Perioperativeblood loss during spine surgery is unavoidable, often substantial, and associated with increased risks of postoperative complications and in-hospital mortality.1–3In addition to the direct morbidity and mortality associated with blood loss itself, perioperative blood transfusion to address blood loss either during or after spine surgery is associated with increased risk of multiple postoperative adverse outcomes.4These include surgical site, urinary, and pulmonary infections, return to the operating room (RTOR), and increased risk of 30-day readmission.4As such, hemostatic strategies continue to garner attention and spur investigation.1,5–7
Tranexamic acid (TXA) is a synthetic analog of lysine, which acts as an antifibrinolytic agent by competing for lysine-binding sites on plasminogen and thus blocking the degradative action of plasminogen/plasmin on fibrin.8As well, TXA was previously shown to be an excellent antifibrinolytic option for total joint arthroplasty and has shown promise for the reduction of perioperative blood loss during spine surgery.9Mounting evidence from randomized controlled trials, meta-analyses, and recent reviews suggests that TXA effectively reduces blood loss and transfusion requirements with minimal risk of hypercoagulable complications.10–12
Questions remain regarding the optimal route and dose of TXA.13–16This is due in part to the heterogeneity of the dosing protocols and study populations in the available literature, highlighting the need for studies that use standardized protocols and broadly representative patient samples. The impact of standardized TXA administration on postoperative complications is also not fully understood.
本研究的目的是评价the effects of a standardized preoperative 2 g bolus dose TXA protocol on perioperative transfusion, blood loss, thromboembolic events, and postoperative outcomes in patients undergoing spinal surgery. It was hypothesized that patients who did not receive TXA would experience higher rates of postoperative transfusions and increased estimated blood loss (EBL).
开云体育世界杯赔率
机构审查委员会批准了这个实验pective review of prospectively enrolled adult spine patients (> 18 years of age). We included patients who underwent elective and emergency spine surgery between September 2018 and July 2021. All procedures were performed by a fellowship-trained spine surgeon. All patients who received TXA perioperatively were treated with a single 2 g bolus dose of intravenous TXA administered prior to skin incision. Patients with a history of symptomatic thromboembolic disease or major contraindication did not receive TXA.17,18For cases of clinical equipoise, the decision to use TXA was at the discretion of the attending surgeon and attending anesthesiologist.
Patients who received TXA were compared with patients who did not receive TXA. Baseline characteristics, surgical variables, and postoperative outcomes were collected from the electronic medical record. These included demographic data, comorbidities (quantified using the adjusted Charlson Comorbidity Index [aCCI]), and history of thromboembolic risk factors such as prior deep venous thrombosis (DVT), estrogen therapy, diagnosed varicose veins, and the existence of a concomitant polytrauma, pelvis fracture, or hip fracture. Home antiplatelet/anticoagulant medications were also recorded. Operative parameters included intraoperative time (minutes), region of the spine, number of operative levels, placement of a vacuum-assisted closure device, and surgical indication, which was categorized as either elective (degenerative or deformity) or nonelective (trauma, tumor, or infection). Surgery performed was grouped broadly into categories of increasing invasiveness. These groups included a minimally invasive procedure such as a microdiscectomy, isolated laminectomy, laminectomy with posterolateral fusion, osteotomy/corpectomy/costotransversectomy or other procedure associated with substantial bone loss, front-back surgery, posterior surgery with concomitant interbody fusion, and irrigation and debridement and/or complex closure.
The primary outcome was the need for perioperative transfusion. The decision to transfuse was considered when postoperative hemoglobin was below a threshold of 7 g/dl or 8 g/dl when symptomatic.4Secondary outcomes included EBL, unplanned RTOR, DVT, pulmonary embolism (PE), and mortality at 30 days, 90 days, and 1 year.9,10,16,19Additional variables included hospital length of stay, time to mobilization (transfer out of bed), and time to ambulation postoperatively. Use of in-hospital preoperative and postoperative DVT prophylaxis medications was recorded and analyzed. All patients received standardized nonchemical DVT prophylaxis, which included sequential compression devices and early mobilization/ambulation with physical and occupational therapy.
所有选修患者保留抗血小板/ anticoagulant home medications preoperatively. Heparinoids were withheld the day before and the day of surgery. Nonsteroidal anti-inflammatory drugs (not containing aspirin) and factor Xa inhibitors were withheld 3 days prior to the day of surgery. Warfarin was withheld 5 days prior to surgery. All antiplatelet agents were withheld 7 days prior to surgery. Additionally, standard postoperative DVT prophylaxis medications included fondaparinux for osteotomy patients on postoperative day 2, aspirin upon discharge and for 3 weeks for anterior lumbar interbody fusion/posterolateral fusion patients, and fondaparinux or a home anticoagulant on postoperative day 2 for patients with a history of DVT/PE with transition to aspirin (or home anticoagulant) for 3 weeks upon discharge.
Statistical analysis was performed using IBM SPSS version 28 (IBM Corp.). Descriptive statistics were calculated, and after normality was checked, continuous variables were analyzed with the two-tailed independent t-test, while categorical variables were analyzed with either the Fisher’s exact test or the chi-square test with a contingency table, depending on the sample size. The primary and secondary outcomes were measured using stepwise multivariate logistic regression for categorical variables and multivariate linear regression for continuous variables. Variables that independently influenced each operative outcome were reported as OR (95% CI). In this study, p < 0.05 was considered significant.
Results
Among the 517 consecutively identified patients, 64 were excluded (16 patients with inadequate electronic medical record data and 48 patients with inaccessible data). The demographic characteristics and baseline information of the no-TXA group (n = 100) compared with those of the TXA group (n = 353) are shown inTable 1. Age, BMI, sex distribution, history of major surgery, history of varicose veins, concomitant hip or leg fracture, concomitant polytrauma, preoperative estrogen therapy, and aCCI scores were all similar between groups. The no-TXA group (14/100 [14%]) had more patients with a history of DVT compared with the TXA group (13/353 [3.7%]) (p < 0.001). The no-TXA group was similar to the TXA group in terms of the percentage of patients on home anticoagulation/antiplatelet medication, except for warfarin (no TXA 5/100 [5%] vs TXA 3/353 [0.8%]) (p = 0.015).
Demographic characteristics and baseline information
| No TXA (n = 100) | TXA (n = 353) | p Value | |
|---|---|---|---|
| Age, yrs | 52.5 (18) | 54.5 (15.9) | 0.28 |
| BMI | 30.3 (6.6) | 29.9 (7.0) | 0.56 |
| Male sex | 55 (55) | 183 (51.8) | 0.58 |
| Prior DVT | 14 (14) | 13 (3.7) | <0.001 |
| History of major surgery | 61 (61) | 190 (53.8) | 0.21 |
| History of varicose veins | 7 (7) | 19日(5.4) | 0.63 |
| Concomitant hip or leg fracture | 2 (2) | 12 (3.4) | 0.74 |
| Concomitant polytrauma | 13 (13) | 32 (9.1) | 0.26 |
| Estrogen therapy | 2 (2) | 20 (5.7) | 0.19 |
| aCCI score | 2.3 (2.5) | 2.3 (2.5) | 0.98 |
| Home DVT prophylaxis | |||
| Aspirin | 19 (19) | 45 (12.7) | 0.11 |
| Plavix | 1 (1) | 1 (0.3) | 0.39 |
| Aspirin/Plavix | 1 (1) | 6 (1.7) | >0.99 |
| Eliquis | 4 (4) | 8 (2.3) | 0.24 |
| Warfarin | 5 (5) | 3 (0.8) | 0.015 |
| Xarelto | 2 (2) | 1 (0.3) | 0.12 |
Values are shown as mean (SD) or number (%). Boldface type indicates statistical significance (p < 0.05).
Perioperative and surgical variables in the no-TXA group compared with those of the TXA group are shown inTable 2. Patients in the no-TXA group were similar to those in the TXA group in terms of the percentages of patients started on in-hospital preoperative DVT prophylaxis and in terms of what agents were used. Patients in the no-TXA group were similar to those in the TXA group in terms of the indications for surgery, except more trauma patients were included in the no-TXA group (41/100 [41%] vs 101/353 [28.6%]) (p = 0.018). Patients in the no-TXA group were similar to those in the TXA group in terms of what regions of the spine were operated on, except a higher percentage of no-TXA–group patients underwent cervical spine procedures (38/100 [38%] vs 86/353 [24.4%]) (p = 0.007). Patients in the no-TXA group were similar to those of the TXA group in terms of what surgical procedures were performed, except that the no-TXA group included more irrigation and debridement and/or complex closure cases (7/100 [7%] vs 8/353 [2.3%]) (p = 0.028). The indications for surgery (degenerative, deformity, trauma, tumor, and infection) were similar between groups. When comparing the two groups, however, we noted that the TXA group had more operative levels (3.4 ± 1.9 vs 4.2 ± 2.6, p = 0.006) and longer operative time (152.5 ± 82.6 minutes vs 214 ± 119.4 minutes, p < 0.001). The TXA group had higher EBL (216 ± 531.2 ml vs 385.9 ± 561.1 ml, p = 0.008). The preoperative and postoperative hemoglobin levels were similar between the no-TXA and TXA groups. The percentages of patients who received a transfusion were similar between the no-TXA and TXA groups. The numbers of units transfused were similar between the no-TXA and TXA groups.
Perioperative and surgical variables
| No TXA (n = 100) | TXA (n = 353) | p Value | |
|---|---|---|---|
| In-hospital preop DVT prophylaxis | |||
| Aspirin | 1 (1) | 2 (0.6) | 0.53 |
| Aspirin/Plavix | 0 | 2 (0.6) | >0.99 |
| Lovenox | 8 (8) | 19日(5.4) | 0.34 |
| Subcutaneous heparin | 2 (2) | 9 (2.5) | >0.99 |
| Intravenous heparin | 0 | 1 (0.3) | >0.99 |
| Indication for surgery | |||
| Nonelective | |||
| Trauma | 41 (41) | 101 (28.6) | 0.018 |
| Tumor | 0 | 6 (1.7) | 0.35 |
| Infection | 4 (4) | 29 (8.2) | 0.19 |
| Elective | |||
| Degenerative | 54 (54) | 209 (59.2) | 0.35 |
| Deformity | 1 (1) | 9 (2.5) | 0.7 |
| Region | |||
| Cervical | 38 (38) | 86 (24.4) | 0.007 |
| Thoracic | 2 (2) | 17 (4.8) | 0.27 |
| Lumbar | 25 (18) | 109 (31) | 0.262 |
| Cervicothoracic | 13 (13) | 52 (15) | 0.670 |
| Thoracolumbar | 5 (5) | 33 (9) | 0.168 |
| Lumbosacral | 17 (17) | 52 (15) | 0.474 |
| Cervicothoracolumbar | 0 | 2 (1) | >0.99 |
| Thoracolumbosacral | 0 | 2 (1) | >0.99 |
| Surgery performed | |||
| Microdiscectomy/foraminotomy | 20 (20) | 50 (14.2) | 0.15 |
| Isolated laminectomy | 9 (9) | 37 (10.5) | 0.85 |
| Posterolateral fusion | 52 (52) | 208 (58.9) | 0.22 |
| Osteotomy/corpectomy/costotransversectomy | 8 (8) | 29 (8.2) | >0.99 |
| Front-back interbody | 4 (4) | 21 (5.9) | 0.62 |
| Irrigation & debridement/complex closure | 7 (7) | 8 (2.3) | 0.028 |
| Mean op levels | 3.4 (1.9) | 4.2 (2.6) | 0.006 |
| Mean op time, mins | 152.5 (82.6) | 214 (119.4) | <0.001 |
| Mean EBL, ml | 216 (531.2) | 385.9 (561.1) | 0.008 |
| Mean preop hemoglobin, g/dl | 12.9 (2.1) | 12.6 (2) | 0.25 |
| Mean postop day 1 hemoglobin, g/dl | 11.6 (2.3) | 11.2 (2.1) | 0.16 |
| Required transfusion | 8 (8) | 26 (7.4) | 0.83 |
| Mean units transfused | 3 (2.6) | 2.6 (2.4) | 0.72 |
| Wound VAC placed | 21 (21) | 139 (39.4) | <0.001 |
VAC = vacuum-assisted closure.
Values are shown as mean (SD) or number (%). Boldface type indicates statistical significance (p < 0.05).
Postoperative outcomes are compared between the no-TXA and TXA groups inTable 3. The two groups were similar in terms of the percentages of patients who received postoperative DVT prophylaxis, what agents were used, and mean time from surgery to initiation of postoperative DVT prophylaxis. Among the patients who underwent nonelective spine surgery and were on home antiplatelet/anticoagulation medication, 1 patient in the no-TXA group had their home medication reversed via fresh frozen plasma and vitamin K administration, and 1 patient in the TXA group received prothrombin complex. Decision-making regarding administration of reversal agents was at the discretion of the attending surgeon and attending anesthesiologist.
Postoperative variables and outcomes
| No TXA (n = 100) | TXA (n = 353) | p Value | |
|---|---|---|---|
| In-hospital postop DVT prophylaxis | |||
| Aspirin | 12 (12) | 39 (11) | 0.86 |
| Aspirin/Plavix | 0 | 5 (1.4) | 0.59 |
| Lovenox | 21 (21) | 70 (19.8) | 0.8 |
| Subcutaneous heparin | 4 (4) | 22 (6.2) | 0.48 |
| Intravenous | |||
| Heparin | 0 | 1 (0.3) | >0.99 |
| Warfarin | 1 (1) | 3 (0.8) | >0.99 |
| Eliquis | 2 (2) | 4 (1.1) | >0.99 |
| Xarelto | 1 (1) | 1 (0.3) | >0.99 |
| Argatroban | 0 | 1 (0.3) | >0.99 |
| Fondaparinux | 0 | 6 (1.7) | 0.35 |
| Mean days to postop DVT prophylaxis | 3.3 (3.3) | 6.4 (6.5) | 0.12 |
| Mean days to postop mobilization | 1.3 (1.6) | 1.7 (3.0) | 0.21 |
| Mean days to postop ambulation | 1.7 (2.6) | 2.1 (3.8) | 0.33 |
| Mean DVT | 2 (2) | 7 (2) | >0.99 |
| Mean PE | 4 (4) | 12 (3.4) | 0.76 |
| Mean 30-day mortality | 2 (2) | 1 (0.3) | 0.12 |
| Mean 90-day mortality | 2 (2) | 3 (0.8) | >0.31 |
| 的意思是1年死亡率 | 3 (3) | 15 (4.2) | 0.77 |
| Mean length of stay | 5.8 (8.5) | 8.2 (11.9) | 0.063 |
| RTOR | 11 (11) | 37 (10.5) | 0.86 |
Values are shown as mean (SD) or number (%).
The TXA and no-TXA groups were similar in terms of times to mobilize and ambulate postoperatively, as well as the incidence rates of postoperative DVT; PE; 30-day, 90-day, and 1-year mortality; length of stay; and unplanned RTOR. Both groups had similar reasons for RTOR, with the most common reason being surgical site infection and the second most common reason being hardware failure due to fracture. In regard to bleeding complications, there was 1 case of epidural hematoma in the no-TXA group and 1 case of seroma in the TXA group. Significant predictors of perioperative outcome after multivariate regression are demonstrated inTable 4. TXA was not an independent predictor of EBL or any other postoperative outcomes.
Significant predictors of perioperative outcome after multivariate regression
| Periop Outcome | Value |
|---|---|
| In-hospital DVT* | |
| Op time | 1.004 (1.000–1.008) |
| Length of stay | 1.03 (1.009–1.06) |
| Blood transfusion | 5.7 (1.7–18.9) |
| In-hospital PE* | |
| Female sex | 0.3 (0.07–0.9) |
| Blood transfusion | 12.4 (4.1–37.9) |
| 1-yr mortality* | |
| Age | 1.06 (1.01–1.1) |
| Op levels | 1.2 (1.01–1.4) |
| Length of stay | 1.04 (1.01–1.07) |
| Periop blood transfusion* | |
| Op levels | 1.2 (1.08–1.4) |
| Length of stay | 1.06 (1.03–1.08) |
| Preop hemoglobin | 0.6 (0.5–0.8) |
| EBL† | |
| Op levels | 108.9 (93.6–124.2) |
| Op time | 1.3 (0.9–1.7) |
| Thoracolumbar fusion | 246.9 (168.8–324.9) |
| Emergency procedure | 186.0 (96.8–275.3) |
| BMI | 9.4 (3.9–14.8) |
| aCCI score | 26.0 (11.5–40.4) |
| Polytrauma | 223.5 (84.7–362.2) |
| Varicose veins | 175.8 (12.3–339.4) |
| Preop anticoagulation | 116.8 (0.6–233.0) |
Logistic analysis showing OR (95% CI).
Linear analysis showing coefficient (95% CI).
Discussion
TXA has shown promise for reducing blood loss in spine surgery;9,13,20however, the exact indications and ideal dosing and delivery strategies for TXA in spine surgery remain loosely defined.13,14The present study examining use of a standardized preoperative 2 g bolus TXA dosing strategy showed that TXA had an excellent safety profile and was not an independent predictor of thromboembolic or other surgical complications. Despite the TXA group having greater mean blood loss, number of operative levels, and operative time, the incidence of postoperative transfusion was not higher in the patients treated with TXA versus those treated without TXA.
The process of fibrinolysis involves the dissolution of fibrin clots via plasmin activation and is essential to hemostasis.21,22TXA impedes this process by inhibiting the lysine-binding regions of plasminogen (plasmin precursor), plasmin itself, and tissue plasminogen activator.23These actions block fibrinolysis and subsequent clot breakdown.19A number of recent studies have reported that the perioperative administration of TXA during spine surgery is associated with both reduced intraoperative blood loss and surgical drain output.19,22,24Additionally, a small number of studies has reported that decreased production of D-dimer and decreased turnover of fibrinogen during spine surgery after TXA administration indicate that TXA is blocking the fibrinolytic pathway.9,22,25,26The preoperative 2 g bolus TXA dosing strategy utilized in this study was selected because it placed the vast majority of patients within the therapeutic range reported in previous trials.34The present study noted several surgical factors that impacted EBL, including the number of operative levels and operative time. These two factors were increased in the TXA group compared with the no-TXA group. Thus, it is not surprising that the TXA group was noted to have higher EBL. Additionally, the number of operative levels was an independent predictor of need for perioperative blood transfusion. However, despite having greater mean EBL, number of operative levels, and operative time, patients treated with TXA did not have a higher perioperative transfusion rate nor a higher rate of any other postoperative complications related to bleeding. In addition to comparing favorably to the group treated without TXA, the patients treated with TXA in the present study, with a transfusion rate of 8%, compared well with groups treated without TXA and reported in the broader spine literature.27–31For instance, a recent large retrospective study of patients who underwent a wide variety of spine surgical procedures reported a transfusion rate of 34.3%.2The authors emphasized the importance of avoiding transfusion due to the associated risk of increased perioperative morbidity and increased direct and indirect healthcare costs.2Thus, it appears that TXA conferred a reduction in transfusion despite higher blood loss, operative levels, and operative time in this study.
The present study noted an excellent safety profile regarding thromboembolic events for TXA, despite a longer operative time, time prior to initiation of postoperative DVT prophylaxis, and length of stay. This finding is consistent with the spine, orthopedic, and neurosurgical literature related to perioperative TXA administration.15,25,32A recent publication reported that even very high-dose TXA protocols were safe for patients undergoing long-segment posterior spinal fusion for deformity correction.33Similarly, a recent systematic review and meta-analysis of TXA use in patients undergoing laminectomy and fusion with posterior instrumentation reported no thromboembolic events.32The authors noted, however, that further investigation was needed, as this finding may be associated with comprehensive exclusion criteria and thus may have involved a degree of bias.15,25,32In the present study, factors that were independently predictive of DVT included increased operative time and length of stay. Despite these factors being higher in the group treated with TXA, there were no significant increases in DVT or PE.
这项工作有几个局限性those intrinsic to the retrospective nature of this study. Case complexity in terms of intraoperative time and operative levels was different between groups. Ultimately, the decision was made to include a broader group of patients in order to adequately power the study for evaluation of the primary outcome and to better assess for thromboembolic complications; however, this may have paradoxically reduced the ability to discriminate differences in EBL between the two groups due to case heterogeneity. Despite small differences in case mix, the demographic characteristics of the two groups indicate that the patients were substantially similar. Our ability to measure perioperative blood loss was limited by institutional protocols, and blood loss was estimated by surgical and anesthesia services. Ideally, future comparative work should be prospective and introduce randomization to minimize bias, and this project is forthcoming.
Conclusions
In a population of patients who underwent spinal surgery for elective and nonelective indications, a standardized preoperative 2 g bolus TXA dosing protocol appeared to have an excellent safety profile in terms of thromboembolic and postoperative outcomes. Additionally, the TXA group had a similar rate of transfusion despite increased surgical complexity, suggesting that TXA may have provided a transfusion benefit. These findings add to the growing body of literature on the merits of TXA in spine surgery. Further prospective studies with larger patient numbers for subgroup analysis are required to further understand the benefits of this treatment in the spine surgery population.
Disclosures
四个博士man reported personal fees from Johnson & Johnson outside the submitted work.
Author Contributions
Conception and design: Dalton, Tang, Mirvish, Wawrose, Lee, Fourman, Shaw. Acquisition of data: Dalton, Setliff, Mirvish, Adida, Shaw. Analysis and interpretation of data: Dalton, Setliff, Sadhwani, Tang, Adida, Wawrose, Shaw. Drafting the article: Dalton, Setliff, Sadhwani, Tang, Wawrose, Fourman, Shaw. Critically revising the article: Dalton, Setliff, Sadhwani, Tang, Wawrose, Lee, Shaw. Reviewed submitted version of manuscript: Dalton, Setliff, Sadhwani, Tang, Wawrose, Fourman, Shaw. Approved the final version of the manuscript on behalf of all authors: Dalton. Statistical analysis: Dalton, Setliff, Fourman, Shaw. Administrative/technical/material support: Shaw. Study supervision: Dalton, Shaw.
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