Medical Therapy versus Sinus Surgery by Using Balloon Sinus Dilation Technology: A Prospective Multicenter Study

Abstract

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.

Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery

“…3 For patients with CRS, medical therapy is usually considered the first line of treatment, and surgical management is offered for patients who failed medical management. Minimally invasive surgeries for CRS include balloon sinuplasty (BSP) 4 and functional endoscopic sinus surgery (FESS). BSP cleared the U.S. Food and Drug Administration (FDA) 510(k) pathway in 2005.…”

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

“…A total of 198 patients were enrolled in the study of whom 146 elected ESS with BSD (n ¼ 41 OR; n ¼ 105 IO) and 52 elected continued MM (see Figure 1 for participant flow). While baseline medical history, QOL, and medication usage are similar to those previously reported at the 24-week interim analysis, 6 an updated summary is provided in Tables 1 and 2, respectively. Baseline characteristics were similar between groups with the following exceptions: (1) RSDI total baseline score was higher in the BSD group (47.9 AE 25.3 vs 39.5 AE 19.9; P ¼ .032), (2) oral antibiotic usage was higher in the BSD group (28.1 AE 15.4 vs 22.8 AE 6.1 days in the prior 90 days; P ¼ .018), (3) allergic rhinitis was more common in the MM group (90.4% vs 68.5%; P ¼ .003), and (4) the BSD group had more sinusrelated medical visits (2.0 AE 2.1 vs 1.2 AE 1.6; P ¼ .013).…”

“…The details of the current study (NCT01685229) including inclusion/exclusion criteria, treatment arms, baseline assessments, outcomes, sample size calculations, and statistical analysis have been previously reported. 6 Briefly, adults aged 19 and older with CRS who had failed MM and who had elected ESS using BSD or continued medical therapy were enrolled in this study. In addition to the CRS diagnosis as per American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) guidelines and medical therapy failure criteria, all patients were required to have a baseline mean 20-item Sino-Nasal Outcome Test (SNOT-20) score of greater than 0.6.…”

“…The primary end point, change in patient-reported QOL as measured by total CSS score 8 from baseline to 24 weeks, has been previously reported. 6 This particular end point was selected as CSS has been shown to be highly sensitive to change following sinus surgery with a high test/retest reliability. 8,9 Here, we report secondary outcomes including changes in CSS, Rhinosinusitis Disability Index (RSDI), 10 and SNOT-20 total and subscores, 7 sinus medication usage, missed days of work/school, number of unscheduled medical care visits, and sinus infections from baseline to the 52-week follow-up.…”

“…4,5 A planned interim analysis, conducted after 125 patients had completed the 24-week followup demonstrated that patients who selected BSD experienced a significantly greater improvement in Chronic Sinusitis Survey (CSS) score from baseline as compared to those patients who elected continued MM (P < .001). 6 The primary objective of this final analysis was to evaluate the durability of treatment effects through the 52-week follow-up.…”