Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients

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• 作者：William E. Bolger ; Christopher L. Brown ; Christopher A. Church ; Andrew N. Goldberg ; Boris Karanfilov ; Frederick A. Kuhn ; Howard L. Levine ; Michael J. Sillers ; Winston C. Vaughan ; Raymond L. Weiss
• 刊名：Otolaryngology - Head and Neck Surgery
• 出版年：2007
• 出版时间：July 2007
• 年：2007
• 卷：137
• 期：1
• 页码：10-20
• 全文大小：4341 K

文摘

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 % ).

Conclusion

Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.