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REMODEL

Table of Contents


Study Background

Overview

REMODEL is the first prospective, multi-center, open-label, randomized, controlled trial with sufficient statistical power to compare standalone Balloon Sinus Dilation to the standard of care, Functional Endoscopic Sinus Surgery (FESS) for the treatment of medically refractory CRS

Treatment

Balloon dilation of maxillary ostia & ethmoid infundibula

Control

Maxillary antrostomy and uncinectomy with or without anterior ethmoidectomy

Inclusion Criteria

  • Age ≥ 18 years
  • Uncomplicated chronic rhinosinusitis of the maxillary sinuses with or without anterior ethmoid disease

  • Diagnosed with chronic or recurrent acute rhinosinusitis per the 2007 adult sinusitis clinical practice guidelines

  • Patients met nationally recognized criteria for medically necessary functional endoscopic sinus surgery. (Anthem Coverage Guideline or BlueCross BlueShield of North Carolina Medical Policy)

Exclusion Criteria

  • Disease in the frontal, posterior ethmoid or sphenoid sinuses that requires surgery
  • Fungal disease

  • Gross polypoid disease

  • Require concurrent nasal surgery or have had previous sinus surgery

  • Nasal surgery within 3 months prior to enrollment

  • Severe septal deviation causing obstruction of the OMC

  • Primary ciliary dysfunction

  • Hemophilia

  • Samter’s Triad


Outcomes & Results

Balloon Dilation (74 patients)

  • 99.3% technical success rate
  • 145 of 146 dilations of the maxillary ostia/ethmoid infundibula were successfully completed

FESS (61 patients)

  • 99.4% technical success rate

  • 118 of 119 attempted maxillary antrostomies with uncinectomies were successfully completed

  • 47 concomitant anterior ethmoidectomies in 25 patients

Summary: 130/135 patients treated (96.3%) completed 12-Month follow-up; 66/66 (100%) and 25/25 (100%) completed 18 and 24 month follow-up, respectively

REMODEL Trial Outcomes

Primary Endpoints
Study Outcomes Balloon Dilation when compared to FESS
No Difference Not Inferior Significantly Better Superior
12-month mean change in SNOT-20   X

Balloon Dilation: -1.59
FESS: -1.60
p-value: <0.001

   
Mean number of debridements per patient       X

Balloon Dilation: 0.2
FESS: 1.0
p-value: <0.0001

Secondary Recovery Outcomes
Study Outcomes Balloon Dilation when compared to FESS
No Difference Not Inferior Significantly Better Superior
Patients discharged with nasal bleeding (%)     X

Balloon Dilation: 32%
FESS: 56%
p-value: 0.009

 
Recovery time (mean # of days)     X

Balloon Dilation: 1.7
FESS: 5.0
p-value: <0.0001

 
Duration of prescription pain medications (mean # of days)     X

Balloon Dilation: 1.0
FESS: 2.8
p-value: <0.0001

 
Secondary Outcomes
Study Outcomes Balloon Dilation when compared to FESS
No Difference Not Inferior Significantly Better Superior
Ostial patency (%) X

>90% in both Balloon Dilation and FESS arms
p-value: NS

     
Reduction (p<0.0001) in acute sinus exacerbations in both arms from 1 year before to 1 year after the procedure X

Balloon Dilation: 5.1 to 0.9
FESS: 4.5 to 0.8
p-value: NS

     
Complications up to 24-months X

Balloon Dilation #: 0
FESS #: 0
p-value: NS

     
Revision surgery rate at 18-months(%) X

Balloon Dilation: 2.7% (1/37)
FESS: 6.9% (2/29)
p-value: NS

     

p-value= Comparison of mean change from baseline to follow-up; P value from paired t-test.

NS=Not significant


Conclusions

Benefits of balloon dilation compared to FESS

  • Less bleeding

  • Reduced use of postoperative pain medication

  • Faster patient recovery

  • Fewer debridements

Balloon dilation has comparable efficacy as FESS

  • Long-term symptom improvement

  • Reduction in acute sinus exacerbations

  • Ostial patency

  • Very low surgical revision rates

Standalone balloon dilation performed in the physicians office is proven to be safe, effective, and a beneficial alternative to FESS in patients with uncomplicated CRS

Download a summary of REMODEL results

Download a slide set summarizing REMODEL results and a meta-analysis of data from 6 standalone balloon sinus dilation trials

References

REMODEL

Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.
Laryngoscope. July 2015. DOI: 10.1002/lary.25507. Click to explore the article.

Bikhazi N, Light J, Schwartz M, Truitt T, Cutler J, REMODEL Study Investigators.Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up
Am J Rhinol Allergy doi.org/10.2500/ajra.2014.28.4064.

Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M.Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial.
Am J Rhinol Allergy doi.org/10.2500/ajra.2013.27.3970.