Evaluation of intervertebral body implant performance using active surveillance of electronic health records.
Evaluation of intervertebral body implant performance using active surveillance of electronic health records.
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DOI：
10.1136/bmjsit-2021-000125
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发表时间：
2022
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旨在评估在主动监测环境中使用电子健康记录（EHR）获得的临床数据评价新型椎间体植入物（IVBI）稳定器械安全性的可行性。回顾性、纵向观察性队列研究，比较脊柱融合术后1年内患者的临床结局。Lahey Health网络，包括美国新英格兰地区的学术三级医院、门诊诊所和独立提供者办事处。所有18岁或以上接受胸椎或腰椎脊柱关节固定术的脊柱手术患者均纳入研究。将2015年4月至2018年12月期间使用CONCORDE Bullet（CB）椎间融合器（DePuy）治疗的患者的临床结局与接受替代脊柱稳定椎间融合器植入物的患者进行了比较。主要终点是1年时的再手术率，次要终点包括首次住院期间的输血需求、1年全因住院率、1年手术部位感染率和1年时的死亡率。在研究期间接受胸椎或腰椎融合手术的606例患者中，136例仅接受CB。与未接受CB的患者相比，未发现1年时的再次手术率或次要安全性结局率存在显著差异。可以成功利用EHR中的数据评估IVBI器械的安全性，在这种情况下，证明与替代脊柱植入物相比，使用CB进行脊柱手术的患者之间的风险调整安全性终点率无显著差异。
To assess the feasibility of using electronic health record (EHR) derived clinical data within an active surveillance setting to evaluate the safety of a novel intervertebral body implant (IVBI) stabilization device. Retrospective, longitudinal observational cohort study comparing clinical outcomes for patients seen through 1 year following spinal fusion surgery. Lahey Health network, which includes academic tertiary hospitals, outpatient clinics, and independent provider offices in the New England region of the USA. All spine surgery patients aged 18 or older who underwent thoracic or lumbar spinal arthrodesis surgeries were included. The clinical outcomes of patients treated with the CONCORDE Bullet (CB) interbody spine system (DePuy) between April 2015 and December 2018 were compared with those patients receiving alternative spine stabilization interbody device implants. The primary endpoint was reoperation rate at 1 year, with secondary endpoints including the requirement for blood transfusion during index hospitalization, 1 year rate of any cause hospitalization, 1 year rate of surgical site infection, and mortality at 1 year. Among the 606 patients undergoing thoracic or lumbar spinal fusion surgery during the study period, 136 received only the CB. In comparison with patients who did not receive the CB, no significant differences were found in the rate of reoperation at 1 year or the rates of secondary safety outcomes. Data derived from the EHR can be successfully leveraged to assess the safety of IVBI devices, in this case demonstrating no significant differences in the rates of risk-adjusted safety endpoints between patients undergoing spinal surgery with the CB as compared with alternative spinal implants.