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.

Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study.

BACKGROUND: Although previous studies of sinus surgery that used balloon catheter dilation technology for the paranasal sinuses (balloon sinus dilation [BSD]) demonstrated safety and efficacy, data that compare BSD with continued medical management (MM) are lacking. OBJECTIVE: To evaluate the outcomes of sinus surgery when using BSD instruments versus MM for patients with chronic rhinosinusitis for whom MM failed. METHODS: Adult patients with chronic rhinosinusitis for whom a minimum of 3 weeks of oral antibiotics, 4 weeks of daily saline solution therapy, and 4 weeks of daily nasal corticosteroids failed were included. Qualifying participants were allowed to self-select sinus surgery with BSD (either an office or operating room setting) or continued MM. The primary end point was the comparison of change in the Chronic Sinusitis Survey score from baseline to 24 weeks. Secondary end points included comparisons of change for the Rhinosinusitis Disability Index (RSDI) and the Sino-Nasal Outcome Test (SNOT-20). RESULTS: A total of 198 patients were enrolled (146 surgery and 52 MM). Of the patients who chose BSD, 72% (105/146) had their procedures completed in an office setting. Overall, BSD instruments were successful in dilating 97.6% of targeted sinuses (561/575). Patients who chose BSD showed a significantly greater improvement in the Chronic Sinusitis Survey score versus MM (42.0 versus 27.0, p < 0.001). Results from the RSDI and SNOT-20 surveys showed similar improvements for surgery versus MM (RSDI, 36.0 versus 18.1, p < 0.001; SNOT-20, 1.7 versus 1.0, p < 0.002). CONCLUSION: Patients who selected sinus surgery in which BSD instruments were used on the peripheral sinuses demonstrated significantly greater improvements in quality of life compared with those who elected ongoing MM. These results were achieved through office-based procedures with the patient under local anesthesia in the majority of patients.

Self-cross-linked hyaluronic acid hydrogel in ethmoidectomy: a randomized, controlled trial.

BACKGROUND: This study was designed to evaluate the safety and efficacy of a novel, self-cross-linked hyaluronic acid (HA) hydrogel compared with carboxymethylcellulose (CMC) viscous foam in promoting healing when applied after ethmoidectomy. A prospective, randomized, controlled, blinded clinical trial was performed. The study was performed by four surgeons operating in two community hospitals. METHODS: Thirty patients with bilateral chronic rhinosinusitis underwent bilateral total ethmoidectomy. Intraoperatively, each patient received 5 mL of HA hydrogel in one ethmoid cavity and 5 mL of CMC contralaterally. The material applied within each ethmoid cavity was randomly assigned before surgery. An independent surgeon, blinded to the material used to treat each ethmoid cavity, evaluated postoperative endoscopic video at 1 and 2 weeks for edema, crusting, and mucopurulence and at 6 and 12 weeks for remucosalization and scarring/synechiae. Twenty-item Sino-Nasal Outcome Test SNOT-20 data were collected at each visit. A small sample underwent endoscopic mucosal biopsy. RESULTS: Twenty-nine of 30 patients completed the protocol. The difference in edema, crusting, and mucopurulence at 1 and 2 weeks was not statistically significant; however, at 6 and 12 weeks, the HA hydrogel showed statistically significant reduction in both overall endoscopic grade (p < 0.05), as well as synechiae formation (p < 0.05), with a trend toward superiority in remucosalization (p = 0.08). Histological analysis of six subjects at 12 weeks showed a nonsignificant trend toward a greater amount of regenerated cilia present with the HA hydrogel (p = 0.23). SNOT-20 scores declined 78.8% from preoperative scores. CONCLUSION: Self-cross-linked HA hydrogel provides superior wound healing to CMC after ethmoidectomy.

Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series.

BACKGROUND: The outcomes of endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, recurrent polyposis, middle turbinate lateralization, and synechiae, often requiring subsequent interventions. A bioabsorbable steroid-eluting sinus implant placed in the operating room following ESS has been proven safe and effective in 2 randomized controlled trials and a subsequent meta-analysis, for its ability to preserve sinus patency, and reduce medical and surgical interventions. This trial sought to evaluate the safety, feasibility, and outcomes of implants placed in the office after achieving hemostasis. METHODS: Twenty patients with CRS underwent ESS including bilateral ethmoidectomy. A steroid-eluting bioabsorbable implant was deployed into each ethmoid cavity in the office within 7 days after ESS. Endoscopic appearance of the ethmoid cavities was evaluated at 1 week, 2 weeks, and 4 weeks postoperatively by the operating surgeon and an independent blinded evaluator. Procedural tolerance was assessed at week 2 using a patient preference questionnaire. The 20-item Sino-Nasal Outcome Test (SNOT-20) questionnaire was completed at baseline, week 2, and week 4. RESULTS: In-office placement of steroid-eluting bioabsorbable implants was well tolerated, with 90% of patients very satisfied with the overall experience, and 80% very satisfied with the recovery process. At 1 month, there were no significant adhesions or frank polyposis, and middle turbinate lateralization was only 5%. Compared to baseline, ethmoid sinus inflammation was significantly reduced (p = 0.03), and the mean SNOT-20 score was significantly improved (p < 0.001). CONCLUSION: In-office placement of steroid-eluting bioabsorbable implants after achieving hemostasis was well tolerated and might improve local drug diffusion and surgical outcomes.