Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis
EXECUTIVE SUMMARY
Background: Chronic rhinosinusitis is a common condition characterized by symptoms of nasal blockage, obstruction, or congestion or nasal discharge, lasting more than 12 weeks. Treatment with nasal steroids, irrigation, and antibiotics are considered first-line treatment for chronic rhinosinusitis. However, surgery is often recommended for patients in whom medical treatment does not relieve symptoms. Functional endoscopic sinus surgery (FESS) is the most frequently used surgical intervention.
Balloon ostial dilation is an alternative technique to FESS for treating chronic rhinosinusitis. Rather than using cutting tools to open sinuses, inflatable balloons are threaded into the sinuses and inflated under pressure. Balloon ostial dilation is applied selectively to some or all of the affected sinuses, depending on the judgment of the treating physician and the ability to successfully access and dilate the involved sinus. Balloon ostial dilation may be as effective as FESS in the treatment of chronic rhinosinusitis. It may be less invasive, in that there is less tissue damage, shorter operative times, shorter recovery times, and less postoperative pain and morbidity.
Objective: The objective of this Assessment is to determine whether balloon ostial dilation improves health outcomes when used as a treatment for chronic rhinosinusitis as compared to standard surgical treatment (FESS).
Search strategy: MEDLINE® was searched (via PubMed) using the terms “balloon” or “dilatation” and “sinusitis.” The search was performed with no time limitation through October 2012, limited to English-language articles on human subjects. Bibliographies of identified articles supplemented the original search.
Selection criteria: Case series, nonrandomized comparison trials and randomized clinical trials of balloon ostial dilation that had a sample size of at least 10 in which clinical outcomes of patients with chronic rhinosinusitis were reported were included. Studies of special populations such as trauma patients were excluded.
Main results: One randomized clinical trial, 3 nonrandomized comparative trials, and 9 case series studies met selection criteria.
The one randomized clinical trial compared balloon ostial dilation of the frontal sinus plus ethmoidectomy (using FESS) versus FESS of the frontal sinus plus ethmoidectomy. In this small poor quality trial of 34 patients, improvements in computed tomography images, symptom scores, and olfactory threshold were noted within each group. No statistical between-group comparisons were reported, but the magnitude of improvement in these outcomes appeared similar.
One nonrandomized retrospective comparative trial evaluated balloon ostial dilation and FESS in 70 adults. Compared to excluded patients, those enrolled had less-severe rhinosinusitis on imaging, and without systemic disease or excessive nasal polyps. Patients undergoing combined balloon ostial dilation and FESS were excluded. The decrease in rhinosinusitis symptoms as measured by the SNOT-20 score was greater in the balloon ostial dilation group than in the FESS group (1.99 versus 1.41, p=0.005) at 3 months. Overall patient satisfaction favored balloon ostial dilation and postoperative narcotic use was less in the balloon ostial dilation group.
The second nonrandomized retrospective study compared balloon ostial dilation to FESS in 31 pediatric patients. No specific rhinosinusitis symptom assessment was performed. Medical charts were reviewed for documentation of the presence and change in symptoms over time. Improvement was documented for 80% of balloon ostial dilation patients and 62.5% of FESS patients (p not significant between the groups).
A third nonrandomized study compared the results of 30 pediatric patients undergoing balloon ostial dilation and adenoidectomy to 19 patients undergoing adenoidectomy. Eighty percent of balloon ostial dilation patients improved at least 0.5 in the SN-5 score compared to 52.6% of adenoidectomy patients. However, the lack of comparison to FESS further limits study implications.
Several case series studies of balloon ostial dilation found improvements in symptom scores after surgery. In the subsets of patients in the various studies followed at least 2 years, symptom improvement appeared durable. Few adverse events were reported. Revision rates after surgery varied from 3 to 9 percent.
Authors’ comments and conclusions: Studies of balloon ostial dilation do not allow conclusions regarding the comparative efficacy of balloon ostial dilation to FESS. The one randomized clinical trial showed roughly similar magnitude of relief of symptoms with no formal comparison between the two treatment arms. The study was underpowered to detect a clinically significant difference between the two treatment arms or to assess a clinically meaningful noninferiority margin.
The nonrandomized studies also do not allow conclusions regarding comparative efficacy. The lack of randomization may bias the study findings. In the comparative study in adults, restriction of the balloon ostial dilation group to subjects who only had balloon ostial dilation without FESS resulted in a group with fewer diseased sinuses than the FESS group. In the other nonrandomized comparative studies of pediatric patients, one showed no difference in improvement of sinusitis symptoms between groups, and the other was of limited relevance because balloon ostial dilation was compared to adenoidectomy rather than FESS.
Although the case series show improvement of sinusitis symptoms after surgery, and appear to show relief up to 2 years after surgery, such studies cannot provide conclusions regarding comparative efficacy to FESS. Potential differences in patient selection and disease severity do not allow comparisons to published studies of FESS. In these studies, patients commonly had both balloon ostial dilation and FESS procedures, further complicating the interpretation of the findings. However, surgical complications attributable to balloon ostial dilation appear uncommon. Revision rates range between 3 and 9 percent.
Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether balloon ostial dilation as a treatment for chronic rhinosinusitis meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria.
1. The technology must have final approval from the appropriate governmental regulatory bodies.
In March 2008, the device “Relieva Sinus Balloon Catheter” (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The indications are for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. In June 2008, the device, FinESS Sinus Treatment (Entellus Medical, Inc, Maple Grove, MN) was cleared for marketing by the FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The evidence is insufficient to determine the effect of the technology on health outcomes. One randomized clinical trial comparing balloon ostial dilation to FESS was inadequately powered and did not evaluate differences in outcomes between the two treatments. While most nonrandomized comparative studies of balloon ostial dilation and FESS show no difference in health outcomes between the two treatments, confounding factors may bias the comparison of the two treatments. Several case series show improvement in symptoms of rhinosinusitis over baseline measures, and such improvement appears durable up to 2 years. Case series do not allow conclusions regarding the comparative efficacy of balloon ostial dilation to FESS.
3. The technology must improve the net health outcome; and
4. The technology must be as beneficial as any established alternatives.
The current evidence does not allow conclusions regarding the comparative efficacy of balloon ostial dilation to FESS.
5. The improvement must be attainable outside the investigational settings.
The evidence is insufficient to demonstrate that balloon ostial dilation improves health outcomes in the investigational setting. Therefore, it cannot be demonstrated whether improvement is attainable outside the investigational setting.
Based on the available evidence, balloon ostial dilation for the treatment for chronic rhinosinusitis does not meet TEC criteria.
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NOTICE OF PURPOSE: TECAssessments are scientific opinions, provided solely for informational purposes.TECAssessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or theTECProgram recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated.
