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手术与非手术治疗的成人脊柱畸形患者发生严重衰弱的概率:3 年期间的生存分析。

Probability of severe frailty development among operative and nonoperative adult spinal deformity patients: an actuarial survivorship analysis over a 3-year period.

机构信息

Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY, USA.

Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY, USA.

出版信息

Spine J. 2020 Aug;20(8):1276-1285. doi: 10.1016/j.spinee.2020.04.010. Epub 2020 Apr 20.

DOI:10.1016/j.spinee.2020.04.010
PMID:32320862
Abstract

BACKGROUND

Little is known of how frailty, a dynamic measure of physiological age, progresses relative to age or disability status. Operative treatment of adult spinal deformity (ASD) may play a role in frailty remediation and maintenance.

PURPOSE

Compare frailty status, severe frailty development, and factors influencing severe frailty development among ASD patients undergoing operative or nonoperative treatment.

DESIGN

Retrospective review with maximum follow-up of 3 years.

SETTING

Prospective, multicenter, ASD database.

PARTICIPANTS

Patients were consecutively enrolled from 13 participating centers.

INCLUSION CRITERIA

≥18 years undergoing either operative or nonoperative treatment for ASD, exclusion criteria: spinal deformity of neuromuscular etiology, presence of active infection, or malignancy. The mean age of the participants analyzed were 54.9 for the operative cohort and 55.0 for the nonoperative cohort.

OUTCOMES MEASURES

Frailty status, severe frailty development, and factors influencing severe frailty development.

METHODS

ASD patients (coronal scoliosis ≥20°, sagittal vertical axis (SVA) ≥5 cm, Pelvic Tilt (PT) ≥25°, or thoracic kyphosis ≥60°) >18 y/o, with Base Line (BL) frailty scores were included. Frailty was scored from 0 to 1 (not frail: <0.3, frail 0.3-0.5, severe frailty >0.5) through the use of ASD-frailty index (FI) which has been validated using the International Spine Study Group (ISSG) ASD database, European Spine Study Group ASD database, and the Scoli-RISK-1 Patient Database. The ISSG is funded through research grants from DePuy Synthes and individual donations and supported the current work. Operative (Op) and Nonoperative (Non-Op) patients were propensity matched. T-tests compared frailty among treatment groups and BL, 1, 2, and ≥3 years. An actuarial Kaplan-Meier survivorship analysis with log-rank (Mantel-Cox) test, adjusting for patients lost to follow-up, determined probability of severe frailty development. Multivariate Cox Regressions gauged the effect of sagittal malalignment, patient and surgical details on severe frailty development.

RESULTS

The analysis includes 472 patients (236 Op, 236 Non-Op) selected by propensity score matching from a cohort of 1,172. Demographics and comorbidities were similar between groups (p>.05). Op exhibited decreased frailty at all follow-up intervals compared with BL (BL: 0.22 vs Y1: 0.18; Y2: 0.16; Y3: 0.15, all p<.001). Non-Op displayed similar frailty from BL to 2Y follow up, and increased frailty at 3Y follow up (0.23 vs 0.25, p=.014). Compared with Non-Op, Op had lower frailty at 1Y (0.18 vs 0.24), 2Y (0.16 vs 0.23), and 3Y (0.15 vs 0.25; all p<.001). Cumulative probability of maintaining nonsevere frailty was (Op: 97.7%, Non-Op: 94.5%) at 1Y, (Op: 95.1%, Non-Op: 90.4%) at 2Y, and (Op: 95.1%, Non-Op: 89.1%) at ≥3Y, (p=.018). Among all patients, baseline depression (hazard ratio: 2.688[1.172-6.167], p=.020), Numeric Rating Scale (NRS) back pain scores (HR: 1.247[1.012-1.537], p=.039), and nonoperative treatment (HR: 2.785[1.167-6.659], p=.021) predicted severe frailty development with having a HR>1.0 and p value<.05. Among operative patients, 6-week postoperative residual SVA malalignment (SRS-Schwab SVA+modifier) (HR: 15.034[1.922-116.940], p=.010) predicted severe frailty development indicated by having a HR>1.0 and p value <.05.

CONCLUSIONS

Non-Op patients were more likely to develop severe frailty, and at a quicker rate. Baseline depression, increased NRS back pain scores, nonoperative treatment, and postoperative sagittal malalignment at 6-week follow-up significantly predicted severe frailty development. Operative intervention and postoperative sagittal balance appear to play significant roles in frailty remediation and maintenance in ASD patients. Frailty is one factor, in a multifactorial conservation, that may be considered when determining operative or nonoperative values for ASD patients. Operating before the onset of severe frailty, may result in a lower complication risk and better long-term clinical outcomes.

摘要

背景

衰弱是一种衡量生理年龄的动态指标,人们对其相对于年龄或残疾状态的进展知之甚少。成人脊柱畸形(ASD)的手术治疗可能在衰弱的矫正和维持中发挥作用。

目的

比较接受手术或非手术治疗的 ASD 患者的衰弱状态、严重衰弱发展情况以及影响严重衰弱发展的因素。

设计

回顾性研究,最长随访 3 年。

地点

前瞻性、多中心 ASD 数据库。

参与者

患者连续纳入 13 个参与中心。

纳入标准

年龄≥18 岁,接受手术或非手术治疗 ASD,排除标准:神经肌肉病因引起的脊柱畸形、存在活动性感染或恶性肿瘤。接受分析的参与者的平均年龄为手术组 54.9 岁,非手术组 55.0 岁。

结局指标

衰弱状态、严重衰弱发展情况以及影响严重衰弱发展的因素。

方法

纳入基线 frailty 评分的 ASD 患者(冠状脊柱侧凸≥20°,矢状垂直轴(SVA)≥5cm,骨盆倾斜度(PT)≥25°,或胸椎后凸角≥60°)。通过使用 ASD 衰弱指数(FI)对衰弱进行评分,该指数已通过国际脊柱研究组(ISSG)ASD 数据库、欧洲脊柱研究组 ASD 数据库和 Scoli-RISK-1 患者数据库进行验证。ISSG 是通过研究资助和个人捐赠资助的,支持当前的工作。手术(Op)和非手术(Non-Op)患者进行倾向匹配。t 检验比较治疗组与基线、1 年、2 年和≥3 年的衰弱情况。使用生存分析 Kaplan-Meier 法(log-rank(Mantel-Cox)检验),对失访患者进行调整,确定严重衰弱发展的概率。多因素 Cox 回归评估矢状面失平衡、患者和手术细节对严重衰弱发展的影响。

结果

该分析包括通过倾向评分匹配从 1172 例队列中选择的 472 例患者(236 例 Op,236 例 Non-Op)。两组的人口统计学和合并症相似(p>.05)。与基线相比,Op 在所有随访时间点的衰弱程度均降低(BL:0.22 vs Y1:0.18;Y2:0.16;Y3:0.15,均 p<.001)。Non-Op 从基线到 2 年随访时的衰弱程度相似,而在 3 年随访时的衰弱程度增加(0.23 vs 0.25,p=.014)。与 Non-Op 相比,Op 在 1 年(0.18 vs 0.24)、2 年(0.16 vs 0.23)和 3 年(0.15 vs 0.25)时的衰弱程度更低(均 p<.001)。1 年时保持非严重衰弱的累积概率为(Op:97.7%,Non-Op:94.5%),2 年时为(Op:95.1%,Non-Op:90.4%),≥3 年时为(Op:95.1%,Non-Op:89.1%),(p=.018)。在所有患者中,基线抑郁(危险比:2.688[1.172-6.167],p=.020)、数字评分量表(NRS)背部疼痛评分(HR:1.247[1.012-1.537],p=.039)和非手术治疗(HR:2.785[1.167-6.659],p=.021)与具有 HR>1.0 和 p 值<.05 的严重衰弱发展相关。在手术患者中,术后 6 周残留 SVA 矢状面不稳定性(SRS-Schwab SVA+修饰符)(HR:15.034[1.922-116.940],p=.010)预测严重衰弱发展,这表明 HR>1.0 和 p 值<.05。

结论

非手术治疗患者更有可能发展为严重衰弱,而且发展速度更快。基线抑郁、增加的 NRS 背部疼痛评分、非手术治疗以及术后 6 周的矢状面失平衡显著预测严重衰弱的发展。手术干预和术后矢状面平衡似乎在 ASD 患者的衰弱矫正和维持中发挥重要作用。衰弱是多因素保护的一个因素,在确定 ASD 患者的手术或非手术治疗价值时可能需要考虑。在严重衰弱发生之前进行手术可能会降低并发症风险并带来更好的长期临床结局。

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