Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients

Received 1 September 2006; accepted 8 February 2007.

Objective

The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy.

Methods

Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20).

Results

At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%).

Conclusion

Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.

a Maryland Sinus Center, Bethesda, MD

b Sandringham District Memorial Hospital, Bayside Network, Melbourne, Australia

c Loma Linda University, Loma Linda, CA

d University of California-San Francisco, San Francisco, CA

e Ohio Sinus Institute, Columbus, OH

f Georgia Nasal and Sinus Institute, Savannah, GA

g Cleveland Nasal, Sinus and Sleep Center, Cleveland, OH

h Alabama Nasal and Sinus Center, Birmingham, AL

i California Sinus Institute, Palo Alto, CA

j Sinus Center of the South, Biloxi, MS.

Corresponding author: William E. Bolger, MD, Maryland Sinus Center, Suburban ENT Associates, 6420 Rockledge Drive, Suite 4200, Bethesda, MD 20817.

PII: S0194-5998(07)00141-6

doi:10.1016/j.otohns.2007.02.006

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