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November 13, 2012

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

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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.

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" and in the research stage only.

However, there is the cost of the balloon itself which is typically not covered by insurance even if a patient wishes to proceed with an unproven treatment. The material cost of the balloon is around $2000 or more. Compare this to the cost of a tube which is around $30 or less. In other words, hospitals would lose money by offering this procedure with current fee schedules.

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 ICA is the (internal) carotid artery. These structures are found right next to each other!

The balloon catheters used for eustachian tube dilation have 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

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.

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 significant risks, expensive, and unproven long-term results, it is actually no wonder that the balloon method has been slow to gain acceptance.

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."


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


9 comments:

  1. 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.

    ReplyDelete
    Replies
    1. 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

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  2. 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.

    ReplyDelete
  3. 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

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  4. 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

    ReplyDelete
  5. 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

    ReplyDelete
    Replies
    1. 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

      Delete
  6. whoever wrote this obviously doesn't have etd

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

    ReplyDelete

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