Tiny Balloons Open Blocked Sinuses
Patients find relief with new, less invasive surgery, researchers report
MONDAY, Sept. 18, 2006 (HealthDay News) -- A new procedure that uses tiny balloon catheters to prop open inflamed sinuses is easing the misery of chronic sinusitis sufferers.
A report on the procedure was to be presented at the American Academy of Otolaryngology Head and Neck Surgery Foundation annual meeting Sunday, in Toronto.
"This new technology presents what seems to be faster healing, less postoperative care, minimal pain and bleeding, and improved quality of life for many patients who suffer with chronic sinusitis," said study investigator Dr. Howard L. Levine, director of the Cleveland Nasal Sinus and Sleep Center.
Chronic sinusitis, which can be due to infection, inflammation or anatomical obstructions, affects some 37 million Americans. Many people with the disorder are helped with antibiotics, but more severe cases call for surgery. In conventional endoscopic sinusotomy, an otolaryngologist uses an endoscope to examine the sinuses, and inserts micro-shavers and delicate instruments to remove diseased bone and soft tissue.
"This enlarges the sinus and returns it to function," Levine explained.
From this concept, balloon catheterization was born. The investigators describe it as another technology that will augment the ability to preserve sinus function.
Dr. David Sherris, chairman of otolaryngology at the University at Buffalo in New York, agreed. "The study shows the balloon catheter is effective in opening some sinuses, and this may prove to be less invasive for certain aspects of sinus surgery," he explained.
Even though it is performed in the operating room under general anesthesia, the new procedure is shorter, with a quicker recovery, the researchers say. Using fluoroscopic imaging, a small flexible wire is guided into the sinus. Over this guide wire, a 3-millimeter, 5-millimeter or 7-millimeter balloon is passed into the sinus cavity. Once positioned, the balloon is dilated, the catheter is removed, and the dilated opening is inspected, Levine said.
The procedure takes from 30 minutes to two hours, depending on degree of pathology and the complexity of the patient's sinus anatomy. Depending on the disease, this procedure can be combined with traditional endoscopic sinus surgery.
The multi-center landmark study analyzed six-month data from 115 patients (41 male, 74 female). Mean patient age was 47.8 years, and ranged from 21 to 76 years. Twenty-one patients (18.3 percent) had previous endoscopic sinus surgery. At 24 weeks, endoscopies showed that 82.1 percent (252 of 307 sinuses) were open. Patients showed consistent symptomatic improvement over baseline, the researchers reported.
No serious adverse events occurred, and there were no complications. Narrowing of dilated openings occurred infrequently, and revision surgery was rarely necessary, the researchers reported.
"Realistically, we know sinusitis is caused by many things -- respiratory infections, allergies. And even with the best of surgical procedures, there are always ups and downs, with the possibility for recurrence," Levine said. "The hope is that (balloon sinusotomy) will lessen disease severity and frequency and, hopefully, cure it."
Patients who are not candidates are those with nasal polyps, previous sinus surgery with severe scarring, or those with previous surgery who have new abnormal bone growth, said Levine.
In the end, people who live with the misery of chronic sinusitis now have a minimally invasive option that can preserve structure and function and allow return to normal activity faster, Levine said. He also speculated that the procedure could lower health-care costs because patients would be back to work and school sooner. "It could reduce costs in the long run, with less postoperative care compared to conventional sinusotomy," he said.
Although he is not currently trained in the procedure, Sherris said he "would be interested in trying it in minor revision sinus surgery and some sinus surgery in children."
"Longer term studies and head-to-head comparisons with standard endoscopic sinus surgery techniques will be necessary to establish the place of balloon sinuplasty in the toolbox of endoscopic sinus surgeons," Sherris said.
Because it is minimally invasive, the procedure could be "ideal for children," Levine said, noting a prospective study is under way to evaluate its feasibility in pediatric cases. The U.S. Food and Drug Administration approved the procedure for adults last year, he noted.
The National Institute of Allergy and Infectious Diseases has more on sinusitis.