Georgia Nasal and Sinus Institute

To assess long-term safety and effectiveness of a multipoint, impedance-controlled, RF ablation device for treatment of chronic rhinitis through 12-month follow-up. A prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6-, 9-, and 12-month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events. Thirty-six participants were enrolled and 35 completed the 12-month follow-up. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6-months, 3.8 ± 2.4 at 9-months, and 4.0 ± 2.1 at 12-months (all p < .0001). At 12-months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point and 80% (28/35) of the participants met the responder criteria of ≥30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6-months, 1.4 ± 1.0 at 9-months, and 1.3 ± 0.8 at 12-months (all p < .0001). At 12-months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ. No related serious adverse events occurred during the study. Impedance-controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up. The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. 4.

Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. A prospective, single-arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Thirty-six participants were enrolled and completed follow-up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p < .0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p < .001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < .0001). At 3months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3months post-procedure. The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. 4.

Messerklinger initially characterized sinonasal mucociliary clearance patterns in the 1950’s using India ink particles and hypothesized that inflammatory disease within the sinuses, as well as anatomic variants, could obstruct mucus outflow. He introduced use of the endoscope for diagnostic evaluation, as well as surgical principles known as the Messerklinger technique [1]. In the following 70 years his technique, known as Endoscopic Sinus Surgery (ESS), was refined and popularized by Stammberger, Kennedy, and others [2,3]. Both emphasized the preservation of normal anatomic structures and re-establishment of natural mucociliary clearance patterns. Towards that end, Kennedy viewed the surgery as a functional and minimally invasive procedure, adding the term “functional” to ESS, with the procedure now widely known as Functional Endoscopic Surgery (FESS) [4]. Since then, minimally invasive endoscopic techniques have been further refined by a multitude of talented multi-disciplinary physicians, too numerous to name here [5].

We sought to evaluate an instrument that allows a drug-eluting catheter to be inserted into the ethmoid sinuses and to demonstrate its safety and reproducibility in a cadaver model. A drug-eluting catheter was placed into 12 cadaveric anterior and posterior ethmoid sinuses by use of a trocar-based insertion device. The device's position was analyzed with computed tomographic scans, and postprocedural dissection was performed. The drug-eluting catheter system was successfully inserted in all ethmoid sinuses without injury to the medial orbital wall, skull base, or sphenoid face. The final position of the distal tip of the catheter averaged 8.1 mm (root mean square [RMS], 3.3 mm) from the skull base, 5.6 mm (RMS, 3.5 mm) from the sphenoid face, and 5.0 mm (RMS, 3.5 mm) from the lamina papyracea; the proximal tip was at the face of the ethmoid bulla and 17.1 mm (RMS, 3.5 mm) below the skull base. A trocar-based instrument can relatively safely and reproducibly introduce a drug-eluting catheter into the ethmoid sinuses without injuring the skull base, lamina papyracea, or sphenoid face. This device may allow safe topical drug delivery into the ethmoid sinuses and serve as a vehicle to treat chronic ethmoid sinusitis with direct and sustained topical therapy.

The LaryngoscopeVolume 109, Issue 11 p. 1852-1853 Article Middle Turbinate Stabilization After Functional Endoscopic Sinus Surgery: The Controlled Synechiae Technique William E. Bolger MD, Corresponding Author William E. Bolger MD Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania.William E. Bolger, MD, FACS, Chief, Division of Rhinology and Sinus Surgery, Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, 3400 Spruce Street, Philadelphia, Pennsylvania 19104, U.S.A.Search for more papers by this authorFrederick A. Kuhn MD, Frederick A. Kuhn MD Department of Georgia Center for Rhinology and Sinus Surgery, Savannah, Georgia.Search for more papers by this authorDavid W. Kennedy MD, David W. Kennedy MD Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania.Search for more papers by this author William E. Bolger MD, Corresponding Author William E. Bolger MD Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania.William E. Bolger, MD, FACS, Chief, Division of Rhinology and Sinus Surgery, Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, 3400 Spruce Street, Philadelphia, Pennsylvania 19104, U.S.A.Search for more papers by this authorFrederick A. Kuhn MD, Frederick A. Kuhn MD Department of Georgia Center for Rhinology and Sinus Surgery, Savannah, Georgia.Search for more papers by this authorDavid W. Kennedy MD, David W. Kennedy MD Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania.Search for more papers by this author First published: 04 January 2009 https://doi.org/10.1097/00005537-199911000-00025Citations: 68Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article.Citing Literature Volume109, Issue11November 1999Pages 1852-1853 RelatedInformation