Simopoulos Thomas, Sharma Sanjiv, Aner Moris, Gill Jatinder S
Department of Anesthesiology, Critical Care and Pain Medicine Beth Israel Deaconess Medical Center, Boston, MA, USA.
Neuromodulation. 2018 Jul;21(5):508-512. doi: 10.1111/ner.12687. Epub 2017 Sep 13.
A trial of spinal cord stimulation (SCS) is a prerequisite to determine efficacy of the therapy prior to placement of a permanent implanted system. A trial may be conducted employing a percutaneously placed temporary cylindrical lead or via a permanently anchored cylindrical lead placed and subsequently secured via open surgical method. There has been little investigation comparing the two methods of trial. This study is a comparative analysis of the two methods both for prediction of success as well as associated morbidity.
Retrospective chart review.
SCS outcomes of percutaneous temporary lead trial or the temporary lead (TL) group and permanent anchored lead trial or permanent lead (PL) group were analyzed for lack of relief, poor paresthesia coverage, false positive trial phase, fading relief, and biological complications.
Outcome data was analyzed for 148 patients in the TL group and 138 patients in the PL group. In comparing the two trial methods, false positive rate of trial was higher (p < 0.05) in the PL group as compared to the TL group (6.35 vs. 1.35%). Cumulative wound infections (6.52 vs. 1.35%), and poor wound healing (4.35 vs. 0%) were also significantly higher in the PL group. Rate of success in the trial phase was equal in both groups.
The percutaneous temporary lead trial group was associated with fewer false positives and wound related complications as compared to permanent anchored lead trial group. There was very little technical advantage of routinely anchoring the trial lead.
脊髓刺激(SCS)试验是在植入永久性系统之前确定该疗法疗效的先决条件。试验可采用经皮放置的临时圆柱形导联进行,或通过开放手术方法放置并随后固定的永久性锚定圆柱形导联进行。很少有研究比较这两种试验方法。本研究是对这两种方法在预测成功率以及相关发病率方面的比较分析。
回顾性病历审查。
分析经皮临时导联试验组(临时导联组)和永久性锚定导联试验组(永久性导联组)的SCS结果,包括缓解不足、感觉异常覆盖不佳、试验阶段假阳性、缓解消退和生物学并发症。
分析了临时导联组148例患者和永久性导联组138例患者的结果数据。比较两种试验方法,永久性导联组的试验假阳性率高于临时导联组(p < 0.05)(6.35%对1.35%)。永久性导联组的累积伤口感染率(6.52%对1.35%)和伤口愈合不良率(4.35%对0%)也显著更高。两组在试验阶段的成功率相同。
与永久性锚定导联试验组相比,经皮临时导联试验组的假阳性和与伤口相关的并发症更少。常规锚定试验导联几乎没有技术优势。