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Optimizing Functional
Endoscopic Sinus Surgery
Outcomes with Drug Delivery
An Online Continuing Education Activity
Sponsored By
Grant Funds Provided By
Welcome to
Optimizing Functional
Endoscopic Sinus Surgery
Outcomes with Drug Delivery
(An Online Continuing Education Activity)
CONTINUING EDUCATION INSTRUCTIONS
This educational activity is being offered online and may be completed at any time.
Steps for Successful Course Completion
To earn continuing education credit, the participant must complete the following steps:
1. Read the overview and objectives to ensure consistency with your own learning
needs and objectives. At the end of the activity, you will be assessed on the
attainment of each objective.
2. Review the content of the activity, paying particular attention to those areas that
reflect the objectives.
3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content.
4. For additional information on an issue or topic, consult the references.
5. To receive credit for this activity complete the evaluation and registration form.
6. A certificate of completion will be available for you to print at the conclusion.
Pfiedler Enterprises will maintain a record of your continuing education credits
and provide verification, if necessary, for 7 years. Requests for certificates must
be submitted in writing by the learner.
If you have any questions, please call: 720-748-6144.
CONTACT INFORMATION:
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All rights reserved
Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014
www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196
Overview
Chronic rhinosinusitis (CRS) is a widespread, debilitating disease that can significantly
affect a person’s quality of life. The care pathway for patients with CRS involves a
complex combination of medical and surgical therapy. While functional endoscopic
sinus surgery (FESS) is a recognized treatment for CRS and various sinus disorders,
the majority of these patients have symptom recurrence typically within one year after
surgery, resulting in poor outcomes. Therefore, numerous perioperative techniques
aimed at maintaining surgical outcomes are generally employed to facilitate
postoperative outcomes. The purpose of this continuing nursing education activity is
to provide a review of the role of drug delivery following FESS in optimizing patient
outcomes. An overview of the anatomy and physiology of the paranasal sinuses, followed
by the clinical implications of CRS, will be presented. The care pathway for CRS patients
will be outlined, including the indications for FESS and the clinical considerations related
to continued medical therapy. The various drug classes and routes of administration to
the sinuses postoperatively will be reviewed and the clinical support data documented in
the literature.
Learner Objectives
After completing this continuing education activity, the participant should be able to:
1. Explain the anatomy and physiology of the paranasal sinuses.
2. Describe the care pathway for patients with CRS.
3. Identify the indications for various drugs after FESS.
4. Differentiate the options for postoperative drug delivery to the sinuses.
Intended Audience
This continuing nursing education activity is intended for otorhinolaryngology nurses and
other health care professionals who are interested in learning more about innovative
drug delivery options for continued medical therapy and improved outcomes in patients
following FESS.
Credit/Credit Information
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered
Nursing, Provider Number CEP14944, for 2.0 contact hours.
Obtaining full credit for this offering depends upon attendance, regardless of
circumstances, from beginning to end. Licensees must provide their license numbers for
record keeping purposes.
The certificate of course completion issued at the conclusion of this course
must be retained in the participant’s records for at least four (4) years as proof of
attendance.
3
IACET
Pfiedler Enterprises has been accredited as an Authorized Provider by the International
Association for Continuing Education and Training (IACET).
CEU Statements
• As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs
that qualify under the ANSI/IACET Standard.
• Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program.
ACCREDITATION
This program has the prior approval of AAPC for 2.0 continuing education hours. Granting
of prior approval in no way constitutes endorsement by AAPC of the program content or the
program sponsor.
Release and Expiration Date:
This continuing education activity was planned and provided in accordance with
accreditation criteria. This material was originally produced in January 2015 and can
no longer be used after January 2017 without being updated; therefore, this continuing
education activity expires January 2017.
Disclaimer
Pfiedler Enterprises does not endorse or promote any commercial product that may be
discussed in this activity.
Support
Funds to support this activity have been provided by Intersect ENT.
Authors/Planning Committee/Reviewer
Rose Moss, RN, MN, CNOR Nurse Consultant/Author/Planning Committee
C & R Moss LLC
Judith I. Pfister, RN, BSN, MBA
Program Manager/Planning Committee
Pfiedler Enterprises
Julia A. Kneedler, RN, MS, EdD
Program Manager/Reviewer
Pfiedler Enterprises
4
Casa Grande, AZ
Aurora, CO
Aurora, CO
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Entities for Those in a Position to Control
Content for this Activity
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interest for individuals who control content for an educational activity. Information
below is provided to the learner, so that a determination can be made if identified
external interests or influences pose potential bias in content, recommendations or
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goal of objectivity, balance and scientific rigor in the activity. For additional information
regarding Pfiedler Enterprises’ disclosure process, visit our website at: http://www.
pfiedlerenterprises.com/disclosure
Disclosure includes relevant financial relationships with commercial interests related to
the subject matter that may be presented in this continuing education activity. “Relevant
financial relationships” are those in any amount, occurring within the past 12 months
that create a conflict of interest. A commercial interest is any entity producing,
marketing, reselling, or distributing health care goods or services consumed by, or used
on, patients.
Activity Authors/ Planning Committee/Reviewer
Rose Moss, RN, MN, CNOR
No conflict of interest
Judith I. Pfister, MBA, RN
Co-owner of company that receives grant funds from commercial entities
Julia A. Kneedler, EdD, RN
Co-owner of company that receives grant funds from commercial entities
5
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6
INTRODUCTION
Chronic rhinosinusitis (CRS) is a widespread disease that represents one of the
most common health care problems in the United States today.1 While the precise
etiology of CRS remains unclear, mucosal inflammation is understood to be one of the
primary underlying causes. In this regard, even minimal inflammation in a localized but
critical area (e.g., the ostiomeatal complex) can result in significant pathology in the
surrounding areas and trigger widespread sinonasal disease.
The care pathway for patients with CRS involves a complex combination of medical
and surgical therapy. Functional endoscopic sinus surgery (FESS) is now a wellestablished treatment option for patients with sinus disease; however, despite
advances in surgical techniques and equipment, the potential for complications during
the postoperative period remains.2 Adverse wound healing in the form of inflammation,
mucosal edema, polyposis, adhesions, and middle turbinate (MT) lateralization may
result in suboptimal outcomes and the recurrence of both the disease and symptoms
postoperatively. Therefore, mitigating these issues has been shown to improve long
term patient outcomes.13
Medications used in the management of CRS patients after FESS include antibiotics,
oral steroids and nasal steroids. The use of nasal steroids is a beneficial component
in postoperative patient management. Steroid-eluting implants may be placed in the
ethmoid sinuses to reduce inflammation and maintain sinus patency.
ANATOMY AND PHYSIOLOGY OF THE PARANASAL
SINUSES
In order to understand the role of drug delivery after FESS, it is helpful to first
briefly review the anatomy and physiology of the paranasal sinuses and the clinical
implications of CRS.
Anatomy and Functions of the Paranasal Sinuses
The paranasal sinuses are air-filled cavities located within the bones around the nose
and eyes that allow for natural ventilation and drainage. There are four sinuses per
side (or eight total), named for the facial bones in which they are located (see Figure
1)3:
• The ethmoid sinuses, which are a collection of small cells in a honeycomb type
structure; and
• The peripheral sinuses, ie, the frontal, maxillary, and sphenoid sinuses. These
are large cells with one common drainage pathway, the ethmoid sinuses.
7


The ethmoid sinuses, which are a collection of small cells in a honeycomb type structure; and
The peripheral sinuses, ie, the frontal, maxillary, and sphenoid sinuses. These are large cells with one comm
drainage pathway, the ethmoid sinuses.
Figure
Sinuses
Figure11–– Paranasal
Paranasal Sinuses
The paranasal sinuses function to:
• Humidify and warm inspired air;
• Regulate intranasal pressure;
• Increase surface area for olfaction;
• Lighten the skull; and
• Absorb shock.
The paranasal sinuses are self-cleansing; goblet cells secrete mucus (up to 1 liter per
day). In addition, they are lined with cilia that beat in unison to clear the sinuses (see
Figure 2).
Figure 2 – Cilia of the Sinuses
Chronic Rhinosinusitis (CRS)
Chronic rhinosinusitis is defined as persistent inflammation of the sinus membrane; it is
frequently classified as with or without polyps (see Figure 3).
8
Figure 3 – Healthy and Diseased Sinus Membranes
Today, CRS is a widespread, debilitating disease. It is more prevalent than heart disease
and asthma in adults and affects 30 million patients in the United States alone.4 In
addition; CRS has a greater impact on a patient’s quality of life than congestive heart
failure or chronic back pain.5 Patients with CRS suffer from:
• Facial pain and pressure;
• Nasal congestion and obstruction;
• Loss of smell and/or taste;
• Loss of sleep; and
• Post-nasal discharge.
The average age of a patient with CRS is 40.
CARE PATHWAY FOR CRS
The CRS care pathway involves a complex combination of medical and surgical therapy
(see
Figure
4). involves a complex combination of medical and surgical therapy (see Figure 4).
The
CRS
care pathway
Figure
– CRS
Care Pathway
Figure
4 – 4CRS
Care Pathway
Medical Therapy
 Nasal Steroids
 Oral Steroids
 Antibiotics
 Decongestants
 Irrigation
Surgery to Open
Sinuses
+/- Balloons
 Surgical Instruments
 Balloons
 Packing
 2-3 Follow-up Visits
Continued Medical
Therapy
 Nasal Steroids
 Oral Steroids
 Steroid-Eluting
Implants
 Antibiotics
 Decongestants
 Irrigation
Medical therapy consists of nasal steroids, oral steroids, antibiotics, decongestants, and irrigation. Functional endoscopic
sinus surgery is performed to open the sinuses; this may require the use of surgical instruments, balloons, and packing, as
well as two to three follow-up visits. After sinus surgery, continued
medical therapies such as nasal and oral steroids and
9
steroid-eluting implants are often utilized. Of the 1.4 million patients offered FESS annually, only about one-third proceed.
Medical therapy consists of nasal steroids, oral steroids, antibiotics, decongestants, and
irrigation. Functional endoscopic sinus surgery is performed to open the sinuses; this
may require the use of surgical instruments, balloons, and packing, as well as two to
three follow-up visits. After sinus surgery, continued medical therapies such as nasal
and oral steroids and steroid-eluting implants are often utilized. Of the 1.4 million patients
offered FESS annually, only about one-third proceed. Unfortunately, 64% of the patients
who have surgery will experience recurrence of symptoms within one year6; in addition,
25% of FESS patients will require more than one procedure to achieve success.7
FESS
Functional Endoscopic Sinus Surgery (FESS) is performed to enlarge the sinus
passageways to restore drainage and aeration. During this procedure, inflamed bone
and tissue in the ethmoid (honeycomb) sinuses are surgically removed. In the peripheral
sinuses, the sinus ostia are enlarged surgically or with balloons; this procedure may
be performed in the operating room or the surgeon’s office. Figure 5 depicts a patient’s
anatomy before and after FESS.
Figure 5 – Patient Anatomy Pre-FESS (left) and Post-FESS (right)
It is important to note that opening the ethmoid sinuses is key to positive patient
outcomes (see Figure 6), because this is where disease originates (especially polyps)
and also where the peripheral sinuses drain. Moreover, persistent disease in the ethmoid
is the reason for failure of therapy directed at other sinuses.8
Obstruction after FESS is the result of:
• Middle turbinate (MT) lateralization (see Figure 7) – this is present in 78% of
patients who need revision procedures9.
• Adhesions/scarring occur in 14% to 21% of patients within 4 weeks;10 these are
present in 56% of patients needing revisions.11
• Disease recurrence of inflammation and/or polyps – this may occur in 60% of
patients postoperatively (see Figure 8).12
10


Adhesions/scarring occur in 14% to 21% of patients within 4 weeks;10 these are present in 56% of patients nee
revisions.11
Disease recurrence of inflammation and/or polyps – this may occur in 60% of patients postoperatively (see Fig
8).12
Figure 6 – Open Sinus Post-FESS
Figure 7 – MT Lateralization
Figure 8 – Inflammation/
Figure 6 – Open Sinus Post-FESS
Figure 7 – MT Lateralization
Figure 8 – Inflammation/Polyps
Polyps
Open
ethmoid
cavity
MT
Septum
MT
Septum
With FESS,
FESS, reducing
scarring
and inflammation
postoperatively
correlates with
the absence
the need
for further surg
With
reducing
scarring
and inflammation
postoperatively
correlates
withofthe
absence
13
Additionally,
six
month
outcomes
correlate
with
positive
long
term
outcomes,
as
symptom
reductions
attained
of the need for further surgery. Additionally, six month 14outcomes correlate with positive longat six mo
postoperatively have been shown to be sustained for 20 months.
term outcomes, as symptom reductions attained at six months postoperatively have been
14
shown
to be
sustainedtechniques
for 20 months.
Numerous
perioperative
are used to maintain surgical outcomes after FESS; these techniques include
mechanical (see Figure 9) and pharmaceutical approaches:
Numerous perioperative techniques are used to maintain surgical outcomes after FESS; these
 Space
filling packing
material(see
usedFigure
to create
barrier.
None of these devices
are approved by the United State
techniques
include
mechanical
9)aand
pharmaceutical
approaches:
15
Septum
Food and
Drugpacking
Administration
(FDA)
for the
of medications.
• Space
filling
material
used
to localized
create aadministration
barrier. None
of these devices are
 Steroid-eluting implant.
approved by the United States Food
and Drug Administration (FDA) for the localized
 Medications delivered to the mucosa,
e.g., antibiotics, as well as oral and topical steroids to control inflammatio
15
administration
of
medications.
discussed below.
• Steroid-eluting implant.
Figure 9 – Mechanical Techniques to Maintain Surgical Outcomes after FESS
• Medications delivered to the mucosa, e.g., antibiotics, as well as oral and topical
steroids to control inflammation, as discussed below.
Figure 9 – Mechanical Techniques to Maintain Surgical Outcomes after FESS
In its January 24, 2014 position statement, the American Rhinologic Society (ARS) endorsed the use of biomaterials
approved by the United States FDA; this includes implants and also stents or packing materials used to reduce complic
and improve outcomes of sinonasal surgical procedures.16 This statement goes on to add that these biomaterials, amo
other potential functions, may have stenting and/or local drug delivery properties and may provide hemostasis or serve
surgical dressing. Biomaterials approved by the U.S. FDA for rhinologic application should not be considered investiga
decision
regarding
use of these
biomaterials
be the Rhinologic
responsibilitySociety
of the treating
physician,
considering
Intheitsfinal
January
24,
2014 position
statement,
theshould
American
(ARS)
endorsed
best
available
scientific
evidence
as
well
as
individual
patient
preference.
the use of biomaterials approved by the United States FDA; this includes implants and also
stents
or packing
used to reduce complications and improve outcomes of sinonasal
INDICATIONS
FORmaterials
DRUGS POSTOPERATIVELY
surgical procedures.16 This statement goes on to add that these biomaterials, among other
potential functions, may have stenting and/or local drug delivery properties and may provide
hemostasis or serve as a surgical dressing. Biomaterials approved by the U.S. FDA for
rhinologic application should not be considered investigational; the final decision regarding
use of these biomaterials should be the responsibility of the treating physician, considering the
best available scientific evidence as well as individual patient preference.
11
INDICATIONS FOR DRUGS POSTOPERATIVELY
While FESS has undergone major developments over the last 25 years, surgical
disruption of the mucosal lining promotes scarring and crusting, which can lead to further
inflammation and infection of the sinus mucosa.17 As previously noted, if sinus patency
is not achieved and maintained in the early postoperative period, the long term outcome
may be compromised. Postoperative care should optimally facilitate an environment
which promotes remucosalization of the sinuses, while minimizing inflammation, crusting,
infection, and scarring in order to maintain the patency of the surgical site. Scarring and
adhesions form primarily within the first two weeks following surgery.
Therefore, despite its effectiveness, sinus surgery must be integrated with long term
medical therapy in CRS patients for long term success, since the procedure itself does
not affect the underlying predisposing causes of the disorder.18 As noted previously, the
primary objective of FESS is to restore drainage and aeration by enlarging the sinus
passageways. Unfortunately, FESS may fail in a significant portion of patients and
is manifested by persistent symptoms, recurrent infections, or the need for revision
surgery.19
Therefore, the goals of continued medical therapy after FESS are to decrease
inflammation, eradicate the infection, reduce morbidity, and prevent complications.20
Medications in the management of CRS patients after FESS include antibiotics, oral
steroids, and nasal steroids; each of these classes of medications and a steroid-eluting
implant for targeted delivery of steroids directly to the sinus mucosa, is discussed in
greater detail below.
OPTIONS FOR DRUG DELIVERY TO THE SINUSES
Overview
Due to the lack of a standardized approach to postoperative care following successful
FESS and the various reported strategies, a debate regarding the components of an
optimal postoperative care protocol remains. In addition to nasal saline irrigations and inoffice endoscopic nasal and sinus cavity debridement, the drug delivery modalities most
commonly described in postoperative care protocols include the use of :
• Systemic antibiotic therapy;
• Systemic corticosteroid therapy;
• Topical corticosteroid therapies;
• Middle meatal spacers infused with drug;21 and
• Drug-eluting stents.
Each of these is described in greater detail below.
Antibiotics
After FESS, antibiotics are used to facilitate healing by preventing infection.22 Antibiotic
therapy is frequently started in the operating room based on preoperative culture or to
provide coverage for the more commonly found organisms.23 Because there is evidence
12
that the underlying bone may become involved in the inflammatory process, long-term
broad-spectrum antibiotic coverage after FESS is often necessary in cases of severe,
chronic, inflammatory disease. The antibiotics generally prescribed are amoxicillin and
potassium clavulanate, cephalosporin, or a quinolone.
While antibiotics are used routinely in the postoperative care of FESS patients, their
efficacy has not been well evaluated. Jiang, et al conducted a study of 71 patients
with CRS who had undergone FESS and were randomly divided into two groups: a
study group (31 patients), who took amoxicillin/clavulanate for 3 weeks after FESS
and the control group (40 patients), for whom no antibiotic was given postoperatively.24
Preoperatively, all of the patients completed a symptom questionnaire and received nasal
endoscopy; swab specimens were taken from the middle meati for bacterial cultures.
These procedures were performed again 3 weeks after surgery. The results showed
that the symptom scores significantly decreased after surgery in both groups of patients;
however, the bacteria identified before and after FESS were statistically different in both
groups. There were no differences in the symptom and endoscopic scores, rates of
bacterial culture, and drug sensitivity to amoxicillin/clavulanate between the two groups
after FESS. The authors concluded that the results of this study demonstrated that
postoperative care with amoxicillin/clavulanate did not improve the short-term outcome of
FESS on CRS or reduce bacterial growth 3 weeks after FESS.
Patients with recurring episodes of CRS after FESS often require multiple courses
of antibiotic therapy for extended durations.25 This, combined with the fact that these
patients have usually been treated with multiple different antibiotics prior to surgery,
makes them especially vulnerable to the development of antibiotic resistance. Therefore,
the issue of increasing antibiotic resistance in sinusitis dictates that antibiotics should be
used with caution.26
Topical antibiotic therapy is another management strategy for patients with CRS.27Topical
therapies would seem to provide a greater concentration of medication to the nasal
cavities, while at the same time lowering toxicity in comparison to systemic antibiotics.
Previous studies have demonstrated nebulization of topical therapies to be clinically
effective in patients with uncontrollable CRS. Vaughn and Carvalho studied 42 patients
with acute exacerbation of CRS, refractory to previous FESS, who received nebulized
antibiotics or standard antibiotic therapy.28 Symptomatic and endoscopic data before and
after the nebulized therapy demonstrated a longer infection-free period (an average of 17
weeks) compared with standard therapy (an average of 6 weeks). Statistically significant
improvements were noted for symptom scores of posterior nasal drainage, thick nasal
debris, facial pressure and pain. Furthermore, the therapy resulted in clearing of the initial
bacteria in 76% of the 50 treatment sessions.
Uren, et al examined the efficacy and tolerability of topical mupirocin for the management
of surgically recalcitrant CRS associated with Staphylococcus aureus infection in 16
patients.29 The patients were treated with twice daily nasal lavages containing 0.05%
mupirocin and lactated ringers salts for a 3 week period. Patients were assessed
before and after treatment in terms of nasoendoscopic findings, microbiology results,
13
and Sinonasal Outcome Test (SNOT) and visual analogue scale questionnaires. The
results demonstrated that 15 of the 16 patients had improved nasoendoscopic findings
after treatment; 12 of the 16 patients noted overall symptom improvement; and 15 of
16 patients had negative swab results for Staphylococcus aureus after treatment. The
authors concluded that nasal lavage with 0.05% mupirocin may represent an effective
and well tolerated alternative treatment for postoperative, refractory CRS.
However, not all published reports support the use of topical antibiotics.30 Desrosiers and
Salas-Prato studied the efficacy of nebulized topical saline-tobramycin solution in 20
patients with CRS for whom FESS had failed to relieve their symptoms.31 The patients
were randomized into two groups and received either a tobramycin-saline solution or a
saline-only solution administered three times a day to the nasal passages via a largeparticle nebulizer for 4 weeks, followed by a 4-week observation period. The outcome
measures assessed were symptoms, quality of life, and endoscopic appearance of
the sinus mucosa. The results of this study demonstrated that both treatments were
well tolerated and produced equivalent improvements in symptoms, quality of life, and
mucosal aspect. Treatment with a tobramycin-saline solution gave patients a more rapid
improvement of pain, but led to the development of nasal congestion; therefore the
addition of tobramycin appears to be of minimal benefit.
Regardless of the mode of delivery or of the specific antibiotic given, if there is evidence
of infection in the cavity post-operatively, the cavity should be recultured under
endoscopic visualization and the antibiotic changed accordingly.
Corticosteroids
Synthetic corticosteroids are man-made drugs that closely resemble cortisol (a steroid
hormone, or glucocorticoid, that the body produces naturally) and are used in medicine
to treat diseases that are caused by an overactive immune system or inflammation.
They bind to glucocorticoid receptors, activating anti-inflammatory proteins that reduce
immune activity and inflammation.32 As previously discussed, oral and nasal steroids are
used after FESS to control inflammation caused by surgery in an effort to maintain the
patency of the open sinus cavity. When delivered topically after FESS, steroids may lead
to improved wound healing by preventing granulation tissue that can lead to adhesions.
Oral Steroids
Steroids are the most commonly used medication in FESS protocols.33 While there have
been no randomized controlled trials specifically assessing the efficacy of postoperative
systemic steroid use for nasal polyposis, the consensus is that a short course of high
dose prednisone is helpful for many patients. 34
A randomized, placebo-controlled trial was conducted by Rupa, et al to determine the
effectiveness of postoperative oral steroids in controlling disease in 24 patients with
allergic fungal sinusitis (AFS) who underwent endoscopic sinus surgery (with or without
open surgery).35The results of this study found that a 12-week course of postoperative
oral prednisone in a tapering dose produced significant subjective and objective
improvements in these AFS patients; in addition, it is effective in preventing early
recurrence.
14
It must be noted that the use of oral steroids carries multiple systemic risks, which
restricts their prolonged use 36; these risks include aseptic necrosis of the femoral head,
calcium demineralization, posterior cataract formation, mood changes, and increases in
blood glucose levels.37 As a result, their use is limited in patients with diabetes, glaucoma
and certain psychological disorders.38 Oral steroid treatment algorithms vary depending
on disease state, degree of polyposis and other comorbidities.
Nasal Steroids
After FESS, patients are often prescribed and instructed to use nasal steroids to
minimize postoperative edema. To minimize the potential of recurrence, patients are
often instructed to continue their use long term.39 Nasal steroids can be administered in
the form of sprays or solutions.40 Studies have shown that intranasal deposition is only
30% since 70% of the drug is washed away via mucociliary clearance.41
In addition, their benefits can be further diminished by postoperative edema, discharge,
crusting, or poor adherence to the treatment regimen.42 A study of 60 CRS patients
conducted by Nabi et al, evaluated patient adherence to nasal spray regimens following
FESS and also studied various factors that predict adherence.43 In this randomized,
blinded, controlled trial, the patients were managed with FESS and started on one
of three postoperative nasal spray regimens. Structured telephone interviews were
conducted after surgery over a 12-month period using a validated questionnaire that
assessed both spray adherence and barriers to adherence. The results demonstrated
that over half (57.4%) of the patients were nonadherent to postoperative nasal sprays,
regardless of which nasal spray regimen they were on. Preoperative SNOT scores, time
after FESS, and the presence of a patient adherence risk factor predicted compliance.
Through knowledge of these results and the clinical implications of this study,
otolaryngologists can selectively use strategies that improve adherence in high-risk
patients and potentially improve surgical outcomes in CRS patients.
In comparison with oral steroid administration, topical steroids are more widely used as
a treatment after FESS because they can be given for longer periods of time without the
associated systemic side effects.44 However, simply applying topical steroids through the
nostrils does not imply delivery of the drug into the sinus; in order to effectively deliver
topical agents into the sinuses, appropriate access and delivery methods are required.45
Middle Meatal Spacers Infused with Drug
After FESS, early topical therapy may be limited due to retained secretions, nasal
crusting, or mucosal edema. For this reason, surgeons have attempted the addition of
drug to middle meatal spacers in order to deliver drug directly to the sinus in the early
postoperative period and attempt to control inflammation. Because these drug-infused
spacers are produced by the treating surgeon, who determines the type and dosage
of steroid, the major disadvantages of this therapy are unknown drug release and
limited data on systemic absorption. Therefore, the ideal dose and safety profile must
be evaluated before these devices can be recommended for routine use.46 Additionally,
these spacers are considered off-label as they have not been cleared by FDA. The
following three studies have assessed the role of drug-infused middle meatal spacers
after FESS:
15
• Cote and Wright47 (level 1b) and Kang, et al48 (level 2b) evaluated postoperative
ethmoid cavity packing soaked with topical triamcinolone in CRS patients with nasal
polyps. These studies demonstrated significant improvements in the endoscopic
appearance in both the early and late postoperative periods, as well as a decreased
recurrence of polyps. The specific protocol used in the study conducted by Cote
and Wright included a triamcinolone-soaked spacer placed within the ethmoid cavity
upon completion of FESS and then removed week 1 at the time of debridement.
• A recent level 1b study conducted by Rudmik, et al used an off-label mixture of
carboxymethylcellulose foam and dexamethasone (4 ml of 4mg/ml) in patients
without nasal polyposis, who underwent FESS for medically refractory CRS.49
While the results did not demonstrate any advantages of the steroid eluting spacer
in comparison to a placebo, the outcomes must be considered in context of the
authors postoperative care protocol, which utilized a short dose of systemic steroids
Bioabsorbable steroid-eluting sinus stent
and large volume
saline irrigations.
Steroid-Eluting Implants
A relatively new technology after FESS is a dissolvable, steroid-eluting implant, which
is designed to maintain sinus patency postoperatively. The spring-like device expands
to prop open the ethmoid sinuses while locally eluting 370 μg of a glucocorticosteroid
(mometasone furoate) during the 30-day postoperative period to reduce inflammation as
well as the need for systemic anti-inflammatory medication (see Figure 10).50
Figure 10
10 –– Perioperative
Course:
FESS
and Placement
of Steroid-Eluting
Implant Implant
Figure
Perioperative
Course:
FESS
and Placement
of Steroid-Eluting
Pre-Surgery
Pre-Surgery
Surgery Complete
Implant Placed
Ethmoid Cavity 30
dayEthmoid
Post-opCavity 30
FIGURE 2. Endoscopic photographs from a study patient. (A) Control stent placed in right postoperative ethmoid sinus cavity and (B) d
Surgery Complete
Implant Placed
day Post-op
placed in left side. (C, D) Same sinuses at day 30 (stents are no longer present). Middle turbinates remain in medial position bilaterally.
change is noted in ethmoid sinus on control stent side (black arrow). Drug eluting stent side (D) is normal. (A) Control stent on right at day 0
 Polyps fill ethmoid cavitystenton leftPotential
forControl
blockage,
inflammation
at day 0. (C)
side at day 30. 
(D)Reduces
Drug-eluting
side at day 30.
inflammation
• Polyps fill ethmoid medialization
• Potential
for
blockage,
•
Reduces
inflammation
procedures
were
permitted.
Patients
were
exdisallowed in order to avoid confounding the
(Catheter shown is the
 Maintains patency
cavity
cluded ifinflammation
they had
known
history of intolerance to corticosThe use of nasal tampons adjacent to the infe
device
delivery
system
teroids, an
steroid–dependent
condition, a history of
was permitted in some patients across all stu
priororal
to deployment
of
immune(Catheter
deficiency,shown
insulin-dependent
diabetes,
or allergic
is the
•
Maintains
patency upon the judgment of the clinician.
implant.)
fungal sinusitis.
Follow-up assessments occurred at postpr
device delivery system
Oral steroidswere not permitted during a 14-day run-in
7, 14, 21, 30, 45, and 60. During follow-
prior to
to deployment
ofIntravenous
51
period
prior
sinus surgery.
decadron
wasa common
doscopic
examination
of administration.
the surgical cavity,
Prior to the development
of steroid-eluting
implants,
oral steroids
were
route
of steroid
implant.)
given prior
to beginning the surgical procedure on the
clots and crusts, and lysis of adhesions was
eluting implants may have
significant
benefit
in
the
treatment
of
CRS;
recently,
Level
1-A
evidence
demonstrates
th
day of surgery. Patients received between 4 and 20 mg
these activities, lysis of adhesions was record
54
may significantly improve
endoscopic
medically
refractory
with The
andextent
without
nasal polyposis.
of decadron
basedoutcomes
upon their for
weight.
Two patients
did CRSpoint.
of debridement
was left
to
Prior to the development
of steroid-eluting
implants,
oral steroids
common
not receive
intravenous (IV) decadron.
Intranasal
steroid were
of theaclinician
caringroute
for the patient. Oral a
sprays 51
were
permitted up to the
day before
surgery.
A 14tranasalbenefit
steroid sprays
were disallowed dur
ofThe
steroid
administration.
Steroid-eluting
implants
may
have
significant
in the
implant is self-expanding
and
conforms
to
the
variable
sinus
anatomy
without
obstructing
the
cavity. The impla
day course of oral antibiotics consisting of amoxicillin with
follow-up period. At day 30, clinicians were
treatment
CRS;the
recently,
evidence
demonstrates
that
they
significantly
expands toofcontact
mucosalLevel
tissue,
which
is important
forhours
effectively
delivering
mometasone
corticos
clavulonic
acid
at a1-A
dose
of 875
mg every
12
begintion tomay
prescribe
steroidsfuroate,
if deemeda necessary
53
ning 1inday
preoperatively
required.
Clindamycin
or
sprays
or irrigation was permitted as neede
over 30 days,
and remains
tissue
outmedically
to 60 was
days,
combating
inflammation.
improve
endoscopic
outcomes
for
refractory
CRS
with
and
without
nasal
levofloxacin was used if penicillin allergy was present.
surgery and during follow-up. The use of th
At the end of the FESS procedure, the patient’s postoperor irrigation in the study varied per physician
polyposis.54
Mometasone furoate (MF)
was selected
as the
anti-inflammatory
agent among numerous evaluated compounds b
ative sinus
cavities were
randomly
assigned by envelope
method to absorbability,
receive either the
corticosteroid-eluting
three important characteristics:
binding
affinity and lowsinus
systemic bioavailability. The compound prefe
Efficacy assessments
stent or an identical non-eluting control stent. Randomizaabsorbs into the sinustion
lining
The drug
has the highest glucocorticoid rece
wasinstead
stratifiedofbythe
sitesurrounding
and followedmucous
a blockedfluid.
scheme
The device performance and efficacy endpo
16
binding affinity, makingthat
it highly
in preventing
inflammation
tissue.
are p
was notpotent
made known
to study centers.
Subjects, once
physi- within
sessed
by Glucocorticoid
direct endoscopicreceptors
examination
The implant is self-expanding and conforms to the variable sinus anatomy without
obstructing the cavity. The implant expands to contact the mucosal tissue, which is
important for effectively delivering mometasone furoate, a corticosteroid, over 30 days,
and remains in tissue out to 60 days, combating inflammation.53
Mometasone furoate (MF) was selected as the anti-inflammatory agent among numerous
evaluated compounds based on three important characteristics: absorbability, binding
affinity and low systemic bioavailability. The compound preferentially absorbs into
the sinus lining instead of the surrounding mucous fluid. The drug has the highest
glucocorticoid receptor binding affinity, making it highly potent in preventing inflammation
once within tissue. Glucocorticoid receptors are the molecules in the surface membranes
of cells throughout the body to which corticosteroids chemically bind. Additionally, the
compound has low systemic bioavailability, meaning that it has negligible systemic safety
side effects.
The steroid is embedded in a bioabsorbable polymer matrix, which controls the release
over time; the steroid is delivered in a sustained fashion directly to the sinus mucosa. The
implant dissolves over 30 to 45 days,54 therefore, no removal is required. The polylactideco-glycolide polymer is the same class of material as dissolvable sutures, but without
additives, colorants or lubricants. It has been proven to be safe and biologically inert in
pre-clinical histologic analysis, ie, no foreign body reaction with either steroid-coated
implants or nondrug-coated implants.55 The implant is contraindicated for patients with
suspected intolerance to mometasone furoate or have known hypersensitivity to lactide,
glycolide or caprolactone copolymers.
The steroid-eluting implant has been clinically proven to optimize postoperative patient
outcomes, and as noted above, is supported by Level 1-A evidence. These clinical study
results demonstrated that the implant is able to mechanically prop the post-surgical
ethmoid cavity open and medically control drug delivery of mometasone furoate, thus
reducing the development of granulation tissue, which is a precursor for scarring.56
Sustained delivery of mometasone furoate reduces inflammation, thereby preventing
obstruction due to adhesions and edema. Adverse effects, including infection, crusting,
headaches, discomfort, and granulation tissue formation, have been reported;57,58
in addition, since the implant gradually dissolves, patients may also notice thin white
fragments migrating from the nose.59
Wei and Kennedy reviewed the mode of action and the evidence supporting the efficacy
of this steroid eluting implant.60 They noted that three recently published clinical trials
demonstrate that a mometasone furoate-eluting implant produced statistically significant
reductions in inflammation, polyp formation, and postoperative adhesions. Additionally,
the implant has been found to significantly decrease the need for postoperative
administration of oral steroids and to also reduce the frequency of postoperative lysis of
adhesions.61 Although the placement of steroid-impregnated packing, sponges, and gels
has previously been utilized in the postoperative sinus cavities, a mometasone furoateeluting implant introduces a new mechanism for sustained, localized and controlled
delivery of topical therapy directly to the nasal mucosa for CRS.
17
SUMMARY
Chronic rhinosinusitis is a widespread, debilitating disease that can significantly
affect a person’s quality of life. The care pathway for patients with CRS involves a
complex combination of medical and surgical therapies. While techniques in FESS
have undergone major developments over the last 25 years, this procedure is now a
well-established treatment option for patients with sinus disease. However, despite
these advances, both surgeons and patients are currently frustrated with the disease
recurrence that takes place so soon after surgery due to inflammation, polyp recurrence,
adhesions, and middle turbinate lateralization. Therefore, numerous perioperative
techniques and continued medical therapy aimed at optimizing surgical outcomes are
generally used to maintain the benefits of FESS.
The goals of continued medical therapy after FESS are to decrease inflammation,
eradicate the infection, reduce morbidity, and prevent complications. Medications used
in the management of CRS patients after FESS include antibiotics, oral steroids, nasal
steroids, and steroid-eluting implants.
18
GLOSSARY
Antibiotics
A chemical substance produced by a
microorganism which has the capacity, in diluted
solutions, to inhibit the growth of or to kill other
microorganisms.
Chronic Rhinosinusitis (CRS)
A term used to describe various entities
characterized by chronic symptoms of nasal and
sinus inflammation or infection; this condition
interferes with drainage and causes mucus to
build-up.
Corticosteroid A man-made drug that closely resembles cortisol
(a hormone that the body produces naturally)
and is used in medicine to treat diseases that
are caused by an overactive immune system or
inflammation.
Ethmoid Sinuses
One of the four paired paranasal sinuses.
Functional Endoscopic Sinus
A minimally invasive surgical procedure
performed to enlarge the sinus
Surgery (FESS)
passageways to restore drainage and aeration.
Nasal Steroids
A corticosteroid spray treatment. The medicine
in the spray is placed directly in the nose to help
reduce symptoms and make breathing through
the nose easier.
Oral Steroids
An anabolic steroidal hormone that has been
manufactured in a manner that allows it to be
administered in an oral fashion.
Paranasal Sinuses
Any of the group of four paired air-filled spaces
in the bones of the face that surround the nasal
cavity; they are lined with mucous membrane,
which is continuous with the lining of the nasal
cavities.
Steroid-Eluting Implant
A medical device implanted in the ethmoid
sinuses to prop open the sinus cavity while
providing controlled drug delivery directly to the
sinus tissue.
19
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24
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Post-Test and Evaluation
25