November 13, 2012

Why Is Eustachian Tube Balloon Dilation to Treat Eustachian Tube Dysfunction Slow to Catch On?


Eustachian tube dysfunction is a phenomenon whereby a person is unable to pop their ears to relieve symptoms of ear pressure, clogging, or fullness. It is much akin to the ear pressure a person experiences when flying, but at ground level. Traditionally, treatment of this condition involved medications like steroid nasal sprays and prednisone along with active valsalva (watch video below). Once medical treatment has failed, ear tube placement has been the step of last resort.

However, a promising new treatment called eustachian tube balloon dilation has been described in March 2011 to address eustachian tube dysfunction at the source (the eustachian tube) surgically rather than indirectly with tube placement across the eardrum. In essence, a balloon is inserted into the eustachian tube and than inflated thereby opening it up (the balloon is "popping" the ear for you). The balloon is than deflated and removed.

Click here to watch a video of this procedure. More info can be found here.

Dr. Dennis Poe in Boston, MA is the researcher who first described this technique in March 2011 and at this time, is offered only in a few centers.

Why has something so simple with equipment so readily available been so slow to gain acceptance by ENTs?

Well, there are several reasons, not the least of which is the fact that this procedure is still considered "experimental" by most insurance companies, though that may change in the near future given that this procedure has recently obtained FDA approval (September 16, 2016).


There is also cost considerations. The material cost of the balloon is around $1000 or more. Compare this to the cost of a tube which is around $30 or less.

Furthermore, there are potentially huge, albeit rare risks associated with balloon dilation of the eustachian tube. These risks are clearly reported by Dr. Dennis Poe who "invented" this procedure in his landmark paper.

The internal carotid artery supplies blood to the brain and can be found right next to the eustachian tube. Take a look at this CT scan of the ear:


ET is the eustachian tube and CA is the carotid artery (EC is the ear canal). These structures are found right next to each other!

The balloon catheters used for eustachian tube dilation have historically contained a fairly pointy tip (though not sharp), but when placed in a directed fashion inside of small diameter tunnel like the eustachian tube, there is the chance that the catheter tip may puncture or injure the carotid artery leading to risk of:

1) horrible bleeding
2) stroke
3) arterial wall dissection or aneurysm formation
4) death

Other risks include subcutaneous emphysema, patulous eustachian tube, nasopharyngeal mucocele, and tinnitus [more info]. 

In most individuals, there is a thin layer of bone that separates the carotid artery from the eustachian tube that does proffer some protection. But, this bone is not always present and therefore can not be counted on to protect the artery from any unintentional injury.

In order to minimize these risks (though the risk is still not ZERO), a CT scan is required to ensure the presence of bone to protect the carotid artery.

Also, advances have been made in the balloon itself to minimize these risks, mainly by making the balloon tip less pointy and sharp as well as making the balloon itself much more flexible. Acclarent has such a balloon called Aera Eustachian Tube Balloon Dilation System that is specifically made for use in the eustachian tube.

Keep in mind that with balloon dilation, it is possible that the bone separating the artery from the eustachian tube can fracture resulting in constant crunching sounds with jaw movement due to the bone fragments rubbing against each other.

So to summarize, given ear tube placement has profoundly less risk, much cheaper, and long history of effectiveness compared to balloon dilation of the eustachian tube which has potentially significant risks, expensive, and unproven long-term results, it is actually no wonder that the balloon method has been slow to gain acceptance though it has been increasing.

Even in expert hands, success rates are only about 60% in resolving ear symptoms 6 months after surgery. [link]

Indeed, in another published article, it specifically states balloon sinuplasty to be a "gizmo" of uncertain safety and efficacy... in fact, the title of the article says it all "Balloon Dilation of the Eustachian Tube Is Indeed a 'Gizmo' Until Future Research Proves Safety and Efficacy."

In another paper, they stated that:
"The evidence of balloon eustachian tuboplasty is poor and biased. No firm conclusions can be made to identify patients who will benefit from the procedure or to accurately predict surgical results. Randomized controlled trials or case-control trials are needed."

However, there is enough supporting evidence being published that this procedure is a viable option to consider for those who are candidates with about 60% success rates. In fact, our office is considering offering this procedure at some point in the near future. Appropriate candidates include those older than 22 years old, lack of bone dehiscence exposing the carotid artery based on CT scan, absence of patulous eustachian tube dysfunction, along with both exam and test findings supportive of eustachian tube dysfunction. Of course, FDA approval does NOT mean insurance coverage which may take a few years. [More Info]

Reference:
Balloon Dilation of the Cartilaginous Eustachian Tube. Otolaryngol Head Neck Surg April 2011 vol. 144 no. 4 563-569

Balloon catheter dilatation of eustachian tube: a preliminary study. Otol Neurotol. 2012 Dec;33(9):1549-52. doi: 10.1097/MAO.0b013e31826a50c3.

Balloon Dilation of the Eustachian Tube Is Indeed a "Gizmo" Until Future Research Proves Safety and Efficacy. Otolaryngol Head Neck Surg. 2014 Jun 3. pii: 0194599814538232.

Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2017 Sep 20. doi: 10.1002/lary.26827. [Epub ahead of print]

Balloon Dilation of the Cartilaginous Portion of the Eustachian Tube. Otolaryngol Head Neck Surg. 2014 Apr 4;151(1):125-130. [Epub ahead of print]

Balloon Eustachian Tuboplasty: A Systematic Review. Otolaryngol Head Neck Surg. 2015 Jan 20. pii: 0194599814567105. [Epub ahead of print]

Balloon dilation for eustachian tube dysfunction: systematic review. J Laryngol Otol. 2016 Jul;130 Suppl 4:S2-6. doi: 10.1017/S0022215116008252.

Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube. Otolaryngol Head Neck Surg. 2019 Jun 4:194599819848423. doi: 10.1177/0194599819848423. [Epub ahead of print] 






Fauquier blog
Fauquier ENT

Dr. Christopher Chang is a private practice otolaryngology, head & neck surgeon specializing in the treatment of problems related to the ear, nose, and throat. Located in Warrenton, VA about 45 minutes west of Washington DC, he also provides inhalant allergy testing/treatment, hearing tests, and dispenses hearing aids.

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35 comments:

Diane Taylor said...

I am wondering where the Dr is getting his information about the possible risks from this surgery. I had the balloon dilation done last year, with great results and no problems. My insurance did cover most of the surgery with my share being very minimal. I asked my surgeon what he thougth about these "risks" raised in this article, and his response was that he has not heard of any of these things every happening during this procedure. Nor does he see them as very likely to happen.

Anonymous said...

The risks explained in this blog article are CLEARLY reported by Dr. Dennis Poe at Harvard University who "invented" this procedure in his landmark paper. Read his entire paper! It's actually quite fascinating!

http://oto.sagepub.com/content/144/4/563.abstract

Diane Taylor said...

Thank you for the link. The Pub Med site doesn't go into that much detail. Dr. Poe and I have correspondeded. I thanked him for inventing such an amazing surgery. He said they are seeing remarkable relief with this procedure, with it having dramatic effects on patients.

Carrie said...

Diane,

Where did you have your surgery? I am from Peoria IL and cannot find anyone in the Midwest to do this. I think I am a perfect candidate. For the past 6 months I cannot get my right ear to pop. I have not been flying, nor do I have allergies. It feels like my eustachian tube has collapsed. I have negative ear pressure, but ENT's don't know what to do about it. Any help is most appreciated! Carrie

Anonymous said...

Hello :)

I live in Vancouver, Canada and also think I would be a perfect candidate for this surgery. Diane, were you featured on a "Drs" episode? I was really excited to see this episode as nobody has been able to help me clear my right ear. It's driving me crazy and I will travel anywhere to get this Balloon Dilation procedure done. If anyone has any advice for me I would really appreciate it!

Shannon

Anonymous said...

I'm in the same boat. I live in Virginia and have tried the ear tubes, only to lose my hearing and have my voice constantly in my head. My right ear drum has healed, left is still in progress, but my hearing is returning with it. What's not healed is the constant pressure in my ETs. Was clearing up some, then I got a sinus infection and ended up with barotrauma in the right ear after coming over a nearby mountain this past weekend. I've been dealing with this for 5 months and am exhausted of it. Any suggestions on where to get the surgery would be appreciated.

Thanks, Lynda

chitchat said...

I've been corresponding with Diane as I also have ETD. She had her surgery performed by Dr. Brian Weeks in San Diego (she had great results). Hope this helps -- Emily

Unknown said...

whoever wrote this obviously doesn't have etd

Anonymous said...

I saw Dr Weeks, Remarkable person/doctor along with his assistant, I have my Eustachain Tube-Plasty set up for October of 2014

Anonymous said...

Hello Anonymous - Can I ask how your surgery with the balloon dilation went?

Anonymous said...

Hello Anonymous - can I ask how your surgery went?

Anonymous said...

Hey, Replying about the Eustachian Tubeoplasty, I backed out for the October surgery due to the fact that they wanted to see if a bacteria was causing my Eustachian tube dysfunction, it was not, my Eustachian tube is a mess. So, allergy shots and everything else didn't work, I go back to San Diego, I live in Tucson, I'm going back in Dec, and the surgery is rescheduled for Jan, I hope it works, I really do, I promise as soon as I get it I will update and inform. Dr Weeks seems squared away.

robbie gareau said...

buy the device sold on internet websites called the Ear Popper, it helped pop my ears better than me than me closing my nostrils with my hand, and helped relieve the ear pain and discomfort from me having eustachian tube dysfunction in my right ear

Anonymous said...

can you please let me know total cost of surgery by Dr. weeks. I only found that doctor who doing this surgery

Anonymous said...

Is that Brian Weeks? Thank you I'm intere4sted in seeing him

Louise said...

I bought one of those ^
Expensive and it doesn't help if your eustachian tubes have collapsed/closed:(

Louise said...

Yes!!! :(

Anonymous said...

How can I correspond with Diane Taylor, I have ETD but got misdiagnosed by my ENT. Please get in touch with me and answere a few questions. I have a doctor who may be willing to do it but it would be nice to talk with you.

Anonymous said...

How can I get in touch with you?

Anonymous said...

I had eustachian tuboplasty performed a few months ago and it was the worst possible thing I could have done. Not only did it not help with my clogged ear and tinnitus, but it made those symptoms MUCH worse. I also had a bad nosebleed that lasted for several days afterwards. Not sure what to do now as I had so much hope with this procedure, but now I totally regret doing it. I wish I had known this procedure is still considered experimental.

Anonymous said...

Hi Diane. You can e mail me at diane@ doggyboutique.com. I don't get an alert when someone posts here so I've kind of been out of the loop! Diane Taylor

Unknown said...

I'm so sorry you had a bad result. I'm not sure who did your surgery, but I had a good friend who had this surgery from a dr who, she was his first patient, and it went terrible. I would advice anyone getting this surgery to do their research on their dr. I know it's not 100% for anyone, but I'd advice to go to a dr who has experience w/this procedure. I'm so sorry you had a bad experience. I was very fortunate to have mine be successful.

Anonymous said...

So Im having this procedure done next week and now Im really scared to have it done.. Can either of you tell me what went wrong with your procedures? This doctor doing mine is an expert in his field and is the chief of head and neck in that dept. He has performed this numerous times as well, however I have yet to find real people whom have had this done, until now.
Please tell me what your symptoms were before as opposed to now if you dont mind sharing? How is it worse now after the procedure..? Again, Im so sorry you contnue to suffer with this evil condition.

Anonymous said...

can you tell me what exactly went wrong with your friend and what it was like for you? Im having this done next week and I am terrified I will just make things worse..:(

Diane Taylor said...

For me it was very easy. No pain, no recovery time. I honestly couldn't tell i had anything done. It was about a 20 min. surgery. I knew when i woke up that my ears were clear. I believe my friends dr had good intentions, but she was his first patient. He tried doing it, in office, under no anesthesia--yikes. She also had sinus issues along with her ETD that needed to be resolved. I know this procedure isn't for everyone, but I wanted to give some hope to people suffering that there are answers out there. Try to stay positive.

Unknown said...

Well I had my right one done 2 weeks ago and so far I'm regretting it. Hurts much worse than before and it won't function on its own. Woke up with hardly any pain but it felt stretched, cause it was. Then it popped open on its own driving through the mountains. Clogged again on and off then popped open on its own. Makes a loud crunching sound when I swallow also. Then it starts to hurt again until I open my mouth and unclog it which also makes a crunching sound. It will not function on its own. I have to constantly open my mouth to get my tube to open which again makes crunching sound, then swallow to shut it it it starts hurting again. This is an all day never ending repetitive chore that I never had before this procedure. Wondering wth happened. ENT keeps saying its swollen tube and to give it time.. I feel like the muscles that open this tune are broken now somehow. Dr. Orders prednisone, so far it's doing nothing for this issue. I feel like something is wrong here or something is being missed and I need answers. Now I have a crappy sore throat I caught from my daughter. My ear hurts now all day long with zero relief! If you put your ear up to mine you can hear the loud crunching sounds of me opening and shouting my ear now. Before procedure, it clogged but I could wiggle to unpop it and feel relief for most of the day as long as I popped it once in awhile. Now it just feels stuck all the time and they don't fluidly open/shut at all..I have to do it or it starts to hurt badly! Any insight to what could be going on would be great.. Anyone?

Unknown said...

Hello Diane,

I've seen the video of you on Dr. Weeks and I was wondering if I could speak to you about your procedure. My email address is Anthony boss@outlook.com.

Anonymous said...

I had Dr. Weeks perform the eustachian tuboplasty surgery on me several years ago to no effect. As a doctor performing an experimental surgery, he definitely wants to report successful results. I was supposedly in the minority, but I'm skeptical. Just wanted to throw in my case so that anyone considering doing the surgery or has already done it has a more accurate picture of the likelihood of success. I found finding successful cases (other than Diane, who was on the doctors show and seems to flood these online blogs) tough to find when I researched the surgery in the blogisphere. Dr. Weeks is a great guy though!

-Charles

Anonymous said...

Hi Charles, I am sorry the dilation didn't work for you. I agree with you, i wish more people who had this done, would come back on these forums and share their experience. I was fortunate to find someone who had the dilation done, before I had mine, who had great results. I am still in touch with her and others who are success stories. I also know of people that it hasn't worked for. Personally, I think that when someone finally finds their answer, whatever it may be, they just want to get off the internet, and get on with their lives. I know i felt that way, after spending 4 yrs searching the internet non stop, and continually talking and thinking about it. I was just happy to be better and wanted to forget the last few yrs. I felt an obligation, to share my story, and to give others a little bit of hope. I recently googled the dilation surgery and there are many drs on there saying they have had 100's of success's. I wish we could hear all their stories, both good & bad. I know i researched on pub med studies before i did my surgery. I am sure it has more information since it's been 6 yrs. Maybe that's a start for getting better statistics. Diane Taylor

Jamie said...

I suffered from ETD for 3 yrs. I underwent Eust.balloon dilation yesterday. Very swollen and some pain today.

Unknown said...

Hi there. Would love to hear more as the days/weeks go on as to how you're feeling and whether you find it easier or harder to deal with your ears now that the procedure is done. I'm in Durham, NC and am weighing having the procedure done with either Dr. Kaylie at Duke or Dr. Gerbe in Chapel Hill. (I tried to click the "notify me" feature if/when you respond but it didn't work...I'm at mount635@aol.com if you'd rather not reply publicly. Thanks!)

MIkeLewis said...

Natasha, I had the procedure done March 2017 and I have the exact same issues as you. It's very frustrating and annoying to deal with this. Can you please let me know if the "crunching sounds" disappeared by now. Also, did all the ETD symptoms resolve by now. Thanks in advance.

MIkeLewis said...

Hi Charles,

I recently did ballon dilation of ET and would like to you ask a few questions. Can you please email me at arashid05@hotmail.com. Thanks .

Anonymous said...

have the surgery next week,
according to the posts above, don't know if is the best thing to do..
have estauchian tube problems for almost 2 years

Anonymous said...

I had this procedure done 8 months ago and it made no difference. Maybe even a little bit worse. I'm probably going to have to go with ear tubes which did help me before I had tuboplasty done.


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