Hyland Sara J, James Daniel C, Gordon Erin M, Salamon Thomas, Smyke Norman A, Smith Adam J, Fanning William J
Department of Pharmacy, OhioHealth Grant Medical Center, Columbus, Ohio.
Department of Pharmacy, OhioHealth Riverside Methodist Hospital, Columbus, Ohio.
Ann Thorac Surg Short Rep. 2023 Jul 12;1(4):691-695. doi: 10.1016/j.atssr.2023.06.006. eCollection 2023 Dec.
Perioperative bleeding remains an important complication of cardiac surgery. Current guidelines support goal-directed use of coagulation factor concentrates in refractory bleeding, but the optimal strategy is unclear. Four-factor prothrombin complex concentrate (4F-PCC) has theoretical advantages over recombinant activated factor VII (rFVIIa) because of expanded mechanistic targets and lower rates of adverse events, but comparative data are limited.
We pursued a retrospective cohort study assessing the implementation of an institutional treatment algorithm for refractory bleeding in cardiac surgery that mediated a practice change in preferred factor product from rFVIIa to 4F-PCC. All cardiac surgery patients at 2 large community hospitals who received 4F-PCC or rFVIIa during 2019-2020 were assessed for inclusion. The primary outcome was all-cause in-hospital mortality.
A total of 42 patients met study criteria. Mortality was nonsignificantly lower in the 4F-PCC group (7.1% vs 28.6%; = .16), as were median total blood products transfused (15 vs 25.5 units; = .11), although median units of cryoprecipitate were significantly lower (0.5 vs 2 units; = .01). Average factor product medication charge per patient was significantly lower in the 4F-PCC group ($9772 vs $50,293; < .001).
A 4F-PCC-based strategy for refractory bleeding in cardiac surgery was associated with reduced cryoprecipitate transfusion and medication costs without significant differences in inpatient mortality or total transfusion exposure. Trends toward decreased mortality and transfusions observed in this quality improvement study should be explored in larger prospective trials.
围手术期出血仍是心脏手术的一个重要并发症。当前指南支持在难治性出血时目标导向使用凝血因子浓缩物，但最佳策略尚不清楚。四因子凝血酶原复合物浓缩物（4F-PCC）由于作用机制靶点更广泛且不良事件发生率较低，相对于重组活化因子VII（rFVIIa）具有理论优势，但比较数据有限。
我们进行了一项回顾性队列研究，评估心脏手术难治性出血的机构治疗算法的实施情况，该算法介导了首选因子产品从rFVIIa变为4F-PCC的实践改变。对2019 - 2020年期间在2家大型社区医院接受4F-PCC或rFVIIa的所有心脏手术患者进行纳入评估。主要结局是全因院内死亡率。
共有42例患者符合研究标准。4F-PCC组的死亡率略低但无显著差异（7.1%对28.6%；P = 0.16），输注的全血制品中位数也较低（15单位对25.5单位；P = 0.11），尽管冷沉淀的中位数单位显著更低（0.5单位对2单位；P = 0.01）。4F-PCC组每位患者的平均因子产品用药费用显著更低（9772美元对50293美元；P < 0.001）。
基于4F-PCC的心脏手术难治性出血策略与冷沉淀输注减少和用药成本降低相关，住院死亡率或总输血暴露无显著差异。在这项质量改进研究中观察到的死亡率和输血减少趋势应在更大规模的前瞻性试验中进行探索。
