Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients.
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%).


CONCLUSIONS
Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.
Bolger
William E
WE
Maryland Sinus Center, Bethesda, MD 20817, USA. sinusmd@comcast.net
Brown
Christopher L
CL
Church
Christopher A
CA
Goldberg
Andrew N
AN
Karanfilov
Boris
B
Kuhn
Frederick A
FA
Levine
Howard L
HL
Sillers
Michael J
MJ
Vaughan
Winston C
WC
Weiss
Raymond L
RL
D000328:Adult; D000368:Aged; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation; D015331:Cohort Studies; D004724:Endoscopy; D004868:Equipment Failure; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D015522:Frontal Sinusitis / Q000601:surgery / Q000628:therapy; D006801:Humans; D008297:Male; D015523:Maxillary Sinusitis / Q000601:surgery / Q000628:therapy; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D019233:Retreatment; D012449:Safety; D012852:Sinusitis / Q000601:surgery / Q000628:therapy*; D015524:Sphenoid Sinusitis / Q000601:surgery / Q000628:therapy; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome