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

Abstract

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.

International consensus statement on allergy and rhinology: rhinosinusitis 2021

“…An initial 24‐week evaluation showed improvement in QoL metrics including the CSS, RSDI and SNOT‐20 2003 . A follow up evaluation at 52‐weeks reported sustained improvement in CSS, RSDI and SNOT‐20 over continued medical therapy 2002 . Challenges of the study limiting generalizability include the non‐randomized nature of the groups, the variability in medical therapy, the use of adjunctive procedures in the BCD group, and poor follow‐up in the medical management group (52% vs 83% in the BCD group).…”

“…A recent prospective, multicenter, nonrandomized, observational, comparative study, the MERLOT study, attempted to assess the utility of BCD in medically refractory CRS 2002 . Patients with CRS self‐selected continued medical therapy or BCD with or without adjunctive surgical procedures, including septoplasty, ethmoidectomy, turbinate reduction, uncinectomy, concha bullosa resection, polypectomy, or sinus irrigations (n = 198, 146 surgery and 52 medical management).…”

Balloon Sinus Dilation Versus Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis: Systematic Review and Meta-Analysis

“… Abbreviations: BSD, balloon sinus dilation; Diff, difference; EMLP, endoscopic modified Lothrop procedure; FEDS, functional endoscopic dilatation sinus surgery; FESS, functional endoscopic sinus surgery; FRC, frontal recess clearance; FS, frontal sinus; IT, inferior turbinate; MM, medical management; NR, not reported; QOL, quality of life; RS, rhinosinusitis; Rx, therapy; VAS, visual analog scale. a Actual values not reported; median LM total on right significantly lower in BSD versus ESS, no difference on the left. b SNOT-20 scores and SD scaled to be out of 5 for purposes of comparison. * Comparator group included opposite sinus. § reported separately for groups with and without polyps but not overall. # In an updated publication 14 with follow-up of 12 months, greater improvements in self-reported QOL from baseline noted with BSD using the Chronic Sinusitis Survey Rhinosinusitis disability index measures and a trend toward improvement using the SNOT-20. …”

Frontier Knowledge and Novel Therapeutic Modalities for Rhinologic Disease

“…Stolovitzky et al prospectively document their 12-month outcomes from an observational study in CRS patients with the addition of balloon sinus dilation compared with medical management alone. 12 Endoscopic dacryocystorhinostomy (DCR) is successful in treating sac and postsac obstruction of the nasolacrimal system. Stenting postprocedure for a variable period of time (4-12 weeks) is a common practice, and Ci ger et al share their experience and clinical outcomes of endoscopic DCR without stenting and without mucosal flaps.…”