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Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients

Authors


  • Funding sources for the study: Acclarent, Inc. (Menlo Park, CA) provided financial and logistic sponsorship for the study, as well as data monitoring, data analysis, and assistance in drafting the manuscript.

  • Potential conflict of interest: Boris Karanfilov, Stacey Silvers, and Ashley Sikand are consultants for Acclarent, Inc. Raza Pasha is a consultant for Acclarent, Inc., and Medtronic, Inc. Alan Shikani, has no conflicts of interest. Michael Sillers is a consultant for Acclarent, Inc. (Scientific Advisory Board).

  • Presented orally at the ARS Annual Spring Meeting in April 2012, San Diego, CA.

  • Public clinical trial registration: http://clinicaltrials.gov/show/NCT01107379. Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS2).

Correspondence to: Boris Karanfilov, MD, Ohio Sinus Institute, 5378 Avery Road, Dublin, OH 43016; e-mail: bk@ohiosinus.com

Abstract

Background

Balloon sinus dilation (BSD) is an increasingly used tool in endoscopic sinus surgery (ESS). The tissue-sparing nature of the instrumentation allows for properly selected patients to undergo office-based procedures under local anesthesia.

Methods

This was an Institutional Review Board (IRB)-approved, prospective, 14-center trial. Patients (n = 203) requiring ESS for medically refractory chronic sinusitis underwent transnasal BSD treatment in an office setting under local anesthesia. Safety, tolerability, technical success, clinical efficacy (20-item Sino-Nasal Outcome Test [SNOT-20]), and radiographic outcome (Lund-Mackay [LMK] score) of ESS with BSD in the office setting were assessed. Subjects were followed at 2, 8, and 24 weeks.

Results

A total of 552 sinuses were dilated in 203 patients: 47.6% maxillaries, 45.5% frontals, and 6.9% sphenoids. Seventy-seven patients were revisions of prior ESS. The mean number of sinuses dilated per subject was 2.7. Technical dilation success was 93.3%, 90.5%, and 93.7% for maxillary, sphenoid, and frontal sinuses, respectively. SNOT-20 and LMK computed tomography (CT) scoring showed statistically significant improvement at 24 weeks (p < 0.0001) and clinically significant improvement in quality of life. The procedure was reported as tolerable or highly tolerable by 82.3% of patients. There were 0.15 postoperative debridements per patient and the majority returned to normal activity within 48 hours. One (0.5%) procedure-related adverse event related to periorbital swelling was reported, which spontaneously resolved shortly after the procedure without further sequelae.

Conclusion

Performance of ESS with BSD in the office under local anesthesia is feasible, well-tolerated, safe, and effective. Twenty-four week follow-up demonstrates clinical and statistical improvement in patient quality of life and radiographic outcomes.

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