Alfirevic Andrej, Duncan Andra, You Jing, Lober Cheryl, Soltesz Edward
Department of Cardiothoracic Anesthesia, Cleveland Clinic, Cleveland, Ohio.
Department of Cardiothoracic Anesthesia, Cleveland Clinic, Cleveland, Ohio.
Ann Thorac Surg. 2014 Aug;98(2):618-24. doi: 10.1016/j.athoracsur.2014.04.126. Epub 2014 Jun 24.
Recombinant activated factor VII (rFVIIa) decreases requirements for allogeneic blood transfusion and chest reexploration in patients undergoing cardiac surgery. Whether rFVIIa increases the risk of postoperative adverse events is unclear. We tested whether rFVIIa administration was associated with increased mortality and neurologic and renal morbidity in patients undergoing cardiac surgery. Risk of thromboembolic complications and the dose-response of rFVIIa on mortality and morbidity were also evaluated.
Of 27,977 patients who had complex cardiac surgery, 164 patients (0.59%) received rFVIIa perioperatively. Using propensity-matching techniques, patients were matched to a maximum of 3 control patients. Patients who received rFVIIa were compared with control patients on risk of mortality, neurologic and renal morbidity, and thromboembolic complications, including a composite of myocardial infarction, pulmonary embolism, and deep venous thrombosis. A corresponding dose-response analysis using multivariable logistic regression was also performed.
Propensity techniques successfully matched 144 patients (88%) with 359 control patients. Of patients who received rFVIIa, 40% experienced in-hospital mortality compared with 18% of control patients (odds ratio, 2.82; 98.3% confidence interval, 1.64 to 4.87; p<0.001). Furthermore, 31% of patients treated with rFVIIa versus 17% of control patients experienced renal morbidity (odds ratio, 2.07; 98.3% confidence interval, 1.19 to 3.62; p=0.002); however, neurologic morbidity and thromboembolic complications were not different among groups. High-dose rFVIIa (>60 μg/kg) did not increase the risk for mortality compared with treatment with low-dose rFVIIa (<60 μg/kg).
Administration of rFVIIa is associated with increased mortality and renal morbidity in patients undergoing cardiac surgery.
重组活化因子VII（rFVIIa）可降低心脏手术患者异体输血需求及开胸再次探查率。rFVIIa是否会增加术后不良事件风险尚不清楚。我们测试了心脏手术患者使用rFVIIa是否与死亡率增加以及神经和肾脏并发症有关。还评估了血栓栓塞并发症风险以及rFVIIa对死亡率和并发症的剂量反应。
在27977例接受复杂心脏手术的患者中，164例（0.59%）围手术期接受了rFVIIa。采用倾向匹配技术，患者最多与3例对照患者匹配。将接受rFVIIa的患者与对照患者在死亡率、神经和肾脏并发症以及血栓栓塞并发症风险方面进行比较，包括心肌梗死、肺栓塞和深静脉血栓形成的综合情况。还使用多变量逻辑回归进行了相应的剂量反应分析。
倾向技术成功将144例患者（88%）与359例对照患者匹配。接受rFVIIa的患者中，40%发生院内死亡，而对照患者为18%（比值比，2.82；98.3%置信区间，1.64至4.87；p<0.001）。此外，接受rFVIIa治疗的患者中有31%发生肾脏并发症，而对照患者为17%（比值比，2.07；98.3%置信区间，1.19至3.62；p=0.002）；然而，各组间神经并发症和血栓栓塞并发症无差异。与低剂量rFVIIa（<60μg/kg）治疗相比，高剂量rFVIIa（>60μg/kg）并未增加死亡风险。
心脏手术患者使用rFVIIa与死亡率增加和肾脏并发症有关。
