In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo-controlled study.

BACKGROUND: A limited number of studies have demonstrated symptomatic improvement for recurrent acute rhinosinusitis (RARS) patients after endoscopic sinus surgery. In this randomized, controlled study we evaluated 24-week outcomes for balloon sinus dilation (BSD) performed in-office (IO) with medical management (MM) as compared with MM only for RARS patients. METHODS: Adults diagnosed with RARS were randomized to groups with BSD plus MM (n = 29) or MM alone (n = 30). Patients who received MM alone also received a sham BSD-IO procedure to blind them to group assignment. Patients were followed to 48 weeks posttreatment. The primary outcome was the difference between arms in change in Chronic Sinusitis Survey (CSS) score from baseline to 24 weeks. Secondary endpoints included comparisons of Rhinosinusitis Disability Index (RSDI) score, medication usage, medical care visits, and sinus infections. RESULTS: Change in patient-reported quality of life (QOL), as measured by the CSS total score from baseline to 24 weeks, was significantly greater in the BSD plus MM group compared with the MM-only group (37.3 ± 24.4 [n = 26] vs 21.8 ± 29.0 [n = 27]; p = 0.0424). CONCLUSION: BSD plus MM proved superior to MM alone in enhancing QOL for RARS patients. BSD plus MM should be considered as a viable treatment option for properly diagnosed RARS patients.

Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study.

OBJECTIVE: Balloon sinus dilation (BSD) instruments afford the opportunity for office-based sinus procedures in properly selected patients with chronic rhinosinusitis (CRS). This study evaluated patient-reported outcomes 1 year after office-based BSD. METHODS: Adult patients with medically refractory CRS were prospectively enrolled into a multicenter, single-arm study and treated with office-based BSD under local anesthesia. Follow-up on 203 patients was conducted at 2, 8, and 24 weeks postsurgery using validated outcome measures for quality of life (SNOT-20) and computed tomography imaging (Lund-Mackay score). After 24 weeks, patients were re-enrolled for 1-year follow-up to evaluate changes in SNOT-20 scores and revisions. RESULTS: All patients who re-enrolled (n = 122) completed the study, with an average follow-up of 1.4 years. Neither preoperative SNOT-20 nor Lund-Mackay CT scores were predictive of re-enrollment and return for follow-up. Compared to baseline, improvements in SNOT-20 scores remained statistically significant (P < .001) and clinically meaningful (mean decrease ≥ 0.8). In patients followed to 1.4 years, 9 of 122 (7.4%) had revision surgery. CONCLUSION: Following office-based BSD, significant improvements in quality of life observed at 24 weeks were maintained 1 year postsurgery. These extended results provide further evidence of office-based BSD as an effective, minimally invasive procedure for appropriately selected patients with CRS.

Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients.

BACKGROUND: Balloon sinus dilation (BSD) is an increasingly used tool in endoscopic sinus surgery (ESS). The tissue-sparing nature of the instrumentation allows for properly selected patients to undergo office-based procedures under local anesthesia. METHODS: This was an Institutional Review Board (IRB)-approved, prospective, 14-center trial. Patients (n = 203) requiring ESS for medically refractory chronic sinusitis underwent transnasal BSD treatment in an office setting under local anesthesia. Safety, tolerability, technical success, clinical efficacy (20-item Sino-Nasal Outcome Test [SNOT-20]), and radiographic outcome (Lund-Mackay [LMK] score) of ESS with BSD in the office setting were assessed. Subjects were followed at 2, 8, and 24 weeks. RESULTS: A total of 552 sinuses were dilated in 203 patients: 47.6% maxillaries, 45.5% frontals, and 6.9% sphenoids. Seventy-seven patients were revisions of prior ESS. The mean number of sinuses dilated per subject was 2.7. Technical dilation success was 93.3%, 90.5%, and 93.7% for maxillary, sphenoid, and frontal sinuses, respectively. SNOT-20 and LMK computed tomography (CT) scoring showed statistically significant improvement at 24 weeks (p < 0.0001) and clinically significant improvement in quality of life. The procedure was reported as tolerable or highly tolerable by 82.3% of patients. There were 0.15 postoperative debridements per patient and the majority returned to normal activity within 48 hours. One (0.5%) procedure-related adverse event related to periorbital swelling was reported, which spontaneously resolved shortly after the procedure without further sequelae. CONCLUSION: Performance of ESS with BSD in the office under local anesthesia is feasible, well-tolerated, safe, and effective. Twenty-four week follow-up demonstrates clinical and statistical improvement in patient quality of life and radiographic outcomes.

Computed tomography-based exploration of infundibular anatomy for maxillary sinus balloon dilation.

OBJECTIVES: A clinically relevant reconstruction of the ethmoid infundibulum and maxillary sinus ostium was developed to use 3-dimensional computed tomographic (CT) imaging technology and measurement software in an effort to better understand the anatomy of the maxillary sinus ostium and to optimize the maxillary sinus balloon dilation technique. METHODS: A retrospective review was performed of reconstructed high-resolution CT scans of patients from a private otolaryngology practice who underwent imaging for evaluation of sinus disease using multiplanar reconstruction software. The CT scans were retrospectively obtained from patients who presented for evaluation of chronic sinus disease and were analyzed with quantitative multiplanar reconstruction software that allowed measurements to be computed in clinically meaningful planes. RESULTS: Data were obtained from 31 sinuses on 18 CT scans. The mean anteroposterior distance from the guidewire exit to the maxillary ostium was 3.5 mm, and the mean optimal guide trajectory ("clocking") angle was 17.50 from the pure axialplane (95% confidence interval, 12.58 degrees to 22.48 degrees). The curvilinear guidewire travel distance was 6.9 mm from the guidewire exit to the ostial entry. CONCLUSIONS: This study reveals specific anatomic information that is applicable to the technique of transnasal maxillary sinus balloon catheter dilation. The data collected allow surgeons to anticipate the direction in which a guidewire must be manipulated in order to correctly enter the maxillary ostium. According to the data, a gentle anterior retraction of the uncinate process and a starting guide orientation 180 from pure lateral will best facilitate maxillary sinus ostial access. Application of the readily available software used for this study affords the opportunity to predict the location of the natural ostium within the infundibulum before operation and customize the technique to each specific patient.