PMID- 36889144
OWN - NLM
STAT- MEDLINE
DCOM- 20230501
LR  - 20230501
IS  - 1532-818X (Electronic)
IS  - 0196-0709 (Linking)
VI  - 44
IP  - 3
DP  - 2023 May-Jun
TI  - Image guided dilation of sinus ostium in revision sinus surgery.
PG  - 103803
LID - S0196-0709(23)00017-0 [pii]
LID - 10.1016/j.amjoto.2023.103803 [doi]
AB  - PURPOSE: Assess if a rigid, image-guided balloon could be used effectively and 
      safely in revision sinus surgery. MATERIALS AND METHODS: A prospective, 
      non-randomized, single-arm, multicenter study to assess the safety and device 
      performance of the NuVent EM Balloon Sinus Dilation System. Adults with CRS in 
      need of revision sinus surgery were enrolled for balloon sinus dilation of a 
      frontal, sphenoid, or maxillary sinus. The primary device performance endpoint 
      was the ability of the device to (1) navigate to; and (2) dilate tissue in 
      subjects with scarred, granulated, or previously surgically-altered tissue 
      (revision). Safety outcomes included the assessment of any operative adverse 
      events (AEs) directly attributable to the device or for which direct cause could 
      not be determined. A follow-up endoscopy was conducted at 14 days post-treatment 
      for assessment of any AEs. Performance outcomes included the surgeon's ability to 
      reach the target sinus (es) and dilate the ostia. Endoscopic photos were captured 
      for each treated sinus pre- and post-dilation. RESULTS: At 6 US clinical sites, 
      51 subjects were enrolled; 1 subject withdrew before treatment due to a cardiac 
      complication from anesthesia. 121 sinuses were treated in 50 subjects. The device 
      performed as expected in 100 % of the 121 treated sinuses, with investigators 
      able to navigate to the treatment area and dilate the sinus ostium without 
      difficulty. Ten AEs were seen in 9 subjects, with 0 related to the device. 
      CONCLUSION: The targeted frontal, maxillary or sphenoid sinus ostium were safely 
      dilated in every revision subject treated, with no AEs directly attributed to the 
      device.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Han, Joseph K
AU  - Han JK
AD  - Eastern Virginia Medical School, Norfolk, VA, USA. Electronic address: 
      hanjk@evms.edu.
FAU - Palmer, James N
AU  - Palmer JN
AD  - University of Pennsylvania, Philadelphia, PA, USA.
FAU - Adappa, Nithin D
AU  - Adappa ND
AD  - University of Pennsylvania, Philadelphia, PA, USA.
FAU - Nachlas, Nathan E
AU  - Nachlas NE
AD  - ENT and Allergy Associates of Florida, Boca Raton, FL, USA.
FAU - Chandra, Rakesh K
AU  - Chandra RK
AD  - Vanderbilt University, Nashville, TN, USA.
FAU - Jacobs, Joseph B
AU  - Jacobs JB
AD  - New York University Medical Center (NYU), New York, NY, USA.
FAU - Manes, R Peter
AU  - Manes RP
AD  - Yale University, New Haven, CT, USA.
FAU - McKenzie, Karen
AU  - McKenzie K
AD  - Medtronic Xomed, Inc., Jacksonville, FL, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230224
PL  - United States
TA  - Am J Otolaryngol
JT  - American journal of otolaryngology
JID - 8000029
SB  - IM
MH  - Adult
MH  - Humans
MH  - Dilatation
MH  - Prospective Studies
MH  - *Rhinitis/surgery
MH  - Maxillary Sinus/surgery
MH  - Catheterization
MH  - Endoscopy
MH  - Chronic Disease
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic rhinosinusitis (CRS) population
OT  - Dilation
OT  - Image-guided balloon
OT  - Revision sinus surgery
OT  - Sinus ostium
COIS- Declaration of competing interest Author disclosures/conflicts of interest are: 
      1) Joseph K. Han works as a consultant for Medtronic Xomed, Inc.; 2) James Nathan 
      Palmer is a consultant for OptiNose, Acclarent, and Medtronic Xomed, Inc.; 3) 
      Nithin Adappa is a consultant for Acclarent and on the Clinical Trial Steering 
      Committee for OptiNose; 4) Rakesh K. Chandra is a consultant for Regeneron, Astra 
      Zeneca and GSK, and on the Clinical Trial Steering Committee for OptiNose; 5) 
      Joseph B. Jacobs has no disclosures to report; 6) Peter Manes received Research 
      and Grant Support from OptiNose; and 7) Karen McKenzie is an employee of 
      Medtronic Xomed, Inc.
EDAT- 2023/03/09 06:00
MHDA- 2023/05/01 06:42
CRDT- 2023/03/08 18:10
PHST- 2022/08/26 00:00 [received]
PHST- 2023/02/09 00:00 [revised]
PHST- 2023/02/19 00:00 [accepted]
PHST- 2023/05/01 06:42 [medline]
PHST- 2023/03/09 06:00 [pubmed]
PHST- 2023/03/08 18:10 [entrez]
AID - S0196-0709(23)00017-0 [pii]
AID - 10.1016/j.amjoto.2023.103803 [doi]
PST - ppublish
SO  - Am J Otolaryngol. 2023 May-Jun;44(3):103803. doi: 10.1016/j.amjoto.2023.103803. 
      Epub 2023 Feb 24.