Department of Neurosurgery, Würzburg University Hospital, Würzburg, Germany.
Department of Neurosurgery, Würzburg University Hospital, Würzburg, Germany,
Stereotact Funct Neurosurg. 2021;99(4):305-312. doi: 10.1159/000512231. Epub 2021 Jan 5.
Deep brain stimulation (DBS) is an approved treatment for movement disorders. Despite high precision in electrode placement, side effects do occur by current spread to adjacent fibers or nuclei. Directional leads (D-leads) are designed to adapt the volume of stimulation relative to the position within the target by horizontal and vertical current steering directions. The feasibility of implanting these new leads, possible difficulties, and complications were the focus of this study.
This analysis is based on 31 patients who underwent a DBS procedure with D-leads and an implantable pulse generator (IPG) capable of multiple independent current control and 31 patients who received non-D-leads with a similar IPG. While trajectory planning and most steps of the surgical procedure were identical to conventional DBS lead implantation, differences in indication, electrode handling, lead control, and complications were documented and analyzed in comparison to a control group with ring electrodes.
During a consecutive series of 51 patients implanted with a DBS system, 31 patients (60.1%) were selected for implantation of D-leads and received 59 D-leads, 28 bilateral, and 3 unilateral implantations. The control group consisted of a consecutive series of a comparable time period, with 31 patients who received conventional ring electrodes. Indication of D-lead implantation was based on the anatomic conditions of the trajectory and target regions and the results of intraoperative test stimulations. In 1 patient, primary D-lead implantation on both sides was performed without any microelectrode implantation to minimize risk for hemorrhage. In the absence of an externally visible marker, the control of implant depth and of the orientation of the D-lead needs to be controlled by X-ray resulting in a longer fluoroscopy time and, therefore, higher X-ray dose compared to conventional lead implantations (415.53 vs. 328.96 Gy cm2; p = 0.09). Mean procedure duration for complete system implantation did not differ between either type of leads (ring electrodes vs. D-leads, 08:55 vs. 09:02 h:min). Surgical complications were unrelated to the type of electrode: surgical revision was necessary and successfully performed in 1 subcutaneous hematoma and 1 unilateral electrode dislocation. A rather rare complication, symptomatic idiopathic delayed-onset edema, was observed in 4 patients with D-leads. They recovered completely within 1-3 weeks, spontaneously or after short-term cortisone medication. In the control group, in a series of 31 patients (20 implanted with Medtronic 3389 lead and 11 with Boston Scientific Vercise lead), not a single problem of this kind was encountered at any time.
Precise positioning of D-leads is more challenging than that of conventional DBS leads. By adding an external lead marker, control of optimal lead position and orientation is enhanced. In case of supposed increased risk for hemorrhage because of vessels crossing all possible trajectories in the pre-surgical navigated simulation program, primary D-lead implantation instead of the sharper microelectrodes may be a feasible alternative and it may offer more options than ring electrodes especially in these cases. Prospective studies comparing ring-mode stimulation to directional stimulation to examine the differences of the clinical effects have been started.
深部脑刺激(DBS)是一种已被批准用于治疗运动障碍的方法。尽管电极的放置精度很高,但电流扩散到相邻的纤维或核也会导致副作用的发生。定向导联(D-导联)旨在通过水平和垂直电流转向方向来适应目标内位置的刺激体积。这项研究的重点是这些新导联的植入可行性、可能出现的困难和并发症。
本分析基于 31 名接受 DBS 手术和可进行多次独立电流控制的植入式脉冲发生器(IPG)的 D-导联植入的患者,以及 31 名接受类似 IPG 的非 D-导联植入的患者。虽然轨迹规划和手术过程的大多数步骤与传统 DBS 导联植入相同,但在与对照组(环形电极)的比较中,记录和分析了适应证、电极处理、导联控制和并发症方面的差异。
在连续 51 名植入 DBS 系统的患者中,有 31 名患者(60.1%)被选择植入 D-导联,并植入了 59 个 D-导联,其中 28 个为双侧植入,3 个为单侧植入。对照组由同一时间段的连续系列患者组成,其中 31 名患者接受了传统的环形电极。D-导联植入的适应证基于轨迹和目标区域的解剖条件以及术中测试刺激的结果。在 1 名患者中,双侧均进行了无微电极植入的原发性 D-导联植入,以最大程度地降低出血风险。由于缺乏外部可见的标记物,需要通过 X 射线来控制植入深度和 D-导联的方向,这导致 X 射线透视时间更长,因此与传统导联植入相比,X 射线剂量更高(415.53 与 328.96 Gy cm2;p = 0.09)。两种导联类型(环形电极与 D-导联)的完整系统植入的平均手术时间没有差异(08:55 与 09:02 h:min)。手术并发症与电极类型无关:需要进行手术修正,并成功地对 1 例皮下血肿和 1 例单侧电极脱位进行了修正。在 4 名接受 D-导联植入的患者中观察到一种相当罕见的并发症,即症状性特发性迟发性水肿,他们在 1-3 周内自行或短期皮质激素治疗后完全恢复。在对照组中,在 31 名患者(20 名接受 Medtronic 3389 导联植入,11 名接受 Boston Scientific Vercise 导联植入)的连续系列中,任何时候都没有遇到过这种类型的问题。
D-导联的精确定位比传统 DBS 导联更具挑战性。通过添加外部导联标记物,可以增强最佳导联位置和方向的控制。在由于血管穿越术前导航模拟程序中所有可能的轨迹而导致出血风险增加的情况下,代替更锋利的微电极进行原发性 D-导联植入可能是一种可行的替代方法,它比环形电极提供了更多的选择,特别是在这些情况下。已经开始了比较环形模式刺激和定向刺激的前瞻性研究,以检查临床效果的差异。