title: Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: The Center for Sinus, Allergy, and Sleep Wellness, Boynton Beach, FL 33437, USA. dbrodner@yahoo.com
authors: David
authors: D
authors: Brodner
authors: Nathan
authors: N
authors: Nachlas
authors: Presley
authors: P
authors: Mock
authors: Theodore
authors: T
authors: Truitt
authors: Michael
authors: M
authors: Armstrong
authors: Raza
authors: R
authors: Pasha
authors: Christopher
authors: C
authors: Jung
authors: James
authors: J
authors: Atkins
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D059747:Nasal Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D010254:Paranasal Sinus Diseases / Q000628:therapy*; D010256:Paranasal Sinuses; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: FESS; balloon dilation; patency; quality of life; rhinosinusitis; safety