Sinus Balloon Catheter Technology Found Safe, Effective in New Study

Released: 9/13/2006 10:00 AM EDT
Embargo expired: 9/17/2006 8:00 AM EDT
Source Newsroom: American Academy of Otolaryngology Head and Neck Surgery (AAOHNS)
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Citations 110th Annual Meeting of the American Academy of Otolaryngology—Head and Neck Surgery Foundation

Newswise — Sinusitis affects 37 million Americans, leading to a wide range of symptoms, which include nasal discharge, headaches or facial pain, and chronic obstruction. The first line of treatment for this often debilitating disorder is an antibiotic. When this first line of treatment fails, surgical treatment -- Functional Endoscopic Sinus Surgery (FESS) " is sometimes recommended. With FESS, specialized instruments are placed into the nose along with a small endoscope to help the surgeon see inside the nose and nasal cavities. The otolaryngologist—head and neck surgeon then removes bone and tissue to enlarge the sinus opening.

Earlier this year a new surgical treatment for sinusitis was introduced to the American public. It involves a small, flexible, sinus balloon catheter that is placed into the nose to reach the sinuses. The sinus balloon catheter, similar in concept to technology found in cardiology, urology, and vascular surgery, is gradually inflated to gently restructure the previously blocked nasal passage, maintaining the integrity of the sinus lining and restoring normal sinus drainage and function. Some surgeons anecdotally report the new devices effectively relieve sinus ostia obstruction with less post-operative pain, scarring, and bleeding than typically seen with traditional instruments. A recently published investigation reports the safety and efficacy of the new devices in relieving sinus obstruction during endoscopic sinus surgery in a small group of ten patients.

Ten otolaryngologist—head and neck surgeons, representing different medical institutions, joined together to study the safety, efficacy and also outcomes in a larger group of 115 patients and observed them for 24 weeks following sinusotomy, or opening a closed sinus. The research objectives were: (1) to evaluate the efficacy of balloon catheter devices in relieving sinus ostial obstruction and maintaining sinus ostia patency; (2) to confirm the safety of sinusotomy using balloon catheters in a large group of patients; and (3) to gain insight into the ability of sinusotomy with balloon catheters to relieve sinus symptoms, either alone or in combination with standard endoscopic sinus surgery techniques.

The authors of the study, entitled "Safety and Efficacy of Balloon Catheter Sinusotomy: A Multi-center 24 Week Analysis in 115 Patients," are William E. Bolger MD, from the Maryland Sinus Center, Bethesda, MD; Christopher L. Brown MD, from the Sandringham District Memorial Hospital, Bayside Network, Melbourne, Australia; Christopher A. Church, MD, at the Loma Linda University, Loma Linda, CA; Andrew N. Goldberg MD MSCE, at the University of California-San Francisco, San Francisco, CA; Boris Karanfilov MD, Ohio Sinus Institute, Columbus, OH; Frederick A. Kuhn MD, Georgia Nasal and Sinus Institute, Savannah, GA; Howard L. Levine MD, Cleveland Nasal, Sinus and Sleep Center, Cleveland, OH; Michael J. Sillers MD, Alabama Nasal and Sinus Center, Birmingham, AL; Winston C. Vaughan MD, California Sinus Institute, Palo Alto, CA; and Raymond L. Weiss MD, from the Sinus Center of the South, Biloxi, MS. Their findings from this multi-institutional study are being presented at the 110th Annual Meeting & OTO EXPO of the American Academy of Otolaryngology—Head and Neck Surgery Foundation, being held September 17-20, 2006, at the Metro Toronto Convention Centre, Toronto, Canada.

Methodology
A multi-center, non-randomized, prospective evaluation of sinusotomy (opening a closed sinus) using balloon catheter devices was conducted in patients for whom endoscopic sinus surgery was recommended, and who had consented to endoscopic surgery, and accepted treatment with balloon sinus catheter devices. Study inclusion criteria included: age of 18 years or greater; diagnosis of chronic sinusitis not responsive to medical management; planned endoscopic sinus surgery. Study exclusion criteria included extensive sinonasal polyps, extensive previous sinonasal surgery, extensive sinonasal osteoneogenesis, cystic fibrosis, Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis), sinonasal tumors or obstructive lesions, history of facial trauma that distorted sinus anatomy, ciliary dysfunction, and pregnancy.

Patients underwent a thorough preoperative evaluation for sinusitis. This included a clinical history, physical examination, sinonasal endoscopy, computed tomographic (CT) scan of the paranasal sinuses and Sino-Nasal Outcome Test (SNOT-20). Nasal cavities were decongested and local anesthesia was administered to the nasal cavity under endoscopic visualization. Standard endoscopic sinus surgery equipment and instruments were used.

Balloon catheter devices used in this investigation included sinus guiding catheters, sinus guide wires, and sinus balloon catheters (Acclarent, Inc.). Fluoroscopy was used intermittently during the procedure to confirm completion of the individual steps, being careful to minimize the total dose of radiation delivered. The guide catheter was introduced into the nasal cavity, under endoscopic visualization, and placed adjacent to the obstructed sinus opening or ostium. A flexible guide wire was introduced through the guiding catheter until the tip of the wire rested near the obstructed sinus ostium. Using fluoroscopy the guide wire was advanced through the obstructed sinus ostium. Then the balloon catheter was advanced over the wire, positioned within the ostium and dilated. Thereafter, the catheter was removed and the dilated ostium was inspected endoscopically.

Patients underwent standard endoscopic sinus surgery postoperative care. Patients were examined and evaluated, and study data were collected, at postoperative visits that occurred one to two weeks, 12 weeks and 24 weeks after their procedure. These visits included an interval history, an endoscopic examination and completion of surveys including the Sino-Nasal Outcome Test (SNOT 20) and a standardized patient questionnaire regarding change in symptoms following sinusotomy using the balloon catheter.

Results
The study population consisted of 115 patients (41 male, 74 female) with an average age of 47.8 years (range of 21-76). Twenty-one patients had a history of previous endoscopic sinus surgery (18.3 percent). After exclusions, a cohort of 109 patients was followed. At the conclusion of the 24-week analysis, endoscopic evaluation was able to visualize the sinusotomy in (82.1 percent) 252/307 sinuses. In 17.9 percent (55/307) endoscopy could not determine ostial patency status. Of the ostia visualized on endoscopy, 98 percent were open (247/252), while two percent (5/252) were considered not open. SNOT-20 scores, reflecting patient assessment, showed consistent symptomatic improvement over baseline.

Serious adverse events related to the sinus balloon catheter devices did not occur. There were no incidents of cerebrospinal fluid leak, diplopia, visual loss, or significant intraoperative bleeding. Stenosis of dilated ostia occurred infrequently and revision surgery was required only rarely. The low rate of revision surgery occurred during a 24-week observation period and a longer observation period may yield additional information.

The researchers suggest that balloon catheter treatment of the sinuses, in its current form, is not appropriate for all sinusitis patients. Patients with sinonasal polyps or extensive previous surgery with significant osteoneogenesis are not appropriate candidates. Also, current balloon devices do not address ethmoid disease. Candidate cases include chronic sinusitis mostly limited to ostial obstruction of the frontal, sphenoid, or maxillary sinuses.

Conclusions
The study population represents a set of patients with disease significant enough to warrant standard endoscopic sinus surgery. In this study, the balloon catheter was utilized as a tool to perform sinusotomy and relieve obstruction of sinus ostia. The sinus balloon catheter tools were effective in dilating sinus ostia and achieved a durable result accompanied by a reduction in patient sinus symptoms.

The study confirms results from earlier safety studies in anatomic specimens and a small highly controlled cohort of patients. Balloon catheter technology appears to be a safe, effective and minimally invasive treatment option to relieve sinus ostial obstruction. The results from this multicenter study with ten otolaryngologists from different parts of the country/world and different practice settings indicate that wider adoption of the devices by otolaryngologists outside of the control of a clinical trial will be safe. The low rate of adverse effects in the initial adoption period is remarkable.


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