Rate Of Thromboembolic Complications Research Articles

High-Dose TXA Is Associated with Less Blood Loss Than Low-Dose TXA without Increased Complications in Patients with Complex Adult Spinal Deformity.

Tranexamic acid (TXA) is commonly utilized to reduce blood loss in adult spinal deformity (ASD) surgery. Despite its widespread use, there is a lack of consensus regarding the optimal dosing regimen. The aim of this study was to assess differences in blood loss and complications between high, medium, and low-dose TXA regimens among patients undergoing surgery for complex ASD. A multicenter database was retrospectively analyzed to identify 265 patients with complex ASD. Patients were separated into 3 groups by TXA regimen: (1) low dose (<20-mg/kg loading dose with ≤2-mg/kg/hr maintenance dose), (2) medium dose (20 to 50-mg/kg loading dose with 2 to 5-mg/kg/hr maintenance dose), and (3) high dose (>50-mg/kg loading dose with ≥5-mg/kg/hr maintenance dose). The measured outcomes included blood loss, complications, and red blood cell (RBC) units transfused intraoperatively and perioperatively. The multivariable analysis controlled for TXA dosing regimen, levels fused, operating room time, preoperative hemoglobin, 3-column osteotomy, and posterior interbody fusion. The cohort was predominantly White (91.3%) and female (69.1%) and had a mean age of 61.6 years. Of the 265 patients, 54 (20.4%) received low-dose, 131 (49.4%) received medium-dose, and 80 (30.2%) received high-dose TXA. The median blood loss was 1,200 mL (interquartile range [IQR], 750 to 2,000). The median RBC units transfused intraoperatively was 1.0 (IQR, 0.0 to 2.0), and the median RBC units transfused perioperatively was 2.0 (IQR, 1.0 to 4.0). Compared with the high-dose group, the low-dose group had increased blood loss (by 513.0 mL; p = 0.022) as well as increased RBC units transfused intraoperatively (by 0.6 units; p < 0.001) and perioperatively (by 0.3 units; p = 0.024). The medium-dose group had increased blood loss (by 491.8 mL; p = 0.006) as well as increased RBC units transfused intraoperatively (by 0.7 units; p < 0.001) and perioperatively (by 0.5 units; p < 0.001) compared with the high-dose group. Patients with ASD who received high-dose intraoperative TXA had fewer RBC transfusions intraoperatively, fewer RBC transfusions perioperatively, and less blood loss than those who received low or medium-dose TXA, with no differences in the rates of seizure or thromboembolic complications. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Proximal Femoral Nail vs Arthroplasty for Unstable Intertrochanteric Fracture in Elderly (Systematic Review &amp; Meta Analysis)

Abstract Background Hip fractures impose a considerable economic burden on healthcare, with intertrochanteric fractures contributing to increasing morbidity. The global incidence of hip fractures is expected to rise to 4.5 million by 2050, primarily due to aging and osteoporosis. Osteoporosis weakens bones, making them susceptible to fractures even from minor traumas, with femoral intertrochanteric fractures being prone to comminution. Aim of the Work To compare between proximal femoral nail and arthroplasty for Unstable intertrochanteric fracture in elderly. The objective is to perform a systematic review to better management procedure. Patients and Methods This systematic review and meta-analysis aimed to compare arthroplasty and proximal femoral nail (PFN) fixation for unstable intertrochanteric fractures in elderly patients. The study included 24 studies with 2699 patients, analyzing factors such as surgery duration, peri-operative blood loss, blood transfusion, complications, Harris hip score (HHS), and mortality. Results PFN had a significantly shorter surgery duration compared to arthroplasty, with the latter exhibiting higher blood loss. Arthroplasty also required more blood transfusion, attributed to its invasive nature. While complications did not significantly differ between groups, arthroplasty showed a higher rate of thromboembolic complications. Mortality rates were significantly higher in the arthroplasty group, emphasizing the importance of early mobilization for patient outcomes. Conclusion Underscores the significant superiority of PFN over hemiarthroplasty in treating elderly patients with intertrochanteric fractures. The PFN group had a statistically shorter operative time, less blood loss, lower mortality compared to the arthroplasty group. However, no significant differences in functional outcomes using HHS were observed between the two compared groups. In addition, no significant differences were found concerning complications between the PFN and arthroplasty groups.

Patient sex and use of tranexamic acid in liver transplantation.

Differences in medical treatment between women and men are common and involve out-of-hospital emergency care, the intensity of pain treatment, and the use of antifibrinolytic treatment in emergency trauma patients. If woman and man receive different antifibrinolytic treatment in highly-standardized major transplant surgery is unknown. We conducted a retrospective cohort study on patients who underwent liver transplantation at Heidelberg University Hospital, Heidelberg, Germany between 2004 and 2017. Logistic regression analyses were performed to determine if sex is associated with the administration of TXA during liver transplantation. Secondary endpoints included venous thrombotic complications, graft failure, mortality, myocardial infarction, hepatic artery thrombosis, and stroke within the first 30 days after liver transplant as well as length of hospital stay and length of intensive care unit stay. Out of 779 patients who underwent liver transplantation, 262 patients received TXA. Female sex was not associated with intraoperative administration of TXA [adjusted OR: 0.929 (95% CI 0.654; 1.320), p = 0.681]. The secondary endpoints graft failure (13.2% vs. 8.4%, women vs. men, p = 0.039), pulmonary embolism (3.4% vs. 0.9%, women vs. men, p = 0.012), stroke (1.7% vs. 0.4%, women vs. men, p = 0.049), and deep vein thrombosis (0.8% vs. 0%, women vs. men, p = 0.031) within 30 days after liver transplantation were more frequent in women. Mortality, myocardial infarction, and other secondary endpoints did not differ between groups. However, in women, the use of TXA was associated with a lower rate in thromboembolic complications. Our data indicate that different from other scenarios with massive bleeding complications the administration of TXA during liver transplantation is not associated with sex. However, sex is associated with the risk for complications, and in woman TXA might have a preventive effect on the rate of thromboembolic complications. Reasons underlying the observed sex bias rate remain uncertain.

Initial Experience with the Derivo 2Heal Flow Diverter under Standard or Reduced-Dose Single Antiplatelet Therapy.

Flow diverters with surface modifications or coatings have been recently introduced to clinical practice with the expectation that they can reduce the rate of thromboembolic complications and residual aneurysms. The purpose of this study is to evaluate the utility of the Derivo 2Heal (D2H) device, a new fibrin and heparin-coated flow diverter. Patients treated by a single operator by using the D2H were retrospectively evaluated for demographic data, aneurysm characteristics, procedural variables, and follow-up data. All patients were treated by using a single D2H, monitored by platelet function testing and kept under single antiplatelet therapy with regular or half-dose clopidogrel or prasugrel after the procedure. Twenty patients with 26 aneurysms were treated. Three presented acutely with subarachnoid hemorrhage. Adjunctive devices were used in 6 patients. There were no technical failures and 2 periprocedural self-limited nonthrombotic minor adverse events. During follow-up, 1 of the acutely ruptured aneurysms reruptured, and 1 patient had a visual TIA. All patients were doing well clinically (19 with mRS of 0 and 1 with 1) at the last follow-up after discharge. The rates of total occlusion on very early angiographic (MRA/CTA or DSA, mean: 2.4 months), DSA (mean: 5.8 months), and midterm angiographic (mean: 14.5 months) follow-up for all versus uncoiled aneurysms were 68% versus 70%, 77.8% versus 90.0%, and 91.7% versus 90.1%, respectively. The absence of permanent neurologic deficits in the periprocedural period and favorable occlusion rates in this preliminary study suggest that the novel coating comprising fibrin and heparin may have the potential to increase the safety and efficacy of flow diversion and needs to be further studied by comparing the D2H device with its bare counterpart and other coated or surface-modified flow diverters.

Impact of the American Society of Anesthesiologists (ASA) classification on hip fracture surgery outcomes: insights from a retrospective analysis

BackgroundThe American Society of Anesthesiologists (ASA) classification is the most used system to assess patient health status before surgery, ranging from I to V levels. This study aims to explore the impact of different ASA risk classes (ASA II [mild risk] and ASA III [severe risk]) on clinical outcomes following hip fracture surgery, including all-cause mortality and postoperative complications.MethodsA retrospective analysis from 2019 to 2021 across three Jordanian centers was conducted. The study included patients aged 65 and above who underwent hip fracture repair surgeries. Preoperative measures, intraoperative management protocols, and postoperative care were collected. Clinical data were extracted from electronic medical records, including demographics, fracture type, intraoperative data, and postoperative outcomes.ResultsThe analysis included 1033 patients, with 501 (48.5%) in the mild anesthetic risk group (ASA I-II) and 532 (51.5%) in the severe anesthetic risk group (ASA III-V). The mean age was 73 years, with a higher prevalence of males in the severe risk group. Patients in the severe risk group had more comorbidities, higher ICU admissions (15.23% vs. 6.18%), longer hospital stays (median 7 vs. 6 days), and higher rates of postoperative thromboembolic complications (3.39% vs. 1.39%) compared to the mild risk group. Additionally, the severe risk group showed higher mortality rates both in-hospital mortality (3.38% vs. 1.39%) and all-cause mortality (16.92% vs. 10.36%). Multivariate analysis identified higher ASA score as independent risk factors for increased all-cause mortality (HR = 1.64 95%CI 1.51–2.34) and thromboembolic complications (OR = 2.85 95%CI 1.16-7). Length of hospital stay was significantly associated with higher ASA score (OR = 1.04 95%CI 0.96–1.11).ConclusionThe study underscores the significant impact of anesthetic risk on the outcomes of hip fracture surgeries. Patients with higher ASA scores associated with severe systemic diseases may have at increased risk of adverse outcomes.

Risk Factors, Antithrombotic Management, and Long-Term Outcomes of Patients Undergoing Endovascular Treatment of Unruptured Intracranial Aneurysms.

Patients receiving endovascular treatment for unruptured intracranial aneurysms (UIAs) face varying risks and benefits with antithrombotic management. This study aimed to evaluate the perioperative and long-term effects of antithrombotic strategies, identify the populations that would benefit, and explore the predictive factors affecting the long-term outcomes. UIA patients undergoing endovascular treatment including stent-assisted coiling or flow diversion between June 2019 and June 2022 were enrolled. We compared perioperative and long-term complications between tirofiban and dual antiplatelet therapy groups. Optimal candidates for each antithrombotic treatment were identified using multivariate logistic regression. Nomograms were developed to determine the significant predictors for thromboembolic complications during follow-up. Among 181 propensity-score matched pairs, the tirofiban group showed a trend toward a lower rate of thromboembolic complications than the DAPT group without elevating major bleeding risk in either period. Homocysteine (Hcy) level ≥10 μmol/L was a significant independent factor associated with thromboembolic complication in both periods. Subgroup analysis highlighted that in patients with high Hcy levels, tirofiban and sustained antiplatelet treatment for ≥12 months were protective factors, while a history of stroke was an independent risk factor for thromboembolic events in follow-up. Four variables were selected to construct a prognostic nomogram, history of hypertension, prior stroke, Hcy level, and the duration of antiplatelet therapy. Perioperative low-dose tirofiban and extended antiplatelet therapy demonstrated a favorable trend in long-term outcomes for UIA patients with preoperative Hcy levels ≥10 μmol/L undergoing endovascular treatment. The prognostic model offers reliable risk prediction and guides antithrombotic strategy decisions.

The safety of perioperative antiplatelet continuation without selection biases in microsurgical decompression surgery for single level lumbar spinal stenosis and lumbar disc herniotomy.

Each institution or physician has to decide on an individual basis whether to continue or discontinue antiplatelet (AP) therapy before spinal surgery. The purpose of this study was to determine if perioperative AP continuation is safe during single-level microsurgical decompression (MSD) for treating lumbar spinal stenosis (LSS) and lumbar disc hernia (LDH) without selection bias. Patients who underwent single-level MSD for LSS and LDH between April 2018 to December 2022 at our institute were included in this retrospective study. We collected data regarding baseline characteristics, medical history/comorbidities, epidural hematoma (EDH) volume, reoperation for EDH, differences between preoperative and one-day postoperative blood cell counts (ΔRBC), hemoglobin (ΔHGB), and hematocrits (ΔHCT), and perioperative thromboembolic complications. Patients were divided into two groups: the AP continuation group received AP treatment before surgery and the control group did not receive antiplatelet medication before surgery. Propensity scores for receiving AP agents were calculated, with one-to-one matching of estimated propensity scores to adjust for patient baseline characteristics and past histories. Reoperation for EDH, EDH volume, ΔRBC, ΔHGB, ΔHCT, and perioperative thromboembolic complications were compared between the groups. The 303 enrolled patients included 41 patients in the AP continuation group. After propensity score matching, the rate of reoperation for EDH, the EDH volume, ΔRBC, ΔHGB, ΔHCT, and perioperative thromboembolic complication rates were not significantly different between the groups. Perioperative AP continuation is safe for single-level lumbar MSD, even without biases.

The Clinical and Radiological Outcomes of the Multimodal Use of the Woven EndoBridge Device: A Large Multicenter Study

The Woven EndoBridge (WEB) is a device used for intrasaccular flow diversion, designed for the elimination of wide-necked bifurcation aneurysms from the circulation. In this study, we aim to assess the safety and efficacy of the WEB and its uses in treating aneurysms of different morphologies and locations. In a retrospective analysis, we compiled a comprehensive dataset from patients treated with the WEB device across three major Australian neurovascular centers from May 2017 to September 2023. The case series encompassed a spectrum of aneurysm types, including wide-necked bifurcation, sidewall, and irregularly shaped aneurysms, as well as cases previously managed with alternative therapeutic strategies. This study additionally encompasses cases where aneurysms were managed using the WEB device in combination with supplementary endovascular devices. The study included 169 aneurysms in 161 patients. The rate of satisfactory aneurysm occlusion was 85.6%, with 86.7% of patients maintaining good functional status at their most recent follow-up. The procedure exhibited a low mortality rate of 0.6% and a thromboembolic complication rate of 7.1% (n= 12/161). There were no instances of postoperative re-rupture and the procedure-related hemorrhage rate was low (1.2%, n= 2/169), aligning with the literature regarding the safety and efficacy of the WEB device. Our multicenter trial reinforces the WEB device's role as an effective and safe modality for intracranial aneurysm management, supporting its expanded application beyond wide-necked bifurcation aneurysms. Further prospective studies are required to delineate its evolving role fully.

The Melody Valve in Small Children Undergoing First Mitral Valve Replacement: Better Than Mechanical?

BackgroundIn small children with left atrioventricular valve dysfunction, valve repair is preferred but some will require valve replacement. No prosthetic valve has growth potential, bioprostheses have poor durability, and mechanical prostheses have high rates of thromboembolic and hemorrhagic complications. We reviewed our experience with a modified bovine jugular vein valve designed for use in the right ventricular outflow tract (Melody valve, Medtronic) and compared this with contemporary mechanical valve replacement. MethodsWe reviewed outcomes of all left-sided atrioventricular valve replacements (AVVR) performed between January 2017 and April 2023 on patients with biventricular circulation less than 5 years old at time of surgery, N = 19. We compared mortality and major morbidity outcomes between mechanical AVVR (mAVVR, n = 14) and Melody AVVR (MAVVR, n=5). ResultsMAVVR was performed on younger and smaller patients (5.7 ± 4.2 vs 28.4 ± 22.3 months, P = .002; 6 ± 1.7 vs10 ± 5.1 kg, P = .01). There were 2 early and 1 late death in the mAVVR group, and none in the MAVVR group. There was a trend towards more hemorrhagic and neurologic complications in the mAVVR group (P = .1, 0.28, respectively). ConclusionsIn this small series, despite its use in younger and smaller patients, our preliminary experience with the Melody valve compares favorably with our contemporaneous outcomes with mechanical prostheses by way of simpler anticoagulation management with a trend towards better overall outcomes.

Single-Dose Intravenous Tranexamic Acid Does Not Increase Venous Thromboembolic Rate or Complication Rate During Hip Arthroscopy

To determine whether tranexamic acid (TXA) is safe to administer preoperatively in patients undergoing hip arthroscopy by comparing the venous thromboembolic rate and complication rate between patients who did and did not receive TXA preoperatively. This was a multicenter consecutive-cohort series of patients who underwent arthroscopic hip surgery between 2014 and 2021. The 2 cohorts comprised patients who did and did not receive TXA preoperatively (single dose of 1-2 g), after a practice change. Data were collected via chart review. Surgical outcomes included days until follow-up, visual analog scale pain score at first follow-up, total operating room (OR) time, number of arthroscopic fluid bags (3 L/bag), and complications and revision operations up to 1 year after surgery. The Mann-Whitney U test was performed for continuous variables, and the χ2 test, for categorical variables. A total of 862 patients were identified: 449 (52%) received TXA and 413 (48%) did not. Patient demographic characteristics including age, sex, height, weight, body mass index, smoking status, and procedures performed, as well as number of anchors used (3.5 anchors for no TXA vs 3.7 anchors for TXA) and traction time (38 minutes for no TXA vs 40 minutes for TXA), did not significantly differ between groups. Significantly more patients underwent prior hip arthroscopy in the TXA group (n= 45; primary, n=404) than in the group that did not receive TXA (n= 25; primary, n= 388) (P= .03). Visual analog scale pain scores at the first follow-up visit (2.61 for no TXA vs 2.62 for TXA, P= .62) and the need for subsequent revision surgery (24 patients with no TXA vs 18 patients with TXA, P= .68) were not significantly different. TXA use was associated with less arthroscopic fluid utilization (5.9 bags of 3 L of fluid for no TXA vs 5.3 bags of 3 L of fluid for TXA, P < .01) and less total OR time (99.5minutes for no TXA vs 90.0 minutes for TXA, P < .01). There was a higher overall complication rate in the group that did not receive TXA (n= 27) than in the group that did (n= 10) (P= .01). However, if lateral femoral cutaneous nerve neurapraxia was excluded, then no difference in complication rate was observed (P= .24). There was no difference in the incidence of venous thromboembolic complications between patients who did and did not receive TXA preoperatively. We observed a lower overall complication rate in patients who received TXA preoperatively; however, this normalized between the 2 groups when lateral femoral cutaneous nerve neuritis was excluded. No difference in early pain control or revision surgery rate was observed between groups. Although there was statistically less arthroscopic fluid utilization and less total OR time in the group that received TXA, further studies are needed to clarify whether this is clinically meaningful. Preoperatively administered TXA is a safe adjunct medication in patients undergoing arthroscopic hip surgery. Level III, retrospective multicenter consecutive series.

700 Flow-redirection Intraluminal Device (FRED) System for the Management of Intracranial Aneurysms: A Systematic Review and Metanalysis

INTRODUCTION: Multiple FDs are available for clinical use. Over the years, the FDs technology has improved considerably. However, overall complications and safety issues using FRED have not been evaluated in detail. Studies comprehensively investigating the clinical and technical events in FRED usage to treat IAs are not available. The purpose of this study is to investigate the outcome, overall complication rates, occlusion rate, retreatment, thromboembolic, and hemorrhagic complications for different patient cohorts treated with FRED flow diverter. METHODS: The following descriptors were used for the search: Flow-Redirection Intraluminal Device (FRED) system for the treatment of Intracranial aneurysms, Intracranial aneurysms, and Complication with no constraints applied was searched. Two authors independently revived and identified the studies, and two independent review authors extracted the data. A random-effect model was used to pool data, and the results were reported (odds ratios and 95% CI); heterogeneity was reported as I2. RESULTS: Nine studies were included in the final analysis, which involved retrospectively and prospectively collected data on 1167 patients. The use of FRED was associated with a rate of occlusion of 85% (95% confidence interval [CI] 79.5%–90.9%). Low retreatment rate of 2.5% (95% CI 1.0%–4.6%), low thromboembolic complication rate of 4.9% (95% CI 3.0%–7.31%), low hemorrhagic complication rate of 1.35% (95% CI 0.7%–2.0%). The mortality rate was 4% (95% CI 0.8%–2.1%). An overall good outcome was 95.1% (95% CI 92.1%–97.4%), and poor outcome was 4.8% (95% CI 2.5%–7.8%). CONCLUSIONS: The available evidence suggests that FRED offers favorable results for the management of intracranial aneurysms, results in high occlusion rate and low complication rates

Does Small Aneurysm Size (

Long-term safety and efficacy outcomes of Surpass Evolve flow diverter (SEFD) in treatment of intracranial aneurysms are lacking. Factors predicting complete aneurysm occlusion are elusive in literature. A retrospective review of all consecutive aneurysms treated with SEFD from February 2020 to July 2022, at a single comprehensive stroke center. Fifty-one patients with 80 aneurysms were included. Mean target aneurysm size was 5.6 mm and mean neck-width 3.42 mm. Small aneurysms (<10 mm) were 75% (n=60), while 25% were >10 mm. Unruptured were 71 (88.7%), previously ruptured were 8 (10%), and partially thrombosed 2.3% (n=1). Mean SEFDs used per patient were 1.07 and 40% (n=22) procedures were performed transradially. Mean procedure time was 59.1 minutes. The technical success rate for device deployment was 100%. Raymond Roy (RR) class I occlusion at 6 month (n=73) was seen among 56.2% (n=41), at 1 year (n=35) among 85.7% (n=30) and at 2 year (n=18) among 88.8% (n=16) aneurysms. Aneurysm size <10 mm significantly predicted RR-I occlusion outcome (odds ratio [OR]: 2.16; confidence interval [CI]: 0.02-4.29) at 6 months. Age, gender, smoking status, hypertension, location of aneurysm, and rupture status did not predict RR-I occlusion outcome. No mortality or permanent neurological morbidity was observed in the cohort. Major complications seen in 7.2% (n=4) patients were stent thrombosis (n=1, 1.8%), carotid-cavernous fistula (n=1, 1.8%) and transient ischemia in 2 (3.6%). Non-flow limiting stenosis was observed in 3 (5.4%) patients. SEFD gives good aneurysm occlusion rates with favorable long-term safety profile and low rate of thromboembolic complications. Small aneurysm size (<10 mm) was associated with complete aneurysm occlusion at 6-month angiographic follow-up. As Surpass Evolve is a newer generation Flow diverter of the Stryker Surpass FDs, with its improved design and applicability in intracranial aneurysms, we believe that more physicians will be encouraged to use this device worldwide.

Andexanet alfa versus non-specific treatments for intracerebral hemorrhage in patients taking factor Xa inhibitors - Individual patient data analysis of ANNEXA-4 and TICH-NOAC.

Data comparing the specific reversal agent andexanet alfa with non-specific treatments in patients with non-traumatic intracerebral hemorrhage (ICH) associated with factor-Xa inhibitor (FXaI) use are scarce. The study aimed to determine the association between the use of andexanet alfa compared with non-specific treatments with the rate of hematoma expansion and thromboembolic complications in patients with FXaI-associated ICH. We performed an individual patient data analysis combining two independent, prospective studies: ANNEXA-4 (180 patients receiving andexanet alfa, NCT02329327) and TICH-NOAC (63 patients receiving tranexamic acid or placebo ± prothrombin complex concentrate, NCT02866838). The primary efficacy outcome was hematoma expansion on follow-up imaging. The primary safety outcome was any thromboembolic complication (ischemic stroke, myocardial infarction, pulmonary embolism, or deep vein thrombosis) at 30 days. We used binary logistic regression models adjusted for baseline hematoma volume, age, calibrated anti-Xa activity, times from last intake of FXaI, and symptom onset to treatment, respectively. Among 243 participants included, the median age was 80 (IQR 75-84) years, baseline hematoma volume was 9.1 (IQR 3.4-21) mL and anti-Xa activity 118 (IQR 78-222) ng/mL. Times from last FXaI intake and symptom onset to treatment were 11 (IQR 7-16) and 4.7 (IQR 3.0-7.6) h, respectively. Overall, 50 patients (22%) experienced hematoma expansion (ANNEXA-4: n=24 (14%); TICH-NOAC: n=26 (41%)). After adjusting for pre-specified confounders (baseline hematoma volume, age, calibrated anti-Xa activity, times from last intake of FXaI, and symptom onset to treatment, respectively), treatment with andexanet alfa was independently associated with decreased odds for hematoma expansion (aOR 0.33, 95% CI 0.13-0.80, p = 0.015). Overall, 26 patients (11%) had any thromboembolic complication within 30 days (ANNEXA-4: n=20 (11%); TICH-NOAC: n=6 (10%)). There was no association between any thromboembolic complication and treatment with andexanet alfa (aOR 0.70, 95% CI 0.16-3.12, p = 0.641). The use of andexanet alfa compared to any other non-specific treatment strategy was associated with decreased odds for hematoma expansion, without increased odds for thromboembolic complications.

Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?

Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors. Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA. Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications. Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.

Periprocedural thromboembolic complications of LEO baby stent in endovascular treatment of intracranial aneurysms: Experience in 149 patients.

To report periprocedural thromboembolic complications of LEO Baby stent-assisted coiling of wide-necked intracranial aneurysms and to analyze the possible influencing factors. We retrospectively identified 149 patients with aneurysms who underwent LEO Baby stent-assisted embolization between October 2018 and March 2022. Clinical and radiographic data of patients were reviewed to determine whether a thromboembolic event had occurred. Multivariate logistic analysis was performed to identify significant factors associated with thromboembolic events. Successful stent deployment of the stent was achieved in all patients in the target artery. There were 66 patients (44.3%) with acutely ruptured aneurysms and 83 patients (55.7%) with unruptured aneurysms. Fourteen (9.4%, 95% confidence interval: 4.7%-14.1%) patients were confirmed to have developed a thromboembolic event, including nine patients with acute intraoperative thrombosis and five patients with postoperative thromboembolic events. The rate of thromboembolic events was 6.0% (5/83) in patients with unruptured aneurysms and 13.6% (9/66) in patients with acutely ruptured aneurysms. There was a trend toward an increased rate of thromboembolic events in patients with acute ruptured aneurysms (p = 0.087). Thromboembolic events were significantly associated with the parent-artery diameter (p = 0.010). Our study demonstrates a low rate of thromboembolic complications in unruptured aneurysms treated with LEO Baby stent. Thromboembolic events appear to be more common in ruptured aneurysms. A small diameter of the parent artery is associated with an increased risk of thromboembolic complications, and more relevant studies are still needed.

Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms.

Thromboembolism is a serious complication of endovascular treatment for ruptured cerebral aneurysms. The administration of antiplatelet agents before endovascular treatment for ruptured cerebral aneurysms may reduce the risk of thromboembolic complications. This study aimed to assess the safety and efficacy of preoperative aspirin administration in endovascular treatment for ruptured cerebral aneurysms. Assuming a 15% incidence rate of both intraoperative thromboembolic morbidity and symptomatic ischemic lesions on magnetic resonance imaging diffusion-weighted imaging scans assessed by an Independent Review Committee, a sample size of 484 will be required to detect a 10% improvement with aspirin administration with 90% power using the Pearson's chi-square test at a two-sided significance level of 2.5% for each primary outcome, after accounting for a 5% dropout rate. ASTOP is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 484 patients with ruptured cerebral aneurysms receiving coil embolization within 72 h of onset will be randomly assigned 1:1 to receive 200 mg of aspirin or placebo before the procedure. The primary outcomes will be the incidence rates of intraoperative thromboembolic complications and symptomatic ischemic lesions on magnetic resonance imaging diffusion-weighted imaging scans evaluated by the Independent Review Committee. The secondary outcomes will be the incidence rate of cerebral ischemic events and all bleeding events within 14 days of enrollment and functional outcomes defined by the modified Rankin Scale score at 90 days. This trial will provide valuable data on the role of antiplatelet agents during endovascular treatment for ruptured cerebral aneurysms. Registration: Japan Registry of Clinical Trials, Identifier: jRCTs031210421.

Avatrombopag for Adults with Early Versus Chronic Immune Thrombocytopenia

Background Avatrombopag (AVA) is a newer thrombopoietin receptor agonist (TPO-RA) with certain advantages over other TPO-RAs. AVA is currently approved to treat adults with immune thrombocytopenia (ITP) in the chronic disease phase (duration &amp;gt;12 months). However, no studies have evaluated the safety and effectiveness of AVA in newly diagnosed ITP (duration &amp;lt;3 months) or persistent ITP (duration 9-12 months), leaving open questions regarding its safety (including thromboembolic risk) and effectiveness in these patients, and also drastically limiting availability of the drug to patients with early ITP, for whom it is off label. We hypothesize that AVA has similar safety and effectiveness in all phases of ITP. Methods We performed a multicenter, observational cohort study of all adult patients with primary or secondary ITP at 4 hospitals treated with AVA to compare outcomes of patients with newly diagnosed or persistent ITP versus patients with chronic ITP. We collected patient and disease characteristics and characteristics and outcomes of AVA treatment, including dosing, platelet counts prior to and during treatment, adverse events, concurrent and rescue therapies for ITP, and platelet transfusions. Platelet outcomes included rates of response (R, the primary outcome, defined as platelet count of ≥50 × 10 9/L) and complete response (CR, platelet count ≥100 × 10 9/L), both on at least one measurement without requirement for rescue therapy. The response fraction (RF) and complete response fraction (CRF), fractions between 0 (representing no instance of response at any timepoint for a patient) and 1 (representing a response at all timepoints for a patient) were calculated for each patient from monthly measurements during the first six months of treatment with avatrombopag. Other outcomes included major bleeding, rescue therapy requirements, thrombocytosis, and adverse events. Results Patient Population. 75 patients were included, 23 patients with newly diagnosed or persistent ITP (17.7 patient-years of AVA exposure) and 52 patients with chronic ITP (65.3 patient-years of AVA exposure). The median (range) age was 55 (18-80) years in the newly diagnosed/persistent ITP group versus 66 (22-90) years in the chronic ITP group; approximately 65% of patients in each group were female. Platelet Outcomes. With regards to the primary outcome, R was achieved in a similar proportion of newly diagnosed/persistent ITP patients (91%) as in chronic ITP patients (96%), P=0.58. Similar proportions also achieved a CR: 86% newly diagnosed/persistent ITP patients versus 81% of chronic ITP patients, P=0.78. Mean RF and CRF were also similar between the two groups ( TABLE). The median platelet count at baseline and over the first six months of treatment by disease phase is illustrated in the FIGURE. Other Outcomes. Incidence of major bleeding and requirement for rescue therapy and platelet transfusion were low in the newly diagnosed/persistent group ( TABLE) and statistically similar to incidences in the chronic group. Safety. The incidence of thrombocytosis (platelet count ≥400 × 10 9/L on ≥1 measurement) was similar (44% in the newly diagnosed/persistent ITP group and 40% in the chronic ITP group). No patient developed an arterial thromboembolic event. No patient in the newly diagnosed/persistent group developed a venous thromboembolism (VTE) and only one patient in the chronic group developed a VTE. No patient in the newly diagnosed/persistent group discontinued AVA due to an adverse event or safety concern. The rate of thromboembolic complications in the entire cohort including 83.0 patient-years of AVA exposure was 1.2 thromboembolic events per 100 patient-years, considerably lower than prior phase 2 and 3 clinical trials of AVA in ITP (which together documented 11 thromboembolic events occurring over 72.4 patient-years of AVA exposure, or 15.2 thromboembolic events per 100 patient-years). Conclusions AVA was safe and effective in patients with newly diagnosed and persistent ITP, with outcomes numerically, statistically, and clinically similar to patients receiving AVA for chronic ITP. Given its lack of dietary restrictions and hepatotoxicity, access to AVA in early ITP could improve disease outcomes and patient health-related quality of life. Further studies are needed to confirm our findings and evaluate the ability of AVA to induce sustained responses off treatment in patients with early ITP.

Six-month Outcomes after PulseRider- and Conventional Single Stent-assisted Embolization for Bifurcation Aneurysms: A Propensity-adjusted Comparison.

Endovascular treatment of wide-necked bifurcation aneurysms (WNBAs) remains challenging despite using a stent. PulseRider is a novel device specifically designed to treat WNBAs, protecting both daughter branches, but the outcomes have not been compared with conventional single stent-assisted embolization. This study aimed to compare the six-month outcomes of PulseRider and single stent-assisted embolization for intracranial unruptured WNBAs using propensity score adjustment. Between February 2012 and October 2021, 46 unruptured WNBAs (34 basilar and 12 middle cerebral arteries) smaller than 10 mm in diameter were treated with PulseRider-assisted embolization (n = 17) or single stent-assisted embolization (n = 29). The immediate and six-month outcomes were compared using inverse probability of treatment weighting analysis. The immediate adequate occlusion rates for the PulseRider- and single stent-assisted embolization were similar (47.1% vs. 62.1%). At six months, adequate occlusion rates for the two groups were also similar (94.1% vs. 86.2%). However, the complete obliteration rate was significantly high after PulseRider-assisted embolization (88.2% vs. 41.4%, adjusted OR 10.54, 95% CI 1.93-57.63). The angiographical improvement rate was also significantly high after PulseRider-assisted embolization (70.6% vs. 37.9%, adjusted OR 6.06, 95% CI 1.54-23.76). The neurologic thromboembolic complication rate was 0% after PulseRider-assisted embolization and 3.4% after single stent-assisted embolization. PulseRider-assisted embolization of WNBAs smaller than 10 mm in diameter was associated with complete obliteration and angiographical improvement at six months. The unique shape of the PulseRider might contribute to the improved midterm aneurysm occlusion.

Abstract 170: Flow Diversion for Distal Aneurysms of the Posterior Circulation: A Multicenter Retrospective Study

Introduction Flow diversion (FD) has emerged as an effective treatment option for intracranial aneurysms (IAs). However, there is limited evidence regarding its safety and efficacy specifically for distal aneurysms of the posterior circulation including posterior inferior cerebellar artery (PICA), anterior inferior cerebellar artery (AICA), superior cerebellar artery (SCA), and the P2 and P3 segment of the posterior cerebral artery (PCA). This study aimed to investigate the outcomes of FD for these aneurysms. Methods A retrospective analysis of a multicentric observational registry was performed between 2014 and 2022. Patients harboring distal aneurysms of the posterior circulation including the PICA, AICA, SCA, and PCA P2‐3 treated with FD were included. Aneurysms characteristics and outcomes were calculated for the total series and a comparison was performed between fusiform/dissecting versus saccular aneurysms. The primary outcome was complete occlusion at last imaging follow up which was defined as per the Raymond Roy occlusion scale. Additional outcomes included the retreatment rate, and thromboembolic and hemorrhagic complications Results Overall, 36 patients with 36 aneurysms were treated with FD with a median age in years of 60.0 (interquartile range [IQR]: 52.8‐65.3 years). Of those, 13 were fusiform/dissecting while 23 were saccular IAs. Complete occlusion was achieved in 78.1% for all IAs at a median follow‐up of 14.0 months (IQR: 9.3‐48.6 months). There was no significant difference in rates of complete occlusion between fusiform/dissecting (91.7%) and saccular aneurysms (70%, p=0.151). Thromboembolic and hemorrhagic complications were observed in four cases (11.1%), and retreatment was required for four IAs (11.4%). There was no significant difference in rates of thromboembolic and hemorrhagic complications, or retreatment between fusiform/dissecting and saccular IAs Conclusion This study suggests the safety and efficacy of FD for distal aneurysms of the posterior circulation. Further larger‐scale studies are warranted to confirm these findings and to explore the long‐term safety and efficacy of FD in this specific aneurysm population.

Застосування антифібринолітичної терапії у періопераційному періоді у дітей та дорослих

перебіг оперативних втручань у дітей можуть ускладнюватися розвиткомперіопераційної кровотечі. Застосування препаратів із антифібринолітичною дією зменшуєта превентує розвиток інтраопераційної крововтрати у дорослих та пацієнтів дитячого віку.Антифібринолітичні препарати такі, як транексамова кислота (ТКК) проявила свою ефективністьу якості зменшення обсягу періопераційної крововтрати, трансфузії у дорослих пацієнтів тадітей при травмі, кардіохірургічних та великих ортопедичних втручань. Проте використанняданого препарату у категорії пацієнтів високого ризику та у навантажувальних дозах &gt; 100 мг/кг може асоціюватися із розвитком тромбоемболічних та судомних ускладнень. Однією із перевагзастосування амінокапронової кислоти (АКК) є її широка доступність, вартість і водночасефективність. Порівнюючи ефективність лізинових похідних у пацієнтів із краніостенозомА. Borst, C. Bonfield зазначають, що при використанні АКК в порівнянні із ТКК підвищуєтьсярівень інтраопераційної крововтрати (21 ± 13 vs. 17 ± 10), проте статистично вона не є значима.Апротинін, у якості препарату для зменшення крововтрати у кардіохірургічних пацієнтів впорівнянні із лізиновими похідними, являється більш ефективним для зниження періопераційної&#x0D; крововтрати. Проте після дослідження The Blood Conservation Using Antifibrinolytics in a Random-ized Trial (BART) (Fergusson D. et al. 2008) є обмежено доступний у багатьох країнах через високу&#x0D; кількість тромбоемболічних ускладнень та підвищену смертність. На даний момент активнодосліджуються протизапальні властивості не лише апротиніну, а й ТКК та АКК.