Overview of Balloon Sinuplasty
Since 2005, a medical procedure called balloon sinuplasty (BSP) has been increasingly used to treat a condition known as chronic rhinosinusitis (CRS). This procedure, which was approved for use by the Federal Drug Administration (FDA), gently opens up the nasal passages using a small inflatable balloon. It’s a lot like what heart doctors have been doing to unblock arteries since the 1970s. This less invasive technique leaves the inside lining of the sinuses intact, which can help the normal working of the sinuses.
The main aim of balloon sinuplasty is to allow the sinuses to drain more effectively by reducing any blockages. This can significantly improve the symptoms of chronic rhinosinusitis.
Chronic rhinosinusitis lasts for more than 12 weeks and involves swelling of the lining of the nose and sinuses. If you have CRS, you may feel a lot of congestion, have a runny nose, feel pressure in your face, lose your sense of smell, and have a blocked nose. Scientists are not completely sure why some people get CRS, but it could be related to different types of infections or problems with the immune system. There are two types of CRS: one with nasal polyps, which are soft, painless growths on the lining of your sinuses, and one without.
About 31 million people are thought to have CRS. Although the main way to manage this condition is through medication, more and more people are undergoing surgery for it. Between 2006 and 2011, around 1 in 3.7 people with CRS had surgery for this condition. Each year, more than 300,000 patients choose to have sinus surgery, which can involve balloon sinuplasty, a different kind of surgery called functional endoscopic sinus surgery (FESS), or a combination of both.
Recently, there has been a push to perform balloon sinuplasty under local sedation only, meaning you are awake but the area is numbed. This can be done in a standard doctor’s office rather than a hospital. This is beneficial because it avoids the need for general anesthesia and can help save costs. There’s been a significant increase in the number of these in-office procedures in recent years. However, there have been concerns about whether the procedure is being used too often because there are a number of medical reasons proposed for its use. Most recently, studies show that the majority of balloon sinuplasty procedures are performed in an office setting due to the ease of availability and popularity of the procedure.
Anatomy and Physiology of Balloon Sinuplasty
The nasal cavity, or the inside of your nose, has several important parts that help with things like treatment and figuring out where things are located. These parts all come from the wall of your nose. By looking at these different parts of your nose, doctors can see the openings of the frontal sinuses, maxillary sinuses, and sphenoid sinuses. These sinuses, along with the passage inside your nose, have a special layer that warms, adds moisture to, and filters the stuff you breathe in.
The frontal sinuses are situated above and in front of your eye sockets. These sinuses drain downwards into either the ethmoid infundibulum or the middle meatus, depending on where the uncinate process attaches. The uncinate process is a small piece of the ethmoid bone that can be attached to three different places. If it’s attached to the lamina papyracea, a thin barrier that separates your nose from the area surrounding your eye, then your frontal sinuses will drain into the middle meatus. This barrier is usually about 0.2 to 0.4 millimeters thick and can break easily if too much force is applied. If the uncinate process attaches to the base of your skull or the middle turbinate, another structure in your nose, then your frontal sinus will drain into the ethmoid infundibulum instead.
The maxillary sinuses are on both sides of your nose and below your eye sockets. They drain into the middle meatus via the ethmoid infundibulum through an opening called the maxillary ostia.
The sphenoid sinuses, which are the furthest back of the sinuses, are located beneath a part of the skull base called the sella turcica. They drain into the superior meatus through an area called the sphenoethmoidal recess.
Why do People Need Balloon Sinuplasty
Ever since a new tool called a nasal balloon device was approved, there’s been a lot of discussion about when it should be used. The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF), a leading organization of ear, nose, and throat doctors, shared its most recent guidelines in 2017.
According to these guidelines, the main use for balloon sinuplasty, which is the procedure where the nasal balloon device is used, is to treat chronic rhinosinusitis without polyps (CRSsNP) that hasn’t gotten better with medication. Chronic rhinosinusitis is a condition where the sinuses are inflamed for at least 12 weeks, and not having polyps means there aren’t small growths in the nose. If a CT scan, a type of medical imaging that gives a detailed picture of the inside of the body, shows that the tissue lining the sinuses is thicker than normal and there is a blockage, then balloon sinuplasty might be the next step.
Balloon sinuplasty might also be used during another type of procedure called functional endoscopic sinus surgery (FESS) in people who have CRSsNP. Other times when it might be used include in people who get sinus infections often and people with barosinusitis, which is a painful condition caused by changes in air pressure.
The AAO-HNSF hasn’t listed specific reasons why balloon sinuplasty might be done in a doctor’s office instead of in a hospital operating room. Usually, it’s up to the doctor to decide what setting is best, but other factors such as whether insurance will cover it, how much money the doctor would get for doing the procedure, how easy it is to get time in an operating room, and other health conditions a person might have can play a role in the decision.
When a Person Should Avoid Balloon Sinuplasty
Balloon sinuplasty is a procedure used to treat certain sinus conditions. However, there are times when it’s not the best option. One such situation is when a person has Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). This is a condition where a lot of tiny growths, called polyps, develop in the nose and sinus openings (ostia). These polyps obstruct the nasal cavity, and the sinuplasty balloon device can’t remove them because it only works to widen the sinus passage, not to remove growths.
Also, while this procedure can work well for sinuses that are single-cell structures, it’s not suited for multi-cell structures like the ethmoids (a grouping of air cells within the nasal cavity), which complicates the process.
There are also other situations when a balloon sinuplasty might not be the best option:
- When a person has a headache but doesn’t have Chronic Rhinosinusitis (CRS) or Recurrent Acute Rhinosinusitis (RARS) – these are conditions featuring inflamed and swollen sinus passages.
- When someone has sleep apnea (a sleep disorder which features paused or shallow breathing) but doesn’t have CRS or RARS.
- When someone has CRS or RARS symptoms but a CT scan (a type of x-ray that gives detailed images) doesn’t show any sinus issues, or when a patient shows no symptoms.
- When a person has allergic fungal sinusitis – an allergy-related condition causing sinus inflammation and polyps.
- When someone has cystic fibrosis – a serious genetic disorder affecting the lungs and other organs.
- If there’s a diagnosed cancer (malignancy).
- If the patient doesn’t want the procedure (patient refusal).
- If they had previous skull base dehiscence – a loss of bone separating the brain from the nasal cavity.
Equipment used for Balloon Sinuplasty
The tools used during a procedure called balloon sinuplasty include:
- A straight or angled nasal endoscope:
This is a small, thin device with a light and a camera that doctors use to look inside your nose and sinus area. - A guide catheter: This tool helps direct the equipment to the right part of your sinus.
- Guidewires: These are thin, flexible wires that the doctor uses to help guide the catheter into the right sinus. Sometimes, these wires may glow under a certain type of x-ray machine (fluoroscopic imaging) or light up under your skin for easier positioning.
- Balloon catheters: These are thin, flexible tubes with small, inflatable balloons on the end. They’re used to gently open up the opening to your sinus, usually inflated to a certain level of pressure.
- A balloon inflation device: This is a tool used to inflate the balloon catheter.
- An irrigation catheter: This is another tube that helps wash out any mucus or other materials from inside your sinus.
The U.S. Food and Drug Administration (the organization that regulates medical devices and drugs in the United States) has only approved two types of devices for use in balloon sinuplasty. The first type can be used to treat frontal and sphenoid sinus diseases in adults, and maxillary sinus diseases in children under 17. The second type can be used for treating maxillary sinus diseases in patients two years and older, and for frontal and sphenoid sinus diseases in patients aged 12 and above.
Who is needed to perform Balloon Sinuplasty?
During the medical procedure, the doctor will likely need some support. This help can come from other people who are part of your healthcare team. This team might include trainee doctors, nursing staff, medical assistants, or well-trained office workers. They play important roles like changing specific tools, making sure the device is clean, or controlling the balloon-like device that is used during the procedure.
Preparing for Balloon Sinuplasty
Before undergoing sinus surgery, doctors typically conduct a thorough examination and ask the patient about their medical history. Patients must also provide written permission, or “informed consent,” before the process can begin. The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNFS) usually suggests getting a CT scan of the sinuses before the surgery. This helps doctors understand the patient’s condition better and plan the procedure more accurately.
Having a record of the patient’s quality of life before the surgery is beneficial as it allows doctors to compare it with the patient’s condition after the surgery. There are several tests to evaluate this, like the Sino-Nasal Outcome Test (SNOT-20), the Wong-Baker FACES Pain Scale, or the Rhinosinusitis Symptom Inventory.
The steps taken before performing the surgery might vary from doctor to doctor, and therefore, there’s no standard step-by-step guide that applies to all cases. Here are general preparation steps for two different settings:
1. Sinus surgery in an operating room: The patient lies on their back on the operating table. After receiving either general anesthesia (which makes the patient unconscious) or conscious sedation (where the patient is awake but relaxed and feeling no pain), the patient is covered with sterile drapes. A nasal decongestant, commonly oxymetazoline, is usually applied to the patient’s nose to constrict the blood vessels and control bleeding during surgery. Then, the doctor injects a localized anesthetic (like lidocaine with or without adrenaline) into various points in the patient’s nose.
2. Preparation for sinus surgery in a medical office: The patient sits in a reclining exam chair. The doctor applies a nasal decongestant and a numbing spray to the patient’s nose and then waits for 10 minutes for it to take effect. Cotton pads soaked in lidocaine or tetracaine (both are numbing medicines) are placed directly in the patient’s nose for 10 more minutes. After this, the doctor injects a localized anesthetic, with or without adrenaline, into specific areas in the patient’s nasal lining.
How is Balloon Sinuplasty performed
After you have been properly prepared and given anesthesia to numb any pain, a doctor will perform a nasal endoscopy – this just means they will insert a special tube with a camera into your nose so they can see the area clearly. This camera helps guide another narrow tube into an opening in your sinuses, then a thin wire is extended into the correct sinus opening. The correct placement of this wire is confirmed either by taking an X-ray or shining a light through the sinus cavities.
Once the wire is confirmed to be in the right place, a medical balloon is moved along the wire until it fully enters the sinus opening. This balloon is then inflated, deflated, and re-inflated, depending on the doctor’s preference. After the deflated balloon is removed, your sinus may be rinsed with a simple salt solution – this is only typically done if you’re in an operating room, as it’s not usually done in a regular doctor’s office due to safety concerns.
After this procedure, also known as Balloon Sinuplasty (BSP), what happens next can depend on your own doctor and situation, but you may have some general steps to follow:
- Your vision and mental status will likely be assessed by a doctor.
- They may recommend a saline nasal spray alongside a short course of nasal steroids to help with healing and recovery.
- Follow-up doctor’s appointments may be scheduled one week, three months, and one year after the procedure. During these visits, your doctor would perform a nasal endoscopy to monitor your progress.
- You might also have a CT scan (a type of X-ray that gives detailed images) of your sinuses three months after the surgery to compare your conditions before and after the procedure.
- Finally, in order to monitor your recovery, your doctor will likely ask you about your symptoms and how you’re feeling three, six, and twelve months after the procedure. You might complete surveys such as the Sino-Nasal Outcome Test, Wong-Baker FACES Pain Scale, or the Rhinosinusitis Symptom Inventory.
Possible Complications of Balloon Sinuplasty
Balloon sinuplasty is a less invasive procedure that’s often used for sinus problems. It’s considered to be safe and effective. In a large study of 115 patients, there were no serious side effects during the 24 weeks following the procedure. Side effects are severe problems that happen after a medical procedure or treatment, such as leakage of cerebrospinal fluid (which is the fluid around your brain and spine), double vision, significant bleeding during the operation, or loss of eyesight. However, nine patients were diagnosed with bacterial sinusitis, which is a type of sinus infection, during the follow-up period. Researchers thought this was likely due to the procedure.
In a follow-up study two years later, 65 of the original 115 patients did not show any adverse events or side effects. This data shows that the procedure continues to be safe in the long term.
However, a more recent study from 2018, which looked at 2851 patients, noted an overall complication rate of about 5.26%. Complications are unexpected problems that develop from a procedure or treatment. These complications were categorised into three groups: orbital complications (which involve the eye socket, 2.95%), bleeding (2.03%), and injuries to the base of the skull (0.35%). Orbital issues included things like fractures, bleeding, infections, excessive tearing, pain, redness, paralysis of muscles around the eyeball, double vision, and other eye disorders. Complications with the base of the skull consisted of leaks of cerebrospinal fluid, air in the skull, skull base injury, and complications with the brain and other parts of the central nervous system, which includes the brain and spinal cord. However, even though some patients experienced these issues, the complication rate went down from 2012 to 2014.
More rare complications include tooth or facial numbness and acute bacterial sinusitis. One unique case even reported a heart attack during the procedure, but this was a patient without any prior heart problems, and the medical team believes this may have happened due to accidental nerve stimulation during the procedure.
What Else Should I Know About Balloon Sinuplasty?
Balloon sinuplasty (BSP) is a newer way to treat sinus problems, and it’s created a lot of conversation among ear-nose-throat doctors. Supporters love that it’s straightforward to perform, safe, cost-effective, and tends to work well. On the other hand, some physicians prefer more traditional methods like Functional Endoscopic Sinus Surgery (FESS), citing reasons similar to those who favor BSP.
The aim of this study was to look into the need for a second round of treatment, known as revision rates, complications, and the cost-effectiveness linked with balloon sinuplasty.
Two important research papers, termed the CLEAR studies, looked at what happened after the balloon sinuplasty surgery. Twelve weeks and twenty-four weeks after the surgery, the researchers found that approximately 80% of the opened up sinus pathways remained open, allowing for normal air flow. The studies also reported that the procedure brought a significant reduction in sinus symptoms. Only 3 patients out of the total treated needed a second surgery due to severe or getting worse blockage of the sinus.
Another important research, the BREATHE 1 study, reinforced the good results of BSP. It confirmed that 95.8% of the openings to maxillary sinuses (sinuses behind your cheekbones) remained open three months after the surgery.
A more recent study compared 2851 Chronic Rhinosinusitis (CRS) patients who underwent BSP surgery with those who underwent traditional FESS or combined (hybrid) procedures. Interestingly, fewer patients needed a revision surgery after a standalone BSP procedure (7.89%) compared to traditional FESS (16.85%) and hybrid procedures (15.15%).
One study compared the recovery time in BSP-treated patients (4 days) with the FESS-treated patients (14 days), highlighting the quicker recovery time with the BSP. In another study, about 90% of patients were back to their daily activities within 2 days after BSP procedure.
Studies have also shown that fewer adhesions (bands of scar tissue linking surfaces of the nose and sinus cavities that usually separate) were formed after BSP when compared with FESS.
While these results are encouraging, it’s noted that a number of significant studies were funded by the primary manufacturers of the BSP devices which introduces the potential for bias. Going forward, we hope that with more data from independently performed BSP procedures, a more definite conclusion can be made about its efficiency. The authors believe that BSP can offer symptomatic relief for patients suffering from chronic sinus disease without major complications, making it a useful tool for ear-nose-throat doctors.
