Department of Anesthesiology, Perioperative and Pain Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.
Anesthesiology. 2024 Dec 1;141(6):1051-1064. doi: 10.1097/ALN.0000000000005208.
Bleeding during cardiac surgery may be refractory to standard interventions. Off-label use of factor eight inhibitor bypass activity (FEIBA) has been described to treat such bleeding. However, reports of safety, particularly thromboembolic outcomes, show mixed results, and reported cohorts have been small.
Adult patients undergoing cardiac surgery on cardiopulmonary bypass between July 1, 2018, and June 30, 2023, at Stanford Hospital (Stanford, California) were reviewed (n = 3,335). Patients who received FEIBA to treat postcardiopulmonary bypass bleeding were matched with those who did not by propensity scores in a 1:1 ratio using nearest neighbor matching (n = 352 per group). The primary outcome was a composite outcome of thromboembolic complications including any one of deep vein thrombosis, pulmonary embolism, unplanned coronary artery intervention, ischemic stroke, and acute limb ischemia, in the postoperative period. Secondary outcomes included renal failure, reoperation, postoperative transfusion, intensive care unit length of stay, and 30-day mortality.
A total of 704 encounters was included in this propensity-matched analysis. The mean dose of FEIBA administered was 7.3 ± 5.5 U/kg. In propensity-matched multivariate logistic regression models, there was no statistically significant difference in odds ratios for thromboembolic outcomes, intensive care unit length of stay, or mortality. Patients who received more than 750 U FEIBA had an increased odds ratio for acute renal failure (odds ratio, 4.14; 95% CI, 1.61 to 10.36; P < 0.001). In multivariate linear regression, patients receiving FEIBA were transfused more plasma and cryoprecipitate postoperatively. However, only the dose range of 501 to 750 U was associated with an increase in transfusion of erythrocytes (β, 2.73; 95% CI, 0.68 to 4.78; P = 0.009) and platelets (β, 1.74; 95% CI, 0.85 to 2.63; P < 0.001).
Low-dose FEIBA administration during cardiac surgery does not increase risk of thromboembolic events, intensive care unit length of stay, or mortality in a propensity-matched cohort. Higher doses were associated with increased acute renal failure and postoperative transfusion. Further studies are required to establish the efficacy of activated factor concentrates to treat refractory bleeding during cardiac surgery.
心脏手术过程中的出血可能对标准干预措施无效。因子八抑制剂旁路活性（FEIBA）的超说明书使用已被描述用于治疗此类出血。然而，关于安全性的报告，特别是血栓栓塞结果，显示出混合的结果，并且报告的队列规模较小。
回顾了 2018 年 7 月 1 日至 2023 年 6 月 30 日期间在斯坦福医院（加利福尼亚州斯坦福）接受体外循环心脏手术的成年患者（n=3335）。通过最近邻匹配（每组 352 例），按倾向评分以 1:1 的比例对接受 FEIBA 治疗体外循环后出血的患者与未接受 FEIBA 治疗的患者进行匹配。主要结局是术后血栓栓塞并发症的复合结局，包括深静脉血栓形成、肺栓塞、计划外冠状动脉介入、缺血性卒中、急性肢体缺血中的任何一种。次要结局包括肾衰竭、再次手术、术后输血、重症监护病房住院时间和 30 天死亡率。
这项倾向匹配分析共纳入了 704 例。FEIBA 的平均剂量为 7.3±5.5 U/kg。在多变量逻辑回归模型中，血栓栓塞结局、重症监护病房住院时间或死亡率的比值比无统计学意义差异。接受超过 750 U FEIBA 的患者发生急性肾衰竭的比值比增加（比值比，4.14；95%置信区间，1.61 至 10.36；P<0.001）。在多变量线性回归中，接受 FEIBA 的患者术后接受更多的血浆和冷沉淀输血。然而，只有 501 至 750 U 的剂量范围与红细胞（β，2.73；95%置信区间，0.68 至 4.78；P=0.009）和血小板（β，1.74；95%置信区间，0.85 至 2.63；P<0.001）输血增加相关。
在心脏手术中给予低剂量 FEIBA 并不会增加血栓栓塞事件、重症监护病房住院时间或死亡率的风险。较高剂量与急性肾衰竭和术后输血增加相关。需要进一步的研究来确定激活的因子浓缩物治疗心脏手术中难治性出血的疗效。
