New results from a randomized trial published in the American Journal of Rhinology and Allergy demonstrate the benefits of in-office balloon dilation for sufferers of chronic sinusitis. Results reported in "Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up" show in-office treatment using balloon sinus dilation is as effective as functional endoscopic sinus surgery (FESS) for patients with chronic sinusitis.
Traditional surgical treatments of chronic sinusitis such as FESS involve cutting and removal of sinus tissue to open narrowed sinus drainage pathways whereas sinus balloon dilation preserves sinus tissue by opening obstructed or narrowed drainage pathways with a high pressure balloon that is temporarily inserted into the nose, placed into the obstructed area and inflated for a few seconds before deflating and removing the balloon.
The REMODEL study, sponsored by Entellus Medical, is the first prospective, multi-center, randomized, controlled trial with sufficient statistical power to compare sinus balloon dilation procedures performed in the office to FESS for the treatment of medically refractory chronic rhinosinusitis.
The REMODEL study involved treatment of 92 patients and 97% of these patients returned for outcomes assessment at 1 year. The study measured sinusitis symptoms, patient recovery, work productivity/activity, the number of episodes of sinusitis, and the need for subsequent procedures. Symptoms were measured using the validated Sino-Nasal Outcome Test (SNOT-20) and showed that, in addition to balloon dilation reducing overall sinusitis symptoms as effectively as FESS, balloon dilation was also as effective at improving rhinologic symptoms, ear and facial symptoms, sleep function and psychological issues. Additionally, patients reported a statistically significant reduction of work impairment and reduction of absenteeism.
Patients in the REMODEL study suffered sinusitis symptoms for an average of over 12 years prior to treatment and patients treated in the balloon arm of the study reported a mean of 5.2 sinusitis episodes in the year immediately prior to treatment. However in the year after treatment with balloon sinus dilation, patients reported an average of only 1.0 episode of sinusitis, and 98% of balloon procedure patients did not require revision surgery. In addition, CT scans showed that 97% of sinus drainage paths were unobstructed and open at 1-year follow-up. These results were not statistically different than the results seen following FESS.
An earlier report of the REMODEL study at six-month follow-up showed that standalone balloon sinus dilation procedures offer significant advantages compared to traditional surgery. Patients treated with balloon dilation experienced significantly fewer post-procedure debridements versus FESS. In addition, the occurrence of postoperative nasal bleeding, duration of prescription pain medication use, recovery time and short-term symptom improvement were all significantly better for patients treated with balloon dilation than with sinus surgery.
According to the 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."
Chronic sinusitis affects 37 million people each year, making it one of the most common health problems in the U.S. It is more prevalent than heart disease and asthma, and has a negative impact on quality of life with chronic symptoms and effects including facial pain and pressure, teeth pain, headaches, fatigue, loss of smell, and sinus infections.
"These results show that the Entellus balloon technology is comparably effective versus the standard of care and a viable treatment for patients with uncomplicated sinusitis who are seeking an effective, minimally invasive option when medical therapy fails to address their symptoms," said Brian Farley, CEO of Entellus Medical. "The REMODEL study is the seventh clinical study performed by Entellus Medical which together resulted in over 450 patients followed for 6, 12, or 24 months after treatment. Study upon study shows a significant level of symptom improvement, low rate of revision surgery, reduction of sinusitis episodes, and reductions in sinus infections and physician visits in the year after standalone balloon sinus dilation. The REMODEL study shows that the prior non-randomized studies produced results that are comparable to those seen in the more scientifically rigorous REMODEL study and thus validate the results from the other six studies completed by the company. Lastly, in addition to the clinical advantages of balloon procedures demonstrated in this study, the costs to the patient and the healthcare system are substantially lower when the procedure is performed in the ENT physician's office compared to the patient receiving traditional sinus surgery in a hospital or surgery center."
Balloon sinus dilation is covered by most health insurance plans in the United States and by Medicare. All national insurers consider standalone balloon sinus dilation a medically necessary procedure for patients with medically refractory chronic sinusitis, resulting in coverage for this procedure for approximately 210 million Americans. However some insurers such as Anthem/WellPoint and some other Blue Cross/Blue Shield plans continue to consider standalone balloon sinus dilation as investigational.