Since the FDA approved the first balloon sinus dilation (BSD) device for the treatment of chronic rhinosinusitis (CRS) in 2008, the number of procedures performed has dramatically increased. For otolaryngologists, it’s appealing to be able to offer a safe, effective, and minimally-invasive treatment in the office. For patients, the approach enables them to return quickly to their activities while avoiding general anesthesia. However, these benefits have contributed to what some believe could be overutilization of BSD.
In a 2011-2014 retrospective analysis published in Otolaryngology-Head and Neck Surgery in August 2018, Duke researchers found significant differences in demographics in patients undergoing BSD for CRS than those undergoing functional endoscopic sinus surgery (FESS). They also found differences in comorbidities between the two patient populations. The results highlighted the need for better-defined indications for use of the BSD technology.
“We wanted to see how often BSD was being done and study the typical patient profile for the procedure,” says lead author David Jang, MD, a Duke endoscopic sinus and skull base surgeon. Using MarketScan (Truven Health Analytics, Ann Arbor, MI), a large, national claims-based database, researchers examined how patients are managed throughout the treatment process, how much the procedure costs, and whether there are differences in demographic factors such as age, gender, and geography.
“We found that the use of BSD is significantly increasing and that there’s a lot of variation based on demographics and geography,” Jang reports. For example, study results showed that a higher proportion of patients undergoing BSD were women ages 65 and older. The use of BSD was disproportionately higher in the southern region of the United States. There was also a higher prevalence of headache disorder and allergic rhinitis in the BSD group than in the FESS and hybrid groups.
“Lots of variation means there’s room for more standardized guidelines that could help physicians direct their patients to the right procedure and help to manage costs,” he explains. “Many physicians are recommending BSD partly because it’s safe, simple, and effective, and can be performed in the office. But if patients aren’t going to benefit from the procedure or are at greater risk for complications, we should recommend conventional surgery,” he says.
Jang credits the advent of “big data” for helping researchers answer questions about clinical care for large groups of people such as the ones involved in this study. “In the past, we were only able to look at patient data from one or a few institutions—hundreds or thousands of patients—but now we can look at data from millions of patients. This allows us to see practice patterns for different parts of the country and for different patient populations, and spot discrepancies in the patterns,” he says, adding that biostatisticians from the Duke Clinical Research Institute were instrumental in working with the massive amount of data required for the study.
Jang says that Duke is engaged in additional research to answer more questions about the growing utilization of BSD. “We’re taking a population health–based approach to our research, looking at pre- and postoperative management of CRS. We’re beginning to ask questions such as: Is CRS being treated with the right antibiotics? How many patients go on to require more surgeries?” Answers to these and other questions could help clinicians more clearly identify the best candidates for the procedure and improve patient outcomes.