Caversaccio Marco, Wimmer Wilhelm, Hoch Annegret, Dejaco Thomas, Schwab Burkard
Department of Otorhinolaryngology- Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Department of Otorhinolaryngology, Klinikum Rechts Der Isar, Technical University of Munich, Munich, Germany.
Eur Arch Otorhinolaryngol. 2025 Jun 6. doi: 10.1007/s00405-025-09502-w.
To estimate incidence rates of adverse events associated with bone-conduction hearing implants from primary literature and to compare rates among different technological designs.
A systematic literature review and meta-regression was conducted to estimate incidence rates of minor and major complications and their consequences (i.e., revision surgery, explantation, re-implantation and becoming a non-user) while testing for effects of device design, age group, mean follow-up time and study type. These four designs of bone-conduction systems were included: 1) active transcutaneous with electromagnetic transducer (aBCIem), 2) active transcutaneous with piezoelectric transducer (aBCIpz), 3) passive transcutaneous (tBAHA), and 4) passive percutaneous (pBAHA).
The final dataset included 170 articles reporting on 6451 implantations and 1847 minor and 668 major events. Mean follow-up time was a significant predictor of incidence rates (p < 0.001), with lower rates reported in studies with longer follow-up times. After adjusting to the median follow-up time, the pooled incidence rate of minor complications was significantly lower in aBCIem (p < 0.05) compared to other designs. For both major events and revision surgery, pooled incidence rates were significantly higher in pBAHA compared to aBCIem (p < 0.001) and tBAHA (p < 0.001), but not compared to aBCIpz (Major: p = 0.197; Revision: p = 0.248). Becoming a non-user occurred significantly more frequently in tBAHA compared to other designs (p < 0.005). No statistically significant differences were found in rates of explantation and explantation with re-implantation.
When comparing across multiple studies, adverse event rates should be adjusted for different lengths of follow-up. Synthesizing published evidence without considering follow-up time may lead to false conclusions.
通过原始文献估计骨传导听力植入物相关不良事件的发生率，并比较不同技术设计之间的发生率。
进行了一项系统的文献综述和元回归分析，以估计轻微和严重并发症的发生率及其后果（即翻修手术、取出、重新植入和不再使用），同时测试设备设计、年龄组、平均随访时间和研究类型的影响。纳入了四种骨传导系统设计：1）带有电磁换能器的有源经皮式（aBCIem），2）带有压电换能器的有源经皮式（aBCIpz），3）无源经皮式（tBAHA），4）无源经皮穿刺式（pBAHA）。
最终数据集包括170篇报告6451例植入以及1847例轻微事件和668例严重事件的文章。平均随访时间是发生率的一个显著预测因素（p < 0.001），随访时间较长的研究报告的发生率较低。在调整到中位随访时间后，与其他设计相比，aBCIem中轻微并发症的合并发生率显著较低（p < 0.05）。对于严重事件和翻修手术，与aBCIem（p < 0.001）和tBAHA（p < 0.001）相比，pBAHA的合并发生率显著较高，但与aBCIpz相比无显著差异（严重事件：p = 0.197；翻修手术：p = 0.248）。与其他设计相比（p < 0.005），tBAHA中不再使用的情况显著更频繁。在取出以及取出后重新植入的发生率方面未发现统计学显著差异。
在多项研究之间进行比较时，应针对不同的随访时长对不良事件发生率进行调整。不考虑随访时间而综合已发表的证据可能会导致错误结论。
