Laser interstitial thermal therapy for deep-seated perivascular brain tumors is not associated with distal ischemia.

PURPOSE: Laser interstitial thermal therapy (LITT) is a minimally invasive cytoreductive treatment option for brain tumors with a risk of vascular injury from catheter placement or thermal energy. This may be of concern with deep-seated tumors that have surrounding end-artery perforators and critical microvasculature. The purpose of this study was to assess the risk of distal ischemia following LITT for deep-seated perivascular brain tumors. METHODS: A retrospective review of a multi-institution database was used to identify patients who underwent LITT between 2013 and 2022 for tumors located within the insula, thalamus, basal ganglia, and anterior perforated substance. Demographic, clinical and volumetric tumor characteristics were collected. The primary outcome was radiographic evidence of distal ischemia on post-ablation magnetic resonance imaging (MRI). RESULTS: 61 LITT ablations for deep-seated perivascular brain tumors were performed. Of the tumors treated, 24 (39%) were low-grade gliomas, 32 (52%) were high-grade gliomas, and 5 (8%) were metastatic. The principal location included 31 (51%) insular, 14 (23%) thalamic, 13 (21%) basal ganglia, and 3 (5%) anterior perforated substance tumors. The average tumor size was 19.6 cm3 with a mean ablation volume of 11.1 cm3. The median extent of ablation was 92% (IQR 30%, 100%). Two patients developed symptomatic intracerebral hemorrhage after LITT. No patient had radiographic evidence of distal ischemia on post-operative diffusion weighted imaging. CONCLUSION: We demonstrate that LITT for deep-seated perivascular brain tumors has minimal ischemic risks and is a feasible cytoreductive treatment option for otherwise difficult to access intracranial tumors.

Genomic Biomarkers of Meningioma: A Focused Review.

Meningiomas represent a phenotypically and genetically diverse group of tumors which often behave in ways that are not simply explained by their pathologic grade. The genetic landscape of meningiomas has become a target of investigation as tumor genomics have been found to impact tumor location, recurrence risk, and malignant potential. Additionally, targeted therapies are being developed that in the future may provide patients with personalized chemotherapy based on the genetic aberrations within their tumor. This review focuses on the most common genetic mutations found in meningiomas of all grades, with an emphasis on the impact on tumor location and clinically relevant tumor characteristics. NF-2 and the non-NF-2 family of genetic mutations are summarized in the context of low-grade and high-grade tumors, followed by a comprehensive discussion regarding the genetic and embryologic basis for meningioma location and phenotypic heterogeneity. Finally, targeted therapies based on tumor genomics currently in use and under investigation are reviewed and future avenues for research are suggested. The field of meningioma genomics has broad implications on the way meningiomas will be treated in the future, and is gradually shifting the way clinicians approach this diverse group of tumors.

Developing Real-world Evidence-Ready Datasets: Time for Clinician Engagement.

PURPOSE OF REVIEW: Real-world data (RWD) applications in healthcare that support learning health systems and pragmatic clinical trials are gaining momentum, largely due to legislation supporting real-world evidence (RWE) for drug approvals. Clinical notes are thought to be the cornerstone of RWD applications, particularly for conditions with limited effective treatments, extrapolation of treatments from other conditions, or heterogenous disease biology and clinical phenotypes. RECENT FINDINGS: Here, we discuss current issues in applying RWD captured at the point-of-care and provide a framework for clinicians to engage in RWD collection. To achieve clinically meaningful results, RWD must be reliably captured using consistent terminology in the description of our patients. RWD complements traditional clinical trials and research by informing the generalizability of results, generating new hypotheses, and creating a large data network for scientific discovery. Effective clinician engagement in the development of RWD applications is necessary for continued progress in the field.

Compressive myelopathy from diffuse spinal dural calcifications in a patient with end-stage renal disease: illustrative case.

BACKGROUND: Diffuse spinal dural calcification is a rare disorder associated with hyperparathyroidism, including the secondary forms associated with renal failure, osteodystrophy, and chronic hypocalcemia. Here, the authors report a rare case of diffuse dural calcification causing spinal cord compression with myelopathy, requiring decompressive surgery with duraplasty to achieve adequate decompression. OBSERVATIONS: A 46-year-old male with a history of renal failure on dialysis presented with 2 months of progressive neuropathic pain, lower-extremity weakness, and nonsustained clonus. Spine imaging showed severe renal osteodystrophy with multilevel compression fractures and diffuse dural calcifications with areas of invagination causing severe spinal cord compression. Decompressive surgery was recommended. In surgery, a thickened and calcified dura was encountered with areas of buckling causing spinal cord compression. The invaginated area of the dura was resected and reconstructed with patch duraplasty. The patient's neurological status remained unchanged postoperatively, and at the 6-month follow-up, the patient reported significant improvement in pain and muscle spasms. LESSONS: Diffuse dural calcifications are a rare complication of prolonged dialysis and secondary hyperparathyroidism. When there is resultant spinal cord compression, this condition requires an intradural approach that addresses the thickened, calcified dura directly to obtain adequate spinal cord decompression.

Laser interstitial thermal therapy for first-line treatment of insular glioma.

OBJECTIVE: Insular gliomas pose a significant surgical challenge due to the complex surrounding functional and vascular anatomy. The authors report their experience using a novel framework for the treatment of insular gliomas with laser interstitial thermal therapy (LITT) and provide representative case examples emphasizing indications, rationale, and technical pearls. METHODS: A prospectively gathered institutional database was used to identify patients with newly diagnosed insular gliomas who underwent LITT between 2015 and 2023. The proposed framework of insular glioma management is guided by tumor size and extent of extra-insular tumor involvement. Patients with tumors localized to the insula (insula-only) were treated with single-session or staged LITT. Patients with insular tumors with frontotemporal involvement (insular+) were treated with insular LITT and standard frontotemporal resection of extra-insular tumor. Clinical and volumetric lesional characteristics were analyzed, with particular emphasis on extent of cytoreductive treatment and safety. RESULTS: Of the 261 patients treated at the authors' institution with LITT between 2015 and 2023, 33 LITT procedures were identified involving 22 unique patients with treatment-naive insular gliomas. Of the 22 patients, 12 had insular-only tumors and were treated with LITT alone, while 10 patients had insular+ lesions and were treated with LITT and resection. The median tumor volume for insular-only tumors was 13.4 cm3 (IQR 10.6, 26.3 cm3), with a median extent of treatment of 100% (IQR 92.1%, 100%). Insular+ lesions were significantly larger, with a median volume of 81.2 cm3 (IQR 51.9, 97 cm3) and median extent of treatment of 96.6% (IQR 93.7%, 100%). All patients with insular-only tumors were discharged the day after ablation, while insular+ patients had significantly longer hospital stays, with 50% staying more than 3 days. Overall, 8% of insular-only patients had permanent neurological deficits compared with 33% of insular+ patients. Two patients' tumors progressed during follow-up: one patient with WHO grade 4 astrocytoma and the other with diffuse glioma not otherwise specified. Patients with grade 4 tumors had the highest rate of permanent neurological deficit (43%) and a larger decline in postoperative Karnofsky Performance Status score (p = 0.046). CONCLUSIONS: The authors present their experience using a novel insular glioma treatment paradigm that incorporates LITT into the broader framework of insular glioma surgery. Their findings suggest that insular LITT is feasible and may allow for high rates of cytoreduction while potentially ameliorating the risks of conventional insular glioma surgery.

Augmented Reality Registration System for Visualization of Skull Landmarks.

BACKGROUND: Augmented reality (AR) is an emerging technology in neurosurgery with the potential to become a strategic tool in the delivery of care and education for trainees. Advances in technology have demonstrated promising use for improving visualization and spatial awareness of critical neuroanatomic structures. In this report, we employ a novel AR registration system for the visualization and targeting of skull landmarks. METHODS: A markerless AR system was used to register 3-dimensional reconstructions of suture lines onto the head via a head-mounted display. Participants were required to identify craniometric points with and without AR assistance. Targeting error was measured as the Euclidian distance between the user-defined location and the true craniometric point on the subjects' heads. RESULTS: All participants successfully registered 3-dimensional reconstructions onto the subjects' heads. Targeting accuracy was significantly improved with AR (3.59 ± 1.29 mm). Across all target points, AR increased accuracy by an average of 19.96 ± 3.80 mm. Posttest surveys revealed that participants felt the technology increased their confidence in identifying landmarks (4.6/5) and that the technology will be useful for clinical care (4.2/5). CONCLUSIONS: While several areas of improvement and innovation can further enhance the use of AR in neurosurgery, this report demonstrates the feasibility of a markerless headset-based AR system for visualizing craniometric points on the skull. As the technology continues to advance, AR is expected to play an increasingly significant role in neurosurgery, transforming how surgeries are performed and improving patient care.

The Potential Negative Effects of Smoking on Cervical and Lumbar Surgery Beyond Pseudarthrosis: A Michigan Spine Surgery Improvement Collaborative Study.

OBJECTIVE: To review the Michigan Spine Surgery Improvement Collaborative registry to investigate the long-term associations between current smoking status and outcomes after elective cervical and lumbar spine surgery. METHODS: Using the Michigan Spine Surgery Improvement Collaborative, we captured all cases from January 1, 2017, to November 21, 2020, with outcomes data available; 19,251 lumbar cases and 7936 cervical cases were included. Multivariate regression analyses were performed to assess the relationship of smoking with the clinical outcomes. RESULTS: Current smoking status was associated with lower urinary retention and satisfaction for patients after lumbar surgery and was associated with less likelihood of achieving minimal clinically important difference in primary outcome measures including Patient-Reported Outcomes Measurement Information System, back pain, leg pain, and EuroQol-5D at 90 days and 1 year after surgery. Current smokers were also less likely to return to work at 90 days and 1 year after surgery. Among patients who underwent cervical surgery, current smokers were less likely to have urinary retention and dysphagia postoperatively. They were less likely to be satisfied with the surgery outcome at 1 year. Current smoking was associated with lower likelihood of achieving minimal clinically important difference in Patient-Reported Outcomes Measurement Information System, neck pain, arm pain, and EuroQol-5D at various time points. There was no difference in return-to-work status. CONCLUSIONS: Our analysis suggests that smoking is negatively associated with functional improvement, patient satisfaction, and return-to-work after elective spine surgery.

Detection of diagnostic and prognostic methylation-based signatures in liquid biopsy specimens from patients with meningiomas.

Recurrence of meningiomas is unpredictable by current invasive methods based on surgically removed specimens. Identification of patients likely to recur using noninvasive approaches could inform treatment strategy, whether intervention or monitoring. In this study, we analyze the DNA methylation levels in blood (serum and plasma) and tissue samples from 155 meningioma patients, compared to other central nervous system tumor and non-tumor entities. We discover DNA methylation markers unique to meningiomas and use artificial intelligence to create accurate and universal models for identifying and predicting meningioma recurrence, using either blood or tissue samples. Here we show that liquid biopsy is a potential noninvasive and reliable tool for diagnosing and predicting outcomes in meningioma patients. This approach can improve personalized management strategies for these patients.

Surgical management of Grisel syndrome in the adult patient: illustrative case.

BACKGROUND: Grisel syndrome describes an infectious soft tissue process that destabilizes the cervical bony elements and ligamentous complexes. This nontraumatic atlantoaxial rotary subluxation occurs in children primarily. This case illustrates a rare case presentation of an adult with Grisel syndrome: infectious destruction of the right atlantoaxial facet joint caused the occiput-C1 vertebra (head) to rotate rightward with lateral horizontal displacement off the C2 vertebra. OBSERVATIONS: Because the infection destroyed the C1 bony arch and atlantoaxial facet joints with epidural extension, the rotated head and atlas pulled the brainstem-cervical spinal cord junction against a fixed odontoid process, resulting in a cord contusion. Because of the highly unstable craniocervical junction, the patient presented with torticollis and left upper extremity weakness. LESSONS: Treatment entailed closed reduction under general anesthesia followed by occipitocervical fusion with an occipital plate, C1 lateral mass screws, and C2-C5 pedicle screws. This case describes the unique surgical pearls necessary for occipitocervical fusion of an unstable craniocervical junction, including tips with neuronavigation, trajectories of the cervical pedicle screws, aligning the lateral mass and pedicle screws with the occipital plate, and nuances with occipitocervical distraction.

Enterovirus-Induced Severe Rhabdomyolysis and Acute Fulminant Liver Failure in an Immunocompetent Adult Requiring Liver Transplantation: A Case Report.

The authors report a case of a young healthy adult with severe rhabdomyolysis and acute fulminant liver failure with multiple organ dysfunction syndromes (MODS), possibly from an enterovirus infection. To the best of our knowledge, this is the first-ever reported case of enterovirus-induced rhabdomyolysis and acute liver failure (ALF) in an immunocompetent adult. It is vital that the treating physician be aware of the association between viral infections, viral myositis, and severe rhabdomyolysis with acute liver failure, which can facilitate the optimal management of such patients. Prompt recognition may provide an opportunity for early interventions, including intravenous immunoglobulin and liver transplantation, if warranted.

A Matched Cohort Analysis of Drain Usage in Elective Anterior Cervical Discectomy and Fusion: A Michigan Spine Surgery Improvement Collaborative (MSSIC) Study.

STUDY DESIGN: This is a retrospective, cohort analysis of multi-institutional database. OBJECTIVE: This study was designed to analyze the impact of drain use following elective anterior cervical discectomy and fusion (ACDF) surgeries. SUMMARY OF BACKGROUND DATA: After ACDF, a drain is often placed to prevent postoperative hematoma. However, there has been no high quality evidence to support its use with ACDF despite the theoretical benefits and risks of drain placement. METHODS: The Michigan Spine Surgery Improvement Collaborative database was queried to identify all patients undergoing elective ACDF between February 2014 and October 2019. Cases were divided into two cohorts based on drain use. Propensity-score matching was utilized to adjust for inherent differences between the two cohorts. Measured outcomes included surgical site hematoma, length of stay, surgical site infection, dysphagia, home discharge, readmission within 30 days, and unplanned reoperation. RESULTS: We identified 7943 patients during the study period. Propensity-score matching yielded 3206 pairs. On univariate analysis of matched cohorts, there were no differences in rate of postoperative hematoma requiring either return to OR or readmission. We noted patients with drains had a higher rate of dysphagia (4.6% vs. 6.3%; P = 0.003) and had longer hospital stay (P < 0.001). On multivariate analysis, drain use was associated with significantly increased length of stay (relative risk 1.23, 95% confidence interval [CI] 1.13-1.34; P < 0.001). There were no significant differences in other outcomes measured. CONCLUSION: Our analysis demonstrated that drain use is associated with significant longer hospital stay.Level of Evidence: 3.

Laser Interstitial Thermal Therapy for First-Line Treatment of Surgically Accessible Recurrent Glioblastoma: Outcomes Compared With a Surgical Cohort.

BACKGROUND: Laser interstitial thermal therapy (LITT) for glioblastoma (GBM) has been reserved for poor surgical candidates and deep "inoperable" lesions. We present the first reported series of LITT for surgically accessible recurrent GBM (rGBM) that would otherwise be treated with surgical resection. OBJECTIVE: To evaluate the use of LITT for unifocal, lobar, first-time rGBM compared with a similar surgical cohort. METHODS: A retrospective institutional database was used to identify patients with unifocal, lobar, first-time rGBM who underwent LITT or resection between 2013 and 2020. Clinical and volumetric lesional characteristics were compared between cohorts. Subgroup analysis of patients with lesions ≤20 cm 3 was also completed. Primary outcomes were overall survival and progression-free survival. RESULTS: Of the 744 patients with rGBM treated from 2013 to 2020, a LITT cohort of 17 patients were compared with 23 similar surgical patients. There were no differences in baseline characteristics, although lesions were larger in the surgical cohort (7.54 vs 4.37 cm 3 , P = .017). Despite differences in lesion size, both cohorts had similar extents of ablation/resection (90.7% vs 95.1%, P = .739). Overall survival (14.1 vs 13.8 months, P = .578) and progression-free survival (3.7 vs 3.3 months, P = 0. 495) were similar. LITT patients had significantly shorter hospital stays (2.2 vs 3.0 days, P = .004). Subgroup analysis of patients with lesions ≤20 cm 3 showed similar outcomes, with LITT allowing for significantly shorter hospital stays. CONCLUSION: We found no difference in survival outcomes or morbidity between LITT and repeat surgery for surgically accessible rGBM while LITT resulted in shorter hospital stays and more efficient postoperative care.

The Effect of Antithrombotics on Hematoma Expansion in Small- to Moderate-Sized Traumatic Intraparenchymal Hemorrhages.

BACKGROUND: Although pre-injury antithrombotic agents, including antiplatelets and anticoagulants, are historically associated with expansion of traumatic intraparenchymal hemorrhage (tIPH), the literature has poorly elucidated the actual risk of hematoma expansion on repeat computed tomography (CT). The objective was to determine the effect of antithrombotic agents on hematoma expansion in tIPH by comparing patients with and without pre-injury antithrombotic medication. METHODS: The volume of all tIPHs over a 5-year period at an academic Level 1 trauma center was measured retrospectively. The initial tIPH was divided into 3 equally sized quantiles. The third tercile, representing the largest subset of tIPH, was then removed from the study population because these patients reflect a different pathophysiologic mechanism that may require a more acute and aggressive level of care with reversal agents and/or operative management. Per institutional policy, all patients with small- to moderate-sized hemorrhages received a 24-hour stability CT scan. Patients who received reversal agents were excluded. RESULTS: Of the 105 patients with a tIPH on the initial head CT scan, small- to moderate-sized hemorrhages were <5 cm3. The size of tIPH on initial imaging did not statistically significantly differ between the antithrombotic cohort (0.7 ± 0.1 cm3) and the non-antithrombotic cohort (0.5 ± 0.1 cm3) (P = 0.091). Similarly, the volume of tIPH failed to differ on 24-hour repeat imaging (1.0 ± 0.2 cm3 vs. 0.6 ± 0.1 cm3, respectively, P = 0.172). Following a multiple linear regression, only history of stroke, not antithrombotic medications, predicted increased tIPH on 24-hour repeat imaging. CONCLUSIONS: In small- to moderate-sized tIPH, withholding antithrombotic agents without reversal may be sufficient.

The influence of sagittal spinopelvic alignment on patient discharge disposition following minimally invasive lumbar interbody fusion.

BACKGROUND: The aim of this study was to investigate the changes to spinopelvic sagittal alignment following minimally invasive (MIS) lumbar interbody fusion, and the influence of such changes on postoperative discharge disposition. METHODS: The Michigan Spine Surgery Improvement Collaborative was queried for all patients who underwent transforaminal lumbar interbody fusion (TLIF)or lateral lumbar interbody fusion (LLIF) procedures for degenerative spine disease. Several spinopelvic sagittal alignment parameters were measured, including sagittal vertical axis (SVA), lumbar lordosis, pelvic tilt, pelvic incidence, and pelvic incidence-lumbar lordosis mismatch. Primary outcome measure-discharge to a rehabilitation facility-was expressed as adjusted odds ratio (ORadj) following a multivariable logistical regression. RESULTS: Of the 83 patients in the study population, 11 (13.2%) were discharged to a rehabilitation facility. Preoperative SVA was equivalent. Postoperative SVA increased to 8.0 cm in the discharge-to-rehabilitation division versus a decrease to 3.6 cm in the discharge-to-home division (P<0.001). The odds of discharge to a rehabilitation facility increased by 25% for every 1-cm increase in postoperative sagittal balance (ORadj =1.27, P=0.014). The strongest predictor of discharge to rehabilitation was increasing decade of life (ORadj =3.13, P=0.201). CONCLUSIONS: Correction of sagittal balance is associated with greater odds of discharge to home. These findings, coupled with the recognized implications of admission to a rehabilitation facility, will emphasize the importance of spine surgeons accounting for SVA into their surgical planning of MIS lumbar interbody fusions.

Reducing Superfluous Opioid Prescribing Practices After Brain Surgery: It Is Time to Talk About Drugs.

BACKGROUND: Opioids are prescribed routinely after cranial surgery despite a paucity of evidence regarding the optimal quantity needed. Overprescribing may adversely contribute to opioid abuse, chronic use, and diversion. OBJECTIVE: To evaluate the effectiveness of a system-wide campaign to reduce opioid prescribing excess while maintaining adequate analgesia. METHODS: A retrospective cohort study of patients undergoing a craniotomy for tumor resection with home disposition before and after a 2-mo educational intervention was completed. The educational initiative was composed of directed didactic seminars targeting senior staff, residents, and advanced practice providers. Opioid prescribing patterns were then assessed for patients discharged before and after the intervention period. RESULTS: A total of 203 patients were discharged home following a craniotomy for tumor resection during the study period: 98 who underwent surgery prior to the educational interventions compared to 105 patients treated post-intervention. Following a 2-mo educational period, the quantity of opioids prescribed decreased by 52% (median morphine milligram equivalent per day [interquartile range], 32.1 [16.1, 64.3] vs 15.4 [0, 32.9], P < .001). Refill requests also decreased by 56% (17% vs 8%, P = .027) despite both groups having similar baseline characteristics. There was no increase in pain scores at outpatient follow-up (1.23 vs 0.85, P = .105). CONCLUSION: A dramatic reduction in opioids prescribed was achieved without affecting refill requests, patient satisfaction, or perceived analgesia. The use of targeted didactic education to safely improve opioid prescribing following intracranial surgery uniquely highlights the ability of simple, evidence-based interventions to impact clinical decision making, lessen potential patient harm, and address national public health concerns.

Occipital fixation techniques and complications.

Occipitocervical fusions in the adult population are most commonly indicated for neoplastic tumors invading the craniocervical junction (CCJ), rheumatological deformities compromising the foramen magnum, and traumatic dislocations resulting in occiput-C1 instability. Appropriate preoperative imaging will not only assist in identifying the pathology but also determine a treatment regimen for the diseased junction. A treatment algorithm for craniocervical disease is proposed. Lesions must first be identified as irreducible versus reducible: restore extension and/or distraction of the craniovertebral junction without injuring the neural elements. Irreducible lesions require decompression only, while reducible lesions require an added fusion. Techniques in fusion are broadly divided into external immobilization versus internal fixation. The former entails halo rings and tongs for a prolonged duration. Fixation surgeries vary from wiring to screw fixation of the occiput-C1 segment. Details of the operation as well as potential complications are discussed.

Giant Choroid Plexus Papilloma Resection Utilizing a Transcollation System.

BACKGROUND: Large vascular brain tumors pose an exceptional challenge in young children. Choroid plexus papilloma (CPP) is an example of a rare, often large and especially vascular neuroepithelial tumor that most commonly arises in children under 5 yr old. Although patients may be cured by total resection, this tumor poses significant surgical risks and challenges related to intraoperative hemostasis. OBJECTIVE: To describe our experience using a transcollation system during brain tumor surgery in a child to achieve hemostasis and minimize blood loss while preserving normal brain tissue. METHODS: A 3-yr-old girl presented following a fall and was found to have a giant CPP growing from the right lateral ventricle. Given the vascularity of the tumor and the low intravascular reserve in a small child, a transcollation device was used to reduce blood loss intraoperatively. RESULTS: Gross total resection was achieved with approximately 300 mL of blood loss without complications. The patient did well postoperatively. Imaging performed at 3 mo after resection revealed return of normal brain architecture. CONCLUSION: Transcollation devices appear to be an effective and safe addition to the armamentarium of neurosurgical hemostatic options in intracranial tumor resection in which there is a high risk of intraoperative hemorrhage.

Antidepressant pharmacotherapy and poststroke motor rehabilitation: A review of neurophysiologic mechanisms and clinical relevance.

According to the National Stroke Association, stroke is the leading cause of adult disability in the United States, where it is estimated that about 795,000 strokes occur on an annual basis. Minimizing the disability burden of a stroke routinely involves behavioral therapies such as physical and occupational therapy, as well as pharmacologic interventions. The positive effect of antidepressants on functional outcomes for patients with poststroke depression is well known and practiced. In the past 15 years, a growing body of evidence has demonstrated that antidepressant pharmacotherapy and selective serotonin reuptake inhibitors specifically have a role in the functional recovery from strokes even in the nondepressed population. The mechanisms by which antidepressants improve motor recovery following stroke are multifactorial, but it is clear that the process involves augmentation of cerebral blood flow, cortical excitation, and potentiation of neural growth factors all resulting in enhancement of neurogeneration. This review will examine the existing evidence and mechanisms behind antidepressant use for motor recovery in stroke patients and discuss the major human clinical trials that have been conducted surrounding this topic. The evidence clearly suggests that antidepressants have a positive impact on poststroke functional recovery regardless of the presence of depression, and although large-scale randomized, controlled trials are still ongoing, antidepressants are emerging as a promising pharmaceutical means of actively lessening the burden of disability following stroke.

Intravenous and Oral Tranexamic Acid Are Equivalent at Reducing Blood Loss in Thoracolumbar Spinal Fusion: A Prospective Randomized Trial.

STUDY DESIGN: A prospective randomized trial of patients enrolled at a university affiliated tertiary medical center between February and December 2017. OBJECTIVE: To compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with intravenous (IV) versus oral (PO) tranexamic acid (TXA). SUMMARY OF BACKGROUND DATA: The use of antifibrinolytic agents such as TXA to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. While evidence supports the use of IV and topical formulations of TXA in spine surgery, the use of PO TXA has not been studied. METHODS: Eighty-three patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into three categories based on number of levels fused (1-2 level fusions, 3-5, and >5). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test (TOST). A P-value of <0.05 suggested equivalence between treatments. RESULTS: Fourty three patients received IV TXA and 40 patients received PO TXA. Patient demographic factors were similar between groups except for body mass index (BMI). The mean reduction of hemoglobin was similar between IV and PO groups (3.36 g/dL vs. 3.43 g/dL, respectively; P = 0.01, equivalence). Similarly, the calculated blood loss was equivalent (1235 mL vs. 1312 mL, respectively; P = 0.02, equivalence). Eight patients (19%) in IV TXA group received a transfusion compared with five patients in PO TXA group (13%) (P = 0.44). One patient (2% and 3% in IV and PO, respectively) in each group experienced a deep venous thrombosis/pulmonary embolism (P = 0.96). CONCLUSION: Patients treated with IV and PO TXA experienced the same perioperative blood loss after spinal fusions. Given its lower cost, PO TXA represents an excellent alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve healthcare cost-efficiency in the studied population. LEVEL OF EVIDENCE: 1.