den Besten Christine A, Harterink Emilie, McDermott Ann-Louise, Hol Myrthe K S
Department of Otorhinolaryngology, Radboud university medical center, Nijmegen, The Netherlands.
Department of Otorhinolaryngology, Birmingham Children's Hospital, Birmingham, United Kingdom.
Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2050-5. doi: 10.1016/j.ijporl.2015.09.010. Epub 2015 Sep 16.
To evaluate clinical outcomes of the Cochlear™ BIA300 in the pediatric population.
Historical cohort study.
Two tertiary referral centers.
All patients implanted with the BIA300 from November 2011 to January 2014 and 17 years or younger during surgery were included in this cohort study.
Number of soft tissue reaction scores according to Holgers, local and systemic treatment of soft tissue reactions, revision surgeries and implant loss.
Since introduction of the BIA300, 79 children have been implanted in both centers. During the mean follow-up of 11.7 months per implant, 15.7% of 115 implants received at least two local treatments for peri-abutment soft tissue reactions. Moreover, in 32 implants an adverse soft tissue reaction (Holgers 2 or higher) was noted at least once. In 28.7% of implants one or multiple revision surgeries were required. Implant loss occurred in 4 patients (3.5% of all implants), additionally, in five children the abutment had to be removed because of persistent soft tissue problems.
The current study confirms good implant survival for these implants in pediatric patients. The number of adverse soft tissue reactions found in the current study resembles numbers reported on previous generation implants and abutments in children. However, for revision surgery (soft tissue revision and/or abutment change), an increase in frequency is noticed compared to reported results on previous generation implants and abutments, whether this is the result of the new implant or other factors cannot be concluded on the current series. The total aspect of the presented data are of importance in the decision making for a specific type of percutaneous bone anchored hearing implant.
评估科利耳™BIA300在儿童群体中的临床疗效。
历史性队列研究。
两家三级转诊中心。
所有在2011年11月至2014年1月期间植入BIA300且手术时年龄在17岁及以下的患者均纳入本队列研究。
根据霍尔格斯标准的软组织反应评分数量、软组织反应的局部和全身治疗、翻修手术及植入体丢失情况。
自BIA300引入以来，两个中心共为79名儿童植入了该产品。每枚植入体的平均随访时间为11.7个月，115枚植入体中有15.7%因植入体周围软组织反应接受了至少两次局部治疗。此外，32枚植入体至少出现过一次不良软组织反应（霍尔格斯2级或更高）。28.7%的植入体需要进行一次或多次翻修手术。4名患者（占所有植入体的3.5%）出现植入体丢失，另外，有5名儿童因持续性软组织问题不得不移除基台。
本研究证实了这些植入体在儿科患者中的良好留存率。本研究中发现的不良软组织反应数量与之前报道的儿童使用上一代植入体和基台时的情况相似。然而，与之前报道的上一代植入体和基台的结果相比，翻修手术（软组织翻修和/或基台更换）的频率有所增加，根据目前的系列研究尚无法确定这是新植入体还是其他因素导致的结果。所呈现数据的整体情况对于特定类型的经皮骨锚式听力植入体的决策具有重要意义。
