Laboratory of Haematology and Blood Bank Unit, Attiko Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Department of Orthopaedic Surgery, University of Pittsburgh Orthopedic Specialists, Pittsburgh, PA, USA.
Clin Orthop Relat Res. 2021 Nov 1;479(11):2457-2467. doi: 10.1097/CORR.0000000000001832.
Venous thromboembolism is a common complication after hip fractures. However, there are no reliable laboratory assays to identify patients at risk for venous thromboembolic (VTE) events after major orthopaedic surgery.
QUESTION/PURPOSES: (1) Are rotational thromboelastometry (ROTEM) findings associated with the presence or development of symptomatic VTE after hip fracture surgery? (2) Were any other patient factors associated with the presence or development of symptomatic VTE after hip fracture surgery? (3) Which ROTEM parameters were the most accurate in terms of detecting the association of hypercoagulability with symptomatic VTE?
This retrospective study was conducted over a 13-month period. In all, 354 patients with femoral neck and peritrochanteric fractures who underwent hip hemiarthoplasty or cephallomedullary nailing were assessed for eligibility. Of those, 99% (349 of 354) were considered eligible for the study, 1% (3 of 354) of patients were excluded due to coagulation disorders, and another 1% (2 of 354) were excluded because they died before the postoperative ROTEM analysis. An additional 4% (13 of 354) of patients were lost before the minimum study follow-up of 3 months, leaving 95% (336 of 354) for analysis. A ROTEM analysis was performed in all patients at the time of their hospital admission, within hours of the injury, and on the second postoperative day. The patients were monitored for the development of symptoms indicative of VTE, and the gold standard tests for diagnosing VTE, such as CT pulmonary angiography or vascular ultrasound, were selectively performed only in symptomatic patients and not routinely in all patients. Therefore, this study evaluates the association of ROTEM with only clinically evident VTE events and not with all VTE events. ROTEM results did not affect the clinical surveillance of the study group and the decision for further work up. To determine whether ROTEM findings were associated with the presence or development of symptomatic VTE, ROTEM parameters were compared between patients with and without symptomatic VTE. To establish whether any other patient factors were associated with the presence or development of symptomatic VTE after hip fracture surgery, clinical parameters and conventional laboratory values were also compared between patients with and without symptomatic VTE. Finally, to determine which ROTEM parameters were the most accurate in terms of detecting the association of hypercoagulability with symptomatic VTE, the area under the curve (AUC) for certain cut off values of ROTEM parameters was calculated.
We found several abnormal ROTEM values to be associated with the presence or development of symptomatic VTE. The preoperative maximum clot firmness was higher in patients with clinically evident VTE than in patients without these complications (median [interquartile range] 70 mm [68 to 71] versus 65 mm [61 to 68]; p < 0.001). The preoperative clot formation time was lower in patients with clinically evident VTE than those without clinically evident VTE (median 61 seconds [58 to 65] versus 70 seconds [67 to 74]; p < 0.001), and also the postoperative clot formation time was lower in patients with clinically evident VTE than those without these complications (median 52 seconds [49 to 59] versus 62 seconds [57 to 68]; p < 0.001). Increased BMI was also associated with clinically evident VTE (odds ratio 1.26 [95% confidence interval 1.07 to 1.53]; p < 0.001). We found no differences between patients with and without clinically evident VTE in terms of age, sex, smoking status, comorbidities, and preoperative use of anticoagulants. Lastly, preoperative clot formation time demonstrated the best performance for detecting the association of hypercoagulability with symptomatic VTE (AUC 0.89 [95% CI 0.81 to 0.97]), with 81% (95% CI 48% to 97%) sensitivity and 86% (95% CI 81% to 89%) specificity for clot formation time ≤ 65 seconds.
ROTEM's performance in this preliminary study was promising in terms of its association with symptomatic VTE. This study extended our earlier work by demonstrating that ROTEM has a high accuracy in detecting the level of hypercoagulability that is associated with symptomatic VTE. However, until its performance is validated in a study that applies a diagnostic gold standard (such as venography, duplex/Doppler, or chest CT) in all patients having ROTEM to confirm its performance, ROTEM should not be used as a regular part of clinical practice.
Level IV, diagnostic study.
静脉血栓栓塞是髋部骨折后常见的并发症。然而,目前还没有可靠的实验室检测方法来识别接受大型骨科手术后发生静脉血栓栓塞(VTE)事件的风险患者。
问题/目的:(1)旋转血栓弹性描记术(ROTEM)的结果与髋部骨折手术后有症状的 VTE 的发生或发展有关吗?(2)是否有任何其他患者因素与髋部骨折手术后有症状的 VTE 的发生或发展有关?(3)哪些 ROTEM 参数在检测与有症状的 VTE 相关的高凝状态方面最准确?
本回顾性研究在 13 个月期间进行。总共评估了 354 例股骨颈和转子间骨折患者,以确定是否适合接受髋关节半髋关节成形术或股骨近端髓内钉固定术。其中,99%(349/354)的患者被认为适合该研究,1%(3/354)的患者因凝血障碍被排除在外,另有 1%(2/354)的患者因在术后 ROTEM 分析前死亡而被排除在外。另有 4%(13/354)的患者在术后 3 个月的最低研究随访前丢失,因此有 95%(336/354)的患者可进行分析。所有患者在入院时、受伤后数小时内和术后第 2 天行 ROTEM 分析。监测患者是否出现提示 VTE 的症状,并选择性地仅对有症状的患者进行 CT 肺动脉造影或血管超声等诊断 VTE 的金标准检测,而不是对所有患者常规进行。因此,本研究仅评估 ROTEM 与临床明显的 VTE 事件的相关性,而不是与所有 VTE 事件的相关性。ROTEM 结果不影响研究组的临床监测和进一步检查的决策。为了确定 ROTEM 结果是否与有症状的 VTE 的发生或发展有关,我们比较了有症状和无症状 VTE 患者的 ROTEM 参数。为了确定髋部骨折手术后是否有任何其他患者因素与有症状的 VTE 的发生或发展有关,我们还比较了有症状和无症状 VTE 患者的临床参数和常规实验室值。最后,为了确定哪些 ROTEM 参数在检测与有症状的 VTE 相关的高凝状态方面最准确,我们计算了某些 ROTEM 参数的曲线下面积(AUC)的截断值。
我们发现几个异常的 ROTEM 值与有症状的 VTE 的发生或发展有关。与无这些并发症的患者相比,有临床明显 VTE 的患者术前最大凝块硬度更高(中位数[四分位数间距]70 毫米[68 至 71]与 65 毫米[61 至 68];p<0.001)。有临床明显 VTE 的患者术前凝血形成时间比无临床明显 VTE 的患者短(中位数 61 秒[58 至 65]与 70 秒[67 至 74];p<0.001),术后凝血形成时间也比无临床明显 VTE 的患者短(中位数 52 秒[49 至 59]与 62 秒[57 至 68];p<0.001)。体重指数(BMI)增加也与有临床明显的 VTE 相关(优势比 1.26[95%置信区间 1.07 至 1.53];p<0.001)。我们没有发现有症状和无症状 VTE 患者在年龄、性别、吸烟状况、合并症和术前使用抗凝剂方面存在差异。最后,术前凝血形成时间在检测与有症状的 VTE 相关的高凝状态方面表现出最佳性能(AUC 0.89[95%置信区间 0.81 至 0.97]),凝血形成时间≤65 秒的敏感性为 81%(95%置信区间 48% 至 97%),特异性为 86%(95%置信区间 81% 至 89%)。
在这项初步研究中,ROTEM 的表现有希望与有症状的 VTE 相关。这项研究通过证明 ROTEM 在检测与有症状的 VTE 相关的高凝状态方面具有较高的准确性,扩展了我们早期的工作。然而,在一项应用金标准(如静脉造影、双功/多普勒或胸部 CT)在所有接受 ROTEM 的患者中进行检测以确认其性能的研究中,ROTEM 的性能得到验证之前,ROTEM 不应该作为临床实践的常规部分。
IV 级,诊断研究。