Nissborg Emelie, Wahlgren Carl-Magnus
Department of Vascular Surgery, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Department of Vascular Surgery, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Ann Vasc Surg. 2019 Oct;60:286-292. doi: 10.1016/j.avsg.2019.02.033. Epub 2019 May 7.
The objective of this clinical study was to investigate the anticoagulant effect of standard fixed dose of heparin during endovascular intervention in the lower extremity arteries.
A prospective clinical pilot study was completed with retrospective quality review of patients between 2015 and 2017 (n = 61). Patients undergoing elective endovascular intervention for arterial insufficiency in the lower extremities were enrolled. A standard fixed intra-arterial dose of 5000 IU of unfractionated heparin (UFH) was administered during the procedure without adjustment for weight or monitoring. Activated clotting time (ACT) was measured before and ten minutes after heparin administration and at the end of the procedure. The primary study end point was the level of heparin anticoagulation after standard perioperative administration.
Mean age was 74 ± 9 years, 48% women. Mean weight was 74 ± 15 kg, and mean BMI, 25.6 ± 4.7 kg/m. The endovascular interventions were performed at the iliac arteries 19.7% (12/61), at the femoral popliteal segment 50.8 % (31/61), below the knee arteries 6.6% (4/61), and at multiple levels 13% (8/61). The perioperative mean ACT increased from baseline 155 ± 43 s (n = 31) to ten minutes after heparin administration 290 ± 70 s (n = 60) (P < 0.01) and was at the end of the procedure 276 ± 73 s (n = 59). Perioperative ACT ten minutes after heparin administration: 5.0% (3/60) of the patients had ACT <200 s, 25.0% (15/60) had ACT 200-250 s, 48.3% (29/60) ACT 251-349, and 21.7% (13/60) ACT ≥350 s. At the end of the procedure, 17.2 % (10/58) of the patients had ACT <200, 24.1 % (14/58) had ACT 200-250 s, 37.9% (22/58) ACT 251-349, and 20.7 % (12/58) ACT ≥350 s. The mean dose of heparin per kg body weight was 70 ± 15 IU/kg. There was a significant difference between the ACT groups when analyzing heparin dose per kg body weight: 54 ± 14 IU/kg for patients with ACT <200, 69 ± 13 IU/kg with ACT 200-250 s, 68 ± 13 IU/kg with ACT 251-349, and 81 ± 18 IU/kg with ACT >350 (P = 0.0095). The same pattern was seen for heparin dose per BMI and DuBois. In univariate logistic regression analysis, ACT ≥350 s was associated with lower body weight (OR 0.92; 95% CI 0.87-0.98; P = 0.008), lower BMI (OR 0.80; 95% CI 0.67-0.96; P = 0.014), and lower body surface area DuBois (OR 0.53; 95% 0.32-0.85; P = 0.009). In multivariable regression, the ACT association with body weight remained (OR 0.92; 95% 0.87-0.98; P = 0.008). There were no perioperative or immediate postoperative bleeding complications requiring blood transfusion or surgical intervention in this study cohort.
The standard heparin dosing of 5000 IU during endovascular intervention for arterial insufficiency in the lower extremities helps achieve ACT >200 s in almost all patients, but most patients were outside recommended target interval. To provide a more consistent and predictable heparinization, a weight-based bolus dose of 70 IU heparin/kg is recommended.
本临床研究的目的是调查标准固定剂量肝素在下肢动脉血管内介入治疗期间的抗凝效果。
完成了一项前瞻性临床试点研究,并对2015年至2017年期间的患者进行了回顾性质量评估(n = 61)。纳入接受下肢动脉供血不足择期血管内介入治疗的患者。在手术过程中给予标准固定动脉内剂量5000 IU普通肝素(UFH),不根据体重调整或进行监测。在肝素给药前、给药后十分钟以及手术结束时测量活化凝血时间(ACT)。主要研究终点是围手术期标准给药后肝素抗凝水平。
平均年龄为74±9岁,女性占48%。平均体重为74±15 kg,平均BMI为25.6±4.7 kg/m²。血管内介入治疗在髂动脉进行的占19.7%(12/61),在股腘段进行的占50.8%(31/61),在膝下动脉进行的占6.6%(4/61),在多个层面进行的占13%(8/61)。围手术期平均ACT从基线的155±43秒(n = 31)增加到肝素给药后十分钟的290±70秒(n = 60)(P < 0.01),在手术结束时为276±73秒(n = 59)。肝素给药后十分钟的围手术期ACT:5.0%(3/60)的患者ACT < 200秒,25.0%(15/60)的患者ACT为200 - 250秒,48.3%(29/60)的患者ACT为251 - 349秒,21.7%(13/60)的患者ACT≥350秒。在手术结束时,17.2%(10/58)的患者ACT < 200,24.1%(14/58)的患者ACT为200 - 250秒,37.9%(22/58)的患者ACT为251 - 349秒,20.7%(12/58)的患者ACT≥350秒。每千克体重的肝素平均剂量为70±15 IU/kg。分析每千克体重的肝素剂量时,ACT组之间存在显著差异:ACT < 200的患者为54±14 IU/kg,ACT为200 - 250秒的患者为69±13 IU/kg,ACT为251 - 349秒的患者为68±13 IU/kg,ACT > 350的患者为81±18 IU/kg(P = 0.0095)。每BMI和杜波依斯体表面积的肝素剂量也呈现相同模式。在单变量逻辑回归分析中,ACT≥350秒与较低体重(OR 0.92;95% CI 0.87 - 0.98;P = 0.008)、较低BMI(OR 0.80;95% CI 0.67 - 0.96;P = 0.014)和较低杜波依斯体表面积(OR 0.53;95% 0.32 - 0.85;P = 0.009)相关。在多变量回归中,ACT与体重的关联仍然存在(OR 0.92;95% 0.87 - 0.98;P = 0.008)。本研究队列中没有围手术期或术后即刻需要输血或手术干预的出血并发症。
在下肢动脉供血不足的血管内介入治疗中,5000 IU的标准肝素剂量几乎可使所有患者的ACT > 200秒,但大多数患者超出了推荐的目标区间。为提供更一致和可预测的肝素化,建议基于体重给予70 IU/kg的推注剂量。