Systematic review and meta-analysis of topical tranexamic acid in spine surgery.

OBJECTIVE: Tranexamic acid (TXA) is an antifibrinolytic drug associated with reduced blood loss in a range of surgical specialties, including neurosurgery, orthopedic surgery, and cardiac surgery. Concerns about venous thromboembolism and seizures from intravenous (IV) TXA have led to increased use of topical TXA. Given the relative scarcity of the literature on topical TXA compared with that on IV TXA within neurosurgery, the authors aimed to conduct a systematic review and meta-analysis on the safety, efficacy, and optimal administration of topical TXA in a wide range of spinal procedures and pathologies. METHODS: The PRISMA guidelines, Cochrane risk of bias tool, and Newcastle-Ottawa Scale were used to extract randomized controlled trials and high-quality case-control and cross-sectional/cohort studies (adult studies only) from PubMed, Web of Science, Cochrane Library, and Embase published between 2016 and 2023. Studies were analyzed by two independent reviewers for variables including dosage, TXA administration route, type of spine procedure, blood loss, adverse events including thromboembolism and infection, postoperative hemoglobin level, and hospitalization length. Pooled analysis comparing intraoperative and postoperative blood loss, postoperative hemoglobin levels, and hospitalization length of stay on the basis of route of TXA administration was conducted. RESULTS: Four cohort studies, 1 cross-sectional study, 1 case-control study, and 12 randomized controlled trials, together involving 2045 patients, were included. The most common route of topical TXA administration was via TXA in saline solution. Other routes of topical TXA included retrograde injection and TXA-soaked Gelfoam. In pooled analysis, topical TXA significantly reduced visible blood loss (standardized mean difference [SMD] -0.22, 95% CI -0.45 to -0.00001), postoperative blood loss (SMD -1.63, 95% CI -2.03 to -1.22), and length of hospital stay (SMD -1.02, 95% CI -1.42 to -0.61), as well as higher postoperative hemoglobin (SMD 0.59, 95% CI 0.34-0.83), compared with non-TXA controls. No significant differences in outcomes were found between topical and IV TXA or between combined (topical and IV) and IV TXA. Thromboembolism and infection rates did not significantly differ between any TXA administration group and non-TXA controls. CONCLUSIONS: In pooled analyses, topical TXA was associated with decreased perioperative blood loss in a wide range of scenarios, including cervical spine surgery and thoracolumbar trauma, as well as in patients with a thromboembolic history.

Shape Memory Nitinol Based Minimally Invasive Spinal Cord Stimulation Device Concept for Improved Pain Management.

BACKGROUND: Spinal cord stimulation (SCS) is a common treatment for neuropathic pain. There are 2 main categories of SCS leads: paddle leads and cylindrical leads. Paddle leads have reduced long-term complications and provide better coverage of target dermatomes when compared to cylindrical leads. However, insertion of a paddle lead requires invasive surgery that comes with significantly higher costs and more short-term complications, such as postoperative pain and infection. In contrast, cylindrical leads can be inserted minimally invasively using percutaneous techniques but provide less coverage of targeted dermatomes and have a higher tendency to migrate from intended neuronal targets. OBJECTIVES: Our objective is to develop a novel improved cylindrical spinal cord stimulation device that can convert into an optimal geometry once exposed to the body's environment after minimally invasive surgery. Such a device would be able to reduce long-term complications, lead migration, and better cover targeted dermatomes. STUDY DESIGN: Biomaterial selection, medical intervention device design with an in-vitro lab-scale test, and cadaveric experimental study. METHODS: A shape memory alloy nitinol-based cylindrical lead was designed, and its nitinol core material was processed and geometrically programmed for percutaneous insertion into the epidural space and morphing into an optimal geometry once exposed to the body's environment. Deployment of the nitinol component of the design was tested in the lab and human cadaveric models of the epidural space. RESULTS: Deployment of the nitinol component of the proposed cylindrical lead was successfully demonstrated in both a lab model of the epidural space and in the epidural space of a human cadaver in a minimally invasive fashion, indicating that a similar component could be used clinically in a full SCS electrode manufactured in a custom final geometry. LIMITATIONS: The focus of this study was to test the deployment of a novel minimally invasive lead that provides optimal coverage of intended dermatomes using in-vitro methods. Our study does not include in vivo trials. We do not test the electrical components of the design proposed since our design does not make changes to the electrical components of current commercially used cylindrical leads. CONCLUSION: The unique shape memory property of nitinol shows promise in allowing cylindrical spinal cord stimulation leads to expand into a more optimal geometry within the epidural space. By having a body temperature-dependent geometry change, nitinol-based cylindrical leads could reduce lead migration, increase dermatomal coverage, and increase electrode density while maintaining the advantages of minimally invasive insertion.