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Safety and outcomes following hybrid balloon and balloon‐only procedures using a multifunction, multisinus balloon dilation tool
Author(s) -
Brodner David,
Nachlas Nathan,
Mock Presley,
Truitt Theodore,
Armstrong Michael,
Pasha Raza,
Jung Christopher,
Atkins James
Publication year - 2013
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.21156
Subject(s) - medicine , balloon , balloon dilation , ostium , surgery , cutting balloon , prospective cohort study , dilator , dissection (medical) , sinus (botany) , radiology , restenosis , stent , botany , biology , genus
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.