Nathalia Velasquez1, Andrew Thamboo1, Waleed M Abuzeid2, Jayakar V Nayak1. 1. Division of Rhinology, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A. 2. Division of Rhinology, Department of Otolaryngology-Head and Neck Surgery, Albert Einstein College of Medicine, Bronx, New York, U.S.A.
Abstract
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. STUDY DESIGN: Single-arm, institutional review board-approved observational study. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:1268-1275, 2017.
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. STUDY DESIGN: Single-arm, institutional review board-approved observational study. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:1268-1275, 2017.
Authors: Peter Baptista; Octavio Garaycochea; Carlos Prieto-Matos; Marta Alvarez de Linera Alperi; Juan Alcalde Journal: Int Arch Otorhinolaryngol Date: 2019-05-28