Faculty Bibliography

STUDY DESIGN: This is a prospective, randomized, double-blinded comparison of tranexamic acid (TXA), epsilon aminocaproic acid (EACA), and placebo used intraoperatively in patients with adult spinal deformity. OBJECTIVE: The purpose of this study was to provide high-quality evidence regarding the comparative efficacies of TXA, EACA, and placebo in reducing blood loss and transfusion requirements in patients undergoing posterior spinal fusion surgery. SUMMARY OF BACKGROUND DATA: Spine deformity surgery usually involves substantial blood loss. The antifibrinolytics TXA and EACA have been shown to improve hemostasis in large blood loss surgical procedures. METHODS: Fifty-one patients undergoing posterior spinal fusion of at least 5 levels for correction of adult spinal deformity were randomized to 1 of 3 treatment groups. Primary outcome measures included intraoperative estimated blood loss, total loss, (estimated blood loss + postoperative blood loss), and transfusion rates. RESULTS: Patients received TXA (n = 19), EACA (n = 19), or placebo (n = 13) in the operating room (mean ages: 60, 47, and 43 yr, respectively); TXA patients were significantly older and had larger estimated blood volumes than both other groups. Total losses were significantly reduced for EACA versus control, and there was a demonstrable but nonsignificant trend toward reduced intraoperative blood loss in both antifibrinolytic arms versus control. EACA had significant reductions in postoperative blood transfusions versus TXA. CONCLUSION: The findings in this study support the use of antifibrinolytics to reduce blood loss in posterior adult spinal deformity surgery. LEVEL OF EVIDENCE: 1.

BACKGROUND CONTEXT: Spine surgery is usually associated with large blood loss necessitating blood transfusions. Blood loss-associated morbidity can be due to direct risks, such as hypotension and organ damage, or as result of blood transfusions. The antifibrinolytic, tranexamic acid (TXA) is a lysine analogues which inhibits activation of plasminogen and has shown to be beneficial in reducing surgical blood loss. PURPOSE: The purpose of the meta-analysis is to consolidate the findings of randomized controlled trials (RCTs) investigating the use of TXA on surgical bleeding in spine surgery. STUDY DESIGN: Meta-analysis STUDY SAMPLE: RCTs investigating effectiveness of intravenous TXA in reducing blood loss in spine surgery, compared to 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 to a placebo/ no treatment group in spine surgery. Meta analysis was performed using RevMan 5. Weighted mean difference was used to summarize findings across the trials for continuous outcomes. Dichotomous data were expressed as risk ratio with 95% confidence intervals (CI). A p < 0.05 was considered statistically significant. RESULTS: Eleven RCTs were included for TXA (644 total patients). TXA reduced intraoperative, postoperative and total blood loss by an average of 219 ml ([-322,-116], p<0.05), 119 ml ([-141,-98], p<0.05) and 202 ml ([-299, -105], p<0.05) respectively. TXA led to a reduction in proportion of patients who received a blood transfusion (RR 0.67 ([0.54, 0.83], p <0.05) relative to placebo. There was one myocardial infarction (MI) in the TXA group and one deep vein thrombosis (DVT) in placebo. CONCLUSION: TXA reduces surgical bleeding and transfusion requirements in patients undergoing spine surgery. TXA does not appear to be associated with an increased incidence of pulmonary embolism, DVT, or MI.

Object The goal of this study was to determine the outcome and risk factors in patients with adult spinal deformity (ASD) who elected to receive nonoperative care. Methods In this retrospective study the authors reviewed a nonoperative branch of the International Spine Study Group database, derived from 10 sites across the US. Specific inclusion criteria included nonoperative treatment for ASD and the availability of Scoliosis Research Society (SRS)-22 scores and radiographic data at baseline (BL) and at 1-year (1Y) follow-up. Health-related quality of life measures were assessed using the SRS-22 and radiographic data. Changes in SRS-22 scores were evaluated by domain and expressed in number of minimum clinically important differences (MCIDs) gained or lost; BL and 1Y scores were also compared with age- and sex-matched normative references. Results One hundred eighty-nine patients (mean age 53 years, 86% female) met inclusion criteria. Pain was the domain with the largest offset for 43% of patients, followed by the Appearance (23%), Activity (18%), and Mental (15%) domains. On average, patients improved 0.3 MCID in Pain over 1Y, without changes in Activity or Appearance. Baseline scores significantly impacted 1Y outcomes, with up to 85% of patients in the mildest category of deformity being classified as < 1 MCID of normative reference at 1Y, versus 0% of patients with the most severe initial deformity. Baseline radiographic parameters did not correlate with outcome. Conclusions Patients who received nonoperative care are significantly more disabled than age- and sex-matched normative references. The likelihood for a patient to reach SRS scores similar to the normative reference at 1Y decreases with increased BL disability. Nonoperative treatment is a viable option for certain patients with ASD, and up to 24% of patients demonstrated significant improvement over 1Y with nonoperative care.