In-Office, Multisinus Balloon Dilation: 1-Year Outcomes from a Prospective, Multicenter, Open Label Trial

Gould, James R.; Alexander, Ian J.; Tomkin, Edward; Brodner, David

doi:10.2500/ajra.2014.28.4043

Cited by 29 publications

(54 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…10 Multiple studies, including a large patient registry of more than 1000 patients demonstrated that the technology appears to be safe, with rare complications. 3,11,12 In our survey, 21% of respondents reported experiencing a complication, including failed attempts at cannulation, scarring and/or adhesions, orbital complications, and significant bleeding. Only three individuals indicated that they had experienced or repaired CSF leaks caused by BCT.…”

Section: Discussionmentioning

confidence: 95%

Attitudes on and Usage of Balloon Catheter Technology in Rhinology: A Survey of the American Rhinologic Society

Halderman

Stokken

Momin

et al. 2015

Am J Rhinol�Allergy

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 95%

Attitudes on and Usage of Balloon Catheter Technology in Rhinology: A Survey of the American Rhinologic Society

Halderman

Stokken

Momin

et al. 2015

Am J Rhinol�Allergy

View full text Add to dashboard Cite

show abstract

“…The first goal of the present report was to provide data on this larger final study cohort and 24‐month follow‐up data. In addition to REMODEL, Entellus Medical (Plymouth, MN) sponsored five multicenter, prospective, controlled, single‐arm, standalone balloon dilation studies that are used in a meta‐analysis . Three of the five studies have been previously published in peer‐reviewed journals.…”

Section: Introductionmentioning

confidence: 99%

REMODEL larger cohort with long‐term outcomes and meta‐analysis of standalone balloon dilation studies

Chandra

Kern

Cutler³

et al. 2015

The Laryngoscope

View full text Add to dashboard Cite

Objectives/HypothesisTo provide the final results from the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long‐term follow‐up) full‐study cohorts and perform meta‐analyses of standalone balloon sinus dilation studies to explore long‐term outcomes in a large patient sample.Study DesignRandomized controlled trial and meta‐analysis.MethodsFinal outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with functional endoscopic sinus surgery (FESS) or in‐office balloon dilation, were evaluated. One hundred thirty patients had 12‐month data, 66 had 18‐month data, and 25 had 24‐month data. In addition, a meta‐analysis evaluated outcomes from six studies including 358 standalone balloon dilation patients with up to 24 months follow‐up.ResultsOutcomes out to 2 years from the REMODEL full‐study cohort are consistent with 6‐month and 12‐month outcomes. In the meta‐analysis of standalone balloon dilation studies, technical success is 97.5%, and mean 20‐item Sino‐Nasal Outcomes Test scores are significantly and clinically improved at all time points (P < .0001). There are significant reductions (P < .0001) in work/school days missed, homebound days, physician/nurse visits, acute infections, and antibiotic prescriptions. Mean recovery time is 1.4 days. Comparison of 12‐month symptom improvements and revision rates between the REMODEL FESS arm (n = 59), REMODEL balloon dilation arm (n = 71), and pooled single‐arm standalone balloon dilation studies (n = 243) demonstrated no statistical difference.ConclusionsAll outcomes are comparable between FESS and balloon dilation at all time points from 6 months to 24 months. Balloon dilation produces faster recovery, less postoperative pain, and fewer debridements than FESS. There is significant, durable benefit in a large series of 358 patients undergoing standalone balloon dilation.Level of Evidence1b. Laryngoscope, 126:44–50, 2016

show abstract

“…Current balloon technologies are applicable to the maxillary, frontal, and sphenoid sinuses, although there is some evidence that anterior ethmoid disease may respond to dilation of the ethmoid infundibulum which occurs in the course of maxillary ostial dilation. 285,286,1132 There have been many studies looking at the safety and efficacy of this technology, but few RCTs. The earliest RCT compared balloon dilation of the frontal recess vs ESS and found no significant difference in outcome.…”

Section: Ixe Aecrs: Complicationsmentioning

confidence: 99%

“…In another study, 9 patients with RARS were treated as part of a larger cohort using an office-based multi-sinus balloon dilation tool/technique. 286 Unfortunately, outcomes data specific to this small RARS group were not provided.…”

Section: Vid2 Rars Management: Essmentioning

confidence: 99%

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis

Orlandi

Kingdom

Hwang

et al. 2016

Int Forum Allergy Rhinol

554

888

View full text Add to dashboard Cite

Background:The body of knowledge regarding rhinosinusitis (RS) continues to expand, with rapid growth in number of publications, yet substantial variability in the quality of those presentations. In an effort to both consolidate and critically appraise this information, rhinologic experts from around the world have produced the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR:RS). Methods:Evidence-based reviews with recommendations (EBRRs) were developed for scores of topics, using previously reported methodology. Where existing evidence was insufficient for an EBRR, an evidence-based review (EBR) was produced. The sections were then synthesized and the entire manuscript was then reviewed by all authors for consensus. Results:The resulting ICAR:RS document addresses multiple topics in RS, including acute RS (ARS), chronic RS (CRS) with and without nasal polyps (CRSwNP and CRSsNP), recurrent acute RS (RARS), acute exacerbation of CRS (AE-CRS), and pediatric RS. Conclusion:As a critical review of the RS literature, ICAR:RS provides a thorough review of pathophysiology and evidence-based recommendations for medical and surgical treatment. It also demonstrates the significant gaps in our understanding of the pathophysiology and optimal management of RS. Too o en the foundation upon which these recommendations are based is comprised of lowerlevel evidence. It is our hope that this summary of the evidence in RS will point out where additional research efforts may be directed. C 2016 ARS-AAOA, LLC. Key Words:rhinosinusitis; chronic rhinosinusitis; acute rhinosinusitis; recurrent acute rhinosinusitis; evidence-based medicine; systematic review; endoscopic sinus surgery List of Abbreviations Used

show abstract

In-Office, Multisinus Balloon Dilation: 1-Year Outcomes from a Prospective, Multicenter, Open Label Trial

Cited by 29 publications

References 30 publications

Attitudes on and Usage of Balloon Catheter Technology in Rhinology: A Survey of the American Rhinologic Society

Attitudes on and Usage of Balloon Catheter Technology in Rhinology: A Survey of the American Rhinologic Society

REMODEL larger cohort with long‐term outcomes and meta‐analysis of standalone balloon dilation studies

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis

Contact Info

Product

Resources

About