Int Forum Allergy Rhinol. 2023 Apr 26. doi: 10.1002/alr.23173. Online ahead of print.
ABSTRACT
BACKGROUND: Nasal airway obstruction (NAO) is a highly prevalent disorder. Septal swell body (SSB) hypertrophy is an often-overlooked contributor to NAO. SSB treatment may relieve symptoms of NAO. The objective of this study was to assess the clinical use of a temperature-controlled radiofrequency (TCRF) device to treat SSBs to improve symptoms in adults with NAO.
METHODS: In this prospective, multicenter, open-label, single arm study, patients with severe or extreme NAO related to SSB hypertrophy received bilateral TCRF treatment in the SSB area. The primary endpoint was improvement in Nasal Obstruction Symptom Evaluation (NOSE) scale scores from baseline to 3 months post-procedure. A subset of study patients underwent computed tomography (CT) imaging to evaluate post-treatment changes in SSB size.
RESULTS: Mean NOSE scale scores significantly improved from 73.5 (SD 14.2) at baseline to 27.9 (SD 17.2) at 3 months post-procedure; a reduction of -45.3 (SD 21.4), (95% confidence interval [CI]: -50.4 to -40.1; p< 0.0001): the responder rate was 95.7% (95% CI: 0.88 to 0.99; p < 0.0001). CT evaluation at 3 months showed statistically significant reductions in the SSB with the greatest reduction in the middle thickness: (mean change -3.4 [SD 1.8] millimeters [95% CI: -4.0 to -2.8; p<.0001]). Minimal adverse events with any relationship to the device or procedure were reported, none were serious in nature and no septal perforations occurred.
CONCLUSIONS: This study demonstrates that temperature-controlled radiofrequency treatment of SSB hypertrophy is well-tolerated and effective at reducing both SSB size and symptoms of NAO at 3 months post-treatment.
PMID:37100587 | DOI:10.1002/alr.23173
