Format

Send to

Choose Destination
See comment in PubMed Commons below
Am J Rhinol Allergy. 2009 May-Jun;23(3):321-7. doi: 10.2500/ajra.2009.23.3274. Epub 2009 Jan 16.

Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia.

Author information

1
Department of Otolaryngology, Loyola University Medical Center, Maywood, Illiniois 60153-3304, USA. jstank@lumc.edu

Abstract

BACKGROUND:

A multicenter study (BREATHE I - Entellus Medical, Inc.) was performed to assess the safety and outcomes of a new, less invasive system that uses direct endoscopic visualization to facilitate balloon dilation of the maxillary sinus ostia and ethmoid infundibulum. General anesthesia was avoided in most subjects to assess feasibility of performing transantral ostial dilatation in an office setting.

METHODS:

Subjects with chronic rhinosinusitis of the maxillary sinuses alone or maxillary and anterior ethmoid sinuses underwent baseline evaluation including CT imaging and symptom assessment using the Sino-Nasal Outcome Test (SNOT 20). Subjects underwent transantral balloon dilation and follow-up evaluation at 1 week, 3 months, and 6 months post-procedure.

RESULTS:

Thirty subjects were treated at three centers. Fifty-five of 58 maxillary ostia were successfully treated for a procedural completion rate of 94.8%. Ninety-seven percent of the procedures were completed under local anesthesia with or without minimal intravenous sedation. There were no device-related serious adverse events or unanticipated adverse device effects. The mean overall SNOT 20 score at baseline was 2.9 +/- 1.0. Mean overall SNOT 20 scores at 1-week, 3-month, and 6-month follow-up were 0.8 +/- 0.8, 0.7 +/- 0.8, and 0.8 +/- 0.9 respectively. Patency at 3-months as confirmed by CT imaging was 95.8%.

CONCLUSION:

These results indicate that transantral balloon dilation of the ostiomeatal complex under local anesthesia appears to be a safe technique for managing isolated maxillary or maxillary and anterior ethmoid sinusitis and can potentially be performed safely in an office setting.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00645762.

PMID:
19419611
DOI:
10.2500/ajra.2009.23.3274
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Ingenta plc
    Loading ...
    Support Center