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ISSN 0974-3618 (Print) www.rjptonline.org
0974-360X (Online)
REVIEW ARTICLE
Balloon
Sinuplasty: Novel Technique for Treatment of Sinusitis
Mansi R. Shah*, Vishal J. Rana, Shreya R. Shah, Hitesh N. Jain,
U.M. Upadhyay
Sigma Institute
of Pharmacy, Vadodara, Gujarat-390016 India.
*Corresponding Author E-mail: shah.mansi723@gmail.com
ABSTRACT:
Sinusitis or rhinosinusitis is inflammation of the paranasal sinuses. It can be
due to infection, allergy, or autoimmune
issues. Balloon catheter dilation
of paranasal sinusostia aims to help open up blocked sinus passages by gently
inflating a small balloon, introduced through the nose via a flexible tube. The
aim is to restore normal sinus drainage and improve symptoms of sinusitis. Sinuplasty
is a medical procedure with dilation by means of a balloon of the Paranasal
Sinusitis ostia region. This procedure is currently used in the maxillary,
frontal and sphenoidal sinuses. These tools functioning basic concept are that
the dilation of the desired region, which may lead to Sixteen atmospheres
pressure in the balloon, produces local micro fractures that end up remodeling
the anatomy, dilates the Ostia and allows a PNS normal aeration without,
however, the removal of the tissues and damage to the nasal mucosa. Balloon
sinuplasty is safe and appears to be effective in the improvement of the
quality of life of patients not responsive to conventional clinical therapy. Balloon Sinuplasty is a procedure followed by ENT
surgeons use for the treatment of blocked sinuses. Unlike traditional sinus surgery, Balloon Sinuplasty requires no cutting and no removal of bone and tissue
KEYWORDS: Sinusitis, Balloon Catheter, Surgical
procedure, Nasal mucosa, Paranasal Sinusitis.
INTRODUCTION:
Recent technological
advances have led
to the development
of several conservative
options for the
treatment of obstructive salivary
disorders of the
ducts (sialolithia-sis and
stenosis) such as
external lithotripsy[1], interventional radiology
[2] and sialoendoscopy. [1,3–5]
. If symptoms are difficult to
control with medications alone, then refer to an ENT specialist and Diagnosis
which are carried out by them it Shown in Fig-1. , The best course of
treatment, including further medication therapy or surgery to open the sinus
passageways. By diagnosing Found chronic sinusitis and are not responding well
to antibiotics it may be goes for surgery, now have a less invasive option Balloon Sinuplasty technology is
clinically proven to be safe, effective and improve the quality of life. It is an endoscopic, catheter based
system for patients suffering from sinusitis. The Food and Drug Administered
Technology uses a small, flexible, sinus balloon catheter to open up blocked
sinus passageways, restoring normal sinus drainage. Steps Of Balloon Sinuplasty technology which is shown in Fig-2.
Received on 20.12.2014 Modified on 28.12.2014
Accepted on 06.01.2015 © RJPT All right reserved
Research J. Pharm. and Tech.
8(2): Feb. 2015; Page 127-130
DOI: 10.5958/0974-360X.2015.00022.0
The benefits of Balloon Sinuplasty technology for
treating chronic sinusitis symptoms include [6]:
Ř Safe
and Effective
Ř Minimally
Invasive
Ř Reduced
Bleeding
Ř Improved
Recovery Time
Ř
Does Not Limit Treatment Options

Fig-1: Difference
between Healthy Sinus and Sinusitis.
http://thesaltspot.com.au/sinusitis/

Fig-2: Balloon Sinuplasty Technology
Classification
of Sinusitis: [7-10]
Acute rhinosinusitis: (less than 4 weeks):
Acute sinusitis is usually precipitated by
an earlier upper respiratory tract infection, generally of viral origin,
mostly caused by rhinoviruses, coronaviruses, and influenza viruses,
others caused by adenoviruses, human parainfluenza viruses, human respiratory
syncytial virus, enteroviruses other than rhinoviruses,
and metapneumovirus.
The most common three causative agents
are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella
catarrhalis responsible for bacterial infection. Until recently, Haemophilus influenza was the most
common bacterial agent to cause sinus infections. However, introduction of the H. Influenza type B (Hib)
vaccine has dramatically decreased H. Influenza type B infections and now Non-Typable H.
Influenza (NTHI) is predominantly seen in clinics.
Approximately 0.5% to 2% of viral sinusitis
results in subsequent bacterial sinusitis. It is thought that nasal irritation
from nose blowing leads to the secondary bacterial infection.
Subacute
rhinosinusitis:
(4-12 weeks)
Represents a transition between acute and
chronic infection.
Chronic
rhinosinusitis:
(more than 12 weeks with or without acute exacerbations).
Chronic sinusitis, lasts longer than three
months that share chronic inflammation of the sinuses as a common symptom.
Symptoms of chronic sinusitis may include
any combination of the following: nasal congestion, facial pain, headache,
night-time coughing, an increase in previously minor or controlled asthma
symptoms, general malaise, thick green or yellow discharge, a feeling
of facial 'fullness' or 'tightness' that may worsen when bending over,
dizziness, aching teeth, and/or halitosis.
By location:
There are several paired paranasal sinuses,
including the frontal, ethmoidal, maxillary and sphenoidal sinuses. The ethmoidal
sinuses are further subdivided into anterior and posterior ethmoid sinuses, the
division of which is defined as the basal lamella of the middle turbinate. In
addition to the severity of disease, discussed below, sinusitis can be
classified by the sinus cavity which it affects:
Maxillary
– can cause pain or pressure in the maxillary (cheek) area (e.g.,
toothache, headache) Frontal – can cause pain or pressure in the frontal
sinus cavity (located above the eyes), headache.
Ethmoidal–
can cause pain or pressure pain between/behind the eyes and headaches.
Sphenoidal
– can cause pain or pressure behind the eyes, but often refers to the
vertex, or top of the head.
Recent theories of sinusitis indicate that
it often occurs as part of a spectrum of diseases that affect the respiratory
tract (i.e., the "one airway" theory) and is often linked to
asthma. All forms of sinusitis may either result in, or be a part of, a
generalized inflammation of the airway, so other airway symptoms, such as
cough, may be associated with it.
Chronic
sinusitis cases are subdivided into cases with polyps and cases without polyps.
When polyps are present, the condition is called chronic hyperplastic
sinusitis; however, the causes are poorly understood and may include allergy,
environmental factors such as dust or pollution, bacterial infection, or fungus
(either allergic, infectious, or reactive). Non-allergic factors, such as vasomotor
rhinitis, can also cause chronic sinus problems. Abnormally narrow sinus
passages, such as having a deviated septum, can impede drainage from the sinus
cavities and be a contributing factor.
Signs and Symptoms [11,12]
Headache/facial pain or pressure of a dull,
constant, or the aching sort over the affected sinuses is common with both
acute and chronic stages of sinusitis. In
Sinusitis Different Signs and Symptoms are appearing which are shown in Fig-3.

Fig-3: Signs and Symptoms of Sinusitis
DIAGNOSIS [13,14]
Acute
If
symptoms last less than 10 days, it is generally considered viral sinusitis.
When symptoms last more than 10 days, it is considered bacterial sinusitis.
At
this point 30% to 50% of cases are bacterial. Imaging by either X ray, CT Scan
or MRI is generally not recommended unless complications develop. Chronic
For
sinusitis lasting more than 12 weeks a CT scan is recommended. Nasal
endoscopy, and clinical symptoms are also used to make a positive diagnosis.
A
tissue sample for histology and cultures can also be collected and tested. Allergic
fungal sinusitis (AFS) is often seen in people with asthma and nasal polyps.
Inclusion and
Exclusion Criteria [14]
Inclusion criteria:
Adult
> age of 18 years
Chronic
sinusitis unresponsive to medical management
Exclusion criteria:
Extensive
sinonasal polyps, cystic fibrosis
Extensive
previous sinonasal surgery
Extensive
sinonasal osteoneogenesis
Sinonasal
tumors,
History
of facial trauma
Ciliary
dysfunction
Pregnancy
Treatment: [15-16]
Conservative
Antibiotics
Corticosteroids
Surgery
·
Surgery should only be considered for
those patients who do not experience sufficient relief from optimal medication.
·
A number of surgical approaches can be
used to access the sinuses and these have generally shifted from external/extra
nasal approaches to intranasal endoscopic ones.
·
The benefit of Functional Endoscopic
Sinus Surgery (FESS) is its ability to allow for a more targeted approach to
the affected sinuses, reducing tissue disruption, and minimizing post-operative
complications.
Procedure for Balloon Catheters Sinuplasty:
The
guide catheter, current indication of catherter (Table 1 and 2) and different
type of catheters shown in Fig-4, is introduced into the nasal cavity under
endoscopic visualization and placed adjacent to the obstructed sinus ostium.
Table:1 Guide-Catheters required for the catheterizing of each
paranasal sinus.
|
Paranasal sinus |
Guide catheter |
Comment |
|
Frontal |
70 degrees |
For the correct dilation of the sinusostium, it may be
previous dilation of the frontal recess required |
|
Maxillary |
90 or 110 degree |
The very balloon our vature may indicate the position for
the natural ostium |
|
Spheroidal |
0 or 30 degree |
The anatomic landmarks used are: Turcic saddle and
anteriorwall of the sphennoidal sinus. |
Table:2 Current indications for the use
of sinuplasty
|
Sr. no |
Affection |
Paranasal sinus |
|
1. |
Chronic
rhinosinusitis |
Frontal,
maxillary and Sphinoidal. |
|
2. |
Barotrauma |
Frontal and
maxillary |
|
3. |
Silent sinus |
Maxillary |
|
4. |
Pneumosinus
dilatants |
Frontal |
|
5. |
Secretion/
abscess aspiration |
Frontal,
maxillary and sphenoidal |
|
6. |
Trauma |
Frontal and
maxillary |
|
7. |
Pediatric
patients |
Maxillary |
The
sinus guide wire is then introduced through the catheter and advanced to the
target sinus. The balloon catheter (5, 6, or 7 mm diameter) is introduced, and
it’s manufactured by different Country shown in (Table 3) and Fig-4, over the
guide wire and positioned across the blocked ostium.
Table:3 List Of Catheter Manufacturer
|
Sr.no |
Manufactured
by |
|
1 |
Acclaret,
Inc (Menlo Park, CA, USA) |
|
2 |
Quest
Medical, Inc (Allen, TX, USA) |
|
3. |
Entellus
Medical, Inc (Maple Grove, MN, USA) |
After
confirming the position of the balloon, it is gradually inflated to a specific
diameter under high pressure to microfracture and mold the bone surrounding the
sinus Ostia. After dilatation the tissues are inspected endoscopically, and if
indicated, the sinus is irrigated using a sinus lavage catheter. The procedure
may be performed under general anesthesia, local anesthesia, or conscious
sedation.
An
average procedure time was 3 hours, including the surgery and post-anesthesia
recovery time. None of the patient required an overnight stay at the hospital.

Fig-4: Different Types of catheters
S-0 and S-30 - sphenoidal sinus;
M-110 and M-90 - maxillary
sinus;
M110S - pediatric maxillary
sinus;
F-70 - frontal sinus
Advantages of Balloon Sinuplasty Treatment
Minimally Invasive
Safe and effective
Reduced Bleeding
Improved Recovery time
Does not limit treatment option
Local Anesthesia
Fast Recovery
Comfortable Surrounding
Potential for significant cost
savings
Limitation of Balloon Sinuplasty Treatment
The balloon can fracture the bones
in your sinus cavity when the balloon is being inflated
Damage to the brain, because the
brain is close to the sinuses
Not all patients will qualify
for this procedure
It does not treat all sinus
related conditions i.e. nasal polyps. Balloon sinuplasty only pushes aside the
membrane whereas nasal polyps need to be cut out
The balloon does not fit into
every sinus cavity
Only about 100 doctors around
the country are trained to offer it.
Difficulty to examine
ostiapostop
CONCLUSION:
Based on the available evidence, balloon
sinuplasty appears to be a safe procedure and has shown short-term efficacy in
relieving symptoms associated with chronic sinusitis. Recently published data
in the leading ENT journal shows that the technology is safe and effective: study
participants experienced no adverse events and received significant relief from
their symptoms. As a surgical tool, its mechanism of action provides distinct
differences as compared with conventional tools. There are, however, a number
of unanswered questions to consider before further widespread adoption occurs.
For example, significant questions remain regarding the use of sinuplasty to
replace FESS in select sinuses, how to use FESS in conjunction with sinuplasty,
better quantification of the clinical risks and efficacy, formulation of
appropriate patient selection criteria, and determining the incremental
cost-effectiveness of sinuplast.
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