Yet Another Sinus Dilation Device - AerOS Sinus Dilation System

Sinus dilation has become all the rage in the past few years to treat chronic sinusitis, especially since CPT codes for this procedure has become available as of January 2012.

The first company was Acclarent who coined the balloon sinuplasty term.

Next was Entellus who produced their simpler system (XprESS and FinESS).

Now, there is SinuSys who has produced a new way to dilate the sinus opening without use of a balloon like Acclarent and Entellus. It is currently pending FDA approval, but is used in Europe.

This new system is called AerOs Sinus Dilation System and utilizes an osmotic self-expanding technology. A "simple" two-step insertion and removal of the device is required. Once inserted, the device gradually expands via low-pressure osmotic pressure in about 60 minutes. At that point, it can be removed.

The device itself is 5mm in size and exerts pressure of 2.5 ATM. The diameter is 3mm before dilation that ultimately expands to 5mm.

Compare this with Acclarent and Entellus balloon devices which are inflated to 12 ATM pressure and expands up to 7mm in size (depending on the model).

My personal concern with this device is the small size of 5mm... the surgeon will have to be super-precise for placement, otherwise, it'll fall out or do nothing.

Also, I question whether a 2mm dilation will actually make any difference. Prior studies have established that 4-5mm ostia size really is the minimal efficacious opening size. Larger is better, especially when the uncinate process is still intact as it would be in pure dilation cases. More study is required.

In any case, when (or if) this new device becomes available in the USA is unclear. It's all up to the FDA now.

Reference:
Feasibility of an osmotically driven, self-expanding device for sinus dilation to treat chronic sinusitis. Poster Presentation

Assessment of the short term patency of the maxillary sinus ostium following dilatation with an osmotic device in a sheep model. Jerome E. Hester, MD, David Edgren, BS, Andrea Koreck, MD, PhD, Jason Fox, BS, Janie Mandrusov, PhD, East Palo Alto, CA USA (Annual Meeting of American Rhinologic Society, September 2012, Poster# P-7).

Treatment of Maxillary Sinusitis Using the SinuSys AerOsTM Sinus Dilation System. White Paper 

Read More

Guns n' Roses Rocker Duff McKagan Underwent Sinus Surgery

Duff McKagan, the bassist of Guns n' Roses, apparently underwent sinus surgery back in December 2010.

According to media reports, his sinus cavities developed significant scar tissue due to years of cocaine abuse.

Sinus surgery due to scar tissue is a relatively rare indication for surgery, but required if they block sinus cavities leading to recurrent sinus infections.

Cocaine abuse more typically causes other sino-nasal abnormalities especially septal perforation.

Exactly what type of sinus surgery Duff McKagan underwent is unclear, but for sinus scar tissue, balloon sinuplasty is typically the route taken and can be performed in the office.

Balloon sinuplasty is when the sinus openings are enlarged using a balloon and can potentially be performed in the office assuming no anatomic contraindications (significant deviated septum, nasal polyps, etc).

However, before sinus surgery is considered in a patient who is suffering from recurrent sinus infections whether scar tissue is present or not, a workup is typically required followed by maximal medical management.

A typical workup includes a CT sinus scan, allergy testing, and nasal endoscopy. If allergy testing is significant, aggressive allergy management is required prior to surgical consideration.

Depending on the CT scan and endoscopic findings, there are two "flavors" of sinus surgery: traditional and balloon sinuplasty.

Traditional sinus surgery, otherwise known as functional endoscopic sinus surgery, is when all sinus disease is physically removed endoscopically from the nose and sinus entrances are enlarged.

Source:
Duff McKagan explains sinus surgery. SFGate 12/17/10

Read More

Motley Crue Bassist Facing Sinus Surgery

Dr. Feelgood may be just a song by Motley Crue, but the band's bassist, Nikki Sixx may be facing sinus surgery.

Per his twitter comment on June 27, 2012:

"Spent a lot of the day at the doctors. The 80s and the damage done. Yes the sinuses are a mess. Eventual surgery. The price we pay."

Typically, before sinus surgery is considered in a patient who is suffering from recurrent sinus infections, a workup is required followed by maximal medical management.

A typical workup includes a CT sinus scan, allergy testing, and nasal endoscopy. If allergy testing is significant, aggressive allergy management is required prior to surgical consideration.

Depending on the CT scan and endoscopic findings, there are two "flavors" of sinus surgery: traditional and balloon sinuplasty.

In traditional sinus surgery, otherwise known as functional endoscopic sinus surgery, is when all sinus disease is physically removed endoscopically from the nose and sinus entrances are enlarged.

Balloon sinuplasty is when the sinus openings are enlarged using a balloon and can potentially be performed in the office assuming no anatomic contraindications (significant deviated septum, nasal polyps, etc).

Exactly what type of sinus surgery Nikki Sixx will pursue is not clear, but regardless of what method is selected, there will be a period of recovery afterwards which almost certainly will include saltwater sinus rinses.

Our office provides both sinus surgery options as well as in-office sinus surgery.

Source:
Nikki Sixx needs surgery for sinus problems. SFGate 6/28/12

Read More

Waking Up to NOT Just Major Colonoscopy Bills...

The New York Times published an article on May 28, 2012 regarding the high anesthesia charges associated with colonoscopy.

What people need to realize is that anesthesia charges apply not just to colonoscopy, but ANY procedure that requires general anesthesia... tonsillectomy, appendectomy, gallbladder surgery, ear tube placement in kids, etc.

With any procedure requiring general anesthesia, a patient is going to receive THREE bills... not just one which is what most reasonable people think.

1) A bill from the surgeon

2) A bill from anesthesia

3) A bill from the hospital

Sometimes the hospital and anesthesia charges are bundled into a single bill.

Often, patients mistakenly focus on the surgeon's charges thinking that's where their largest out-of-pocket cost is going to lie. However, the surgeon's fee is almost always the lowest of the charges.

Let's take a look at the New York Time's article...

The GI doctors actually performing the colonoscopy procedure got paid around $200. The anesthesia charges were around $2000 or 10x more (note that insurance coverage was an issue in this article and IF insurance did cover, out-of-pocket charges would have been significantly lower).

And than... if the procedure is done in the hospital, the hospital charges will often be around $5000 or 25x more.

These charges are similar to that found for many ENT procedures as well including tonsillectomy. (Of note, all insurances that we participate with... the anesthesia group I work with also participates with.)

On a more personal note, I recently underwent a general surgical procedure myself performed under general anesthesia in the hospital and got the following charges (3 different bills):

1) Surgeon's charge of $425 of which I owed $148.54 (difference covered by insurance)
2) Anesthesia charge of $1,400 of which I owed $140 (difference covered by insurance)
3) Hospital charge of $3,710.25 of which I owed $559.05 (difference covered by insurance)

Now if anesthesia did not participate with my insurance company, than I would have been fully responsible for anesthesia's full charge of $1,400. This situation is what the New York Time's article mainly focused on.

SO what is a cost-conscious patient to do?

Rather than focusing on the surgeon doing the procedure, the biggest cost-savings will occur negotiating with the hospital followed by anesthesia.

OR... avoid having procedures done in the hospital altogether to avoid hospital charges followed by avoid general anesthesia if at all possible and stick with local anesthesia alone. You will than ONLY have to deal with surgical charges which the surgeon should be able to inform up-front.

WHY do surgeons do procedures in the hospital rather than the office?

Beyond patient and procedural factors which may require general anesthesia, procedures may preferentially be performed in the hospital due to money. No big surprise there, but it may not be for the reasons people may suspect.

Let's take a real life example... balloon sinuplasty.

Balloon sinuplasty is an innovative minimally invasive surgical procedure to treat chronic sinusitis. Prior to 2011, this procedure was almost always performed in the operating room in the hospital though it could have been performed in the office.

Why?

The balloon used for this procedure costs around $2000 and is not reusable.

The reimbursement for the surgeon to perform this procedure was around $200+ depending on the number of sinuses addressed and insurance company.

SO... if balloon sinuplasty was performed in the office prior to 2011, the surgeon would have spent $2000 to do the procedure and than would have gotten paid only $200+ meaning a loss of ~$1800.

Why not charge the patient for the balloon device? Because it is called balance-billing and it is illegal.

So what is a surgeon to do if a patient desires balloon sinuplasty and yet the surgeon doesn't want to lose money?

You do it in the hospital... where the hospital eats the $2000 cost of purchasing the balloon device... and the surgeon still gets paid $200.

However, starting in 2012, insurance companies started reimbursing surgeons for the cost of the device which is why all of a sudden, balloon sinuplasty is now being performed in the office.

This type of financial calculation occurs all the time in medical offices.

Even a pediatrician's office where gardasil vaccination is often not offered... Why? Because the vaccine costs more than what the pediatrician will get reimbursed to give it.

Source:
Waking up to Major Colonoscopy Bills. New York Times 5/28/12

Read More

Unnecessary Sinus Surgery

A well-respected ENT surgeon, Dr. Salah Salman, recently wrote a book, "Scrubbed Out," critical of the American health system with its links to corporation, powerful lobbies, administrators, and bureaucrats resulting in care driven by money rather than by medical necessity.

In particular, he focuses in one part of his book on endoscopic sinus surgery in the treatment of chronic sinusitis. The excerpt from the book is quite lengthy and I encourage anybody interested to read a lightly edited version here.

In essence, there are a few unscrupulous sinus surgeons who perform sinus surgery for every patient with facial pain and pressure even though there's no evidence for any chronic sinus infection whether on CT, endoscopic exam, and other objective testing.

Indeed, in my practice, perhaps only 10% (if not less) of patients with chronic "sinus" complaints actually have pathology related directly to the sinuses that merits consideration of sinus surgery. More commonly, symptoms suggestive of a chronic sinus infection are more commonly related to allergies and atypical facial pain syndromes (ie, migraines, sluder's neuralgia, contact point headaches, etc).

Unfortunately, in many physicians' minds including patients, if multiple courses of antibiotics do not resolve pan-facial pain/pressure, the sinuses must be horrible and something more aggressive geared towards the sinuses must happen.

And there's a few ENT surgeons willing to do just that... and mistakenly so.

It's not just ENTs, but allergists and infectious disease specialists who also may accommodate what the patient wants for treatment, even if it is incorrect.

If such patients see an allergist in the belief that their symptoms are due to allergies, they will get allergy testing and allergy shots.

If they see an infectious disease specialist, they will get antibiotics.

A much neglected specialist for patients with "sinus" problems are the neurologists given so many of these patients are actually suffering from atypical facial pain syndromes... but nobody (physicians, pharmaceutical companies, hospitals, bureaucrats) gets paid much for this particular problem... and so it gets ignored.

Though sinus surgery has been abused in the past into the present, a more recent, highly reimbursed, and "sexy" sinus procedural development is balloon sinuplasty, also ripe for being abused.

Traditional sinus surgery and now balloon sinuplasty certainly have their place in the treatment of true chronic sinus pathology with astounding success, but only in highly selected patients.

As with everything, the right treatment in the right patient is the right way of doing things.


Source:
Book Excerpt: A Saga Of ‘Fishy’ Surgery For Chronic Sinus Trouble. WBUR.ORG March 2, 2012

Read More

In-Office Sinus Surgery Without General Anesthesia

There has been tremendous advances in sinus surgery over the past decade. From the elimination of nasal packing after most routine sinus surgery to the more recent use of balloons to open the sinus cavities, patient comfort has improved greatly after this particular operation. What used to be a several week recovery may now only be a few days.

Balloon sinuplasty in particular has been revolutionary in the surgical treatment of chronic sinusitis. Though sinus surgery normally is performed under general anesthesia, balloon sinuplasty now allows this operation to be performed awake WITHOUT sedation using local anesthesia only.

At its essence, sinus surgery "opens" up blocked sinus cavities to allow drainage and ventilation. Traditional sinus surgery "removes" tissue to accomplish this goal whereas balloon sinuplasty stretches open the sinus cavity without the need for tissue removal.

Given the lack of tissue removal with balloon sinuplasty, there is less pain and faster recovery after the procedure.

What are the steps?

After adequate anesthesia of the nose using both topical and injectable numbing medicine... Step 1 Under endoscopic guidance, the balloon catheter is introduced into the nasal cavity and guided towards the target sinus cavity opening. Depending on the system used, a sinus guidewire or sinus illumination may be used to help with the guidance.
Step 2 Once the sinus balloon catheter is correctly positioned across the blocked sinus opening, the balloon is gradually inflated to stretch open the ostia.
Step 3 After several seconds, the sinus balloon catheter is then deflated and removed leaving an enlarged sinus opening allowing for the return of sinus drainage. There is little to no disruption to mucosal lining.

Of course, not all patients are candidates for balloon sinuplasty, let alone this procedure to be done awake with local anesthesia alone.

In particular, balloon sinuplasty can only address blockages involving the frontal, maxillary, and sphenoid sinus cavities. Ethmoid sinus cavities can NOT be corrected using this method.

Also, balloon sinuplasty does not allow for tissue biopsies (by definition, the advantage of balloon sinuplasty is the lack of need to remove any sinus or nasal tissues). As such, if there are any masses present including nasal polyps, traditional sinus surgery is the better way to go.

Read More