The role of minimally invasive sinus procedures

Rhinologists and otolaryngologists recently are at a crossroads about new treatments for chronic sinus infections. This biggest game changer is the Acclarent Ballon Sinuplasty technology that allows for a tiny catheter to thread an inflatable balloon across narrow sinus openings and stretch it (think heart catheters & angioplasty). This technology has been available in the operating room since about 2005. The big twist is that in 2011 the procedure became available as an office-based technology to ENT docs, opening the door to surgical sinus procedures that don’t require general anesthesia.

So far the big criticisms of the technology center around its long term effectiveness. Ease of use and lucrative reimbursements for surgeons make the the procedure also at risk for abuse and over-utilization. It may wind up that a procedure with the opportunity to lower treatment costs overall actually winds up costing the system more, as more patients are willing to have the procedure done – even in the case of otherwise minimal symptoms that would not have been treated with surgery before (this is arguably better for patients’ wellbeing however).

To be fair there is a growing library of data on effectiveness of the procedure, even out to 5-7 years. Also to be fair, there is not really great evidence that our prior surgical techniques were all that fantastic anyway.

Tools that are currently costly, although less controversial, include steroid eluting implant devices. While an old-fashioned concept, treatment with steroid hormones to reduce inflammation is not very specific therapy, but is effective. IntersectENT‘s Propel device is a novel steroid-releasing temporary implant placed in the sinuses during surgery. They have shown improved healing and reduced problems after surgery with their first product. They no doubt will be looking to apply their success in the immediate post-operative timeframe to chronic treatment, likely looking for a place in office-based technologies. Currently this is not available in the office.

In summary, as a patient you may now be offered a minimally invasive treatment option. As a physician, you now have treatment options that do not involve general anesthesia or a long recovery period. Probably for the next 10 years we will see an explosion of minimally invasive treatment options out of the device industry. It will probably take another 10 years to assess which technologies really work and change the disease landscape.

The art of medicine still remains that we must apply the right technologies to the right patients.

Rare parotid gland cancer takes the life of Beastie Boys’ Adam Yauch

RIP Beastie Boys’ “MCA” Adam Yauch who died after a three year battle with a rare cancer of the parotid gland.

Tongue Stabilization vs Mandibular Advancement Appliances for OSA

Comparative Effects of Two Oral Appliances on Upper Airway Structure in Obstructive Sleep Apnea.

These two devices were compared in this recent Sleep journal study published April 2011.  The paper points out the growing evidence toward adopting oral appliance therapy for the treatment of obstructive sleep apnea.  In this paper the authors reviewed the airway characteristics of persons using a tongue stabilizer and those using a mandibular advancement device.  They found no real  difference in response rates (success of treatment judged by sleep study) between the two groups, however the tongue-stabilizing device seemed to physically open the airway slightly more.

Oral appliance therapy is quickly becoming a viable and well-studied treatment alternative for mild and moderate obstructive sleep apnea.  Validity of the tongue stabilizing device adds another treatment option for apnea patients to consider.

Will Affirma Put an End to Diagnostic Thyroid Surgery?

A new patented genetic test seeks to reduce the number of unnecessary thyroid surgeries. Veracyte is a company that has a patent on Affirma, a genetic testing tool that extracts genetic information from thyroid needle biopsies and compares it to a database of known thyroid cancer-associated genetic mutations. Statistical rigor is applied and the specimen is then labelled either “Benign” or “Suspicious”. The company reports that a “Benign” result has a 95% negative predictive value (meaning up to 5% of these will actually be cancer still).

The first question this raises is just who will benefit? A fine needle biopsy is performed in the office based on some degree of initial suspicion of a nodule (like its size being greater than 1.5cm). Then that material is looked at under a microscope by a cytopathologist. Ideally the result comes back “benign” or “highly suspicious” (likely a cancer). However about 30% will come back with an in-between “indeterminate” result. What to do with that result depends on the preferences of the doctor, the patient, and characteristics of how the nodule looks. Still 80% of these indeterminates will turn out to be not cancer anyway.

Long story short, it results in about 75% of thyroid surgeries really serving no benefit whatsoever. And only carrying costs and risk.

Affirma takes these 30% indeterminate samples and tries to see if their gene profile is at high risk for cancer. From their studies they are able to label about half of these “benign”/low risk and half of these high risk. This in theory eliminates half of the “diagnostic” thyroid surgeries.

In the long run tests like these are likely the wave and standard of the future, for not only initial cancer diagnosis but identifying treatment options for known cancers and monitoring a cancer’s responsiveness. In the short run though we are still left with a test that says “benign” but may in fact be a cancer (up to 5% are). Not only that, but thyroid nodules are very very common, meaning that there can be expected hundreds or thousands that would be labelled “benign” but in fact be cancerous. (The unspoken good news is that thyroid cancer is usually very slow growing so waiting a few months or even a year for diagnosis usually still has a good outcome).

So we are still left making decisions based on doctor preference, patient preference/comfort level, and the overall look of the lump. And in fact, even with a benign genetic study, everyone still recommends a follow up ultrasound to look for changes in the lump.

I give a cautious thumbs up to Affirma and have started using it in selected cases.

Feature with Dr. Redding: When Do I go to the Doctor with a Cold?

Exactly when to visit your doctor with cold symptoms can be puzzling.  Every week I see patients that can’t seem to wait to come in to let me know they have “been sick for three days”, whereas others “have been fighting this for 3 months” before they seek care.

A recent study in the Journal of the American Medical Association shows that treating an acute sinus infection with an antibiotic did no better than a sugar pill – they all had the same rate of clearing up at 10 days.  Similarly, studies are currently battling it out about whether antibiotics have any impact at all on the course of simple ear infections.  So when is it really beneficial to visit the doctor with your acute upper respiratory infection?

By far the most common kinds of upper respiratory infections (URIs)we humans get are VIRAL in nature.  Viruses are very communicable person-to-person, usually cause symptoms of sore throat, cough, runny nose, muscle aches, nasal congestion, and even some bronchitis or fevers.  Viral infections usually run their course in about 1 week, after which there can be some residual inflammation in the lungs and sinus linings to keep your symptoms lingering for another week or so.  For most common viruses there really is no specific anti-viral pill that will do any good.  The only medicines we have are to control the symptoms – medicines to suppress cough, improve body aches, reduce congestion, and help you sleep.

If after a week you are still no better or are getting worse, there is then the possibility that a bacterial sinus infection, bronchitis, or even pneumonia is setting in.  These infections can be more serious but do respond to antibiotics.  Because it does not seem that taking antibiotics ahead of time will actually prevent a bacterial infection, doctors recommend waiting out a cold for about 7-10 days before starting an antibiotic.

I asked a local Allergy, Asthma, and Immunology specialist, Dr. David Redding, to provide some thoughts about persistent cough.  Dr. Redding recommends a conservative approach to cough for most uncomplicated patients.  ”A cough may last four to six weeks after the infection has cleared,” says Redding.  Sometimes this is a simple sporadic cough and other times this can develop into a “coughing fit” that can be quite troubling.  ”A ‘coughing fit’ really does not have any special medical significance,” says Redding.  ”It may simply be the way your voice box and wind pipe are healing and there is little we can do.”  Coughing in a teenager or adult, without shortness-of-breath or chest tightness, is generally not due to asthma.

Warning signs for pneumonia are:  an abrupt onset of an excessive amount of coughing productive of mucus that does not feel like it is coming from the nose, severe fatigue, temperature in an adult over 100.0 degrees F, shortness-of-breath, and overall feeling worse than you have felt with “colds” in the past.

In short, two weeks is a good cut-off period for visiting the doctor with sinus or chest symptoms that are not improving yet.  Of course, use your common sense with any general guideline.  Coughing up blood, being very short of breath, chest pain, swelling of the face, vision change, and severe headache can all be signs of something more serious and should not be ignored.  Also, elderly patients over 75 years old, and those with impaired immune systems should report earlier to their doctor.

Dr. David Redding is in practice at The Redding Allergy & Asthma Center, 3193 Howell Mill Rd #102, Atlanta, Georgia.  He can be reached at (404) 355-0078 or www.reddingallergyatl.com.

No antibiotics for sinusitis? -JAMA

A new study published in the Journal of the American Medical Association disputes benefit provided by antibiotics for sinus infections.  In this study patients were randomly given a placebo pill or amoxicillin (a basic first-line antibiotic for sinus infections) for 10 days.  They found that there was no difference in symptom improvement at day 3 or day 10 of antibiotic treatment.

What does this mean?  The study’s main effect will be to give primary care doctors more evidence to refrain from giving antibiotics for early-stage infections.  This is something doctors already know, however there is heavy pressure from many patients that essentially demand and expect a dose of antibiotics for viral illnesses.  This results in many many healthcare dollars going towards medicines that do no good.

This study does not address patients with prolonged sinus symptoms, or the double-flare whereby an obvious “cold” seems to get better then reverses course and “settles into” the sinuses and worsening again a week or so later.

Amoxicillin for Acute Rhinosinusitis, February 15, 2012, Garbutt et al. 307 7: 685 — JAMA.

(This begs the question, “when do I go to the doctor with a respiratory infection”?  This will be the topic of an upcoming feature post.)

Bacon — a New Cure for Nosebleeds ?

Bacon — a New Cure for Nosebleeds – ABC News.

Wow, crazy.  This will do doubt spur a little device/pharma development.

While you’re feeling porcine, check out the Iberian’s Pig’s Bacon-infused Old Fashioned.