Perioperative safety assessment and complications follow-up of simultaneous bilateral cochlear implantation in young infants
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摘要: 目的 评估低龄婴幼儿同期双侧人工耳蜗植入的围术期安全性及长期并发症，为临床小龄儿童双侧同期人工耳蜗植入提供参考数据。 方法 连续入组2018年8月至2019年8月在解放军总医院耳鼻咽喉科就诊拟行人工耳蜗植入的74例先天性重度-极重度感音神经性聋婴幼儿，手术年龄6~23个月，单侧还是双侧植入在病情的基础上由父母决定。研究分为单侧人工耳蜗植入(UCI)1岁前组、1岁后组，同期双侧人工耳蜗植入(BCI)1岁前组、1岁后组。评估围手术期风险变量、麻醉及手术并发症、其他术后不良事件等安全性指标，并发症随访至术后5~6年。比较单、双侧植入及1岁前、1岁后植入在这些指标上是否存在统计学差异。 结果 共40例BCI患者(1岁前23例，1岁后17例)和34例UCI患者(1岁前20例，1岁后14例)纳入研究。在围手术期风险变量方面，BCI组麻醉时长、手术时长、出血量显著大于UCI组，但小于UCI组的2倍；2组均无麻醉并发症发生；2组术后住院天数差异无统计学意义。手术并发症方面，术后5年内BCI组发生7例并发症(2例主要，5例次要)，UCI组发生7例并发症(1例主要，6例次要)，2组在并发症发生率上均差异无统计学意义。在其他术后不良事件方面，BCI组总不良事件发生率显著高于UCI组(80.0% vs 38.2%)，术后中度以上贫血发生率显著高于UCI组(60.0% vs 20.6%)，平均血红蛋白水平低于UCI组[(92.35±12.14) g/L vs (102.39±13.09) g/L]；2组术后发热率无明显差异(50.0% vs 52.9%)，术后C反应蛋白水平无明显差异。在BCI组内，1岁前植入的总不良事件发生率显著高于1岁后(91.3% vs 64.7%)，术后高热发生率显著高于1岁后(26.1% vs 0)，术后中重度贫血发生率显著高于1岁后(78.3% vs 35.3%)。 结论 低龄婴幼儿双侧同期人工耳蜗植入总体风险可控，其与单侧植入比较，麻醉及手术并发症未见增多，但围手术期风险及不良事件发生率升高，尤其是对于1岁前植入者，应予以特殊关注。Abstract: Objective To evaluate the perioperative safety and long-term complications of simultaneous bilateral cochlear implantation(BCI) in young infants, providing reference data for clinical BCI in young children. Methods Seventy-four infants aged 6-23 months with congenital severe to profound sensorineural hearing loss who were candidates for cochlear implantation at the Department of Otolaryngology, Chinese PLA General Hospital between August 2018 and August 2019 were consecutively enrolled. Parents made the decision to implant either unilaterally or bilaterally. Participants were divided into unilateral cochlear implantation(UCI) group(before and after 12 months of age) and simultaneous BCI group(before and after 12 months of age). Safety indicators, including perioperative risk variables, complications, and other postoperative adverse events were monitored, with complications followed up for 5-6 years. Comparisons were made between the BCI and UCI, as well as between implantation before and after 12 months of age regarding perioperative safety and long-term complications. Results A total of 40 BCI patients(23 before 12 months, 17 after 12 months) and 34 UCI patients(20 before 12 months, 14 after 12 months) were included in the study. Regarding perioperative risk variables, the BCI group showed significantly longer anesthesia duration, operative time, and greater blood loss compared to the UCI group, though less than twice that of the UCI group; no anesthetic complications occurred in either group; and there was no significant difference in postoperative hospital stay between the groups. Regarding surgical complications during the 5-year follow-up period, the BCI group experienced 7 complications(2 major, 5 minor), while the UCI group had 7 complications(1 major, 6 minor), with no statistical differences between groups. Regarding other postoperative adverse events, the BCI group demonstrated significantly higher total adverse event rates than the UCI group(80.0% vs 38.2%), with higher rates of moderate to severe anemia(60.0% vs 20.6%) and lower mean hemoglobin levels[(92.35±12.14) g/L vs(102.39±13.09) g/L]. No significant differences were found in postoperative fever rates(50.0% vs 52.9%) or C-reactive protein levels between groups. Within the BCI group, patients implanted before 12 months indicated notably higher rates of total adverse events(91.3% vs 64.7%), high fever(26.1% vs 0), and moderate to severe anemia(78.3% vs 35.3%) compared to those implanted after 12 months. Conclusion Simultaneous BCI in young children under 2 years of age demonstrates controllable overall risks. Compared to UCI, while it shows no increase in anesthetic or surgical complications, it presents higher perioperative risks and adverse event rates, especially in patients implanted before 12 months of age, warranting special attention from medical staff.
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Key words:
- infants /
- cochlear implantation /
- bilateral /
- safety /
- complications
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表 1 BCI与UCI组患儿基本资料比较
项目 BCI(40例) UCI(34例) t P 性别(男︰女)/例 24︰16 22︰12 - 0.810 7 月龄/月 12.48±4.05 13.35±4.59 0.855 0.395 3 体重/kg 9.72±1.40 10.32±1.49 1.765 0.081 7 术前血红蛋白/(g/L) 119.90±6.86 118.00±11.15 0.884 0.379 5 术前血细胞比容/(L/L) 0.36±0.02 0.35±0.02 1.548 0.126 0 术前C反应蛋白/(mg/dL) 0.06±0.02 0.07±0.05 0.885 0.379 4 
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表 2 BCI组内1岁前与1岁后患儿基本资料比较
项目 BCI < 1岁(23例) BCI≥1岁(17例) t P 性别(男︰女)/例 12︰11 12︰5 - 0.332 2 月龄/月 9.56±1.44 16.44±2.92 9.558 < 0.000 1 体重/kg 8.98±0.83 10.72±1.40 4.809 < 0.000 1 术前血红蛋白/(g/L) 117.91±6.17 122.59±6.84 2.205 0.033 6 术前血细胞比容/(L/L) 0.35±0.02 0.36±0.02 1.982 0.054 7 术前C反应蛋白/(mg/dL) 0.06±0.02 0.05±0.01 1.199 0.239 9
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表 3 BCI < 1岁组和BCI≥1岁组围术期风险变量比较
项目 BCI < 1岁(23例) BCI≥1岁(17例) t P 麻醉时长/min 232.95±39.29 214.06±41.06 1.422 0.163 3 手术时长/min 178.09±47.28 154.59±42.88 1.561 0.127 0 术中出血量/mL 14.32±8.43 12.94±4.87 0.585 0.562 3 术后住院天数 4.77±0.67 4.00±0.84 3.113 0.003 6
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表 4 人工耳蜗植入术后并发症及相关处理
序号/组别 并发症名称 并发症类型 发现时间/诱因 处理方法 1/G1 暂时性面瘫 次要 术后即刻/电钻热损伤 激素保守治疗，2个月完全恢复 2/G1 眩晕 次要 术后第1周/EVAS 止晕、止吐卧床休息后好转 3/G1 植入体周围水/血肿 次要 术后5年/不明 消炎、抗过敏，3个月消肿 4/G2 电极异位 主要 术后1个月/不明 二次手术矫正 4/G2 脑膜炎 主要 术后3年、5年各发作1次/不明 儿科ICU抗感染 5/G2 植入体周围水/血肿 次要 术后4年/磕碰 自行消退 5/G2 线圈位置皮肤发红 次要 术后5年/磁力过大 调整磁铁吸力 6/G3 眩晕 次要 术后每年发作2~5次/EVAS，剧烈运动后 卧床休息后自行缓解 7/G3 植入体周围水/血肿 次要 术后3年，持续数月/原因不明 消炎、抗过敏，局部穿刺抽出血性液体 7/G3 皮肤破溃感染 主要 术后4年 手术取出植入体，清创引流，半年后同侧重新植入 8/G3 植入体周围水/血肿 次要 术后1~5年共发作4次/不明 消炎、抗过敏，10~40 d消肿 9/G4 切口处皮肤损伤 次要 术中/电钻损伤 局部换药，2周恢复 10/G4 眩晕 次要 术后第1周/EVAS 止晕止吐卧床休息后好转 11/G4 鼓膜穿孔 次要 术后即刻/术中损伤 耳道内填塞碘仿纱条，2周恢复 EVAS：前庭水管扩大综合征。
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表 5 UCI组和BCI组其他不良事件比较
人次 其他不良事件 UCI(34例) BCI(40例) G3 G4 合计 G1 G2 合计 中热 9 6 15 7 8 15 高热 2 1 3 6 0 6 中度贫血 6 0 6 17 6 23 重度贫血 1 0 1 1 0 1 甲流 0 0 0 1 0 1 腹泻 1 0 1 2 1 3 总计 19 7 26 34 15 49
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