As the allergy season approachs a lot of folks are having issues with their sinuses. However, there are some people who just cannot seem to get relief for their nasty nose activity without doing something a bit more drastic. For people facing the idea of a sinus surgery here is something you may want to know. A recent study has shown that it can be just as effective to try a different procedure instead. It’s called in-office balloon dilation, and it’s a much less invasive alternative.
Researchers conducted a random experiment on patients dealing with chronic sinusitis, which is the lead cause of sinus related headaches. The research was dubbed the REMODEL study, and their trial results have just been published in the American Journal of Rhinology and Allergy. Some of these patients had standalone balloon dilation while others received a functional endoscopic sinus surgery (FESS).
The REMODEL study was conducted in multiple centers and involved 92 patients, with 97% of those patients returning for a one year follow-up. It measured each patient’s symptoms, recovery, productivity, number of episodes of sinusitis they had all year, and any need for subsequent procedures. To conduct this study, they used the validated Sino-Nasal Outcome Test (Snot-20).
At a six month follow-up of some patients, studies showed that standalone balloon sinus dilation procedures offer significant advantages compared to traditional surgery. Patients experienced significantly fewer post-procedure debridements versus FESS, and less time was needed for prescription pain medications as the recovery time was much better and short-term symptom improvement occurred sooner.
At the one year follow-up, the symptoms were again measured with and revealed that not only was the balloon just as effective as surgery, it also seemed to improve nasal symptoms, ear and facial symptoms, sleep function and even psychological issues. Work reduction and absenteeism were also reduced.
These patients suffered symptoms for an average of over 12 years prior to treatment, with the mean average of episode in the year prior to treatment for their sinus symptoms being roughly five attacks. The following year, the sinusitis reported average was reduced to one, and a full 98% of those who received balloon dilation did not require any additional procedures. Statistically, these results were not significantly different from those of the people who had received the surgery.
According to lead author Dr. Nadim Bikhazi, “These results prove that patients experience significant, lasting sinus symptom improvement with office balloon dilation that is as effective as FESS. The quality of life for patients is dramatically improved, as they are able to quickly return to their daily activities and experience distinct symptom relief.”
The REMODEL study was the seventh clinical study performed by Entellus Medical, the makers of the balloon procedure. Together, these studies resulted in over 450 patients who were followed for up to 24 months after treatment, and showed a significant level of symptom improvement with a low rate of revision surgery. Additionally, the costs to the patient and the healthcare system are substantially lower because the balloon procedure is performed in-office and does not require a hospital stay.
The balloon procedure is covered by most health insurance plans in the United States, including Medicare. It is considered a medically necessary procedure for patients with refractory chronic sinusitis by most companies.
In this clip, a sinus expert explains FESS and how it works: