalent to that of traditional techniques. The sharp-tipped screw placement technique appears biomechanically viable and has the advantage of saving time during insertion. CLINICAL RELEVANCE: Single-step screw placement using high resolution 3-dimensional navigation has the potential to streamline workflow and reduce operative time.

Experimental Protocol and Phantom Design and Development for Performance Characterization of Conventional Devices for Peripheral Vascular Interventions.

Conventional catheter-based interventions for treating peripheral artery disease suffer high failure and complication rates. The mechanical interactions with the anatomy constrain catheter controllability, while their length and flexibility limit their pushability. Also, the 2D X-ray fluoroscopy guiding these procedures fails to provide sufficient feedback about the device location relative to the anatomy. Our study aims to quantify the performance of conventional non-steerable (NS) and steerable (S) catheters in phantom and ex vivo experiments. In a 10 mm diameter, 30 cm long artery phantom model, with four operators, we evaluated the success rate and crossing time in accessing 1.25 mm target channels, the accessible workspace, and the force delivered through each catheter. For clinical relevance, we evaluated the success rate and crossing time in crossing ex vivo chronic total occlusions. For the S and NS catheters, respectively, users successfully accessed 69 and 31% of the targets, 68 and 45% of the cross-sectional area, and could deliver 14.2 and 10.2 g of mean force. Using a NS catheter, users crossed 0.0 and 9.5% of the fixed and fresh lesions, respectively. Overall, we quantified the limitations of conventional catheters (navigation, reachable workspace, and pushability) for peripheral interventions; this can serve as a basis for comparison with other devices.

Early palliative care consultation offsets hospitalization duration and costs for elderly patients with traumatic brain injuries: Insights from a Level 1 trauma center.

We identified factors and outcomes associated with inpatient palliative care (PC) consultation, stratified into early and late timing, for patients over age 65 with traumatic brain injuries (TBI). Patients over age 65 presenting to a single institution with TBI and intracranial hemorrhage from January 2013-September 2020 were included. Patient demographics and various outcomes were analyzed. Inpatient PC consultation was uncommon (4 % out of 576 patients). Characteristics associated with likelihood of consultation were severe TBI (OR = 5.030, 95 % CI 1.096-23.082, p =.038) and pre-existing dementia (OR = 6.577, 95 % CI 1.726-25.073, p =.006). Average consultation timing was 8.6 (standard deviation ± 7.0) days. Patients with PC consults had longer overall (p =.0031) and intensive care unit (ICU) length of stays (LOS) (p <.0001), more days intubated (p <.0001) and higher costs (p =.0006), although those with earlier-than-average PC consultation had shorter overall (p =.0062) and ICU (p =.011) LOS as well as fewer ventilator days (p =.030) and lower costs (p =.0003). Older patients with TBI are more likely to receive PC based on pre-existing dementia and severe TBI. Patients with PC consultations had worse LOS and higher costs. However, these effects were mitigated by earlier PC involvement. Our study emphasizes the need for timely PC consultation in a vulnerable patient population.