Balloon Sinuplasty: An Effective, Disruptive

Technology

Nadim Bikhazi, MD Department of Otolaryngology

Ogden Clinic May 13, 2014

Sinusitis Overview

Statistics

• 37 million afflicted in the US alone1,2

• $8.6 billion in healthcare costs3

• Over 58 million days of restricted activity/year3

• Accounts for 1 in 5 antibiotic Rx4,5

• 525,000 sinus surgeries per year in the US6

Common Symptoms

• Heavy purulent drainage

• Facial pressure and fullness

• Nasal congestion

• Fatigue

• Facial or dental pain

• Headache

1 Benninger, M. et al. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003; 129S: S1-S32. 2 Lusk R, Bothwell MR, Piccirillo J. Long-term follow-up for children treated with surgical intervention for chronic rhinosinusitis. Laryngoscope 2006; 116:(12) 2099-2107. 3 Ray, N., et al. Healthcare expenditures for sinusitis in 1996: Contributions of asthma, rhinitis, and other airway disorders. J Allergy Clin Immunol 1999; 103: 408-414. (Inflation Adjusted as per CPI to 2010 dollars.) 4 Gill JM, Fleischut P, Haas S, Pellini B, Crawford A, Nash DB. Use of antibiotics for adult upper respiratory infections in outpatient settings: a national ambulatory network study. Fam Med. 2006;38(5):349-354 5 Rosenfeld RM, Andes D, Bhattacharyya N, et al. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007;137(3):(suppl) S1-S31 6 Thomson Reuters Outpatient Procedure Database.

Medication used to treat bacterial infection and allergies and provide symptomatic relief to the patient.

Sinusitis Treatment Options

For patients who fail medical management and suffer from complex sinus disease. More invasive than balloon dilation.

Ideal for patients who fail medical therapy but do not need, want, or are unable to have sinus surgery.

Medical Therapy Office Sinus Dilation Sinus Surgery

Limitations:

– Does not address underlying anatomy

– Side effects

Limitations:

– May not be able to treat some complex sinus disease

Limitations:

– Requires general anesthesia

– Longer recovery

Balloon Sinuplasty

• Idea taken from interventional cardiology

• Cleared by FDA in 2005

• Concern: technology finding a disease to Tx

• Less invasive

• Quicker recovery

• ? Outcomes

Disruptive Technology

Any technology which displaces current technology leading to a transformation of that field

-Clayton Christensen

Disruptive Technologies

1995

Previous Disruptive Technology in Sinusitis

• Functional Endoscopic Sinus Surgery (FESS)

– 1985 -Introduced to US-David Kennedy MD

– Allowed intranasal endoscopy

– Minimized tissue disruption

– Now broadly accepted

– Moved to tissue sparing

Technology: advanced our understanding of pathophysiology of sinusitis

Limitations of FESS

• Tissue damage---scarring

• Involves general anesthesia

• High failure: asthma, nasal polyps, allergies, Samter’s- 10-15%

• Still with severe complications-orbital injury, CSF leak- 1-3%

How Balloon Dilation Addresses Sinusitis

Critical Site: Ostiomeatal Complex OMC -Junction of middle turbinate/ethmoid/ uncinate process (mucosal contact) -Place where antigens are deposited -Critical area for common sinus flow -Necessary to expand patency with balloon dilation

Technique

Intended Use

Treatment of frontal recesses, sphenoid sinus ostia, maxillary ostia

How Office Balloon Sinus Dilation Works

Sinuplasty Safety Data

• Multiple studies (CLEAR, ORIOS I/II, Patient Registry) reveal safety of maxillary balloon with up to 2 year f/u

• Frontal sinuses (PLAZA study)

• Children (INTACT) study

Consistent safety among a variety of sinuses addressed and patients

Clinical Data

• Balloon only data demonstrates significant reduction of symptoms (SNOT-20)

• Hybrid procedures (balloon + surgery) -significant level of symptom reduction

• Low revision surgery rates within 12 months

• High patient satisfaction and fast return to normal activities

NEW Clinical Data:

Publication

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial.

Jeffrey Cutler, M.D., Nadim Bikhazi, M.D., Joshua Light, M.D., Theodore Truitt, M.D., Michael Schwartz, M.D., and the REMODEL Study Investigators

Am. J Rhinol Allergy 27, 1-7, 2013; doi: 10.2500/ajra.2013.27.3970.

Published electronically on Aug 5, 2013

In-print publication expected in Sept-Oct 2013

Patient Selection (Inclusion)

• Adults ≥ 18 years

• Maxillary and anterior ethmoid sinuses

• Uncomplicated rhinosinusitis

• Met 2007 Adult Sinusitis Guidelines for CRS or RARS – (CRS) > 12 weeks duration of symptoms and evidence of inflammation

– (RARS) ≥ 4 episodes/year of acute bacterial rhinosinusitis

• Met 2011 coverage guidelines for medically necessary FESS – Anthem or BCBS of North Carolina coverage policies

– Specified failure of optimal/maximal medical therapy

– Does not specify nor require CT evidence of mucosal thickening

Patient Selection (Exclusion)

• 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

Primary Study Endpoints

1. Long-term symptom improvement – Assessed by mean change in overall Sino-Nasal Outcome Test (SNOT-20) score

between Baseline and 6-Month follow-up

2. Mean number of postoperative debridements – Transnasal removal of dead, contaminated or adherent tissue or foreign

material that may promote infection or impede healing throughout the study period

Secondary Study Endpoints

1. Post-discharge recovery outcomes – Nausea

– Nasal bleeding

– Duration of analgesic use

– Recovery time (time to return to baseline level of activity before surgery)

2. Short-term symptom improvement – Combined one-week & one-month changes in SNOT-20 scores

3. Complication rate – Serious device-related or procedure related adverse event

4. Revision rate

Characteristic

Balloon Dilation

(n = 50)

Control (FESS)

(n = 42) p-value

Mean ± SD or n (%) Mean ± SD or n (%)

Age (years) 47.0 ± 14.6 47.9 ± 14.5 NS

Gender (Female) 34 (68.0%) 23 (54.8%) NS

Ethnicity (Caucasian) 42 (84.0%) 36 (85.7%) NS

Smoking History (Never smoked) 29 (58.0%) 27 (64.3%) NS

Allergies

All year

Seasonal

21 (42.0%)

13 (26.0%)

17 (40.5%)

12 (28.6%)

NS

Asthma/bronchitis 8 (16.0%) 8 (19.0%) NS

Previous Nasal Surgery 7 (14.0%) 8 (19.0%) NS

Septal Deviation 30 (60.0%) 25 (59.5%) NS

Lund-MacKay Score 3.2 ± 3.2 3.6 ± 3.5 NS

Sinuses Affected

Maxillary only

Maxillary and anterior ethmoid

31 (62.0%)

19 (38.0%)

26 (61.9%)

16 (38.1%)

NS

Chronic Rhinosinusitis Diagnosis

Chronic (> 12 weeks duration)

Recurrent acute (≥ 4 episodes in 1 yr)

34 (68.0%)

16 (32.0%)

29 (69.0%)

13 (31.0%)

NS

No. of Sinusitis episodes past yr 4.5 ± 1.8 5.2 ± 2.8 NS

Duration of Sinusitis (yrs) 12.4 ± 13.0 12.7 ± 13.9 NS

Baseline Characteristics & Demographics

Procedure Summary

• Balloon Dilation (50 patients) – 52 patients randomized / 50 underwent balloon dilation

• 1 did not want to undergo in-office balloon dilation

– 99% technical success rate

– 97 of 98 dilations of the maxillary ostia/ethmoid infundibula were successfully completed

• FESS (42 patients) – 53 patients randomized / 42 underwent FESS

• 8 did not want to undergo FESS

– 99% technical success rate

– 80 of 81 attempted maxillary antrostomies with uncinectomies were successfully completed

• 41 concomitant anterior ethmoidectomies in 22 patients

Summary: 91/92 patients treated (99%) completed 6-Month follow-up

Results: SNOT-20 (Primary)

0

1

2

3

4

5

Mean

SN

OT-2

0 S

co

re

Δ = -1.7 Δ = -1.6

p<0.001

Baseline Baseline 6 Months 6 Months

Balloon Dilation Control (FESS)

Conclusion: Balloon dilation is not inferior to FESS for symptom improvement

Problem as bad

as it can be

No problem

Results: Debridement Rate (Primary)

0

10

20

30

40

50

Balloon Dilation

Control (FESS)

Mean /patient

1.2 ± 0.9

Balloon Dilation Control (FESS)

p<0.0001

Mean /patient

0.1 ± 0.6

Conclusion: Balloon dilation results in less post-op debridements than FESS

Tota

l # o

f D

eb

ridem

ents

Results: Recovery Outcomes (Secondary)

0

10

20

30

40

50

60

Post-discharge nausea Discharged with nasal bleeding

Balloon Dilation

Control (FESS)

17%

Conclusion: Post-op nasal bleeding is less for balloon dilation versus FESS

Perc

en

tag

e o

f P

ati

en

ts

p=NS

p=0.011

6%

55%

28%

Results: Recovery Outcomes (Secondary)

0

1

2

3

4

5

6

Recovery time Duration of Rx pain meds Duration of OTC painmeds

Balloon Dilation

Control (FESS)4.8

0.9

Conclusion: Recovery time and duration of Rx pain medications are significantly better for balloon dilation versus FESS

Mean

Nu

mb

er

of

Days

p=0.002

p<0.001 p=NS

1.6

2.8

1.6

2.7

Results: Short-Term SNOT-20 (Secondary)

Follow-Up

Interval

Balloon Dilation (BD) Control (FESS) Difference

BD-FESS

(95% CI)

p-value n

Mean Change

± SD n

Mean Change

± SD

1 Week 48 -1.5 +/-0.9 41 -1.0 ± 1.1 -0.3

(-0.5, -0.1) 0.014

1 Month 49 -1.7 ± 1.0 40 -1.6 ± 1.0

Conclusion: Short-term symptom improvement is significantly better for balloon dilation versus FESS

Secondary Study Endpoints

• Complications:

– No complications occurred in balloon dilation arm or FESS arm

• Revision Surgeries: – Balloon dilation: 2% (1 patient)

– FESS: 2.4% (1 patient)

Results: Subgroup Analyses (SNOT-20)

Conclusion: Results are similar within and between study arms for all subgroups

Subgroup

Balloon Dilation Control (FESS) p-

value n Mean Change

± SD n

Mean Change

± SD

Diseased Sinuses

Maxillary only 30 -1.6 ± 1.1 25 -1.6 ± 1.0 NS

Maxillary & anterior ethmoid 18 -1.7 ± 1.0 16 -1.6 ± 0.9 NS

Accessory Ostium

Yes 17 -1.8 ± 1.4 9 -1.9 ± 0.6 NS

No 31 -1.6 ± 0.9 32 -1.5 ± 1.0 NS

Septal Deviation

Yes 28 -1.7 ± 1.2 24 -1.6 ± 1.0 NS

No 20 -1.7 ± 1.0 17 -1.7 ± 1.0 NS

Chronic Rhinosinusitis Diagnosis

CRS 32 -1.7 ± 1.1 28 -1.6 ± 1.0 NS

RARS 16 -1.6 ± 1,1 13 -1.6 ± 0.9 NS

Long term follow up

• Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up (Am. J Rhinol Allergy)

Nadim Bikhazi, MD1, Joshua Light, MD2, Theodore Truitt, MD3, Michael Schwartz, MD4, Jeffrey Cutler, MD5 and for the REMODEL Study Investigators

- 1 year data that balloon sinuplasty was non-inferior to FESS for reductions in sinusitis (decrease in sinusitis episodes 4.2/3.5)

-Improvements in daily activity and overall work productivity in both

-Revision surgery rates 2% in both groups

Conclusions

• Standalone balloon dilation and FESS are both safe and effective treatments for treating medically refractory uncomplicated rhinosinusitis in the maxillary/anterior ethmoid sinuses

• Post-operative debridement after balloon dilation is lower versus FESS (p<.05)

• Balloon dilation recovery outcomes are better versus FESS (p<.05) – Frequency of nasal bleeding

– Duration of Rx pain medication

– Time to return to normal daily activities

– Short-term and Long-term symptom improvement

Clinical Data Overview

Comparison of Revision Rate

Conclusion: Revision rates for standalone and hybrid balloon procedures are within the ranges for FESS

10.0%

12.5%

10.9%

9.0%

6.8% 7.0%

2.4%

10.4% 10.8%

2.4%

9.2%

2.9% 2.3%

6.8%

3.0%

5.8%

2.0%

0.0%

5.0%

10.0%

15.0%

20.0%

Hoffman(1990)

1009 Mo

Lund(1991)

244.6 Mo

Marks(1999)

3935 Yr

Jakobsen(2000)

2371 Yr

Albu(2010)

4112 to 7 Yrs

Becker(2007)

7727 Mo

REMODELCutler(2013)

426 Mo

Chiu(2004)

6732 Mo

Friedman(2006)

15772 Mo

PatiENT RegistryLevine(2008)1036

40 Wk

CLEARWeiss(2008)

652 Yr

Atkins(2011)

1391 Yr

XprESSBrodner(2012)

441 Yr

BREATHEStankiewicz

(2012)59

27 Mo

ORIOS2Karanfilov (2012)

20324 Wk

RELIEFLevine(2013)

691 yr

REMODELCutler(2013)

496 Mo

Traditional FESS Non-frontal FESS Frontal FESS Stand-alone balloon and hybrid balloon

Stand-alone balloon

Symptomatic Improvement (SNOT 20) Through 2 Years

• Sustained statistically significant (p<0.0001) & clinically meaningful (Δ ≥ 0.8) improvement

• Patients treated in the office [19] reported an average pain of 2.7 (0=no pain; 10=severe).

• Sinus symptoms improved approximately 70%.

• Approximately 92% of patients were satisfied with the balloon procedure.

• Patients with maxillary and anterior ethmoid disease improved as much as those with only maxillary disease.

Long-Term Follow-Up Results – Symptomatic Improvement (BREATHE I/BREATHE I LTF)

0

1

2

3

4

5

Baseline 1-Week(p<0.0001)

3-Month(p<0.0001)

6-Month(p<0.0001)

1-Year(p<0.0001)

2-Year(p<0.0001)

Maxillary Only [N=39]

Maxillary & Anterior Ethmoid [N=20]

Clinically Meaningful

(Problem as bad as it can be)

(No Problem)

Stankiewicz J, Truitt T, Atkins J, Winegar B, Cink P, Raviv J, Henderson D, Tami T. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2012 May; 2(3): 199-206.

Post-Op Healthcare Utilization (Rhinosinusitis Symptom Inventory)

• Statistically significant (p<0.0001) reduction in number of MD/nurse visits due to nasal problems for CRS and RARS patients

• Statistically significant (p≤0.001) reduction in antibiotic use for CRS and RARS patients

In-Office Final Results - Healthcare Utilization (RELIEF)

0

2

4

6

8

10

Pre-Op(1-Yr interval before

procedure)

Post-Op(1-Yr interval after procedure)

CRS

RARS

0

2

4

6

8

10

12

Pre-Op(1-Yr interval before

procedure)

Post-Op(1-Yr interval after procedure)

CRS

RARS

Average No. of Antibiotic Courses Average No. MD/Nurse Visits for Nasal Problems

In-office standalone balloon dilation in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with 1-year follow-ups. Publication pending.

Summary of Balloon Dilation Results

• Proven safety in OR and in office-setting

• Well-tolerated by patients using local anesthesia only

• High rate of technical success (access and dilate targeted ostia)

• Durable improvement in sinus symptoms through minimum of 2 years that is both significant and meaningful (SNOT 20)

• Demonstrated low rate of revision sinus surgery in range acceptable for ESS

• High rate of patient satisfaction

• Significant reduction in post-operative health care utilization

Data and references included on previous slides.

Recurrent Sinusitis • Spikes of sinusitis resolving in between

• May respond to medical therapy during each episode of symptoms

• Patient/physician is frustrated with the cycle of infections and medications

Disease Conditions to Consider

Chronic Sinusitis • Patients who have continual sinusitis

symptoms despite lengthy rounds of medication

• Patients for office based balloon treatments:

• Co-morbidities that prevent surgery

• Those who are opposed to traditional sinus surgery

Comparing Balloon Sinus Dilation/ Endoscopic Sinus Surgery

Why consider in-office balloon sinus dilation vs. endoscopic sinus surgery?

• Convenient in-office procedure4

• Quick recovery1,2

• May reduce healthcare costs5

BALLOON SINUS DILATION VS ENDOSCOPIC SINUS SURGERY1

1 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. 2 Stankiewicz J, Truitt T, Atkins J, Winegar B, Cink P, Raviv J, Henderson D, Tami T. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2012 May; 2(3): 199-206. 3 Stankiewicz J, Tami T, Truitt T, Atkins J, Liepert D, Winegar B. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J of Rhinology. 2009 May-June; 321-327. 4 Gould, James D., MD FACS. “In-Office Balloon Dilation: Procedure Techniques and Outcomes Using a Malleable Multi-Sinus Dilation Tool.” ENT Journal. Vendome Healthcare Media, 19 Dec. 2013. 5 2013 National Average Cost to Medicare for FESS using CPT 31254-50, 31256-50, 31237-50:

ASC Procedure Surgeon fee of $563 + Anesthesiologist fee of $408 + ASC payment of $2,843 + bilateral post-op debridement fee of $504 HOPD Procedure Surgeon fee of $563 + Anesthesiologist fee of $408 + HOPD payment of $5,068 + bilateral post-op debridement fee of $504

2013 National Average Cost to Medicare for Office Procedure using CPT 31295-50, 31231: Office Procedure Surgeon fee of $3,345 + bilateral post-op nasal endoscopy fee of $219 Medicare office reimbursement fee covers all costs to perform a procedure performed in the office setting (supplies, equipment, labor, time & overhead) Medicare shows the unilateral rate on their website and the bilateral rate is calculated based on the 50% rule for multiple procedures.

Procedure Video--Frontal