Quick relief is now available for many patients with chronic sinusitis. Once considered a painful and messy surgical operation, the majority of blocked sinuses can be dilated in the doctor’s office under local anesthesia. A recently published clinical trial has proven that balloon sinus dilation is significantly less painful, less bloody, and offers faster return to normal activity than sinus surgery. “Many patients return to work the same day,” says Mike Armstrong, M.D., a principle investigator in the REMODEL study, published on-line Aug 5, 2013.
With traditional surgery, bone and tissue are removed through the nose to create larger openings into the sinuses. With balloon sinuplasty, as it is often called, a small balloon is passed through the natural openings and inflated briefly to dilate the drainage pathway. The technique is similar to that used to dilate blocked coronary arteries. If tissue is not removed, there is very little bleeding, and the procedure can be safely and comfortably performed in the office. Most patients find the procedure momentarily painful, as with any dental procedure, but easily tolerated. In many cases, the actual balloon procedure takes less than one minute per side.
The REMODEL study was the first randomized clinical trial to compare traditional endoscopic sinus surgery to balloon sinus dilation in the office. Over 100 adult volunteers who needed sinus surgery were assigned at random to one of the two procedures. About 20% of the patients assigned to traditional surgery dropped out of the study, leaving 50 for balloon dilation and 42 for surgery. Balloon dilation patients had significantly less pain and bleeding, and returned to work faster than surgical patients. For example, balloon dilation patients took prescription pain relievers for less than one day on average, and resumed normal activity within one and half days. By contrast, surgical patients took pain pills for nearly three days, and required almost 5 days to recover — some patients needed more than ten days after surgery before resuming normal activity. Bleeding was twice as likely after traditional surgery compared to balloon dilation. The improvement in sinus symptoms was reported almost immediately in the balloon dilation group, who were significantly better than the surgery group within one week. However, by one month, the surgical group was equally improved, and long term results appear to be comparable. The study is on-going, and will be following all patients for at least 12 months. To read or download the entire report free of charge, visit: http://www.ingentaconnect.com/content/ocean/ajra/pre-prints/3970
The mid-Atlantic research site for the REMODEL study was Richmond Sinus and Allergy, a division of Richmond ENT. Dr. Armstrong first described in-office maxillary sinus surgery in 1999, and has been performing balloon dilation since 2007. Surgeries under anesthesia were performed at the attached Medarva Stony Point Surgery Center, Virgina’s largest multispecialty surgery center and a center of excellence in balloon sinuplasty for over five years. While the surgery center is known for pioneering less invasive outpatient surgical procedures, the affiliated Medarva Foundation awards over $250,000 per year to Virginia physician-scientists studying causes and treatments of sinusitis, deafness, blindness and congenital disorders. For more information, visit www.StonyPointSC.com
In-office balloon sinus dilation is covered favorably by most insurance companies, including Medicare and Medicaid, who recognize the savings achieved when patients are treated outside of hospitals. For many patients, the cost of balloon dilation is no more than an ordinary office visit copayment. One notable exception is Anthem Blue Cross, which has maintained a policy that Balloon Sinuplasty is experimental and not a covered benefit. The REMODEL study was specifically designed using the Anthem criteria for surgery as a minimum requirement for all volunteers. The investigators hope that the REMODEL study, and others like it, will encourage Anthem to reconsider its policy, and provide its members with the same choices afforded most other patients.