xRead - Nasal Obstruction (September 2024) Full Articles

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International consensus statement on rhinosinusitis

Rizzo et al. 285 reported the theoretical budget impact on a healthcare system from use of a drug-eluting sinus implant. However, it was not patient-based research so it was not included. Prior studies summarized in ICAR-RS-2016 assessed outcome measures such as clinician-based endoscopic score, number of adhesions, presence of polyps, etc. There was clear evidence that steroid-eluting implants improved these endoscopic outcomes compared to non-impregnated implants. However, there were no RCTs which assessed patient-based outcomes such as HRQoL. Therefore, we conclude that there is Grade A evidence supporting benefit in endoscopic appearance, and we make a recommendation for the use of steroid-eluting implants or spacers in select patients with CRS and / or nasal polyposis (see Section XII.D.7 ). Systemic Steroids. There was 1 new report on this topic. 2259 It was a sequential (non-randomized) trial in 60 patients with eosinophilic polyps, comparing 2 groups where the initial treatment group received topical steroids daily and a subsequent treatment group received topical steroids daily plus two 20-day tapering courses of oral methylprednisolone every year (further details of treat ment timing were not provided). Patients were enrolled over 2 year periods, and were treated daily with topical steroids, so different patients had different durations of treatment, but all patients were followed at least 36 months after surgery. The authors found no differences in polyp recurrence rate, or in disease-free interval between groups at 1 year. This is level 4 evidence, which does not change the prior evidence-based recommendation that the use of systemic steroids is an option. Mitomycin C. There was no new evidence on this treat ment in the review period. The ICAR-RS-2016 review found no clear evidence of benefit with topical use of Mito mycin C, and there were potential side effects, so there was a recommendation against the use of Mitomycin C. Other treatments. Mozzanica et al. 2260 performed a mul ticenter, prospective, double-blinded RCT comparing post operative irrigation with normal saline BID (control, n = 30) vs normal saline with 9 mg Sodium Hyaluronate BID (n = 26) for 6 weeks. Outcomes were the Lund-Kennedy endoscopic score, SNOT-22, NOSE, and a visual analogue symptom scale, at 3 and 6 weeks. They found no statis tically significant differences in any outcome at 6 weeks. The authors focused on a few small subscale differences, and concluded that sodium hyaluronate “may be a useful adjunct,” but their actual data do not support a recommen dation. Although not exactly a “treatment,” there was 1 study addressing outcomes with nose blowing after ESS. 2261 It was a small RCT (n = 39) comparing nose blowing twice a day for 1 week with no nose blowing. The study was very

small and likely underpowered to detect small differences, and based on the outcomes they concluded that judicious nose blowing after ESS “may be permissible.”

XII.F Outcomes of Sinus Surgery There are many outcome metrics by which the effi cacy of surgery for CRS can be determined, including objective and patient-reported. In general, current litera ture broadly demonstrates that ESS improves both objec tive and patient-reported metrics in patients that have failed previous appropriate medical treatments, includ ing endoscopy scores, 1816,2262 sinus-specific QoL, 1816 cardi nal symptoms, 1949 non-cardinal symptoms, 2263 and overall health utility. 2264 Patients undergoing revision surgery also experience significant improvement, although the magni tude is slightly less than primary surgery patients, likely because of the selection bias of more severe inflammatory disease in those requiring revision surgery. 1814,1816,1936 Although the above outcome measures are all relevant, there has been general agreement that sinus-specific QoL is particularly important from the patient perspective. 1773 The SNOT-22 is perhaps the most widely utilized instru ment currently and has been found to be valid and reliable. 2265 A recent systematic review with meta-analysis identified 40 unique studies reporting SNOT-22 outcomes after ESS for CRS, totaling 5547 patients. 1938 The summary change in mean SNOT-22 across all studies was 24.4 (95% CI, 22.0-26.8) at an average follow-up of 10.6 months, a change well above the minimal clinically important differ ence of 8.9. A similar review focused on CRSwNP, iden tifying 15 unique cohorts encompassing 3048 patients. 2266 Pooled analyses of SNOT-22 scores revealed a mean change of 23.0 points (95% CI, 20.2-25.8; p < 0.001). The majority of data supporting the efficacy of ESS for CRS comes from uncontrolled cohort studies; how ever, there has been a recent push toward the inclusion of comparison groups. Comparative effectiveness studies of patients treated medically vs surgically can be divided into RCTs and real world, non-randomized observational comparison studies. The most recent Cochrane Review highlights the lack of high quality RCTs from which to draw firm conclusions. 2267 The reality is that formal RCTs comparing medical treatment to surgery are challenging given the difficulty recruiting patients into protocols that randomize to surgical arms, as well as ethical concerns with blinding and sham procedures. Smith et al. have pub lished non-randomized real-world, multi-center observa tional studies. These studies have demonstrated signifi cant benefits of ESS over continued medical therapy in patients who have failed an initial trial of appropriate medical treatment, including at least culture-directed or