Patients were then followed at seven, 30, and 90 days after the procedure and at each time period underwent a nasal endoscopy. In addition, they were interviewed at one, seven, 30, 90, 180, and 365 days to assess nasal symptoms and side effects.
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September 2018The study used the Total Nasal Symptom Score (TNSS), a validated scoring system that rates severity of rhinorrhea, nasal congestion, nasal itching, and sneezing symptoms, as the primary outcome measure. All patients completed the TNSS prior to the procedure to establish a baseline score.
The study found a significant reduction in TNSS at 30 days after the procedure from baseline (2.6 vs. 6.2, respectively) in all 27 patients. This reduction continued to be significant at 90 days (2.7 vs. 6.2, respectively) in 24 patients, at 180 days (2.3 vs. 6.2, respectively) in 21 patients, and at 365 days (1.9 vs. 6.2, respectively) in 15 patients.
In addition to the reduction in symptoms, the procedure was safe and well tolerated, with 74% of patients reporting no or only mild pain/discomfort on the first day following the procedure. Other side effects experienced one day after the procedure, including severe ear blockage and severe nasal dryness, improved or fully resolved after 30 days. No patients reported dry eye.
Importantly, the procedure was done in an office setting. “This technology can be easily incorporated into the flow of an otolaryngology clinic,” said Dr. Luong. “It takes about 20 to 30 minutes to complete, with most of the time allotted to application of topical anesthesia. The treatment itself takes a little over a minute on each side.”
Like most new technologies, however, reimbursement remains a challenge, she said.
That said, Dr. Luong emphasized the initial promising results of the study and the benefits it shows in improving nasal congestion with minimal adverse effects. “This technology is important because post-nasal drainage is a very common complaint, and up until now the current treatment options require either a daily application or a procedure performed in the operating room under general anesthesia,” she said.
Balloon Dilation with Medical Therapy for Persistent ETD
Balloon dilation with medical therapy for persistent eustachian tube dysfunction (ETD) is a relatively new technology that has emerged over the past several years (Laryngoscope 2018;128:1200–1206; Otol Neurotol. 2018;39:894–902). Two systems are now approved by the Food and Drug Administration: the AERA Eustachian Tube Balloon Dilation System (Acclarent, Irvine, Calif.) and the XprESS ENT Dilation System (Entellus Medical).