xRead - Nasal Obstruction (September 2024) Full Articles

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International consensus statement on rhinosinusitis

XII.D.1.c. Balloon Dilation Balloon catheter dilation (BCD) was introduced in 2005 as a treatment for surgical management of paranasal sinus inflammatory disease. Despite widespread usage, there is a relative paucity of robust clinical trials evaluating the efficacy of balloon technology in patients with CRS. The CLEAR study, the initial large-scale cohort investi gation, demonstrated the safety and technical feasibility of BCD, with improvements in SNOT-20 scores and ostial patency in 109 patients. However, the patient cohort in this study was not clearly defined and management was not standardized. 2001 The ORIOS study began as an initial prospective, single arm, non-randomized, multicenter evaluation of in-office BCD in 38 patients with CRS. 1796 In-office technical suc cess was 89% with no adverse complications. Significant reduction of mean SNOT-20 scores at all time points ( p < 0.0001) was reported. An improvement in mean Lund Mackay score from 6.62 at baseline to 2.79 was noted at 24 weeks ( p < 0.001). The follow up ORIOS2 study included a larger cohort and showed similar findings with follow up to 52 weeks. 1797,1798 The use of adjunctive procedures, the lack of a control group, loss to follow-up and non standardized medical management confounded the sec ondary outcomes. A recent prospective, multicenter, nonrandomized, observational, comparative study, the MERLOT study, attempted to assess the utility of BCD in medically refrac tory CRS. 2002 Patients with CRS self-selected continued medical therapy or BCD with or without adjunctive sur gical procedures, including septoplasty, ethmoidectomy, turbinate reduction, uncinectomy, concha bullosa resec tion, polypectomy, or sinus irrigations (n = 198, 146 surgery and 52 medical management). An initial 24-week evalua tion 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 Chal lenges 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 manage ment group (52% vs 83% in the BCD group). Two randomized control trials have been performed to compare the efficacy of BCD to ESS. 2004–2006 The REMODEL trial is the largest of these trials with 92 patients enrolled, it is the only randomized control trial with sufficient power to draw conclusions. 2006 Eligible patients were at least 18 years of age and were diagnosed with either chronic or recurrent RS (68% CRS and 32% RARS in the final cohort). Prior medical therapy was not delineated although patients met criteria per the 2007 Adult Sinusitis Clinical Practice Guidelines. Patients with

posterior ethmoid, sphenoid, frontal, fungal and polypoid disease were excluded yielding a fairly uniform study cohort with maxillary disease only (62%) or maxillary and anterior ethmoid disease (38%). Patients were random ized to either in-office balloon dilation of the maxillary sinus or operative ESS, including uncinectomy and maxil lary antrostomy with or without anterior ethmoidectomy. Postoperative follow-up assessments were conducted at 1 week, 1 month, 3 months, and 6 months. Primary end points included improvement in mean SNOT-20 scores and required number of postoperative debridements by blinded assessment. Timing of baseline SNOT-20 for RARS was not reported. Six-month follow-up was 98.9%. Impor tant findings included equivalent mean SNOT-20 score change between groups (1.67 ± 1.10 in the balloon arm and 1.60 ± 0.96 in the ESS arm). ESS had a higher requirement for debridement (0.1 ± 0.6 in the balloon arm and 1.2 ± 1.0 in the ESS arm, p < 0.0001). Secondary findings included a 0% complication rate in both arms and faster return to nor mal daily activity (1.6 vs 4.8 days, p = 0.001) and less pain medication requirement (0.9 days vs 2.8 days, p < 0.001) in the balloon arm. A follow up study at 12 months demon strated equivalent improvement in SNOT-20 (-1.64 ± 1.06 in the balloon arm and − 1.65 ± 0.94 in the ESS arm). 2005 Challenges of the REMODEL study include limited dis ease severity in the study cohort and industry support. Nonetheless, the REMODEL study provides level 1 evi dence that BCD may be a potential treatment option for patients with limited disease involving the maxillary and/or anterior ethmoid sinuses, where appropriate med ical therapy has failed. A recent randomized, placebo controlled trial in patients with RARS showed BCD plus medical management proved superior to medical manage ment alone further potentially supporting its role in mini mal diseased states. 511 Balloon Catheter Dilation Aggregate Grade of Evidence: C (Level 2: 1 study; level 3: 1 study; level 4: 7 studies; Table XII-16). Benefit: Balloon catheter dilation may have poten tial benefit in patients with limited maxillary and anterior ethmoid disease. Harm: Minimal harm with risk of minor bleed ing and patient discomfort; major harm though uncommon with reported risk of CSF leak and sig nificant eye swelling from orbital entry (see Table II-1). Cost: Balloon-dilation technology is associated with increased equipment costs and potential for overutilization.