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 pneumoniaeHaemophilus 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.

 

http://www.arquivosdeorl.org.br/conteudo/imagesFORL/12-04-10-fig01.jpg

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.

 

REFERENCES:

1.       Nahlieli O, Baruchin AM.  Long-term  experience  with  endoscopicdiagnosis  and  treatment  of  salivary  gland  inflammatory  diseases.  Laryngoscope, 110 (1); 2000: 988–993.

2.        Drage NA, Brown JE, Escudier MP, McGurk  M.  Interventional radiology  in  the  removal  of  salivary  calculi.  Radiology, 214 (2) ; 2000: 139–142.

3.       Maresh  A,  Kutler  DI,  Kacker  A.  Sianoendoscopy  in  the  diagnosis  and  management  of  obstructive  sialadenitis.  Laryngoscope, 121(4) ; 2011: 495–500.

4.       Lari  N,  Chossegros  C,  Thiery  G,  Guyot  L,  Blanc  JL,  Marchal  F.  Sialen-doscopy  of  the  salivary  glands.  Revue  de  Stomatologie  et  de  Chirurgie Maxillo-Faciale, 109 (5) ; 2008: 167–171.

5.       Marchal  F,  Dulguerov  P,  Becker  M,  Barki  G,  Disant  F,  Lehmann  W. Submandibular  diagnostic  and  interventional  sialendoscopy:  new  procedure  for  ductal  disorders.  Annals  of  Otology,  Rhinology  and  Laryngology, 111(4); 2002: 27–35.

6.       Hamilos DJ. Chronic sinusitis. Allergy Clinical Immunology, 106 (6); 2000: 213-227.

7.       Stankiewicz J. Cost Analysis in the Diagnosis of Chronic Rhinosinusitis, American Journal of Rhinology, 17(3); 2003: 139-142.

8.       Subramnanian H. A Retrospective Analysis of Treatment Outcomes and Time to Relapse after Intensive Medical Treatment for Chronic Sinusitis. American Journal of Rhinology,16(6); 2002: 303-312

9.       Hessler J., Clinical outcomes of chronic rhinosinusitis in response to medical therapy: Results of a prospective study. American Journal of Rhinology, 21(1); 2007: 10-18

10.     http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed date 12th August 2014. 

11.     Weiss RL., Long-term outcome analysis of balloon catheter sinusotomy: two-year follow up. Otolaryngol Head Neck Surg, 139; 2008: S38-S46.

12.     Vaughan W. Review of balloon Sinuplasty. Current Opinion Otolaryngol Head Neck Surg, 6 (1); 2008: 2-9.

13.     Ramdan HH. Safty and feasibility of balloon sinuplasty for treatment of chronic rhinosinusitis in children. Ann Otol Rhinol Laryngol, 118(3); 2009: 161-165.

14.     Nayak DR, Balakrishnan R, Murty KD. Endoscopic physiologic approach to allergy associated chronic rhinosinusitis: a preliminary study. Ear Nose Throat Journal. 80 (5); 2001: 390-403.

15.     Wittkopf ML, Becker SS, Duncavage JA, Russell PT. Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis. Otolaryngol Head Neck Surgery,140(4); 2009: 596-598.

16.     Slow JK, Al Kadah B, Wemer JA. Balloon sinuplasty: a current hot topic in rhinology. Ear Arch Otorhinolaryngol, 265(5); 2008: 509-511.