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Meta-Analysis of Balloon Sinus Dilation Clinical Trial Outcomes

6 Trials - 38 Centers - 358 Patients - 846 Sinuses Treated

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:

Clinical Studies Patients Treated Sinuses Treated Patients @ 6 mo Follow-Up Patients @ 12 mo Follow-Up Patients @ 24 mo Follow-Up
REMODEL Balloon Dilation 74 146 73 71 15
XprESS Multi-Sinus 81 313 72 76  
XprESS Maxillary Pilot 21 42 21    
RELIEF 69 135 62 65  
FinESS Registry 42 79 32 35  
BREATHE 71 131 70 67 59
TOTAL 358 846 330 314 74

Empty cells indicate follow-up visits that were not required for the particular study.

The data show balloon sinus dilation delivers excellent clinical outcomes:


High Technical Success Rate

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

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

Significant, Clinically Meaningful and Durable Symptom Relief

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

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

Low Rate of Revision

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

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

Comfortable Office-Based Procedure

Relevant Studies: XprESS Multi-Sinus, RELIEF, BREATHE, XprESS Maxillary Pilot

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

Limited Post-Operative Bleeding, Need for Pain Medications, and Debridements

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

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

Quick Recovery

Relevant Studies: REMODEL, XprESS Pilot

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

  • 1.4 Days - mean recovery time

Improved Productivity; Decreased Activity Impairment and Healthcare Utilization

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

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:

Work Limitations Questionnaire (WLQ) Over Time: Random Effects Model

Statistically significant improvements from baseline in 4 out of 5 domains at all time points through 24 months.

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

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

To explore the full study, click here.

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. July 2015. DOI: 10.1002/lary.25507.