Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool

Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. doi: 10.1002/alr.21156. Epub 2013 Feb 19.


Background: A multicenter prospective study was conducted to assess the safety and sustained effectiveness of a new instrument possessing multifunctionality as an ostium seeker, suction-irrigator, and malleable balloon-dilator indicated for treating multiple sinuses.

Methods: Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Results: A total of 497 balloon dilations (279 frontal, 138 sphenoid, and 80 maxillary) were attempted in 175 patients. Over 96% (479/497) of the attempted sinus dilations were successfully completed, while 18 dilations were converted to traditional dissection due to an inability to access or dilate the targeted anatomy. Two (1.1%) nonserious adverse events were reported following hybrid-balloon dilation and both were unrelated to the device or the procedure. Forty-four of 50 patients in the extended follow-up cohort completed the 1-year follow-up. Sinus symptom improvement in this group improved significantly from an average severity of 1.9 ± 1.1 to 0.8 ± 0.7 (p < 0.0001) and 1-year ostial patency was 91.6% (76/83). One revision surgery (2.3%) was performed.

Conclusion: These results indicate that a multifunctional, malleable, balloon-dilating device can be safely and successfully used to treat multiple sinuses with sustained ostial patency and symptom improvement for at least 1 year.

Trial registration: NCT01115309.

Keywords: FESS; balloon dilation; patency; quality of life; rhinosinusitis; safety.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Catheterization / instrumentation*
  • Catheterization / methods
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Nasal Surgical Procedures / instrumentation*
  • Nasal Surgical Procedures / methods
  • Paranasal Sinus Diseases / therapy*
  • Paranasal Sinuses*
  • Prospective Studies
  • Treatment Outcome

Associated data