Abstract：
OBJECTIVE: Balloon dilation of the Eustachian tube (BDET) has not been evaluated extensively in children outside of retrospective case series. The purpose of this study is to report the long-term safety and efficacy of this procedure in children with matched controls.
METHODS: This is a two-center retrospective matched cohort study. Children having undergone tympanostomy tube (TT) placement and adenoidectomy with recurrence of symptoms underwent BDET at an academic affiliated multi-specialty practice. Comparison was made with children receiving TT at a tertiary medical center, matching for number of prior TT, prior adenoidectomy, age, and sex. Outcome measures were risk of failure and the need for additional surgery. Kaplan-Meier survival plots were used to compare risk of failure.
RESULTS: Thirty-three Eustachian tubes were dilated in 20 patients, aged 14 months-14 years. All patients had previously undergone TT insertion and adenoidectomy. Patients undergoing BDET had normal post-operative tympanograms in 80 % of cases. Mean follow up was 6.7 years with 2 patients failing in the BDET group and 8 in the TT insertion group. Dilated patients had a significantly lower risk of failure than those who underwent TT insertion (adjusted HR: 0.18; 95 % CI: 0.04, 0.81; p = 0.03). The probability of being failure free at six years was 88 % (95 % CI: 71, 95 %) in the BDET cohort and 53 % (95 % CI: 33, 70 %) in the TT insertion cohort. There were no complications.
CONCLUSIONS: BDET appears to be safe and possibly superior to TT placement in children with refractory Eustachian tube dysfunction.
METHODS: 2b.
METHODS: This is a two-center retrospective matched cohort study. Children having undergone tympanostomy tube (TT) placement and adenoidectomy with recurrence of symptoms underwent BDET at an academic affiliated multi-specialty practice. Comparison was made with children receiving TT at a tertiary medical center, matching for number of prior TT, prior adenoidectomy, age, and sex. Outcome measures were risk of failure and the need for additional surgery. Kaplan-Meier survival plots were used to compare risk of failure.
RESULTS: Thirty-three Eustachian tubes were dilated in 20 patients, aged 14 months-14 years. All patients had previously undergone TT insertion and adenoidectomy. Patients undergoing BDET had normal post-operative tympanograms in 80 % of cases. Mean follow up was 6.7 years with 2 patients failing in the BDET group and 8 in the TT insertion group. Dilated patients had a significantly lower risk of failure than those who underwent TT insertion (adjusted HR: 0.18; 95 % CI: 0.04, 0.81; p = 0.03). The probability of being failure free at six years was 88 % (95 % CI: 71, 95 %) in the BDET cohort and 53 % (95 % CI: 33, 70 %) in the TT insertion cohort. There were no complications.
CONCLUSIONS: BDET appears to be safe and possibly superior to TT placement in children with refractory Eustachian tube dysfunction.
METHODS: 2b.
摘要：
目的：在回顾性病例系列以外的儿童中，尚未对咽鼓管（BDET）的球囊扩张进行广泛评估。这项研究的目的是报告该程序在具有匹配对照的儿童中的长期安全性和有效性。
方法：这是一项双中心回顾性配对队列研究。在学术附属的多专业实践中，接受鼓膜造口管（TT）放置和腺样体切除术并复发症状的儿童接受了BDET。与在三级医疗中心接受TT的儿童进行了比较，匹配先前TT的数量，先前的腺样体切除术，年龄,和性爱。结果测量是失败的风险和需要额外的手术。使用Kaplan-Meier生存图来比较失败的风险。
结果：20例患者33例咽鼓管扩张，14个月-14岁。所有患者先前都进行了TT插入和腺样体切除术。接受BDET的患者在80％的病例中术后鼓室图正常。平均随访时间为6.7年，BDET组2例患者失败，TT插入组8例。与接受TT插入的患者相比，扩张患者的失败风险显着降低（调整后的HR：0.18；95％CI：0.04，0.81；p=0.03）。在BDET队列中，六年无失效的概率为88％（95％CI：71，95％），在TT插入队列中为53％（95％CI：33，70％）。没有并发症。
结论：BDET在难治性咽鼓管功能障碍患儿中似乎是安全的，可能优于TT放置。
方法：2b.
方法：这是一项双中心回顾性配对队列研究。在学术附属的多专业实践中，接受鼓膜造口管（TT）放置和腺样体切除术并复发症状的儿童接受了BDET。与在三级医疗中心接受TT的儿童进行了比较，匹配先前TT的数量，先前的腺样体切除术，年龄,和性爱。结果测量是失败的风险和需要额外的手术。使用Kaplan-Meier生存图来比较失败的风险。
结果：20例患者33例咽鼓管扩张，14个月-14岁。所有患者先前都进行了TT插入和腺样体切除术。接受BDET的患者在80％的病例中术后鼓室图正常。平均随访时间为6.7年，BDET组2例患者失败，TT插入组8例。与接受TT插入的患者相比，扩张患者的失败风险显着降低（调整后的HR：0.18；95％CI：0.04，0.81；p=0.03）。在BDET队列中，六年无失效的概率为88％（95％CI：71，95％），在TT插入队列中为53％（95％CI：33，70％）。没有并发症。
结论：BDET在难治性咽鼓管功能障碍患儿中似乎是安全的，可能优于TT放置。
方法：2b.
