Petraglia Frank W, Farber S Harrison, Han Jing L, Verla Terence, Gallis John, Lokhnygina Yuliya, Parente Beth, Hickey Patrick, Turner Dennis A, Lad Shivanand P
School of Medicine, Duke University School of Medicine, Durham, NC, USA.
Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
Neuromodulation. 2016 Jan;19(1):31-7. doi: 10.1111/ner.12351. Epub 2015 Nov 16.
The most popular surgical method for deep brain stimulation (DBS) in Parkinson's disease (PD) is simultaneous bilateral DBS. However, some centers conduct a staged unilateral approach advocating that reduced continuous intraoperative time reduces postoperative complications, thus justifying the cost of a second operative session. To test these assumptions, we performed a retrospective analysis of the Truven Health MarketScan® Database.
Using the MarketScan Database, we retrospectively analyzed patients that underwent simultaneous bilateral or staged unilateral DBS between 2000 and 2009. The main outcome measures were 90-day postoperative complication rates, number of reprogramming hours one year following procedure, and annualized healthcare cost. The outcome measures were compared between cohorts using multivariate regressions controlling for appropriate covariates.
A total of 713 patients that underwent DBS between 2000 and 2009 met inclusion criteria for the study. Of these patients, 556 underwent simultaneous bilateral DBS and 157 received staged unilateral DBS. No statistically significant differences were found between groups in the rate of infection (simultaneous: 4.3% vs. staged: 7.0%; p = 0.178), pneumonia (3.1% vs. 5.7%; p = 0.283), hemorrhage (2.9% vs. 2.5%; p = 0.844), pulmonary embolism (0.5% vs. 1.3%), and device-related complications (0.5% vs. 0.0%). Patients in the staged cohort had a higher rate of lead revision in 90 days (3.2% vs. 12.7%; RR = 3.07; p < 0.001). The staged cohort had a higher mean (SD) number of reprogramming hours within one year of procedure (6.0 ± 5.7 vs. 7.8 ± 8.1; RR = 1.17; p < 0.001). No significant difference was found between the mean (SD) annualized payments between the cohorts ($86,100 ± $94,700 vs. $102,100 ± $121,500; p = 0.148).
Our study did not find a significant difference between 90-day postoperative complication rates or annualized cost between the staged and simultaneous cohorts. Thus, we believe that it is important to consider other factors when deciding between the staged and simultaneous DBS. Such factors include patient convenience and the laterality of symptoms.
帕金森病(PD)深部脑刺激(DBS)最常用的手术方法是同期双侧DBS。然而,一些中心采用分期单侧手术方法,主张减少术中持续时间可降低术后并发症,从而证明二次手术的费用合理。为验证这些假设,我们对Truven Health MarketScan®数据库进行了回顾性分析。
利用MarketScan数据库,我们回顾性分析了2000年至2009年间接受同期双侧或分期单侧DBS的患者。主要观察指标为术后90天并发症发生率、术后一年的重新编程小时数以及年化医疗费用。使用多变量回归并控制适当的协变量,对队列之间的观察指标进行比较。
2000年至2009年间接受DBS的713例患者符合本研究的纳入标准。其中,556例接受同期双侧DBS,157例接受分期单侧DBS。两组在感染率(同期:4.3% vs.分期:7.0%;p = 0.178)、肺炎(3.1% vs. 5.7%;p = 0.283)、出血(2.9% vs. 2.5%;p = 0.844)、肺栓塞(0.5% vs. 1.3%)以及与设备相关的并发症(0.5% vs. 0.0%)方面未发现统计学显著差异。分期队列的患者在90天内的导线修订率较高(3.2% vs. 12.7%;RR = 3.07;p < 0.001)。分期队列在术后一年内的平均(标准差)重新编程小时数较多(6.0±5.7 vs. 7.8±8.1;RR = 1.17;p < 0.001)。两组之间的平均(标准差)年化费用无显著差异(86,100美元±94,700美元 vs. 102,100美元±121,500美元;p = 0.148)。
我们的研究未发现分期和同期队列在术后90天并发症发生率或年化费用方面存在显著差异。因此,我们认为在决定采用分期还是同期DBS时,考虑其他因素很重要。这些因素包括患者的便利性和症状的侧重性。