In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial.

BACKGROUND: The objective of this prospective, multicenter study was to assess 1-year changes in sinonasal symptoms and health care use after office-based multisinus balloon dilation. METHODS: Adults diagnosed with chronic or recurrent acute rhinosinusitis per the 2007 adult sinusitis guidelines were enrolled in this Institutional Review Board-approved study. Balloon dilation of the maxillary sinuses/ethmoid infundibula with or without frontal or sphenoid ostial dilation was performed in the physician's office under local anesthesia. Intraoperative procedure technical success and subject procedure tolerance were recorded. Efficacy was assessed using the patient-reported 20-item Sino-Nasal Outcome Test (SNOT-20) and Rhinosinusitis Symptom Inventory (RSI). Complications and revision surgeries were also recorded. RESULTS: A total of 313 ostial dilations were attempted and 307 were successfully completed (98.1%) in 81 subjects. Mean procedure tolerance was 2.8 ± 2.2 (0 = no pain; 10 = severe pain). Clinically meaningful and statistically significant (p < 0.0001) mean SNOT-20 symptom improvement was observed at 1 and 6 months and sustained through 1 year. The RSI treatment effect for all major rhinosinusitis symptoms was "large" and improvement in each was significant (p < 0.0001). Compared with the previous 1-year period, patients reported an average of 2.3 fewer acute sinus infections (p < 0.0001), 2.4 fewer antibiotic courses taken (p < 0.0001), and 3.0 fewer sinus-related physician visits (p < 0.0001) after balloon dilation. No serious device or procedure-related adverse events occurred. One subject (1.3%) underwent revision surgery. CONCLUSION: In-office, multisinus balloon dilation is safe, effective, and well tolerated. Patients reported significant reductions in both sinonasal symptoms and health care use after balloon dilation. Efficacy observed at 1 and 6 month follow-up was sustained through 1 year with a very low rate of revision surgery. This study was a part of the clinical trial NCT01612780 registered at www.clinicaltrials.gov.

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

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.

Accuracy of transnasal cannulation and dilation of the maxillary ostium in cadavers with intact uncinates.

BACKGROUND: Transnasal cannulation of the natural ostium in patients with an intact uncinate process is complicated by the lack of direct visualization of the ostium. Accuracy of transnasal dilation of the maxillary ostium was evaluated for a malleable-tipped balloon device that was bent to specific angles for avoiding the fontanelle during cannulation. METHODS: Transnasal cannulation and dilation of 42 cadaver maxillary sinus ostia was attempted by 6 surgeons including 3 with very limited clinical experience using the study device. All physicians received procedure training including the technique to shape the balloon device into the recommended 135° maxillary configuration. Tissue dissection was prohibited. Canine fossa trephination and transantral endoscopy were used to evaluate cannulation and dilation outcomes. Physician operators were blinded to transantral images and results were documented by two observers. RESULTS: Appropriate transnasal cannulation and dilation of natural maxillary sinus ostia occurred in 92.9% (39/42) of attempts. Two failures emanated from procedural deviations. In one deviation, the bend angle was changed to 90° and the device tip did not cannulate the ostium. In the second, the device was passed through a preexisting hole in the uncinate and cannulated the natural ostium. A third failure occurred when the device was passed through the fontanelle creating a false lumen. CONCLUSION: Using recommended procedural techniques and a malleable-tipped balloon device, newly trained and experienced physicians alike can perform uncinate-preserving transnasal cannulation and dilation of the maxillary ostium with a high rate of success.

Periosteal readhesion after brow-lift in New Zealand white rabbits.

OBJECTIVES: To define the postoperative time interval required for elevated periosteum to readhere to the skull and regain its preoperative strength, and to evaluate whether fixation of the periosteum affects this interval or the strength of postoperative readhesion. DESIGN: Prospective analysis of variance and covariance with repeated measures. SUBJECTS: Thirty-six New Zealand white rabbits, each serving as its own control. INTERVENTIONS: Subperiosteal elevation was performed on one side of the skull, leaving the contralateral periosteum untouched. The periosteum in half of the subjects was lifted and fixed to a resorbable screw, with the comparison group undergoing subperiosteal elevation only, without lifting and fixation. Several adhesion characteristics were subsequently examined at postoperative weeks 1, 3, 5, 7, 8, 9, 10, 11, and 12. Half of the subjects were assessed histologically to determine attachment of periosteum onto underlying bone. The other half underwent analysis of periosteal readhesion strength. RESULTS: The 3 independent measures of periosteal adherence to the skull all lacked significant differences between sides after the first postoperative week. Blinded histologic analysis showed no evidence of ongoing periosteal healing and demonstrated no difference between operated-on and nonoperated-on sides. Analysis of periosteal stiffness (P =.76) and energy density (P =.74) also demonstrated no significant differences between sides. CONCLUSIONS: Periosteal readhesion after surgical elevation is virtually complete by the seventh postoperative day. In addition, tension secondary to periosteal elevation with suspension has no influence on postoperative healing. These findings will contribute to the debate regarding the most appropriate brow-lift fixation technique.