Chaaban Mohamad R, Rana Nikunj, Baillargeon Jacques, Baillargeon Gwen, Resto Vicente, Kuo Yong-Fang
1 Department of Otolaryngology, University of Texas Medical Branch, Galveston, Texas.
2 Office of Biostatistics, Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston, Texas.
Am J Rhinol Allergy. 2018 Sep;32(5):388-396. doi: 10.1177/1945892418782248. Epub 2018 Jun 27.
Background Since the Food and Drug Administration approval of balloon sinuplasty (BSP) in 2005, no nationally representative population-based studies have examined the outcomes and adverse events of BSP. Objective To assess the rates of complications and revision surgery in patients who received BSP, functional endoscopic sinus surgery (FESS), or a hybrid procedure. Methods Using one of the nation's largest commercial insurance databases, we conducted a retrospective cohort study of pediatric and adult patients diagnosed with chronic rhinosinusitis between 2011 and 2014 who underwent BSP, conventional FESS, or a hybrid procedure. The primary outcomes were surgical complication and revision rates within 6 months of initial surgery. Results A total of 16,040 patients who underwent sinus surgery were included. Overall, 2,851 patients underwent BSP, 11,955 underwent conventional FESS, and 1 234 underwent a hybrid procedure. BSP surgery was more likely to have been performed in an office setting (86.53%) compared to FESS (0.74%). The complication rate was 5.26% for BSP and 7.35% for conventional FESS. Revision rates were 7.89% for BSP, 16.85% for FESS, and 15.15% for a hybrid procedure. Conclusion Despite the low overall risk, major complications occur with BSP including cerebrospinal fluid leak, pneumocephalus, orbital complications, and severe bleeding. Otolaryngologists should discuss these risks with their patients. Prospective studies are still needed to compare outcomes of BSP with those of FESS.
背景 自2005年美国食品药品监督管理局批准球囊鼻窦成形术(BSP)以来,尚无全国代表性的基于人群的研究对BSP的疗效和不良事件进行过考察。目的 评估接受BSP、功能性鼻内镜鼻窦手术(FESS)或混合手术的患者的并发症发生率和翻修手术率。方法 利用美国最大的商业保险数据库之一,我们对2011年至2014年间被诊断为慢性鼻-鼻窦炎并接受BSP、传统FESS或混合手术的儿科和成年患者进行了一项回顾性队列研究。主要结局为初次手术后6个月内的手术并发症和翻修率。结果 总共纳入了16040例接受鼻窦手术的患者。总体而言,2851例患者接受了BSP,11955例接受了传统FESS,1234例接受了混合手术。与FESS(0.74%)相比,BSP手术更有可能在门诊进行(86.53%)。BSP的并发症发生率为5.26%,传统FESS为7.35%。BSP的翻修率为7.89%,FESS为16.85%,混合手术为15.15%。结论 尽管总体风险较低,但BSP仍会发生包括脑脊液漏、气颅、眼眶并发症和严重出血在内的严重并发症。耳鼻喉科医生应与患者讨论这些风险。仍需要进行前瞻性研究以比较BSP与FESS的疗效。