Kristina Bianco

Efficacy of tranexamic acid on surgical bleeding in spine surgery: a meta-analysis.

BACKGROUND CONTEXT Spine surgery is usually associated with large amount of blood loss, necessitating blood transfusions. Blood loss-associated morbidity can be because of direct risks, such as hypotension and organ damage, or as a result of blood transfusions. The antifibrinolytic, tranexamic acid (TXA), is a lysine analog that inhibits activation of plasminogen and has shown to be beneficial in reducing surgical blood loss. PURPOSE To consolidate the findings of randomized controlled trials (RCTs) investigating the use of TXA on surgical bleeding in spine surgery. STUDY DESIGN A metaanalysis. STUDY SAMPLE Randomized controlled trials investigating the effectiveness of intravenous TXA in reducing blood loss in spine surgery, compared with a placebo/no treatment group. METHODS MEDLINE, Embase, Cochrane controlled trials register, and Google Scholar were used to identify RCTs published before January 2014 that examined the effectiveness of intravenous TXA on reduction of blood loss and blood transfusions, compared with a placebo/no treatment group in spine surgery. Metaanalysis was performed using RevMan 5. Weighted mean difference with 95% confidence intervals was used to summarize the findings across the trials for continuous outcomes. Dichotomous data were expressed as risk ratios with 95% confidence intervals. A p<.05 was considered statistically significant. RESULTS Eleven RCTs were included for TXA (644 total patients). Tranexamic acid reduced intraoperative, postoperative, and total blood loss by an average of 219 mL ([-322, -116], p<.05), 119 mL ([-141, -98], p<.05), and 202 mL ([-299, -105], p<.05), respectively. Tranexamic acid led to a reduction in proportion of patients who received a blood transfusion (risk ratio 0.67 [0.54, 0.83], p<.05) relative to placebo. There was one myocardial infarction (MI) in the TXA group and one deep vein thrombosis (DVT) in placebo. CONCLUSIONS Tranexamic acid reduces surgical bleeding and transfusion requirements in patients undergoing spine surgery. Tranexamic acid does not appear to be associated with an increased incidence of pulmonary embolism, DVT, or MI.

Complications and intercenter variability of three-column osteotomies for spinal deformity surgery: a retrospective review of 423 patients.

OBJECT Three-column resection osteotomies (3COs) are commonly performed for sagittal deformity but have high rates of reported complications. Authors of this study aimed to examine the incidence of and intercenter variability in major intraoperative complications (IOCs), major postoperative complications (POCs) up to 6 weeks postsurgery, and overall complications (that is, both IOCs and POCs). They also aimed to investigate the incidence of and intercenter variability in blood loss during 3CO procedures. METHODS The incidence of IOCs, POCs, and overall complications associated with 3COs were retrospectively determined for the study population and for each of 8 participating surgical centers. The incidence of major blood loss (MBL) over 4 L and the percentage of total blood volume lost were also determined for the study population and each surgical center. Complication rates and blood loss were compared between patients with one and those with two osteotomies, as well as between patients with one thoracic osteotomy (ThO) and those with one lumbar or sacral osteotomy (LSO). Risk factors for developing complications were determined. RESULTS Retrospective review of prospectively acquired data for 423 consecutive patients who had undergone 3CO at 8 surgical centers was performed. The incidence of major IOCs, POCs, and overall complications was 7%, 39%, and 42%, respectively, for the study population overall. The most common IOC was spinal cord deficit (2.6%) and the most common POC was unplanned return to the operating room (19.4%). Patients with two osteotomies had more POCs (56% vs 38%, p = 0.04) than the patients with one osteotomy. Those with ThO had more IOCs (16% vs 6%, p = 0.03), POCs (58% vs 34%, p < 0.01), and overall complications (67% vs 37%, p < 0.01) than the patients with LSO. There was significant variation in the incidence of IOCs, POCs, and overall complications among the 8 sites (p < 0.01). The incidence of MBL was 24% for the study population, which varied significantly between sites (p < 0.01). Patients with MBL had a higher risk of IOCs, POCs, and overall complications (OR 2.15, 1.76, and 2.01, respectively). The average percentage of total blood volume lost was 55% for the study population, which also varied among sites (p < 0.01). CONCLUSIONS Given the complexity of 3COs for spinal deformity, it is important for spine surgeons to understand the risk factors and complication rates associated with these procedures. In this study, the overall incidence of major complications following 3CO procedures was 42%. Risks for developing complications included an older age (> 60 years), two osteotomies, ThO, and MBL.

Complications and Intercenter Variability of Three-Column Resection Osteotomies for Spinal Deformity Surgery: A Retrospective Review of 423 Patients

Study Type Retrospective review of a prospectively collected multicenter database. Introduction Three-column resection osteotomies (3CO), including pedicle subtraction osteotomies and vertebral column resections are performed for correction of sagittal deformity; however, they have high rates of reported complications. This study examined the incidence and intercenter variability of major intraoperative complications (IOC), postoperative complications (POC), and overall complications (IOC + POC) up to 6 weeks postoperation. Objective The aim of the study is to examine the incidence and intercenter variability of major complications associated with 3CO. Patients and Methods A retrospective review of patients with 3CO from eight different sites was performed. The incidence and types of complications were determined for the study population (N = 423). The analysis compared patients with one (n = 391) and two (n = 32) osteotomies, as well as patients with a thoracic osteotomy (ThO) (n = 72) versus a lumbosacral osteotomy (LSO) (n = 319) of the spine. Subsequent analysis was performed to compare sites with low-osteotomy volumes (< 50 patients) to sites with large osteotomy volumes (more than 50 patients). Major blood loss (MBL) was defined as more than 4L. Results Of the 423 patients, the incidence of major IOC, POC, and overall complications was 28, 45, and 58%, respectively (Table 1). The most common major IOC was MBL (24%) and the most common POC was unplanned return to the operating room (OR) (19%). Other IOC included cord deficit (2.6%), pneumothorax (1.5%), large vessel injury (1.7%), nerve root injury (1.4%), and cardiac arrest (0.2%). Other POC included motor deficit (12.1%), deep infection (7.6%), acute respiratory distress/failure (4.7%), deep venous thrombosis (3.1%), pulmonary embolism (2.8%), arrhythmia (1.2%), reintubation and sepsis (0.7%), cauda equine syndrome, myocardial infarction, visual deficit, stroke (0.5%), and death (0.2%). Patients with one 3CO had significantly less POC (43 vs. 69%, p < 0.01) and overall complications (57 vs. 75%, p < 0.01) than patients with two 3CO (Fig. 1). IOC, MBL, and return to the OR were not significantly different between groups. Patients with ThO had significantly more POC (66 vs. 39%, p < 0.01) and overall complications (76 vs. 53%, p < 0.001) than patients with LSO. Patients with LSO had more MBL (25 vs. 14%, p = 0.04). Patients with ThO had more unplanned return to OR (41 vs. 14%, p < 0.001) (Fig. 2). The incidence of IOC was greater for the low-volume sites than high-volume sites (46 vs. 23%, p < 0.001). Low-volume sites had a higher frequency of patients with MBL than high-volume sites (45 vs. 18%, p < 0.001) (Fig. 3). Patients who experienced MBL had a significantly longer operating time (p < 0.001) and a higher risk of developing other IOC, POC, and overall complications (OR = 2.18, 1.51, 1.63, respectively) than patients who did not experience substantial blood loss. Conclusions The overall incidence of complications was 58% following 3CO surgery. There was significant variation in incidence of complications depending on the number, location, and experience of performing osteotomies. Risks for developing complications included having two osteotomies, ThO, surgery at a low-volume center, and blood loss more than 4 L. With a better understanding of 3CO complications and risk factors, physicians may be more informed in the decision-making process of sagittal plane deformity correction.

Degenerative Spondylolisthesis: An Analysis of the Nationwide Inpatient Sample Database.

Study Design. Analysis of the Nationwide Inpatient Sample database. Objective. To investigate national trends, risks, and benefits of surgical interventions for degenerative spondylolisthesis (DS). Summary of Background Data. The surgical management of DS continues to evolve whereas the most clinically and cost-effective treatment is debated. With an aging US population and growing restraints on a financially burdened health care system, a clear understanding of national trends in the surgical management of DS is needed. Methods. The Nationwide Inpatient Sample database was queried for patients with DS undergoing lumbar fusions from 2001 to 2010, using International Classification of Diseases, Ninth Revision (ICD-9) diagnosis and procedure codes. Analyses compared instrumented posterolateral fusion (PLF), posterolateral fusion with anterior lumbar interbody fusion (ALIF + PLF), PLF with posterior interbody fusion (P/TLIF + PLF), anterior instrumented interbody fusion (ALIF), and posterior interbody fusion with posterior instrumentation (P/TLIF). Clinical data were analyzed representing the initial acute phase care after surgery. Results. There were 48,911 DS surgical procedures identified, representing 237,383 procedures. The percentage of patients undergoing PLF, ALIF + PLF, or ALIF increased whereas the percentage of P/TLIF or P/TLIF + PLF decreased over time. Total charges were less (P < 0.001), average length of hospital stay was shorter (P < 0.01), and average age was older (P < 0.01) for patients who underwent PLF compared with any other procedure. Type of procedure varied on the basis of the geographic region of the hospital, teaching versus nonteaching hospital, and size of hospital (P < 0.01). Patients who had P/TLIF + PLF or ALIF had a higher risk of mortality than patients who had PLF (odds ratios: 5.02, 2.22, respectively). Patients were more likely to develop a complication if they had ALIF + PLF, P/TLIF + PLF, ALIF, and P/TLIF than if they had PLF (odds ratios: 1.45, 1.23, 1.49, 1.12, respectively). Conclusion. Variation in the surgical management of DS related to patient demographics, hospital charges, length of hospital stay, insurance type, comorbidities, and complication rates was found within the Nationwide Inpatient Sample database. During the acute phase of care immediately after surgery, PLF procedures were found to reduce length of hospital stay, hospital charges, and postoperative complications. Level of Evidence: 3

Risk Factors for Reoperation in Patients Treated Surgically for Lumbar Stenosis: A Subanalysis of the 8-year Data From the SPORT Trial.

Study Design. A retrospective subgroup analysis was performed on surgically treated patients from the lumbar spinal stenosis (SpS) arm of the Spine Patient Outcomes Research Trial (SPORT), randomized, and observational cohorts. Objective. To identify risk factors for reoperation in patients treated surgically for SpS and compare outcomes between patients who underwent reoperation with those who did not. Summary of Background Data. SpS is one of the most common indications for surgery in the elderly; however, few long-term studies have identified risk factors for reoperation. Methods. A post-hoc subgroup analysis was performed on patients from the SpS arm of the SPORT, randomized and observational cohorts. Baseline characteristics were analyzed between reoperation and no-reoperation groups using univariate and multivariate analysis on data 8 years postoperation. Results. Of the 417 study patients, 88% underwent decompression only, 5% noninstrumented fusion, and 6% instrumented fusion. At the 8-year follow-up, the reoperation rate was 18%; 52% of reoperations were for recurrent stenosis or progressive spondylolisthesis, 25% for complication or other reason, and 16% for new condition. Of patients who underwent a reoperation, 42% did so within 2 years, 70% within 4 years, and 84% within 6 years. Patients who underwent reoperation were less likely to have presented with any neurological deficit (43% reop vs. 57% no reop, P = 0.04). Patients improved less at follow-up in the reoperation group (P < 0.001). Conclusion. In patients undergoing surgical treatment for SpS, the reoperation rate at 8-year follow-up was 18%. Patients with a reoperation were less likely to have a baseline neurological deficit. Patients who did not undergo reoperation had better patient reported outcomes at 8-year follow-up compared with those who had repeat surgery. Level of Evidence: 2

Effectiveness of Postoperative Wound Drains in One- and Two-Level Cervical Spine Fusions

Background Cervical drains have historically been used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re-intubation, delayed extubation, or respiratory distress. Recently, some surgeons have ceased using drains because they may prolong hospital stay, operative time, or patient discomfort. The objective of this retrospective case-control series is to investigate the effectiveness of postoperative drains following one- and two-level cervical fusions. Methods A chart review was conducted at a single institution from 2010-2013. Outcome measures included operative time, hospital stay, estimated blood loss and incidence of wound complications (infection, hematoma, edema, and complications with wound healing or evacuation), respiratory complications (delayed extubation, re-intubation, and respiratory treatment), and overall complications (wound complications, respiratory complications, dysphagia, and other complications). Statistical analyses including independent samples t-test, chi-square, analysis of covariance, and linear regression were used to compare patients who received a postoperative drain to those who did not. Results The study population included 39 patients who received a postoperative drain and 42 patients who did not. There were no differences in demographics between the two groups. Patients with drains showed increased operative time (100.1 vs 69.3 min, p < 0.001), hospital stay (38.9 vs. 31.7 hrs, p = 0.021), and blood loss (62.7 vs 29.1 mL, p < 0.001) compared to patients without drains. The frequency of wound complications, respiratory complications, and overall complications did not vary significantly between groups. Conclusions/Level of Evidence Cervical drains may not be necessary for patients undergoing one- and two-level cervical fusion. While there were no differences in incidence of complications between groups, patients treated with drains had significantly longer operative time and length of hospital stay. Clinical relevance This could contribute to excessive costs for patients treated with drains, despite the lack of compelling evidence of the advantages of this treatment in the literature and in the current study.

Cervical spondylotic myelopathy: National trends in the treatment and peri-operative outcomes over 10 years

BACKGROUND Recent studies show increases in cervical spine surgery prevalence and cervical spondylotic myelopathy (CSM) diagnoses in the US. However, few studies have examined outcomes for CSM surgical management, particularly on a nationwide scale. OBJECTIVE Evaluate national trends from 2001 to 2010 for CSM patient surgical approach, postoperative outcomes, and hospital characteristics. METHODS A retrospective nationwide database analysis provided by the Nationwide Inpatient Sample (NIS) including CSM patients aged 25+ who underwent anterior and/or posterior cervical fusion or laminoplasty from 2001 to 2010. Patients with fractures, 9+ levels fused, or any cancer were excluded. Measures included demographics, hospital data, and procedure-related complications. Yearly trends were analyzed using linear regression modeling. RESULTS 54,348 discharge cases were identified. ACDF, posterior only, and combined anterior/posterior approach volumes significantly increased from 2001 to 2010 (98.62%, 303.07%, and 576.19%; respectively, p<0.05). However, laminoplasty volume remained unchanged (p>0.05). Total charges for ACDF, posterior only, combined anterior/posterior, and laminoplasty approaches all significantly increased (138.72%, 176.74%, 182.48%, and 144.85%, respectively; p<0.05). For all procedures, overall mortality significantly decreased by 45.34% (p=0.001) and overall morbidity increased by 33.82% (p=0.0002). For all procedures except ACDF, which saw a significantly decrease by 8.75% (p<0.0001), length of hospital stay was unchanged. CONCLUSIONS For CSM patients between 2001 and 2010, combined surgical approach increased sixfold, posterior only approach increased threefold, and ACDF doubled; laminoplasties without fusion volume remained the same. Mortality decreased whereas morbidity and total charges increased. Length of stay decreased only for ACDF approach. This study provides clinically useful data to direct future research, improving patient outcomes.

Feasibility of a Cost-Effective, Video Analysis Software–Based Mobility Protocol for Objective Spine Kinematics and Gait Metrics: A Proof of Concept Study

The purpose of this study was to investigate the potential of a high‐throughput, easily implemented, cost‐effective, video analysis software–based mobility protocol to quantify spine kinematics. This prospective cohort study of clinical biomechanics implemented 2‐dimensional (2D) image processing at a tertiary‐care academic institution. Ten healthy, able‐bodied volunteers were recruited for 2D videography of gait and functional motion. The reliability of a 2D video analysis software program for gait and range of motion metrics was evaluated over 2 independent experimental sessions, assessing for inter‐trial, inter‐session, and inter‐rater reliability. Healthy volunteers were evaluated for simple forward and side bending, rotation, treadmill stride length, and more complex seated‐to‐standing tasks. Based on established intraclass correlation coefficients, results indicated that reliability was considered good to excellent for simple forward and side bending, rotation, stride length, and more complex sit‐to‐standing tasks. In conclusion, a cost‐effective, 2D, video analysis software–based mobility protocol represents a feasible and clinically useful approach for objective spine kinematics and gait metrics. As the complication rate of operative management in the setting of spinal deformity is weighed against functional performance and quality of life measures, an objective analysis tool in combination with an appropriate protocol will aid in clinical assessments and lead to an increased evidence base for management options and decision algorithms.

Two-Year Results of the Prospective Spine Treatment Outcomes Study: Analysis of Postoperative Clinical Outcomes Between Patients with and without a History of Previous Cervical Spine Surgery

OBJECTIVE History of previous cervical spine surgery is a frequently cited cause of worse outcomes after cervical spine surgery. The purpose of this study was to determine any differences in clinical outcomes after cervical spine surgery between patients with and without a history of previous cervical spine surgery. METHODS A multicenter prospective database was reviewed retrospectively to identify patients with cervical spondylosis undergoing surgery with a minimum 2-year follow-up. Patients were divided into 2 groups: patients with (W) or without (WO) previous history of cervical spine surgery. Statistical analyses of Health-Related Quality of Life scores were analyzed with statistical software to fit linear mixed models for continuous longitudinal outcome. RESULTS A total of 1286 patients (377 W, 909 WO) met criteria for inclusion. Overall, patients in both groups experienced an improvement in their Health-Related Quality of Life scores. However, patients in the W group had significantly decreased improvement compared with WO patients in the Neck Disability Index score and the following SF-36 domain scores: Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Health Transition, and Physical Component Summary at all time points (P < 0.05). There was no statistically significant difference between the W and WO groups in operative time, estimated blood loss, length of stay, or complications (P > 0.05). CONCLUSIONS Patients with a history of previous cervical spine surgery had inferior improvement in quality of life outcome scores. Patients with a history of previous surgical intervention who elect to undergo subsequent surgeries should be appropriately counseled about expected results.

Arm Pain Versus Neck Pain: A Novel Ratio as a Predictor of Post-Operative Clinical Outcomes in Cervical Radiculopathy Patients

ABSTRACT Background: Informed patient selection and counseling is key in improving surgical outcomes. Understanding the impact that certain baseline variables can have on postoperative outcomes is essential in optimizing treatment for certain symptoms, such as radiculopathy from cervical spine pathologies. The aim was to identify baseline characteristics that were related to improved or worsened postoperative outcomes for patients undergoing surgery for cervical spine radiculopathic pain. Methods: Retrospective review of prospectively collected data. Patient Sample: Surgical cervical spine patients with a diagnosis classification of “degenerative.” Diagnoses included in the “degenerative” category were those that caused radiculopathy: cervical disc herniation, cervical stenosis, and cervical spondylosis without myelopathy. Baseline variables considered as predictors were: (1) age, (2) body mass index (BMI), (3) gender, (4) history of cervical spine surgery, (5) baseline Neck Disability Index (NDI) score, (6) baseline SF-36 Physical Component Summary (PCS) scores, (7) baseline SF-36 Mental Component Summary (MCS) scores, (8) Visual Analog Scale (VAS) Arm score, and (9) VAS Neck. Outcome Measures: Improvement in NDI (≥50%), VAS Arm/Neck (≥50%), SF-36 PCS/MCS (≥10%) scores at 2-years postoperative. An arm-to-neck ratio (ANR) was also generated from baseline VAS scores. Univariate and multivariate analyses evaluated predictors for 2-year postoperative outcome improvements, controlling for surgical complications and technique. Results: Three hundred ninety-eight patients were included. Patients with ANR ≤ 1 (n = 214) were less likely to reach improvements in 2-year NDI (30.0% vs 39.2%, P = .050) and SF-36 PCS (42.4% vs 53.5%, P = .025). Multivariate analysis for neck disability revealed higher baseline SF-36 PCS (odds ratio [OR] 1.053) and MCS (OR 1.028) were associated with over 50% improvements. Higher baseline NDI were reduced odds of postoperative neck pain improvement (OR 0.958). Arm pain greater than neck pain at baseline was associated with both increased odds of postoperative arm pain improvement (OR 1.707) and SF36 PCS improvement (OR 1.495). Conclusions: This study identified specific symptom locations and health-related quality of life (HRQL) scores, which were associated with postoperative pain and disability improvement. In particular, baseline arm pain greater than neck pain was determined to have the greatest impact on whether patients met at least 50% improvement in their upper body pain score. These findings are important for clinicians to optimize patient outcomes through effective preoperative counseling.