Meta-Analysis

Meta-analysis of balloon sinus dilation clinical trial outcomes:

6 trials, 38 centers, 358 patients, 846 sinuses treated.

Overview

A recent article published in The Laryngoscope provides the most comprehensive analysis of clinical outcomes for balloon sinus dilation reported to date, including a meta-analysis of patient level data from 6 key standalone balloon sinus dilation studies sponsored by Entellus Medical.

The data show balloon sinus dilation delivers excellent clinical outcomes.


High technical success rate

  • 97.5% pooled technical success rate for 6 studies (825/846 sinuses)

  • Relevant studies: REMODEL, XprESS Multi-Sinus, XprESS Maxillary Pilot, RELIEF, FinESS Registry, BREATHE

 

Significant, clinically meaningful and durable symptom relief

  • Mean SNOT-20 overall and subscale score changes from baseline are significantly improved and clinically meaningful at all time points.

  • Relevant studies: REMODEL, XprESS Multi-Sinus, XprESS Maxillary Pilot, RELIEF, FinESS Registry, BREATHE

Mean SNOT-20 scores over time for balloon sinus dilation: random effects model

Mean SNOT

 

Low rate of revision

  • Data show a low need of revision surgery for balloon sinus dilation patients at 12 months:

    • 3.2% pooled single arm balloon dilation studies

  • This data is aligned with results from the REMODEL study, which showed no statistical difference between balloon sinus dilation and functional endoscopic sinus surgery arms at 12-months:

    • 1.4% REMODEL balloon sinus dilation arm

    • 1.7% REMODEL FESS arm

  • Relevant studies: REMODEL, XprESS Multi-Sinus, RELIEF, FinESS Registry, BREATHE

 

Comfortable office-based procedure

  • Data affirms procedure can be performed comfortably in the office:

    • Low 2.6 mean pain score, on a 0 - 10 scale, where 0=0 no pain and 10=worst conceivable pain

  • Relevant studies: XprESS Multi-Sinus, RELIEF, BREATHE, XprESS Maxillary Pilot

 

Limited post-operative bleeding, need for pain medications, and debridements

  • Bleeding, post-operative pain and debridements can negatively impact patient treatment experience. Data show balloon sinus dilation patients had:

    • 13.8% (32/232) balloon patients reported nasal bleeding

    • 0.8 days mean time prescription pain medications taken

    • 0.16 mean debridements per patient

  • Relevant Studies: REMODEL, XprESS Maxillary Pilot, RELIEF, BREATHE

 

Quick recovery

  • Balloon sinus dilation patients reported a quick return to normal activities:

    • 1.4 days - mean recovery time

  • Relevant studies: REMODEL, XprESS Pilot

 

Improved productivity; decreased activity impairment and healthcare utilization

  • Clinical trials used both the Work Limitation Questionnaire and Rhinosinusitis Symptom Inventory to understand the impact of treatment on quality-of-life and productivity measures. Data highlights:

  • Rhinosinusitis Symptom Inventory data show a statistically significant improvements in key lost productivity measures as well as decreases in healthcare utilization. Select highlights:

    • Mean number of days homebound due to nasal problems: 12 months before treatment: 8.3; 12 months after treatment: 2.0

    • Mean number of antibiotic courses: 12 months before treatment: 4.5; 12 months after treatment: 1.6

  • Relevant studies: REMODEL, XprESS Multi-Sinus, RELIEF, FinESS Registry, BREATHE
     


Conclusions

Meta-analysis demonstrates:

  1. Significant and durable benefit of balloon dilation in a large series of patients (n=358), among whom 74 were followed to 2 years

  2. No significant difference in symptom improvement and revision rates between the REMODEL FESS arm (n=59) and a large standalone balloon dilation patient sample (n=314)

  3. Standalone balloon sinus dilation can be performed as an in-office procedure, with faster recovery, decreased post-procedural pain, and less requirement for debridement
     


Featured publication

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. 2016 Jan;126(1):44-50.

Browse clinical data:

Sinusitis

Eustachian tube dysfunction

Nasal airway obstruction

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