A look at recent literature on the pros and cons of balloon sinuplasty as well as cases where the technology was useful to complete the procedure safely with the best outcome for the patient

1. August 2, 2017
Elisabeth Ference, MD MPH
Assistant Professor of Clinical Otolaryngology-Head and Neck Surgery
Tina and Rick Caruso Department of Otolaryngology-Head and Neck Surgery
Keck School of Medicine of University of Southern California

2.  None
 I have received no funding from any of the
manufacturers of the products I am
discussing

3.  How does it work
 Evidence
 How is it currently being used
 Role in the OR
 Role in the Office
 Future Studies

4.  In most systems, initial
access obtained by
endoscopic placement of
guide wire
 Position confirmed with
direct visualization,
transillumination or
image guidance
 Balloon catheter
advanced over guide
wire and inflated
 Able to irrigate in most
systems
http://www.ent-specialist.org/balloon-sinuplasty.php

6.  Initially described by Lanza in 19931
 Fogarty balloon catheter
 Improve frontal recess mucosal swelling
 Initial cadaver study in 20052
 6 heads, 31 sinuses
 Trial in 10 patients with persistent CRS after failed medical
therapy3
 18 sinuses
 No follow up period
 Proof of Concept
 Approved by FDA in 2005
1. Lanza DC. “Postoperative care and avoiding frontal recess stenosis.” In: Abstracts of the International Advanced Sinus Symposium.
Philiadelphia; 1993.
2. Bolger WE, Vaughn WC. “Catheter based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model.” Am J
Rhinol 2006; 20(3): 290-4.
3. Brown CL, Bolger WE. ”Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation.” Ann
Otol Rhinol Laryngol 2006; 115(4): 293-9.

7.  CLEAR study1-3
 109 patients without polyps unresponsive to medical therapy
▪ “Balloon only” and “hybrid”
 Follow-up to 24 weeks, later papers followed cohort to 1 and 2 years
 Improvement in SNOT-20, Lund Mackay scores with ostial patency
▪ 94% Maxillary at one year
▪ 92% Frontal at one year
▪ 86% Sphenoid at one year
 Single-arm, uncontrolled observational study
 Received CPT codes January 1, 2011
 EPOS 2012: “the place of these systems in the sinus surgeon’s
armamentarium remains unclear”
Bolger WE, Brown CL, Church CA, et al. ”Safety and outcomes of balloon catheter technology: a multicenter 24-week analysis of 115
patients.” Otolaryngol Head Neck Surg 2007; 37(1):10-20
Kuhn FA, Church CA, Goldberg AN, et al. “Balloon catheter sinusotomy: one-year follow-up – outcomes and role in functional endoscopic
sinus surgery.” Otolaryngol Head Neck Surg 2008; 139: S27-37.
Weiss RL, Church CA, Kuhn FA, et al. “Long term outcome analysis of balloon catheter sinusotomy: two-year follow-up.” Otolaryngol Head
Neck Surg 2008; 139: S38-46.

8.  2 randomized controlled trials
 No significant difference in Quality of Life or Revision
Rate
 Decreased post-operative recovery time in BCD
 Limited disease severity
 Maxillary with or without anterior ethmoid disease only
 Excluded polyposis, fungal disease, deviated septum
Levy JM, Marino MJ, and McCoul ED. “Paranasal Sinus Balloon Catheter Dilation for Treatment of Chronic Rhinosinusitis: A Systematic Review and Meta-
analysis.” Otolaryngol Head Neck Surg 2016; 154(1): 33-40.
Chandra RK, Kern RC, Cutler JL, Welch KC, and Russell PT. “REMODEL Larger Cohort with Long-Term Outcomes and Meta-Analysis of Standalone Balloon
Dilation Studies.” Laryngoscope 2016; 126(1)” 44-50.

9.  State Ambulatory Surgery
Database (SASD) for CA, FL,
MD, and NY for 2011
 Extracted all patients with
CPT codes for traditional
endoscopic sinus surgery or
BCD
 Considered traditional ESS
vs hybrid procedure
 Hybrid procedure: any
procedure which used balloon
technology alone or in
conjunction with endoscopic
techniques
Ference EH, Graber M, Conley D, Chandra RK, Tan BK, Evans C, Pynnonen M, Smith SS. “Operative utilization of balloon versus traditional
endoscopic sinus surgery.” Laryngoscope. 2015; 125(1): 49-56.
Ference EH, Schroeder JW Jr, Qureshi H, Conley D, Chandra RK, Tan BK, Shintani Smith S. “Current Utilization of balloon dilation versus
endoscopic techniques in pediatric sinus surgery.” Otolaryngol Head Neck Surg. 2014; 852-60.

10.  33,776 balloon or endoscopic sinus surgeries
were performed at 738 facilities.
 8% of cases involved BCD
 5% of maxillary sinus surgery performed with
balloon, versus 14% of frontal sinus surgery

11. *
*
*
TotalChargeinDollars
Median Charge greater for cases utilizing balloon catheter dilation
compared to traditional endoscopic sinus surgery

12. *
TotalORTimeinMinutes
Median OR time was 8 minutes less for Mini-ESS procedures
involving BCD but not different for maxillary antrostomy or Pan-
ESS procedures

13.  Geographic disparity: used more often in NY
compared to California
 Demographic disparity:
 Black and Asian patients less likely to have balloon
procedure, when controlling for payer and household
income in zipcode
 BCD was used more in patients with chronic
disease and more extensive surgery
 Procedures using balloon technology on average
more expensive with minimal decrease in OR
time

14.  Svider et al: almost
200% increase in
frontal sinus surgery
charged to Medicare
 Greatest increase
between 2007-2011
 Pynnonen and Davis:
 rates of frontal sinus
surgery more than
doubled in Florida
between 2000-2009
 rates of Pan-FESS tripled
Svider PF, Sekhsaria V, Cohen DS, Eloy JA, Setzen M, Folbe AJ. “Geographic and temporal trends in frontal sinus surgery.” International Forum of Allergy &
Rhinology 2015; 15(1): 46-54.
Pynnonen MA, Davos MM. “Extent of sinus surgery, 2000 to 2009: a population-based study.” Laryngoscope 2014; 124(4):820-5.

15. Given limited resources and additional surgical costs,
where does this technology increase
effectiveness or efficiency?

16.  50 yo M with alpha-1 antitrypsin liver failure,
renal failure, thrombocytopenia
 Found on CT brain to have CRS
 Treated with antibiotics and steroids for
months at OSH without improvement
 Transferred to UCLA for consideration of
transplant

18.  Mucosal injury can lead to long term stenosis
 Variable and complex anatomy: narrow
diameter
 Possible decrease risk of bleeding

19.  Video File

21.  20 yo F with frontal headache, nasal
obstruction, post nasal drip

23.  Suprabullar cell and frontal bullar cells are
superior to the ethmoid bulla
Palmer, J and Chiu, A. 2013

24.  12% failure rate of BCD (104 sinuses)1
 Complex frontal recess pneumatization or
osteoneogenesis
 Hybrid approach2
 Decreased blood loss
 Decreased operating time (4 min)
 Allows access without open approach
1. Heimgartner S, Eckardt J, Simmen D, Briner HR, Leunig A, Caversaccio MD. “Limitations of balloon sinuplasty in frontal sinus
surgery.” Eur Arch Otorhinolaryngol. 2011; 268(10): 1463-7.
2. Hathorn IF, Pace-Asciak P, Habib AR, Sunkaraneni V, Javer AR. “Randomized controlled trial: hybrid technique using balloon dilation
of the frontal sinus drainage pathway.” International Forum of Allergy & Rhinology. 2015; 5(2): 167-173.

25.  Video File

26.  REMODEL, RELIEF and
XprESS in office,
BREATHE under local
with or without sedation
 Technical success 97.5%
 SNOT-20 outcomes
improved at all time
points
 Significant reductions in:
 work/school days missed
 physician/nurse visits
 acute infections
 antibiotics prescriptions
Chandra RK, Kern RC, Cutler JL, Welch KC, and Russell PT. “REMODEL Larger Cohort with Long-Term Outcomes and Meta-Analysis of Standalone Balloon
Dilation Studies.” Laryngoscope 2016; 126(1)” 44-50.

27.  Patients have limited disease severity
 ”Normal” LM score of 4 (95% CI 3.4-5.1)1
 Exclude patients with prior surgery and fungal
disease, some studies exclude polyposis,
posterior ethmoid or sphenoid disease
1. Ashraf N, Bhattacharyya N. ”Determination of the ‘incidental’ Lund score for staging of chronic sinusitis.” Otolaryngol Head Neck Surg. 2001; 125: 483-486
2. Gould J, Alexander I, Tomkin E, Brodner D. “In-office, multisinus balloon dilation: 1-year outcomes from a prospective, multicenter, open label trial.”
American Journal of Rhinology & Allergy 2014; 28(2): 156-163.

28.  40 yo M 6 weeks after Draf III (Modified
Lothrop) complicated by post-operative
pseudomonal infection

30.  Rate of frontal sinus patency approximately
92% after Draf IIa1 and 95% after Draf III2
 No definitive management strategy (topical
medications, stenting, debridement)
 Avoids revision surgery
American Journal of Rhinology 2008; 22(6): 621-624
1. Naidoo Y, Wen D, Bassiouni A, Keen M, Wormald PJ. “Long-term results after primary frontal sinus surgery.” Int Forum Allergy Rhinol. 2012; 2(3): 185-90
2. Naidoo Y, Bassiouni A, Keen M, Wormald PJ. “Long-term outcomes for the endoscopic modified Lothrop/Draf III procedure: a 10-year review.”
Laryngoscope. 2014; 12(4):43-9.

32.  Post-operative bleeding
 Orbital complications
 Dilation in wrong location (especially if variations in
frontal recess pneumatization) leading to no
improvement or worsened obstruction
 Of note, recent review of D.O.D. database found:
 7.8% with post-op complications
 Most common: bleeding, pain greater than expectation
 2 most serious complications (orbital chemosis and
proptosis and facial subcutaneous emphysema) in patients
with LM=0
Laury, AM, Bowe SN, Stramiello J, McMains KC. “Balloon dilation of sinus ostia in the Department of Defense: Diagnoses, Actual Indications,
and Outcomes.” Laryngoscope. Epub 2016.

33.  Extensive sinus disease
 Nasal polyps
 Paranasal sinus masses
 Extensive
osteoneogenesis
 Extensive scarring
 Cystic fibrosis
 Ciliary dyskinesia
 Frontal recess
pneumatization patterns
(unless using a hybrid
technique)

34.  Post-operative quality of life following BCD in a
representative population with CRS
 Use of balloon for atypical facial pain/ headache
 D.O.D. Study (Laury et al) found that most common
alternate condition that BCD is being used to treat

35. Advantages
 Less distortion of anatomy
and mucosal disruption
 May minimize synechiae
formation and ostial stenosis
 May decrease need for
postoperative debridements
 Management of critically ill
patients with acute
rhinosinusitis
 SurgicalTool
 Office setting with
minimal anesthetic
requirements
Disadvantages
 Instrumentation not
reuseable
 Cost of disposable
instruments increase total
cost of procedure
 Offset by reduced OR time?
 Complex pneumatization
patterns, significant
osteogenesis, extensive
mucosal disease
 Surgeon must be able to
perform traditional surgery if
needed
 Ethmoid sinuses

36. Acknowledgements:
Dr. Rakesh Chandra
Dr. David Conley
Dr. Robert Kern
Dr. Jivianne Lee
Dr. Stephanie Smith
Dr. Jeffrey Suh
Dr. BruceTan
Dr. MarileneWang
Dr. KevinWelch