In-Office Balloon Sinuplasty Application And Indication Pasha

Raza Pasha,, MD
Houston, Texas
This presentation is designed to provide information on procedures involving Acclarent
Devices in an office setting
setting. It also describes anesthesia options for outpatient treatment
treatment. It is
not intended to be a substitute for proper training or experience in the administration of local
anesthetics, which should be acquired prior to employing any of them.
Acclarent Devices are intended for use by or under the direction of a physician who is trained
in the use of Balloon Sinuplasty Technology. Prior to use, it is important to read the
Instructions for Use and to understand the contraindications, warnings, and precautions
associated with these devices, as well as all products mentioned in this video.
In addition, performing sinus surgery in an office setting requires specific medical expertise
relating to discretionary anesthetic use. In order to manage possible adverse reactions,
trained personnel and resuscitative equipment, oxygen and other resuscitative drugs must be
immediately available when local anesthetic agents are administered to mucous membranes
membranes.
For further information, please contact the Acclarent Medical Affairs Group at
[email protected]
Disclaimers
 Medical Consultant Acclarent
 ORIOS‐2 Primary Investigator
 Medtronic Consultant
 Xpress Registry with Entellis
Agenda
 Indications & Patient Selection
 Case Studies
 Current Studies (ORIOS trials, Rhinogenic HA)
Controversies
Consensus??
Rhinosinusitis Diagnosis and Medical Management for the Clinician: A Synopsis of Recent Consensus Guidelines (Mayo Clin
f R
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G id li (M Cli Proc. 2011:86(5):427‐443
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Synopsis
What We Agree
What We Don’t Agree
• Duration of CRS >12 weeks
• Testing: CT, Allergy w/u, endoscopy, • SSx: congestion, mucopurulence, pressure, SS i l
immunological w/u
decreased smell
• Failed Medical Management (abx, • Length of oral steroids (1‐2 weeks)
nasal steroids, saline)
• Classification
• Surgery Receommendations (1st line)
• Cultures
• What to irrigate (abx, surfactant, steroids)
id )
* Critera are for negative/minimal CT findings (absent chronic mucosal thickening)
Functional Endoscopic Sinus
Functional Endoscopic Sinus Surgery
 1970’s/1980’s: Endoscopic Sinus Surgery develops in Europe (Messerklinger Wigand Draf Stammberger)
Europe (Messerklinger, Wigand, Draf, Stammberger)
 mid 1980
mid 1980’s: Gain popularity in the US (Kennedy
s: Gain popularity in the US (Kennedy, Toffel, Toffel Rice, Schaefer, Close, Levine)
 mid 1990: More accepted in US (Mackay, Kaluskar, Patil)
FESS Criticisms
 “Success rates of around 90% have been reported using the 



old "unphysiological" operation of inferior y
meatalantrostomy” Marginal improvement of FESS vs Caldwell Luc (Penttila et al, 1992)
FESS versus IMA (British Academic Congress in Otolaryngology, Dublin, 1991)
“Instrumentation for FESS is costly and expensive CT scans are needed”
d d”
“The endoscopic operations take longer than conventional g y
surgery”
Balloon Sinuplasty
 2002 California‐based engineers cadaveric studies
 2005 FDA approval
 2006 First “in‐man” study by Brown and Bolger
 2007 CLEAR study  2008 1‐2 yr follow‐up CLEAR study
 2009 ORIOS 1
 2011 ORIOS 2
Controversies with Balloon Sinuplasty
 "We have not found these techniques and instruments 



to be more effective than traditional endoscopic sinus surgery techniques.
surgery techniques.”
“We really don't know its long‐term efficacy or who are the best candidates for the procedure.”
“The role of balloon catheterization hasn't been fully established yet and wouldn't replace standard surgery in most cases.
in most cases.”
“…the main drawbacks are its cost.”
"This thing about being a minimally invasive alternative, that's mostly marketing"
Take Home Point
Reduce most criticisms and controversy to…
Indication and Application
I
Open Approach (Surgical)
II
Endoscopic Approach (Surgical)
III
In‐Office Techniques
Your own experience…
OR
Office
Advantages In‐Office Balloon Sinuplasty






Avoid General Anesthesia
Minimally Invasive (Function NO)
Minimally Invasive (Function, NO)
Same‐Day Recovery
Quick
Easier to Schedule
Convenient
 Expand Indications!!!
Indication
I
II
• Acute Sinusitis
• Mild Chronic Sinusitis
• Unilateral Sinus Disease
• Revisions
• Barosinusitis
III
• Moderate/Severe Sinusitis
• Pregnancy
• Anesthesia Intolerance
IV
• Recurrent Sinusitis
R
t Si
iti
• Migraine‐Triggers
Contraindications
Tolerance
Structural
Conditions
• Anxiety
• Pain Tolerance
• Claustrophobic
• Severe Septal
Deflection
• Distorted Facial Anatomy (Trauma)
• Atelectatic
Si
Sinuses
• Osseous Stenosis
• Non
Non‐functional functional Sinuses (Post‐Op, Ciliary Dyskenesia)
• Presence of Irreversible Diseased Tissue (Polyps, P l
Mucoceles)
Case Study 1
45 y male, hx
45 yo
,
of right g
sided facal pain for 6 months; Tx with oral steroids abxs nasal steroids, abxs, nasal sprays.
Prior hx
h of in‐office RF f
ff
turbinate reduction.
PreOp
Case Study 1
S/P 2 weeks, In‐Office Balloon Sinuplasty with vortex.
Case Study 2
37 yo. Male, 3 year hx facial pain, HA, Tx
33 mos of nasal steroids, multiple Abx’s
,
p
Case Study 2
2 weeks PostOp
Case Study 3
45 yo. Male, primary complaint of congestion, occasional facial pain. Septoplasty/TR 2001. Oxymetazoline abuse y
Case Study 3
2 weeks PostOp
The ORIOS Study
Completed in 2009, the ORIOS 1 study compared Balloon Sinuplasty™ In‐Office with traditional and hybrid FESS in the operating room.
i 93% rated office-based
BSP as tolerable or
better
Comparable symptom
resolution across treatment
arms
Significant cost
reduction in office
setting
h
d
The ORIOS
Study
Detailed Outcomes
ORIOS 2
 Multi‐institutional study of In‐office Technique only
 Larger study
 2, 8, and 24 week follow‐up
 Emphasize patient tolerability
 Refinement of technique
Rhinogenic Headaches
 Recurrent Sinus Headaches
 Barosinusitis
 Migraine Variant Triggers
 Contact Point Headaches
 Pain Source: trigeminal nucleus, ostia> interior
 Tx: Septoplasty, “Mini‐FESS,” “Mini‐Sept.” Concha
Removal Botulism Toxin Partial Turbinectomies
Removal, Botulism Toxin, Partial Turbinectomies
Pasha Symptomatic Criteria
Pasha Symptomatic Criteria for In‐Office BS* Inclusion Criteria
Exclusion Criteria
Anatomical: HA/FP localized to mid face, HA/FP localized to mid face retro‐orbital, frontalis, or occipital
• Presence of severe septal deviation, or deviation or septal spur
• Presence of nasal polyposis, midline facial defects
• Presence of active acute sinusitis
• Presence of significant mucosal disease on CT (Lund Mackay >10)
• Pregnancy
• Planned procedure (septoplasty, ESS)
1.HA/FP worse or triggered with flight/heights/diving
AND/OR
2 HA/FP improves with topical 2.
decongestants/anesthesia
AND/OR
3. HA/FP associated with congestion/rhinitis
* Criteria are for negative/minimal CT findings (absent chronic mucosal thickening)
Migraine Headaches/Triggers
 Classic Migraine Criteria: >5 HA with 2 of 4 g
5
4
characteristics (unilateral, pulsatile, moderate intensity, aggravated with activity)
 Inclusion/Exclusion Criteria similar Recurrent Sinusitis*
 n=16
HIT
T Scale
76
 FS/MS combinations 66
 @ 8 wks 7/11 56
completely p
y
asymptomatic
 1 conversion to OR
46
36
Baseline 2 wks
8 wks
24 wks
N= 16 14 11 1
* Preliminary data only, higher n‐value, multi‐institutional, longer term f/u required. Barosinusitis Sinusitis*
 n=5
HIT
T Scale
76
 FS/MS combinations 66
 @ 2 wks 3/5 completely p
y
asymptomatic
56
46
36
Baseline 2 wks
8 wks
24 wks
N= 5 5 2 2
* Preliminary data only, higher n‐value, multi‐
institutional, longer term f/u required.