Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study.
BACKGROUND
Although previous studies of sinus surgery that used balloon catheter dilation technology for the paranasal sinuses (balloon sinus dilation [BSD]) demonstrated safety and efficacy, data that compare BSD with continued medical management (MM) are lacking.


OBJECTIVE
To evaluate the outcomes of sinus surgery when using BSD instruments versus MM for patients with chronic rhinosinusitis for whom MM failed.


METHODS
Adult patients with chronic rhinosinusitis for whom a minimum of 3 weeks of oral antibiotics, 4 weeks of daily saline solution therapy, and 4 weeks of daily nasal corticosteroids failed were included. Qualifying participants were allowed to self-select sinus surgery with BSD (either an office or operating room setting) or continued MM. The primary end point was the comparison of change in the Chronic Sinusitis Survey score from baseline to 24 weeks. Secondary end points included comparisons of change for the Rhinosinusitis Disability Index (RSDI) and the Sino-Nasal Outcome Test (SNOT-20).


RESULTS
A total of 198 patients were enrolled (146 surgery and 52 MM). Of the patients who chose BSD, 72% (105/146) had their procedures completed in an office setting. Overall, BSD instruments were successful in dilating 97.6% of targeted sinuses (561/575). Patients who chose BSD showed a significantly greater improvement in the Chronic Sinusitis Survey score versus MM (42.0 versus 27.0, p < 0.001). Results from the RSDI and SNOT-20 surveys showed similar improvements for surgery versus MM (RSDI, 36.0 versus 18.1, p < 0.001; SNOT-20, 1.7 versus 1.0, p < 0.002).


CONCLUSIONS
Patients who selected sinus surgery in which BSD instruments were used on the peripheral sinuses demonstrated significantly greater improvements in quality of life compared with those who elected ongoing MM. These results were achieved through office-based procedures with the patient under local anesthesia in the majority of patients.
Department of Otolaryngology-Head & Neck Surgery, University of Virginia, Charlottesville, Virginia, USA.
Spencer C
SC
Payne
Pablo
P
Stolovitzky
Neelesh
N
Mehendale
Keith
K
Matheny
William
W
Brown
Anthony
A
Rieder
Douglas
D
Liepert
Ewen
E
Tseng
Andrew
A
Gould
Scott
S
Powell
Daniel
D
Van Himbergen
Boris
B
Karanfilov
Daniel
D
Harfe
Laura
L
England
Christopher
C
Melroy
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization; D002908:Chronic Disease; D004724:Endoscopy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010256:Paranasal Sinuses / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D012220:Rhinitis / Q000601:surgery / Q000628:therapy*; D012852:Sinusitis / Q000601:surgery / Q000628:therapy*
D000305:Adrenal Cortex Hormones