Abari Jaouad, Matulic Marco, Galeazzi Pablo, Assadi Masoud Zoka, Van de Heyning Paul, Topsakal Vedat
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
CASCINATION AG, Bern, Switzerland.
PLoS One. 2025 Jun 26;20(6):e0326614. doi: 10.1371/journal.pone.0326614. eCollection 2025.
Robot-assisted cochlear implantation surgery (RACIS) involves the drilling of a keyhole access to the inner ear for cochlear implant placement to treat patients with severe-to-profound sensorineural hearing loss. RACIS with the HEARO-procedure does not require the drilling of a mastoidectomy and posterior tympanotomy to pass through the facial recess. Instead, it directly drills through it guarding a safe distance from both the facial nerve and chorda tympani. Cochlear implantation surgery involves a well described risk for facial nerve injury when passing through the facial recess. Neuromonitoring as a safety protocol gained great importance in conventional CI surgery and is proving its benefits in RACIS. RACIS in the HEARO-procedure involves a customized facial nerve monitoring (FNM) device that was designed and tested in an animal model study. Here, this device was retrospectively assessed in the largest series of patients undergoing the HEARO-procedure.
The safety protocol in the HEARO-procedure involves FNM and intra-operative cone-beam CT (CBCT) imaging with a 0.1 mm spatial resolution. The customized FNM device was employed, using both active mono- and bipolar stimulation to estimate the distance to the facial nerve in RACIS. Linear regression was used to determine if the minimum stimulation thresholds (FNM) could significantly predict the intra-operative distance (CBCT) between the drilled trajectory and the facial nerve. Logistic regression was used to calculate if FNM can distinguish distances smaller and greater than 0.4 mm to the facial nerve.
The minimum stimulation thresholds significantly predicted the distances between the drilling trajectory and the facial nerve for both the monopolar (p = 0.001) and bipolar 3 (p = 0.008) stimulation configuration. Both the monopolar (β = -0.189, S.E. = 0.063, p = 0.003) and bipolar 3 (β = -0.187, S.E. = 0.080, p = 0.019) stimulation configuration are negative and significant predictors of the probability of the distance being smaller than 0.4 mm.
FNM will alert the surgeon when the drilling trajectory comes closer than 0.4 mm to the facial nerve in RACIS. A linear relationship was observed between the minimum stimulation thresholds and the intra-operative distance towards the facial nerve.
机器人辅助人工耳蜗植入手术（RACIS）包括钻一个通向内耳的锁孔通路，以便植入人工耳蜗，治疗重度至极重度感音神经性听力损失患者。采用HEARO手术的RACIS不需要进行乳突切除术和后鼓室切开术来穿过面神经隐窝。相反，它直接穿过面神经隐窝，与面神经和鼓索保持安全距离。在穿过面神经隐窝时，人工耳蜗植入手术存在面神经损伤的明确风险。神经监测作为一种安全方案，在传统人工耳蜗植入手术中变得非常重要，并且在RACIS中也证明了其益处。采用HEARO手术的RACIS涉及一种定制的面神经监测（FNM）设备，该设备在动物模型研究中进行了设计和测试。在此，对接受HEARO手术的最大系列患者进行了该设备的回顾性评估。
HEARO手术中的安全方案包括FNM和术中锥束CT（CBCT）成像，空间分辨率为0.1毫米。采用定制的FNM设备，使用主动单极和双极刺激来估计RACIS中面神经的距离。使用线性回归来确定最小刺激阈值（FNM）是否能显著预测钻孔轨迹与面神经之间的术中距离（CBCT）。使用逻辑回归来计算FNM是否能区分距面神经小于和大于0.4毫米的距离。
对于单极（p = 0.001）和双极3（p = 0.008）刺激配置，最小刺激阈值显著预测了钻孔轨迹与面神经之间的距离。单极（β = -0.189，标准误 = 0.063，p = 0.003）和双极3（β = -0.187，标准误 = 0.080，p = 0.019）刺激配置都是距离小于0.4毫米概率的负向且显著预测因子。
在RACIS中，当钻孔轨迹与面神经的距离小于0.4毫米时，FNM会提醒外科医生。观察到最小刺激阈值与术中面神经距离之间存在线性关系。
