Lee Brian, Zubair Muhammad N, Marquez Yvette D, Lee David M, Kalayjian Laura A, Heck Christianne N, Liu Charles Y
Department of Neurosurgery, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
Department of Neurosurgery, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
World Neurosurg. 2015 Sep;84(3):719-26. doi: 10.1016/j.wneu.2015.04.050. Epub 2015 May 1.
The clinical results for the RNS System (NeuroPace, Mountain View, California, USA) closed-loop responsive neurostimulator for the treatment of medically intractable partial-onset seizures have been encouraging. The University of Southern California (USC) Neurorestoration Center and the Keck Hospital of USC have become the world's first institutions to implant an RNS System post U.S. Food and Drug Administration (FDA) approval. As one of the study centers, we review our experience with our group of patients who have been implanted with the RNS System.
A total of 40 surgeries by a single surgeon were performed on 10 patients (7 male and 3 female) with an average age of 39.2 years (24-66 years) and were followed for an average of 45 months (30-54 months). The average age at seizure onset was 14 years (birth-37 years) with an average of 4.7 (3-12) failed antiepileptic drugs. We reviewed the patients' charts for complications from the surgeries including infections requiring surgical intervention, hematomas, hardware failures, and death.
Of the 40 surgeries, there were 10 initial implantations of the neurostimulator and leads, 24 neurostimulator replacements for expected end of neurostimulator service, 2 incision and drainage procedures (I & Ds) for soft tissue infection followed by 1 explantation and 1 reimplantation (same patient), and 2 revisions because of one lead that was damaged at the exit point between the skull and a titanium mesh and the second lead that was damaged at an acute bend over the skull (same patient). Eight of the patients had no complications and underwent an average of 2.7 neurostimulator replacements over 7 consecutive years to date. Each patient underwent routine postoperative computed tomography imaging of the brain, and none had any intracranial hematomas or misplaced leads requiring revision surgery. Finally, there were no deaths in our patient population.
Our experience with the NeuroPace RNS System over an average follow-up of 45 months suggests that the surgery and device are safe when placed by an experienced surgeon. Although there were no clinically significant hematomas or patient deaths, we did have 1 patient each with infection and lead damage at the point of exit from the skull. We compare the results of this study with other neuromodulation procedures for epilepsy to evaluate the safety and complications associated with the RNS System. Our initial experience suggests that the RNS System can be readily incorporated into an active epilepsy surgical center.
RNS系统（美国加利福尼亚州山景城NeuroPace公司）作为一种闭环反应性神经刺激器，用于治疗药物难治性局灶性发作，其临床效果令人鼓舞。南加州大学（USC）神经修复中心和南加州大学凯克医院已成为美国食品药品监督管理局（FDA）批准后全球首批植入RNS系统的机构。作为研究中心之一，我们回顾了我们这组植入RNS系统患者的经验。
由一名外科医生对10例患者（7例男性和3例女性）共进行了40次手术，患者平均年龄39.2岁（24 - 66岁），平均随访45个月（30 - 54个月）。癫痫发作的平均起始年龄为14岁（出生 - 37岁），平均有4.7种（3 - 12种）抗癫痫药物治疗失败。我们查阅了患者病历，以了解手术并发症，包括需要手术干预的感染、血肿、硬件故障和死亡情况。
在这40次手术中，有10次为神经刺激器和电极的初次植入，24次为因神经刺激器预期使用寿命结束而进行的更换，2次为软组织感染的切开引流术（I&Ds），随后1次取出和1次重新植入（同一患者），还有2次因一根电极在颅骨与钛网之间的出口点受损以及另一根电极在颅骨上方的锐角弯曲处受损（同一患者）而进行的修复。8例患者无并发症，迄今为止在连续7年中平均进行了2.7次神经刺激器更换。每位患者术后均接受了脑部常规计算机断层扫描成像，无一例出现颅内血肿或电极位置不当需要进行翻修手术。最后，我们的患者群体中没有死亡病例。
我们对NeuroPace RNS系统平均随访45个月的经验表明，由经验丰富的外科医生进行手术和植入该设备是安全的。虽然没有临床上显著的血肿或患者死亡情况，但我们确实有1例患者出现感染，1例患者的电极在颅骨出口处受损。我们将本研究结果与其他用于癫痫的神经调节手术结果进行比较，以评估与RNS系统相关的安全性和并发症。我们的初步经验表明，RNS系统可以很容易地纳入一个活跃的癫痫手术中心。
