Department of Neurosurgery, Duke University Medical Center, Durham, NC.
Duke University Medical Center, Department of Neurosurgery, Durham, NC.
Pain Physician. 2017 Sep;20(6):E797-E805.
Failed back surgery syndrome (FBSS) is a cause of significant morbidity for up to 40% of patients following spine surgery, and is estimated to cost almost $20 billion. Treatment options for these patients currently include conventional medical management (CMM), repeat operation, or spinal cord stimulation (SCS). Much of the published data regarding cost effectiveness of SCS comprise smaller scale randomized controlled trials (RCTs) rather than large databases capturing practices throughout the US. SCS has been shown to have superior outcomes to CMM or repeat spinal operation in several landmark studies, yet there are few large studies examining its long-term economic impact.
This study compares health care utilization for SCS compared to other management in patients with FBSS.
Retrospective.
Inpatient and outpatient sample.
Patients with a history of FBSS from 2000 to 2012 were selected. We compared those who received SCS to those who underwent conventional management. A longitudinal analysis was used to model the value of log(cost) in each one year interval using a generalized estimating equations (GEE) model to account for the correlation of the same patient's cost in multiple years. Similarly, a Poisson GEE model with the log link was applied to correlated count outcomes.
We identified 122,827 FBSS patients. Of these, 5,328 underwent SCS implantation (4.34%) and 117,499 underwent conventional management. Total annual costs decreased over time following implantation of the SCS system, with follow-up analysis at 1, 3, 6, and 9 years. The longitudinal GEE model demonstrated that placement of an SCS system was associated with an initial increase in total costs at the time of implantation (cost ratio [CR]: 1.74; 95% confidence interval [CI]: 1.41, 2.15, P < 0.001), however there was a significant and sustained 68% decrease in cost in the year following SCS placement (CR: 0.32; 95% CI: 0.24, 0.42, P < 0.001) compared to CMM. There was also an aggregate time trend that for each additional year after SCS, cost decreased on average 40% percent annually (CR: 0.60; 95% CI: 0.55, 0.65, P < 0.001), with follow-up up to 1, 3, 6, and 9 years post-procedure.
Costs are not correlated with patient outcomes, patients are not stratified in terms of complexity of prior back surgery, as well as inherent limitations of a retrospective analysis.
We found that from 2000 to 2012, only 4.3% of patients across the United States with FBSS were treated with SCS. Long-term total annual costs for these patients were significantly reduced compared to patients with conventional management. Although implantation of an SCS system results in a short-term increase in costs at one year, the subsequent annual cumulative costs were significantly decreased long-term in the following 9 years after implantation. This study combines the largest group of FBSS patients studied to date along with the longest follow-up interval ever analyzed. Since SCS has repeatedly been shown to have superior efficacy to CMM in randomized clinical trials, the current study demonstrating improved long-term health economics at 1, 3, 6, and 9 years supports the long-term cost utility of SCS in the treatment of FBSS patients. Key words: Failed back surgery syndrome, spinal cord stimulation, back pain, leg pain, neuromodulation, FBSS, SCS.
高达 40%的脊柱手术后患者会出现失败的脊柱手术综合征（FBSS），这是一种重大的发病症状，并且据估计其治疗费用接近 200 亿美元。目前，这些患者的治疗选择包括常规医疗管理（CMM）、再次手术或脊髓刺激（SCS）。关于 SCS 的成本效益的大量已发表数据包括规模较小的随机对照试验（RCT），而不是涵盖整个美国实践的大型数据库。几项具有里程碑意义的研究表明，SCS 在治疗 FBSS 患者方面优于 CMM 或再次脊柱手术，但很少有大型研究检查其长期经济影响。
本研究比较了 SCS 与 FBSS 患者其他管理方法的医疗保健利用情况。
回顾性。
住院和门诊样本。
选择 2000 年至 2012 年有 FBSS 病史的患者。我们比较了接受 SCS 治疗的患者和接受常规治疗的患者。使用广义估计方程（GEE）模型对每个一年间隔的对数（成本）值进行纵向分析，以考虑同一患者在多年中的成本相关性。同样，应用对数链接的泊松 GEE 模型来处理相关的计数结果。
我们确定了 122827 例 FBSS 患者。其中，5328 例接受了 SCS 植入（4.34%），117499 例接受了常规治疗。在 SCS 系统植入后，总年度成本随着时间的推移而降低，在 1、3、6 和 9 年的随访分析中。纵向 GEE 模型表明，在植入 SCS 系统时，总费用会立即增加（成本比 [CR]：1.74；95%置信区间 [CI]：1.41，2.15，P <0.001），然而，在 SCS 植入后一年，费用显著且持续下降 68%（CR：0.32；95%CI：0.24，0.42，P <0.001）与 CMM 相比。还有一个总体时间趋势，即 SCS 后每年的费用平均每年下降 40%（CR：0.60；95%CI：0.55，0.65，P <0.001），随访时间最长可达 1、3、6 和 9 年。
成本与患者结局不相关，患者在先前脊柱手术的复杂性方面没有分层，以及回顾性分析的固有局限性。
我们发现，2000 年至 2012 年期间，美国只有 4.3%的 FBSS 患者接受了 SCS 治疗。与接受常规治疗的患者相比，这些患者的长期总年度成本显著降低。尽管植入 SCS 系统会在一年时导致短期成本增加，但随后的年度累计成本在植入后 9 年内显著降低。本研究结合了迄今为止最大的一组 FBSS 患者研究和最长的随访间隔分析。由于 SCS 在随机临床试验中已多次显示出优于 CMM 的疗效，因此目前的研究表明，在 1、3、6 和 9 年时具有更好的长期健康经济学效果，支持 SCS 在 FBSS 患者治疗中的长期成本效用。关键词：失败的脊柱手术综合征、脊髓刺激、背痛、腿痛、神经调节、FBSS、SCS。
