Cancienne Jourdan M, Werner Brian C, Browne James A
Department of Orthopaedic Surgery, University of Virginia Health System, PO Box 800159 HSC, Charlottesville, VA, 22908, USA.
Clin Orthop Relat Res. 2017 Jun;475(6):1642-1649. doi: 10.1007/s11999-017-5246-4. Epub 2017 Jan 23.
Despite substantial research into the use of glycemic markers to stratify infection risk in patients with diabetes mellitus, there is little evidence to support a perioperative hemoglobin A1c (HbA1c) level associated with an increased risk of deep postoperative infection after TKA.
QUESTIONS/PURPOSES: (1) Is there an association between perioperative HbA1c level in patients with diabetes and deep postoperative infection after primary TKA? (2) Is the perioperative HbA1c level in patients with diabetes a useful test as an independent predictor for postoperative infection after TKA?
We queried the PearlDiver Patient Records Database Humana dataset for patients who underwent primary TKA. This is a for-fee insurance patient-records database that contains records for more than 20 million patients with orthopaedic diagnoses from 2007 to the second quarter of 2015. The data for patients from this study were taken from the Humana dataset since this is the only insurer that includes laboratory data among the available databases. Although it is difficult to calculate attrition in this database, in the current study the minimum number of patients with at least 1 year followup was 86%. Patients with diabetes who had an HbA1c level obtained within 3 months of surgery were identified, stratified based on their HbA1c level in 0.5 mg/dL increments, and then compared with patients with diabetes without an HbA1c level within 3 months of surgery. Patients who had an HbA1c level within 3 months of surgery had slightly higher rates of polyneuropathy, chronic renal failure, and chronic kidney disease Stages 2 and 3. Otherwise, these groups were similar regarding rates of peripheral vascular disease, microvascular ischemic disease, metabolic syndrome, gastroparesis, end stage renal disease, age, and gender. Deep infection was defined as an infection resulting in operative intervention within 1 year of the primary TKA, and the incidence of such intervention for each HbA1c group then was identified. A receiver operating characteristic (ROC) analysis was performed to determine a threshold value of the HbA1c, and an area under the curve (AUC) analysis was performed to measure the accuracy and clinical utility of HbA1c as an independent predictor for postoperative infection.
The rate of infection requiring operative intervention ranged from a low of 0.8% with an HbA1c of 5.49 mg/dL or less, up to 3.5% for patients with HbA1c level greater than 11.5 mg/dL. The ROC analysis indicated that the best threshold was an HbA1c of 8.0 mg/dL (1.7; 95% CI, 1.2-2.4 mg/dL; p = 0.004), however, the AUC of 0.548 (95% CI, 0.50-0.59; p = 0.025) indicated that this threshold was inaccurate and only slightly better than chance, and thus alone could not serve as an independent discriminator of infection risk.
The risk of deep postoperative infection requiring surgical intervention after TKA in patients with diabetes mellitus increases as the perioperative HbA1c increases. While a threshold HbA1c level of 8.0 mg/dL was identified, it cannot by itself serve as an independent predictor of postoperative infection in patients with diabetes mellitus because its sensitivity is so low. Future studies should determine what other confounders other than an elevated HbA1c level contribute to increased infection risk and whether decreasing HbA1c levels before TKA will decrease the subsequent risk of infection after surgery.
Level III, diagnostic study.
尽管对使用血糖标志物对糖尿病患者的感染风险进行分层做了大量研究,但几乎没有证据支持全膝关节置换术(TKA)后与深部术后感染风险增加相关的围手术期糖化血红蛋白(HbA1c)水平。
问题/目的:(1)糖尿病患者围手术期HbA1c水平与初次TKA术后深部感染之间是否存在关联?(2)糖尿病患者围手术期HbA1c水平作为TKA术后感染的独立预测指标是否是一项有用的检测?
我们在PearlDiver患者记录数据库的Humana数据集中查询接受初次TKA的患者。这是一个收费的保险患者记录数据库,包含2007年至2015年第二季度超过2000万例骨科诊断患者的记录。本研究中患者的数据取自Humana数据集,因为这是现有数据库中唯一包含实验室数据的保险公司。尽管在这个数据库中很难计算损耗率,但在本研究中,至少有1年随访的患者的最小数量为86%。识别出在手术3个月内获得HbA1c水平的糖尿病患者,根据其HbA1c水平以0.5mg/dL的增量进行分层,然后与手术3个月内未获得HbA1c水平的糖尿病患者进行比较。手术3个月内有HbA1c水平的患者在多发性神经病变、慢性肾衰竭以及慢性肾脏病2期和3期的发生率略高。除此之外,这些组在周围血管疾病、微血管缺血性疾病、代谢综合征、胃轻瘫、终末期肾病、年龄和性别发生率方面相似。深部感染定义为初次TKA后1年内导致手术干预的感染,然后确定每个HbA1c组的此类干预发生率。进行受试者操作特征(ROC)分析以确定HbA1c的阈值,并进行曲线下面积(AUC)分析以测量HbA1c作为术后感染独立预测指标的准确性和临床实用性。
需要手术干预的感染率范围为:HbA1c为5.49mg/dL或更低时低至0.8%,HbA1c水平大于11.5mg/dL的患者高达3.5%。ROC分析表明最佳阈值为HbA1c 8.0mg/dL(1.7;95%CI,1.2 - 2.4mg/dL;p = 0.004),然而,AUC为0.548(95%CI,0.50 - 0.59;p = 0.025)表明该阈值不准确,仅略优于随机猜测,因此单独不能作为感染风险的独立判别指标。
糖尿病患者TKA术后需要手术干预的深部术后感染风险随着围手术期HbA1c升高而增加。虽然确定了阈值HbA1c水平为8.0mg/dL,但它本身不能作为糖尿病患者术后感染的独立预测指标,因为其敏感性很低。未来的研究应确定除HbA1c水平升高外还有哪些其他混杂因素导致感染风险增加,以及TKA术前降低HbA1c水平是否会降低术后随后的感染风险。
III级,诊断性研究。