PFO Closure for Migraine: An Update

12-14 years ago, there was a lot of discussion about “PFO closure” for migraine.

PFO stands for patent foramen ovale, a hole in the heart between the right and left chambers. A PFO is a common developmental condition, affecting about 1 in 4 people. But you may never know you have it.

patent foramen ovaleSurgery can be done to close the PFO, for example if someone has low blood oxygen levels that may be caused by the defect. But years ago, patients who had the surgery for various reasons began to report that their migraine attacks had also subsided.

And so began the investigations and the trials. The well known MIST trials, originally planned as a series of four trials, were cancelled before the second one was completed. The results were not encouraging.

More studies have been done recently, and results continue to be mixed at best.

So why is PFO closure still being discussed? First, because some patients do experience a reduction in migraine symptoms after PFO closure. Second, it’s clear that migraine and PFO are somehow linked – PFO patients are much more likely to have migraine, and migraine patients are more likely to have PFO.

But a relationship does not mean that fixing one problem will fix the other, as trials have shown.

But there is more. For example, particles that move from one side of the heart to the other (through a shunt) may lead to migraine – not to mention the relationship between stroke, PFO and migraine. These particles in the blood may trigger a cortical spreading depression, a key part of the migraine chain-reaction.

In short, there are good reasons to think that PFO may actually increase migraine attacks.

So why doesn’t everyone with migraine just have the surgery? There are actually good reasons. And this has been one of the downfalls of the trials – patients simply don’t want to have heart surgery – even if it’s fairly simple surgery.

Though the surgery is generally safe, there are risks. In a report published earlier this month, PFO and Migraine: Is There a Role for Closure?, the authors noted that “several potentially life-threatening procedure-related adverse events occurred in the clinical trials”. There are also concerns that the surgery may lead to other health problems down the road.

Researchers remain intrigued by the possible connection between PFO closure and migraine. Although trials have been disappointing, it’s still worth trying to understand the connection, which may lead to other types of treatment. And it could be that we can find a certain type of migraine patient who will benefit from PFO closure, even if those are a small percentage of migraineurs.

But in the mean time, the poor chance of success, and risk of other health issues, and availability of many better treatments, continue to leave PFO closure in the area of research and not in the area of recommended treatments.

As the authors of the above say, although some patients who have the surgery for other reasons may see a decrease in migraine symptoms (either due to the closure or other reasons?), they “recommend against offering PFO closure as a preventive treatment for migraine”.

See also Closing PFO closure for migraine?

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Migraine + Migraine-related = Expensive

Insurance companies, governments, and in the end – we the migraine patients – spend a LOT of money on treatment. And it’s those who are suffering the most, and who are the most disabled, who are going to have the highest expenses.

Dr. Kenneth E. Thorpe from Emory University in Atlanta, USA, recently put together a paper showing a different perspective on the cost of migraine in society.

Very often we look at the cost of migraine treatment as an individual thing – days lost to migraine, medications taken, time in the hospital, due to migraine . . .
Migraine + Comorbid Conditions
But this overlooks something very important – migraine does not always come alone. There are a number of other diseases and disorders that tend to come along with migraine. These are known as “comorbid” conditions.

Here’s an example from Dr. Thorpe’s paper, using USA stats only. In 2015, about $5.4 billion dollars were spent in the USA for treating chronic migraine (yes, that’s only chronic migraine – this does not include all the other types of migraine, never mind related headache disorders). 5.4 billion!

Now, what does it cost for chronic migraine + comorbid conditions? Over $40 billion.

Wow. Just taking the 5.4 billion per year – let’s cure migraine and use the money to solve world hunger! (Ok, I’m being simplistic – but seriously, there are things we could do with 5.4 billion…)

So what are these comorbid conditions? Some of the top ones included mental and mood disorders, arthritis, hypertension and heart disease.

As disability increased, so did the cost. And disability was worse with more comorbid conditions (remember, many chronic migraine sufferers have several comorbid conditions).

Dr. Thorpe made the important observation that we really do need to treat the “whole person”. It may be easy to give someone with a “headache” a “pill”, but migraine patients need treatment that takes into consideration other conditions and their own health risks and medical history.

For us as patients, we need to be aware of other conditions and symptoms that we may forget about because we’re focused on the PAIN of migraine.

Dr. Dawn C. Buse offers this note for her fellow doctors and specialists:

In general, people with more comorbid conditions use greater health care resources including medical appointments, hospitalizations, medications, and even phone calls to providers. Comorbidities are more common in chronic migraine. They make treatment more complicated and are associated with worse outcomes. I recommend that all providers screen for common comorbidities and treat or refer as appropriate.

In other words, doctors should be aware of the possible comorbid conditions, and should think about treatments that can help the whole person.

Read more details from NeurologyAdvisor: Comorbidities Have a Significant Impact on Chronic Migraine Health Care Costs

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10 Headache and Migraine News Highlights from the past 3 Months (March 2017 edition)

Yes, it’s time for a March update of your picks from the last three months! Yes, it’s March already. Here in the northern hemisphere, spring is springing.

Lots of posts about upcoming treatments, new research, and a few practical helps.

The most popular posts are first, and the three in bold had the most “likes” on Facebook (in this case, the three most popular overall were also most popular on Facebook).

  1. Women, Migraine, and Stroke
  2. A “Smart” Non-Drug Arm Patch to Fight Migraine
  3. Candesartan for Migraine
  4. 5 Ways to Maximize Your Omega-3 Supplements
  5. Cluster Headaches Causes
  6. 7 Ways to Stick to Your New Treatment (or not)
  7. A Quick Update on Cefaly for Migraine
  8. Vitamin B2 (riboflavin) for Migraine
  9. The Early Stages of a new Hemiplegic Migraine Treatment
  10. Chemotherapy Headache
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A Migraine Treatment for Pregnant Women, Children, and maybe You (video)

Although there are many good migraine treatments available for children and pregnant women, the number of well tested treatments is small compared to what is available for the rest of us. This is especially true if the migraine symptoms are severe, and the patient has already tried many of the standard treatments.

One treatment that may help these patients is a sphenopalatine ganglion (SPG) block. This simple, out-patient procedure has actually been practised for decades, but it’s benefiting from new technology.

The “new” method is to use a specially designed device, inserted into the nose, to deliver a local aesthetic to the SPG, a nerve bundle.

You may ask – what good is a temporary local aesthetic in fighting migraine? First, the procedure seems to interrupt the “migraine circuit”, bringing almost instant relief in many cases (though not necessarily total relief). But that’s not all – some patients find that it relieves their attacks for months afterwards.

Back in 2015, a study was done in Phoenix (USA) to see how children and teens responded to this treatment. There were 133 procedures performed on 85 patients, using lidocaine as the anesthetic. Scoring migraine pain from 1 to 10, the patients’ pain on average decreased from 5.55 to 3.28, almost immediately. (Study abstract: Safety and efficacy of sphenopalatine ganglion blockade in children – initial experience)

At first this may not seem like a huge improvement. But remember, these are patients who probably have suffered from severe headaches and who have already tried many other treatments. Also remember that improvement will vary – some won’t experience significant relief, while others will improve much more than the average.

But there’s one more thing to keep in mind. This treatment has the potential to fight symptoms for several months afterwards. Although this wasn’t a part of the study, the potential of better health for several months and fewer other medications makes this treatment one to seriously consider.

There is also much less worry about side effects, other than possible irritation to the nasal passage (although your doctor should be fairly careful to minimize the chance of this).

The sphenopalatine ganglion block is a treatment that should be seriously considered in pregnancy and for children and teens. But it’s not limited to those groups. Anyone with severe migraine that is not responding to the front line treatments may benefit.

One of the devices that is used for the SPG block (and the one used in the study above) is the SphenoCath. The brief promotional video below shows how the SphenoCath works and what the benefits are. Keep reading below the video if you’re interested in seeing the actual procedure being performed.

If you’re interesting in seeing the actual procedure, anesthesiologist Dr. Ezra B. Riber from the USA has a video demonstrating the block with a woman with migraine. See SphenoCath® Headache Treatment. If the procedure seems a little involved, that’s because Dr. Riber is taking steps to make the experience as comfortable as possible, with little to no irritation to the patient.

See also Innovative treatment offers relief to children with frequent migraine headaches

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A “Smart” Non-Drug Arm Patch to Fight Migraine

A new form of migraine treatment is in the testing phase – a new kind of migraine fighting patch. Of course, putting a patch on your body for medical reasons, even to fight migraine, isn’t anything new. Of course, we’ve had mixed success in the past – take the famous example of Zecuity, which shows no signs of returning to the market soon.

But these are mostly drug options. How about a non-invasive, non-drug patch? One that you can actually control from your smart phone? How would that work?

The company is Theranica, and the Nerivio Migra patch is the product currently being tested.

Nerivio MigraRecently I updated you on the Cefaly device, which is billed as a external trigeminal nerve stimulator (e-TNS). Various similar devices are available or are being tested for migraine.

Although we don’t completely understand how these devices fight pain, one theory is the “pain inhibits pain” theory. The idea is that pain in one part of the body may actually inhibit pain in another part.

But who wants to hammer their finger, to stop a migraine attack? No thanks. So – what if we could trick the body into thinking that there was pain, even though we couldn’t feel it?

Now things get really complicated, but that is one way of looking at nerve stimulation.

However you look at it, there is evidence that such devices can lower your migraine pain (without causing more pain!).

Now unlike Cefaly, this new patch is not a preventative, but an abortive. It’s intended to stop individual attacks. But what else sets it apart?

Well, Theranica asked some questions – how can we make a device that’s more discreet – less bulky – so that it could easily be hidden and used anywhere? How can we make sure there is no pain, or muscle “twitching” when the device is used? And how can we avoid parts of the body that are often the most sensitive during a migraine attack (head and neck)? And most importantly, how can we create a device that will provide long term relief?

And so, Nerivio Migra was born. Designed as a wireless patch, placed high on the arm, it tries to balance being portable, easy to use, and effective.

A preliminary study has already been completed, showing promise. Compared to sham treatment, patients were far more likely to report a reduction in pain – in many cases, a complete elimination of pain. The results were easily comparable to taking sumatriptan, a common migraine-targeting medication.

The study was small, and there were some problems with it, so it’s time for a (hopefully) more robust study. The study is not yet recruiting participants, but will be soon. If you live in the United States or Israel, and suffer from episodic migraine, you may be eligible. For more details and contact information, just go here.

Whether or not Nerivio Migra is ultimately successful, it represents more thoughtful progress and research into non-drug, non-invasive treatments for migraine. Stay tuned.

For a detailed discussion of the medical theories behind Nerivio Migra, see Acute Migraine Pain Relief via Remote Electrical Nerve Stimulation – a systematic analysis

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