Sinuplasty (procedure)
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Balloon sinuplasty is a procedure that ear, nose and throat surgeons may use for the treatment of blocked
sinuses Paranasal sinuses are a group of four paired air-filled spaces that surround the nasal cavity. The maxillary sinuses are located under the eyes; the frontal sinuses are above the eyes; the ethmoidal sinuses are between the eyes and the sphenoid ...
. Patients diagnosed with
sinusitis Sinusitis, also known as rhinosinusitis, is inflammation of the mucous membranes that line the sinuses resulting in symptoms that may include thick nasal mucus, a plugged nose, and facial pain. Other signs and symptoms may include fever, head ...
but not responding to medications may be candidates for sinus surgery. Balloon technology was initially cleared by the
U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
in 2005 and is an
endoscopic An endoscopy is a procedure used in medicine to look inside the body. The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes are insert ...
,
catheter In medicine, a catheter (/ˈkæθətər/) is a thin tubing (material), tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgi ...
-based system for chronic sinusitis. It uses a balloon over a wire catheter to dilate sinus passageways. The balloon is inflated with the goal of dilating the sinus openings, widening the walls of the sinus passageway and restoring normal drainage.


Overview

Sinus surgery with balloons may be performed in a hospital, outpatient surgery setting or in the physician’s office under local anesthesia. The physician inserts a guide catheter through the nostril and near the sinus opening under endoscopic visualization. A flexible guide wire is then introduced into the targeted sinus to confirm access. Most guide wires have a light on the tip which may produce light transmission seen through the skin to help the physician with correct placement of the guide wire. Once access to a blocked sinus is confirmed, a balloon catheter is advanced over the guide wire and positioned in the blocked sinus opening for inflation. The balloon is inflated. The entire procedure takes around 30 minutes and if the procedure is successful, the sinus will remain open after the balloon is deflated and removed for up to 24 months.


Research

Since the initial introduction of sinus dilation, a number of clinical studies have explored its safety, effectiveness, durability, and patient benefits. Data from these studies show that, for appropriate patients, sinus dilation: * is extraordinarily safe—0.1% complication rate across 8 studies representing approximately 900 patientsBikhazi, N. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up, Am J Rhinol Allergy 2014; May 20
pub ahead of print A pub (short for public house) is a kind of drinking establishment which is licensed to serve alcoholic drinks for consumption on the premises. The term ''public house'' first appeared in the United Kingdom in late 17th century, and was ...
/ref> * delivers consistent, significant, lasting symptom improvement * is effective for treatment of patients with chronic or recurrent sinusitis, patients with frontal, maxillary and sphenoid disease, and patients with or without allergies, asthma, septal deviations, and previous surgery * can be performed comfortably and effectively under local anesthesia in an office setting To better understand sinus dilation’s role in treatment, many physicians sought a direct comparison of balloon sinus dilation to the current standard of care, functional endoscopic sinus surgery. Outcomes from the first prospective, multi-center, randomized controlled trial with sufficient statistical power to compare sinus dilation to functional endoscopic sinus surgery were published in the ''American Journal of Rhinology & Allergy'' in 2013 and 2014. Data from the study shows that balloon sinus dilation is as effective as functional sinus surgery, and delivers a better patient recovery experience. Balloon and surgical patients experienced a similar, significant level of: * symptom improvement * decline in number of rhinosinusitis episodes requiring medication in year after treatment * improvements in work productivity and activity level Patients who had balloon sinus dilation experienced a much quicker recovery, less bleeding, and less need for prescription pain medication. Overall, data from these studies address key clinical questions, and affirm sinus dilation’s role as an alternative to traditional surgery.


Benefits

The balloon technique is an alternative, less invasive treatment than the traditional functional endoscopic sinus surgery (FESS). The sinuses are dilated with a balloon instead of using metal instruments to cut and remove tissue to increase the openings. Because of less risk and fewer complications, balloon sinuplasty can be performed in the office under local anesthesia. This opens up an avenue of treatment for patients with sinus disease who otherwise would not be candidates for surgery secondary to age, health conditions, previous reactions to general anesthesia, or fear of "going under". For the right patient, this procedure can have the same degree of impact on reduction of symptoms as the formal surgery.


Limitations

Balloon sinuplasty may not be appropriate for all chronic and recurrent sinusitis patients. Clinical studies have typically excluded patients with: *
Eosinophilic Eosinophilic (Greek suffix -phil-, meaning ''loves eosin'') is the staining of tissues, cells, or organelles after they have been washed with eosin, a dye. Eosin is an acidic dye for staining cell cytoplasm, collagen, and muscle fibers. ''E ...
disease * Severe polyposis or fungal
sinusitis Sinusitis, also known as rhinosinusitis, is inflammation of the mucous membranes that line the sinuses resulting in symptoms that may include thick nasal mucus, a plugged nose, and facial pain. Other signs and symptoms may include fever, head ...
* Severe septal deviation * Cystic fibrosis *
Samter's triad Aspirin exacerbated respiratory disease (AERD), also termed aspirin-induced asthma, is a medical condition initially defined as consisting of three key features: asthma, respiratory symptoms exacerbated by aspirin and other nonsteroidal anti-inf ...
*
Facial trauma Facial trauma, also called maxillofacial trauma, is any physical trauma to the face. Facial trauma can involve soft tissue injuries such as burns, lacerations and bruises, or fractures of the facial bones such as nasal fractures and fractures ...


References


Further reading

* * * {{cite journal , vauthors=Karanfilov B, etal , year = 2013 , title = Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients , journal = Int Forum Allergy Rhinol , volume = 3 , issue = 5, pages = 404–411 , doi=10.1002/alr.21112, pmid = 23136057 , s2cid = 25806185 Sinus surgery