Utilization of Balloon versus Traditional Endoscopic Sinus SurgeryElisabeth Ference, James Schroeder, Madeline

Graber, Hannan Quereshi, David Conley, Rakesh Chandra, Melissa Pynnonen,

Charlesnika Evans, Bruce Tan, Stephanie Smith

Balloon Catheter Dilation Approved by FDA in 2005

Received CPT codes January 1, 2011

Few trials comparing traditional endoscopic sinus surgery with balloon catheter dilation (BCD)

EPOS: “the place of these systems in the sinus surgeon’s armamentarium remains unclear”

http://care.american-rhinologic.org/sinuplasty?print

Pros and Cons

Advantages Less mucosal disruption

Management of critically ill patients with acute rhinosinusitis

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

Study Objectives

1. Quantify how often being performed

2. Describe demographics

3. Determine how utilization varies based on surgical volume

4. Compare mean charges and mean OR times

http://care.american-rhinologic.org/ess

MethodsState Ambulatory Surgery Database (SASD) for CA, FL, MD, and NY for 2011

Extracted patients via CPT codesLooked at adults (> 18 years old) and pediatric (<18 years old) separately

Considered traditional ESS vs hybrid procedure Hybrid procedure: any procedure which used balloon technology alone or in conjunction with endoscopic techniques

Adult Sample Size

33,776 balloon or endoscopic sinus surgeries were performed at 738 facilities.

Within the subset of patients from Florida and Maryland, 581 surgeons performed 12,827 sinus surgeries

Type of FESS

Num ber of Procedures M axillary Ethm oid Sphenoid Frontal

Traditi-onal Balloon Traditi-

onal Traditi-onal Balloon Traditi-

onal Balloon

Endoscopic 26,532 --- 25,242 10,063 --- 11,931 --- Standalone Balloon --- 580 --- --- 217 --- 398

Hybrid 1,112 761 1805 467 403 177 1,550

Total 27,644 1,341 27,047 10,530 620 12,108 1,948 Percent of Procedures 95.37% 4.63% NA 94.44% 5.56% 86.14% 13.86%

Number of Sinus Procedures Performed in Adults

Regression for Odds of Balloon Procedure Compared to Traditional

Odds Ratio 95% Confidence Interval

Analysis of Effects p-Value

Gender M ale 0.87 0.80-0.94 <0.001 Fem ale --- ---

Race W hite --- --- <0.001 Black 0.69 0.56-0.84 Latino 0.98 0.85-1.13 Asian 0.56 0.42-0.74 Other Race 0.55 0.44-0.69

Num ber of Chronic Diseases

0 --- --- <0.001 1-3 1.71 1.24-2.36 >4 2.00 1.43-2.80

State CA --- --- <0.001 Florida 1.05 0.92-1.17 M aryland 0.88 0.71-1.08 New York 1.84 1.65-2.06

Facility Case Volum e

Low (<62/year) --- --- <0.001 M edium (63-138/year) 1.10 1.00-1.21 High (>139/year) 0.71 0.64-0.80

Num ber of Sinus Types Per Case

1 0.58 0.51-0.66 <0.001 2 0.50 0.45-0.57 3 1.30 1.16-1.45 4 --- ---

BCD used more in patients with chronic disease, and less in patients with limited surgery

Surgeon Volume High and medium volume surgeons were more likely to use balloons

We thought there might be a relationship between surgeon volume and percentage of cases which used balloons, BUT…..

Total Number of Surgeries Per Surgeon

Perc

ent

of Hyb

rid

Proc

edur

es

NO RELATIONSHIP between the Percentage of Hybrid Procedures and Surgeon

Volume

Comparison of Charge

*

**

Total Ch

arge

in

Doll

ars

Median Charge greater for cases utilizing balloon catheter dilation compared to traditional endoscopic sinus surgery

Comparison of OR Time

*To

tal OR

Tim

e in

Minu

tes

Median OR time was 8 minutes less for Mini-ESS procedures involving BCD but not different for

maxillary antrostomy or Pan-ESS procedures

Pediatric Sinus SurgeryIndications for surgery different than in adults

Surgical intervention for CRS in children controversial EPOS recommends begin with adenoidectomy and possible irrigation or BCD with traditional ESS for treatment failures

Children without enlarged adenoids or with significant mucosal disease may be treated immediately with traditional ESS

Pediatric Sample Size

2,662 sinus surgery cases at 448 facilities in 2011

11.9% utilized balloon technology

Regression for Odds of Balloon Procedure Compared to Traditional

Param eter M odel Odds Ratio 95% Confidence

Interval p-value

Adenoids No --- --- <0.001 Yes 2.50 1.84-3.41

Asthm a No --- --- <0.001 Yes 1.94 1.38-2.73

Allergic Rhinitis No --- --- 0.041 Yes 1.77 1.03-3.07

Cystic Fibrosis No --- --- 0.040 Yes 0.33 0.11-0.95

GERD No --- --- <0.001 Yes 2.79 1.59-4.90

Children with asthma, allergic rhinitis, GERD or also having adenoidectomy more likely to have

BCD, and children with CF less likely

Comparison of Charge

Endoscopic Balloon W ilcoxon Rank Sum N M edian 25th and 75th

Quartile N M edian 25th and 75th

Quartile M axillary Only 92 $9,803.50 ($6,082.00,

$15,722.00) 19 $11,950.0 ($10,271.0.,

$18,153.00) 0.042

M axillary and Adenoidectom y

64 $11,770.00 ($6,964.00, $15,541.00)

40 $15,930.00 ($12,547.50, $19,179.50)

<0.001

Median Charge greater for cases utilizing balloon catheter dilation compared to

traditional endoscopic sinus surgery, with no decrease in OR time

LimitationsNot include office based procedures using balloon technology

Challenges of administrative data Disparities in collected variables across states

Procedures or co-morbidities may be miscoded Not possible to know indications for surgery

Unable to differentiate rhinology specialist with complex case mix from general otolaryngologist

Inability to distinguish unilateral from bilateral

Adult Conclusions

8% of cases involved BCDSignificant geographic and demographic disparities in use of balloon technology

Procedures using balloon technology on average more expensive with minimal decrease in OR time

Pediatric Conclusions12% of cases involved BCDDifference in practice patterns based on co-morbidities such as asthma, allergic rhinitis, GERD and cystic fibrosis

Increased utilization of balloon technology during sinus surgery concurrent with adenoidectomy

Maxillary sinus procedures, with or without adenoidectomy, using balloon technology significantly more expensive and no decrease in OR time

Thank You:Senior Author:Stephanie Shintani Smith

Medical Students:Madeline Graber Hannan Quereshi

Co-authors:Charlesnika EvansMelissa PynnonenDavid ConleyRakesh Chandra Bruce Tan James Schroeder