Velasquez Nathalia, Thamboo Andrew, Abuzeid Waleed M, Nayak Jayakar V
Division of Rhinology, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.
Division of Rhinology, Department of Otolaryngology-Head and Neck Surgery, Albert Einstein College of Medicine, Bronx, New York, U.S.A.
Laryngoscope. 2017 Jun;127(6):1268-1275. doi: 10.1002/lary.26493. Epub 2017 Feb 14.
OBJECTIVES/HYPOTHESIS: Current rhinologic practice is devoid of minimally invasive procedures dedicated to the treatment of ethmoid sinusitis to improve ventilation and topical drug delivery. We have recently described a handheld spiral punch to create minimally invasive ethmoid punch sinusotomy (EPS) sites into the ethmoid bulla and basal lamella, which significantly increased irrigant access to the ethmoid sinuses in cadaver models. Here, we conducted a clinical feasibility study to determine the initial safety evaluation of EPS in chronic rhinosinusitis without polyposis (CRSsNP) patients with active ethmoid disease.
Single-arm, institutional review board-approved observational study.
This study was performed in CRSsNP patients who failed medical management; were candidates for standard, traditional functional endoscopic sinus surgery; and were offered the option of EPS. EPS characteristics (patency, remucosalization) and complications (closure, mucus recirculation) were collected. Alterations in radiographic disease and symptoms after EPS were determined by Lund Mackay (LM) scoring and 22-item Sinonasal Outcome Test (SNOT-22) scoring, which was collected up to 6 months post-procedure.
Thirty-two of 40 possible ethmoid compartments (17 of 20 anterior, 15 of 20 posterior) underwent EPS. Twenty-nine of 32 EPS sites remained patent (n = 29, 90.6%), with a minority displaying evidence of restenosis (n = 9, 28.1%) or closure (n = 3, 9.3%). All patent EPS sites had complete remucosalization (n = 29, 100%) with no evidence of mucus recirculation (n = 0, 0%) or other complications secondary to healing or device use. Ethmoid sinus cavities with a pre-EPS LM score of 1 or 2 universally improved to an LM score of 0 following EPS (n = 30 of 30, 100%). SNOT-22 scores significantly improved, with a mean reduction of 33.1 (49.6 ± 7.5 pre-EPS vs 16.5 ± 7.7 post-EPS, p < .0001).
This feasibility study demonstrates that EPS appears to be a safe, minimally invasive procedure to treat ethmoid sinusitis in CRSsNP patients unresponsive to medical therapy that establishes ethmoid ventilation, and likely improves effective sinus irrigation. Conducting a clinical trial would be appropriate in assessing a potential role for EPS in the management of this condition.
目的/假设：目前的鼻科实践中缺乏专门用于治疗筛窦炎以改善通气和局部药物递送的微创手术。我们最近描述了一种手持式螺旋打孔器，用于在筛泡和基板上创建微创筛窦打孔鼻窦切开术（EPS）部位，这在尸体模型中显著增加了灌洗液进入筛窦的通道。在此，我们进行了一项临床可行性研究，以确定EPS在患有活动性筛窦疾病的无息肉慢性鼻-鼻窦炎（CRSsNP）患者中的初步安全性评估。
单臂、经机构审查委员会批准的观察性研究。
本研究在药物治疗失败的CRSsNP患者中进行；这些患者是标准传统功能性内镜鼻窦手术的候选者，并提供了EPS选项。收集EPS的特征（通畅性、黏膜再形成）和并发症（闭合、黏液再循环）。通过Lund Mackay（LM）评分和22项鼻鼻窦结局测试（SNOT-22）评分确定EPS后影像学疾病和症状的变化，这些评分在术后6个月内收集。
40个可能的筛窦间隔中有32个（20个前筛窦中的17个，20个后筛窦中的15个）接受了EPS。32个EPS部位中有29个保持通畅（n = 29，90.6%），少数显示有再狭窄（n = 9，28.1%）或闭合（n = 3，9.3%）的证据。所有通畅的EPS部位均有完全的黏膜再形成（n = 29，100%），没有黏液再循环（n = 0，0%）或其他因愈合或使用器械引起的并发症的证据。EPS前LM评分为1或2的筛窦腔在EPS后普遍改善至LM评分为0（30个中的30个，100%）。SNOT-22评分显著改善，平均降低33.1（EPS前49.6±7.5 vs EPS后16.5±7.7，p <.0001）。
这项可行性研究表明，EPS似乎是一种安全的微创手术，可用于治疗对药物治疗无反应的CRSsNP患者的筛窦炎，建立筛窦通气，并可能改善有效的鼻窦冲洗。进行临床试验以评估EPS在这种疾病管理中的潜在作用是合适的。
4。《喉镜》，127:1268 - 1275，2017年。
