Balloon Sinuplasty Overview

What Is Ballon Sinuplasty?

Balloon sinuplasty is an endoscopic surgical procedure for the treatment of blocked nasal
sinuses. Patients diagnosed with chronic sinusitis but not responding well to medications
may be candidates for some type of sinus surgery. Two options are balloon sinuplasty and
functional endoscopic sinus surgery (FESS). [1][2][3][4].

If you would like to learn more about Balloon Sinuplasty, please go to the following websites:

Patient-Resources
Procedure-Video
Testimonials

Balloon sinuplasty is an endoscopic, catheter-based system for patients suffering from
sinusitis. The procedure has been cleared by the U.S. Food and Drug Administration in 2005.[5]
It uses a small, flexible balloon catheter to enlarge sinus passageways. When the balloon is inflated,
it widens the walls of the sinus passageway, with the goal of restoring normal sinus drainage without
damaging the sinus lining.

The Procedure

Sinus surgery with Balloon Sinuplasty may be performed safely in a hospital, outpatient
surgery center, or a doctor’s office. The surgeon and patient will determine whether the
procedure is best done under traditional general anesthesia or local anesthesia depending
upon the patient’s medical history and the type of sinus disease that needs to be managed.
The Maryland Nose & Sinus center is equipped with the state-of-the-art video technology
and Luma Light to perform Balloon Sinuplasty under local anesthesia. Patients can
expect to be done in less than an hour, and return to work the next day.

When performing Balloon Sinuplasty, the physician inserts a sinus guide catheter through
the nostril to gain access to the sinus ostia (opening) under endoscopic visualization. The
endoscope allows the physician to see through the nasal passages to the sinus cavities to
ensure that he/she is inserting the catheter into the proper location. A sinus guide wire or
sinus illumination system is then introduced into the targeted sinus via the sinus guide
catheter.

 

 

 

 

 

 

 

 

 

 

 

The sinus illumination system provides a targeted fiber optic light transmission that helps the physician place the sinus guide catheter in the correct place. When the Balloon Sinuplasty system was introduced in 2005, illuminated wires did not exist and surgeons confirmed the location of the wires with low level x-ray using fluoroscopy.

 

 

Once access to the intended location is confirmed (which can be done either by Luma light or fluoroscopy), the balloon catheter is introduced into the sinus cavity over the sinus guide wire or sinus illumination system and positioned in the blocked ostium for inflation. Once the position has been confirmed visually, the balloon is inflated to unblock the narrow or blocked ostium. The balloon is then deflated and removed. Next, an irrigation catheter may be advanced over the sinus guide wire or sinus illumination system to flush out the sinus of any mucus or pus. Finally, the sinus irrigation catheter is removed from the sinus to allow the sinus cavity to drain any mucus and/or pus. Newer balloon catheters have the irrigation system incorporated into the balloon making the procedure simpler with fewer steps.

Multicenter Registry of Balloon Catheter Outcomes for 1,036 Patients (PatiENT Registry) indicate that 91.6% functional patency and 95.2% symptoms relief one year after the procedure.

 

 

 

 

 

 

 

 

 

 

 

 

History

 

 

Balloon sinuplasty technology was developed by Acclarent, Inc., and was brought to market in 2005 after FDA approval. Dr. Shikani performed the first 20Balloon Sinuplasty Procedures  in Maryland in 2006. He was the recipient of grant from Acclarent in 2006 to evaluate the feasibility of performing balloon sinuplasty under Navigation Guidance, hence avoiding the risk of fluoroscopy-radiation exposure.

Patients with sinus disease in the maxillary sinus (under the cheek), frontal sinus (over the eyes), and sphenoid sinus (in the middle of the head) and caused by obstruction can benefit from Balloon Sinuplasty. Balloon Sinuplasty technology is not used in the ethmoid sinuses (between the eyes). Balloon Sinuplasty can be used alone to manage disease in the frontal, maxillary or sphenoid sinuses. It can be combined with traditional sinus technologies to manage disease in the maxillary, frontal and/or sphenoid sinus when there is disease in the ethmoid sinus (hybrid procedure). Once the sinus is open, a culture of the mucus can be obtained with an irrigating catheter to test for specific bacteria and/or fungus.
Just like traditional surgery, for those patients who have infection in the bone of the sinuses (osteitis), hybrid Balloon Sinuplasty surgery may be needed followed by long term antibiotics given by mouth or intravenously. Since Balloon Sinuplasty permits surgical management of the sinus disease with preservation of tissue and rarely requires packing, return to normal activities may occur earlier than traditional sinus surgical procedures. As with any sinus surgery, Balloon Sinuplasty or traditional surgery, additional treatment medically or surgically may be needed depending the cause of the sinus disease.

The Maryland Nose & Sinus center is equipped with the state-of-the-art video technology and Luma Light to perform Balloon Sinuplasty under local anesthesia. Patients can expect to be done in less than an hour, and return to work the next day.

If you would like to learn more about Balloon Sinuplasty, please go to the following websites:

Patient-Resources
Procedure-Video
Testimonials

Since January 2011 Balloon Sinuplasty became approved by the FDA for patients under local anesthesia in an office setup.

 

 

 

 

 

 

 

 

 

 

 

 

 

Dr Shikani was part of the ORIOS study in 2010 that allowed Acclarent, Inc. to get FDA approval in 2011 for balloon sinuplasty in the office. He was the first to perform the procedure under local anesthesia in Maryland and has since taught many otolaryngologists and rhinology fellows how to do it.

Dr Shikani is the Director of the Maryland ENT Rhinology Fellowship Program at Union Memorial Hospital; there are only 27 Rhinology programs in the United States listed by the American Rhinology Society.

 

 

 

 

 

 

References

 

• Hamilos, D.,J Allergy Clin Immunol 1999; 103: 408-414
• Stankiewicz, J. et al, Am J Rhinol 2003; 17(3): 139-142
• Subramnanian, H., et al, Am J Rhinol 2003; 16(6): 303:312
• Hessler, J., et al, Am J Rhinol 2007; 21(1): 10-18
• Medtech Insight, A600, 2002 and A566, 2005
• Bolger, WE, et al; Safety and Outcomes of Balloon Catheter Sinusotomoy: A Multi-Center 24-Week Analysis in 115 Patients; Otolaryngology – Head and Neck Surgery, July 2007, Vol. 137, No. 1, P. 10-20
• What is balloon sinuplasty?