Medical Therapy Versus Balloon Sinus Dilation in Adults With Chronic Rhinosinusitis (MERLOT): 12-Month Follow-up.

Background Chronic rhinosinusitis (CRS) is a devastating disease affecting nearly 30 million people in the United States. An interim analysis of data from the present study suggested that, in patients who had previously failed medical therapy, balloon sinus dilation (BSD) plus medical management (MM) provides a significant improvement in the quality of life (QOL) at 24 weeks postprocedure compared to MM alone. Objective The primary objective of this final analysis was to evaluate the durability of treatment effects through the 52-week follow-up. Methods Adults aged 19 and older with CRS who had failed MM elected either BSD plus MM or continued MM. Patients were evaluated at 2 (BSD arm only), 12, 24, and 52 weeks posttreatment. Balloon dilations were performed either as an office-based procedure under local anesthesia or in the operating room per physicians' and patients' discretion. The primary end point was change in patient-reported QOL as measured by Chronic Sinusitis Survey (CSS) total score from baseline to the 24-week follow-up. Secondary outcomes including changes in CSS, Rhinosinusitis Disability Index (RSDI), and Sino-Nasal Outcome Test (SNOT) total and subscores, sinus medication usage, missed days of work/school, number of medical care visits, and sinus infections from baseline to the 52-week follow-up are reported here within. Results BSD led to sustained greater improvements in self-reported QOL using the CSS and RSDI total scores with a trend toward improvement in the SNOT-20 total score from baseline to the 52-week follow-up compared to continued MM. There were no changes in medication usage apart from nasal steroid usage for which the MM cohort had an increase in usage. There were no device-related serious adverse events. Conclusion The current analysis highlights the safety, effectiveness, and durability of BSD in CRS patients aged 19 and older who had previously failed MM.

Patient Education for Endoscopic Sinus Surgery: Preliminary Experience Using 3D-Printed Clinical Imaging Data.

Within the Ear, Nose, and Throat (ENT) medical space, a relatively small fraction of patients follow through with elective surgeries to fix ailments such as a deviated septum or occluded sinus passage. Patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. Here we report the usage of advanced, polyjet 3D printing methods to develop a multimaterial replica of human nasal sinus anatomy, derived from clinical X-ray computed tomography (CT) data, to be used as an educational aid during physician consultation. The final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. A two-arm, single-center, randomized, prospective study was then performed in which 50 ENT surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. Statistically significant improvements in patient ratings of their physician's explanation of their treatment options (p = 0.020), self-rated anatomical understanding (p = 0.043), self-rated understanding of disease state (p = 0.016), and effectiveness of the visualization (p = 0.007) were noted from the population that viewed the 3D education model, indicating it is an effective tool which ENT surgeons may use to educate and interact with patients.