Department of Otorhinolaryngology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.
Department of Cardiology and Pulmonology, Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.
Eur Arch Otorhinolaryngol. 2021 Feb;278(2):477-483. doi: 10.1007/s00405-020-06170-w. Epub 2020 Jun 26.
Since 2001, hypoglossal nerve stimulators have been implanted in patients with obstructive sleep apnea around the world, initially in trial situations but more recently also in regular care settings. Medium term data indicate effectiveness and tolerability of treatment. However, when assessing the safety of the procedure, the safe feasibility of explantation or reimplantation must also be considered.
Nine patients with an implanted respiratory-driven hypoglossal nerve stimulator. We have evaluated the feasibility and safety of explantation or re-implantation with another stimulation system.
In 2012, nine patients were implanted with a respiratory-driven hypoglossal nerve stimulator as part of the Apnex Medical Pivotal Study. The study was ended in 2013. For a variety of reasons, the system was explanted from all nine patients by the year 2019. Three of these patients were re-implanted with a different system with respiratory sensing during the same session (mean incision to closure time for explantation 88.2 ± 35.01 min., mean incision to closure time for re-implantation 221.75 ± 52.73 min.). Due to extensive scar tissue formation, all procedures were technically challenging. Complication rate was significantly higher when re-implantation was performed or attempted in the same surgical session (0 of 5 patients with explantation versus 3 of 4 patients with attempted re-implantation; p = 0.018). There was no significant difference between the AHI values before and after implantation in patients with re-implantation.
Explantation and re-implantation are technically challenging though possible procedures. The single-staged equilateral reimplantation of another hypoglossal nerve stimulation system can, but need not, be successful.
自 2001 年以来，舌下神经刺激器已在全球范围内用于治疗阻塞性睡眠呼吸暂停患者，最初是在试验环境中，但最近也在常规护理环境中。中期数据表明了治疗的有效性和耐受性。然而，在评估该程序的安全性时，还必须考虑到取出或重新植入的安全性和可行性。
9 名植入呼吸驱动性舌下神经刺激器的患者。我们评估了使用另一种刺激系统进行取出或重新植入的可行性和安全性。
2012 年，9 名患者作为 Apnex Medical 关键研究的一部分植入了呼吸驱动性舌下神经刺激器。该研究于 2013 年结束。由于各种原因，到 2019 年，所有 9 名患者的系统都被取出。其中 3 名患者在同一手术中使用具有呼吸感应功能的不同系统重新植入（取出的平均切口至闭合时间为 88.2±35.01 分钟，重新植入的平均切口至闭合时间为 221.75±52.73 分钟）。由于广泛的疤痕组织形成，所有手术都具有技术挑战性。在同一手术中进行或尝试重新植入时，并发症发生率明显更高（取出 5 例患者中无一例发生并发症，而尝试重新植入的 4 例患者中有 3 例发生并发症；p=0.018）。重新植入患者的 AHI 值在植入前后没有显著差异。
取出和重新植入虽然具有挑战性，但也是可行的程序。可以进行，但不一定成功，进行另一个舌下神经刺激系统的等边形单阶段重新植入。
