Pellisé Ferran, Serra-Burriel Miquel, Smith Justin S, Haddad Sleiman, Kelly Michael P, Vila-Casademunt Alba, Sánchez Pérez-Grueso Francisco Javier, Bess Shay, Gum Jeffrey L, Burton Douglas C, Acaroğlu Emre, Kleinstück Frank, Lafage Virginie, Obeid Ibrahim, Schwab Frank, Shaffrey Christopher I, Alanay Ahmet, Ames Christopher
1Spine Surgery Unit, Vall d'Hebron Hospital, Barcelona, Spain.
2Center for Research in Health and Economics, Universitat Pompeu Fabra, Barcelona, Spain.
J Neurosurg Spine. 2019 Jun 28;31(4):587-599. doi: 10.3171/2019.3.SPINE181452. Print 2019 Oct 1.
Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO).
Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis.
The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%-75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs.
The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.
成人脊柱畸形(ASD)手术的主要并发症(MCs)发生率较高。目前,关于不良结局的公开信息仅限于登记处的平均估计值。本研究的目的是评估ASD手术后不良事件的发生率,并开发和验证一种用于预测MC、住院再入院(RA)和非计划再次手术(RO)的事件发生时间风险的工具。
使用随机生存森林算法为每个结局创建两个模型,在80%的随机划分中进行训练,并在其余20%中进行测试。查询、合并并分析了两个独立的前瞻性多中心ASD数据库,分别来自欧洲大陆和美国。分析纳入了2008年至2016年期间在5个国家23个地点由57名外科医生进行手术治疗的ASD患者。
最终样本包括1612例ASD患者:平均(标准差)年龄56.7(17.4)岁,女性占76.6%,融合椎体节段数为10.4(4.3)个,55.1%的患者进行了骨盆固定,观察年限为2047.9年。Kaplan-Meier估计显示,12.1%的患者在术后10天至少发生一次MC;90天时为21.5%;2年时为36%。在术后并发症模型的开发样本中,以一致性统计量衡量的辨别力高达71.7%(95%CI 68%-75%)。手术侵袭性、年龄、畸形程度和虚弱是MCs的最强预测因素。MCs在2年时的个体累积风险估计范围为3.9%至74.1%,RA为3.17%至44.2%,RO为2.67%至51.9%。
为ASD手术后MC、RA和RO的发生及时间创建准确的预后模型是可行的。所呈现的患者风险概况的变异性以及模型的辨别力和校准突出表明,为患者和临床医生获取事件发生时间风险估计具有潜在益处。