Her migraines were cured: MISTifying?

Pumpkins and brightly colored mums dot neighborhood porches

In south-central Kentucky when autumn leaves blush fiery orange and a morning chill calls for the season's first sweater, fleshy pumpkins and brightly colored mums dot neighborhood porches. When lacy arachnid creations crown lampposts and doorframes and fluffy clouds fly by a full harvest moon, we know it's time for our annual cystic-fibrosis (CF) chili supper and auction. My niece was diagnosed with CF at age two, so we take great pride that just five or so families in our area have raised well over a quarter of a million dollars for CF research in the past 16 years. The auction has become both a fall celebration of how well the children are doing and a casual social opportunity for families, neighbors, and friends to visit and reconnect. One of those old acquaintances, a patient I haven't seen in years, walked over just as I was about to announce the auction and said, "Remember me?" How could Deborah think I would ever forget her? "You had a [patent foramen ovale] PFO closure, and now your migraines are cured . . . right? Still cured?" I asked hesitantly. "Yes absolutely," she responded, beaming, obviously celebrating the successful new life she found and is still enjoying postprocedure.

Nine years ago, Deborah bent over to feed her dogs and lost the use of her left arm for 30 minutes. Two years later, she attempted to answer the phone at work and awoke lying against her boss in the floor. "In the ambulance, I could hear EMTs asking me simple questions like my birthday, and I just couldn't speak. It was so frustrating," she said. Her expressive aphasia lasted for a full two hours. At the young age of 38, seemingly with no risk factors for cerebrovascular accident (CVA), the experience was both horrifying and puzzling. A hypercoagulable panel was normal. The MRI confirmed embolic stroke, and when pieced together with frequent disabling migraines, the echo findings of a PFO, right-to-left shunting without Valsalva, and an atrial septal aneurysm were hardly surprising. We quickly referred her to Dr John Gurley at the University of Kentucky, Lexington. It's amazing how far we've come in the interventional world, as his letter in 2003 states "hopefully we will gain [internal review board] IRB approval by the end of the month for the Amplatzer device." Just a few weeks following a successful procedure early in the history of percutaneous closure, she was permanently migraine free.

The debate regarding the migraine-related benefit of PFO closure rages on in the literature today, but not in Deborah's heart. She knows it can work and cardiovascular specialists all over the world know it too. heartwire reported on an Italian prospective nonrandomized study on the topic in 2009. Published in the American Journal of Cardiology, Papa et al studied 76 migraine patients with indications for PFO closure including stroke, transient ischemic attack, and lone migraine associated with cerebral ischemic lesions on MRI. In the study, 97% of patients achieved total closure using one of three devices approved in Europe. "Closure abolished or improved migraines in four out of five patients," Shelley Wood reported. "At 12 months, 46% of patients reported no migraine recurrence." Dr Papa stated, "Our results have indicated that in a selected population sharing similar clinical and brain-imaging features likely due to systemic embolization, percutaneous PFO closure is highly effective in reducing migraine severity." Deborah would concur. It's been completely effective for her.

But others aren't so sure. The MIST trial, published in 2008, found no difference in the frequency or severity of migraine in those randomized to PFO closure or a sham procedure. There were allegations of incomplete closure in one-third of patients by one investigator, who was dropped from the study. His findings were in direct opposition to the published results that only four of 78 patients had residual shunting. Allegations of lack of access to shunt calculations, banished investigators, ethical debates, and legal proceedings are all ingredients that continue to bubble in a cauldron of controversy, fitting for the Halloween season approaching.

Meanwhile, Deborah is celebrating life one day at a time. She's had a baby and leads a life far more joyful than the old life that was once woven between ER visits. "The last stroke was so severe, I am certain I would be dead by now if it weren't for that procedure," she told me today while traveling on fall break in the Great Smoky Mountains with her family.

I imagine that as fall in Kentucky approaches, Deborah probably shops for mums, rakes leaves, and sweeps down spiders' webs without a single thought of needing to spend hours parked in the local emergency room. No more horrible waits with a "suffering rag" on her forehead, waiting for pain medications to kick in. I'm grateful her therapy predated publication of the cursed MIST trial. She's living proof that complete shunt closure can cure migraine in some patients with ischemic cerebral symptoms. Thanks to Dr John Gurley and this remarkable procedure, Deborah's headaches have been banished to the netherworld. Her story is another great reason for an autumn celebration indeed.

Your comments

	Her migraines were cured: MISTifying?
	# 1 of 9	October 7, 2012 12:58 (EDT)
	Dan	This is a great story and remarkable recovery. One nagging question in my mind - why did she have the clots in the first place? If she has no thrombophilia, didn't smoke, didn't take estrogen/progesterone/testosterone, then why did she have such recurrent venous thromboembolism (since all paradoxical embolization starts on the venous side and traverses to the arterial side).  What was the source of her clots - iliac, renal, IVC, calf veins, etc.  Did she have a family history of VTE?  (venous thromboembolism). I would have ensured she remain on lifelong anticoagulation regardless of PFO closure, since she is at risk of further venous clotting issues and perhaps thromboembolic pulmonary hypertension (you've protected her systemic arterial side, but not her pulmonary arteries).  I feel there is something missing in this story.
	# 2 of 9	October 8, 2012 10:17 (EDT)
	Teri Robert	This is wonderful and I wish Deborah the very best of luck. That said, Migraine is a genetic neurological disease for which, at this time, there is no cure. What the PFO closure did was address one trigger of Deborah's Migraine attacks, not the cause of the disease.  She's indeed fortunate if the effects of her PFO were her only trigger. Unfortunately, I've known other Migraineurs who were Migraine-free for a period after PFO closure only to have their Migraine begin again after a perios of time because they had other triggers. I share this not to lessen Deborah's success, but to add perspective for other Migraineurs who think that PFO closure might "cure" their Migraines.
	# 3 of 9	October 8, 2012 12:33 (EDT)
	LeelooMinai	Hi there!  I find your article very interesting...I had to have two PFO closures due to residual shunting; the first one was an experimental device for migraines, the second was placed to stop my heart wall from being damaged further and to close the PFO that the first device failed to. I had extreme shunting, even after my first closure.  It did not do anything for the shunt whatsoever.  Because I have migraine with aura that last through the attacks, I am considered high stroke risk so I must remain on anti-coagulants and blood thinners for life. I congratulate Deborah on her migraine cessation, but I also want to warn readers that this is NOT a typical PFO closure response.  I had the opposite reaction - mine got worse, and I didn't think that was possible.  Now, I did not have a stroke like Deborah did, but it's possible that I could have.  Even now, with the PFO closed - if material breaks off of either of the devices, I could still have a stroke.  But I don't worry about it overly much - and I was bull-headed and had the sugery anyway because I was positive I would live a more fulfilling life when I read articles about people who had great success with the surgery.  Even 47% monthly migraine cessation like the MIST II trial indicated was acceptable to me since I have migraines every day of the month, barring maybe one or two. In my research over the past few years, and from chatting with others like me who are desperate to find anything from the pain, I have to send them copies of the article I wrote on the procedure, statistics, and uncertainty of migraine cessation/reduction, because they are looking for a "cure" that is not available for migraines, and for some, a surgery that will make them worse.  I do not like being a pessimist any longer, and I am SO happy that this procedure worked for Deborah, that I do not want to rain on her parade - rather, I want the public to know this is not something you should run to your cardiologist about without looking for stories, articles, research, and talking to your doctor at length about before you do it. In my opinion, this procedure will never be approved for treating migraines in the United States.  The data just doesn't reflect a positive spin on the risks vs. outcome factors, not to mention skewed data and research studies that are not meeting their endpoints but claiming modest success anyway.  In the case of PFO closure for migraine, being a skeptic is OK.  I learned the hard way.  I just want people to be aware that this is not a miracle for everyone, and complete cessation of migraine afterwards is VERY rare. Migraine is a genetic disorder; and triggers can change over time.  Unfortunately even if someone has initial success with this therapy, migraine can find a way around it as bodies change and adapt or reject environmental stimuli.  One is never "cured" of migraine; it's just a difference in trigger thresholds.
	# 4 of 9	October 8, 2012 07:24 (EDT)
	Melissa	Dan, I believe the issue was relegated to sedentary lifestyle with OC's on board, ong work days at the desk, etc.  I have not seen her as a patient for years, so not certain if she remains on anticoagulants, etc. but at least interrupted them long enough for pregnancy/delivery. Teri and Lee, Thanks for your commentary and your perspective.  Melissa
	# 5 of 9	October 12, 2012 11:58 (EDT)
	Stephen Soldo	Well you have to be careful with this mode of therapy.  It many respects it can be a treatment looking for a disease.  In practice, for a while, I saw a proliferation of PFO closures for indications that were tenuous at best.  I don't think the problem lies with the procedure, but our inability to "regulate" patient selction.  Lots of people have headaches.  Lots of people have PFO's.   I am not sure that our profession is doing a good job looking over our colleagues' shoulder when it comes to things like this.
	# 6 of 9	October 12, 2012 01:24 (EDT)
	Rick	It is unfortunate that all patients in this day and time are required to have 2 strokes before hospitals are allowed to do a PFO closure. This is FDA requirements!!! Please write your senators and congressmen and women to overturn this insane requirement !!!!!!
	# 7 of 9	October 14, 2012 04:35 (EDT)
	Dan	Melissa, thanks for your reply. That clarifies very nicely. I've sent a few young patients with cryptogenic strokes for PFO closure. In each case, the PFO was their only risk factory/imaging substrate for their event. I did not think we should wait for a second event to occur.
	# 8 of 9	October 21, 2012 05:26 (EDT)
	Jacques	It looks hard to believe PFO on the causal path leading to migraines, TIAs and CVAs ! If It is, then veinous clots have to be present before coughing or Valsava and have to cross to the left circulation, instead of giving pulmonary embolism. Another assumption could be raised : left atrium is the clotting source, promoted by atrial septal abnormality. ASA is frequently associated with PFO. In patients with migraines and PFO and ASA, did TEE ever display sludging or clotting in Left Atrium ? Did EKG ever display paroxysmal atrial fibrillation ?
	# 9 of 9	October 29, 2012 09:55 (EDT)
	Rob	I had a PFO closure done in 2003.   I can tell you that it stopped my migraines for the last 9 years.   I had no expectations towards that end - this was just to prevent future strokes.   3 months after the procedure I told my Doctor "I don't know what you did, but my migraines are gone completely"   - It is wonderful.   It worked for me.   I was not part of any study - but you can add my success to the list.

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